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gemcitabine

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Description

Gemcitabine is a nucleoside analog chemotherapy drug used to treat various cancers, including pancreatic, breast, lung, and bladder cancers. Its synthesis involves a multi-step process starting from the nucleoside deoxycytidine. Gemcitabine is a prodrug that is converted into its active form, gemcitabine diphosphate, within the cell. This active form inhibits DNA polymerase and ribonucleotide reductase, thus disrupting DNA replication and cell division. Gemcitabine is studied extensively due to its effectiveness in treating various cancers, particularly in combination with other chemotherapeutic agents. Its mechanism of action and potential for targeted drug delivery continue to be areas of ongoing research.'

gemcitabine : A 2'-deoxycytidine having geminal fluoro substituents in the 2'-position. An inhibitor of ribonucleotide reductase, gemcitabine is used in the treatment of various carcinomas, particularly non-small cell lung cancer, pancreatic cancer, bladder cancer and breast cancer. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID60750
CHEMBL ID888
CHEBI ID175901
SCHEMBL ID4295
MeSH IDM0158478

Synonyms (88)

Synonym
HY-17026
AB01274777-01
AB01274777-02
nsc-613327
4-amino-1-[(2r,4r,5r)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one
gemcitabina [inn-spanish]
gemcitabinum [inn-latin]
c9h11f2n3o4
cytidine, 2'-deoxy-2',2'-difluoro-
gamcitabine
nsc 613327
ccris 8984
cytidine, 2'-deoxy-2',2'-difluoro-2'-deoxy-.beta.-d-2',2'-difluorocytidine
gemzar (hydrochloride)
2'-deoxy-.beta.-d-2',2'-difluorocytidine
4-amino-1-[(2r,4r,5r)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]pyrimidin-2-one
2',2'-dif-dc
ly188011
4-amino-1-[3,3-difluoro-4-hydroxy-5-(hydroxymethyl) tetrahydrofuran-2-yl]-1h-pyrimidin-2-one
95058-81-4
C07650
gemcitabine
2',2'-difluorodeoxycytidine
DB00441
4-amino-1-((2r,4r,5r)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)-tetrahydrofuran-2-yl)pyrimidin-2(1h)-one
2'-deoxy-2',2'-difluorocytidine
gemcitabine (usan/inn)
D02368
2',2'-difluoro-2'-deoxycytidine
HMS2089P10
CHEMBL888
CHEBI:175901 ,
gemcitabine free base
NCGC00168784-02
gemcel
b76n6sbz8r ,
hsdb 7567
zefei
gemcitabine [usan:inn:ban]
gemcitabina
gemlip
gemcitabinum
folfugem
unii-b76n6sbz8r
AKOS015920303
BCP9000721
BCPP000219
gemcitabine [mi]
gemcitabine [who-dd]
gemcitabine [usan]
gemcitabine [hsdb]
gemcitabine [inn]
gemcitabine [vandf]
CS-0643
S1714
4-amino-1-[(2r,4r,5r)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,2-dihydropyrimidin-2-one
gtpl4793
CCG-221183
DL-215
2'deoxy-2',2'-difluorocytidine
SCHEMBL4295
2VPP
4-amino-1-((2r,4r,5r)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2(1h)-one
AB01274777_05
AB01274777_06
DTXSID3040487
4PD5
J-001056
GS-3582
Z1741982024
sr-05000001491
SR-05000001491-2
SR-05000001491-1
2`-deoxy-2`,2`-difluorocytidine
HMS3715N07
NCGC00168784-08
SW199649-2
gemcitabine (gemzar)
95058-81-4 (free base)
Q414143
BRD-K15108141-001-04-1
bdbm429521
med.21724, compound gemcitabine
NCGC00168784-12
EN300-267822
G0544
BP-58640
4-amino-1-[(2r,4r,5r)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydro-2-furanyl]-2(1h)-pyrimidinone

Research Excerpts

Overview

Gemcitabine (dFdC) is a nucleoside analogue commonly used in cancer therapy but with limited efficacy due to a high susceptibility to cancer cell resistance. It is a common treatment for pancreatic cancer; however, it is thought that treatment may fail because tumor stroma prevents drug distribution to tumor cells.

ExcerptReferenceRelevance
"Gemcitabine is a nucleoside analogue commonly used in cancer therapy but with limited efficacy due to a high susceptibility to cancer cell resistance. "( Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
Balzarini, J; Blagden, S; Ghazaly, E; Jiang, WG; Lopez, MH; Mason, M; McGuigan, C; Slusarczyk, M; Thompson, E, 2014
)
2.12
"Gemcitabine (dFdC) is a cytidine analog remarkably active against a wide range of solid tumors. "( N-Acyl-phosphoramidates as potential novel form of gemcitabine prodrugs.
Baraniak, J; Cieslak, M; Kaczmarek, R; Krakowiak, A; Krolewska, K; Kulik, K; Nawrot, B; Pietkiewicz, A; Radzikowska, E, 2014
)
2.1
"Gemcitabine (dFdC) is an anticancer agent used against a variety of solid tumours."( Development of bioactive gemcitabine-D-Lys
Chatzigiannis, CM; Karampelas, T; Liapakis, G; Sayyad, N; Spyridaki, K; Tamvakopoulos, C; Tzakos, AG; Vrettos, EI, 2019
)
1.54
"Gemcitabine (dFdC) is a nucleoside analogue used in the treatment of various cancers, being a standard treatment for advanced pancreatic cancer. "( Development of potent CPP6-gemcitabine conjugates against human prostate cancer cell line (PC-3).
Correia, C; Duarte, D; Ferreira, A; Moreira, S; Vale, N; Vasconcelos, MH; Xavier, CPR, 2020
)
2.3
"Gemcitabine is an effective single-agent chemotherapy used in advanced stages of cutaneous T-cell lymphoma (CTCL). "( Clinical Outcomes of Advanced-Stage Cutaneous Lymphoma under Low-Dose Gemcitabine Treatment: Real-Life Data from the German Cutaneous Lymphoma Network.
Assaf, C; Blazejak, C; Gambichler, T; Gosman, J; Klemke, CD; Nicolay, JP; Olk, J; Stadler, R; Stendel, S; Stranzenbach, R; Wehkamp, U; Weyermann, M; Wobser, M, 2022
)
2.4
"Gemcitabine is a nucleoside analog effective against several solid tumors. "( Permeability of Gemcitabine and PBPK Modeling to Assess Oral Administration.
Ferreira, A; Lapa, R; Vale, N, 2021
)
2.41
"Gemcitabine (dFdC) is a common treatment for pancreatic cancer; however, it is thought that treatment may fail because tumor stroma prevents drug distribution to tumor cells. "( Method To Visualize the Intratumor Distribution and Impact of Gemcitabine in Pancreatic Ductal Adenocarcinoma by Multimodal Imaging.
Andrén, PE; Atkinson, J; Barnes, J; Barry, ST; Brais, R; Bunch, J; Dunlop, CR; Goodwin, RJA; Gopinathan, A; Hamm, G; Jodrell, DI; Johnson, TI; Kaistha, BP; Lau, A; Ling, S; Maglennon, G; Nilsson, A; Race, AM; Richards, FM; Sansom, OJ; Serra, MP; Smith, A; Strittmatter, N; Sutton, D; Takats, Z; Wallez, Y; Wilson, J; Wong, E, 2022
)
2.4
"Gemcitabine is a well-known radiosensitizer. "( Neoadjuvant concurrent chemoradiotherapy using infusional gemcitabine in locally advanced rectal cancer: A phase II trial.
Abduljabbar, A; Alashwah, A; Alhomoud, S; Aljubran, A; Almanea, H; Alsanea, N; Alsuhaibani, A; Alzahrani, A; Ashari, L; Badran, A; Bazarbashi, S; Elhassan, T; Elshenawy, MA; Ghebeh, H; Mohiuddin, M; Neimatallah, M, 2022
)
2.41
"Gemcitabine is a nucleoside analog that has been used widely as an anticancer drug for the treatment of a variety of conditions, including ovarian, bladder, non-small-cell lung, pancreatic, and breast cancer. "( Recent Development of Prodrugs of Gemcitabine.
Pandit, B; Royzen, M, 2022
)
2.44
"Gemcitabine and alisertib are a feasible strategy with potential for disease control in multiple heavily pre-treated tumors, though gastrointestinal and hematologic toxicity was apparent."( A phase I dose escalation, dose expansion and pharmacokinetic trial of gemcitabine and alisertib in advanced solid tumors and pancreatic cancer.
Chen, JA; Gandara, DR; Huynh, JC; Kelly, KL; Kim, EJ; Li, T; Mack, PC; Mahaffey, N; Martinez, A; Matsukuma, K; Riess, JW; Semrad, TJ; Tam, K; Wu, CY; Yu, AM, 2022
)
1.68
"Gemcitabine resistance is a frequently occurring and intractable obstacle in pancreatic cancer treatment. "( CASC9 potentiates gemcitabine resistance in pancreatic cancer by reciprocally activating NRF2 and the NF-κB signaling pathway.
Chen, L; Gong, Q; Li, H; Tang, Z; Tao, J; Zhang, Z; Zhao, C, 2023
)
2.69
"Gemcitabine resistance is a major challenge in the treatment of PDAC."( Pancreatic ductal adenocarcinoma cells regulated the gemcitabine-resistance function of CAFs by LINC00460.
Hou, X; Li, JH; Li, SJ; Li, YX; Ni, X; Wu, X; Yin, XY; Zhao, W; Zhu, XX, 2022
)
1.69
"Gemcitabine-docetaxel is an efficacious second-line treatment for DDLPS. "( Retrospective evaluation of the role of gemcitabine-docetaxel in well-differentiated and dedifferentiated liposarcoma.
Amini, B; Araujo, D; Benjamin, RS; Cloutier, JM; Conley, AP; Feig, B; Keung, EZ; Lin, H; Livingston, JA; Ludwig, J; Nassif, EF; Patel, S; Ratan, R; Ravi, V; Roland, CL; Somaiah, N; Thirasastr, P; Wang, WL; Zarzour, MA; Zhou, X, 2023
)
2.62
"Gemcitabine (GEM) is an anticancer drug inhibiting DNA synthesis. "( Gemcitabine alters sialic acid binding of the glycocalyx and induces inflammatory cytokine production in cultured endothelial cells.
Akiyama, M; Gunji, M; Honda, K; Kang, D; Mukai, S; Sawa, C; Takaki, T, 2023
)
3.8
"Gemcitabine is a widely used anti-cancer drug of pyrimidine structure, which can exist as a free base molecular form in crystals. "( Characterization of tautomeric forms of anti-cancer drug gemcitabine and their interconversion upon mechano-chemical treatment, using ATR-FTIR spectroscopy and complementary methods.
Henry, B; Samokhvalov, A, 2023
)
2.6
"Gemcitabine is an antineoplastic drug commonly used in the treatment of several types of cancers including pancreatic cancer and non-small cell lung cancer. "( Electrophysiological evaluation of an anticancer drug gemcitabine on cardiotoxicity revealing down-regulation and modification of the activation gating properties in the human rapid delayed rectifier potassium channel.
Kume, S; Kurokawa, T; Liu, G; Liu, Y; Morishima, M; Ono, K; Osanai, H; Wang, P; Wei, M; Yoshimura, K; Zheng, M; Zhu, X, 2023
)
2.6
"Gemcitabine is an analogue of cytidine arabinoside, used alone or in combination chemotherapy to treat various type of cancer. "( An ultra-high-performance chromatography method to study the long term stability of gemcitabine in dose banding conditions.
Bihin, B; Closset, M; Colsoul, ML; Galanti, L; Goderniaux, N; Hecq, JD; Jamart, J; Odou, P; Onorati, S; Soumoy, L, 2023
)
2.58
"Gemcitabine is a well-tolerated pyrimidine antimetabolite chemotherapeutic that is increasingly utilized to treat non-small cell lung carcinoma, breast, pancreatic, and urogenital cancers. "( Gemcitabine-associated DRESS syndrome: A case report.
Bayram, E; Paydas, S; Toyran, T, 2023
)
3.8
"Gemcitabine (GEM) is a common and effective first-line chemotherapeutic drug for the treatment of NSCLC."( Phosphorylation of Bcl-2 by JNK confers gemcitabine resistance in lung cancer cells by reducing autophagy-mediated cell death.
Chen, MC; Chiu, CH; Huang, CY; Kuo, CH; Kuo, WW; Li, CC; Liao, PH; Lin, YJ; Lin, YM; Ramesh, S; Wang, TF, 2023
)
1.9
"Gemcitabine (GCB) is an anticancer drug used to treat several types of tumors such as colorectal cancer; however, it suffers from tumor cell resistance, and therefore, treatment failure."( Chemomodulatory Effect of the Marine-Derived Metabolite "Terrein" on the Anticancer Properties of Gemcitabine in Colorectal Cancer Cells.
Abuhijjleh, RK; Al Saeedy, DY; Al-Abd, AM; Ashmawy, NS; Elhady, SS; Gouda, AE, 2023
)
1.85
"Gemcitabine is a nucleoside analog antimetabolite used in various malignancies, including metastatic breast cancer. "( Gemcitabine-associated digital necrosis in metastatic breast cancer.
Doğan, M; Kurtuluş, A; Özdemir, M; Türkel, A, 2023
)
3.8
"Gemcitabine is an important chemotherapeutic agent for patients with PDAC; however, the efficacy of gemcitabine is limited due to resistance."( Nuclear PLD1 combined with NPM1 induces gemcitabine resistance through tumorigenic IL7R in pancreatic adenocarcinoma.
Chang, A; Ding, J; Feng, Y; Fu, D; Gao, C; Gao, S; Hao, J; Huang, C; Liu, J; Liu, Y; Ma, X; Ma, Y; Tang, B; Wang, H; Wang, X; Yan, J; Yang, S; Zhang, Z; Zhao, R; Zhao, T, 2023
)
1.9
"Gemcitabine is a nucleoside analog that has been successfully used in the treatment of multiple cancers. "( PTEN deficiency facilitates gemcitabine efficacy in cancer by modulating the phosphorylation of PP2Ac and DCK.
Cui, XW; Dong, LW; Feng, XF; Jiang, TY; Lin, YK; Pan, YF; Tan, YX; Wang, HY; Yuan, ZG; Zeng, TM, 2023
)
2.65
"Gemcitabine (GEM) is a second-line anticancer drug of choice for some colorectal cancer (CRC) patients, and GEM inability to be commonly available in the clinic due to the lack of clarity of the exact action targets."( Comprehensive analysis identifies novel targets of gemcitabine to improve chemotherapy treatment strategies for colorectal cancer.
Jiang, Y; Liang, L; Ling, X; Shen, J; Sun, L; Zeng, X; Zhang, X, 2023
)
2.6
"Gemcitabine is a chemotherapeutic agent, widely used for the treatment of many types of cancer. "( Cytidine deaminase enzyme activity is a predictive biomarker in gemcitabine-treated cancer patients.
Abbaspour, A; Dehghani, M; Firuzi, O; Ghorbani, M; Moosavi, F; Omidvari, S; Ramzi, M; Rostamipour, HA; Setayesh, M; Tavakkoli, M, 2023
)
2.59
"Gemcitabine (GEM) is a standard chemotherapeutic agent for patients with pancreatic cancer; however, GEM-based chemotherapy has a high rate of toxicity. "( Inhibitory effect of liriopesides B in combination with gemcitabine on human pancreatic cancer cells.
Chen, M; Gan, L; Hong, P; Jin, J; Li, D; Liu, W; Wei, X; Wong, W; Wu, M; Wu, P; Wu, R; Xu, X; Zhang, K; Zheng, X, 2024
)
3.13
"Gemcitabine is a frequently used chemotherapeutic agent which can be used as a monotherapy or in combination."( AUM302, a novel triple kinase PIM/PI3K/mTOR inhibitor, is a potent in vitro pancreatic cancer growth inhibitor.
Baines, AT; Bialkowska, AB; Graves, LM; Ingle, K; LaComb, JF, 2023
)
1.63
"Gemcitabine is a first-line drug for patients with unresectable pancreatic cancer."( Oncogenic ADAM28 induces gemcitabine resistance and predicts a poor prognosis in pancreatic cancer.
Chen, J; Chen, ZH; Huang, JL; Ma, XK; Wei, L; Wen, JY; Wu, DH, 2019
)
1.54
"Gemcitabine is a mainstay for pancreatic treatment."( Gemcitabine loaded autologous exosomes for effective and safe chemotherapy of pancreatic cancer.
Cai, JX; Hu, XB; Li, YJ; Wang, JM; Wu, JY; Xiang, DX, 2020
)
2.72
"Gemcitabine (GEM) is a chemotherapeutic agent, which is known to battle cancer but challenging due to its hydrophilic nature. "( Optimization of nanoemulsion containing gemcitabine and evaluation of its cytotoxicity towards human fetal lung fibroblast (MRC5) and human lung carcinoma (A549) cells.
Abdul Rahman, MB; Ashari, SE; Salim, N; Wahgiman, NA, 2019
)
2.22
"Gemcitabine is an anticancer drug used to treat a wide range of solid tumors and is a first line treatment for pancreatic cancer. "( Combination of Gemcitabine with Cell-Penetrating Peptides: A Pharmacokinetic Approach Using In Silico Tools.
Ferreira, A; Lapa, R; Vale, N, 2019
)
2.31
"Gemcitabine is a chemotherapeutic agent used in a wide variety of solid tumours. "( Gemcitabine-induced pseudocellulitis: a case report and review of the literature.
Bami, H; Boldt, G; Goodman, C; Vincent, M, 2019
)
3.4
"Gemcitabine is a nucleoside analogue that has been shown to sensitise tumour cells to radiation."( Gemcitabine potentiates the anti-tumour effect of radiation on medullary thyroid cancer.
Forssell-Aronsson, E; Montelius, M; Nilsson, O; Sandblom, V; Shubbar, E; Spetz, J; Ståhl, I; Swanpalmer, J, 2019
)
2.68
"Gemcitabine (GEM) is a powerful anticancer drug for various cancers. "( Polymeric modification of gemcitabine via cyclic acetal linkage for enhanced anticancer potency with negligible side effects.
Honda, Y; Inaba, T; Kim, J; Liu, X; Matsui, M; Nishiyama, N; Nomoto, T; Takemoto, H; Taniwaki, K; Tomoda, K; Toyoda, M; Yamada, N, 2020
)
2.3
"Gemcitabine is a deoxycytidine analog that has been used for a broad spectrum of tumor, such as nonsmall-cell lung cancer, bladder cancer and pancreatic cancer. "( Determination of Gemcitabine in Plasma of Bladder Cancer Patients by Hydrophilic Interaction Chromatography with Ultraviolet Detection.
Hayama, T; Hiraki, R; Miyata, Y; Nakamura, N; Nakashima, M; Nakashima, MN; Ohyama, K; Sakai, H; Wang, M; Yasuda, T, 2020
)
2.34
"Gemcitabine (Gem) is a key drug for pancreatic cancer, yet limited by high systemic toxicity, low bioavailability and poor pharmacokinetic profiles. "( Biomimetic Gemcitabine-Lipid Prodrug Nanoparticles for Pancreatic Cancer.
Bean, PA; Bulanadi, JC; de Campo, L; Gong, X; Julovi, SM; Moghaddam, MJ; Smith, RC; Xue, A, 2020
)
2.39
"Gemcitabine is a pyrimidine nucleoside drug which has been approved by FDA to treat lung cancer."( Gemcitabine and checkpoint blockade exhibit synergistic anti-tumor effects in a model of murine lung carcinoma.
Du, B; Lai, J; Lin, M; Wang, Y; Wen, X, 2020
)
2.72
"Gemcitabine (GEM) is a commonly used treatment for advanced pancreatic cancer. "( (3E,5E)-3,5-Bis(pyridin-3-methylene)-tetrahydrothiopyran-4-one enhances the inhibitory effect of gemcitabine on pancreatic cancer cells.
Chen, M; Goodin, S; Li, D; Liu, W; Ma, Y; Sheng, Z; Wang, X; Wu, P; Xu, X; Zhang, K; Zheng, X; Zhou, R, 2020
)
2.22
"Gemcitabine is an intravenously administered anti-cancer nucleoside analogue. "( Pharmacokinetics of gemcitabine and its amino acid ester prodrug following intravenous and oral administrations in mice.
Shi, J; Smith, DE; Thompson, BR; Zhu, HJ, 2020
)
2.32
"Gemcitabine is a drug of choice in the treatment of human pancreatic cancer. "( A G-quadruplex-binding compound shows potent activity in human gemcitabine-resistant pancreatic cancer cells.
Ahmed, AA; Marchetti, C; Neidle, S; Ohnmacht, SA, 2020
)
2.24
"Gemcitabine (GMT) is a nucleoside analog used in the treatment of a variety of solid tumors. "( Poly(anhydride-ester) gemcitabine: Synthesis and particle engineering of a high payload hydrolysable polymeric drug for cancer therapy.
Almuqbil, RM; da Rocha, SRP; Fines, CB; Heyder, RS; Sunbul, FS, 2021
)
2.38
"Gemcitabine is an antitumour agent currently used in the treatment of several types of cancer with known properties as a radiosensitizer. "( p38β (MAPK11) mediates gemcitabine-associated radiosensitivity in sarcoma experimental models.
Andrés, I; Arconada-Luque, E; Belandia, B; Bossi, G; Fernández-Aroca, DM; Garcia-Flores, N; Ortega-Muelas, M; Pascual-Serra, R; Roche, O; Ruiz-Hidalgo, MJ; Sabater, S; Sánchez-Prieto, R, 2021
)
2.37
"Gemcitabine is an anticancer drug used to treat a wide range of solid tumors and is a first-line treatment for pancreatic cancer."( Gemcitabine Peptide-Based Conjugates and Their Application in Targeted Tumor Therapy.
Hawryłkiewicz, A; Ptaszyńska, N, 2021
)
2.79
"Gemcitabine is a frequently used chemotherapeutic agent but its effects on the immune system are incompletely understood. "( Immune monitoring in mesothelioma patients identifies novel immune-modulatory functions of gemcitabine associating with clinical response.
Aerts, JG; Baas, P; Biesma, B; Bootsma, GP; Burgers, JA; Cornelissen, R; Dammeijer, F; De Gooijer, CJ; Jebbink, M; Kaijen-Lambers, MEH; Klaase, L; Lievense, LA; Lukkes, M; Mankor, J; Stigt, JA; Van der Noort, V; van Gulijk, M; Vroman, H; Waasdorp, C, 2021
)
2.28
"Gemcitabine is a nucleoside analog and pyrimidine antimetabolite that inhibits RNA synthesis, currently approved for use to treat a variety of cancers, among which ovarian cancers. "( Gemcitabine-induced dilated-cardiomyopathy in patient with platinum-refractory ovarian-cancer: A case report and literature review.
Di Benedetto, L; Gozzi, E; Lazzeroni, R; Pietranera, M; Raimondi, FM; Raimondi, L; Rossi, L; Spinelli, GP, 2021
)
3.51
"Gemcitabine is a cytidine analogue that is often used in conjunction with nab-paclitaxel in the treatment of pancreatic cancer."( Paraspinal radiation recall myositis after gemcitabine for pancreatic adenocarcinoma.
Barrios-Anderson, A; Radhakrishnan, R; Shimanovsky, A; Yu, E, 2021
)
1.61
"Gemcitabine hydrochloride is an established chemotherapeutic agent in several solid tumors. "( Development of Ag nanoparticle-carbon quantum dot nanocomplex as fluorescence sensor for determination of gemcitabine.
Esmaeili, E; Karami, C; Moradi, S; Shahlaei, M; Shekarbeygi, Z, 2021
)
2.28
"Gemcitabine is a broadly prescribed chemotherapy, the use of which can be limited by renal adverse events, including thrombotic microangiopathy (TMA)."( Eculizumab in gemcitabine-induced thrombotic microangiopathy: experience of the French thrombotic microangiopathies reference centre.
Benhamou, Y; Chiche, NJ; Coindre, JP; Coppo, P; Daviet, F; François, A; Frémeaux-Bacchi, V; Grall, M; Grangé, S; Guerrot, D; Karras, A; Pouteil-Noble, C; Presne, C; Provot, F; Veyradier, A, 2021
)
2.42
"Gemcitabine is a commonly used antimetabolite that has been effective in a broad spec- trum of tumors so far. "( Gemcitabine-Related Atrial Fibrillation: A Case Report and Review of the Literature.
Abdallah, IB; Balti, M; Chourabi, C; Fehri, W; Haddaoui, A; Nasr, SB; Zribi, A, 2022
)
3.61
"Gemcitabine is a radiosensitizing drug that has shown efficacy and safety in this context."( Effectiveness of Concomitant Chemoradiotherapy with Gemcitabine in Locally Advanced Cervical Cancer Patients with Comorbidities.
Arango-Bravo, E; Brau-Figueroa, H; Castro-Eguiluz, D; Cetina-Pérez, L; Cruz-Bautista, I; Galicia-Carmona, T; Jiménez-Lima, R; Lugo-Alferez, LA, 2022
)
1.69
"Gemcitabine/cisplatin is a standard-of-care systemic therapy, but has a modest impact on survival and harbors toxicities, including myelosuppression, nephropathy, neuropathy, and ototoxicity."( Synergistic combination of cytotoxic chemotherapy and cyclin-dependent kinase 4/6 inhibitors in biliary tract cancers.
Abdelrahman, AM; Ahn, DH; Alva-Ruiz, R; Arora, M; Baker, AT; Barrett, MT; Bekaii-Saab, TS; Bogenberger, JM; Borad, MJ; Braggio, E; Buetow, KH; Chen, X; Dumbauld, CR; Egan, JB; Eskelinen, EL; Gamb, SI; Kosiorek, HE; Leiting, JL; Mansfield, AS; Meurice, N; Nagalo, BM; Roberts, LR; Salomao, MA; Serrano Uson Junior, PL; Sonbol, MB; Truty, MJ; Yonkus, J; Zhou, Y, 2022
)
1.44
"Gemcitabine (GCB) is a first-line chemotherapeutic drug for pancreatic cancer (PCa). "( Enhancement of gemcitabine efficacy by K73-03 via epigenetically regulation of miR-421/SPINK1 in gemcitabine resistant pancreatic cancer cells.
Al-Radhi, M; Awsh, M; Baldi, S; Chu, P; Fang, J; Jia, J; Li, X; Ma, X; Peng, J; Safi, M; Shopit, A; Shu, X; Tang, Z; Wang, F; Wang, S, 2021
)
2.42
"Gemcitabine is a chemotherapy drug. "( Gemcitabine-induced coronary vasospasm: A case report.
Eken, A; Katırcıbaşı, MT, 2017
)
3.34
"Gemcitabine is an antineoplastic drug that is frequently used with good results in the treatment of lung cancer, pancreatic cancer, breast cancer, ovarian cancer, and malignant lymphoma."( [Comparison of Preparation Efficiency and Therapeutic Safety between Generic Products of Gemcitabine].
Amada, K; Itoh, H; Nakahara, R; Ono, H; Sato, Y, 2017
)
1.4
"Gemcitabine plus S-1 is a viable treatment alternative to gemcitabine, which is one of the standard treatments in patients with LAPC."( Efficacy and safety of gemcitabine plus S-1 in pancreatic cancer: a pooled analysis of individual patient data.
Furuse, J; Hamada, C; Ikari, T; Imai, S; Isayama, H; Ishii, H; Nakai, Y; Okamura, S; Okusaka, T, 2017
)
2.21
"Gemcitabine is an anticancer agent acting against several solid tumors. "( Pharmacological factors affecting accumulation of gemcitabine's active metabolite, gemcitabine triphosphate.
Ghazaly, E; Peters, GJ; Rizzuto, I, 2017
)
2.15
"Gemcitabine is an antimetabolite drug used for the treatment of pancreatic cancer that can have profound detrimental effects on oogenesis and ovarian function."( Successful pregnancy after mucinous cystic neoplasm with invasive carcinoma of the pancreas in a patient with polycystic ovarian syndrome: a case report.
Carlan, SJ; Guzman, A; Holloman, C; Madruga, M; Sundharkrishnan, L, 2017
)
1.18
"Gemcitabine is a widely used chemotherapeutic drug, but limited therapeutic efficacy is achieved due to chemoresistance."( Mechanistic Evaluation and Translational Signature of Gemcitabine-induced Chemoresistance by Quantitative Phosphoproteomics Analysis with iTRAQ Labeling Mass Spectrometry.
Duan, Q; Li, H; Shen, Q; Wang, C; Wu, H; Yin, T; Zhang, Z; Zhao, H, 2017
)
1.42
"Gemcitabine is a nucleoside analog currently used for the treatment of various solid tumors as a single agent or in combination with other chemotherapeutic drugs. "( Gemcitabine and glioblastoma: challenges and current perspectives.
Bastiancich, C; Bastiat, G; Lagarce, F, 2018
)
3.37
"Gemcitabine is a nucleoside analogue effective against a number of cancers. "( N-trimethyl chitosan nanoparticles and CSKSSDYQC peptide: N-trimethyl chitosan conjugates enhance the oral bioavailability of gemcitabine to treat breast cancer.
Chen, G; Huang, Y; Lu, W; Svirskis, D; Wen, J; Ying, M, 2018
)
2.13
"Gemcitabine is a chemotherapeutic agent used to treat several solid organ malignancies. "( A case of gemcitabine-related acute lipodermatosclerosis.
Huang, WW; McGregor, S; Nyckowski, T, 2019
)
2.36
"Gemcitabine resistance is a major obstacle for effective treatment of bladder cancer. "( miR-129-5p inhibits gemcitabine resistance and promotes cell apoptosis of bladder cancer cells by targeting Wnt5a.
Cao, J; Li, S; Wang, Q; Wu, G, 2018
)
2.25
"Gemcitabine is a frontline agent of chemotherapy for bladder cancer despite its limited efficacy due to chemoresistance, there is an acute need to decipher mechanisms underlying chemosensitivity to gemcitabinein in bladder cancer cells."( GnT-V promotes chemosensitivity to gemcitabine in bladder cancer cells through β1,6 GlcNAc branch modification of human equilibrative nucleoside transporter 1.
Cong, X; Dong, X; Fan, J; Fang, S; Tang, Y; Wang, S; Yuan, Y, 2018
)
1.48
"Gemcitabine is a standard chemotherapeutic agent for patients suffering from pancreatic cancer. "( Melatonin and its metabolite N1-acetyl-N2-formyl-5-methoxykynuramine (afmk) enhance chemosensitivity to gemcitabine in pancreatic carcinoma cells (PANC-1).
Bonior, J; Góralska, M; Jastrzębska, M; Jaworek, J; Leja-Szpak, A; Link-Lenczowski, P; Nawrot-Porąbka, K; Pierzchalski, P, 2018
)
2.14
"Gemcitabine is a standard treatment for advanced pancreatic cancer patients but can cause chemoresistance during treatment. "( Resveratrol enhances the chemotherapeutic response and reverses the stemness induced by gemcitabine in pancreatic cancer cells via targeting SREBP1.
Cao, J; Cheng, L; Duan, W; Jiang, Z; Li, J; Li, X; Ma, J; Ma, Q; Qian, W; Sun, L; Wang, F; Wu, E; Wu, Z; Yan, B; Zhou, C, 2019
)
2.18
"Gemcitabine serves as a first-line chemotherapy agent for advanced pancreatic cancer (PC). "( Gemcitabine exhibits a suppressive effect on pancreatic cancer cell growth by regulating processing of PVT1 to miR1207.
Liang, Z; Liu, C; Liu, Z; Wang, H; Yang, G; You, L; Zhang, J; Zhang, T; Zhao, F; Zhao, Y, 2018
)
3.37
"Gemcitabine (Gem) is a MDSC-depleting chemotherapeutic agent; however, its clinical use is hampered by its drug resistance and inefficient in vivo delivery."( Gemcitabine nanoparticles promote antitumor immunity against melanoma.
Bush, X; Chen, JA; Yan, B; Zhang, Y, 2019
)
2.68
"Gemcitabine is a principal chemotherapeutic agent for biliary tract cancer (BTC). "( Human equilibrative nucleoside transporter 1 (hENT1) expression as a predictive biomarker for gemcitabine chemotherapy in biliary tract cancer.
Hwang, JH; Kim, H; Kim, J; Kim, JW; Kim, YT; Lee, JC; Lee, SH; Paik, WH; Ryu, JK, 2018
)
2.14
"Gemcitabine is an important component of pancreatic cancer clinical management. "( Insights into gemcitabine resistance and the potential for therapeutic monitoring.
Bhinderwala, F; Chaika, NV; Gebregiworgis, T; Powers, R; Purohit, V; Singh, PK, 2018
)
2.28
"Gemcitabine is an introduced treatment for BC and also has immunomodulatory function, but the immunoregulation mechanism is not clear."( RS 504393 inhibits M-MDSCs recruiting in immune microenvironment of bladder cancer after gemcitabine treatment.
Fan, J; Jiang, JT; Liu, ZH; Mu, XY; Sun, F; Tan, MY; Wang, RJ; Wang, X; Wu, K; Yao, ZX; Zheng, JH; Zheng, Z, 2019
)
1.46
"Gemcitabine (Gem) is a standard first-line treatment for pancreatic cancer (PC). "( A novel gemcitabine derivative-loaded liposome with great pancreas-targeting ability.
Li, PW; Luo, S; Tian, BL; Wang, L; Xiao, LY; Zeng, YC; Zhang, ZR, 2019
)
2.39
"Gemcitabine is a fluoropyrimidine analogue that is used as a mainstay of chemotherapy treatment for pancreatic and ovarian cancers, amongst others. "( Genome-scale CRISPR/Cas9 screen determines factors modulating sensitivity to ProTide NUC-1031.
Bré, J; Chan, TH; Harrison, DJ; Mullen, P; Reynolds, PA; Sarr, A; Um, IH, 2019
)
1.96
"Gemcitabine is a widely used chemotherapeutic drug that is administered via intravenous infusion due to a low oral bioavailability of only 10%. "( Mechanisms of gemcitabine oral absorption as determined by in situ intestinal perfusions in mice.
Hu, Y; Smith, DE; Thompson, BR, 2019
)
2.32
"Gemcitabine is a nucleoside-chemotherapeutic which was recently shown to act as a radiosensitizer in high-grade glioma."( Gemcitabine, vinorelbine and cyclooxygenase inhibitors in the treatment of glioblastoma. Ultrastructural analyses in C6 glioma in vitro.
Altinoz, MA; Bilir, A; Elmaci, İ; Ozpinar, A, 2019
)
2.68
"Gemcitabine is a hydrophilic clinical anticancer drug that requires nucleoside transporters to cross plasma membranes and enter cells. "( Human concentrative nucleoside transporter 3 transfection with ultrasound and microbubbles in nucleoside transport deficient HEK293 cells greatly increases gemcitabine uptake.
Cass, CE; Evans, D; Favis, N; Paproski, RJ; Yao, SY; Young, JD; Zemp, RJ, 2013
)
2.03
"Gemcitabine (Gem) is a chemotherapeutic drug routinely used for the treatment for pancreatic cancer patients."( Dendritic cell immunotherapy combined with gemcitabine chemotherapy enhances survival in a murine model of pancreatic carcinoma.
Ghansah, T; Kinney, K; Kodumudi, K; Pilon-Thomas, S; Sarnaik, AA; Springett, G; Vohra, N; Weber, A, 2013
)
1.37
"Gemcitabine is a pyrimidine nucleoside analog that is a commonly used chemotherapeutic agent for unresectable or recurrent biliary tract cancer (BTC). "( Prognostic predictive values of gemcitabine sensitivity-related gene products for unresectable or recurrent biliary tract cancer treated with gemcitabine alone.
Amano, R; Hirakawa, K; Kimura, K; Murata, A; Nakata, B; Yamada, N; Yashiro, M, 2013
)
2.12
"Gemcitabine is a chemotherapy drug used in different carcinomas, although because it displays a short biological half-life, its plasmatic levels can quickly drop below the effective threshold. "( Functionalized magnetic nanoparticles as vehicles for the delivery of the antitumor drug gemcitabine to tumor cells. Physicochemical in vitro evaluation.
Carazo, A; Delgado, AV; Gómez-Sotomayor, R; Munoz-Gamez, JA; Rudzka, K; Ruiz-Extremera, A; Salmerón, J; Viota, JL, 2013
)
2.05
"Gemcitabine is an effective chemotherapeutic agent for advanced gallbladder cancer. "( Combination chemotherapy of nafamostat mesylate with gemcitabine for gallbladder cancer targeting nuclear factor-κB activation.
Fujiwara, Y; Furukawa, K; Haruki, K; Iwase, R; Misawa, T; Ohashi, T; Shiba, H; Uwagawa, T; Yanaga, K, 2013
)
2.08
"Gemcitabine is a mainstay in the treatment of biliary and pancreatic cancers, with limited efficacy in most settings. "( Rapid deaminator status is associated with poor clinical outcome in pancreatic cancer patients treated with a gemcitabine-based regimen.
Ciccolini, J; Dahan, L; Duluc, M; Fina, F; Lacarelle, B; Norguet, E; Ouafik, L; Seitz, JF; Serdjebi, C, 2013
)
2.04
"Gemcitabine is a first-line drug utilised in the chemotherapy of pancreatic cancer; however, this drug induces chemo-resistance and toxicity to normal tissue during treatment. "( Andrographolide causes apoptosis via inactivation of STAT3 and Akt and potentiates antitumor activity of gemcitabine in pancreatic cancer.
Bao, GQ; Pan, CP; Peng, CH; Shen, BY; Shi, MM; Zhang, YJ, 2013
)
2.05
"Gemcitabine is a nucleoside analog that is indicated in the treatment of pancreatic cancer. "( Do hENT1 and RRM1 predict the clinical benefit of gemcitabine in pancreatic cancer?
Dumontet, C; Jordheim, LP, 2013
)
2.09
"Gemcitabine (GEM) is an approved treatment for unresectable pancreatic cancer; however, its role in treating resected pancreatic cancer is less clear. "( Gemcitabine Adjuvant Therapy for Resected Pancreatic Cancer: A Meta-analysis.
Tan, ZM; Wang, LY; Yu, Z; Yuan, YH; Zhong, W, 2015
)
3.3
"Gemcitabine is a chemotherapeutic that is widely used for the treatment of a variety of haematological malignancies and has become the standard chemotherapy for the treatment of advanced pancreatic cancer. "( Gemcitabine-mediated tumour regression and p53-dependent gene expression: implications for colon and pancreatic cancer therapy.
Clements, D; Giacomantonio, CA; Gujar, SA; Hill, R; Lee, PW; Madureira, PA; Rabb, M; Waisman, DM, 2013
)
3.28
"Gemcitabine-induced TMA is an underdiagnosed condition characterized by high mortality rates. "( Gemcitabine-related thrombotic microangiopathy: a single-centre retrospective series.
Carvalheira, JB; Leal, F; Macedo, LT, 2014
)
3.29
"Gemcitabine is a widely used drug in the treatment of advanced pancreatic cancer and other malignancies. "( [Hemolytic-uremic syndrome associated with gemcitabine use: report of one case].
Goecke, H; Méndez, GP; Parodi, C; Vega, J, 2013
)
2.1
"Gemcitabine is a chemotherapy agent commonly used in the treatment of non-small cell lung cancer (NSCLC) that has been demonstrated to induce apoptosis in NSCLC cells by increasing functionally active Fas expression. "( Gemcitabine sensitizes lung cancer cells to Fas/FasL system-mediated killing.
Di Sano, C; Ferraro, M; Gjomarkaj, M; Melis, M; Pace, E; Profita, M; Siena, L; Spatafora, M, 2014
)
3.29
"Gemcitabine is a deoxycytidine antagonist that has characteristics different from those of the deoxycytidine antagonist cytarabine(Ara-C)."( [Chemotherapy using gemcitabine hydrochloride for malignant lymphoma].
Asou, H; Kiyosawa, K; Maeda, K; Takeuchi, K; Taniai, H, 2013
)
1.43
"Gemcitabine (GEM) is a first line chemotherapeutic drug for advanced pancreatic cancer. "( Gemcitabine-treated pancreatic cancer cell medium induces the specific CTL antitumor activity by stimulating the maturation of dendritic cells.
Ding, X; Liu, W; Luo, H; Lv, Y; Pan, J; Pei, Q; Zhu, H; Zou, X, 2014
)
3.29
"Gemcitabine is a chemotherapeutic agent used for treatment of a variety of malignancies. "( Gemcitabine-Induced Pseudocellulitis in a Patient With Recurrent Lymphedema: A Case Report and Review of the Current Literature.
Calvo, M; Curtis, S; Gucalp, R; Hong, S,
)
3.02
"Gemcitabine is a proper regimen for postoperative adjuvant chemotherapy."( A single center experience: post-transplantation adjuvant chemotherapy impacts the prognosis of hepatocellular carcinoma patients.
Han, Z; Peng, Z; Sun, H; Wu, J, 2014
)
1.12
"Gemcitabine is a recently developed treatment option."( Antitumor activity of the c-Myc inhibitor KSI-3716 in gemcitabine-resistant bladder cancer.
Ahn, KO; Jeong, KC; Jung, NR; Lee, KH; Lee, SJ; Park, WS; Seo, HK; Shin, JS, 2014
)
1.37
"Gemcitabine is a potent anticancer drug approved for the treatment of pancreatic, non-small-cell lung, breast, and ovarian cancers. "( Enhanced tumor delivery of gemcitabine via PEG-DSPE/TPGS mixed micelles.
Dai, X; Fan, W; Katragadda, U; Mckinley, D; Tan, C; Teng, Q; Wang, Y, 2014
)
2.14
"Gemcitabine (GEM) is a pyrimidine nucleoside analogue that is a new chemotherapeutic agent used for treating various cancers. "( Gemcitabine chemotherapy induces phenotypic alterations of tumor cells that facilitate antitumor T cell responses in a mouse model of oral cancer.
Arai, N; Fuse, H; Heshiki, W; Nakamori, K; Noguchi, M; Takei, R; Tomihara, K; Zhang, B, 2014
)
3.29
"Gemcitabine is a nucleoside analogue used widely across haemato-oncology. "( Gemcitabine-induced large vessel vasculitis demonstrated by PET CT: a rare, important side effect.
Collins, GP; Eyre, TA; Gooding, S; Hatton, C; Moore, N; Patel, I, 2014
)
3.29
"Gemcitabine is a fluorinated nucleoside currently administered against a number of cancers. "( The synthesis of gemcitabine.
Brown, K; Dixey, M; Linclau, B; Weymouth-Wilson, A, 2014
)
2.18
"Gemcitabine is a potential chemotherapy drug for treatment of head and neck squamous cell carcinoma (HNSCC), however, the poor or partial response of HNSCC patients to gemcitabine demonstrated the urgent need for gemcitabine biomarkers to improve the therapy. "( DNA microarray reveals ZNF195 and SBF1 are potential biomarkers for gemcitabine sensitivity in head and neck squamous cell carcinoma cell lines.
Cui, L; Ji, SL; Xiong, L; Zhang, CY; Zheng, HL; Zhu, MH, 2014
)
2.08
"Gemcitabine is a standard chemotherapeutic agent for locally advanced and metastatic pancreatic cancer. "( BRG1 promotes chemoresistance of pancreatic cancer cells through crosstalking with Akt signalling.
Kornmann, M; Liu, X; Ma, Y; Tian, X; Wang, F; Yang, Y, 2014
)
1.85
"Gemcitabine is a nucleoside analog, which is a commonly used agent for various solid organ malignancies."( Gemcitabine-induced cardiomyopathy: a case report and review of the literature.
Boyella, R; Gottesman, S; Juneman, E; Khan, MF, 2014
)
2.57
"Gemcitabine is a potent replication inhibitor used to treat cancers with mutations in HR genes such as BRCA2."( BRCA2 and RAD51 promote double-strand break formation and cell death in response to gemcitabine.
Groth, P; Jones, RM; Kotsantis, P; Petermann, E; Stewart, GS, 2014
)
1.35
"Gemcitabine is an anticancer drug which is a less immune-destructive agent than others."( NKG2D-directed cytokine-activated killer lymphocyte therapy combined with gemcitabine for patients with chemoresistant metastatic solid tumors.
Hirano, T; Katano, M; Kiyota, A; Koya, N; Morisaki, T; Onishi, H; Tanaka, H; Umebayashi, M, 2014
)
1.35
"Gemcitabine is an anticancer drug used in the treatment of different cancer types, including pancreatic ductal adenocarcinoma. "( Effect of gemcitabine and retinoic acid loaded PAMAM dendrimer-coated magnetic nanoparticles on pancreatic cancer and stellate cell lines.
Erkan, M; Gündüz, U; Kleeff, J; Parsian, M; Ünsoy, G; Yalçin, S, 2014
)
2.25
"Gemcitabine is a potent nucleoside analogue against solid tumors, but development of drug resistance is a substantial problem. "( Hyperthermia inhibits recombination repair of gemcitabine-stalled replication forks.
Cisneros, BT; Corr, SJ; Curley, SA; Liu, H; Raoof, M; Wilson, LJ; Zhu, C, 2014
)
2.1
"Gemcitabine is a nucleoside analogue that causes cytotoxicity by inducing DNA replication blocks."( A gemcitabine sensitivity screen identifies a role for NEK9 in the replication stress response.
Ehdaivand, S; Hardy, CW; Liang, D; Liu, EA; Madden, MZ; Pan, Y; Petrova, AV; Robinson, MH; Rudra, S; Smith, SC; Torres, MA; Wang, H; Wang, J; Wang, Y; Warren, MD; Yu, DS, 2014
)
1.85
"Gemcitabine is a first‑line chemotherapeutic agent used in the treatment of pancreatic cancer; however resistance of the disease to the drug often develops over time. "( Enhancement of the effects of gemcitabine against pancreatic cancer by oridonin via the mitochondrial caspase-dependent signaling pathway.
Bu, HQ; Huang, H; Jin, HM; Li, Y; Liu, DL; Zhao, JF, 2014
)
2.13
"Gemcitabine is a modified cytidine analog having two fluorine atoms at the 2'-position of the ribose ring. "( One-electron oxidation of gemcitabine and analogs: mechanism of formation of C3' and C2' sugar radicals.
Adhikary, A; Hindi, RM; Kumar, A; Rayala, R; Sevilla, MD; Wnuk, SF, 2014
)
2.15
"Gemcitabine is a well tolerated chemotherapeutic agent with a high first pass clearance."( Gemcitabine transcatheter arterial chemoembolization for unresectable hepatocellular carcinoma.
Franko, J; Gamblin, TC; Hammond, JS; Heckman, JT; Holloway, SE; Orons, PD,
)
2.3
"Gemcitabine is a drug commonly used to treat pancreatic cancer but chemoresistance to it is a common clinical issue. "( KML001 enhances anticancer activity of gemcitabine against pancreatic cancer cells.
Lee, JK; Lee, KH; Lee, KT; Rhee, JC; Yang, MH; Yang, S, 2015
)
2.13
"Gemcitabine is an anti-cancer drug with clinically uses in the treatment of various neoplasms, including breast, ovarian, non-small cell lung, pancreaticand cervical cancers, T-cell malignancies, germ cell tumours, and hepatocellular carcinomas. "( Anti-mutagenic activity of Salvia merjamie extract against gemcitabine.
Alanazi, KM, 2015
)
2.1
"Gemcitabine is a key drug for the treatment of pancreatic cancer; however, with its limitation in clinical benefits, the development of another potent therapeutic is necessary. "( Randomized phase II/III clinical trial of elpamotide for patients with advanced pancreatic cancer: PEGASUS-PC Study.
Boku, N; Fukutomi, A; Furukawa, M; Ikeda, M; Ishii, H; Maguchi, H; Miyazawa, M; Mizuno, N; Nishio, K; Ohashi, Y; Ohkawa, S; Okusaka, T; Tani, M; Togashi, Y; Tsunoda, T; Ueno, H; Yamao, K; Yamaue, H, 2015
)
1.86
"Gemcitabine is an approved chemotherapy drug for NSCLC."( A Novel Strategy to Improve the Therapeutic Efficacy of Gemcitabine for Non-Small Cell Lung Cancer by the Tumor-Penetrating Peptide iRGD.
Li, H; Li, K; Wang, H; Zhang, Q; Zhang, Y; Zheng, J, 2015
)
1.38
"Gemcitabine (GEM) is an important anticancer nucleoside analog though deactivation and multi-drug resistance frequently happen."( Molecular self-assembly of amphiphilic cyclic phosphoryl gemcitabine with different N-fatty acyl tails and enhanced anticancer effects of the self-assembled nanostructures.
Du, L; Jin, Y; Wang, S; Yao, W, 2015
)
1.38
"Gemcitabine is a chemotherapeutic agent that eliminates both tumor cells and MDSCs, improving the immune environment favorable for subsequent treatment."( Progression of Large Lymphoma Is Significantly Impeded with a Combination of Gemcitabine Chemotherapy and Dendritic Cells Intra-Tumor Vaccination.
Cao, M; Chen, YC; Fan, ZF; Hu, SY; Li, WX; Liu, L; Sun, XM; Wang, LX; Yang, ZF; Zhou, JY; Zhu, XJ, 2015
)
1.37
"Gemcitabine is a common treatment, but response rates are low, perhaps due in part to tumor hypoxia."( Distribution of Gemcitabine Is Nearly Homogenous in Two Orthotopic Murine Models of Pancreatic Cancer.
Humm, JL; Kramer, RM; Russell, J, 2015
)
1.48
"Gemcitabine is a standard chemotherapeutic agent since 1997, but survival benefit is not satisfactory."( [Recent Advances in Palliative Chemotherapy for Unresectable Pancreatic Cancer].
Ryu, JK, 2015
)
1.14
"Gemcitabine was found to be a lytic inducer via activation of the ataxia telangiectasia-mutated (ATM)/p53 genotoxic stress pathway in EBVaGC."( Targeted therapy for Epstein-Barr virus-associated gastric carcinoma using low-dose gemcitabine-induced lytic activation.
Ambinder, RF; Chen, J; Choi, TH; Chong, CR; Dong, SM; Hayward, SD; Kim, EJ; Kim, H; Lee, HG; Lee, JM; Liu, JO; Park, JH; Park, PG, 2015
)
1.36
"Gemcitabine is an analog of deoxycytidine (pyrimidine antimetabolite) with antitumor activity."( The relationship between RRM1 gene polymorphisms and effectiveness of gemcitabine-based first-line chemotherapy in advanced NSCLC patient.
Ciesielka, M; Homa, I; Kozioł, P; Krawczyk, P; Małecka-Massalska, T; Milanowski, J; Mlak, R; Powrózek, T; Prendecka, M, 2016
)
1.39
"Gemcitabine (GEM) is a highly hydrophil anticancer drug which extensively used in the clinic for the treatment of a range of solid tumors, including pancreatic and lung cancers. "( Influence of PEG Molecular Weight on the Drug Release and In vitro Cytotoxicity of Single-Walled Carbon Nanotubes-PEG-Gemcitabine Conjugates.
Atyabi, F; Dinarvand, R; Kazemi, B; Razzazan, A, 2016
)
2.09
"Gemcitabine is a pyrimidine antimetabolite that has shown efficacy when used systemically in bladder cancer with only mild toxicity compared to other chemotherapeutic agents."( The safety and efficacy of gemcitabine for the treatment of bladder cancer.
Boegemann, M; Krabbe, LM; Schlack, K; Schrader, AJ; Steinestel, J, 2016
)
1.45
"Gemcitabine is a chemotherapeutic agent that has a different mechanism of action compared to alkylating agents and shows excellent radio-sensitizing properties."( Lauroyl-gemcitabine-loaded lipid nanocapsule hydrogel for the treatment of glioblastoma.
Bastiancich, C; Bastiat, G; Danhier, F; Lagarce, F; Pitorre, M; Préat, V; Ucakar, B; Vanvarenberg, K, 2016
)
1.59
"Gemcitabine appears to be a potent radiation sensitizer, and when combined with radiation therapy, it shows encouraging tumor response. "( Radiochemotherapy with Gemcitabine in Unresectable Extrahepatic Cholangiocarcinoma: Long-term Results of a Phase II Study.
Ardito, F; Autorino, R; Balducci, M; Deodato, F; Gambacorta, MA; Giuliante, F; Macchia, G; Mantini, G; Mattiucci, GC; Morganti, AG; Perri, V; Tagliaferri, L; Tringali, A; Valentini, V, 2016
)
2.19
"Gemcitabine is an important anticancer therapeutics approved for treatment of several human cancers including locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). "( 14-3-3σ regulation of and interaction with YAP1 in acquired gemcitabine resistance via promoting ribonucleotide reductase expression.
Dong, Z; Qin, L; Zhang, JT, 2016
)
2.12
"Gemcitabine is an antitumor agent with broad clinical application. "( A rash diagnosis: Gemcitabine-associated pseudocellulitis.
Epperla, N; Strouse, C, 2017
)
2.23
"Gemcitabine (GEM) is an anticancer agent widely used in non-small cell lung and pancreatic cancers. "( In vivo drug delivery of gemcitabine with PEGylated single-walled carbon nanotubes.
Atyabi, F; Dinarvand, R; Kazemi, B; Razzazan, A, 2016
)
2.18
"Gemcitabine is an antimetabolite ranking among the most prescribed anticancer drugs worldwide. "( Pharmacokinetics and pharmacogenetics of Gemcitabine as a mainstay in adult and pediatric oncology: an EORTC-PAMM perspective.
Ciccolini, J; Giovannetti, E; Peters, GJ; Serdjebi, C, 2016
)
2.14
"Gemcitabine is an important pyrimidine antimetabolite that inhibits cellular DNA synthesis. "( Antitumor gemcitabine conjugated micelles from amphiphilic comb-like random copolymers.
Cen, Y; Lin, X; Wang, J; Wu, Q; Zhang, X, 2016
)
2.28
"Gemcitabine is a medication used to treat various types of malignant neoplasms. "( Hemolytic uremic syndrome due to gemcitabine in a young woman with cholangiocarcinoma.
Aristizabal-Alzate, A; Florez-Vargas, AA; Galvez-Cárdenas, KM; Higuita, LM; Nieto-Ríos, JF; Ocampo-Kohn, C; Rincón, CI; Zuluaga-Quintero, M; Zuluaga-Valencia, GA, 2016
)
2.16
"Gemcitabine (GmcH) is an effective anti-cancer agent used in the chemotherapy of lung cancer. "( Augmented delivery of gemcitabine in lung cancer cells exploring mannose anchored solid lipid nanoparticles.
Kesharwani, P; Maheshwari, R; Pandey, H; Soni, N; Tekade, RK, 2016
)
2.19
"Gemcitabine is a clinically established anticancer agent potent in various solid tumors but limited by its rapid metabolic inactivation and off-target toxicity. "( Gemcitabine Based Peptide Conjugate with Improved Metabolic Properties and Dual Mode of Efficacy.
Argyros, O; Fokas, D; Karampelas, T; Skavatsou, E; Tamvakopoulos, C, 2017
)
3.34
"Gemcitabine is a widely-used anti-cancer drug with a well-defined mechanism of action in normal and transformed epithelial cells. "( Gemcitabine kills proliferating endothelial cells exclusively via acid sphingomyelinase activation.
Fuks, Z; Haimovitz-Friedman, A; Kolesnick, R; Tap, WD; van Hell, AJ, 2017
)
3.34
"Gemcitabine-radiotherapy is a standard treatment for locally advanced pancreatic cancer. "( The combination of epidermal growth factor receptor inhibitors with gemcitabine and radiation in pancreatic cancer.
Kollar, LE; Lawrence, TS; Maybaum, J; Morgan, MA; Normolle, DP; Parsels, LA, 2008
)
2.02
"Gemcitabine is a potent radiosensitizer of pancreatic cancer cells. "( [Three-dimensional conformal radiation therapy concurrent with full dose Gemcitabine for locally advanced inoperable pancreatic cancer].
Catane, R; Kundel, Y; Mendlovic, S; Pfeffer, R; Rabin, T; Symon, Z, 2008
)
2.02
"Gemcitabine is a pyrimidine antimetabolite with activity in a number of cancers. "( Gemcitabine-induced pulmonary toxicity during adjuvant therapy in a patient with pancreatic cancer.
Cornfeld, D; Lansigan, F; Saif, MW; Shaib, W; Syrigos, K, 2008
)
3.23
"Gemcitabine is a known risk factor for hemolytic uremic syndrome (HUS), which can often have a rapidly fatal clinical course despite intervention with steroids, plasmapheresis and hemodialysis."( Rituximab-based therapy for gemcitabine-induced hemolytic uremic syndrome in a patient with metastatic pancreatic adenocarcinoma: a case report.
Becker, J; Bharthuar, A; Deeb, G; Egloff, L; George, M; Iyer, RV; Lohr, JW, 2009
)
1.37
"Gemcitabine is an active drug in this disease."( Gemcitabine, irinotecan and celecoxib in patients with biliary cancer.
Mayo, MS; Smith, HJ; Watkins, JF; Williamson, SK, 2009
)
2.52
"Gemcitabine is a promising adjuvant treatment for patients with resected pancreatic adenocarcinoma and its use in combination with radiotherapy is under exploration. "( Human equilibrative nucleoside transporter 1 and human concentrative nucleoside transporter 3 predict survival after adjuvant gemcitabine therapy in resected pancreatic adenocarcinoma.
Cass, CE; Demetter, P; Devière, J; Lai, R; Mackey, JR; Maréchal, R; Peeters, M; Polus, M; Salmon, I; Van Laethem, JL; Young, J, 2009
)
2
"Gemcitabine (GMZ) is a chemotherapeutic agent with well established effects on cell growth arrest and apoptosis. "( Downregulation of neutral ceramidase by gemcitabine: Implications for cell cycle regulation.
Hannun, YA; Wu, BX; Zeidan, YH, 2009
)
2.06
"Gemcitabine is an anti-cancer agent of first-line chemotherapy for patient with pancreatic carcinoma."( [A case of drug induced interstitial pneumonitis after gemcitabine treatment for pancreatic carcinoma].
Ishibashi, Y; Ito, Y, 2009
)
1.32
"Gemcitabine (Gemc) is an efficient chemotherapeutic drug in various cancer types (e.g., pancreas) but has only limited effects on hormone-refractory prostate cancer (HRPCa). "( Liposomal gemcitabine (GemLip)-efficient drug against hormone-refractory Du145 and PC-3 prostate cancer xenografts.
Esser, N; Graeser, R; Jantscheff, P; Kluth, J; Massing, U; Unger, C; Ziroli, V, 2009
)
2.2
"Gemcitabine is a pyrimidine analogue which has shown efficacy and a favourable safety profile in solid tumours and haematological malignancies."( Gemcitabine treatment in cutaneous T-cell lymphoma: a multicentre study of 23 cases.
Bachelez, H; Beylot-Barry, M; Chaoui, D; Dubertret, L; Ingen-Housz-Oro, S; Jidar, K; Morel, P; Paul, C; Sigal-Grinberg, M, 2009
)
2.52
"Gemcitabine is an anti-cancer drug known to be safe and effective for pancreatic or biliary tract cancers, but lung injury is also known to be a rare side effect that sometimes becomes severe. "( [Seven cases of gemcitabine-induced lung injury during treatment for pancreatic or biliary tract cancers].
Amitani, R; Hatano, K; Ikeda, A; Kawakami, H; Kimura, T; Kita, R; Maruo, T; Matsuo, H; Nakatsuji, M; Nishijima, N; Nishikawa, H; Okabe, Y; Osaki, Y; Saito, S; Tsumura, T, 2009
)
2.14
"Gemcitabine is a cytotoxic nucleoside analog, which is widely used in the treatment of malignancies. "( Clinical pharmacology and pharmacogenetics of gemcitabine.
Innocenti, F; Soo, RA; Wong, A; Yong, WP, 2009
)
2.05
"Gemcitabine is a first-line agent for advanced pancreatic cancer therapy. "( Gemcitabine-based chemogene therapy for pancreatic cancer using Ad-dCK::UMK GDEPT and TS/RR siRNA strategies.
Bigand, C; Hajri, A; Parmentier, C; Réjiba, S, 2009
)
3.24
"Gemcitabine hydrochloride is an anticancer nucleoside analogue indicated in clinic for the treatment of various solid tumors. "( Polymeric nanoparticulate system augmented the anticancer therapeutic efficacy of gemcitabine.
Arias, JL; Couvreur, P; Reddy, LH, 2009
)
2.02
"Gemcitabine is a broadly active pyrimidine nucleoside antimetabolite that is incorporated into DNA and causes chain termination."( The role of pemetrexed combined with gemcitabine for non-small-cell lung cancer.
Ngeow, J; Toh, CK, 2010
)
1.35
"Gemcitabine is a standard therapy for pancreatic cancer."( A phase I study of imexon plus gemcitabine as first-line therapy for advanced pancreatic cancer.
Boytim, ML; Cohen, SJ; Conkling, P; Davis, P; Dorr, RT; Hersh, EM; Modiano, MR; Patt, YZ; Zalupski, MM, 2010
)
1.37
"Gemcitabine is a chemotherapy agent that may cause unpredictable side effects. "( Fatal gemcitabine-induced pulmonary toxicity in metastatic gallbladder adenocarcinoma.
Capelozzi, VL; Galvão, FH; Pestana, JO, 2010
)
2.28
"Gemcitabine (Gem) is a dFdC analogue with activity against several solid tumors. "( Tranilast strongly sensitizes pancreatic cancer cells to gemcitabine via decreasing protein expression of ribonucleotide reductase 1.
Hashiguchi, K; Hiraki, M; Kai, K; Kitajima, Y; Mitsuno, M; Miyazaki, K; Nakamura, J; Noshiro, H; Ohtaka, K, 2010
)
2.05
"Gemcitabine is a deoxycytidine (dCyd) analog with activity in leukemia and solid tumors, which requires phosphorylation by deoxycytidine kinase (dCK). "( Antiproliferative activity, mechanism of action and oral antitumor activity of CP-4126, a fatty acid derivative of gemcitabine, in in vitro and in vivo tumor models.
Adema, AD; Balzarini, J; Bergman, AM; Bruheim, S; Fichtner, I; Fodstad, O; Hendriks, HR; Myhren, F; Noordhuis, P; Peters, GJ; Sandvold, ML, 2011
)
2.02
"Gemcitabine is a chemotherapy agent frequently used for the treatment of pancreatic cancer as well as metastatic breast, lung, and ovarian cancer. "( Toxicities of gemcitabine in patients with severe hepatic dysfunction.
Hall, PD; Teusink, AC, 2010
)
2.16
"Gemcitabine is a nucleoside analogue used for treatment of multiple cancers. "( Gemcitabine-associated large vessel vasculitis presenting as fever of unknown origin.
Bernstein, SA; Edison, JD; Hamilton, CA; Ramsay, LB; Schlegal, KE; Stany, MP, 2010
)
3.25
"Gemcitabine is a first line cancer drug widely used for the treatment of pancreatic cancer. "( Potentiation of gemcitabine by Turmeric Force in pancreatic cancer cell lines.
Aviram, A; Escalon, E; Melnick, SJ; Ramachandran, C; Resek, AP, 2010
)
2.15
"Gemcitabine is an anticancer nucleoside analogue active against a wide variety of solid tumors. "( Interaction of a new anticancer prodrug, gemcitabine-squalene, with a model membrane: coupled DSC and XRD study.
Amenitsch, H; Bourgaux, C; Couvreur, P; Desmaële, D; Keller, G; Lepêtre-Mouelhi, S; Ollivon, M; Pili, B, 2010
)
2.07
"Gemcitabine (Gemzar) is a nucleoside analogue used as a cytotoxic agent for the treatment of various carcinomas: pancreatic cancer, bladder cancer, breast cancer, and non-small-cell-lung cancer. "( Hand-foot hyperpigmentation skin lesions associated with combination gemcitabine-carboplatin (GemCarbo) therapy.
Chaudhary, RT; Kleynberg, RL; Sofi, AA, 2011
)
2.05
"Gemcitabine is a commonly used chemotherapeutic agent for advanced biliary tract carcinoma (BTC), although its efficacy is insufficient. "( Ribonucleotide reductase subunit M1 assessed by quantitative double-fluorescence immunohistochemistry predicts the efficacy of gemcitabine in biliary tract carcinoma.
Hashiguchi, K; Hiraki, M; Kai, K; Kitajima, Y; Kohya, N; Miyazaki, K; Nakamura, J; Noshiro, H; Ohtaka, K; Tokunaga, O, 2010
)
2.01
"Gemcitabine is an effective agent in pancreatic adenocarcinoma. "( Fixed-dose-rate gemcitabine infusion in patients with advanced pancreatic or biliary tree adenocarcinoma.
Ballesteros, D; Carrera, S; Casas, R; Fernández, R; Fuente, N; López-Vivanco, G; Mané, JM; Marrodán, I; Mielgo, X; Muñoz, A; Rubio, I; Sancho, A,
)
1.92
"Gemcitabine is a nucleoside analogue with broad antitumor activity."( Gemcitabine and docetaxel in metastatic, castrate-resistant prostate cancer: results from a phase 2 trial.
Dreicer, R; Elson, P; Garcia, JA; Hutson, TE; Shepard, D, 2011
)
2.53
"Gemcitabine is a cytotoxic nucleoside analog, which is widely used in the treatment of malignancies, and in particular in pancreatic carcinoma."( [The role of membrane transporters in cellular resistance of pancreatic carcinoma to gemcitabine].
Mohelníková-Duchonová, B; Soucek, P, 2010
)
1.31
"Gemcitabine is a very well tolerated drug with mild myelosuppression, asthenia and nausea/vomiting as its main toxicities."( Gemox: a widely useful therapy against solid tumors-review and personal experience.
Meriggi, F; Zaniboni, A, 2010
)
1.08
"Gemcitabine is a cytotoxic cytidine analog, which is widely used in anti-cancer therapy. "( Gemcitabine functions epigenetically by inhibiting repair mediated DNA demethylation.
Barreto, G; Döderlein, G; Niehrs, C; Schäfer, A; Schomacher, L, 2010
)
3.25
"Gemcitabine is an effective chemotherapy against non-small cell lung cancer (NSCLC). "( Isolation and characterization of gemcitabine-resistant human non-small cell lung cancer A549 cells.
Ikeda, R; Jiang, Z; Kolesar, JM; Lau, E; Sachidanandam, K; Vermeulen, LC; Yamada, K, 2011
)
2.09
"Gemcitabine is a potent chemotherapeutic that exerts cytotoxic activity against several leukemias and a wide spectrum of carcinomas. "( Synthesis of a covalent gemcitabine-(carbamate)-[anti-HER2/neu] immunochemotherapeutic and its cytotoxic anti-neoplastic activity against chemotherapeutic-resistant SKBr-3 mammary carcinoma.
Coyne, CP; Jones, T; Pharr, T, 2011
)
2.12
"Gemcitabine is a pyrimidine analog effective against many solid tumors. "( Effect of its deaminated metabolite, 2',2'-difluorodeoxyuridine, on the transport and toxicity of gemcitabine in HeLa cells.
Hodge, LS; Taub, ME; Tracy, TS, 2011
)
2.03
"Gemcitabine is a nucleoside analogue with anticancer activity. "( Connexin-26 is a key factor mediating gemcitabine bystander effect.
Carrió, M; Cascante, A; Fillat, C; García-Ribas, I; Garcia-Rodríguez, L; Mazo, A; Pérez-Torras, S, 2011
)
2.08
"Gemcitabine (dFdC or Gem) is a water-soluble cytotoxic drug, with poor cellular uptake in the absence of a nucleoside transporter. "( Interaction of self-assembled squalenoyl gemcitabine nanoparticles with phospholipid-cholesterol monolayers mimicking a biomembrane.
Ambike, A; Couvreur, P; Lepêtre-Mouelhi, S; Rosilio, V; Stella, B, 2011
)
2.08
"Gemcitabine is a promising drug for cholangiocarcinoma treatment. "( Gene expression analysis for predicting gemcitabine resistance in human cholangiocarcinoma.
Anazawa, T; Gotoh, M; Kenjo, A; Kimura, T; Saito, T; Sato, J; Sato, Y; Tsuchiya, T, 2011
)
2.08
"Gemcitabine not only functions as a suicide nucleoside analog but also inhibits DNA polymerase activity and results in the termination of chain elongation."( UBE2M-mediated p27(Kip1) degradation in gemcitabine cytotoxicity.
Chao, SY; Chou, CH; Hour, TC; Hu, HT; Huang, AM; Kao, YT; Lin, PY; Liou, JY; Lu, CY; Pu, YS; Toh, S, 2011
)
1.36
"Gemcitabine (dFdC) is a chemotherapeutic nucleoside analog that undergoes uptake via equilibrative nucleoside transporters (hENT) followed by sequential phosphorylation to the active triphosphate moiety (dFdCTP). "( The deaminated metabolite of gemcitabine, 2',2'-difluorodeoxyuridine, modulates the rate of gemcitabine transport and intracellular phosphorylation via deoxycytidine kinase.
Hodge, LS; Taub, ME; Tracy, TS, 2011
)
2.1
"Gemcitabine is a deoxycytidine analog used in the treatment of various solid tumors. "( Stearoyl gemcitabine nanoparticles overcome resistance related to the over-expression of ribonucleotide reductase subunit M1.
Chung, WG; Cui, Z; Lansakara-P, DS; Sandoval, MA; Sloat, BR, 2012
)
2.24
"Gemcitabine is a promising adjuvant treatment for patients with resected pancreatic cancer. "( Immunohistochemical analysis of human equilibrative nucleoside transporter-1 (hENT1) predicts survival in resected pancreatic cancer patients treated with adjuvant gemcitabine monotherapy.
Akaike, M; Kameda, Y; Mikayama, H; Miyagi, Y; Morinaga, S; Nakamura, Y; Ohkawa, S; Shiozawa, M; Tamagawa, H; Watanabe, T; Yamamoto, N, 2012
)
2.02
"Gemcitabine is a commonly used chemotherapeutic agent for a variety of tumors. "( Gemcitabine-induced posterior reversible encephalopathy syndrome: a case report.
Belfiglio, M; Cioffi, P; Grappasonni, I; Laudadio, L; Nuzzo, A; Petrelli, F, 2012
)
3.26
"Gemcitabine is an established chemotherapy agent in several solid tumors. "( Determination of the phosphorylated metabolites of gemcitabine and of difluorodeoxyuridine by LCMSMS.
Giovannetti, E; Honeywell, RJ; Peters, GJ, 2011
)
2.06
"Gemcitabine resistance is a common problem of pancreatic cancer chemotherapy, and how to reverse it plays an important role in the treatment of pancreatic cancer. "( Emodin reverses gemcitabine resistance in pancreatic cancer cells via the mitochondrial apoptosis pathway in vitro.
Bu, H; Chen, H; Guo, HC; Li, H; Lin, SZ; Liu, DL; Liu, HB; Ni, ZL; Tong, HF; Wang, ZH, 2012
)
2.17
"Gemcitabine is a relatively new anticancer drug that has shown activity against bladder cancer."( Intravesical gemcitabine for non-muscle invasive bladder cancer.
Cleves, A; Jones, G; Kynaston, HG; Mason, M; Shelley, M; Wilt, TJ, 2012
)
1.47
"Gemcitabine is a relatively new anticancer drug that has shown activity against bladder cancer."( Intravesical gemcitabine therapy for non-muscle invasive bladder cancer (NMIBC): a systematic review.
Cleves, A; Jones, G; Kynaston, HG; Mason, MD; Shelley, MD; Wilt, TJ, 2012
)
1.47
"Gemcitabine is a nucleoside analog with many faces, which shows a remarkable activity in a variety of cancers, most likely because it has a unique metabolism, a so-called self-potentiation."( Nucleoside and nucleobase analogs in cancer treatment: not only sapacitabine, but also gemcitabine.
Diaz, I; Muggia, F; Peters, GJ, 2012
)
1.32
"Gemcitabine is a key drug for the treatment of pancreatic cancer. "( Human equilibrative nucleoside transporter 1 level does not predict prognosis in pancreatic cancer patients treated with neoadjuvant chemoradiation including gemcitabine.
Ishikawa, O; Katayama, K; Kawada, N; Nagata, S; Nakamura, S; Ohigashi, H; Takahashi, H; Tomita, Y; Uehara, H, 2012
)
2.02
"Gemcitabine is a potent radiosensitizer. "( A two-cohort phase I study of weekly oxaliplatin and gemcitabine, then oxaliplatin, gemcitabine, and erlotinib during radiotherapy for unresectable pancreatic carcinoma.
Aklilu, M; Bernard, SA; Blackstock, AW; Davies, JM; Goldberg, RM; Ivanova, A; O'Neil, BH; Raftery, L; Tepper, JE, 2013
)
2.08
"Gemcitabine hydrochloride is a very safe medicine that even outpatients can be administered, and the bone marrow depression that is the dose limiting factor remains moderate and does not need special treatment, although it is confirmed in most cases. "( [Analysis of risk factors of drug-induced lung injury in patients receiving gemcitabine treatment].
Atsumi, I; Fujita, T; Miki, Y; Nakamichi, H; Nakamura, H; Shiokawa, M; Suzuki, R; Tomita, K; Totsuka, K; Tsuji, D, 2012
)
2.05
"Gemcitabine is a deoxycytidine analog antimetabolite that is now accepted as first-line treatment for advanced and metastatic pancreatic carcinoma. "( Gemcitabine-associated livedoid thrombotic microangiopathy with associated sclerema neonatorum-like microscopic changes.
Cañueto, J; Fernández-López, E; Mir-Bonafé, JM; Román-Curto, C; Santos-Briz, A; Unamuno, P, 2012
)
3.26
"Gemcitabine is an effective anti-cancer agent against solid tumors. "( Gemcitabine causes telomere attrition by stabilizing TRF2.
Chao, Y; Chu, WC; Lan, KH; Lee, SD; Lee, WP; Li, CP; Lin, HC; Su, CH; Tsai, YC, 2012
)
3.26
"Gemcitabine (GEM) is a nucleoside analog agent against a wide variety of tumors. "( Enhanced anticancer activity of gemcitabine coupling with conjugated linoleic acid against human breast cancer in vitro and in vivo.
Feng, Q; Gao, SY; Tao, XM; Wang, JB; Wang, JC; Zhang, LR; Zhang, Q, 2012
)
2.11
"Gemcitabine is a deoxycytidine analog used for the treatment of a wide range of solid tumors. "( Silencing of ribonucleotide reductase subunit M1 potentiates the antitumor activity of gemcitabine in resistant cancer cells.
Chung, WG; Cui, Z; Digiovanni, J; Kiguchi, K; Wonganan, P; Zhu, S, 2012
)
2.04
"Gemcitabine is a standard of care for the treatment of pancreatic cancer."( Molecular evidence for increased antitumor activity of gemcitabine in combination with a cyclin-dependent kinase inhibitor, P276-00 in pancreatic cancers.
Joshi, K; Joshi, KS; Khanwalkar, H; Manohar, SM; Rathos, MJ, 2012
)
1.35
"Gemcitabine is a known cytotoxic agent with a wide spectrum of antitumor activity. "( Role of chitosan nanoparticles in the oral absorption of Gemcitabine.
Derakhshandeh, K; Fathi, S, 2012
)
2.07
"Gemcitabine is an analogue of pyrimidine cytosine and functions as an anti-metabolite."( Gemcitabine reactivates epigenetically silenced genes and functions as a DNA methyltransferase inhibitor.
Almgren, M; Baird, AM; Dockry, E; Ekström, TJ; Gray, SG; Hollywood, D; Meunier, A; Nikolaidis, G; O'Byrne, KJ; O'Kelly, F; Perry, AS, 2012
)
2.54
"Gemcitabine is a nucleoside analog that is currently the best available single-agent chemotherapeutic drug for pancreatic cancer. "( Aptamer-mediated delivery of chemotherapy to pancreatic cancer cells.
Cheek, MA; Ellington, AD; Li, N; Ray, P; Sharaf, ML; Shaw, BR; Sullenger, BA; White, RR, 2012
)
1.82
"Gemcitabine is a promising candidate for single-agent maintenance therapy because of little toxicity and good tolerability."( Randomized Phase II trial of paclitaxel and carboplatin followed by gemcitabine switch-maintenance therapy versus gemcitabine and carboplatin followed by gemcitabine continuation-maintenance therapy in previously untreated advanced non-small cell lung can
Hirashima, T; Imamura, F; Kawase, I; Kijima, T; Komuta, K; Minami, S; Nakatani, T; Namba, Y; Ogata, Y; Okafuji, K; Osaki, T; Otsuka, T; Shiroyama, T; Tachibana, I; Uchida, J; Yamamoto, S, 2013
)
1.35
"Gemcitabine is an excellent candidate for regional therapy. "( Pharmacokinetics of intrathecal gemcitabine in nonhuman primates.
Balis, FM; Berg, SL; Blaney, SM; Egorin, MJ; Kerr, JZ; McCully, CM; Zuhowski, EG, 2002
)
2.04
"Gemcitabine/vinorelbine is an active, well-tolerated combination in both front-line and second/third-line therapy for Stage IIIB/IV NSCLC. "( The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma: potential for decreased toxicity and combination with biological therapy.
Blumenschein, G; Fossella, FV; Glisson, BS; Herbst, RS; Hong, WK; Jung, MS; Khuri, FR; Kies, MS; Kurie, JM; Lee, JJ; Lee, JS; Liu, DD; Lu, C; Lu, R; Munden, RF; Papadimitrakopoulou, VA; Pisters, KM; Shin, DM; Zinner, R, 2002
)
2
"Gemcitabine is a prodrug that requires intracellular activation by phosphorylation into its active triphosphate dFdCTP form."( Role of deoxycytidine kinase (dCK) activity in gemcitabine's radioenhancement in mice and human cell lines in vitro.
Bruniaux, M; De Bast, M; De Coster, B; Grégoire, V; Octave-Prignot, M; Rosier, JF; Scalliet, P, 2002
)
1.29
"Gemcitabine is a pyrimidine nucleoside analog with antitumor activity against solid tumor malignancies and leukemia. "( Gemcitabine alone or combined with cisplatin in relapsed or refractory multiple myeloma.
Alesiani, F; Corvatta, L; Leoni, P; Malerba, L; Marconi, M; Mele, A; Offidani, M; Olivieri, A; Rupoli, S, 2002
)
3.2
"Gemcitabine (Gem) is a deoxycytidine analogue whose active metabolite, dFdCTP, blocks DNA elongation and has a cytotoxic effect. "( Time and sequence dependence of hydroxyurea in combination with gemcitabine in human KB cells.
Hsu, M; Hu, E; Kay, K; Mi, S; Mo, X; Shih, J; Tsai, J; Yen, Y; Zhou, B,
)
1.81
"Gemcitabine is a nucleoside analogue and its cytotoxicity is correlated with incorporation into genomic DNA and concomitant inhibition of DNA synthesis."( Gemcitabine (2',2'-difluoro-2'-deoxycytidine), an antimetabolite that poisons topoisomerase I.
Gioffre, C; Gmeiner, WH; Goldwasser, F; Hertel, LW; Kohlhagen, G; Pommier, Y; Pon, RT; Pourquier, P; Urasaki, Y; Yu, S, 2002
)
2.48
"Gemcitabine is a nucleoside analogue that has shown to have antineoplastic activity in different solid tumours (lung, pancreas, bladder, colon, ovarian, and breast cancer) and malignant mesothelioma. "( Gemcitabine-induced erysipeloid skin lesions in a patient with malignant mesothelioma.
Aydogdu, I; Kaya, E; Kuku, I; Sevinc, A, 2002
)
3.2
"Gemcitabine is a newly developed drug for treating advanced non-small cell lung cancer (NSCLC). "( [Gemcitabine in the treatment of advanced non-small cell lung cancer: report of one case].
Duan, EY; Liu, AH; Wang, XS; Wu, YX; Zhou, Y, 2002
)
2.67
"Gemcitabine is an active agent in pancreatic cancer, with known radiosensitizing properties. "( Phase II study of gemcitabine combined with radiation therapy in patients with localized, unresectable pancreatic cancer.
Epelbaum, R; Faraggi, D; Gaitini, D; Kuten, A; Mizrahi, S; Nasrallah, S; Rosenblatt, E, 2002
)
2.09
"Gemcitabine is a new antimetabolite selected for clinical trials based on its activity in preclinical studies."( [Gemicitabine in the treatment of epithelial ovarian cancer].
Gutierrez, M; Lhomme, C; Pautier, P, 2002
)
1.04
"Gemcitabine is a molecule presenting with major radiosensitizing or radio-potentiator capacities. "( [Combined gemcitabine and radiotherapy].
Mornex, F, 2002
)
2.16
"Gemcitabine is a highly effective agent that warrants farther evaluation as a component of multidrug chemotherapy."( Cyclophosphamide, doxorubicin, and gemcitabine combination chemotherapy for treatment of metastatic and locally advanced breast cancer.
Durgam, S; Levin, M; Novetsky, A, 2002
)
1.31
"Gemcitabine is a nucleoside analog with activity against solid tumors, including breast and non-small cell lung cancers."( Early detection and successful treatment of drug-induced pneumonitis with corticosteroids.
Ash-Bernal, R; Browner, I; Erlich, R, 2002
)
1.04
"Gemcitabine is an active antitumor agent in the treatment of advanced pancreatic cancer, and has shown potential synergistic activity with the oral fluoropyrimidine capecitabine in previous phase I/II trials. "( Biweekly high-dose gemcitabine alone or in combination with capecitabine in patients with metastatic pancreatic adenocarcinoma: a randomized phase II trial.
Depisch, D; Haider, K; Kornek, GV; Kwasny, W; Lang, F; Raderer, M; Scheithauer, W; Schmid, K; Schneeweiss, B; Schüll, B; Ulrich-Pur, H, 2003
)
2.09
"Gemcitabine is a pyrimidine nucleoside antimetabolite that is approved worldwide for the treatment of pancreatic and non-small cell lung cancers, and bladder cancer outside the United States."( Preclinical and clinical studies with combinations of pemetrexed and gemcitabine.
Adjei, AA, 2002
)
1.27
"Gemcitabine cisplatin is a very active combination for this tumor, therefore we explored the activity of gemcitabine in combination with oxaliplatin."( Induction chemotherapy with gemcitabine and oxaliplatin for locally advanced cervical carcinoma.
Chanona, G; de la Garza, J; Dueñas-González, A; Gomez, E; González, A; López-Graniel, C; Mohar, A; Rivera, L; Trejo-Becerril, C, 2003
)
1.33
"Gemcitabine is an effective drug against NSCLC and has a structure similar to cytarabine, which has been widely used in intrathecal chemotherapy."( Intrathecal gemcitabine chemotherapy for non-small cell lung cancer patients with meningeal carcinomatosis--a case report.
Chen, MC; Chen, YM; Perng, RP; Tsai, CM, 2003
)
1.42
"Gemcitabine is an antimetabolite drug with proven antitumor activity and tolerability in metastatic breast cancer. "( Role of gemcitabine in the treatment of advanced and metastatic breast cancer.
Heinemann, V, 2003
)
2.2
"Gemcitabine is a novel agent that has also shown good antitumor activity in advanced breast cancer."( Gemcitabine and anthracyclines in breast cancer.
Jassem, J, 2003
)
2.48
"Gemcitabine and docetaxel is an active second-line combination in patients with advanced urothelial carcinoma. "( Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium: a trial of the Eastern Cooperative Oncology Group.
Dreicer, R; George, CS; Manola, J; Roth, BJ; Schneider, DJ; Schwerkoske, JF; Wilding, G, 2003
)
2.1
"Gemcitabine is an antimetabolite similar in structure to cytosine arabinoside with early studies demonstrating activity in a variety of cancers."( Gemcitabine, Paclitaxel, and piritrexim: a phase I study.
Alberti, D; Arzoomanian, RZ; Bailey, HH; Binger, K; Feierabend, C; Liu, G; Marnocha, R; Thomas, JP; Volkman, J; Wilding, G, 2003
)
2.48
"Gemcitabine (dFdC) is a pyrimidine antimetabolite with broad spectrum activity against tumors. "( Simultaneous determination of gemcitabine and its metabolite in human plasma by high-performance liquid chromatography.
Aksoy, Y; Kadioğlu, YY; Yilmaz, B, 2003
)
2.05
"Gemcitabine is a novel nucleoside analogue with clinical anticancer activity in several malignancies. "( A phase II trial of gemcitabine in the treatment of advanced bile duct and periampullary carcinomas.
Chen, HH; Chen, JS; Lin, MH; Su, WC, 2003
)
2.09
"Gemcitabine is an important drug in the treatment of non-small cell lung cancer. "( [Acute pulmonary toxicity due to gemcitabine: a role for asbestos exposure?].
Barlési, F; Doddoli, C; Gimenez, C; Greillier, L; Kleisbauer, JP; Lima, G, 2003
)
2.04
"Gemcitabine is a deoxycytidine analogue, used intravenously in the treatment of several tumours, including transitional cell carcinoma of the bladder. "( Pharmacokinetics of intravesical gemcitabine: a preclinical study in pigs.
Peters, GJ; Schalken, JA; van der Heijden, AG; Vriesema, JL; Witjes, JA, 2003
)
2.04
"Gemcitabine is an active agent in NSCLC with a good toxicity profile and lends itself to this type of investigation."( Domiciliary chemotherapy with gemcitabine is safe and acceptable to advanced non-small-cell lung cancer patients: results of a feasibility study.
Addington-Hall, JM; Anderson, H; Keane, K; McKendrik, J; Peake, MD; Thatcher, N, 2003
)
1.33
"Gemcitabine is an approved antimetabolite chemotherapeutic agent effective as single agent in patients with solid tumors (ST)."( Mistletoe and gemcitabine in patients with advanced cancer: a model for the phase I study of botanicals and botanical-drug interactions in cancer therapy.
Blackman, MR; Grem, J; Mansky, PJ; Monahan, BP; Wallerstedt, DB, 2003
)
1.4
"Gemcitabine is a nucleoside analog that can affect cell-mediated immunity, and this may contribute to an increased risk of reactivation of hepatitis B."( Gemcitabine and reactivation of hepatitis B.
Cheong, K; Karapetis, CS; Li, J, 2003
)
2.48
"Gemcitabine is a pyrimidine nucleoside antimetabolite that has shown activity in a variety of solid tumors, a good toxicity profile, and non-overlapping toxicity with other chemotherapeutic drugs."( Rationale for the use of gemcitabine in breast cancer (Review).
Andreola, G; Crucitta, E; D'Aprile, M; De Lena, M; Locopo, N; Lorusso, V; Marini, L; Silvestris, N, 2004
)
1.35
"Gemcitabine is a deoxycytidine analogue, used systemically for several tumours, such as non-localised bladder cancer, where it is effective and well tolerated."( Intravesical gemcitabine: a phase 1 and pharmacokinetic study.
Laan, A; Peters, GJ; Schalken, JA; van der Heijden, AG; Vriesema, JL; Witjes, JA, 2004
)
1.41
"Gemcitabine (GEM) is an alternative chemotherapeutic agent for patients with metastatic bladder cancer. "( Gemcitabine-induced vasculitis in advanced transitional cell carcinoma of the bladder.
Akar, S; Akkoc, N; Birlik, M; Kirkali, Z; Manisali, M; Onen, F; Ozer, E; Tuzel, E, 2004
)
3.21
"Gemcitabine is a relatively new deoxycytidine analog (2',2'-difluorodeoxycytidine) with structural similarities to cytosine arabinoside (Ara-C). "( Gemcitabine-induced severe pulmonary toxicity.
Barlési, F; Doddoli, C; Gimenez, C; Kleisbauer, JP; Villani, P, 2004
)
3.21
"Gemcitabine is an inhibitor of ribonucleotide reductase (RR) and DNA synthesis and is an effective agent in the treatment of pancreas cancer. "( Synergistic cytotoxicity and pharmacogenetics of gemcitabine and pemetrexed combination in pancreatic cancer cell lines.
Danesi, R; Del Tacca, M; Giovannetti, E; Mey, V; Mosca, I, 2004
)
2.02
"Gemcitabine is an analogue of deoxycytidine with activity against several solid tumors. "( Resistance to gemcitabine in a human follicular lymphoma cell line is due to partial deletion of the deoxycytidine kinase gene.
Clarke, ML; Cros, E; Dumontet, C; Galmarini, CM; Jordheim, L; Mackey, JR; Santos, CL, 2004
)
2.13
"Gemcitabine seems to be an attractive agent for salvage chemotherapy in ovarian carcinoma patients who failed with prior lines of chemotherapy."( Long-term disease-free survival effected by gemcitabine in a heavily pretreated patient with recurrent ovarian carcinoma.
Piura, B, 2005
)
2.03
"Gemcitabine is a nucleosid analog approved for use in the treatment of metastatic urothelial carcinoma of the bladder. "( Gemcitabine-associated scleroderma-like changes of the lower extremities.
Bessis, D; Guilhou, JJ; Guillot, B; Legouffe, E, 2004
)
3.21
"Gemcitabine is a promising agent for the treatment of resectable advanced pancreatic cancer, and a randomized control trial is warranted for gemcitabine-based chemotherapy."( [Role of postoperative adjuvant chemotherapy with gemcitabine for pancreatic cancer: feasibility and anti-tumor effect].
Hatakeyama, K; Kurosaki, I; Shimizu, T; Tsuchiya, Y, 2004
)
1.3
"Gemcitabine is a new standard chemotherapeutic agent used in the treatment of pancreatic cancer, but the mechanisms of gemcitabine sensitivity are still controversial. "( Selenoprotein P, as a predictor for evaluating gemcitabine resistance in human pancreatic cancer cells.
Maehara, S; Maehara, Y; Saito, Y; Shimada, M; Shirabe, K; Takahashi, K; Tanaka, S, 2004
)
2.02
"Gemcitabine is a promising compound for the treatment of human lung cancer. "( Extracellular signal-regulated kinase activation and Bcl-2 downregulation mediate apoptosis after gemcitabine treatment partly via a p53-independent pathway.
Chang, GC; Chen, CY; Hsu, SL; Sheu, GT; Tsai, JR; Wu, WJ, 2004
)
1.98
"Gemcitabine is a known anticancer agent rapidly deaminated to the inactive metabolite 2',2'-difluorodeoxyuridine; it must therefore be administered at very high dose. "( Preparation, characterization, cytotoxicity and pharmacokinetics of liposomes containing lipophilic gemcitabine prodrugs.
Arpicco, S; Brusa, P; Cattel, L; Ceruti, M; Immordino, ML; Rocco, F, 2004
)
1.98
"Gemcitabine is a deoxycytidine analog, which can be inactivated by deamination catalyzed by deoxycytidine deaminase (dCDA). "( Antiproliferative activity and mechanism of action of fatty acid derivatives of gemcitabine in leukemia and solid tumor cell lines and in human xenografts.
Bergman, AM; Breistøl, K; Comijn, EM; Fodstad, O; Hendriks, HR; Kuiper, CM; Myhren, F; Noordhuis, P; Peters, GJ; Sandvold, ML; Smid, K; Voorn, DA, 2004
)
1.99
"Gemcitabine is a commonly used chemotherapy for biliary tree carcinomas, achieving response rates of 10% to 60%. "( A Phase II trial of fixed dose rate gemcitabine in patients with advanced biliary tree carcinoma.
Dai, L; Eng, C; Kindler, HL; Mani, S; Ramanathan, RK; Ramathan, RK; Remick, SC; Wade-Oliver, KT; Wong, MK, 2004
)
2.04
"Gemcitabine is a rather new anti-cancer agent, which is quite potent against a range of drug resistant tumors, particularly breast cancer."( Acetaminophen and DMSO modulate growth and gemcitabine cytotoxicity in FM3A breast cancer cells in vitro.
Altinoz, MA; Bilir, A; Guneri, AD, 2004
)
1.31
"Gemcitabine is a promising new chemotherapeutic agent that can be used safely in dogs with cancer."( Clinical evaluation of gemcitabine in dogs with spontaneously occurring malignancies.
Couto, CG; Gallant, SL; Kisseberth, WC; Kosarek, CE,
)
1.16
"Gemcitabine is a pro-drug that has to be phosphorylated to gemcitabine-triphosphate in order to exhibit its antineoplastic activity. "( Prolonged infusion of gemcitabine in advanced solid tumors: a phase-I-study.
Beinert, T; Flath, B; Possinger, K; Schmid, P; Schweigert, M; Sezer, O, 2005
)
2.09
"Gemcitabine is a pyrimidine analog that is active in patients with aggressive lymphomas and Hodgkin disease. "( A phase II study of single agent gemcitabine in relapsed or refractory follicular or small lymphocytic non-Hodgkin lymphomas: a Hoosier Oncology Group Study.
Bufill, J; Cripe, LD; Fisher, W; Ganjoo, KN; Huh, SY; Jung, SH; McClean, J; Robertson, MJ; Williams, S, 2005
)
2.05
"Gemcitabine is a novel nucleoside analogue, which acts synergistically with cisplatin both in vitro and in clinical studies."( Gemcitabine, cisplatin and methylprednisolone (GEM-P) is an effective salvage regimen in patients with relapsed and refractory lymphoma.
Catovsky, D; Chau, I; Cunningham, D; Hill, M; Horwich, A; Ng, M; Norman, AR; Waters, J; Wotherspoon, A, 2005
)
2.49
"Gemcitabine is a deoxycytidine analog that inhibits DNA synthesis and repair and has a broad spectrum of antitumor activity."( Phase II study of gemcitabine in children with relapsed acute lymphoblastic leukemia or acute myelogenous leukemia (ADVL0022): a Children's Oncology Group Report.
Angiolillo, AL; Chen, Z; Krailo, M; Reaman, G; Whitlock, J, 2006
)
1.39
"Gemcitabine (G) is a novel deoxycitidine analogue that has been proven to be a potent radiosensitizer."( Concurrent chemoradiotherapy with low dose weekly gemcitabine in stage III non-small cell lung cancer.
Abacioglu, U; Caglar, H; Sengoz, M; Turhal, NS; Yumuk, PF, 2005
)
1.3
"Gemcitabine is a pyrimidine antimetabolite which has shown activity in metastatic breast cancer both as a single agent, but also in various combination regimens. "( Gemcitabine in metastatic breast cancer.
Heinemann, V, 2005
)
3.21
"Gemcitabine (dFdCyd) is an analog of cytosine arabinoside with anti-tumor activity in several human cancers. "( Gemcitabine inhibits viability, growth, and metastasis of osteosarcoma cell lines.
Ando, T; Hamada, Y; Ichikawa, J; Nakao, A; Okamoto, A; Tasaka, K, 2005
)
3.21
"Gemcitabine is a pyrimidine nucleoside analog that is clinically active against pancreatic cancer. "( Activation of p38 mitogen-activated protein kinase is necessary for gemcitabine-induced cytotoxicity in human pancreatic cancer cells.
Habiro, A; Izawa, T; Kohgo, Y; Koizumi, K; Mizukami, Y; Nakano, Y; Okumura, T; Tanno, S,
)
1.81
"Gemcitabine seems to be a promising new drug without severe burden even for patients who are refractory to other cytostatic drugs."( Gemcitabine in the treatment of advanced head and neck cancer.
Bier, J; Gath, HJ; Oettle, H; Raguse, JD; Riess, H, 2005
)
2.49
"Gemcitabine is a newer pyrimidine analog used for the treatment of solid tumors. "( Gemcitabine-induced respiratory failure associated with elevated erythrocyte sedimentation rate (ESR).
Arunabh, T; Davidoff, S; Shah, RD, 2006
)
3.22
"Gemcitabine is a deoxycytidine (dCyd) analogue with activity against several solid cancers. "( In vivo induction of resistance to gemcitabine results in increased expression of ribonucleotide reductase subunit M1 as the major determinant.
Bergman, AM; Eijk, PP; Hubeek, I; Peters, GJ; Ruiz van Haperen, VW; Smid, K; van den Ijssel, P; Veerman, G; Ylstra, B, 2005
)
2.05
"Gemcitabine is an effective treatment for Hodgkin's disease. "( Gemcitabine in the treatment of relapsed and refractory Hodgkin's disease.
Aurer, I; Bogdanić, V; Labar, B; Mrsić, M; Nemet, D; Radman, I; Sertić, D; Zupancić-Salek, S, 2005
)
3.21
"Gemcitabine-paclitaxel is a dominated option with higher costs and a reduction in mean survival time compared with cisplatin-paclitaxel."( Economic evaluation of three two-drug chemotherapy regimens in advanced non-small-cell lung cancer.
Lianes, P; Neymark, N; Smit, EF; van Meerbeeck, JP, 2005
)
1.05
"Gemcitabine is a commonly used therapy for many solid tumors. "( Expression microarray analysis and oligo array comparative genomic hybridization of acquired gemcitabine resistance in mouse colon reveals selection for chromosomal aberrations.
Bergman, AM; Costa, JL; Meijer, GA; Oudejans, CB; Peters, GJ; Smid, K; van de Wiel, MA; Ylstra, B, 2005
)
1.99
"Gemcitabine is a novel agent that has shown consistent activity as a single agent in the treatment of platinum-resistant ovarian cancer and a favorable toxicity profile."( Gemcitabine in epithelial ovarian cancer treatment: current role and future perspectives.
Adamo, V; Ferrandina, G; Fruscella, E; Lorusso, D; Marini, L; Scambia, G,
)
2.3
"Gemcitabine considered is to be a well-tolerated cytostatic drug with little known side effects. "( Bullous dermatosis associated with gemcitabine therapy for non-small-cell lung carcinoma.
Amal, K; Fethi, el M; Habib, G; Imen, A; Ines, Z; Sameh, el F, 2006
)
2.05
"Gemcitabine is a cytosine arabinoside prodrug analog which shows significant activity, as single agent, in metastatic breast cancer."( [Metastatic breast cancer: new chemotherapy regimens with taxanes].
Lopez, M,
)
0.85
"Gemcitabine is a chemotherapeutic agent used to treat a variety of cancers in humans and dogs. "( Pharmacokinetics of gemcitabine and its primary metabolite in dogs after intravenous bolus dosing and its in vitro pharmacodynamics.
Freise, KJ; Martín-Jiménez, T, 2006
)
2.1
"Gemcitabine is a relatively new chemotherapeutic compound used to treat a variety of cancers in dogs. "( Pharmacokinetics of gemcitabine and its primary metabolite in dogs after intravenous infusion.
Freise, KJ; Martín-Jiménez, T, 2006
)
2.1
"Gemcitabine is a purine analog with known activity in many solid tumors, namely lung, breast, pancreatic, genitourinary and head/neck cancers. "( Gemcitabine and atrial fibrillation: a rare manifestation of chemotherapy toxicity.
Carbone, C; Codecà, C; Ferrari, D; Foa, P; Fumagalli, L; Gilardi, L; Marussi, D; Oldani, S; Tartaro, T; Zannier, F, 2006
)
3.22
"Gemcitabine is an interesting candidate for a three-drug combination because of its different mechanism of action and non-overlapping toxicity with respect to the other two drugs."( Phase II study of gemcitabine, doxorubicin and paclitaxel (GAT) as first-line chemotherapy for metastatic breast cancer: a translational research experience.
Amadori, D; Frassineti, GL; Gianni, L; Maltoni, R; Massa, I; Milandri, C; Nanni, O; Passardi, A; Zoli, W; Zumaglini, F, 2006
)
1.39
"Gemcitabine is a nucleoside analogue with activity against solid tumors. "( Gemcitabine pharmacogenomics: cytidine deaminase and deoxycytidylate deaminase gene resequencing and functional genomics.
Ames, MM; Eckloff, BW; Gilbert, JA; Ji, Y; Pelleymounter, LL; Salavaggione, OE; Weinshilboum, RM; Wieben, ED, 2006
)
3.22
"Gemcitabine is a commonly used chemotherapeutic agent structurally and pharmacologically similar to cytarabine. "( Clinical features and correlates of gemcitabine-associated lung injury: findings from the RADAR project.
Belknap, SM; Bennett, CL; Kuzel, TM; Lyons, EA; Raisch, DW; Slimack, N; Yarnold, PR, 2006
)
2.05
"Gemcitabine is an active agent in pancreatic cancer, showing clinical synergy with 5-fluorouracil (5-FU). "( Gemcitabine combined with 5-fluorouracil for the treatment of advanced carcinoma of the pancreas.
Andreadis, C; Gennatas, C; Michalaki, V; Mouratidou, D; Photopoulos, A; Tsavaris, N; Voros, D,
)
3.02
"Gemcitabine (dFdC) is an active antitumour agent with radiosensitising properties, shown both in preclinical and clinical studies. "( The relation between deoxycytidine kinase activity and the radiosensitising effect of gemcitabine in eight different human tumour cell lines.
De Pooter, CM; Kamphuis, JA; Korst, AE; Lambrechts, HA; Lardon, F; Pattyn, GG; Pauwels, B; Peters, GJ; Vermorken, JB, 2006
)
2
"Gemcitabine is a nucleoside analogue with proven activity in advanced and metastatic breast cancer. "( Gemcitabine: monochemotherapy of breast cancer.
Ferrazzi, E; Stievano, L, 2006
)
3.22
"Gemcitabine is a novel agent that has shown promising activity as a single agent in the treatment of platinum-resistant ovarian cancer and a favorable toxicity profile."( Role of gemcitabine in ovarian cancer treatment.
Di Stefano, A; Fanfani, F; Lorusso, D; Scambia, G, 2006
)
1.49
"Gemcitabine is an acceptable control arm for future trials investigating scheduling and combinations with novel agents."( Chemotherapy and radiotherapy for inoperable advanced pancreatic cancer.
Goldstein, D; Karapetis, C; Steer, CB; Strickland, A; Yip, D, 2006
)
1.06
"Gemcitabine is an effective monotherapy with a 68% overall response rate in patients with advanced, heavily pretreated CTCL."( Phase II evaluation of gemcitabine monotherapy for cutaneous T-cell lymphoma.
Apisarnthanarax, N; David, CL; Duvic, M; Kurzrock, R; Talpur, R; Wen, S, 2006
)
2.09
"Gemcitabine (dFdCyd) is a deoxycytidine analogue showing a broad spectrum of cytotoxic activity; additionally, at non-cytotoxic concentrations, it is a potent radiosensitiser. "( Gemcitabine treatment of experimental C6 glioma: the effects on cell cycle and apoptotic rate.
Brunetti, E; Bucci, B; Canese, R; Carapella, CM; Caroli, F; Carpinelli, G; D'Agnano, I; Giannarelli, D; Podo, F; Raus, L,
)
3.02
"Gemcitabine/carboplatin is a convenient and effective treatment for advanced-stage non-small-cell lung cancer (NSCLC), but modification of the schedule to diminish thrombocytopenia is worthwhile."( Randomized, multicenter, open-label phase II study of gemcitabine plus single-dose versus split-dose carboplatin in the treatment of patients with advanced-stage non-small-cell lung cancer.
Blankenburg, T; Chemaissani, A; Guetz, S; Laier-Groeneveld, G; Reck, M; Schneider, CP; Schuette, W; Virchow, JC; von Weikersthal, LF, 2006
)
2.02
"Gemcitabine is a nucleoside analog with clinical relevance in the treatment of several solid tumors, including breast carcinoma. "( Gene expression profiling of breast cancer cells in response to gemcitabine: NF-kappaB pathway activation as a potential mechanism of resistance.
Antón, A; Cuevas, C; Hernández-Vargas, H; Julián-Tendero, M; Moreno-Bueno, G; Palacios, J; Ríos, MJ; Rodríguez-Pinilla, SM; Sánchez-Rovira, P, 2007
)
2.02
"Gemcitabine is a first line agent for pancreatic cancer, but yields minimal survival benefit. "( Treatment with gemcitabine and TRA-8 anti-death receptor-5 mAb reduces pancreatic adenocarcinoma cell viability in vitro and growth in vivo.
Buchsbaum, DJ; DeRosier, LC; Huang, ZQ; Sellers, JC; Vickers, SM, 2006
)
2.13
"Gemcitabine is an anticancer agent rapidly deaminated to the inactive metabolite 2',2'-difluorodeoxyuridine. "( Characterization of lipophilic gemcitabine prodrug-liposomal membrane interaction by differential scanning calorimetry.
Castelli, F; Cattel, L; Ceruti, M; Rocco, F; Sarpietro, MG,
)
1.86
"Gemcitabine is a nucleotide analogue with a broad spectrum of anticancer activity."( Phase I study of bryostatin 1 and gemcitabine.
El-Rayes, BF; Gadgeel, S; Lorusso, P; Manza, S; Philip, PA; Shields, AF, 2006
)
1.33
"Gemcitabine is an inhibitor of ribonucleotide reductase (RR) and DNA polymerization with promising activity in hematologic malignancies. "( Cytotoxic activity of gemcitabine and correlation with expression profile of drug-related genes in human lymphoid cells.
Barsanti, G; Danesi, R; Del Tacca, M; Giovannetti, E; Loni, L; Mey, V; Nannizzi, S; Ricciardi, S; Savarino, G, 2007
)
2.1
"Gemcitabine is a deoxycytidine analogue that exhibits antitumoral activity against adenocarcinomas of the colon, lung and pancreas. "( Antitumor activity and pharmacokinetics of liposomes containing lipophilic gemcitabine prodrugs.
Brusa, P; Cattel, L; Immordino, ML; Rocco, F,
)
1.8
"Gemcitabine is a nucleoside analogue that is incorporated into replicating DNA, resulting in partial chain termination and stalling of replication forks. "( H2AX phosphorylation marks gemcitabine-induced stalled replication forks and their collapse upon S-phase checkpoint abrogation.
Ewald, B; Plunkett, W; Sampath, D, 2007
)
2.08
"Gemcitabine is an antimetabolite agent that is active against lung and pancreatic cancers."( Circadian physiology is a toxicity target of the anticancer drug gemcitabine in mice.
Lévi, F; Li, XM, 2007
)
1.3
"Gemcitabine is a pyrimidine nucleoside analogue anticancer agent that has shown promising anti-tumor activity in several experimental models of brain tumor. "( Pharmacokinetics of gemcitabine in tumor and non-tumor extracellular fluid of brain: an in vivo assessment in rats employing intracerebral microdialysis.
Apparaju, SK; Desai, PB; Gudelsky, GA, 2008
)
2.11
"Gemcitabine monotherapy is a sufficiently active and well-tolerated therapy for patients who have previously undergone chemotherapy with a platinum-based regimen."( Efficacy and safety of gemcitabine monotherapy in patients with transitional cell carcinoma after Cisplatin-containing therapy: a Japanese experience.
Akaza, H; Miki, T; Miyanaga, N; Naito, S; Taniai, H; Usami, M, 2007
)
2.09
"Gemcitabine is an efficacious cytotoxic agent used in the treatment of unresectable pancreatic carcinoma (PC). "( Ribonucleotide reductase subunit M2 mRNA expression in pretreatment biopsies obtained from unresectable pancreatic carcinomas.
Fukushima, N; Itoi, T; Itokawa, F; Kasuya, K; Kurihara, T; Moriyasu, F; Sofuni, A; Tsuchida, A; Tsuchiya, T, 2007
)
1.78
"Gemcitabine is a deoxycytidine analogue that has a broad spectrum of antitumour activity in many solid tumours including pancreatic cancer. "( Pharmacogenomics of gemcitabine: can genetic studies lead to tailor-made therapy?
Kaniwa, N; Kiyosawa, K; Ueno, H, 2007
)
2.11
"Gemcitabine is a nucleoside analogue that inhibits ribonucleotide reductase and interferes with DNA replication."( Short versus continuous gemcitabine treatment of non-small cell lung cancer in an in vitro cell culture bioreactor system.
Fisher, JE; Kirstein, MN; Kratzke, RA; Le, CT; Marker, PH; Wieman, KM; Williams, BW; Yee, D, 2007
)
1.37
"Gemcitabine is a chemotherapeutic agent whose cutaneous toxicities are easily mistaken for infections. "( Gemcitabine-related "pseudocellulitis": report of 2 cases and review of the literature.
Bunce, PE; Gold, WL; Liles, WC; Tan, DH, 2007
)
3.23
"Gemcitabine-oxaliplatin is an active and tolerable combination with response rate that merits further study in patients with impaired renal function but good performance status."( Gemcitabine and oxaliplatin combination: a multicenter phase II trial in unfit patients with locally advanced or metastatic urothelial cancer.
Albanell, J; Bellmunt, J; Berrocal, A; Carles, J; Climent, M; Esteban, E; Fabregat, X; Font, A; Garcia-Ribas, I; Gonzalez-Larriba, JL; Marfa, X, 2007
)
3.23
"Gemcitabine is a widely used clinical chemotherapeutic agent against locally advanced and metastatic pancreatic cancer."( Effects of the proteasome inhibitor bortezomib on gene expression profiles of pancreatic cancer cells.
Gao, SL; Shen, HW; Tang, ZY; Wu, YL, 2008
)
1.07
"Gemcitabine (GEM) is a potent radiosensitizer and in addition has activity as an anticancer agent in SCCHN."( Phase II feasibility study of concurrent radiotherapy and gemcitabine in chemonaive patients with squamous cell carcinoma of the head and neck: long-term follow up data.
Dyck, J; Huizing, MT; Schrijvers, D; Specenier, PM; Van den Brande, J; Van den Weyngaert, D; Van Laer, C; Vermorken, JB; Weyler, J, 2007
)
1.31
"Gemcitabine is a structural analogue of the deoxycytidine with 2 fluorine atoms."( [Gemcitabine: from preclinic to clinic passing by pharmacokinetics].
Lansiaux, A; Lokiec, F, 2007
)
1.97
"Gemcitabine is a well-tolerated anti-tumour drug with broad-spectrum activity. "( [Gemcitabine and digestive carcinomas].
André, T; Blanchard, P; Huguet, F, 2007
)
2.69
"Gemcitabine-squalene is a new prodrug that self-organizes in water forming nanoassemblies. "( Simultaneous determination of gemcitabine and gemcitabine-squalene by liquid chromatography-tandem mass spectrometry in human plasma.
Couvreur, P; Deroussent, A; Khoury, H; Paci, A; Reddy, LH; Vassal, G, 2007
)
2.07
"Gemcitabine is an antimetabolite drug used in the treatment of various solid tumours, including lung, pancreatic or gynaecological cancers. "( Toxic death case in a patient undergoing gemcitabine-based chemotherapy in relation with cytidine deaminase downregulation.
Blesius, A; Ciccolini, J; Dahan, L; Duluc, M; Dupuis, C; Evrard, A; Favre, R; Franceschini, F; Giacometti, S; Mercier, C; Milano, G; Ortiz, A; Raynal, C; Salas, S; Seitz, JF, 2007
)
2.05
"Gemcitabine/vinorelbine is a reasonable nonplatinum agent-based doublet therapy for patients with advanced NSCLC."( Paclitaxel/Carboplatin/gemcitabine versus gemcitabine/vinorelbine in advanced non-small-cell lung cancer: a phase II/III study of the Minnie Pearl Cancer Research Network.
Burris, HA; Gandhi, JG; Gray, JR; Greco, FA; Hainsworth, JD; Kuzur, ME; Pati, A; Shipley, D; Spigel, DR; Thompson, DS; Webb, CD; Yardley, DA, 2007
)
1.37
"Gemcitabine is an anticancer drug which is metabolized to a number of metabolites, administered using different dosing regimens and increasingly used in combination with oxaliplatin."( Population pharmacokinetics of gemcitabine and its metabolite in patients with cancer: effect of oxaliplatin and infusion rate.
Galettis, P; Jiang, X; Links, M; McLachlan, AJ; Mitchell, PL, 2008
)
1.35
"Gemcitabine is an antimetabolite that is incorporated as a triphosphate into DNA."( Role of gemcitabine in metastatic breast cancer patients: a short review.
Cinieri, S; La Torre, I; Lorusso, V; Numico, G; Orlando, L; Pezzella, G; Silvestris, N, 2008
)
1.5
"Gemcitabine is a commonly used chemotherapeutic agent for a variety of tumor types. "( Gemcitabine-induced reversible posterior leukoencephalopathy syndrome: a case report and review of the literature.
George, TJ; Rajasekhar, A, 2007
)
3.23
"Gemcitabine is a new important drug used to treat solid tumors including non-small cell lung cancer, pancreatic, bladder and breast cancers. "( [Favorable outcome of gemcitabine-induced acute respiratory distress syndrome].
Aletti, M; Bauduceau, O; Bonnichon, A; Borne, M; Ceccaldi, B; Fayolle, M; Le Moulec, S; Margery, J; Vedrine, L, 2007
)
2.1
"Gemcitabine is an active agent in the treatment of bladder cancer. "( Primary chemotherapy with low-dose prolonged infusion gemcitabine and cisplatin in patients with bladder cancer: a Phase II trial.
Abdel Warith, A; El Malt, O; Emara, ME; Gaafar, RM; Khaled, H; Mansour, O; Zaghloul, MS,
)
1.82
"Gemcitabine is a chemotherapeutic drug widely used in the treatment of non-small cell lung carcinoma, especially in advanced lung adenocarcinoma. "( NS-398 enhances the efficacy of gemcitabine against lung adenocarcinoma through up-regulation of p21WAF1 and p27KIP1 protein.
Chen, XJ; Qu, X; Xiao, W; Zhou, SY, 2008
)
2.07
"Gemcitabine is a key agent for the first-line therapy of advanced pancreatic cancer."( [Chemotherapy for pancreatic cancer].
Kim, YT, 2008
)
1.07
"Gemcitabine-based therapy is an acceptable standard for unresectable locally advanced/metastatic pancreatic cancer, but average median survival is only 6 months."( New directions in the management of advanced pancreatic cancer: a review.
Rocha-Lima, CM, 2008
)
1.07
"Gemcitabine is a strong radiosensitizer, and a phase I study confirmed the feasibility of CCR with low-dose gemcitabine administered twice-weekly in NSCLC patients."( Induction chemotherapy with cisplatin and gemcitabine followed by concurrent chemoradiation with twice-weekly gemcitabine in unresectable stage III non-small cell lung cancer: final results of a phase II study.
Algara, M; Bastus, R; Blanco, R; Bover, I; Domenech, M; Gay, M; Mesía, C; Montesinos, J; Nogué, M; Solé, J; Terrassa, J; Vadell, C, 2008
)
1.33
"Gemcitabine is an effective drug in advanced biliary tract carcinoma with a low toxicity profile. "( Chemotherapy with gemcitabine in advanced biliary tract carcinoma.
Gerson, R; Serrano, A, 2008
)
2.12
"Gemcitabine (dFdC) is a new anticancer nucleoside that is an analog of deoxycytidine. "( Gemcitabine: metabolism, mechanisms of action, and self-potentiation.
Gandhi, V; Grunewald, R; Heinemann, V; Huang, P; Plunkett, W; Xu, YZ, 1995
)
3.18
"Gemcitabine is a novel nucleoside analog that has shown clinical activity in a variety of solid tumors. "( Radiosensitization of human tumor cells by gemcitabine in vitro.
Lawrence, TS; Shewach, DS, 1995
)
2
"Gemcitabine (GEM) is a novel deoxycytidine analogue which has shown promising antitumor activity in solid tumor models and a broad range of schedule-dependent MTDs (12-4560 mg/m2) in preliminary clinical studies. "( Weekly gemcitabine in advanced or metastatic solid tumors. A clinical phase I study.
Calabresi, F; Ceribelli, A; Crecco, M; Pollera, CF, 1994
)
2.19
"Gemcitabine is a new pyrimidine antimetabolite with novel metabolic properties and mechanism of action. "( A phase II study of Gemcitabine (LY 188011) in patients with advanced squamous cell carcinoma of the head and neck. EORTC Early Clinical Trials Group.
Bruntsch, U; Catimel, G; Clavel, M; de Mulder, P; Judson, I; Piccart, M; Sessa, C; Vermorken, JB; Verweij, J; Wanders, J, 1994
)
2.05
"Gemcitabine is a drug with documented anti-tumor activity in patients with advanced squamous cell carcinoma of the head and neck."( A phase II study of Gemcitabine (LY 188011) in patients with advanced squamous cell carcinoma of the head and neck. EORTC Early Clinical Trials Group.
Bruntsch, U; Catimel, G; Clavel, M; de Mulder, P; Judson, I; Piccart, M; Sessa, C; Vermorken, JB; Verweij, J; Wanders, J, 1994
)
2.05
"Gemcitabine is a well-tolerated new drug with activity in platinum-resistant ovarian cancer patients."( Phase II study of gemcitabine (2',2'-difluorodeoxycytidine) in previously treated ovarian cancer patients.
Hansen, M; Hansen, OP; Lund, B; Neijt, JP; Theilade, K, 1994
)
2.07
"Gemcitabine is a novel nucleoside analog which demonstrated a broad spectrum of preclinical activity in solid tumor models, and responses in patients with pancreas cancer during phase I evaluation. "( Phase II trial of gemcitabine (2,2'-difluorodeoxycytidine) in patients with adenocarcinoma of the pancreas.
Brown, TD; Casper, ES; Flombaum, CD; Green, MR; Heelan, RT; Kelsen, DP; Tarassoff, PG; Trochanowski, B, 1994
)
2.07
"Gemcitabine is a new ara-C derivative and shows much more potent cytotoxic action than ara-C, which may be explained by the fact that its intracellular concentration can be maintained over a longer period. "( [Antitumor activity of combination treatment combining gemcitabine with cisplatin or vindesine against human lung cancer xenografted in nude mice].
Fujita, F; Fujita, M; Sakamoto, Y, 1994
)
1.98
"Gemcitabine is a water-soluble analogue of deoxycytidine which has shown significant antitumour activity in a broad panel of slow-growing murine and human carcinomas. "( Gemcitabine in patients with advanced malignant melanoma or gastric cancer: phase II studies of the EORTC Early Clinical Trials Group.
Aamdal, S; Eppelbaum, R; Franklin, H; Sessa, C; Smyth, JF; Sulkes, A; Ten Bokkel Huinink, W; Vermorken, J; Wanders, J; Wolff, I, 1994
)
3.17
"Gemcitabine is an active new agent in the treatment of NSCLC. "( Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study.
Anderson, H; Bach, F; Hansen, HH; Lund, B; Thatcher, N; Walling, J, 1994
)
2.01
"Gemcitabine (dFdC) is a new cytidine analogue which is active mainly by the incorporation of its triphosphate (dFdCTP) into DNA, leading to cell death. "( 2',2'-Difluoro-deoxycytidine (gemcitabine) incorporation into RNA and DNA of tumour cell lines.
Peters, GJ; Ruiz van Haperen, VW; Veerman, G; Vermorken, JB, 1993
)
2.02
"Gemcitabine is a fluorine-substituted cytarabine analog with broad experimental antitumor activity. "( Gemcitabine: a phase II study in patients with advanced renal cancer.
Blatter, J; De Mulder, PH; Jakse, G; Osieka, R; Weissbach, L, 1996
)
3.18
"Gemcitabine is a nucleoside analogue with activity in non-small-cell lung cancer (NSCLC). "( Gemcitabine in the treatment of non-small-cell lung cancer.
Burkes, RL; Shepherd, FA, 1995
)
3.18
"Gemcitabine is a novel nucleoside analogue with activity in solid tumours. "( Activity of gemcitabine in patients with non-small cell lung cancer: a multicentre, extended phase II study.
Burkes, RL; Cortes-Funes, H; Cottier, B; Gatzemeier, U; Gottfried, M; Groen, HJ; Le Chevalier, T; Mattson, K; Rosso, R; Shepherd, FA; Tonato, M; Voi, M; Weynants, P, 1996
)
2.12
"Gemcitabine is a nucleoside analogue developed for use in solid tumours."( Economic value of gemcitabine compared to cisplatin and etoposide in non-small cell lung cancer.
Copley-Merriman, C; Corral, J; Dorr, FA; King, K; McDonald, RC; Voi, M; Whiteside, R, 1996
)
1.35
"Gemcitabine is a nucleoside analog which exhibits metabolic characteristics that distinguish it from related compounds and may explain its activity in solid tumors. "( Gemcitabine: preclinical pharmacology and mechanisms of action.
Gandhi, V; Huang, P; Plunkett, W; Searcy, CE, 1996
)
3.18
"Gemcitabine is a new deoxycytidine analog that exhibits significant cytotoxicity against a variety of cultured murine and human tumor cells. "( Comparison of the antitumor activity of gemcitabine and ara-C in a panel of human breast, colon, lung and pancreatic xenograft models.
Boder, GB; Grindey, GB; Hertel, LW; Houghton, JA; Houghton, PJ; Merriman, RL; Rutherford, PG; Schultz, RM; Tanzer, LR, 1996
)
2
"Gemcitabine is a nucleoside analogue with excellent clinical activity against solid tumors. "( Gemcitabine and radiosensitization in human tumor cells.
Lawrence, TS; Shewach, DS, 1996
)
3.18
"Gemcitabine is a deoxycytidine-analogue antimetabolite with activity against some solid tumors."( Gemcitabine: a cytidine analogue active against solid tumors.
Hui, YF; Reitz, J, 1997
)
2.46
"Gemcitabine is a well-tolerated chemotherapeutic agent for NSCLC. "( Gemcitabine versus the combination of cisplatin and etoposide in patients with inoperable non-small-cell lung cancer in a phase II randomized study.
Chen, YM; Lin, WC; Ming-Liu, J; Perng, RP; Tsai, CM; Whang-Peng, J; Yang, KY, 1997
)
3.18
"Gemcitabine is a nucleoside analogue with significant antitumour activity in many human solid tumours."( Advanced breast cancer: investigational role of gemcitabine.
Carmichael, J; Walling, J, 1997
)
1.27
"Gemcitabine is a potent radiosensitizer of human tumor cells. "( Gemcitabine-mediated radiosensitization.
Eisbruch, A; Lawrence, TS; Shewach, DS, 1997
)
3.18
"Gemcitabine is a novel nucleoside analogue that has demonstrated activity against several solid tumors. "( Single-agent gemcitabine in non-small cell lung cancer: the French experience.
Gottfried, M; Le Chevalier, T, 1997
)
2.11
"Gemcitabine is a novel nucleoside analogue with a unique mechanism of action. "( Phase I studies of gemcitabine combined with carboplatin or paclitaxel.
Pedersen, AG, 1997
)
2.07
"Gemcitabine is a nucleoside analog with demonstrated activity against NSCLC, yet it has low toxicity."( Weekly gemcitabine and monthly cisplatin for advanced non-small cell lung carcinoma.
Abratt, RP; Bezwoda, WR; Goedhals, L; Hacking, DJ, 1997
)
1.47
"Gemcitabine is a novel pyrimidine nucleoside whose activity has been demonstrated on solid tumors. "( [A phase II multicenter study of gemcitabine in non small cell lung cancers].
Burkes, RL; Cortes-Funes, H; Cottier, B; Gatzemeier, U; Gottfried, M; Groen, HJ; Le Chevalier, T; Mattson, K; Ponzio, A; Rosso, R; Shepherd, F; Tonato, M; Voi, M; Weynants, P, 1997
)
2.02
"Gemcitabine (GEM) is a novel nucleoside analogue with a unique mechanism of action. "( Prolonged infusion gemcitabine: a clinical phase I study at low- (300 mg/m2) and high-dose (875 mg/m2) levels.
Calabresi, F; Ceribelli, A; Crecco, M; Oliva, C; Pollera, CF, 1997
)
2.07
"Gemcitabine is a novel nucleoside analog with unique activity against a wide range of solid tumors. "( Activity of gemcitabine in the treatment of patients with non-small cell lung cancer: a multicenter phase II study.
Kurita, Y; Nakai, Y; Niitani, H; Yokoyama, A; Yoneda, S, 1997
)
2.12
"Gemcitabine is a novel anticancer agent showing activity with relatively mild toxicity across a range of solid tumors including non-small cell lung cancer (NSCLC). "( Safety profile of gemcitabine, a novel anticancer agent, in non-small cell lung cancer.
Abratt, R; Cortes-Funes, H; Lund, B; Martin, C, 1997
)
2.07
"Gemcitabine is a novel pyrimidine antagonist with activity in a number of tumour types."( Clinical response benefit in patients with advanced pancreatic cancer. Role of gemcitabine.
Carmichael, J, 1997
)
1.25
"Gemcitabine is a novel fluorine-substituted cytarabine (Ara-C) analogue with activity against a range of solid tumours. "( Effects of gemcitabine on renal function in patients with non-small cell lung cancer.
Gietema, JA; Groen, HJ; Meijer, S; Smit, EF, 1998
)
2.13
"Gemcitabine is a novel nucleoside analog with demonstrated efficacy across a range of solid tumors. "( Gemcitabine--a safety review.
Aapro, MS; Hatty, S; Martin, C, 1998
)
3.19
"Gemcitabine (GEMZAR) is a novel nucleoside analogue with activity in a range of preclinical models both in vitro and in vivo. "( The role of gemcitabine in the treatment of other tumours.
Carmichael, J, 1998
)
2.12
"Gemcitabine (GEM) is a pyrimidine analog that blocks DNA synthesis, whereas, paclitaxel (TAX) is a mitotic spindle poison that promotes microtubular aggregation."( Bcl-2 overexpression is associated with resistance to paclitaxel, but not gemcitabine, in multiple myeloma cells.
Fey, V; Gazitt, Y; Hilsenbeck, SG; Montegomrey, W; Rothenberg, ML; Thomas, C, 1998
)
1.25
"Gemcitabine is a nucleoside analog that is useful in the treatment of solid tumors. "( Successful treatment of gemcitabine toxicity with a brief course of oral corticosteroid therapy.
Miller, V; Vander Els, NJ, 1998
)
2.05
"Gemcitabine is a novel nucleoside analogue which has shown promising results in most solid tumors; like the arabinosylcytosine analogue, gemcitabine may be an active drug in lymphoproliferative malignancies. "( Therapy with gemcitabine in pretreated peripheral T-cell lymphoma patients.
Albertini, P; Bendandi, M; Gherlinzoni, F; Magagnoli, M; Orcioni, GF; Pileri, SA; Tura, S; Zinzani, PL, 1998
)
2.11
"Gemcitabine is a novel antimetabolite drug that acts by multiple mechanisms, including inhibition of ribonucleoside diphosphate reductase, of dCMP deaminase and of dCTP incorporation into DNA and RNA. "( Gemcitabine cytotoxicity of human malignant glioma cells: modulation by antioxidants, BCL-2 and dexamethasone.
Dichgans, J; Durka, S; Rieger, J; Streffer, J; Weller, M, 1999
)
3.19
"Gemcitabine is a novel cytotoxic drug with promising activity against pancreatic adenocarcinoma."( Elevated reticulocyte count--a clue to the diagnosis of haemolytic-uraemic syndrome (HUS) associated with gemcitabine therapy for metastatic duodenal papillary carcinoma: a case report.
Huhn, D; Oettle, H; Riess, H; Serke, S, 1999
)
1.24
"Gemcitabine seems to be an active drug for the treatment of pleural mesothelioma."( Impressive remission in a patient with locally advanced malignant pleural mesothelioma treated with gemcitabine.
Bamberg, M; Brandes, A; Classen, J; Schott, U; Weinmann, M, 1999
)
1.24
"Gemcitabine is a new nucleoside antimetabolite with established activity against solid tumours. "( Gemcitabine in the treatment of ovarian cancer.
Hansen, SW; Sessa, C; Tuxen, MK, 1999
)
3.19
"Gemcitabine is a novel nucleoside analogue with unique activity against a range of solid tumors including non-small cell lung cancer (NSCLC) and pancreatic cancer."( Review of the pharmacoeconomic research on gemcitabine in the treatment of advanced non-small cell lung cancer.
Liepa, AM; Minshall, ME, 1998
)
2.01
"Gemcitabine is a new nucleoside analogue that produces a clinical response in 30% of patients with unresectable pancreatic carcinoma. "( Gemcitabine-induced programmed cell death (apoptosis) of human pancreatic carcinoma is determined by Bcl-2 content.
Bold, RJ; Chandra, J; McConkey, DJ,
)
3.02
"Gemcitabine hydrochloride is a novel anti-cancer drug which is marketed as an indication for non-small cell lung cancer (NSCLC). "( [Gemcitabine hydrochloride is a new anti-cancer agent which will be available in the patients with non-small cell lung cancer (NSCLC) in Japan].
Yokoyama, A, 1999
)
2.66
"Gemcitabine (Gemzar) is a nucleoside analog increasingly used in the treatment of a variety of solid tumors. "( Gemcitabine and UFT plus oral calcium folinate: phase I study.
Arlauskas, P; Ibrahim, D; Philip, PA; Shields, A; Zalupski, M, 1999
)
3.19
"Gemcitabine is an active agent in the treatment of metastatic breast cancer. "( Phase II trial of gemcitabine as prolonged infusion in metastatic breast cancer.
Akrivakis, K; Flath, B; Grosse, Y; Mergenthaler, HG; Possinger, K; Schmid, P; Sezer, O, 1999
)
2.08
"Gemcitabine is a potent radiosensitizer in both laboratory studies and in the clinic. "( Radiosensitization by gemcitabine.
Eisbruch, A; Fields, MT; Lawrence, TS; McGinn, CJ; Shewach, DS, 1999
)
2.06
"Gemcitabine is a chemotherapy agent with efficacy in the treatment of lung, pancreas, bladder and breast cancer. "( Leucovorin, 5-fluorouracil, and gemcitabine: a phase I study.
Grant, S; Poplin, E; Roberts, J; Rubin, E; Tombs, M, 1999
)
2.03
"Gemcitabine is a novel antimetabolite which has shown anti-tumor activity against a variety of tumors including non-small-cell lung cancer (NSCLC). "( The role of single-agent gemcitabine in the treatment of non-small-cell lung cancer.
Kelly, K, 1999
)
2.05
"Gemcitabine is a fluoridated pyrimidine related to cytosine arabinoside that has significant activity in solid tumor models. "( Single-agent gemcitabine and gemcitabine/irinotecan combination (irimogem) in non-small cell lung cancer.
Bahadori, HR; Eckardt, JR; Green, MR; Leong, SS; Perkel, JA; Putman, T; Rocha Lima, CM; Safa, AR; Sherman, CA, 1999
)
2.12
"Gemcitabine is a cytotoxic pyrimidine antimetabolite with broad activity against solid tumors."( A phase I trial of MTA and gemcitabine in patients with locally advanced or metastatic cancer.
Adjei, AA; Erlichman, C, 1999
)
1.32
"Gemcitabine is a relatively new drug that has been shown in both clinical trials and in vitro systems to have more potent antitumor activity than araC."( Effects of gemcitabine and araC on in vitro DNA synthesis mediated by the human breast cell DNA synthesome.
Abdel-Aziz, W; Hickey, RJ; Jiang, HY; Malkas, LH, 2000
)
1.42
"Gemcitabine is a deoxycytidine analog with broad antitumor activity. "( Time- and dose-limiting erysipeloid rash confined to areas of lymphedema following treatment with gemcitabine--a report of three cases.
Bamberg, M; Brandes, A; Plasswilm, L; Reichmann, U, 2000
)
1.97
"Gemcitabine (dFdC) is a new nucleoside analogue with promising activity in different solid tumors. "( Radiation enhancement of gemcitabine in two human squamous cell carcinoma cell lines.
Böttcher, HD; Damrau, M; Jüling-Pohlit, L; Karapetian, M; Mose, S; Rahn, A; Ramm, U; Taborski, B,
)
1.88
"Gemcitabine is a nucleoside analog that is active in the treatment of various solid tumors. "( Severe acute lung injury induced by gemcitabine.
Giaccone, G; Golding, RP; Linskens, RK; van Groeningen, CJ, 2000
)
2.02
"Gemcitabine is a promising new drug in patients with locally advanced and/or metastatic transitional cell carcinoma of the urothelium. "( Gemcitabine in locally advanced and/or metastatic bladder cancer.
von der Maase, H, 2000
)
3.19
"Gemcitabine is an antimetabolic drug for solid tumors. "( Gemcitabine-induced atrial fibrillation: a hitherto unreported manifestation of drug toxicity.
Abbate, A; Campisi, C; Di Cosimo, S; Di Sciascio, G; Gravante, G; Patti, G; Santini, D; Tonini, G; Vincenzi, B, 2000
)
3.19
"Gemcitabine (dFdC) is a new nucleoside antimetabolite of deoxycytidine that resembles cytarabine (Ara-C) in both its structure and metabolism. "( The interaction of gemcitabine and cytarabine on murine leukemias L1210 or P388 and on human normal and leukemic cell growth in vitro.
Korycka, A; Lech-Maranda, E; Robak, T, 2000
)
2.08
"Gemcitabine is an effective agent in the treatment of metastatic breast cancer. "( Prolonged infusion of gemcitabine in stage IV breast cancer: a phase I study.
Akrivakis, K; Flath, B; Mergenthaler, HG; Possinger, K; Schmid, P; Schweigert, M; Sezer, O, 1999
)
2.06
"Gemcitabine is a new fluorine-substituted cytarabine compound."( Clinical update of gemcitabine in pancreas cancer.
Au, E, 2000
)
1.36
"Gemcitabine (Gemzar) is a novel deoxycitidine drug that has demonstrated promising single-agent activity in non-small-cell lung cancer and has been proven to be a potent radiosensitizer. "( Combination chemoradiotherapy with gemcitabine: potential applications.
Choy, H, 2000
)
2.03
"Gemcitabine is a novel antimetabolite with considerable activity in NSCLC."( A phase I/II trial of paclitaxel, carboplatin, and gemcitabine in untreated patients with advanced non-small cell lung cancer.
Bunn, PA; Kelly, K; Mikhaeel-Kamel, N; Murphy, J; Pan, Z; Prindiville, S, 2000
)
1.28
"Gemcitabine (dFdC) is a prodrug that undergoes metabolism by cytidine deaminase to form an inactive metabolite, 2',2'-difluorodeoxyuridine (dFdU). "( Pharmacokinetics of gemcitabine and 2',2'-difluorodeoxyuridine in a patient with ascites.
Delauter, BJ; Egorin, MJ; Plunkett, W; Ramanathan, RK; Stover, LL; Zamboni, WC; Zuhowski, EG, 2000
)
2.07
"Gemcitabine (Gem) is a deoxycytidine analog that is effective against pancreatic cancer and other malignancies following conversion to the 5'-O-mono-, di- and tri-phosphate forms. "( Antineoplastic activity of a novel multimeric gemcitabine-monophosphate prodrug against thyroid cancer cells in vitro.
Bitoova, M; Cinatl, J; Gmeiner, WH; Gröschel, B; Kornhuber, B; Kotchetkov, R; Krivtchik, AA; Trump, E,
)
1.83
"Gemcitabine (G) is an active new drug."( Paclitaxel and carboplatin in combination with gemcitabine: a phase I-II trial in patients with advanced non-small-cell lung cancer. Gruppo Studio Tumori Polmonari Veneto (GSTPV).
Barbieri, F; Bearz, A; Ceresoli, GL; Favaretto, A; Frustaci, S; Ghiotto, C; Oniga, F; Paccagnella, A; Schiavon, S; Villa, E, 2000
)
1.29
"Gemcitabine is a chemotherapeutic agent with proven antitumor effects in pancreatic and non-small cell lung cancer; however, studies establishing the definite significance in other solid tumors are still in progress. "( Unexpected severe myelotoxicity of gemcitabine in pretreated breast cancer patients.
Gnant, MF; Jakesz, R; Locker, GJ; Marosi, C; Schmidinger, M; Steger, GG; Wenzel, C; Zielinski, CC, 2001
)
2.03
"Gemcitabine is a new drug of antimetabolite nucleoside group used in treatment of cancers since 1996."( Preliminary evaluation of influence of gemcitabine (Gemzar) on proliferation and neuroendocrine activity of human TT cell line: immunocytochemical investigations.
Azzadin, A; Chyczewski, L; Dadan, J; Dziecioł, J; Puchalski, Z; Sawicki, B; Wołczyński, S, 2001
)
1.3
"Gemcitabine (dFdC) is a difluorine-substituted deoxycytidine analogue that has demonstrated antitumor activity against both leukemias and solid tumors. "( Plasma and cerebrospinal fluid pharmacokinetics of gemcitabine after intravenous administration in nonhuman primates.
Aleksic, A; Berg, SL; Blaney, S; Dauser, R; Egorin, MJ; Kerr, JZ; McGuffey, L; Nuchtern, J, 2001
)
2.01
"Gemcitabine is a new anticancer agent with a mild toxicity profile, which has demonstrated antineoplastic activity in many solid tumors."( Phase II study of systemic gemcitabine chemotherapy for advanced unresectable hepatobiliary carcinomas.
Kubicka, S; Lorenz, M; Manns, M; Rudolph, KL; Tietze, MK,
)
1.15
"Gemcitabine is a promising new agent that has been recently studied for palliation of advanced (stage IV) unresectable pancreatic cancer. "( Antimetastatic efficacy of adjuvant gemcitabine in a pancreatic cancer orthotopic model.
Baranov, E; Bouvet, M; Hoffma, RM; Jiang, P; Lee, NC; Moossa, AR; Nardin, S; Rashidi, B; Wang, X; Yang, M, 2000
)
2.02
"Gemcitabine is a nucleoside antimetabolite with established activity against several solid tumors. "( Gemcitabine in the treatment of ovarian cancer.
Hansen, SW, 2001
)
3.2
"Gemcitabine is an established agent in the treatment of a number of solid tumours but also has activity in haematological malignancies which might be exploited by the use of extended infusion schedules."( Nucleoside analogues in the treatment of haematological malignancies.
Johnson, SA, 2001
)
1.03
"Gemcitabine is a pyrimidine analogue that showed significant activity in solid malignancies. "( Gemcitabine in hematologic malignancies.
Gandhi, V; Krett, N; Nabhan, C; Rosen, S, 2001
)
3.2
"Gemcitabine is a broadly active pyrimidine nucleoside antimetabolite, which is approved for the treatment of pancreatic and non-small cell lung cancers."( Gemcitabine and pemetrexed disodium combinations in vitro and in vivo.
Adjei, AA, 2001
)
2.47
"Gemcitabine is a relatively new agent with promising activity in solid tumors. "( Expression of a non-functional p53 affects the sensitivity of cancer cells to gemcitabine.
Clarke, ML; Dumontet, C; Falette, N; Galmarini, CM; Mackey, JR; Puisieux, A, 2002
)
1.99
"Gemcitabine is a pyrimidine analog of deoxycytidine with activity against nonhematologic and hematologic malignancies. "( Severe pulmonary toxicity in a patient treated with gemcitabine.
Baraona, FJ; Kett, DH; Rosado, MF; Schein, RM; Sridhar, KS, 2002
)
2.01
"Gemcitabine is a pyrimidine analog with a similar chemical structure and mechanism of action, as cytarabine. "( Gemcitabine-induced pulmonary toxicity: case report and review of the literature.
Ahmed, I; Gupta, N; Mehrotra, B; Nissel-Horowitz, S; Patel, D; Steinberg, H, 2002
)
3.2
"Gemcitabine is considered to be a well-tolerated and safe cytostatic drug because of the relative lack of side effects. "( Gemcitabine-induced acute lipodermatosclerosis-like reaction.
Chiu, HC; Chu, CY; Yang, CH,
)
3.02
"Gemcitabine is a nucleoside analog used in solid tumors since 1987. "( [Hemolytic-uremic syndrome complicating a long-term treatment with gemcitabine. Report of a case and review of the literature].
Aparicio, M; De Precigout, V; Delclaux, C; Dilhuydy, MS; Pariente, A, 2002
)
1.99
"Gemcitabine appears to be a new cause of thrombotic microangiopathy."( [Hemolytic-uremic syndrome complicating a long-term treatment with gemcitabine. Report of a case and review of the literature].
Aparicio, M; De Precigout, V; Delclaux, C; Dilhuydy, MS; Pariente, A, 2002
)
1.27
"Gemcitabine is an increasingly used and generally well tolerated anticancer drug. "( Gemcitabine-related pulmonary toxicity.
Gunz, A; Joerger, M; Pestalozzi, BC; Speich, R, 2002
)
3.2
"Gemcitabine is a nucleoside analogue that is frequently used to treat non-small cell lung cancer."( Gemcitabine exerts a selective effect on the humoral immune response: implications for combination chemo-immunotherapy.
Lake, RA; Nowak, AK; Robinson, BW, 2002
)
2.48
"Gemcitabine is a new deoxycytidine derivative that shows a distinguishing, potent antitumor activity against various human tumor lines transplanted to nude mice. "( [Antitumor activity of combination treatment combining gemcitabine with topotecin against human lung cancer xenografted in nude mice].
Fujita, F; Fujita, M; Koike, M, 2002
)
2
"Gemcitabine is a cytosine arabinoside (Ara-C) analog with activity in many human tumor systems. "( The evaluation of gemcitabine in resistant or relapsing multiple myeloma, phase II: a Southwest Oncology Group study.
Barlogie, B; Crowley, JJ; Hussein, MA; Moore, DF; Weick, JK, 2002
)
2.09
"Gemcitabine is a pyrimidine analog which has demonstrated antitumoral activity in a variety of solid tumors including bladder, non-small cell lung and pancreatic cancers. "( [Gemcitabine and ionizing radiations: radiosensitization or radio-chemotherapy combination].
Azria, D; Culine, S; Dubois, JB; Jacot, W; Lemanski, C; Prost, P; Ychou, M, 2002
)
2.67
"Gemcitabine is a therapeutic agent that has been recently employed in the treatment of various cancers. "( [Acute respiratory failure due to Gemcitabine-induced pulmonary toxicity].
Caliandro, R; Girard, P; Grunenwald, D; Lamer, C; Lenoir, S; Stern, JB; Théodore, C, 2002
)
2.04
"Gemcitabine is a newer agent with a unique mode of action that involves DNA chain termination and mechanisms that result in self-potentiation."( Overview: gemcitabine as single-agent therapy for advanced breast cancer.
Tripathy, D, 2002
)
1.44
"Gemcitabine is an active agent against non-small-cell lung cancer (NSCLC) and has demonstrated activity in breast cancer as well."( Preclinical studies of gemcitabine and trastuzumab in breast and lung cancer cell lines.
Bunn, PA; Chan, DC; Franklin, WA; Helfrich, B; Hirsch, FR; Varella-Garcia, M, 2002
)
1.35
"Gemcitabine is an active drug in advanced breast cancer both as a single agent and in combination with other chemotherapeutic agents. "( Gemcitabine in breast cancer: future directions.
Tripathy, D, 2002
)
3.2
"Gemcitabine is a pyrimidine analogue that has shown activity in a variety of solid tumors, a good toxicity profile, and nonoverlapping toxicity with other chemotherapeutic agents."( Neoadjuvant gemcitabine therapy for breast cancer.
Dueñas, R; Fernández, M; Jaén, A; Lozano, A; Martínez, E; Medina, B; Mohedano, N; Porras, I; Sánchez-Rovira, P, 2002
)
1.41
"Gemcitabine appears to be a potent radiation sensitizer, and when combined with radiation therapy, it has shown encouraging tumor responses."( Concurrent infusional gemcitabine and radiation in the treatment of advanced unresectable GI malignancy: a phase I study.
Hanna, N; John, W; Kudrimoti, M; McGrath, PC; Mohiuddin, M; Regine, WF,
)
1.17
"Gemcitabine is an active agent in non-small cell lung cancer, with single-agent treatment producing response rates of approximately 20% and median survivals of approximately 7 to 9 months. "( Gemcitabine versus gemcitabine/carboplatin in advanced non-small cell lung cancer: preliminary findings in a phase III trial of the Swedish Lung Cancer Study Group.
Sederholm, C, 2002
)
3.2
"Gemcitabine acts as an inhibitor of ribonucleoside diphosphate reductase and inhibits DNA synthesis."( [New antitumor antimetabolites--gemcitabine and DMDC].
Fukuoka, M; Matsui, K, 1992
)
1.29

Effects

Gemcitabine has a molecular weight of 299 D, lower than that of commonly-used intravesical chemotherapeutic agents such as mitomycin C and doxorubicin. Myelosuppression is the most common side effect, while non-hematological events are relatively uncommon.

Gemcitabine has been the standard chemotherapeutic agent in pancreatic cancer. It is increasingly prescribed for the treatment of gallbladder cancer. Gemcitabin has mild renal toxicity, but cases of gemcitabines-associated hemolytic-uremic syndrome (HUS) have been reported.

ExcerptReferenceRelevance
"Gemcitabine has a modest activity in heavily pre-treated colorectal cancer patients and may be an option in good performance status patients."( The efficacy of gemcitabine as salvage treatment in patients with refractory advanced colorectal cancer (CRC): a single institution experience.
Hotchkiss, S; Kaley, K; Penney, R; Saif, MW; Strimpakos, AS; Syrigos, KN, 2011
)
2.16
"Gemcitabine has a good toxicity profile, with myelosuppression being the most common side effect, while non-hematological events are relatively uncommon."( Role of gemcitabine in cancer therapy.
Bartolini, S; Cappuzzo, F; Finocchiaro, G; Gioia, V; Toschi, L, 2005
)
1.48
"Gemcitabine has a molecular weight of 299 D, lower than that of commonly-used intravesical chemotherapeutic agents such as mitomycin C (389 D) and doxorubicin (589 D). "( Actual experience and future development of gemcitabine in superficial bladder cancer.
Frea, B; Gontero, P, 2006
)
2.04
"Gemcitabine has a possible role for stage IV pancreatic cancer."( Impact of gemcitabine on the survival of patients with stage IV pancreatic cancer.
Ajiki, T; Fujino, Y; Kamigaki, T; Kamoda, Y; Kuroda, Y; Matsumoto, I; Takase, S; Ueda, T; Yasuda, T, 2007
)
2.18
"Gemcitabine has a relatively safe profile."( Gemcitabine-induced liver fibrosis in a patient with pancreatic cancer.
Cornfeld, D; Saif, MW; Shahrokni, A, 2007
)
2.5
"Gemcitabine has an unusually mild side effect profile for such an active agent."( Efficacy and safety profile of gemcitabine in non-small-cell lung cancer: a phase II study.
Abratt, RP; Bezwoda, WR; Falkson, G; Goedhals, L; Hacking, D; Rugg, TA, 1994
)
1.3
"Gemcitabine has a role in the palliative treatment of patients with advanced non-small cell lung cancer."( Gemcitabine: symptomatic benefit in advanced non-small cell lung cancer.
Anderson, H; Bradley, B; Jayson, G; Ranson, M; Thatcher, N, 1997
)
2.46
"Gemcitabine has a mild toxicity profile that allows it to be combined easily in triplet combinations with other doublets."( Triplet chemotherapy with gemcitabine, a platinum, and a third agent in the treatment of advanced non-small cell lung cancer.
Bunn, PA, 1999
)
1.32
"Gemcitabine (Gemzar) has a significant impact upon survival and quality of life for patients with pancreatic cancer, compared with 5-fluorouracil (5-FU). "( Phase I trial of gemcitabine (Gemzar), 24 h infusion 5-fluorouracil and folinic acid in patients with inoperable pancreatic cancer.
Arning, M; Diebold, T; Hochmuth, K; Huhn, D; Langrehr, J; Neuhaus, P; Oettle, H; Pelzer, U; Riess, H; Schmidt, CA; Vogl, TJ, 1999
)
2.09
"Gemcitabine has been regarded as the mainstay of chemotherapy for pancreatic cancer; however, it is accompanied with a high rate of chemoresistance."( Heat shock factor 1 inhibition sensitizes pancreatic cancer to gemcitabine via the suppression of cancer stem cell-like properties.
Chen, K; Chen, Z; Li, J; Ma, J; Ma, Q; Qian, W; Qin, T; Wang, Z; Wu, E; Wu, Z; Xiao, Y, 2022
)
1.68
"Gemcitabine and cisplatin has limited benefit as treatment for advanced biliary tract cancer (BTC). "( A randomized phase 2 trial of nivolumab, gemcitabine, and cisplatin or nivolumab and ipilimumab in previously untreated advanced biliary cancer: BilT-01.
Beg, MS; Deming, DA; Griffith, KA; Mahalingam, D; Sahai, V; Shaib, WL; Zalupski, MM; Zhen, DB, 2022
)
2.43
"Gemcitabine has shown clinical activity against angiosarcoma in small series, alone, or combined with taxanes. "( Single-agent gemcitabine in patients with advanced, pre-treated angiosarcoma: A multicenter, retrospective study.
Adam, J; Bahleda, R; Briand, S; Cavalcanti, A; Cesne, AL; Chamseddine, AN; Court, C; Fadel, E; Faron, M; Haddag-Miliani, L; Henon, C; Honoré, C; Levy, A; Mercier, O; Mir, O; Ngo, C; Pechoux, CL; Ropert, S; Verret, B; Watson, S, 2023
)
2.72
"Gemcitabine (Gem) has been recommended as a first-line clinical chemotherapeutics for pancreatic ductal adenocarcinoma (PDAC) treatment. "( A tumor microenvironment-stimuli responsive nano-prodrug for overcoming gemcitabine chemoresistance by co-delivered miRNA-21 modulator.
Chen, Y; Hu, Q; Jin, P; Liang, T; Que, R; Xu, M; Yao, Z; Zhang, F, 2023
)
2.59
"Gemcitabine (Gem) has been a standard first-line drug for pancreatic cancer (PCa) treatment; however, Gem's rapid metabolism and systemic instability (short half-life) limit its clinical outcome. "( Biological evaluation of novel gemcitabine analog in patient-derived xenograft models of pancreatic cancer.
Agyare, E; Bulusu, R; Frimpong, E; Han, B; Inkoom, A; Ndemazie, NB; Poku, R; Smith, T; Trevino, J; Zhu, X, 2023
)
2.64
"Gemcitabine resistance has brought great challenges to the treatment of pancreatic cancer. "( m6A eraser FTO impairs gemcitabine resistance in pancreatic cancer through influencing NEDD4 mRNA stability by regulating the PTEN/PI3K/AKT pathway.
Gao, W; Lin, K; Pan, Y; Shi, T; Yu, Y; Zhang, J; Zhang, S; Zheng, Z; Zhou, E, 2023
)
2.66
"Gemcitabine has been widely used as a chemotherapeutic drug. "( RGDV-modified gemcitabine: a nano-medicine capable of prolonging half-life, overcoming resistance and eliminating bone marrow toxicity of gemcitabine.
Liu, W; Mao, Y; Peng, S; Wang, Y; Wu, J; Zhang, X; Zhao, M; Zhao, S, 2019
)
2.32
"Gemcitabine (GEM) has been the recommended first-line drug for patients with pancreatic ductal adenocarcinoma cancer (PDAC) for the last twenty years. "( Theranostic nanoparticles enabling the release of phosphorylated gemcitabine for advanced pancreatic cancer therapy.
Ding, X; Huang, W; Jiang, C; Li, F; Sun, T; Wang, Q; Wang, Z; Wu, Z; Zhu, X, 2020
)
2.24
"Gemcitabine has been a standard of care for the treatment of pancreatic cancer for over 20 years, but as a single agent gemcitabine is not curative."( Developing effective combination therapy for pancreatic cancer: An overview.
Garcia, PL; Miller, AL; Yoon, KJ, 2020
)
1.28
"Gemcitabine has been used as first-line chemotherapy against lung cancer, but many patients experience cancer recurrence. "( Low-Dose Gemcitabine Treatment Enhances Immunogenicity and Natural Killer Cell-Driven Tumor Immunity in Lung Cancer.
Cong, J; Jiao, D; Jin, L; Li, Z; Wang, D; Xu, L; Zhang, X; Zheng, X, 2020
)
2.42
"Gemcitabine has been proved to be effective in many advanced cancer. "( Considering gemcitabine-based combination chemotherapy as a potential treatment for advanced oesophageal cancer: A meta-analysis of randomised trials.
Cheng, X; Hu, X; Jia, Z; Liang, X; Yang, J; Zhai, Y, 2020
)
2.38
"Gemcitabine has been the standard chemotherapy for advanced pancreatic cancer patients for the last two decades."( Blockade of endothelin receptor A enhances the therapeutic efficacy of gemcitabine in pancreatic cancer cells.
Ahn, HM; Kim, DG; Kim, YJ, 2020
)
1.51
"Gemcitabine has shown promising effects on the response and prognosis in patients with metastatic breast cancer."( Gemcitabine as adjuvant chemotherapy in patients with high-risk early breast cancer-results from the randomized phase III SUCCESS-A trial.
Andergassen, U; Bauer, E; Beckmann, MW; Bekes, I; Blohmer, JU; Brucker, SY; de Gregorio, A; de Gregorio, N; Deniz, M; Fasching, PA; Fehm, TN; Fink, V; Forstbauer, H; Friedl, TWP; Häberle, L; Heinrich, G; Janni, W; Lato, K; Lorenz, R; Mahner, S; Müller, V; Rack, B; Schneeweiss, A; Schrader, I; Tesch, H, 2020
)
2.72
"Gemcitabine has been a commonly used therapeutic agent for treatment of pancreatic cancer. "( ERK-mediated transcriptional activation of Dicer is involved in gemcitabine resistance of pancreatic cancer.
Chen, HA; Chiu, CF; Chuang, TH; Hsieh, CL; Hsu, TW; Huang, MT; Leo Su, J; Su, CM; Su, YH, 2021
)
2.3
"Gemcitabine-based therapy has modest activity in CCS. "( Efficacy of Gemcitabine-based Chemotherapy in Clear Cell Sarcoma of Soft Tissue.
Benson, C; Cojocaru, E; Fisher, C; Gennatas, S; Huang, P; Jones, RL; Messiou, C; Miah, AB; Thway, K; Zaidi, S, 2020
)
2.38
"Gemcitabine (GEM) has antiproliferative effects on lymphocytes, which are potent pathogenic actors of rheumatoid arthritis (RA). "( Antiinflammatory and antioxidant effects of gemcitabine in collagen-induced arthritis model.
Dağli, AF; Karataş, A; Koca, SS; Orhan, C; Özgen, M; Şahin, K; Tuzcu, M, 2017
)
2.16
"Gemcitabine has been the first line systemic treatment for pancreatic cancer."( Disrupting glutamine metabolic pathways to sensitize gemcitabine-resistant pancreatic cancer.
Brentnall, TA; Chen, R; Jung, L; Lai, LA; Pan, S; Pillarisetty, VG; Riddell, J; Sullivan, Y; Wang, L; Wong, M, 2017
)
1.43
"Gemcitabine has been standard of care in advanced pancreatic adenocarcinomas (PC) for almost two decades. "( S-1 (Teysuno) and gemcitabine in Caucasian patients with unresectable pancreatic adenocarcinoma.
Bjerregaard, JK; Ejlsmark, MW; Jensen, HA; Krogh, M; Pfeiffer, P; Schonnemann, KR; Winther, SB, 2018
)
2.26
"Gemcitabine has been the standard drug for patients with advanced pancreatic cancer."( Mechanism Comparison of Gemcitabine and Dasatinib-Resistant Pancreatic Cancer by Integrating mRNA and miRNA Expression Profiles.
Chen, B; Chen, Z; Shi, K; Zhao, L, 2018
)
1.51
"Gemcitabine has been the mainstay chemotherapy for around two decades with little improvement in overall survival (OS) for patients with advanced disease."( Nab-paclitaxel in combination with gemcitabine for the treatment of metastatic pancreas cancer: the South Wales experience.
Gwynne, SH; Quinton, AE; Yim, KL, 2018
)
1.48
"Gemcitabine with platinum has limited efficacy for treatment of advanced cholangiocarcinoma, necessitating an evaluation of alternative drug combinations. "( Nab-Paclitaxel and Gemcitabine as First-line Treatment of Advanced or Metastatic Cholangiocarcinoma: A Phase 2 Clinical Trial.
Benson, AB; Catalano, PJ; Lubner, SJ; Menge, MR; Munshi, HG; Nimeiri, HS; O'Dwyer, PJ; Sahai, V; Zalupski, MM, 2018
)
2.25
"Gemcitabine has been associated with thrombotic microangiopathy (TMA). "( Thrombotic microangiopathy associated with gemcitabine use: Presentation and outcome in a national French retrospective cohort.
Burtey, S; Coppo, P; Daviet, F; Duffaud, F; Frémeaux-Bacchi, V; Grandvuillemin, A; Grange, S; Jourde-Chiche, N; Mancini, J; Micallef, J; Moussi-Francès, J; Poullin, P; Pourroy, B; Rouby, F; Sabatier, R; Sallée, M, 2019
)
2.22
"Gemcitabine (GEM) has become the standard chemotherapy for PDAC; however, acquired resistance to GEM is a major challenge."( Mechanisms of metformin's anti‑tumor activity against gemcitabine‑resistant pancreatic adenocarcinoma.
Kitagawa, Y; Suzuki, K; Suzuki, Y; Takeuchi, O, 2019
)
1.48
"Gemcitabine (GEM) has been widely used for pancreatic cancer (PC) treatment but limited by the development of drug resistance. "( S-Adenosylmethionine synergistically enhances the antitumor effect of gemcitabine against pancreatic cancer through JAK2/STAT3 pathway.
Bi, T; Gao, Q; Liu, L; Liu, Y; Qin, L; Shen, G, 2019
)
2.19
"Gemcitabine has limited clinical benefits in pancreatic ductal adenocarcinoma. "( Comparative benefits of Nab-paclitaxel over gemcitabine or polysorbate-based docetaxel in experimental pancreatic cancer.
Awasthi, N; Hinz, S; Schwarz, AM; Schwarz, MA; Schwarz, RE; Wang, C; Williams, NS; Zhang, C, 2013
)
2.09
"Gemcitabine has been associated with an increased risk of arterial and venous thromboembolic events (ATEs and VTEs), although the overall risk remains unclear. "( Risk of venous and arterial thromboembolic events in cancer patients treated with gemcitabine: a systematic review and meta-analysis.
Lin, F; Qi, WX; Shen, Z; Sun, YJ; Tang, LN; Yao, Y, 2013
)
2.06
"Gemcitabine has been approved for MBC since February 2010."( [Clinical experience with gemcitabine treatment for metastatic breast cancer].
Aogi, K; Hara, F; Kiyoto, S; Ohsumi, S; Takabatake, D; Takahashi, M; Takashima, S; Watanabe, M, 2013
)
1.41
"Gemcitabine has potent radiosensitizing properties in preclinical and clinical trials, so it can be utilized simultaneously with radiation."( Concurrent chemoradiation with weekly gemcitabine and cisplatin for locally advanced cervical cancer.
Akbari, EH; Esmati, E; Hashemi, FA; Kalaghchi, B, 2013
)
1.38
"Gemcitabine monotherapy has been the standard of care for patients with metastatic pancreatic cancer for several decades. "( Treatment of metastatic pancreatic adenocarcinoma: a review.
Berlin, JD; Pauff, JM; Thota, R, 2014
)
1.85
"Gemcitabine has been approved by the FDA/SFDA for use as a first-line therapeutic drug against advanced or metastatic breast cancer."( The cytoprotective role of gemcitabine-induced autophagy associated with apoptosis inhibition in triple-negative MDA-MB-231 breast cancer cells.
Chen, L; Chen, M; Dai, F; He, M; Shen, P; Song, Y; Wan, X; Xiao, P, 2014
)
1.42
"Gemcitabine has limited clinical benefits for pancreatic cancer patients. "( HS-104, a PI3K inhibitor, enhances the anticancer efficacy of gemcitabine in pancreatic cancer.
Fang, Z; Hong, S; Hong, SS; Jung, KH; Lee, H; Son, MK; Yan, HH, 2014
)
2.09
"Gemcitabine has been more and more widely used for the treatment of gallbladder cancer; however, the response rate is not satisfactory."( Phenoxodiol enhances the antitumor activity of gemcitabine in gallbladder cancer through suppressing Akt/mTOR pathway.
Feng, J; Huang, X; Huang, Z; Li, Y, 2014
)
1.38
"Gemcitabine has shown activity and acceptable safety profile in B-cell lymphomas."( Clinical activity of a new regimen combining gemcitabine and alemtuzumab in high-risk relapsed/refractory chronic lymphocytic leukemia patients.
Hebraud, B; Houyau, P; Laurent, G; Oberic, L; Recher, C; Suc, E; Vaillant, W; Ysebaert, L, 2015
)
1.4
"Gemcitabine has modest activity in pre-treated EOC. "( Treatment outcomes of gemcitabine in refractory or recurrent epithelial ovarian cancer patients.
Chanpanitkitchot, S; Khunnarong, J; Pataradool, K; Srijaipracharoen, S; Tangjitgamol, S; Thavaramara, T, 2014
)
2.16
"Gemcitabine has the ability to induce T24 cell apoptosis, and this effect is enhanced when it is combined with lentinan."( Lentinan reduces tumor progression by enhancing gemcitabine chemotherapy in urothelial bladder cancer.
Sun, M; Wu, B; Xie, Q; Zhan, Y; Zhao, W, 2015
)
1.39
"Gemcitabine (G) has been shown to sensitize pancreatic cancer to radiotherapy but requires lower doses of G and thus delays aggressive systemic treatment, potentially leading to distant failure. "( Multi-institutional phase I study of low-dose ultra-fractionated radiotherapy as a chemosensitizer for gemcitabine and erlotinib in patients with locally advanced or limited metastatic pancreatic cancer.
Adaire, B; Cescon, TP; Choi, M; Cohen, SJ; Duncan, G; Hall, MJ; Joiner, M; Konski, A; McSpadden, E; Meropol, NJ; Meyer, JE; Philip, P; Shields, A, 2014
)
2.06
"Gemcitabine has been used most commonly as an anticancer drug to treat advanced pancreatic cancer patients. "( Ratio of phosphorylated HSP27 to nonphosphorylated HSP27 biphasically acts as a determinant of cellular fate in gemcitabine-resistant pancreatic cancer cells.
Choi, HJ; Han, Z; Hwang, YS; Je, S; Kang, D; Kang, S; Kim, JH; Kim, SY; Song, JJ, 2015
)
2.07
"Gemcitabine has long been the standard of care for treating pancreatic ductal adenocarcinoma (PDAC), despite its poor pharmacokinetics/dynamics and rapid development of drug resistance. "( Self-assembled nanoscale coordination polymers carrying oxaliplatin and gemcitabine for synergistic combination therapy of pancreatic cancer.
He, C; Lin, W; Liu, D; Lu, K; Poon, C, 2015
)
2.09
"Gemcitabine, which has modest activity in pancreas cancer, activates Chk1, a client protein of HSP90."( Phase II trial of gemcitabine and tanespimycin (17AAG) in metastatic pancreatic cancer: a Mayo Clinic Phase II Consortium study.
Erlichman, C; Foster, NR; Kim, GP; McWilliams, RR; Pedersen, KS; Wang-Gillam, A, 2015
)
1.47
"Gemcitabine also has anti-tumor activity in MBC and a favourable toxicity profile."( Phase I and pharmacological trial of lapatinib in combination with gemcitabine in patients with advanced breast cancer.
Beijnen, JH; Boss, DS; Grob, M; Huitema, AD; Keessen, M; Rehorst, H; Rosing, H; Schellens, JH; Smit, WM; Tibben, MM; van der Noll, R; Wymenga, AN, 2015
)
1.37
"Gemcitabine has been the standard treatment during the last decade."( Interplay Between Gemcitabine and Erlotinib Over Pancreatic Adenocarcinoma Cells.
Alejandre, MJ; Delgado, JR; Linares, A; Palomino-Morales, RJ; Perales, S; Torres, C, 2016
)
1.49
"Gemcitabine has established antitumor activity against solid tumors, including head and neck, ovarian, and non-small cell lung cancers."( Adenovirus-Mediated E2F-1 Gene Transfer Augments Gemcitabine-Induced Apoptosis in Human Colon Cancer Cells.
Jiang, Y; Lin, Z; Liu, G; Ren, N; Shi, Y; Xu, W, 2015
)
1.39
"Gemcitabine has been the cornerstone of PDA treatment in all stages of the disease for the last two decades, but gemcitabine resistance develops within weeks of chemotherapy initiation."( Gemcitabine resistance in pancreatic ductal adenocarcinoma.
Binenbaum, Y; Gil, Z; Na'ara, S, 2015
)
2.58
"And gemcitabine has been the standard of care for advanced pancreatic cancer."( Gemcitabine plus cisplatin versus gemcitabine alone in the treatment of pancreatic cancer: a meta-analysis.
Huang, S; Li, Q; Liu, Z; Miao, X; Ouyang, G; Wen, Y; Xiong, L, 2016
)
2.36
"Gemcitabine monotherapy has been the gold standard for many years."( Safety of palliative chemotherapy in advanced pancreatic cancer.
Boeck, S; Haas, M; Heinemann, V; Kruger, S; Westphalen, CB, 2016
)
1.16
"Gemcitabine has been used as a therapeutic drug combined with cisplatin for the treatment of lung cancer patients. "( Gemcitabine-Induced Autophagy Protects Human Lung Cancer Cells from Apoptotic Death.
Jiang, ZF; Liu, RY; Shao, LJ; Wu, HM, 2016
)
3.32
"Gemcitabine has been an acceptable standard for more than a decade."( Novel advances in pancreatic cancer treatment.
Rocha-Lima, C; Vulfovich, M, 2008
)
1.07
"Gemcitabine has been widely studied in elderly patients affected by advanced non-small cell lung cancer (NSCLC). "( The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients.
Barbera, S; Brancaccio, L; De Maio, E; Gridelli, C; Maione, P; Morabito, A; Perrone, F; Piantedosi, F; Piazza, E; Renda, F; Sannicolo, M; Signoriello, G, 2008
)
2.05
"Gemcitabine has been recommended as an active agent for salvage chemotherapy in patients with recurrent epithelial ovarian cancer, but no clinical study of this agent has been conducted for Japanese women with ovarian cancer. "( Phase II study of single-agent gemcitabine in heavily pretreated Japanese patients with recurrent ovarian cancer.
Etoh, T; Hoshiai, H; Koike, E; Nakai, H; Watanabe, Y, 2008
)
2.07
"Gemcitabine has been shown to exhibit significant clinical activity against pancreatic cancer and has become a first-line chemotherapeutic for this disease in recent years. "( Annexin II overexpression predicts rapid recurrence after surgery in pancreatic cancer patients undergoing gemcitabine-adjuvant chemotherapy.
Kato, A; Kimura, F; Miyazaki, M; Nomura, F; Ohtsuka, M; Shida, T; Shimizu, H; Takano, S; Togawa, A; Tomonaga, T; Yoshidome, H; Yoshitomi, H, 2008
)
2
"Gemcitabine has well-recognized activity in the treatment of ovarian cancer. "( A phase II trial of fixed-dosed rate gemcitabine in platinum-resistant ovarian cancer: a GEICO (Grupo Español de Investigación en Cáncer de Ovario) Trial.
Adrover Cebrian, E; Alonso Carrion, L; Arcusa Lanza, A; Bover Barcelo, I; Calvo Garcia, E; Casado Herraez, A; Churruca Galaz, C; Fabregat i Mayol, X; Gonzalez Martin, A; Herrero Ibañez, A; Mellado, B; Ojeda Gonzalez, B; Poveda Velasco, A; Rubio Perez, MJ, 2008
)
2.06
"Gemcitabine (Gemzar) has been the standard treatment for metastatic pancreatic cancer based primarily on clinical benefits. "( Second-line therapy for gemcitabine-refractory pancreatic cancer: is there a standard?
Almhanna, K; Kim, R, 2008
)
2.1
"Gemcitabine (G) has shown activity in mantle cell lymphoma (MCL) as a single agent. "( Results of a Phase II trial of gemcitabine, mitoxantrone, and rituximab in relapsed or refractory mantle cell lymphoma.
Flynn, PJ; Garbo, LE; Kolibaba, KS; MacRae, MA; Rauch, MA; Wang, Y, 2009
)
2.08
"Gemcitabine has been associated with important thrombotic and vascular side effects. "( Gemcitabine: vascular toxicity and prothrombotic potential.
Dasanu, CA, 2008
)
3.23
"Gemcitabine has antitumor activity in pancreatic cancer."( A phase II study of gemcitabine and oxaliplatin (Oxigem) in unresectable gall bladder cancer.
DattaGupta, S; Deo, S; Dwary, A; Garg, P; Mohanti, B; Pal, S; Raina, V; Rath, G; Sahni, P; Sharma, A; Shukla, N; Thulkar, S, 2010
)
1.41
"Gemcitabine has been the standard of care for pancreatic cancer for a decade but is only effective in some patients."( HuR modulates gemcitabine efficacy: new perspectives in pancreatic cancer treatment.
Maréchal, R; Van Laethem, JL, 2009
)
1.43
"Gemcitabine has been standard therapy for advanced pancreatic cancer for well over a decade."( Novel agents for the treatment of adenocarcinoma of the pancreas.
Mackenzie, RP; McCollum, AD, 2009
)
1.07
"Gemcitabine (GEM) has shown synergy with vinorelbine (VRL) in preclinical models, and has a toxicity profile that is different from VRL, another recently approved cytotoxic drug that seems to be effective in the treatment of breast cancer."( A phase II study of gemcitabine combined with vinorelbine as first-line chemotherapy for metastatic breast cancer.
Abdelhamid, T; El-Mesidi, S; Elzawhri, H; Goda, Y; Kandeel, A; Koheil, H; Meshref, M; Saad, E; Shehata, S; Zaki, M, 2010
)
1.41
"Gemcitabine has known activity against EOC."( Sorafenib in combination with gemcitabine in recurrent epithelial ovarian cancer: a study of the Princess Margaret Hospital Phase II Consortium.
Elit, L; Hirte, HW; Macalpine, K; Oza, AM; Schilder, RJ; Wang, L; Welch, SA; Wright, JJ, 2010
)
1.37
"Gemcitabine has been a standard treatment for patients with advanced pancreatic cancer for a decade."( Modified vaccinia Ankara expressing survivin combined with gemcitabine generates specific antitumor effects in a murine pancreatic carcinoma model.
Diamond, DJ; Ellenhorn, JD; Ishizaki, H; Manuel, ER; Song, GY; Srivastava, T; Sun, S, 2011
)
1.33
"Both gemcitabine and erlotinib have been demonstrated to improve survival in patients with metastatic disease."( Phase II study of gemcitabine and erlotinib as adjuvant therapy for patients with resected pancreatic cancer.
Bahary, N; Bao, PQ; Bartlett, DL; Hughes, SJ; Krasinkas, A; Lee, KK; Lembersky, BC; Moser, AJ; Ramanathan, RK; Zeh, HJ, 2011
)
1.16
"Gemcitabine has minimal activity in the treatment of recurrent or persistent endometrial carcinoma at the dose and schedule tested."( A phase II study of gemcitabine (gemzar, LY188011) in the treatment of recurrent or persistent endometrial carcinoma: a gynecologic oncology group study.
Blessing, JA; Hoffman, JS; Lachance, JA; Miller, DS; Moore, KN; Rotmensch, J; Spirtos, NM; Tait, DL, 2011
)
2.14
"Gemcitabine has been a first-line chemotherapy agent for advanced pancreatic cancer, which is associated with one of the lowest 5 years survival rates among human cancers. "( Genome-wide screen identifies PVT1 as a regulator of Gemcitabine sensitivity in human pancreatic cancer cells.
Chang, D; Du, HZ; You, L; Zhao, YP, 2011
)
2.06
"Gemcitabine has been adopted as the standard first-line agent for advanced pancreatic cancer, but the progression free survival with gemcitabine is short."( [Second line chemotherapy for pancreatic cancer].
Park, JY, 2011
)
1.09
"Gemcitabine (GEM) has been reported to be more effective in unresectable pancreatic cancer and biliary cancer compared with other chemotherapeutic drugs."( Safety evaluation of self-expanding metallic biliary stents eluting gemcitabine in a porcine model.
Chung, JB; Chung, MJ; Kim, H; Kim, KS; Park, S; Park, SW, 2012
)
1.34
"Gemcitabine (Gem) has limited clinical benefits in pancreatic ductal adenocarcinoma (PDAC). "( Antitumour activity of sunitinib in combination with gemcitabine in experimental pancreatic cancer.
Awasthi, N; Schwarz, MA; Schwarz, RE, 2011
)
2.06
"Gemcitabine has a modest activity in heavily pre-treated colorectal cancer patients and may be an option in good performance status patients."( The efficacy of gemcitabine as salvage treatment in patients with refractory advanced colorectal cancer (CRC): a single institution experience.
Hotchkiss, S; Kaley, K; Penney, R; Saif, MW; Strimpakos, AS; Syrigos, KN, 2011
)
2.16
"Gemcitabine has limited clinical benefits for pancreatic ductal adenocarcinoma (PDAC). "( The efficacy of a novel, dual PI3K/mTOR inhibitor NVP-BEZ235 to enhance chemotherapy and antiangiogenic response in pancreatic cancer.
Awasthi, N; Schwarz, MA; Schwarz, RE; Yen, PL, 2012
)
1.82
"Gemcitabine has been recognized as a standard chemotherapy in advanced pancreas cancer(APC). "( A phase II trial of Erlotinib in combination with gemcitabine and cisplatin in advanced pancreatic cancer.
Cha, YJ; Go, S; Hwang, IG; Jang, JS; Kang, JH; Kang, MH; Kwon, HC; Lee, GW; Lee, S; Oh, SY, 2012
)
2.07
"Gemcitabine has been used for pancreatic cancer as the most effective anticancer drug."( Heat-shock protein 27 plays the key role in gemcitabine-resistance of pancreatic cancer cells.
Kaino, S; Kuramitsu, Y; Nakamura, K; Ryozawa, S; Sakaida, I; Suenaga, S; Taba, K; Wang, Y, 2012
)
1.36
"Gemcitabine has good clinical activity against NSCLC and is well tolerated by the patients."( BOOP as a rare complication of gemcitabine therapy.
Cocco, A; Daw, HA; Kawsar, HI; Spiro, TP, 2011
)
1.38
"Gemcitabine has high activity against nasopharyngeal carcinoma (NPC). "( Expression of RRM1 and its association with resistancy to gemcitabine-based chemotherapy in advanced nasopharyngeal carcinoma.
Hu, ZH; Huang, Y; Xue, C; Zhang, J; Zhang, JW; Zhang, L; Zhao, HY; Zhao, LP; Zhao, YY, 2012
)
2.07
"Gemcitabine (Gem) has limited clinical benefits in pancreatic ductal adenocarcinoma (PDAC). "( Evaluation of poly-mechanistic antiangiogenic combinations to enhance cytotoxic therapy response in pancreatic cancer.
Awasthi, N; Ruan, W; Schwarz, MA; Schwarz, RE; Zhang, C, 2012
)
1.82
"Gemcitabine has been widely used, and cisplatin plus gemcitabine is considered as standard first-line chemotherapy for patients with advanced biliary tract cancer. "( A retrospective study of S-1 monotherapy as second-line treatment for patients with advanced biliary tract cancer.
Andou, T; Kameda, R; Kobayashi, S; Morinaga, S; Ohkawa, S; Ueno, M; Yamamoto, N, 2012
)
1.82
"Gemcitabine has been the most commonly used drug over the past decade and is still the cornerstone of therapy in adjuvant and metastatic settings."( Molecular changes in pancreatic cancer: implications for molecular targeting therapy.
Bachet, JB; Demetter, P; Maréchal, R; Salmon, I; Van Laethem, JL; Verset, L, 2012
)
1.1
"Gemcitabine has limited clinical benefits in pancreatic ductal adenocarcinoma (PDAC). "( BMS-754807, a small-molecule inhibitor of insulin-like growth factor-1 receptor/insulin receptor, enhances gemcitabine response in pancreatic cancer.
Awasthi, N; Ruan, W; Schwarz, MA; Schwarz, RE; Zhang, C, 2012
)
2.03
"H-gemcitabine has low toxicity because it is membrane-impermeable; however, it still has high tumor efficacy because of its ability to target gemcitabine to E-DNA in tumors."( H-gemcitabine: a new gemcitabine prodrug for treating cancer.
Acharya, AP; Dasari, M; Kim, D; Lee, S; Molinaro, R; Murthy, N; Rhea, J, 2013
)
1.67
"Gemcitabine has been the standard chemotherapeutic agent in pancreatic cancer. "( Pancreatic cancer - cost for overtreatment with gemcitabine.
Andersson, R; Ansari, D; Tingstedt, B, 2013
)
2.09
"Gemcitabine has been increasingly prescribed for the treatment of gallbladder cancer. "( Icariin potentiates the antitumor activity of gemcitabine in gallbladder cancer by suppressing NF-κB.
Chen, GY; Ding, YB; Liu, JL; Xia, JG; Zhang, DC, 2013
)
2.09
"Gemcitabine has been tested as a radiosensitizer in various biological models, and radiation dose modification factors (DMF) have been reported in the range between 1.1 and 2.4."( Role of deoxycytidine kinase (dCK) activity in gemcitabine's radioenhancement in mice and human cell lines in vitro.
Bruniaux, M; De Bast, M; De Coster, B; Grégoire, V; Octave-Prignot, M; Rosier, JF; Scalliet, P, 2002
)
1.29
"Gemcitabine has substantial activity as an intravesical agent in BCG-refractory TCC and warrants further investigation. "( Phase I trial of intravesical gemcitabine in bacillus Calmette-Guérin-refractory transitional-cell carcinoma of the bladder.
Bajorin, D; Dalbagni, G; dePalma, D; Donat, MS; Herr, HW; Mazumdar, M; Rabbani, F; Russo, P; Sheinfeld, J; Sogani, P; Tong, W, 2002
)
2.05
"Gemcitabine has modest antitumor activity in advanced pancreatic cancer. "( The pemetrexed/gemcitabine combination in pancreatic cancer.
Kindler, HL, 2002
)
2.11
"Gemcitabine has been reported to be an active agent in pancreatic cancer. "( New applications of gemcitabine and future directions in the management of pancreatic cancer.
Abbruzzese, JL, 2002
)
2.08
"Gemcitabine has mild renal toxicity, but cases of gemcitabine-associated hemolytic-uremic syndrome (HUS) have been reported."( Gemcitabine-associated hemolytic-uremic syndrome.
Joerger, M; Pestalozzi, BC; Walter, RB, 2002
)
3.2
"Gemcitabine has shown promising activity in heavily pretreated patients with HD and NHL even in those who have progressed after autologous stem cell transplantation."( Gemcitabine and its combinations in the treatment of malignant lymphoma.
Chau, I; Cunningham, D; Watkins, D, 2002
)
2.48
"Gemcitabine has demonstrated a good efficacy in number of tumor types. "( [Gemcitabine and breast cancer].
Besse, B; Spano, JP, 2002
)
2.67
"Gemcitabine has demonstrated promising activity in phase II studies in metastatic breast cancer and gynaecologic tumors; phase III trials are ongoing."( [Updates on gemcitabine at the American Society of Clinical Oncology congress (ASCO, 2002) ].
André, T; Culine, S; Epaud, C; Gligorov, J, 2002
)
1.41
"Gemcitabine has become one of the key drugs in the treatment of patients with locally advanced and metastatic transitional cell carcinoma of the urothelium. "( Gemcitabine in transitional cell carcinoma of the urothelium.
von der Maase, H, 2003
)
3.2
"Gemcitabine has modest activity in this disease."( Systemic therapy for advanced pancreatic cancer.
El-Rayes, BF; Philip, PA, 2002
)
1.04
"Gemcitabine has evolved as standard therapy in advanced pancreatic cancer since the demonstration of a significant clinical benefit. "( Activity of raltitrexed and gemcitabine in advanced pancreatic cancer.
Aebi, S; Borner, MM; Büchler, MW; Friess, H; Kralidis, E, 2003
)
2.06
"Gemcitabine has shown a broad range of activity in solid tumors, including previously untreated small-cell lung cancer (SCLC). "( Phase II trial of gemcitabine in refractory or relapsed small-cell lung cancer: Eastern Cooperative Oncology Group Trial 1597.
Blanke, C; Declerck, L; DeVore, R; Johnson, D; Masters, GA; Miller, K; Sandler, A, 2003
)
2.1
"Gemcitabine has modest activity in previously treated SCLC patients. "( Phase II trial of gemcitabine in refractory or relapsed small-cell lung cancer: Eastern Cooperative Oncology Group Trial 1597.
Blanke, C; Declerck, L; DeVore, R; Johnson, D; Masters, GA; Miller, K; Sandler, A, 2003
)
2.1
"Gemcitabine has thus become the de facto standard of care for advanced pancreatic cancer, and current efforts are directed toward finding strategies that can capitalize on and extend these clinical benefits."( Chemotherapy for advanced pancreatic cancer.
Haller, DG, 2003
)
1.04
"Gemcitabine (GEM) has potential activity in advanced pancreatic cancer and is a powerful radiosensitizer."( Postoperative adjuvant gemcitabine and concurrent radiation after curative resection of pancreatic head carcinoma: a phase II study.
Closon, MT; Closset, J; Collette, M; Demols, A; Gastelblum, P; Gay, F; Gelin, M; Houbiers, G; Houtte, PV; Polus, M; Van Laethem, JL, 2003
)
1.35
"Gemcitabine has recently been shown to be an improvement over 5-fluorouracil in patients with advanced disease."( Initial experience combining cyclooxygenase-2 inhibition with chemoradiation for locally advanced pancreatic cancer.
Crane, CH; Janjan, NA; Mason, K; Milas, L, 2003
)
1.04
"Gemcitabine has shown therapeutic activity in a variety of malignancies, including ovarian cancer. "( Gemcitabine as a single-agent treatment for ovarian cancer.
Fowler, WC; Van Le, L, 2003
)
3.2
"Gemcitabine has become one of the key drugs in the management of NSCLC, alone or in association with platin compounds."( The emerging role of pemetrexed (Alimta) and gemcitabine in non-small cell lung cancer.
Le Chevalier, T, 2003
)
1.3
"Gemcitabine has replaced 5-fluorouracil-based chemotherapy as the standard of care."( New perspectives in the management of pancreas cancer.
Haller, DG, 2003
)
1.04
"Gemcitabine has been extensively studied in the oncology literature and at this time is thought to be a low-risk hepatotoxin causing hepatic adaptation and transient, reversible liver enzyme elevation, rarely leading to termination of gemcitabine therapy for solid tumors."( Fatal cholestatic liver failure associated with gemcitabine therapy.
Lambiase, L; Li, J; Monteiro, C; Robinson, K; Schiff, M, 2003
)
1.3
"Gemcitabine has been shown to be active as a single agent and in combination with other drugs, including carboplatin and paclitaxel, in the treatment of patients with recurrent ovarian cancer."( Gemcitabine: current role and future options in the treatment of ovarian cancer.
D'Agostino, G; Ferrandina, G; Fruscella, E; Gallo, D; Scambia, G, 2003
)
2.48
"Gemcitabine (GEM) has replaced 5-fluorouracil (5-FU)-based chemotherapy as the standard of care."( [Chemotherapy for pancreatic cancer].
Abe, H; Akada, M; Egawa, S; Fukuyama, S; Matsuno, S; Motoi, F; Ottomo, S; Sunamura, M; Takeda, K, 2003
)
1.04
"Gemcitabine has been prescribed for patients with inoperable human pancreatic ductal carcinoma as a first-line chemotherapy."( Gemcitabine suppresses malignant ascites of human pancreatic cancer: correlation with VEGF expression in ascites.
Chayama, K; Iiboshi, T; Kariya, K; Kobayashi, K; Kuwada, Y; Kuwahara, K; Miyata, H; Morinaka, K; Murakami, M; Noma, B; Sasaki, T; Serikawa, M; Yamasaki, S, 2004
)
2.49
"Gemcitabine has demonstrated significant antitumor activity in patients with advanced breast cancer when used either as a single agent or in combination with other active drugs (as a doublet or a triplet)."( Rationale and clinical trial design for evaluating gemcitabine as neoadjuvant and adjuvant therapy for breast cancer.
Geyer, CE; Mamounas, EP; Swain, SM, 2004
)
1.3
"Gemcitabine has been evaluated in combination with paclitaxel, docetaxel, anthracyclines, vinorelbine, and cisplatin as first-line treatment and after prior chemotherapy in patients with metastatic breast cancer. "( Gemcitabine combination chemotherapy in metastatic breast cancer: phase II experience.
O'Shaughnessy, J, 2003
)
3.2
"Gemcitabine has recently emerged as the standard single agent in advanced stages of the disease and pharmacokinetic refinements such as the use of a fixed-dose infusion rate may further improve still rather modest result figures."( Emerging drugs in pancreatic cancer.
Boige, V; Ducreux, M; Malka, D, 2004
)
1.04
"Gemcitabine has been reported to be a potent radiosensitiser in human pancreatic cell lines. "( Phase II study of radiotherapy combined with gemcitabine for locally advanced pancreatic cancer.
Ikeda, H; Ikeda, M; Ito, Y; Kagami, Y; Morizane, C; Okusaka, T; Takezako, Y; Ueno, H, 2004
)
2.03
"Gemcitabine has documented efficacy in this setting."( Pilot study of fixed-infusion rate gemcitabine with Cisplatin and dexamethasone in patients with relapsed or refractory lymphoma.
Colovos, C; Emmanouilides, C; Hernandez, L; Pinter-Brown, L; Rosen, P; Schiller, G; Territo, M, 2004
)
1.32
"Gemcitabine has been shown to have modest activity and low and well-tolerated toxicity in heavily pretreated patients with recurrent ovarian carcinoma."( Long-term disease-free survival effected by gemcitabine in a heavily pretreated patient with recurrent ovarian carcinoma.
Piura, B, 2005
)
2.03
"Gemcitabine has been recently recognized as standard treatment in advanced pancreatic cancer. "( Gemcitabine and continuous infusion of 5-fluorouracil in locally advanced and metastatic pancreatic cancer: a phase I-II study.
Barana, D; Bassi, C; Cavallini, G; Cetto, GL; Falconi, M; Manno, P; Oliani, C; Padovani, M; Pederzoli, P,
)
3.02
"Gemcitabine has some activity and low and well tolerated toxicity in heavily pretreated patients with platinum-resistant recurrent ovarian, peritoneal and fallopian tube carcinoma."( Gemcitabine in heavily pretreated patients with recurrent ovarian, peritoneal and fallopian tube carcinoma.
Piura, B; Rabinovich, A, 2004
)
3.21
"Gemcitabine (Gemzar) has elicited considerable interest in this disease, as a combination partner in chemotherapeutic regimens."( New investigative regimens and cytotoxic agents in thoracic cancers: gemcitabine and pemetrexed.
Bunn, P, 2004
)
1.28
"Gemcitabine has demonstrated clinical activity in solid tumors. "( Non-toxic and short treatment with gemcitabine inhibits in vitro migration of HT-1080 cells.
Alcouffe, C; Boutonnat, J; Clément-Lacroix, J; Mousseau, M; Ronot, X, 2004
)
2.04
"Gemcitabine has broad activity in a variety of solid tumors including biliary tract carcinomas. "( Gemcitabine, 5-fluorouracil, and leucovorin in advanced biliary tract and gallbladder carcinoma: a North Central Cancer Treatment Group phase II trial.
Al-Khatib, H; Alberts, SR; Burgart, L; Cera, PJ; Finch, TR; Flynn, PJ; Knost, JA; Levitt, R; Mahoney, MR; Tschetter, LK; Windschitl, HE, 2005
)
3.21
"Gemcitabine has been included as a partner for paclitaxel in the tAnGo trial based on high response rates, including high complete response rates, observed in phase II trials of the combination in more advanced disease and based on the tolerability and safety of the combination compared with those of other taxane-containing two-drug combinations."( Adjuvant chemotherapy for early-stage breast cancer: the tAnGo trial.
Poole, C, 2004
)
1.04
"Gemcitabine has been the standard regimen for advanced pancreatic cancer, but the effect on the response rate and survival is still disappointing, leading to many trials of combination chemotherapy. "( [A phase II study of combination chemotherapy with gemcitabine, 5-fluorouracil, and cisplatin for advanced pancreatic cancer].
Choi, SB; Kim, SR; Lee, HY; Yuh, YJ, 2005
)
2.02
"Gemcitabine therapy has been associated with radiation recall reactions when used in the treatment of carcinoma. "( Gemcitabine-induced pericardial effusion and tamponade after unblocked cardiac irradiation.
Carver, JR; Elstrom, R; Glatstein, E; Luger, S; Nasta, SD; Porter, DL; Schuster, SJ; Stadtmauer, EA; Tsai, DE; Vogl, DT, 2005
)
3.21
"Gemcitabine has demonstrated a broad spectrum anti-tumoural effect and a favourable toxicity profile."( Gemcitabine in the treatment of advanced head and neck cancer.
Bier, J; Gath, HJ; Oettle, H; Raguse, JD; Riess, H, 2005
)
2.49
"Gemcitabine has excellent radiosensitizing properties, as shown in both preclinical and clinical studies. "( Unraveling the mechanism of radiosensitization by gemcitabine: the role of TP53.
Andriessen, V; Baay, MF; Korst, AE; Lambrechts, HA; Lardon, F; Pattyn, GG; Pauwels, B; Pooter, CM; Vermorken, JB, 2005
)
2.02
"Gemcitabine has demonstrated response in similar cancers."( The role of gemcitabine in the treatment of cholangiocarcinoma and gallbladder cancer: a systematic review.
Brouwers, MC; Dingle, BH; Rumble, RB, 2005
)
1.43
"Gemcitabine has minimal activity as a single agent at this dose and schedule in advanced STS. "( Phase II trial of gemcitabine as first line chemotherapy in patients with metastatic or unresectable soft tissue sarcoma.
Borden, EC; Karen, A; Mills, GM; Rankin, C; Von Burton, G; Zalupski, MM, 2006
)
2.11
"Gemcitabine has a good toxicity profile, with myelosuppression being the most common side effect, while non-hematological events are relatively uncommon."( Role of gemcitabine in cancer therapy.
Bartolini, S; Cappuzzo, F; Finocchiaro, G; Gioia, V; Toschi, L, 2005
)
1.48
"Gemcitabine has been previously reported to be causative of acute myocardial infarction."( Gemcitabine and acute myocardial infarction--a case report.
Bdair, FM; Graham, SP; Javle, MM; Smith, PF,
)
2.3
"Gemcitabine has activity in a high-risk patient population and remains a viable option for some patients who refuse cystectomy."( Phase II trial of intravesical gemcitabine in bacille Calmette-Guérin-refractory transitional cell carcinoma of the bladder.
Bajorin, D; Ben-Porat, L; Bochner, B; Dalbagni, G; Donat, MS; Herr, HW; Russo, P; Sheinfeld, J; Sogani, P, 2006
)
2.06
"Gemcitabine has proven active in combination with paclitaxel and, on this basis, a phase III trial showed a significantly higher response rate than paclitaxel alone (39.3% v 25.6%)."( Overview of gemcitabine activity in advanced breast cancer.
Smith, IE, 2006
)
1.43
"Gemcitabine has a molecular weight of 299 D, lower than that of commonly-used intravesical chemotherapeutic agents such as mitomycin C (389 D) and doxorubicin (589 D). "( Actual experience and future development of gemcitabine in superficial bladder cancer.
Frea, B; Gontero, P, 2006
)
2.04
"Gemcitabine has been shown to exert a radiosensitizing effect in various epithelial cancers. "( Combination therapy using gemcitabine and radioimmunotherapy in nude mice with small peritoneal metastases of colonic origin.
Bleichrodt, RP; Boerman, OC; Goldenberg, DM; Koppe, MJ; Oyen, WJ; Verhofstad, AA, 2006
)
2.08
"Gemcitabine has been shown to be effective as a single agent in a variety of tumors including nonHodgkin's lymphoma. "( Single agent gemcitabine chemotherapy in dogs with spontaneously occurring lymphoma.
Cosgrove, SB; Gamblin, RM; Griffice, K; Hahn, KA; Khanna, C; Rusk, A; Turner, AI,
)
1.94
"Gemcitabine has been shown to ameliorate disease related symptoms and to prolong overall survival in pancreatic cancer.Yet, resistance to Gemcitabine is commonly observed in this tumour entity and has been linked to increased expression of anti-apoptotic bcl-2. "( bcl-2-specific siRNAs restore gemcitabine sensitivity in human pancreatic cancer cells.
Dietze, O; Hahn, EG; Herold, C; Neureiter, D; Ocker, M; Okamoto, K; Zopf, S,
)
1.86
"Gemcitabine has been one of the most commonly used agents for pancreatic adenocarcinoma chemotherapy, but the determinants of the sensitivity of and resistance to this agent are not yet fully understood. "( Human equilibrative nucleoside transporter 1 is associated with the chemosensitivity of gemcitabine in human pancreatic adenocarcinoma and biliary tract carcinoma cells.
Danenberg, PV; Endo, I; Fujii, Y; Ichikawa, Y; Ishikawa, T; Matsuyama, R; Mori, R; Shimada, H; Taniguchi, K; Togo, S; Ueda, M, 2007
)
2
"Gemcitabine has a possible role for stage IV pancreatic cancer."( Impact of gemcitabine on the survival of patients with stage IV pancreatic cancer.
Ajiki, T; Fujino, Y; Kamigaki, T; Kamoda, Y; Kuroda, Y; Matsumoto, I; Takase, S; Ueda, T; Yasuda, T, 2007
)
2.18
"Gemcitabine has a relatively safe profile."( Gemcitabine-induced liver fibrosis in a patient with pancreatic cancer.
Cornfeld, D; Saif, MW; Shahrokni, A, 2007
)
2.5
"Gemcitabine has been reported to cause this condition rarely."( Gemcitabine-induced hemolytic uremic syndrome in ovarian carcinoma.
Kad, R; Kalra, N; Osama, S, 2007
)
2.5
"Gemcitabine has been a standard treatment for advanced pancreatic cancer since it was shown a decade ago to result in a superior clinical benefit response and survival compared with bolus 5-fluorouracil (5-FU)."( Pancreatic cancer--is the wall crumbling?
Chua, YJ; Zalcberg, JR, 2008
)
1.07
"Gemcitabine has been reported as a single drug, in 12 trials and as a combination in 21 studies. "( Chemotherapy with gemcitabine in advanced biliary tract carcinoma.
Gerson, R; Serrano, A, 2008
)
2.12
"Gemcitabine has also shown activity in platinum-resistant patients with an overall response rate of 23% (95% CI 10%-40%)."( New cytostatic drugs in ovarian cancer.
Eisenhauer, EA; Hansen, HH; Hansen, M; Neijt, JP; Piccart, MJ; Sessa, C; Thigpen, JT, 1993
)
1.01
"Gemcitabine has an unusually mild side effect profile for such an active agent."( Efficacy and safety profile of gemcitabine in non-small-cell lung cancer: a phase II study.
Abratt, RP; Bezwoda, WR; Falkson, G; Goedhals, L; Hacking, D; Rugg, TA, 1994
)
1.3
"Gemcitabine has modest activity in pancreatic cancer, a limited positive improvement on a range of patient benefit parameters and has a mild toxicity profile."( Phase II study of gemcitabine in patients with advanced pancreatic cancer.
Blatter, J; Carmichael, J; Fink, U; Harris, AL; Russell, RC; Spiessi, G; Spittle, MF, 1996
)
1.35
"Gemcitabine has also been studied in combination with other drugs active in NSCLC."( Gemcitabine in the treatment of non-small-cell lung cancer.
Burkes, RL; Shepherd, FA, 1995
)
2.46
"Gemcitabine has been found to be promising in the chemotherapy of other tumors with low proliferative activity, but its effectiveness against myeloma cells has not been analyzed so far."( 2',2'-Difluorodeoxycytidine (gemcitabine) induces apoptosis in myeloma cell lines resistant to steroids and 2-chlorodeoxyadenosine (2-CdA).
Boeck, G; Egle, A; Geisen, F; Greil, R; Gruber, J; Konwalinka, G; Sgonc, R; Villunger, A, 1996
)
1.31
"Gemcitabine has been administered using two different treatment schedules: once weekly or twice weekly for 3 weeks followed by a week of rest (one cycle)."( Gemcitabine: once-weekly schedule active and better tolerated than twice-weekly schedule.
Anderson, H; Lund, B; Martin, C; Thatcher, N, 1996
)
2.46
"Gemcitabine has shown phase II activity against a range of solid tumor malignancies. "( A phase I study of gemcitabine and carboplatin in non-small cell lung cancer.
Allerheiligen, S; Carmichael, J; Walling, J, 1996
)
2.07
"Gemcitabine has high clinical activity in several solid tumors that are treated with radiotherapy and/or chemotherapy. "( Radiosensitization of human solid tumor cell lines with gemcitabine.
Lawrence, TS; Shewach, DS, 1996
)
1.98
"Gemcitabine has some activity in heavily pretreated ovarian cancer patients and deserves further investigation in this malignancy."( Activity of gemcitabine in patients with advanced ovarian cancer: responses seen following platinum and paclitaxel.
Francis, PA; Michael, M; Millward, MJ; Rischin, D; Shapiro, JD; Toner, GC; Walcher, V, 1996
)
1.39
"Gemcitabine has been shown to be a potent radiosensitizer in a variety of tumor cell lines, including HT-29 colorectal carcinoma, pancreatic cancer, breast, non-small cell lung and head and neck cancer cell lines."( Gemcitabine and radiosensitization in human tumor cells.
Lawrence, TS; Shewach, DS, 1996
)
2.46
"Gemcitabine has been found to be active against colony-forming units from patients with non-small cell lung, breast, ovarian, and pancreatic cancers."( Activity of gemcitabine in a human tumor cloning assay as a basis for clinical trials with gemcitabine. San Antonio Drug Development Team.
Von Hoff, DD, 1996
)
1.39
"Gemcitabine has shown some activity against non-small-cell lung cancer, particularly when combined with cisplatin or ifosfamide."( Gemcitabine: a cytidine analogue active against solid tumors.
Hui, YF; Reitz, J, 1997
)
2.46
"Gemcitabine has a role in the palliative treatment of patients with advanced non-small cell lung cancer."( Gemcitabine: symptomatic benefit in advanced non-small cell lung cancer.
Anderson, H; Bradley, B; Jayson, G; Ranson, M; Thatcher, N, 1997
)
2.46
"Gemcitabine also has dose- and time-dependent radiosensitization properties in vitro."( Enhancement of radiation-induced regrowth delay by gemcitabine in a human tumor xenograft model.
Ball, DL; Groves, J; Joschko, MA; Millward, MJ; Palatsides, M; Webster, LK; Yuen, K, 1997
)
1.27
"Gemcitabine has shown activity in different solid tumors. "( Phase II trial of gemcitabine in advanced non-small-cell lung cancer.
Aigner, K; Baumgartner, G; Forstner, B; Huber, H; Hubner, M; Krajnik, G; Krejcy, K; Kummer, F; Malayeri, R; Pirker, R; Ulsperger, E; Zöchbauer, S, 1997
)
2.07
"Gemcitabine has promising single-agent activity against urothelial cancer with a favorable toxicity profile. "( Gemcitabine: a promising new agent in the treatment of advanced urothelial cancer.
Ernst, DS; Huan, S; Moore, MJ; Murray, N; Tannock, IF, 1997
)
3.18
"Gemcitabine has been evaluated in 3 phase II studies revealing anti-tumour activity, albeit to a modest degree of around 10%."( Clinical response benefit in patients with advanced pancreatic cancer. Role of gemcitabine.
Carmichael, J, 1997
)
1.25
"Gemcitabine has demonstrated single-agent activity in advanced, incurable non-small cell lung cancer, yielding response rates of > or =20%, and, in combination with cisplatin, response rates of 30% to 60%. "( Gemcitabine and carboplatin in combination: phase I and phase II studies.
Calvert, P; Langer, CJ; Ozols, RF, 1998
)
3.19
"Gemcitabine has demonstrated significant single-agent activity in NSCLC."( Gemcitabine and radiation therapy for non-small cell lung cancer.
Gregor, A; Turrisi, AT; Vokes, EE, 1998
)
2.46
"Gemcitabine has activity against untreated SCLC."( Evaluation of new drugs in small cell lung cancer: the activity of gemcitabine.
Postmus, PE; Schramel, FM; Smit, EF, 1998
)
1.26
"Gemcitabine, which has shown considerable potential for the treatment of solid tumors, was a relatively poor inhibitor of [3H]formycin B uptake via the equilibrative transporters (IC50 approximately 400 microM)."( Interaction of 2',2'-difluorodeoxycytidine (gemcitabine) and formycin B with the Na+-dependent and -independent nucleoside transporters of Ehrlich ascites tumor cells.
Burke, T; Ferguson, PJ; Hammond, JR; Lee, S, 1998
)
1.28
"Gemcitabine has shown single-agent activity in metastatic breast cancer. "( Gemcitabine plus dose-escalated epirubicin in advanced breast cancer: results of a phase I study.
Akrivakis, C; Arning, M; Flath, B; Lüftner, D; Mergenthaler, HG; Ohnmacht, U; Possinger, K, 1998
)
3.19
"Gemcitabine has demonstrated single-agent activity in advanced, incurable non-small cell lung cancer, yielding response rates of > or =20%. "( Gemcitabine and carboplatin in combination: an update of phase I and phase II studies in non-small cell lung cancer.
Calvert, P; Edelman, MJ; Gandara, DR; Langer, CJ; Ozols, RF, 1999
)
3.19
"Gemcitabine has a mild toxicity profile that allows it to be combined easily in triplet combinations with other doublets."( Triplet chemotherapy with gemcitabine, a platinum, and a third agent in the treatment of advanced non-small cell lung cancer.
Bunn, PA, 1999
)
1.32
"Gemcitabine has shown activity in patients with less chemosensitive solid tumors. "( A Phase II study of gemcitabine in patients with malignant pleural mesothelioma. European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group.
Ardizzoni, A; Baas, P; Debruyne, C; Giaccone, G; Gridelli, C; Groen, HJ; Lentz, M; Manegold, C; van Marck, EA; van Meerbeeck, JP, 1999
)
2.07
"Gemcitabine has been already approved as indications for NSCLC as well as pancreatic cancer abroad and now there have been discussions on its efficacy against other kinds of cancer such as breast cancer."( [Gemcitabine hydrochloride is a new anti-cancer agent which will be available in the patients with non-small cell lung cancer (NSCLC) in Japan].
Yokoyama, A, 1999
)
1.93
"Gemcitabine has most frequently been combined with cisplatin, yielding a combined response rate of 44% (intention-to-treat; 95% CI 36% to 47%) or 45% (efficacy; 95% CI 39% to 51%) from 7 phase II studies."( The use of gemcitabine in non-small-cell lung cancer. Provincial Lung Cancer Disease Site Group. Provincial Systemic Treatment Disease Site Group.
Eady, A; Evans, WK; Gagliardi, A; Kocha, W; Newman, TE, 1999
)
1.41
"Gemcitabine has shown very modest activity when used as a single agent or in combination therapy, although further data from ongoing research have not yet been reported."( Chemotherapy in head and neck cancer. Overview of newer agents.
Khattab, J; Urba, SG, 1999
)
1.02
"Both gemcitabine and docetaxel have been associated with pulmonary toxicity when used as single agents. "( Severe pulmonary toxicity in patients treated with a combination of docetaxel and gemcitabine for metastatic transitional cell carcinoma.
Bateman, AC; Cook, T; Dunsford, ML; Mead, GM; Tung, K, 1999
)
1.04
"Gemcitabine (Gemzar) has a significant impact upon survival and quality of life for patients with pancreatic cancer, compared with 5-fluorouracil (5-FU). "( Phase I trial of gemcitabine (Gemzar), 24 h infusion 5-fluorouracil and folinic acid in patients with inoperable pancreatic cancer.
Arning, M; Diebold, T; Hochmuth, K; Huhn, D; Langrehr, J; Neuhaus, P; Oettle, H; Pelzer, U; Riess, H; Schmidt, CA; Vogl, TJ, 1999
)
2.09
"Gemcitabine also has been shown to be more effective than best supportive care in non-small cell lung cancer."( Single-agent gemcitabine and gemcitabine/irinotecan combination (irimogem) in non-small cell lung cancer.
Bahadori, HR; Eckardt, JR; Green, MR; Leong, SS; Perkel, JA; Putman, T; Rocha Lima, CM; Safa, AR; Sherman, CA, 1999
)
1.39
"Gemcitabine and docetaxel have been claimed to be active single agents in advanced pancreatic cancer. "( A phase I-II study of gemcitabine and docetaxel in advanced pancreatic cancer: a report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD).
Cascinu, S; Catalano, G; Catalano, V; Gasparini, G; Gattuso, D; Giordani, P; Morabito, A; Pancera, G; Silva, RR, 1999
)
2.06
"Gemcitabine has been shown to be an active agent in the treatment of patients with recurrent ovarian cancer."( The role of gemcitabine in the treatment of ovarian cancer.
Ozols, RF, 2000
)
1.41
"Gemcitabine has been demonstrated active in non-small cell lung cancer (NSCLC). "( Cisplatin-carboplatin-gemcitabine or ifosfamide-gemcitabine in advanced non-small cell lung carcinoma: two pilot studies.
Berghmans, T; Klastersky, J; Markiewicz, E; Mommen, P; Sculier, JP,
)
1.89
"Gemcitabine has recently been compared favorably to 5-fluorouracil (5-FU) as the standard chemotherapy for advanced pancreas cancer. "( A phase II study of gemcitabine and 5-fluorouracil in metastatic pancreatic cancer: an Eastern Cooperative Oncology Group Study (E3296).
Adak, S; Berlin, JD; Blaszkowsky, L; Flinker, D; Harris, JE; Vaughn, DJ, 2000
)
2.07
"Gemcitabine has demonstrated clinical activity against several common cancers. "( The study of gemcitabine in combination with other chemotherapeutic agents as an effective treatment for prostate cancer.
Brumfield, SK; Lehr, JE; Mahoney, M; Muenchen, HJ; Pienta, KJ; Pilat, MJ; Quigley, MM,
)
1.94
"Gemcitabine has been recently added to the 5-fluorouracil (5-FU) protocol in the treatment of both new and 5-FU refractory patients with pancreatic cancer. "( Comparison of 5-FU and leucovorin to gemcitabine in the treatment of pancreatic cancer.
Figer, A; Klein, B; Levin, I; Mishaeli, M; Sadikov, E,
)
1.85
"Gemcitabine has promising single-agent activity in advanced breast disease. "( Gemcitabine in combination with doxorubicin in advanced breast cancer: final results of a phase II pharmacokinetic trial.
Alba, E; García-Conde, J; Khayat, D; Lluch, A; Moreno-Nogueira, JA; Palomero, M; Pérez-Manga, G; Rivelles, N, 2000
)
3.19
"Gemcitabine therapy has not been widely assessed in the treatment of hematological malignancies. "( Gemcitabine for relapsed or resistant lymphoma.
Flamm, M; Garrett, TJ; Heitjan, D; Johnson, SA; Keohan, ML; Lee, RT; Oster, MW; Ruiz, J; Rule, SA; Savage, DG; Tighe, M, 2000
)
3.19
"Gemcitabine has substantial activity and acceptable toxicity in heavily pre-treated patients with advanced lymphoma. "( Gemcitabine for relapsed or resistant lymphoma.
Flamm, M; Garrett, TJ; Heitjan, D; Johnson, SA; Keohan, ML; Lee, RT; Oster, MW; Ruiz, J; Rule, SA; Savage, DG; Tighe, M, 2000
)
3.19
"Gemcitabine has evoked interest not only because of its intrinsic activity against this cancer, but also because of its effect of inhibiting repair of DNA that has been damaged by drugs like cisplatin."( Gemcitabine and cisplatin in locally advanced and/or metastatic bladder cancer.
von der Maase, H, 2000
)
2.47
"Also gemcitabine has shown interesting results in this setting, with a 19% response rate and a median and 1-year survival rate of 34 weeks and 45%, respectively."( Second-line chemotherapy for recurrent non-small cell lung cancer: do new agents make a difference?
Buccheri, G; Ferrigno, D, 2000
)
0.76
"Gemcitabine has shown interesting clinical activity in initial phase II clinical trials in a variety of malignancies, including the aerodigestive malignancies, squamous-cell carcinoma of the head/neck and both non-small-cell and small-cell lung cancer."( Phase II trial of gemcitabine in patients with previously untreated metastatic cancer of the esophagus or gastroesophageal junction.
Einhorn, LH; Kindler, HL; Kraut, M; Masters, G; Mitchell, E; Nicol, S; Raghavan, D; Sandler, AB, 2000
)
1.36
"Gemcitabine has been shown to improve survival and quality of life parameters compared to fluorouracil alone in advanced pancreatic cancer [J Clin Oncol 1997;15:2403-2413]. "( Activity of gemcitabine and continuous infusion fluorouracil in advanced pancreatic cancer.
Aebi, S; Borner, MM; Büchler, MW; Friess, H; Ludwig, CU; Maurer, CA; Pampallona, S; Rauch, DP, 2001
)
2.13
"Gemcitabine has been shown to be an active agent in the treatment of pancreatic cancer. "( Gemcitabine following radiotherapy with concurrent 5-fluorouracil for nonmetastatic adenocarcinoma of the pancreas.
Kachnic, LA; Lauve, AD; Manning, MA; Neifeld, JP; Shaw, JE, 2001
)
3.2
"Gemcitabine (Gemzar) has demonstrated activity in a broad range of solid tumors with good tolerance. "( Optimizing chemoradiation in locally advanced non-small-cell lung cancer.
Choy, H; Curran, WJ, 2001
)
1.75
"Gemcitabine has modest activity in patients with resistant SCLC. "( Single-agent gemcitabine in patients with resistant small-cell lung cancer.
Groen, HJ; Postmus, PE; Schlösser, NJ; Schramel, FM; Smit, EF; van der Lee, I; van Putten, JW, 2001
)
2.12
"Gemcitabine has modest activity in the treatment of advanced pancreatic cancer and is a potent radiosensitizer. "( Phase I trial of gemcitabine combined with radiation for the treatment of locally advanced pancreatic adenocarcinoma.
Abbruzzese, JL; Charnsangavej, C; Evans, DB; Gravel, DM; Janjan, NA; Lee, JE; Lenzi, R; Pisters, PW; Wolff, RA, 2001
)
2.09
"Gemcitabine has activity in advanced ovarian cancer, with responses in platinum-resistant disease. "( Multicenter phase II study of gemcitabine in previously untreated patients with advanced epithelial ovarian cancer.
Ahern, J; Carmichael, J; Dombernowsky, P; Hansen, H; Hansen, M; Harper, PG; Highley, MS; Hirsch, F; Lund, B; Parnis, FX; Underhill, CR; Williams, C, 2001
)
2.04
"Gemcitabine has been well studied in the laboratory, with respect to mechanisms of radiosensitization and strategies that may increase the therapeutic index."( Recent advances in the use of radiosensitizing nucleosides.
Lawrence, TS; McGinn, CJ, 2001
)
1.03
"Gemcitabine has shown in vitro and in vivo radiosensitizing properties, synergistic activity with cisplatin, and cytotoxic activity against SCC-HN."( Gemcitabine, cisplatin, and radiation in advanced, unresectable squamous cell carcinoma of the head and neck: a feasibility study.
Benasso, M; Corvò, R; Marchetti, G; Merlano, M; Numico, G; Pallestrini, E; Ricci, I; Rosso, R; Sanguineti, G; Santelli, A; Vitale, V, 2001
)
2.47
"Gemcitabine has moderate activity in NPC with minimal toxicity, and is also an effective salvage agent for patients who have failed or progressed after treatment with other agents."( Gemcitabine in metastatic nasopharyngeal carcinoma of the undifferentiated type.
Fong, KW; Foo, KF; Koh, L; Leong, SS; Lian, LG; Machin, D; Tai, BC; Tan, EH; Tan, T; Wee, JT, 2002
)
3.2
"Gemcitabine has demonstrated single-agent efficacy in the treatment of advanced breast cancer, with response rates of up to 42%. "( Gemcitabine/anthracycline combinations in metastatic breast cancer.
Zielinski, CC, 2002
)
3.2
"Gemcitabine has become a new standard for treatment of advanced pancreatic cancer. "( Present and future treatment of pancreatic cancer.
Heinemann, V, 2002
)
1.76

Actions

Gemcitabine displays antitumor activity in intensively pretreated and refractory germ cell tumors. It can inhibit DNA chain elongation, is a potent radiosensitizer and it can enhance antitumors immune activity. Gemcitabne (dFdC) can increase the sensitivity of both cisplatin (CDDP)-sensitive and -resistant cell lines.

ExcerptReferenceRelevance
"Gemcitabine can inhibit DNA chain elongation, is a potent radiosensitizer and it can enhance antitumor immune activity, but it also presents some drawbacks (e.g., short half-life, side effects, chemoresistance)."( Gemcitabine and glioblastoma: challenges and current perspectives.
Bastiancich, C; Bastiat, G; Lagarce, F, 2018
)
2.64
"Gemcitabine treatment promotes the generation of CCL2 and CCL2 could attach to C-C chemokine receptor type 2 (CCR2) to recruit M-MDSCs."( RS 504393 inhibits M-MDSCs recruiting in immune microenvironment of bladder cancer after gemcitabine treatment.
Fan, J; Jiang, JT; Liu, ZH; Mu, XY; Sun, F; Tan, MY; Wang, RJ; Wang, X; Wu, K; Yao, ZX; Zheng, JH; Zheng, Z, 2019
)
1.46
"Gemcitabine metabolites cause the termination of DNA replication and induction of apoptosis. "( Diagnostic Microdosing Approach to Study Gemcitabine Resistance.
Cimino, GD; de Vere White, R; Henderson, PT; Malfatti, MA; Pan, CX; Scharadin, TM; Turteltaub, K; Wang, S; Zhang, H; Zimmermann, M, 2016
)
2.14
"Gemcitabine given at a lower dose intensity than standard should be considered as valuable therapeutic option in elderly or poor PS patients with advanced NSCLC unfit for platinum."( When less is better: the safety and efficacy of reduced intensity gemcitabine in a difficult patient population with advanced non-small-cell lung cancer.
Calvani, N; Cinefra, M; Cinieri, S; D'Amico, M; Fedele, P; Marino, A; Nacci, A; Orlando, L; Rizzo, P; Schiavone, P; Sponziello, F, 2013
)
1.35
"Gemcitabine (dFdC) can increase the sensitivity of both cisplatin (CDDP)-sensitive and -resistant cell lines. "( Effects of gemcitabine on cis-platinum-DNA adduct formation and repair in a panel of gemcitabine and cisplatin-sensitive or -resistant human ovarian cancer cell lines.
Comijn, EC; Lakerveld, B; Noordhuis, P; Peters, GJ; Pinedo, HM; Smid, K; Van der Vijgh, WJ; Van Moorsel, CJ; Voorn, D; Weaver, D; Willey, JC, 2006
)
2.17
"Gemcitabine (dFdC) may cause radiosensitization by specific interference with homologous recombination-mediated DNA double-strand break repair. "( Gemcitabine as a radiosensitizer in undifferentiated tumors.
Barten-van Rijbroek, AD; El Sharouni, SY; Kal, HB,
)
3.02
"Gemcitabine treatment may inhibit tumor progression and prolong survival in gallbladder cancer by inhibiting cell proliferation and inducing apoptosis."( Antitumor effect of gemcitabine on orthotopically inoculated human gallbladder cancer cells in nude mice.
Ajiki, T; Fujimori, T; Fujita, T; Hirata, K; Hori, H; Horiuchi, H; Kamigaki, T; Kuroda, Y; Mita, Y; Okazaki, T, 2007
)
2.11
"Gemcitabine displays antitumor activity in intensively pretreated and refractory germ cell tumors. "( Gemcitabine in patients with relapsed or cisplatin-refractory testicular cancer.
Beyer, J; Bokemeyer, C; Casper, J; Gerl, A; Harstrick, A; Kanz, L; Niederle, N; Schmoll, HJ; Schöffski, P, 1999
)
3.19
"Gemcitabine was able to increase the activity of fludarabine only when low doses of the former were employed. "( In vitro study of the combination gemcitabine + fludarabine on freshly isolated chronic lymphocytic leukemia cells.
Magagnoli, M; Pellacani, A; Tosi, P; Tura, S; Visani, G; Zinzani, PL, 1999
)
2.03
"Gemcitabine did not cause apoptosis in the BT474 cells."( Akt, MAPK (Erk1/2), and p38 act in concert to promote apoptosis in response to ErbB receptor family inhibition.
Fry, DW; Nelson, JM, 2001
)
1.03

Treatment

Gemcitabine treatment can effectively increase the total proportion of infiltrating immune cells. It can reduce the proportion of myeloid-derived suppressor cells (MDSCs) and macrophages, and increase T cells proportion without significant growth inhibition. Gem citabine/erlotinib treatment offers limited benefit in unselected patient.

ExcerptReferenceRelevance
"Gemcitabine treatment led to MUC5AC overexpression, resulting in disruption of E-cadherin/β-catenin junctions and the nuclear translocation of β-catenin, which increased c-Myc expression, with a concomitant rise in glutamine uptake and glutamate release."( Mucin 5AC Serves as the Nexus for β-Catenin/c-Myc Interplay to Promote Glutamine Dependency During Pancreatic Cancer Chemoresistance.
Atri, P; Batra, SK; Bhatia, R; Cox, JL; Ganguly, K; Kaur, S; Kisling, A; Kumar, S; Mallya, K; Ram Krishn, S; Rauth, S; Shinde, D; Thomas, V; Thompson, C; Vengoji, R, 2022
)
1.44
"Gemcitabine treatment can effectively increase the total proportion of infiltrating immune cells, reduce the proportion of myeloid-derived suppressor cells (MDSCs) and macrophages, and increase T cells proportion without significant growth inhibition. "( Gemcitabine-facilitated modulation of the tumor microenvironment and PD-1/PD-L1 blockade generate a synergistic antitumor effect in a murine hepatocellular carcinoma model.
Chen, X; Fang, D; Guan, J; He, X; Shi, ZW; Wang, H; Wang, X, 2022
)
3.61
"Gemcitabine treatment induced phosphorylation of IGF1R and increased the expression of phosphor-cJun, Ets1, and Egr1 within 72 h."( Gemcitabine resistance of pancreatic cancer cells is mediated by IGF1R dependent upregulation of CD44 expression and isoform switching.
Cao, L; Chen, C; Freeman, JW; Karnad, A; Kumar, AP; Zhao, S; Zhao, X, 2022
)
2.89
"Gemcitabine, a standard treatment for pancreatic cancer, often has poor outcomes for patients as a result of chemoresistance."( SLC38A5 Modulates Ferroptosis to Overcome Gemcitabine Resistance in Pancreatic Cancer.
Cheong, JH; Hong, WC; Kang, HW; Kim, HJ; Kim, HS; Kim, JH; Kim, M; Kim, MJ; Lee, DE; Park, JS, 2023
)
1.9
"Gemcitabine treatment was associated with significantly more neutropenia, whereas pegylated liposomal doxorubicin was associated with significantly more hand-foot syndrome."( Gemcitabine for recurrent ovarian cancer - a systematic review and meta-analysis.
Berg, T; Nøttrup, TJ; Roed, H, 2019
)
2.68
"Gemcitabine/erlotinib treatment offers limited benefit in unselected patients with pancreatic ductal adenocarcinoma (PDAC). "( Correlation of skin rash and overall survival in patients with pancreatic cancer treated with gemcitabine and erlotinib - results from a non-interventional multi-center study.
Beringer, A; Fuchs, M; Garlipp, B; Hahn, L; Heinemann, V; Kukiolka, T; Kütting, F; Malfertheiner, P; Reiser, M; Waldschmidt, DT; Westphalen, CB, 2020
)
2.22
"Gemcitabine treatment induces tumor cell apoptosis and PD-L1 expression."( Gemcitabine and checkpoint blockade exhibit synergistic anti-tumor effects in a model of murine lung carcinoma.
Du, B; Lai, J; Lin, M; Wang, Y; Wen, X, 2020
)
2.72
"Gemcitabine/carboplatin treatment is known to cause severe adverse drug reactions which can lead to the need for reduction or cessation of chemotherapy. "( Genetic association of gemcitabine/carboplatin-induced leukopenia and neutropenia in non-small cell lung cancer patients using whole-exome sequencing.
Apellániz-Ruiz, M; Björn, N; Brandén, E; De Petris, L; Gréen, H; Koyi, H; Lewensohn, R; Lundeberg, J; Pradhananga, S; Rodríguez-Antona, C; Sigurgeirsson, B; Svedberg, A, 2020
)
2.31
"In gemcitabine-treated mice, EpCAM-positive tumors had high ENT1 expression and reduced metastasis, whereas tumors with N-cadherin expression resisted gemcitabine treatment and formed extensive secondary metastatic nodules."( EMT-Induced Gemcitabine Resistance in Pancreatic Cancer Involves the Functional Loss of Equilibrative Nucleoside Transporter 1.
Campbell, MJ; Chen, W; Govindarajan, R; Hung, SW; Li, J; Nayak, D; Persaud, AK; Raj, R; Weadick, B; Williams, TM, 2021
)
1.51
"Gemcitabine treatment was significantly associated with an increased NK-cell- and decreased T-regulatory cell proliferation whereas the opposite occurred in control patients. "( Immune monitoring in mesothelioma patients identifies novel immune-modulatory functions of gemcitabine associating with clinical response.
Aerts, JG; Baas, P; Biesma, B; Bootsma, GP; Burgers, JA; Cornelissen, R; Dammeijer, F; De Gooijer, CJ; Jebbink, M; Kaijen-Lambers, MEH; Klaase, L; Lievense, LA; Lukkes, M; Mankor, J; Stigt, JA; Van der Noort, V; van Gulijk, M; Vroman, H; Waasdorp, C, 2021
)
2.28
"Gemcitabine treatment was associated with widespread effects on circulating immune cells of mesothelioma patients with responding patients displaying increased NK-cell and PD-1 + T-cell proliferation. "( Immune monitoring in mesothelioma patients identifies novel immune-modulatory functions of gemcitabine associating with clinical response.
Aerts, JG; Baas, P; Biesma, B; Bootsma, GP; Burgers, JA; Cornelissen, R; Dammeijer, F; De Gooijer, CJ; Jebbink, M; Kaijen-Lambers, MEH; Klaase, L; Lievense, LA; Lukkes, M; Mankor, J; Stigt, JA; Van der Noort, V; van Gulijk, M; Vroman, H; Waasdorp, C, 2021
)
2.28
"Gemcitabine treatment activates both the Wnt/β-catenin and RAS/ERK pathways."( Suppression of Wnt/β-catenin and RAS/ERK pathways provides a therapeutic strategy for gemcitabine-resistant pancreatic cancer.
Choi, KY; Han, G; Lee, SH; Ryu, WJ, 2021
)
1.57
"Gemcitabine treatment for pancreatic cancer may result in resumption of ovulation in women with polycystic ovarian syndrome and these women should be counseled accordingly."( Successful pregnancy after mucinous cystic neoplasm with invasive carcinoma of the pancreas in a patient with polycystic ovarian syndrome: a case report.
Carlan, SJ; Guzman, A; Holloman, C; Madruga, M; Sundharkrishnan, L, 2017
)
1.9
"Gemcitabine treatment induced ER stress and promoted mutant p53-R273H stabilization via transcriptionally activated uPA which may contribute to chemoresistance to gemcitabine. "( Gemcitabine treatment induces endoplasmic reticular (ER) stress and subsequently upregulates urokinase plasminogen activator (uPA) to block mitochondrial-dependent apoptosis in Panc-1 cancer stem-like cells (CSCs).
Chen, Y; Tian, B; Wang, L; Wang, W; Zhang, Y; Zhu, Y, 2017
)
3.34
"Gemcitabine treatment caused upregulation of ZEB1 protein through post-transcriptional mechanisms in mesenchymal PDAC cells within a context of global inhibition of protein synthesis."( Alternative polyadenylation of ZEB1 promotes its translation during genotoxic stress in pancreatic cancer cells.
Bielli, P; Capurso, G; Farini, D; Fave, GD; Panzeri, V; Passacantilli, I; Pilozzi, E; Sette, C, 2017
)
1.18
"Gemcitabine is a standard treatment for advanced pancreatic cancer patients but can cause chemoresistance during treatment. "( Resveratrol enhances the chemotherapeutic response and reverses the stemness induced by gemcitabine in pancreatic cancer cells via targeting SREBP1.
Cao, J; Cheng, L; Duan, W; Jiang, Z; Li, J; Li, X; Ma, J; Ma, Q; Qian, W; Sun, L; Wang, F; Wu, E; Wu, Z; Yan, B; Zhou, C, 2019
)
2.18
"Gemcitabine treatment promotes the generation of CCL2 and CCL2 could attach to C-C chemokine receptor type 2 (CCR2) to recruit M-MDSCs."( RS 504393 inhibits M-MDSCs recruiting in immune microenvironment of bladder cancer after gemcitabine treatment.
Fan, J; Jiang, JT; Liu, ZH; Mu, XY; Sun, F; Tan, MY; Wang, RJ; Wang, X; Wu, K; Yao, ZX; Zheng, JH; Zheng, Z, 2019
)
1.46
"Gemcitabine treatment showed good response but not capable of inducing tumor regressions and targeting the tumor-resident cancer stem cells (CD24(+)CD44(+) and ALDH(+) tumor cells)."( Notch signaling pathway targeted therapy suppresses tumor progression and metastatic spread in pancreatic cancer.
Campbell, NR; De Oliveira, E; de Wilde, RF; Hidalgo, M; Korangath, P; Maitra, A; Pai, SG; Rajeshkumar, NV; Rasheed, ZA; Streppel, MM; Yabuuchi, S, 2013
)
1.11
"Gemcitabine treatment visibly increased pERK1/2 levels in BxPC-3 and PANC-1 cells. "( ERK1/2 activity contributes to gemcitabine resistance in pancreatic cancer cells.
Jiang, Y; Jiao, X; Sun, S; Zheng, C, 2013
)
2.12
"Gemcitabine treatment altered the PTM profile of proteins involved in various biological functions, some known cancer associated genes, many potentially cancer-associated genes, and several cancer-signaling networks, including canonical and noncanonical WNT and PI3K/Akt/MTOR pathways."( Identification of new mechanisms of cellular response to chemotherapy by tracking changes in post-translational modifications by ubiquitin and ubiquitin-like proteins.
Audebert, S; Baudelet, E; Bidaut, G; Bonacci, T; Borg, JP; Camoin, L; Garcia, M; Iovanna, JL; Perkins, ND; Soubeyran, P; Witzel, II, 2014
)
1.12
"Gemcitabine treatment decreased EpCAM-positive CTCs in NSCLC patients and inhibited EMT by the HGF/cMET pathway."( Gemcitabine inhibits the micrometastasis of non-small cell lung cancer by targeting the EpCAM-positive circulating tumor cells via the HGF/cMET pathway.
Guo, YH; Liao, ZJ; Nan, KJ; Xu, R; Yao, JT; Zhao, Z, 2014
)
2.57
"Gemcitabine treatment maintained the CSC population with simultaneous maintenance of PD2 and CSC marker expression."( Novel role of pancreatic differentiation 2 in facilitating self-renewal and drug resistance of pancreatic cancer stem cells.
Batra, SK; Dey, P; Ganti, AK; Ponnusamy, MP; Rachagani, S; Vaz, AP, 2014
)
1.12
"Upon gemcitabine treatment, HSP27-overexpressing cells displayed an early S-phase arrest subsequently followed by a strongly increased sub-G1 fraction."( Overexpression of heat shock protein 27 (HSP27) increases gemcitabine sensitivity in pancreatic cancer cells through S-phase arrest and apoptosis.
De Toni, EN; Gallmeier, E; Göke, B; Guo, Y; Hocke, S; Kampmann, E; Ochs, S; Ziesch, A, 2015
)
1.12
"Gemcitabine based treatment is currently a standard first line treatment for patients with advanced pancreatic cancer, however overall survival remains poor, and few options are available for patients that fail gemcitabine based therapy. "( Gemcitabine resistant pancreatic cancer cell lines acquire an invasive phenotype with collateral hypersensitivity to histone deacetylase inhibitors.
Cress, AE; Dorr, RT; Landowski, TH; Patel, C; Patel, H; Pond, E; Pond, KW; Samulitis, BK; Wisner, L, 2015
)
3.3
"Gemcitabine treatment enhanced the activity of ERK1/2 in the BXPC-3 cells. "( pERK1/2 silencing sensitizes pancreatic cancer BXPC-3 cell to gemcitabine-induced apoptosis via regulating Bax and Bcl-2 expression.
Chen, D; Dong, X; Hao, F; Liu, Z; Lu, X; Ni, G; Wang, M, 2015
)
2.1
"Gemcitabine-treatment of human-umbilical-vein-endothelial-cells (HUVECs) did not promote the growth of HUVECs; however, it was induced when treated with conditioned media from gemcitabine-treated (Gem-CM) PC cells due to increased cell-cycle progression and apoptotic-resistance."( Gemcitabine triggers angiogenesis-promoting molecular signals in pancreatic cancer cells: Therapeutic implications.
Arora, S; Bhardwaj, A; Carter, JE; Khan, MA; Singh, AP; Singh, S; Srivastava, SK; Zubair, H, 2015
)
2.58
"Gemcitabine treatment stimulated endogenous PTK6 overexpression in MIAPaCa2 and Panc1 cells."( PTK6 Potentiates Gemcitabine-Induced Apoptosis by Prolonging S-phase and Enhancing DNA Damage in Pancreatic Cancer.
Basson, MD; Ito, H; Ono, H, 2015
)
1.48
"Gemcitabine, a first-line treatment for pancreatic cancer, prolongs patient survival by several months, and combination treatment with gemcitabine and other anti-cancer drugs in the clinic do not show any significant effects on overall survival."( Zidovudine, an anti-viral drug, resensitizes gemcitabine-resistant pancreatic cancer cells to gemcitabine by inhibition of the Akt-GSK3β-Snail pathway.
Hoshino, T; Kodama, R; Mizushima, T; Moritomo, S; Namba, T, 2015
)
1.4
"Gemcitabine is a common treatment, but response rates are low, perhaps due in part to tumor hypoxia."( Distribution of Gemcitabine Is Nearly Homogenous in Two Orthotopic Murine Models of Pancreatic Cancer.
Humm, JL; Kramer, RM; Russell, J, 2015
)
1.48
"Gemcitabine treatment upregulated the levels of anti-apoptosis proteins (Mcl-2 and Bcl-2) in both scrambled control and maspin-KD cells; however, the fold changes in Mcl-1 and Bcl-2 expression were larger in gemcitabine-treated scrambled control cells than in maspin-KD cells."( Maspin mediates the gemcitabine sensitivity of hormone-independent prostate cancer.
Chang, YJ; Huang, CY; Huang, MT; Lin, FY; Luo, SD; Tai, CJ; Uyanga, B, 2016
)
1.48
"Gemcitabine treatment alone induced a significant increase in CHK1 autophosphorylation over untreated tumors."( LY2603618, a selective CHK1 inhibitor, enhances the anti-tumor effect of gemcitabine in xenograft tumor models.
Barda, D; Barnard, D; Beckmann, R; Burke, T; Diaz, HB; Donoho, G; Jones, B; King, C; Marshall, M, 2016
)
1.39
"Gemcitabine treatment is widely used to treat patients with certain solid tumors and relapsed/refractory hematological malignancies."( Gemcitabine-Based Treatment in Poor-Prognosis Patients with Relapsed and Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma--a Multicenter Polish Experience.
Butrym, A; Drozd-Sokołowska, J; Giza, A; Jurczak, W; Kuliczkowski, K; Kumiega, B; Paszkiewicz-Kozik, E; Rybka, J; Wróbel, T,
)
2.3
"Gemcitabine treatment leads to the activation of ERα-ERK-P62 signal pathway in MCF-7 cells which may augment the autophagic degradation, thus results in the excessive activation of autophagy and irreversible autophagic cell death eventually."( Inhibition of ERα/ERK/P62 cascades induces "autophagic switch" in the estrogen receptor-positive breast cancer cells exposed to gemcitabine.
Chen, L; Chen, M; Dai, F; He, M; Pan, T; Shen, P; Song, Y; Wan, X; Wang, Q; Xiao, P, 2016
)
1.36
"In gemcitabine-treated cells, HAb18G/CD147 was up-regulated; and HAb18G/CD147 down-regulation or inhibition attenuated gemcitabine-enhanced invasion."( Gemcitabine enhances cell invasion via activating HAb18G/CD147-EGFR-pSTAT3 signaling.
Chen, ZN; Fu, ZG; Jiang, JL; Li, L; Meng, Y; Wu, B; Wu, XQ; Xu, BQ; Xu, L, 2016
)
2.39
"Gemcitabine is the treatment used clinically, however, gemcitabine resistance leads to limited efficacy and patient survival rates of only a few months following diagnosis."( Sclareolide enhances gemcitabine‑induced cell death through mediating the NICD and Gli1 pathways in gemcitabine‑resistant human pancreatic cancer.
Chen, S; Dong, MS; Wang, Y; Zhang, JH; Zhang, WL, 2017
)
1.5
"Gemcitabine treatment followed by removal allowed prolonged progression through S phase, contributing to synergy of the gemcitabine --> SN-38 sequence."( Overcoming S-phase checkpoint-mediated resistance: sequence-dependent synergy of gemcitabine and 7-ethyl-10-hydroxycamptothecin (SN-38) in human carcinoma cell lines.
Ames, MM; Dai, NT; Flatten, KS; Gálvez-Peralta, M; Karnitz, LM; Kaufmann, SH; Loegering, DA; Safgren, SL; Wagner, JM, 2008
)
1.29
"In gemcitabine-pretreated Capan-2 cells, 84% of the cell population was in the G(2)M phase of the cell cycle."( Enhancement of somatostatin-receptor-targeted (177)Lu-[DOTA(0)-Tyr(3)]-octreotide therapy by gemcitabine pretreatment-mediated receptor uptake, up-regulation and cell cycle modulation.
Atcher, RW; Nayak, TK; Norenberg, JP; Prossnitz, ER, 2008
)
1.08
"Gemcitabine pretreatment up-regulates sstr expression and acts as a radiosensitizer through cell cycle modulation. "( Enhancement of somatostatin-receptor-targeted (177)Lu-[DOTA(0)-Tyr(3)]-octreotide therapy by gemcitabine pretreatment-mediated receptor uptake, up-regulation and cell cycle modulation.
Atcher, RW; Nayak, TK; Norenberg, JP; Prossnitz, ER, 2008
)
2.01
"Gemcitabine pretreatment increased the apparent initial radiation-induced DNA fragmentation specifically for S-phase cells."( S-phase cell-specific modification by gemcitabine of PFGE-analyzed radiation-induced DNA fragmentation and rejoining.
Debus, J; Jensen, A; Weber, KJ, 2008
)
1.34
"Gemcitabine and cisplatin treatment were administered to patients with advanced-stage, non-small-cell lung cancer. "( Gemcitabine and cisplatin treatment of advanced-stage non-small-cell lung cancer in patients given cisplatin on day 8.
Akcali, Z; Calikusu, Z; Ozyilkan, O; Sakalli, H,
)
3.02
"Gemcitabine treatment did not activate NFkappaB either in vitro or in vivo."( Nuclear factor-kappaB p65/relA silencing induces apoptosis and increases gemcitabine effectiveness in a subset of pancreatic cancer cells.
Arumugam, T; Ji, B; Levin, PA; Logsdon, CD; Lopez-Berestein, G; McConkey, DJ; Pan, X; Ramachandran, V; Sood, AK; Vivas-Mejia, PE; Yamamoto, T, 2008
)
1.3
"Gemcitabine treatment was well tolerated, with no dogs experiencing clinically relevant haematological or gastrointestinal toxicity."( Adjuvant gemcitabine after surgical removal of aggressive malignant mammary tumours in dogs.
Abramo, F; Lorenzo, RM; Marconato, L; Ratto, A; Zini, E, 2008
)
1.48
"In gemcitabine-pretreated pancreatic cancer, salvage chemotherapy has not been established, and the prognostic factors are not completely known. "( Efficacy of infusional 5-fluorouracil, doxorubicin, and mitomycin-C (iFAM) in the treatment of patients with gemcitabine-pretreated pancreatic cancer and analysis of prognostic factors in a salvage setting.
Bang, YJ; Han, SW; Im, SA; Kim, TY; Lee, KH; Lim, KH; Oh, DY, 2011
)
1.2
"Gemcitabine treatment of mice bearing tumors, with a high GJIC capacity, resulted in a significant delay in tumor progression."( Connexin-26 is a key factor mediating gemcitabine bystander effect.
Carrió, M; Cascante, A; Fillat, C; García-Ribas, I; Garcia-Rodríguez, L; Mazo, A; Pérez-Torras, S, 2011
)
1.36
"The gemcitabine-based treatments had comparable activity and tolerability. "( Biweekly gemcitabine-paclitaxel, gemcitabine-carboplatin, or gemcitabine-cisplatin as first-line treatment in metastatic breast cancer after anthracycline failure: a phase II randomized selection trial.
Chung, HC; Del Giglio, A; Feng, J; Jiang, Z; Kim, SB; Malzyner, A; Pen, DL; Shen, LJ; Xu, B; Yu, S, 2011
)
1.34
"Gemcitabine is standard treatment for pancreatic cancer but has limited clinical benefit due to chemoresistance. "( Dimethylamino parthenolide enhances the inhibitory effects of gemcitabine in human pancreatic cancer cells.
Beane, JD; Crooks, PA; Holcomb, BK; Schmidt, CM; Waters, JA; Yip-Schneider, MT, 2012
)
2.06
"Gemcitabine treatment had a comparable effect."( hTERT-siRNA could potentiate the cytotoxic effect of gemcitabine to pancreatic cancer cells Bxpc-3.
Tan, J; Zhou, X; Zhu, H, 2012
)
1.35
"In gemcitabine-treated cells, nuclear fragmentation and DNA ladder formation were observed."( Involvement of phosphatidylinositol 3-kinase/Akt pathway in gemcitabine-induced apoptosis-like cell death in insulinoma cell line INS-1.
Motoshige, H; Oyama, K; Sakurai, K; Takahashi, K, 2012
)
1.14
"Gemcitabine was held and treatment began with fluorouracil and concurrent radiation."( Gemcitabine-induced gouty arthritis attacks.
Bottiglieri, S; Mehdi, S; Mo, JH; Patel, R; Tierson, N, 2013
)
2.55
"Gemcitabine, used in the treatment of pulmonary, pancreatic and urothelial carcinomas, is generally well tolerated, but has recently been implied in the occurrence of TMA."( [Gemcitabine-induced thrombotic microangiopathy].
Colle, B; Debourdeau, P; Estival, JL; Pavic, M; Teixeira, L; Zammit, C, 2002
)
1.95
"Gemcitabine hydrochloride treatment (1,000 mg/m2/week x 3/4 weeks) was started."( [A case of pancreatic tail cancer with peritoneal carcinosis treated with gemcitabine hydrochloride].
Fujii, T; Maemura, M; Morishita, Y; Ohwada, S; Roppongi, T; Takeyoshi, I; Yamada, T, 2002
)
1.27
"Gemcitabine treatment caused apoptosis in MM cell lines as measured by an increase in DNA cleavage, an increase in annexin V binding, a decrease in the mitochondrial membrane potential, and activation of caspase activity."( Caspase activation is required for gemcitabine activity in multiple myeloma cell lines.
Gajria, D; Gandhi, V; Ghias, K; Krett, NL; Nabhan, C; Rosen, ST, 2002
)
1.31
"Gemcitabine treatment in end-stage renal disease with intermittent standard hemodialysis treatment is safe and well tolerated. "( Pharmacokinetics of gemcitabine in a patient with end-stage renal disease: effective clearance of its main metabolite by standard hemodialysis treatment.
Ehninger, G; Franz, T; Gross, P; Haufe, T; Kiani, A; Köhne, CH; Passauer, J; Schleyer, E, 2003
)
2.09
"Gemcitabine treatment of patients with locally advanced or metastatic pancreatic cancer is effective and well-tolerated."( Gemcitabine monotherapy in patients with locally advanced or metastatic pancreatic cancer: a prospective observational study.
Bednarik, O; Bustova, I; Karasek, P; Kocakova, I; Melichar, B; Petruzelka, L; Skacel, T; Spurny, V; Trason, T, 2003
)
2.48
"The gemcitabine treatment for 1 h had no effect on cell proliferation, viability, cycle or migration on HT-1080 cells."( Non-toxic and short treatment with gemcitabine inhibits in vitro migration of HT-1080 cells.
Alcouffe, C; Boutonnat, J; Clément-Lacroix, J; Mousseau, M; Ronot, X, 2004
)
1.08
"In Gemcitabine treatment, elderly patients with unresectable pancreatic cancer are more likely to suffer from haematological and non-haematological adverse effects than non-elderly patients. "( [Clinical problems in gemcitabine treatment for unresectable pancreatic cancer in the elderly--a multicentric retrospective study of 53 cases].
Fujimori, Y; Furut, K; Hanazaki, K; Hasebe, O; Hayashi, K; Hisa, T; Hosokawa, K; Kajikawa, S; Kaneko, G; Kawa, S; Kiyosawa, K; Maejima, S; Matsuda, Y; Miwa, S; Miyagawa, S; Mukawa, K; Ochi, Y; Shikama, N; Tajiri, K; Takeuchi, N, 2004
)
1.26
"Gemcitabine treatment, as well as stimulation of CD95, resulted in cleavage of effector caspase 3 as well as its substrate PARP and caspase 9, followed by DNA fragmentation. "( Apoptosis by gemcitabine in non-small cell lung cancer cell line KNS62 is induced downstream of caspase 8 and is profoundly blocked by Bcl-xL over-expression.
Boehle, AS; Boenicke, L; Dohrmann, P; Kalthoff, H; Kurdow, R; Schniewind, B; Zoefelt, S, 2005
)
2.14
"Gemcitabine-carboplatin treatment significantly improves the PFS of patients with platinum-sensitive recurrent ovarian cancer."( Combination therapy with gemcitabine and carboplatin in recurrent ovarian cancer.
Du Bois, A; Eisenhauer, E; Pfisterer, J; Vergote, I,
)
1.16
"Gemcitabine treatment of Colo357 cells increased CD95 surface expression, raising the possibility of the involvement of CD95 in gemcitabine-mediated caspase-8 activation."( Gemcitabine-mediated apoptosis is associated with increased CD95 surface expression but is not inhibited by DN-FADD in Colo357 pancreatic cancer cells.
Christgen, M; Jueschke, A; Kalthoff, H; Schniewind, B; Ungefroren, H, 2005
)
2.49
"Gemcitabine treatment may inhibit tumor progression and prolong survival in gallbladder cancer by inhibiting cell proliferation and inducing apoptosis."( Antitumor effect of gemcitabine on orthotopically inoculated human gallbladder cancer cells in nude mice.
Ajiki, T; Fujimori, T; Fujita, T; Hirata, K; Hori, H; Horiuchi, H; Kamigaki, T; Kuroda, Y; Mita, Y; Okazaki, T, 2007
)
2.11
"Gemcitabine treatment resulted in a decrease for G1 fraction relative to controls."( Short versus continuous gemcitabine treatment of non-small cell lung cancer in an in vitro cell culture bioreactor system.
Fisher, JE; Kirstein, MN; Kratzke, RA; Le, CT; Marker, PH; Wieman, KM; Williams, BW; Yee, D, 2007
)
1.37
"Gemcitabine treatment attenuated the tumor-suppressive environment by eliminating CD11b(+)/Gr-1(+) myeloid-derived suppressor cells."( A combination of chemoimmunotherapies can efficiently break self-tolerance and induce antitumor immunity in a tolerogenic murine tumor model.
Chang, SY; Chang, WS; Kang, CY; Kim, YJ; Kim, YS; Ko, HJ; Ko, SY; Sakaguchi, S, 2007
)
1.06
"Gemcitabine treatment data were taken from a large NSCLC study and data from retrospective chart reviews identified through the National Oncology Data Base."( Economic value of gemcitabine compared to cisplatin and etoposide in non-small cell lung cancer.
Copley-Merriman, C; Corral, J; Dorr, FA; King, K; McDonald, RC; Voi, M; Whiteside, R, 1996
)
1.35
"Gemcitabine treatment alone reduced median tumor volume from 538 to 152 mm3."( Epidermal growth factor receptor blockade with C225 plus gemcitabine results in regression of human pancreatic carcinoma growing orthotopically in nude mice by antiangiogenic mechanisms.
Abbruzzese, JL; Bruns, CJ; Davis, DW; Evans, DB; Harbison, MT; Hicklin, DJ; McConkey, DJ; Portera, CA; Radinsky, R; Tsan, R, 2000
)
1.27
"Gemcitabine treatment appeared most effective."( [Experience with chemotherapy for advanced pancreatic carcinoma].
Gershanovich, ML; Ignashov, AM; Ivanova, NE; Kokhanenko, NIu; Osipenko, SK; Rybakov, GV, 2000
)
1.03
"Gemcitabine treatment resulted in a moderate increase in the percentage of apoptotic cells that was accompanied by activation of p38 and MAPK (ERK1/2)."( Akt, MAPK (Erk1/2), and p38 act in concert to promote apoptosis in response to ErbB receptor family inhibition.
Fry, DW; Nelson, JM, 2001
)
1.03
"Gemcitabine treatment decreased the expression of IkappaB-alpha protein and, concomitantly, increased the activity of nuclear factor-kappaB (NF-kappaB) transcription factor, a known inhibitor of the apoptotic response."( Inhibitor of apoptosis-1 (IAP-1) expression and apoptosis in non-small-cell lung cancer cells exposed to gemcitabine.
Bandala, E; Espinosa, M; Maldonado, V; Meléndez-Zajgla, J, 2001
)
1.25
"Treatment with gemcitabine monophosphate significantly increased apoptosis of cancer cells, enabled reduction in the proportion of immunosuppressive tumor-associated macrophages and myeloid-derived suppressor cells, and did not increase expression of cancer stem cell markers."( Nano-delivery of Gemcitabine Derivative as a Therapeutic Strategy in a Desmoplastic KRAS Mutant Pancreatic Cancer.
Bao, M; Das, M; Huang, L; Li, J, 2020
)
1.24
"Treatment with gemcitabine and nab-paclitaxel is associated with maintained QoL in relevant proportions of patients."( Quality of life and outcome of patients with metastatic pancreatic cancer receiving first-line chemotherapy with nab-paclitaxel and gemcitabine: Real-life results from the prospective QOLIXANE trial of the Platform for Outcome, Quality of Life and Transla
Al-Batran, SE; Aldaoud, A; Behringer, DM; Bildat, S; Blau, W; Büchner-Steudel, P; Däßler, KU; Dörfel, S; Eschenburg, H; Ettrich, TJ; Feustel, HP; Fietz, T; Forstbauer, H; Gallmeier, E; Götze, TO; Groschek, M; Hahn, L; Harich, HD; Hausen, GZ; Höffkes, HG; Hofheinz, RD; Homann, N; Jacobasch, L; Koenigsmann, M; Kretzschmar, A; Kunzmann, V; Mahlmann, S; Messmann, H; Papke, J; Pauligk, C; Peters, U; Pink, D; Reichart, A; Schaaf, M; Schlag, R; Schönherr, C; Schubert, J; Schuch, G; Schulz, H; Schwindel, U; Siegler, G; Springfeld, C; Stauch, M; Trojan, J; Uhlig, J; Vehling-Kaiser, U; Vogel, A; von Weikersthal, LF; Waibel, K; Waidmann, O; Wehmeyer, J; Weniger, J; Wierecky, J; Wolf, M; Wörns, MA; Zahn, MO, 2021
)
1.17
"Pretreatment with gemcitabine before nab-paclitaxel increased Cav-1 and albumin uptake and significantly decreased proliferation and clonogenicity compared with concurrent treatment, which correlated with increased levels of apoptosis. "( Altered Gemcitabine and Nab-paclitaxel Scheduling Improves Therapeutic Efficacy Compared with Standard Concurrent Treatment in Preclinical Models of Pancreatic Cancer.
Abushahin, L; Chakravarti, A; Cruz-Monserrate, Z; Hegazi, A; Jacob, JR; Palanichamy, K; Robb, R; Shyu, DL; Trevino, JG; Williams, TM; Wolfe, AR; Yang, L, 2021
)
1.39
"Pretreatment with gemcitabine significantly increased nab-paclitaxel uptake and correlated with an increased treatment efficacy and survival benefit in preclinical models, compared with standard concurrent treatment. "( Altered Gemcitabine and Nab-paclitaxel Scheduling Improves Therapeutic Efficacy Compared with Standard Concurrent Treatment in Preclinical Models of Pancreatic Cancer.
Abushahin, L; Chakravarti, A; Cruz-Monserrate, Z; Hegazi, A; Jacob, JR; Palanichamy, K; Robb, R; Shyu, DL; Trevino, JG; Williams, TM; Wolfe, AR; Yang, L, 2021
)
1.39
"Treatment with gemcitabine + romidepsin + cisplatin reduced the TNBC MDA-MB231 and MDA-MB468 cell survival to ~ 50% and ~ 15%, as well as invasiveness to ~ 31% and ~ 13%, respectively. "( A triple combination gemcitabine + romidepsin + cisplatin to effectively control triple-negative breast cancer tumor development, recurrence, and metastasis.
Archibald, CJ; Hunt, JT; Pattarawat, P; Poloway, J; Wang, HR, 2021
)
1.29
"Treatment with gemcitabine caused undesirable activation of ERK1/2 in PDAC cells, but cotreatment with the FBP1-derived small peptide inhibitor FBP1 E4 overcame gemcitabine-induced ERK activation, thereby increasing the anticancer efficacy of gemcitabine in PDAC."( Fructose-1,6-bisphosphatase Inhibits ERK Activation and Bypasses Gemcitabine Resistance in Pancreatic Cancer by Blocking IQGAP1-MAPK Interaction.
Billadeau, DD; Huang, H; Jin, X; Ma, T; Pan, Y; Tang, AH; Wang, L; Wu, H; Zhang, L, 2017
)
1.03
"Treatment with gemcitabine and carboplatin is efficacious with manageable toxicity profile in the real world non-clinical trial setting."( Gemcitabine and carboplatin in metastatic nonsmall cell lung cancer: Experience from a tertiary cancer center in South India.
Devika, T; Dubashi, B; Kayal, S; Kumar, R; Shewade, DG,
)
1.93
"Treatment with gemcitabine plus i.v. "( Reduction in circulating pro-angiogenic and pro-inflammatory factors is related to improved outcomes in patients with advanced pancreatic cancer treated with gemcitabine and intravenous omega-3 fish oil.
Arshad, A; Chung, WY; Dennison, AR; Metcalfe, MS; Steward, W, 2013
)
0.94
"Treatment with gemcitabine increased the levels of EGFRTyr1068 and ERK phosphorylation in the PDAC cell lines tested. "( Inhibiting signal transducer and activator of transcription-3 increases response to gemcitabine and delays progression of pancreatic cancer.
Cao, L; Freeman, JW; Hill, P; Nawrocki, ST; Peterson, L; Venkatasubbarao, K; Zhao, S; Zhou, Q, 2013
)
0.97
"Treatment with gemcitabine plus losartan further prolonged the survival time to 102.6 ± 16.5 days compared with that in the control group (P < 0.0001)."( Antitumor effect of angiotensin II type 1 receptor blocker losartan for orthotopic rat pancreatic adenocarcinoma.
Hirooka, S; Inoue, K; Kim, S; Kwon, AH; Matsui, Y; Satoi, S; Toyokawa, H; Yamaki, S; Yamamoto, T; Yamao, J; Yanagimoto, H, 2014
)
0.74
"Pre-treatment with gemcitabine and subsequent exposure to CAK cells induced greater cytotoxicity than either treatment alone."( NKG2D-directed cytokine-activated killer lymphocyte therapy combined with gemcitabine for patients with chemoresistant metastatic solid tumors.
Hirano, T; Katano, M; Kiyota, A; Koya, N; Morisaki, T; Onishi, H; Tanaka, H; Umebayashi, M, 2014
)
0.95
"Treatment with gemcitabine + MK-8776 significantly increased pO2 and inhibited glioma growth assessed by MRI."( Monitoring oxygen levels in orthotopic human glioma xenograft following carbogen inhalation and chemotherapy by implantable resonator-based oximetry.
Du, G; Eastman, A; Gimi, B; Hou, H; Khan, N; Krishnamurthy Nemani, V; Montano, R; Song, R; Swartz, HM, 2015
)
0.76
"Treatment with gemcitabine or a gemcitabine-containing regimen appeared to be feasible and well tolerated in the older patients who were selected to receive chemotherapy. "( Incidence of hematologic toxicity in older adults treated with gemcitabine or a gemcitabine-containing regimen in routine clinical practice: a multicenter retrospective cohort study.
Beijnen, JH; Crombag, MR; de Vries Schultink, AH; Huitema, AD; Schellens, JH, 2014
)
0.99
"Treatment with gemcitabine demonstrated clinically equivalent efficacy with a significantly improved safety profile compared with those receiving docetaxel in the second-line setting for advanced NSCLC in this study. "( Comparison of Single Agent Gemcitabine and Docetaxel in Second-Line Therapy for Advanced Stage Non-Small Cell Lung Cancer in a University Hospital in Turkey.
Baha, A; Ozturk, C; Yıldırım, F; Yurdakul, AS, 2015
)
1.07
"Treatment with gemcitabine may be safely continued in patients with this complication, though recurrence of the rash is common following repeated doses."( A rash diagnosis: Gemcitabine-associated pseudocellulitis.
Epperla, N; Strouse, C, 2017
)
1.13
"Treatment with gemcitabine only indicated significant radiosensitization in the CaSki cell line in combination with augmented resistance against gemcitabine application alone."( The combined effect of fludarabine monophosphate and radiation as well as gemcitabine and radiation on squamous carcinoma tumor cell lines in vitro.
Christiansen, H; Hermann, RM; Lucke, EM; Nitsche, M; Peters, K; Pradier, O; Rave-Frank, M; Schmidberger, H, 2008
)
0.92
"Treatment with gemcitabine, the most potent chemotherapeutic against this cancer up to date, is not curative, and resistance may appear."( Improvement of gemcitabine-based therapy of pancreatic carcinoma by means of oncolytic parvovirus H-1PV.
Angelova, AL; Aprahamian, M; Balboni, G; Dinsart, C; Giese, NA; Grekova, SP; Hajri, A; Herrmann, A; Leuchs, B; Raykov, Z; Rommelaere, J, 2009
)
1.05
"Treatment with gemcitabine provides modest benefits in patients with metastatic pancreatic cancer. "( Phase III trial of bevacizumab in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer.
Bennouna, J; Cosaert, J; Gill, S; Humblet, Y; Moore, MJ; Scheithauer, W; Shang, A; Van Cutsem, E; Van Laethem, JL; Verslype, C; Vervenne, WL, 2009
)
0.96
"Treatment with gemcitabine, the most widely used chemotherapeutic against pancreatic cancer, is not curative and resistance may occur."( Synthetic lethal RNAi screening identifies sensitizing targets for gemcitabine therapy in pancreatic cancer.
Arora, S; Azorsa, DO; Basu, GD; Bisanz, KM; Choudhary, A; Gonzales, IM; Henderson, MC; Kiefer, JA; Mousses, S; Trent, JM; Von Hoff, DD, 2009
)
0.93
"Treatment with gemcitabine combined with radiation therapy according to the present schedule is well tolerated and can provide prolonged survival in patients with localized, unresectable pancreatic cancer."( Phase II study of radiation therapy combined with weekly low-dose gemcitabine for locally advanced, unresectable pancreatic cancer.
Doi, R; Fujii, T; Hiraoka, M; Matsuo, Y; Mitsumori, M; Nakamura, A; Oya, N; Shibuya, K, 2011
)
0.96
"Treatment with gemcitabine, which reduced the cell viability and augmented the cell apoptotic rate, activated and subsequently attenuated ERK and EGFR signals."( Amphiregulin regulates the activation of ERK and Akt through epidermal growth factor receptor and HER3 signals involved in the progression of pancreatic cancer.
Fukami, T; Funakoshi, A; Kuroki, M; Miyamoto, S; Yagi, H; Yoshizato, T; Yotsumoto, F, 2010
)
0.7
"Pre-treatment with gemcitabine and subsequent exposure to CAK cells induced greater cytotoxicity than either treatment alone."( Combinatorial cytotoxicity of gemcitabine and cytokine-activated killer cells in hepatocellular carcinoma via the NKG2D-MICA/B system.
Katano, M; Kiyota, A; Koya, N; Morisaki, T; Nagamatsu, I; Ogino, T; Onishi, H; Tanaka, H; Umebayashi, M, 2011
)
0.98
"Treatment with gemcitabine led to the following results: (1) a significant decrease of viable T24 cells after treatment at the highest concentration (3.12 μM) tested; (2) scattered, elongated and vacuolated 5637 and T24 cells; (3) a cytostatic effect in both cell lines; and (4) significant upregulation of the BRCA1, CCNE1, CDK2, CDK6, CDKN1A, CDKN2B, E2F4, GADD45A, MAD2L2, CCNH, SERTAD1, CDC1, and CHEK1 genes."( Toxicogenomic activity of gemcitabine in two TP53-mutated bladder cancer cell lines: special focus on cell cycle-related genes.
da Silva, GN; de Camargo, EA; Salvadori, DM, 2012
)
1.02
"Treatment with gemcitabine concomitant with radiation therapy according to the present schedule is well tolerated and can provide prolonged CBR and disease stabilization in patients with localized, unresectable pancreatic cancer."( Phase II study of gemcitabine combined with radiation therapy in patients with localized, unresectable pancreatic cancer.
Epelbaum, R; Faraggi, D; Gaitini, D; Kuten, A; Mizrahi, S; Nasrallah, S; Rosenblatt, E, 2002
)
1
"Treatment with gemcitabine was less effective under hypoxia."( Hyperoxia-induced improvement of the in vitro response to gemcitabine in transitional cell carcinoma.
Albers, P; Dederichs, F; Fechner, G; Müller, S; Schmidt, D; Vaupel, P,
)
0.72
"Treatment with gemcitabine did not significantly differ from control."( Inhibition of PDGFR phosphorylation and Src and Akt activity by GN963 leads to therapy of human pancreatic cancer growing orthotopically in nude mice.
Baker, CH; Caron, A; Fidler, IJ; Gallick, GE; Nesbit, M; Summy, JM; Trevino, JG; Zhang, F, 2006
)
0.67
"Treatment with gemcitabine and oxaliplatin was well tolerated with primarily hematologic toxicity at the MTD. "( A phase I study of oxaliplatin in combination with gemcitabine: correlation of clinical outcome with gene expression.
Chow, W; Doroshow, J; Frankel, P; Gandara, D; Juhasz, A; Lenz, HJ; Leong, L; Lim, D; Margolin, K; Morgan, R; Newman, E; Shibata, S; Somlo, G; Synold, T; Yen, Y, 2007
)
0.94
"Treatment with gemcitabine/doxorubicin in combination also resulted in a significant suppression of the head and neck squamous cell carcinoma (HNSCC) tumor growth in severe combined immunodeficiency mice bearing the UM-SCC-22A xenografts."( Role of human longevity assurance gene 1 and C18-ceramide in chemotherapy-induced cell death in human head and neck squamous cell carcinomas.
Bialewski, J; Hannun, YA; Jazwinski, SM; Jiang, JC; Ogretmen, B; Ponnusamy, S; Rossi, MJ; Senkal, CE; Sinha, D, 2007
)
0.68
"Treatment with gemcitabine-cisplatin combination TACE resulted in significantly longer survival (13.8 months) compared to TACE with gemcitabine alone (6.3 months)."( Treatment of unresectable cholangiocarcinoma with gemcitabine-based transcatheter arterial chemoembolization (TACE): a single-institution experience.
Balaa, FK; Carr, BI; Gamblin, TC; Geller, DA; Gusani, NJ; Marsh, JW; Steel, JL; Zajko, AB, 2008
)
0.94
"Pretreatment with gemcitabine followed by BRYO resulted in decreased cell viability, increased apoptosis, and inhibited NF-kappaB than either agent alone or BRYO followed by gemcitabine."( Protein kinase C: a target for therapy in pancreatic cancer.
Ali, S; El-Rayes, BF; Philip, PA; Sarkar, FH, 2008
)
0.67
"Treatment with gemcitabine resulted in an increase in FDG uptake with increasing dose and time after the end of therapy."( Fluorodeoxyglucose uptake in vitro: aspects of method and effects of treatment with gemcitabine.
Altmann, A; Bellemann, ME; Blatter, J; Haberkorn, U; Kahn, B; Morr, I; Oberdorfer, F; van Kaick, G, 1994
)
0.85
"Treatment with gemcitabine produced moderate to severe toxicity as grade 3-4 neutropenia requiring dose modification was seen in 40% of patients treated."( Phase II trial of 150-minute weekly infusion of gemcitabine in advanced colorectal cancer: minimal activity in colorectal cancer.
Ansari, RH; Garcia, JC; Gibbons, J; Knost, JA; Kugler, JW; Mani, S; Schilsky, RL; Sciortino, DF; Vokes, EE,
)
0.73
"Treatment with gemcitabine in patients with pancreatic cancer may be a cost-effective alternative, but the results need to be confirmed in future randomised trials."( Treatment of locally advanced pancreatic carcinoma in Sweden. A health economic comparison of palliative treatment with best supportive care versus palliative treatment with gemcitabine in combination with best supportive care.
Ragnarson-Tennvall, G; Wilking, N, 1999
)
0.85
"Treatment by gemcitabine allowed rapid and persistent improvement of the body weight and a prolonged survival (18 months)."( [Splenic vascular occlusion in the course of pancreatic cancer].
Demeaux, H; Dilhuydy, MS; Faure, I; Leng, B; Mercié, P; Pellegrin, JL; Viallard, JF, 2000
)
0.66
"Treatment was gemcitabine 800 mg/m2 days 1, 8, 15 and docetaxel 100 mg/m2 day 1, with cycles repeated every four weeks."( Second-line chemotherapy for non-small-cell lung cancer with monthly docetaxel and weekly gemcitabine: a phase II trial.
Blair, S; Carman, L; Colborn, D; George, C; Jones, J; Kuebler, JP; Laufman, LR; Moore, T; Patel, T; Roach, R; Rupert, R; Spiridonidis, CH; Zangmeister, J, 2001
)
0.88
"Treatment with gemcitabine was well tolerated."( Gemcitabine in the second-line therapy of patients with carcinoma of unknown primary site: a phase II trial of the Minnie Pearl Cancer Research Network.
Bramham, J; Burris, HA; Calvert, SW; Greco, FA; Hainsworth, JD; Scullin, DC; Willcutt, NT, 2001
)
2.09
"Treatment was gemcitabine 800 mg/m2 days 1, 8, 15 and docetaxel 100 mg/M2 on day 1, with cycles repeated every four weeks."( Monthly docetaxel and weekly gemcitabine in metastatic breast cancer: a phase II trial.
Carman, L; Colborn, D; Gutterman, L; Jones, J; Kuebler, JP; Larrimer, N; Laufman, LR; Moore, T; Patel, T; Pritchard, J; Roach, R; Segal, M; Spiridonidis, CH; Zangmeister, J, 2001
)
0.95
"Treatment with gemcitabine resulted in an increase of DNA-PK and p53 protein and an increase in the phosphorylation of p53 at Ser15."( Interaction of p53 and DNA-PK in response to nucleoside analogues: potential role as a sensor complex for DNA damage.
Achanta, G; Feng, L; Huang, P; Pelicano, H; Plunkett, W, 2001
)
0.65
"Treatment with gemcitabine alone resulted in growth inhibition in both breast and NSCLC cell lines."( Preclinical studies of gemcitabine and trastuzumab in breast and lung cancer cell lines.
Bunn, PA; Chan, DC; Franklin, WA; Helfrich, B; Hirsch, FR; Varella-Garcia, M, 2002
)
0.96

Toxicity

Gemcitabine displayed minimal toxicity in elderly patients. Side-effect profile does not seem to be affected by patient age. This side-effect is a previously unreported sign of drug toxicity. A high level of awareness to this problem is warranted when this drug is administered.

ExcerptReferenceRelevance
" dFdCyd was clearly more toxic to SW1573 cells at 4 x 10(5) cells per dish than at 400 cells per dish."( Effect of hyperthermia on the cytotoxicity of 2',2'-difluorodeoxycytidine (gemcitabine) in cultured SW1573 cells.
Bakker, PJ; Geerdink, A; Haveman, J; Rietbroek, RC; Van Rijn, J, 1995
)
0.52
" Gemcitabine has an unusually mild side effect profile for such an active agent."( Efficacy and safety profile of gemcitabine in non-small-cell lung cancer: a phase II study.
Abratt, RP; Bezwoda, WR; Falkson, G; Goedhals, L; Hacking, D; Rugg, TA, 1994
)
1.48
" Furthermore, gemcitabine displayed minimal toxicity in elderly patients, and the side-effect profile does not seem to be affected by patient age."( Safety profile of gemcitabine.
Martin, C; Mosconi, AM; Tonato, M, 1995
)
0.99
"The two cell lines significantly differed in their sensitivity to the toxic effects of the drug; the normal cell line was much more resistant than its transformed counterpart."( Effects of gemcitabine in normal and transformed human lung cell cultures: cytotoxicity and increase in radiation sensitivity.
Casamassima, F; Gulisano, M; Milano, F; Pacini, S; Pazzagli, M; Pinzani, P; Ruggiero, M,
)
0.52
" This side-effect of gemcitabine infusion is a previously unreported sign of drug toxicity; therefore, a high level of awareness to this problem is warranted when this drug is administered."( Gemcitabine-induced atrial fibrillation: a hitherto unreported manifestation of drug toxicity.
Abbate, A; Campisi, C; Di Cosimo, S; Di Sciascio, G; Gravante, G; Patti, G; Santini, D; Tonini, G; Vincenzi, B, 2000
)
2.07
"The nucleoside analog gemcitabine is a potent radiosensitizer of both tumor and normal mucosa, so severe toxic reactions have resulted from its combination with radiation in some clinical treatment schedules for pancreatic cancer."( WR-2721 reduces intestinal toxicity from concurrent gemcitabine and radiation treatment.
Crane, CH; Janjan, NA; Mason, KA; Milas, L; Phan, TP; Vrdoljak, E, 2001
)
0.88
" No toxic death was reported."( Gemcitabine, Ifosfamide and Navelbine (GIN): activity and safety of a non-platinum-based triplet in advanced non-small-cell lung cancer (NSCLC).
Ardizzoni, A; Baldini, E; Boni, L; Cafferata, MA; Conte, PF; Neumaier, C; Prochilo, T; Rosso, R; Tibaldi, C, 2001
)
1.75
" Toxic effects were notable for significant myelosuppression, with > or =Grade 3 granulocytopenia seen in 55% of the patients on the untreated arm and 67% of the patients on the previously treated arm."( The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma: potential for decreased toxicity and combination with biological therapy.
Blumenschein, G; Fossella, FV; Glisson, BS; Herbst, RS; Hong, WK; Jung, MS; Khuri, FR; Kies, MS; Kurie, JM; Lee, JJ; Lee, JS; Liu, DD; Lu, C; Lu, R; Munden, RF; Papadimitrakopoulou, VA; Pisters, KM; Shin, DM; Zinner, R, 2002
)
0.56
" The toxicity profile of the gemcitabine/vinorelbine combination was quite favorable, with minimal Grade 3 and 4 toxic effects aside from granulocytopenia, which resulted in numerous Day 15 skipped doses but no significant febrile neutropenia or infection."( The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma: potential for decreased toxicity and combination with biological therapy.
Blumenschein, G; Fossella, FV; Glisson, BS; Herbst, RS; Hong, WK; Jung, MS; Khuri, FR; Kies, MS; Kurie, JM; Lee, JJ; Lee, JS; Liu, DD; Lu, C; Lu, R; Munden, RF; Papadimitrakopoulou, VA; Pisters, KM; Shin, DM; Zinner, R, 2002
)
0.85
" The most common treatment-related adverse events reported during therapy with IMC-C225 were an acne-like rash and hypersensitivity reactions."( Safety experience with IMC-C225, an anti-epidermal growth factor receptor antibody.
Needle, MN, 2002
)
0.31
" Myelosuppression is the most common toxic effect but its use sometimes leads to severe pulmonary toxicity by means of diffuse alveolar damage or sub-acute interstitial pneumonitis."( [Acute pulmonary toxicity due to gemcitabine: a role for asbestos exposure?].
Barlési, F; Doddoli, C; Gimenez, C; Greillier, L; Kleisbauer, JP; Lima, G, 2003
)
0.6
"No toxic deaths occurred."( Gemcitabine plus cisplatin in adjuvant regimen for bladder cancer. Toxicity evaluation.
Carini, M; Corvino, C; Lapini, A; Meliani, E; Serni, S, 2003
)
1.76
" We have concluded that the gemcitabine/cisplatin combination is a safe outpatient modality for the first line treatment of advanced non-small cell lung cancer patients."( [Gemcitabine-cisplatin combination in the first line treatment of non-small cell lung cancer. Our experience and analysis of safety].
Lénárt, T; Sárosi, V, 2003
)
1.52
" The most commonly reported adverse events were diarrhea, acne-like skin rash, nausea, vomiting and asthenia."( Fatal pulmonary toxicity in a patient treated with gefitinib for non-small cell lung cancer after previous hemolytic-uremic syndrome due to gemcitabine.
Herchenhorn, D; Rabinowits, G; Rabinowits, M; Torres, W; Weatge, D, 2003
)
0.52
" In addition, CED of carboplatin or gemcitabine to tumors in this glioma model is safe and has potent antitumor effects."( Safety and efficacy of convection-enhanced delivery of gemcitabine or carboplatin in a malignant glioma model in rats.
Degen, JW; Lonser, RR; Oldfield, EH; Vortmeyer, AO; Walbridge, S, 2003
)
0.84
" However, the study was prematurely closed because of a high incidence of severe pulmonary adverse events."( High incidence of pulmonary toxicity of weekly docetaxel and gemcitabine in patients with non-small cell lung cancer: results of a dose-finding study.
Agelaki, S; Bozionelou, V; Georgoulias, V; Kakolyris, S; Kalbakis, K; Kouroussis, C; Malas, K; Mavroudis, D; Souglakos, J; Voloudaki, A, 2004
)
0.56
" Thus, this regimen is safe as regards clinically significant lung toxicity."( A prospective study on lung toxicity in patients treated with gemcitabine and carboplatin: clinical, radiological and functional assessment.
Dafni, U; Dimopoulos, MA; Dimopoulou, I; Efstathiou, E; Kastritis, E; Lyberopoulos, P; Moulopoulos, LA; Papadimitriou, C; Roussos, C; Samakovli, A, 2004
)
0.56
" Pulmonary administration of gemcitabine is safe in rats at a maximum tolerated dose of 4 mg/kg once a week for 9 weeks."( Safety of pulmonary administration of gemcitabine in rats.
Diot, P; Dubus, JC; Gagnadoux, F; Grimbert, D; Le Pape, A; Leblond, V; Lemarié, E; Montharu, J; Racineux, JL; Urban, T; Vecellio, L, 2005
)
0.89
" In conclusion, the combination of dFdC and CPEC is highly toxic to neuroblastoma in vitro."( Cyclopentenyl cytosine-induced activation of deoxycytidine kinase increases gemcitabine anabolism and cytotoxicity in neuroblastoma.
Bierau, J; Caron, HN; Leen, R; Meinsma, R; van Gennip, AH; van Kuilenburg, AB, 2006
)
0.56
"5%) were the most severe adverse events."( Gemcitabine and cisplatin in the treatment of elderly patients with advanced non-small cell lung cancer: impact of comorbidities on safety and efficacy outcome.
Giannarelli, D; Moscetti, L; Nelli, F; Padalino, D; Pollera, CF; Sperduti, I, 2005
)
1.77
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
" We assume that 2',2'-difluorodeoxyuridine, an active metabolite of gemcitabine, could be responsible for the toxic effect."( Gemcitabine and atrial fibrillation: a rare manifestation of chemotherapy toxicity.
Carbone, C; Codecà, C; Ferrari, D; Foa, P; Fumagalli, L; Gilardi, L; Marussi, D; Oldani, S; Tartaro, T; Zannier, F, 2006
)
2.01
"Our data show that whereas TRAIL alone or together with selected chemotherapeutic drugs seems to be safe, the combination of TRAIL with cisplatin is toxic to PHH."( Preclinical differentiation between apparently safe and potentially hepatotoxic applications of TRAIL either alone or in combination with chemotherapeutic drugs.
Büchler, P; Ganten, TM; Haas, TL; Koschny, R; Schader, MB; Schulze-Bergkamen, H; Stremmel, W; Sykora, J; Untergasser, A; Walczak, H, 2006
)
0.33
" The most common reported adverse events reflected the known toxicity profile induced by gemcitabine-cisplatin without ABT-510."( A phase I study assessing the safety and pharmacokinetics of the thrombospondin-1-mimetic angiogenesis inhibitor ABT-510 with gemcitabine and cisplatin in patients with solid tumors.
Carr, RA; de Vos, FY; Eskens, FA; Gietema, JA; Groen, HJ; Hoekstra, R; Humerickhouse, RA; Knight, RA; Loos, WJ; Uges, DR; van der Gaast, A, 2006
)
0.76
" This cycle was repeated at least three times, or until disease progression or intolerable adverse events were observed."( Efficacy and safety of gemcitabine monotherapy in patients with transitional cell carcinoma after Cisplatin-containing therapy: a Japanese experience.
Akaza, H; Miki, T; Miyanaga, N; Naito, S; Taniai, H; Usami, M, 2007
)
0.65
" All adverse drug reactions seen in the study were manageable."( Efficacy and safety of gemcitabine monotherapy in patients with transitional cell carcinoma after Cisplatin-containing therapy: a Japanese experience.
Akaza, H; Miki, T; Miyanaga, N; Naito, S; Taniai, H; Usami, M, 2007
)
0.65
" This approach to treatment of locally advanced pancreatic cancer is safe and promising, with good local control for a substantial proportion of patients, and merits testing in a randomised trial."( Gemcitabine with a specific conformal 3D 5FU radiochemotherapy technique is safe and effective in the definitive management of locally advanced pancreatic cancer.
Davies, T; Goldstein, D; Harvey, J; Kotasek, D; Michael, M; Reece, W; Shapiro, J; Spry, N; Underhill, C; Van Hazel, G; Walpole, E, 2007
)
1.78
" Both therapeutic agents were suspected as a possible cause of this adverse event."( Severe lung and skin toxicity during treatment with gemcitabine and erlotinib for metastatic pancreatic cancer.
Boeck, S; Hausmann, A; Heinemann, V; Reibke, R; Schulz, C, 2007
)
0.59
" Treatment of patients diagnosed with pancreatic cancer with radiotherapy and 5-fluorouracil was a safer approach than treatment with radiotherapy and gemcitabine, which induced more severe toxic adverse effects."( The effect of combined treatment methods on survival and toxicity in patients with pancreatic cancer.
Brasiūniene, B; Juozaityte, E, 2007
)
0.54
" The major adverse events were grade I-II myelosuppression, peripheral neurologic toxicities, nausea and vomiting."( [Efficacy and toxicity of gemcitabine combined vinorelbine on metastatic breast cancer: a report of 34 cases].
Jiang, WQ; Liu, DG; Teng, XY; Zhou, NN, 2007
)
0.64
"The aim of this Phase II study was to examine whether concurrent continuous infusion 5-fluorouracil (CI 5FU) plus three-dimensional conformal planning radiotherapy sandwiched between gemcitabine chemotherapy is effective, tolerable, and safe in the management of pancreatic cancer."( 3D radiotherapy can be safely combined with sandwich systemic gemcitabine chemotherapy in the management of pancreatic cancer: factors influencing outcome.
Borg, M; Carroll, S; Davies, T; Goldstein, D; Graham, P; Harvey, J; Iacopetta, B; Kneebone, A; Macleod, C; Millar, JL; Ngan, SY; Reece, WH; Spry, N; Zissiadis, Y, 2008
)
0.78
"This three-dimensional chemoradiotherapy regimen is safe and promising, with encouraging local control for a substantial proportion of patients, and merits testing in a randomized trial."( 3D radiotherapy can be safely combined with sandwich systemic gemcitabine chemotherapy in the management of pancreatic cancer: factors influencing outcome.
Borg, M; Carroll, S; Davies, T; Goldstein, D; Graham, P; Harvey, J; Iacopetta, B; Kneebone, A; Macleod, C; Millar, JL; Ngan, SY; Reece, WH; Spry, N; Zissiadis, Y, 2008
)
0.59
"No early or toxic deaths were observed."( [Combination of carboplatin and gemcitabine is a safe and feasible regimen in adjuvant therapy for stage II and IIIA NSCLC].
Kameda, A; Minami, K; Miyahara, E; Noso, Y; Suzuki, T; Tsutani, Y, 2008
)
0.63
"In the present study, the combination of carboplatin and gemcitabine has been a safe and feasible regimen in adjuvant therapy for stage II and IIIA NSCLC."( [Combination of carboplatin and gemcitabine is a safe and feasible regimen in adjuvant therapy for stage II and IIIA NSCLC].
Kameda, A; Minami, K; Miyahara, E; Noso, Y; Suzuki, T; Tsutani, Y, 2008
)
0.87
" The most common grade 3 or 4 adverse events were hypertension (11%), neutropenia (9%), diarrhea (7%), dyspnea (7%), and thromboembolic events (7%)."( Efficacy and safety of oxaliplatin and gemcitabine with bevacizumab in advanced non-small cell lung cancer.
Davila, E; Lilenbaum, R; Raez, L; Seigel, L; Tseng, J, 2008
)
0.62
" Several other severe nonhematological adverse effects were well tolerated and easily managed."( A pilot study evaluating the efficacy and toxicity of biweekly gemcitabine and pegylated liposomal doxorubicin in recurrent platinum-resistant epithelial ovarian cancer.
Aydiner, A; Derin, D; Guney, N; Tas, F; Topuz, E, 2008
)
0.59
"A biweekly schedule of gemcitabine combined with PLD is an active and safe chemotherapy regimen with acceptable and easily manageable toxicities in women with recurrent platinum-resistant ovarian cancer."( A pilot study evaluating the efficacy and toxicity of biweekly gemcitabine and pegylated liposomal doxorubicin in recurrent platinum-resistant epithelial ovarian cancer.
Aydiner, A; Derin, D; Guney, N; Tas, F; Topuz, E, 2008
)
0.9
"Expandable metallic stent placement is safe and effective in patients with unresectable pancreatic cancer receiving GEM."( Efficacy and safety of metallic stents in patients with unresectable pancreatic cancer receiving gemcitabine.
Arizumi, T; Hirano, K; Isayama, H; Ito, Y; Kawabe, T; Kogure, H; Matsubara, S; Nakai, Y; Omata, M; Sasahira, N; Sasaki, T; Tada, M; Togawa, O; Tsujino, T; Yagioka, H; Yoshida, H, 2008
)
0.56
" Sixteen patients (62%) experienced motesanib-related adverse events, most commonly lethargy (n=6), diarrhoea (n=4), fatigue (n=3), headache (n=3), and nausea (n=3)."( Safety and pharmacokinetics of motesanib in combination with gemcitabine for the treatment of patients with solid tumours.
Lipton, L; McCoy, S; McGreivy, J; Price, TJ; Rosenthal, MA; Sun, YN, 2008
)
0.59
" The most common side effect is myelosuppression."( Gemcitabine-induced pulmonary toxicity during adjuvant therapy in a patient with pancreatic cancer.
Cornfeld, D; Lansigan, F; Saif, MW; Shaib, W; Syrigos, K, 2008
)
1.79
" Additional studies that evaluate the aerosol route of administration of gemcitabine in humans should be safe and are warranted."( Aerosol gemcitabine: preclinical safety and in vivo antitumor activity in osteosarcoma-bearing dogs.
Anderson, PM; Cannan, VA; Crabbs, TA; Gordon, N; Kleinerman, E; Koshkina, N; Rodriguez, CO; Skorupski, KA; Wilson, DW, 2010
)
1.03
" Hand-foot syndrome (HFS) is a relatively common side effect of cytotoxic chemotherapy."( Toxicity and efficacy of 5-fluorouracil and capecitabine in a patient with TYMS gene polymorphism: A challenge or a dilemma?
Rajebi, MR; Saif, MW; Shahrokni, A, 2009
)
0.35
" We assumed that combined toxic effect of gemcitabine and vinorelbine resulted in serious cutaneous toxicity under pre-existing condition of diffuse ichthyosis."( [Serious cutaneous toxicity following ifosfamide, gemcitabine and vinorelbine therapy in a patient with relapsed Hodgkin lymphoma and ichthyosis].
Konífrová, E; Móciková, H; Stríteský, J, 2009
)
0.87
" In this study, we compared the dosage of carboplatin (CBDCA) calculated using MDRD with that calculated by conservative creatinine clearance (Ccr), and investigated the actual dosage given and the incidence of its adverse effects."( [Clinical evaluation of calculating carboplatin doses using modification of diet in renal disease (MDRD) estimate and adverse events].
Adachi, S; Kimura, M; Matsumoto, R; Matsuoka, T; Nakao, T; Okada, K; Tanaka, Y; Usami, E; Yasuda, T; Yoshimura, T, 2009
)
0.35
" The most common suspected adverse events were nausea, vomiting, rash, diarrhoea, peripheral oedema, anaemia, lymphopenia, thrombocytopenia, pyrexia, neutropenia, asthenia, leucopenia, and abdominal pain, and most were of grades 1-2 severity."( Safety and activity of masitinib in combination with gemcitabine in patients with advanced pancreatic cancer.
Deplanque, G; Hammel, P; Hermine, O; Kinet, JP; Levy, P; Mitry, E; Mornex, F; Moussy, A; Raymond, E; Rougier, P; Seitz, JF, 2010
)
0.61
"5%) and grade 4 non-hematologic adverse events (n = 2) were rare, with no treatment-related deaths."( Efficacy and safety of gemcitabine, carboplatin, dexamethasone, and rituximab in patients with relapsed/refractory lymphoma: a prospective multi-center phase II study by the Puget Sound Oncology Consortium.
Daniels, JT; Garrison, MA; Gjerset, GF; Gooley, TA; Gopal, AK; Lonergan, M; Murphy, AE; Pagel, JM; Petersdorf, SH; Press, OW; Shustov, AR; Smith, JC, 2010
)
0.67
" In general, the most toxic compound was 5-FU."( Ecotoxicity and genotoxicity assessment of cytotoxic antineoplastic drugs and their metabolites.
Blaha, L; Dott, W; Kovalova, L; Zounkova, R, 2010
)
0.36
" Adverse reactions observed included grade 1 neutropenia and grade 1 appetite loss."( [A dialysis patient with advanced lung adenocarcinoma who was safely given biweekly gemcitabine therapy].
Hashimoto, H; Obara, K; Oshika, Y; Shimizu, E; Tanaka, Y, 2010
)
0.59
" At each cycle, adverse events were assessed, and concomitant medications, transfusions, and hospitalizations were recorded."( Safety and resource utilization by non-small cell lung cancer histology: results from the randomized phase III study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaïve patients with advanced non-small cell lung cancer.
Douillard, JY; Eckardt, J; Liepa, AM; Novello, S; O'Brien, M; Paz-Ares, L; Pimentel, FL; Simms, L; Visseren-Grul, C; von Pawel, J, 2010
)
0.56
" During these studies the compound DM12 was identified as new, perspective and safe agent for adjuvant therapy."( Cytotoxic effects of new trans-2,4-diaryl-r-3-methyl-1,2,3,4-tetrahydroquinolines and their interaction with antitumoral drugs gemcitabine and paclitaxel on cellular lines of human breast cancer.
Arenas, DR; Arvelo, F; Kouznetsov, VV; Muñoz, A; Sojo, F, 2011
)
0.58
" Therefore, concomitant use of the ZD55-dNKmut and dFdC could be a novel targeted strategy in suicide gene therapy with safe control of excessive virus replication."( Adenovirus-mediated Drosophila melanogaster deoxyribonucleoside kinase mutants combined with gemcitabine harbor a safe cancer treatment profile.
He, A; Ma, S; Sun, Z; Xu, H; Zhao, L; Zheng, X; Zhu, Z, 2011
)
0.59
" The severe hematological adverse events related to EGFR TKIs treatment were rare."( The safety and efficacy of EGFR TKIs monotherapy versus single-agent chemotherapy using third-generation cytotoxics as the first-line treatment for patients with advanced non-small cell lung cancer and poor performance status.
Chen, B; Liu, S; Wang, D; Wang, Y; Wu, J; Zhao, W, 2011
)
0.37
"To observe the clinical efficacy and adverse effects of taxol plus carboplatin (TP) or gemcitabine plus carboplatin (GP) in patients with advanced non-small-cell lung carcinoma."( [Clinical efficacy and adverse effects of taxol plus carboplatin or gemcitabine plus carboplatin in patients with advanced non-small-cell lung carcinoma].
Wang, XY; Zhao, YL, 2010
)
0.82
" All toxic effects of gemcitabine in dogs were recorded."( Toxic effects and antitumor response of gemcitabine in combination with piroxicam treatment in dogs with transitional cell carcinoma of the urinary bladder.
Jeglum, AK; Lindner, D; Marconato, L; Nelson, V; Suslak-Brown, L; Zini, E, 2011
)
0.95
" However, this combination of chemotherapy did provide a new treatment alternative with fewer adverse effects."( Toxic effects and antitumor response of gemcitabine in combination with piroxicam treatment in dogs with transitional cell carcinoma of the urinary bladder.
Jeglum, AK; Lindner, D; Marconato, L; Nelson, V; Suslak-Brown, L; Zini, E, 2011
)
0.64
" Grade 3-4 neutropenia was the major adverse event in both schedules: 37."( A 4-week versus a 3-week schedule of gemcitabine monotherapy for advanced pancreatic cancer: a randomized phase II study to evaluate toxicity and dose intensity.
Fujii, M; Harada, R; Hirao, K; Ishida, E; Kato, H; Kawamoto, H; Kurihara, N; Mizuno, O; Noma, Y; Ogawa, T; Sakakihara, I; Tsutsumi, K; Yamamoto, K; Yamamoto, N, 2011
)
0.64
" Gastrointestinal adverse events (nausea, vomiting and diarrhea) were commonly observed in both treatment groups."( A phase II open-label randomized study to assess the efficacy and safety of selumetinib (AZD6244 [ARRY-142886]) versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line gemcitabine therapy.
Bodoky, G; Ciuleanu, TE; La Stella, PJ; Pover, G; Spigel, DR; Tebbutt, NC; Timcheva, C, 2012
)
0.56
"Most grade 3/4 adverse events seen after 10 cycles were hematological toxicities."( Long-term gemcitabine administration in heavily pretreated Japanese patients with metastatic breast cancer: additional safety analysis of a phase II study.
Funai, J; Ishii, M; Saeki, T; Takao, S; Takashima, S; Tokuda, Y, 2012
)
0.78
" Grade 2 and 3 toxic effects included fatigue, vomiting, dyspnea, and cough."( Aerosolized gemcitabine in patients with carcinoma of the lung: feasibility and safety study.
Boidron-Celle, M; Diot, P; el Houfia, A; Gagnadoux, F; Giraudeau, B; Grimbert, D; Hureaux, J; le Pape, A; Lemarie, E; Pichon, E; Prunier, C; Valat, C; Vecellio, L, 2011
)
0.75
" The time of reccurrence and adverse effects were recorded."( [Evaluation of the efficacy and safety of intravesical instillation with gemcitabine after first-line intravesical chemotherapy failure in the treatment of non-muscle-invasive bladder cancer].
Cao, M; Chen, HG; Ma, CK; Ma, J; Xue, W, 2011
)
0.6
" The incident of over common terminology criteria for adverse events (CTCAE) grade 2 white blood cell decreased was significantly reduced in patients treated at 15:00 compared with those treated at 9:00 (p=0."( The relationship between treatment time of gemcitabine and development of hematologic toxicity in cancer patients.
Aizawa, K; Fukunaga, E; Hamada, A; Iwata, K; Jingami, S; Saito, H; Sakai, S; Yoshida, M, 2011
)
0.63
"Nephrotoxicity is an inherent adverse effect of certain anticancer drugs and may result in a variety of functional consequences that include any combination of glomerular or tubular dysfunction, hypertension and disturbance of the renal endocrine function."( Nephrotoxicity of anticancer drugs--an underestimated problem?
Kruse, V; Lameire, N; Rottey, S,
)
0.13
" Treatment-emergent adverse events were generally mild and included fatigue, nausea, vomiting, and chills."( Safety and pharmacokinetics of ganitumab (AMG 479) combined with sorafenib, panitumumab, erlotinib, or gemcitabine in patients with advanced solid tumors.
Chan, E; Deng, H; Friberg, G; Gilbert, J; Hwang, YC; Mahalingam, D; McCaffery, I; Michael, SA; Mita, AC; Mita, MM; Mulay, M; Puzanov, I; Rosen, LS; Sarantopoulos, J; Shubhakar, P; Zhu, M, 2012
)
0.59
"Ganitumab up to 12 mg/kg was well tolerated, without adverse effects on pharmacokinetics in combination with either sorafenib, panitumumab, erlotinib, or gemcitabine."( Safety and pharmacokinetics of ganitumab (AMG 479) combined with sorafenib, panitumumab, erlotinib, or gemcitabine in patients with advanced solid tumors.
Chan, E; Deng, H; Friberg, G; Gilbert, J; Hwang, YC; Mahalingam, D; McCaffery, I; Michael, SA; Mita, AC; Mita, MM; Mulay, M; Puzanov, I; Rosen, LS; Sarantopoulos, J; Shubhakar, P; Zhu, M, 2012
)
0.79
"The morbidity of abdominal and pelvic SFP performed on a miscellaneous group of patients in our institute was analyzed and potential risk factors for adverse events were evaluated."( Complications and toxicity after abdominal and pelvic hypoxic stop-flow perfusion chemotherapy: incidence and assessment of risk factors.
Askoxylakis, J; de Bree, E; Melissas, J; Metaxari, M; Michalakis, J; Romanos, J; Tsiftsis, DD; Tsogkas, J; Volakakis, E, 2012
)
0.38
" In total, 28 adverse effects were observed after 30% of the procedures."( Complications and toxicity after abdominal and pelvic hypoxic stop-flow perfusion chemotherapy: incidence and assessment of risk factors.
Askoxylakis, J; de Bree, E; Melissas, J; Metaxari, M; Michalakis, J; Romanos, J; Tsiftsis, DD; Tsogkas, J; Volakakis, E, 2012
)
0.38
" Grade three or worse adverse events were mainly hand-foot syndrome (11%), and there were no grade four adverse events."( Prospective efficacy and safety study of neoadjuvant gemcitabine with capecitabine combination chemotherapy for borderline-resectable or unresectable locally advanced pancreatic adenocarcinoma.
Han, DJ; Kim, JH; Kim, MH; Kim, SC; Kim, TW; Lee, JL; Lee, SK; Lee, SS; Park, DH; Park, JH; Seo, DW; Shin, SH, 2012
)
0.63
" In an attempt to design an efficacious and safe prehematopoietic stem cell transplantation conditioning regimen, we investigated the cytotoxicity of the combination of busulfan (B), melphalan (M), and gemcitabine (G) in lymphoma cell lines in the absence or presence of drugs that induce epigenetic changes."( Epigenetic modifiers enhance the synergistic cytotoxicity of combined nucleoside analog-DNA alkylating agents in lymphoma cell lines.
Andersson, BS; Champlin, RE; Li, Y; Murray, D; Nieto, Y; Valdez, BC; Wang, G, 2012
)
0.57
" The aim of this study is to evaluate the response rate and toxic side effects of gemcitabine-cisplatin (GC) in patients with advanced/metastatic bladder carcinoma."( [The efficacy and toxicity of gemcitabine and cisplatin chemotherapy in advanced/metastatic bladder urothelial carcinoma].
Arslan, M; Ceylan, Y; Degirmenci, T; Gunlusoy, B; Kara, C; Kozacıoğlu, Z; Vardar, E, 2012
)
0.89
" Data such as patient background, treatment details, adverse events occurring during the observational period, laboratory values of liver enzyme and survival status were collected 3 and 12 months after the start of therapy."( Safety and effectiveness of gemcitabine in 260 patients with biliary tract cancer in a Japanese clinical practice based on post-marketing surveillance in Japan.
Kobayashi, N; Nishiuma, S; Okubo, S; Taketsuna, M; Taniai, H, 2012
)
0.67
" Haematotoxicities were the most common adverse drug reactions."( Safety and effectiveness of gemcitabine in 260 patients with biliary tract cancer in a Japanese clinical practice based on post-marketing surveillance in Japan.
Kobayashi, N; Nishiuma, S; Okubo, S; Taketsuna, M; Taniai, H, 2012
)
0.67
" Major grade 3/4 adverse events included neutropenia (28."( Uridine diphosphate glucuronosyl transferase 1 family polypeptide A1 gene (UGT1A1) polymorphisms are associated with toxicity and efficacy in irinotecan monotherapy for refractory pancreatic cancer.
Hamada, T; Hirano, K; Ijichi, H; Isayama, H; Kawakubo, K; Kogure, H; Koike, K; Miyabayashi, K; Mizuno, S; Mohri, D; Nakai, Y; Sasahira, N; Sasaki, T; Satoh, Y; Tada, M; Takahara, N; Takai, D; Uchino, R; Yamamoto, N; Yatomi, Y, 2013
)
0.39
"Due to the various inter-individual differences in the biological characteristics of tumor cells, as well as issues on the efficacy, adverse reactions, and defects of existing drugs, we compared the clinical efficacy and toxicity of pemetrexed and gemcitabine combined with cisplatin for the treatment of previously untreated advanced non-small cell lung cancer (NSCLC)."( [Efficacy and toxicity of pemetrexed or gemcitabine combined with cisplatin in the treatment of patients with advanced non-small cell lung cancer].
Cheng, G; Hu, C; Hu, X; Huang, C; Jiao, S; Li, K; Luo, R; Lv, W; Ouyang, X; Sun, Y; Wang, J; Wang, M; Wang, Y; Wang, Z; Zhang, S; Zheng, R, 2012
)
0.83
" The rate of adverse reactions, including white blood cell reduction, lower platelet count, lower hemoglobin, and hair loss in the PP group was significantly lower than that in the GP group."( [Efficacy and toxicity of pemetrexed or gemcitabine combined with cisplatin in the treatment of patients with advanced non-small cell lung cancer].
Cheng, G; Hu, C; Hu, X; Huang, C; Jiao, S; Li, K; Luo, R; Lv, W; Ouyang, X; Sun, Y; Wang, J; Wang, M; Wang, Y; Wang, Z; Zhang, S; Zheng, R, 2012
)
0.65
"The clinical efficacy of pemetrexed and gemcitabine combined with cisplatin for the treatment of previously untreated advanced NSCLC was roughly the same, but the adverse reactions decreased significantly in the PP group compared with those in the GP group."( [Efficacy and toxicity of pemetrexed or gemcitabine combined with cisplatin in the treatment of patients with advanced non-small cell lung cancer].
Cheng, G; Hu, C; Hu, X; Huang, C; Jiao, S; Li, K; Luo, R; Lv, W; Ouyang, X; Sun, Y; Wang, J; Wang, M; Wang, Y; Wang, Z; Zhang, S; Zheng, R, 2012
)
0.91
" Data such as patient background, treatment details, adverse events, tumor response, serum CA19-9 levels and drug-related symptom improvement were assessed."( Safety and effectiveness of gemcitabine in 855 patients with pancreatic cancer under Japanese clinical practice based on post-marketing surveillance in Japan.
Ashida, R; Ioka, T; Katayama, K; Kobayashi, N; Takakura, R; Tanaka, S; Taniai, H, 2013
)
0.68
"9%) patients reported drug-related adverse events, with 97 patients (11."( Safety and effectiveness of gemcitabine in 855 patients with pancreatic cancer under Japanese clinical practice based on post-marketing surveillance in Japan.
Ashida, R; Ioka, T; Katayama, K; Kobayashi, N; Takakura, R; Tanaka, S; Taniai, H, 2013
)
0.68
" The toxicity profile was excellent with only 8 % of overall G3-G4 adverse events."( When less is better: the safety and efficacy of reduced intensity gemcitabine in a difficult patient population with advanced non-small-cell lung cancer.
Calvani, N; Cinefra, M; Cinieri, S; D'Amico, M; Fedele, P; Marino, A; Nacci, A; Orlando, L; Rizzo, P; Schiavone, P; Sponziello, F, 2013
)
0.63
"SBRT with concurrent full dose gemcitabine is safe when administered to patients with LAPC."( Stereotactic body radiation therapy with concurrent full-dose gemcitabine for locally advanced pancreatic cancer: a pilot trial demonstrating safety.
Berzcel, L; Charabaty, A; Collins, SP; Gurka, MK; Haddad, N; Jackson, P; Jha, R; Johnson, CD; Lei, S; Ley, L; Marshall, JL; Pishvaian, MJ; Slack, R; Suy, S; Tse, G, 2013
)
0.92
" Safe margin-negative resection (R0) surgery was defined as R0 surgery without reintervention during the NACRT period and no postoperative complications."( Covered self-expandable metal stent deployment promises safe neoadjuvant chemoradiation therapy in patients with borderline resectable pancreatic head cancer.
Endo, I; Hosono, K; Kobayashi, N; Kubota, K; Matsuyama, R; Mori, R; Nakajima, A; Sato, T; Taniguchi, K; Watanabe, S, 2014
)
0.4
" Safe R0 surgery obtained in groups B and C was 11% (2/19) and 67% (10/15), respectively (P < 0."( Covered self-expandable metal stent deployment promises safe neoadjuvant chemoradiation therapy in patients with borderline resectable pancreatic head cancer.
Endo, I; Hosono, K; Kobayashi, N; Kubota, K; Matsuyama, R; Mori, R; Nakajima, A; Sato, T; Taniguchi, K; Watanabe, S, 2014
)
0.4
"CSEMS should be considered to relieve symptomatic biliary obstruction in patients with BRPHC receiving NACRT in view of the high attainability rate of safe R0 surgery compared to that with PS deployment."( Covered self-expandable metal stent deployment promises safe neoadjuvant chemoradiation therapy in patients with borderline resectable pancreatic head cancer.
Endo, I; Hosono, K; Kobayashi, N; Kubota, K; Matsuyama, R; Mori, R; Nakajima, A; Sato, T; Taniguchi, K; Watanabe, S, 2014
)
0.4
" Secondary end points included overall survival (OS) and toxic effect."( Multicenter phase II trial to investigate safety and efficacy of gemcitabine combined with cetuximab as adjuvant therapy in pancreatic cancer (ATIP).
Barth, PJ; Bartsch, DK; Brendel, C; Ebert, MP; Endlicher, E; Fass, J; Fensterer, H; Gress, TM; Hofheinz, R; Kornmann, M; Lindig, U; Märten, A; Michl, P; Müller, HH; Schade-Brittinger, C; Schmidt, WE; Settmacher, U; Tebbe, S, 2013
)
0.63
" Subgroup analyses revealed a nonsignificant increase in DFS for patients with versus without skin toxic effect ≥ grade 2 (median 14."( Multicenter phase II trial to investigate safety and efficacy of gemcitabine combined with cetuximab as adjuvant therapy in pancreatic cancer (ATIP).
Barth, PJ; Bartsch, DK; Brendel, C; Ebert, MP; Endlicher, E; Fass, J; Fensterer, H; Gress, TM; Hofheinz, R; Kornmann, M; Lindig, U; Märten, A; Michl, P; Müller, HH; Schade-Brittinger, C; Schmidt, WE; Settmacher, U; Tebbe, S, 2013
)
0.63
" Trends for improved DFS in patients with wild-type K-Ras and skin toxic effect remain to be confirmed."( Multicenter phase II trial to investigate safety and efficacy of gemcitabine combined with cetuximab as adjuvant therapy in pancreatic cancer (ATIP).
Barth, PJ; Bartsch, DK; Brendel, C; Ebert, MP; Endlicher, E; Fass, J; Fensterer, H; Gress, TM; Hofheinz, R; Kornmann, M; Lindig, U; Märten, A; Michl, P; Müller, HH; Schade-Brittinger, C; Schmidt, WE; Settmacher, U; Tebbe, S, 2013
)
0.63
" Toxicity was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events."( Intra-arterial infusion chemotherapy for advanced non-small-cell lung cancer: preliminary experience on the safety, efficacy, and clinical outcomes.
Dong, S; Li, WT; Peng, WJ; Ye, XD; Yuan, Z, 2013
)
0.39
"The most frequent drug-related adverse events were cough (n = 17; 42."( Intra-arterial infusion chemotherapy for advanced non-small-cell lung cancer: preliminary experience on the safety, efficacy, and clinical outcomes.
Dong, S; Li, WT; Peng, WJ; Ye, XD; Yuan, Z, 2013
)
0.39
"Intra-arterial infusion chemotherapy for advanced lung cancer has the potential to reduce the size of tumors and has no severe adverse effects."( Intra-arterial infusion chemotherapy for advanced non-small-cell lung cancer: preliminary experience on the safety, efficacy, and clinical outcomes.
Dong, S; Li, WT; Peng, WJ; Ye, XD; Yuan, Z, 2013
)
0.39
" Asian patients had higher rates of hematologic toxicities but lower rates of other adverse events."( Consistent efficacy and safety of gemcitabine-paclitaxel in patients with metastatic breast cancer: a retrospective comparison of East Asian and global studies.
Chi, HD; Liu, Z; Orlando, M; Quinlivan, M; Xu, B; Zhang, XQ, 2014
)
0.68
" The most common (≥10% patients) treatment-emergent adverse events were gemcitabine-related thrombocytopenia (40%) followed by sorafenib-related hand-foot skin reaction and anorexia (33% each)."( Efficacy and safety of sorafenib-gemcitabine combination therapy in advanced hepatocellular carcinoma: an open-label Phase II feasibility study.
Ahmad, S; Khattak, J; Murad, S; Naqi, N, 2014
)
0.92
"Active hexose-correlated compound (AHCC), an extract of basidiomycete mushroom, is used as health food to enhance the therapeutic effects and reduce the adverse effects of chemotherapy."( Active hexose-correlated compound down-regulates HSP27 of pancreatic cancer cells, and helps the cytotoxic effect of gemcitabine.
Kaino, S; Kuramitsu, Y; Maehara, S; Maehara, Y; Nakamura, K; Sakaida, I; Suenaga, S, 2014
)
0.61
" The proportion reporting at least one adverse event (any grade) with C, G, V, and E was 45%, 65%, 75%, and 63%."( A comparison of toxicity and health care resource use between eribulin, capecitabine, gemcitabine, and vinorelbine in patients with metastatic breast cancer treated in a community oncology setting.
Beegle, N; Blau, S; Cox, D; Dranitsaris, G; Faria, C; Kalberer, T, 2015
)
0.64
" Multivariate analysis demonstrated that a heavy smoking history (40 or more pack-year smoking history) was an independent adverse prognostic factor for OS."( Safety and efficacy of gemcitabine or pemetrexed in combination with a platinum in patients with non-small-cell lung cancer and prior interstitial lung disease.
Ahn, JS; Ahn, MJ; Chang, W; Choi, MK; Chung, MP; Hong, JY; Jung, HA; Kim, M; Kim, S; Lee, SJ; Park, K; Park, S; Sun, JM, 2014
)
0.71
" Other most common adverse events were neutropenia and nausea."( Safety, tolerability, pharmacokinetics and antitumor activity of ganitumab, an investigational fully human monoclonal antibody to insulin-like growth factor type 1 receptor, combined with gemcitabine as first-line therapy in patients with metastatic pancr
Fukutomi, A; Gansert, J; Ikeda, M; Kobayashi, Y; Okusaka, T; Shibayama, K; Takubo, T, 2014
)
0.59
" The most frequently reported grade 3/4 treatment-related adverse events included thrombocytopenia 33%, neutropenia 16% and hand-foot skin reaction 13%."( Efficacy and safety of sorafenib in combination with gemcitabine in patients with advanced hepatocellular carcinoma: a multicenter, open-label, single-arm phase II study.
Srimuninnimit, V; Sriuranpong, V; Suwanvecho, S, 2014
)
0.65
" The incidence of adverse events was evaluated by CTCAE v4."( Renal toxicity associated with weekly cisplatin and gemcitabine combination therapy for treatment of advanced biliary tract cancer.
Goda, Y; Irie, K; Kobayashi, S; Morimoto, M; Ohkawa, S; Ueno, M, 2014
)
0.65
"The severity of the toxic side effects of chemotherapy shows a great deal of interindividual variability, and much of this variation is likely genetically based."( Using Drosophila melanogaster to identify chemotherapy toxicity genes.
King, EG; Kislukhin, G; Long, AD; Walters, KN, 2014
)
0.4
"The fixed dose rate (FDR) gemcitabine infusion in combination with docetaxel is an effective treatment regimen for patients with relapsed/refractory soft tissue sarcoma, and with tolerable adverse reactions."( [Efficacy and safety of fixed dose rate gemcitabine infusion in combination with docetaxel in patients with relapsed/refractory soft tissue sarcoma].
Guo, H; Liu, Y; Yang, S; Yao, S; Yao, Z; Zhao, Y, 2014
)
0.97
"ILP with GEM is a safe and reproducible technique in this large-animal model, which includes 1 month of survival."( Acute and delayed toxicity of gemcitabine administered during isolated lung perfusion: a preclinical dose-escalation study in pigs.
Bernard, A; Bouchot, O; Charon-Barra, C; Derangere, V; Ghiringhelli, F; Lokiec, F; Magnin, G; Pagès, PB, 2015
)
0.71
" Dose delays and reductions due to adverse events were needed in 8 patients."( Initial safety and efficacy of cisplatin and gemcitabine combination chemotherapy for unresectable biliary tract cancer.
Shibata, Y, 2014
)
0.66
" Combining electroporation-mediated chemotherapeutics with interleukin 12 (IL-12) plasmid DNA produces a strong yet safe anti-tumour effect for treating primary and refractory tumours."( Safe and effective treatment of spontaneous neoplasms with interleukin 12 electro-chemo-gene therapy.
Cutrera, J; Gumpel, E; Jones, P; Kicenuik, K; King, G; Li, S; Xia, X, 2015
)
0.42
" Common adverse events with axitinib/gemcitabine in Japanese patients were fatigue, anorexia, dysphonia, nausea and decreased platelet count."( Efficacy and safety of axitinib in combination with gemcitabine in advanced pancreatic cancer: subgroup analyses by region, including Japan, from the global randomized Phase III trial.
Boku, N; Bycott, P; Fujii, Y; Furuse, J; Ioka, T; Kamei, Y; Namazu, K; Ohkawa, S; Okusaka, T; Sawaki, A; Takahashi, S; Umeyama, Y, 2015
)
0.94
" With regard to adverse events, the rates of nausea (p<0."( [A three-week regimen of S-1 monotherapy reduced gastrointestinal toxicity and maintained efficacy in patients with gemcitabine-refractory advanced pancreatic cancer].
Funazaki, H; Ikeda, M; Katayama, S; Kobayashi, M; Kondo, S; Kuwahara, A; Mitsunaga, S; Morizane, C; Ochiai, A; Ohno, I; Okusaka, T; Okuyama, H; Sakamoto, Y; Shimizu, S; Takahashi, H; Tanaka, H; Ueno, H, 2015
)
0.63
"Preoperative autophagy inhibition with HCQ plus gemcitabine is safe and well tolerated."( Safety and Biologic Response of Pre-operative Autophagy Inhibition in Combination with Gemcitabine in Patients with Pancreatic Adenocarcinoma.
Bahary, N; Bao, P; Bartlett, DL; Boone, BA; Espina, V; Liotta, LA; Lotze, MT; Loughran, P; Moser, AJ; Normolle, DP; Singhi, AD; Wu, WC; Zeh, HJ; Zureikat, AH, 2015
)
0.9
"A total of 61 patients with relapse and refractory non-Hodgkin's lymphoma (NHL) treated with chanotherapy of GEMOX regimen from 2010 Jannary -2013 year were selected, and their clinical data were collected, and the short-term efficacy, toxic effects and short-term survival were analyzed."( [Safety and efficacy evaluation of gemcitabine combined with oxaliplatin for the treatment of patients with lymphoma].
Chen, BL; Liu, L; Qin, SH; Tan, QL; Zhao, Z, 2015
)
0.69
" The adverse reactions mainly observed in blood and digestive tract, but were mild; adverse reactions were reduced or disappeared after stoping drugs or symptomatic treatment."( [Safety and efficacy evaluation of gemcitabine combined with oxaliplatin for the treatment of patients with lymphoma].
Chen, BL; Liu, L; Qin, SH; Tan, QL; Zhao, Z, 2015
)
0.69
"To prevent adverse drug reactions in the post-marketing phase, therapeutic drug monitoring and various laboratory tests have been used for decades."( [Utilization of Genomic Biomarkers for Post-marketing Safety of Drugs].
Kaniwa, N, 2015
)
0.42
" The most common grade 3 or higher adverse events were neutropenia (8% in the RIG + GEM group versus 6% in the GEM group), hyponatremia (17% versus 4%), and anemia (8% versus 4%)."( A phase II/III randomized study to compare the efficacy and safety of rigosertib plus gemcitabine versus gemcitabine alone in patients with previously untreated metastatic pancreatic cancer.
Aisner, DL; Bajaj, R; Baranda, JC; Bathini, V; Berlin, J; Boles, J; Cho, JK; Cohen, DJ; Cohen, SJ; Coveler, L; Cusnir, M; Fanta, P; Fehrenbacher, L; Gomes, CL; Granfortuna, J; Jimeno, A; Ma, WW; Maguire, R; Maniar, M; McRee, AJ; Menter, AR; Messersmith, WA; Nazemzadeh, R; O'Neil, BH; Olowokure, OO; Phillip, P; Radford, J; Rarick, M; Scott, AJ; Tejani, MA; Wilhelm, F, 2015
)
0.64
" The two groups were compared in terms of median survival and adverse events to chemotherapy."( The effectiveness and safety of platinum-based pemetrexed and platinum-based gemcitabine treatment in patients with malignant pleural mesothelioma.
Ak, G; Akarsu, M; Metintas, M; Metintas, S, 2015
)
0.65
"The study indicates that platinum-based gemcitabine is effective and a safe schema in malignant pleural mesothelioma."( The effectiveness and safety of platinum-based pemetrexed and platinum-based gemcitabine treatment in patients with malignant pleural mesothelioma.
Ak, G; Akarsu, M; Metintas, M; Metintas, S, 2015
)
0.91
" Common terminology criteria for adverse events (CTCAE) grade 3-4 haematological toxicity and dose reduction and/or stop of treatment after the first course of chemotherapy were defined as primary and secondary toxicity outcomes."( Low muscle mass is associated with chemotherapy-induced haematological toxicity in advanced non-small cell lung cancer.
Aass, N; Baracos, VE; Benth, JŠ; Fløtten, Ø; Grønberg, BH; Hjermstad, MJ; Jordhøy, M; Sjøblom, B, 2015
)
0.42
" The frequency and severity of adverse events were consistent with previous analyses; no new safety concerns were identified."( Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer.
Aghajanian, C; Blank, SV; Goff, B; Husain, A; Nycum, LR; Wang, YV, 2015
)
0.42
" Our data suggest that single-dose gemcitabine together with G-CSF is an effective mobilization regimen in myeloma patients and a safe alternative non-myelosuppressive mobilization chemotherapy for myeloma patients with bortezomib-induced polyneuropathy."( Stem cell mobilization chemotherapy with gemcitabine is effective and safe in myeloma patients with bortezomib-induced neurotoxicity.
Betticher, D; Egger, T; Keller, S; Mansouri Taleghani, B; Mueller, BU; Pabst, T; Rauch, D; Seipel, K, 2016
)
0.98
" However, some studies have been stopped owing to the development of severe adverse events."( Safety and efficacy of combination therapy with low-dose gemcitabine, paclitaxel, and sorafenib in patients with cisplatin-resistant urothelial cancer.
Asai, A; Matsuo, T; Mitsunari, K; Miyata, Y; Ohba, K; Sakai, H, 2015
)
0.66
"The purpose of this study is to evaluate the fluctuations of coagulation parameters during cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) and confirm beyond doubt that epidural anaesthesia is safe with this type of operations."( Lack of significant intraoperative coagulopathy in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) indicates that epidural anaesthesia is a safe option.
Alevizos, L; Daskalou, T; Eleftheriadis, S; Iatrou, C; Korakianitis, O; Mavroudis, C; Stamou, K; Tentes, AA; Vogiatzaki, T, 2015
)
0.42
"Our results support the belief that epidural analgesia is a safe option in cytoreductive surgery and HIPEC despite certain intraoperative fluctuations in coagulation parameters."( Lack of significant intraoperative coagulopathy in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) indicates that epidural anaesthesia is a safe option.
Alevizos, L; Daskalou, T; Eleftheriadis, S; Iatrou, C; Korakianitis, O; Mavroudis, C; Stamou, K; Tentes, AA; Vogiatzaki, T, 2015
)
0.42
" The efficacy and adverse reactions in patients of the study and control groups were observed and compared."( [Safety and efficacy of gemcitabine combined with S-1 in the treatment of advanced pancreatic cancer].
He, P; Jiang, Y; Yang, K; Zheng, L; Zhong, H, 2015
)
0.72
" The major adverse reactions were myelosuppression and digestive tract reactions, and the adverse reactions in the study group were lower than those in the control group."( [Safety and efficacy of gemcitabine combined with S-1 in the treatment of advanced pancreatic cancer].
He, P; Jiang, Y; Yang, K; Zheng, L; Zhong, H, 2015
)
0.72
"Gemcitabine combined with S-1 is effective and safe in the treatment of advanced pancreatic cancer, with less side effects, and can be tolerated by the patients."( [Safety and efficacy of gemcitabine combined with S-1 in the treatment of advanced pancreatic cancer].
He, P; Jiang, Y; Yang, K; Zheng, L; Zhong, H, 2015
)
2.17
" During neoadjuvant therapy, 21 patients (84 %) suffered from adverse events."( Evaluation of the safety and pathological effects of neoadjuvant full-dose gemcitabine combination radiation therapy in patients with biliary tract cancer.
Akita, H; Gotoh, K; Ishikawa, O; Kobayashi, S; Marubashi, S; Nishiyama, K; Ohigashi, H; Sakon, M; Takahashi, H; Teshima, T; Tomokuni, A; Yamada, T; Yano, M, 2015
)
0.65
"Severe toxicity and interruption of radiotherapy were more frequent in patients with multiple adverse predictive factors."( Predictive factors for survival and correlation to toxicity in advanced Stage III non-small cell lung cancer patients with concurrent chemoradiation.
Ahn, SJ; Ban, HJ; Chung, WK; Jeong, JU; Kim, KS; Kim, YC; Kim, YH; Nam, TK; Oh, IJ; Song, JY; Yoon, MS, 2016
)
0.43
" Grade 3/4 hematologic adverse events included neutropenia (28%) and leukopenia (11%); adverse events led to discontinuation in 33% of patients."( An open-label, dose-escalation study to evaluate the safety and pharmacokinetics of CEP-9722 (a PARP-1 and PARP-2 inhibitor) in combination with gemcitabine and cisplatin in patients with advanced solid tumors.
Aftimos, P; Awada, A; Bahleda, R; Bourbouloux, E; Campone, M; Frenel, JS; Gombos, A; Soria, JC; Varga, A, 2016
)
0.63
"The present study was conducted to determine whether active hexose correlated compound (AHCC), a functional food extracted from cultured basidiomycetes, possesses the potential to attenuate adverse events in unresectable pancreas ductal adenocarcinoma (PDAC) patients receiving chemotherapy."( Alleviating Effect of Active Hexose Correlated Compound (AHCC) on Chemotherapy-Related Adverse Events in Patients with Unresectable Pancreatic Ductal Adenocarcinoma.
Hirooka, S; Inoue, K; Kon, M; Kotsuka, M; Matsui, Y; Michiura, T; Ryota, H; Satoi, S; Tsuta, K; Yamaki, S; Yamamoto, T; Yanagimoto, H, 2016
)
0.43
" This rare adverse event is more frequent in the presence of edema."( Erysipeloid rash: A rare adverse event induced by gemcitabine.
Gutiérrez, D; Juez, I; Ruiz-Casado, A,
)
0.38
"This data suggests that nab-paclitaxel and gemcitabine is a safe and effective neoadjuvant treatment for potentially resectable pancreatic adenocarcinoma."( Preoperative treatment with gemcitabine plus nab-paclitaxel is a safe and effective chemotherapy for pancreatic adenocarcinoma.
Alvarez, R; Caruso, R; Diaz, E; Duran, H; Fabra, I; Ferri, V; Hidalgo, M; Ielpo, B; Malavé, L; Plaza, C; Quijano, Y; Vicente, E, 2016
)
0.99
" Grade 3-4 adverse events included leukopenia (2/39), and neutropenia (3/39) in first-line therapy versus neutropenia (1/40) and thrombocytopenia (2/40) in second-line treatment."( A retrospective analysis of efficacy and safety of adding bevacizumab to chemotherapy as first- and second-line therapy in advanced non-small-cell lung cancer (NSCLC).
Chen, N; Fang, W; Hu, Z; Huang, J; Quan, R; Zhan, J; Zhang, H; Zhang, L; Zhou, T, 2016
)
0.43
" In both cohorts, disease progression was the most common primary reason for discontinuing pertuzumab, and the most common all-grade adverse events (AEs) were fatigue/asthenia, anemia, and diarrhea."( Pertuzumab Plus Chemotherapy for Platinum-Resistant Ovarian Cancer: Safety Run-in Results of the PENELOPE Trial.
Bastiere-Truchot, L; Berton-Rigaud, D; Colombo, N; Del Campo, JM; du Bois, A; Gadducci, A; García, Y; González-Martín, A; Kiermaier, A; Kurzeder, C; Mahner, S; Marmé, F; Martin, N; Ortega, E; Ottevanger, P; Pautier, P; Rau, J; Selle, F, 2016
)
0.43
" Adverse events of interest with the largest difference between treatment groups in EGFR > 0 patients (Grade ≥3) were hypomagnesemia (10% versus <1%) and skin rash (6% versus <1%)."( Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with st
Hirsch, FR; Hozak, RR; Kurek, R; Paz-Ares, L; Shahidi, J; Socinski, MA; Soldatenkova, V; Thatcher, N; Varella-Garcia, M, 2016
)
0.64
" Adverse effects were tolerable, with dose reduced upfront in 23 % patients and 11."( Second-Line Palliative Chemotherapy in Advanced Gall Bladder Cancer, CAP-IRI: Safe and Effective Option.
Goel, M; Gupta, S; Jandyal, S; Ostwal, V; Pande, N; Patkar, S; Ramadwar, M; Ramaswamy, A; Sahu, A; Shetty, N, 2016
)
0.43
" As for the toxicity profile, the most common adverse events (AEs) were hematologic reactions, skin rash, and gastrointestinal reactions."( Efficacy and safety of gemcitabine plus erlotinib for locally advanced or metastatic pancreatic cancer: a systematic review and meta-analysis.
Guo, J; Han, X; Hu, GF; Liu, LY; Tang, N; Wang, X; Wang, Y; Wang, ZH; Zhang, QQ, 2016
)
0.74
" Four important transporter genes are expressed in the kidney, including organic cation transporter 2 (OCT2), multidrug and toxin extrusion 1 (MATE1), ATP-binding cassette subfamily B member 1 (ABCB1), and ATP-binding cassette subfamily C member 2 (ABCC2), and genetic polymorphisms in these genes may alter the efficacy and adverse effects of platinum drugs."( Associations of genetic polymorphisms of the transporters organic cation transporter 2 (OCT2), multidrug and toxin extrusion 1 (MATE1), and ATP-binding cassette subfamily C member 2 (ABCC2) with platinum-based chemotherapy response and toxicity in non-sma
Chen, J; Liu, JY; Liu, ZQ; Qian, CY; Wang, Y; Yin, JY; Zheng, Y; Zhou, HH, 2016
)
0.43
" Select adverse events (those with a potential immunologic cause) of any grade were observed in six, four, six, and five patients in arms A, B, C, and D, respectively."( Safety and efficacy of nivolumab and standard chemotherapy drug combination in patients with advanced non-small-cell lung cancer: a four arms phase Ib study.
Fujiwara, Y; Goto, K; Horinouchi, H; Hozumi, H; Kanda, S; Kitazono, S; Kubo, E; Mizugaki, H; Nokihara, H; Shiraishi, H; Sunami, K; Tamura, T; Tanaka, A; Utsumi, H; Yamamoto, N, 2016
)
0.43
" Our data highlight the importance of managing adverse events and indicate that patients should be treated until PD when possible."( Efficacy and safety profile of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer treated to disease progression: a subanalysis from a phase 3 trial (MPACT).
Li, JS; McGovern, D; Romano, A; Römmler-Zehrer, J; Stahl, M; Vogel, A, 2016
)
0.69
" The combined hazard ratio (HR) or risk ratio; the corresponding 95% confidence intervals of progression-free survival, overall survival, and overall response rate; and grade 3-4 adverse events were examined."( Therapeutic efficacy and safety of S-1-based combination therapy compare with S-1 monotherapy following gemcitabine failure in pancreatic cancer: a meta-analysis.
Hu, Z; Ju, B; Lu, S; Wang, W; Xie, H; Yang, Q; Zhang, Y; Zhao, X; Zheng, S; Zhou, D; Zhou, L; Zhou, X, 2016
)
0.65
" Gemcitabine may be relatively safe in heavily pretreated ovarian cancer patients."( Response to and toxicity of gemcitabine for recurrent ovarian cancer according to number of previous chemotherapy regimens.
Fujiwara, H; Machida, S; Matsubara, S; Morisawa, H; Nagashima, T; Saga, Y; Takahashi, S; Takahashi, Y; Takei, Y; Taneichi, A, 2017
)
1.66
"Web of knowledge, PubMed, Ovid, Embase, and Cochrane Library were searched to identify relevant studies and extract data on overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and common grade 3 or 4 adverse events."( The efficacy and safety of platinum plus gemcitabine (PG) chemotherapy with or without molecular targeted agent (MTA) in first-line treatment of non-small cell lung cancer (NSCLC).
He, J; Li, T; Liu, P; Luo, L; Yang, J; Yu, M, 2016
)
0.7
" The combination chemotherapy also showed a higher frequency of grade 3 or higher toxic effects in patients with advanced NSCLC than PG chemotherapy."( The efficacy and safety of platinum plus gemcitabine (PG) chemotherapy with or without molecular targeted agent (MTA) in first-line treatment of non-small cell lung cancer (NSCLC).
He, J; Li, T; Liu, P; Luo, L; Yang, J; Yu, M, 2016
)
0.7
" A numerically higher proportion of patients experienced serious adverse events (AEs), grade ≥ 3 AEs, and AEs with an outcome of death for neci+GC versus GC in EA patients and EA patients versus non-EA patients for neci+GC."( Efficacy and Safety of First-Line Necitumumab Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in East Asian Patients with Stage IV Squamous Non-small Cell Lung Cancer: A Subgroup Analysis of the Phase 3, Open-Label, Randomized SQUIRE Study
Ahn, MJ; Bello, M; Cho, EK; Depenbrock, H; Orlando, M; Park, K; Puri, T; Soldatenkova, V; Song, EK; Thongprasert, S, 2017
)
0.71
" Nausea and vomiting occurred as adverse event (AE) in eight out of 25 treatments (32%), with seven of eight events (87."( Degradable Starch Microspheres Transcatheter Arterial Chemoembolization (DSM-TACE) in Intrahepatic Cholangiocellular Carcinoma (ICC): Results from a National Multi-Center Study on Safety and Efficacy.
Albrecht, T; Michalik, K; Nolte-Ernsting, C; Pereira, PL; Pützler, M; Schicho, A; Stroszczynski, C; Wiggermann, P, 2017
)
0.46
" However, its fat solubility is high, and several adverse events, such as myelosuppression, are known to develop during its use."( [Comparison of Preparation Efficiency and Therapeutic Safety between Generic Products of Gemcitabine].
Amada, K; Itoh, H; Nakahara, R; Ono, H; Sato, Y, 2017
)
0.68
"Our results confirm that GP has an adverse impact on the renal function of patients with UUT-UC who retain a solitary kidney, but it can be safely administered to the majority of these patients without inducing SNT."( The renal safety and efficacy of combined gemcitabine plus cisplatin and gemcitabine plus carboplatin chemotherapy in Chinese patients with a solitary kidney after nephroureterectomy.
An, X; Deng, YF; Jiang, WQ; Li, LR; Shao, C; Shi, YX; Sun, P; Thomas, R; Xue, C; Yang, W, 2017
)
0.72
" Haemocytopenia was the predominant adverse effect, and acute toxicity was moderate, tolerable and well managed in both arms."( The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers.
Chang, Y; Duan, W; Fu, X; Li, L; Li, X; Li, Z; Nan, F; Sun, Z; Wang, X; Wu, J; Yan, J; Young, KH; Zhang, L; Zhang, M; Zhang, X, 2017
)
0.75
" Primary outcomes were the rates of complete ablation 12 months after the procedure, and rates of serious and minor adverse events within 30 days of the procedure."( The Safety and Efficacy of an Alcohol-Free Pancreatic Cyst Ablation Protocol.
Ancrile, BB; Birkholz, JH; Blandford, JT; Dye, CE; Gusani, NJ; Headlee, BD; Heisey, HD; Levenick, JM; Maranki, JL; Mathew, A; McGarrity, TJ; Moyer, MT; Sharzehi, S, 2017
)
0.46
" Serious adverse events occurred in 6% of patients in the control group vs none of the patients in the alcohol-free group."( The Safety and Efficacy of an Alcohol-Free Pancreatic Cyst Ablation Protocol.
Ancrile, BB; Birkholz, JH; Blandford, JT; Dye, CE; Gusani, NJ; Headlee, BD; Heisey, HD; Levenick, JM; Maranki, JL; Mathew, A; McGarrity, TJ; Moyer, MT; Sharzehi, S, 2017
)
0.46
"In this prospective, randomized, controlled trial, we found that alcohol is not required for effective EUS-guided pancreatic cyst ablation, and when alcohol is removed from the ablation process, there is a significant reduction in associated adverse events."( The Safety and Efficacy of an Alcohol-Free Pancreatic Cyst Ablation Protocol.
Ancrile, BB; Birkholz, JH; Blandford, JT; Dye, CE; Gusani, NJ; Headlee, BD; Heisey, HD; Levenick, JM; Maranki, JL; Mathew, A; McGarrity, TJ; Moyer, MT; Sharzehi, S, 2017
)
0.46
" The treatment response and adverse events were compared between the 2 groups every 2 cycles."( Efficacy and Safety of Vinorelbine Plus Cisplatin vs. Gemcitabine Plus Cisplatin for Treatment of Metastatic Triple-Negative Breast Cancer After Failure with Anthracyclines and Taxanes.
Wang, J; Wang, M; Wang, Z; Yang, Y; Zheng, R; Zou, W, 2017
)
0.7
" In this subgroup analysis we compared patients treated with necitumumab monotherapy after completion of ≥ 4 cycles of chemotherapy with those in the chemotherapy arm who were progression-free and did not discontinue because of adverse events (AEs) after completion of ≥ 4 cycles of chemotherapy (gemcitabine-cisplatin nonprogressors)."( Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer.
Bálint, B; Ciuleanu, T; Depenbrock, H; Luft, AV; Molinier, O; Nanda, S; Obasaju, C; Paz-Ares, L; Ramlau, R; Socinski, MA; Szafrański, W; Szczesna, A; Thatcher, N, 2018
)
0.66
" There is significant uncertainty as to whether using closed-system drug-transfer devices (CSTD) in addition to safe handling decreases the contamination and risk of staff exposure to infusional hazardous drugs compared to safe handling alone."( Closed-system drug-transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff.
Best, LM; Bussières, JF; Gurusamy, KS; Korva, M; Lennan, E; Tanguay, C, 2018
)
0.48
"To assess the effects of closed-system drug-transfer of infusional hazardous drugs plus safe handling versus safe handling alone for reducing staff exposure to infusional hazardous drugs and risk of staff contamination."( Closed-system drug-transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff.
Best, LM; Bussières, JF; Gurusamy, KS; Korva, M; Lennan, E; Tanguay, C, 2018
)
0.48
"We included comparative studies of any study design (irrespective of language, blinding, or publication status) that compared CSTD plus safe handling versus safe handling alone for infusional hazardous drugs."( Closed-system drug-transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff.
Best, LM; Bussières, JF; Gurusamy, KS; Korva, M; Lennan, E; Tanguay, C, 2018
)
0.48
" In 21 studies, the people who used the intervention (CSTD plus safe handling) and control (safe handling alone) were pharmacists or pharmacy technicians; in the other two studies, the people who used the intervention and control were nurses, pharmacists, or pharmacy technicians."( Closed-system drug-transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff.
Best, LM; Bussières, JF; Gurusamy, KS; Korva, M; Lennan, E; Tanguay, C, 2018
)
0.48
"There is currently no evidence to support or refute the routine use of closed-system drug transfer devices in addition to safe handling of infusional hazardous drugs, as there is no evidence of differences in exposure or financial benefits between CSTD plus safe handling versus safe handling alone (very low-quality evidence)."( Closed-system drug-transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff.
Best, LM; Bussières, JF; Gurusamy, KS; Korva, M; Lennan, E; Tanguay, C, 2018
)
0.48
" Hematological adverse events were commonly seen in both group (12."( Efficacy and safety comparison of nabpaclitaxel plus S-1 and gemcitabine plus S-1 as first-line chemotherapy for metastatic pancreatic cancer.
Fan, Y; Feng, Y; Guo, X; Liu, T; Lou, W; Wang, D; Wang, Y; Wu, L; Wu, W; Xu, B; Xu, Y; Zhou, Y, 2018
)
0.72
" Treatment-related adverse events were mostly manageable, but one patient died as a result of febrile neutropenia."( Comparison of efficacy and toxicity of second-line combination chemotherapy regimens in patients with advanced urothelial carcinoma.
Iguchi, T; Kato, M; Kuratsukuri, K; Nakatani, T; Nishihara, C; Takeyama, Y; Tamada, S; Yamasaki, T, 2018
)
0.48
"Nab-P/G administrations in our pts with cholestatic hyperbilirubinaemia suffering from APC were feasible and safe with respect to individualised dose administrations."( Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis.
Bahra, M; Denecke, T; Jühling, A; Klein, F; Pelzer, U; Riess, H; Roemmler-Zehrer, J; Sinn, M; Striefler, J; Wislocka, L, 2018
)
0.74
"The drug-loaded NPs present increased toxicity over human breast cancer cells without increasing toxic effects over endothelial cells."( Gemcitabine delivered by fucoidan/chitosan nanoparticles presents increased toxicity over human breast cancer cells.
Martins, A; Neves, NM; Oliveira, C; Reis, RL; Silva, TH, 2018
)
1.92
" We compared the disease control rate, median overall survival (OS), and adverse events (AEs) between the two groups."( The efficacy and safety of nab paclitaxel plus gemcitabine in elderly patients over 75 years with unresectable pancreatic cancer compared with younger patients.
Hirose, Y; Ishii, A; Ishimoto, U; Iwaku, A; Kinoshita, A; Koike, K; Mizuno, Y; Saruta, M; Shibata, K; Shoji, R; Yokota, T, 2019
)
0.77
" To evaluate the safety profile, every adverse event from the start of the treatment and up to 10 days after its completion was registered."( Effectiveness and safety of nab-paclitaxel/gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma.
Alfaro-Olea, A; Casajús-Navasal, A; Marín-Gorricho, R; Nebot-Villacampa, MJ; Uriarte-Pinto, M; Zafra-Morales, R, 2020
)
0.82
"Health-care personnel handling antineoplastic drugs could be at risk for adverse health effects."( Antineoplastic drug occupational exposure: a new integrated approach to evaluate exposure and early genotoxic and cytotoxic effects by no-invasive Buccal Micronucleus Cytome Assay biomarker.
Boccia, R; Buresti, G; Carbonari, D; Cavallo, D; Chiarella, P; Ciervo, A; Colosio, C; Delrio, P; Fresegna, AM; Iavicoli, S; Jemos, C; Maiello, R; Maiolino, P; Mandić-Rajčević, S; Marchetti, P; Omodeo Salè, E; Rubino, FM; Ursini, CL, 2019
)
0.51
" Autologous exosomes are safe and effective vehicles for targeted delivery of GEM against pancreatic cancer."( Gemcitabine loaded autologous exosomes for effective and safe chemotherapy of pancreatic cancer.
Cai, JX; Hu, XB; Li, YJ; Wang, JM; Wu, JY; Xiang, DX, 2020
)
2
" However, their use in the elderly is discouraged because of adverse events."( The efficacy and toxicity of chemotherapy in the elderly with advanced pancreatic cancer.
Bai, XL; Chen, W; Chen, YW; Fu, QH; Gao, SL; Guo, CX; Huang, DB; Li, X; Liang, TB; Ma, T; Que, RS; Su, W; Tang, TY; Zhang, Q; Zhang, XC, 2020
)
0.56
" The objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), overall survival (OS) and adverse events were compared between the groups."( The efficacy and toxicity of chemotherapy in the elderly with advanced pancreatic cancer.
Bai, XL; Chen, W; Chen, YW; Fu, QH; Gao, SL; Guo, CX; Huang, DB; Li, X; Liang, TB; Ma, T; Que, RS; Su, W; Tang, TY; Zhang, Q; Zhang, XC, 2020
)
0.56
" However, the elderly patients suffered a higher incidence of severe adverse events (50% vs."( The efficacy and toxicity of chemotherapy in the elderly with advanced pancreatic cancer.
Bai, XL; Chen, W; Chen, YW; Fu, QH; Gao, SL; Guo, CX; Huang, DB; Li, X; Liang, TB; Ma, T; Que, RS; Su, W; Tang, TY; Zhang, Q; Zhang, XC, 2020
)
0.56
"Considering the high costs for developing a new anticancer agent, we used the FDA-approved drugs gemcitabine, romidepsin (is approved for T-cell lymphoma and is under clinical trial for TNBC), and cisplatin to economically formulate an efficacious and safe combination regimen."( Formulation of a triple combination gemcitabine plus romidepsin + cisplatin regimen to efficaciously and safely control triple-negative breast cancer tumor development.
Odoi, A; Pattarawat, P; Pfisterer, B; Wallace, S; Wang, HR, 2020
)
1.05
" In stage two, an additional 20 patients were enrolled at a starting dose as defined in stage one, provided that in stage ≥1 objective response or ≥2 stable diseases were observed and ≤3 patients had serious adverse events (SAEs) within the first 6 weeks of treatment."( Efficacy and safety of FOLFIRINOX as salvage treatment in advanced biliary tract cancer: an open-label, single arm, phase 2 trial.
Belkouz, A; de Vos-Geelen, J; Eskens, FALM; Klümpen, HJ; Mathôt, RAA; Punt, CJA; van Gulik, TM; van Oijen, MGH; Wilmink, JW, 2020
)
0.56
" One patient had a SAE during the first 6 weeks of treatment, and five patients required a dose reduction due to adverse events."( Efficacy and safety of FOLFIRINOX as salvage treatment in advanced biliary tract cancer: an open-label, single arm, phase 2 trial.
Belkouz, A; de Vos-Geelen, J; Eskens, FALM; Klümpen, HJ; Mathôt, RAA; Punt, CJA; van Gulik, TM; van Oijen, MGH; Wilmink, JW, 2020
)
0.56
" Of note, the molecular design of P-GEM achieved minimal accumulation in normal tissues, resulting in negligible GEM-derived adverse effects (e."( Polymeric modification of gemcitabine via cyclic acetal linkage for enhanced anticancer potency with negligible side effects.
Honda, Y; Inaba, T; Kim, J; Liu, X; Matsui, M; Nishiyama, N; Nomoto, T; Takemoto, H; Taniwaki, K; Tomoda, K; Toyoda, M; Yamada, N, 2020
)
0.86
" We used the Anderson-Gill survival model to compare the risk of developing an adverse event after antibacterial prescription with time unexposed to antibacterials."( Antibacterial Use Is Associated with an Increased Risk of Hematologic and Gastrointestinal Adverse Events in Patients Treated with Gemcitabine for Stage IV Pancreatic Cancer.
Buse, JB; Corty, RW; Fine, JP; Langworthy, BW; Lund, JL; Sanoff, HK, 2020
)
0.76
"Antibacterial exposure was associated with an increased risk of gemcitabine-associated, dose-limiting adverse events, including aggregate hematologic and gastrointestinal events, as well as four specific hematologic adverse events, suggesting that intratumor bacteria may be responsible for a clinically significant portion of gemcitabine metabolism."( Antibacterial Use Is Associated with an Increased Risk of Hematologic and Gastrointestinal Adverse Events in Patients Treated with Gemcitabine for Stage IV Pancreatic Cancer.
Buse, JB; Corty, RW; Fine, JP; Langworthy, BW; Lund, JL; Sanoff, HK, 2020
)
1
" AuNPs as carriers of chemotherapeutics allow for reduced concentrations whilst maintaining the expected effect, and thus reducing the costs of therapy and adverse effects."( Assessment of Anti-Tumor potential and safety of application of Glutathione stabilized Gold Nanoparticles conjugated with Chemotherapeutics.
Barcinska, E; Inkielewicz-Stepniak, I; Sobczak, K; Steckiewicz, KP; Tomczyk, E; Wojcik, M, 2020
)
0.56
" No unexpected severe adverse events or treatment-related deaths occurred."( Five-year safety and efficacy data from a phase Ib study of nivolumab and chemotherapy in advanced non-small-cell lung cancer.
Fujiwara, Y; Goto, Y; Horinouchi, H; Kanda, S; Nokihara, H; Ohe, Y; Tamura, T; Yamamoto, N; Yamamoto, T, 2020
)
0.56
" Data of overall survival (OS), progression-free survival (PFS), 1-year survival rate, objective response rate (ORR), disease control rate (DCR) and adverse events were extracted and meta-analyzed."( Efficacy and safety of gemcitabine plus capecitabine in the treatment of advanced or metastatic pancreatic cancer: a systematic review and meta-analysis.
Li, PC; Lin, GH; Wang, BC; Xiao, BY, 2020
)
0.87
" No toxic death was observed."( Safety and Efficacy of Gemcitabine, Docetaxel, Capecitabine, Cisplatin as Second-line Therapy for Advanced Pancreatic Cancer After FOLFIRINOX.
Bengrine, L; Fumet, JD; Ghiringhelli, F; Granconato, L; Hennequin, A; Palmier, R; Vincent, J, 2020
)
0.87
" However, hematological toxicity is a major side effect of GC therapy in patients with UC."( Risk Associated with Severe Hematological Toxicity in Patients with Urothelial Cancer Receiving Combination Chemotherapy of Gemcitabine and Cisplatin.
Fujimiya, T; Kurihara, T; Nagatani, A; Ogawa, Y; Sasaki, H; Sasaki, T; Sunaga, T; Takahashi, N; Watanabe, T; Yamagishi, M, 2020
)
0.76
" The most common treatment-emergent adverse events were fatigue (75."( Safety and Efficacy of Andecaliximab (GS-5745) Plus Gemcitabine and Nab-Paclitaxel in Patients with Advanced Pancreatic Adenocarcinoma: Results from a Phase I Study.
Bendell, J; Berlin, J; Bhargava, P; Brachmann, CB; Chaves, J; Gordon, M; Khan, SA; Liu, J; Patel, MR; Shah, MA; Sharma, S; Starodub, A; Thai, D; Wainberg, ZA; Windsor, KS; Zavodovskaya, M, 2020
)
0.81
" However, whether adverse events (AEs) during AC influence the prognosis of patients with resected PDAC who do or do not receive NAC remains uncertain."( Impact of adverse events of adjuvant and neoadjuvant chemotherapies on outcomes of patients with pancreatic ductal adenocarcinoma.
Aoki, T; Iso, Y; Kubota, K; Matsumoto, T; Mori, S; Park, KH; Sakuraoka, Y; Shimizu, T; Shiraki, T; Yamaguchi, T, 2021
)
0.62
" Treatment response, European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30), progression-free survival (PFS), overall survival (OS), and adverse events were assessed during the follow-up."( Drug-eluting bead bronchial arterial chemoembolization vs. chemotherapy in treating advanced non-small cell lung cancer: comparison of treatment efficacy, safety and quality of life.
Bao, PT; Lin, H; Liu, XF; Mu, M; Pan, P; Tian, FF; Wang, Q; Zhang, R; Zhao, WG, 2021
)
0.62
" Furthermore, two groups all exhibited mild and tolerable adverse events."( Drug-eluting bead bronchial arterial chemoembolization vs. chemotherapy in treating advanced non-small cell lung cancer: comparison of treatment efficacy, safety and quality of life.
Bao, PT; Lin, H; Liu, XF; Mu, M; Pan, P; Tian, FF; Wang, Q; Zhang, R; Zhao, WG, 2021
)
0.62
" (20%) terminated S-1 due to adverse events."( Efficacy and safety of S-1 following gemcitabine with cisplatin for advanced biliary tract cancer.
Andoh, A; Fukutomi, A; Fushiki, K; Hamauchi, S; Inoue, H; Kawakami, T; Machida, N; Onozawa, Y; Shirasu, H; Todaka, A; Tsushima, T; Yamazaki, K; Yasui, H; Yokota, T, 2021
)
0.89
" Overall survival, overall response rate, incidence of acute and late toxicity, and adverse events are the minor endpoints."( Efficacy and safety of two different adjuvant chemotherapy regimens in combination with concurrent chemoradiotherapy in treating patients with advanced nasopharyngeal carcinoma: A protocol for randomized controlled trial.
Cui, J; Pan, LX; Tan, HF; Xiao, Z; Zhang, LL, 2021
)
0.62
"Current available therapies for pancreatic ductal adenocarcinoma (PDAC) provide minimal overall survival benefits and cause severe adverse effects."( Novel Seleno-Aspirinyl Compound AS-10 Induces Apoptosis, G1 Arrest of Pancreatic Ductal Adenocarcinoma Cells, Inhibits Their NF-κB Signaling, and Synergizes with Gemcitabine Cytotoxicity.
Amin, S; K Pandey, M; Karelia, DN; Kim, S; Lu, J; Plano, D; Sharma, AK, 2021
)
0.82
" The best tumor response, overall survival (OS), and adverse events in each group were compared."( Safety and Efficacy of Gemcitabine Plus Nab-Paclitaxel for Metastatic Pancreatic Cancer Patients Undergoing Biliary Stent Placement.
Ibusuki, M; Inoue, T; Ito, K; Kimoto, S; Kitano, R; Kobayashi, Y; Nakade, Y; Ohashi, T; Sakamoto, K; Sumida, Y; Yoneda, M, 2022
)
1.03
" However, careful management and appropriate reintervention to treat biliary tract-related adverse events are required."( Safety and Efficacy of Gemcitabine Plus Nab-Paclitaxel for Metastatic Pancreatic Cancer Patients Undergoing Biliary Stent Placement.
Ibusuki, M; Inoue, T; Ito, K; Kimoto, S; Kitano, R; Kobayashi, Y; Nakade, Y; Ohashi, T; Sakamoto, K; Sumida, Y; Yoneda, M, 2022
)
1.03
" The endpoints included overall survival (OS), progression-free survival (PFS), distant failure-free survival (DMFS), locoregional failure-free survival (LRFFS) and treatment-related adverse events (AEs)."( The safety and efficacy of gemcitabine and cisplatin (GP)-based induction chemotherapy plus concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: a meta-analysis.
Jia, Z; Tang, M; Zhang, J, 2022
)
1.02
" Moreover, the incidence of adverse events of all grades (RR = 1."( A meta-analysis comparing the efficacy and safety of gemcitabine plus cisplatin induction chemotherapy in patients with locoregionally advanced NPC.
Kang, W; Li, Y; Liao, J; Xiao, L, 2022
)
0.97
" Three patients experienced grade 3 adverse events."( Efficacy and Safety of Gemcitabine Plus Cisplatin as Potential Preoperative Chemotherapy in Locally Advanced Intrahepatic, Perihilar, and Mid-Cholangiocarcinoma: A Retrospective Cohort Study.
Belkouz, A; Besselink, MG; Busch, OR; Erdmann, JI; Franken, LC; Klümpen, HJ; Nooijen, LE; Oulad Abdennabi, I; Swijnenburg, RJ, 2021
)
0.93
"Gem/cis may be a safe and feasible preoperative treatment in initially unresectable locally advanced or borderline resectable cholangiocarcinoma."( Efficacy and Safety of Gemcitabine Plus Cisplatin as Potential Preoperative Chemotherapy in Locally Advanced Intrahepatic, Perihilar, and Mid-Cholangiocarcinoma: A Retrospective Cohort Study.
Belkouz, A; Besselink, MG; Busch, OR; Erdmann, JI; Franken, LC; Klümpen, HJ; Nooijen, LE; Oulad Abdennabi, I; Swijnenburg, RJ, 2021
)
0.93
" This potential adverse event should be considered when all common causes of persistent vasoplegia are ruled out, such as shock related to bleeding, infection, allergic reaction, or pulmonary embolic phenomenon."( Persistent Postoperative Vasoplegia After Ureteronephrectomy Due To Suspected Intravesical Gemcitabine Toxicity.
Bohorquez, MA; Carr, ZJ; Yan, L, 2021
)
0.84
" Ten patients (4 in Arm 1, 6 in Arm 2) experienced ≥1 treatment-emergent adverse events (TEAEs)."( The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial.
Aron, M; Brummelhuis, ISG; Chau, A; Cutie, CJ; Daneshmand, S; Keegan, KA; Maffeo, JC; Pohar, KS; Raybold, B; Reynolds, DL; Steinberg, GD; Witjes, JA, 2022
)
0.97
"Controlled intravesical gemcitabine release via TAR-200 was safe and well tolerated in patients with MIBC."( The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial.
Aron, M; Brummelhuis, ISG; Chau, A; Cutie, CJ; Daneshmand, S; Keegan, KA; Maffeo, JC; Pohar, KS; Raybold, B; Reynolds, DL; Steinberg, GD; Witjes, JA, 2022
)
1.27
" Pooled analyses for progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR) and grade 3/4 treatment-emergent adverse events (TRAEs) were undertaken."( Efficacy and safety of FOLFIRINOX as second-line chemotherapy for advanced pancreatic cancer after gemcitabine-based therapy: A systematic review and meta-analysis.
Li, X; Lu, W; Tang, K; Wang, L, 2022
)
0.94
" However, grade 3/4 adverse events were more frequently reported in patients administered FOLFIRINOX compared with the other three regimens."( Efficacy and safety of FOLFIRINOX as second-line chemotherapy for advanced pancreatic cancer after gemcitabine-based therapy: A systematic review and meta-analysis.
Li, X; Lu, W; Tang, K; Wang, L, 2022
)
0.94
" Patient-related side effects measured by CTCAE (Common Terminology Criteria for Adverse Events)version 5 showed that the BCG group had higher toxicity profile as compared to Gem/Doce group."( Quality of Life, Efficacy, and Safety of Sequential Intravesical Gemcitabine + Docetaxel versus BCG for Non-Muscle Invasive Urinary Bladder Cancer: A Pilot Study.
Kumar, S; Pareek, T; Parmar, K; Sharma, AP, 2022
)
0.96
" In a fimaporfin dose-escalation phase I clinical study, we administered PCI with gemcitabine in patients with perihilar CCA (n = 16) to establish a safe and tolerable fimaporfin dose and to get early signals of efficacy."( Photochemical Internalization of Gemcitabine Is Safe and Effective in Locally Advanced Inoperable Cholangiocarcinoma.
Dechêne, A; Finnesand, L; Hoffmeister, A; Høgset, A; Jakobs, R; Jürgensen, C; Kasper, S; Neu, B; Olivecrona, H; Palmer, D; Schirra, J; Selbo, PK; Sturgess, R; Trojan, J; Walday, P, 2022
)
1.23
"Photochemical internalization with gemcitabine was found to be safe and resulted in encouraging response and survival rates in patients with unresectable perihilar CCA."( Photochemical Internalization of Gemcitabine Is Safe and Effective in Locally Advanced Inoperable Cholangiocarcinoma.
Dechêne, A; Finnesand, L; Hoffmeister, A; Høgset, A; Jakobs, R; Jürgensen, C; Kasper, S; Neu, B; Olivecrona, H; Palmer, D; Schirra, J; Selbo, PK; Sturgess, R; Trojan, J; Walday, P, 2022
)
1.28
" The incidence of severe adverse events was higher with GnP than with Gem; however, the difference was not significant."( Comparing the Efficacy and Safety of Gemcitabine plus Nab-Paclitaxel versus Gemcitabine Alone in Older Adults with Unresectable Pancreatic Cancer.
Arima, S; Doi, K; Furuse, J; Hayashi, H; Higuchi, H; Hisano, T; Imaoka, H; Ishii, H; Ishii, S; Kawabe, K; Kitano, Y; Kobayashi, S; Kojima, Y; Maruki, Y; Misumi, T; Miwa, H; Nagano, H; Naganuma, A; Nakashima, K; Okano, N; Ozaka, M; Shioji, K; Suzuki, M; Suzuki, R; Tanaka, K; Todaka, A; Tsuji, K; Tsumura, H; Ueno, M; Umemoto, K; Yamaguchi, H; Yamashita, T, 2022
)
0.99
"GnP is more efficacious than Gem in patients aged ≥76 years with uPC despite demonstrating a higher incidence of severe adverse events."( Comparing the Efficacy and Safety of Gemcitabine plus Nab-Paclitaxel versus Gemcitabine Alone in Older Adults with Unresectable Pancreatic Cancer.
Arima, S; Doi, K; Furuse, J; Hayashi, H; Higuchi, H; Hisano, T; Imaoka, H; Ishii, H; Ishii, S; Kawabe, K; Kitano, Y; Kobayashi, S; Kojima, Y; Maruki, Y; Misumi, T; Miwa, H; Nagano, H; Naganuma, A; Nakashima, K; Okano, N; Ozaka, M; Shioji, K; Suzuki, M; Suzuki, R; Tanaka, K; Todaka, A; Tsuji, K; Tsumura, H; Ueno, M; Umemoto, K; Yamaguchi, H; Yamashita, T, 2022
)
0.99
" Treatment-related adverse events were less frequent in the PD-1 inhibitor group than in the carboplatin-gemcitabine group (57."( The efficacy and safety of first-line treatment in cisplatin-ineligible advanced upper tract urothelial carcinoma patients: a comparison of PD-1 inhibitor and carboplatin plus gemcitabine chemotherapy.
Bao, Y; Cai, M; Chen, M; Chen, Z; Fu, C; Guo, J; Hu, H; Huang, J; Huang, Z; Jiang, S; Li, C; Su, R; Wang, Z; Wei, Q; Xue, W; Yuan, Y; Zheng, B, 2022
)
1.13
"We analyzed the incidence, time to first onset, and time to resolution for adverse events that require special attention and other selected toxicities in the nal-IRI combination group (n = 46)."( Liposomal irinotecan with fluorouracil and leucovorin after gemcitabine-based therapy in Japanese patients with metastatic pancreatic cancer: additional safety analysis of a randomized phase 2 trial.
Furuse, J; Furuya, M; Ikeda, M; Ioka, T; Okusaka, T; Teng, Z; Ueno, M, 2023
)
1.15
"3%) were the most commonly reported treatment-emergent adverse events, with a median time to onset of 21."( Liposomal irinotecan with fluorouracil and leucovorin after gemcitabine-based therapy in Japanese patients with metastatic pancreatic cancer: additional safety analysis of a randomized phase 2 trial.
Furuse, J; Furuya, M; Ikeda, M; Ioka, T; Okusaka, T; Teng, Z; Ueno, M, 2023
)
1.15
" Although the treatment-emergent adverse events occurred were controllable, patients with prolonged toxicities should be closely managed."( Liposomal irinotecan with fluorouracil and leucovorin after gemcitabine-based therapy in Japanese patients with metastatic pancreatic cancer: additional safety analysis of a randomized phase 2 trial.
Furuse, J; Furuya, M; Ikeda, M; Ioka, T; Okusaka, T; Teng, Z; Ueno, M, 2023
)
1.15
" CP and CG were compared in terms of progression-free survival (PFS), overall survival (OS), and incidence of adverse events (AEs)."( Efficacy and Safety of First-line Carboplatin-paclitaxel and Carboplatin-gemcitabine in Patients With Advanced Triple-negative Breast Cancer: A Monocentric, Retrospective Comparison.
Bianchi, GV; Cantarelli, B; Capri, G; de Braud, F; Depretto, C; Fucà, G; Leporati, R; Ligorio, F; Lobefaro, R; Manoukian, S; Mariani, L; Peverelli, G; Presti, D; Pruneri, G; Rametta, A; Scaperrotta, G; Vernieri, C; Vingiani, A; Zattarin, E, 2023
)
1.14
" The outcomes of interest were risk of recurrence, progression, treatment-related adverse events, and discontinuation."( The efficacy and safety outcomes of lower dose BCG compared to intravesical chemotherapy in non-muscle-invasive bladder cancer: A network meta-analysis.
Araki, M; Babjuk, M; Bekku, K; Chlosta, M; Kawada, T; Laukhtina, E; Pradere, B; Shariat, SF; Teoh, JY; von Deimling, M; Yanagisawa, T, 2023
)
0.91
" Acute toxicity was assessed (Common Terminology Criteria for Adverse Events) weekly during radiotherapy and at 10 weeks after the start of treatment."( Acute Toxicity of Hypofractionated and Conventionally Fractionated (Chemo)Radiotherapy Regimens for Bladder Cancer: An Exploratory Analysis from the RAIDER Trial.
Alonzi, R; Birtle, A; Cheung, KC; Choudhury, A; Foroudi, F; Gribble, H; Griffin, C; Hafeez, S; Hall, E; Henry, A; Hilman, S; Hindson, B; Huddart, R; Lewis, R; McLaren, DB; McNair, H; Muthukumar, D; Nikapota, A; Olorunfemi, A; Omar, A; Parikh, O; Philipps, L; Rimmer, Y; Syndikus, I; Tolentino, A; Varughese, M; Vassallo-Bonner, C; Webster, A, 2023
)
0.91
"Grade 2+ acute adverse events are common."( Acute Toxicity of Hypofractionated and Conventionally Fractionated (Chemo)Radiotherapy Regimens for Bladder Cancer: An Exploratory Analysis from the RAIDER Trial.
Alonzi, R; Birtle, A; Cheung, KC; Choudhury, A; Foroudi, F; Gribble, H; Griffin, C; Hafeez, S; Hall, E; Henry, A; Hilman, S; Hindson, B; Huddart, R; Lewis, R; McLaren, DB; McNair, H; Muthukumar, D; Nikapota, A; Olorunfemi, A; Omar, A; Parikh, O; Philipps, L; Rimmer, Y; Syndikus, I; Tolentino, A; Varughese, M; Vassallo-Bonner, C; Webster, A, 2023
)
0.91
" None of the patients discontinued the study due to adverse events."( Safety and efficacy of trastuzumab biosimilar plus irinotecan or gemcitabine in patients with previously treated HER2 (ERBB2)-positive non-breast/non-gastric solid tumors: a phase II basket trial with circulating tumor DNA analysis.
Ahn, JH; Chun, SM; Hong, YS; Hyung, J; Jang, JP; Jeon, S; Jeong, JH; Jun, HR; Jung, CK; Kim, J; Kim, JE; Kim, TW; Lee, JY; Yoo, C; Yoon, S, 2023
)
1.15
"Trastuzumab plus irinotecan or gemcitabine was safe and feasible for patients with previously treated HER2-positive advanced solid tumors with modest efficacy outcomes, and ctDNA analysis was useful for detecting HER2 amplification."( Safety and efficacy of trastuzumab biosimilar plus irinotecan or gemcitabine in patients with previously treated HER2 (ERBB2)-positive non-breast/non-gastric solid tumors: a phase II basket trial with circulating tumor DNA analysis.
Ahn, JH; Chun, SM; Hong, YS; Hyung, J; Jang, JP; Jeon, S; Jeong, JH; Jun, HR; Jung, CK; Kim, J; Kim, JE; Kim, TW; Lee, JY; Yoo, C; Yoon, S, 2023
)
1.43
" The PFS, ORR, and incidence of severe adverse events were comparable between the GS and GnP groups."( Efficacy and safety of gemcitabine plus S-1
Bai, C; Cheng, Y; Tang, H; Wang, X; Wang, Y; Ying, J; Zhu, Z, 2023
)
1.22
"Bevacizumab, Ovarian cancer, Platinum-based chemotherapy, Tolerability, Adverse clinical events."( Efficacy and Safety of Combined Chemotherapy Regimens with Bevacizumab in Platinum-sensitive Ovarian Cancers.
Ates, O; Buyukkor, M; Tay, F, 2023
)
0.91
" These toxic effects were further exacerbated with combination administration."( SIRT3-dependent mitochondrial redox homeostasis mitigates CHK1 inhibition combined with gemcitabine treatment induced cardiotoxicity in hiPSC-CMs and mice.
Bao, YL; Chen, JW; Du, C; Gu, AH; Gu, LF; Ji, Y; Jiang, QQ; Shan, TK; Sun, CQ; Wang, H; Wang, LS; Wang, QM; Wang, SB; Wei, TW; Xie, LP; Yang, TT; Zhou, LH, 2023
)
1.13
"Antineoplastic drugs are among the most toxic pharmaceuticals."( Hazard assessment of antineoplastic drugs and metabolites using cytotoxicity and genotoxicity assays.
Francisco, LFV; Gomes, INF; Klein, MO; Reis, RM; Serrano, SV; Silveira, HCS,
)
0.13

Pharmacokinetics

The anticancer potential of gemcitabine, a nucleoside analog, is compromised due to the enzymatic degradation into inactive form. A population pharmacokinetic model that included CDA genotypes was successfully constructed. The pharmacodynamic model developed provides a quantitative, mechanistic interpretation of gem citabine efficacy in 3 pancreatic cancer cell lines.

ExcerptReferenceRelevance
" The pharmacokinetic behavior of dFdC was compared with that of sera-C or BH-AC (N4-behenoyl ara-C) using experimental animals."( [Pharmacokinetic studies of dFdC (2',2'-difluorodeoxycytidine), ara-C and BH-AC (N4-behenoyl ara-C) in experimental animals].
Fujita, H; Okamoto, M, 1992
)
0.28
" Pharmacokinetic analysis showed that the initial tumor uptake of dFdC was flow limited, and a significant inverse correlation between the geometric FR and initial drug uptake was found."( Intratumor pharmacokinetics, flow resistance, and metabolism during gemcitabine infusion in ex vivo perfused human small cell lung cancer.
Brown, TJ; Jain, RK; Kristjansen, PE; Shipley, LA, 1996
)
0.53
"The long intracellular half-life of gemcitabine's active metabolite, difluorodeoxycytidine triphosphate (dFdCTP), suggested that small increases in peak intracellular dFdCTP levels would have a profound effect on its intracellular area under the curve (AUC)."( Clinical results of a pharmacodynamically-based strategy for higher dosing of gemcitabine in patients with solid tumors.
Abbruzzese, JL; Gravel, D; Plunkett, W; Raber, MN; Touroutoglou, N, 1998
)
0.8
"To determine possible schedule dependent pharmacokinetic and pharmacodynamic interactions between gemcitabine (2',2'-difluorodeoxycytidine, dFdC) and cisplatin (cis-diammine-dichloroplatinum, CDDP) in patients with advanced stage solid tumors in a phase I trial."( Pharmacokinetic schedule finding study of the combination of gemcitabine and cisplatin in patients with solid tumors.
Kroep, JR; Peters, GJ; Pinedo, HM; Postmus, PE; van der Vijgh, WJ; van Groeningen, CJ; van Moorsel, CJ; Veerman, G; Vermorken, JB; Voorn, DA, 1999
)
0.76
"To assess possible pharmacokinetic and pharmacodynamic interactions between gemcitabine and paclitaxel in a phase I/II study in non-small-cell lung cancer (NSCLC) patients."( Gemcitabine and paclitaxel: pharmacokinetic and pharmacodynamic interactions in patients with non-small-cell lung cancer.
Beijnen, JH; Giaccone, G; Kroep, JR; Peters, GJ; Pinedo, HM; Postmus, PE; Rosing, H; Smit, EF; van Groeningen, CJ; van Moorsel, CJ; Voorn, DA, 1999
)
1.98
" The aim of this phase II study was to determine the efficacy, toxicity, and pharmacokinetic profile of gemcitabine administered with doxorubicin as first-line treatment in patients with metastatic breast cancer."( Gemcitabine in combination with doxorubicin in advanced breast cancer: final results of a phase II pharmacokinetic trial.
Alba, E; García-Conde, J; Khayat, D; Lluch, A; Moreno-Nogueira, JA; Palomero, M; Pérez-Manga, G; Rivelles, N, 2000
)
1.96
" Blood samples were drawn on day 8 of cycles 1, 2, and 3 and of subsequent odd cycles for gemcitabine pharmacokinetic determinations and before and after the first dose of cycle 1 or 2 for doxorubicin determinations."( Gemcitabine in combination with doxorubicin in advanced breast cancer: final results of a phase II pharmacokinetic trial.
Alba, E; García-Conde, J; Khayat, D; Lluch, A; Moreno-Nogueira, JA; Palomero, M; Pérez-Manga, G; Rivelles, N, 2000
)
1.97
" There were no apparent pharmacokinetic differences among the three groups or compared with historical controls."( Phase I and pharmacokinetic trial of gemcitabine in patients with hepatic or renal dysfunction: Cancer and Leukemia Group B 9565.
Budman, D; Byrd, J; Egorin, MJ; Hawkins, M; Hohl, R; Hollis, D; Mani, S; Meropol, NJ; Ratain, MJ; Rosner, GL; Venook, AP, 2000
)
0.58
"To evaluate the maximum-tolerated dose, dose-limiting toxicities (DLTs), and pharmacokinetic profile of vesnarinone given once daily in combination with gemcitabine."( Phase I and pharmacokinetic study of the differentiating agent vesnarinone in combination with gemcitabine in patients with advanced cancer.
Drengler, RL; Eckhardt, SG; Felton, SA; Garner, AM; Hammond, LA; Hidalgo, M; Mallikaarjun, S; Patnaik, A; Rowinsky, EK; Siu, LL; Tammara, BK; Von Hoff, DD, 2000
)
0.72
" Pharmacokinetic studies of vesnarinone revealed significant interpatient variability at any given dose level."( Phase I and pharmacokinetic study of the differentiating agent vesnarinone in combination with gemcitabine in patients with advanced cancer.
Drengler, RL; Eckhardt, SG; Felton, SA; Garner, AM; Hammond, LA; Hidalgo, M; Mallikaarjun, S; Patnaik, A; Rowinsky, EK; Siu, LL; Tammara, BK; Von Hoff, DD, 2000
)
0.53
" There is no evidence of pharmacokinetic interaction between vesnarinone and gemcitabine."( Phase I and pharmacokinetic study of the differentiating agent vesnarinone in combination with gemcitabine in patients with advanced cancer.
Drengler, RL; Eckhardt, SG; Felton, SA; Garner, AM; Hammond, LA; Hidalgo, M; Mallikaarjun, S; Patnaik, A; Rowinsky, EK; Siu, LL; Tammara, BK; Von Hoff, DD, 2000
)
0.75
" Pharmacokinetic studies of gemcitabine have been performed in both adults and children but to date there have been no detailed studies of its penetration into cerebrospinal fluid (CSF)."( Plasma and cerebrospinal fluid pharmacokinetics of gemcitabine after intravenous administration in nonhuman primates.
Aleksic, A; Berg, SL; Blaney, S; Dauser, R; Egorin, MJ; Kerr, JZ; McGuffey, L; Nuchtern, J, 2001
)
0.86
"To determine the maximum tolerated duration of infusions at the fixed gemcitabine dose rate of 10 mg/m(2)/min and to analyze the pharmacodynamic actions in leukemia blasts during gemcitabine therapy."( Prolonged infusion of gemcitabine: clinical and pharmacodynamic studies during a phase I trial in relapsed acute myelogenous leukemia.
Ayres, M; Du, M; Estey, EH; Gandhi, V; Plunkett, W, 2002
)
0.86
" Pharmacokinetic and pharmacodynamic investigations were undertaken in circulating AML blasts."( Prolonged infusion of gemcitabine: clinical and pharmacodynamic studies during a phase I trial in relapsed acute myelogenous leukemia.
Ayres, M; Du, M; Estey, EH; Gandhi, V; Plunkett, W, 2002
)
0.63
" The favorable toxicity profile and pharmacokinetic and pharmacodynamic features warrant combination with DNA-damaging agents."( Prolonged infusion of gemcitabine: clinical and pharmacodynamic studies during a phase I trial in relapsed acute myelogenous leukemia.
Ayres, M; Du, M; Estey, EH; Gandhi, V; Plunkett, W, 2002
)
0.63
"Our results demonstrate a large pharmacokinetic advantage of intrathecal gemcitabine and support a planned Phase I clinical trial of this dosing strategy."( Pharmacokinetics of intrathecal gemcitabine in nonhuman primates.
Balis, FM; Berg, SL; Blaney, SM; Egorin, MJ; Kerr, JZ; McCully, CM; Zuhowski, EG, 2002
)
0.83
"The objectives of this study were to investigate the disposition of gemcitabine, epirubicin, paclitaxel, 2',2'-difluorodeoxyuridine and epirubicinol, and characterize the pharmacokinetic and pharmacodynamic profile of treatment in patients with breast cancer."( Gemcitabine, epirubicin and paclitaxel: pharmacokinetic and pharmacodynamic interactions in advanced breast cancer.
Conte, PF; Danesi, R; Del Tacca, M; Donati, S; Fogli, S; Gennari, A, 2002
)
1.99
"The aim of this study was to determine the toxicity profile, the recommended dose (RD) and the pharmacokinetic parameters, and to evaluate the antitumor activity of gemcitabine combined with oxaliplatin in patients with advanced non-small-cell lung cancer (NSCLC) and ovarian carcinoma (OC)."( Phase I-II and pharmacokinetic study of gemcitabine combined with oxaliplatin in patients with advanced non-small-cell lung cancer and ovarian carcinoma.
Armand, JP; Faivre, S; Kayitalire, L; Le Chevalier, T; Lhommé, C; Lokiec, F; Monnerat, C; Novello, S; Pautier, P; Raymond, E; Ruffié, P; Taieb, J, 2002
)
0.78
" The pharmacokinetic study revealed no significant interaction between the two drugs."( A dose-escalation and pharmacokinetic study of gemcitabine and oxaliplatin in patients with advanced solid tumors.
Agelaki, S; Androulakis, N; Georgoulias, V; Kakolyris, S; Kalbakis, K; Kouroussis, C; Marselos, M; Mavroudis, D; Nikolaidou, M; Pappas, P; Samonis, G; Souglakos, J; Vardakis, N, 2003
)
0.58
"For gemcitabine, the maximal plasma concentration, terminal half-life (t(1/2)) and area under the concentration-time curve (AUC) were similar to those reported for patients with normal renal function."( Pharmacokinetics of gemcitabine in a patient with end-stage renal disease: effective clearance of its main metabolite by standard hemodialysis treatment.
Ehninger, G; Franz, T; Gross, P; Haufe, T; Kiani, A; Köhne, CH; Passauer, J; Schleyer, E, 2003
)
1.2
" The pharmacokinetic data suggest that dose adjustment of gemcitabine should be avoided to ensure its full cytotoxic activity, and that hemodialysis treatment should be initiated 6-12 h after its administration to minimize the potential side effects of the metabolite dFdU."( Pharmacokinetics of gemcitabine in a patient with end-stage renal disease: effective clearance of its main metabolite by standard hemodialysis treatment.
Ehninger, G; Franz, T; Gross, P; Haufe, T; Kiani, A; Köhne, CH; Passauer, J; Schleyer, E, 2003
)
0.89
" We designed this pharmacokinetic study to assess the ability of a fixed dose rate of gemcitabine to achieve the desired steady-state concentration in the absence and presence of paclitaxel in patients with solid tumors."( Gemcitabine pharmacokinetics and interaction with paclitaxel in patients with advanced non-small-cell lung cancer.
Faucette, SR; Gillenwater, HH; Hawke, RL; Lindley, C; Pescatore, SL; Shord, SS; Socinski, MA, 2003
)
1.98
"Of 13 patients included in the pharmacokinetic analysis, 61% achieved the desired steady-state concentration (C(ss)) with gemcitabine alone (C1D1), whereas only 0 to 45% of patients achieved the desired C(ss) with paclitaxel and gemcitabine, depending on the treatment cycle."( Gemcitabine pharmacokinetics and interaction with paclitaxel in patients with advanced non-small-cell lung cancer.
Faucette, SR; Gillenwater, HH; Hawke, RL; Lindley, C; Pescatore, SL; Shord, SS; Socinski, MA, 2003
)
1.97
"Gemcitabine plasma pharmacokinetic parameters are significantly altered in the presence of paclitaxel."( Gemcitabine pharmacokinetics and interaction with paclitaxel in patients with advanced non-small-cell lung cancer.
Faucette, SR; Gillenwater, HH; Hawke, RL; Lindley, C; Pescatore, SL; Shord, SS; Socinski, MA, 2003
)
3.2
"To evaluate the pharmacokinetic parameters, efficacy and toxicity of a combination of gemcitabine (GEM) and vinorelbine (VNB) in recurrent heavily pre-treated squamous cell head and neck carcinoma."( Gemcitabine and vinorelbine in recurrent head and neck cancer: pharmacokinetic and clinical results.
Airoldi, M; Bumma, C; Cattel, L; Cortesina, G; Gabriele, P; Giordano, C; Novello, S; Passera, R; Pedani, F,
)
1.8
" Pharmacokinetic investigations were performed on 9 patients receiving GEM and VNB."( Gemcitabine and vinorelbine in recurrent head and neck cancer: pharmacokinetic and clinical results.
Airoldi, M; Bumma, C; Cattel, L; Cortesina, G; Gabriele, P; Giordano, C; Novello, S; Passera, R; Pedani, F,
)
1.57
" Vinorelbine serum levels showed no evidence of any pharmacokinetic interaction with GEM; most of all, no rebound in VNB disposition can be produced by GEM pre-administration."( Gemcitabine and vinorelbine in recurrent head and neck cancer: pharmacokinetic and clinical results.
Airoldi, M; Bumma, C; Cattel, L; Cortesina, G; Gabriele, P; Giordano, C; Novello, S; Passera, R; Pedani, F,
)
1.57
" Moreover, this drug association does not alter the pharmacokinetic profile of both drugs, also compared to GEM monotherapy."( Gemcitabine and vinorelbine in recurrent head and neck cancer: pharmacokinetic and clinical results.
Airoldi, M; Bumma, C; Cattel, L; Cortesina, G; Gabriele, P; Giordano, C; Novello, S; Passera, R; Pedani, F,
)
1.57
" We investigated the use of this agent administered intravesically in pigs for histological studies of the bladder and pharmacokinetic research."( Pharmacokinetics of intravesical gemcitabine: a preclinical study in pigs.
Peters, GJ; Schalken, JA; van der Heijden, AG; Vriesema, JL; Witjes, JA, 2003
)
0.6
" The study also sought to identify drug-drug pharmacokinetic interactions, evaluate effects on protein farnesylation, and seek preliminary evidence for clinical activity."( A phase I, pharmacokinetic, and biological study of the farnesyltransferase inhibitor tipifarnib in combination with gemcitabine in patients with advanced malignancies.
Eckhardt, SG; Gentner, L; Goetz, A; Hammond, LA; Izbicka, E; McCreery, H; Mori, M; Patnaik, A; Richards, H; Rowinsky, EK; Rybak, ME; Schwartz, G; Takimoto, CH; Terada, K; Tolcher, AA; Zhang, S, 2003
)
0.53
" To identify pharmacokinetic interactions, the treatment and plasma sampling schemes were designed to permit comparisons of the pharmacokinetic behavior of each agent administered alone and together."( A phase I, pharmacokinetic, and biological study of the farnesyltransferase inhibitor tipifarnib in combination with gemcitabine in patients with advanced malignancies.
Eckhardt, SG; Gentner, L; Goetz, A; Hammond, LA; Izbicka, E; McCreery, H; Mori, M; Patnaik, A; Richards, H; Rowinsky, EK; Rybak, ME; Schwartz, G; Takimoto, CH; Terada, K; Tolcher, AA; Zhang, S, 2003
)
0.53
" There was no evidence of clinically relevant pharmacokinetic interactions between tipifarnib and gemcitabine."( A phase I, pharmacokinetic, and biological study of the farnesyltransferase inhibitor tipifarnib in combination with gemcitabine in patients with advanced malignancies.
Eckhardt, SG; Gentner, L; Goetz, A; Hammond, LA; Izbicka, E; McCreery, H; Mori, M; Patnaik, A; Richards, H; Rowinsky, EK; Rybak, ME; Schwartz, G; Takimoto, CH; Terada, K; Tolcher, AA; Zhang, S, 2003
)
0.75
" We investigated the use of three dose levels of gemcitabine when given intravesically in humans for safety and pharmacokinetic research."( Intravesical gemcitabine: a phase 1 and pharmacokinetic study.
Laan, A; Peters, GJ; Schalken, JA; van der Heijden, AG; Vriesema, JL; Witjes, JA, 2004
)
0.95
" Plasma concentration data were pooled and analyzed using a population pharmacokinetic program (NONMEM)."( Gemcitabine in patients with solid tumors and renal impairment: a pharmacokinetic phase I study.
Delaloge, S; Di Palma, M; Forgue, ST; Le Chevalier, T; Llombart, A; Ni, L; Tourani, JM; Turpin, F, 2004
)
1.77
" Mean gemcitabine clearance and half-life values were 2140 mL/min/m(2) and 13."( Phase I trial and pharmacokinetics of gemcitabine in children with advanced solid tumors.
Ames, MM; Holcenberg, J; Krailo, MD; Kuttesch, J; Qu, W; Reid, JM; Safgren, SL; Seibel, NL, 2004
)
1.08
"In this phase I study we determined the pharmacokinetic and toxicity profiles of a single intravesical instillation of gemcitabine administered immediately after complete transurethral resection (TUR) plus multiple random biopsies."( Phase I pharmacokinetic study of a single intravesical instillation of gemcitabine administered immediately after transurethral resection plus multiple random biopsies in patients with superficial bladder cancer.
Carcas, A; Duque, B; Garcia-Ribas, I; Palou, J; Salvador, J; Segarra, J; Villavicencio, H, 2004
)
0.77
" The favorable toxicity and pharmacokinetic profiles of intravesical gemcitabine support future phase II studies with this agent."( Phase I pharmacokinetic study of a single intravesical instillation of gemcitabine administered immediately after transurethral resection plus multiple random biopsies in patients with superficial bladder cancer.
Carcas, A; Duque, B; Garcia-Ribas, I; Palou, J; Salvador, J; Segarra, J; Villavicencio, H, 2004
)
0.79
"To investigate a possible pharmacokinetic interaction between gemcitabine (GEM) and vinorelbine (VNR), when co-administered following the alternate sequences GEM-VNR and VNR-GEM."( Gemcitabine plus vinorelbine chemotherapy regimens: a pharmacokinetic study of alternate administration sequences.
Airoldi, M; Cagliero, E; Cattel, L; Goffredo, F; Passera, R; Stella, B, 2004
)
2.01
"GEM serum levels showed higher Cmax and AUC(tot) in the VNR-GEM protocol than in the GEM-VNR and GEM groups."( Gemcitabine plus vinorelbine chemotherapy regimens: a pharmacokinetic study of alternate administration sequences.
Airoldi, M; Cagliero, E; Cattel, L; Goffredo, F; Passera, R; Stella, B, 2004
)
1.77
" Pharmacokinetic analyses of plasma gemcitabine and pemetrexed concentrations were performed."( A phase IB study of the pharmacokinetics of gemcitabine and pemetrexed, when administered in rapid sequence to patients with advanced solid tumors.
Adjei, AA; Alberts, SR; Atherton, PJ; Burch, PA; Dy, GK; Erlichman, C; Goldberg, RM; Hanson, LJ; Pitot, HC; Reid, JM; Rubin, J; Sloan, JA; Suri, A, 2005
)
0.86
" There was no pharmacokinetic interaction between the two drugs."( A phase IB study of the pharmacokinetics of gemcitabine and pemetrexed, when administered in rapid sequence to patients with advanced solid tumors.
Adjei, AA; Alberts, SR; Atherton, PJ; Burch, PA; Dy, GK; Erlichman, C; Goldberg, RM; Hanson, LJ; Pitot, HC; Reid, JM; Rubin, J; Sloan, JA; Suri, A, 2005
)
0.59
" 3P97 Pharmaceutical Kinetics Software was used for the calculation of pharmacokinetic parameters."( Pharmacokinetics of gemcitabine in Chinese patients with non-small-cell lung cancer.
Cai, J; Huang, MZ; Liu, J; Shentu, JZ; Wang, LR; Xu, N, 2005
)
0.65
" Pharmacokinetic analysis was performed after the first (= MONO) and after the third gemcitabine infusion (= TMAB)."( Pharmacokinetics of gemcitabine combined with trastuzumab in patients with advanced breast cancer.
Czejka, M; Heinz, D; Muric, L; Ostermann, E; Schueller, J, 2005
)
0.88
"2 min (TMAB) reaching a mean peak concentration of 35."( Pharmacokinetics of gemcitabine combined with trastuzumab in patients with advanced breast cancer.
Czejka, M; Heinz, D; Muric, L; Ostermann, E; Schueller, J, 2005
)
0.65
" Venous blood samples at different time intervals were taken throughout 270 minutes for pharmacokinetic analyses of gemcitabine and its inactive metabolite 2'-2'-difluorodeoxyuridine (dFdU)."( Comparative pharmacokinetics and metabolic pathway of gemcitabine during intravenous and intra-arterial delivery in unresectable pancreatic cancer patients.
Abbas, J; Al-Kutoubi, A; Bikhazi, AB; Chehal, AA; Habbal, MZ; Khalifeh, MJ; Malaeb, LA; Mourad, FH; Shamseddine, AI, 2005
)
0.79
" The aim of the study was to determine the pharmacokinetic profile of gemcitabine, administered intravesically in patients with carcinoma in situ(CIS)."( Pharmacokinetic study of intravesical gemcitabine in carcinoma in situ of the bladder refractory to bacillus Calmette-Guérin therapy.
Bassi, P; Crucitta, E; Dal Moro, F; De Marco, V; Longo, F; Marini, L; Pinto, F; Tavolini, IM; Zucchetti, M, 2005
)
0.83
" No pharmacokinetic interaction between oxaliplatin and gemcitabine was detected."( A phase 1 and pharmacokinetic study of gemcitabine and oxaliplatin in patients with solid tumors.
Cebon, J; Davis, ID; de Souza, P; Galettis, P; Gan, HK; Links, M; Mitchell, PL, 2006
)
0.85
" This study revealed no significant pharmacokinetic interaction between the 2 drugs in the GEM-OXA or in the OXA-GEM sequence."( Gemcitabine and oxaliplatin in patients with pancreatic adenocarcinoma: clinical and pharmacokinetic data.
Airoldi, M; Cattel, L; Milla, P; Passera, R; Pedani, F; Zanon, C, 2006
)
1.78
"The combination of GEM and OXA was well tolerated and showed a promising activity in patients with advanced pancreatic adenocarcinoma; no sequence-dependent pharmacokinetic interaction occurred when comparing the GEM-OXA versus the OXA-GEM sequence, with a 24-hour interval."( Gemcitabine and oxaliplatin in patients with pancreatic adenocarcinoma: clinical and pharmacokinetic data.
Airoldi, M; Cattel, L; Milla, P; Passera, R; Pedani, F; Zanon, C, 2006
)
1.78
" Furthermore, the intracellular accumulation of the active metabolite gemcitabine triphosphate, as a surrogate pharmacodynamic endpoint, was also determined in vitro in canine melanoma cells."( Pharmacokinetics of gemcitabine and its primary metabolite in dogs after intravenous bolus dosing and its in vitro pharmacodynamics.
Freise, KJ; Martín-Jiménez, T, 2006
)
0.89
" No clinically significant pharmacokinetic interactions between ABT-510, gemcitabine and platinum were observed."( A phase I study assessing the safety and pharmacokinetics of the thrombospondin-1-mimetic angiogenesis inhibitor ABT-510 with gemcitabine and cisplatin in patients with solid tumors.
Carr, RA; de Vos, FY; Eskens, FA; Gietema, JA; Groen, HJ; Hoekstra, R; Humerickhouse, RA; Knight, RA; Loos, WJ; Uges, DR; van der Gaast, A, 2006
)
0.77
" Pharmacokinetic interactions were not observed and adding ABT-510 does not appear to increase toxicity."( A phase I study assessing the safety and pharmacokinetics of the thrombospondin-1-mimetic angiogenesis inhibitor ABT-510 with gemcitabine and cisplatin in patients with solid tumors.
Carr, RA; de Vos, FY; Eskens, FA; Gietema, JA; Groen, HJ; Hoekstra, R; Humerickhouse, RA; Knight, RA; Loos, WJ; Uges, DR; van der Gaast, A, 2006
)
0.54
" Herein we provide the preclinical and clinical rationale for studies examining the concept of pharmacodynamic separation as a means for overcoming hypothesized antagonism of EGFR TKIs and chemotherapy."( Pharmacodynamic separation of epidermal growth factor receptor tyrosine kinase inhibitors and chemotherapy in non-small-cell lung cancer.
Davies, AM; Gandara, DR; Gumerlock, PH; Ho, C; Lara, PN; Mack, P, 2006
)
0.33
"Twenty patients were enrolled for both pharmacokinetic and clinical studies."( Pharmacokinetic evaluation of gemcitabine and 2',2'-difluorodeoxycytidine-5'-triphosphate after prolonged infusion in patients affected by different solid tumors.
Airoldi, M; Cattel, L; Delprino, L; Milla, P; Passera, R; Pedani, F, 2006
)
0.62
" Possible pharmacokinetic interactions were studied in 10 patients, by administering on cycle 1 gemcitabine d1/oxaliplatin d2 (GEM-OXA) and on cycle 2 oxaliplatin d1/gemcitabine d2 (OXA-GEM)."( Gemcitabine and oxaliplatin in patients with metastatic breast cancer resistant to or pretreated with both anthracyclines and taxanes: clinical and pharmacokinetic data.
Airoldi, M; Cattel, L; Delprino, L; Micari, C; Passera, R; Pedani, F, 2006
)
1.99
" The GEM-OXA and OXA-GEM schedules showed a similar pharmacokinetic behavior, with no sequence-dependent interaction."( Gemcitabine and oxaliplatin in patients with metastatic breast cancer resistant to or pretreated with both anthracyclines and taxanes: clinical and pharmacokinetic data.
Airoldi, M; Cattel, L; Delprino, L; Micari, C; Passera, R; Pedani, F, 2006
)
1.78
"The combination gemcitabine plus oxaliplatin has moderate activity in anthracycline and taxanes resistant/relapsed heavily treated patients, mild toxicity and no administration sequence-dependent pharmacokinetic interactions."( Gemcitabine and oxaliplatin in patients with metastatic breast cancer resistant to or pretreated with both anthracyclines and taxanes: clinical and pharmacokinetic data.
Airoldi, M; Cattel, L; Delprino, L; Micari, C; Passera, R; Pedani, F, 2006
)
2.12
"We investigated the possible pharmacokinetic interactions of gemcitabine and oxaliplatin in patients with advanced solid tumors."( Coadministration of oxaliplatin does not influence the pharmacokinetics of gemcitabine.
Georgoulias, V; Marselos, M; Mavroudis, D; Nikolaidou, M; Pappas, P, 2006
)
0.81
" Pharmacokinetic parameters of gemcitabine and plasma CDA activities significantly depended on the number of haplotype *3."( Pharmacokinetics of gemcitabine in Japanese cancer patients: the impact of a cytidine deaminase polymorphism.
Furuse, J; Hasegawa, R; Ishii, H; Kamatani, N; Kaniwa, N; Kikura-Hanajiri, R; Kim, SR; Maekawa, K; Okusaka, T; Ozawa, S; Saijo, N; Saito, Y; Sawada, J; Sugiyama, E; Ueno, H; Yoshida, T, 2007
)
0.95
"To improve the pharmacokinetic behavior and the antitumor activity of the drug, the gemcitabine prodrug, 4-(N)-stearoylgemcitabine (C18gem) was incorporated in liposomes and both the pharmacokinetic and the in vivo activity of this formulation intravenously or peritumorally administered in nude female CR1:Nu/Nu(CD-1)BR mice grafted with HT-29 and KB 396p cells were studied."( Antitumor activity and pharmacokinetics of liposomes containing lipophilic gemcitabine prodrugs.
Brusa, P; Cattel, L; Immordino, ML; Rocco, F,
)
0.59
" However, the pharmacokinetic behavior of gemcitabine in the central nervous system, especially in brain tumors is currently not well understood."( Pharmacokinetics of gemcitabine in tumor and non-tumor extracellular fluid of brain: an in vivo assessment in rats employing intracerebral microdialysis.
Apparaju, SK; Desai, PB; Gudelsky, GA, 2008
)
0.93
" DLTs and pharmacokinetic (PK) parameters of all drugs were determined during the first cycle of treatment."( A dose escalation and pharmacokinetic study of biweekly pegylated liposomal doxorubicin, paclitaxel and gemcitabine in patients with advanced solid tumours.
Agelaki, S; Androulakis, N; Bozionelou, V; Georgoulias, V; Giassas, S; Kalykaki, A; Kentepozidis, N; Marselos, M; Mavroudis, D; Nikolaidou, M; Pappas, P; Vamvakas, L, 2007
)
0.55
" Circulating endothelial cell numbers and CD146 and CD133 mRNA expression were evaluated as pharmacodynamic markers."( Phase I pharmacokinetic and pharmacodynamic study of the oral protein kinase C beta-inhibitor enzastaurin in combination with gemcitabine and cisplatin in patients with advanced cancer.
Beerepoot, LV; Beijnen, JH; Enas, N; Mehra, N; Musib, L; Radema, SA; Rademaker-Lakhai, JM; Schellens, JH; van Hal, G; van Maanen, R; Vermaat, JS; Visseren-Grul, CM; Voest, EE; Witteveen, EO, 2007
)
0.55
" This regimen is well tolerated with no significant alterations in the pharmacokinetic variables of any drug."( Phase I pharmacokinetic and pharmacodynamic study of the oral protein kinase C beta-inhibitor enzastaurin in combination with gemcitabine and cisplatin in patients with advanced cancer.
Beerepoot, LV; Beijnen, JH; Enas, N; Mehra, N; Musib, L; Radema, SA; Rademaker-Lakhai, JM; Schellens, JH; van Hal, G; van Maanen, R; Vermaat, JS; Visseren-Grul, CM; Voest, EE; Witteveen, EO, 2007
)
0.55
" The relationships between pharmacokinetic parameters and hematological adverse effects, as well as pharmacological effects, were examined."( Pharmacokinetics and pharmacodynamics of paclitaxel with carboplatin or gemcitabine, and effects of CYP3A5 and MDR1 polymorphisms in patients with urogenital cancers.
Inui, K; Ito, N; Jiko, M; Kamoto, T; Masuda, S; Motohashi, H; Nakamura, E; Ogawa, O; Okuda, M; Sato, E; Segawa, T; Takahashi, K; Yano, I, 2007
)
0.57
"To investigate the relationship between peak concentration (Cmax) of gemcitabine at fixed-dose-rate and its hematological toxicity profile in patients with advanced non-small-cell lung cancer (NSCLC)."( [Peak concentration of gemcitabine at fixed-dose-rate and its hematological toxicity profile].
Huang, MZ; Wang, LR; Zhang, GB, 2007
)
0.88
"The mean value of Cmax in 21 eligible patients was(4."( [Peak concentration of gemcitabine at fixed-dose-rate and its hematological toxicity profile].
Huang, MZ; Wang, LR; Zhang, GB, 2007
)
0.65
"The results of relationship between Cmax and toxicity profile suggest that gemcitabine administration should be individualized in order to decrease the occurrence of ADR."( [Peak concentration of gemcitabine at fixed-dose-rate and its hematological toxicity profile].
Huang, MZ; Wang, LR; Zhang, GB, 2007
)
0.88
" Limited pharmacokinetic data did not suggest any clinically relevant pharmacological influence of 3-AP on gemcitabine."( A multicenter phase II trial of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP, Triapine) and gemcitabine in advanced non-small-cell lung cancer with pharmacokinetic evaluation using peripheral blood mononuclear cells.
Chan, AT; Goh, BC; Lam, KC; Leong, SS; Ma, B; Mo, F; Mok, T; Soo, R; Tan, EH; Wang, LZ; Zee, B, 2008
)
0.77
"Gemcitabine and dfdu plasma concentration-time and clinical data from 94 patients with cancer and nonlinear mixed effect modelling were used to characterize gemcitabine and metabolite pharmacokinetic variability and identify influential covariates."( Population pharmacokinetics of gemcitabine and its metabolite in patients with cancer: effect of oxaliplatin and infusion rate.
Galettis, P; Jiang, X; Links, M; McLachlan, AJ; Mitchell, PL, 2008
)
2.07
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" Herein, this paper brings comprehensive pharmacokinetic and biodistribution insights that may explain the previously observed greater efficacy of SQdFdC nanoassemblies against experimental leukemia."( Squalenoylation favorably modifies the in vivo pharmacokinetics and biodistribution of gemcitabine in mice.
Besnard, M; Chacun, H; Cintrat, JC; Couvreur, P; Declèves, X; Deroussent, A; Desmaële, D; Dubernet, C; Ferreira, H; Khoury, H; Laugier, C; Lepêtre-Mouelhi, S; Paci, A; Reddy, LH; Rousseau, B; Vassal, G, 2008
)
0.57
"This tumor response pharmacodynamic model aims to describe primary lesion shrinkage in non-small cell lung cancer over time and determine if concentration-based exposure metrics for gemcitabine or that of its metabolites, 2',2'-difluorodeoxyuridine or gemcitabine triphosphate, are better than gemcitabine dose for prediction of individual response."( A pharmacodynamic model for the time course of tumor shrinkage by gemcitabine + carboplatin in non-small cell lung cancer patients.
Goh, BC; Holford, NH; Lee, HS; Lee, SC; Soo, RA; Tham, LS; Wang, L; Yong, WP, 2008
)
0.77
" In conclusion, treatment with motesanib plus gemcitabine was well tolerated, with adverse event and pharmacokinetic profiles similar to that observed in monotherapy studies."( Safety and pharmacokinetics of motesanib in combination with gemcitabine for the treatment of patients with solid tumours.
Lipton, L; McCoy, S; McGreivy, J; Price, TJ; Rosenthal, MA; Sun, YN, 2008
)
0.85
" All patients were assessable for toxicity and pharmacokinetic analysis."( Pharmacokinetics of gemcitabine at fixed-dose rate infusion in patients with normal and impaired hepatic function.
Citro, G; Cognetti, F; Colantonio, S; Contestabile, M; Di Segni, S; Felici, A; Milella, M; Nuvoli, B; Sacconi, A; Sperduti, I; Zaratti, M, 2009
)
0.68
" No pharmacokinetic drug interactions were detected."( A dose escalation and pharmacokinetic study of the biweekly administration of paclitaxel, gemcitabine and oxaliplatin in patients with advanced solid tumors.
Georgoulias, V; Kotsakis, A; Marselos, M; Mavroudis, D; Nikolaidou, M; Pappas, P; Saridaki, Z; Souglakos, J; Vardakis, N, 2009
)
0.57
" Since the measurement of mRNA expression requires a very small amount of biopsy tissue and is highly quantitative, the development of a pharmacodynamic (PD) biomarker leveraging mRNA expression is eagerly anticipated in order to estimate target engagement of anti-cancer agents."( Discovery of gene expression-based pharmacodynamic biomarker for a p53 context-specific anti-tumor drug Wee1 inhibitor.
Arai, T; Hirai, H; Itadani, H; Kotani, H; Mizuarai, S; Nishibata, T; Yamanaka, K, 2009
)
0.35
" On day 1 or day 8 of the first cycle, patients received one administration by 24-h intravenous infusion for pharmacokinetic comparison and to determine hepatic extraction."( A phase I and pharmacokinetic study of gemcitabine given by 24-h hepatic arterial infusion.
Giaccone, G; Honeywell, RJ; Laan, AC; Mammatas, LH; Peters, GJ; Ruyter, R; van den Berg, FG; van Groeningen, CJ; van Riel, JM, 2009
)
0.62
" Pharmacokinetic analysis showed a significantly lower maximum gemcitabine plasma concentration (C(max): HAI, 26, 80 and 128 nM, respectively; IV, 229, 264 and 293 nM, respectively) and area under the plasma-concentration-versus-time curve (AUC(0-24h): HAI, 386, 1247 and 2033 nmol x h/L, respectively; IV, 3526, 4818 and 5363 nmol x h/L, respectively) during HAI, compared with intravenous infusion (both P<0."( A phase I and pharmacokinetic study of gemcitabine given by 24-h hepatic arterial infusion.
Giaccone, G; Honeywell, RJ; Laan, AC; Mammatas, LH; Peters, GJ; Ruyter, R; van den Berg, FG; van Groeningen, CJ; van Riel, JM, 2009
)
0.86
"Although some studies have suggested that gemcitabine delivered as a fixed dose rate (FDR) infusion of 10 mg/m(2)/min could be more effective than when administered as the standard 30-min infusion, the available pharmacokinetic data are still too limited to draw definitive conclusions."( Pharmacokinetic study of gemcitabine, given as prolonged infusion at fixed dose rate, in combination with cisplatin in patients with advanced non-small-cell lung cancer.
Caffo, O; Cassetta, MI; Fallani, S; Galligioni, E; Marangon, E; Mini, E; Murgia, V; Nobili, S; Novelli, A; Sala, F; Zucchetti, M, 2010
)
0.93
" Plasmatic and intracellular pharmacokinetic analyses were performed on blood samples collected at defined time points before, during and after gemcitabine infusion."( Pharmacokinetic study of gemcitabine, given as prolonged infusion at fixed dose rate, in combination with cisplatin in patients with advanced non-small-cell lung cancer.
Caffo, O; Cassetta, MI; Fallani, S; Galligioni, E; Marangon, E; Mini, E; Murgia, V; Nobili, S; Novelli, A; Sala, F; Zucchetti, M, 2010
)
0.86
"The plasmatic pharmacokinetic parameters were clearly different when the patients received a higher gemcitabine dose in the second cycle compared to the lower dose of the first course; in the same time, the intracellular drug levels were not modified."( Pharmacokinetic study of gemcitabine, given as prolonged infusion at fixed dose rate, in combination with cisplatin in patients with advanced non-small-cell lung cancer.
Caffo, O; Cassetta, MI; Fallani, S; Galligioni, E; Marangon, E; Mini, E; Murgia, V; Nobili, S; Novelli, A; Sala, F; Zucchetti, M, 2010
)
0.88
"The maximum concentration (Cmax), the area under the curve from the drug administration to the infinite time (AUCinf), and the elimination half-life (T1/2) of GEM were not significantly different between GEM administration with and without S-1."( Plasma pharmacokinetics after combined therapy of gemcitabine and oral S-1 for unresectable pancreatic cancer.
Amano, R; Hirakawa, K; Hirakawa, T; Nakao, S; Nakata, B; Okita, Y; Shinto, O; Tamura, T; Yamada, N, 2010
)
0.61
" The investigation of the carrier biodistribution and the drug pharmacokinetic profile furnished the rationalization of the efficacy of the vesicular system containing the active compound 10-fold less concentrated; in fact, liposomes promoted the concentration of the drug inside the tumor and they increased its plasmatic half-life."( Gemcitabine-loaded PEGylated unilamellar liposomes vs GEMZAR: biodistribution, pharmacokinetic features and in vivo antitumor activity.
Celia, C; Cosco, D; Costante, G; Filetti, S; Fresta, M; Iannone, M; Paolino, D; Puxeddu, E; Racanicchi, L; Russo, D; Trapasso, E, 2010
)
1.8
" Plasma and urine pharmacokinetic parameters were calculated non-compartmentally and compartmentally."( Plasma pharmacokinetics and oral bioavailability of the 3,4,5,6-tetrahydrouridine (THU) prodrug, triacetyl-THU (taTHU), in mice.
Ames, MM; Bai, L; Beumer, JH; Clausen, DM; Covey, JM; D'Argenio, DZ; Egorin, MJ; Eiseman, JL; Gilbert, JA; Hershberger, PA; Holleran, JL; Parise, RA; Yellow-Duke, AE, 2011
)
0.37
"To assess in a phase II pharmacokinetic study whether different pH levels, dilution volumes and exposure times affect intracellular bioavailability and systemic absorption of gemcitabine."( Pharmacokinetic study to optimize the intravesical administration of gemcitabine.
Berta, G; Carbone, F; Cattel, L; Fiorito, C; Gontero, P; Medana, C; Milla, P; Paone, TC; Tizzani, A, 2010
)
0.79
" Genetic polymorphisms of DCK and SLC29A1 (hENT1) had no significant correlation with gemcitabine pharmacokinetic parameters."( Population pharmacokinetics of gemcitabine and its metabolite in Japanese cancer patients: impact of genetic polymorphisms.
Furuse, J; Hasegawa, R; Ikeda, M; Ishii, H; Kaniwa, N; Kim, SR; Kondo, S; Morizane, C; Okusaka, T; Saijo, N; Saito, Y; Sawada, J; Sugiyama, E; Tamura, T; Ueno, H; Yamamoto, N; Yoshida, T, 2010
)
0.87
"A population pharmacokinetic model that included CDA genotypes as a covariate for gemcitabine and dFdU in Japanese cancer patients was successfully constructed."( Population pharmacokinetics of gemcitabine and its metabolite in Japanese cancer patients: impact of genetic polymorphisms.
Furuse, J; Hasegawa, R; Ikeda, M; Ishii, H; Kaniwa, N; Kim, SR; Kondo, S; Morizane, C; Okusaka, T; Saijo, N; Saito, Y; Sawada, J; Sugiyama, E; Tamura, T; Ueno, H; Yamamoto, N; Yoshida, T, 2010
)
0.87
" Plasma concentrations of GEM and dFdU were measured and individual pharmacokinetic profiles were determined."( Equilibrative nucleoside transporter 1 genotype, cytidine deaminase activity and age predict gemcitabine plasma clearance in patients with solid tumours.
Barile, C; Bolzonella, C; Bononi, A; Crepaldi, G; Gusella, M; Meneghetti, S; Menon, D; Modena, Y; Padrini, R; Pasini, F; Stievano, L; Toso, S, 2011
)
0.59
" To maximize the likelihood of their clinical success, it is essential to optimize drug scheduling as well as pharmacodynamic biomarkers in preclinical models."( Assessment of chk1 phosphorylation as a pharmacodynamic biomarker of chk1 inhibition.
Arumugarajah, S; Brown, JL; Gross, M; Hassan, MC; Hylander-Gans, L; Lawrence, TS; Maybaum, J; Morgan, MA; Morosini, D; Parsels, JD; Parsels, LA; Qian, Y; Simeone, DM; Tanska, DM; Zabludoff, SD; Zhao, L, 2011
)
0.37
" Potential pharmacodynamic biomarkers including pChk1, pChk2, pHistone H3, and caspase-3 were evaluated in vitro, followed by assessment of promising candidate biomarkers in vivo."( Assessment of chk1 phosphorylation as a pharmacodynamic biomarker of chk1 inhibition.
Arumugarajah, S; Brown, JL; Gross, M; Hassan, MC; Hylander-Gans, L; Lawrence, TS; Maybaum, J; Morgan, MA; Morosini, D; Parsels, JD; Parsels, LA; Qian, Y; Simeone, DM; Tanska, DM; Zabludoff, SD; Zhao, L, 2011
)
0.37
"A phase I and pharmacokinetic study was conducted to determine the maximum tolerated dose and to establish the recommended dose of vinflunine (VFL) administered on day 1 every 21 days combined with gemcitabine given on days 1 and 8 every 3 weeks."( Phase I and pharmacokinetic study of IV vinflunine in combination with gemcitabine for treatment of advanced non-small cell lung cancer in Chemonaive patients.
Bennouna, J; Favrel, S; Lemarie, E; Pinel, MC; Pouget, JC; Senellart, H; Tourani, JM; Tournoux-Facon, C, 2011
)
0.79
"To develop and internally validate a population pharmacokinetic model for gemcitabine and its metabolite 2',2'-difluorodeoxyuridine (dFdU); and to evaluate its predictive perfomance for personalizing the dosage used in cancer patients."( [Population pharmacokinetics of gemcitabine applied to personalize the dosage used in cancer patients].
Duart-Duart, MJ; Escudero-Ortiz, V; Pérez-Ruixo, JJ; Ramón-López, A; Valenzuela, B,
)
0.65
" A 2-compartment pharmacokinetic model was implemented in the NONMEN VI program to determine the appropriate pharmacokinetic parameters."( [Population pharmacokinetics of gemcitabine applied to personalize the dosage used in cancer patients].
Duart-Duart, MJ; Escudero-Ortiz, V; Pérez-Ruixo, JJ; Ramón-López, A; Valenzuela, B,
)
0.41
" Internal validation confirmed that the population pharmacokinetic model was appropriate for describing the plasma concentrations of gemcitabine and dFdU over time, as well as its variability in the study population."( [Population pharmacokinetics of gemcitabine applied to personalize the dosage used in cancer patients].
Duart-Duart, MJ; Escudero-Ortiz, V; Pérez-Ruixo, JJ; Ramón-López, A; Valenzuela, B,
)
0.62
"The population pharmacokinetic model adequately characterised the gemcitabine and dFdU plasma concentrations in the study population over time, and can be used to accurately and precisely optimise gemcitabine dosing regimens in cancer patients."( [Population pharmacokinetics of gemcitabine applied to personalize the dosage used in cancer patients].
Duart-Duart, MJ; Escudero-Ortiz, V; Pérez-Ruixo, JJ; Ramón-López, A; Valenzuela, B,
)
0.65
" The pharmacodynamic model adequately predicted the observed data."( Pharmacodynamic modeling of sequence-dependent antitumor activity of insulin-like growth factor blockade and gemcitabine.
Brundage, RC; Hull, JM; Khatri, A; Kirstein, MN; Williams, BW; Yee, D, 2012
)
0.59
" In this paper, we deal with the inference of a pharmacokinetic network from the concentrations of the drug and its metabolites observed at discrete time points."( Inferring biochemical reaction pathways: the case of the gemcitabine pharmacokinetics.
Casagrande, A; Fantaccini, G; Lecca, P; Morpurgo, D; Priami, C, 2012
)
0.62
"The aim of this study was to evaluate the association of gemcitabine pathway SNPs with detailed pharmacokinetic measures obtained from solid tumor patients receiving gemcitabine-based therapy."( Pathway-based pharmacogenomics of gemcitabine pharmacokinetics in patients with solid tumors.
Dudek, AZ; Greeno, EW; Khatri, A; Kirstein, MN; Kratzke, RA; Lamba, JK; Mitra, AK; Skubitz, KM, 2012
)
0.9
" Therefore, we suggest that human skin equivalents could represent a promising tool for the identification and validation of novel pharmacodynamic biomarkers."( Skin equivalents: a tool for the discovery and validation of pharmacodynamic biomarkers.
Failla, CM; Gallinari, P; Orecchia, A; Paolini, C; Steinkühler, C; Zambruno, G, 2013
)
0.39
" Pharmacodynamic activity of A(1-7) in platelet production and retention of scheduled dose intensity were also determined."( Pharmacodynamic stimulation of thrombogenesis by angiotensin (1-7) in recurrent ovarian cancer patients receiving gemcitabine and platinum-based chemotherapy.
Cruickshank, S; Delmore, JE; diZerega, GS; Drummond, L; Peterson, KJ; Pham, H; Reed, E; Rodgers, KE; Schwartz, BM, 2013
)
0.6
"A 100 mcg/kg dose of A(1-7) was shown to produce pharmacodynamic effects on peripheral blood platelet counts, preserve planned dose intensity, and reduce Grade 3-4 thrombocytopenia following gemcitabine and platinum chemotherapy."( Pharmacodynamic stimulation of thrombogenesis by angiotensin (1-7) in recurrent ovarian cancer patients receiving gemcitabine and platinum-based chemotherapy.
Cruickshank, S; Delmore, JE; diZerega, GS; Drummond, L; Peterson, KJ; Pham, H; Reed, E; Rodgers, KE; Schwartz, BM, 2013
)
0.79
"This phase I study of fixed dose rate (FDR) gemcitabine and carboplatin assessed the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), safety, pharmacokinetic (PK)/pharmacodynamic (PD) profile and preliminary anti-tumor activity in patients with recurrent ovarian cancer (OC)."( Phase I dose-escalation study and population pharmacokinetic analysis of fixed dose rate gemcitabine plus carboplatin as second-line therapy in patients with ovarian cancer.
Beijnen, JH; Huitema, AD; Leijen, S; Schellens, JH; van Werkhoven, E; Veltkamp, SA, 2013
)
0.87
" Population pharmacokinetic modeling and simulation were performed to further investigate the optimal schedule."( Phase I dose-escalation study and population pharmacokinetic analysis of fixed dose rate gemcitabine plus carboplatin as second-line therapy in patients with ovarian cancer.
Beijnen, JH; Huitema, AD; Leijen, S; Schellens, JH; van Werkhoven, E; Veltkamp, SA, 2013
)
0.61
" Six of the eight pharmacodynamic parameters assume the same value as in the corresponding single drug models."( A predictive pharmacokinetic-pharmacodynamic model of tumor growth kinetics in xenograft mice after administration of anticancer agents given in combination.
Del Bene, F; Germani, M; Magni, P; Terranova, N, 2013
)
0.39
" To provide a quantitative framework for characterizing the cell cycle and apoptotic effects of gemcitabine, we developed a pharmacodynamic model in which the activation of cell cycle checkpoints or cell death is dependent on gemcitabine exposure."( Pharmacodynamic modeling of cell cycle and apoptotic effects of gemcitabine on pancreatic adenocarcinoma cells.
Hamed, SS; Jusko, WJ; Straubinger, RM, 2013
)
0.85
"The pharmacodynamic model developed provides a quantitative, mechanistic interpretation of gemcitabine efficacy in 3 pancreatic cancer cell lines, and provides useful insights for rational selection of chemotherapeutic agents for combination therapy."( Pharmacodynamic modeling of cell cycle and apoptotic effects of gemcitabine on pancreatic adenocarcinoma cells.
Hamed, SS; Jusko, WJ; Straubinger, RM, 2013
)
0.85
" Thus, we investigated the growth-inhibitory potential of nemorosone on pancreatic cancer xenografts in NMRI nu/nu mice and determined basic pharmacokinetic parameters."( In vivo activity and pharmacokinetics of nemorosone on pancreatic cancer xenografts.
Hilger, RA; Hoheisel, JD; Holtrup, F; Werner, J; Wolf, RJ, 2013
)
0.39
" Selected conjugates were efficacious in the in vitro assays with one of them, namely, GSG, displaying high antiproliferative activity in CaP cell lines along with significant metabolic and pharmacokinetic advantages in comparison to gemcitabine."( GnRH-Gemcitabine conjugates for the treatment of androgen-independent prostate cancer: pharmacokinetic enhancements combined with targeted drug delivery.
Argyros, O; Fokas, D; Karampelas, T; Kolios, G; Liapakis, G; Millar, RP; Morgan, K; Pappas, C; Sayyad, N; Spyridaki, K; Tamvakopoulos, C; Tzakos, AG, 2014
)
1.1
"To define the safety, efficacy, and pharmacogenetic and pharmacodynamic effects of sorafenib with gemcitabine-based chemoradiotherapy (CRT) in locally advanced pancreatic cancer."( Phase 1 pharmacogenetic and pharmacodynamic study of sorafenib with concurrent radiation therapy and gemcitabine in locally advanced unresectable pancreatic cancer.
Akisik, FM; Anderson, S; Bu, G; Cardenes, HR; Chiorean, EG; Clark, R; Deluca, J; DeWitt, J; Helft, P; Johnson, CS; Johnston, EL; Loehrer, PJ; Perkins, SM; Sandrasegaran, K; Schneider, BP; Shahda, S; Spittler, AJ, 2014
)
0.84
" No apparent pharmacokinetic drug-drug interaction was observed."( Safety, tolerability, pharmacokinetics and antitumor activity of ganitumab, an investigational fully human monoclonal antibody to insulin-like growth factor type 1 receptor, combined with gemcitabine as first-line therapy in patients with metastatic pancr
Fukutomi, A; Gansert, J; Ikeda, M; Kobayashi, Y; Okusaka, T; Shibayama, K; Takubo, T, 2014
)
0.59
" We conducted this investigation to determine whether or not the TK line is useful for pharmacokinetic study of the chemotherapeutic agent gemcitabine (GEM)."( Cholangiocarcinoma cell line TK may be useful for the pharmacokinetic study of the chemotherapeutic agent gemcitabine.
Akiyama, N; Akiyoshi, K; Fujioka, K; Funamizu, N; Ikeda, K; Kamada, M; Manome, Y; Watanabe, M, 2014
)
0.82
" We tested a pharmacodynamic separation approach for erlotinib plus gemcitabine and interrogated EGFR signaling intermediates as potential surrogates for the efficacy of this strategy."( Pharmacodynamic separation of gemcitabine and erlotinib in locally advanced or metastatic pancreatic cancer: therapeutic and biomarker results.
Barzi, A; Beckett, L; Burich, RA; Gong, IY; Holland, W; Hutchins, IM; Kim, EJ; Lara, PN; Lenz, HJ; Mack, P; Semrad, T; Snyder-Solis, L; Tanaka, M, 2015
)
0.94
" Therapeutic drug monitoring is a valid tool to determine the pharmacokinetic of a drug and individualized drug therapy, adjusting patient's dose requirement through the measurement and interpretation of drug concentrations."( [Clinical application, limits and perspectives of pharmacogenetic and pharmacokinetic analysis of anticancer drugs].
Chantry, AS; Ciccolini, J; Lacarelle, B; Quaranta, S,
)
0.13
"We developed a prospective randomized multicenter pharmacokinetic study (ONCOPERF01) to compare the influence of three infusion techniques (gravity-fed infusion-GFI, infusion pump-IP, and gravity-fed infusion with post-administration rinsing-PAR) to assess the impact of both flow rate and post-administration rinsing on gemcitabine pharmacokinetics during three consecutive administrations."( Influence of infusion method on gemcitabine pharmacokinetics: a controlled randomized multicenter trial.
Barthélémy, C; Décaudin, B; Hebbar, M; Lemahieu, N; Michel, P; Odou, P; Pinçon, C; Romano, O; Simon, N; Vasseur, M, 2015
)
0.87
" Herein, the intracellular pharmacokinetic behavior of D-luciferin was investigated in pancreatic cancer cell lines in real time by using bioluminescence imaging."( Gemcitabine upregulates ABCG2/BCRP and modulates the intracellular pharmacokinetic profiles of bioluminescence in pancreatic cancer cells.
Gu, M; Li, F; Liu, J; Sun, Y; Wei, Y; Xiong, Y; Zhu, L, 2016
)
1.88
"This study investigates the combined effects of gemcitabine and trabectedin (ecteinascidin 743) in two pancreatic cancer cell lines and proposes a pharmacodynamic (PD) model to quantify their pharmacological interactions."( Pharmacodynamic modeling of combined chemotherapeutic effects predicts synergistic activity of gemcitabine and trabectedin in pancreatic cancer cells.
Jusko, WJ; Koch, G; Miao, X; Straubinger, RM, 2016
)
0.91
" A pharmacokinetic evaluation of gemcitabine and its main metabolite, 2',2'-difluorodeoxyuridine (dFdU), was conducted at the initial administration of gemcitabine, which was given by intravenous infusion over 30 min at a dose of 800-1,000 mg/m2."( Pharmacokinetic Study of Adjuvant Gemcitabine Therapy for Biliary Tract Cancer following Major Hepatectomy (KHBO1101).
Ajiki, T; Fujiwara, Y; Hamada, A; Hatano, E; Ioka, T; Kanai, M; Kobayashi, S; Minami, H; Nagano, H; Takashima, Y; Toyoda, M; Yoshimura, K, 2015
)
0.98
"Thirteen patients were enrolled from August 2011 to January 2013, with 12 ultimately completing the pharmacokinetic study."( Pharmacokinetic Study of Adjuvant Gemcitabine Therapy for Biliary Tract Cancer following Major Hepatectomy (KHBO1101).
Ajiki, T; Fujiwara, Y; Hamada, A; Hatano, E; Ioka, T; Kanai, M; Kobayashi, S; Minami, H; Nagano, H; Takashima, Y; Toyoda, M; Yoshimura, K, 2015
)
0.7
" Statistically significant differences between the groups were revealed for almost all analysed pharmacokinetic parameters for erlotinib and OSI420."( The alteration of pharmacokinetics of erlotinib and OSI420 in type 1 diabetic rabbits.
Grabowski, T; Grześkowiak, E; Karbownik, A; Sobańska, K; Szałek, E; Wolc, A, 2016
)
0.43
"The anticancer potential of gemcitabine, a nucleoside analog, is compromised due to the enzymatic degradation into inactive form leading to the short half-life in systemic circulation."( Long-circulatory nanoparticles for gemcitabine delivery: Development and investigation of pharmacokinetics and in-vivo anticancer efficacy.
Alam, N; Gupta, M; Gupta, PN; Khare, V; Kour, S; Kumar, A; Mahajan, G; Mondhe, DM; Saxena, AK; Singh, A; Singh, G; Singh, SK, 2016
)
1.01
"A method for Bayesian prediction of myelosuppression profiles during chemotherapy using a population pharmacodynamic model is proposed, and predictabilities of nadir values and times to nadir (Tnadir) after gemcitabine and carboplatin treatment were evaluated."( Population Pharmacodynamic Model for Bayesian Prediction of Myelosuppression Profiles Based on Routine Clinical Data after Gemcitabine and Carboplatin Treatment.
Chisaki, Y; Terada, T; Yano, Y, 2016
)
0.83
" The effects of HYT on pharmacokinetics of the two drugs were estimated by non-compartmental analysis and pharmacokinetic modeling."( Alterations in Pharmacokinetics of Gemcitabine and Erlotinib by Concurrent Administration of Hyangsayukgunja-Tang, a Gastroprotective Herbal Medicine.
Bulitta, JB; Jeong, SW; Joo, SH; Kim, S; Kim, TH; Kwon, DR; Lee, DY; Ma, E; Park, GY; Shin, BS; Shin, S; Weon, KY; Yoo, SD, 2017
)
0.73
" This well validated method was successfully applied to demonstrate the pharmacokinetic behavior and the metabolic transformation of FY363 in rats."( Sensitive analysis and pharmacokinetic study of a novel gemcitabine carbamate prodrug and its active metabolite gemcitabine in rats using LC-ESI-MS/MS.
Chang, Q; Peng, Y; Sun, J; Wang, G; Wang, W; Zhang, X; Zhou, F; Zhou, Y, 2018
)
0.73
"The pharmacodynamic interactions among trifluoperazine (TFP), gemcitabine (GEM), and paclitaxel (PTX) were assessed in pancreatic cancer cells (PANC-1)."( Assessment of Three-Drug Combination Pharmacodynamic Interactions in Pancreatic Cancer Cells.
Jusko, WJ; Molins, EAG, 2018
)
0.72
" In this study, pharmacokinetic information derived from experiments and the literature was utilized to develop full physiologically-based pharmacokinetic (PBPK) models that characterize individual drugs."( Physiologically-based pharmacokinetic and pharmacodynamic models for gemcitabine and birinapant in pancreatic cancer xenografts.
Jusko, WJ; Straubinger, RM; Trueman, S; Zhu, X, 2018
)
0.72
" In this approach, we further carried out systematic pharmacokinetic and pharmacodynamic study of MBRI-001 in vitro and in vivo."( In vitro and in vivo pharmacokinetic and pharmacodynamic study of MBRI-001, a deuterium-substituted plinabulin derivative as a potent anti-cancer agent.
Cheng, H; Deng, M; Ding, Z; Dou, G; Hou, Y; Li, F; Li, W; Ma, M; Zhao, J, 2018
)
0.48
" Taken together, the amino acid transporter-targeting gemcitabine prodrug, Gem-Thr, was found to be effective on pancreatic cancer cells and to offer an efficient potential means of treating pancreatic cancer with significantly better pharmacokinetic characteristics than gemcitabine."( Synthesis of Gemcitabine-Threonine Amide Prodrug Effective on Pancreatic Cancer Cells with Improved Pharmacokinetic Properties.
Fang, Z; Hong, S; Hong, SS; Jung, HY; Maeng, HJ; Yoon, JH, 2018
)
1.1
" PEGylated liposomes decorated with folic acid have been investigated for several anticancer agents not only to extend plasma half-life but also for tumor targeting via folic acid receptors which overexpressed on tumor cell surface."( Gemcitabine-loaded Folic Acid Tagged Liposomes: Improved Pharmacokinetic and Biodistribution Profile.
Muddana Eswara, BR; Panduragaiah, VM; Sidramappa, MA; Unnam, S, 2019
)
1.96
" The comparative in vivo pharmacokinetic and biodistribution characteristics of radiolabeled (99mTc-labeled) plain GEM solution, and all liposomal formulations (conventional:CLs; stealth: SLs; folate targeted: FTLs) were evaluated in mice model."( Gemcitabine-loaded Folic Acid Tagged Liposomes: Improved Pharmacokinetic and Biodistribution Profile.
Muddana Eswara, BR; Panduragaiah, VM; Sidramappa, MA; Unnam, S, 2019
)
1.96
"We sought to examine the pharmacodynamic activation of the DNA damage response (DDR) pathway in tumors following anticancer treatment for confirmation of target engagement."( Evaluation of Pharmacodynamic Responses to Cancer Therapeutic Agents Using DNA Damage Markers.
Barrett, AM; Chen, A; Doroshow, JH; Dull, AB; Hollingshead, MG; Kinders, RJ; Kummar, S; Lawrence, SM; Parchment, RE; Wilsker, DF, 2019
)
0.51
"Because of inherent biological variability, baseline DDR biomarker levels were evaluated in a colorectal cancer microarray to establish clinically relevant thresholds for pharmacodynamic activation."( Evaluation of Pharmacodynamic Responses to Cancer Therapeutic Agents Using DNA Damage Markers.
Barrett, AM; Chen, A; Doroshow, JH; Dull, AB; Hollingshead, MG; Kinders, RJ; Kummar, S; Lawrence, SM; Parchment, RE; Wilsker, DF, 2019
)
0.51
"5-2 h and had an elimination half-life of 8 h."( Population pharmacokinetics and exposure-overall survival analysis of the transforming growth factor-β inhibitor galunisertib in patients with pancreatic cancer.
Benhadji, KA; Cleverly, A; Gueorguieva, I; Lahn, MM; Macarulla, T; Melisi, D; Merz, V; Miles, C; Tabernero, J; Waterhouse, TH, 2019
)
0.51
"The aim of this work is to build a mechanistic multiscale pharmacokinetic model for the anticancer drug 2',2'-difluorodeoxycytidine (gemcitabine, dFdC), able to describe the concentrations of dFdC metabolites in the pancreatic tumor tissue in dependence of physiological and genetic patient characteristics, and, more in general, to explore the capabilities and limitations of this kind of modeling strategy."( Mechanistic Multiscale Pharmacokinetic Model for the Anticancer Drug 2',2'-difluorodeoxycytidine (Gemcitabine) in Pancreatic Cancer.
Garcia-Cremades, M; Magni, P; Melillo, N; Troconiz, IF, 2020
)
0.98
" To address potential concerns that iohexol administered during a course of chemotherapy impacts that therapy, we performed in vitro and in vivo pharmacokinetic drug-drug interaction evaluations of iohexol."( Evaluation of the pharmacokinetic drug-drug interaction potential of iohexol, a renal filtration marker.
Beumer, JH; Christner, S; Chu, E; Guo, J; Holleran, JL; Ivy, SP; Joshi, A; Kiesel, B; Miller, BM; Parise, RA; Taylor, S; Venkataramanan, R, 2020
)
0.56
" Measuring GFR with iohexol to better dose carboplatin is unlikely to alter the safety or efficacy of chemotherapy through pharmacokinetic drug-drug interactions."( Evaluation of the pharmacokinetic drug-drug interaction potential of iohexol, a renal filtration marker.
Beumer, JH; Christner, S; Chu, E; Guo, J; Holleran, JL; Ivy, SP; Joshi, A; Kiesel, B; Miller, BM; Parise, RA; Taylor, S; Venkataramanan, R, 2020
)
0.56
" We successfully applied the validated method to the analysis of dFdC and dFdU in mouse plasma, brain, and brain tumor tissue in a preclinical pharmacokinetic study."( LC-MS/MS method for quantitation of gemcitabine and its metabolite 2',2'-difluoro-2'-deoxyuridine in mouse plasma and brain tissue: Application to a preclinical pharmacokinetic study.
Davis, A; Gibson, EG; Roussel, MF; Stewart, CF; Zhong, B, 2021
)
0.9
" When co-delivered with pSL, zebularine increased cellular gemcitabine concentration by 4-fold, and extended the half-life of gemcitabine in plasma by 22-fold in rats."( Zebularine suppressed gemcitabine-induced senescence and improved the cellular and plasma pharmacokinetics of gemcitabine, augmented by liposomal co-delivery.
Leung, E; Lozano Hernandez, L; Reginald-Opara, JN; Svirskis, D; Tang, M; Wang, H; Wu, Z, 2021
)
1.18
"Co-delivery of curcumin with gemcitabine using PSL not only increased the intracellular gemcitabine concentration thus cytotoxicity to MIA PaCa-2 cells but also significantly improved the pharmacokinetic profiles for both drugs."( Co-Delivery Using pH-Sensitive Liposomes to Pancreatic Cancer Cells: the Effects of Curcumin on Cellular Concentration and Pharmacokinetics of Gemcitabine.
Li, Y; Paxton, JW; Wu, Z; Xu, H, 2021
)
1.11
" The pharmacokinetic parameters were studied with high-performance liquid chromatography (HPLC) and atomic absorption spectroscopy (AAS)."( Building and behavior of a pH-stimuli responsive chitosan nanoparticles loaded with folic acid conjugated gemcitabine silver colloids in MDA-MB-453 metastatic breast cancer cell line and pharmacokinetics in rats.
Babu, D; Gautam, M; Karuppaiah, A; Natrajan, T; Nesamony, J; Rajan, R; Ranganathan, H; Sankar, V; Selvaraj, D; Siram, K, 2021
)
0.83
" The data were supplemented with pharmacokinetic data in patients included in four previously conducted clinical trials."( Is age just a number? A population pharmacokinetic study of gemcitabine.
Beijnen, JH; Boosman, RJ; Crombag, MBS; Huitema, ADR; Steeghs, N; van Erp, NP, 2022
)
0.96
"In total, pharmacokinetic data were available of 197 patients, of whom 83 patients were aged ≥ 70 years (42%)."( Is age just a number? A population pharmacokinetic study of gemcitabine.
Beijnen, JH; Boosman, RJ; Crombag, MBS; Huitema, ADR; Steeghs, N; van Erp, NP, 2022
)
0.96
" Age-related dose adjustments for gemcitabine based on pharmacokinetic considerations are not recommended."( Is age just a number? A population pharmacokinetic study of gemcitabine.
Beijnen, JH; Boosman, RJ; Crombag, MBS; Huitema, ADR; Steeghs, N; van Erp, NP, 2022
)
1.24
" No significant changes in pharmacokinetic parameters for gemcitabine or its metabolite dFdU were observed with alisertib co-administration."( A phase I dose escalation, dose expansion and pharmacokinetic trial of gemcitabine and alisertib in advanced solid tumors and pancreatic cancer.
Chen, JA; Gandara, DR; Huynh, JC; Kelly, KL; Kim, EJ; Li, T; Mack, PC; Mahaffey, N; Martinez, A; Matsukuma, K; Riess, JW; Semrad, TJ; Tam, K; Wu, CY; Yu, AM, 2022
)
1.2
"This study evaluates the herb-drug interaction between DBD's major components and gemcitabine and validates the underlying pharmacokinetic mechanism."( Gemcitabine enhances pharmacokinetic exposure of the major components of Danggui Buxue Decoction in rat via the promotion of intestinal permeability and down-regulation of CYP3A for combination treatment of non-small cell lung cancer.
Chang, M; Cheng, TT; Hang, TJ; Hu, ZL; Song, M; Sun, XY; Xu, X, 2023
)
2.58
"The combination of gemcitabine significantly altered the pharmacokinetic profiles of DBD's major components in rats."( Gemcitabine enhances pharmacokinetic exposure of the major components of Danggui Buxue Decoction in rat via the promotion of intestinal permeability and down-regulation of CYP3A for combination treatment of non-small cell lung cancer.
Chang, M; Cheng, TT; Hang, TJ; Hu, ZL; Song, M; Sun, XY; Xu, X, 2023
)
2.68

Compound-Compound Interactions

Gemcitabine (GEM) and cisplatin (CDDP) were employed as representative antineoplastic agents to observe effects of continuous low-dose chemotherapy with GEM or GEM combined with CDDP. The pharmacokinetic profile of galunisertib in combination with gem citabine was similar to that previously observe.

ExcerptReferenceRelevance
"To determine the maximum-tolerated dose of monthly docetaxel combined with fixed-dose weekly gemcitabine and describe the dose-limiting toxicities (DLTs) of the combination."( Phase I study of docetaxel dose escalation in combination with fixed weekly gemcitabine in patients with advanced malignancies.
Jones, J; Laufman, LR; Nicol, S; Rhodes, VA; Spiridonidis, CH; Wallace, K, 1998
)
0.75
"Gemcitabine 800 mg/m2 days 1,8, and 15 can be safely combined with docetaxel 100 mg/m2 day 1 of a 28-day cycle."( Phase I study of docetaxel dose escalation in combination with fixed weekly gemcitabine in patients with advanced malignancies.
Jones, J; Laufman, LR; Nicol, S; Rhodes, VA; Spiridonidis, CH; Wallace, K, 1998
)
1.97
" We have studied the anti-cancer effect of vesnarinone in combination with cisplatin, VP-16 (etoposide) and gemcitabine, against human lung cancer cell lines (PC-9 and Lu 134A) using the MTT assay and isobologram analysis."( Effect of vesnarinone in combination with anti-cancer drugs on lung cancer cell lines.
Fujita, M; Higashino, K; Tsuchida, T, 1999
)
0.52
"This study assessed the cytotoxic effects of the nucleoside analog gemcitabine in combination with the diaminocyclohexane platinum compound oxaliplatin."( Supraadditive effect of 2',2'-difluorodeoxycytidine (gemcitabine) in combination with oxaliplatin in human cancer cell lines.
Cvitkovic, E; Faivre, S; Raymond, E; Woynarowski, JM, 1999
)
0.79
" The aim of this study was to perform a health economic evaluation of present standard treatment (in most cases, palliative treatment in combination with best supportive care) versus palliative treatment with gemcitabine in combination with best supportive care in patients with locally advanced pancreatic carcinoma."( Treatment of locally advanced pancreatic carcinoma in Sweden. A health economic comparison of palliative treatment with best supportive care versus palliative treatment with gemcitabine in combination with best supportive care.
Ragnarson-Tennvall, G; Wilking, N, 1999
)
0.68
"To investigate the schedule-dependency of 2',2'difluorodeoxycytidine (dFdC, Gemcitabine) combined with hyperthermia (HT), in vitro as well as in vivo."( Effectiveness of 2',2'difluorodeoxycytidine (Gemcitabine) combined with hyperthermia in rat R-1 rhabdomyosarcoma in vitro and in vivo.
Bakker, PJ; Beumer, C; Haveman, J; Rodermond, HM; Van Bree, C,
)
0.62
"The efficacy of dFdC combined with HT is schedule-dependent both in vitro and in vivo."( Effectiveness of 2',2'difluorodeoxycytidine (Gemcitabine) combined with hyperthermia in rat R-1 rhabdomyosarcoma in vitro and in vivo.
Bakker, PJ; Beumer, C; Haveman, J; Rodermond, HM; Van Bree, C,
)
0.39
" Our studies examine the ability of gemcitabine, both alone and in combination with other chemotherapeutic agents, to inhibit the in vitro and in vivo growth of several prostate cancer cell lines."( The study of gemcitabine in combination with other chemotherapeutic agents as an effective treatment for prostate cancer.
Brumfield, SK; Lehr, JE; Mahoney, M; Muenchen, HJ; Pienta, KJ; Pilat, MJ; Quigley, MM,
)
0.78
"The results revealed synergistic cytotoxicity when vinflunine was combined with cisplatin, mitomycin C, doxorubicin or 5-fluorouracil."( In vitro synergistic effects of vinflunine, a novel fluorinated vinca alkaloid, in combination with other anticancer drugs.
Barret, JM; Etiévant, C; Hill, BT, 2000
)
0.31
" The aim of this phase II study was to determine the efficacy, toxicity, and pharmacokinetic profile of gemcitabine administered with doxorubicin as first-line treatment in patients with metastatic breast cancer."( Gemcitabine in combination with doxorubicin in advanced breast cancer: final results of a phase II pharmacokinetic trial.
Alba, E; García-Conde, J; Khayat, D; Lluch, A; Moreno-Nogueira, JA; Palomero, M; Pérez-Manga, G; Rivelles, N, 2000
)
1.96
"Induction of apoptosis in vitro using gemcitabine (dFdC) in combination with cladribine (2-CdA) and other cytotoxic drugs on malignant mononuclear cells (MNCs) of patients with acute myeloid leukemia (AML, n=20) and chronic lymphocytic leukemia (CLL, n =20) in myeloid (HL60, HEL) and lymphatic cell lines (HUT78, JURKAT) was investigated using different incubation conditions (simultaneous and consecutive)."( Induction of apoptosis using 2',2' difluorodeoxycytidine (gemcitabine) in combination with antimetabolites or anthracyclines on malignant lymphatic and myeloid cells. Antagonism or synergism depends on incubation schedule and origin of neoplastic cells.
Boehrer, S; Chow, KU; Hoelzer, D; Mitrou, PS; Napieralski, S; Pourebrahim, F; Ries, J; Rummel, MJ; Stein, J; Stieler, M; Weidmann, E, 2000
)
0.82
"To evaluate the maximum-tolerated dose, dose-limiting toxicities (DLTs), and pharmacokinetic profile of vesnarinone given once daily in combination with gemcitabine."( Phase I and pharmacokinetic study of the differentiating agent vesnarinone in combination with gemcitabine in patients with advanced cancer.
Drengler, RL; Eckhardt, SG; Felton, SA; Garner, AM; Hammond, LA; Hidalgo, M; Mallikaarjun, S; Patnaik, A; Rowinsky, EK; Siu, LL; Tammara, BK; Von Hoff, DD, 2000
)
0.72
"Twenty-six patients were treated with oral vesnarinone once daily on a continuous schedule at doses of 60, 90, 120, 150, and 180 mg in combination with intravenous (IV) gemcitabine at a dose of 1,000 mg/m(2) on days 1, 8, and 15 every 4 weeks."( Phase I and pharmacokinetic study of the differentiating agent vesnarinone in combination with gemcitabine in patients with advanced cancer.
Drengler, RL; Eckhardt, SG; Felton, SA; Garner, AM; Hammond, LA; Hidalgo, M; Mallikaarjun, S; Patnaik, A; Rowinsky, EK; Siu, LL; Tammara, BK; Von Hoff, DD, 2000
)
0.72
"When combined with gemcitabine, the recommended dose of vesnarinone for phase II evaluations is 90 mg orally once daily with gemcitabine 1,000 mg/m(2) IV on days 1, 8, and 15 every 4 weeks."( Phase I and pharmacokinetic study of the differentiating agent vesnarinone in combination with gemcitabine in patients with advanced cancer.
Drengler, RL; Eckhardt, SG; Felton, SA; Garner, AM; Hammond, LA; Hidalgo, M; Mallikaarjun, S; Patnaik, A; Rowinsky, EK; Siu, LL; Tammara, BK; Von Hoff, DD, 2000
)
0.85
" The present study was initiated to investigate the efficacy of gemcitabine in combination with 5-FU-FA."( A phase II trial of gemcitabine in combination with 5-fluorouracil (24-hour) and folinic acid in patients with chemonaive advanced pancreatic cancer.
Arning, M; Arnold, D; Herrenberger, J; Huhn, D; Kindler, M; Korsten, EW; Langrehr, J; Musch, R; Oettle, H; Pelzer, U; Reitzig, P; Riess, H; Stroszczynski, C, 2000
)
0.87
" Herein, we describe the case of a 73-year-old woman with breast cancer metastatic to the liver, who developed noncardiogenic pulmonary edema (NPE) while on treatment with gemcitabine plus docetaxel combination with granulocyte colony-stimulating factor (G-CSF) support."( Chemotherapy-induced noncardiogenic pulmonary edema related to gemcitabine plus docetaxel combination with granulocyte colony-stimulating factor support.
Briasoulis, E; Constantopoulos, S; Froudarakis, M; Milionis, HJ; Pavlidis, N; Peponis, I, 2000
)
0.74
"We conducted a single-institution phase I clinical trial to determine the maximum-tolerated dose (MTD) and define the toxic effects of stealth liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer."( Phase I study of stealth liposomal doxorubicin in combination with gemcitabine in the treatment of patients with metastatic breast cancer.
Bast, RC; Booser, D; Esteva, FJ; Esteva, FL; Hortobagyi, GN; Murray, JL; Rahman, Z; Rivera, E; Rosales, MM; Syrewicz, L; Theriault, RL; Valero, V, 2001
)
0.74
" Docetaxel combined with other new agents, particularly gemcitabine, may offer another useful alternative to cisplatin-based chemotherapy in patients with good performance status."( Challenging the platinum combinations: docetaxel (Taxotere) combined with gemcitabine or vinorelbine in non-small cell lung cancer.
Douillard, JY; Eckardt, J; Georgoulias, V; Manegold, C; Miller, V; Scagliotti, G, 2001
)
0.79
" Based on its favorable toxicity profile, carboplatin has supplanted cisplatin for use in combination with paclitaxel in several different tumor types."( Gemcitabine in combination with new platinum compounds: an update.
Edelman, MJ; Gandara, DR; Lara, PN; Lau, DH, 2001
)
1.75
"Docetaxel in combination with gemcitabine is an active front-line chemotherapy regimen against non-small cell lung cancer (NSCLC) with acceptable toxicity."( Docetaxel in combination with gemcitabine plus rhG-CSF support as second-line treatment in non-small cell lung cancer. A multicenter phase II study.
Agelaki, S; Androulakis, N; Bania, E; Chainis, K; Georgoulias, V; Kakolyris, S; Kalofonos, C; Kouroussis, C; Papadakis, E; Rapti, A; Sarra, E; Toubis, M; Tsiafaki, X; Vardakis, N, 2001
)
0.89
" To design successful therapeutic strategies involving compounds either alone or in combination with others, it is necessary to understand their mechanism of action."( Cell cycle effects of nonsteroidal anti-inflammatory drugs and enhanced growth inhibition in combination with gemcitabine in pancreatic carcinoma cells.
Crowell, PL; Jung, SH; Marshall, MS; Sweeney, CJ; Yip-Schneider, MT, 2001
)
0.52
" This two-step study firstly aimed at determining the maximum tolerated and recommended doses of docetaxel given every 3 weeks in combination with a fixed dose of gemcitabine; the phase I study paid particular attention to pharmacokinetics."( Dose-finding, pharmacokinetic and phase II study of docetaxel in combination with gemcitabine in patients with inoperable non-small cell lung cancer.
Ardiet, C; Azarian, MR; Morere, JF; Pujol, JL; Quantin, X; Rebattu, P; Schuller-Lebeau, MP,
)
0.55
"The following range of docetaxel dosages were tested in the phase I study; 60, 75, 85, and 100 mg m(-2) given on day 8 in combination with gemcitabine 1000 mg m(-2) delivered on days 1 and 8 of a 3-week cycle."( Dose-finding, pharmacokinetic and phase II study of docetaxel in combination with gemcitabine in patients with inoperable non-small cell lung cancer.
Ardiet, C; Azarian, MR; Morere, JF; Pujol, JL; Quantin, X; Rebattu, P; Schuller-Lebeau, MP,
)
0.56
"Gemcitabine, 1000 mg m(-2) days 1 and 8 in combination with docetaxel, 85 mg m(-2), day 8, given every 3 weeks could be considered as an active regimen with manageable toxicities in locally advanced or metastatic NSCLC."( Dose-finding, pharmacokinetic and phase II study of docetaxel in combination with gemcitabine in patients with inoperable non-small cell lung cancer.
Ardiet, C; Azarian, MR; Morere, JF; Pujol, JL; Quantin, X; Rebattu, P; Schuller-Lebeau, MP,
)
1.8
"The purpose of this study was to analyze the drug interactions of paclitaxel (PTX) with epirubicin (EPI), carboplatin (CBDCA), gemcitabine (GEM) and vinorelbine (VIN) in human breast cancer cells and compare the cytotoxic activity of each drug combination in primary breast cancer samples."( Drug interactions and cytotoxic effects of paclitaxel in combination with carboplatin, epirubicin, gemcitabine or vinorelbine in breast cancer cell lines and tumor samples.
Beryt, M; Felber, M; Hepp, H; Kahlert, S; Konecny, G; Langer, E; Lude, S; Pegram, M; Slamon, D; Untch, M, 2001
)
0.73
" Schedule 1 maximum tolerated dose of gemcitabine was 600 mg/m(2)/week when combined with 5-fluorouracil (5-FU) at 200 mg/m(2)/day (Days 1-21) repeated every 4 weeks."( Phase I study to evaluate multiple regimens of intravenous 5-fluorouracil administered in combination with weekly gemcitabine in patients with advanced solid tumors: a potential broadly active regimen for advanced solid tumor malignancies.
Bertucci, D; Mani, S; Ratain, MJ; Schilsky, RL; Stadler, WM; Vogelzang, NJ, 2001
)
0.79
"For Phase II development, gemcitabine 450-600 mg/m(2) on Days 1, 8, and 15 can be safely combined with 5-FU 200 mg/m(2) given as a continuous infusion (Days 1-21) of a 28-day cycle or gemcitabine 1800 mg/m(2) Days 1 and 8 given with 5-FU 200 mg/m(2) as a continuous infusion (Days 1-14) of a 21-day cycle."( Phase I study to evaluate multiple regimens of intravenous 5-fluorouracil administered in combination with weekly gemcitabine in patients with advanced solid tumors: a potential broadly active regimen for advanced solid tumor malignancies.
Bertucci, D; Mani, S; Ratain, MJ; Schilsky, RL; Stadler, WM; Vogelzang, NJ, 2001
)
0.82
"Gemcitabine alone or in combination with cisplatin was assessed to be a cost-effective or cost-saving therapy when compared with best supportive care, standard chemotherapy regimens and novel chemotherapy combinations."( Economic evaluation of gemcitabine alone and in combination with cisplatin in the treatment of nonsmall cell lung cancer.
Aristides, M; Botwood, N; Lees, M; Maniadakis, N; McKendrick, J; Stephenson, D, 2002
)
2.07
" The combination of gemcitabine and vinorelbine could be a useful regimen in standard clinical practice and has the potential for efficient combination with biologic/targeted therapy."( The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma: potential for decreased toxicity and combination with biological therapy.
Blumenschein, G; Fossella, FV; Glisson, BS; Herbst, RS; Hong, WK; Jung, MS; Khuri, FR; Kies, MS; Kurie, JM; Lee, JJ; Lee, JS; Liu, DD; Lu, C; Lu, R; Munden, RF; Papadimitrakopoulou, VA; Pisters, KM; Shin, DM; Zinner, R, 2002
)
0.88
"The aim of this study was to determine the toxicity profile, the recommended dose (RD) and the pharmacokinetic parameters, and to evaluate the antitumor activity of gemcitabine combined with oxaliplatin in patients with advanced non-small-cell lung cancer (NSCLC) and ovarian carcinoma (OC)."( Phase I-II and pharmacokinetic study of gemcitabine combined with oxaliplatin in patients with advanced non-small-cell lung cancer and ovarian carcinoma.
Armand, JP; Faivre, S; Kayitalire, L; Le Chevalier, T; Lhommé, C; Lokiec, F; Monnerat, C; Novello, S; Pautier, P; Raymond, E; Ruffié, P; Taieb, J, 2002
)
0.78
" This phase I study was designed to find the maximum tolerated dose (MTD) of weekly cisplatin in combination with standard doses of gemcitabine (1,000 mg/m(2), 30 min) and 5-FU (750 mg/m(2), 24 h)/folinic acid (200 mg/m(2), 30 min)."( Phase I study of gemcitabine in combination with cisplatin, 5-fluorouracil and folinic acid in patients with advanced esophageal cancer.
Arnold, D; Hoepffner, N; Kern, M; Neuhaus, P; Oettle, H; Riess, H; Settmacher, U, 2002
)
0.86
" Therefore, a phase II study was conducted to evaluate the efficacy of gemcitabine combined with radiation therapy in patients with localized unresectable adenocarcinoma of the pancreas."( Phase II study of gemcitabine combined with radiation therapy in patients with localized, unresectable pancreatic cancer.
Epelbaum, R; Faraggi, D; Gaitini, D; Kuten, A; Mizrahi, S; Nasrallah, S; Rosenblatt, E, 2002
)
0.88
" This, combined with preclinical synergism, prompted the Gynecologic Oncology Group to determine the maximum tolerated dose (MTD) of this combination."( Phase I escalation of gemcitabine combined with protracted oral etoposide in gynecologic malignancies: A Gynecologic Oncology Group study.
Bookman, MA; Garcia, AA; Look, KY; Mutch, DG; Rodriguez-Rodriguez, L, 2002
)
0.63
"The purpose of this study was to determine the maximum tolerated dose, pharmacokinetic profile, and evidence of antitumor activity of CI-994 used in combination with gemcitabine."( Phase I study of oral CI-994 in combination with gemcitabine in treatment of patients with advanced cancer.
Cunningham, CC; Eager, R; Grove, W; Mennel, R; Nemunaitis, JJ; Olson, S; Orr, D; Williams, A,
)
0.58
"These data show that administration of IFN-alpha at optimal biological dose and schedule in combination with gemcitabine induced apoptosis in tumor-associated endothelial cells and decreased growth of human pancreatic cancer cells in the pancreas, leading to a significant increase in survival."( Administration of optimal biological dose and schedule of interferon alpha combined with gemcitabine induces apoptosis in tumor-associated endothelial cells and reduces growth of human pancreatic carcinoma implanted orthotopically in nude mice.
Baker, CH; Bucana, CD; Evans, DB; Fidler, IJ; Hwang, R; Killion, JJ; Pisters, PW; Solorzano, CC, 2003
)
0.75
"To determine the maximally tolerated dose (MTD) of gemcitabine administered at a fixed dose-rate of 10 mg/m(2) per min in combination with fixed dose carboplatin, to evaluate the toxicity of this regimen and to determine the pharmacokinetics of plasma gemcitabine."( Phase I trial of fixed dose-rate gemcitabine in combination with carboplatin in chemonaive advanced non-small-cell lung cancer: a Cancer Therapeutics Research Group study.
Goh, BC; Lee, HS; Lee, SC; Lehnert, M; Lim, HL; Millward, MJ; Soo, RA; Tok, LT; Wang, LZ, 2003
)
0.85
"Gemcitabine administered as a 75-min infusion at a fixed dose rate of 10 mg/m(2)/min on days 1 and 8 in combination with carboplatin on day 1 every 21 days is tolerable and active in NSCLC."( Phase I trial of fixed dose-rate gemcitabine in combination with carboplatin in chemonaive advanced non-small-cell lung cancer: a Cancer Therapeutics Research Group study.
Goh, BC; Lee, HS; Lee, SC; Lehnert, M; Lim, HL; Millward, MJ; Soo, RA; Tok, LT; Wang, LZ, 2003
)
2.04
"The objectives of the current study were to determine the maximum tolerated dose and to evaluate the efficacy of gemcitabine given in combination with strontium-89 to patients with androgen independent prostate carcinoma."( A Phase I/II study of strontium-89 combined with gemcitabine in the treatment of patients with androgen independent prostate carcinoma and bone metastases.
Delpassand, ES; Logothetis, CJ; Millikan, RE; Pagliaro, LC; Tu, SM; Williams, D, 2003
)
0.78
" To investigate the activity and toxicity of the cisplatin plus gemcitabine combination with gemcitabine at a fixed infusion rate in patients with advanced non-small cell lung carcinoma (NSCLC), the authors conducted a randomized Phase II trial of cisplatin plus gemcitabine at the 30-minute standard infusion (calibration arm) or cisplatin plus gemcitabine at a fixed infusion rate (experimental arm)."( Prolonged gemcitabine infusion in advanced non-small cell lung carcinoma: a randomized phase II study of two different schedules in combination with cisplatin.
Antimi, M; Barduagni, M; Ceribelli, A; Cognetti, F; Cortesi, E; De Marinis, F; Fabi, A; Gamucci, T; Giannarelli, D; Gridelli, C; Maione, P; Migliorino, MR, 2003
)
0.96
" As single agent or in combination with chemotherapy rituximab has shown significant activity in patients with relapsing or refractory aggressive lymphomas."( Rituximab in combination with vinorelbine/gemcitabine chemotherapy in patients with primary refractory or early relapsed T cell rich B cell lymphoma. A pilot study.
Economopoulos, T; Fountzilas, G; Raptis, S; Rontogianni, D; Valsami, S; Xiros, N, 2003
)
0.58
"We conducted a phase II clinical trial to determine the clinical efficacy and safety of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer."( Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer.
Adinin, R; Arun, B; Hoelzer, K; Hortobagyi, GN; Pusztai, L; Rivera, E; Royce, M; Valero, V; Wade, JL; Walters, R, 2003
)
0.75
"Pegylated liposomal doxorubicin in combination with gemcitabine is active and well tolerated in patients with metastatic breast cancer."( Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer.
Adinin, R; Arun, B; Hoelzer, K; Hortobagyi, GN; Pusztai, L; Rivera, E; Royce, M; Valero, V; Wade, JL; Walters, R, 2003
)
0.8
" This reduces the clinical applicability of this predictive assay for radiotherapy in combination with gemcitabine."( Colour junctions as predictors of radiosensitivity: X-irradiation combined with gemcitabine in a lung carcinoma cell line.
Castro Kreder, N; Franken, NA; Haveman, J; Van Bree, C, 2003
)
0.76
"To assess the feasibility of administering tipifarnib, an oral nonpeptidomimetic competitive inhibitor of farnesyltransferase, in combination with gemcitabine and recommend doses for disease-directed clinical trials."( A phase I, pharmacokinetic, and biological study of the farnesyltransferase inhibitor tipifarnib in combination with gemcitabine in patients with advanced malignancies.
Eckhardt, SG; Gentner, L; Goetz, A; Hammond, LA; Izbicka, E; McCreery, H; Mori, M; Patnaik, A; Richards, H; Rowinsky, EK; Rybak, ME; Schwartz, G; Takimoto, CH; Terada, K; Tolcher, AA; Zhang, S, 2003
)
0.73
" The pharmacologic features of this drug enable its combination with other antiblastic agents, such as vinorelbine, gemcitabine, paclitaxel and docetaxel."( Antiblastic drug combinations with ifosfamide: an update.
Badalamenti, G; Fulfaro, F; Gebbia, N; Russo, A; Valerio, MR, 2003
)
0.53
" In this study, one cycle of chemotherapy combined the following: ifosfamide: 3 g/m2 fixed dose (24-hour intravenous infusion) combined with mesna, day 1; gemcitabine: starting dose 1,000 mg/m2/d, escalating by 250 mg/m2 increments, days 1 and 15; cisplatin: starting dose 80 mg/m2, subsequently 100 mg/m2, day 15; in cohorts of at least 3 patients."( Phase I study with dose escalation of gemcitabine and cisplatin in combination with ifosfamide (GIP) in patients with non-small-cell lung carcinoma.
Billiart, I; Bourgeois, H; Chabrun, V; Chieze, S; Daban, A; Ferrand, V; Germain, T; Lemerre, D; Meurice, JC; Tourani, JM, 2004
)
0.79
" This dose-finding phase I study was designed to establish the maximum tolerated dose (MTD) of PKC412 when combined with cisplatin-gemcitabine."( Phase I study of PKC412 (N-benzoyl-staurosporine), a novel oral protein kinase C inhibitor, combined with gemcitabine and cisplatin in patients with non-small-cell lung cancer.
Berthaud, P; Faivre, S; Henriksson, R; Le Chevalier, T; Monnerat, C; Novello, S; Raymond, E, 2004
)
0.74
" Gefitinib has demonstrated encouraging efficacy in advanced NSCLC in phase II trials in pretreated patients, and a phase I trial of gefitinib in combination with gemcitabine and cisplatin showed favorable tolerability."( Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial--INTACT 1.
Averbuch, SD; Fandi, A; Gatzemeier, U; Giaccone, G; Grous, J; Herbst, RS; Johnson, DH; Manegold, C; Miller, V; Natale, RB; Ochs, JS; Pluzanska, A; Rennie, P; Rosell, R; Scagliotti, G; Schiller, JH; Von Pawel, J; Wolf, MK, 2004
)
0.81
"Gefitinib in combination with gemcitabine and cisplatin in chemotherapy-naive patients with advanced NSCLC did not have improved efficacy over gemcitabine and cisplatin alone."( Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial--INTACT 1.
Averbuch, SD; Fandi, A; Gatzemeier, U; Giaccone, G; Grous, J; Herbst, RS; Johnson, DH; Manegold, C; Miller, V; Natale, RB; Ochs, JS; Pluzanska, A; Rennie, P; Rosell, R; Scagliotti, G; Schiller, JH; Von Pawel, J; Wolf, MK, 2004
)
0.9
" The aim was to investigate the therapeutic efficacy and tolerance of mitomycin C (MMC) in combination with gemcitabine (GEM) or capecitabine (CAPE) in previously untreated patients with advanced biliary tract cancer."( Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: a randomised phase II trial.
Depisch, D; Gruenberger, T; Karall, K; Kornek, GV; Laengle, F; Lang, F; Penz, M; Scheithauer, W; Schuell, B, 2004
)
0.77
"A total of 51 patients were entered in this study and randomly allocated to treatment with MMC 8 mg/m2 on day 1 in combination with GEM 2000 mg/m2 on days 1 and 15 every 4 weeks, or MMC 8 mg/m2 on day 1 plus CAPE 2000 mg/m2/day on days 1-14, every 4 weeks."( Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: a randomised phase II trial.
Depisch, D; Gruenberger, T; Karall, K; Kornek, GV; Laengle, F; Lang, F; Penz, M; Scheithauer, W; Schuell, B, 2004
)
0.56
" These data provide a proof-of-principle for the clinical use of LErafAON in combination with chemotherapy for cancer treatment."( Combination with liposome-entrapped, ends-modified raf antisense oligonucleotide (LErafAON) improves the anti-tumor efficacies of cisplatin, epirubicin, mitoxantrone, docetaxel and gemcitabine.
Ahmad, I; Dritschilo, A; Gokhale, PC; Kasid, UN; Pei, J; Rahman, A; Zhang, C, 2004
)
0.52
" Therefore, we conducted a phase II study of gemcitabine combined with UFT in metastatic pancreatic cancer patients and assessed the efficacy and the toxicity of the regimen."( Phase II study of gemcitabine combined with uracil-tegafur in metastatic pancreatic cancer.
Choi, SH; Heo, JS; Im, YH; Jung, CW; Kang, WK; Kim, K; Kim, WS; Lee, J; Lee, JK; Lee, KT; Lee, MH; Lee, SI; Lim, DH; Park, JO; Park, K; Song, SY, 2004
)
0.92
"To develop a combination regimen for clinical testing, we performed a dose escalation study of ZD0473 in combination with gemcitabine."( A phase I, dose escalation trial of ZD0473, a novel platinum analogue, in combination with gemcitabine.
Algazy, KM; Flaherty, KT; Giatonio, B; O'Dwyer, PJ; Redlinger, M; Stevenson, JP, 2004
)
0.75
"We have shown that the currently used chemotherapeutic drugs for pancreatic adenocarcinoma combined with restoration of p16(INK4A) expression hold promise for the adjuvant treatment of this disease."( 5-Fluorouracil or gemcitabine combined with adenoviral-mediated reintroduction of p16INK4A greatly enhanced cytotoxicity in Panc-1 pancreatic adenocarcinoma cells.
Costello, E; Ghaneh, P; Greenhalf, W; Halloran, CM; Neoptolemos, JP; Shore, S; Wilson, D; Zumstein, L, 2004
)
0.66
" The effectiveness of LY293111, alone and in combination with gemcitabine was investigated in a heterotopic xenograft model in athymic mice using HT29 and LoVo human colonic cancer cells."( Effect of LY293111 in combination with gemcitabine in colonic cancer.
Adrian, TE; Ding, XZ; Hennig, R; Jovanovic, BD; Tong, WG; Witt, RC, 2004
)
0.83
"Bortezomib improves efficacy in combination with gemcitabine and carboplatin in NSCLC, but sequential effects are important and must be considered when developing therapeutic regimens."( Effects of the proteasome inhibitor bortezomib alone and in combination with chemotherapy in the A549 non-small-cell lung cancer cell line.
Bold, RJ; Mortenson, MM; Schlieman, MG; Virudachalam, S, 2004
)
0.58
"Cetuximab in combination with gemcitabine showed promising activity against advanced pancreatic cancer."( Cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor, in combination with gemcitabine for advanced pancreatic cancer: a multicenter phase II Trial.
Abbruzzese, JL; Deutsch, J; LoBuglio, A; Needle, M; Rosenberg, A; Schmidt, W; Wolff, RA; Xiong, HQ, 2004
)
0.83
" This study was conducted to evaluate the efficacy and toxicity of radiotherapy combined with gemcitabine for locally advanced pancreatic cancer."( Phase II study of radiotherapy combined with gemcitabine for locally advanced pancreatic cancer.
Ikeda, H; Ikeda, M; Ito, Y; Kagami, Y; Morizane, C; Okusaka, T; Takezako, Y; Ueno, H, 2004
)
0.8
" Therefore, we examined transfection of the human pancreatic cancer cell line DAN-G with a retrovirus encoding for IFN-alpha and the effect of IFN-alpha gene expression alone or in combination with gemcitabine on growth inhibition of DAN-G pancreatic cancer cells in vitro and in vivo in orthotopically implanted DAN-G cells in nude mice."( Retroviral IFN-alpha gene transfer combined with gemcitabine acts synergistically via cell cycle alteration in human pancreatic carcinoma cells implanted orthotopically in nude mice.
Abraham, NG; Gorschlüter, M; Märten, A; Nagaraj, S; Sauerbruch, T; Schmidt-Wolf, IG; Strehl, J; Ziske, C, 2004
)
0.77
"To evaluate the efficacy, toxicity and survival of intraoperative 125I brachytherapy combined with chemotherapy for advanced pancreatic cancer."( [Intraoperative 125I brachytherapy combined with chemotherapy for pancreatic cancer].
Duan, XN; Liu, YH; Shen, WJ; Wan, YL; Wang, DM; Yang, YM; Yu, SP; Zhou, G, 2004
)
0.32
"Interoperative 125I brachytherapy combined with chemotherapy for advanced pancreatic cancer can control tumor, relieve pain and improve quality of life."( [Intraoperative 125I brachytherapy combined with chemotherapy for pancreatic cancer].
Duan, XN; Liu, YH; Shen, WJ; Wan, YL; Wang, DM; Yang, YM; Yu, SP; Zhou, G, 2004
)
0.32
"LY900003 can be administered safely in combination with cisplatin and gemcitabine and is associated with antitumor activity in patients with advanced NSCLC."( A phase I/II study of LY900003, an antisense inhibitor of protein kinase C-alpha, in combination with cisplatin and gemcitabine in patients with advanced non-small cell lung cancer.
Belt, R; Dow, E; Figueroa, JA; Geary, R; George, S; Holmlund, J; Leonardo, J; McCachren, S; Miller, GL; Modiano, M; Oliver, JW; Otterson, GA; Ritch, P; Valdivieso, M; Villalona-Calero, MA, 2004
)
0.77
"To determine maximum tolerated dose (MTD) and evidence of antitumor activity of topotecan in combination with gemcitabine in refractory cancer patients."( Phase I trial of topotecan in combination with gemcitabine in refractory solid tumor patients.
Adams, N; Cunningham, CC; MacEachern, JB; Nemunaitis, J; Paulson, AS; Rich, D; Ruxer, RL; Vukelja, S, 2004
)
0.79
"In this study we have used a standardised ATP-based tumour chemosensitivity assay (ATP-TCA) to measure the activity of gefitinib alone or in combination with different cytotoxic drugs (cisplatin, gemcitabine, oxaliplatin and treosulfan) against a variety of solid tumours (n = 86), including breast, colorectal, oesophageal and ovarian cancer, carcinoma of unknown primary site, cutaneous and uveal melanoma, non-small cell lung cancer (NSCLC) and sarcoma."( The in vitro effect of gefitinib ('Iressa') alone and in combination with cytotoxic chemotherapy on human solid tumours.
Cree, IA; Di Nicolantonio, F; Glaysher, S; Johnson, P; Knight, LA; Mercer, S; Sharma, S; Whitehouse, P, 2004
)
0.51
" Interestingly, gefitinib had both positive and negative effects when used in combination with different cytotoxics."( The in vitro effect of gefitinib ('Iressa') alone and in combination with cytotoxic chemotherapy on human solid tumours.
Cree, IA; Di Nicolantonio, F; Glaysher, S; Johnson, P; Knight, LA; Mercer, S; Sharma, S; Whitehouse, P, 2004
)
0.32
" Treatment of advanced and metastatic NSCLC with TPZ in combination with Gemcitabine/Cisplatin was well feasible and showed results recording to currently published data."( [Phase II-trial of tirapazamine in combination with cisplatin and gemcitabine in patients with advanced non-small-cell-lung-cancer (NSCLC)].
Gatzemeier, U; Groth, G; Nimmermann, C; Reck, M; von Pawel, J, 2004
)
0.79
" Chemotherapy combined with antiangiogenic therapy has synergistic effects."( [Antitumor effects of interferon-gamma-inducible protein 10 combined with gemcitabine].
Deng, HX; Kan, B; Li, J; Mei, K; Tian, L; Wei, YQ; Wen, YJ, 2005
)
0.56
"Therapy of IP-10 combined with gemcitabine has significantly synergistic antitumor effect compared with IP-10 or gemcitabine alone."( [Antitumor effects of interferon-gamma-inducible protein 10 combined with gemcitabine].
Deng, HX; Kan, B; Li, J; Mei, K; Tian, L; Wei, YQ; Wen, YJ, 2005
)
0.85
" Further enrollment was terminated in March 2003 as a result of a phase III trial suggesting that aprinocarsen did not have an added survival benefit when combined with paclitaxel and carboplatin therapy in patients with NSCLC."( Randomized phase II evaluation of aprinocarsen in combination with gemcitabine and cisplatin for patients with advanced/metastatic non-small cell lung cancer.
Canon, JL; John, W; Lahn, M; Mali, P; Peterson, P; Pirker, R; Riska, H; Vansteenkiste, J, 2005
)
0.56
"The objective of this study was to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of S-1, an oral fluorouracil derivative, combined with gemcitabine, the current standard treatment for advanced pancreatic cancer (APC)."( Phase I trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer.
Ishihara, T; Kato, H; Kobayashi, A; Nakamura, K; Saisho, H; Sudo, K; Tadenuma, H; Yamaguchi, T, 2005
)
0.79
"One of the emerging problems concerning the use of antiangiogenic drugs, when used in combination with certain chemotherapy regimens, is enhanced rates and severity of adverse clotting events."( In vitro procoagulant activity induced in endothelial cells by chemotherapy and antiangiogenic drug combinations: modulation by lower-dose chemotherapy.
du Manoir, J; Francia, G; Hicklin, DJ; Kerbel, RS; Ma, L; Rak, J; Viloria-Petit, A, 2005
)
0.33
") gemcitabine (GEM) at low dose plus oral chemotherapy with uracil-tegafur (UFT) and cyclophosphamide (CPA) in combination with radiotherapy (RT) against recurrent and advanced pancreatic cancers."( Phase II study on low dose gemcitabine plus oral chemotherapy with uracil-tegafur and cyclophosphamide in combination with radiotherapy against recurrent and advanced pancreatic cancer.
Endo, S; Hashimoto, K; Higami, T; Itakura, M; Koike, M; Maruyama, R; Nio, Y; Tsuji, M; Yamaguchi, K; Yano, S, 2005
)
1.35
" Use of the anti-CD20 monoclonal antibody rituximab in combination with chemotherapy for B-NHL is becoming prevalent in clinical practice, but has not been extensively studied in pre-clinical models."( Enhanced efficacy of gemcitabine in combination with anti-CD20 monoclonal antibody against CD20+ non-Hodgkin's lymphoma cell lines in vitro and in scid mice.
Jin, F; Joshi, I; Obasaju, C; Smith, MR, 2005
)
0.65
" Patients in study arm A will be treated with chemoradiation using intensity modulated radiation therapy (IMRT) combined with gemcitabine and simultaneous cetuximab infusions."( Randomized phase II--study evaluating EGFR targeting therapy with cetuximab in combination with radiotherapy and chemotherapy for patients with locally advanced pancreatic cancer--PARC: study protocol [ISRCTN56652283].
Abdollahi, A; Buchler, MW; Buechler, P; Debus, J; Didinger, B; Friess, H; Heeger, S; Herfarth, KK; Huber, PE; Krempien, R; Muenter, MW; Nill, S; Timke, C, 2005
)
0.53
"This phase I trial was designed to determine the safety and maximum tolerated dose (MTD) of tipifarnib in combination with gemcitabine and cisplatin in patients with advanced solid tumours."( Phase I and pharmacological study of the farnesyltransferase inhibitor tipifarnib (Zarnestra, R115777) in combination with gemcitabine and cisplatin in patients with advanced solid tumours.
Beijnen, JH; Crul, M; Howes, A; Pluim, D; Schellens, JH; Siegel-Lakhai, WS; Solanki, B; Sparidans, RW; Zhang, S, 2005
)
0.74
" injection of gemcitabine did not inhibit tumor growth, its combination with AEE788 and STI571 produced >80% inhibition of tumor growth and prolonged survival in parallel with increases in number of tumor cells and tumor-associated endothelial cell apoptosis, decreased microvascular density, decreased proliferation rate, and prolonged survival."( Simultaneous inhibition of EGFR, VEGFR, and platelet-derived growth factor receptor signaling combined with gemcitabine produces therapy of human pancreatic carcinoma and prolongs survival in an orthotopic nude mouse model.
Abbruzzese, JL; Baker, CH; Bucana, CD; Fan, D; Fidler, IJ; Kitadai, Y; Kuwai, T; Sasaki, T; Yokoi, K, 2005
)
0.9
" Radiation consisted of 4500-5000 cGy in 25 daily fractions combined with brachytherapy to take point A to > or = 8500 cGy."( Weekly gemcitabine and cisplatin in combination with pelvic radiation in the primary therapy of cervical cancer: a phase I trial of the Puget Sound Oncology Consortium.
Garcia, R; Goff, BA; Greer, B; Koh, WJ; Swensen, RE; Swisher, EM; Tamimi, H, 2006
)
0.79
" The aim of this study was to evaluate the therapeutic efficacy of Ad-NK4 in combination with gemcitabine (GEM) against pancreatic cancer."( Peritumoral injection of adenovirus vector expressing NK4 combined with gemcitabine treatment suppresses growth and metastasis of human pancreatic cancer cells implanted orthotopically in nude mice and prolongs survival.
Inadome, N; Maemondo, M; Matsumoto, K; Mizumoto, K; Murakami, M; Nagai, E; Nakamura, T; Nukiwa, T; Ogura, Y; Saimura, M; Tanaka, M, 2006
)
0.79
"A total of 208 cycles of chemotherapy were given with a median of 4 per patient."( Fixed dose-rate infusion of gemcitabine in combination with cisplatin and UFT in advanced carcinoma of the pancreas.
Barón, MG; Casado, E; Castañón, C; Castro, J; Cruz, M; Feliu, J; Fonseca, E; Jara, C; Jaráiz, AR; León, A; Lomas, M; Sáenz, JG, 2006
)
0.63
" Then, the effects of this ceramide, alone or in combination with GMZ, on the growth of UM-SCC-22A xenografts in SCID mice was assessed following the determination of preclinical parameters, such as maximum tolerated dose, clearance from the blood, and bioaccumulation."( Potent antitumor activity of a novel cationic pyridinium-ceramide alone or in combination with gemcitabine against human head and neck squamous cell carcinomas in vitro and in vivo.
Bielawska, A; Bielawski, J; Cobanoglu, B; Day, TA; Hannun, YA; Koybasi, S; Meyer, M; Obeid, LM; Ogretmen, B; Ponnusamy, S; Rossi, MJ; Senkal, CE; Sinha, D; Sundararaj, K; Szulc, Z, 2006
)
0.55
" Lipoplatin at 125 mg/m2 was defined as dose limiting toxicity (DLT) and 100 mg/m2 as the maximum tolerated dose (MTD) in combination with 1000 mg/m2 of gemcitabine."( Liposomal cisplatin combined with gemcitabine in pretreated advanced pancreatic cancer patients: a phase I-II study.
Boulikas, T; Rigatos, SK; Stathopoulos, GP; Stathopoulos, JG; Vougiouka, M, 2006
)
0.81
"GEMOX-B could be safely administered with close monitoring and had moderate antitumor activity for patients with advanced HCC."( Phase II study of gemcitabine and oxaliplatin in combination with bevacizumab in patients with advanced hepatocellular carcinoma.
Bhargava, P; Blaszkowsky, LS; Clark, JW; Enzinger, PC; Hale, KE; Horgan, K; Muzikansky, A; Ryan, DP; Sheehan, S; Stuart, K; Zhu, AX, 2006
)
0.67
"We present here a case of severe, but reversible, congestive cardiac failure in a lung cancer patient who had no prior cardiac history, after receiving an experimental treatment of bortezomib combined with chemotherapy."( Severe reversible cardiac failure after bortezomib treatment combined with chemotherapy in a non-small cell lung cancer patient: a case report.
Giaccone, G; Voortman, J, 2006
)
0.33
"We conducted a phase II trial of gemcitabine with S-1, oral fluorouracil (5-FU) prodrug tegafur combined with two modulators, 5-chloro-2, 4-dihydroxypyridine and potassium oxonate, to evaluate the activity and toxicity of such a combination in metastatic pancreatic cancer (MPC) patients."( Phase II trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer.
Ishihara, T; Kato, H; Nakamura, K; Saisho, H; Sudo, K; Yamaguchi, T, 2006
)
0.88
" Patients were treated with weekly T (4 mg/kg on day 0, then 2 mg/kg), in combination with gem (800 mg/m(2)) and vin (25 mg/m(2)) on days 1 and 8, every 21 days."( Trastuzumab in combination with gemcitabine and vinorelbine as second-line therapy for HER-2/neu overexpressing metastatic breast cancer.
Amici, S; Bonginelli, P; Bonsignori, M; Carillio, G; De Sio, L; Fanelli, M; Gasparini, G; Gattuso, D; Longo, R; Mariani, L; Massaccesi, C; Morabito, A; Torino, F, 2006
)
0.62
" The aim of this study is to investigate the efficacy and toxicity of divided dose of cisplatin combined with gemcitabine in chemo-naïve patients with malignant mesothelioma."( Divided dose of cisplatin combined with gemcitabine in malignant mesothelioma.
Akbulut, H; Büyükçelik, A; Demirkazik, A; Dinçol, D; Gören, D; Içli, F; Mousa, U; Onur, H; Senler, FC; Utkan, G; Yalçin, B, 2006
)
0.81
" Furthermore, cell fusion in combination with chemotherapy resulted in strongly enhanced Annexin V binding, an early marker for apoptosis, when compared with single treatment."( Enhanced killing of pancreatic cancer cells by expression of fusogenic membrane glycoproteins in combination with chemotherapy.
Hoffmann, D; Wildner, O, 2006
)
0.33
"05), 10(-6) mg/ml gemcitabine in combination with 10(-4) mg/ml TNP-470 had significant effect (P<0."( Inhibition of expression of vascular endothelial growth factor and its receptors in pulmonary adenocarcinoma cell by TNP-470 in combination with gemcitabine.
Tu, LF; Wang, LH; Wang, XF; Zhou, JY, 2006
)
0.87
" Findings from preclinical studies prompted a Phase I trial to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of bortezomib in combination with gemcitabine in patients with recurring/refractory advanced solid tumors."( Phase I clinical trial of bortezomib in combination with gemcitabine in patients with advanced solid tumors.
Appleman, LJ; Clark, JW; Cusack, J; Eder, JP; Enzinger, PC; Fidias, P; Fishman, M; Kashala, O; Lynch, T; Ryan, DP; Supko, JG; Zhu, AX, 2006
)
0.77
" Preclinically, gemcitabine has demonstrated synergy when combined with platinum compounds."( A phase I study of oxaliplatin in combination with gemcitabine: correlation of clinical outcome with gene expression.
Chow, W; Doroshow, J; Frankel, P; Gandara, D; Juhasz, A; Lenz, HJ; Leong, L; Lim, D; Margolin, K; Morgan, R; Newman, E; Shibata, S; Somlo, G; Synold, T; Yen, Y, 2007
)
0.94
" A phase II study was undertaken to determine the efficacy of a single dose of cisplatin in combination with weekly gemcitabine in patients with metastatic pancreatic carcinoma."( Phase II study of cisplatin combined with weekly gemcitabine in the treatment of patients with metastatic pancreatic carcinoma.
Bang, S; Chung, JB; Jeon, TJ; Kim, MH; Park, JY; Park, SW; Song, SY, 2006
)
0.8
"The modified regimen of a single dose of cisplatin per cycle in combination with weekly gemcitabine appeared to have a more favorable therapeutic index and comparable toxicity profiles."( Phase II study of cisplatin combined with weekly gemcitabine in the treatment of patients with metastatic pancreatic carcinoma.
Bang, S; Chung, JB; Jeon, TJ; Kim, MH; Park, JY; Park, SW; Song, SY, 2006
)
0.81
" Only the initial 1 course was administered with 5-FU (500 mg/body) as an inpatient, and further courses were performed as an outpatient with no severe adverse events."( A case report--The marked response to gemcitabine combined with irinotecan and low-dose cisplatin chemotherapy for advanced gastric cancer with multiple liver metastases.
Fujiwara, T; Gochi, A; Kagawa, S; Tanaka, N; Teraishi, F; Uno, F, 2006
)
0.6
"The objective of this study was to determine the maximum tolerated dose and dose-limiting toxicity (DLT) of carboplatin in combination with gemcitabine and irinotecan in patients with solid tumors."( Phase I study of carboplatin in combination with gemcitabine and irinotecan in patients with solid tumors: preliminary evidence of activity in small cell and neuroendocrine carcinomas.
Antonia, S; Chiappori, A; de Lima Lopes, G; Haura, E; Langevin, M; Lush, R; Rocha-Lima, CM; Simon, G; Sullivan, D, 2007
)
0.8
"Carboplatin in combination with gemcitabine and irinotecan was feasible."( Phase I study of carboplatin in combination with gemcitabine and irinotecan in patients with solid tumors: preliminary evidence of activity in small cell and neuroendocrine carcinomas.
Antonia, S; Chiappori, A; de Lima Lopes, G; Haura, E; Langevin, M; Lush, R; Rocha-Lima, CM; Simon, G; Sullivan, D, 2007
)
0.88
" On the basis of pre-clinical evidence and some clinical data, we conducted a phase II study of 13-cis-retinoic acid (13-cis-RA) in combination with gemcitabine in patients with unresectable pancreatic carcinoma."( 13-cis-Retinoic acid in combination with gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer--report of a pilot phase II study.
Dalgleish, A; Hill, M; Lofts, F; Maraveyas, A; Michael, A, 2007
)
0.8
"The aim of this phase II study was to evaluate the response rate to gemcitabine combined with cisplatin in patients with locally advanced, metastatic or recurrent biliary tract cancer who had received no prior chemotherapy."( Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas.
Ahn, MJ; Kim, HK; Kim, JS; Kim, TY; Lee, J; Lee, MA; Lee, NS; Lim, HY; Park, BJ, 2008
)
0.92
" Combination with other treatment modalities such as chemotherapy may overcome immunoresistance of cancer cells."( Dendritic cell-based vaccination combined with gemcitabine increases survival in a murine pancreatic carcinoma model.
Bauer, C; Bauernfeind, F; Dauer, M; Eigler, A; Endres, S; Lehr, HA; Orban, M; Schnurr, M; Sterzik, A, 2007
)
0.6
"DC-based immunotherapy may not only be successfully combined with gemcitabine for the treatment of advanced pancreatic carcinoma, but may also be effective in preventing local recurrence or metastatisation in tumour-free patients."( Dendritic cell-based vaccination combined with gemcitabine increases survival in a murine pancreatic carcinoma model.
Bauer, C; Bauernfeind, F; Dauer, M; Eigler, A; Endres, S; Lehr, HA; Orban, M; Schnurr, M; Sterzik, A, 2007
)
0.83
" This phase III, randomized, double-blind, placebo-controlled, multicenter trial evaluated the efficacy and safety of erlotinib in combination with cisplatin and gemcitabine as first-line treatment for advanced non-small-cell lung cancer (NSCLC)."( Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: the Tarceva Lung Cancer Investigation Trial.
De Rosa, F; Gatzemeier, U; Janaskova, T; Karnicka-Mlodkowski, H; Kaukel, E; Manikhas, GM; Milanowski, J; Pesek, M; Pluzanska, A; Ramlau, R; Roubec, J; Serwatowski, P; Strausz, J; Szczesna, A; Vansteenkiste, J; Von Pawel, J, 2007
)
0.78
"Patients received erlotinib (150 mg/d) or placebo, combined with up to six 21-day cycles of chemotherapy (gemcitabine 1,250 mg/m2 on days 1 and 8 and cisplatin 80 mg/m2 on day 1)."( Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: the Tarceva Lung Cancer Investigation Trial.
De Rosa, F; Gatzemeier, U; Janaskova, T; Karnicka-Mlodkowski, H; Kaukel, E; Manikhas, GM; Milanowski, J; Pesek, M; Pluzanska, A; Ramlau, R; Roubec, J; Serwatowski, P; Strausz, J; Szczesna, A; Vansteenkiste, J; Von Pawel, J, 2007
)
0.79
"To establish maximum tolerated dose (MTD) and tolerability of two schedules of bortezomib in combination with cisplatin and gemcitabine as first-line treatment of patients with advanced solid tumors."( A parallel dose-escalation study of weekly and twice-weekly bortezomib in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced solid tumors.
Giaccone, G; Honeywell, R; Kuenen, BC; Peters, GJ; Smit, EF; van de Velde, H; Voortman, J, 2007
)
0.77
"Previous studies have indicated that, in combination with cisplatin, fixed dose rate gemcitabine may be more efficacious than standard infusion gemcitabine."( Gemcitabine administered as a short infusion versus a fixed dose rate in combination with cisplatin for the treatment of patients with advanced non-small cell lung cancer.
Blajman, CR; Del Giglio, A; Fein, L; Hall, BJ; Orlando, M; Pereira, JR; Richardet, E; Schwartsmann, G; van Kooten, M; West, TM, 2007
)
2.01
"The aim was to evaluate the efficacy of gemcitabine combined with a platinum agent compared to single-agent gemcitabine in a pooled analysis of two randomized trials."( Increased survival using platinum analog combined with gemcitabine as compared to single-agent gemcitabine in advanced pancreatic cancer: pooled analysis of two randomized trials, the GERCOR/GISCAD intergroup study and a German multicenter study.
Heinemann, V; Hinke, A; Labianca, R; Louvet, C, 2007
)
0.85
"To evaluate safety and pharmacokinetics and to establish the maximum tolerated dose of glufosfamide when administered in combination with gemcitabine in advanced solid tumors."( A Phase 1 dose-escalation trial of glufosfamide in combination with gemcitabine in solid tumors including pancreatic adenocarcinoma.
Chiorean, EG; Colowick, AB; Dragovich, T; Hamm, J; Jung, DT; Kroll, S; Langmuir, VK; Loehrer, PJ; Tidmarsh, GF, 2008
)
0.78
"Phase I data indicate that full dose glufosfamide (4,500 mg/m(2)) can be given safely in combination with gemcitabine."( A Phase 1 dose-escalation trial of glufosfamide in combination with gemcitabine in solid tumors including pancreatic adenocarcinoma.
Chiorean, EG; Colowick, AB; Dragovich, T; Hamm, J; Jung, DT; Kroll, S; Langmuir, VK; Loehrer, PJ; Tidmarsh, GF, 2008
)
0.79
"To investigate the antiproliferative effect of the histone deacetylase (HDAC) inhibitor MS-275 on cholangiocarcinoma cells alone and in combination with conventional cytostatic drugs (gemcitabine or doxorubicin) or the novel anticancer agents sorafenib or bortezomib."( Histone deacetylase inhibitor MS-275 alone or combined with bortezomib or sorafenib exhibits strong antiproliferative action in human cholangiocarcinoma cells.
Baradari, V; Höpfner, M; Huether, A; Scherübl, H; Schuppan, D, 2007
)
0.53
" Furthermore, additive anti-neoplastic effects were observed when MS-275 treatment was combined with gemcitabine or doxorubicin, while combination with the multi-kinase inhibitor sorafenib or the proteasome inhibitor bortezomib resulted in overadditive anti-neoplastic effects."( Histone deacetylase inhibitor MS-275 alone or combined with bortezomib or sorafenib exhibits strong antiproliferative action in human cholangiocarcinoma cells.
Baradari, V; Höpfner, M; Huether, A; Scherübl, H; Schuppan, D, 2007
)
0.56
"The growth of human cholangiocarcinoma cells can be potently inhibited by MS-275 alone or in combination with conventional cytostatic drugs or new, targeted anticancer agents."( Histone deacetylase inhibitor MS-275 alone or combined with bortezomib or sorafenib exhibits strong antiproliferative action in human cholangiocarcinoma cells.
Baradari, V; Höpfner, M; Huether, A; Scherübl, H; Schuppan, D, 2007
)
0.34
" The MTD for erlotinib in combination with twice weekly gemcitabine-based chemoradiation was 100 mg/day."( A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma.
Capanu, M; Duffy, A; Kelsen, DP; Kortmansky, J; Minsky, B; O'Reilly, EM; Puleio, S; Saltz, L; Schwartz, GK, 2008
)
0.85
"In combination with fixed dose gemcitabine at 40 mg/m(2) twice weekly and radiation at 180 cGy/day, the MTD of erlotinib was found to be 100 mg/day."( A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma.
Capanu, M; Duffy, A; Kelsen, DP; Kortmansky, J; Minsky, B; O'Reilly, EM; Puleio, S; Saltz, L; Schwartz, GK, 2008
)
0.89
"These very preliminary data suggest that nab-P in combination with B with and without G is a safe regimen and a formal phase II trial has been developed at the University of Miami to confirm its safety and clinical activity."( Paclitaxel albumin-bound particles (abraxane) in combination with bevacizumab with or without gemcitabine: early experience at the University of Miami/Braman Family Breast Cancer Institute.
Gluck, S; Lobo, C; Lopes, G; Silva, O, 2007
)
0.56
"The purpose of this trial was to define the maximum tolerated duration (MTD), dose-limiting toxicity (DLT), regimen-related toxicities (RRT), and pharmacokinetics of gemcitabine infused at a fixed dose rate (FDR) of 10 mg/m2/min, combined with docetaxel/melphalan/carboplatin, using autologous stem cell transplantation (ASCT)."( Phase I and pharmacokinetic study of gemcitabine administered at fixed-dose rate, combined with docetaxel/melphalan/carboplatin, with autologous hematopoietic progenitor-cell support, in patients with advanced refractory tumors.
Aldaz, A; Aramendía, JM; Aristu, J; Centeno, C; Hernández, M; Moreno, M; Nieto, Y; Pérez-Calvo, J; Rifón, J; Sayar, O; Viteri, S; Viúdez, A; Zafra, A; Zufia, L, 2007
)
0.81
"To evaluate the anti-tumor effect and toxicity of gemcitabine combined with platinum chemotherapy on recurrent epithelial ovarian cancer."( Phase II study of gemcitabine combined with platinum chemotherapy for recurrent epithelial ovarian cancer.
Huang, HF; Lang, JH; Pan, LY; Peng, P; Shen, K; Wu, M; Yang, JX, 2007
)
0.93
"Phase II study of gemcitabine combined with platinum chemotherapy was carried out in 22 patients with recurrent epithelial ovarian cancer."( Phase II study of gemcitabine combined with platinum chemotherapy for recurrent epithelial ovarian cancer.
Huang, HF; Lang, JH; Pan, LY; Peng, P; Shen, K; Wu, M; Yang, JX, 2007
)
1.01
"0) after initiation of gemcitabine combined with platinum chemotherapy."( Phase II study of gemcitabine combined with platinum chemotherapy for recurrent epithelial ovarian cancer.
Huang, HF; Lang, JH; Pan, LY; Peng, P; Shen, K; Wu, M; Yang, JX, 2007
)
0.98
"Gemcitabine combined with platinum chemotherapy appears to be an effective and well-tolerant treatment for recurrent epithelial ovarian cancer, including platinum-resistant or -refractory diseases."( Phase II study of gemcitabine combined with platinum chemotherapy for recurrent epithelial ovarian cancer.
Huang, HF; Lang, JH; Pan, LY; Peng, P; Shen, K; Wu, M; Yang, JX, 2007
)
2.12
"To determine the antitumor activity of the anti-mesothelin immunotoxin SS1P in combination with gemcitabine against mesothelin-expressing tumor xenografts."( Anti-mesothelin immunotoxin SS1P in combination with gemcitabine results in increased activity against mesothelin-expressing tumor xenografts.
Broaddus, VC; Hassan, R; Liewehr, DJ; Wilson, S; Zhang, J, 2007
)
0.81
"The in vitro activity of SS1P in combination with gemcitabine against the mesothelin-expressing cell line A431/K5 was evaluated using cytotoxicity and apoptosis assays."( Anti-mesothelin immunotoxin SS1P in combination with gemcitabine results in increased activity against mesothelin-expressing tumor xenografts.
Broaddus, VC; Hassan, R; Liewehr, DJ; Wilson, S; Zhang, J, 2007
)
0.84
" In contrast, in the in vivo setting, there was a marked synergy when SS1P was combined with gemcitabine for the treatment of mesothelin-expressing tumor xenografts."( Anti-mesothelin immunotoxin SS1P in combination with gemcitabine results in increased activity against mesothelin-expressing tumor xenografts.
Broaddus, VC; Hassan, R; Liewehr, DJ; Wilson, S; Zhang, J, 2007
)
0.81
"SS1P in combination with gemcitabine results in marked antitumor activity against mesothelin-expressing tumors."( Anti-mesothelin immunotoxin SS1P in combination with gemcitabine results in increased activity against mesothelin-expressing tumor xenografts.
Broaddus, VC; Hassan, R; Liewehr, DJ; Wilson, S; Zhang, J, 2007
)
0.89
" The objective of this phase 2 trial was to investigate the activity of gemcitabine in combination with rituximab in patients with recurring or refractory HL."( Phase 2 study of gemcitabine in combination with rituximab in patients with recurrent or refractory Hodgkin lymphoma.
Fayad, LE; Goy, A; Hagemeister, F; McLaughlin, P; Neelapu, S; Oki, Y; Pro, B; Romaguera, J; Samaniego, F; Younes, A, 2008
)
0.92
" The favorable safety profile and the ease of its administration in outpatient settings warrant investigating it further in combination with other active drugs."( Phase 2 study of gemcitabine in combination with rituximab in patients with recurrent or refractory Hodgkin lymphoma.
Fayad, LE; Goy, A; Hagemeister, F; McLaughlin, P; Neelapu, S; Oki, Y; Pro, B; Romaguera, J; Samaniego, F; Younes, A, 2008
)
0.69
" We conducted a phase I study of gemcitabine and carboplatin in combination with bortezomib."( The proteasome inhibitor bortezomib in combination with gemcitabine and carboplatin in advanced non-small cell lung cancer: a California Cancer Consortium Phase I study.
Bold, R; Davies, AM; Gandara, DR; Gumerlock, PH; Lara, PN; Lau, DH; Lenz, HJ; Ruel, C; Schenkein, DP; Shibata, S, 2008
)
0.87
"Chemotherapy regimens including gemcitabine in combination with microtubule inhibitors such as docetaxel and paclitaxel have wide clinical application."( A phase I trial of gemcitabine in combination with patupilone in patients with advanced solid tumors.
Alberti, D; Bailey, H; Brandon, H; Eickhoff, J; Holen, K; Morgan-Meadows, S; Oliver, K; Schelman, W; Thomas, JP; Wilding, G, 2008
)
0.96
" The human lung carcinoma MV522 cell line and its corresponding xenograft model were used to evaluate the activity of irofulven in combination with these different agents."( Synergy of Irofulven in combination with various anti-metabolites, enzyme inhibitors, and miscellaneous agents in MV522 lung carcinoma cells: marked interaction with gemcitabine and 5-fluorouracil.
Estes, LA; Kelner, MJ; McMorris, TC; Rojas, RJ; Suthipinijtham, P, 2008
)
0.54
" The objectives of this study were to determine safety and efficacy in chemotherapy-naive patients with metastatic pancreatic cancer receiving bevacizumab in combination with fixed-dose rate (FDR) gemcitabine and low-dose cisplatin."( A phase II study evaluating bevacizumab in combination with fixed-dose rate gemcitabine and low-dose cisplatin for metastatic pancreatic cancer: is an anti-VEGF strategy still applicable?
Bergsland, EK; Dito, E; Hwang, J; Ko, AH; Schillinger, B; Scott, J; Tempero, MA; Venook, AP; Wong, D; Xu, Z, 2008
)
0.76
"The authors conducted a phase 2 trial of the antiepidermal growth factor receptor (EGFR) monoclonal antibody cetuximab in combination with the gemcitabine plus oxaliplatin (GEMOX) regimen in patients with documented progressive hepatocellular carcinoma (HCC)."( Gemcitabine plus oxaliplatin (GEMOX) combined with cetuximab in patients with progressive advanced stage hepatocellular carcinoma: results of a multicenter phase 2 study.
Artru, P; Asnacios, A; Fartoux, L; Hebbar, M; Louafi S, S; Mansoubakht, T; Poynard, T; Romano, O; Rosmorduc, O; Taieb, J; Tesmoingt, C, 2008
)
1.99
" This trial was designed to determine the maximum tolerated dose and dose limiting toxicities (DLT) of nab-paclitaxel in combination with gemcitabine."( Phase I trial of nanoparticle albumin-bound paclitaxel in combination with gemcitabine in patients with thoracic malignancies.
Dees, EC; Goldberg, RM; Hayes, DN; Lee, CB; Moore, DT; Socinski, MA; Stinchcombe, TE, 2008
)
0.78
"The maximum tolerated dose of nab-paclitaxel is 300 mg/m in combination with gemcitabine 1000 mg/m on days 1, 8 every 21 days."( Phase I trial of nanoparticle albumin-bound paclitaxel in combination with gemcitabine in patients with thoracic malignancies.
Dees, EC; Goldberg, RM; Hayes, DN; Lee, CB; Moore, DT; Socinski, MA; Stinchcombe, TE, 2008
)
0.81
"Our results show that the regimen of gemcitabine combined with capecitabine is effective and well tolerated in patients with unresectable relapsed or metastatic carcinoma of the biliary tract."( [Gemcitabine combined with capecitabine in the treatment for 41 patients with relapsed or metastatic biliary tract carcinoma].
Chen, X; Chen, ZS; Li, J; Ouyang, XN; Xie, FW; Yu, ZY, 2008
)
1.53
"This randomized phase II study investigated the efficacy and safety of a new taxane, larotaxel (XRP9881), in combination with either cisplatin or gemcitabine in the first-line treatment of patients with nonirradiable stage IIIB or stage IV non-small cell lung cancer to select the combination having the most promising antitumor activity."( Randomized multicenter phase II study of larotaxel (XRP9881) in combination with cisplatin or gemcitabine as first-line chemotherapy in nonirradiable stage IIIB or stage IV non-small cell lung cancer.
Besenval, M; Bosquee, L; Brain, E; Dansin, E; Dohollou, N; Gervais, R; Quoix, E; Sessa, C; Urban, T; Vansteenkiste, J; Zatloukal, P, 2008
)
0.77
"Both larotaxel combinations were effective and manageable, however all measured efficacy parameters (response rate, progression free survival, and survival) seemed to favor the combination with cisplatin."( Randomized multicenter phase II study of larotaxel (XRP9881) in combination with cisplatin or gemcitabine as first-line chemotherapy in nonirradiable stage IIIB or stage IV non-small cell lung cancer.
Besenval, M; Bosquee, L; Brain, E; Dansin, E; Dohollou, N; Gervais, R; Quoix, E; Sessa, C; Urban, T; Vansteenkiste, J; Zatloukal, P, 2008
)
0.57
" We then examined the antitumor effect of IAB-1 in combination with anticancer drugs against RCC."( Significant antitumor activity of cationic multilamellar liposomes containing human interferon-beta gene in combination with 5-fluorouracil against human renal cell carcinoma.
Abe, K; Fujiwara, J; Hayashi, I; Ishida, H; Kawauchi, A; Miki, T; Mizuno, M; Mizutani, Y; Nakanishi, H; Okada, K; Toiyama, D; Yamamoto, K; Yoshida, J, 2008
)
0.35
" We wanted to evaluate matuzumab (EMD72000), a fully humanized ErbB-1-specific monoclonal antibody in combination with gemcitabine in experimental pancreatic cancer."( Matuzumab short-term therapy in experimental pancreatic cancer: prolonged antitumor activity in combination with gemcitabine.
Amendt, C; Bruns, CJ; Eichhorn, ME; Ischenko, I; Jauch, KW; Kleespies, A; Mantell, O; Seeliger, H, 2008
)
0.77
"To evaluate the efficacy and safety of gemcitabine-oxaliplatin (GEMOX) combined with huachansu (cinobufagin) injection treatment in patients with locally advanced or metastatic gallbladder carcinoma (GBC), and to assess the quality of life (QOL) of such patients."( Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma.
Pan, BR; Qin, TJ; Ruan, ZP; Yun, J; Zhang, LX; Zhao, XH, 2008
)
0.93
"GEMOX combined with huachansu (cinobufagin) injection is well tolerated, effective, thus improving the QOL of patients with advanced GBC."( Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma.
Pan, BR; Qin, TJ; Ruan, ZP; Yun, J; Zhang, LX; Zhao, XH, 2008
)
0.66
" This open, multicenter, single-arm phase I/II study assessed the safety and activity of gemcitabine in combination with non-pegylated liposomal doxorubicin (Myocet), a more cardiac-friendly anthracycline, in the first-line treatment of patients with advanced breast cancer."( Non-pegylated liposomal doxorubicin combined with gemcitabine as first-line treatment for metastatic or locally advanced breast cancer. Final results of a phase I/II trial.
Adrover, E; Calvo, L; Colomer, R; De la Haba, J; Del Barco, S; Rifà, J; Sánchez, P; Tusquets, I; Virizuela, JA, 2009
)
0.83
"The aim of this open-label phase 1b study was to assess the safety and pharmacokinetics of motesanib in combination with gemcitabine in patients with advanced solid tumours."( Safety and pharmacokinetics of motesanib in combination with gemcitabine for the treatment of patients with solid tumours.
Lipton, L; McCoy, S; McGreivy, J; Price, TJ; Rosenthal, MA; Sun, YN, 2008
)
0.8
" This study was to evaluate the efficacy of three-dimensional conformal gamma-knife radiotherapy combined with thermochemotherapy on locally advanced pancreatic cancer."( [Efficacy of whole body gamma-knife radiotherapy combined with thermochemotherapy on locally advanced pancreatic cancer].
Cai, CL; Kang, JB; Li, JG; Nie, Q; Qi, WJ; Wang, B; Zhang, LP, 2008
)
0.35
"3-D conformal gamma-knife radiotherapy combined with thermochemotherapy is well tolerated and is relatively effective for most patients with locally advanced pancreatic cancer."( [Efficacy of whole body gamma-knife radiotherapy combined with thermochemotherapy on locally advanced pancreatic cancer].
Cai, CL; Kang, JB; Li, JG; Nie, Q; Qi, WJ; Wang, B; Zhang, LP, 2008
)
0.35
"Women with measurable MBC pretreated with anthracycline- and taxane-based chemotherapy received oral gefitinib (250 mg/day) continuously combined with intravenous gemcitabine 1000 mg/m2 and vinorelbine 25 mg/m2 on day 1, every 2 weeks."( Gefitinib in combination with gemcitabine and vinorelbine in patients with metastatic breast cancer pre-treated with taxane and anthracycline chemotherapy: a phase I/II trial.
Amarantidis, K; Georgoulias, V; Gioulbasanis, I; Ignatiadis, M; Kakolyris, S; Kalbakis, K; Kalykaki, A; Mavroudis, D; Saridaki, Z; Vamvakas, L,
)
0.62
" Significant activity and favorable toxicity profile provides a basis for considering this regimen for further evaluation in phase III trials or in combination with biologic agents."( Phase II trial of weekly nab (nanoparticle albumin-bound)-paclitaxel (nab-paclitaxel) (Abraxane) in combination with gemcitabine in patients with metastatic breast cancer (N0531).
Bane, CL; Gross, GG; LaPlant, BR; Palmieri, FM; Roy, V, 2009
)
0.56
"Cediranib at 30 mg daily can be combined with standard doses of cisplatin/gemcitabine with encouraging anti-tumour activity, and is the recommended phase III dose."( A phase I and pharmacokinetic study of daily oral cediranib, an inhibitor of vascular endothelial growth factor tyrosine kinases, in combination with cisplatin and gemcitabine in patients with advanced non-small cell lung cancer: a study of the National C
Chen, E; Feld, R; Gauthier, I; Goss, G; Laurie, S; Leighl, N; Powers, J; Seymour, L; Shepherd, FA, 2009
)
0.78
" The levels of pro-caspase-3 were decreased by heat treatment combined with gemcitabine."( Effect of hyperthermia combined with gemcitabine on apoptotic cell death in cultured human pancreatic cancer cell lines.
Adachi, S; Handa, O; Ishikawa, T; Kokura, S; Naito, Y; Okayama, T; Takagi, T; Yoshikawa, T, 2009
)
0.86
"In the treatment of advanced non-small cell lung cancer, gemcitabine in low dose in prolonged infusion in combination with cisplatin has low toxicity and has activity comparable with gemcitabine in higher dose in standard brief infusion."( Gemcitabine in brief versus prolonged low-dose infusion, both combined with cisplatin, for advanced non-small cell lung cancer: a randomized phase II clinical trial.
Kovac, V; Smrdel, U; Vrankar, M; Zadnik, V; Zwitter, M, 2009
)
2.04
"A phase I study was initiated to determine the maximum tolerated dose (MTD) of prolonged-infusion gemcitabine combined with cyclophosphamide in patients with metastatic breast carcinoma (MBC)."( Phase I study of prolonged-infusion gemcitabine combined with cyclophosphamide in patients with metastatic carcinoma of the breast: tolerability of an optimal dose schedule.
Estephan, F; Esteva, FJ; Frye, DK; Ibrahim, NK; Mejia, JA; Valero, V, 2009
)
0.85
" The aim of the present study is to clarify the effectiveness of GEM combined with CDDP and 5FU (GFP) therapy for unresectable biliary carcinoma."( Usefulness of gemcitabine combined with 5-fluorouracil and cisplatin (GFP) in patients for unresectable biliary carcinoma.
Arakawa, Y; Hanaoka, J; Ikegami, T; Imura, S; Kanamoto, M; Kanemura, H; Morine, Y; Nii, A; Shimada, M,
)
0.49
" The present study was designed to evaluate the efficacy of low-dose gemcitabine combined with ginsenoside Rg3 on angiogenesis and growth of established Lewis lung carcinoma in mice."( Inhibitory effect of ginsenoside Rg3 combined with gemcitabine on angiogenesis and growth of lung cancer in mice.
Cui, DD; Huang, XB; Huang, Y; Ji, LL; Liu, TG; Mao, SH; Song, HB; Yi, C, 2009
)
0.84
"Ginsenoside Rg3 combined with gemcitabine may significantly inhibit angiogenesis and growth of lung cancer and improve survival and quality of life of tumor-bearing mice."( Inhibitory effect of ginsenoside Rg3 combined with gemcitabine on angiogenesis and growth of lung cancer in mice.
Cui, DD; Huang, XB; Huang, Y; Ji, LL; Liu, TG; Mao, SH; Song, HB; Yi, C, 2009
)
0.89
"To evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of mapatumumab, a fully human monoclonal antibody targeting tumor necrosis factor-related apoptosis-inducing ligand receptor 1 (TRAIL-R1), in combination with gemcitabine and cisplatin."( Mapatumumab, a fully human agonistic monoclonal antibody that targets TRAIL-R1, in combination with gemcitabine and cisplatin: a phase I study.
de Vries, EG; Eskens, FA; Fox, NL; Gietema, JA; Loos, WJ; Miceli, R; Mom, CH; Oldenhuis, CN; Sleijfer, S; Verweij, J, 2009
)
0.75
"Mapatumumab in combination with gemcitabine and cisplatin is safe and well tolerated at doses up to 30 mg/kg."( Mapatumumab, a fully human agonistic monoclonal antibody that targets TRAIL-R1, in combination with gemcitabine and cisplatin: a phase I study.
de Vries, EG; Eskens, FA; Fox, NL; Gietema, JA; Loos, WJ; Miceli, R; Mom, CH; Oldenhuis, CN; Sleijfer, S; Verweij, J, 2009
)
0.85
" After two cycles, a 4-week outpatient treatment of gemcitabine (1000 mg/m(2)) on days 1 and 15 combined with 5-FU (500 mg/m(2)) and CDDP (7 mg/m(2)) on days 1 and 15 was commenced."( Phase II trial of gemcitabine combined with 5-fluorouracil and cisplatin (GFP) chemotherapy in patients with advanced biliary tree cancers.
Gion, T; Harimoto, N; Itoh, S; Maehara, Y; Sugimachi, K; Taketomi, A; Tsujita, E; Yamashita, Y, 2010
)
0.95
" We hypothesized that thalidomide, an oral antiangiogenic agent, when combined with chemotherapy, and as maintenance treatment, would improve survival in patients with advanced non-small-cell lung cancer (NSCLC)."( Randomized double-blind placebo-controlled trial of thalidomide in combination with gemcitabine and Carboplatin in advanced non-small-cell lung cancer.
Gilligan, D; Gower, N; Hackshaw, A; Jitlal, M; Lee, SM; Ottensmeier, C; Price, A; Rudd, R; Spiro, S; Woll, PJ, 2009
)
0.58
"In this large trial of patients with NSCLC, thalidomide in combination with chemotherapy did not improve survival overall, but increased the risk of thrombotic events."( Randomized double-blind placebo-controlled trial of thalidomide in combination with gemcitabine and Carboplatin in advanced non-small-cell lung cancer.
Gilligan, D; Gower, N; Hackshaw, A; Jitlal, M; Lee, SM; Ottensmeier, C; Price, A; Rudd, R; Spiro, S; Woll, PJ, 2009
)
0.58
" While clinical efficacy was limited with the viral mutants alone, outcomes were improved in combination with chemotherapeutics."( Optimisation of replication-selective oncolytic adenoviral mutants in combination with chemotherapeutics.
Halldén, G, 2009
)
0.35
" We explored the efficacy and toxicity of gemcitabine administered at a fixed dose rate or in combination with cisplatin, docetaxel, or irinotecan in a multi-institutional, randomized, phase II study."( Randomized phase II study of gemcitabine administered at a fixed dose rate or in combination with cisplatin, docetaxel, or irinotecan in patients with metastatic pancreatic cancer: CALGB 89904.
Cusnir, M; Enzinger, PC; Goldberg, RM; Gorsch, SM; Hollis, DR; Kindler, HL; Kulke, MH; Mayer, RJ; Niedzwiecki, D; Tempero, MA, 2009
)
0.91
" The recommended phase II dose of flavopiridol was 45 mg/m in combination with irinotecan and gemcitabine every 2 weeks."( A phase I study of flavopiridol in combination with gemcitabine and irinotecan in patients with metastatic cancer.
Chyi Lee, F; Fekrazad, HM; Rabinowitz, I; Royce, M; Smith, HO; Verschraegen, CF, 2010
)
0.83
"The every 2 week dosing is well tolerated with a phase II recommended dose of 45 mg/m of flavopiridol in combination with irinotecan (80 mg/m) and gemcitabine (800 mg/m)."( A phase I study of flavopiridol in combination with gemcitabine and irinotecan in patients with metastatic cancer.
Chyi Lee, F; Fekrazad, HM; Rabinowitz, I; Royce, M; Smith, HO; Verschraegen, CF, 2010
)
0.81
"To observe the effects of Shenyi Capsule combined with gemcitabine plus cisplatin (GP) regimen in treatment of advanced esophageal cancer."( [Efficacy of Shenyi Capsule combined with gemcitabine plus cisplatin in treatment of advanced esophageal cancer: a randomized controlled trial].
Fan, QX; Huang, JY; Sun, Y; Zhang, YQ, 2009
)
0.86
" Patients in the treatment group were treated with Shenyi Capsule combined with GP regimen, and patients in the control group were treated with GP regimen alone."( [Efficacy of Shenyi Capsule combined with gemcitabine plus cisplatin in treatment of advanced esophageal cancer: a randomized controlled trial].
Fan, QX; Huang, JY; Sun, Y; Zhang, YQ, 2009
)
0.62
"Shenyi Capsule combined with GP regimen is feasible and safe in treatment of advanced esophageal cancer, and the effects are better than chemotherapy alone."( [Efficacy of Shenyi Capsule combined with gemcitabine plus cisplatin in treatment of advanced esophageal cancer: a randomized controlled trial].
Fan, QX; Huang, JY; Sun, Y; Zhang, YQ, 2009
)
0.62
" Peptide-specific CTL could be induced by the VEGFR2-169 peptide vaccine at a high rate, even in combination with gemcitabine."( Phase I clinical trial using peptide vaccine for human vascular endothelial growth factor receptor 2 in combination with gemcitabine for patients with advanced pancreatic cancer.
Hirono, S; Kawai, M; Miyazawa, M; Nakamura, Y; Ohsawa, R; Tani, M; Tsunoda, T; Yamaue, H, 2010
)
0.78
"To investigate the influence of the recombinant human endostatin and gemcitabine combined with HIFU on the mouse xenograft model of pancreatic cancer."( The effect of endostatin and gemcitabine combined with HIFU on the animal xenograft model of human pancreatic cancer.
Gu, YH; Guo, RH; Lin, QF; Liu, LX; Shu, YQ; Wang, RS, 2010
)
0.89
" Each arm was treated with gemcitabine, endostatin, gemcitabine combined with endostatin and normal saline respectively."( The effect of endostatin and gemcitabine combined with HIFU on the animal xenograft model of human pancreatic cancer.
Gu, YH; Guo, RH; Lin, QF; Liu, LX; Shu, YQ; Wang, RS, 2010
)
0.95
" HIFU combined with chemotherapy and/or targeted therapy may enhance the effect for pancreatic cancer."( The effect of endostatin and gemcitabine combined with HIFU on the animal xenograft model of human pancreatic cancer.
Gu, YH; Guo, RH; Lin, QF; Liu, LX; Shu, YQ; Wang, RS, 2010
)
0.65
"25 MBq of PT-RAIT combined with a monthly cycle of gemcitabine (3 weekly, 6-mg doses) significantly enhanced survival, compared with PT-RAIT alone."( Pretargeted radioimmunotherapy of pancreatic cancer xenografts: TF10-90Y-IMP-288 alone and combined with gemcitabine.
Chang, CH; Gold, DV; Goldenberg, DM; Karacay, H; McBride, WJ; Ragland, DR; Rossi, EA; Sharkey, RM, 2009
)
0.82
"Z-360 is safe and well tolerated when combined with gemcitabine."( A phase Ib/IIa trial to evaluate the CCK2 receptor antagonist Z-360 in combination with gemcitabine in patients with advanced pancreatic cancer.
Borbath, I; Caplin, ME; Coxon, F; Kato, H; Larvin, M; Meyer, T; Nagano, E; Palmer, DH; Peeters, M; Valle, JW; Waters, JS, 2010
)
0.83
" Twenty-three patients experiencing progression following 6 months after concluding platinum-based chemotherapy were managed with second-line treatment with carboplatin combined with gemcitabine or pemetrexed."( High response of second-line chemotherapy with pemetrexed or gemcitabine combined with carboplatin in patients with non-small-cell lung cancer experiencing progression following 6 months after concluding platinum-based chemotherapy.
Arrieta, O; Astorga, A; Flores-Estrada, D; Martinez-Barrera, L; Michel Ortega, RM; Pachuca, D; Villarreal-Garza, C, 2011
)
0.8
"Through a phase I study with a fixed radiation dose of 54 Gy and escalating doses of weekly gemcitabine, we established a recommended dose of gemcitabine at 250 mg/m in combination with radiation therapy for patients with unresectable pancreatic cancer."( Phase II study of radiation therapy combined with weekly low-dose gemcitabine for locally advanced, unresectable pancreatic cancer.
Doi, R; Fujii, T; Hiraoka, M; Matsuo, Y; Mitsumori, M; Nakamura, A; Oya, N; Shibuya, K, 2011
)
0.83
"Treatment with gemcitabine combined with radiation therapy according to the present schedule is well tolerated and can provide prolonged survival in patients with localized, unresectable pancreatic cancer."( Phase II study of radiation therapy combined with weekly low-dose gemcitabine for locally advanced, unresectable pancreatic cancer.
Doi, R; Fujii, T; Hiraoka, M; Matsuo, Y; Mitsumori, M; Nakamura, A; Oya, N; Shibuya, K, 2011
)
0.96
" This study is aimed to investigate the plasmatic and intracellular pharmacokinetics of gemcitabine given as FDR at doses of 600 and 1,200 mg/m(2) in combination with 75 mg/m(2) of cisplatin in advanced non-small-cell lung cancer (NSCLC) patients."( Pharmacokinetic study of gemcitabine, given as prolonged infusion at fixed dose rate, in combination with cisplatin in patients with advanced non-small-cell lung cancer.
Caffo, O; Cassetta, MI; Fallani, S; Galligioni, E; Marangon, E; Mini, E; Murgia, V; Nobili, S; Novelli, A; Sala, F; Zucchetti, M, 2010
)
0.89
" This study evaluates the therapeutic potential of masitinib in pancreatic cancer, as a single agent and in combination with gemcitabine."( Masitinib combined with standard gemcitabine chemotherapy: in vitro and in vivo studies in human pancreatic tumour cell lines and ectopic mouse model.
Bader, T; Bertucci, F; Castéran, N; Dubreuil, P; Finetti, P; Hanssens, K; Hermine, O; Humbert, M; Iovanna, J; Letard, S; Mansfield, CD; Moussy, A, 2010
)
0.85
"To evaluate the efficacy and safety of masitinib combined with gemcitabine in patients with advanced pancreatic cancer."( Safety and activity of masitinib in combination with gemcitabine in patients with advanced pancreatic cancer.
Deplanque, G; Hammel, P; Hermine, O; Kinet, JP; Levy, P; Mitry, E; Mornex, F; Moussy, A; Raymond, E; Rougier, P; Seitz, JF, 2010
)
0.85
"Twenty-two non-randomised patients with unresectable, locally advanced (n = 9) or metastatic pancreatic cancer (n = 13) received oral masitinib (9 mg/kg/day) combined with standard gemcitabine."( Safety and activity of masitinib in combination with gemcitabine in patients with advanced pancreatic cancer.
Deplanque, G; Hammel, P; Hermine, O; Kinet, JP; Levy, P; Mitry, E; Mornex, F; Moussy, A; Raymond, E; Rougier, P; Seitz, JF, 2010
)
0.8
"The efficacy and safety of masitinib combined with gemcitabine are encouraging, with extended survival and median TTP that support initiation of a phase 3 trial."( Safety and activity of masitinib in combination with gemcitabine in patients with advanced pancreatic cancer.
Deplanque, G; Hammel, P; Hermine, O; Kinet, JP; Levy, P; Mitry, E; Mornex, F; Moussy, A; Raymond, E; Rougier, P; Seitz, JF, 2010
)
0.86
" This study determined the response rate for fixed-dose-rate (FDR) gemcitabine combined with cisplatin."( Fixed-dose-rate gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas.
Abdi, E; Ackland, SP; Brown, C; Gainford, MC; Gebski, V; Goldstein, D; Jefford, M; Miller, D; Selva-Nayagam, S; Shannon, J; Tebbutt, N; van Hazel, G, 2011
)
0.95
" We have investigated the role of artemisone (ATM), a novel derivative of artemisinin (ART) in a cancer setting both alone and in combination with established chemotherapeutic agents."( In vitro study of the anti-cancer effects of artemisone alone or in combination with other chemotherapeutic agents.
Chan, WC; Dalgleish, AG; Gravett, AM; Haynes, RK; Krishna, S; Liu, WM; Wilson, NL, 2011
)
0.37
" Finally, ART and ATM were combined with the common anti-cancer agents oxaliplatin, gemcitabine and thalidomide."( In vitro study of the anti-cancer effects of artemisone alone or in combination with other chemotherapeutic agents.
Chan, WC; Dalgleish, AG; Gravett, AM; Haynes, RK; Krishna, S; Liu, WM; Wilson, NL, 2011
)
0.59
"To investigate the antiproliferative and apoptotic effects of gemcitabine combined with gum mastic and the underlying mechanisms in human pancreatic cancer cell lines."( Gemcitabine combined with gum mastic causes potent growth inhibition and apoptosis of pancreatic cancer cells.
Ai, KX; He, ML; Huang, XY; Li, A; Qin, HL; Wang, HC; Yuan, Z; Zheng, Q, 2010
)
2.04
" When cells were treated with gemcitabine in combination with gum mastic, the IkappaBalpha level was increased, whereas NF-kappaB activation was blocked; the expression of Bax protein was substantially increased, but Bcl-2 protein was down-regulated."( Gemcitabine combined with gum mastic causes potent growth inhibition and apoptosis of pancreatic cancer cells.
Ai, KX; He, ML; Huang, XY; Li, A; Qin, HL; Wang, HC; Yuan, Z; Zheng, Q, 2010
)
2.09
"Gemcitabine combined with gum mastic causes potent apoptosis in pancreatic cancer cells."( Gemcitabine combined with gum mastic causes potent growth inhibition and apoptosis of pancreatic cancer cells.
Ai, KX; He, ML; Huang, XY; Li, A; Qin, HL; Wang, HC; Yuan, Z; Zheng, Q, 2010
)
3.25
"This Phase I study investigated the safety, tolerability, and pharmacokinetics of vandetanib when administered with either gemcitabine plus cisplatin (GC) or vinorelbine plus cisplatin (VC) in patients with previously untreated locally advanced or metastatic non-small cell lung cancer."( A phase I study of Vandetanib in combination with vinorelbine/cisplatin or gemcitabine/cisplatin as first-line treatment for advanced non-small cell lung cancer.
Blackhall, FH; Kennedy, SJ; Milenkova, T; Nicolson, M; O'brien, M; Schmid, P; Taylor, P; Thatcher, N, 2010
)
0.8
"In this study, in patients with previously untreated advanced non-small cell lung cancer, vandetanib 100 mg/d in combination with either VC or GC was not tolerated."( A phase I study of Vandetanib in combination with vinorelbine/cisplatin or gemcitabine/cisplatin as first-line treatment for advanced non-small cell lung cancer.
Blackhall, FH; Kennedy, SJ; Milenkova, T; Nicolson, M; O'brien, M; Schmid, P; Taylor, P; Thatcher, N, 2010
)
0.59
"This phase II randomised trial was designed to evaluate the therapeutic efficacy and feasibility of radio frequency regional hyperthermia in combination with chemotherapy for patients with advanced non-small lung cancer (NSCLC)."( The regimen of gemcitabine and cisplatin combined with radio frequency hyperthermia for advanced non-small cell lung cancer: a phase II study.
Li, XD; Shen, H; Shu, YQ; Wang, RS; Wu, CP; Yin, YM, 2011
)
0.72
" Group A patients were treated by radio frequency regional hyperthermia in combination with the regimen of gemcitabine and cisplatin (GP)."( The regimen of gemcitabine and cisplatin combined with radio frequency hyperthermia for advanced non-small cell lung cancer: a phase II study.
Li, XD; Shen, H; Shu, YQ; Wang, RS; Wu, CP; Yin, YM, 2011
)
0.94
"Radio-frequency regional hyperthermia in combination with chemotherapy (GP) is a safe, well tolerated, and effective therapeutic modality for patients with advanced NSCLC."( The regimen of gemcitabine and cisplatin combined with radio frequency hyperthermia for advanced non-small cell lung cancer: a phase II study.
Li, XD; Shen, H; Shu, YQ; Wang, RS; Wu, CP; Yin, YM, 2011
)
0.72
"To evaluate the efficacy,clinical benefits and toxicities of gemcitabine combined with erlotinib for advanced pancreatic cancer."( [Efficacy of gemcitabine combined with erlotinib in patients with advanced pancreatic cancer].
Bai, CM; Cheng, YJ; Zhang, ZJ, 2010
)
0.97
"Gemcitabine combined with erlotinib is an effective regimen for pancreatic cancer with good clinical tolerance."( [Efficacy of gemcitabine combined with erlotinib in patients with advanced pancreatic cancer].
Bai, CM; Cheng, YJ; Zhang, ZJ, 2010
)
2.17
"The aim was to determine the potential of the allosteric mammalian target of rapamycin inhibitor, everolimus, to act in combination with cytotoxic anticancer compounds in vitro and in vivo."( Evaluation of the mTOR inhibitor, everolimus, in combination with cytotoxic antitumor agents using human tumor models in vitro and in vivo.
Brandt, R; Lane, HA; Lassota, P; McSheehy, PM; O'Reilly, T; Wartmann, M, 2011
)
0.37
"To compare the tolerability, efficacy, and safety profiles of pegylated liposomal doxorubicin in combination with carboplatin (PLD-Carbo) with those of gemcitabine-carboplatin (Gem-Carbo) for the treatment of patients with platinum-sensitive recurrent ovarian cancer (PSROC) by reviewing the published literature."( Tolerability, efficacy, and safety of pegylated liposomal Doxorubicin in combination with Carboplatin versus gemcitabine-Carboplatin for the treatment of platinum-sensitive recurrent ovarian cancer: a systematic review.
Grendys, EC; Holloway, RW; Lefebvre, P; McMeekin, S; Vekeman, F, 2010
)
0.77
" Patients with previously untreated aggressive NHL were randomized to receive either eight cycles of (R)CHOP given every 3 wk or (R)CHOP combined with gemcitabine [Gem-(R)CHOP]."( Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in untreated aggressive non-Hodgkin's lymphoma--EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54).
Aurer, I; Baila, L; Eghbali, H; Fortpied, C; Khaled, HM; Raemaekers, J; van der Maazen, RW, 2011
)
0.81
"To assess objective response rates after 4 cycles of gemcitabine in combination with oxaliplatin in children and adolescents with relapsed or refractory solid tumours."( Phase II study of gemcitabine combined with oxaliplatin in relapsed or refractory paediatric solid malignancies: An innovative therapy for children with Cancer European Consortium Study.
Aerts, I; Boos, J; Cesare, C; Chisholm, J; Couanet, D; Devos, A; Dias, N; Frappaz, D; Gentet, JC; Geoerger, B; Hain, S; Jaspan, T; Le Deley, MC; Leblond, P; Mc Hugh, K; Riccardi, R; Vassal, G; Zwaan, CM, 2011
)
0.95
" We hypothesize that a cancer vaccine targeting survivin can achieve enhanced efficacy when combined with gemcitabine."( Modified vaccinia Ankara expressing survivin combined with gemcitabine generates specific antitumor effects in a murine pancreatic carcinoma model.
Diamond, DJ; Ellenhorn, JD; Ishizaki, H; Manuel, ER; Song, GY; Srivastava, T; Sun, S, 2011
)
0.83
" This phase I study was performed to identify the optimal dose of pomalidomide to be used in combination with gemcitabine in the treatment of patients with metastatic pancreatic cancer."( A phase I, dose-escalation study of pomalidomide (CC-4047) in combination with gemcitabine in metastatic pancreas cancer.
Bendell, JC; Burris, HA; Hainsworth, JD; Infante, JR; Jones, SF; Messersmith, WA; Spigel, DR; Weekes, CD; Yardley, DA, 2011
)
0.81
"To compare the efficacy and toxicity of chemotherapy combined with insterstitial (125)I seed implantation brachytherapy in unresectable staged IIIa/IIIb non-small cell lung cancer."( [Efficacy and safety of chemotherapy combined with interstitial (125)I seed implantation brachytherapy in unresectable stage IIIa/IIIb non-small cell lung cancer].
Fan, XW; Shan, L; Yang, SF; Zhang, GQ, 2010
)
0.36
" Among them 37 cases were of the study group, treated with NP/GP scheme synchronization chemotherapy combined with (125)I seed implantation brachytherapy, while 39 cases in the control group were given NP/GP scheme chemotherapy."( [Efficacy and safety of chemotherapy combined with interstitial (125)I seed implantation brachytherapy in unresectable stage IIIa/IIIb non-small cell lung cancer].
Fan, XW; Shan, L; Yang, SF; Zhang, GQ, 2010
)
0.36
"The (125)I seed implantation brachytherapy combined with concurrent chemotherapy shows a low complication rate, acceptable toxicity, and good therapeutic effectiveness, and is an effective and satisfactory therapeutic modality in the management of locally advanced non-small cell lung cancer."( [Efficacy and safety of chemotherapy combined with interstitial (125)I seed implantation brachytherapy in unresectable stage IIIa/IIIb non-small cell lung cancer].
Fan, XW; Shan, L; Yang, SF; Zhang, GQ, 2010
)
0.36
" We conducted this study to investigate its efficacy and safety when combined with chemotherapy in patients with advanced solid tumors."( Efficacy and safety of endostar combined with chemotherapy in patients with advanced solid tumors.
Huang, XE; Jiang, Y; Li, Y; Xiang, J; Yan, PW, 2010
)
0.36
"5 mg/m2 /day as an intravenous infusion for more than 7 days, in combination with chemotherapy."( Efficacy and safety of endostar combined with chemotherapy in patients with advanced solid tumors.
Huang, XE; Jiang, Y; Li, Y; Xiang, J; Yan, PW, 2010
)
0.36
"Our study revealed that toxicity of Endostar combined with chemotherapy in the treatment of solid tumors was tolerable with moderate efficacy."( Efficacy and safety of endostar combined with chemotherapy in patients with advanced solid tumors.
Huang, XE; Jiang, Y; Li, Y; Xiang, J; Yan, PW, 2010
)
0.36
"This phase I/II study of saracatinib in combination with gemcitabine in patients with advanced pancreatic cancer was conducted by the NCIC Clinical Trials Group."( A phase I/II study of the Src inhibitor saracatinib (AZD0530) in combination with gemcitabine in advanced pancreatic cancer.
Chen, E; Gauthier, I; Gill, S; Goel, R; Hedley, D; Jonker, D; McIntosh, L; Moore, MJ; Renouf, DJ; Seymour, L; Southwood, B; Walde, D; Walsh, W, 2012
)
0.85
" In phase I saracatinib was escalated in combination with gemcitabine (1000 mg/m(2)) to determine the recommended phase II dose (RP2D)."( A phase I/II study of the Src inhibitor saracatinib (AZD0530) in combination with gemcitabine in advanced pancreatic cancer.
Chen, E; Gauthier, I; Gill, S; Goel, R; Hedley, D; Jonker, D; McIntosh, L; Moore, MJ; Renouf, DJ; Seymour, L; Southwood, B; Walde, D; Walsh, W, 2012
)
0.85
" Saracatinib 175 mg PO daily was chosen as the RP2D in combination with gemcitabine."( A phase I/II study of the Src inhibitor saracatinib (AZD0530) in combination with gemcitabine in advanced pancreatic cancer.
Chen, E; Gauthier, I; Gill, S; Goel, R; Hedley, D; Jonker, D; McIntosh, L; Moore, MJ; Renouf, DJ; Seymour, L; Southwood, B; Walde, D; Walsh, W, 2012
)
0.84
"Saracatinib 175 mg daily in combination with gemcitabine is well tolerated but the combination did not improve efficacy over what would be expected from gemcitabine alone."( A phase I/II study of the Src inhibitor saracatinib (AZD0530) in combination with gemcitabine in advanced pancreatic cancer.
Chen, E; Gauthier, I; Gill, S; Goel, R; Hedley, D; Jonker, D; McIntosh, L; Moore, MJ; Renouf, DJ; Seymour, L; Southwood, B; Walde, D; Walsh, W, 2012
)
0.86
"The purpose of this analysis was to investigate the enzyme activity and specificity of adenovirus-mediated Drosophila melanogaster deoxyribonucleoside kinase (Dm-dNK) mutants in combination with gemcitabine."( Adenovirus-mediated Drosophila melanogaster deoxyribonucleoside kinase mutants combined with gemcitabine harbor a safe cancer treatment profile.
He, A; Ma, S; Sun, Z; Xu, H; Zhao, L; Zheng, X; Zhu, Z, 2011
)
0.78
" The aim of this multicenter, randomized phase II study was to evaluate clinical activity and safety of sorafenib in combination with erlotinib or gemcitabine in unselected untreated elderly patients with non-small-cell lung cancer (NSCLC)."( Sorafenib in combination with erlotinib or with gemcitabine in elderly patients with advanced non-small-cell lung cancer: a randomized phase II study.
Cerea, G; Chella, A; Ciardiello, F; de Marinis, F; Di Maio, M; Fasano, M; Favaretto, A; Gridelli, C; Maione, P; Mattioli, R; Morgillo, F; Pasello, G; Ricciardi, S; Rossi, A; Tortora, G, 2011
)
0.82
" Using the indwelling catheter-port system with the unification of the pancreatic blood supply, we initially conducted an arterial infusion of weekly high-dose 5-FU (1,000 mg/m2/qw) combined with systemic gemcitabine (1,000 mg/m2/qw)."( [Locally advanced pancreatic cancer successfully treated by arterial infusion chemotherapy combined with stereotactic radiotherapy--a case report].
Anai, H; Hasegawa, M; Kichikawa, K; Maeda, S; Masada, T; Morimoto, K; Nakajima, Y; Nishiofuku, H; Sakaguchi, H; Sho, M; Sueyoshi, S; Tamamoto, T; Tanaka, T; Yamamoto, K, 2010
)
0.55
"To assess the efficacy and toxicity of pegylated liposomal doxorubicin combined with gemcitabine as first-line chemotherapy in metastatic breast cancer patients in a phase II trial."( Phase II trial of pegylated liposomal doxorubicin in combination with gemcitabine in metastatic breast cancer patients.
Chaigneau, L; Chargari, C; Clavreul, G; Dumanoir, C; Jacquin, JP; Magné, N; Mélis, A; Merrouche, Y; Mille, D; Nourissat, A; Orfeuvre, H; Savary, J; Thorin, J, 2012
)
0.84
"To confirm the efficacy and toxicity of Erlotinib in combination with Gemcitabine and Capecitabine when used as a first-line therapy in metastatic/recurrent pancreatic cancer (PC)."( A phase II trial of erlotinib in combination with gemcitabine and capecitabine in previously untreated metastatic/recurrent pancreatic cancer: combined analysis with translational research.
Bang, YJ; Kang, HJ; Kim, BS; Kim, JS; Lee, KH; Lee, KW; Oh, DY; Park, YS; Ryoo, HM; Sohn, CH; Song, HS; Zang, DY, 2012
)
0.87
"Patients received oral panobinostat administered 2 or 3 times weekly (continuous or intermittent dosing in combination with intravenous gemcitabine administered on days 1, 8, and 15 every 28 days or on days 1 and 8 every 21 days)."( A phase I study of panobinostat in combination with gemcitabine in the treatment of solid tumors.
Bendell, JC; Burris, HA; Greco, FA; Infante, JR; Jones, SF; Murphy, PB; Spigel, DR; Thompson, DS; Yardley, DA, 2011
)
0.82
" The recommended doses for further study are intermittent oral panobinostat administered at a dose of 10 mg 3 times weekly for 2 weeks in combination with gemcitabine 800 mg/m2 administered intravenously on days 1 and 8 every 21 days."( A phase I study of panobinostat in combination with gemcitabine in the treatment of solid tumors.
Bendell, JC; Burris, HA; Greco, FA; Infante, JR; Jones, SF; Murphy, PB; Spigel, DR; Thompson, DS; Yardley, DA, 2011
)
0.82
"Administration of gemcitabine in combination with piroxicam treatment failed to provide a longer overall survival time in dogs with TCC of the urinary bladder, compared with previously reported treatment strategies."( Toxic effects and antitumor response of gemcitabine in combination with piroxicam treatment in dogs with transitional cell carcinoma of the urinary bladder.
Jeglum, AK; Lindner, D; Marconato, L; Nelson, V; Suslak-Brown, L; Zini, E, 2011
)
0.97
"Gemcitabine at low doses combined with cisplatin is a potent radiosensitizer effective in patients with LAHN cancer."( Weekly gemcitabine and cisplatin in combination with radiotherapy in patients with locally advanced head-and-neck cancer: Phase I study.
Afonso, SL; da Silva, LG; Stefano, EJ; Tavares, VC; Viani, GA, 2011
)
2.27
"This paper presents a summary of the evidence review group (ERG) report into the use of bevacizumab (Avastin®, Roche) in combination with a taxane for the treatment of untreated metastatic breast cancer (mBC)."( Bevacizumab in combination with a taxane for the first-line treatment of HER2-negative metastatic breast cancer.
Eastwood, A; Epstein, D; Fox, D; Rodgers, M; Soares, M; Yang, H, 2011
)
0.37
" We propose to define the recommended dose of vinflunine in combination with gemcitabine for treatment of advanced NSCLC in chemonaive patients."( Phase I and pharmacokinetic study of IV vinflunine in combination with gemcitabine for treatment of advanced non-small cell lung cancer in Chemonaive patients.
Bennouna, J; Favrel, S; Lemarie, E; Pinel, MC; Pouget, JC; Senellart, H; Tourani, JM; Tournoux-Facon, C, 2011
)
0.83
"A phase I and pharmacokinetic study was conducted to determine the maximum tolerated dose and to establish the recommended dose of vinflunine (VFL) administered on day 1 every 21 days combined with gemcitabine given on days 1 and 8 every 3 weeks."( Phase I and pharmacokinetic study of IV vinflunine in combination with gemcitabine for treatment of advanced non-small cell lung cancer in Chemonaive patients.
Bennouna, J; Favrel, S; Lemarie, E; Pinel, MC; Pouget, JC; Senellart, H; Tourani, JM; Tournoux-Facon, C, 2011
)
0.79
" The recommended dose was established at the dose of VFL 320 mg/m² combined with gemcitabine 1000 mg/m²."( Phase I and pharmacokinetic study of IV vinflunine in combination with gemcitabine for treatment of advanced non-small cell lung cancer in Chemonaive patients.
Bennouna, J; Favrel, S; Lemarie, E; Pinel, MC; Pouget, JC; Senellart, H; Tourani, JM; Tournoux-Facon, C, 2011
)
0.83
"The combination of VFL 320 mg/m² administered on day 1 combined with gemcitabine 1000 mg/m² given on days 1 and 8 every 3 weeks is established as the RD and was shown to be active in these chemonaive NSCLC patients."( Phase I and pharmacokinetic study of IV vinflunine in combination with gemcitabine for treatment of advanced non-small cell lung cancer in Chemonaive patients.
Bennouna, J; Favrel, S; Lemarie, E; Pinel, MC; Pouget, JC; Senellart, H; Tourani, JM; Tournoux-Facon, C, 2011
)
0.84
" The results indicate that this drug combination has no statistical significance on the development of pre-neoplastic urothelial lesions and had only a minor impact on invasive bladder cancer incidence in mice."( Experimental study of the anticancer effect of gemcitabine combined with sirolimus on chemically induced urothelial lesions.
Colaço, A; Lopes, C; Oliveira, PA; Palomino, LF; Santos, L; Vala, H; Vasconcelos-Nóbrega, C, 2011
)
0.63
"This paper reports the first case of a patient with hepatocellular carcinoma with lymph node metastasis treated by sorafenib combined with gemcitabine plus oxaliplatin, with a partial response and normalization of α fetoprotein, which allowed curative surgery."( Neoadjuvant sorafenib combined with gemcitabine plus oxaliplatin in advanced hepatocellular carcinoma.
Belghiti, J; Botti, M; Boussaha, T; Dubreuil, O; Housset, M; Landi, B; Rougier, P; Taieb, J; Trouilloud, I; Williet, N, 2011
)
0.85
" In the present study, we have tested the cytotoxicity of ascorbate to MMe cells in combination with drugs used in MMe therapy, such as cisplatin, etoposide, gemcitabine, imatinib, paclitaxel, and raltitrexed, as well as with promising antitumor compounds like taurolidine, α-tocopherol succinate, and epigallocatechin-3-gallate (EGCG)."( In vitro screening of synergistic ascorbate-drug combinations for the treatment of malignant mesothelioma.
Burlando, B; Martinotti, S; Ranzato, E, 2011
)
0.57
" The safety and pharmacokinetics of axitinib in combination with gemcitabine in patients with advanced pancreatic cancer was evaluated in the phase I portion of this trial."( Phase I study of axitinib (AG-013736) in combination with gemcitabine in patients with advanced pancreatic cancer.
Kim, S; Moore, MJ; Pithavala, YK; Ricart, AD; Rixe, O; Spano, JP, 2012
)
0.86
" This study investigated the safety, pharmacokinetics, and preliminary efficacy of sorafenib in combination with gemcitabine and cisplatin."( Phase IB study of sorafenib in combination with gemcitabine and cisplatin in patients with refractory solid tumors.
Brendel, E; Kornacker, M; Kummer, G; Schultheis, B; Strumberg, D; Xia, C; Zeth, M, 2012
)
0.85
" No clinically relevant pharmacokinetic drug-drug interaction between sorafenib, cisplatin, and gemcitabine was detected."( Phase IB study of sorafenib in combination with gemcitabine and cisplatin in patients with refractory solid tumors.
Brendel, E; Kornacker, M; Kummer, G; Schultheis, B; Strumberg, D; Xia, C; Zeth, M, 2012
)
0.85
"Sorafenib as continuous oral treatment in combination with gemcitabine and cisplatin demonstrated an acceptable safety profile."( Phase IB study of sorafenib in combination with gemcitabine and cisplatin in patients with refractory solid tumors.
Brendel, E; Kornacker, M; Kummer, G; Schultheis, B; Strumberg, D; Xia, C; Zeth, M, 2012
)
0.88
" This study aimed to define safe doses of gemcitabine plus oxaliplatin when combined with imatinib (potent PDGFR-β inhibitor) in patients with advanced gemcitabine-refractory pancreatic cancer (PC)."( A dose escalation study of gemcitabine plus oxaliplatin in combination with imatinib for gemcitabine-refractory advanced pancreatic adenocarcinoma.
Barbachano, Y; Brown, G; Chau, I; Cunningham, D; Hawkes, EA; Oates, J; Starling, N; Thomas, J; Thomas, K; Watkins, D; Webb, J, 2012
)
0.94
"In gemcitabine-refractory PC, gemcitabine (1000 mg/m(2)) and oxaliplatin (85 mg/m(2)) can be safely combined with imatinib given on a 7 days on and 7 days off intermittent schedule."( A dose escalation study of gemcitabine plus oxaliplatin in combination with imatinib for gemcitabine-refractory advanced pancreatic adenocarcinoma.
Barbachano, Y; Brown, G; Chau, I; Cunningham, D; Hawkes, EA; Oates, J; Starling, N; Thomas, J; Thomas, K; Watkins, D; Webb, J, 2012
)
1.3
"Patients with advanced or metastatic cancer were treated with escalating doses of LY2334737 monotherapy or in combination with continuous daily administration of 100 mg erlotinib."( Phase I study of Oral gemcitabine prodrug (LY2334737) alone and in combination with erlotinib in patients with advanced solid tumors.
Beijnen, JH; Benhadji, KA; Callies, S; Garcia-Ribas, I; Jansen, RS; Koolen, SL; Kronemeijer, RH; Langenberg, MH; Nol, A; Schellens, JH; Slapak, CA; Voest, EE; Witteveen, PO, 2011
)
0.68
" In conclusion, thalidomide alone, or in combination with cisplatin/gemcitabine, controlled disease for >6 months in ∼30% of patients."( The predictive role of serum VEGF in an advanced malignant mesothelioma patient cohort treated with thalidomide alone or combined with cisplatin/gemcitabine.
Abraham, R; Clarke, S; Cullen, M; Davey, R; Harvie, R; Kao, SC; Kerestes, Z; Marx, G; Paturi, F; Pavlakis, N; Taylor, R, 2012
)
0.81
"This phase 1b study assessed the maximum tolerated dose (MTD), safety, and pharmacokinetics of motesanib (a small-molecule antagonist of VEGF receptors 1, 2, and 3; platelet-derived growth factor receptor; and Kit) administered once daily (QD) or twice daily (BID) in combination with erlotinib and gemcitabine in patients with solid tumors."( Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study.
Adewoye, AH; Desai, J; Johnson, J; Kotasek, D; McCoy, S; Price, T; Siu, LL; Sun, YN; Tebbutt, N; Welch, S, 2011
)
0.79
"Patients received weekly intravenous gemcitabine (1000 mg/m2) and erlotinib (100 mg QD) alone (control cohort) or in combination with motesanib (50 mg QD, 75 mg BID, 125 mg QD, or 100 mg QD; cohorts 1-4); or erlotinib (150 mg QD) in combination with motesanib (100 or 125 mg QD; cohorts 5 and 6)."( Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study.
Adewoye, AH; Desai, J; Johnson, J; Kotasek, D; McCoy, S; Price, T; Siu, LL; Sun, YN; Tebbutt, N; Welch, S, 2011
)
0.88
" The MTD of motesanib in combination with gemcitabine and erlotinib was 100 mg QD."( Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study.
Adewoye, AH; Desai, J; Johnson, J; Kotasek, D; McCoy, S; Price, T; Siu, LL; Sun, YN; Tebbutt, N; Welch, S, 2011
)
0.87
" Motesanib 125 mg QD was tolerable only in combination with erlotinib alone."( Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study.
Adewoye, AH; Desai, J; Johnson, J; Kotasek, D; McCoy, S; Price, T; Siu, LL; Sun, YN; Tebbutt, N; Welch, S, 2011
)
0.61
"In the current study, we have evaluated the clinical and immunological responses in patients with advanced pancreatic carcinoma who received dendritic cell (DC)-based immunotherapy in combination with gemcitabine and/or S-1."( Clinical and immunologic evaluation of dendritic cell-based immunotherapy in combination with gemcitabine and/or S-1 in patients with advanced pancreatic carcinoma.
Homma, S; Imai, K; Kimura, Y; Koido, S; Okamoto, M; Shimamura, K; Shimodaira, S; Sunamura, M; Takahashi, H; Tomoda, T; Tsukada, J; Yonemitsu, Y, 2012
)
0.79
"Dendritic cell-based immunotherapy (DC vaccine alone or DC vaccine plus lymphokine-activated killer [LAK] cell therapy) in combination with gemcitabine and/or S-1 has been carried out in 49 patients with inoperable pancreatic carcinoma refractory to standard treatment."( Clinical and immunologic evaluation of dendritic cell-based immunotherapy in combination with gemcitabine and/or S-1 in patients with advanced pancreatic carcinoma.
Homma, S; Imai, K; Kimura, Y; Koido, S; Okamoto, M; Shimamura, K; Shimodaira, S; Sunamura, M; Takahashi, H; Tomoda, T; Tsukada, J; Yonemitsu, Y, 2012
)
0.8
" Survival of patients receiving DC vaccine and chemotherapy plus LAK cell therapy was longer than those receiving DC vaccine in combination with chemotherapy but no LAK cells."( Clinical and immunologic evaluation of dendritic cell-based immunotherapy in combination with gemcitabine and/or S-1 in patients with advanced pancreatic carcinoma.
Homma, S; Imai, K; Kimura, Y; Koido, S; Okamoto, M; Shimamura, K; Shimodaira, S; Sunamura, M; Takahashi, H; Tomoda, T; Tsukada, J; Yonemitsu, Y, 2012
)
0.6
"Dendritic cell vaccine-based immunotherapy combined with chemotherapy was shown to be safe and possibly effective in patients with advanced pancreatic cancer refractory to standard treatment."( Clinical and immunologic evaluation of dendritic cell-based immunotherapy in combination with gemcitabine and/or S-1 in patients with advanced pancreatic carcinoma.
Homma, S; Imai, K; Kimura, Y; Koido, S; Okamoto, M; Shimamura, K; Shimodaira, S; Sunamura, M; Takahashi, H; Tomoda, T; Tsukada, J; Yonemitsu, Y, 2012
)
0.6
" In combination with gemcitabine, median survival was further prolonged."( An oncolytic adenovirus defective in pRb-binding (dl922-947) can efficiently eliminate pancreatic cancer cells and tumors in vivo in combination with 5-FU or gemcitabine.
Bhattacharyya, M; Eddouadi, A; Francis, J; Halldén, G; Lemoine, NR, 2011
)
0.89
"To evaluate the activity and tolerance of gemcitabine in combination with docetaxel and capecitabine in previously untreated patients with advanced pancreatic cancer."( Docetaxel plus gemcitabine in combination with capecitabine as treatment for inoperable pancreatic cancer: a phase II study.
Amarantidis, K; Chamalidou, E; Chelis, L; Chiotis, A; Courcoutsakis, N; Dimopoulos, P; Kakolyris, S; Prassopoulos, P; Tentes, A; Xenidis, N, 2012
)
1
" The primary objective of this open-label phase I trial was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of vandetanib in combination with gemcitabine in patients with unresectable, locally advanced or metastatic pancreatic adenocarcinoma (PAC)."( Phase I dose-finding study of vandetanib in combination with gemcitabine in locally advanced unresectable or metastatic pancreatic adenocarcinoma.
Cerny, T; De Dosso, S; Koeberle, D; Renggli, V; Saletti, P; Sessa, C, 2011
)
0.81
"Vandetanib 100 mg/day is the RD in combination with gemcitabine in the treatment of patients with advanced PAC."( Phase I dose-finding study of vandetanib in combination with gemcitabine in locally advanced unresectable or metastatic pancreatic adenocarcinoma.
Cerny, T; De Dosso, S; Koeberle, D; Renggli, V; Saletti, P; Sessa, C, 2011
)
0.86
"To evaluate the efficacy of regional arterial infusion of the synthetic serine protease inhibitor nafamostat mesilate combined with gemcitabine for the treatment of patients with unresectable locally advanced or metastatic pancreatic cancer."( Phase II study of gemcitabine in combination with regional arterial infusion of nafamostat mesilate for advanced pancreatic cancer.
Gocho, T; Hirohara, S; Ito, R; Misawa, T; Sadaoka, S; Tsutsui, N; Uwagawa, T; Yanaga, K, 2013
)
0.93
" In this study, we evaluated the efficacy of PF00299804, an irreversible pan-HER inhibitor, in eight BTC cell lines alone or combined with gemcitabine."( The irreversible pan-HER inhibitor PF00299804 alone or combined with gemcitabine has an antitumor effect in biliary tract cancer cell lines.
Bang, YJ; Han, SW; Im, SA; Kim, HP; Kim, TY; Min, AR; Nam, HJ; Oh, DY; Song, SH; Yoon, YK, 2012
)
0.82
" This trial tested custirsen (OGX-011), an inhibitor of CLU protein production, combined with gemcitabine/platinum in patients with advanced non-small cell lung cancer (NSCLC)."( Phase I/II trial of custirsen (OGX-011), an inhibitor of clusterin, in combination with a gemcitabine and platinum regimen in patients with previously untreated advanced non-small cell lung cancer.
Cormier, Y; Gitlitz, B; Gleave, ME; Hao, D; Laskin, JJ; Lee, C; Murray, N; Nemunaitis, J; Nicholas, G; Nugent, F; Pressnail, B; Sanborn, R; Stephenson, J; Ung, Y; Vincent, M, 2012
)
0.82
" Custirsen was infused during a loading dose period and weekly in combination with gemcitabine (1250 mg/m) on days 1 and 8 and with cisplatin (75 mg/m) or carboplatin (area under the curve 5) on day 1 of each 21-day cycle."( Phase I/II trial of custirsen (OGX-011), an inhibitor of clusterin, in combination with a gemcitabine and platinum regimen in patients with previously untreated advanced non-small cell lung cancer.
Cormier, Y; Gitlitz, B; Gleave, ME; Hao, D; Laskin, JJ; Lee, C; Murray, N; Nemunaitis, J; Nicholas, G; Nugent, F; Pressnail, B; Sanborn, R; Stephenson, J; Ung, Y; Vincent, M, 2012
)
0.83
"The potential of EHT 6706, a novel tubulin-binding agent, was investigated in combination with ionizing radiation (IR) and with conventional cytotoxic chemotherapy agents."( Assessment of the novel tubulin-binding agent EHT 6706 in combination with ionizing radiation or chemotherapy.
Bourhis, J; Casagrande, AS; Chargari, C; Clémenson, C; Désiré, L; Deutsch, E, 2012
)
0.38
" There are currently insufficient safety data in human subjects, particularly when ascorbic acid is combined with chemotherapy."( Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer.
Bazzan, AJ; Deshmukh, S; Levine, M; Littman, S; Mitchell, E; Monti, DA; Newberg, AB; Pillai, MV; Yeo, CJ; Zabrecky, G, 2012
)
0.61
" This, combined with the observed response to treatment, suggests the need for a phase II study of longer duration."( Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer.
Bazzan, AJ; Deshmukh, S; Levine, M; Littman, S; Mitchell, E; Monti, DA; Newberg, AB; Pillai, MV; Yeo, CJ; Zabrecky, G, 2012
)
0.61
" Paclitaxel and campthothecin demonstrated the most prominent cytotoxic effect in combination with carbon ion radiotherapy."( In vitro evaluation of photon and carbon ion radiotherapy in combination with chemotherapy in glioblastoma cells.
Brons, S; Combs, SE; Debus, J; Haberer, T; Habermehl, D; Rieken, S; Weber, KJ; Winter, M; Zipp, L, 2012
)
0.38
"In this study, we evaluate the efficacy of autologous cytokine-induced killer cells (CIK) transfusion used in combination with gemcitabine and cisplatin (GC) chemotherapy to treat nasopharyngeal carcinoma in patients with distant metastasis after radiotherapy."( Autologous cytokine-induced killer cell transfusion in combination with gemcitabine plus cisplatin regimen chemotherapy for metastatic nasopharyngeal carcinoma.
Gu, MF; Li, JJ; Liu, LZ; Pan, K; Shen, WX; Xia, JC; Zhang, H,
)
0.57
"To evaluate the efficacy and safety of gemcitabine in combination with vinorelbine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer (MBC)."( Gemcitabine in combination with vinorelbine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer.
Cui, Y; Dong, N; Guo, Q; Li, H; Wang, M, 2012
)
2.09
"Gemcitabine in combination with vinorelbine is active and safe in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer."( Gemcitabine in combination with vinorelbine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer.
Cui, Y; Dong, N; Guo, Q; Li, H; Wang, M, 2012
)
3.26
"To compare the overall survival rates of good-prognosis carcinomas of an unknown primary site (CUPS) patients treated with cisplatin alone (C) or in combination with gemcitabine (CG)."( Cisplatin alone or combined with gemcitabine in carcinomas of unknown primary: results of the randomised GEFCAPI 02 trial.
Blot, E; Bouzy, J; Chaigneau, L; Culine, S; Fizazi, K; Fourcade, A; Gross-Goupil, M; Kaminsky, MC; Laplanche, A; Lesimple, T; Lortholary, A; Négrier, S; Penel, N; Priou, F; Provencal, J; Voog, E, 2012
)
0.86
" The goal of our study was to determine whether RT in combination with isolated lung perfusion increases lung toxicity."( Isolated lung perfusion with gemcitabine combined with radiotherapy: no additional lung toxicity in an experimental model.
De Pooter, C; den Hengst, W; Hendriks, J; Pauwels, P; Van den Weyngaert, D; Van Schil, P; Van Thielen, J; Wittock, A, 2012
)
0.67
"Rodents were randomized into eight groups: sham group, RT, intravenous gemcitabine, intravenous gemcitabine combined with RT, isolated lung perfusion with hydroxyethyl starch (HES) or gemcitabine, isolated lung perfusion with HES or gemcitabine combined with RT."( Isolated lung perfusion with gemcitabine combined with radiotherapy: no additional lung toxicity in an experimental model.
De Pooter, C; den Hengst, W; Hendriks, J; Pauwels, P; Van den Weyngaert, D; Van Schil, P; Van Thielen, J; Wittock, A, 2012
)
0.9
" After isolated lung perfusion with gemcitabine combined with RT, there was moderate to severe fibrosis and mild to severe haemosiderosis."( Isolated lung perfusion with gemcitabine combined with radiotherapy: no additional lung toxicity in an experimental model.
De Pooter, C; den Hengst, W; Hendriks, J; Pauwels, P; Van den Weyngaert, D; Van Schil, P; Van Thielen, J; Wittock, A, 2012
)
0.95
"The aim of this study was to discuss the clinical effectiveness of high intensity focused ultrasound (HIFU) combined with gemcitabine administered by intra-arterial infusion on intermediate and advanced pancreatic cancer."( [Efficacy evaluation of high intensity focused ultrasound combined with intra-arterial infusion of gemcitabine in the treatment of pancreatic cancer].
Chen, J; Gui, YZ; Long, HX; Sun, Y; Zhang, WH; Zhang, XY; Zhong, GC; Zhu, B, 2012
)
0.8
" Twenty-four patients of the experimental group were treated by HIFU combined with gemcitabine, and 24 patients of the the HIFU group were treated by HIFU alone."( [Efficacy evaluation of high intensity focused ultrasound combined with intra-arterial infusion of gemcitabine in the treatment of pancreatic cancer].
Chen, J; Gui, YZ; Long, HX; Sun, Y; Zhang, WH; Zhang, XY; Zhong, GC; Zhu, B, 2012
)
0.82
"This phase 1b dose-escalation study assessed safety, tolerability, and pharmacokinetics of ganitumab, a fully human monoclonal antibody against the insulin-like growth factor 1 (IGF1) receptor, combined with targeted agents or cytotoxic chemotherapy in patients with advanced solid tumors."( Safety and pharmacokinetics of ganitumab (AMG 479) combined with sorafenib, panitumumab, erlotinib, or gemcitabine in patients with advanced solid tumors.
Chan, E; Deng, H; Friberg, G; Gilbert, J; Hwang, YC; Mahalingam, D; McCaffery, I; Michael, SA; Mita, AC; Mita, MM; Mulay, M; Puzanov, I; Rosen, LS; Sarantopoulos, J; Shubhakar, P; Zhu, M, 2012
)
0.59
" every 2 weeks) combined with either sorafenib 400 mg twice daily, panitumumab 6 mg/kg every 2 weeks, erlotinib 150 mg once daily, or gemcitabine 1,000 mg/m(2) on days 1, 8, and 15 of each 4-week cycle."( Safety and pharmacokinetics of ganitumab (AMG 479) combined with sorafenib, panitumumab, erlotinib, or gemcitabine in patients with advanced solid tumors.
Chan, E; Deng, H; Friberg, G; Gilbert, J; Hwang, YC; Mahalingam, D; McCaffery, I; Michael, SA; Mita, AC; Mita, MM; Mulay, M; Puzanov, I; Rosen, LS; Sarantopoulos, J; Shubhakar, P; Zhu, M, 2012
)
0.8
"Ganitumab up to 12 mg/kg appeared well tolerated combined with sorafenib, panitumumab, erlotinib, or gemcitabine."( Safety and pharmacokinetics of ganitumab (AMG 479) combined with sorafenib, panitumumab, erlotinib, or gemcitabine in patients with advanced solid tumors.
Chan, E; Deng, H; Friberg, G; Gilbert, J; Hwang, YC; Mahalingam, D; McCaffery, I; Michael, SA; Mita, AC; Mita, MM; Mulay, M; Puzanov, I; Rosen, LS; Sarantopoulos, J; Shubhakar, P; Zhu, M, 2012
)
0.81
"Ganitumab up to 12 mg/kg was well tolerated, without adverse effects on pharmacokinetics in combination with either sorafenib, panitumumab, erlotinib, or gemcitabine."( Safety and pharmacokinetics of ganitumab (AMG 479) combined with sorafenib, panitumumab, erlotinib, or gemcitabine in patients with advanced solid tumors.
Chan, E; Deng, H; Friberg, G; Gilbert, J; Hwang, YC; Mahalingam, D; McCaffery, I; Michael, SA; Mita, AC; Mita, MM; Mulay, M; Puzanov, I; Rosen, LS; Sarantopoulos, J; Shubhakar, P; Zhu, M, 2012
)
0.79
" Here, we report two cases of disseminated TNBC with extensive cutaneous metastases and a remarkable response to PLD in combination with gemcitabine."( Activity of pegylated liposomal doxorubicin in combination with gemcitabine in triple negative breast cancer with skin involvement: two case reports.
Adamo, B; Adamo, V; Agostino, RM; Caristi, N; Franchina, T; Proto, C; Ricciardi, GR, 2012
)
0.82
" This not only has implications for how this drug combination mediates anticancer effects but also demonstrates the importance of evaluating mechanisms of drug activity within malignant cells."( Drug interactions: the importance of looking inside cancer cells.
Clark, JW, 2012
)
0.38
"From September 2008 to October 2011, a total of 31 patients of NSCLC with multiple brain metastases (≥3) received selected incranial, bronchial and corresponding target arterial infusion chemotherapy combined with EGFR-TKIs."( [Selected arterial infusion chemotherapy combined with target drugs for non-small cell lung cancer with multiple brain metastase].
Guo, Z; Li, J, 2012
)
0.38
"We evaluated the efficacy and safety of ganitumab (a mAb antagonist of insulin-like growth factor 1 receptor) or conatumumab (a mAb agonist of human death receptor 5) combined with gemcitabine in a randomized phase 2 trial in patients with metastatic pancreatic cancer."( A randomized, placebo-controlled phase 2 study of ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine in patients with metastatic pancreatic cancer.
Bray, SL; Chan, D; Feigal, EG; Fuchs, CS; Galimi, F; Garbo, LE; Garon, EB; Hei, Y; Kindler, HL; Kocs, DM; Loh, E; McGreivy, J; Richards, DA; Rocha-Lima, CM; Safran, H; Stephenson, JJ, 2012
)
0.78
" gemcitabine 1000 mg/m(2) (days 1, 8, and 15 of each 28-day cycle) combined with open-label ganitumab (12 mg/kg every 2 weeks [Q2W]), double-blind conatumumab (10 mg/kg Q2W), or double-blind placebo Q2W."( A randomized, placebo-controlled phase 2 study of ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine in patients with metastatic pancreatic cancer.
Bray, SL; Chan, D; Feigal, EG; Fuchs, CS; Galimi, F; Garbo, LE; Garon, EB; Hei, Y; Kindler, HL; Kocs, DM; Loh, E; McGreivy, J; Richards, DA; Rocha-Lima, CM; Safran, H; Stephenson, JJ, 2012
)
1.5
"Ganitumab combined with gemcitabine had tolerable toxicity and showed trends toward an improved 6-month survival rate and overall survival."( A randomized, placebo-controlled phase 2 study of ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine in patients with metastatic pancreatic cancer.
Bray, SL; Chan, D; Feigal, EG; Fuchs, CS; Galimi, F; Garbo, LE; Garon, EB; Hei, Y; Kindler, HL; Kocs, DM; Loh, E; McGreivy, J; Richards, DA; Rocha-Lima, CM; Safran, H; Stephenson, JJ, 2012
)
0.9
" A phase 1b safety/efficacy study of dacetuzumab in combination with rituximab and gemcitabine was conducted in relapsed/refractory diffuse large B-cell lymphoma (DLBCL)."( Pilot study of dacetuzumab in combination with rituximab and gemcitabine for relapsed or refractory diffuse large B-cell lymphoma.
Bartlett, N; Beaven, A; Drachman, JG; Forero-Torres, A; Lobuglio, AF; Moskowitz, CH; Myint, H; Nasta, S; Northfelt, DW; Whiting, NC, 2013
)
0.86
"Huachansu when combined with gemcitabine did not improve the outcome of patients with locally advanced and/or metastatic pancreatic cancer."( Prospective randomised evaluation of traditional Chinese medicine combined with chemotherapy: a randomised phase II study of wild toad extract plus gemcitabine in patients with advanced pancreatic adenocarcinomas.
Chang, DZ; Cohen, L; Garrett, CR; Huo, Y; Liu, L; Meng, Z; Ng, CS; Shen, Y; Spelman, AR; Yang, P; Zhao, Q, 2012
)
0.87
"To evaluate in vitro effects of gemcitabine alone and in combination with carboplatin on canine transitional cell carcinoma (TCC) cell lines."( Effects of gemcitabine and gemcitabine in combination with carboplatin on five canine transitional cell carcinoma cell lines.
Chew, DJ; de Brito Galvao, JF; Inpanbutr, N; Kisseberth, WC; Murahari, S; Sutayatram, S, 2012
)
1.05
" We also show here that gemcitabine in combination with P276-00 is much more effective as an antitumor agent compared with either agent alone in the PANC-1 xenograft tumor model in SCID mice."( Molecular evidence for increased antitumor activity of gemcitabine in combination with a cyclin-dependent kinase inhibitor, P276-00 in pancreatic cancers.
Joshi, K; Joshi, KS; Khanwalkar, H; Manohar, SM; Rathos, MJ, 2012
)
0.93
" Phase IIb clinical trials of P276-00 in combination with gemcitabine in pancreatic cancer patients are ongoing."( Molecular evidence for increased antitumor activity of gemcitabine in combination with a cyclin-dependent kinase inhibitor, P276-00 in pancreatic cancers.
Joshi, K; Joshi, KS; Khanwalkar, H; Manohar, SM; Rathos, MJ, 2012
)
0.87
" Recently, fluorouracil/leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) demonstrated their superiority in first-line therapy."( Influcence of localization of primary tumor on effectiveness of 5-fluorouracil/leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) in patients with metastatic pancreatic adenocarcinoma: a retrospective study.
Chauffert, B; Gentil, J; Ghiringhelli, F; Lorgis, V, 2012
)
0.38
"To explore the efficacy of concurrent chemoradiotherapy combined with Kanglaite Injection (KI) for locally advanced pancreatic carcinoma patients."( [Curative effect of 3D-CRT combined with gemcitabine concurrently with addition of Kanglaite Injection in treatment of locally advanced pancreatic].
Deng, LC; Shen, WS; Shu, ZQ, 2012
)
0.64
"In the present study, the effects of 12-O-tetra-decanoylphorbol-13-acetate (TPA) alone or in combination with gemcitabine on the growth of Panc-1 pancreatic cancer cells cultured in vitro or grown in NCr immunodeficient nude mice were investigated."( Effects of 12-O-tetradecanoylphorbol-13-acetate in combination with gemcitabine on Panc-1 pancreatic cancer cells cultured in vitro or Panc-1 tumors grown in immunodeficient mice.
Conney, AH; Cui, XX; Gao, Z; Huang, MT; Liu, Y; Rabson, AB; Verano, M; Zheng, X, 2012
)
0.81
"In a modified 3 + 3 enrollment scheme, oral once-daily pazopanib was administered with intravenous gemcitabine (Days 1 and 8, 21-day cycles)."( A Phase I study of pazopanib in combination with gemcitabine in patients with advanced solid tumors.
Ball, HA; Botbyl, J; Gibson, DM; Jeffels, M; Madi, A; Nokay, B; Plummer, R; Richly, H; Rubin, S; Scheulen, ME; Weller, S, 2013
)
0.86
"Due to the various inter-individual differences in the biological characteristics of tumor cells, as well as issues on the efficacy, adverse reactions, and defects of existing drugs, we compared the clinical efficacy and toxicity of pemetrexed and gemcitabine combined with cisplatin for the treatment of previously untreated advanced non-small cell lung cancer (NSCLC)."( [Efficacy and toxicity of pemetrexed or gemcitabine combined with cisplatin in the treatment of patients with advanced non-small cell lung cancer].
Cheng, G; Hu, C; Hu, X; Huang, C; Jiao, S; Li, K; Luo, R; Lv, W; Ouyang, X; Sun, Y; Wang, J; Wang, M; Wang, Y; Wang, Z; Zhang, S; Zheng, R, 2012
)
0.83
"251 patients were randomly divided into pemetrexed combined with cisplatin group (PP group) with 127 cases and gemcitabine combined with cisplatin group (GP group) with 124 cases."( [Efficacy and toxicity of pemetrexed or gemcitabine combined with cisplatin in the treatment of patients with advanced non-small cell lung cancer].
Cheng, G; Hu, C; Hu, X; Huang, C; Jiao, S; Li, K; Luo, R; Lv, W; Ouyang, X; Sun, Y; Wang, J; Wang, M; Wang, Y; Wang, Z; Zhang, S; Zheng, R, 2012
)
0.86
"The clinical efficacy of pemetrexed and gemcitabine combined with cisplatin for the treatment of previously untreated advanced NSCLC was roughly the same, but the adverse reactions decreased significantly in the PP group compared with those in the GP group."( [Efficacy and toxicity of pemetrexed or gemcitabine combined with cisplatin in the treatment of patients with advanced non-small cell lung cancer].
Cheng, G; Hu, C; Hu, X; Huang, C; Jiao, S; Li, K; Luo, R; Lv, W; Ouyang, X; Sun, Y; Wang, J; Wang, M; Wang, Y; Wang, Z; Zhang, S; Zheng, R, 2012
)
0.91
"MEK inhibition has clinical activity against biliary cancers and might therefore be successfully combined with gemcitabine, one of the most active chemotherapy agents for these cancers."( Sequence dependence of MEK inhibitor AZD6244 combined with gemcitabine for the treatment of biliary cancer.
Cao, P; Chen, E; Green, DE; Hedley, DW; Ibrahimov, E; Knox, JJ; McNamara, MG; Metran-Nascente, C; Serra, S; Tsao, M; Vines, D; Xu, J, 2013
)
0.84
"The purpose of this phase Ib clinical trial was to determine the maximum tolerated dose (MTD) of PR-104 a bioreductive pre-prodrug given in combination with gemcitabine or docetaxel in patients with advanced solid tumours."( PR-104 a bioreductive pre-prodrug combined with gemcitabine or docetaxel in a phase Ib study of patients with advanced solid tumours.
Gu, Y; Jameson, MB; McKeage, MJ; Melink, TJ; Rajendran, J; Ramanathan, RK; Tchekmedyian, NS; Wilson, WR, 2012
)
0.83
"PR-104 was administered as a one-hour intravenous infusion combined with docetaxel 60 to 75 mg/m2 on day one given with or without granulocyte colony stimulating factor (G-CSF) on day two or administrated with gemcitabine 800 mg/m2 on days one and eight, of a 21-day treatment cycle."( PR-104 a bioreductive pre-prodrug combined with gemcitabine or docetaxel in a phase Ib study of patients with advanced solid tumours.
Gu, Y; Jameson, MB; McKeage, MJ; Melink, TJ; Rajendran, J; Ramanathan, RK; Tchekmedyian, NS; Wilson, WR, 2012
)
0.82
" The MTD of PR-104 was 140 mg/m2 when combined with gemcitabine, 200 mg/m2 when combined with docetaxel 60 mg/m2, 770 mg/m2 when combined with docetaxel 60 mg/m2 plus G-CSF and ≥770 mg/m2 when combined with docetaxel 75 mg/m2 plus G-CSF."( PR-104 a bioreductive pre-prodrug combined with gemcitabine or docetaxel in a phase Ib study of patients with advanced solid tumours.
Gu, Y; Jameson, MB; McKeage, MJ; Melink, TJ; Rajendran, J; Ramanathan, RK; Tchekmedyian, NS; Wilson, WR, 2012
)
0.89
" A recommended dose was identified for phase II trials of PR-104 of 770 mg/m2 combined with docetaxel 60 to 75 mg/m2 both given on day one of a 21-day treatment cycle supported by prophylactic G-CSF (NCT00459836)."( PR-104 a bioreductive pre-prodrug combined with gemcitabine or docetaxel in a phase Ib study of patients with advanced solid tumours.
Gu, Y; Jameson, MB; McKeage, MJ; Melink, TJ; Rajendran, J; Ramanathan, RK; Tchekmedyian, NS; Wilson, WR, 2012
)
0.63
" SM-164 could be a promising new agent for treatment of PC in combination with gemcitabine."( Therapy of Smac mimetic SM-164 in combination with gemcitabine for pancreatic cancer.
Chen, G; You, L; Zhang, J; Zhang, TP; Zhao, YP; Zhou, B, 2013
)
0.87
"The aim of this study was to investigate prognostic factors of survival for patients with unresectable pancreatic cancer treated with nafamostat mesilate combined with gemcitabine chemotherapy."( Prognostic factors of unresectable pancreatic cancer treated with nafamostat mesilate combined with gemcitabine chemotherapy.
Fujiwara, Y; Furukawa, K; Gocho, T; Haruki, K; Iwase, R; Misawa, T; Shiba, H; Uwagawa, T; Yanaga, K, 2012
)
0.79
"The study included 41 patients who were diagnosed with unresectable pancreatic cancer and eligible for our clinical study of nafamostat mesilate, combined with gemcitabine chemotherapy for unresectable pancreatic cancer between February 2007 and November 2010 at Jikei University Hospital."( Prognostic factors of unresectable pancreatic cancer treated with nafamostat mesilate combined with gemcitabine chemotherapy.
Fujiwara, Y; Furukawa, K; Gocho, T; Haruki, K; Iwase, R; Misawa, T; Shiba, H; Uwagawa, T; Yanaga, K, 2012
)
0.79
"Jaundice, ascites, high lymphocyte count and high serum CA19-9 levels are independent prognostic predictors for poor overall survival of patients with unresectable pancreatic cancer treated with nafamostat mesilate combined with gemcitabine chemotherapy."( Prognostic factors of unresectable pancreatic cancer treated with nafamostat mesilate combined with gemcitabine chemotherapy.
Fujiwara, Y; Furukawa, K; Gocho, T; Haruki, K; Iwase, R; Misawa, T; Shiba, H; Uwagawa, T; Yanaga, K, 2012
)
0.78
"The aims of this study were to establish the maximum tolerated dose (MTD) of oxaliplatin in combination with fixed doses of gemcitabine, irinotecan, and 5-fluorouracil/leucovorin (G-FLIE) in solid tumors, including advanced pancreatic cancer, and to evaluate the toxicity of the regimen."( Phase I study of oxaliplatin in combination with gemcitabine, irinotecan, and 5-fluorouracil/leucovorin (G-FLIE) in patients with metastatic solid tumors including adenocarcinoma of the pancreas.
Chalasani, SB; Chung, MS; Grossbard, ML; Kozuch, PS; Malamud, S; Mirzoyev, T; Olszewski, AJ, 2013
)
0.85
"The aim of this phase I trial was to define the maximum tolerated dose (MTD), the dose-limiting toxicity (DLT) and the recommended dose of erlotinib combined with capecitabine and gemcitabine in the treatment of advanced pancreatic cancer (APC)."( Phase I trial of gemcitabine combined with capecitabine and erlotinib in advanced pancreatic cancer: a clinical and pharmacological study.
Bennouna, J; Chamorey, E; Douillard, JY; Etienne-Grimaldi, MC; Follana, P; Francois, E; Mari, V; Michel, C; Milano, G; Renée, N; Senellart, H, 2012
)
0.91
" Patients had received G (day 1, 1000 mg/m(2)) and Cis (day 2 and 4, 25 mg/m(2)) in combination with RHT (day 2 and 4, 1 h) biweekly for 4 months."( Gemcitabine and cisplatin combined with regional hyperthermia as second-line treatment in patients with gemcitabine-refractory advanced pancreatic cancer.
Abdel-Rahman, S; Berger, F; Dieterle, N; Issels, RD; Milani, V; Salat, C; Tschoep-Lechner, KE, 2013
)
1.83
" The aim of this study was to characterize this pancreatic carcinoma model and to determine the effects of Plasma Gun alone or in combination with gemcitabine."( Effects of a non thermal plasma treatment alone or in combination with gemcitabine in a MIA PaCa2-luc orthotopic pancreatic carcinoma model.
Brullé, L; Le Pape, A; Lerondel, S; Martel, E; Pouvesle, JM; Richard, S; Riès, D; Robert, E; Trichet, V; Vandamme, M, 2012
)
0.81
"To assess the efficacy and safety of percutaneous cryoablation (PCC) and (125)I seed implantation combined with chemotherapy for advanced pancreatic cancer."( [Percutaneous cryoablation and (125)I seed implantation combined with chemotherapy for advanced pancreatic cancer: report of 67 cases].
He, LH; Niu, LZ; Xu, KC; Yang, ZZ; Zhou, L; Zuo, JS, 2012
)
0.38
"Sixty-seven patients with advanced pancreatic cancer (6 in stage III, 61 in stage IV) received PCC and (125)I seed implantation combined with concomitant gemcitabine hydrochloride and DDP chemotherapy."( [Percutaneous cryoablation and (125)I seed implantation combined with chemotherapy for advanced pancreatic cancer: report of 67 cases].
He, LH; Niu, LZ; Xu, KC; Yang, ZZ; Zhou, L; Zuo, JS, 2012
)
0.58
"Percutaneous cryoablation and (125)I seed implantation combined with chemotherapy are effective and safe for the treatment of advanced pancreatic cancer."( [Percutaneous cryoablation and (125)I seed implantation combined with chemotherapy for advanced pancreatic cancer: report of 67 cases].
He, LH; Niu, LZ; Xu, KC; Yang, ZZ; Zhou, L; Zuo, JS, 2012
)
0.38
"To evaluate the 6-mo overall survival, safety and tolerability of lenalidomide in combination with standard gemcitabine as first-line treatment for patients with metastatic pancreatic cancer."( Lenalidomide in combination with gemcitabine as first-line treatment for patients with metastatic carcinoma of the pancreas: a Sarah Cannon Research Institute phase II trial.
Arkenau, HT; Bendell, JC; Burris, HA; Hainsworth, JD; Infante, JR; Jones, GT; Lane, CM; Rubin, MS; Spigel, DR; Waterhouse, D, 2013
)
0.88
"HAI nab-paclitaxel in combination with gemcitabine and bevacizumab was well tolerated and had antitumor activity in selected patients with advanced cancer and liver metastases."( A phase I study of hepatic arterial infusion of nab-paclitaxel in combination with intravenous gemcitabine and bevacizumab for patients with advanced cancers and predominant liver metastases.
Hess, KR; Hong, D; Naing, A; Nwosu, U; Tsimberidou, AM; Wheler, J; Wolff, RA; Ye, Y, 2013
)
0.88
"To evaluate the efficacy and tolerability of the urokinase plasminogen activator (uPA) inhibitor upamostat in combination with gemcitabine in locally advanced pancreatic adenocarcinoma (LAPC)."( Phase II randomised proof-of-concept study of the urokinase inhibitor upamostat (WX-671) in combination with gemcitabine compared with gemcitabine alone in patients with non-resectable, locally advanced pancreatic cancer.
Bevan, P; Boeck, S; Ebert, MP; Heinemann, V; Laubender, RP; Mala, C, 2013
)
0.81
"Within a prospective multicenter study, LAPC patients were randomly assigned to receive 1000 mg m(-2) of gemcitabine IV weekly either alone (arm A) or in combination with 200 mg (arm B) or 400 mg (arm C) oral upamostat daily."( Phase II randomised proof-of-concept study of the urokinase inhibitor upamostat (WX-671) in combination with gemcitabine compared with gemcitabine alone in patients with non-resectable, locally advanced pancreatic cancer.
Bevan, P; Boeck, S; Ebert, MP; Heinemann, V; Laubender, RP; Mala, C, 2013
)
0.82
" We have designed a trial to assess whether first-line chemotherapy using liposomal paclitaxel combined with cisplatin (LP regimen) is superior to gemcitabine combined with cisplatin (GP regimen) in efficacy (both short-term and long-term efficacy) and safety (adverse events; AEs)."( Assessing the effectiveness and safety of liposomal paclitaxel in combination with cisplatin as first-line chemotherapy for patients with advanced NSCLC with regional lymph-node metastasis: study protocol for a randomized controlled trial (PLC-GC trial).
Bingjing, Z; Hu, L; Liang, G; Rufu, X; Xiangdong, Z; Yuliang, W, 2013
)
0.59
" Bortezomib, a proteasome inhibitor,markedly enhanced the cytotoxic effects of panobinostat combined with gemcitabine."( Identification of unique synergistic drug combinations associated with downexpression of survivin in a preclinical breast cancer model system.
Budman, DR; Calabro, A; Lesser, M; Rosen, L, 2012
)
0.59
" There were no clinically significant drug-drug interactions."( Sunitinib in combination with gemcitabine for advanced solid tumours: a phase I dose-finding study.
Chen, I; McDermott, DF; Michaelson, MD; Patyna, S; Ruiz-Garcia, A; Ryan, DP; Schwarzberg, AB; Shapiro, GI; Stephenson, P; Tye, L; Zhu, AX, 2013
)
0.68
"Sunitinib plus gemcitabine on Schedule 2/1 with growth factor support was well tolerated and safely administered at maximum doses of each drug, without significant drug-drug interactions."( Sunitinib in combination with gemcitabine for advanced solid tumours: a phase I dose-finding study.
Chen, I; McDermott, DF; Michaelson, MD; Patyna, S; Ruiz-Garcia, A; Ryan, DP; Schwarzberg, AB; Shapiro, GI; Stephenson, P; Tye, L; Zhu, AX, 2013
)
1.03
"Oral MSC1992371A can be administered at a MTD of 37 mg/m(2) in combination with the standard 1,000 mg/m(2) dose of gemcitabine, but hematologic toxicity requires careful monitoring."( A phase I schedule dependency study of the aurora kinase inhibitor MSC1992371A in combination with gemcitabine in patients with solid tumors.
Alexandre, J; Awada, A; Besse-Hammer, T; Faivre, S; Gianella-Borradori, A; Goldwasser, F; Jego, V; Raymond, E; Rejeb, N; Trandafir, L, 2014
)
0.83
" BLU in combination with gemcitabine arrested the cell cycle at the G1-G0 phase and induced apoptosis."( BLU enhances the effects of anti-angiogenic activity in combination with gemcitabine-based chemotherapeutic agents.
Byun, HJ; Kim, BR; Park, SY; Rho, SB; Yoo, HJ, 2013
)
0.92
"This phase 1b study determined the safety, tolerability, and recommended phase 2 dose (RP2D) and schedule of trametinib in combination with gemcitabine."( A phase 1b study of trametinib, an oral Mitogen-activated protein kinase kinase (MEK) inhibitor, in combination with gemcitabine in advanced solid tumours.
Bellew, KM; Bendell, JC; Burris, HA; Cox, DS; Durante, M; Infante, JR; Jones, SF; Le, NT; Papadopoulos, KP; Park, JJ; Patnaik, A; Rasco, D; Smith, L; Tolcher, AW, 2013
)
0.8
" During expansion, trametinib 2mg was combined with gemcitabine."( A phase 1b study of trametinib, an oral Mitogen-activated protein kinase kinase (MEK) inhibitor, in combination with gemcitabine in advanced solid tumours.
Bellew, KM; Bendell, JC; Burris, HA; Cox, DS; Durante, M; Infante, JR; Jones, SF; Le, NT; Papadopoulos, KP; Park, JJ; Patnaik, A; Rasco, D; Smith, L; Tolcher, AW, 2013
)
0.85
"Administration of trametinib at its full monotherapy dose of 2mg daily in combination with standard gemcitabine dosing (1000 mg/m(2) IV Days 1, 8, and 15 every 28 days) was feasible."( A phase 1b study of trametinib, an oral Mitogen-activated protein kinase kinase (MEK) inhibitor, in combination with gemcitabine in advanced solid tumours.
Bellew, KM; Bendell, JC; Burris, HA; Cox, DS; Durante, M; Infante, JR; Jones, SF; Le, NT; Papadopoulos, KP; Park, JJ; Patnaik, A; Rasco, D; Smith, L; Tolcher, AW, 2013
)
0.82
" Elimination of Tregs alone or in combination with DC-based vaccination had no effect on pancreatic tumor growth or survival."( Dendritic cell immunotherapy combined with gemcitabine chemotherapy enhances survival in a murine model of pancreatic carcinoma.
Ghansah, T; Kinney, K; Kodumudi, K; Pilon-Thomas, S; Sarnaik, AA; Springett, G; Vohra, N; Weber, A, 2013
)
0.65
"To establish the recommended phase II dose of the oral γ-secretase inhibitor RO4929097 (RO) in combination with gemcitabine; secondary objectives include the evaluation of safety, tolerability, pharmacokinetics, biomarkers of Notch signaling and preliminary anti-tumor activity."( A phase I study of the oral gamma secretase inhibitor R04929097 in combination with gemcitabine in patients with advanced solid tumors (PHL-078/CTEP 8575).
Bedard, PL; Chen, EX; Chen, Z; Clarke, BA; Cohen, B; Hirte, HW; Hotte, SJ; Ivy, SP; McWhirter, E; Moore, MJ; Oza, AM; Razak, AR; Reedijk, M; Richter, S; Siu, LL; Stathis, A; Tran, B; Wang, L; Zhang, WJ, 2014
)
0.84
" The recommended phase II dose of RO was 30 mg in combination with gemcitabine 1,000 mg/m(2)."( A phase I study of the oral gamma secretase inhibitor R04929097 in combination with gemcitabine in patients with advanced solid tumors (PHL-078/CTEP 8575).
Bedard, PL; Chen, EX; Chen, Z; Clarke, BA; Cohen, B; Hirte, HW; Hotte, SJ; Ivy, SP; McWhirter, E; Moore, MJ; Oza, AM; Razak, AR; Reedijk, M; Richter, S; Siu, LL; Stathis, A; Tran, B; Wang, L; Zhang, WJ, 2014
)
0.86
" Here we report the first phase 2 study of erlotinib in combination with adjuvant chemoradiation and chemotherapy for resected PDAC."( Phase 2 study of erlotinib combined with adjuvant chemoradiation and chemotherapy in patients with resectable pancreatic cancer.
Blackford, AL; Cameron, JL; Choti, MA; De Jesus-Acosta, A; Donehower, RC; Edil, BH; Ellsworth, S; Fan, KY; Hacker-Prietz, A; Herman, JM; Hidalgo, M; Hruban, RH; Laheru, DA; Le, DT; Pawlik, TM; Schulick, RD; Wild, AT; Wolfgang, CL; Wood, LD; Zheng, L, 2013
)
0.39
"Erlotinib can be safely administered with adjuvant IMRT-based CRT and chemotherapy."( Phase 2 study of erlotinib combined with adjuvant chemoradiation and chemotherapy in patients with resectable pancreatic cancer.
Blackford, AL; Cameron, JL; Choti, MA; De Jesus-Acosta, A; Donehower, RC; Edil, BH; Ellsworth, S; Fan, KY; Hacker-Prietz, A; Herman, JM; Hidalgo, M; Hruban, RH; Laheru, DA; Le, DT; Pawlik, TM; Schulick, RD; Wild, AT; Wolfgang, CL; Wood, LD; Zheng, L, 2013
)
0.39
"To investigate the inhibitory effect of geraniol alone, or in combination with gemcitabine, on the proliferation of BXPC-3 pancreatic cancer cells."( Inhibitory effect of geraniol in combination with gemcitabine on proliferation of BXPC-3 human pancreatic cancer cells.
Jin, X; Liu, G; Miao, X; Sun, J; Zhong, D, 2013
)
0.87
" Geraniol alone or combined with gemcitabine induced BXPC-3 cell apoptosis."( Inhibitory effect of geraniol in combination with gemcitabine on proliferation of BXPC-3 human pancreatic cancer cells.
Jin, X; Liu, G; Miao, X; Sun, J; Zhong, D, 2013
)
0.92
"To examine the antagonistic effects of anti-extracellular matrix metalloprotease inducer (anti-EMMPRIN) antibody when combined with chemotherapy using a hypovascular pancreatic tumor model."( Antagonistic effects of anti-EMMPRIN antibody when combined with chemotherapy against hypovascular pancreatic cancers.
Beasley, TM; Boothman, DA; Buchsbaum, DJ; Kim, H; Lee, SK; Li, LS; Martin, A; Rigell, CJ; Samuel, SL; Stockard, CR; Umphrey, HR; Zhai, G; Zinn, KR, 2014
)
0.4
" Similarly, tumor growth was significantly suppressed by β-lapachone alone, and additive effects were noted when combined with gemcitabine, but the therapeutic efficacy was reduced when anti-EMMPRIN antibody was added."( Antagonistic effects of anti-EMMPRIN antibody when combined with chemotherapy against hypovascular pancreatic cancers.
Beasley, TM; Boothman, DA; Buchsbaum, DJ; Kim, H; Lee, SK; Li, LS; Martin, A; Rigell, CJ; Samuel, SL; Stockard, CR; Umphrey, HR; Zhai, G; Zinn, KR, 2014
)
0.61
"To observe the clinical efficacy and safety of pemetrexed or gemcitabine combined with carboplatin as the first-line therapy in elderly patients with advanced non-small cell lung cancer (NSCLC)."( [Efficacy and safety of pemetrexed or gemcitabine combined with carboplatin as the first-line therapy in elderly patients with advanced non-small cell lung cancer].
Shi, X; Yu, XM; Zhang, YP; Zhao, J, 2013
)
0.9
" Thus, pemetrexed combined with carboplatin is an effective chemotherapeutic regimen for advanced NSCLC in elderly patients."( [Efficacy and safety of pemetrexed or gemcitabine combined with carboplatin as the first-line therapy in elderly patients with advanced non-small cell lung cancer].
Shi, X; Yu, XM; Zhang, YP; Zhao, J, 2013
)
0.66
"This open-label, Phase I, dose-escalation study evaluated the safety, pharmacokinetics (PK) and preliminary efficacy (RECIST) of AZD7762 alone and in combination with gemcitabine in Japanese patients with advanced solid tumours (NCT00937664)."( Phase I, dose-escalation study of AZD7762 alone and in combination with gemcitabine in Japanese patients with advanced solid tumours.
Agbo, F; Arita, S; Esaki, T; Fujimoto, C; Hamatake, M; Hirai, F; Kometani, T; Makiyama, A; Nosaki, K; Seto, T; Shi, X; Takeoka, H, 2013
)
0.82
"The maximum tolerated dose of AZD7762 in combination with gemcitabine, 1,000 mg/m(2) was determined as 21 mg in Japanese patients."( Phase I, dose-escalation study of AZD7762 alone and in combination with gemcitabine in Japanese patients with advanced solid tumours.
Agbo, F; Arita, S; Esaki, T; Fujimoto, C; Hamatake, M; Hirai, F; Kometani, T; Makiyama, A; Nosaki, K; Seto, T; Shi, X; Takeoka, H, 2013
)
0.87
" The objective of this research was to enhance the efficacy and drug-resistance for pancreatic carcinoma by using inhibition of SIRT1 combined with gemcitabine therapy methods."( Inhibition of SIRT1 combined with gemcitabine therapy for pancreatic carcinoma.
Gong, DJ; Guo, QQ; Yu, M; Zhang, JM; Zhuang, B, 2013
)
0.87
"To assess the efficacy and safety of carboplatin-based chemotherapy when compared with cisplatin-based chemotherapy, both in combination with a third-generation drug, in people with advanced NSCLC."( Cisplatin versus carboplatin in combination with third-generation drugs for advanced non-small cell lung cancer.
da Silva, EM; de Castria, TB; Gois, AF; Riera, R, 2013
)
0.39
"Randomised clinical trials comparing regimens with carboplatin or cisplatin combined with a third-generation drug in people with locally advanced or metastatic NSCLC."( Cisplatin versus carboplatin in combination with third-generation drugs for advanced non-small cell lung cancer.
da Silva, EM; de Castria, TB; Gois, AF; Riera, R, 2013
)
0.39
"This phase I study investigated the maximum-tolerated dose (MTD), safety, pharmacodynamics, immunologic correlatives, and antitumor activity of CP-870,893, an agonist CD40 antibody, when administered in combination with gemcitabine in patients with advanced pancreatic ductal adenocarcinoma (PDA)."( A phase I study of an agonist CD40 monoclonal antibody (CP-870,893) in combination with gemcitabine in patients with advanced pancreatic ductal adenocarcinoma.
Alavi, A; Beatty, GL; Brothers, A; Chiorean, EG; O'Dwyer, PJ; Saboury, B; Sun, W; Teitelbaum, UR; Torigian, DA; Troxel, AB; Vonderheide, RH, 2013
)
0.8
"CP-870,893 in combination with gemcitabine was well-tolerated and associated with antitumor activity in patients with PDA."( A phase I study of an agonist CD40 monoclonal antibody (CP-870,893) in combination with gemcitabine in patients with advanced pancreatic ductal adenocarcinoma.
Alavi, A; Beatty, GL; Brothers, A; Chiorean, EG; O'Dwyer, PJ; Saboury, B; Sun, W; Teitelbaum, UR; Torigian, DA; Troxel, AB; Vonderheide, RH, 2013
)
0.9
"We aimed at investigating in vitro the cytotoxic activity (determined using WST-1, apoptosis and cell cycle assays) of gemcitabine, alone or in combination with mitotane, in mitotane-sensitive H295R and mitotane-insensitive SW-13 cells."( Cytotoxic activity of gemcitabine, alone or in combination with mitotane, in adrenocortical carcinoma cell lines.
Berruti, A; Carturan, S; Germano, A; Lo Buono, N; Papotti, M; Rapa, I; Terzolo, M; Volante, M, 2014
)
0.93
" We selected those patients for our study who were receiving treatment with paclitaxel, gemcitabine or etoposide in combination with platinum based drugs."( Survival analysis in advanced non small cell lung cancer treated with platinum based chemotherapy in combination with paclitaxel, gemcitabine and etoposide.
Jamil, K; Naidu Madireddy, UR; Natukula, K; Pingali, UR; Suresh Attili, VS, 2013
)
0.82
"To investigate the therapeutic efficacy of double-mutated oncolytic adenovirus AxdAdB-3 in combination with gemcitabine for treating bladder cancer in an orthotopic nude mouse model."( [Double-mutated oncolytic adenovirus combined with gemcitabine for treating an orthotopic nude mouse model of bladder cancer].
Chen, GP; Li, DC; Li, FY; Liu, Z; Wang, H; Wang, ZP; Zhao, Y, 2013
)
0.85
" AxdAdB-3 combined with gemcitabine significantly inhibited the growth of bladder cancer cell lines."( [Double-mutated oncolytic adenovirus combined with gemcitabine for treating an orthotopic nude mouse model of bladder cancer].
Chen, GP; Li, DC; Li, FY; Liu, Z; Wang, H; Wang, ZP; Zhao, Y, 2013
)
0.95
"Intravesical instillation therapy with AxdAdB-3 in combination with gemcitabine can effectively inhibit the orthotopic bladder cancer in nude mouse, and further relevant clinical studies are guaranteed."( [Double-mutated oncolytic adenovirus combined with gemcitabine for treating an orthotopic nude mouse model of bladder cancer].
Chen, GP; Li, DC; Li, FY; Liu, Z; Wang, H; Wang, ZP; Zhao, Y, 2013
)
0.88
"L19-tumor necrosis factor alpha (L19mTNF-α; L), a fusion protein consisting of mouse TNFα and the human antibody fragment L19 directed to the extra domain-B (ED-B) of fibronectin, is able to selectively target tumor vasculature and to exert a long-lasting therapeutic activity in combination with melphalan (M) in syngeneic mouse tumor models."( Schedule-dependent therapeutic efficacy of L19mTNF-α and melphalan combined with gemcitabine.
Balza, E; Borsi, L; Carnemolla, B; Castellani, P; Mortara, L; Orecchia, P, 2013
)
0.62
" In addition three other human tumour cell lines (A549: lung, LN-229: glioblastoma, PANC-1: pancreas) were tested for the combination with camptothecin."( Comparison of the effects of photon versus carbon ion irradiation when combined with chemotherapy in vitro.
Brons, S; Combs, SE; Debus, J; Haberer, T; Schlaich, F; Weber, KJ, 2013
)
0.39
" In combination with chemotherapy additive toxicity was the prevailing effect."( Comparison of the effects of photon versus carbon ion irradiation when combined with chemotherapy in vitro.
Brons, S; Combs, SE; Debus, J; Haberer, T; Schlaich, F; Weber, KJ, 2013
)
0.39
" In H460 xenografts, CKD-516 combined with gemcitabine significantly delayed tumor growth up to 57 % and 36 % as compared to control and gemcitabine alone, respectively."( CKD-516 displays vascular disrupting properties and enhances anti-tumor activity in combination with chemotherapy in a murine tumor model.
Cha, H; Cho, WJ; Dung, le TK; Lee, HY; Lee, SJ; Min, YJ; Moon, CH; Park, JW, 2014
)
0.67
"CKD-516 is a novel agent with vascular disrupting properties and enhances anti-tumor activity in combination with chemotherapy."( CKD-516 displays vascular disrupting properties and enhances anti-tumor activity in combination with chemotherapy in a murine tumor model.
Cha, H; Cho, WJ; Dung, le TK; Lee, HY; Lee, SJ; Min, YJ; Moon, CH; Park, JW, 2014
)
0.4
" IFN-γ-producing cells were induced by the KIF20A-derived peptide vaccine at a high rate, even in combination with GEM."( A phase I clinical trial of vaccination with KIF20A-derived peptide in combination with gemcitabine for patients with advanced pancreatic cancer.
Hazama, S; Iida, M; Matsui, H; Oka, M; Shindo, Y; Suzuki, N; Takeda, K; Ueno, T; Yoshimura, K; Yoshino, S, 2014
)
0.62
"01), but all significantly smaller than that in the control group; HIFU combined with gemcitabine resulted in the most obvious reduction in the tumor volume."( [Effect of high-intensity focused ultrasound combined with gemcitabine on subcutaneous pancreatic cancer in nude mice].
Fang, L; Hu, H; Li, F; Liu, L; Mao, Y; Zhu, H, 2013
)
0.86
"HIFU therapy produces definite therapeutic effect on human pancreatic cancer in the nude mouse model, and its combination with chemotherapy is the optimal treatment modality."( [Effect of high-intensity focused ultrasound combined with gemcitabine on subcutaneous pancreatic cancer in nude mice].
Fang, L; Hu, H; Li, F; Liu, L; Mao, Y; Zhu, H, 2013
)
0.63
"To determine the maximum tolerated dose and the recommended dose (RD) for phase II trials of elisidepsin (Irvalec®) in combination with carboplatin or gemcitabine."( Phase I study of elisidepsin (Irvalec®) in combination with carboplatin or gemcitabine in patients with advanced malignancies.
Alexandre, J; Coronado, C; Dios, JL; Faivre, S; Fernández-García, EM; Goldwasser, F; Kahatt, CM; Miguel-Lillo, B; Paramio, PG; Raymond, E, 2014
)
0.83
"Infra-optimal doses of elisidepsin and carboplatin and a lack of antitumor activity despite using active drug concentrations in combination with gemcitabine do not warrant further clinical development for these two combinations."( Phase I study of elisidepsin (Irvalec®) in combination with carboplatin or gemcitabine in patients with advanced malignancies.
Alexandre, J; Coronado, C; Dios, JL; Faivre, S; Fernández-García, EM; Goldwasser, F; Kahatt, CM; Miguel-Lillo, B; Paramio, PG; Raymond, E, 2014
)
0.83
" This phase 2 trial evaluated the efficacy of tigatuzumab combined with gemcitabine in 62 chemotherapy-naive patients with histologically or cytologically confirmed unresectable or metastatic pancreatic cancer."( Phase 2, multicenter, open-label study of tigatuzumab (CS-1008), a humanized monoclonal antibody targeting death receptor 5, in combination with gemcitabine in chemotherapy-naive patients with unresectable or metastatic pancreatic cancer.
Arrowsmith, E; Austin, T; Beckman, R; Forero-Torres, A; Greenberg, J; Hart, L; He, AR; Infante, JR; Jin, X; Rosen, M; Saleh, M; Trent, D; Vickers, S; von Roemeling, R; Wade, J; Wang, Q; Waterhouse, D; Wong, L, 2013
)
0.82
"Forty-two patients received AZD7762 6 mg (n = 9), 9 mg (n = 3), 14 mg (n = 6), 21 mg (n = 3), 30 mg (n = 7), 32 mg (n = 6), and 40 mg (n = 8), in combination with gemcitabine."( Phase I dose-escalation study of AZD7762, a checkpoint kinase inhibitor, in combination with gemcitabine in US patients with advanced solid tumors.
Agbo, F; Azad, N; Barker, P; Carducci, M; Carter, J; Cosgrove, D; Knight, R; Lorusso, P; Malburg, L; Oakes, P; Quinn, MF; Sausville, E; Senderowicz, A; Zabludoff, S, 2014
)
0.82
"The maximum-tolerated dose of AZD7762 in combination with gemcitabine 1,000 mg/m(2) was 30 mg."( Phase I dose-escalation study of AZD7762, a checkpoint kinase inhibitor, in combination with gemcitabine in US patients with advanced solid tumors.
Agbo, F; Azad, N; Barker, P; Carducci, M; Carter, J; Cosgrove, D; Knight, R; Lorusso, P; Malburg, L; Oakes, P; Quinn, MF; Sausville, E; Senderowicz, A; Zabludoff, S, 2014
)
0.87
" WT1 vaccine in combination with gemcitabine was well tolerated for patients with advanced pancreatic cancer."( Wilms tumor gene (WT1) peptide-based cancer vaccine combined with gemcitabine for patients with advanced pancreatic cancer.
Doki, Y; Eguchi, H; Hara, K; Homma, S; Hosen, N; Ikegami, M; Ito, T; Kawase, I; Kitagawa, T; Koido, S; Komita, H; Kumanogoh, A; Mori, M; Morimoto, S; Morita, S; Nagano, H; Nakae, Y; Nakata, J; Nishida, S; Ohkusa, T; Oji, Y; Oka, Y; Sakamoto, J; Sugiyama, H; Tajiri, H; Takahara, A; Takeda, Y; Tanaka, T; Toyama, Y; Tsuboi, A; Wada, H; Yanagisawa, S,
)
0.65
"This study was aimed to investigate the effect of Honokiol (HNK) combined with Gemcitabine (GEM) on the proliferation and apoptosis of human Burkitt lymphoma Raji cells."( [Honokiol combined with Gemcitabine synergistically inhibits the proliferation of human Burkitt lymphoma cells and induces their apoptosis].
Fan, JX; Guo, KY; Hung, YX; Wang, J; Xu, XJ; Ye, YB; Zhang, MW, 2014
)
0.94
" TL-118, a novel drug combination has been recently developed to inhibit tumor angiogenesis."( TL-118 and gemcitabine drug combination display therapeutic efficacy in a MYCN amplified orthotopic neuroblastoma murine model--evaluation by MRI.
Abramovitch, R; Corchia, N; Dery, E; Fried, I; Gross, E; Komar-Stossel, C; Meir, K, 2014
)
0.79
"To evaluate the therapy effects of (125)I implantation combined with chemoradiotherapy on pancreatic cancer patients."( (125)I particle implantation combined with chemoradiotherapy to treat advanced pancreatic cancer.
Di, XY; Guo, JM; Jiang, HT; Yu, Q; Yu, YP; Zhu, Y, 2014
)
0.4
"(125)I implanted into tumour combined with chemoradiotherapy has higher local control rate of advanced pancreatic cancer than chemoradiotherapy."( (125)I particle implantation combined with chemoradiotherapy to treat advanced pancreatic cancer.
Di, XY; Guo, JM; Jiang, HT; Yu, Q; Yu, YP; Zhu, Y, 2014
)
0.4
" In combination with gemcitabine, the peptide demonstrated enhanced in vitro cytotoxicity as well as tumor growth inhibition in an animal model."( Anti-tumor efficacy of a therapeutic peptide based on thermo-responsive elastin-like polypeptide in combination with gemcitabine.
Raucher, D; Ryu, JS, 2014
)
0.93
" This study was conducted to elucidate the safety and efficacy of palliative chemotherapy with gemcitabine or pemetrexed, both in combination with a platinum agent in NSCLC patients with ILD."( Safety and efficacy of gemcitabine or pemetrexed in combination with a platinum in patients with non-small-cell lung cancer and prior interstitial lung disease.
Ahn, JS; Ahn, MJ; Chang, W; Choi, MK; Chung, MP; Hong, JY; Jung, HA; Kim, M; Kim, S; Lee, SJ; Park, K; Park, S; Sun, JM, 2014
)
0.93
"Patients with advanced or recurrent NSCLC and ILD who received gemcitabine or pemetrexed in combination with a platinum agent as first-line chemotherapy were retrospectively analyzed."( Safety and efficacy of gemcitabine or pemetrexed in combination with a platinum in patients with non-small-cell lung cancer and prior interstitial lung disease.
Ahn, JS; Ahn, MJ; Chang, W; Choi, MK; Chung, MP; Hong, JY; Jung, HA; Kim, M; Kim, S; Lee, SJ; Park, K; Park, S; Sun, JM, 2014
)
0.95
"Our results suggest that gemcitabine or pemetrexed in combination with platinum agents could be a feasible option for advanced NSCLC with ILD with some risk of AE-ILD or early death."( Safety and efficacy of gemcitabine or pemetrexed in combination with a platinum in patients with non-small-cell lung cancer and prior interstitial lung disease.
Ahn, JS; Ahn, MJ; Chang, W; Choi, MK; Chung, MP; Hong, JY; Jung, HA; Kim, M; Kim, S; Lee, SJ; Park, K; Park, S; Sun, JM, 2014
)
1.02
"Patients with advanced or metastatic solid tumors were treated with escalating doses of tivantinib (120-360 mg capsules) in combination with gemcitabine (1000 mg/m(2) weekly for 3 of 4 weeks)."( A phase I dose escalation study of oral c-MET inhibitor tivantinib (ARQ 197) in combination with gemcitabine in patients with solid tumors.
Abbadessa, G; Bendell, J; Camacho, LH; Chen, Y; Infante, JR; Jones, S; Kazakin, J; Kurkjian, CD; Moore, KM; Pant, S; Saleh, M; Schwartz, B; Wang, Y, 2014
)
0.82
"This Phase 1 study aimed to determine the recommended Phase 2 dose of LY2334737, an oral gemcitabine prodrug, when combined with standard dose docetaxel treatment in patients with advanced solid tumors."( Phase 1 dose escalation and pharmacokinetic evaluation of oral gemcitabine prodrug (LY2334737) in combination with docetaxel in patients with advanced solid tumors.
Aguirre, E; Benhadji, KA; Callies, S; Garcia, M; Gil-Martín, M; Llombart, A; Morales, S; Oaknin, A; Salazar, R; Wickremsinhe, ER, 2014
)
0.86
" PK data were consistent with the first-in-man study of LY2334737 and did not reveal any drug-drug interaction between LY2334737 and docetaxel."( Phase 1 dose escalation and pharmacokinetic evaluation of oral gemcitabine prodrug (LY2334737) in combination with docetaxel in patients with advanced solid tumors.
Aguirre, E; Benhadji, KA; Callies, S; Garcia, M; Gil-Martín, M; Llombart, A; Morales, S; Oaknin, A; Salazar, R; Wickremsinhe, ER, 2014
)
0.64
" However, ganitumab 20 mg/kg in combination with gemcitabine had not been administered to patients with metastatic pancreatic cancer."( Safety, tolerability, pharmacokinetics and antitumor activity of ganitumab, an investigational fully human monoclonal antibody to insulin-like growth factor type 1 receptor, combined with gemcitabine as first-line therapy in patients with metastatic pancr
Fukutomi, A; Gansert, J; Ikeda, M; Kobayashi, Y; Okusaka, T; Shibayama, K; Takubo, T, 2014
)
0.85
" No apparent pharmacokinetic drug-drug interaction was observed."( Safety, tolerability, pharmacokinetics and antitumor activity of ganitumab, an investigational fully human monoclonal antibody to insulin-like growth factor type 1 receptor, combined with gemcitabine as first-line therapy in patients with metastatic pancr
Fukutomi, A; Gansert, J; Ikeda, M; Kobayashi, Y; Okusaka, T; Shibayama, K; Takubo, T, 2014
)
0.59
"Ganitumab 20 mg/kg combined with gemcitabine 1000 mg/m(2) was tolerable and showed an acceptable safety profile in patients with untreated metastatic pancreatic cancer."( Safety, tolerability, pharmacokinetics and antitumor activity of ganitumab, an investigational fully human monoclonal antibody to insulin-like growth factor type 1 receptor, combined with gemcitabine as first-line therapy in patients with metastatic pancr
Fukutomi, A; Gansert, J; Ikeda, M; Kobayashi, Y; Okusaka, T; Shibayama, K; Takubo, T, 2014
)
0.87
"To evaluate the curative effect and clinical application of hepatic arterial infusion (HAI) chemotherapy combined with endogenetic field tumor hyperthermia (EFTH) in patients with hilar cholangiocarcinoma."( Hepatic arterial infusion chemotherapy combined with endogenetic hyperthermia treatment of hilar cholangiocarcinoma.
Chen, YT; Sun, HL; Teng, H; Xu, LF; Yao, HR,
)
0.13
"HAI chemotherapy combined with EFTH is safe, minimally invasive, and well tolerated."( Hepatic arterial infusion chemotherapy combined with endogenetic hyperthermia treatment of hilar cholangiocarcinoma.
Chen, YT; Sun, HL; Teng, H; Xu, LF; Yao, HR,
)
0.13
" In the present study, we investigated the efficacy of treatment with systemic gemcitabine (GEM) combined with HAIC with cisplatin (CDDP), 5-fluorouracil (5-FU), and isovorin in patients with advanced ICC."( Systemic gemcitabine combined with hepatic arterial infusion chemotherapy with cisplatin, 5-fluorouracil, and isovorin for the treatment of advanced intrahepatic cholangiocarcinoma: a pilot study.
Harima, Y; Hidaka, I; Ishikawa, T; Marumoto, M; Marumoto, Y; Saeki, I; Sakaida, I; Segawa, M; Takami, T; Terai, S; Uchida, K; Urata, Y; Yamaguchi, Y; Yamasaki, T,
)
0.78
"Seven patients with advanced ICC, who received systemic GEM combined with HAIC with CDDP, 5-FU, and isovorin were studied."( Systemic gemcitabine combined with hepatic arterial infusion chemotherapy with cisplatin, 5-fluorouracil, and isovorin for the treatment of advanced intrahepatic cholangiocarcinoma: a pilot study.
Harima, Y; Hidaka, I; Ishikawa, T; Marumoto, M; Marumoto, Y; Saeki, I; Sakaida, I; Segawa, M; Takami, T; Terai, S; Uchida, K; Urata, Y; Yamaguchi, Y; Yamasaki, T,
)
0.55
"Although this is a pilot study, we suggest that systemic GEM combined with HAIC with CDDP, 5-FU, and isovorin, may be a useful therapy for patients with advanced ICC."( Systemic gemcitabine combined with hepatic arterial infusion chemotherapy with cisplatin, 5-fluorouracil, and isovorin for the treatment of advanced intrahepatic cholangiocarcinoma: a pilot study.
Harima, Y; Hidaka, I; Ishikawa, T; Marumoto, M; Marumoto, Y; Saeki, I; Sakaida, I; Segawa, M; Takami, T; Terai, S; Uchida, K; Urata, Y; Yamaguchi, Y; Yamasaki, T,
)
0.55
" Combination with standard chemotherapy may strengthen antitumor therapy."( A phase I dose escalation trial of tremelimumab (CP-675,206) in combination with gemcitabine in chemotherapy-naive patients with metastatic pancreatic cancer.
Aglietta, M; Bagalà, C; Barone, C; Cagnazzo, C; Colombi, F; Fly, KD; Gioeni, L; Huang, B; Leone, F; Miller, WH; Moore, MJ; Sawyer, MB; Wang, E, 2014
)
0.63
"To investigate the safety, optimal dosing, pharmacokinetics and clinical activity of a regimen of navitoclax (ABT-263) combined with gemcitabine in patients with solid tumors."( A phase I clinical trial of navitoclax, a targeted high-affinity Bcl-2 family inhibitor, in combination with gemcitabine in patients with solid tumors.
Busman, T; Cleary, JM; Franklin, C; Graham, A; Holen, K; Hurwitz, HI; Lima, CM; Mabry, M; Montero, AJ; Shapiro, GI; Uronis, H; Yang, J, 2014
)
0.82
" No clinically significant pharmacokinetic drug-drug interactions were observed."( A phase I clinical trial of navitoclax, a targeted high-affinity Bcl-2 family inhibitor, in combination with gemcitabine in patients with solid tumors.
Busman, T; Cleary, JM; Franklin, C; Graham, A; Holen, K; Hurwitz, HI; Lima, CM; Mabry, M; Montero, AJ; Shapiro, GI; Uronis, H; Yang, J, 2014
)
0.61
" In calu-6 xenografts, LY2835219 in combination with gemcitabine enhanced in vivo antitumor activity without a G1 cell cycle arrest, but was associated with a reduction of ribonucleotide reductase expression."( Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine.
Ajamie, RT; Cai, S; Chan, EM; Cronier, D; de Dios, A; Del Prado, M; Flack, RS; Gelbert, LM; Iversen, P; Kreklau, E; Lallena, MJ; Lin, X; Neubauer, BL; Sanchez-Martinez, C; Torres, R; Wishart, GN; Young, J, 2014
)
0.85
" Carlumab could be safely administered at 10 or 15 mg/kg in combination with standard-of-care chemotherapy and was well-tolerated, although no long-term suppression of serum CCL2 or significant tumor responses were observed."( Carlumab, an anti-C-C chemokine ligand 2 monoclonal antibody, in combination with four chemotherapy regimens for the treatment of patients with solid tumors: an open-label, multicenter phase 1b study.
Brana, I; Calles, A; Calvo, E; de Boer, CJ; LoRusso, PM; Puchalski, TA; Seetharam, S; Tabernero, J; Yee, LK; Zhong, B, 2015
)
0.42
" This systematic evaluation compared the efficacy and safety profiles of gemcitabine combined with targeted agents (GEM + TA) versus gemcitabine administered as monotherapy or combined with placebo (GEM ± PLC) in LA/MPC patients."( Comparison of gemcitabine combined with targeted agent therapy versus gemcitabine monotherapy in the management of advanced pancreatic cancer.
Cao, B; Li, Q; Wen, Z; Yan, H; Yuan, Z; Zhang, R, 2014
)
0.99
" Treatment was administered with gemcitabine (1,000 mg/m(2) on days 1 and 8), cisplatin (70 mg/m(2)), or carboplatin (AUC 5) on day 1, and dovitinib (orally on days 1-5, 8-12, and 15-19), every 21 days."( Phase Ib study of dovitinib in combination with gemcitabine plus cisplatin or gemcitabine plus carboplatin in patients with advanced solid tumors.
Galsky, MD; Gimpel-Tetra, K; Godbold, J; Holcombe, RF; Lee, KM; Lowe, N; Misiukiewicz, K; Oh, WK; Posner, M; Soto, R; Tsao, CK, 2014
)
0.94
"Dovitinib in combination with gemcitabine plus cisplatin or gemcitabine plus carboplatin was poorly tolerated due to myelosuppression."( Phase Ib study of dovitinib in combination with gemcitabine plus cisplatin or gemcitabine plus carboplatin in patients with advanced solid tumors.
Galsky, MD; Gimpel-Tetra, K; Godbold, J; Holcombe, RF; Lee, KM; Lowe, N; Misiukiewicz, K; Oh, WK; Posner, M; Soto, R; Tsao, CK, 2014
)
0.95
" We conducted a phase II trial to determine the safety and efficacy of Endostar, an endogenous inhibitor of angiogenesis, in combination with GC chemotherapy."( A phase II trial of Endostar combined with gemcitabine and cisplatin chemotherapy in patients with metastatic nasopharyngeal carcinoma (NCT01612286).
Chen, XZ; Jin, T; Li, B, 2013
)
0.65
"In this study, we compared the efficacy and safety of the oral fluoropyrimidine S-1 as monotherapy or in combination with leucovorin as the second-line treatment for patients with metastatic pancreatic cancer whose disease had progressed on gemcitabine treatment."( S-1 as monotherapy or in combination with leucovorin as second-line treatment in gemcitabine-refractory advanced pancreatic cancer: a randomized, open-label, multicenter, phase II study.
Ba, Y; Bai, Y; Ge, F; Jia, R; Li, F; Lin, L; Wang, Y; Xu, H; Xu, J; Xu, N; Zhang, Y, 2014
)
0.81
" Patients randomly received S-1 or S-1 in combination with leucovorin (SL arm) in 21-day cycles."( S-1 as monotherapy or in combination with leucovorin as second-line treatment in gemcitabine-refractory advanced pancreatic cancer: a randomized, open-label, multicenter, phase II study.
Ba, Y; Bai, Y; Ge, F; Jia, R; Li, F; Lin, L; Wang, Y; Xu, H; Xu, J; Xu, N; Zhang, Y, 2014
)
0.63
"To evaluate the efficacy and safety of fixed dose rate (FDR) gemcitabine infusion in combination with docetaxel in patients with relapsed/refractory soft tissue sarcoma."( [Efficacy and safety of fixed dose rate gemcitabine infusion in combination with docetaxel in patients with relapsed/refractory soft tissue sarcoma].
Guo, H; Liu, Y; Yang, S; Yao, S; Yao, Z; Zhao, Y, 2014
)
0.91
"The fixed dose rate (FDR) gemcitabine infusion in combination with docetaxel is an effective treatment regimen for patients with relapsed/refractory soft tissue sarcoma, and with tolerable adverse reactions."( [Efficacy and safety of fixed dose rate gemcitabine infusion in combination with docetaxel in patients with relapsed/refractory soft tissue sarcoma].
Guo, H; Liu, Y; Yang, S; Yao, S; Yao, Z; Zhao, Y, 2014
)
0.97
"The aim of the study was to evaluate the efficacy and safety of intratumoral chemotherapy with paclitaxel liposome combined with systemic chemotherapy as induction therapy in clinical stage III unresectable non-small cell lung cancer (NSCLC)."( Intratumoral chemotherapy with paclitaxel liposome combined with systemic chemotherapy: a new method of neoadjuvant chemotherapy for stage III unresectable non-small cell lung cancer.
Ai, Z; Lu, B; Sun, L; Xu, J; Yan, X, 2015
)
0.42
" Overall, 63 treatment-naïve participants were recruited and received up to six 21-d cycles of cisplatin 70 mg/m2 (intravenously [IV], day 1) and gemcitabine 1000 mg/m2 (IV, days 1 and 8) combined with sunitinib 37."( SUCCINCT: an open-label, single-arm, non-randomised, phase 2 trial of gemcitabine and cisplatin chemotherapy in combination with sunitinib as first-line treatment for patients with advanced urothelial carcinoma.
Barber, J; Casbard, A; Chester, J; Cowles, R; Crabb, S; Elliott, T; Evans, J; Geldart, T; Griffiths, G; Huddart, RA; Jones, RJ; Mead, G; Protheroe, A; Smith, J, 2015
)
0.85
"To analyze the efficacy and survival associated factors of gefitinib combined with cisplatin and gemcitabine for advanced non-small cell lung cancer."( Efficacy and survival-associated factors with gefitinib combined with cisplatin and gemcitabine for advanced non- small cell lung cancer.
Fang, H; Lin, RY; Sun, MX; Tian, Y; Wang, Q; Wang, XY; Yu, JL; Zhao, YL, 2014
)
0.84
"A total of 57 patients with advanced non-small cell lung cancer (NSCLC), who received platinum-based chemotherapy regimens for more than 1 cycle, were treated with gefitinib combined with cisplatin and gemcitabine until disease progression."( Efficacy and survival-associated factors with gefitinib combined with cisplatin and gemcitabine for advanced non- small cell lung cancer.
Fang, H; Lin, RY; Sun, MX; Tian, Y; Wang, Q; Wang, XY; Yu, JL; Zhao, YL, 2014
)
0.81
"Gefitinib combined with cisplatin andgemcitabine, is effective for patients with IIIb~IV NSCLC who received multiple cycles of chemotherapy."( Efficacy and survival-associated factors with gefitinib combined with cisplatin and gemcitabine for advanced non- small cell lung cancer.
Fang, H; Lin, RY; Sun, MX; Tian, Y; Wang, Q; Wang, XY; Yu, JL; Zhao, YL, 2014
)
0.9
"We determined the safety, pharmacokinetics, pharmacodynamics, and recommended phase II dose of MK-8776 (SCH 900776), a potent, selective checkpoint kinase 1 (Chk1) inhibitor, as monotherapy and in combination with gemcitabine in a first-in-human phase I clinical trial in patients with advanced solid tumor malignancies."( Phase I dose-escalation trial of checkpoint kinase 1 inhibitor MK-8776 as monotherapy and in combination with gemcitabine in patients with advanced solid tumors.
Ashworth, MT; Daud, AI; Freshwater, T; Goldman, JW; Grabowsky, JA; Isaacs, R; Kang, SP; Loechner, S; Mendelson, D; Munster, PN; Parry, D; Rosen, LS; Shanahan, F; Shumway, S; Sorge, C; Springett, G; Strosberg, J; Venook, AP, 2015
)
0.82
"Forty-three patients were treated by intravenous infusion with MK-8776 at seven dose levels ranging from 10 to 150 mg/m(2) as monotherapy and then in combination with gemcitabine 800 mg/m(2) (part A, n = 26) or gemcitabine 1,000 mg/m(2) (part B, n = 17)."( Phase I dose-escalation trial of checkpoint kinase 1 inhibitor MK-8776 as monotherapy and in combination with gemcitabine in patients with advanced solid tumors.
Ashworth, MT; Daud, AI; Freshwater, T; Goldman, JW; Grabowsky, JA; Isaacs, R; Kang, SP; Loechner, S; Mendelson, D; Munster, PN; Parry, D; Rosen, LS; Shanahan, F; Shumway, S; Sorge, C; Springett, G; Strosberg, J; Venook, AP, 2015
)
0.82
"MK-8776 was well tolerated as monotherapy and in combination with gemcitabine."( Phase I dose-escalation trial of checkpoint kinase 1 inhibitor MK-8776 as monotherapy and in combination with gemcitabine in patients with advanced solid tumors.
Ashworth, MT; Daud, AI; Freshwater, T; Goldman, JW; Grabowsky, JA; Isaacs, R; Kang, SP; Loechner, S; Mendelson, D; Munster, PN; Parry, D; Rosen, LS; Shanahan, F; Shumway, S; Sorge, C; Springett, G; Strosberg, J; Venook, AP, 2015
)
0.87
"This double-blind, phase 3 study assessed the efficacy and safety of ganitumab combined with gemcitabine as first-line treatment of metastatic pancreatic cancer."( A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial.
Azevedo, S; Bach, BA; Bodoky, G; Carrato, A; Fuchs, CS; Gansert, JL; Haddad, V; Ikeda, M; Lipton, LR; Loberg, R; Melichar, B; Moore, MJ; Nemecek, R; Ohkawa, S; Okusaka, T; Peeters, M; Riess, H; Świeboda-Sadlej, A; Szczylik, C; Tjulandin, SA; Van Cutsem, E; Van Laethem, JL, 2015
)
0.85
"Ganitumab combined with gemcitabine had manageable toxicity but did not improve OS, compared with gemcitabine alone in unselected patients with metastatic pancreatic cancer."( A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial.
Azevedo, S; Bach, BA; Bodoky, G; Carrato, A; Fuchs, CS; Gansert, JL; Haddad, V; Ikeda, M; Lipton, LR; Loberg, R; Melichar, B; Moore, MJ; Nemecek, R; Ohkawa, S; Okusaka, T; Peeters, M; Riess, H; Świeboda-Sadlej, A; Szczylik, C; Tjulandin, SA; Van Cutsem, E; Van Laethem, JL, 2015
)
0.94
"This study aimed to evaluate the feasibility of and immune response to Wilms tumor gene 1 (WT1) peptide-pulsed dendritic cell vaccination combined with gemcitabine (DCGEM) as a first-line therapy among patients with advanced pancreatic cancer."( Phase I pilot study of Wilms tumor gene 1 peptide-pulsed dendritic cell vaccination combined with gemcitabine in pancreatic cancer.
Aiura, K; Fujita, T; Hamamoto, Y; Higuchi, H; Itano, O; Kawakami, Y; Kitagawa, Y; Kitago, M; Matsuda, T; Mayanagi, S; Okamoto, M; Sakurai, T; Sunamura, M; Taguchi, J; Takaishi, H; Takeuchi, H, 2015
)
0.83
" Collectively, our findings suggest that PG545 exerts anti-tumor activity by disrupting Wnt/β-catenin signaling and combination with gemcitabine should be considered as a novel therapeutic strategy for pancreatic cancer treatment."( The heparan sulfate mimetic PG545 interferes with Wnt/β-catenin signaling and significantly suppresses pancreatic tumorigenesis alone and in combination with gemcitabine.
Dredge, K; Hammond, E; Jung, DB; Jung, JH; Kim, B; Kim, EO; Kim, J; Kim, SH; Mukhopadhyay, D; Shridhar, V; Wang, E; Yun, M, 2015
)
0.82
" The objectives of the present study were to define maximum tolerated dose and the recommended phase II dose (RPTD) of AXL1717 in combination with gemcitabine HCl and carboplatin in non-small cell lung cancer (NSCLC)."( A phase I pilot study of the insulin-like growth factor 1 receptor pathway modulator AXL1717 in combination with gemcitabine HCl and carboplatin in previously untreated, locally advanced, or metastatic non-small cell lung cancer.
Bergqvist, M; Bergström, S; Brandén, E; Ekman, S; Harmenberg, J; Holgersson, G; Jerling, M; Klockare, M; Koyi, H; Larsson, O; Lundström, KL; Ringbom, M, 2015
)
0.83
"The primary objective of this study was to determine the activity and safety of 3-weekly oxaliplatin combined with gemcitabine and oral capecitabine in the first-line treatment of advanced biliary tract cancer."( Three-weekly oxaliplatin combined with gemcitabine and capecitabine in the first-line treatment of patients with advanced biliary tract cancer.
Fiaschi, AI; Francini, E; Laera, L; Marrelli, D; Petrioli, R; Roviello, F; Roviello, G, 2015
)
0.9
"We reviewed the hospital database and finally included 26 recurrent ovarian cancer patients who were treated with bevacizumab combined with gemcibabine or paclitaxel or single agent."( A retrospective clinical study of bevacizumab combined with gemcibabine or paclitaxel in the treatment of recurrent ovarian cancer.
Ding, T; Liu, XH; Lv, QY; Song, J; Wang, SH; Wang, Y; Wei, MH; Wu, MD; Yang, QH; Zhou, J; Zhou, YF, 2014
)
0.4
"Under the treatment of bevacizumab combined with gemcibabine or paclitaxel, 2 complete response (7."( A retrospective clinical study of bevacizumab combined with gemcibabine or paclitaxel in the treatment of recurrent ovarian cancer.
Ding, T; Liu, XH; Lv, QY; Song, J; Wang, SH; Wang, Y; Wei, MH; Wu, MD; Yang, QH; Zhou, J; Zhou, YF, 2014
)
0.4
"Bevacizumab combined with gemcibabine or paclitaxel was a promising treatment schedule for platinum-resistance recurrent ovarian cancer."( A retrospective clinical study of bevacizumab combined with gemcibabine or paclitaxel in the treatment of recurrent ovarian cancer.
Ding, T; Liu, XH; Lv, QY; Song, J; Wang, SH; Wang, Y; Wei, MH; Wu, MD; Yang, QH; Zhou, J; Zhou, YF, 2014
)
0.4
" The aim of this retrospective study was to evaluate the activity and toxicity of bevacizumab combined with chemotherapy in the treatment of recurrence or platinum-refractory ovarian cancer."( Bevacizumab combined with chemotherapy in the treatment of recurrence or platinum-refractory ovarian cancer: a retrospective study of 37 cases.
Li, Y; Shang, YM; Yang, Y; Zheng, H, 2014
)
0.4
"Totally, 37 ovarian cancer patients with complete data who treated with bevacizumab combined with chemotherapy were reviewed from the databases of Beijing Cancer hospital and included in this retrospective study."( Bevacizumab combined with chemotherapy in the treatment of recurrence or platinum-refractory ovarian cancer: a retrospective study of 37 cases.
Li, Y; Shang, YM; Yang, Y; Zheng, H, 2014
)
0.4
" The maximum tolerated dose (MTD) of lenalidomide given in combination with gemcitabine was defined as the highest dose level at which no more than one out of four (25%) subjects experiences a dose-limiting toxicity (DLT)."( A phase I dose-escalation study of lenalidomide in combination with gemcitabine in patients with advanced pancreatic cancer.
Liljefors, M; Rossmann, E; Ullenhag, GJ, 2015
)
0.88
"To evaluate the maximum tolerated dose, safety profile, pharmacokinetics, and pharmacodynamics of pegaspargase (PEG-ASP) in combination with gemcitabine in patients with advanced metastatic solid tumors and lymphoma."( A multicenter, open-label, Phase 1 study evaluating the safety and tolerability of pegaspargase in combination with gemcitabine in advanced metastatic solid tumors and lymphoma.
Anthony, S; Babiker, HM; Borad, MJ; Buchbinder, A; Grem, J; Keilani, T; Mita, M, 2015
)
0.83
" Seventeen patients were treated with of PEG-ASP in combination with gemcitabine."( A multicenter, open-label, Phase 1 study evaluating the safety and tolerability of pegaspargase in combination with gemcitabine in advanced metastatic solid tumors and lymphoma.
Anthony, S; Babiker, HM; Borad, MJ; Buchbinder, A; Grem, J; Keilani, T; Mita, M, 2015
)
0.86
" Murine studies have previously demonstrated that treatment with the late-autophagy inhibitor chloroquine in combination with chemotherapy limited tumor growth."( Safety and Biologic Response of Pre-operative Autophagy Inhibition in Combination with Gemcitabine in Patients with Pancreatic Adenocarcinoma.
Bahary, N; Bao, P; Bartlett, DL; Boone, BA; Espina, V; Liotta, LA; Lotze, MT; Loughran, P; Moser, AJ; Normolle, DP; Singhi, AD; Wu, WC; Zeh, HJ; Zureikat, AH, 2015
)
0.64
"This multicentre, open-label, randomized, controlled phase II study evaluated cilengitide in combination with cetuximab and platinum-based chemotherapy, compared with cetuximab and chemotherapy alone, as first-line treatment of patients with advanced non-small-cell lung cancer (NSCLC)."( Cilengitide combined with cetuximab and platinum-based chemotherapy as first-line treatment in advanced non-small-cell lung cancer (NSCLC) patients: results of an open-label, randomized, controlled phase II study (CERTO).
Atanackovic, D; Barlesi, F; Bennouna, J; Feurer, M; Germonpre, P; Goekkurt, E; Gridelli, C; Hicking, C; Krzakowski, M; Lena, H; Milanowski, J; O'Byrne, K; Picard, M; Schuette, W; Straub, J; Szczesna, A; Vansteenkiste, J; Verhoeven, D; Waller, CF, 2015
)
0.42
"Gemcitabine combined with oxaliplatin for treatment of relapse-refractory lymphoma shows singnificant efficacy and low toxicity, this regimen can be used as a second-line chemotheray in clinic."( [Safety and efficacy evaluation of gemcitabine combined with oxaliplatin for the treatment of patients with lymphoma].
Chen, BL; Liu, L; Qin, SH; Tan, QL; Zhao, Z, 2015
)
2.14
"The PANCOSTABRAX study evaluated the cost-effectiveness of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in combination with gemcitabine (GEM) versus GEM alone in the treatment of patients with metastatic pancreatic cancer in Spain."( Cost-utility analysis of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in combination with gemcitabine in metastatic pancreatic cancer in Spain: results of the PANCOSTABRAX study.
Benedit, P; Carrato, A; García, P; Gostkorzewicz, J; López, R; Macarulla, T; Pérez-Alcántara, F; Rivera, F; Sastre, J, 2015
)
0.84
" This novel siRNA based drug was studied, in combination with chemotherapy, as targeted therapy for Locally Advanced Pancreatic Cancer (LAPC)."( RNAi therapy targeting KRAS in combination with chemotherapy for locally advanced pancreatic cancer patients.
Dancour, A; David, EB; Domb, A; Eliakim, R; Gabai, RM; Galun, E; Golan, T; Goldes, Y; Goldin, E; Harari, G; Hen, N; Hubert, A; Khvalevsky, EZ; Kopleman, Y; Lahav, M; Raskin, S; Segal, A; Shemi, A, 2015
)
0.42
" In the present study, the antiproliferative and proapoptotic abilities of ABL alone or in combination with gemcitabine in a human NSCLC cell line were investigated."( 1‑O‑acetylbritannilactone combined with gemcitabine elicits growth inhibition and apoptosis in A549 human non‑small cell lung cancer cells.
Li, H; Qiao, JO; Wang, F, 2015
)
0.9
"Cediranib did not improve the progression-free survival of patients with advanced biliary tract cancer in combination with cisplatin and gemcitabine, which remains the standard of care."( Cediranib or placebo in combination with cisplatin and gemcitabine chemotherapy for patients with advanced biliary tract cancer (ABC-03): a randomised phase 2 trial.
Anthoney, DA; Backen, AC; Beare, S; Bridgewater, JA; Corrie, P; Cunningham, D; Dive, C; Duggan, M; Lopes, A; Madhusudan, S; Maraveyas, A; Morris, K; Palmer, DH; Rees, C; Ross, PJ; Steward, WP; Valle, JW; Wasan, H; Waters, JS, 2015
)
0.87
"To evaluate the efficacy and safety of Chinese herbal medicine combined with systemic chemotherapy and/or regional arterial perfusion for pancreatic cancer with liver metastases (PCLM)."( [A Retrospective Study of Chinese Herbal Medicine Combined with Systemic Chemotherapy and/or Regional Arterial Perfusion for Pancreatic Cancer with Liver Metastases].
Liu, F; Ouyang, HQ; Pan, ZY; Xie, GR; Yan, ZC, 2015
)
0.42
"We retrospectively selected 292 patients with PCLM who were treated by Chinese herbal medicine combined with systemic chemotherapy and/or regional arterial perfusion at Tianjin Medical University Cancer Hospital from January 2001 to December 2010."( [A Retrospective Study of Chinese Herbal Medicine Combined with Systemic Chemotherapy and/or Regional Arterial Perfusion for Pancreatic Cancer with Liver Metastases].
Liu, F; Ouyang, HQ; Pan, ZY; Xie, GR; Yan, ZC, 2015
)
0.42
"Chinese herbal medicine combined with systemic chemotherapy and/or regional arterial perfusion was effective and safe, and it could be optimally selected as palliative therapy for PCLM."( [A Retrospective Study of Chinese Herbal Medicine Combined with Systemic Chemotherapy and/or Regional Arterial Perfusion for Pancreatic Cancer with Liver Metastases].
Liu, F; Ouyang, HQ; Pan, ZY; Xie, GR; Yan, ZC, 2015
)
0.42
" In order to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of single-agent trametinib (part 1) and trametinib in combination with gemcitabine (part 2), we undertook the first clinical study of this combination in Japanese patients with cancer and herein report our results."( A phase I/Ib study of trametinib (GSK1120212) alone and in combination with gemcitabine in Japanese patients with advanced solid tumors.
Fujisaka, Y; Furuse, J; Kasuga, A; Kitamura, H; Kurata, T; Matsushita, H; Mukaiyama, A; Nagashima, F; Nakagawa, K; Naruge, D; Nishimura, Y; Nishina, S; Okamoto, W; Shimizu, T; Takasu, A, 2015
)
0.84
"0 mg once daily) in combination with gemcitabine (1000 mg/m(2))."( A phase I/Ib study of trametinib (GSK1120212) alone and in combination with gemcitabine in Japanese patients with advanced solid tumors.
Fujisaka, Y; Furuse, J; Kasuga, A; Kitamura, H; Kurata, T; Matsushita, H; Mukaiyama, A; Nagashima, F; Nakagawa, K; Naruge, D; Nishimura, Y; Nishina, S; Okamoto, W; Shimizu, T; Takasu, A, 2015
)
0.92
"This phase I trial evaluated LY2603618, a selective inhibitor of the DNA damage checkpoint kinase 1, in combination with gemcitabine."( Phase I study of LY2603618, a CHK1 inhibitor, in combination with gemcitabine in Japanese patients with solid tumors.
Doi, T; Fuse, N; Hynes, SM; Lin, AB; Matsubara, N; Naito, Y; Nakamura, T; Shitara, K; Uenaka, K; Yoshino, T, 2015
)
0.86
"Lapatinib has proven efficacy as monotherapy and in combination with capecitabine in patients with metastatic breast cancer (MBC) overexpressing HER2 and/or EGFR."( Phase I and pharmacological trial of lapatinib in combination with gemcitabine in patients with advanced breast cancer.
Beijnen, JH; Boss, DS; Grob, M; Huitema, AD; Keessen, M; Rehorst, H; Rosing, H; Schellens, JH; Smit, WM; Tibben, MM; van der Noll, R; Wymenga, AN, 2015
)
0.65
"To study the effectiveness of human recombinant endostatin injection (Endostar®) combined with cisplatin doublets in treating advanced non-small cell lung cancer (NSCLC), and to evaluate outcome by CT perfusion imaging."( Human Recombinant Endostatin Combined with Cisplatin Based Doublets in Treating Patients with Advanced NSCLC and Evaluation by CT Perfusion Imaging.
Chen, SQ; Cui, FB; Gao, EY; Jiang, BQ; Li, M; Shu, RB; Sun, P; Tang, W; Wang, H; Zhang, FL; Zhang, Y, 2015
)
0.42
"The response rate with Endostar® administered 4 days before chemotherapy and combined with chemotherapy from day 5 in group A was better than Endostar® combined with chemotherapy from the first day, and CT perfusion imaging could be a reasonable method for evaluation of patient outcomes."( Human Recombinant Endostatin Combined with Cisplatin Based Doublets in Treating Patients with Advanced NSCLC and Evaluation by CT Perfusion Imaging.
Chen, SQ; Cui, FB; Gao, EY; Jiang, BQ; Li, M; Shu, RB; Sun, P; Tang, W; Wang, H; Zhang, FL; Zhang, Y, 2015
)
0.42
" However, chemotherapy can be immune stimulative especially in combination with an immunotherapy."( In vitro immunomodulatory properties of gemcitabine alone and in combination with interferon-alpha.
Bazhin, AV; Brecht, R; Fritz, J; Karakhanova, S; Nachtigall, I; Werner, J, 2015
)
0.68
"To evaluate the safety and efficacy of gemcitabine combined with S-1 in the treatment of advanced pancreatic cancer."( [Safety and efficacy of gemcitabine combined with S-1 in the treatment of advanced pancreatic cancer].
He, P; Jiang, Y; Yang, K; Zheng, L; Zhong, H, 2015
)
0.99
"Gemcitabine combined with S-1 is effective and safe in the treatment of advanced pancreatic cancer, with less side effects, and can be tolerated by the patients."( [Safety and efficacy of gemcitabine combined with S-1 in the treatment of advanced pancreatic cancer].
He, P; Jiang, Y; Yang, K; Zheng, L; Zhong, H, 2015
)
2.17
" LY294002 and gemcitabine hydrochloride combined with IR better inhibited cell migration, VM formation and MMP-2 mRNA expression of Panc-1 cells in vitro, and we also proved that the novel therapeutic regimen better inhibited tumor growth, tumor metastasis and VM formation of orthotopic Panc-1 xenografts by suppressing the PI3K/MMPs/Ln-5γ2 signaling pathway in vivo."( The effect of PI3K inhibitor LY294002 and gemcitabine hydrochloride combined with ionizing radiation on the formation of vasculogenic mimicry of Panc-1 cells in vitro and in vivo.
Bai, R; Ding, T; Lan, X; Liu, S; Yin, L; Yu, Y; Zhang, L; Zhao, J, 2016
)
1.06
" In this context, alternatives to the lapatinib (L) and capecitabine (C) regimen, evaluating L combined with other cytotoxic drugs, are warranted."( A Phase II Randomized Study of Lapatinib Combined With Capecitabine, Vinorelbine, or Gemcitabine in Patients With HER2-Positive Metastatic Breast Cancer With Progression After a Taxane (Latin American Cooperative Oncology Group 0801 Study).
Barrios, CH; Bines, J; Blajman, C; Capó, A; Fanelli, M; Fein, L; Gómez, HL; Ismael, G; Lerzo, G; Mano, M; Martínez-Mesa, J; Neciosup, S; Nerón, Y; Pinczowski, H; Sampaio, C; Santi, PX; Tosello, C; Varela, MS; Werutsky, G; Zarba, JJ, 2016
)
0.66
"In the present phase II, multicenter study, patients with HER2(+) MBC with progression after taxane were randomized between L, 1250 mg, combined with C, 2000 mg/m(2) on days 1 to 14 (LC), vinorelbine (V), 25 mg/m(2) on days 1 and 8 (LV), or gemcitabine (G), 1000 mg/m(2) on days 1 and 8 (LG), every 21 days."( A Phase II Randomized Study of Lapatinib Combined With Capecitabine, Vinorelbine, or Gemcitabine in Patients With HER2-Positive Metastatic Breast Cancer With Progression After a Taxane (Latin American Cooperative Oncology Group 0801 Study).
Barrios, CH; Bines, J; Blajman, C; Capó, A; Fanelli, M; Fein, L; Gómez, HL; Ismael, G; Lerzo, G; Mano, M; Martínez-Mesa, J; Neciosup, S; Nerón, Y; Pinczowski, H; Sampaio, C; Santi, PX; Tosello, C; Varela, MS; Werutsky, G; Zarba, JJ, 2016
)
0.84
" The purpose of this prospective study is to evaluate the feasibility and the efficacy of radiotherapy in combination with gemcitabine and EGFR targeting therapy for patients with locally advanced disease."( Prospective study of cetuximab and gemcitabine in combination with radiation therapy: feasibility and efficacy in locally advanced pancreatic head cancer.
Borzomati, D; Coppola, R; D'Angelillo, RM; Fiore, M; Floreno, B; Ippolito, E; Ramella, S; Trecca, P; Trodella, L; Trodella, LE; Valeri, S, 2015
)
0.9
"To evaluate the efficacy and safety of gemcitabine combined with ifosfamide (GI regimen)in patients with recurrent or metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy."( [Efficacy and safety evaluation of gemcitabine combined with ifosfamide in patients with advanced nasopharyngeal carcinoma after failure of platinum-based chemotherapy].
Dong, M; Gui, L; He, X; Hu, S; Jia, B; Liu, P; Qin, Y; Yang, J; Yang, S; Zhang, C; Zhou, S, 2015
)
0.96
" This phase I study evaluated the safety profile of vandetanib in combination with standard doses of gemcitabine and capecitabine in order to determine the maximum tolerated dose (MTD)."( Phase I trial of vandetanib in combination with gemcitabine and capecitabine in patients with advanced solid tumors with an expanded cohort in pancreatic and biliary cancers.
Bradshaw-Pierce, EL; Eckhardt, SG; Eppers, S; Freas, E; Kane, MA; Kessler, ER; Leong, S; Lieu, CH; Messersmith, WA; Nallapreddy, S; O'byrant, CL; Pitts, TM; Spratlin, J; Weekes, C, 2016
)
0.91
" The effect of inhibition of PAK1 by either shRNA knock-down (KD), or by a selective inhibitor, FRAX597, alone or in combination with gemcitabine, on cell proliferation and migration/invasion was measured by thymidine uptake and Boyden chamber assays, respectively."( FRAX597, a PAK1 inhibitor, synergistically reduces pancreatic cancer growth when combined with gemcitabine.
Baldwin, GS; He, H; Lowy, AM; Nikfarjam, M; Patel, O; Yeo, D, 2016
)
0.86
" When combined with gemcitabine, FRAX597 synergistically inhibited pancreatic cancer proliferation in vitro and inhibited tumour growth in vivo."( FRAX597, a PAK1 inhibitor, synergistically reduces pancreatic cancer growth when combined with gemcitabine.
Baldwin, GS; He, H; Lowy, AM; Nikfarjam, M; Patel, O; Yeo, D, 2016
)
0.98
" The primary objective of this study was to determine the maximum-tolerated dose of CEP-9722 in combination with gemcitabine and cisplatin in patients with advanced solid tumors."( An open-label, dose-escalation study to evaluate the safety and pharmacokinetics of CEP-9722 (a PARP-1 and PARP-2 inhibitor) in combination with gemcitabine and cisplatin in patients with advanced solid tumors.
Aftimos, P; Awada, A; Bahleda, R; Bourbouloux, E; Campone, M; Frenel, JS; Gombos, A; Soria, JC; Varga, A, 2016
)
0.85
" Pancreaticoduodenectomy combined with hepatic artery resection was performed, and an end-to-end anastomosis was made between the common and proper hepatic artery to reconstruct the hepatic artery."( [A Case of Pancreatic Head Cancer Treated with Pancreaticoduodenectomy Combined with Hepatic Artery Resection Following Neoadjuvant Chemotherapy].
Furukawa, K; Kagawa, S; Kato, A; Kuboki, S; Maeda, S; Miyazaki, M; Ohtsuka, M; Sakai, N; Shimizu, H; Suzuki, D; Takano, S; Takayashiki, T; Yoshitomi, H, 2015
)
0.42
" The objective of the ABC-04 trial was to establish the recommended dose of selumetinib in combination with CisGem in patients with ABC."( A phase 1b study of Selumetinib in combination with Cisplatin and Gemcitabine in advanced or metastatic biliary tract cancer: the ABC-04 study.
Beare, S; Bridgewater, J; Duggan, M; Lee, D; Lopes, A; McEntee, D; Ricamara, M; Sukumaran, A; Valle, JW; Wasan, H, 2016
)
0.67
"The recommended dose of selumetinib when combined with CisGem was 75 mg bd."( A phase 1b study of Selumetinib in combination with Cisplatin and Gemcitabine in advanced or metastatic biliary tract cancer: the ABC-04 study.
Beare, S; Bridgewater, J; Duggan, M; Lee, D; Lopes, A; McEntee, D; Ricamara, M; Sukumaran, A; Valle, JW; Wasan, H, 2016
)
0.67
" It has been shown that compound kushen injection in combination with chemotherapy can enhance the efficacy and reduce the toxicity."( A multicenter randomized controlled open-label trial to assess the efficacy of compound kushen injection in combination with single-agent chemotherapy in treatment of elderly patients with advanced non-small cell lung cancer: study protocol for a randomiz
Hou, W; Lin, HS; Liu, J; Wang, XQ, 2016
)
0.43
" Three hundred seventy elderly patients with advanced non-small cell lung cancer will be randomly divided into experimental (n = 185) and control groups (n = 185) to receive compound kushen injection in combination with single-agent chemotherapy or standard platinum-based doublet chemotherapy for two cycles."( A multicenter randomized controlled open-label trial to assess the efficacy of compound kushen injection in combination with single-agent chemotherapy in treatment of elderly patients with advanced non-small cell lung cancer: study protocol for a randomiz
Hou, W; Lin, HS; Liu, J; Wang, XQ, 2016
)
0.43
" This study will determine whether or not the efficacy of compound kushen injection in combination with single-agent chemotherapy is comparable to that of platinum-based doublet chemotherapy, and whether or not the toxicity of compound kushen injection in combination with single-agent chemotherapy is lower than that of platinum-based doublet chemotherapy."( A multicenter randomized controlled open-label trial to assess the efficacy of compound kushen injection in combination with single-agent chemotherapy in treatment of elderly patients with advanced non-small cell lung cancer: study protocol for a randomiz
Hou, W; Lin, HS; Liu, J; Wang, XQ, 2016
)
0.43
" Preclinical and phase I clinical data suggest activity of bortezomib in NSCLC, either as monotherapy or in combination with chemotherapeutic agents including gemcitabine and cisplatin."( A phase II, open-label trial of bortezomib (VELCADE(®)) in combination with gemcitabine and cisplatin in patients with locally advanced or metastatic non-small cell lung cancer.
Agelaki, S; Filippa, G; Georgoulias, V; Kentepozidis, N; Kontopodis, E; Kotsakis, A; Mala, A; Mavroudis, D; Moutsos, M; Syrigos, K; Vamvakas, L; Ziras, N, 2016
)
0.86
" on days 1 and 8, and starting on day 21 (cycle 2), bortezomib (days 1 and 8) in combination with gemcitabine 1000 mg/m(2), (days 1 and 8), and cisplatin 70 mg/m(2) (day 1) in cycles of 21 days."( A phase II, open-label trial of bortezomib (VELCADE(®)) in combination with gemcitabine and cisplatin in patients with locally advanced or metastatic non-small cell lung cancer.
Agelaki, S; Filippa, G; Georgoulias, V; Kentepozidis, N; Kontopodis, E; Kotsakis, A; Mala, A; Mavroudis, D; Moutsos, M; Syrigos, K; Vamvakas, L; Ziras, N, 2016
)
0.88
" The effect of afatinib, as either a single agent or in combination with gemcitabine (GEM), on tumor growth was determined using NPC tumor xenografts in mice."( In vitro and in vivo efficacy of afatinib as a single agent or in combination with gemcitabine for the treatment of nasopharyngeal carcinoma.
Fang, W; Tian, Y; Xue, C; Zhan, J; Zhang, J; Zhang, L; Zhao, Y, 2016
)
0.89
" Afatinib in combination with GEM demonstrated significant antitumor effect in an NPC xenograft model."( In vitro and in vivo efficacy of afatinib as a single agent or in combination with gemcitabine for the treatment of nasopharyngeal carcinoma.
Fang, W; Tian, Y; Xue, C; Zhan, J; Zhang, J; Zhang, L; Zhao, Y, 2016
)
0.66
" The purpose of this dose escalation phase Ib study was to assess the safety, maximum tolerated dose (MTD) and pharmacokinetics (PK) of AXP107-11 in combination with gemcitabine in treatment-naïve patients with inoperable pancreatic carcinoma."( A phase I dose escalation trial of AXP107-11, a novel multi-component crystalline form of genistein, in combination with gemcitabine in chemotherapy-naive patients with unresectable pancreatic cancer.
Berkenstam, A; Frödin, JE; Karimi, M; Kartalis, N; Löhr, JM; Omazic, B; Verbeke, CS,
)
0.53
"AXP107-11 was given orally in escalating doses (400 mg-1600 mg daily) in combination with standard gemcitabine treatment (1000 mg/m(2)/week) for the first seven of eight weeks and thereafter for a maximum of four × four-week treatment cycles."( A phase I dose escalation trial of AXP107-11, a novel multi-component crystalline form of genistein, in combination with gemcitabine in chemotherapy-naive patients with unresectable pancreatic cancer.
Berkenstam, A; Frödin, JE; Karimi, M; Kartalis, N; Löhr, JM; Omazic, B; Verbeke, CS,
)
0.56
"Treatment of pancreatic cancer patients with AXP107-11 in combination with gemcitabine resulted in a favorable PK-profile with high serum levels without signs of either hematological or non-hematological toxicity."( A phase I dose escalation trial of AXP107-11, a novel multi-component crystalline form of genistein, in combination with gemcitabine in chemotherapy-naive patients with unresectable pancreatic cancer.
Berkenstam, A; Frödin, JE; Karimi, M; Kartalis, N; Löhr, JM; Omazic, B; Verbeke, CS,
)
0.57
" Here, we report combination therapies in which TOP3 was combined with gemcitabine or TS-1."( Hypoxia-inducible factor-targeting prodrug TOP3 combined with gemcitabine or TS-1 improves pancreatic cancer survival in an orthotopic model.
Hoang, NT; Kadonosono, T; Kizaka-Kondoh, S; Kuchimaru, T, 2016
)
0.91
" CheckMate 012, a phase I, multicohort study, was conducted to explore the safety and efficacy of nivolumab as monotherapy or combined with current standard therapies in first-line advanced NSCLC."( Nivolumab in Combination With Platinum-Based Doublet Chemotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer.
Antonia, S; Borghaei, H; Brahmer, JR; Chen, AC; Chow, LQ; Gerber, DE; Gettinger, S; Goldman, JW; Harbison, CT; Hellmann, MD; Juergens, RA; Laurie, SA; Nathan, FE; Rizvi, NA; Shen, Y; Shepherd, FA, 2016
)
0.43
" The present study assessed the ability of MET, alone or in combination with gemcitabine (GEM), to inhibit the growth of the human CFPAC‑1 pancreatic cancer cell line in vitro and in vivo."( Inhibitory effect of metformin combined with gemcitabine on pancreatic cancer cells in vitro and in vivo.
He, Z; Jia, Z; Shi, Y; Xu, C, 2016
)
0.92
" This phase I study defined the recommended phase II dose of LY2603618 combined with gemcitabine."( Phase I Study of CHK1 Inhibitor LY2603618 in Combination with Gemcitabine in Patients with Solid Tumors.
Becerra, C; Bence Lin, A; Braiteh, F; Calvo, E; Galsky, MD; Hurt, K; Hynes, SM; Jameson, G; Lin, J; McKane, S; McWilliams, R; Richards, D; Von Hoff, D; Wickremsinhe, ER, 2016
)
0.9
"The maximum tolerated dose of LY2603618 combined with gemcitabine was 200 mg/m2, but a fixed LY2603618 dose of 230 mg combined with gemcitabine was selected as the recommended phase II dose."( Phase I Study of CHK1 Inhibitor LY2603618 in Combination with Gemcitabine in Patients with Solid Tumors.
Becerra, C; Bence Lin, A; Braiteh, F; Calvo, E; Galsky, MD; Hurt, K; Hynes, SM; Jameson, G; Lin, J; McKane, S; McWilliams, R; Richards, D; Von Hoff, D; Wickremsinhe, ER, 2016
)
0.92
" This retrospective study aimed to assess the efficacy of repeated iodine-125 seed implantations combined with external beam radiotherapy (EBRT) for locally recurrent or metastatic stage-III/IV non-small cell lung cancer (NSCLC)."( Repeated iodine-125 seed implantations combined with external beam radiotherapy for the treatment of locally recurrent or metastatic stage III/IV non-small cell lung cancer: a retrospective study.
Dan, G; Deng, D; Jiang, J; Li, W; Zheng, X; Zheng, Y, 2016
)
0.43
"The results of this study demonstrated that repeated implantation of radioactive particles combined with EBRT is a safe treatment that effectively controlled local recurrence and metastasis of stage III/IV NSCLC."( Repeated iodine-125 seed implantations combined with external beam radiotherapy for the treatment of locally recurrent or metastatic stage III/IV non-small cell lung cancer: a retrospective study.
Dan, G; Deng, D; Jiang, J; Li, W; Zheng, X; Zheng, Y, 2016
)
0.43
" The aim of this study was to evaluate the effect of telomerase peptide vaccination, GV1001 combined with gemcitabine in treatment of pancreatic ductal adenocardinoma (PDAC)."( The anti-fibrotic effect of GV1001 combined with gemcitabine on treatment of pancreatic ductal adenocarcinoma.
Hwnag, YI; Jeon, J; Kang, JS; Kim, H; Kim, TW; Kim, Y; Lee, WJ; Park, JH; Park, JK, 2016
)
0.9
" This single-center phase Ib study investigated the tolerability, safety, and pharmacokinetics of nivolumab combined with standard chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC)."( Safety and efficacy of nivolumab and standard chemotherapy drug combination in patients with advanced non-small-cell lung cancer: a four arms phase Ib study.
Fujiwara, Y; Goto, K; Horinouchi, H; Hozumi, H; Kanda, S; Kitazono, S; Kubo, E; Mizugaki, H; Nokihara, H; Shiraishi, H; Sunami, K; Tamura, T; Tanaka, A; Utsumi, H; Yamamoto, N, 2016
)
0.43
"We retrospectively investigated the efficacy and safety of pegaspargase, gemcitabine, and oxaliplatin (P-GEMOX) combined with different dose radiotherapy (RT) in the treatment of 35 newly diagnosed, stage IE to IIE ENKTL patients at our institution from October 2011 to September 2015."( Effectiveness of pegaspargase, gemcitabine, and oxaliplatin (P-GEMOX) chemotherapy combined with radiotherapy in newly diagnosed, stage IE to IIE, nasal-type, extranodal natural killer/T-cell lymphoma.
Li, L; Wei, W; Wu, P; Zhang, ZH, 2017
)
0.97
"The research showed that the treatment of P-GEMOX combined with RT was a tolerable and effective treatment for localized nasal natural killer/T-cell lymphoma."( Effectiveness of pegaspargase, gemcitabine, and oxaliplatin (P-GEMOX) chemotherapy combined with radiotherapy in newly diagnosed, stage IE to IIE, nasal-type, extranodal natural killer/T-cell lymphoma.
Li, L; Wei, W; Wu, P; Zhang, ZH, 2017
)
0.74
" In the S/P arm, patients were treated orally with sorafenib continuous dosing at two dose levels (DL1: 200 mg twice daily and DL2: 400 mg twice daily) combined with plitidepsin (1."( Phase I dose-escalation study of plitidepsin in combination with sorafenib or gemcitabine in patients with refractory solid tumors or lymphomas.
Alfaro, V; Aspeslagh, S; Bahleda, R; Extremera, S; Fudio, S; Gyan, E; Hollebecque, A; Salles, G; Soria, JC; Soto-Matos, A; Stein, M, 2017
)
0.68
" However, the safety and efficacy of nimotuzumab combined with chemotherapy in locally advanced or metastatic esophageal cancer patients remain unclear."( Nimotuzumab Combined with Chemotherapy is a Promising Treatment for Locally Advanced and Metastatic Esophageal Cancer.
Han, X; Lu, N; Pan, Y; Xu, J, 2017
)
0.46
"We searched for randomized controlled trials (RCTs) of gemcitabine monotherapy versus gemcitabine in combination with a second cytotoxic agent in patients with LA/MPC."( Gemcitabine in Combination with a Second Cytotoxic Agent in the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer: a Systematic Review and Meta-Analysis.
Cao, YB; Li, Q; Ma, YX; Sun, Y; Xu, CA; Zhang, XW, 2017
)
2.15
" Different gemcitabine-based combinations showed different antitumor activity, and doublet regimens of gemcitabine in combination with a taxoid or a fluoropyrimidine, in particular an oral fluoropyrimidine provided significant survival benefits in the first-line treatment of unresectable LA/MPC."( Gemcitabine in Combination with a Second Cytotoxic Agent in the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer: a Systematic Review and Meta-Analysis.
Cao, YB; Li, Q; Ma, YX; Sun, Y; Xu, CA; Zhang, XW, 2017
)
2.29
" This study evaluated the efficacy of intensity modulated radiotherapy in combination with gemcitabine and S-1 as neoadjuvant chemoradiotherapy (NACRT) for borderline-resectable pancreatic cancer with arterial involvement (BR-A)."( A phase II trial of neoadjuvant chemoradiotherapy with intensity-modulated radiotherapy combined with gemcitabine and S-1 for borderline-resectable pancreatic cancer with arterial involvement.
Hijikata, Y; Hosokawa, Y; Kasuya, K; Katsumata, K; Nagakawa, Y; Nakajima, T; Nakayama, H; Sahara, Y; Takishita, C; Tokuuye, K; Tsuchida, A, 2017
)
0.89
" The pharmacokinetic profile of galunisertib in combination with gemcitabine was similar to that previously observed for galunisertib alone."( Phase 1b study of galunisertib in combination with gemcitabine in Japanese patients with metastatic or locally advanced pancreatic cancer.
Benhadji, KA; Fujii, H; Ikeda, M; Kondo, S; Lahn, MMF; Ogasawara, K; Takahashi, H; Ueno, H, 2017
)
0.94
" This phase I determined the maximal tolerable dose (MTD), dose-limiting toxicities (DLT), antitumor activity, pharmacokinetics (PK), and pharmacodynamics (PD) of veliparib combined with gemcitabine."( Phase I study of veliparib in combination with gemcitabine.
Almokadem, S; Appleman, L; Belani, CP; Beumer, JH; Carneiro, BA; Chen, A; Chu, E; Ding, F; Hershberger, PA; Holleran, J; Jiang, Y; Ken Czambel, R; Kiesel, BF; Kontopodis, E; Lin, Y; Petro, D; Puhalla, S; Rachid, M; Schmitz, JC; Stoller, R, 2017
)
0.9
"IMRT combined with GP for locoregionally advanced NPC is well tolerated, effective, and convenient, and warrants further studies."( Long-term results of a phase II study of gemcitabine and cisplatin chemotherapy combined with intensity-modulated radiotherapy in locoregionally advanced nasopharyngeal carcinoma.
He, X; Hu, C; Ou, D; Wu, M, 2017
)
0.72
"This randomized study showed that nimo in combination with gem is safe and well tolerated."( Gemcitabine combined with the monoclonal antibody nimotuzumab is an active first-line regimen in KRAS wildtype patients with locally advanced or metastatic pancreatic cancer: a multicenter, randomized phase IIb study.
Behringer, DM; Berdel, WE; Bulitta, M; De Dosso, S; Dommach, M; Ebert, MP; Goker, E; Hofheinz, R; Kerkhoff, A; Kneba, M; Overkamp, F; Reuter, D; Rohrberg, R; Schlegel, F; Schmidt, WE; Schultheis, B; Siveke, J; Steinmetz, T; Strumberg, D; Yalcin, S, 2017
)
1.9
"Evaluate toxicity of two treatment arms, A (cetuximab) and B (bevacizumab), when combined with gemcitabine, and chemoradiation in patients with completely resected pancreatic carcinoma."( An Intergroup Randomized Phase II Study of Bevacizumab or Cetuximab in Combination with Gemcitabine and in Combination with Chemoradiation in Patients with Resected Pancreatic Carcinoma: A Trial of the ECOG-ACRIN Cancer Research Group (E2204).
Abbruzzese, JL; Benson, AB; Berlin, JD; Blackstock, AW; Catalano, P; Feng, Y; Lowy, AM; McWilliams, RR; Philip, PA, 2018
)
0.92
"Patients with R0/R1 resection were randomized 1:1 to cetuximab or bevacizumab administered in combination with gemcitabine for two treatment cycles."( An Intergroup Randomized Phase II Study of Bevacizumab or Cetuximab in Combination with Gemcitabine and in Combination with Chemoradiation in Patients with Resected Pancreatic Carcinoma: A Trial of the ECOG-ACRIN Cancer Research Group (E2204).
Abbruzzese, JL; Benson, AB; Berlin, JD; Blackstock, AW; Catalano, P; Feng, Y; Lowy, AM; McWilliams, RR; Philip, PA, 2018
)
0.91
"The aim of this retrospective study was to clarify the effectiveness of chemotherapy with gemcitabine combined with low-dose 5-fluorouracil and cisplatin (GFP) for advanced biliary carcinoma after hepatectomy."( Effect of Adjuvant Gemcitabine Combined with Low-dose 5-Fluorouracil and Cisplatin Chemotherapy for Advanced Biliary Carcinoma.
Arakawa, Y; Ikemoto, T; Imura, S; Iwahashi, S; Morine, Y; Saito, YU; Shimada, M; Yamada, S, 2017
)
1
" Furthermore, we demonstrated that FANCD2 depletion combined with CHK1 inhibitor MK-8776 significantly potentiated the cytotoxicity of gemcitabine to the two LSC cell lines, compared to individual FANCD2 depletion or MK-8776 treatment."( Suppression of the FA pathway combined with CHK1 inhibitor hypersensitize lung cancer cells to gemcitabine.
Chen, P; Dai, CH; Jiang, Q; Lan, T; Li, J; Li, MY; Su, JY; Wang, Y; Wu, Y, 2017
)
0.88
" In this study, our goal is to evaluate the therapeutic efficacy of mocetinostat alone and in combination with gemcitabine in LMS."( Mocetinostat combined with gemcitabine for the treatment of leiomyosarcoma: Preclinical correlates.
Batte, K; Bid, HK; Braggio, D; Casadei, L; Choy, E; Iwenofu, OH; Koller, D; Lev, D; Lopez, G; Pollock, R; Strohecker, A; Yu, P; Zewdu, A, 2017
)
0.96
"To evaluate the safety and efficacy of mocetinostat (a Class I/IV HDAC inhibitor) in combination with gemcitabine in patients with solid tumors, including pancreatic cancer."( Phase I/II study of mocetinostat in combination with gemcitabine for patients with advanced pancreatic cancer and other advanced solid tumors.
Alcindor, T; Chan, E; Chao, R; Chiorean, EG; Gabrail, NY; Hurwitz, H; O'Dwyer, PJ; Potvin, D, 2018
)
0.95
"Mocetinostat TIW in combination with gemcitabine was associated with significant toxicities in patients with advanced pancreatic cancer."( Phase I/II study of mocetinostat in combination with gemcitabine for patients with advanced pancreatic cancer and other advanced solid tumors.
Alcindor, T; Chan, E; Chao, R; Chiorean, EG; Gabrail, NY; Hurwitz, H; O'Dwyer, PJ; Potvin, D, 2018
)
1
"To investigate the predictive value of secreted protein acidic and rich in cysteine (SPARC) expression in patients with PDAC treated with adjuvant gemcitabine in combination with S-1 (adjuvant GS) or adjuvant gemcitabine alone (adjuvant G alone)."( The high stromal SPARC expression is independently associated with poor survival of patients with resected pancreatic ductal adenocarcinoma treated with adjuvant gemcitabine in combination with S-1 or adjuvant gemcitabine alone.
Kondo, N; Murakami, Y; Nakagawa, N; Okano, K; Shintakuya, R; Sueda, T; Takahashi, S; Uemura, K, 2018
)
0.88
" Here, we tested DFMO in combination with a polyamine transport inhibitor (PTI), Trimer44NMe, against Gemcitabine-resistant PDAC cells."( Difluoromethylornithine Combined with a Polyamine Transport Inhibitor Is Effective against Gemcitabine Resistant Pancreatic Cancer.
Altomare, DA; Copik, AJ; Gitto, SB; Hogan, FC; Oyer, JL; Pandey, V; Phanstiel, O, 2018
)
0.92
" Our study highlights the molecular targetability of HDACs 1, 7, and 8, confirm their PDAC-CSCs maintaining role, and demonstrate that compared to SAHA, TSA modulates the epigenetically- mediated oncogenic activity of PDAC-CSCs, and potentiate Gemcitabine therapeutic activity, making a case for further exploration of TSA activity alone or in combination with Gemcitabine in PDAC therapy."( Depletion of HDAC1, 7 and 8 by Histone Deacetylase Inhibition Confers Elimination of Pancreatic Cancer Stem Cells in Combination with Gemcitabine.
Cai, MH; Sun, Z; Tu, YX; Wang, BK; Xu, XG; Yan, SL; Ying, Y, 2018
)
0.87
" Pathway inhibition by γ-secretase inhibitors has been shown to be effective in pre-clinical models of pancreatic cancer, in combination with gemcitabine."( A phase I trial of the γ-secretase inhibitor MK-0752 in combination with gemcitabine in patients with pancreatic ductal adenocarcinoma.
Anthoney, DA; Basu, B; Cook, N; Evans, J; Farmer-Hall, H; Gopinathan, A; Halford, S; Hampson, LV; Hategan, M; Jodrell, D; McLeod, R; Nebozhyn, M; Palmer, D; Propper, D; Smith, DM; Steward, WP; Turner, H; Tuveson, D; Venugopal, B, 2018
)
0.91
" We examined the safety of WT1-peptide pulsed dendritic cell (WT1-DC) vaccine in combination with chemotherapy in patients with surgically resected pancreatic cancer."( WT1-pulsed Dendritic Cell Vaccine Combined with Chemotherapy for Resected Pancreatic Cancer in a Phase I Study.
Kobayashi, M; Koido, S; Koizumi, T; Koya, T; Nagai, K; Okamoto, M; Sano, K; Shimodaira, S; Sugiyama, H; Yanagisawa, R, 2018
)
0.48
"Eight patients with resectable pancreatic cancer undergoing surgery either combined with S-1 or S-1 plus gemcitabine therapy were enrolled."( WT1-pulsed Dendritic Cell Vaccine Combined with Chemotherapy for Resected Pancreatic Cancer in a Phase I Study.
Kobayashi, M; Koido, S; Koizumi, T; Koya, T; Nagai, K; Okamoto, M; Sano, K; Shimodaira, S; Sugiyama, H; Yanagisawa, R, 2018
)
0.69
"The present study aimed to investigate the effects of obatoclax (OBX) combined with gemcitabine (GEM) treatment on the proliferation, migration, invasion and epithelial‑mesenchymal transition (EMT) related proteins of pancreatic cancer cell line BxPC‑3 under hypoxic conditions."( Effects of obatoclax combined with gemcitabine on the biological activity of pancreatic cancer cells under hypoxic conditions.
Hou, XF; Li, K; Li, S; Wang, JF; Wu, C; Xu, SN, 2018
)
0.98
" We evaluated the safety, tolerability, and pharmacokinetic properties of GDC-0575 alone and in combination with gemcitabine."( Phase I study of the checkpoint kinase 1 inhibitor GDC-0575 in combination with gemcitabine in patients with refractory solid tumors.
Blackwood, EM; Cousin, S; DuPree, K; Epler, J; Hamilton, E; Hollebecque, A; Infante, JR; Italiano, A; Lauchle, JO; LoRusso, PM; Lu, X; Mahrus, S; Moein, A; Moore, KN; Murray, ER; Peale, FV; Postel-Vinay, S; Schutzman, JL; Shapiro, GI; Soria, JC; Tagen, M; Tolaney, S; Toulmonde, M, 2018
)
0.92
"In this phase I open-label study, in the dose escalation stage, patients were enrolled in a GDC-0575 monotherapy Arm (1) or GDC-0575 combination with gemcitabine Arm (2) to determine the maximum tolerated dose."( Phase I study of the checkpoint kinase 1 inhibitor GDC-0575 in combination with gemcitabine in patients with refractory solid tumors.
Blackwood, EM; Cousin, S; DuPree, K; Epler, J; Hamilton, E; Hollebecque, A; Infante, JR; Italiano, A; Lauchle, JO; LoRusso, PM; Lu, X; Mahrus, S; Moein, A; Moore, KN; Murray, ER; Peale, FV; Postel-Vinay, S; Schutzman, JL; Shapiro, GI; Soria, JC; Tagen, M; Tolaney, S; Toulmonde, M, 2018
)
0.91
" No pharmacokinetic drug-drug interaction was observed between GDC-0575 and gemcitabine."( Phase I study of the checkpoint kinase 1 inhibitor GDC-0575 in combination with gemcitabine in patients with refractory solid tumors.
Blackwood, EM; Cousin, S; DuPree, K; Epler, J; Hamilton, E; Hollebecque, A; Infante, JR; Italiano, A; Lauchle, JO; LoRusso, PM; Lu, X; Mahrus, S; Moein, A; Moore, KN; Murray, ER; Peale, FV; Postel-Vinay, S; Schutzman, JL; Shapiro, GI; Soria, JC; Tagen, M; Tolaney, S; Toulmonde, M, 2018
)
0.94
"GDC-0575 can be safely administered as a monotherapy and in combination with gemcitabine; however, overall tolerability with gemcitabine was modest."( Phase I study of the checkpoint kinase 1 inhibitor GDC-0575 in combination with gemcitabine in patients with refractory solid tumors.
Blackwood, EM; Cousin, S; DuPree, K; Epler, J; Hamilton, E; Hollebecque, A; Infante, JR; Italiano, A; Lauchle, JO; LoRusso, PM; Lu, X; Mahrus, S; Moein, A; Moore, KN; Murray, ER; Peale, FV; Postel-Vinay, S; Schutzman, JL; Shapiro, GI; Soria, JC; Tagen, M; Tolaney, S; Toulmonde, M, 2018
)
0.94
" In the present study, we show that gemcitabine (GEM) in combination with TRA was more effective than TRA alone."( MEK inhibitor trametinib in combination with gemcitabine regresses a patient-derived orthotopic xenograft (PDOX) pancreatic cancer nude mouse model.
Bouvet, M; Clary, B; Delong, JC; Hoffman, RM; Hwang, HK; Igarashi, K; Kawaguchi, K; Kiyuna, T; Lwin, TM; Miyake, K; Miyake, M; Murakami, T; Singh, SR; Unno, M, 2018
)
1.02
" Thus, in combination with GP chemotherapy, CE could be a suitable alternative to DE in locally advanced or metastatic SCC patients, resulting in less hemoptysis, less treatment time, and lower costs."( Influence of different drug delivery methods for Endostar combined with a gemcitabine/cisplatin regimen in locally advanced or metastatic lung squamous cell carcinoma: A retrospective observational study.
Dai, H; Huang, J; Shen, H; Yao, D; Yuan, Y, 2018
)
0.71
" Experimental Design Patients were enrolled into five cohorts of increasing doses of MMB between 100 and 200 mg administered once or twice daily in combination with nab-P + G in 28-day cycles to determine maximum tolerated dose (MTD)."( Phase 1 dose-escalation study of momelotinib, a Janus kinase 1/2 inhibitor, combined with gemcitabine and nab-paclitaxel in patients with previously untreated metastatic pancreatic ductal adenocarcinoma.
Barbie, D; Chaves, J; Fuchs, CS; Hahn, WC; Hendifar, A; Koh, B; Ng, K; Starodub, A; Yang, Y, 2019
)
0.74
" In this prospective study, we investigated gemcitabine, cisplatin, and dexamethasone (GDP) combined with methotrexate (MTX) and pegaspargase (PEG-L) as front-line treatment in PTCL."( Gemcitabine, cisplatin, and dexamethasone (GDP) in combination with methotrexate and pegaspargase is active in newly diagnosed peripheral T cell lymphoma patients: a phase 2, single-center, open-label study in China.
Cai, H; Cao, X; Chen, M; Duan, M; Han, B; Li, J; Zhang, W; Zhang, Y; Zhou, D; Zhu, T; Zhuang, J, 2019
)
2.22
" Methods We used the standard 3 + 3 dose escalation design with cohort expansion to evaluate 2 dose levels of enzalutamide: 80 mg and 160 mg/day orally (phase 1a) in combination with gemcitabine and nab-paclitaxel in metastatic pancreatic cancer patients."( Phase 1 trial of enzalutamide in combination with gemcitabine and nab-paclitaxel for the treatment of advanced pancreatic cancer.
Copolla, D; Goyal, G; Kim, J; Kim, R; Kommalapati, A; Mahipal, A; Neuger, A; Soares, H; Tella, SH, 2019
)
0.96
"The authors undertook a phase 1 study of gemcitabine in combination with escalating doses of paricalcitol administered weekly intravenously in patients with advanced cancers."( A phase 1, open-label, dose escalation study of intravenous paricalcitol in combination with gemcitabine in patients with advanced malignancies.
Fetterly, G; Fountzilas, C; Iyer, R; Javle, M; Johnson, C; Ma, Y; Tan, W, 2018
)
0.97
" Furthermore, the inhibitory effect of oVV‑Smac combined with gemcitabine was also evaluated."( Gemcitabine combined with an engineered oncolytic vaccinia virus exhibits a synergistic suppressive effect on the tumor growth of pancreatic cancer.
Chen, W; Fan, W; Huang, F; Lu, X; Mou, X; Ru, G; Wang, S; Zhang, X, 2019
)
2.2
" We investigated the efficacy of first-line gemcitabine and cisplatin (GP) chemotherapy versus gemcitabine and cisplatin chemotherapy combined with the anti-angiogenic drug endostar (GP + E) in advanced thymoma and thymic carcinoma."( Efficacy and toxicities of gemcitabine and cisplatin combined with endostar in advanced thymoma and thymic carcinoma.
Chen, X; Dai, L; Fang, J; Han, J; Han, S; Hu, W; Long, J; Ma, X; Nie, J; Tian, G; Wang, Y; Zhang, Z, 2019
)
1.07
" Chemotherapy combined with endostar could improve the overall response rate, but did not prolong PFS or OS."( Efficacy and toxicities of gemcitabine and cisplatin combined with endostar in advanced thymoma and thymic carcinoma.
Chen, X; Dai, L; Fang, J; Han, J; Han, S; Hu, W; Long, J; Ma, X; Nie, J; Tian, G; Wang, Y; Zhang, Z, 2019
)
0.81
" This study was designed to investigate the effects of microwave hyperthermia combined with gemcitabine on the proliferation and apoptosis of human lung squamous cell carcinoma (NCI-H1703 and NCI-H2170) in vitro."( [Microwave Hyperthermia Combined with Gemcitabine Inhibits Proliferation 
and Induces Apoptosis of Human Lung Squamous Carcinoma Cells].
Ma, S; Yang, D; Yang, Y; Zhao, Y, 2018
)
0.97
" Furthermore, Western blot analysis showed that microwave hyperthermia combined with gemcitabine could up-regulate the p53, Caspase-3, Cleaved-Caspase-3, Cleaved-PARP and Bax protein expression."( [Microwave Hyperthermia Combined with Gemcitabine Inhibits Proliferation 
and Induces Apoptosis of Human Lung Squamous Carcinoma Cells].
Ma, S; Yang, D; Yang, Y; Zhao, Y, 2018
)
0.98
"Microwave hyperthermia combined with gemcitabine remarkably inhibit the proliferation and induce apoptosis of human lung squamous cell carcinoma in vitro."( [Microwave Hyperthermia Combined with Gemcitabine Inhibits Proliferation 
and Induces Apoptosis of Human Lung Squamous Carcinoma Cells].
Ma, S; Yang, D; Yang, Y; Zhao, Y, 2018
)
1.02
" Tyrosine kinase inhibitors (TKIs), including erlotinib and gefitinib, which block the action of the human epidermal growth factor receptor type 1 receptor, provide small increases in patient survival when administered with gemcitabine."( Targeting retinoblastoma protein phosphorylation in combination with EGFR inhibition in pancreatic cancer cells.
Abraham, RG; Dedi, B; Krucher, NA; Thomas, NA, 2019
)
0.7
"To investigate the clinical efficacy of bevacizumab combined with gemcitabine and cisplatin (GP) combination chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC)."( Clinical efficacy of bevacizumab combined with gemcitabine and cisplatin combination chemotherapy in the treatment of advanced non-small cell lung cancer.
Duan, J; Liu, D; Shi, Y; Yang, Z,
)
0.63
" Patients in the control group were treated with GP chemotherapy, while patients in observation group were treated with intravenous infusion of bevacizumab combined with GP chemotherapy."( Clinical efficacy of bevacizumab combined with gemcitabine and cisplatin combination chemotherapy in the treatment of advanced non-small cell lung cancer.
Duan, J; Liu, D; Shi, Y; Yang, Z,
)
0.39
" This study aimed to investigate the curative effects and safety of hyperthermia combined with chemotherapy (HCT) for advanced patients with non-small cell lung cancer (NSCLC), especially those with malignant pleural effusion."( Radiofrequency deep hyperthermia combined with chemotherapy in the treatment of advanced non-small cell lung cancer.
Lai, ZY; Li, Y; Mu, JB; Xie, J; Xu, J; Yang, MD; Yang, WH; Zhang, GH, 2019
)
0.51
" The HCT group was treated with gemcitabine and cisplatin (GP) regimen combined with regional radiofrequency deep hyperthermia, while the CT group was treated with GP regimen only."( Radiofrequency deep hyperthermia combined with chemotherapy in the treatment of advanced non-small cell lung cancer.
Lai, ZY; Li, Y; Mu, JB; Xie, J; Xu, J; Yang, MD; Yang, WH; Zhang, GH, 2019
)
0.8
"Hyperthermia combined with chemotherapy might lead to the development of better therapeutic strategy for advanced NSCLC with malignant pleural effusion patients."( Radiofrequency deep hyperthermia combined with chemotherapy in the treatment of advanced non-small cell lung cancer.
Lai, ZY; Li, Y; Mu, JB; Xie, J; Xu, J; Yang, MD; Yang, WH; Zhang, GH, 2019
)
0.51
" This phase Ib study evaluated vantictumab in combination with nab-paclitaxel and gemcitabine in patients with untreated metastatic pancreatic adenocarcinoma."( A phase 1b dose escalation study of Wnt pathway inhibitor vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated metastatic pancreatic cancer.
Berlin, J; Cardin, DB; Cohen, SJ; Davis, SL; Dotan, E; Kapoun, AM; Lenz, HJ; Messersmith, WA; O'Neil, BH; Shahda, S; Stagg, RJ, 2020
)
1
" In this study, we built on our preclinical studies to evaluate the safety and efficacy of AZD1775 in combination with gemcitabine and radiation in patients with newly diagnosed locally advanced pancreatic cancer."( Dose Escalation Trial of the Wee1 Inhibitor Adavosertib (AZD1775) in Combination With Gemcitabine and Radiation for Patients With Locally Advanced Pancreatic Cancer.
Al-Hawaray, M; Cho, CS; Cuneo, KC; Devasia, T; Lawrence, TS; Maybaum, J; Morgan, MA; Nathan, H; Parsels, JD; Parsels, LA; Sahai, V; Schipper, MJ; Zalupski, MM, 2019
)
0.95
"AZD1775 in combination with gemcitabine and radiation therapy was well tolerated at a dose that produced target engagement in a surrogate tissue."( Dose Escalation Trial of the Wee1 Inhibitor Adavosertib (AZD1775) in Combination With Gemcitabine and Radiation for Patients With Locally Advanced Pancreatic Cancer.
Al-Hawaray, M; Cho, CS; Cuneo, KC; Devasia, T; Lawrence, TS; Maybaum, J; Morgan, MA; Nathan, H; Parsels, JD; Parsels, LA; Sahai, V; Schipper, MJ; Zalupski, MM, 2019
)
1.03
"This study aimed to examine the efficacy of metabolically supported administration of chemotherapy combined with ketogenic diet, hyperthermia, and hyperbaric oxygen therapy (HBOT) in patients with metastatic pancreatic cancer."( Long-Term Survival Outcomes of Metabolically Supported Chemotherapy with Gemcitabine-Based or FOLFIRINOX Regimen Combined with Ketogenic Diet, Hyperthermia, and Hyperbaric Oxygen Therapy in Metastatic Pancreatic Cancer.
Iyikesici, MS, 2020
)
0.79
" In conclusion, MDC-1112 should be further explored as a potential agent to be used in combination with GEM for treating PC."( Phospho-valproic acid (MDC-1112) reduces pancreatic cancer growth in patient-derived tumor xenografts and KPC mice: enhanced efficacy when combined with gemcitabine.
Digiovanni, MG; Lacomb, JF; Luo, D; Mackenzie, GG; Rigas, B; Wei, R; Williams, JL, 2020
)
0.76
"This study aimed to evaluate the clinical outcomes, toxicity, and prognostic factors of SBRT combined with gemcitabine plus capecitabine (GEM-CAP) in treating locally advanced pancreatic cancer (LAPC)."( Clinical outcomes and prognostic factors of stereotactic body radiation therapy combined with gemcitabine plus capecitabine for locally advanced unresectable pancreatic cancer.
Huang, GC; Ji, XQ; Jiang, CC; Li, AM; Li, B; Shen, ZT; Yuan, X; Zhou, H; Zhu, XX, 2020
)
0.99
"A total of 56 patients with LAPC treated with SBRT combined with GEM-CAP were reviewed from October 2010 to October 2016."( Clinical outcomes and prognostic factors of stereotactic body radiation therapy combined with gemcitabine plus capecitabine for locally advanced unresectable pancreatic cancer.
Huang, GC; Ji, XQ; Jiang, CC; Li, AM; Li, B; Shen, ZT; Yuan, X; Zhou, H; Zhu, XX, 2020
)
0.78
"To evaluate clinical outcomes when HAI chemotherapy is combined with systemic chemotherapy in patients with unresectable IHC."( Assessment of Hepatic Arterial Infusion of Floxuridine in Combination With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Clinical Trial.
Allen, PJ; Balachandran, VP; Boerner, T; Boucher, TM; Cercek, A; Chapman, WC; Chou, JF; D'Angelica, MI; DeMatteo, RP; Diaz, LA; Do, RKG; Drebin, JA; Fields, RC; Gönen, M; Harding, JJ; Hauser, HF; Hawkins, WG; Jarnagin, WR; Kemeny, NE; Kingham, TP; Lim, KH; Lowery, MA; Majella Doyle, MB; Reidy-Lagunes, D; Saltz, L; Sanchez-Vega, F; Schultz, N; Strasberg, SM; Tan, BR; Vachharajani, N; Varghese, AM, 2020
)
0.78
" We hypothesized that pelareorep in combination with pembrolizumab and chemotherapy in patients with PDAC would be safe and effective."( Pembrolizumab in Combination with the Oncolytic Virus Pelareorep and Chemotherapy in Patients with Advanced Pancreatic Adenocarcinoma: A Phase Ib Study.
Arora, SP; Cheetham, K; Coffey, M; Eng, KH; Fields, P; Fountzilas, C; Kalinski, P; Mahalingam, D; Moseley, JL; Nuovo, G; Raber, P; Wilkinson, GA; Zhang, B, 2020
)
0.56
"This Phase IIb (NCT02195180) open-label study evaluated erythrocyte-encapsulated asparaginase (eryaspase) in combination with chemotherapy in second-line advanced pancreatic adenocarcinoma."( Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial.
Andre, T; Bachet, JB; Bouche, O; Cros, J; De La Fouchardiere, C; El Hajbi, F; El Hariry, I; Fabienne, P; Faroux, R; Guimbaud, R; Gupta, A; Hamm, A; Hammel, P; Kay, R; Lecomte, T; Louvet, C; Metges, JP; Mineur, L; Rebischung, C; Tougeron, D; Tournigand, C, 2020
)
0.56
"Eligible patients were randomized 2:1 to either eryaspase in combination with gemcitabine or mFOLFOX6 (eryaspase arm), or to gemcitabine or mFOLFOX6 alone (control arm)."( Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial.
Andre, T; Bachet, JB; Bouche, O; Cros, J; De La Fouchardiere, C; El Hajbi, F; El Hariry, I; Fabienne, P; Faroux, R; Guimbaud, R; Gupta, A; Hamm, A; Hammel, P; Kay, R; Lecomte, T; Louvet, C; Metges, JP; Mineur, L; Rebischung, C; Tougeron, D; Tournigand, C, 2020
)
0.79
"Eryaspase in combination with chemotherapy is associated with improvements in OS and PFS, irrespective of ASNS expression in second-line advanced pancreatic adenocarcinoma."( Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial.
Andre, T; Bachet, JB; Bouche, O; Cros, J; De La Fouchardiere, C; El Hajbi, F; El Hariry, I; Fabienne, P; Faroux, R; Guimbaud, R; Gupta, A; Hamm, A; Hammel, P; Kay, R; Lecomte, T; Louvet, C; Metges, JP; Mineur, L; Rebischung, C; Tougeron, D; Tournigand, C, 2020
)
0.56
"LMS03 failed to show that second-line therapy, with gemcitabine combined with pazopanib, followed by pazopanib alone, was beneficial for advanced LMS patients."( A phase II of gemcitabine combined with pazopanib followed by pazopanib maintenance, as second-line treatment in patients with advanced leiomyosarcomas: A unicancer French Sarcoma Group study (LMS03 study).
Bay, JO; Bertucci, F; Bompas, E; Bozec, L; Chenuc, G; Chevreau, C; Cupissol, D; Delaye, J; Delcambre, C; Duffaud, F; Eymard, JC; Guillemet, C; Isambert, N; Italiano, A; Pautier, P; Penel, N; Piperno-Neumann, S; Ray-Coquard, I; Rios, M; Saada, E, 2020
)
1.17
"This study evaluated the efficacy and safety of docetaxel combined with lobaplatin, relative to docetaxel combined with gemcitabine, for treating patients with recurrent metastatic breast cancer (rMBC)."( Pilot study of docetaxel combined with lobaplatin or gemcitabine for recurrent and metastatic breast cancer.
Chang, J; Chen, T; He, M; Hong, W; Li, F; Li, H; Li, J; Liu, L; Luo, D; Ran, L; Shan, L; Song, Y; Wang, B; Wang, H, 2019
)
0.97
" To this end, we developed and evaluated a novel drug combination of gemcitabine and paclitaxel (GT)."( Novel drug combination nanoparticles exhibit enhanced plasma exposure and dose-responsive effects on eliminating breast cancer lung metastasis.
Griffin, JI; Ho, RJY; McConnachie, LA; Mu, Q; Wu, Y; Yu, J; Zhu, L, 2020
)
0.79
" The patients in MPC group were treated with microwave ablation (MWA) combined with PC while patients in MGC group were given MWA combined with gemcitabine plus cisplatin (GC)."( Comparative clinical study on microwave ablation combined with gemcitabine and cisplatin or combined with pemetrexed and cisplatin in treatment of advanced NSCLC.
Feng, Y; Wang, L; Wu, Y; Zhang, Y; Zhou, Y, 2020
)
1
"Many research has indicated that some Chinese herb injections (CHIs) might be beneficial in combination with chemotherapy, however, with inconsistent results."( Comparative efficacy of Chinese herbal injections combined with GP regimen chemotherapy for patients with advanced NSCLC: A protocol for systematic review and network meta-analysis.
Li, J; Liu, TT; Xu, BW; Zhu, GH, 2020
)
0.56
" We researched clinical significance of circPVT1 in patients with non-small cell lung cancer (NSCLC) who received cisplatin combined with gemcitabine chemotherapy."( Clinical significance of circPVT1 in patients with non-small cell lung cancer who received cisplatin combined with gemcitabine chemotherapy.
Bao, C; Cai, S; Chen, Q; Kong, J; Liu, S; Lu, H; Luo, J; Xie, X, 2021
)
1.03
" In addition, after cisplatin combined with gemcitabine chemotherapy, circPVT1 expression was decreased, and circPVT1 expression in the chemotherapy-resistant group was higher than in the chemotherapy-sensitive group."( Clinical significance of circPVT1 in patients with non-small cell lung cancer who received cisplatin combined with gemcitabine chemotherapy.
Bao, C; Cai, S; Chen, Q; Kong, J; Liu, S; Lu, H; Luo, J; Xie, X, 2021
)
1.09
"Our study revealed the clinical significance of circPVT1 in NSCLC after cisplatin combined with gemcitabine chemotherapy."( Clinical significance of circPVT1 in patients with non-small cell lung cancer who received cisplatin combined with gemcitabine chemotherapy.
Bao, C; Cai, S; Chen, Q; Kong, J; Liu, S; Lu, H; Luo, J; Xie, X, 2021
)
1.05
"Reports of the efficacy of induction chemotherapy (IC) combined with concurrent chemoradiotherapy (CCRT) on locoregionally advanced nasopharyngeal carcinoma (NPC) are scarce."( Gemcitabine combined with cisplatin vs. taxane, cisplatin, and fluorouracil in the treatment of locally advanced nasopharyngeal carcinoma: a retrospective case-control study.
Chen, WP; Huang, YM; Li, SL; Lu, L; Qi, CH; Qiao, SQ, 2020
)
2
"This study retrospectively analyzed 827 patients with advanced NPC who received IC combined with CCRT in People's Hospital of Rizhao, China from January 2006 to June 2012."( Gemcitabine combined with cisplatin vs. taxane, cisplatin, and fluorouracil in the treatment of locally advanced nasopharyngeal carcinoma: a retrospective case-control study.
Chen, WP; Huang, YM; Li, SL; Lu, L; Qi, CH; Qiao, SQ, 2020
)
2
"The clinical efficacy of the GP regimen combined with CCRT for the treatment of locoregionally advanced NPC may be better than that of the TPF regimen."( Gemcitabine combined with cisplatin vs. taxane, cisplatin, and fluorouracil in the treatment of locally advanced nasopharyngeal carcinoma: a retrospective case-control study.
Chen, WP; Huang, YM; Li, SL; Lu, L; Qi, CH; Qiao, SQ, 2020
)
2
" To address potential concerns that iohexol administered during a course of chemotherapy impacts that therapy, we performed in vitro and in vivo pharmacokinetic drug-drug interaction evaluations of iohexol."( Evaluation of the pharmacokinetic drug-drug interaction potential of iohexol, a renal filtration marker.
Beumer, JH; Christner, S; Chu, E; Guo, J; Holleran, JL; Ivy, SP; Joshi, A; Kiesel, B; Miller, BM; Parise, RA; Taylor, S; Venkataramanan, R, 2020
)
0.56
"Iohexol is unlikely to affect the clinical pharmacokinetics of carboplatin, paclitaxel, gemcitabine, or other agents used in combination with carboplatin treatment."( Evaluation of the pharmacokinetic drug-drug interaction potential of iohexol, a renal filtration marker.
Beumer, JH; Christner, S; Chu, E; Guo, J; Holleran, JL; Ivy, SP; Joshi, A; Kiesel, B; Miller, BM; Parise, RA; Taylor, S; Venkataramanan, R, 2020
)
0.78
" In this study, we administered apatinib in combination with chemotherapy to achieve good disease control."( Chemotherapy combined with apatinib for the treatment of desmoplastic small round cell tumors: A case report.
Cheng, X; Li, Y; Tian, Y, 2020
)
0.56
" This report describes a Phase Ib clinical trial investigating PG-11047 in combination with cytotoxic and anti-angiogenic chemotherapeutic agents in patients with advanced refractory metastatic solid tumors or lymphoma."( A Phase Ib multicenter, dose-escalation study of the polyamine analogue PG-11047 in combination with gemcitabine, docetaxel, bevacizumab, erlotinib, cisplatin, 5-fluorouracil, or sunitinib in patients with advanced solid tumors or lymphoma.
Becerra, CHR; Boyd, TE; Casero, RA; Conkling, PR; Fitzgerald, M; Garbo, LE; Jotte, RM; Marton, LJ; Murray Stewart, T; Richards, DA; Smith, DA; Stephenson, JJ; Vogelzang, NJ; Von Hoff, D; Wu, HH, 2021
)
0.84
"The maximum tolerated dose (MTD) of PG-11047 in combination with bevacizumab, erlotinib, cisplatin, and 5-FU was 590 mg."( A Phase Ib multicenter, dose-escalation study of the polyamine analogue PG-11047 in combination with gemcitabine, docetaxel, bevacizumab, erlotinib, cisplatin, 5-fluorouracil, or sunitinib in patients with advanced solid tumors or lymphoma.
Becerra, CHR; Boyd, TE; Casero, RA; Conkling, PR; Fitzgerald, M; Garbo, LE; Jotte, RM; Marton, LJ; Murray Stewart, T; Richards, DA; Smith, DA; Stephenson, JJ; Vogelzang, NJ; Von Hoff, D; Wu, HH, 2021
)
0.84
"Results of this Phase Ib trial indicate that PG-11047 can be safely administered to patients in combination with bevacizumab, erlotinib, cisplatin, and 5-FU on the once weekly dosing schedule described and may provide therapeutic benefit."( A Phase Ib multicenter, dose-escalation study of the polyamine analogue PG-11047 in combination with gemcitabine, docetaxel, bevacizumab, erlotinib, cisplatin, 5-fluorouracil, or sunitinib in patients with advanced solid tumors or lymphoma.
Becerra, CHR; Boyd, TE; Casero, RA; Conkling, PR; Fitzgerald, M; Garbo, LE; Jotte, RM; Marton, LJ; Murray Stewart, T; Richards, DA; Smith, DA; Stephenson, JJ; Vogelzang, NJ; Von Hoff, D; Wu, HH, 2021
)
0.84
" Therefore, this study attempts to elucidate the efficiency and safety of concurrent chemoradiotherapy combined with adjuvant chemotherapy (gemcitabine plus cisplatin versus 5-fluorouracil plus cisplatin) for treating patients with NPC."( Efficacy and safety of two different adjuvant chemotherapy regimens in combination with concurrent chemoradiotherapy in treating patients with advanced nasopharyngeal carcinoma: A protocol for randomized controlled trial.
Cui, J; Pan, LX; Tan, HF; Xiao, Z; Zhang, LL, 2021
)
0.82
"This study is a randomized, multicentral, open-labelled trial to assess the clinical efficiency and safety of using concurrent chemoradiotherapy combined with adjuvant chemotherapy as a therapeutic measure for advanced NPC patients."( Efficacy and safety of two different adjuvant chemotherapy regimens in combination with concurrent chemoradiotherapy in treating patients with advanced nasopharyngeal carcinoma: A protocol for randomized controlled trial.
Cui, J; Pan, LX; Tan, HF; Xiao, Z; Zhang, LL, 2021
)
0.62
"The current research evaluates the clinical efficiency and safety of utilising concurrent chemoradiotherapy combined with adjuvant chemotherapy as a therapeutic strategy to treat advanced NPC patients."( Efficacy and safety of two different adjuvant chemotherapy regimens in combination with concurrent chemoradiotherapy in treating patients with advanced nasopharyngeal carcinoma: A protocol for randomized controlled trial.
Cui, J; Pan, LX; Tan, HF; Xiao, Z; Zhang, LL, 2021
)
0.62
" Cell invasion and metastasis-related factors decreased after AMD3100 combined with gemcitabine."( The effect of gemcitabine combined with AMD3100 applying to cholangiocarcinoma RBE cell lines to CXCR4/CXCL12 axis.
Bian, W; Liu, JH; Liu, SG; Lv, HT; Wang, WB; Xing, L; Zhang, TF, 2021
)
1.21
"Between November 2013 and May 2015, 71 patients were randomized to chemotherapy in combination with DCVAC/OvCa or to chemotherapy alone."( Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial.
Bartos, P; Bartunkova, J; Chovanec, J; Cibula, D; Fucikova, J; Galluzzi, L; Hassan, HIB; Hein, A; Hraska, M; Hrnciarova, T; Kieszko, D; Klat, J; Knapp, P; Madry, R; Mallmann, P; Markowska, J; Melichar, B; Minar, L; Pecen, L; Pluta, M; Rob, L; Spacek, J; Spisek, R; Streb, J; Valha, P; Wimberger, P, 2021
)
0.62
"DCVAC/OvCa combined with chemotherapy had a favorable safety profile in patients with platinum-sensitive ovarian cancer."( Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial.
Bartos, P; Bartunkova, J; Chovanec, J; Cibula, D; Fucikova, J; Galluzzi, L; Hassan, HIB; Hein, A; Hraska, M; Hrnciarova, T; Kieszko, D; Klat, J; Knapp, P; Madry, R; Mallmann, P; Markowska, J; Melichar, B; Minar, L; Pecen, L; Pluta, M; Rob, L; Spacek, J; Spisek, R; Streb, J; Valha, P; Wimberger, P, 2021
)
0.62
" In complex diseases like cancer, single-agent approaches are often insufficient for an effective treatment, and drug combination therapies can be implemented."( New In Vitro-In Silico Approach for the Prediction of In Vivo Performance of Drug Combinations.
Correia, C; Ferreira, A; Lapa, R; Santos, J; Urtti, A; Vale, N; Yliperttula, M, 2021
)
0.62
"In this phase I, dose-escalation study, we sought to determine the maximum tolerated dose (MTD) of the anaplastic lymphoma kinase/c-ROS oncogene 1 receptor (ALK/ROS1) inhibitor ceritinib in combination with gemcitabine-based chemotherapy in patients with advanced solid tumors."( A phase I study of the anaplastic lymphoma kinase inhibitor ceritinib in combination with gemcitabine-based chemotherapy in patients with advanced solid tumors.
Adjei, A; Attwood, K; Bshara, W; Evans, R; Fountzilas, C; Ghasemi, M; Goey, A; Groman, A; Iyer, R; Ma, WW; Opyrchal, M; Wilton, J, 2021
)
1.03
" The purpose of this study was to further investigate its synergistic antitumor efficiency in combination with low-dose chemotherapeutic gemcitabine (GEM) on the subcutaneous hepatocellular carcinoma xenograft model in nude mice."( Synergistic Effect of Baculovirus-Mediated Endostatin and Angiostatin Combined with Gemcitabine in Hepatocellular Carcinoma.
Bai, C; Fan, H; Ji, Y; Wang, Z; Yang, M; Yang, W, 2022
)
1.15
" Herein, a murine xenograft model of human aggressive B cell lymphoma (BCL) was established to explore anti-lymphoma efficiency of L-CDDP combined with GEM."( Cisplatin Loaded Poly(L-glutamic acid)-g-Methoxy Polyethylene Glycol Complex Nanoparticles Combined with Gemcitabine Presents Improved Safety and Lasting Anti-Tumor Efficacy in a Murine Xenograft Model of Human Aggressive B Cell Lymphoma.
Bai, O; Guo, W; Liu, Z; Song, W; Tang, Z; Wang, S; Yu, H; Zhang, D, 2021
)
0.84
"s) or rosmarinic acid in combination with gemcitabine on Panc-1 pancreatic cancer cells."( Complementary effects of Orthosiphon stamineus standardized ethanolic extract and rosmarinic acid in combination with gemcitabine on pancreatic cancer.
Abdul Majid, AMS; Asif, M; Oon, CE; Yehya, AHS, 2021
)
1.09
"To evaluate the efficacy of recombinant human endostatin combined with gemcitabine and cisplatin in the treatment of non-small-cell lung cancer (NSCLC)."( Systematic Evaluation Meta-Analysis of the Efficacy of Recombinant Human Endostatin Combined with Gemcitabine and Cisplatin in Non-Small-Cell Lung Cancer.
He, Y; Huang, M; Yi, C; Zhang, L, 2022
)
1.17
"The databases of Cochrane Library, Embase, ClinicalTrials, PubMed, HowNet, Wanfang, and VIP were searched to collect randomized controlled trials (RCTs) of recombinant human endostatin combined with gemcitabine and cisplatin (experimental group) and gemcitabine combined with cisplatin (control group) for comparative study."( Systematic Evaluation Meta-Analysis of the Efficacy of Recombinant Human Endostatin Combined with Gemcitabine and Cisplatin in Non-Small-Cell Lung Cancer.
He, Y; Huang, M; Yi, C; Zhang, L, 2022
)
1.13
"Endobiliary RFA prolonged the patency period of uncovered SEMS combined with GC therapy in patients with eCCA."( Endobiliary Radiofrequency Ablation Combined with Gemcitabine and Cisplatin in Patients with Unresectable Extrahepatic Cholangiocarcinoma.
Ibusuki, M; Inoue, T; Ito, K; Kitano, R; Kobayashi, Y; Naitoh, I; Nakade, Y; Sumida, Y; Yoneda, M, 2022
)
0.97
"To evaluate the efficacy of bevacizumab and gemcitabine in combination with cisplatin in the treatment of esophageal cancer and the effect on the incidence of adverse reactions."( Efficacy of Bevacizumab and Gemcitabine in Combination with Cisplatin in the Treatment of Esophageal Cancer and the Effect on the Incidence of Adverse Reactions.
Cai, L; Chen, S; Li, J; Wang, J; Zhao, Q, 2022
)
1.28
" The control group was treated with gemcitabine combined with cisplatin, and the study group was treated with the triple therapy of bevacizumab, gemcitabine, and cisplatin."( Efficacy of Bevacizumab and Gemcitabine in Combination with Cisplatin in the Treatment of Esophageal Cancer and the Effect on the Incidence of Adverse Reactions.
Cai, L; Chen, S; Li, J; Wang, J; Zhao, Q, 2022
)
1.29
"The clinical efficiency of bevacizumab and gemcitabine combined with cisplatin in the treatment of esophageal cancer is remarkable, which improves the survival of patients, and is worthy of clinical promotion and application."( Efficacy of Bevacizumab and Gemcitabine in Combination with Cisplatin in the Treatment of Esophageal Cancer and the Effect on the Incidence of Adverse Reactions.
Cai, L; Chen, S; Li, J; Wang, J; Zhao, Q, 2022
)
1.28
" This open-label, phase I study (TRX518-003) evaluated the safety and efficacy of repeated dose TRX518 monotherapy and in combination with gemcitabine, pembrolizumab, or nivolumab in advanced solid tumors."( Phase IB Study of GITR Agonist Antibody TRX518 Singly and in Combination with Gemcitabine, Pembrolizumab, or Nivolumab in Patients with Advanced Solid Tumors.
Bajor, D; Bauer, T; Davar, D; Holland, A; Luke, JJ; Merghoub, T; Naik, GS; Newman, W; Piper, D; Qi, J; Rixe, O; Sato, T; Sifferlen, L; Sirard, CA; Wang, H; Wolchok, JD; Wong, P; Zappasodi, R, 2022
)
1.15
"To explore the efficacy and safety of gemcitabine (GEM) combined with cisplatin (DDP) in the treatment of recurrent/metastatic nasopharyngeal carcinoma (NPC)."( Gemcitabine Combined with Cisplatin Has a Better Effect in the Treatment of Recurrent/Metastatic Advanced Nasopharyngeal Carcinoma.
Cai, MB; Li, ZM; Nie, YH; Tan, YR; Yang, Q; Zhu, HB, 2022
)
2.44
"GEM combined with DDP can provide more clinical benefits for patients with recurrent/metastatic advanced NPC, with less side effects, high tolerance and significant efficacy, which can be further promoted in clinical use."( Gemcitabine Combined with Cisplatin Has a Better Effect in the Treatment of Recurrent/Metastatic Advanced Nasopharyngeal Carcinoma.
Cai, MB; Li, ZM; Nie, YH; Tan, YR; Yang, Q; Zhu, HB, 2022
)
2.16
"Platinum is recommended in combination with gemcitabine in the treatment of metastatic triple-negative breast cancer (mTNBC)."( A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer.
Cai, L; Guo, X; Hu, X; Jiang, Z; Luo, J; Pan, Y; Shao, Z; Sun, T; Teng, YE; Wang, B; Wang, S; Wang, X; Wang, Z; Wu, J; Yan, M; Zhang, J; Zhao, Y, 2022
)
1.27
"Gemcitabine (GEM) and cisplatin (CDDP) were employed as representative antineoplastic agents to observe effects of continuous low-dose chemotherapy with GEM or GEM combined with CDDP (GEM+CDDP) on tumor formation and growthin xenograft tumor models in vivo."( Promotion of tumor progression induced by continuous low-dose administration of antineoplastic agent gemcitabine or gemcitabine combined with cisplatin.
Chen, Y; Feng, W; Feng, Y; Li, H; Liu, H; You, H; Zheng, Q, 2022
)
2.38
" The primary objective was to determine the recommended phase 2 dose of crenigacestat combined with other anticancer agents (gemcitabine/cisplatin or gemcitabine/carboplatin)."( A phase 1b study of crenigacestat (LY3039478) in combination with gemcitabine and cisplatin or gemcitabine and carboplatin in patients with advanced or metastatic solid tumors.
Anderson, B; Azaro, A; Benhadji, KA; Cassier, PA; Massard, C; Oakley, G; Pant, S; Yu, D; Yuen, E, 2022
)
1.16
"This study demonstrated that the Notch inhibitor, crenigacestat, combined with different anticancer agents (gemcitabine, cisplatin, and carboplatin) was poorly tolerated and resulted in disappointing clinical activity in patients with advanced or metastatic solid tumors."( A phase 1b study of crenigacestat (LY3039478) in combination with gemcitabine and cisplatin or gemcitabine and carboplatin in patients with advanced or metastatic solid tumors.
Anderson, B; Azaro, A; Benhadji, KA; Cassier, PA; Massard, C; Oakley, G; Pant, S; Yu, D; Yuen, E, 2022
)
1.17
"A double-blind, randomized, placebo-controlled, phase 2 trial assessed gemcitabine in combination with the wee1 inhibitor adavosertib or placebo in platinum resistant or refractory high grade serous ovarian cancer (HGSOC), demonstrating improved progression free and overall survival favouring the adavosertib/gemcitabine arm."( Patient self-reporting of tolerability using PRO-CTCAE in a randomized double-blind, placebo-controlled phase II trial comparing gemcitabine in combination with adavosertib or placebo in patients with platinum resistant or refractory epithelial ovarian ca
Bowering, V; Chang, K; Dhani, NC; Karakasis, K; Kavak, N; Lheureux, S; Madariaga, A; Mitchell, SA; Oza, AM; Pittman, T; Quintos, J; Ramsahai, J; Wang, L; Welch, SA, 2022
)
1.16
"In the treatment of gallbladder cancer, the use of gemcitabine and oxaliplatin combined with apatinib can effectively control the progression of patients' disease."( Effects of Gemcitabine and Oxaliplatin Combined with Apatinib on Immune Function and Levels of SIL-2R and sicAM-1 in Patients with Gallbladder Cancer.
Hu, W; Li, K; Liu, K; Qu, L, 2022
)
1.36
"This study aimed to investigate the efficacy and safety of anti-PD-1 immunotherapy combined with gemcitabine chemotherapy in multiline treatment of advanced pancreatic cancer."( Clinical Study of Anti-PD-1 Immunotherapy Combined with Gemcitabine Chemotherapy in Multiline Treatment of Advanced Pancreatic Cancer.
Du, S; Fan, L; Li, Y; Liu, Y; Wang, J, 2022
)
1.19
" In this study, we investigated the safety and efficacy of gemcitabine and cisplatin (GP), combined with a PD-1 inhibitor, in patients with locally advanced HNSCC."( Neoadjuvant toripalimab combined with gemcitabine and cisplatin in resectable locally advanced head and neck squamous cell carcinoma (NeoTGP01): An open label, single-arm, phase Ib clinical trial.
Feng, W; Hong, H; Huang, X; Jiang, W; Li, Z; Liang, J; Liang, L; Liu, Q; Liu, Y; Liu, ZG; Peng, Y; Xian, S; Yang, S; Zhang, Y; Zhang, Z; Zhong, G; Zhou, Y, 2022
)
1.24
"This was a Phase I/II trial of the novel checkpoint kinase 1 (Chk1) inhibitor SRA737 given in combination with gemcitabine."( A Phase I/II Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination with Low-Dose Gemcitabine in Patients with Advanced Cancer.
Anthoney, A; Arkenau, T; Banerji, U; Blagden, S; Carter, L; Garralda, E; Jones, R; Klencke, BJ; Kowalski, MM; Kristeleit, R; Moreno, V; Plummer, R; Roda, D; Roxburgh, P; Sarker, D; Walter, HS, 2023
)
1.34
"The RP2D was determined to be 500 mg SRA737 combined with low-dose (250 mg/m2) gemcitabine."( A Phase I/II Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination with Low-Dose Gemcitabine in Patients with Advanced Cancer.
Anthoney, A; Arkenau, T; Banerji, U; Blagden, S; Carter, L; Garralda, E; Jones, R; Klencke, BJ; Kowalski, MM; Kristeleit, R; Moreno, V; Plummer, R; Roda, D; Roxburgh, P; Sarker, D; Walter, HS, 2023
)
1.36
"SRA737 in combination with low-dose gemcitabine was well tolerated with lower myelotoxicity than has been seen at standard doses of gemcitabine or with other combinations of Chk1 inhibitors with gemcitabine."( A Phase I/II Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination with Low-Dose Gemcitabine in Patients with Advanced Cancer.
Anthoney, A; Arkenau, T; Banerji, U; Blagden, S; Carter, L; Garralda, E; Jones, R; Klencke, BJ; Kowalski, MM; Kristeleit, R; Moreno, V; Plummer, R; Roda, D; Roxburgh, P; Sarker, D; Walter, HS, 2023
)
1.41
"We reported a patient with unresectable ICC who received lenvatinib and pembrolizumab in combination with gemcitabine plus cisplatin (GP) chemotherapy and subsequently underwent radical liver resection."( Conversion therapy for advanced intrahepatic cholangiocarcinoma with lenvatinib and pembrolizumab combined with gemcitabine plus cisplatin: A case report and literature review.
Chen, XP; Luo, C; Zhang, BX; Zhang, W; Zhang, ZY, 2022
)
1.15
"Lenvatinib and anti-PD1 antibody pembrolizumab in combination with GP chemotherapy provided promising antitumor efficacy with reasonable tolerability, which may be a potentially feasible and safe conversion therapy strategy for patients with initially unresectable and advanced ICC."( Conversion therapy for advanced intrahepatic cholangiocarcinoma with lenvatinib and pembrolizumab combined with gemcitabine plus cisplatin: A case report and literature review.
Chen, XP; Luo, C; Zhang, BX; Zhang, W; Zhang, ZY, 2022
)
0.93
" We report here the results of a retrospective multi-centre study evaluating the efficacy of MGAD (methotrexate, gemcitabine, L-asparaginase and dexamethasone) regimen (two cycles) combined with 'sandwich' radiotherapy in 35 patients with localised newly diagnosed extranodal NK/T-cell lymphoma."( Efficacy of a short sandwich protocol, methotrexate, gemcitabine, L-asparaginase and dexamethasone chemotherapy combined with radiotherapy, in localised newly diagnosed NK/T-cell lymphoma: A French retrospective study.
Bachy, E; Cartron, G; Chaubard, S; Chauchet, A; Clavert, A; Couronné, L; Damaj, G; Fornecker, LM; Gaulard, P; Ghesquières, H; Gressin, R; Hermine, O; Jaccard, A; Lavergne, D; Le Gouill, S; Lemonnier, F; Marouf, A; Michot, JM; Obéric, L; Rossignol, J; Salles, G; Sibon, D; Tournilhac, O; Vargaftig, J; Waultier-Rascalou, A, 2023
)
1.37
" In phase Ib, devimistat was infused over 2 hours in combination with GC on days 1 and 8 every 21 days with a primary objective to determine the recommended phase II dose (RP2D)."( Devimistat in Combination with Gemcitabine and Cisplatin in Biliary Tract Cancer: Preclinical Evaluation and Phase Ib Multicenter Clinical Trial (BilT-04).
Achreja, A; Animasahun, O; Chinnaiyan, AM; Choppara, S; Crysler, O; Dippman, D; Enzler, T; Griffith, KA; Gunchick, V; Hsiehchen, D; Kumar-Sinha, C; Mohan, A; Nagrath, D; Nenwani, M; Sahai, V; Wuchu, F; Zalupski, MM; Zhen, DB, 2023
)
1.2
" One DLT was observed, and the RP2D of devimistat was determined to be 2,000 mg/m2 in combination with GC."( Devimistat in Combination with Gemcitabine and Cisplatin in Biliary Tract Cancer: Preclinical Evaluation and Phase Ib Multicenter Clinical Trial (BilT-04).
Achreja, A; Animasahun, O; Chinnaiyan, AM; Choppara, S; Crysler, O; Dippman, D; Enzler, T; Griffith, KA; Gunchick, V; Hsiehchen, D; Kumar-Sinha, C; Mohan, A; Nagrath, D; Nenwani, M; Sahai, V; Wuchu, F; Zalupski, MM; Zhen, DB, 2023
)
1.2
"Devimistat in combination with GC is well tolerated and has an acceptable safety profile in patients with untreated advanced BTC."( Devimistat in Combination with Gemcitabine and Cisplatin in Biliary Tract Cancer: Preclinical Evaluation and Phase Ib Multicenter Clinical Trial (BilT-04).
Achreja, A; Animasahun, O; Chinnaiyan, AM; Choppara, S; Crysler, O; Dippman, D; Enzler, T; Griffith, KA; Gunchick, V; Hsiehchen, D; Kumar-Sinha, C; Mohan, A; Nagrath, D; Nenwani, M; Sahai, V; Wuchu, F; Zalupski, MM; Zhen, DB, 2023
)
1.2
" The participants will receive GEMOX chemotherapy combined with atezolizumab plus bevacizumab."( Gemcitabine and cisplatin or oxaliplatin chemotherapy combined with atezolizumab plus bevacizumab for advanced biliary tract cancers: a single-arm trial.
Cheng, SQ; Cheng, YQ; Feng, S; Guo, WX; Ni, QZ; Shi, J; Wang, K; Xiang, YJ; Yu, HM; Zhai, J, 2023
)
2.35
" Identifying the key target that determines gemcitabine resistance in PDAC and reversing gemcitabine resistance using target inhibitors in combination with gemcitabine are crucial steps in the quest to improve survival prognosis in patients with PDAC."( Nuclear PLD1 combined with NPM1 induces gemcitabine resistance through tumorigenic IL7R in pancreatic adenocarcinoma.
Chang, A; Ding, J; Feng, Y; Fu, D; Gao, C; Gao, S; Hao, J; Huang, C; Liu, J; Liu, Y; Ma, X; Ma, Y; Tang, B; Wang, H; Wang, X; Yan, J; Yang, S; Zhang, Z; Zhao, R; Zhao, T, 2023
)
1.44
" With this in mind, enhanced chemotherapeutical regimes, in combination with local irradiation, should be evaluated."( Treatment of primary or recurrent non-resectable pancreatic cancer with proton beam irradiation combined with gemcitabine-based chemotherapy.
Dumke, C; Eberle, F; Engenhart-Cabillic, R; Exeli, L; Hauswald, H; Lautenschlaeger, S, 2023
)
1.12
" We previously observed that a ketogenic diet (KD) combined with gemcitabine enhances overall survival in the autochthonous LSL-KrasG12D/+; LSL-Trp53 R172H/+; Pdx1-Cre (KPC) mouse model."( A Ketogenic Diet in Combination with Gemcitabine Mitigates Pancreatic Cancer-Associated Cachexia in Male and Female KPC Mice.
Baar, K; Chen, S; Cortez, NE; Crone, R; Gomes, AV; Hong, BV; Mackenzie, GG; Pathak, S; Rodriguez Lanzi, C; Sule, R; Wang, F, 2023
)
1.42
" Six treatment cycles with a gemcitabine and oxaliplatin (GEMOX) regimen combined with camrelizumab immunotherapy achieved a partial response and successful tumor conversion, as tumor invasion of the second porta hepatis and right hepatic artery was no longer evident."( Case Report: Camrelizumab combined with gemcitabine and oxaliplatin in the treatment of advanced intrahepatic cholangiocarcinoma: a case report and literature review.
Chen, J; Li, H; Lin, H; Sun, H; Wang, X; Zhang, Z, 2023
)
1.47
"Administration of CHK1-targeted anticancer therapies is associated with an increased cumulative risk of cardiac complications, which is further amplified when combined with gemcitabine."( SIRT3-dependent mitochondrial redox homeostasis mitigates CHK1 inhibition combined with gemcitabine treatment induced cardiotoxicity in hiPSC-CMs and mice.
Bao, YL; Chen, JW; Du, C; Gu, AH; Gu, LF; Ji, Y; Jiang, QQ; Shan, TK; Sun, CQ; Wang, H; Wang, LS; Wang, QM; Wang, SB; Wei, TW; Xie, LP; Yang, TT; Zhou, LH, 2023
)
1.33
" Furthermore, LirB combined with GEM had potent inhibitory effects on pancreatic cancer stem cells (CSCs)."( Inhibitory effect of liriopesides B in combination with gemcitabine on human pancreatic cancer cells.
Chen, M; Gan, L; Hong, P; Jin, J; Li, D; Liu, W; Wei, X; Wong, W; Wu, M; Wu, P; Wu, R; Xu, X; Zhang, K; Zheng, X, 2024
)
1.69

Bioavailability

Gemcitabine (Gem) is low mainly due to its poor intestinal permeability and rapid metabolism. Valproate amide 3 is orally bioavailable and releases gem citabine into the systemic circulation after passing through the intestinal mucosa. Polymer-drug conjugates have spawned an approach to improve the cytotoxicity efficiency and bioavailability of gem Citabine by chemical modification.

ExcerptReferenceRelevance
" One limitation to its use is the necessity of co-injecting cimetidine to increase its bioavailability and hence its sensitivity for PET detection."( Use of 5-[(76)Br]bromo-2'-fluoro-2'-deoxyuridine as a ligand for tumour proliferation: validation in an animal tumour model.
Bergström, M; Borbath, I; Grégoire, V; Långström, B; Laryea, D; Pauwels, S, 2002
)
0.31
"Gefitinib (Iressa, ZD 1839) is an orally bioavailable small molecule that selectively inhibits epidermal growth factor receptor(EGFR) tyrosine kinase activity."( [Molecular targeted therapy--non-small-cell lung cancer and gefitinib].
Horio, Y; Mitsudomi, T; Shimizu, J, 2005
)
0.33
" Here we have analyzed the role of nucleoside transporters in nucleoside-derived drug bioavailability and action in mantle cell lymphoma (MCL) cells."( Expression of human equilibrative nucleoside transporter 1 (hENT1) and its correlation with gemcitabine uptake and cytotoxicity in mantle cell lymphoma.
Campo, E; Casado, FJ; Colomer, D; Marcé, S; Molina-Arcas, M; Pastor-Anglada, M; Villamor, N, 2006
)
0.55
" Its stability as well as bioavailability can be increased by making prodrugs."( Characterization of lipophilic gemcitabine prodrug-liposomal membrane interaction by differential scanning calorimetry.
Castelli, F; Cattel, L; Ceruti, M; Rocco, F; Sarpietro, MG,
)
0.42
"The stability and bioavailability of anticancer agents, such as gemcitabine, can be increased by forming prodrugs."( Interaction of lipophilic gemcitabine prodrugs with biomembrane models studied by Langmuir-Blodgett technique.
Castelli, F; Cattel, L; Ceruti, M; Rocco, F; Sarpietro, MG, 2007
)
0.88
" EGFR inhibition may be achieved either by small-molecule orally bioavailable tyrosine kinase inhibitors, such as gefitinib or erlotinib, or else by large-molecule receptor antibodies, such as cetuximab or panitumumab."( Tumor resensitization to erlotinib following brief substitution of cetuximab.
Epstein, RJ; Leung, TW, 2008
)
0.35
"One of the key challenges in anticancer therapy is the toxicity and poor bioavailability of the anticancer drugs."( Targeted delivery of gemcitabine to pancreatic adenocarcinoma using cetuximab as a targeting agent.
Ames, MM; Bhattacharya, R; Buhrow, SA; Dutta, S; Katarya, A; Lau, JS; Muders, M; Mukherjee, P; Mukhopadhyay, D; Patra, CR; Reid, JM; Safgren, SL; Wang, E; Wang, S; Yaszemski, MJ, 2008
)
0.66
" When mizoribine was administered orally in conscious rats, the bioavailability of mizoribine estimated by urinary excretion percentage of unchanged mizoribine was a dose dependent: 53."( Characterization of intestinal absorption of mizoribine mediated by concentrative nucleoside transporters in rats.
Kamio, Y; Mori, N; Murakami, T; Yokooji, T, 2008
)
0.35
" Systemic exposure to dFdC was low with an estimated bioavailability of 10%."( Oral administration of gemcitabine in patients with refractory tumors: a clinical and pharmacologic study.
Andre, VA; Beijnen, JH; Callies, S; Jansen, RS; Kloeker-Rhoades, S; Pluim, D; Rosing, H; Schellens, JH; Slapak, CA; Veltkamp, SA; Visseren-Grul, CM, 2008
)
0.66
" and orally substantially increased oral bioavailability of dFdC."( Modulation of gemcitabine (2',2'-difluoro-2'-deoxycytidine) pharmacokinetics, metabolism, and bioavailability in mice by 3,4,5,6-tetrahydrouridine.
Beumer, JH; Covey, JM; Egorin, MJ; Eiseman, JL; Joseph, E; Parise, RA, 2008
)
0.71
" Hence, modulation of a specific nucleoside transporter may affect bioavailability and contribute significantly to sensitizing tumor cells to these anticancer agents."( Adenoviral-mediated overexpression of human equilibrative nucleoside transporter 1 (hENT1) enhances gemcitabine response in human pancreatic cancer.
Carbó, N; Casado, FJ; García-Manteiga, J; Mazo, A; Mercadé, E; Pastor-Anglada, M; Pérez-Torras, S, 2008
)
0.56
" Valproate amide 3 is orally bioavailable and releases gemcitabine into the systemic circulation after passing through the intestinal mucosa."( Synthesis, crystallization, and biological evaluation of an orally active prodrug of gemcitabine.
Bao, J; Bender, DM; Dantzig, AH; Diseroad, WD; Law, KL; Magnus, NA; McCarthy, JR; Perkins, EJ; Peterson, JA; Pu, YJ; Remick, DM; Reutzel-Edens, SM; Starling, JJ; Stephenson, GA; Vaid, RK; Zhang, D, 2009
)
0.82
" Bioavailability of compounds were checked by in vitro cytotoxicity study and confirmed to be nontoxic."( Synthesis and biological evaluation of simple methoxylated chalcones as anticancer, anti-inflammatory and antioxidant agents.
Bandgar, BP; Bodade, RG; Gawande, SS; Khobragade, CN; Totre, JV, 2010
)
0.36
"Curcumin induces cancer cell growth arrest and apoptosis in vitro, but its poor bioavailability in vivo limits its antitumor efficacy."( Gemcitabine sensitivity can be induced in pancreatic cancer cells through modulation of miR-200 and miR-21 expression by curcumin or its analogue CDF.
Ahmad, A; Ali, S; Banerjee, S; Dominiak, K; Padhye, S; Philip, PA; Sarkar, FH; Schaffert, JM; Wang, Z, 2010
)
1.8
"To assess in a phase II pharmacokinetic study whether different pH levels, dilution volumes and exposure times affect intracellular bioavailability and systemic absorption of gemcitabine."( Pharmacokinetic study to optimize the intravesical administration of gemcitabine.
Berta, G; Carbone, F; Cattel, L; Fiorito, C; Gontero, P; Medana, C; Milla, P; Paone, TC; Tizzani, A, 2010
)
0.79
"The most commonly reported administration scheme of gemcitabine produced the lowest tissue bioavailability of dFdC."( Pharmacokinetic study to optimize the intravesical administration of gemcitabine.
Berta, G; Carbone, F; Cattel, L; Fiorito, C; Gontero, P; Medana, C; Milla, P; Paone, TC; Tizzani, A, 2010
)
0.85
" We have engineered a polymeric nanoparticle encapsulated curcumin formulation (NanoCurc) that shows remarkably higher systemic bioavailability in plasma and tissues compared with free curcumin upon parenteral administration."( Systemic administration of polymeric nanoparticle-encapsulated curcumin (NanoCurc) blocks tumor growth and metastases in preclinical models of pancreatic cancer.
Bisht, S; Chenna, V; Feldmann, G; Goggins, MG; Hong, SM; Karikari, C; Maitra, A; Mizuma, M; Ottenhof, NA; Pramanik, D; Ravi, R; Rudek, MA; Sharma, R, 2010
)
0.36
" Polymer-drug conjugates, in this regard have spawned an approach to improve the cytotoxicity efficiency and bioavailability of gemcitabine by chemical modification."( Long circulation and cytotoxicity of PEGylated gemcitabine and its potential for the treatment of pancreatic cancer.
Sahoo, SK; Vandana, M, 2010
)
0.82
" We have developed a novel synthetic compound-CDF, which showed greater bioavailability in animal tissues such as pancreas, and also induced cell growth inhibition and apoptosis, which was mediated by inactivation of NF-κB, COX-2, and VEGF in pancreatic cancer (PC) cells."( Anti-tumor activity of a novel compound-CDF is mediated by regulating miR-21, miR-200, and PTEN in pancreatic cancer.
Aboukameel, A; Ali, S; Banerjee, S; Bao, B; Kong, D; Padhye, S; Philip, PA; Sarkar, FH; Sarkar, SH; Wang, Z, 2011
)
0.37
"5-fold higher than that in control rats, whereas the bioavailability of cephalexin remained unchanged."( Modulation in concentrative nucleoside transporters-mediated intestinal absorption of mizoribine, an immunosuppressive agent, in lipopolysaccharide-treated rats.
Ishiguro, M; Kamio, Y; Mori, N; Murakami, T; Shimomukai, Y; Yokooji, T, 2011
)
0.37
" NanoHHI particles have an average diameter of approximately 60 nm, forms uniform aqueous suspension, and improved systemic bioavailability compared with the parent compound."( A polymeric nanoparticle encapsulated small-molecule inhibitor of Hedgehog signaling (NanoHHI) bypasses secondary mutational resistance to Smoothened antagonists.
Aftab, BT; Campbell, NR; Chenna, V; Hong, SM; Hu, C; Karikari, C; Khan, SR; Maitra, A; Pramanik, D; Rudek, MA; Rudin, CM; Zhao, M, 2012
)
0.38
" We hypothesize that NF-κB suppression with the novel, orally bioavailable inhibitor dimethylamino parthenolide (DMAPT) will sensitize pancreatic cancer cells to gemcitabine."( Dimethylamino parthenolide enhances the inhibitory effects of gemcitabine in human pancreatic cancer cells.
Beane, JD; Crooks, PA; Holcomb, BK; Schmidt, CM; Waters, JA; Yip-Schneider, MT, 2012
)
0.82
" In vivo pharmacokinetic study showed that the CLA-GEM conjugate had a longer plasma half-life and a higher bioavailability compared to that of unmodified GEM."( Enhanced anticancer activity of gemcitabine coupling with conjugated linoleic acid against human breast cancer in vitro and in vivo.
Feng, Q; Gao, SY; Tao, XM; Wang, JB; Wang, JC; Zhang, LR; Zhang, Q, 2012
)
0.66
"Sapacitabine is an orally bioavailable prodrug of the nucleoside analog 2'-C-cyano-2'-deoxy-1-β-D-arabino-pentofuranosylcytosine (CNDAC)."( Sapacitabine, the prodrug of CNDAC, is a nucleoside analog with a unique action mechanism of inducing DNA strand breaks.
Liu, XJ; Nowak, B; Plunkett, W; Wang, YQ, 2012
)
0.38
"Owing to poor curcumin solubility, we have used cyclodextrins (CD) as an excipient allowing a considerable increase of aqueous solubility and bioavailability of curcumin."( Curcumin-cyclodextrin complexes potentiate gemcitabine effects in an orthotopic mouse model of lung cancer.
Bekaert, S; Cataldo, D; Chiap, P; Coia, I; Evrard, B; Foidart, JM; Gueders, M; Noel, A; Paulissen, G; Rocks, N; Van Heugen, JC, 2012
)
0.64
" A novel series of potent and orally bioavailable 3-alkoxyamino-5-(pyridin-2-ylamino)pyrazine-2-carbonitrile CHK1 inhibitors was generated by hybridization of two lead scaffolds derived from fragment-based drug design and optimized for CHK1 potency and high selectivity using a cell-based assay cascade."( Discovery of 3-alkoxyamino-5-(pyridin-2-ylamino)pyrazine-2-carbonitriles as selective, orally bioavailable CHK1 inhibitors.
Aherne, GW; Box, G; Boxall, KJ; Collins, I; de Haven Brandon, AK; Eccles, SA; Eve, PD; Garrett, MD; Hayes, A; Lainchbury, M; Matthews, TP; McHardy, T; Raynaud, FI; Reader, JC; Valenti, MR; Walton, MI, 2012
)
0.38
" In vivo pharmacokinetics showed the oral bioavailability of D07001-F4 to be 34%."( In vitro and in vivo studies of pharmacokinetics and antitumor efficacy of D07001-F4, an oral gemcitabine formulation.
Chang, LC; Hao, WH; Hsu, CS; Hsu, KY; Hsu, PJ; Hsueh, SP; Wang, JJ, 2013
)
0.61
" Our previous reports suggested that SL-01 possesses superior bioavailability and anticancer activity to gemcitabine in mice."( Pharmacokinetics and metabolism of SL-01, a prodrug of gemcitabine, in rats.
Li, G; Li, W; Li, Y; Qin, Y; Qu, X; Sun, C; Wang, R; Zhao, C, 2013
)
0.85
" The absolute bioavailability for the sum of gemcitabine was 32."( Pharmacokinetics and metabolism of SL-01, a prodrug of gemcitabine, in rats.
Li, G; Li, W; Li, Y; Qin, Y; Qu, X; Sun, C; Wang, R; Zhao, C, 2013
)
0.9
"SL-01 displayed improved absorption, good distribution, high clearance, long mean residence time, and moderate bioavailability after administered intravenously or orally to rats."( Pharmacokinetics and metabolism of SL-01, a prodrug of gemcitabine, in rats.
Li, G; Li, W; Li, Y; Qin, Y; Qu, X; Sun, C; Wang, R; Zhao, C, 2013
)
0.64
" Intriguingly, the proposed triple therapy approach could be further enhanced by using a PEGylated formulation of gemcitabine, which significantly increased its bioavailability and tissue penetration, resulting in a further improved overall outcome."( Multimodal Treatment Eliminates Cancer Stem Cells and Leads to Long-Term Survival in Primary Human Pancreatic Cancer Tissue Xenografts.
Bakker, A; Balic, A; Garcia, E; Hahn, SA; Heeschen, C; Hermann, PC; Hidalgo, M; Sahoo, SK; Sainz, B; Trabulo, SM; Tunici, P; Vandana, M, 2013
)
0.6
" Nanoparticle-based drug delivery systems can provide an alternative approach for regulating the bioavailability of this and most other anticancer drugs."( Functionalized magnetic nanoparticles as vehicles for the delivery of the antitumor drug gemcitabine to tumor cells. Physicochemical in vitro evaluation.
Carazo, A; Delgado, AV; Gómez-Sotomayor, R; Munoz-Gamez, JA; Rudzka, K; Ruiz-Extremera, A; Salmerón, J; Viota, JL, 2013
)
0.61
" Here, we describe the characterization of GNE-900, an ATP-competitive, selective, and orally bioavailable ChK1 inhibitor."( Combination drug scheduling defines a "window of opportunity" for chemopotentiation of gemcitabine by an orally bioavailable, selective ChK1 inhibitor, GNE-900.
Blackwood, E; Cain, G; Choi, J; Epler, J; Evangelista, M; Flagella, M; Gazzard, L; Halladay, J; Jackson, PK; Jakubiak, D; Kowanetz, K; Malek, S; O'Brien, T; Ramiscal, J; Schmidt, S; Williams, K; Wong, K; Xiao, Y; Yee, S; Yen, I, 2013
)
0.61
"As an initial step towards the clinical translation of these drugs for the treatment of HIV-1 infection, we synthesized decitabine and gemcitabine prodrugs in order to increase drug permeability, which has generally been shown to correlate with increased bioavailability in vivo."( Characterization of permeability, stability and anti-HIV-1 activity of decitabine and gemcitabine divalerate prodrugs.
Bonnac, L; Clouser, CL; Mansky, LM; Patterson, SE, 2014
)
0.83
"The aim of study was to formulate PLGA nanoparticles (NPs) of Gemcitabine HCl for enhanced oral bioavailability via absorption through M cells of Peyer's patches."( Enhanced bioavailability and intestinal uptake of Gemcitabine HCl loaded PLGA nanoparticles after oral delivery.
Joshi, G; Kumar, A; Sawant, K, 2014
)
0.9
" Here we present the genesis of this novel series and the identification of GNE-783, a potent, selective and orally bioavailable inhibitor of ChK1."( Discovery of the 1,7-diazacarbazole class of inhibitors of checkpoint kinase 1.
Appleton, B; Chapman, K; Chen, H; Clark, K; Drobnick, J; Gazzard, L; Goodacre, S; Halladay, J; Lyssikatos, J; Malek, S; Schmidt, S; Sideris, S; Wiesmann, C; Williams, K; Wu, P; Yen, I, 2014
)
0.4
"AXL1717 is an orally bioavailable IGF-1R pathway modulator that has been shown to have anti-tumoral effects."( A phase I pilot study of the insulin-like growth factor 1 receptor pathway modulator AXL1717 in combination with gemcitabine HCl and carboplatin in previously untreated, locally advanced, or metastatic non-small cell lung cancer.
Bergqvist, M; Bergström, S; Brandén, E; Ekman, S; Harmenberg, J; Holgersson, G; Jerling, M; Klockare, M; Koyi, H; Larsson, O; Lundström, KL; Ringbom, M, 2015
)
0.63
" However, effective delivery of drugs in combination at the tumor site is marred by low bioavailability and systemic toxicity of individual drugs."( Synergistic activity of combination therapy with PEGylated pemetrexed and gemcitabine for an effective cancer treatment.
Sahoo, SK; Vandana, M, 2015
)
0.65
" Mouse oral bioavailability was complete (100%) with extensive tumor exposure."( The clinical development candidate CCT245737 is an orally active CHK1 inhibitor with preclinical activity in RAS mutant NSCLC and Eµ-MYC driven B-cell lymphoma.
Aherne, GW; Box, G; Boxall, KJ; Collins, I; De Haven Brandon, AK; Eccles, SA; Eve, PD; Garrett, MD; Hayes, A; Henley, AT; Hunter, JE; Lainchbury, M; Matthews, TP; McHardy, T; Osborne, J; Perkins, ND; Raynaud, FI; Reader, JC; Swales, K; Tall, M; Valenti, MR; Walton, MI, 2016
)
0.43
" AXP107-11 has improved physiochemical properties and oral bioavailability compared to the natural form of genistein, and it is possible that combining AXP107-11 with chemotherapy may increase the effect and reduce chemoresistance."( A phase I dose escalation trial of AXP107-11, a novel multi-component crystalline form of genistein, in combination with gemcitabine in chemotherapy-naive patients with unresectable pancreatic cancer.
Berkenstam, A; Frödin, JE; Karimi, M; Kartalis, N; Löhr, JM; Omazic, B; Verbeke, CS,
)
0.34
" 3,5-bis(2-fluorobenzylidene)-4-piperidone (EF24), a novel synthetic curcumin analog, has shown promising in vitro therapeutic efficacy in various human cancer cells, but insufficient water solubility and systemic bioavailability limit its clinical application."( A liposomal formulation of the synthetic curcumin analog EF24 (Lipo-EF24) inhibits pancreatic cancer progression: towards future combination therapies.
Bendas, G; Bisht, S; Brossart, P; Feldmann, G; Holdenrieder, S; Nolting, J; Rupp, A; Schlesinger, M; Schubert, R; Wenzel, J, 2016
)
0.43
" The pharmacokinetic study revealed a high bioavailability of arctigenin and rapid conjugation of the drug with glucuronic acid."( Phase I trial of GBS-01 for advanced pancreatic cancer refractory to gemcitabine.
Esumi, H; Fujioka, R; Hasegawa, H; Hashimoto, Y; Ikeda, M; Kishino, S; Mitsunaga, S; Miyoshi, C; Mochizuki, N; Nomura, S; Ohno, I; Sato, A; Takahashi, H; Takahashi, R; Toyosaki, K; Tsuchihara, K; Yomoda, S, 2016
)
0.67
" UA-medoxomil (NX-201), one of our UA prodrugs, showed an improved bioavailability about 200times better than UA in rodent model."( Discovery of ursolic acid prodrug (NX-201): Pharmacokinetics and in vivo antitumor effects in PANC-1 pancreatic cancer.
Chun, KH; Kim, J; Kim, Y; Lim, JW; Yoon, Y, 2016
)
0.43
" Because of the high OCTN2 affinity, the hexane diacid-linked prodrug demonstrated significantly improved stability (3-fold), cellular permeability (15-fold), and oral bioavailability (5-fold), while causing no toxicity as compared to gemcitabine."( Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
Chen, H; Ding, D; Dong, J; He, Z; Kou, L; Liu, X; Luo, C; Sun, J; Sun, M; Wang, G; Wang, J; Yi, X; Zhang, D; Zhao, D, 2017
)
0.88
" IVC bypasses bioavailability barriers of oral ingestion, provides pharmacological concentrations in tissues, and exhibits selective cytotoxic effects in cancer cells through peroxide formation."( High Dose Parenteral Ascorbate Inhibited Pancreatic Cancer Growth and Metastasis: Mechanisms and a Phase I/IIa study.
Chen, P; Chen, Q; Dong, R; Drisko, JA; Fan, F; Godwin, AK; Levine, M; Pessetto, Z; Polireddy, K; Reed, G; Violet, PC; Williamson, S; Yu, J, 2017
)
0.46
" Furthermore, this nanoparticle can efficiently target pancreatic cancer in vivo, resulting in the enhanced bioavailability and efficacy of Gem."( A Nanoparticle Carrier for Co-Delivery of Gemcitabine and Small Interfering RNA in Pancreatic Cancer Therapy.
Chen, S; Chen, Y; Huang, K; Li, J; Li, Y; Lian, G; Yang, K; Zeng, L, 2016
)
0.7
" However, the full potential of this drug has not been realised, in part due to low oral bioavailability and frequent dosing requirements."( N-trimethyl chitosan nanoparticles and CSKSSDYQC peptide: N-trimethyl chitosan conjugates enhance the oral bioavailability of gemcitabine to treat breast cancer.
Chen, G; Huang, Y; Lu, W; Svirskis, D; Wen, J; Ying, M, 2018
)
0.69
"To improve bioavailability and provide resistance to deamination, an array of gemcitabine (dFdC) prodrugs carrying the acyl modifications has been successful in the optimization of pharmacokinetic properties of dFdC, but the reports about 4-N-carbobenzoxy-dFdC (Cbz-dFdC), a dFdC prodrug bearing alkyloxycarbonyl modification, are relatively rare."( Simultaneous determination of gemcitabine prodrug, gemcitabine and its major metabolite 2', 2'-difluorodeoxyuridine in rat plasma by UFLC-MS/MS.
Aa, L; Fei, F; Hao, K; Jiang, W; Liu, J; Lu, L; Pei, X; Peng, Y; Sun, Y; Wang, G; Wang, J; Zhen, L, 2018
)
1
" Finally, the carbonate linkage bond-bearing group, especially the one with a linker lacking a disulfide bond, stood out with remarkably increased bioavailability (21-fold greater than GEM) and efficient tumor free-GEM accumulation (8-fold of GEM), which consequently contributed to excellent in vivo antitumor efficacy."( Striking a Balance between Carbonate/Carbamate Linkage Bond- and Reduction-Sensitive Disulfide Bond-Bearing Linker for Tailored Controlled Release: In Situ Covalent-Albumin-Binding Gemcitabine Prodrugs Promote Bioavailability and Tumor Accumulation.
Ding, H; He, Z; Kan, Q; Kou, L; Li, D; Li, Z; Luo, C; Na, K; Sun, J; Wang, K; Wang, M; Zhang, H; Zhao, D; Zhong, L, 2018
)
0.67
" Because of its tumor selective activation, novel mechanism of action, excellent oral bioavailability and candidate biomarkers for patient selection, RX-3117 has the potential to replace gemcitabine in the treatment of a spectrum of cancer types."( RX-3117 (fluorocyclopentenyl cytosine): a novel specific antimetabolite for selective cancer treatment.
Balboni, B; Benaim, E; El Hassouni, B; Giovannetti, E; Heaton, C; Honeywell, RJ; Kim, DJ; Lee, YB; Peters, GJ; Peterson, C; Poore, J; Sarkisjan, D, 2019
)
0.7
"Gemcitabine is a widely used chemotherapeutic drug that is administered via intravenous infusion due to a low oral bioavailability of only 10%."( Mechanisms of gemcitabine oral absorption as determined by in situ intestinal perfusions in mice.
Hu, Y; Smith, DE; Thompson, BR, 2019
)
2.32
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" The oral bioavailability of Gemcitabine (Gem) is low mainly due to its poor intestinal permeability and rapid metabolism."( A facile di-acid mono-amidation strategy to prepare cyclization-activating mono-carboxylate transporter 1-targeting gemcitabine prodrugs for enhanced oral delivery.
Chen, H; He, Z; Jian, W; Liu, X; Sun, J; Sun, M; Sun, Y; Wang, G; Wang, Y, 2020
)
1.06
"Formulated forms of cancer therapeutics enhance the efficacy of treatment by more precise targeting, increased bioavailability of drugs, and an aptitude of some delivery systems to overcome multiple drug resistance of tumors."( Biodegradable Polymeric Multilayer Capsules for Therapy of Lung Cancer.
Abakumova, TO; Antipina, MN; Brichkina, AI; Brzozowska, AM; Gorin, DA; Kakran, M; Ketkar, A; Lau, HH; Loh, HM; Novoselova, MV; Trushina, DB; Zatsepin, TS, 2020
)
0.56
"Improving the bioavailability and tumor-targeting ability of a prodrug, as well as monitoring its active ingredient release in vivo, is still a challenge in cancer diagnosis and therapy."( Nanomized tumor-microenvironment-active NIR fluorescent prodrug for ensuring synchronous occurrences of drug release and fluorescence tracing.
Cao, J; Guo, Z; Li, Q; Wang, Q; Zhang, J; Zhu, S; Zhu, WH, 2019
)
0.51
"Gemcitabine (Gem) is a key drug for pancreatic cancer, yet limited by high systemic toxicity, low bioavailability and poor pharmacokinetic profiles."( Biomimetic Gemcitabine-Lipid Prodrug Nanoparticles for Pancreatic Cancer.
Bean, PA; Bulanadi, JC; de Campo, L; Gong, X; Julovi, SM; Moghaddam, MJ; Smith, RC; Xue, A, 2020
)
2.39
" These studies revealed that V-Gem undergoes rapid systemic elimination (half-life < 1 min) and has a low oral bioavailability (<1%)."( Pharmacokinetics of gemcitabine and its amino acid ester prodrug following intravenous and oral administrations in mice.
Shi, J; Smith, DE; Thompson, BR; Zhu, HJ, 2020
)
0.88
" Pancreatic cancer is relatively insensitive to chemotherapy due to multiple factors, including reduced bioavailability of drugs to tumor cells."( A MET Targeting Antibody-Drug Conjugate Overcomes Gemcitabine Resistance in Pancreatic Cancer.
Betancourt, O; Cazes, A; Esparza, E; Gymnopoulos, M; Jaquish, D; Lowy, AM; Mose, ES; Tiriac, H; Wascher, AA; Wong, E, 2021
)
0.87
" In this study, TMC was used as a mucoadhesive adjuvant to enhance the oral bioavailability and hence antitumour effects of gemcitabine formulated into nanocomplexes composed of poly(lactic-co-glycolic acid) nanoparticles (PLGA NPs) conjugated with d-α-tocopheryl polyethylene glycol 1000 succinate (TPGS)."( N-trimethyl chitosan coated nano-complexes enhance the oral bioavailability and chemotherapeutic effects of gemcitabine.
Chen, G; Li, H; Liu, M; Lu, W; Svirskis, D; Wen, J; Ying, M, 2021
)
1.04
"Drug-polymer conjugates that can self-assemble into nanoparticles are promising drug delivery systems that improve the drug bioavailability and allow their controlled release."( Supramolecular Organization of Polymer Prodrug Nanoparticles Revealed by Coarse-Grained Simulations.
Gao, P; Ha-Duong, T; Nicolas, J, 2021
)
0.62
" In vivopharmacokinetic study showed superior bioavailability and in vivo therapeutic efficacy investigation exhibited strongest anticancer activity of glycan and EGFR targeted NPs (GMC-CSN-SA-Cxmab-NPs)."( Dual targeting pH responsive chitosan nanoparticles for enhanced active cellular internalization of gemcitabine in non-small cell lung cancer.
Chawla, R; Kumar, A; Kumar, K; Mishra, M; Rawat, SG, 2023
)
1.13

Dosage Studied

The gemcitabine (GEM)-carboplatin (CBDCA) combination is widely used for non-small cell lung cancer (NSCLC) and has some efficacy in elderly patients. A high incidence of thrombocytopenia is observed.

ExcerptRelevanceReference
" Although 2008/C13 cells were slightly cross-resistant to 4-hydroperoxycyclophosphamide, the drug displayed a steep dose-response (colony growth inhibition) effect toward these cells."( Deoxycytidine protects normal bone marrow progenitors against Ara-C and gemcitabine cytotoxicity without compromising their activity against cisplatin-resistant human ovarian cancer cells.
Bhalla, K; Bullock, G; Holladay, C; Ibrado, AM; Jasiok, M; Lutzky, J; Singh, S, 1992
)
0.52
"7 and the mean dosage delivered was 725 mg/m2 per injection."( Advanced breast cancer: a phase II trial with gemcitabine.
Beykirch, M; Carmichael, J; Harris, AL; Kerr, H; Phillip, P; Possinger, K; Walling, J, 1995
)
0.55
" In rat, excretion of radioactivity in the urine 24 h after daily dosing was nearly constant, but excretion of radioactivity in the faeces slightly increased with increasing number of doses."( Disposition of gemcitabine in rat and dog after single and multiple dosings.
Esumi, Y; Kawai, M; Mitsugi, K; Seki, H; Takao, A, 1994
)
0.64
" Further evaluation, including the use of more intense dosing and/or combination therapy, is warranted."( Phase II trial of gemcitabine (2,2'-difluorodeoxycytidine) in patients with adenocarcinoma of the pancreas.
Brown, TD; Casper, ES; Flombaum, CD; Green, MR; Heelan, RT; Kelsen, DP; Tarassoff, PG; Trochanowski, B, 1994
)
0.62
" Twenty percent dosage escalation was permitted after course no."( Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study.
Anderson, H; Bach, F; Hansen, HH; Lund, B; Thatcher, N; Walling, J, 1994
)
0.57
" Hematologic toxicity was not severe with this dosing schedule; however, two patients developed dyspnea with bronchospasm after repeated injections of drug."( Gemcitabine in advanced renal cell carcinoma. A phase II study of the National Cancer Institute of Canada Clinical Trials Group.
Eisenhauer, EA; Mertens, WC; Moore, M; Muldal, A; Stewart, D; Venner, P; Wong, D, 1993
)
1.73
"5 and the mean dosage received was 890 mg m2 per injection."( Phase II study of gemcitabine in patients with advanced pancreatic cancer.
Blatter, J; Carmichael, J; Fink, U; Harris, AL; Russell, RC; Spiessi, G; Spittle, MF, 1996
)
0.63
" In one study 50 patients were treated with gemcitabine and cisplatin given weekly x 3 every 4 weeks, cisplatin at a dosage of 25-30 mg/m2 and gemcitabine at doses escalating from 1000 mg/m2 in steps of 250 mg/m2 per cycle, 38 of 50 patients have been evaluated to date, with an overall response rate of 31."( Gemcitabine in the treatment of non-small-cell lung cancer.
Burkes, RL; Shepherd, FA, 1995
)
2
" LY188011 was administered weekly for 3 consecutive weeks starting with an initial dose of 60 mg/m2 (1n) and then increasing the dosage to 1,000 mg/m2 (16."( [LY188011 phase I study. Research Group of Gemcitabine (LY188011)].
Fukuoka, M; Furue, H; Furuse, K; Majima, H; Morimoto, K; Nakamura, T; Nakao, I; Niitani, H; Ohta, K; Shimoyama, T; Taguchi, T; Tsukagoshi, S; Wakui, A, 1996
)
0.56
" Dose-response data suggest that a dose of 1000 mg/m2 or more is required for optimal therapeutic effect."( Phase II trials of single-agent activity of gemcitabine in patients with advanced non-small cell lung cancer: an overview.
Shepherd, FA, 1995
)
0.55
" Carboplatin dosing was escalated and determined using the Calvert formula, and three patients were treated at the initial predicted dose of area under the curve (AUC) 4 mg/mL/min."( A phase I study of gemcitabine and carboplatin in non-small cell lung cancer.
Allerheiligen, S; Carmichael, J; Walling, J, 1996
)
0.62
" Gemcitabine was well tolerated thus, although gemcitabine at the dosage and schedule chosen had only small activity, the observed toxicity may permit further dose escalation or a more frequent administration of the drug."( Experimental and clinical efficacy of 2', 2'-difluorodeoxycytidine (gemcitabine) against renal cell carcinoma.
Blatter, J; De Mulder, PH; Jakse, G; Osieka, R; Rohde, D; Weissbach, L,
)
1.28
"This regimen of gemcitabine and cisplatin was effective, with high response and survival rates and few dosage modifications during its administration."( Weekly gemcitabine with monthly cisplatin: effective chemotherapy for advanced non-small-cell lung cancer.
Abratt, RP; Bezwoda, WR; Goedhals, L; Hacking, DJ, 1997
)
1.1
"The pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and dosage and administration of gemcitabine are reviewed."( Gemcitabine: a cytidine analogue active against solid tumors.
Hui, YF; Reitz, J, 1997
)
1.95
" Combination effects were analyzed by means of a three-dimensional model, which directly elucidates the shape of the dose-response surface over the entire clinical dose range, identifies regions of statistically significant synergy and antagonism, and quantifies these effects."( In vitro interaction between gemcitabine and other anticancer drugs using a novel three-dimensional model.
Kanzawa, F; Saijo, N, 1997
)
0.59
" Modifications of dosing schedules and the use of premedication regimens have resulted in better efficacy and more manageable side effects with such combinations."( Overview of current and future chemotherapeutic agents in non-small cell lung cancer.
Natale, RB, 1997
)
0.3
" Preclinical studies suggest that the efficacy of gemcitabine is more schedule than dose related, and it is concluded that this is not the most appropriate dosing schedule for gemcitabine."( Phase I study of gemcitabine using a once every 2 weeks schedule.
Clavel, MD; Guastalla, JP; Hatty, SR; McDaniels, C; Seitz, DE; Tanis, B; Vermorken, JB, 1997
)
0.89
" Five phase II studies have been performed using different scheduling and dosage regimens."( Combination studies with gemcitabine in the treatment of non-small-cell lung cancer.
Steward, WP, 1998
)
0.6
" The median dosage of gemcitabine per scheduled infusion was statistically higher with the day 15 cisplatin regimens (combined) compared with any of the other regimens treating at 1,000 mg/m2 (P < ."( Combined cisplatin and gemcitabine for non-small cell lung cancer: influence of scheduling on toxicity and drug delivery.
Abratt, RP; Crinò, L; Green, MR; Nguyen, B; Peters, GJ; Sandler, A; Shepherd, FA; Steward, WP, 1998
)
0.93
" Comparison with standard 30-minute bolus dosing will be evaluated in subsequent randomized phase II trials."( Clinical results of a pharmacodynamically-based strategy for higher dosing of gemcitabine in patients with solid tumors.
Abbruzzese, JL; Gravel, D; Plunkett, W; Raber, MN; Touroutoglou, N, 1998
)
0.53
" Gemcitabine was administered at a dosage of 1200 mg/m2 as a 30-min intravenous infusion on days 1, 8 and 15, repeated every 28 days."( A phase II study of gemcitabine in patients with transitional cell carcinoma of the urinary tract previously treated with platinum. Italian Co-operative Group on Bladder Cancer.
Antimi, M; De Lena, M; Frassineti, GL; Gridelli, C; Lorusso, V; Luporini, G; Oliva, C; Pacini, M; Pollera, CF, 1998
)
1.53
" Patients were treated on days 1, 8, and 15 of a 28-day schedule at the dosage of 1200 mg/m2 for a total of three courses."( Therapy with gemcitabine in pretreated peripheral T-cell lymphoma patients.
Albertini, P; Bendandi, M; Gherlinzoni, F; Magagnoli, M; Orcioni, GF; Pileri, SA; Tura, S; Zinzani, PL, 1998
)
0.67
" 5-FU was given via protracted venous infusion (PVI) at a fixed dosage of 200 mg/m2/d, and gemcitabine was administered weekly for 3 consecutive weeks every 4 weeks."( Phase I-II study of gemcitabine and fluorouracil as a continuous infusion in patients with pancreatic cancer.
Alonso, S; Castellano, D; Cortes-Funes, H; Diaz-Puente, M; Gravalos, C; Hidalgo, M; Hitt, R; Paz-Ares, L, 1999
)
0.85
" Day-15 gemcitabine dosing is problematic and may contribute to excessive thrombocytopenia when gemcitabine is combined with carboplatin."( Gemcitabine and carboplatin in combination: an update of phase I and phase II studies in non-small cell lung cancer.
Calvert, P; Edelman, MJ; Gandara, DR; Langer, CJ; Ozols, RF, 1999
)
2.18
" Dose-response relationships for the cytotoxic effects of gemcitabine were determined using methylthiotetrazole assays, and induction of apoptosis was confirmed by fluorescence-activated cell sorting analysis."( Gemcitabine-induced programmed cell death (apoptosis) of human pancreatic carcinoma is determined by Bcl-2 content.
Bold, RJ; Chandra, J; McConkey, DJ,
)
1.82
"At the prescribed dosage and schedule, single agent gemcitabine appears to have limited activity in chemotherapy-naive patients with malignant pleural mesothelioma."( A Phase II study of gemcitabine in patients with malignant pleural mesothelioma. European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group.
Ardizzoni, A; Baas, P; Debruyne, C; Giaccone, G; Gridelli, C; Groen, HJ; Lentz, M; Manegold, C; van Marck, EA; van Meerbeeck, JP, 1999
)
0.88
" The dosage of cisplatin was fixed to 80 mg/m2 and the dosage of Gemcitabine was gradually escalated in 3 dosing level from 600, 800 to 1,000 mg/m2."( [Phase I study of gemcitabine hydrochloride (LY 188011) combination therapy with cisplatin in the patients with non-small cell lung cancer].
Hara, N; Kurita, Y; Matsui, K; Nakai, Y; Niitani, H; Ohhashi, Y; Yokoyama, A, 1999
)
0.88
" Although the efficacy of this drug was confirmed in terms of the combination therapy from the results, the optimal dosage schedule of this drug was not established because each study showed a different result in terms of the dosage as well as the dosage interval, thus, it is necessary to discuss and establish the optimal dosage schedule."( [Gemcitabine hydrochloride is a new anti-cancer agent which will be available in the patients with non-small cell lung cancer (NSCLC) in Japan].
Yokoyama, A, 1999
)
1.21
" To decrease toxicity, the dosage of dFdC was lowered to 50 mg/kg and combined with the total dose of CDDP on day 0, which caused a better antitumour effect than the combination of 60 mg/kg dFdC and 3 mg/kg CDDP (q6dx2) with acceptable toxicity."( Scheduling of gemcitabine and cisplatin in Lewis lung tumour bearing mice.
Peters, GJ; Pinedo, HM; Postmus, PE; van Moorsel, CJ; Veerman, G; Vermorken, JB, 1999
)
0.66
"5 mg/week; however, the warfarin dosage had to be reduced to 48."( Identification of a gemcitabine-warfarin interaction.
Kinikar, SA; Kolesar, JM, 1999
)
0.63
"The dosage and scheduling of VNR and GEM in the pilot study resulted in neutropenia necessitating reductions or delays in treatment, and consequently low dose intensity."( Phase II study of vinorelbine and gemcitabine for inoperable stage IIIB-IV non-small-cell lung cancer.
Halme, M; Isokangas, OP; Joensuu, H; Knuuttila, A; Lindström, I; Mäntylä, M; Mattson, K; Nikkanen, V; Viren, M, 1999
)
0.58
"In phase I, dose-limiting toxicity occurred at the dosage of 1,500 mg/m(2) gemcitabine, with three of five patients developing grade 4 thrombocytopenia."( Phase I/II study of gemcitabine plus vinorelbine as first-line chemotherapy of non-small-cell lung cancer.
Brunetti, C; Carpagnano, F; Cinieri, S; Cisternino, ML; De Lena, M; Di Rienzo, G; Frasci, G; Lorusso, V; Napoli, G; Orlando, S; Palazzo, S; Panza, N, 2000
)
0.86
" There are several strategies for increasing dose intensity, one being a protracted daily dosing strategy without major dose reduction for toxicity."( Cytotoxic chemotherapy regimens that increase dose per cycle (dose intensity) by extending daily dosing from 5 consecutive days to 28 consecutive days and beyond.
Albella, B; Bueren, JA; Keyes, KA; LoRusso, PM; Parchment, RE, 2000
)
0.31
" The dosing schedule remained fixed, and any dose of gemcitabine that could not be given on time was omitted."( Gemcitabine in the treatment of refractory Hodgkin's disease: results of a multicenter phase II study.
Benoehr, C; Bonadonna, G; Bonfante, V; Bredenfeld, H; Devizzi, L; Diehl, V; Fiedler, F; Pacini, M; Parra, HS; Santoro, A; Tesch, H; Viviani, S, 2000
)
2
" Patients with elevated creatinine levels seem to have increased sensitivity to gemcitabine, but the data are not adequate to support a specific dosing recommendation."( Phase I and pharmacokinetic trial of gemcitabine in patients with hepatic or renal dysfunction: Cancer and Leukemia Group B 9565.
Budman, D; Byrd, J; Egorin, MJ; Hawkins, M; Hohl, R; Hollis, D; Mani, S; Meropol, NJ; Ratain, MJ; Rosner, GL; Venook, AP, 2000
)
0.81
" Several trials evaluating different dosing regimens of gemcitabine plus paclitaxel or docetaxel are ongoing or planned."( Gemcitabine and paclitaxel combination therapy in transitional cell carcinoma of the urothelium.
Burris, HS; Greco, FA; Hainsworth, JD; Meluch, AA, 2000
)
2
" This article describes recent clinical trials evaluating gemcitabine plus carboplatin, and the impact of the dosing schedule on the feasibility and tolerability of this combination."( Gemcitabine/carboplatin combination regimens: importance of dose schedule.
Edelman, MJ; Gandara, DR; Lara, PN; Lau, DH, 2000
)
1.99
" We conclude that the administered dosage and schedule of gemcitabine and cisplatin in patients with locally advanced or metastatic cancer of the pancreas constitutes an active cytotoxic regimen associated with moderate toxicity."( Phase II study of gemcitabine in combination with cisplatin in patients with locally advanced and/or metastatic pancreatic cancer.
Brodowicz, T; Függer, R; Jakesz, R; Köstler, WJ; Steger, GG; Teleky, B; Tomek, S; Vaclavik, I; Wolfram, RM; Zielinski, CC, 2000
)
0.88
"In a multicenter phase II Italian trial that used a 28-day dosing schedule of gemcitabine on days 1, 8, and 15 and cisplatin on day 2, thrombocytopenia and neutropenia were the main dose-limiting toxicities observed."( Decreased myelotoxicity of gemcitabine and cisplatin in advanced non-small cell lung cancer (NSCLC) with cisplatin infusion on day 15.
Corona, M; Cortesi, E; Gasperoni, S; Grifalchi, F; Lembo, A; Moscetti, L; Oliva, A; Padovani, A; Ramponi, S,
)
0.66
" Combined dosing of NDP with GEM resulted in synergistically enhanced inhibition of tumor growth in the Ma44 tumor model."( Preclinical in vivo antitumor efficacy of nedaplatin with gemcitabine against human lung cancer.
Hojo, K; Maekawa, R; Maki, H; Matsumoto, M; Nishitani, Y; Takeda, Y; Wada, T; Yoshioka, T, 2001
)
0.55
" Initial trials combining gemcitabine and carboplatin using standard days 1, 8, and 15 dosing of gemcitabine suggested that thrombocytopenia was problematic."( Gemcitabine in combination with new platinum compounds: an update.
Edelman, MJ; Gandara, DR; Lara, PN; Lau, DH, 2001
)
2.05
" Further study of this regimen should concentrate on the dosage and the sequence of administration."( Phase II study of concurrent gemcitabine and radiotherapy in locally advanced stage IIIB cervical carcinoma.
Chansilpa, Y; Ieumwananontachai, N; Pattaranutaporn, P; Thephamongkhol, K; Therasakvichya, S; Thirapakawong, C, 2001
)
0.6
" The dosage of gemcitabine was 1 g/m2 weekly on day 1, 8 and 15."( Combination of gemcitabine and cisplatin in advanced non-small cell lung cancer.
Chewaskulyong, B; Pothirat, C; Thongprasert, S, 2001
)
1.02
"5 and 15 days in the HS746T xenograft and between 5 and 25 days in the Hep3B xenograft over the dosage range (3 to 30 mg/kg)."( Antiangiogenic and antitumor effects of a protein kinase C beta inhibitor in human hepatocellular and gastric cancer xenografts.
Alvarez, E; Faul, MM; Liu, P; Menon, K; Shih, C; Teicher, BA,
)
0.13
"This Phase II study evaluated a flexible 3- or 4-week dosing schedule of gemcitabine and vinorelbine to determine its effect on response rate and survival of patients with metastatic nonsmall cell lung carcinoma (NSCLC)."( Flexible chemotherapy regimen with gemcitabine and vinorelbine for metastatic nonsmall cell lung carcinoma: a phase II multicenter trial.
Ayoub, J; Cormier, Y; Hirsh, V; Iglésias, JL; Langleben, A; Pintos, J, 2001
)
0.82
" Cumulative dose-response plots of primary breast cancer tumor cells responding in vitro with > or = 90% growth inhibition showed a strong dose dependence for both EPI/PTX and CBDCA/PTX."( Drug interactions and cytotoxic effects of paclitaxel in combination with carboplatin, epirubicin, gemcitabine or vinorelbine in breast cancer cell lines and tumor samples.
Beryt, M; Felber, M; Hepp, H; Kahlert, S; Konecny, G; Langer, E; Lude, S; Pegram, M; Slamon, D; Untch, M, 2001
)
0.53
"We conclude that this drug combination and dosage are feasible and have potential as either a front- or second-line chemotherapeutic regimen for advanced lung cancer, and phase II/III trials should be performed."( Gemcitabine and vinorelbine in patients with advanced lung cancer: preclinical studies and report of a phase I trial.
Anderson, I; Dang, NH; Elias, A; Herbst, RS; Leong, T; Lynch, C; Salgia, R; Skarin, AT; Strauss, G; Teicher, BA; Vasconcelles, M; Zacarola, P, 2001
)
1.75
" These studies consisted of single-dose and steady-state dosing regimen studies, the latter to assess drug distribution in normal brain and brain tumors."( Targeted delivery of a peripheral benzodiazepine receptor ligand-gemcitabine conjugate to brain tumors in a xenograft model.
Adams, AL; Gallo, JM; Guo, P; Guo, Z; Li, S; Ma, J, 2001
)
0.55
" Tumor response was determined in animals receiving a similar dosing schedule of dFdCyd."( Tumor uptake and elimination of 2',2'-difluoro-2'-deoxycytidine (gemcitabine) after deoxycytidine kinase gene transfer: correlation with in vivo tumor response.
Blackstock, AW; Case, LD; Hess, SM; Lightfoot, H; Mitchell, BS; Mukherji, SK; Swarts, SG; Tepper, JE, 2001
)
0.55
" The schedule 2 maximum tolerated dose of gemcitabine was 2200 mg/m(2)/week when combined with 5-FU dosed at 200 mg/m(2)/day (Days 1-14) repeated every 3 weeks."( Phase I study to evaluate multiple regimens of intravenous 5-fluorouracil administered in combination with weekly gemcitabine in patients with advanced solid tumors: a potential broadly active regimen for advanced solid tumor malignancies.
Bertucci, D; Mani, S; Ratain, MJ; Schilsky, RL; Stadler, WM; Vogelzang, NJ, 2001
)
0.79
" Despite prompt initiation of antimycotic therapy the outcome was fatal; dosage of conventional and liposomal amphotericin B was limited due to treatment-related toxicities."( A novel type of metastatically spreading subcutaneous aspergillosis without epidermal lesions following allogeneic stem cell transplantation.
Bethe, U; Cornely, OA; Pels, H; Ritzkowsky, A; Seibold, M; Soehngen, D; Toepelt, K, 2001
)
0.31
"Paclitaxel pharmacokinetics did not change as a result of dosage escalation of gemcitabine from 1,500 to 2,000 mg/m2."( Drug distribution and pharmacokinetic/pharmacodynamic relationship of paclitaxel and gemcitabine in patients with non-small-cell lung cancer.
Curigliano, G; Danesi, R; De Braud, F; De Pas, T; Del Tacca, M; Fogli, S; Giovannetti, G, 2001
)
0.76
" In addition, gemcitabine 1,500 mg/m2 is the recommended dosage in combination with paclitaxel 100 mg/m2 for future phase II studies, due to its predictable kinetic behaviour and less severe thrombocytopenia than expected."( Drug distribution and pharmacokinetic/pharmacodynamic relationship of paclitaxel and gemcitabine in patients with non-small-cell lung cancer.
Curigliano, G; Danesi, R; De Braud, F; De Pas, T; Del Tacca, M; Fogli, S; Giovannetti, G, 2001
)
0.9
" Current research in pancreatic cancer involves newer dosing schedules of gemcitabine, and combinations of gemcitabine with novel agents."( Pancreatic cancer: the evolving role of systemic therapy.
Adsay, NV; El-Rayes, BF; Philip, PA, 2001
)
0.54
" Prediction of the drug sensitivity of each patient and cell kill kinetics of the drug may improve the outcome of treatment and avoid unnecessary dosing of the drug."( Prediction of cell kill kinetics of anticancer agents using the collagen gel droplet embedded-culture drug sensitivity test.
Komiyama, M; Mori, T; Ohnishi, M; Okada, H; Tsutsui, A; Yabushita, H,
)
0.13
" To our knowledge, this is one of the few cases of ROC in which partial remissions using conventionally dosed chemotherapy were achieved repeatedly despite a unfavorable relapse-free interval after high-dose chemotherapy for primary disease."( Individualized long-term chemotherapy for recurrent ovarian cancer after failing high-dose treatment.
Breidenbach, M; Kurbacher, CM; Mallmann, P; Rein, DT, 2002
)
0.31
"The antitumor activity of gemcitabine is not dose-response related but schedule-dependent."( Toxicity of a 24-hour infusion of gemcitabine in biliary tract and pancreatic cancer: a pilot study.
Assmann, G; Eckel, F; Lersch, C; Schulte-Frohlinde, E, 2002
)
0.89
" In the control group, chemotherapy was performed via peripheral veins with the same dosage as the experimental group."( [Regional intra-arterial infusion chemotherapy for pancreatic cancer: an experimental study].
Fu, D; Hua, Y; Ni, Q; Wang, L; Yu, X; Zhang, Q; Zhang, Y, 2002
)
0.31
" With a fixed interval between chemotherapy and XRT taken from these studies, the dose-response relationship was examined for XRT in the range of 20-65 Gy."( Effect of gemcitabine on acute and late radiation toxicity of skin and underlying soft tissues to single-dose irradiation in a nude mice model.
Bamberg, M; Budach, W; Classen, J; Hehr, T; Paulsen, F, 2002
)
0.72
" Onset, duration, and extent of acute skin toxicity, as well as skin and leg contracture, were not significantly modulated by GEM in the dose-response experiments with GEM applied 2 h before XRT."( Effect of gemcitabine on acute and late radiation toxicity of skin and underlying soft tissues to single-dose irradiation in a nude mice model.
Bamberg, M; Budach, W; Classen, J; Hehr, T; Paulsen, F, 2002
)
0.72
" The usual dosage of gemcitabine in these cases was 1000 mg/m(2) given on a weekly basis."( Gemcitabine-induced radiation recall.
Brooks, S; Burstein, HJ; Devlin, PM; Fuchs, CS; Jänne, PA; Jeter, MD; Loeffler, JS; Salgia, R; Wen, P, 2002
)
2.08
" The most appropriate dosing option appeared to be 400 mg x m(-2) per day of oral UFT for 14 consecutive days with 900 mg x m(-2) gemcitabine on days 8 and 15."( A phase I study of combination chemotherapy with gemcitabine and oral UFT for advanced non-small cell lung cancer.
Asoh, H; Ichinose, Y; Semba, H; Seto, T; Yamamoto, H; Yoh, K, 2002
)
0.77
"Our results demonstrate a large pharmacokinetic advantage of intrathecal gemcitabine and support a planned Phase I clinical trial of this dosing strategy."( Pharmacokinetics of intrathecal gemcitabine in nonhuman primates.
Balis, FM; Berg, SL; Blaney, SM; Egorin, MJ; Kerr, JZ; McCully, CM; Zuhowski, EG, 2002
)
0.83
" The combined dosing of NDP with GEM resulted in synergistically enhanced inhibition of tumor growth against Ma44/GEM."( Preclinical combination chemotherapy of nedaplatin with gemcitabine against gemcitabine-refractory human lung cancer.
Hojo, K; Maekawa, R; Matsumoto, M; Nishitani, Y; Takeda, Y; Wada, T; Yoshioka, T, 2002
)
0.56
"The maximum tolerated dosage of gemcitabine is 75 mg/m(2)/week with paclitaxel 40 mg/m(2)/week and conventional 50."( Gemcitabine, paclitaxel, and radiation for locally advanced pancreatic cancer: a Phase I trial.
Akerman, P; Cioffi, W; Cruff, D; Dipetrillo, T; Iannitti, D; Quirk, D; Ramdin, N; Rich, T; Safran, H; Shah, S, 2002
)
2.04
" Treatment schedule consisted of DCT at the dosage of 50 mg/m(2) with conventional steroid premedication and GEM at the dosage of 2,000 mg/m(2)."( Gemcitabine and docetaxel every 2 weeks in advanced non-small cell lung cancer: a phase II study of the Gruppo Oncologico Italia Meridionale.
Borsellino, N; Cazzato, C; Colucci, G; Durini, E; Galetta, D; Gebbia, V; Giotta, F; Pezzella, G; Romito, S, 2002
)
1.76
" The treatment plan consisted of weekly gemcitabine for three weeks with twice daily dosing of 5-FU and eniluracil for 21 days beginning on day one of gemcitabine."( Phase I study of eniluracil, oral 5-fluororacil and gemcitabine in patients with advanced malignancy.
Alberti, D; Arzoomanian, RZ; Bailey, H; Berlin, JD; Binger, K; Feierabend, C; Marrocha, R; Morgan-Meadows, S; Mulkerin, D; Thomas, JP; Volkman, J; Wilding, G, 2002
)
0.83
"In a phase I trial, carried out on 21 patients, grade 4 neutropenia, as dose-limiting toxicity, occurred at the dosage level of paclitaxel 80 mg/m(2)."( Phase I/II study of paclitaxel, gemcitabine and vinorelbine as first-line chemotherapy of non-small-cell lung cancer.
Carpagnano, F; Crucitta, E; De Lena, M; Guida, M; Lorusso, V; Mancarella, S; Panza, N; Sambiasi, D; Silvestris, N, 2002
)
0.6
" Dose-limiting thrombocytopenia at week 3 necessitated less frequent gemcitabine dosing (days 1 and 15 of each cycle)."( A dose-escalation study of weekly topotecan, cisplatin, and gemcitabine front-line therapy in patients with inoperable non-small cell lung cancer.
Biggs, DD; Grubbs, SS; Guarino, MJ; Himelstein, AL; Hogaboom, K; Schneider, CJ; Tilak, S, 2002
)
0.79
" DX-8951f was significantly effective in a dose-response manner on the BxPC-3 primary tumor."( Efficacy of camptothecin analog DX-8951f (Exatecan Mesylate) on human pancreatic cancer in an orthotopic metastatic model.
Bouvet, M; Hoffman, RM; Moossa, AR; Nassirpour, R; Sun, FX; Tohgo, A; Yagi, S, 2003
)
0.32
" In phase I, on 23 patients entered on study, dose-limiting toxicity occurred at the dosage of 1200 mg m(-2) gemcitabine and 10 mg m(-2) mitoxantrone, with three out of five patients developing grade 4 neutropenia."( Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer.
Calabrese, P; Caporusso, L; Catino, A; Crucitta, E; D'Amico, C; De Lena, M; Guida, M; Latorre, A; Lorusso, V; Mazzei, A; Sambiasi, D; Schittulli, F; Silvestris, N, 2003
)
0.85
"The dose-response curves obtained with the SRB assay and the CA were very similar up to 6 Gy."( Comparison of the sulforhodamine B assay and the clonogenic assay for in vitro chemoradiation studies.
Baay, MF; de Pooter, CM; Korst, AE; Lambrechts, HA; Lardon, F; Pattyn, GG; Pauwels, B; Vermorken, JB, 2003
)
0.32
" Dose-limiting toxicities were thrombocytopenia and liver failure, and with repeated dosing neutropenia was commonly observed."( Phase I trial of fixed dose-rate gemcitabine in combination with carboplatin in chemonaive advanced non-small-cell lung cancer: a Cancer Therapeutics Research Group study.
Goh, BC; Lee, HS; Lee, SC; Lehnert, M; Lim, HL; Millward, MJ; Soo, RA; Tok, LT; Wang, LZ, 2003
)
0.6
" In subsequent cohorts, the weekly dosing frequency of gemcitabine was increased until weekly administration was reached."( A Phase I study of gemcitabine with concurrent radiotherapy in stage III, locally advanced non-small cell lung cancer.
Gregor, A; Groen, HJ; Little, FA; Price, A; van der Leest, AH; van Putten, JW, 2003
)
0.89
" Among the newer agents available for the experimental treatment arms, three stood out-gemcitabine, polyethylene-glycol (PEG)-liposomal doxorubicin, and topotecan-based on evidence of their activity demonstrated in previous phase I and II trials and, with appropriate dosage modifications, manageable toxicity when used in combination with platinum."( Clinical trials of newer regimens for treating ovarian cancer: the rationale for Gynecologic Oncology Group Protocol GOG 182-ICON5.
Bookman, M; Copeland, LJ; Trimble, E, 2003
)
0.54
" The exact dosing and different mechanism of action of gemcitabine make it attractive for these combinations."( Gemcitabine combination chemotherapy of ovarian cancer.
Mutch, DG, 2003
)
2.01
" Clinical trials that include pharmacokinetic and pharmacodynamic studies may be the most efficient way to optimize the therapeutic efficacy of ifosfamide and define the dosing and scheduling."( Antiblastic drug combinations with ifosfamide: an update.
Badalamenti, G; Fulfaro, F; Gebbia, N; Russo, A; Valerio, MR, 2003
)
0.32
"The antitumor effect of gemcitabine is not dose-response related but schedule dependent."( Phase II trial of a 24-hour infusion of gemcitabine in previously untreated patients with advanced pancreatic adenocarcinoma.
Eckel, F; Erdmann, J; Lersch, C; Mayr, M; Schmelz, R, 2003
)
0.89
"The purpose was to determine the optimal multifractionated (MF) dosing schedule to permit the delivery of four active agents in nonsmall cell lung cancer simultaneously in alternating doublets (docetaxel-cisplatin alternating with gemcitabine-vinorelbine)."( Alternating doublets: establishing the optimal multifractionated dosing schedule to administer docetaxel, cisplatin, gemcitabine, and vinorelbine in combination.
Anderson, N; Coco, F; Lokich, J, 2003
)
0.71
" Administration of more than 2 courses was attempted for each patient, with the same dosage levels at all 3 scheduled steps."( [Phase I study of gemcitabine (GEM) and UFT combination chemotherapy for unresectable/recurrent pancreatic cancer].
Dono, K; Maruhashi, S; Miyamoto, A; Monden, M; Nagano, H; Nakamori, S; Sakon, M; Takahashi, Y; Tujie, M; Umeshita, K, 2004
)
0.66
" This phase I trial aimed to determine the dose-limiting toxicity (DLT), maximum tolerated dose [maximum tolerated dosage (MTD)], and recommended dose (RD) of a GIP combination in patients with advanced/metastatic NSCLC."( Phase I study with dose escalation of gemcitabine and cisplatin in combination with ifosfamide (GIP) in patients with non-small-cell lung carcinoma.
Billiart, I; Bourgeois, H; Chabrun, V; Chieze, S; Daban, A; Ferrand, V; Germain, T; Lemerre, D; Meurice, JC; Tourani, JM, 2004
)
0.59
"4%) of the 110 cycles following dosage reduction (P = ."( Paclitaxel and gemcitabine as salvage treatment in metastatic breast cancer.
Murad, AM, 2003
)
0.67
"This study utilized MiaPaCa pancreatic xenografts to demonstrate irofulven antitumor activity using either a daily or intermittent dosing schedule."( Activity of irofulven against human pancreatic carcinoma cell lines in vitro and in vivo.
MacDonald, JR; Roth, S; Van Laar, ES; Waters, SJ; Weitman, S,
)
0.13
"Both dosing regimens of irofulven demonstrated curative activity against the MiaPaCa xenografts."( Activity of irofulven against human pancreatic carcinoma cell lines in vitro and in vivo.
MacDonald, JR; Roth, S; Van Laar, ES; Waters, SJ; Weitman, S,
)
0.13
"These results support further clinical characterization of intermittent irofulven dosing schedules and suggest that irofulven combined with gemcitabine may have activity in patients with pancreatic tumors."( Activity of irofulven against human pancreatic carcinoma cell lines in vitro and in vivo.
MacDonald, JR; Roth, S; Van Laar, ES; Waters, SJ; Weitman, S,
)
0.33
"We hypothesized that the shape of a dose-response curve would be determined by the major mechanisms of resistance of a cancer to the drug being studied."( Phase II study of alternating chemotherapy regimens for advanced non-small cell lung cancer.
MacLeod, P; Maziak, DE; Shamji, FM; Stewart, DJ; Tomiak, E, 2004
)
0.32
" Animals were inspected daily for signs of toxicity and distress, body weight changes, and water and food consumption; electrocardiogram, blood pressure, and urinalysis were recorded before dosing and after 4 and 8 weeks of treatment."( Experimental study on the toxicity and the local and systemic tolerability of gemcitabine after topical treatment of the rabbit bladder.
Clementi, G; Costantino, G; Lempereur, L; Matera, M; Vasquez, E; Vasta, D, 2004
)
0.55
" Although there was a differential dose-response rate among dose levels, increasing the gemcitabine dose beyond 2200mg/m2 did not show increased clinical response."( Phase I study of gemcitabine given weekly as a short infusion for non-small cell lung cancer: results and possible immune system-related mechanisms.
Ferson, PF; Friberg, D; Gooding, WE; Kassem, B; Keenan, R; Landreneau, RJ; Levitt, ML; Lindberg, CA; Miketic, LM; Ponas, RS; Sabatine, JM; Tarasoff, P; Trenn, MR; Whiteside, TL; Yousem, SA, 2004
)
0.89
" Additional phase II trials have focused on optimizing dosing and schedule schemas with the demonstration of impressive efficacy with acceptable toxicity with the biweekly administration."( Gemcitabine and docetaxel in metastatic and neoadjuvant treatment of breast cancer.
Yardley, DA, 2004
)
1.77
" Although the study exhibited a high response rate, the neuropathy encountered in the study, and the need to eliminate gemcitabine in 54% of the patients due to bone marrow suppression merits further investigation of the dosing schedule."( Pilot study of outpatient paclitaxel, carboplatin and gemcitabine for advanced stage epithelial ovarian, peritoneal, and fallopian tube cancer.
Birk, CL; Brown, JV; Goldstein, BH; Graham, C; Mattison, J; Micha, JP; Rettenmaier, MA, 2004
)
0.78
"Treatment consisted of six courses of chemotherapy with gemcitabine at a dosage of 1,200 mg/m2 on days 1 and 8, every 21 days."( Single-agent gemcitabine in previously untreated elderly patients with advanced bladder carcinoma: response to treatment and correlation with the comprehensive geriatric assessment.
Bertetto, O; Botta, M; Castagneto, B; Ferraris, V; Marenco, D; Mencoboni, M; Repetto, L; Scaltriti, L; Zai, S, 2004
)
0.94
" The use of such combinations requires smart planning and choice of the drugs to be combined, their proper dosing as well as correct sequence and schedule of application."( Targeting metastatic leiomyosarcoma by rapamycin plus gemcitabine: an intriguing clinical observation.
Merimsky, O, 2004
)
0.57
" The initial dosage of gemcitabine was 800 mg/m(2) weekly times three with 1 week off until progressive disease or adverse side effects prohibited further therapy."( Evaluation of gemcitabine in previously treated patients with non-squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group.
Blessing, J; Cohn, DE; Schilder, RJ, 2005
)
1
" The aim of this study was to determine the maximally tolerable dosage of gemcitabine and docetaxel using a weekly administration regimen."( Phase I trial using weekly administration of gemcitabine and docetaxel in patients with advanced pancreatic carcinoma.
Hribaschek, A; Lippert, H; Lueck, A; Meyer, F; Ridwelski, K, 2004
)
0.81
"Thirty-two patients with metastatic NPC were treated with combination chemotherapy that included paclitaxel 70 mg/m(2) on Days 1 and 8, carboplatin dosed to area under curve of 5 on Day 1, and gemcitabine 1000 mg/m(2) on Days 1 and 8 every 21 days for a maximum of 8 cycles."( Paclitaxel, carboplatin, and gemcitabine in metastatic nasopharyngeal carcinoma: a Phase II trial using a triplet combination.
Foo, KF; Leong, SS; Lim, WT; Tan, EH; Tan, SB; Tan, T; Tay, MH; Thng, CH; Toh, CK; Wee, J, 2005
)
0.81
"Antiangiogenic therapy shows significant anti-tumor and anti-metastatic effects, and is helpful to reduce the dosage of cytotoxic drugs and the side effects."( Antiangiogenic therapy for human pancreatic carcinoma xenografts in nude mice.
Huang, WG; Jia, L; Yuan, SZ; Zhang, MH, 2005
)
0.33
" Eighty-five patients affected by advanced TCC and measurable disease were randomized to receive either paclitaxel at dosage of 70 mg/m2, gemcitabine 1000 mg/m2 and cisplatin 35 mg/m2 on days 1 and 8 every 3 weeks (GCP) or gemcitabine 1000 mg/m2 on days 1, 8, 15 and cisplatin 70 mg/m2 on day 2 every 4 weeks (GC)."( Randomised, open-label, phase II trial of paclitaxel, gemcitabine and cisplatin versus gemcitabine and cisplatin as first-line chemotherapy in advanced transitional cell carcinoma of the urothelium.
Comella, P; Crucitta, E; De Lena, M; Gebbia, V; Lorusso, V; Mancarella, S; Mangiameli, A; Manzione, L; Muci, D; Palmeri, S; Pezzella, G; Rosati, G; Silvestris, N; Sobrero, A, 2005
)
0.78
" Preclinical data have suggested a possible dose-response relationship of gemcitabine."( Increased dose-intensity of gemcitabine in advanced non small cell lung cancer (NSCLC): a multicenter phase II study in elderly patients from the "polmone toscano group" (POLTO).
Bernardini, I; Chioni, A; Conte, PF; Fabbri, A; Falcone, A; Ferrari, K; Galli, L; Grosso, AM; Innocenti, F; Orlandini, C; Pegna, AL; Ricci, S; Russo, F; Tibaldi, C; Tognarini, L, 2005
)
0.85
" Dose-response regression lines were used to compare the individual susceptibilities to gemcitabine with respect to the chromosome aberration and sister-chromatid exchange frequencies."( In vitro genotoxic effects of the anticancer drug gemcitabine in human lymphocytes.
Aydemir, N; Bilaloğlu, R; Celikler, S, 2005
)
0.8
" Intraperitoneal GCB administration at similar dosage had no effect on lung metastases."( Aerosol gemcitabine inhibits the growth of primary osteosarcoma and osteosarcoma lung metastases.
Kleinerman, ES; Koshkina, NV, 2005
)
0.76
"Gemcitabine as a single agent, in this dosage and schedule, has minimal clinical activity in relapsed or refractory low-grade lymphomas and was associated with considerable toxicity."( A phase II study of gemcitabine in patients with relapsed or refractory low-grade non-Hodgkin lymphoma.
Larson, BJ; Lynch, JW; Mendenhall, NP; Pusateri, A; Waples, JM, 2005
)
2.09
" Gemcitabine dosing produced least body weight loss and least neutropenia after injection at 11 vs 23 HALO, whether the drug was given alone or with cisplatin (P=0."( Preclinical relevance of dosing time for the therapeutic index of gemcitabine-cisplatin.
Filipski, E; Focan, C; Kayitalire, L; Lévi, F; Li, XM; Sun, J; Tanaka, K, 2005
)
1.48
" However the results of this study did not show expected treatment efficacy and we raise the idea of cisplatin dosage relevance in this combination."( Gemcitabine plus cisplatine and paclitaxel (GCP) in second-line treatment of germ cell tumors (GCT): a phase II study.
Hlavatá, Z; Koza, I; Mardiak, J; Mego, M; Obertová, J; Recková, M; Sálek, T; Sycová-Milá, Z, 2005
)
1.77
" Untoward side-effects were moderate, reversible and, therefore, did not require dosage to be corrected or cut down."( [Gemcitabine plus cisplatin therapy in breast cancer refractory to anthracyclines, docetaxel and capecitabine].
Filatova, LV; Gershanovich, ML; Semiglazova, TIu, 2005
)
1.24
" Study of genomic DNA showed 12-fold increase in R1 gene dosage in MCF7 1K cells."( Increased expression of the large subunit of ribonucleotide reductase is involved in resistance to gemcitabine in human mammary adenocarcinoma cells.
Dumontet, C; Galmarini, CM; Guittet, O; Jordheim, LP; Lepoivre, M, 2005
)
0.55
" We present a concise review of cancer chemotherapy dosing in the setting of liver dysfunction."( Chemotherapy dosing in the setting of liver dysfunction.
Eklund, JW; Mulcahy, MF; Trifilio, S, 2005
)
0.33
" Gemcitabine was administered as a 30-minutes infusion at a dosage of 1 g/m2 on day 1, 8 and 15 every 4 weeks."( An open label, non-comparative phase II study of gemcitabine as salvage treatment for patients with pretreated adult type soft tissue sarcoma.
Azemar, M; Bokemeyer, C; Hartmann, JT; Horger, M; Huober, J; Jakob, A; Kanz, L; Oechsle, K, 2006
)
1.5
" A single dose seemed ineffective, and the multiple dosing regimens seemed effective."( Randomized phase II marker lesion study evaluating effect of scheduling on response to intravesical gemcitabine in recurrent Stage Ta urothelial cell carcinoma of the bladder.
Beckman, E; Carringer, M; Gårdmark, T; Malmström, PU, 2005
)
0.54
" With G-CSF support, all except 2 patients were administered as per schedule, and the TXT dosage in 2 patients was reduced."( [Phase II study of gemcitabine (GEM) and docetaxel (TXT) combination chemotherapy for unresectable non small cell lung cancer].
Kuramoto, K; Terao, I, 2005
)
0.66
" In single and multiple dosing experiments, mice received ZD6126, gemcitabine, a combination of both agents, or no treatment."( Vascular targeting in pancreatic cancer: the novel tubulin-binding agent ZD6126 reveals antitumor activity in primary and metastatic tumor models.
Barge, A; Bruns, CJ; Friedrich, M; Jauch, KW; Kleespies, A; Köhl, G; Ryan, AJ, 2005
)
0.57
"Gemcitabine-resistant pancreatic cancer cell strain SW1990/GZ was induced by increasing drug dosage intermittently, then the changes of its biological features and the activity of TrxR were examined."( [Drug resistance and activity changes of thioredoxin reductase in pancreatic cancer cells strain SW1990 induced by gemcitabine].
Chen, G; Li, LJ; Niu, BZ; Wu, YD; Zhao, YP, 2005
)
1.98
"This article describes a woman with metastatic upper gastrointestinal cancer who developed thoracic myelopathy unexpectedly after standard dosage and fractionation radiotherapy."( Myelopathy after radiation therapy and chemotherapy with capecitabine and gemcitabine.
Barstis, JL; Black, AC, 2005
)
0.56
"We performed intraperitoneal and intrapleural dosing gemcitabine (GEM) to eight patients with advanced pancreatic cancer having peritoneal or pleural carcinomatosis and evaluated its actions and safety."( [Intraperitoneal and intrapleural gemcitabine in patients with advanced pancreatic cancer].
Akiyama, T; Hirata, K; Homma, H; Kogawa, K; Koike, K; Mezawa, S; Takahashi, S, 2005
)
0.86
" Most patients were switched to an every-other-week dosing schedule."( Phase II study of fixed dose rate gemcitabine with cisplatin for metastatic adenocarcinoma of the pancreas.
Bergsland, EK; Dito, E; Ko, AH; Schillinger, B; Tempero, MA; Venook, AP, 2006
)
0.61
" Emphasis was on the use of very low doses of each drug and of different dosing schedules."( Preclinical in vivo activity of a combination gemcitabine/liposomal doxorubicin against cisplatin-resistant human ovarian cancer (A2780/CDDP).
Apollonio, P; Ferlini, C; Fruscella, E; Gallo, D; Mancuso, S; Scambia, G,
)
0.39
" Dosage reduction was performed for cytopenias and/or other grade 3 or 4 toxicity."( Phase II trial of gemcitabine as first line chemotherapy in patients with metastatic or unresectable soft tissue sarcoma.
Borden, EC; Karen, A; Mills, GM; Rankin, C; Von Burton, G; Zalupski, MM, 2006
)
0.67
" Daily dosing of imatinib with concurrent administration of cytotoxic chemotherapy (either gemcitabine or doxorubicin) at standard doses was associated with toxicity that was clinically unacceptable."( Selective kinase inhibition with daily imatinib intensifies toxicity of chemotherapy in patients with solid tumours.
Appleman, LJ; Demetri, GD; Desai, J; George, S; Manola, J; Paul Eder, J; Ryan, DP, 2006
)
0.55
" These data can be used to rationally design gemcitabine dosage regimes for canine oncology patients and as a basis for future investigations on the in vivo intracellular accumulation of gemcitabine triphosphate in dogs."( Pharmacokinetics of gemcitabine and its primary metabolite in dogs after intravenous bolus dosing and its in vitro pharmacodynamics.
Freise, KJ; Martín-Jiménez, T, 2006
)
0.92
" 5-fluoruracil 750 mg sq m(-1), leucovorin 75 mg sq m(-1), epirubicin 45 mg sq m(-1), carboplatin 225 mg sq m(-1) were administered every 3 weeks into celiac axis for three cycles (FLEC regimen), then gemcitabine at the dosage of 1 g sq m(-1) on days 1, 8 and 15 every 4 weeks for 3 months (FLECG regimen)."( Adjuvant intra-arterial 5-fluoruracil, leucovorin, epirubicin and carboplatin with or without systemic gemcitabine after curative resection for pancreatic adenocarcinoma.
Cantore, M; Capelli, P; Fiorentini, G; Iacono, C; Lombardi, M; Mambrini, A; Pacetti, P; Pagani, M; Pederzoli, P; Pulica, C; Serio, G; Torri, T, 2006
)
0.74
" The dose intensity of gemcitabine of the 35 patients with 5-FU dosage set at MTD was 593 mg/m2 per week."( Phase I-II trial of weekly gemcitabine plus high-dose 5-fluorouracil and leucovorin in advanced pancreatic cancer.
Chang, JY; Chao, Y; Chen, LT; Cheng, AL; Chuang, TR; Hsu, C; Hsu, CH; Jan, CM; Liu, TW; Shiah, HS; Whang-Peng, J; Yu, WL, 2006
)
0.94
" Fixed dose rate gemcitabine is active and feasible, supporting the concept of fixed dosing rate of gemcitabine in advanced NSCLC."( A multicentre randomised phase II study of carboplatin in combination with gemcitabine at standard rate or fixed dose rate infusion in patients with advanced stage non-small-cell lung cancer.
Beale, P; Boyer, M; Goh, BC; Lee, HS; Lee, SC; Liang, S; Lim, HL; Millward, M; Soo, RA; Tham, LS; Wang, LZ; Yong, WP, 2006
)
0.9
" Growth inhibition assays were conducted in each cell line evaluating combinations of the Ic25, Ic50, and Ic90 to determine optimal dosing for the combination of gemcitabine plus cisplatin."( Determination of the mechanism of gemcitabine modulation of cisplatin drug resistance in panel of human endometrial cancer cell lines.
Brown, J; Gaikwad, A; Ramondetta, LM; Smith, JA; Wolf, JK, 2006
)
0.81
" The purpose of the study was to determine the optimal dosage and the maximal tolerated dose (MTD) of a specified schedule of gemcitabine and ifosfamide."( Dose-finding study of fixed dose gemcitabine and escalating doses of ifosfamide given on days 1 and 8 in patients with advanced non-small cell lung cancer.
Aschroft, L; Baka, S; Blackhall, F; Buchholz, E; Lorigan, P; Manegold, C; Nagel, S; Schott-von-Römer, K; Thatcher, N, 2006
)
0.82
" Divided dose of cisplatin combined with gemcitabine, at the current dosage and schedule, appears to be an active regimen in chemotherapy-naïve patients with malignant mesothelioma, and well-tolerated."( Divided dose of cisplatin combined with gemcitabine in malignant mesothelioma.
Akbulut, H; Büyükçelik, A; Demirkazik, A; Dinçol, D; Gören, D; Içli, F; Mousa, U; Onur, H; Senler, FC; Utkan, G; Yalçin, B, 2006
)
0.87
" We thus conducted a phase I/II study of gemcitabine and infusional 5-FU in Japanese patients to determine a recommended dosage for this combination and clarify efficacy and toxicity."( A phase I/II study of combination chemotherapy with gemcitabine and 5-fluorouracil for advanced pancreatic cancer.
Funakoshi, A; Furuse, J; Ishii, H; Okusaka, T; Sumii, T; Ueno, H, 2006
)
0.85
" Results from phase I determined the recommended dosage to be examined in phase II for effect on survival period, clinical benefit response (CBR), tumor response and safety."( A phase I/II study of combination chemotherapy with gemcitabine and 5-fluorouracil for advanced pancreatic cancer.
Funakoshi, A; Furuse, J; Ishii, H; Okusaka, T; Sumii, T; Ueno, H, 2006
)
0.58
" Dose limiting toxicities in phase I determined the recommended 5-FU dosage at 400 mg/m(2)/day."( A phase I/II study of combination chemotherapy with gemcitabine and 5-fluorouracil for advanced pancreatic cancer.
Funakoshi, A; Furuse, J; Ishii, H; Okusaka, T; Sumii, T; Ueno, H, 2006
)
0.58
" These indications of an antagonistic interaction between GEM and 5-FU in some pancreatic cancer context urge further investigation of both genetic and non-genetic differences to identify the variables most relevant for optimal selection and dosing of treatment for the individual patient."( Antagonistic interactions between gemcitabine and 5-fluorouracil in the human pancreatic carcinoma cell line Capan-2.
Bellone, G; Bertetto, O; Buffolino, A; Busso, V; Carbone, A; Emanuelli, G; Novarino, A; Scirelli, T; Smirne, C; Tosetti, L, 2006
)
0.61
" Gemcitabine alone was dosed at 1,000 mg/m2 up to 7 weeks in the first cycle, then once a week for the first 3 weeks of a 4-week cycle."( Randomized phase III study of exatecan and gemcitabine compared with gemcitabine alone in untreated advanced pancreatic cancer.
Abou-Alfa, GK; Ackerman, J; De Jager, RL; Eckhardt, SG; Feit, K; Harker, G; Hurwitz, H; Letourneau, R; Modiano, M; O'Reilly, EM; Tchekmedyian, NS, 2006
)
1.51
" Due to the dosage for carboplatin by AUC an adaptation to the glomerular filtration rate is possible."( [Gemcitabine and carboplatin chemotherapy in advanced transitional cell carcinoma in regard to patients with impaired renal function].
Helke, C; Hoschke, B; May, M, 2006
)
1.24
"Gemcitabine and paclitaxel (Taxol) each provides an efficacious non-platinum option for the treatment of advanced non-small-cell lung cancer (NSCLC), but the optimal dosage and schedule of the two agents used in combination are not well defined."( Randomized phase II trial of gemcitabine plus weekly versus three-weekly paclitaxel in previously untreated advanced non-small-cell lung cancer.
Belani, CP; Clark, RH; Dakhil, S; Desch, CE; Monberg, MJ; Obasaju, CK; Rooney, DK; Waterhouse, DM; Ye, Z, 2007
)
2.07
" Pharmacokinetic data for 24 h after dosing were obtained for both day 1 (gemcitabine without oxaliplatin coadministration) and day 8 (gemcitabine with oxaliplatin) during the first cycle of treatment."( Coadministration of oxaliplatin does not influence the pharmacokinetics of gemcitabine.
Georgoulias, V; Marselos, M; Mavroudis, D; Nikolaidou, M; Pappas, P, 2006
)
0.79
"Firstly, the maximum tolerated dose (MTD) of gemcitabine was determined, when administered intraperitoneally at two different dosing schedules (0."( Combination therapy using gemcitabine and radioimmunotherapy in nude mice with small peritoneal metastases of colonic origin.
Bleichrodt, RP; Boerman, OC; Goldenberg, DM; Koppe, MJ; Oyen, WJ; Verhofstad, AA, 2006
)
0.89
" The GEM dosage was decreased to 800 mg/m2 after the initial 21 patients because 3 patients developed interstitial lung disease (ILD)."( Phase II trial of gemcitabine and docetaxel in patients with completely resected stage IIA-IIIA non-small-cell lung cancer.
Eguchi, K; Hada, E; Izumi, Y; Kawamura, M; Kobayashi, K; Koike, T; Sakaguchi, H; Yamato, Y, 2007
)
0.67
" In the escalating phase of the trial, patients were enrolled in sequential cohorts using 100 or 150 mg oral daily dosing of erlotinib."( Erlotinib plus gemcitabine in patients with unresectable pancreatic cancer and other solid tumors: phase IB trial.
Dragovich, T; Hage, G; Hamilton, M; Huberman, M; Nadler, P; Patnaik, A; Rowinsky, EK; Von Hoff, DD; Wolf, J; Wood, D, 2007
)
0.69
" Consequently gemcitabine dosage was reduced at the second treatment in 8 of 21 dogs or a dose delay of 1-7 days and a reduction of dosage was used in 7 of 21 dogs."( Single agent gemcitabine chemotherapy in dogs with spontaneously occurring lymphoma.
Cosgrove, SB; Gamblin, RM; Griffice, K; Hahn, KA; Khanna, C; Rusk, A; Turner, AI,
)
0.86
" administration of gemcitabine is tolerated within the tested dosage range."( Phase I trial of intraperitoneal gemcitabine in the treatment of advanced malignancies primarily confined to the peritoneal cavity.
Chow, W; Chu, D; Doroshow, JH; Frankel, P; Koczywas, M; Leong, L; Lim, D; Lin, P; Margolin, K; Morgan, RJ; Paz, B; Schwarz, RE; Shibata, S; Somlo, G; Stalter, S; Synold, TW; Tetef, M; Twardowski, P; Wagman, L; Xi, B; Yen, Y, 2007
)
0.95
" Dosing schedule was modified for toxicity (doses constant but administered on Days 1 and 15 of a 28-day cycle)."( Gemcitabine and vinorelbine combination chemotherapy for patients with advanced soft tissue sarcomas: results of a phase II trial.
Demetri, GD; Desai, J; Dileo, P; George, S; Harmon, DC; Morgan, JA; Polson, K; Quigley, MT; Salesi, JM; Zahrieh, D, 2007
)
1.78
"The study accrued 40 patients, and 248 dosing cycles were administered (range, 1-32)."( Gemcitabine and vinorelbine combination chemotherapy for patients with advanced soft tissue sarcomas: results of a phase II trial.
Demetri, GD; Desai, J; Dileo, P; George, S; Harmon, DC; Morgan, JA; Polson, K; Quigley, MT; Salesi, JM; Zahrieh, D, 2007
)
1.78
"Chemonaive patients with stage IIIB/IV NSCLC and an Eastern Cooperative Oncology Group performance status of 0 to 2 received either 500 mg/m2 of pemetrexed (day 1, every 3 weeks) for eight cycles, or the same dosage of pemetrexed for cycles 1 and 2 and then 1200 mg/m2 of gemcitabine (days 1 and 8, every 3 weeks) for cycles 3 and 4 (repeated once for a total of eight cycles)."( Single-agent pemetrexed or sequential pemetrexed/gemcitabine as front-line treatment of advanced non-small cell lung cancer in elderly patients or patients ineligible for platinum-based chemotherapy: a multicenter, randomized, phase II trial.
Caffo, O; Favaretto, A; Gregorc, V; Gridelli, C; Kaukel, E; Manegold, C; Martoni, A; Migliorino, MR; Müller, TR; Muñoz, M; Peterson, P; Reck, M; Rossi, A; Russo, F; Schmittel, A, 2007
)
0.77
" Tolerability for this drug is best following dosing at ZT 11 in mice."( Circadian physiology is a toxicity target of the anticancer drug gemcitabine in mice.
Lévi, F; Li, XM, 2007
)
0.58
" A sensitive analytical method for the quantitation of gemcitabine is required for the assessment of alternative dosage and treatment schemes."( Rapid determination of gemcitabine in plasma and serum using reversed-phase HPLC.
Cerny, T; Früh, M; Lanz, C; Lauterburg, BH; Thormann, W, 2007
)
0.9
" Another goal was to find the optimal individual schedule by adjusting frequency and dosage according to patient tolerability."( Low dose gemcitabine plus cisplatin in a weekly-based regimen as salvage therapy for relapsed breast cancer after taxane-anthracycline-containing regimens.
Alés-Martínez, JE; Aramburo González, PM; Sánchez-Escribano Morcuende, R, 2007
)
0.76
" The results were evaluated by two-way analysis of variance followed by post-hoc tests, and nonlinear regression analysis for dose-response rates."( Everolimus and mycophenolate mofetil sensitize human pancreatic cancer cells to gemcitabine in vitro: a novel adjunct to standard chemotherapy?
Dillmann, S; Henne-Bruns, D; Keller, F; Klug, F; Mayer, JM; Stracke, S; Tuncyurek, P, 2007
)
0.57
" In addition to reassurance, pregabalin was prescribed for these myotonic symptoms at a dosage of 50 mg by mouth three times daily."( Successful amelioration of oxaliplatin-induced hyperexcitability syndrome with the antiepileptic pregabalin in a patient with pancreatic cancer.
Hashmi, S; Saif, MW, 2008
)
0.35
"The addition of intermittently dosed IM to GEM at low to full dose was associated with broad antitumor activity and little increase in toxicity."( Phase I and pharmacokinetic study of imatinib mesylate (Gleevec) and gemcitabine in patients with refractory solid tumors.
Ali, Y; Egorin, MJ; Gharibo, MM; Gounder, MK; Lagattuta, TF; Lin, Y; Poplin, EA; Rubin, EH; Stein, MN, 2007
)
0.57
" Gemcitabine is an anticancer drug which is metabolized to a number of metabolites, administered using different dosing regimens and increasingly used in combination with oxaliplatin."( Population pharmacokinetics of gemcitabine and its metabolite in patients with cancer: effect of oxaliplatin and infusion rate.
Galettis, P; Jiang, X; Links, M; McLachlan, AJ; Mitchell, PL, 2008
)
1.54
" The most common reason for reduction of the dosage or for cycle delay in the combined scheme was neutropenia."( Feasibility and efficacy of chemotherapy with gemcitabine mono and with paclitaxel/mitoxantron in gynaecological cancers.
Cordes, T; Fischer, D; Friedrich, M; Lüdders, D; Maass, N; Schroer, A; Villena-Heinsen, C, 2007
)
0.6
" The trial protocol was changed by reducing the cisplatin dosage to 20 mg/m(2)."( Weekly gemcitabine and cisplatin concurrent with pelvic irradiation for primary therapy of cervical cancer: report of the first seven cases in Thai women.
Chumworathayi, B; Krusun, S; Luanratanakorn, S; Pattamadilok, J; Tangvorapongchai, V; Yuenyao, P, 2007
)
0.79
" We designed a dosing schema that used multiple sequential exchanges of a peritoneal dialysate containing dFdC in an effort to produce prolonged IP dFdC exposure."( Intraperitoneal gemcitabine pharmacokinetics: a pilot and pharmacokinetic study in patients with advanced adenocarcinoma of the pancreas.
Alexander, HR; Bartlett, DL; Dedrick, RL; Egorin, MJ; Gamblin, TC; Herscher, LL; Lagattuta, TF; Libutti, SK; Russo, A; Zuhowski, EG, 2008
)
0.69
" The observed self-induction of gemcitabine metabolism has broad implications for the dosing of nucleoside analogs."( Randomized crossover study evaluating the effect of gemcitabine infusion dose rate: evidence of auto-induction of gemcitabine accumulation.
de Souza, PL; Galettis, P; Grimison, P; Jelinek, M; Liauw, W; Links, MJ; Manners, S; Metharom, E, 2007
)
0.87
" In conclusion, gemcitabine and cisplatin combination therapy with this biweekly schedule and dosage is moderately active and extremely safe in patients with metastatic breast cancer previously treated with anthracycline and taxanes."( Biweekly administration of gemcitabine and cisplatin chemotherapy in patients with anthracycline and taxane-pretreated metastatic breast cancer.
Aydiner, A; Camlica, H; Derin, D; Guney, N; Tas, F; Topuz, E, 2008
)
0.99
" Although select patients may benefit from treatment, the overall risk:benefit ratio is unfavorable, and other dosing regimens and therapeutic options should be explored in this setting."( Excess toxicity associated with docetaxel and irinotecan in patients with metastatic, gemcitabine-refractory pancreatic cancer: results of a phase II study.
Bergsland, EK; Dito, E; Ko, AH; Schillinger, B; Tempero, MA; Venook, AP, 2008
)
0.57
" In the event of progressive disease, the dosage was increased for subsequent cycles."( [Irinotecan plus gemcitabine(IRINOGEM)in the treatment of biliary malignancies].
Hatakeyama, K; Muneoka, K; Sakata, J; Sasaki, M; Shirai, Y; Toshima, M; Wakai, T, 2008
)
0.69
"We show here that, consistent with our previous in vitro studies, gemcitabine inhibited tumor growth, whereas pemetrexed was ineffective, even at the highest dosage tested."( Imatinib mesylate enhances therapeutic effects of gemcitabine in human malignant mesothelioma xenografts.
Bertino, P; Cilli, M; Favoni, R; Gaudino, G; Mutti, L; Piccardi, F; Porta, C, 2008
)
0.84
" At level 1, 4/6 patients experienced DLTs; dosing decreased to level 0 and 4/5 patients experienced DLTs."( Phase I study of a 3-drug regimen of gemcitabine/cisplatin/pemetrexed in patients with metastatic transitional cell carcinoma of the urothelium.
Atienza, D; Awasthi, S; Berry, W; Delaune, R; Deutsch, M; Dien, PY; Gregory, TF; Hood, K; Hutson, TE; Ilegbodu, D; Kolodziej, MJ; Mull, S; Muscato, JJ; Nicol, S; Raju, RN; Ruxer, RL; Vukelja, S, 2008
)
0.62
" However, a 4- to 5-day spaced dosing schedule (injections on day 0, 4, 8, and 13) was proved to be safer in terms of weight loss and hematological and other toxicity."( Preclinical toxicology (subacute and acute) and efficacy of a new squalenoyl gemcitabine anticancer nanomedicine.
Couvreur, P; Desmaële, D; Dubernet, C; Marque, PE; Mouelhi, SL; Reddy, LH, 2008
)
0.57
" Three alternate dosing sequences were used during cycle 1 to examine dynamic changes in molecular profiles."( A phase II study of sequential neoadjuvant gemcitabine plus doxorubicin followed by gemcitabine plus cisplatin in patients with operable breast cancer: prediction of response using molecular profiling.
Awasthy, B; Chacko, RT; Dawar, R; Dhindsa, N; Hu, Z; Julka, PK; Koppiker, CB; Lin, B; Ma, D; Miller, ID; Nag, S; Nair, A; Nair, S; Oh, DS; Parshad, R; Perou, CM, 2008
)
0.61
" dFdC, and peripheral blood mononuclear cells were collected 7qdx1d dosing of dFdC."( Extensive metabolism and hepatic accumulation of gemcitabine after multiple oral and intravenous administration in mice.
Beijnen, JH; Pluim, D; Schellens, JH; van Tellingen, O; Veltkamp, SA, 2008
)
0.6
" In addition to standard threeweekly dosing regimens, alternative schedules of administration of taxanes and gemcitabine doublets (weekly, twoweekly) might deserve further investigation due to their potential usefulness in reducing pharmacological toxicity while maintaining or increasing dose-intensity and clinical efficacy."( Taxanes and gemcitabine doublets in the management of HER-2 negative metastatic breast cancer: towards optimization of association and schedule.
Carlini, P; Cognetti, F; De Laurentiis, M; Fabi, A; Felici, A; Ferretti, G; Graziano, V; Introna, M; Metro, G; Nuzzo, C; Papaldo, P; Pellegrini, D; Russillo, M; Vici, P,
)
0.72
" In patients with abnormal renal function, dosage adjustment is often required to improve the renal tolerance, and also to limit the risk of extra-renal toxicities (such as haematological toxicities) induced by a drug overdosage, in those patients with reduced drug-elimination."( [Chemotherapy and renal toxicity].
Deray, G; Isnard-Bagnis, C; Janus, N; Karie, S; Launay-Vacher, V, 2008
)
0.35
" Patients received one of two dosing schemes: (a) once daily dosing for 14 days of a 21-day cycle or (b) every other day dosing for 21 days of a 28-day cycle."( Oral administration of gemcitabine in patients with refractory tumors: a clinical and pharmacologic study.
Andre, VA; Beijnen, JH; Callies, S; Jansen, RS; Kloeker-Rhoades, S; Pluim, D; Rosing, H; Schellens, JH; Slapak, CA; Veltkamp, SA; Visseren-Grul, CM, 2008
)
0.66
" We investigated the ability of THU to decrease elimination and first-pass effect by CD, thereby enabling oral dosing of dFdC."( Modulation of gemcitabine (2',2'-difluoro-2'-deoxycytidine) pharmacokinetics, metabolism, and bioavailability in mice by 3,4,5,6-tetrahydrouridine.
Beumer, JH; Covey, JM; Egorin, MJ; Eiseman, JL; Joseph, E; Parise, RA, 2008
)
0.71
"Coadministration of THU enables oral dosing of dFdC and warrants clinical testing."( Modulation of gemcitabine (2',2'-difluoro-2'-deoxycytidine) pharmacokinetics, metabolism, and bioavailability in mice by 3,4,5,6-tetrahydrouridine.
Beumer, JH; Covey, JM; Egorin, MJ; Eiseman, JL; Joseph, E; Parise, RA, 2008
)
0.71
"Single-agent PPX, dosed at 175 mg/m, is active and well tolerated in PS 2 patients with advanced NSCLC."( Randomized phase III trial comparing single-agent paclitaxel Poliglumex (CT-2103, PPX) with single-agent gemcitabine or vinorelbine for the treatment of PS 2 patients with chemotherapy-naïve advanced non-small cell lung cancer.
Bandstra, B; Bilynsky, BT; Bondarenko, IN; Eisenfeld, AJ; Ganul, VL; Hotko, YS; Kostinsky, IY; O'Brien, ME; Oldham, FB; Popovich, AY; Sandalic, L; Sandler, AB; Singer, JW; Socinski, MA; Tomova, A, 2008
)
0.56
" However, with MTD dosing this drug ratio is not optimal to produce synergy and future studies using ratiometric dosing are required to confirm these findings."( Phase I evaluation of gemcitabine, mitoxantrone, and their effect on plasma disposition of fludarabine in patients with relapsed or refractory acute myeloid leukemia.
Adams, DJ; Decastro, CM; Gockerman, JP; Moore, JO; Peterson, BL; Petros, WP; Rao, AV; Rizzieri, DA; Sand, GJ; Spasojevic, I; Younis, IR, 2008
)
0.66
" Unresectable stage III NSCLC patients received CDDP (60 mg/m(2)), GEM (1g/m(2), days 1 and 8) and VNR (25mg/m(2), days 1 and 8) with reduced dosage of GEM and VNR during radiotherapy (66Gy)."( A phase III randomised study comparing concomitant radiochemotherapy as induction versus consolidation treatment in patients with locally advanced unresectable non-small cell lung cancer.
Alard, S; Berghmans, T; Giner, V; Holbrechts, S; Koumakis, G; Leclercq, N; Lecomte, J; Meert, AP; Paesmans, M; Richez, M; Roelandts, M; Sculier, JP; Van Houtte, P, 2009
)
0.35
" GEM was administrated at a dosage of 1 g/m(2) intravenously weekly 3 of 4 weeks and UFT at a dosage of 200 mg/day orally continuously."( A randomized phase II trial of adjuvant chemotherapy with uracil/tegafur and gemcitabine versus gemcitabine alone in patients with resected pancreatic cancer.
Furukawa, K; Ito, H; Kato, A; Kimura, F; Miyazaki, M; Nozawa, S; Otsuka, M; Shimizu, H; Togawa, A; Yoshidome, H; Yoshitomi, H, 2008
)
0.57
" Anticancer drugs were studied with regard to their potential renal toxicity and need for dosage adjustment."( Lung cancer and renal insufficiency: prevalence and anticancer drug issues.
Beuzeboc, P; Deray, G; Etessami, R; Gligorov, J; Janus, N; Launay-Vacher, V; Morere, JF; Oudard, S; Pourrat, X; Ray-Coquard, I; Spano, JP,
)
0.13
" However, the patient suffered relatively severe side effects, and it was necessary to change the dosing schedule of gemcitabine."( A patient with unresectable advanced pancreatic cancer achieving long-term survival with gemcitabine chemotherapy.
Izuishi, K; Kakinoki, K; Maeba, T; Okamoto, Y; Okano, K; Suzuki, Y; Usuki, H; Wakabayashi, H, 2008
)
0.78
"To prove that combining gemcitabine and H-1PV in a model of pancreatic carcinoma may reduce the dosage of the toxic drug and/or improve the overall anticancer effect."( Improvement of gemcitabine-based therapy of pancreatic carcinoma by means of oncolytic parvovirus H-1PV.
Angelova, AL; Aprahamian, M; Balboni, G; Dinsart, C; Giese, NA; Grekova, SP; Hajri, A; Herrmann, A; Leuchs, B; Raykov, Z; Rommelaere, J, 2009
)
1.01
" Response rate in this study was modest, and optimization of dosing of this combination is required."( Combined gemcitabine and carboplatin therapy for carcinomas in dogs.
Cadile, CD; Dervisis, NG; Dominguez, PA; Kitchell, BE; Sarbu, L,
)
0.55
" Grade 3/4 creatinine increase occurred in 6 patients on glufosfamide, including 4 with dosing errors."( A randomised Phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine.
Bodoky, G; Ciuleanu, TE; Garin, AM; Kroll, S; Langmuir, VK; Pavlovsky, AV; Tidmarsh, GT, 2009
)
0.55
" Cholangiocellular carcinoma cells (TFK-1 cells) were treated either with 8 Gy (RTB group) or 16 Gy (RTA group) (188)Re or with (188)Re irradiation (8 Gy) combined with either gemcitabine (8 Gy/Gem) or 5-fluorouracil (8 Gy/5-FU) at a dosage of 20 microg/ml medium for 4 days and subsequently compared with an untreated control group."( Impact of rhenium-188, gemcitabine, and 5-fluorouracil on cholangiocellular carcinoma cells: an in vitro study.
Bantleon, R; Farkas, E; Kehlbach, R; Werner, M; Wiesinger, B; Wiskirchen, J, 2009
)
0.86
"Gemcitabine as a single agent, in this dosage and at this schedule, evidenced minimal clinical activity in cases of advanced MZL."( Phase II study of gemcitabine for treatment of patients with advanced stage marginal zone B-cell lymphoma: Consortium for Improving Survival of Lymphoma (CISL) trial.
Choi, YJ; Chung, JS; Kang, HJ; Kim, HJ; Kim, SH; Kim, SJ; Kim, WS; Lee, DH; Oh, SY; Ryoo, BY; Suh, C, 2010
)
2.14
" Adjustments in gemcitabine dosage during radiotherapy or changes in radiotherapy planning could reduce toxicity."( High frequency of radiation pneumonitis in patients with locally advanced non-small cell lung cancer treated with concurrent radiotherapy and gemcitabine after induction with gemcitabine and carboplatin.
Arrieta, O; Astorga-Ramos, AM; de la Garza, J; Gallardo-Rincón, D; Martínez-Barrera, L; Michel, RM; Villarreal-Garza, C, 2009
)
0.9
" cytotoxicity) of interest in these studies are based on the effects of an individual dosage of a drug on the cell lines, or a summary of results at many dosages of a drug (e."( A Bayesian hierarchical nonlinear model for assessing the association between genetic variation and drug cytotoxicity.
Fridley, BL; Jenkins, G; Schaid, DJ; Wang, L, 2009
)
0.35
" When sirolimus was added to this regimen at a dosage to achieve a serum level of at least 10 ng/dL at the time of the gemcitabine and docetaxel infusion, their tumors regressed."( Sirolimus can reverse resistance to gemcitabine, capecitabine and docetaxel combination therapy in pancreatic cancer.
Sherman, WH, 2009
)
0.84
" Dose-response studies showed that the drug inhibited 50% growth of seven pancreatic cancer cell lines at 10(-7) mol/L, whereas clonogenic growth was significantly inhibited at 5 x 10(-8) mol/L."( Cucurbitacin B induces apoptosis by inhibition of the JAK/STAT pathway and potentiates antiproliferative effects of gemcitabine on pancreatic cancer cells.
Abbassi, S; Doan, NB; Iwanski, GB; Koeffler, HP; Lin, P; Okamoto, R; Said, JW; Song, JH; Thoennissen, NH; Toh, M; Xie, WD; Yin, D, 2009
)
0.56
" Alternative dosing of glufosfamide plus gemcitabine should be explored."( A phase 2 trial of glufosfamide in combination with gemcitabine in chemotherapy-naive pancreatic adenocarcinoma.
Barrios, CH; Chiorean, EG; Dragovich, T; Gorini, CF; Hamm, J; Jung, DT; Kroll, S; Langmuir, VK; Loehrer, PJ; Tidmarsh, GT, 2010
)
0.88
"6% at dose 2, suggesting a dose-response relationship between OS and Rexin-G dosage."( Advanced phase I/II studies of targeted gene delivery in vivo: intravenous Rexin-G for gemcitabine-resistant metastatic pancreatic cancer.
Blackwelder, WC; Chawla, SP; Chua, VS; Fernandez, L; Gordon, EM; Hall, FL; Quon, D, 2010
)
0.58
"The every 2 week dosing is well tolerated with a phase II recommended dose of 45 mg/m of flavopiridol in combination with irinotecan (80 mg/m) and gemcitabine (800 mg/m)."( A phase I study of flavopiridol in combination with gemcitabine and irinotecan in patients with metastatic cancer.
Chyi Lee, F; Fekrazad, HM; Rabinowitz, I; Royce, M; Smith, HO; Verschraegen, CF, 2010
)
0.81
" In this study, we compared the dosage of carboplatin (CBDCA) calculated using MDRD with that calculated by conservative creatinine clearance (Ccr), and investigated the actual dosage given and the incidence of its adverse effects."( [Clinical evaluation of calculating carboplatin doses using modification of diet in renal disease (MDRD) estimate and adverse events].
Adachi, S; Kimura, M; Matsumoto, R; Matsuoka, T; Nakao, T; Okada, K; Tanaka, Y; Usami, E; Yasuda, T; Yoshimura, T, 2009
)
0.35
" Target plasma concentrations were correctly predicted by our previously described dosing nomogram."( Phase I trial of non-cytotoxic suramin as a modulator of docetaxel and gemcitabine therapy in previously treated patients with non-small cell lung cancer.
Au, JL; Bekaii-Saab, T; Chen, L; Grever, M; Guillaume Wientjes, M; Jensen, RR; Lam, ET; Li, X; Murgo, AJ; Otterson, GA; Shen, T; Villalona-Calero, MA; Wei, Y, 2010
)
0.59
"This study was conducted to evaluate the efficacy and safety and to compare dosing schedules of gemcitabine combined with S-1 in chemo-naïve non-small cell lung cancer patients."( Randomized phase II study of two different schedules of gemcitabine and oral S-1 in chemo-naïve patients with advanced non-small cell lung cancer.
Ando, M; Funada, Y; Hata, A; Katakami, N; Kotani, Y; Negoro, S; Satouchi, M; Shimada, T; Urata, Y; Yoshimura, S, 2010
)
0.83
" In phase I, dosage for levels 1, 2, and 3 was set at 600, 800, and 1000 mg/m, respectively, and was increased in 3 to 6 patients at a time."( Phase I/II study of hepatic arterial infusion chemotherapy with gemcitabine in patients with unresectable intrahepatic cholangiocarcinoma (JIVROSG-0301).
Anai, H; Arai, Y; Aramaki, T; Ikeda, M; Inaba, Y; Kumada, T; Najima, M; Sato, Y; Sone, M; Tanigawa, N; Yamaura, H; Yoshioka, T, 2011
)
0.61
"5 or 50mg/day intermittently (Schedule 2/1: 2 weeks on treatment, 1 week off treatment) or 25mg continuous daily dosing (CDD) schedule with intravenous infusions of gemcitabine (1000 or 1250 mg/m(2) days 1, 8) and cisplatin (80 mg/m(2) day 1)."( Sunitinib in combination with gemcitabine plus cisplatin for advanced non-small cell lung cancer: a phase I dose-escalation study.
Cedres, S; Chao, R; Felip, E; Frickhofen, N; Fuhr, HG; Gatzemeier, U; Heigener, D; Lanzalone, S; Reck, M; Ruiz-Garcia, A; Stephenson, P; Thall, A, 2010
)
0.84
" To date there is limited information on dosing of gemcitabine in patients with an elevated total bilirubin."( Toxicities of gemcitabine in patients with severe hepatic dysfunction.
Hall, PD; Teusink, AC, 2010
)
0.97
" The MTT cytotoxicity dose-response studies revealed the placebo at/or below 1 mg/ml has no effect on MIA PaCa-2 or BxPC-3 cells."( Chitosan and glyceryl monooleate nanostructures containing gemcitabine: potential delivery system for pancreatic cancer treatment.
Dash, AK; Khurana, J; Nagvekar, AA; Trickler, WJ, 2010
)
0.6
" Hematologic toxicities limiting day 8 gemcitabine dosing were observed in the first 20 patients, prompting a protocol amendment to evaluate pemetrexed 500 mg/m2 followed by gemcitabine 1500 mg/m2 on day 1 of a 14-day cycle."( A phase II trial of pemetrexed and gemcitabine in patients with metastatic breast cancer who have received prior taxane therapy.
Elias, AD; Gralow, J; Muscato, J; Neubauer, M; O'Shaughnessy, JA; Orlando, M; Pippen, J; Shonukan, O; Stokoe, C; Vaughn, LG; Wang, Y, 2010
)
0.91
" Treatment consisted of gemcitabine at a dosage of 1,250 mg/m(2) administered intravenously over a 30-minute period on days 1 and 8 of each 21-day cycle until progression."( Phase II study of second line gemcitabine single chemotherapy for biliary tract cancer patients with 5-fluorouracil refractoriness.
Ha, CY; Hong, SC; Hwang, IG; Jang, JS; Jeong, CY; Kang, JH; Kim, HJ; Kim, TH; Kwon, HC; Lee, GW; Oh, SY, 2011
)
0.96
"Following significant hematotoxicity, dosing was modified to gemcitabine 1000 mg/m (Days 1, 8), capecitabine 1000 mg twice daily (Days 1-14), and bevacizumab 15 mg/kg (Day 1) on a 21-day cycle with evaluation every 3 cycles."( A phase II trial of gemcitabine, capecitabine, and bevacizumab in metastatic renal carcinoma.
Chung, EK; Hahn, OM; Karrison, T; Kasza, K; Manchen, E; Posadas, EM; Stadler, WM, 2011
)
0.93
" Recent studies demonstrated that frequent dosing of chemotherapeutic drugs at relatively lower doses in metronomic regimens also confers anti-tumour activity but with fewer side effects."( Metronomic gemcitabine suppresses tumour growth, improves perfusion, and reduces hypoxia in human pancreatic ductal adenocarcinoma.
Baker, JH; Buczkowski, AK; Cham, KK; Chang, CW; Chu, EM; Chung, SW; Flexman, JA; Kozlowski, P; Minchinton, AI; Ng, SS; Owen, DA; Reinsberg, SA; Scudamore, CH; Takhar, KS; Wong, MQ; Yapp, DT; Yung, A, 2010
)
0.75
"Metronomic dosing of gemcitabine is active in pancreatic cancer and is accompanied by pronounced changes in the tumour microenvironment."( Metronomic gemcitabine suppresses tumour growth, improves perfusion, and reduces hypoxia in human pancreatic ductal adenocarcinoma.
Baker, JH; Buczkowski, AK; Cham, KK; Chang, CW; Chu, EM; Chung, SW; Flexman, JA; Kozlowski, P; Minchinton, AI; Ng, SS; Owen, DA; Reinsberg, SA; Scudamore, CH; Takhar, KS; Wong, MQ; Yapp, DT; Yung, A, 2010
)
1.07
" carboplatin dosed at an area-under-the-curve (AUC) of 5 over 60 min on day 1 of a 21-day cycle."( Gemcitabine with carboplatin for advanced biliary tract cancers: a phase II single institution study.
Fournier, CC; James, JS; Picus, J; Suresh, R; Tan, BR; Trinkhaus, K; Williams, KJ, 2010
)
1.8
"Due to rapid tumor progression and toxicity at this dosage and schedule in a multicenter setting, it was not feasible to deliver a prolonged regimen."( Randomized phase III trial of 2nd line gemcitabine and paclitaxel chemotherapy in patients with advanced bladder cancer: short-term versus prolonged treatment [German Association of Urological Oncology (AUO) trial AB 20/99].
Albers, P; Fechner, G; Fimmers, R; Heidenreich, A; Heimbach, D; Lehmann, J; Niegisch, G; Park, SI; Siener, R; Steiner, U, 2011
)
0.64
" Although some patients may benefit from the treatment, other dosing regimens and novel taxanes such as Nab-paclitaxel should be explored in this setting."( Docetaxel second-line therapy in patients with advanced pancreatic cancer: a retrospective study.
Kaley, K; Penney, R; Saif, MW; Syrigos, K, 2010
)
0.36
" Dosing in both treatment phases was generally well tolerated with manageable toxicities and no requirement for dose reduction."( Sorafenib after combination therapy with gemcitabine plus doxorubicine in patients with sarcomatoid renal cell carcinoma: a prospective evaluation.
Bader, M; Haseke, N; Karl, A; Roosen, A; Siebels, M; Stadler, T; Staehler, M; Stief, CG, 2010
)
0.63
" They may be useful for the improvement of control over gemcitabine toxicity, correction of its dosage regime, and efficacious prevention of the most serious side effects."( [Specific features of toxicological profile of gemcitabine, an antitumour agent from the group of anti-metabolites].
Baĭkova, VN; Parshina, NA; Pleteneva, TV,
)
0.63
"Area under the curve (AUC) dosing is routinely carried out for carboplatin, but the chosen target AUC values remain largely empirical."( Factors for hematopoietic toxicity of carboplatin: refining the targeting of carboplatin systemic exposure.
Billaud, EM; Bobin-Dubigeon, C; Boisdron-Celle, M; Boyer, JC; Chatelut, E; Concordet, D; Durdux, C; Etienne-Grimaldi, MC; Evrard, A; Floquet, A; Gladieff, L; Laffont, CM; Lafont, T; Lansiaux, A; Le Guellec, C; Mazières, J; Mousseau, M; Ollivier, F; Pinguet, F; Schmitt, A, 2010
)
0.36
"The combination of sorafenib plus gemcitabine and capecitabine is tolerable, but requires attenuation of sorafenib and capecitabine dosing because of the overlapping toxicity of hand-foot syndrome."( A phase I trial of sorafenib plus gemcitabine and capecitabine for patients with advanced renal cell carcinoma: New York Cancer Consortium Trial NCI 6981.
Jeske, S; Kung, S; Lehrer, D; Matulich, D; Mazumdar, M; Milowsky, MI; Nanus, DM; Selzer, J; Sung, M; Tagawa, ST; Wright, JJ, 2011
)
0.93
" Understanding the mechanism of this phenomena and its occurrence with other drugs is important for rational dosing of gemcitabine and design of gemcitabine combinations."( Modulation of gemcitabine accumulation by DNA-damaging agents: mechanisms and specificity in an in vitro model.
Galettis, P; Links, M; Manners, S; Metharom, E, 2010
)
0.93
" Intermittent dosing of pomalidomide allowed substantially higher doses than were previously reported with a continuous schedule."( A phase I, dose-escalation study of pomalidomide (CC-4047) in combination with gemcitabine in metastatic pancreas cancer.
Bendell, JC; Burris, HA; Hainsworth, JD; Infante, JR; Jones, SF; Messersmith, WA; Spigel, DR; Weekes, CD; Yardley, DA, 2011
)
0.6
"Gemcitabine-resistant pancreatic cancer cell line SW1990/GZ was obtained by treating parental cell line SW1990 in vitro with increasing dosage of gemcitabine in culture medium intermittently for 24 weeks."( [Establish a gemcitabine-resistant pancreatic cancer cell line SW1990/GZ and research the relationship between SW1990/GZ and pancreatic cancer stem cell].
An, Y; Cai, HH; Dai, CC; Lu, ZP; Miao, Y; Qian, ZY; Wei, JS; Xu, ZK; Yao, J, 2010
)
2.17
"Patients received reovirus in various doses, initially we dosed for five consecutive days but this was poorly tolerated."( A phase I study of the combination of intravenous reovirus type 3 Dearing and gemcitabine in patients with advanced cancer.
Arkenau, HT; Coffey, M; de Bono, JS; Evans, TR; Gill, G; Harrington, K; Lolkema, MP; Mettinger, K; Morrison, R; Roulstone, V; Roxburgh, P; Twigger, K, 2011
)
0.6
" First, we provide advances into administration schedules and dosing regimens for the combination treatment in in vivo pancreatic tumour."( Aurora B kinase inhibitor AZD1152: determinants of action and ability to enhance chemotherapeutics effectiveness in pancreatic and colon cancer.
Azzariti, A; Bocci, G; Chiarappa, P; Del Bufalo, D; Del Tacca, M; Fioravanti, A; Mangia, A; Paradiso, A; Porcelli, L; Quatrale, AE; Sebastian, S; Simone, GM; Sini, P, 2011
)
0.37
"Controversy exists over the optimal dosing for the nucleoside analogue gemcitabine."( The pharmacological advantage of prolonged dose rate gemcitabine is restricted to patients with variant alleles of cytidine deaminase c.79A>C.
de Souza, PL; Galettis, P; Hoskins, JM; Jelinek, M; Liauw, W; Links, M; Manners, S; Metharom, E, 2011
)
0.85
" This represents a classical interaction between genes and environment and provides support for the consideration of both CDA genotype and infusion duration in development of an individualized dosing strategy."( The pharmacological advantage of prolonged dose rate gemcitabine is restricted to patients with variant alleles of cytidine deaminase c.79A>C.
de Souza, PL; Galettis, P; Hoskins, JM; Jelinek, M; Liauw, W; Links, M; Manners, S; Metharom, E, 2011
)
0.62
" Though grade 3 neutropenia appeared after 2 courses of the combined therapy, the patient well tolerated it after controlling the dosing schedule."( [A case of complete response of gemcitabine (GEM) monotherapy-refractive liver metastatic pancreatic cancer treated with GEM+S-1 combined chemotherapy].
Hatata, T; Ikeguchi, M; Kondo, A; Naka, T; Takaya, S; Taniguchi, K, 2011
)
0.65
" MK-1775, when dosed with GEM, abrogated the checkpoint arrest to promote mitotic entry and facilitated tumor cell death as compared to control and GEM-treated tumors."( MK-1775, a potent Wee1 inhibitor, synergizes with gemcitabine to achieve tumor regressions, selectively in p53-deficient pancreatic cancer xenografts.
Brooks, D; De Oliveira, E; Demuth, T; Hidalgo, M; Hirai, H; Maitra, A; Mizuarai, S; Ottenhof, N; Rajeshkumar, NV; Shumway, SD; Watters, J, 2011
)
0.62
"Pancreatic ductal adenocarcinoma tumour tissue from genetically engineered mouse models of pancreatic cancer (KP ( FL/FL ) C and KP ( R172H/+) C) was collected after dosing the mice with gemcitabine."( A novel method for quantification of gemcitabine and its metabolites 2',2'-difluorodeoxyuridine and gemcitabine triphosphate in tumour tissue by LC-MS/MS: comparison with (19)F NMR spectroscopy.
Bapiro, TE; Cook, N; Frese, KK; Goldgraben, MA; Griffiths, JR; Jacobetz, MA; Jodrell, DI; Madhu, B; Olive, KP; Richards, FM; Smith, DM; Tuveson, DA, 2011
)
0.81
"4 Gy in 28 fractions, followed by brachytherapy [BCT] 30 to 35 Gy in 96 hours, and then two adjuvant 21-day cycles of cisplatin, 50 mg/m(2) on day 1, plus gemcitabine, 1,000 mg/m(2) on days 1 and 8) or to arm B (cisplatin and concurrent XRT followed by BCT only; dosing same as for arm A)."( Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix.
Alcedo, JC; Barraclough, H; Beslija, S; Blair, JM; Casanova, L; Dueñas-González, A; Hameed, S; Orlando, M; Patel, F; Pattaranutaporn, P; Zarbá, JJ, 2011
)
0.81
"Patients received oral panobinostat administered 2 or 3 times weekly (continuous or intermittent dosing in combination with intravenous gemcitabine administered on days 1, 8, and 15 every 28 days or on days 1 and 8 every 21 days)."( A phase I study of panobinostat in combination with gemcitabine in the treatment of solid tumors.
Bendell, JC; Burris, HA; Greco, FA; Infante, JR; Jones, SF; Murphy, PB; Spigel, DR; Thompson, DS; Yardley, DA, 2011
)
0.82
" Together these data support the clinical investigation of AZD7762 with gemcitabine in pancreatic cancer under a dosing schedule in which gemcitabine is administered concurrent with or before AZD7762 and in conjunction with skin biopsies to measure pS345 Chk1."( Assessment of chk1 phosphorylation as a pharmacodynamic biomarker of chk1 inhibition.
Arumugarajah, S; Brown, JL; Gross, M; Hassan, MC; Hylander-Gans, L; Lawrence, TS; Maybaum, J; Morgan, MA; Morosini, D; Parsels, JD; Parsels, LA; Qian, Y; Simeone, DM; Tanska, DM; Zabludoff, SD; Zhao, L, 2011
)
0.6
"0% of the planned theoretical dosage of carboplatin and 58% of patients received more than 85."( Toxicity profile and adherence to the pharmacotherapeutic regimen of gemcitabine-carboplatin in non-small cell lung cancer.
Albert Marí, A; Boquera Ferrer, ML; Gómez Herrero, D; Merino Sanjuán, M; Víctor Jiménez Torres, N,
)
0.37
"This dosing schedule of FDR gemcitabine plus capecitabine is active in patients with advanced pancreatobiliary cancers."( Optimizing the administration of fixed-dose rate gemcitabine plus capecitabine using an alternating-week schedule: a dose finding and early efficacy study in advanced pancreatic and biliary carcinomas.
Bergsland, EK; Coakley, FV; Dito, E; Espinoza, AM; Hanover, CS; Jones, KA; Kelley, RK; Ko, AH; Ong, A; Tempero, MA; Venook, AP, 2012
)
0.93
" The literature on chemotherapy in advanced cholangiocarcinoma is difficult to interpret because of the heterogeneity of cholangiocarcinoma, the use of various chemotherapeutic agents in different combinations and dosing regimens, and the small size of existing patient cohorts."( Emerging pharmacotherapeutic strategies for cholangiocarcinoma.
Dasanu, CA; Majumder, S; Trikudanathan, G, 2011
)
0.37
" Dose-response curves obtained for each compound by applying the neutral red uptake (NRU) assay to MMe cells growing in vitro, allowed to obtain IC50 values for each compound used singularly."( In vitro screening of synergistic ascorbate-drug combinations for the treatment of malignant mesothelioma.
Burlando, B; Martinotti, S; Ranzato, E, 2011
)
0.37
" This has potential utility in treatment selection and genotype-based dosing strategies."( Gemcitabine and platinum pathway pharmacogenetics in Asian breast cancer patients.
Cordero, MT; Goh, BC; Lee, SC; Ng, SS; Soong, R; Wang, LZ; Wong, AL; Yap, HL; Yeo, WL; Yong, WP,
)
1.57
" The patient received adjuvant gemcitabine plus cisplatin chemotherapy at a cisplatin dosage reduced by 50%."( Synchronous bilateral urothelial cancer in a kidney recipient.
Chikaraishi, T; Kimura, K; Kudo, H; Miyano, S; Nakazawa, R; Sasaki, H, 2011
)
0.66
" During radiotherapy, most patients received GEM at a dosage of 250 to 350 mg/m(2) intravenously weekly for approximately 6 weeks."( Concurrent radiotherapy and gemcitabine for unresectable pancreatic adenocarcinoma: impact of adjuvant chemotherapy on survival.
Hirokawa, N; Ito, Y; Karasawa, K; Kokubo, M; Nemoto, K; Nishimura, Y; Ogawa, K; Ogo, E; Onishi, H; Saito, T; Shibuya, H; Shibuya, K, 2012
)
0.67
"To develop and internally validate a population pharmacokinetic model for gemcitabine and its metabolite 2',2'-difluorodeoxyuridine (dFdU); and to evaluate its predictive perfomance for personalizing the dosage used in cancer patients."( [Population pharmacokinetics of gemcitabine applied to personalize the dosage used in cancer patients].
Duart-Duart, MJ; Escudero-Ortiz, V; Pérez-Ruixo, JJ; Ramón-López, A; Valenzuela, B,
)
0.65
"The population pharmacokinetic model adequately characterised the gemcitabine and dFdU plasma concentrations in the study population over time, and can be used to accurately and precisely optimise gemcitabine dosing regimens in cancer patients."( [Population pharmacokinetics of gemcitabine applied to personalize the dosage used in cancer patients].
Duart-Duart, MJ; Escudero-Ortiz, V; Pérez-Ruixo, JJ; Ramón-López, A; Valenzuela, B,
)
0.65
" Of 14 recruited subjects enrolled, nine completed the study (three in each dosage tier)."( Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer.
Bazzan, AJ; Deshmukh, S; Levine, M; Littman, S; Mitchell, E; Monti, DA; Newberg, AB; Pillai, MV; Yeo, CJ; Zabrecky, G, 2012
)
0.61
"Although the recommended dosage is restricted to a lower level compared to younger patients, combination therapy using CBDCA with GEM is tolerable and promising for elderly patients with advanced NSCLC."( A phase I/II study of carboplatin plus gemcitabine for elderly patients with advanced non-small cell lung cancer: West Japan Thoracic Oncology Group Trial (WJTOG) 2905.
Aoki, T; Fukuoka, M; Hirashima, T; Ikeda, N; Ishiguro, T; Iwamoto, Y; Kawaguchi, T; Kotani, Y; Kurata, T; Nakagawa, K; Sawa, T; Tsuboi, M, 2012
)
0.65
" The antitumor activity, different dosing sequences, and dosing regimens of TH-302 in combination with commonly used conventional chemotherapeutics were investigated in human tumor xenograft models."( TH-302, a hypoxia-activated prodrug with broad in vivo preclinical combination therapy efficacy: optimization of dosing regimens and schedules.
Ahluwalia, D; Ammons, WS; Baker, AF; Cranmer, LD; Curd, JG; Duan, JX; Ferraro, D; Hart, CP; Liu, Q; Matteucci, MD; Sun, JD; Wang, J; Wang, Y, 2012
)
0.38
" Simultaneous administration of TH-302 and chemotherapeutics increased toxicity versus schedules with dosing separations."( TH-302, a hypoxia-activated prodrug with broad in vivo preclinical combination therapy efficacy: optimization of dosing regimens and schedules.
Ahluwalia, D; Ammons, WS; Baker, AF; Cranmer, LD; Curd, JG; Duan, JX; Ferraro, D; Hart, CP; Liu, Q; Matteucci, MD; Sun, JD; Wang, J; Wang, Y, 2012
)
0.38
"In the current study, gemcitabine-docetaxel combination therapy at this dosage and schedule was found to be well tolerated and marginally effective, which could be considered as salvage therapy for patients with recurrent or refractory high-grade osteosarcoma."( Efficacy and safety of gemcitabine-docetaxel combination therapy for recurrent or refractory high-grade osteosarcoma in China: a retrospective study of 18 patients.
He, AN; Lin, F; Qi, WX; Shen, Z; Tang, LN; Yao, Y, 2012
)
1
" Secondary endpoints included progression-free survival, response rate, grade 3-4 toxicity, dosage modifications and CA 19-9 course."( Second-line therapy for gemcitabine-pretreated advanced or metastatic pancreatic cancer.
Altwegg, R; Assenat, E; Caillo, L; Faure, S; Flori, N; Guillaumon, V; Mazard, T; Samalin, E; Senesse, P; Thezenas, S; Ychou, M, 2012
)
0.69
" As it is simple, cheap and less time consuming, it can be suitably applied for the estimation of GMCT in dosage forms."( Analytical detection and method development of anticancer drug Gemcitabine HCl using gold nanoparticles.
Joshi, KV; Menon, SK; Mistry, BR; Patel, RV; Sutariya, PG, 2012
)
0.62
" Fractionated dosing of cycle 1 allowed almost twice the radiation dose compared with single-dose radioimmunotherapy."( Fractionated radioimmunotherapy with (90) Y-clivatuzumab tetraxetan and low-dose gemcitabine is active in advanced pancreatic cancer: A phase 1 trial.
Bekaii-Saab, T; Gold, DV; Goldenberg, DM; Goldsmith, SJ; Guarino, MJ; Gulec, SA; Hall, N; Holt, M; Horne, H; Kauh, J; Lee, D; Manzone, T; Montero, AJ; O'Neil, BH; Ocean, AJ; Pennington, KL; Serafini, AN; Sheikh, A; Sung, MW; Wegener, WA, 2012
)
0.61
" The optimal dosage and schedule of platinum-based doublet should be investigated in future prospective clinical trials."( Doublet versus single cytotoxic agent as first-line treatment for elderly patients with advanced non-small-cell lung cancer: a systematic review and meta-analysis.
He, AN; Lin, F; Qi, WX; Shen, Z; Tang, LN; Yao, Y, 2012
)
0.38
" IL-2 and GM-CSF were administered from day 4 to day 8 at a dosage of 2 MIU/m ( 2) and 100 μg, respectively."( A pilot study of paclitaxel combined with gemcitabine followed by interleukin-2 and granulocyte macrophage colony-stimulating factor for patients with metastatic melanoma.
Ding, Y; Liao, Y; Peng, RQ; Zhang, X; Zhang, XS; Zheng, LM, 2012
)
0.64
" Similar dose-response lapatinib experiments were conducted with varying concentrations of 5-FU or GEM and isobolograms were constructed to evaluate therapeutic synergy."( Dual ErbB1 and ErbB2 receptor tyrosine kinase inhibition exerts synergistic effect with conventional chemotherapy in pancreatic cancer.
Drebin, JA; Pippin, JA; Singla, S, 2012
)
0.38
" However, optimal dosing schedule, including drug selection, number of cycles, and interval between chemotherapy and cystectomy, as well as acceptable regimens remain to be established."( Efficacies and safety of neoadjuvant gemcitabine plus carboplatin followed by immediate cystectomy in patients with muscle-invasive bladder cancer, including those unfit for cisplatin: a prospective single-arm study.
Hashimoto, Y; Hatakeyama, S; Kamimura, N; Koie, T; Ohyama, C; Yamamoto, H; Yoneyama, T, 2013
)
0.66
" However, rapid metabolism and shorter half-life of drug mandate higher dose and frequent dosing schedule which subsequently results into higher toxicity."( Site specific/targeted delivery of gemcitabine through anisamide anchored chitosan/poly ethylene glycol nanoparticles: an improved understanding of lung cancer therapeutic intervention.
Campbell, C; Dwivedi, P; Garg, NK; Tyagi, RK, 2012
)
0.66
"The combination of AZD6244 plus gemcitabine is highly schedule dependent, and predicted to be more effective in the clinic using sequential rather than simultaneous dosing protocols."( Sequence dependence of MEK inhibitor AZD6244 combined with gemcitabine for the treatment of biliary cancer.
Cao, P; Chen, E; Green, DE; Hedley, DW; Ibrahimov, E; Knox, JJ; McNamara, MG; Metran-Nascente, C; Serra, S; Tsao, M; Vines, D; Xu, J, 2013
)
0.92
" It exerted a stronger, quicker effect on the reduction of HEK293 cell growth in vitro in comparison with free GEM and had an in vivo antitumoral effect on the proliferation of xenograft tumors at a drug dosage tenfold less than its saline solution."( Gemcitabine-loaded biocompatible nanocapsules for the effective treatment of human cancer.
Celano, M; Cosco, D; Fresta, M; Moretti, S; Paolino, D; Puxeddu, E; Russo, D, 2013
)
1.83
"Patients with advanced solid tumors received three weekly AVE1642 dosed at 6 mg/kg, chosen following previous study, with 75 (cohort A) or 100 mg/m(2) (B) docetaxel, 1250 mg/m(2) gemcitabine/100 mg erlotinib (C1), or 60 mg/m(2) doxorubicin (D1)."( Phase I study of humanized monoclonal antibody AVE1642 directed against the type 1 insulin-like growth factor receptor (IGF-1R), administered in combination with anticancer therapies to patients with advanced solid tumors.
Bahleda, R; Blay, JY; Dieras, V; LoRusso, P; Macaulay, VM; Mery-Mignard, D; Middleton, MR; Protheroe, AS; Sessa, C; Soria, JC; Tolcher, A, 2013
)
0.58
" Cisplatin and gemcitabine dosing regimens and clinical data were further summarized using weighted averages."( Pooled analysis of clinical outcomes with neoadjuvant cisplatin and gemcitabine chemotherapy for muscle invasive bladder cancer.
Pal, SK; Ruel, N; Vogelzang, N; Wilson, TG; Yuh, BE, 2013
)
0.98
" Oral dosing of mice results in absorption of intact prodrug with slow systemic hydrolysis yielding higher plasma levels of LY2334737 than gemcitabine and prolonged gemcitabine exposure."( Efficacy of low-dose oral metronomic dosing of the prodrug of gemcitabine, LY2334737, in human tumor xenografts.
Dantzig, AH; Donoho, GP; Durland-Busbice, S; Perkins, EJ; Pratt, SE; Shepard, RL; Starling, JJ; Wickremsinhe, ER, 2013
)
0.83
" The C max of gemcitabine produced by intravenous SL-01 was higher than that of gemcitabine dosed intravenously."( Pharmacokinetics and metabolism of SL-01, a prodrug of gemcitabine, in rats.
Li, G; Li, W; Li, Y; Qin, Y; Qu, X; Sun, C; Wang, R; Zhao, C, 2013
)
1
"5mg) was escalated in a 3+3 design with standard gemcitabine dosing (1000 mg/m(2) IV Days 1, 8, and 15 of 28-day cycles)."( A phase 1b study of trametinib, an oral Mitogen-activated protein kinase kinase (MEK) inhibitor, in combination with gemcitabine in advanced solid tumours.
Bellew, KM; Bendell, JC; Burris, HA; Cox, DS; Durante, M; Infante, JR; Jones, SF; Le, NT; Papadopoulos, KP; Park, JJ; Patnaik, A; Rasco, D; Smith, L; Tolcher, AW, 2013
)
0.85
"Administration of trametinib at its full monotherapy dose of 2mg daily in combination with standard gemcitabine dosing (1000 mg/m(2) IV Days 1, 8, and 15 every 28 days) was feasible."( A phase 1b study of trametinib, an oral Mitogen-activated protein kinase kinase (MEK) inhibitor, in combination with gemcitabine in advanced solid tumours.
Bellew, KM; Bendell, JC; Burris, HA; Cox, DS; Durante, M; Infante, JR; Jones, SF; Le, NT; Papadopoulos, KP; Park, JJ; Patnaik, A; Rasco, D; Smith, L; Tolcher, AW, 2013
)
0.82
" The toxicities observed at the 40 mg dose may require the development of alternative dosing schedules."( Phase I study of oral gemcitabine prodrug (LY2334737) in Japanese patients with advanced solid tumors.
Benhadji, KA; Makiuchi, T; Nokihara, H; Sekiguchi, R; Slapak, CA; Tamura, T; Uenaka, K; Yamada, Y; Yamamoto, N, 2013
)
0.7
" For this concurrent treatment, a high dosage of gemcitabine and a short-term delay before HIFU are recommended to maximize the therapeutic effect."( Pulsed high-intensity focused ultrasound enhances apoptosis of pancreatic cancer xenograft with gemcitabine.
Choi, BI; Choi, Y; Han, JK; Kim, H; Lee, ES; Lee, JY; Park, J, 2013
)
0.86
" The dosage of S-1 was based on the body surface area (BSA) as follows: 40 mg bid (total 80 mg/day) for a BSA of <1."( Phase II trial of gemcitabine and S-1 for patients with advanced pancreatic cancer.
Choi, DR; Han, B; Jang, G; Jeon, JY; Jung, JY; Kim, HJ; Kim, HS; Kim, HY; Kim, IG; Kim, JH; Kwon, JH; Park, CK; Song, H; Zang, DY, 2013
)
0.72
"6%) while 5 patients had extended-interval dosage (17."( Two-week combination chemotherapy with gemcitabine, high-dose folinic acid and 5 fluorouracil (GEMFUFOL) as first-line treatment of metastatic biliary tract cancers.
Oztop, I; Unal, OU; Unek, IT; Yilmaz, AU, 2013
)
0.66
" A total cisplatin dosage of 100 mg/cycle was administered on 2 days (50 mg/d on days 2 and 3) as an intravenous infusion."( Feasibility of pre- and postoperative gemcitabine-plus-cisplatin systemic chemotherapy for the treatment of locally advanced urothelial carcinoma in kidney transplant patients.
Wang, W; Wang, Y; Zhang, P; Zhang, XD, 2013
)
0.66
"There is no optimal dosing schedule of gemcitabine (GEM) and cisplatin (CDDP) combination for cancer patients with renal failure (RF) on hemodialysis (HD)."( Administration of gemcitabine and cisplatin in cancer patients with renal failure under hemodialysis.
Chang, PY; Dai, MS; Ho, CL; Yao, NS,
)
0.73
" The transport and enzymatic profiles of 5'-D-valyl-gemcitabine and 5'-D-phenylalanyl-gemcitabine suggest their potential for increased oral uptake and delayed enzymatic bioconversion as well as enhanced uptake and cytotoxic activity in cancer cells, would facilitate the development of oral dosage form for anti-cancer agents and, hence, improve the quality of life for the cancer patients."( The development of orally administrable gemcitabine prodrugs with D-enantiomer amino acids: enhanced membrane permeability and enzymatic stability.
Amidon, GL; Hilfinger, JM; Incecayir, T; Song, X; Tsume, Y, 2014
)
0.92
" Dose-response curves were constructed, and the combination index (CI) for drug interaction was calculated."( Dasatinib (BMS-35482) interacts synergistically with docetaxel, gemcitabine, topotecan, and doxorubicin in ovarian cancer cells with high SRC pathway activation and protein expression.
Adams, DJ; Grace, L; Jia, J; Murphy, SK; Nixon, AB; Secord, AA; Teoh, D, 2014
)
0.64
" Sorafenib was dosed orally 400 mg twice daily until progression, except during CRT when it was escalated from 200 mg to 400 mg daily, and 400 mg twice daily."( Phase 1 pharmacogenetic and pharmacodynamic study of sorafenib with concurrent radiation therapy and gemcitabine in locally advanced unresectable pancreatic cancer.
Akisik, FM; Anderson, S; Bu, G; Cardenes, HR; Chiorean, EG; Clark, R; Deluca, J; DeWitt, J; Helft, P; Johnson, CS; Johnston, EL; Loehrer, PJ; Perkins, SM; Sandrasegaran, K; Schneider, BP; Shahda, S; Spittler, AJ, 2014
)
0.62
"2% of the patients developed side effects resulting in dosage reductions."( Chemotherapy for advanced pancreatic adenocarcinoma in elderly patients (≥70 years of age): a retrospective cohort study at the National Center for Tumor Diseases Heidelberg.
Abel, U; Berger, AK; Harig, S; Jäger, D; Komander, C; Springfeld, C,
)
0.13
" The degree to which biweekly dosing may present a more rationale schedule for this triplet should be evaluated further."( A phase II study of gemcitabine, carboplatin and bevacizumab for the treatment of platinum-sensitive recurrent ovarian cancer.
Callahan, MJ; Cobb, B; Cohn, DE; Copeland, LJ; Eisenhauer, EL; Fowler, JM; O'Malley, DM; Salani, R; Sutton, G; Zanagnolo, V, 2014
)
0.73
"Patients with solid tumors for which gemcitabine was deemed an appropriate therapy were enrolled into one of two different dosing schedules (21-day dosing schedule: navitoclax administered orally on days 1-3 and 8-10,; and gemcitabine 1,000 mg/m(2) on days 1 and 8; 28-day dosing schedule: navitoclax administrated orally on days 1-3, 8-10, and 15-17; and gemcitabine 1,000 mg/m(2) on days 1, 8 and 15)."( A phase I clinical trial of navitoclax, a targeted high-affinity Bcl-2 family inhibitor, in combination with gemcitabine in patients with solid tumors.
Busman, T; Cleary, JM; Franklin, C; Graham, A; Holen, K; Hurwitz, HI; Lima, CM; Mabry, M; Montero, AJ; Shapiro, GI; Uronis, H; Yang, J, 2014
)
0.89
"Vatalanib treatment consisted of a twice daily oral dosing using a "ramp-up schedule," beginning with 250 mg bid during week 1,500 mg bid during week 2, and 750 mg bid on week three and thereafter."( Phase II trial of vatalanib in patients with advanced or metastatic pancreatic adenocarcinoma after first-line gemcitabine therapy (PCRT O4-001).
Baker, AF; Bolejack, V; Burris, H; Crowley, J; Dayyani, F; Dragovich, T; Hidalgo, M; Laheru, D; Raghunand, N; Ritch, P; Rosen, P; Seng, J; Smith, L; Von Hoff, DD, 2014
)
0.61
" A stratified dosing strategy based on the relative CDA activity would increase efficiency."( Selection of the best blood compartment to measure cytidine deaminase activity to stratify for optimal gemcitabine or cytarabine treatment.
Ciccolini, J; Etienne-Grimaldi, MC; Giovannetti, E; Honeywell, RJ; Losekoot, N; Maulandi, M; Milano, G; Peters, GJ; Serdjebi, C, 2014
)
0.62
" In particular, we focus on Abstract #4124, which investigated the potential predictive role of human equilibrative nucleoside transporter 1 (hENT1) in patients treated with adjuvant gemcitabine for pancreatic cancer, on Abstract #4125, which examined the tolerability of a modified FOLFORINOX study based on UGT1A1*28 genotype guided dosing of IRI in patients with advanced pancreatic cancer, and on Abstract #4130, which confirmed the predictive role of circulating tumor and invasive cells (CTICs) from patients with unresectable pancreatic cancer in second-line chemotherapy treatment setting."( Pharmacogenetics in pancreatic cancer.
Peponi, E; Saif, MW; Syrigos, KN; Tourkantonis, IS, 2014
)
0.59
" Because tasisulam is highly albumin-bound, patients in the tumor-specific confirmation arms were dosed targeting specific albumin-corrected exposure ranges (AUCalb) identified during dose-escalation (3,500 h*μg/mL [75th percentile] for docetaxel, temozolomide, and cisplatin; 4,000 h*μg/mL for gemcitabine and erlotinib)."( An innovative, multi-arm, complete phase 1b study of the novel anti-cancer agent tasisulam in patients with advanced solid tumors.
Becerra, CR; Braiteh, F; Chen, J; Chow, KH; Conkling, PR; Garbo, L; Ilaria, R; Jotte, RM; Richards, DA; Robert-Vizcarrondo, F; Smith, DA; Stephenson, J; Tai, DF; Turner, PK; Von Hoff, DD, 2015
)
0.59
"01 dosed at 1250 mg/m(2) on Days 1, 8, and 15 of a 4-week cycle."( A phase II, open-label, multicenter study to evaluate the antitumor efficacy of CO-1.01 as second-line therapy for gemcitabine-refractory patients with stage IV pancreatic adenocarcinoma and negative tumor hENT1 expression.
Allen, A; Bahary, N; Dragovich, T; Hosein, PJ; Laheru, D; LaValle, J; Li, D; Lowery, MA; O'Reilly, EM; Pant, S; Rolfe, L; Ryan, DP; Saif, MW; Yu, KH,
)
0.34
" However, further sophisticated dosing and scheduling of combination chemotherapy are needed because of a significant proportion of dose reduction."( Phase II study of gemcitabine and vinorelbine as second- or third-line therapy in patients with primary refractory or platinum-resistant recurrent ovarian and primary peritoneal cancer by the Korean Cancer Study Group (KCSG)_KCSG GY10-10.
Byun, JH; Hong, SH; Jung, KH; Kim, HG; Kim, HY; Kim, KH; Lee, HJ; Lee, NR; Lee, S; Lee, SC; Park, KH; Rha, SY; Woo, IS; Yun, J, 2015
)
0.75
" Targeted therapies do not require any adjustment of the dosage in case of moderate or severe renal insufficiency but adapting the doses of biphosphonates to renal function is necessary."( [Impact of lung cancer treatments on renal function].
Belaiche, S; Couraud, S; Moro-Sibilot, D; Sakhri, L; Toffart, AC, 2014
)
0.4
" Continuous dosing of olaparib or combination with gemcitabine at doses >600 mg/m(2) was not considered to have an acceptable tolerability profile for further study."( Phase I study of olaparib plus gemcitabine in patients with advanced solid tumours and comparison with gemcitabine alone in patients with locally advanced/metastatic pancreatic cancer.
Bendell, J; Burke, W; Burris, H; Chau, I; Fielding, A; Hochster, H; Middleton, MR; O'Reilly, EM, 2015
)
0.95
" We created the Johns Hopkins Hospital Dose Index to characterize chemotherapeutic dosing regimens and accurately assess sufficient neoadjuvant dosing regarding patient tolerance."( Gemcitabine and cisplatin neoadjuvant chemotherapy for muscle-invasive urothelial carcinoma: Predicting response and assessing outcomes.
Baras, A; Berman, D; Bivalacqua, TJ; Eisenberger, M; Faraj, S; Gandhi, NM; Hahn, NM; Hoque, MO; Kates, M; Liu, JJ; Munari, E; Netto, GJ; Reis, LO; Schoenberg, MP, 2015
)
1.86
" The tolerability profile demonstrated in the dose escalation schedule of lenalidomide suggests the dosing of lenalidomide to be 25 mg daily on days 1-21 with standard dosing of gemcitabine and merits further evaluation in a phase II trial."( A phase I dose-escalation study of lenalidomide in combination with gemcitabine in patients with advanced pancreatic cancer.
Liljefors, M; Rossmann, E; Ullenhag, GJ, 2015
)
0.84
" Using genomic biomarkers, patients at high risk for developing side effects can be distinguished before initiating medical treatment, allowing the choice of an appropriate drug/initial dosage regimen."( [Utilization of Genomic Biomarkers for Post-marketing Safety of Drugs].
Kaniwa, N, 2015
)
0.42
" Busulfan dosing targeted 4000 μM-minute/day (days -8 to -5)."( Vorinostat Combined with High-Dose Gemcitabine, Busulfan, and Melphalan with Autologous Stem Cell Transplantation in Patients with Refractory Lymphomas.
Ahmed, S; Alousi, A; Anderlini, P; Andersson, BS; Bashir, Q; Champlin, R; Dabaja, B; Fanale, M; Gulbis, A; Hagemeister, F; Hosing, C; Jones, RB; Liu, Y; Nieto, Y; Oki, Y; Pinnix, C; Popat, U; Qazilbash, M; Shah, N; Shpall, EJ; Thall, PF; Valdez, BC, 2015
)
0.69
" The first dose level (DL A) tested vorinostat as daily oral dosing from days 1 to 14."( Phase I study of combination of vorinostat, carboplatin, and gemcitabine in women with recurrent, platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer.
Berlin, S; Campos, S; Horowitz, N; Krasner, C; Lee, H; Liu, J; Matulonis, U; Obermayer, E; Penson, R; Whalen, C, 2015
)
0.66
" Gemcitabine pharmacokinetics was determined with a two-compartment model after plasma dosing with an HPLC-UV method."( Influence of infusion method on gemcitabine pharmacokinetics: a controlled randomized multicenter trial.
Barthélémy, C; Décaudin, B; Hebbar, M; Lemahieu, N; Michel, P; Odou, P; Pinçon, C; Romano, O; Simon, N; Vasseur, M, 2015
)
1.61
" We investigated if higher drug doses per kg LBM were associated with increased toxicity in stage IIIB/IV non-small cell lung cancer (NSCLC) patients receiving a first-line chemotherapy regimen dosed according to body surface area (BSA)."( Low muscle mass is associated with chemotherapy-induced haematological toxicity in advanced non-small cell lung cancer.
Aass, N; Baracos, VE; Benth, JŠ; Fløtten, Ø; Grønberg, BH; Hjermstad, MJ; Jordhøy, M; Sjøblom, B, 2015
)
0.42
" Dosage regimens were optimized as predicted by modeling and simulations, which would provide reference for preclinical study and translational research as well."( Semi-Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for the Combination Use of Dexamethasone and Gemcitabine in Breast Cancer.
Hua, M; Ji, S; Li, L; Lu, W; Ren, Y; Wang, L; Yuan, Y; Zhou, S; Zhou, T; Zhou, X, 2015
)
0.63
" The release time and dosage of GEM were precisely controlled via external voltage."( Voltage/pH-Driven Mechanized Silica Nanoparticles for the Multimodal Controlled Release of Drugs.
Fu, J; Sun, G; Wang, M; Wang, T; Zhou, B, 2015
)
0.42
" The most common dosing regimen was gemcitabine 1250 mg/m(2) given on days 1 and 8 plus cisplatin 70 mg/m(2) on day 1 every 21 days, with some receiving gemcitabine at a dose of 1000 mg/m(2)."( Tolerability of Gemcitabine Plus Cisplatin for Treatment of Urothelial Cancer in the Elderly Population.
Dolan, DE; Gupta, S; Jan, AS; Lombardi, K, 2016
)
1.06
" It was dosed daily with gemcitabine (1,000 mg/m2 on days 1, 8 and 15) and cisplatin (70 mg/m2 on day 2) every 28 days."( Results from a Phase I Study of Lapatinib with Gemcitabine and Cisplatin in Advanced or Metastatic Bladder Cancer: EORTC Trial 30061.
Agerbaek, M; Cerbone, L; Collette, S; Daugaard, G; Marreaud, S; Sengeløv, L; Sternberg, CN; Van Herpen, C; Zhang, J, 2016
)
0.99
" In addition, gemcitabine increased the elimination rate of the ABCG2 substrate, D-luciferin, and decreased D-luciferin accumulation in BxPC3 and Panc1 cells in a dose-response manner."( Gemcitabine upregulates ABCG2/BCRP and modulates the intracellular pharmacokinetic profiles of bioluminescence in pancreatic cancer cells.
Gu, M; Li, F; Liu, J; Sun, Y; Wei, Y; Xiong, Y; Zhu, L, 2016
)
2.24
" A prospective study should be performed to examine whether dosage adjustment using neutropenia grade as an indicator would improve prognosis."( Chemotherapy-induced neutropenia as a prognostic factor in patients with unresectable pancreatic cancer.
Ishii, M; Kitamura, K; Kiuchi, Y; Kogo, M; Kurihara, T; Shimada, K; Shimizu, S; Yoneyama, K; Yoshida, H, 2015
)
0.42
" The best combination efficacy occurred when LY2603618 was given 24 h following dosing with gemcitabine."( LY2603618, a selective CHK1 inhibitor, enhances the anti-tumor effect of gemcitabine in xenograft tumor models.
Barda, D; Barnard, D; Beckmann, R; Burke, T; Diaz, HB; Donoho, G; Jones, B; King, C; Marshall, M, 2016
)
0.89
" Functional assays addressed pharmacological dose-response effects in lymphoblastoid cell lines (LCLs) and pancreatic cancer cell lines (including upon RNAi), gene expression analyses, and allele-specific transcription factor binding."( Relevance of Sp Binding Site Polymorphism in WWOX for Treatment Outcome in Pancreatic Cancer.
Bockhorn, M; Brockmöller, J; Gaedcke, J; Ghadimi, BM; Güngör, C; Hackert, T; Hank, T; Haubrock, M; Izbicki, JR; Johnsen, SA; Lüske, CM; Pflüger, R; Rapp, J; Roppel, S; Schaudinn, A; Schirmer, MA; Strobel, O; Werner, J; Zimmer, C, 2016
)
0.43
"The addition of erlotinib to gemcitabine and nab-paclitaxel is not tolerable at standard single-agent dosing of all drugs."( A phase 1b study of erlotinib in combination with gemcitabine and nab-paclitaxel in patients with previously untreated advanced pancreatic cancer: an Academic Oncology GI Cancer Consortium study.
Ames, P; Berlin, J; Catalano, PM; Cohen, SJ; Davies, A; Horan, J; Leichman, L; McKinley, M; O'Neil, BH; Weekes, CD, 2016
)
0.98
"Two primary human pancreatic cancer xenograft lines were dosed metronomically with gemcitabine or DC101 weekly."( The differential effects of metronomic gemcitabine and antiangiogenic treatment in patient-derived xenografts of pancreatic cancer: treatment effects on metabolism, vascular function, cell proliferation, and tumor growth.
Buczkowski, AK; Chung, SW; Kozlowski, P; Kyle, AH; Minchinton, AI; Ng, SS; Owen, DA; Scudamore, CH; Tso, J; Valdez, SM; Wong, MQ; Yapp, DT; Yung, A, 2016
)
0.93
" The reproducibility, repeatability, and applicability of the analysis to pharmaceutical dosage forms and human serum samples were also examined."( Electrochemical DNA biosensor based on poly(2,6-pyridinedicarboxylic acid) modified glassy carbon electrode for the determination of anticancer drug gemcitabine.
Pekyardımcı, Ş; Tığ, GA; Zeybek, B, 2016
)
0.63
" Enoxaparin was started at a therapeutic, renally adjusted dosage of 60 mg subcutaneously once daily after the patient's hematomas resolved and hemoglobin level stabilized."( Evidence of a clinically significant interaction between warfarin and intravesical gemcitabine.
Feuz, L; Gee, ME; Krajewski, KC; Kurtzhalts, K, 2016
)
0.66
" Additionally, MTX-GEM ASMP-NPs could achieve the same anticancer effect with the greatly reduced dosage compared with the free drugs according to the dose-reduction index (DRI) values of MTX and GEM in MTX-GEM ASMP-NPs, which may be beneficial for reducing the side effects."( Self-Delivery Nanoparticles of Amphiphilic Methotrexate-Gemcitabine Prodrug for Synergistic Combination Chemotherapy via Effect of Deoxyribonucleotide Pools.
Hu, M; Huang, P; Huang, W; Wang, Y; Yan, D; Zhu, X, 2016
)
0.68
"In this study, we investigated the dosage effect of gemcitabine, an inhibitor of ribonucleotide reductase (RR), on cellular levels of ribonucleotides and deoxyribonucleotides using high performance liquid chromatography-electrospray ionization tandem mass spectrometric method."( Profiling ribonucleotide and deoxyribonucleotide pools perturbed by gemcitabine in human non-small cell lung cancer cells.
Chang, ZF; Chen, QQ; Guo, JR; Lam, CW; Wang, CY; Wong, VK; Zhang, W, 2016
)
0.92
" In the S/P arm, patients were treated orally with sorafenib continuous dosing at two dose levels (DL1: 200 mg twice daily and DL2: 400 mg twice daily) combined with plitidepsin (1."( Phase I dose-escalation study of plitidepsin in combination with sorafenib or gemcitabine in patients with refractory solid tumors or lymphomas.
Alfaro, V; Aspeslagh, S; Bahleda, R; Extremera, S; Fudio, S; Gyan, E; Hollebecque, A; Salles, G; Soria, JC; Soto-Matos, A; Stein, M, 2017
)
0.68
" Electronic pharmacy records were used to abstract information on the type, length, and dosage of statin exposures starting in the year prior to diagnosis."( Influence of Statins and Cholesterol on Mortality Among Patients With Pancreatic Cancer.
Chang, JI; Huang, BZ; Li, E; Wu, BU; Xiang, AH, 2017
)
0.46
" For GEM conjugates, triple doses with dosage 5 mg/kg were given on days 0, 7, and 14 (q7dx3), whereas a single dose regime with 20 mg/kg was applied on day 0 for PTX conjugates treatment."( Backbone Degradable N-(2-Hydroxypropyl)methacrylamide Copolymer Conjugates with Gemcitabine and Paclitaxel: Impact of Molecular Weight on Activity toward Human Ovarian Carcinoma Xenografts.
Fang, Y; Kopeček, J; Li, Y; Pan, H; Yang, J; Zhang, L; Zhang, R, 2017
)
0.68
" The GnRH-R agonistic potential of GSG was investigated by quantifying the testosterone levels in animals dosed daily with GSG, while an in vitro colony forming assay together with in vivo whole blood measurements were performed to elucidate the hematotoxicity profile of GSG."( Gemcitabine Based Peptide Conjugate with Improved Metabolic Properties and Dual Mode of Efficacy.
Argyros, O; Fokas, D; Karampelas, T; Skavatsou, E; Tamvakopoulos, C, 2017
)
1.9
" Twelve patients received weekly dosing at 60 to 100 mg/m²."( Universal tolerance of nab-paclitaxel for gynecologic malignancies in patients with prior taxane hypersensitivity reactions.
Mahdi, H; Maurer, K; Michener, C; Rose, PG, 2017
)
0.46
" This study illustrates that co-encapsulation in a single carrier is not always desirable for the delivery of drug combinations, when the activity depends on the dosing sequence."( Mixed Liposome Approach for Ratiometric and Sequential Delivery of Paclitaxel and Gemcitabine.
Liu, Y; Tamam, H; Yeo, Y, 2018
)
0.71
"Unintentional passive diffusion of conventional small molecular weight pharmaceuticals across intact membranes of normal healthy cells in tissues and organ systems induces sequelae that limit therapeutic dosage and duration of administration."( Selectively Targeted Anti-Neoplastic Cytotoxicity of Three Immunopharmaceuticals with Covalently Bound Fludarabine, Gemcitabine and Dexamethasone Moieties Synthesized Utilizing Organic Chemistry Reactions in a Multi-Stage Regimen.
Coyne, CP; Narayanan, L, 2018
)
0.69
"2 g/m2 and carboplatin AUC 5 dosing schedule."( Gemcitabine and carboplatin in metastatic nonsmall cell lung cancer: Experience from a tertiary cancer center in South India.
Devika, T; Dubashi, B; Kayal, S; Kumar, R; Shewade, DG,
)
1.57
" However, a clinically available therapeutic regimen for this compound needs to be established and its functional mechanisms in relation to the dosing schedule need to be clarified."( Analysis of the prolonged infusion of DFP-10917, a deoxycytidine analog, as a therapeutic strategy for the treatment of human tumor xenografts in vivo.
Eshima, K; Fukushima, M; Iizuka, K; Jin, C; Zhang, C, 2018
)
0.48
" However, the full potential of this drug has not been realised, in part due to low oral bioavailability and frequent dosing requirements."( N-trimethyl chitosan nanoparticles and CSKSSDYQC peptide: N-trimethyl chitosan conjugates enhance the oral bioavailability of gemcitabine to treat breast cancer.
Chen, G; Huang, Y; Lu, W; Svirskis, D; Wen, J; Ying, M, 2018
)
0.69
" Alternatively, the concept of prior dosing allows for the application of dialyzable chemotherapeutic drugs using a normal dose, with an HD followed shortly after to mimic normal renal function."( Chemotherapeutic agents eligible for prior dosing in pancreatic cancer patients requiring hemodialysis: a systematic review
.
Egger, J; Hann, A; Hermann, PC; Keller, F; Nosalski, E; Seufferlein, T, 2018
)
0.48
" We tapered off the opioid analgesia dosage because the cancer pain was relieved after 1 course."( [A Case of Successful Treatment with Gemcitabine plus Nab-Paclitaxel Therapy for Nonresected Pancreatic Body Cancer(Stage IVb)].
Endo, T; Hasegawa, K; Isogai, J; Kamiya, A; Kaneko, J; Kobayashi, K; Kondoh, I; Maejima, K; Maejima, S; Takatsuno, Y, 2018
)
0.75
" The application of multidrug combination and adjuvant-drug carriers is a feasible strategy to overcome the limitations while minimizing the dosage of single drug and acquiring the synergistic effects in tumor therapy."( Co-delivery of paclitaxel and gemcitabine by methoxy poly(ethylene glycol)-poly(lactide-coglycolide)-polypeptide nanoparticles for effective breast cancer therapy.
Dong, S; Duan, Y; Guo, Y; Li, Z; Ma, M; Niu, L; Shi, Y; Wang, C; Wang, N; Zhang, M, 2018
)
0.77
"A retrospective analysis of gemcitabine dosage prepared over three months permitted to explain our consumption of this drug, and by modelling, to characterize the good prescription interval for each dosage."( [Comparative costs study between ready-to-administer bag of gemcitabine and production in reconstitution unit].
Lortal, B; Pouplin, M,
)
0.67
" Structure-based modification of mifepristone led to the discovery of ORIC-101 (28), a highly potent steroidal GR antagonist with reduced androgen receptor (AR) agonistic activity amenable for dosing in androgen receptor positive tumors and with improved CYP2C8 and CYP2C9 inhibition profile to minimize drug-drug interaction potential."( Discovery of a Potent and Selective Steroidal Glucocorticoid Receptor Antagonist (ORIC-101).
Chen, C; Du, X; Eksterowicz, J; Fantin, VR; Huang, E; Huang, T; Jackson, E; Jahchan, N; Kawai, H; McGee, LR; Medina, JC; Rew, Y; Sun, D; Sutimantanapi, D; Waszczuk, J; Yan, X; Ye, Q; Zavorotinskaya, T; Zhou, H; Zhu, L, 2018
)
0.48
" During the treatment, morphine dosage kept the same or decreased in 20 patients (47."( KML001, an arsenic compound, as salvage chemotherapy in refractory biliary tract cancers: A prospective study.
Bang, S; Chung, MJ; Jo, JH; Kang, H; Lee, HS; Park, JY; Park, SW; Song, SY, 2019
)
0.51
" However, efforts to seize the normalization window have constrained the development of vascular normalization therapy in clinical applications owing to the lack of circulating biomarkers and the tedious dosage regimes."( Attempts to strengthen and simplify the tumor vascular normalization strategy using tumor vessel normalization promoting nanomedicines.
Du, S; Lu, Y; Xiong, H; Xu, C; Yao, J, 2019
)
0.51
" The approach consisted of building a translational model combining pre-clinical pharmacokinetic-pharmacodynamic (PKPD) models and parameters, with dosing paradigms used in the clinics along with clinical PK models to derive tumour profiles in humans driving overall survival."( Translational Framework Predicting Tumour Response in Gemcitabine-Treated Patients with Advanced Pancreatic and Ovarian Cancer from Xenograft Studies.
Garcia-Cremades, M; Iversen, PW; Pitou, C; Troconiz, IF, 2019
)
0.76
"The dose escalation, confirmation, and expansion results support the dosing of merestinib at 120 mg once daily, based on acceptable exposure and safety at this dose."( First-in-Human Phase I Study of Merestinib, an Oral Multikinase Inhibitor, in Patients with Advanced Cancer.
Birnbaum, A; Cohen, RB; Denlinger, CS; Giles, J; He, AR; Hwang, J; Lewis, N; Moser, B; Mynderse, M; Niland, M; Plimack, ER; Sama, A; Sato, T; Walgren, R; Wallin, J; Zhang, W, 2019
)
0.51
" The dosing used in this trial is described in the qualifying statements, while it should be noted that the dose of capecitabine may also be determined by institutional and regional practices."( Adjuvant Therapy for Resected Biliary Tract Cancer: ASCO Clinical Practice Guideline.
Bachini, M; Bekaii-Saab, T; Crane, C; Edeline, J; El-Khoueiry, A; Feng, M; Katz, MHG; Kennedy, EB; Maithel, SK; Primrose, J; Shroff, RT; Soares, HP; Valle, J, 2019
)
0.51
" Patients received vantictumab at escalating doses in combination with standard dosing of nab-paclitaxel and gemcitabine according to a 3 + 3 design."( A phase 1b dose escalation study of Wnt pathway inhibitor vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated metastatic pancreatic cancer.
Berlin, J; Cardin, DB; Cohen, SJ; Davis, SL; Dotan, E; Kapoun, AM; Lenz, HJ; Messersmith, WA; O'Neil, BH; Shahda, S; Stagg, RJ, 2020
)
0.98
"Galunisertib 300 mg/day was given orally as intermittent dosing and gemcitabine as per label."( Population pharmacokinetics and exposure-overall survival analysis of the transforming growth factor-β inhibitor galunisertib in patients with pancreatic cancer.
Benhadji, KA; Cleverly, A; Gueorguieva, I; Lahn, MM; Macarulla, T; Melisi, D; Merz, V; Miles, C; Tabernero, J; Waterhouse, TH, 2019
)
0.75
"This analysis suggests that 300 mg/day galunisertib administered as 150 mg twice daily for 14 days on/14 days off treatment is an appropriate dosing regimen for patients with pancreatic cancer."( Population pharmacokinetics and exposure-overall survival analysis of the transforming growth factor-β inhibitor galunisertib in patients with pancreatic cancer.
Benhadji, KA; Cleverly, A; Gueorguieva, I; Lahn, MM; Macarulla, T; Melisi, D; Merz, V; Miles, C; Tabernero, J; Waterhouse, TH, 2019
)
0.51
" ExoGEM treatment, in tumor-bearing mice, significantly suppressed tumor growth, with prolonged survival in a dose-response manner, but caused minimal damage to normal tissues."( Gemcitabine loaded autologous exosomes for effective and safe chemotherapy of pancreatic cancer.
Cai, JX; Hu, XB; Li, YJ; Wang, JM; Wu, JY; Xiang, DX, 2020
)
2
" In this study, we established two stable multidrug-resistant cell lines, BxPC-3-GR and CFPAC-1-GR, from their corresponding parental cells through exposure to GEM following a stepwise incremental dosing strategy."( Identification of chemoresistance-related mRNAs based on gemcitabine-resistant pancreatic cancer cell lines.
Ding, Y; Ge, W; Huang, Y; Kong, Y; Wang, W; Yan, Y; Zhang, L; Zheng, H; Zhou, J; Zhou, X; Zhu, W, 2020
)
0.8
" A dose-response study indicates that GT DcNP provided a therapeutic index of ~15."( Novel drug combination nanoparticles exhibit enhanced plasma exposure and dose-responsive effects on eliminating breast cancer lung metastasis.
Griffin, JI; Ho, RJY; McConnachie, LA; Mu, Q; Wu, Y; Yu, J; Zhu, L, 2020
)
0.56
"The gemcitabine (GEM)-carboplatin (CBDCA) combination is widely used for non-small cell lung cancer (NSCLC) and has some efficacy in elderly patients; however, a high incidence of thrombocytopenia is observed, and the optimal dosage and administration schedules are unknown."( Phase II Study on Biweekly Combination Therapy of Gemcitabine plus Carboplatin for the Treatment of Elderly Patients with Advanced Non-Small Cell Lung Cancer.
Akamine, S; Ebi, N; Ichiki, M; Matsumoto, T; Nakanishi, Y; Takayama, K; Tokunaga, S; Uchino, J; Yamada, T, 2020
)
1.37
" Most remarkably, drug loaded coaxial fibers, particularly doxorubicin-containing fibers, had higher anticancer effect in vivo compared to systemic injection of equivalent dosage of the drugs."( Coaxial mussel-inspired biofibers: making of a robust and efficacious depot for cancer drug delivery.
Foroughi, J; Kim, SC; Shim, IK; Spinks, GM; Talebian, S; Vine, KL, 2020
)
0.56
" On the basis of preclinical data, sequential dosing was evaluated in cohort 4 (ipafricept day 1 followed nab-paclitaxel + gemcitabine day 3)."( Phase Ib Study of Wnt Inhibitor Ipafricept with Gemcitabine and nab-paclitaxel in Patients with Previously Untreated Stage IV Pancreatic Cancer.
Astsaturov, I; Brachmann, RK; Cardin, DB; Cohen, SJ; Denlinger, CS; Dotan, E; Kapoun, AM; Lenz, HJ; Messersmith, W; O'Neil, B; Shahda, S; Stagg, RJ; Uttamsingh, S; Weekes, C, 2020
)
1.02
" Anti-PanC efficacy of single agents vs combination in the three tumor explants, both at the end of active dosing regimen and following a drug-washout phase were compared."( Bitter melon juice intake with gemcitabine intervention circumvents resistance to gemcitabine in pancreatic patient-derived xenograft tumors.
Agarwal, C; Agarwal, R; Bagby, SM; Dhar, D; Kumar, D; Messersmith, WA; Orlicky, DJ; Pitts, TM; Raina, K; Wempe, MF, 2020
)
0.84
" Whereas reductions of NTx dosage was more common in elderly patients in comparison 1 (p = 0."( Neoadjuvant therapy in elderly patients receiving FOLFIRINOX or gemcitabine/nab-paclitaxel for borderline resectable or locally advanced pancreatic cancer is feasible and lead to a similar oncological outcome compared to non-aged patients - Results of the
Ceyhan, GO; Damm, M; Kordes, M; Maggino, L; Moir, J; Rosendahl, J; Schorn, S; Weniger, M, 2020
)
0.8
" Attempts to improve the dosing regimen of gemcitabine were aimed at maximising the intracellular gemcitabine triphosphate concentrations."( Intracellular Pharmacokinetics of Pyrimidine Analogues used in Oncology and the Correlation with Drug Action.
Beijnen, JH; Derissen, EJB, 2020
)
0.82
"Results of this Phase Ib trial indicate that PG-11047 can be safely administered to patients in combination with bevacizumab, erlotinib, cisplatin, and 5-FU on the once weekly dosing schedule described and may provide therapeutic benefit."( A Phase Ib multicenter, dose-escalation study of the polyamine analogue PG-11047 in combination with gemcitabine, docetaxel, bevacizumab, erlotinib, cisplatin, 5-fluorouracil, or sunitinib in patients with advanced solid tumors or lymphoma.
Becerra, CHR; Boyd, TE; Casero, RA; Conkling, PR; Fitzgerald, M; Garbo, LE; Jotte, RM; Marton, LJ; Murray Stewart, T; Richards, DA; Smith, DA; Stephenson, JJ; Vogelzang, NJ; Von Hoff, D; Wu, HH, 2021
)
0.84
" Protocol variability and dosage differences limit statistical interpretation."( Nephron-sparing management of upper tract urothelial carcinoma.
Farrow, JM; Gryzinski, GM; Kern, SQ; Sundaram, CP, 2021
)
0.62
"Pharmacokinetic (PK) studies improve the design of dosing regimens in preclinical and clinical settings."( New In Vitro-In Silico Approach for the Prediction of In Vivo Performance of Drug Combinations.
Correia, C; Ferreira, A; Lapa, R; Santos, J; Urtti, A; Vale, N; Yliperttula, M, 2021
)
0.62
" Accurate assessment of renal function is indispensable for determining cisplatin dosing to enhance the safety and effectiveness of cisplatin."( Evaluation of renal function using cystatin C-based estimated glomerular filtration rate in patients with urothelial carcinoma treated with gemcitabine and cisplatin chemotherapy.
Hamada, S; Kadowaki, D; Miyamura, S; Nishimura, F; Oniki, K; Saruwatari, J; Ushijima, T, 2021
)
0.82
" This approach has proven its efficacy, although drug dosing and scheduling are often chosen empirically."( Minimal PK/PD model for simultaneous description of the maximal tolerated dose and metronomic treatment outcomes in mouse tumor models.
Bogdanov, AA; Chubenko, VA; Klimenko, VV; Knyazev, NA; Moiseyenko, VM; Terterov, IN, 2021
)
0.62
" Chemotherapy dosing based on body composition, rather than conventional anthropometric measures, may be effective in reducing treatment toxicity."( An exploratory study of body composition as a predictor of dose-limiting toxicity in metastatic pancreatic cancer treated with gemcitabine plus nab-paclitaxel.
Chambers, C; Chen, A; Eurich, DT; Ha, V; McCall, M; Sawyer, MB; Youn, S, 2021
)
0.83
" Berzosertib plus cisplatin with gemcitabine was associated with significantly higher hematologic toxicities despite attenuated dosing of cisplatin with gemcitabine."( Effect of Cisplatin and Gemcitabine With or Without Berzosertib in Patients With Advanced Urothelial Carcinoma: A Phase 2 Randomized Clinical Trial.
Cui, Y; Dreicer, R; Emamekhoo, H; Frankel, PH; Hoimes, C; Kim, WY; Lara, PN; Lyou, Y; Michaelson, D; Milowsky, M; Mortazavi, A; Newman, E; Pal, SK; Parikh, M; Parikh, R; Srinivas, S; Teply, B; Vaishampayan, U; Weng, P; Zhang, T, 2021
)
1.21
"A retrospective, multicenter study was conducted on 64 CTCL and BPDCN patients treated with gemcitabine in average absolute dosage of 1,800 mg/m2 per cycle, which is 50% lower compared to standard dosage of 3,600 mg/m2 per cycle (1,200 mg/m2 day 1, 8, 15)."( Clinical Outcomes of Advanced-Stage Cutaneous Lymphoma under Low-Dose Gemcitabine Treatment: Real-Life Data from the German Cutaneous Lymphoma Network.
Assaf, C; Blazejak, C; Gambichler, T; Gosman, J; Klemke, CD; Nicolay, JP; Olk, J; Stadler, R; Stendel, S; Stranzenbach, R; Wehkamp, U; Weyermann, M; Wobser, M, 2022
)
1.18
" The traditional dosing schedule of GA is days 1, 8, and 15 of a 28-day cycle."( Dosing Schedules of Gemcitabine and nab-Paclitaxel for Older Adults With Metastatic Pancreatic Cancer.
Dotan, E; Handorf, E; Winer, A, 2021
)
0.94
" Patients were grouped by dosing at treatment initiation (traditional vs modified dosing schedules)."( Dosing Schedules of Gemcitabine and nab-Paclitaxel for Older Adults With Metastatic Pancreatic Cancer.
Dotan, E; Handorf, E; Winer, A, 2021
)
0.94
"In this real-world cohort, treatment of older mPDAC patients with a modified dosing schedule of GA resulted in shorter TOT and worse OS vs a traditional dosing schedule."( Dosing Schedules of Gemcitabine and nab-Paclitaxel for Older Adults With Metastatic Pancreatic Cancer.
Dotan, E; Handorf, E; Winer, A, 2021
)
0.94
" We developed dosage guidelines to dose modify gem and nab without granulocyte colony-stimulating factors."( Use of
Chambers, CR; Chen, A; Ghosh, S; Ha, VH; Sawyer, MB, 2022
)
0.72
" Besides these two strategies, physiologically based pharmacokinetic models (PBPK models) are also the key for predicting drug distribution based on physiological data, which is very important for personalized medicine, so that the correct drug and dosage regimen can be administered according to each patient's physiology."( Two Possible Strategies for Drug Modification of Gemcitabine and Future Contributions to Personalized Medicine.
Pereira, M; Vale, N, 2022
)
0.98
"The aim of our retrospective study was to evaluate the efficacy of a continuous therapy with a lower dosage of gemcitabine compared to those usually administered in patients with cutaneous T cell lymphomas (CTCL)."( Continuous low-dose gemcitabine in primary cutaneous T cell lymphoma: A retrospective study.
Bianchi, L; Cantonetti, M; Di Raimondo, C; Meconi, F; Monopoli, A; Narducci, MG; Nunzi, A; Rapisarda, V; Scala, E; Tesei, C; Vaccarini, S; Zizzari, A, 2022
)
1.26
"Of 23 patients in the intention-to-treat population (11 in Arm 1, 12 in Arm 2), 20 completed both dosing cycles of TAR-200."( The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial.
Aron, M; Brummelhuis, ISG; Chau, A; Cutie, CJ; Daneshmand, S; Keegan, KA; Maffeo, JC; Pohar, KS; Raybold, B; Reynolds, DL; Steinberg, GD; Witjes, JA, 2022
)
0.97
" Selumetinib was dosed at 75 mg BID but amended to 50 mg BID due to toxicity."( Randomised, Phase II study of selumetinib, an oral inhibitor of MEK, in combination with cisplatin and gemcitabine chemotherapy for patients with advanced biliary tract cancer.
Chen, E; DeLuca, S; Dhani, N; Doherty, MK; Hedley, D; Jang, R; Knox, JJ; McNamara, MG; O'Kane, GM; Pedutem, T; Sim, HW; Tam, VC; Tang, P; Wang, L, 2022
)
0.94
"During treatment, the dosage of sintilimab was halved in 2 patients due to adverse reactions."( Clinical Study of Anti-PD-1 Immunotherapy Combined with Gemcitabine Chemotherapy in Multiline Treatment of Advanced Pancreatic Cancer.
Du, S; Fan, L; Li, Y; Liu, Y; Wang, J, 2022
)
0.97
" The dosing period was 23."( [GEM plus CDDP Combination Therapy for Unresectable Biliary Tract Cancer-A Single Institution Experience].
Aoyama, S; Hata, T; Hiraki, M; Ikeshima, R; Katsura, Y; Katsuyama, S; Kihara, Y; Kinoshita, M; Masuzawa, T; Muneta, M; Murata, K; Ohmura, Y; Shinke, G; Sugimura, K; Takeda, Y, 2023
)
0.91
" These findings provide critical information for clinical research on DBD as an adjuvant for NSCLC with gemcitabine and help make potential dosage adjustments more scientifically and rationally."( Gemcitabine enhances pharmacokinetic exposure of the major components of Danggui Buxue Decoction in rat via the promotion of intestinal permeability and down-regulation of CYP3A for combination treatment of non-small cell lung cancer.
Chang, M; Cheng, TT; Hang, TJ; Hu, ZL; Song, M; Sun, XY; Xu, X, 2023
)
2.57
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (11)

RoleDescription
antineoplastic agentA substance that inhibits or prevents the proliferation of neoplasms.
antimetaboliteA substance which is structurally similar to a metabolite but which competes with it or replaces it, and so prevents or reduces its normal utilization.
antiviral drugA substance used in the prophylaxis or therapy of virus diseases.
immunosuppressive agentAn agent that suppresses immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-cells or by inhibiting the activation of helper cells. In addition, an immunosuppressive agent is a role played by a compound which is exhibited by a capability to diminish the extent and/or voracity of an immune response.
photosensitizing agentA chemical compound that can be excited by light of a specific wavelength and subsequently transfer energy to a chosen reactant. This is commonly molecular oxygen within a cancer tissue, which is converted to (highly rective) singlet state oxygen. This rapidly reacts with any nearby biomolecules, ultimately killing the cancer cells.
DNA synthesis inhibitorAny substance that inhibits the synthesis of DNA.
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitorAn EC 1.17.* (oxidoreductase acting on CH or CH2) inhibitor that inhibits the action of ribonucleoside-diphosphate reductase (EC 1.17.4.1).
environmental contaminantAny minor or unwanted substance introduced into the environment that can have undesired effects.
xenobioticA xenobiotic (Greek, xenos "foreign"; bios "life") is a compound that is foreign to a living organism. Principal xenobiotics include: drugs, carcinogens and various compounds that have been introduced into the environment by artificial means.
radiosensitizing agentA drug that makes increases the sensitivity of tumour cells to radiation therapy.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (2)

ClassDescription
organofluorine compoundAn organofluorine compound is a compound containing at least one carbon-fluorine bond.
pyrimidine 2'-deoxyribonucleoside
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (2)

PathwayProteinsCompounds
Gemcitabine Action Pathway138
Gemcitabine Metabolism Pathway138

Protein Targets (15)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, DEOXYNUCLEOSIDE KINASEDrosophila melanogaster (fruit fly)IC50 (µMol)0.76000.76000.76000.7600AID977608
Equilibrative nucleoside transporter 1Homo sapiens (human)IC50 (µMol)0.19000.00013.688363.0000AID1694958
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Spike glycoproteinBetacoronavirus England 1EC50 (µMol)3.08000.00304.57559.8200AID1804127
Replicase polyprotein 1abBetacoronavirus England 1EC50 (µMol)3.08000.00304.57559.8200AID1804127
Transmembrane protease serine 2Homo sapiens (human)EC50 (µMol)3.08000.00304.51689.8200AID1804127
Procathepsin LHomo sapiens (human)EC50 (µMol)3.08000.00304.48749.8200AID1804127
Replicase polyprotein 1aSevere acute respiratory syndrome-related coronavirusEC50 (µMol)3.08000.00304.61369.8200AID1804127
Replicase polyprotein 1abHuman coronavirus 229EEC50 (µMol)3.08000.00304.61369.8200AID1804127
Replicase polyprotein 1abSevere acute respiratory syndrome-related coronavirusEC50 (µMol)3.08000.00304.45549.8200AID1804127
Replicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2EC50 (µMol)3.08000.00304.11059.8200AID1804127
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusEC50 (µMol)3.08000.00304.57559.8200AID1804127
Angiotensin-converting enzyme 2 Homo sapiens (human)EC50 (µMol)3.08000.00304.57559.8200AID1804127
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Deoxycytidine kinaseHomo sapiens (human)Km1.77500.40003.57908.5000AID1222343; AID278932
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (87)

Processvia Protein(s)Taxonomy
viral translationTransmembrane protease serine 2Homo sapiens (human)
proteolysisTransmembrane protease serine 2Homo sapiens (human)
protein autoprocessingTransmembrane protease serine 2Homo sapiens (human)
positive regulation of viral entry into host cellTransmembrane protease serine 2Homo sapiens (human)
adaptive immune responseProcathepsin LHomo sapiens (human)
proteolysisProcathepsin LHomo sapiens (human)
protein autoprocessingProcathepsin LHomo sapiens (human)
fusion of virus membrane with host plasma membraneProcathepsin LHomo sapiens (human)
receptor-mediated endocytosis of virus by host cellProcathepsin LHomo sapiens (human)
antigen processing and presentationProcathepsin LHomo sapiens (human)
antigen processing and presentation of exogenous peptide antigen via MHC class IIProcathepsin LHomo sapiens (human)
collagen catabolic processProcathepsin LHomo sapiens (human)
zymogen activationProcathepsin LHomo sapiens (human)
enkephalin processingProcathepsin LHomo sapiens (human)
fusion of virus membrane with host endosome membraneProcathepsin LHomo sapiens (human)
CD4-positive, alpha-beta T cell lineage commitmentProcathepsin LHomo sapiens (human)
symbiont entry into host cellProcathepsin LHomo sapiens (human)
antigen processing and presentation of peptide antigenProcathepsin LHomo sapiens (human)
proteolysis involved in protein catabolic processProcathepsin LHomo sapiens (human)
elastin catabolic processProcathepsin LHomo sapiens (human)
macrophage apoptotic processProcathepsin LHomo sapiens (human)
cellular response to thyroid hormone stimulusProcathepsin LHomo sapiens (human)
positive regulation of apoptotic signaling pathwayProcathepsin LHomo sapiens (human)
positive regulation of peptidase activityProcathepsin LHomo sapiens (human)
immune responseProcathepsin LHomo sapiens (human)
symbiont-mediated perturbation of host ubiquitin-like protein modificationReplicase polyprotein 1aSevere acute respiratory syndrome-related coronavirus
symbiont-mediated perturbation of host ubiquitin-like protein modificationReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
pyrimidine nucleotide metabolic processDeoxycytidine kinaseHomo sapiens (human)
CMP biosynthetic processDeoxycytidine kinaseHomo sapiens (human)
dAMP salvageDeoxycytidine kinaseHomo sapiens (human)
nucleoside phosphate biosynthetic processDeoxycytidine kinaseHomo sapiens (human)
cell surface receptor signaling pathwayCytidine deaminaseHomo sapiens (human)
pyrimidine-containing compound salvageCytidine deaminaseHomo sapiens (human)
cytidine deaminationCytidine deaminaseHomo sapiens (human)
cytosine metabolic processCytidine deaminaseHomo sapiens (human)
negative regulation of cell growthCytidine deaminaseHomo sapiens (human)
UMP salvageCytidine deaminaseHomo sapiens (human)
negative regulation of nucleotide metabolic processCytidine deaminaseHomo sapiens (human)
response to cycloheximideCytidine deaminaseHomo sapiens (human)
cellular response to external biotic stimulusCytidine deaminaseHomo sapiens (human)
neurotransmitter uptakeEquilibrative nucleoside transporter 1Homo sapiens (human)
nucleobase-containing compound metabolic processEquilibrative nucleoside transporter 1Homo sapiens (human)
xenobiotic metabolic processEquilibrative nucleoside transporter 1Homo sapiens (human)
neurotransmitter transportEquilibrative nucleoside transporter 1Homo sapiens (human)
xenobiotic transmembrane transportEquilibrative nucleoside transporter 1Homo sapiens (human)
lactationEquilibrative nucleoside transporter 1Homo sapiens (human)
nucleobase transportEquilibrative nucleoside transporter 1Homo sapiens (human)
adenine transportEquilibrative nucleoside transporter 1Homo sapiens (human)
nucleoside transportEquilibrative nucleoside transporter 1Homo sapiens (human)
purine nucleoside transmembrane transportEquilibrative nucleoside transporter 1Homo sapiens (human)
cytidine transportEquilibrative nucleoside transporter 1Homo sapiens (human)
uridine transmembrane transportEquilibrative nucleoside transporter 1Homo sapiens (human)
adenosine transportEquilibrative nucleoside transporter 1Homo sapiens (human)
inosine transportEquilibrative nucleoside transporter 1Homo sapiens (human)
hypoxanthine transportEquilibrative nucleoside transporter 1Homo sapiens (human)
thymine transportEquilibrative nucleoside transporter 1Homo sapiens (human)
excitatory postsynaptic potentialEquilibrative nucleoside transporter 1Homo sapiens (human)
cellular response to glucose stimulusEquilibrative nucleoside transporter 1Homo sapiens (human)
cellular response to hypoxiaEquilibrative nucleoside transporter 1Homo sapiens (human)
pyrimidine-containing compound transmembrane transportEquilibrative nucleoside transporter 1Homo sapiens (human)
transport across blood-brain barrierEquilibrative nucleoside transporter 1Homo sapiens (human)
nucleoside transmembrane transportEquilibrative nucleoside transporter 1Homo sapiens (human)
guanine transmembrane transportEquilibrative nucleoside transporter 1Homo sapiens (human)
uracil transmembrane transportEquilibrative nucleoside transporter 1Homo sapiens (human)
pyrimidine nucleobase transmembrane transportEquilibrative nucleoside transporter 1Homo sapiens (human)
purine nucleobase transmembrane transportEquilibrative nucleoside transporter 1Homo sapiens (human)
negative regulation of signaling receptor activityAngiotensin-converting enzyme 2 Homo sapiens (human)
symbiont entry into host cellAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of cytokine productionAngiotensin-converting enzyme 2 Homo sapiens (human)
angiotensin maturationAngiotensin-converting enzyme 2 Homo sapiens (human)
angiotensin-mediated drinking behaviorAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of systemic arterial blood pressure by renin-angiotensinAngiotensin-converting enzyme 2 Homo sapiens (human)
tryptophan transportAngiotensin-converting enzyme 2 Homo sapiens (human)
viral life cycleAngiotensin-converting enzyme 2 Homo sapiens (human)
receptor-mediated endocytosis of virus by host cellAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of vasoconstrictionAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of transmembrane transporter activityAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of cell population proliferationAngiotensin-converting enzyme 2 Homo sapiens (human)
symbiont entry into host cellAngiotensin-converting enzyme 2 Homo sapiens (human)
receptor-mediated virion attachment to host cellAngiotensin-converting enzyme 2 Homo sapiens (human)
negative regulation of smooth muscle cell proliferationAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of inflammatory responseAngiotensin-converting enzyme 2 Homo sapiens (human)
positive regulation of amino acid transportAngiotensin-converting enzyme 2 Homo sapiens (human)
maternal process involved in female pregnancyAngiotensin-converting enzyme 2 Homo sapiens (human)
positive regulation of cardiac muscle contractionAngiotensin-converting enzyme 2 Homo sapiens (human)
membrane fusionAngiotensin-converting enzyme 2 Homo sapiens (human)
negative regulation of ERK1 and ERK2 cascadeAngiotensin-converting enzyme 2 Homo sapiens (human)
blood vessel diameter maintenanceAngiotensin-converting enzyme 2 Homo sapiens (human)
entry receptor-mediated virion attachment to host cellAngiotensin-converting enzyme 2 Homo sapiens (human)
positive regulation of gap junction assemblyAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of cardiac conductionAngiotensin-converting enzyme 2 Homo sapiens (human)
positive regulation of L-proline import across plasma membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processAngiotensin-converting enzyme 2 Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (47)

Processvia Protein(s)Taxonomy
serine-type endopeptidase activityTransmembrane protease serine 2Homo sapiens (human)
protein bindingTransmembrane protease serine 2Homo sapiens (human)
serine-type peptidase activityTransmembrane protease serine 2Homo sapiens (human)
fibronectin bindingProcathepsin LHomo sapiens (human)
cysteine-type endopeptidase activityProcathepsin LHomo sapiens (human)
protein bindingProcathepsin LHomo sapiens (human)
collagen bindingProcathepsin LHomo sapiens (human)
cysteine-type peptidase activityProcathepsin LHomo sapiens (human)
histone bindingProcathepsin LHomo sapiens (human)
proteoglycan bindingProcathepsin LHomo sapiens (human)
serpin family protein bindingProcathepsin LHomo sapiens (human)
cysteine-type endopeptidase activator activity involved in apoptotic processProcathepsin LHomo sapiens (human)
RNA-dependent RNA polymerase activityReplicase polyprotein 1aSevere acute respiratory syndrome-related coronavirus
cysteine-type endopeptidase activityReplicase polyprotein 1aSevere acute respiratory syndrome-related coronavirus
K63-linked deubiquitinase activityReplicase polyprotein 1aSevere acute respiratory syndrome-related coronavirus
K48-linked deubiquitinase activityReplicase polyprotein 1aSevere acute respiratory syndrome-related coronavirus
3'-5'-RNA exonuclease activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
RNA-dependent RNA polymerase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
cysteine-type endopeptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
mRNA 5'-cap (guanine-N7-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
mRNA (nucleoside-2'-O-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
5'-3' RNA helicase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
K63-linked deubiquitinase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
K48-linked deubiquitinase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
3'-5'-RNA exonuclease activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
RNA-dependent RNA polymerase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
cysteine-type endopeptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA 5'-cap (guanine-N7-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA (nucleoside-2'-O-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA guanylyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
RNA endonuclease activity, producing 3'-phosphomonoestersReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
ISG15-specific peptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
5'-3' RNA helicase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
protein guanylyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
deoxyadenosine kinase activityDeoxycytidine kinaseHomo sapiens (human)
deoxycytidine kinase activityDeoxycytidine kinaseHomo sapiens (human)
deoxyguanosine kinase activityDeoxycytidine kinaseHomo sapiens (human)
ATP bindingDeoxycytidine kinaseHomo sapiens (human)
protein homodimerization activityDeoxycytidine kinaseHomo sapiens (human)
cytidine kinase activityDeoxycytidine kinaseHomo sapiens (human)
nucleoside bindingCytidine deaminaseHomo sapiens (human)
cytidine deaminase activityCytidine deaminaseHomo sapiens (human)
protein bindingCytidine deaminaseHomo sapiens (human)
zinc ion bindingCytidine deaminaseHomo sapiens (human)
identical protein bindingCytidine deaminaseHomo sapiens (human)
protein homodimerization activityCytidine deaminaseHomo sapiens (human)
neurotransmitter transmembrane transporter activityEquilibrative nucleoside transporter 1Homo sapiens (human)
nucleoside transmembrane transporter activityEquilibrative nucleoside transporter 1Homo sapiens (human)
adenine transmembrane transporter activityEquilibrative nucleoside transporter 1Homo sapiens (human)
guanine transmembrane transporter activityEquilibrative nucleoside transporter 1Homo sapiens (human)
uracil transmembrane transporter activityEquilibrative nucleoside transporter 1Homo sapiens (human)
purine nucleoside transmembrane transporter activityEquilibrative nucleoside transporter 1Homo sapiens (human)
cytidine transmembrane transporter activityEquilibrative nucleoside transporter 1Homo sapiens (human)
uridine transmembrane transporter activityEquilibrative nucleoside transporter 1Homo sapiens (human)
pyrimidine- and adenosine-specific:sodium symporter activityEquilibrative nucleoside transporter 1Homo sapiens (human)
virus receptor activityAngiotensin-converting enzyme 2 Homo sapiens (human)
endopeptidase activityAngiotensin-converting enzyme 2 Homo sapiens (human)
carboxypeptidase activityAngiotensin-converting enzyme 2 Homo sapiens (human)
metallocarboxypeptidase activityAngiotensin-converting enzyme 2 Homo sapiens (human)
protein bindingAngiotensin-converting enzyme 2 Homo sapiens (human)
metallopeptidase activityAngiotensin-converting enzyme 2 Homo sapiens (human)
peptidyl-dipeptidase activityAngiotensin-converting enzyme 2 Homo sapiens (human)
zinc ion bindingAngiotensin-converting enzyme 2 Homo sapiens (human)
identical protein bindingAngiotensin-converting enzyme 2 Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (34)

Processvia Protein(s)Taxonomy
extracellular regionTransmembrane protease serine 2Homo sapiens (human)
nucleoplasmTransmembrane protease serine 2Homo sapiens (human)
plasma membraneTransmembrane protease serine 2Homo sapiens (human)
extracellular exosomeTransmembrane protease serine 2Homo sapiens (human)
extracellular regionProcathepsin LHomo sapiens (human)
extracellular spaceProcathepsin LHomo sapiens (human)
nucleusProcathepsin LHomo sapiens (human)
lysosomeProcathepsin LHomo sapiens (human)
multivesicular bodyProcathepsin LHomo sapiens (human)
Golgi apparatusProcathepsin LHomo sapiens (human)
plasma membraneProcathepsin LHomo sapiens (human)
apical plasma membraneProcathepsin LHomo sapiens (human)
endolysosome lumenProcathepsin LHomo sapiens (human)
chromaffin granuleProcathepsin LHomo sapiens (human)
lysosomal lumenProcathepsin LHomo sapiens (human)
intracellular membrane-bounded organelleProcathepsin LHomo sapiens (human)
collagen-containing extracellular matrixProcathepsin LHomo sapiens (human)
extracellular exosomeProcathepsin LHomo sapiens (human)
endocytic vesicle lumenProcathepsin LHomo sapiens (human)
extracellular spaceProcathepsin LHomo sapiens (human)
lysosomeProcathepsin LHomo sapiens (human)
double membrane vesicle viral factory outer membraneReplicase polyprotein 1aSevere acute respiratory syndrome-related coronavirus
double membrane vesicle viral factory outer membraneReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
double membrane vesicle viral factory outer membraneReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
nucleoplasmDeoxycytidine kinaseHomo sapiens (human)
cytosolDeoxycytidine kinaseHomo sapiens (human)
mitochondrionDeoxycytidine kinaseHomo sapiens (human)
cytoplasmDeoxycytidine kinaseHomo sapiens (human)
extracellular regionCytidine deaminaseHomo sapiens (human)
cytosolCytidine deaminaseHomo sapiens (human)
secretory granule lumenCytidine deaminaseHomo sapiens (human)
tertiary granule lumenCytidine deaminaseHomo sapiens (human)
ficolin-1-rich granule lumenCytidine deaminaseHomo sapiens (human)
cytosolCytidine deaminaseHomo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
plasma membraneEquilibrative nucleoside transporter 1Homo sapiens (human)
membraneEquilibrative nucleoside transporter 1Homo sapiens (human)
basolateral plasma membraneEquilibrative nucleoside transporter 1Homo sapiens (human)
apical plasma membraneEquilibrative nucleoside transporter 1Homo sapiens (human)
presynapseEquilibrative nucleoside transporter 1Homo sapiens (human)
postsynapseEquilibrative nucleoside transporter 1Homo sapiens (human)
plasma membraneEquilibrative nucleoside transporter 1Homo sapiens (human)
plasma membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
extracellular regionAngiotensin-converting enzyme 2 Homo sapiens (human)
extracellular spaceAngiotensin-converting enzyme 2 Homo sapiens (human)
endoplasmic reticulum lumenAngiotensin-converting enzyme 2 Homo sapiens (human)
plasma membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
ciliumAngiotensin-converting enzyme 2 Homo sapiens (human)
cell surfaceAngiotensin-converting enzyme 2 Homo sapiens (human)
membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
apical plasma membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
endocytic vesicle membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
brush border membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
membrane raftAngiotensin-converting enzyme 2 Homo sapiens (human)
extracellular exosomeAngiotensin-converting enzyme 2 Homo sapiens (human)
extracellular spaceAngiotensin-converting enzyme 2 Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (906)

Assay IDTitleYearJournalArticle
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1772129Inhibition of CHK1 in human HT-29 cells assessed as increase in phosphorylation at S345 residue at 40 nM incubated for 24 hrs by Western blot analysis2021Journal of medicinal chemistry, 10-28, Volume: 64, Issue:20
Discovery and Development of a Potent, Selective, and Orally Bioavailable CHK1 Inhibitor Candidate: 5-((4-((3-Amino-3-methylbutyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)picolinonitrile.
AID253425Ability (18 umol/kg) tested on mortality of non-diseased CD2F1 mice at day 8 (n=8)2005Bioorganic & medicinal chemistry letters, May-16, Volume: 15, Issue:10
Synthesis and biological evaluation of gemcitabine-lipid conjugate (NEO6002).
AID301992Antiproliferative activity against human DU145 cells by MTT assay2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Structure-based design and synthesis of (5-arylamino-2H-pyrazol-3-yl)-biphenyl-2',4'-diols as novel and potent human CHK1 inhibitors.
AID1412567Cytotoxicity against mouse B16F10 cells assessed as decrease in cell viability after 72 hrs by MTT assay2018MedChemComm, May-01, Volume: 9, Issue:5
Development of a peptide-based bifunctional chelator conjugated to a cytotoxic drug for the treatment of melanotic melanoma.
AID517592Growth inhibition of human MIAPaCa2 cells after 48 hrs by MTT assay2010Bioorganic & medicinal chemistry letters, Oct-15, Volume: 20, Issue:20
A novel arylethynyltriazole acyclonucleoside inhibits proliferation of drug-resistant pancreatic cancer cells.
AID718350Growth inhibition of human MIAPaCa2 cells after 48 hrs by SRB assay2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
New adamantane phenylalkylamines with σ-receptor binding affinity and anticancer activity, associated with putative antagonism of neuropathic pain.
AID1682874Toxicity in BALB/c mouse allografted with mouse Panc02 cells assessed as effect on body weight at 100 mg/kg, ip administered every day measured after 19 days2021Bioorganic & medicinal chemistry, 01-01, Volume: 29Design, synthesis and biological evaluation of imidazolopyridone derivatives as novel BRD4 inhibitors.
AID1064247Cytotoxicity against human PANC1 cells in nutrient-deprived medium after 24 hrs by WST-8 assay2014Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2
Discovery of 2-pyridineformamide thiosemicarbazones as potent antiausterity agents.
AID340155Antitumor activity against human HT29 cells after 48 hrs by MTS assay2008Journal of medicinal chemistry, Jul-24, Volume: 51, Issue:14
Ribose-modified purine nucleosides as ribonucleotide reductase inhibitors. Synthesis, antitumor activity, and molecular modeling of N6-substituted 3'-C-methyladenosine derivatives.
AID267643Decrease in tumor growth in mouse xenografted with MiaPaCa2 cells at 120 mg/kg/day, ip after 21 days2006Bioorganic & medicinal chemistry letters, Jul-01, Volume: 16, Issue:13
Discovery and SAR of oxindole-pyridine-based protein kinase B/Akt inhibitors for treating cancers.
AID683842Cytotoxicity against human MIAPaCa2 cells after 72 hrs by resazurin assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
Comparison of the cytotoxic effects of enantiopure PPAPs, including nemorosone and clusianone.
AID1684803Antiviral activity against Hepatitis C virus assessed as inhibition of viral replication incubated for 3 days by Renilla luciferase based assay2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1867131Cytotoxicity against human BXPC-3 cells assessed as inhibition of cell growth incubated for 72 hrs by SRB assay2022Journal of natural products, 04-22, Volume: 85, Issue:4
Cytotoxic Nitrobenzoyl Sesquiterpenoids from an Antarctica Sponge-Derived
AID611471Cytotoxicity against human MES-SA cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID676700Cytotoxicity against human MIAPaCa2 cells grown in nutrient-rich medium after 24 hrs by WST8 assay2012Journal of natural products, Jun-22, Volume: 75, Issue:6
Antiausterity agents from Uvaria dac and their preferential cytotoxic activity against human pancreatic cancer cell lines in a nutrient-deprived condition.
AID1197746Stimulation of human OATP1B3-mediated [3H]CCK-8 at 100 uM after 5 mins relative to control2015European journal of medicinal chemistry, Mar-06, Volume: 92Interaction of human organic anion transporter polypeptides 1B1 and 1B3 with antineoplastic compounds.
AID1807098Cytotoxicity against human KG-1a cells assessed as viable cells at 1 uM for 48 hrs by FITC-PE analysis (Rvb = 3.9 to 4%)2021Journal of medicinal chemistry, 06-24, Volume: 64, Issue:12
Single Diastereomers of the Clinical Anticancer ProTide Agents NUC-1031 and NUC-3373 Preferentially Target Cancer Stem Cells
AID719547Antitumor activity against human Calu6 cells xenografted in athymic mouse assessed as tumor growth delay at 100 mg/kg, iv tid for 7 days (Rvb = 6.9 1.6)2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Discovery of 3-alkoxyamino-5-(pyridin-2-ylamino)pyrazine-2-carbonitriles as selective, orally bioavailable CHK1 inhibitors.
AID1298296Reduction in dCTP level in human U373-MAGI cells at 2.5 nM after 6 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1298401Increase in 5-aza-dCTP/dCTP ratio in human U373-MAGI cells at 25 nM preincubated for 2 hrs followed by 5-aza-C addition measured after 4 hrs by LC-MS/MS analysis relative to 5-aza-C2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1533374Antiproliferative activity against human BJ cells after 3 days by MTS assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID1054209Cytotoxicity against human U373-MAGI cells by CellTitre-Glo assay2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
5,6-Dihydro-5-aza-2'-deoxycytidine potentiates the anti-HIV-1 activity of ribonucleotide reductase inhibitors.
AID676565Antitumor activity against human A549 cells xenografted in nu/nu mouse assessed as inhibition of tumor volume at 10 mg/kg, ip administered three times a week for 3 weeks2012Journal of medicinal chemistry, May-10, Volume: 55, Issue:9
Fluorocyclopentenyl-cytosine with broad spectrum and potent antitumor activity.
AID1867129Cytotoxicity against human ASPC1 cells assessed as inhibition of cell growth incubated for 72 hrs by SRB assay2022Journal of natural products, 04-22, Volume: 85, Issue:4
Cytotoxic Nitrobenzoyl Sesquiterpenoids from an Antarctica Sponge-Derived
AID718347Growth inhibition of human BxPC3 cells after 48 hrs by SRB assay2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
New adamantane phenylalkylamines with σ-receptor binding affinity and anticancer activity, associated with putative antagonism of neuropathic pain.
AID611461Cytotoxicity against human SK-N-AS cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1682878Upregulation of caspase 3 in BALB/c mouse allografted with mouse Panc02 cells assessed as effect on body weight at 100 mg/kg, ip administered every day measured after 20 days by immunohistochemical analysis2021Bioorganic & medicinal chemistry, 01-01, Volume: 29Design, synthesis and biological evaluation of imidazolopyridone derivatives as novel BRD4 inhibitors.
AID341999Antimicrobial activity against Staphylococcus aureus ATCC 29213 after 20 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID503807Antiproliferative activity against human SF539 cells expressing p53 gene after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1550508Cytotoxicity against human PANC1 cells incubated for 24 hrs by MTT assay2019European journal of medicinal chemistry, May-15, Volume: 170Multi-target compounds acting in cancer progression: Focus on thiosemicarbazone, thiazole and thiazolidinone analogues.
AID1441786Cytotoxicity against human HeLaS3 cells assessed as reduction in cell viability after 72 hrs by XTT assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID687150Induction of apoptosis in multidrug-resistant human MIAPaCa2 cells assessed as early apoptotic cells after 48 hrs using AnnexinV-FITC conjugated 7- AAD staining by flow cytometry (Rvb = 2.54%)2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
A novel bitriazolyl acyclonucleoside endowed with dual antiproliferative and immunomodulatory activity.
AID1124959Cytotoxicity against human HeLa cells assessed as reduction of cell survival after 72 hrs by MTT assay2014Bioorganic & medicinal chemistry, Apr-01, Volume: 22, Issue:7
N-Acyl-phosphoramidates as potential novel form of gemcitabine prodrugs.
AID526354Antiproliferative activity against human p53 deficient K562 cells after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1602093Antiproliferative activity against human MDA-MB-231 cells measured after 72 hrs by MTT assay2019European journal of medicinal chemistry, Mar-15, Volume: 166Development of bioactive gemcitabine-D-Lys
AID1416687Cytostatic activity against human K562-TAX cells after 3 days by MTS assay2017MedChemComm, Sep-01, Volume: 8, Issue:9
Sugar modified pyrimido[4,5-
AID426606Cytotoxicity against human A549 cells after 72 hrs by MTT assay2009Bioorganic & medicinal chemistry letters, May-15, Volume: 19, Issue:10
Synthesis and cytotoxicities of icogenin analogues with disaccharide residues.
AID1203915Cytotoxicity against human A549 cells assessed as combination index treated at 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1486081Antiproliferative activity against human BxPC3 cells after 72 hrs by CCK8 assay2017Bioorganic & medicinal chemistry, 08-01, Volume: 25, Issue:15
Design, synthesis and biological evaluation of sulfonamide-substituted diphenylpyrimidine derivatives (Sul-DPPYs) as potent focal adhesion kinase (FAK) inhibitors with antitumor activity.
AID117642In vivo activity against transplanted Mam-16/C/ Taxol tumors of mice; Not active2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID1742797Selectivity index, ratio of IC50 for cytotoxicity against human HCV-29 cells to IC50 for cytotoxicity against human T-24 cells2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID1549861Toxicity in human PANC1 cells xenografted in nude mouse assessed as pathological changes in liver at 30 mg/kg, ip administered every 3 days for 4 weeks post tumor inoculation by hematoxylin and eosin staining based assay2019European journal of medicinal chemistry, May-15, Volume: 170Synthesis and evaluation of tetrahydroquinolin-2(1H)-one derivatives as novel anti-pancreatic cancer agents via targeting autophagy.
AID1533376Antiproliferative activity against human A549 cells after 3 days by MTS assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID1151325Cytotoxicity against human HeLa cells assessed as cell viability after 24 hrs by WST-1 assay2014Journal of natural products, May-23, Volume: 77, Issue:5
Cytotoxic alkylated hydroquinone, phenol, and cyclohexenone derivatives from Aspergillus violaceofuscus Gasperini.
AID1908847Induction of apoptosis in human MIA PaCa-2 cells assessed as late apoptotic cells at 0.5 uM incubated for 24 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 2.04%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID342005Antibacterial activity against deoxyribonucleotide kinase-deficient Escherichia coli KY895 expressing Streptococcus pyogenes recombinant thymidine kinase2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID1455106Antiproliferative activity against human MDA-MB-231 cells2018Journal of medicinal chemistry, 02-08, Volume: 61, Issue:3
Adventures in Scaffold Morphing: Discovery of Fused Ring Heterocyclic Checkpoint Kinase 1 (CHK1) Inhibitors.
AID1480635Tmax in Wistar rat at 50 mg/kg, po administered as single dose by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID1382702Antiproliferative activity against human MIAPaCa2 cells after 70 hrs by alamar blue assay2018European journal of medicinal chemistry, Mar-25, Volume: 148Enediynes bearing polyfluoroaryl sulfoxide as new antiproliferative agents with dual targeting of microtubules and DNA.
AID340166Decrease in intracellular dATP pool in human HL60 cells at 40 uM relative to control2008Journal of medicinal chemistry, Jul-24, Volume: 51, Issue:14
Ribose-modified purine nucleosides as ribonucleotide reductase inhibitors. Synthesis, antitumor activity, and molecular modeling of N6-substituted 3'-C-methyladenosine derivatives.
AID292214Growth inhibition of dCK deficient CEM cells by SRB assay in presence of dipyridamole2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID1203904Cytotoxicity against human MRC5 cells treated at LA + compound sequent. compound for 24 hrs, LA + compound for 24 hrs additional, total 48 hrs 2:1 and 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID503795Antiproliferative activity against p53 deficient human SF268 cells after 72 hrs2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID746536Cytotoxicity against human MIAPaCa2 cells at 0.5 uM after 72 hrs by MTT assay2013Bioorganic & medicinal chemistry letters, May-15, Volume: 23, Issue:10
Synthesis, characterization and anti-tumor activity of novel thymoquinone analogs against pancreatic cancer.
AID1807080Cytotoxicity against human HT-29 cells assessed as cell death incubated for 72 hrs by flow cytometry based Annexin V/7-AAD assay2021Journal of medicinal chemistry, 06-24, Volume: 64, Issue:12
Single Diastereomers of the Clinical Anticancer ProTide Agents NUC-1031 and NUC-3373 Preferentially Target Cancer Stem Cells
AID1776704Antiproliferative activity against human PANC-1 cells assessed as reduction in cell viability after 48 hrs by MTT assay2021Bioorganic & medicinal chemistry letters, 07-15, Volume: 44New indenopyrazole linked oxadiazole conjugates as anti-pancreatic cancer agents: Design, synthesis, in silico studies including 3D-QSAR analysis.
AID526362Antiproliferative activity against human SF539 cells expressing p53 after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1589124Selectivity index, ratio of IC50 for cytotoxicity in human NHDF cells to IC50 for cytotoxicity in human KB cells2019Bioorganic & medicinal chemistry letters, 09-15, Volume: 29, Issue:18
Synthesis and in vitro anticancer activity of new gemcitabine-nucleoside analogue dimers containing methyltriazole or ester-methyltriazole linker.
AID459143Growth inhibition of human HCT116 cells at 500 nM after 24 hrs by propidium iodide assay2010Bioorganic & medicinal chemistry, Feb, Volume: 18, Issue:3
Synthesis and biological evaluation of simple methoxylated chalcones as anticancer, anti-inflammatory and antioxidant agents.
AID1412574Induction of apoptosis in mouse B16F10 cells assessed as nuclear fragmentation at IC50 after 72 hrs by DAPI staining-based fluorescence microscopic method2018MedChemComm, May-01, Volume: 9, Issue:5
Development of a peptide-based bifunctional chelator conjugated to a cytotoxic drug for the treatment of melanotic melanoma.
AID445377Cell cycle arrest in human CCRF-CEM assessed as accumulation at G2/M phase at 5 x GIC50 after 24 hrs by flow cytometry2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1385959Antitumor activity against human AsPC1 cells xenografted in BALB/c nu/nu mouse co-implanted with human PSC assessed as reduction in tumor volume at 75 mg/kg/day, po administered twice per week via gavage measured after 28 days2018Journal of medicinal chemistry, 09-27, Volume: 61, Issue:18
6-Substituted Hexamethylene Amiloride (HMA) Derivatives as Potent and Selective Inhibitors of the Human Urokinase Plasminogen Activator for Use in Cancer.
AID1410093Antiproliferative activity against human H460 cells at 500 nM after 48 hrs by propidium iodide staining based fluorometry relative to control2018ACS medicinal chemistry letters, Mar-08, Volume: 9, Issue:3
Synthesis and Biological Screening of Pyrano[3,2-
AID427706Cytotoxicity against human K562 cells by sulforhodamine B method2009Journal of medicinal chemistry, Sep-10, Volume: 52, Issue:17
Discovery of a new template for anticancer agents: 2'-deoxy-2'-fluoro-4'-selenoarabinofuranosyl-cytosine (2'-F-4'-seleno-ara-C).
AID1713602Antiproliferative activity against human KG1 cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID459137Growth inhibition of human Calu1 cells at 500 nM after 24 hrs by propidium iodide assay2010Bioorganic & medicinal chemistry, Feb, Volume: 18, Issue:3
Synthesis and biological evaluation of simple methoxylated chalcones as anticancer, anti-inflammatory and antioxidant agents.
AID1054211Antiviral activity against HIV1 infected in human U373-MAGI cells assessed as increase in mutant frequency incubated for 2 hrs prior to viral infection followed by compound washout after 24 hrs measured 72 hrs post-infection by flow cytometry2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
5,6-Dihydro-5-aza-2'-deoxycytidine potentiates the anti-HIV-1 activity of ribonucleotide reductase inhibitors.
AID301991Antiproliferative activity against human MDA-MB-231 cells by MTT assay2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Structure-based design and synthesis of (5-arylamino-2H-pyrazol-3-yl)-biphenyl-2',4'-diols as novel and potent human CHK1 inhibitors.
AID1589119Cytotoxicity in human A549 cells assessed as reduction in cell viability incubated for 72 hrs by SRB assay2019Bioorganic & medicinal chemistry letters, 09-15, Volume: 29, Issue:18
Synthesis and in vitro anticancer activity of new gemcitabine-nucleoside analogue dimers containing methyltriazole or ester-methyltriazole linker.
AID1694958Substrate activity at ENT1 in human BXPC-3 cells assessed as inhibition of cell growth pretreated with ENT1 inhibitor nitrobenzylthioinosine for 5 mins measured after 72 hrs by SRB assay2020RSC medicinal chemistry, Feb-01, Volume: 11, Issue:2
Development of potent CPP6-gemcitabine conjugates against human prostate cancer cell line (PC-3).
AID1908850Induction of apoptosis in human MIA PaCa-2 cells assessed as early apoptotic cells at 0.1 uM incubated for 48 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 1.8%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1742793Antiproliferative activity against human Bel-7402 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID500351Induction of cell cycle arrest in human MCF7 cells expressing p53 gene assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1824950Induction of apoptosis in human WM266-4 cells assessed as late apoptotic cells at 1 uM measured after 72 hrs by Annexin V-FITC and PI staining based flow cytometry analysis (Rvb = 0.5%)2022Journal of medicinal chemistry, 01-13, Volume: 65, Issue:1
Integrin-Mediated Targeted Cancer Therapy Using c(RGDyK)-Based Conjugates of Gemcitabine.
AID1549859Toxicity in human PANC1 cells xenografted in nude mouse assessed as change in body weight at 30 mg/kg, ip administered every 3 days for 4 weeks post tumor inoculation2019European journal of medicinal chemistry, May-15, Volume: 170Synthesis and evaluation of tetrahydroquinolin-2(1H)-one derivatives as novel anti-pancreatic cancer agents via targeting autophagy.
AID292209Growth inhibition of H460 cells by SRB assay in presence of dipyridamole2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID1724271Down regulation of MAPK11 expression in mouse xenografted with human MIAPaCa2 cells at 15 mg/kg, iv administered twice per week for 28 days and measured on day 28 by Western blot analysis2020ACS medicinal chemistry letters, Aug-13, Volume: 11, Issue:8
Asymmetrically Substituted Quadruplex-Binding Naphthalene Diimide Showing Potent Activity in Pancreatic Cancer Models.
AID1480616Drug transport assessed as OCTN2 transporter mediated drug uptake in human Caco2 cells at 1 to 800 uM at 4 degC incubated for 10 mins2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID445372Cell cycle arrest in human CCRF-CEM assessed as accumulation at G1 phase at 1 x GIC50 after 24 hrs by flow cytometry2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1741736Cytotoxicity against human PANC-1 cells assessed as reduction in cell viability measured after 72 hrs by SRB assay2020European journal of medicinal chemistry, Oct-15, Volume: 204Design, synthesis and high antitumor potential of new unsymmetrical bisacridine derivatives towards human solid tumors, specifically pancreatic cancers and their unique ability to stabilize DNA G-quadruplexes.
AID1807088Cytotoxicity against human KG-1a cells assessed as viable cells at 0.25 uM for 48 hrs by FITC-PE analysis (Rvb = 3.9 to 4%)2021Journal of medicinal chemistry, 06-24, Volume: 64, Issue:12
Single Diastereomers of the Clinical Anticancer ProTide Agents NUC-1031 and NUC-3373 Preferentially Target Cancer Stem Cells
AID117782In vivo activity against transplanted Mel-B16 tumors of mice; Not active2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID1728101Antiproliferative activity against human MDA-MB-231 cells assessed as cell viability after 24 hrs2021European journal of medicinal chemistry, Jan-15, Volume: 210Potent antiproliferative activity of bradykinin B2 receptor selective agonist FR-190997 and analogue structures thereof: A paradox resolved?
AID1908824Cytotoxicity against human HPDE cells assessed as inhibition of cell growth incubated for 72 hrs by MTT assay2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1908835Induction of cell cycle arrest in human MIA PaCa-2 cells assessed as accumulation of cells in G2/M phase at 0.1 uM incubated for 48 hrs by RNase/propidium iodide staining based flow cytometry analysis (Rvb = 2.71%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1755774In vivo agonist activity at GnRH-R in C57BL6/N mouse assessed as release of testosterone in blood at 105.2 ug/kg, ip measured after 2 hrs by LC-MS/MS analysis
AID1457456Antitumor activity against human A2780 cells xenografted in CD-1 Foxn1 nude mouse assessed as tumor regression at 133 umol/kg, ip four times for every three days after 100 to 120 days2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
Influence of a Basic Side Chain on the Properties of Hypoxia-Selective Nitro Analogues of the Duocarmycins: Demonstration of Substantial Anticancer Activity in Combination with Irradiation or Chemotherapy.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID611458Cytotoxicity against human MCF7 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID526361Antiproliferative activity against human p53 deficient PC3 cells after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID676696Cytotoxicity against human MIAPaCa2 cells grown in nutrient-deprived medium after 24 hrs by WST8 assay2012Journal of natural products, Jun-22, Volume: 75, Issue:6
Antiausterity agents from Uvaria dac and their preferential cytotoxic activity against human pancreatic cancer cell lines in a nutrient-deprived condition.
AID1776705Antiproliferative activity against human Caco-2 cells assessed as reduction in cell viability after 48 hrs by MTT assay2021Bioorganic & medicinal chemistry letters, 07-15, Volume: 44New indenopyrazole linked oxadiazole conjugates as anti-pancreatic cancer agents: Design, synthesis, in silico studies including 3D-QSAR analysis.
AID1908837Induction of cell cycle arrest in human MIA PaCa-2 cells assessed as accumulation of cells in G0/G1 phase at 0.1 uM incubated for 24 hrs by RNase/propidium iodide staining based flow cytometry analysis (Rvb = 64.3%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID292201Growth inhibition of H460 cells by SRB assay2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID1824948Induction of apoptosis in human WM266-4 cells assessed as viable cells at 1 uM measured after 72 hrs by Annexin V-FITC and PI staining based flow cytometry analysis (Rvb = 98.2%)2022Journal of medicinal chemistry, 01-13, Volume: 65, Issue:1
Integrin-Mediated Targeted Cancer Therapy Using c(RGDyK)-Based Conjugates of Gemcitabine.
AID1480632Cmax in Wistar rat at 7.5 mg/kg, iv administered as single dose by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1742841Induction of ferroptosis in human T-24 cells assessed as downregulation of GPx4 at 2 to 12 uM by Western blot analysis2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID292208Growth inhibition of H292 cells by SRB assay in presence of dipyridamole2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID1850289Antiproliferative activity against human HCV-29 cells measured after 48 hrs by MTT assay
AID249694Ability (18 umol/kg) tested for inhibition of BxPC-3 human pancreatic tumor growth (n=8)2005Bioorganic & medicinal chemistry letters, May-16, Volume: 15, Issue:10
Synthesis and biological evaluation of gemcitabine-lipid conjugate (NEO6002).
AID438548Inhibition of DNA synthesis in chemoresistant human MIAPaCa2 cells assessed as incorporation of [3H]thymidine into DNA after 4 hrs by liquid scintillation counting2009Journal of medicinal chemistry, Oct-08, Volume: 52, Issue:19
Novel triazole ribonucleoside down-regulates heat shock protein 27 and induces potent anticancer activity on drug-resistant pancreatic cancer.
AID1684815Antiviral activity against Human cytomegalovirus AD169 infected in human HEL cells assessed as reduction in virus plaque formation measured on day 6 to 7 post-viral infection2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID477295Octanol-water partition coefficient, log P of the compound2010European journal of medicinal chemistry, Apr, Volume: 45, Issue:4
QSPR modeling of octanol/water partition coefficient of antineoplastic agents by balance of correlations.
AID1871667Anticancer activity against human SW1990 cells assessed as cell growth inhibition measured after 72 hrs by Cell-Titre Glo luminescent cell viability assay2022European journal of medicinal chemistry, Feb-05, Volume: 229Current status of carbazole hybrids as anticancer agents.
AID286459Cytotoxicity against SW1573 cells after 72 hrs by SRB assay2007Journal of medicinal chemistry, May-03, Volume: 50, Issue:9
In vitro optimization of non-small cell lung cancer activity with troxacitabine, L-1,3-dioxolane-cytidine, prodrugs.
AID1696862Inhibition of cell migration in human CAPAN-1 cells assessed as wound healing rate at 0.2 uM incubated for 24 hrs by wound healing assay (Rvb = 63%)2020Journal of medicinal chemistry, 10-08, Volume: 63, Issue:19
DPAGT1 Inhibitors of Capuramycin Analogues and Their Antimigratory Activities of Solid Tumors.
AID1807081Cytotoxicity against human LNCaP cells assessed as cell death incubated for 72 hrs by flow cytometry based Annexin V/7-AAD assay2021Journal of medicinal chemistry, 06-24, Volume: 64, Issue:12
Single Diastereomers of the Clinical Anticancer ProTide Agents NUC-1031 and NUC-3373 Preferentially Target Cancer Stem Cells
AID1358794Cell cycle arrest in human HT-29 cells assessed as accumulation at S phase at 25 nM after 48 hrs by propidium iodide/RNase staining-based flow cytometric analysis (Rvb = 30.9%)2018European journal of medicinal chemistry, May-10, Volume: 151Synthesis and biological evaluation of 2,6-disubstituted-9H-purine, 2,4-disubstitued-thieno[3,2-d]pyrimidine and -7H-pyrrolo[2,3-d]pyrimidine analogues as novel CHK1 inhibitors.
AID526349Antiproliferative activity against human HCT116 cells expressing p53 after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1457450Toxicity in CD-1 Foxn1 nude mouse xenografted with human SiHa cells assessed as lose in body weight at 133 umol/kg, ip four times for every three days after 100 to 120 days2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
Influence of a Basic Side Chain on the Properties of Hypoxia-Selective Nitro Analogues of the Duocarmycins: Demonstration of Substantial Anticancer Activity in Combination with Irradiation or Chemotherapy.
AID500350Induction of cell cycle arrest in p53 deficient human OVCAR8 cells assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1486079Antiproliferative activity against human AsPC1 cells after 72 hrs by CCK8 assay2017Bioorganic & medicinal chemistry, 08-01, Volume: 25, Issue:15
Design, synthesis and biological evaluation of sulfonamide-substituted diphenylpyrimidine derivatives (Sul-DPPYs) as potent focal adhesion kinase (FAK) inhibitors with antitumor activity.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID648694Growth inhibition of human Calu1 cells at 500 nM after 48 hrs by WST-8 assay2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
One pot synthesis and anticancer activity of dimeric phloroglucinols.
AID1203902Cytotoxicity against human MRC5 cells after 48 hrs by SRB assay2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1203900Cytotoxicity against human A549 cells treated at LA + compound sequent. LA for 24 hrs), LA + GEM (24 hrs additional, total 48 hrs) 2:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1441779Cytotoxicity against human HCT116 cells assessed as cell growth inhibition after 72 hrs by MTS assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID1480663Cytotoxicity against human BxPC3 cells assessed as decrease in cell viability at 0.1 to 200 uM after 48 hrs by MTT assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID459140Growth inhibition of human H460 cells at 500 nM after 24 hrs by propidium iodide assay2010Bioorganic & medicinal chemistry, Feb, Volume: 18, Issue:3
Synthesis and biological evaluation of simple methoxylated chalcones as anticancer, anti-inflammatory and antioxidant agents.
AID1730427Stability in pH 2 aqueous buffer assessed as parent compound remaining at 200 uM measured after 4 hrs by UV spectrophotometry2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1222341Drug metabolism assessed as 2',2'-difluorodeoxycytidine formation incubated for 1 min in presence of human recombinant N-terminal His-tagged DCK Ile24Val mutant expressed in Escherichia coli BL21(DE3) cells by liquid chromatography-tandem mass spectrometr2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1742806Induction of apoptosis in human T-24 cells assessed as necrotic cells at 3 uM in presence of vZAD incubated for 8 hrs by annexin V-FITC and PI staining based flow cytometry analysis (Rvb = 0.84 %)2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID1416683Cytostatic activity against human CEM/DNR cells after 3 days by MTS assay2017MedChemComm, Sep-01, Volume: 8, Issue:9
Sugar modified pyrimido[4,5-
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1589122Cytotoxicity in human NHDF cells assessed as reduction in cell viability incubated for 72 hrs by SRB assay2019Bioorganic & medicinal chemistry letters, 09-15, Volume: 29, Issue:18
Synthesis and in vitro anticancer activity of new gemcitabine-nucleoside analogue dimers containing methyltriazole or ester-methyltriazole linker.
AID503798Antiproliferative activity against p53 deficient human SW480 cells after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID648698Cytotoxicity against human PANC1 cells after 48 hrs by WST-8 assay2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
One pot synthesis and anticancer activity of dimeric phloroglucinols.
AID292206Growth inhibition of dCK deficient CEM cells by SRB assay2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID1298291Reduction in dGTP level in human U373-MAGI cells at 25 nM after 6 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1862942Antiproliferative activity against human A549 cells assessed as inhibition of cell growth2022Bioorganic & medicinal chemistry letters, 09-15, Volume: 72Design, synthesis and antitumor activity study of a gemcitabine prodrug conjugated with a HDAC6 inhibitor.
AID1812919Cytotoxicity against human SW1990 assessed as cell viability measured for 72 hrs by cell titer glo luminescent assay2021Journal of natural products, 08-27, Volume: 84, Issue:8
Monomeric, Dimeric, and Trimeric Tropane Alkaloids from
AID683841Cytotoxicity against human MCF7 cells after 72 hrs by resazurin assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
Comparison of the cytotoxic effects of enantiopure PPAPs, including nemorosone and clusianone.
AID1713592Antiproliferative activity against human HEL cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID1694320Anticancer activity against human SMMC-7721 cells assessed as inhibition of cell proliferation measured after 72 hrs by MTT assay2021Bioorganic & medicinal chemistry, 02-15, Volume: 32Novel penta-1,4-diene-3-one derivatives containing quinazoline and oxime ether fragments: Design, synthesis and bioactivity.
AID500349Induction of cell cycle arrest in p53 deficient human A2780/E6 cells as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1908813Cytotoxicity against human BXPC-3 cells assessed as inhibition of cell growth incubated for 72 hrs by MTT assay2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID426605Cytotoxicity against human PANC1 cells after 72 hrs by MTT assay2009Bioorganic & medicinal chemistry letters, May-15, Volume: 19, Issue:10
Synthesis and cytotoxicities of icogenin analogues with disaccharide residues.
AID1075469Cytotoxicity against human PANC1 cells assessed as cell viability by MTT assay in absence of hENT1 inhibitor dipyridamole2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID342012Activity of Staphylococcus aureus CCM 885 recombinant deoxyadenosine kinase2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID1054181Antiviral activity against HIV1 infected in human U373-MAGI cells assessed as C to T mutation at 20 nM (Rvb = 13%)2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
5,6-Dihydro-5-aza-2'-deoxycytidine potentiates the anti-HIV-1 activity of ribonucleotide reductase inhibitors.
AID1265588Antitumor activity against human MIAPaCa2 cells xenografted in athymic nude mouse assessed as tumor growth inhibition at 100 mg/kg, ip twice weekly2015Bioorganic & medicinal chemistry letters, Dec-15, Volume: 25, Issue:24
Synthesis, in vitro, and in vivo evaluation of novel functionalized quaternary ammonium curcuminoids as potential anti-cancer agents.
AID1693843Cytotoxicity against human MIA PaCa-2 cells expressing CD73 assessed as reduction in cell viability by CCK8 assay2021Bioorganic & medicinal chemistry letters, 02-15, Volume: 34Discovery of natural product ellagic acid as a potent CD73 and CD39 dual inhibitor.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1730410Cytotoxicity against human MCF7 cells assessed as reduction in cell viability measured after 96 hrs by celltiter-glo assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1467156Antiproliferative activity against human HT-29 cells after 48 hrs by sulforhodamine B assay2017Bioorganic & medicinal chemistry letters, 07-01, Volume: 27, Issue:13
Gemcitabine anti-proliferative activity significantly enhanced upon conjugation with cell-penetrating peptides.
AID1730415Antiviral activity against HCV infected in human Huh-7 cells assessed as reduction in viral replication at 25 to 1000 nM measured after 48 hrs in presence of deoxycytidine by luciferase reporter gene assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1054173Antiviral activity against HIV1 infected in human U373-MAGI cells assessed as induction of mutations at 20 nM (Rvb = 18%)2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
5,6-Dihydro-5-aza-2'-deoxycytidine potentiates the anti-HIV-1 activity of ribonucleotide reductase inhibitors.
AID526351Antiproliferative activity against human p53 deficient HeLa cells after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID658990Growth inhibition of human MIAPaCa2 cells after 48 hrs by SRB assay2012Bioorganic & medicinal chemistry, May-15, Volume: 20, Issue:10
Synthesis, σ₁, σ₂-receptors binding affinity and antiproliferative action of new C1-substituted adamantanes.
AID503805Antiproliferative activity against human HCT116 cells expressing p53 gene after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID302923Inhibition of tumor growth in PaCa2 cells xenografted nu/nu mouse at 80 mg/kg2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Optimization of naphthalimide-imidazoacridone with potent antitumor activity leading to clinical candidate (HKH40A, RTA 502).
AID1824951Induction of apoptosis in human WM266-4 cells assessed as necrotic cells at 1 uM measured after 72 hrs by Annexin V-FITC and PI staining based flow cytometry analysis (Rvb = 1.2%)2022Journal of medicinal chemistry, 01-13, Volume: 65, Issue:1
Integrin-Mediated Targeted Cancer Therapy Using c(RGDyK)-Based Conjugates of Gemcitabine.
AID687149Induction of apoptosis in multidrug-resistant human MIAPaCa2 cells assessed as late apoptotic cells after 48 hrs using AnnexinV-FITC conjugated 7- AAD staining by flow cytometry (Rvb = 0.21%)2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
A novel bitriazolyl acyclonucleoside endowed with dual antiproliferative and immunomodulatory activity.
AID537477Growth inhibition of human MDA-MB-231 cells at 0.1 uM after 96 hrs by sulforhodamine B assay relative to control2010Bioorganic & medicinal chemistry, Nov-15, Volume: 18, Issue:22
Synthesis and anticancer activity of new 1-[(5 or 6-substituted 2-alkoxyquinoxalin-3-yl)aminocarbonyl]-4-(hetero)arylpiperazine derivatives.
AID1298338Increase in 5-aza-dCTP/dCTP ratio in human U373-MAGI cells at 2.5 nM preincubated for 2 hrs followed by 5-aza-dC addition measured after 4 hrs by LC-MS/MS analysis relative to 5-aza-dC2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID676695Cytotoxicity against human PSN1 cells grown in nutrient-deprived medium after 24 hrs by WST8 assay2012Journal of natural products, Jun-22, Volume: 75, Issue:6
Antiausterity agents from Uvaria dac and their preferential cytotoxic activity against human pancreatic cancer cell lines in a nutrient-deprived condition.
AID1684816Antiviral activity against thymidine kinase deficient Varicella zoster virus 07-1 infected in human HEL cells assessed as reduction in virus plaque formation measured on day 5 post-viral infection2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID200580Inhibitory activity against SCC-25 (human, squamous cell carcinoma, tongue) cell line2003Journal of medicinal chemistry, Sep-11, Volume: 46, Issue:19
Synthesis and cytotoxic activity of two novel 1-dodecylthio-2-decyloxypropyl-3-phosphatidic acid conjugates with gemcitabine and cytosine arabinoside.
AID1486082Antiproliferative activity against human Ramos cells after 72 hrs by CCK8 assay2017Bioorganic & medicinal chemistry, 08-01, Volume: 25, Issue:15
Design, synthesis and biological evaluation of sulfonamide-substituted diphenylpyrimidine derivatives (Sul-DPPYs) as potent focal adhesion kinase (FAK) inhibitors with antitumor activity.
AID1441777Cytotoxicity against human MRC5 cells assessed as cell growth inhibition after 72 hrs by MTS assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID1908841Induction of apoptosis in human MIA PaCa-2 cells assessed as viable cells at 0.1 uM incubated for 24 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 90.2%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID676697Cytotoxicity against human KLM1 cells grown in nutrient-deprived medium after 24 hrs by WST8 assay2012Journal of natural products, Jun-22, Volume: 75, Issue:6
Antiausterity agents from Uvaria dac and their preferential cytotoxic activity against human pancreatic cancer cell lines in a nutrient-deprived condition.
AID445370Cell cycle arrest in human CCRF-CEM assessed as accumulation at subG1 phase at 1 x GIC50 after 24 hrs by flow cytometry2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1862947Antiproliferative activity against human MDA-MB-231 cells assessed as inhibition of cell growth pretreated with hENT1 inhibitor, dipyridamole at 10 uM followed by compound addition2022Bioorganic & medicinal chemistry letters, 09-15, Volume: 72Design, synthesis and antitumor activity study of a gemcitabine prodrug conjugated with a HDAC6 inhibitor.
AID1177589Cytotoxicity against human SW1990 cells assessed as reduction in cell viability2014Journal of natural products, Aug-22, Volume: 77, Issue:8
Brocazines A-F, Cytotoxic Bisthiodiketopiperazine Derivatives from Penicillium brocae MA-231, an Endophytic Fungus Derived from the Marine Mangrove Plant Avicennia marina.
AID1824949Induction of apoptosis in human WM266-4 cells assessed as early apoptotic cells at 1 uM measured after 72 hrs by Annexin V-FITC and PI staining based flow cytometry analysis (Rvb = 0.2%)2022Journal of medicinal chemistry, 01-13, Volume: 65, Issue:1
Integrin-Mediated Targeted Cancer Therapy Using c(RGDyK)-Based Conjugates of Gemcitabine.
AID1742796Cytotoxicity against human HCV-29 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID500343Induction of cell cycle arrest in p53 deficient human K562 cells assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1589120Cytotoxicity in human U87 cells assessed as reduction in cell viability incubated for 72 hrs by SRB assay2019Bioorganic & medicinal chemistry letters, 09-15, Volume: 29, Issue:18
Synthesis and in vitro anticancer activity of new gemcitabine-nucleoside analogue dimers containing methyltriazole or ester-methyltriazole linker.
AID1151327Cytotoxicity against human Jurkat cells assessed as cell viability after 24 hrs by WST-1 assay2014Journal of natural products, May-23, Volume: 77, Issue:5
Cytotoxic alkylated hydroquinone, phenol, and cyclohexenone derivatives from Aspergillus violaceofuscus Gasperini.
AID1385952Antitumor activity against human PSC xenografted in BALB/c nu/nu mouse co-implanted with human AsPC1 cells assessed as reduction in tumor volume at 75 mg/kg/day, po administered twice per week via gavage measured after 28 days2018Journal of medicinal chemistry, 09-27, Volume: 61, Issue:18
6-Substituted Hexamethylene Amiloride (HMA) Derivatives as Potent and Selective Inhibitors of the Human Urokinase Plasminogen Activator for Use in Cancer.
AID1151329Cytotoxicity against human HCT116 cells assessed as cell viability after 24 hrs by WST-1 assay2014Journal of natural products, May-23, Volume: 77, Issue:5
Cytotoxic alkylated hydroquinone, phenol, and cyclohexenone derivatives from Aspergillus violaceofuscus Gasperini.
AID426603Cytotoxicity against human BxPC3 cells after 72 hrs by MTT assay2009Bioorganic & medicinal chemistry letters, May-15, Volume: 19, Issue:10
Synthesis and cytotoxicities of icogenin analogues with disaccharide residues.
AID719544Antitumor activity against human SW620 cells xenografted in athymic mouse assessed as tumor growth delay at 100 mg/kg, iv tid for 4 days (Rvb = 5.3 1.3)2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Discovery of 3-alkoxyamino-5-(pyridin-2-ylamino)pyrazine-2-carbonitriles as selective, orally bioavailable CHK1 inhibitors.
AID1480634Tmax in Wistar rat at 7.5 mg/kg, iv administered as single dose by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1730418Antiviral activity against HCV infected in human Huh-7 cells assessed as reduction in viral replication at 500 nM measured within 6 hrs by luciferase reporter gene assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID611452Cytotoxicity against human K562 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1426828Cytotoxicity against human MCF7 cells incubated for 72 hrs under hypoxic condition by MTT assay2017Journal of medicinal chemistry, 02-09, Volume: 60, Issue:3
Total Syntheses and Biological Activities of Vinylamycin Analogues.
AID1776706Antiproliferative activity against human MRC5 cells assessed as reduction in cell viability after 48 hrs by MTT assay2021Bioorganic & medicinal chemistry letters, 07-15, Volume: 44New indenopyrazole linked oxadiazole conjugates as anti-pancreatic cancer agents: Design, synthesis, in silico studies including 3D-QSAR analysis.
AID503800Antiproliferative activity against p53 deficient human HCT116/E6 cells after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID57711In vitro cytotoxic activity against prostate carcinoma (DU-145) cells assayed by inhibition of [3H]-labeled thymidine incorporation2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
O-Phosphonatomethylcholine, its analogues, alkyl esters, and their biological activity.
AID1216056Cytotoxicity against human Patu-S cells by crystal violet staining2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Drug efflux transporter multidrug resistance-associated protein 5 affects sensitivity of pancreatic cancer cell lines to the nucleoside anticancer drug 5-fluorouracil.
AID717968Antitumor activity against human BxPC3 cells xenografted in SCID mouse assessed as tumor growth inhibition at 70 mg/kg, ip administered twice a week for three cycles measured after 3 cycles relative to control2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
New adamantane phenylalkylamines with σ-receptor binding affinity and anticancer activity, associated with putative antagonism of neuropathic pain.
AID278933Ratio of Kcat to Km for human dCK expressed in HepG2 cells2007Antimicrobial agents and chemotherapy, Feb, Volume: 51, Issue:2
Mechanism of activation of beta-D-2'-deoxy-2'-fluoro-2'-c-methylcytidine and inhibition of hepatitis C virus NS5B RNA polymerase.
AID1294504Cytotoxicity against human PC3 cells assessed as reduction in cell viability after 72 hrs by MTS assay2016Bioorganic & medicinal chemistry letters, May-01, Volume: 26, Issue:9
L-Aspartic and l-glutamic acid ester-based ProTides of anticancer nucleosides: Synthesis and antitumoral evaluation.
AID292200Growth inhibition of H292 cells by SRB assay2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID503799Antiproliferative activity against p53 deficient human COLO205 cells after 72 hrs2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1203921Cytotoxicity against human A549 cells assessed as dose reduction index ratio treated at simultaneous combination at 0.6 fraction inhibition after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1908812Cytotoxicity against human PANC-1 cells assessed as inhibition of cell growth incubated for 72 hrs by MTT assay2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1298279Reduction in dTTP level in human U373-MAGI cells at 2.5 nM after 6 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1696864Inhibition of cell migration in human PD002 cells assessed as wound healing rate at 0.2 uM incubated for 24 hrs by wound healing assay (Rvb = 63%)2020Journal of medicinal chemistry, 10-08, Volume: 63, Issue:19
DPAGT1 Inhibitors of Capuramycin Analogues and Their Antimigratory Activities of Solid Tumors.
AID1328102Antiausteritic activity against human PANC1 cells in nutrient-deprived medium measured after 24 hrs by WST8 assay2016Journal of natural products, 08-26, Volume: 79, Issue:8
Chemical Constituents of Mangifera indica and Their Antiausterity Activity against the PANC-1 Human Pancreatic Cancer Cell Line.
AID1654145Cytotoxicity against human PANC1 cells assessed as reduction in cell viability at 0.05 to 100 uM after 74 hrs by crystal violet staining based assay
AID253426Ability (27 umol/kg) tested on mortality of non-diseased CD2F1 mice at day 8 (n=8)2005Bioorganic & medicinal chemistry letters, May-16, Volume: 15, Issue:10
Synthesis and biological evaluation of gemcitabine-lipid conjugate (NEO6002).
AID292202Growth inhibition of SW1573 cells by SRB assay2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID1298321Reduction in dCTP level in human U373-MAGI cells at 2.5 nM preincubated for 2 hrs followed by 5-aza-C addition measured after 4 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1124962Cytotoxicity against human CFPAC-1 cells assessed as reduction of cell survival after 96 hrs by MTT assay2014Bioorganic & medicinal chemistry, Apr-01, Volume: 22, Issue:7
N-Acyl-phosphoramidates as potential novel form of gemcitabine prodrugs.
AID1075456Toxicity in Balb/c nude mouse xenografted with human BxPC3 cells assessed as change in body weight at 0.19 to 0.076 mmol/kg, ip administered 2 times per week for 2 weeks measured every week during compound treatment2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID1472808Growth inhibition of human HCT116 cells after 72 hrs by Hoechst 33258 dye based fluorescence assay2018Journal of medicinal chemistry, 02-08, Volume: 61, Issue:3
Structure-Guided Synthesis and Mechanistic Studies Reveal Sweetspots on Naphthyl Salicyl Hydrazone Scaffold as Non-Nucleosidic Competitive, Reversible Inhibitors of Human Ribonucleotide Reductase.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1755771Antiproliferative activity against human DU-145 cells measured after 72 hrs by MTT assay
AID1224155Prodrug conversion in phosphate buffered saline assessed as gemcitabine retention time at 100 uM after 6 to 24 hrs by HPLC analysis in presence of palladium-resins2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
Development and bioorthogonal activation of palladium-labile prodrugs of gemcitabine.
AID341997Antimicrobial activity against Streptococcus sp. 07706-1 after 20 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID1203910Cytotoxicity against human T24 cells treated at LA + compound sequent. LA for 24 hrs), LA + GEM (24 hrs additional, total 48 hrs) 2:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID500354Induction of cell cycle arrest in human SF539 cells expressing p53 gene assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1550507Cytotoxicity against human MIAPaCa2 cells incubated for 24 hrs by MTT assay2019European journal of medicinal chemistry, May-15, Volume: 170Multi-target compounds acting in cancer progression: Focus on thiosemicarbazone, thiazole and thiazolidinone analogues.
AID445376Cell cycle arrest in human CCRF-CEM assessed as accumulation at G2/M phase at 1 x GIC50 after 24 hrs by flow cytometry2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1742799Induction of apoptosis in human T-24 cells assessed as late apoptotic cells at 3 uM incubated for 8 hrs by annexin V-FITC and PI staining based flow cytometry analysis (Rvb = 1.71 %)2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID718967Antitumor activity against human MIAPaCa2 cells xenografted in SCID mouse assessed as tumor growth inhibition at 120 mg/kg/day, ip measured on day 21 to day 44 relative to vehicle-treated control2012Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24
Hit to Lead optimization of a novel class of squarate-containing polo-like kinases inhibitors.
AID117781In vivo activity against transplanted Mam-17/Adr tumors of mice; Not active2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID1416685Cytostatic activity against human HCT116 p53-/- cells after 3 days by MTS assay2017MedChemComm, Sep-01, Volume: 8, Issue:9
Sugar modified pyrimido[4,5-
AID1267267Cytotoxicity against human PANC1 cells assessed as viable cells at 50 uM2016European journal of medicinal chemistry, Jan-01, Volume: 107Structure-activity relationship study of anticancer thymidine-quinoxaline conjugates under the low radiance of long wavelength ultraviolet light for photodynamic therapy.
AID648763Cytotoxicity against human Calu1 cells after 48 hrs by WST-8 assay2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
One pot synthesis and anticancer activity of dimeric phloroglucinols.
AID611467Cytotoxicity against human PC3 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1358350Selectivity index, ratio of IC50 against human PANC1 cells under normoxic condition to IC50 for human PANC1 cells under hypoxic condition2018European journal of medicinal chemistry, May-10, Volume: 151Syntheses and anti-pancreatic cancer activities of rakicidin A analogues.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1684811Selectivity index, ratio of CC50 for human HEL cells to EC50 for antiviral activity against thymidine kinase positive Varicella zoster virus OKA infected in human HEL cells2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1203906Cytotoxicity against human MRC5 cells treated at LA + compound sequent. LA for 24 hrs), LA + GEM (24 hrs additional, total 48 hrs) 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID493450Cytotoxicity against human HuH7 cells by MTS assay2010Bioorganic & medicinal chemistry letters, Aug-01, Volume: 20, Issue:15
Synthesis and anti-HCV activity of 3',4'-oxetane nucleosides.
AID1908844Induction of apoptosis in human MIA PaCa-2 cells assessed as necrotic cells at 0.1 uM incubated for 24 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 2.7%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID286458Cytotoxicity against A549 cells after 72 hrs by SRB assay2007Journal of medicinal chemistry, May-03, Volume: 50, Issue:9
In vitro optimization of non-small cell lung cancer activity with troxacitabine, L-1,3-dioxolane-cytidine, prodrugs.
AID1480629AUC (0 to 24 hrs) in Wistar rat at 50 mg/kg, po administered as single dose by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID658991Growth inhibition of human BxPC3 cells after 48 hrs by SRB assay2012Bioorganic & medicinal chemistry, May-15, Volume: 20, Issue:10
Synthesis, σ₁, σ₂-receptors binding affinity and antiproliferative action of new C1-substituted adamantanes.
AID1455109Antiproliferative activity against human H460 cells harboring dominant negative p53 construct2018Journal of medicinal chemistry, 02-08, Volume: 61, Issue:3
Adventures in Scaffold Morphing: Discovery of Fused Ring Heterocyclic Checkpoint Kinase 1 (CHK1) Inhibitors.
AID1742795Antiproliferative activity against human T-24 cells assessed as reduction in cell viability measured upto 72 hrs by MTT assay2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID1589123Selectivity index, ratio of IC50 for cytotoxicity in human NHDF cells to IC50 for cytotoxicity in human HeLa cells2019Bioorganic & medicinal chemistry letters, 09-15, Volume: 29, Issue:18
Synthesis and in vitro anticancer activity of new gemcitabine-nucleoside analogue dimers containing methyltriazole or ester-methyltriazole linker.
AID1216060Cytotoxicity against human DAN-G cells by crystal violet staining2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Drug efflux transporter multidrug resistance-associated protein 5 affects sensitivity of pancreatic cancer cell lines to the nucleoside anticancer drug 5-fluorouracil.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1124957Cytotoxicity against human K562 cells assessed as reduction of cell survival after 48 hrs by MTT assay2014Bioorganic & medicinal chemistry, Apr-01, Volume: 22, Issue:7
N-Acyl-phosphoramidates as potential novel form of gemcitabine prodrugs.
AID503806Antiproliferative activity against human HCT15 cells expressing p53 gene after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID666081Cytotoxicity against human Calu1 cells at 1000 nM after 48 hrs by WST-1 assay2012Bioorganic & medicinal chemistry letters, Jun-15, Volume: 22, Issue:12
Simple, fast and efficient synthesis of β-keto esters from the esters of heteroaryl compounds, its antimicrobial study and cytotoxicity towards various cancer cell lines.
AID1824952Inhibition of clonogenicity in human WM266-4 cells assessed as proportion of cell colonies at 1 uM measured after 72 hrs relative to control2022Journal of medicinal chemistry, 01-13, Volume: 65, Issue:1
Integrin-Mediated Targeted Cancer Therapy Using c(RGDyK)-Based Conjugates of Gemcitabine.
AID1684809Antiviral activity against SARS-CoV-2 UC-1074 infected in African green monkey Vero cells assessed as reduction in virus plaque formation measured on day 5 post-viral infection by microscopic analysis2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1682871Antitumor activity against mouse Panc02 allografted in BALB/c mouse assessed as reduction in tumor weight at 100 mg/kg, ip administered every day for 20 days relative to control2021Bioorganic & medicinal chemistry, 01-01, Volume: 29Design, synthesis and biological evaluation of imidazolopyridone derivatives as novel BRD4 inhibitors.
AID1441776Cytotoxicity against human BJ cells assessed as cell growth inhibition after 72 hrs by MTS assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID1871325Selectivity index, ratio of IC50 for cytotoxicity against human BEAS-2B cells to IC50 for cytotoxicity against human A549 cells2021European journal of medicinal chemistry, Dec-15, Volume: 226A gulose moiety contributes to the belomycin (BLM) disaccharide selective targeting to lung cancer cells.
AID1358793Cell cycle arrest in human HT-29 cells assessed as accumulation at G1 phase at 25 nM after 48 hrs by propidium iodide/RNase staining-based flow cytometric analysis (Rvb = 62.1%)2018European journal of medicinal chemistry, May-10, Volume: 151Synthesis and biological evaluation of 2,6-disubstituted-9H-purine, 2,4-disubstitued-thieno[3,2-d]pyrimidine and -7H-pyrrolo[2,3-d]pyrimidine analogues as novel CHK1 inhibitors.
AID1772139Induction of S296 phosphorylation in tumor of mouse xenografted with human HT-29 cells at 100 mg/kg, iv dosed once a week for 22 days by Western blot analysis2021Journal of medicinal chemistry, 10-28, Volume: 64, Issue:20
Discovery and Development of a Potent, Selective, and Orally Bioavailable CHK1 Inhibitor Candidate: 5-((4-((3-Amino-3-methylbutyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)picolinonitrile.
AID476696Antiproliferative activity against human MIAPaCa2 cells assessed as cell viability at 50 uM after 48 hrs by MTT assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
N-aryltriazole ribonucleosides with potent antiproliferative activity against drug-resistant pancreatic cancer.
AID770685Cytotoxicity against human HT-29 cells after 48 hrs by MTT assay2013Bioorganic & medicinal chemistry letters, Oct-01, Volume: 23, Issue:19
Design, synthesis and ex vivo evaluation of colon-specific azo based prodrugs of anticancer agents.
AID426608Cytotoxicity against human A2780 cells after 72 hrs by MTT assay2009Bioorganic & medicinal chemistry letters, May-15, Volume: 19, Issue:10
Synthesis and cytotoxicities of icogenin analogues with disaccharide residues.
AID41517Inhibitory activity against BG-1 (human, breast adenocarcinoma) cell line2003Journal of medicinal chemistry, Sep-11, Volume: 46, Issue:19
Synthesis and cytotoxic activity of two novel 1-dodecylthio-2-decyloxypropyl-3-phosphatidic acid conjugates with gemcitabine and cytosine arabinoside.
AID1298366Potentiation of 5-Aza-C-induced antiviral activity against VSV-G pseudotyped HIV-1 NL4-3 infected in human U373-MAGI cells assessed as 5-Aza-C EC50 at 2.5 nM preincubated for 2 hrs followed by 5-Aza-C addition for 2 hrs and subsequent viral infection meas2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1807092Cytotoxicity against human KG-1a cells assessed as reduction in leukemic stem cells fraction up to 2.5 uM measured after 48 hrs by FACS assay2021Journal of medicinal chemistry, 06-24, Volume: 64, Issue:12
Single Diastereomers of the Clinical Anticancer ProTide Agents NUC-1031 and NUC-3373 Preferentially Target Cancer Stem Cells
AID1533375Antiproliferative activity against human MRC5 cells after 3 days by MTS assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID445374Cell cycle arrest in human CCRF-CEM assessed as accumulation at S phase at 1 x GIC50 after 24 hrs by flow cytometry2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1742805Induction of apoptosis in human T-24 cells assessed as late apoptotic cells at 3 uM in presence of vZAD incubated for 8 hrs by annexin V-FITC and PI staining based flow cytometry analysis (Rvb = 1.71 %)2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1170037Antiproliferative activity against gemcitabine-resistant human MDA-MB-231 cells after 48 hrs by MTT assay2014Journal of medicinal chemistry, Nov-26, Volume: 57, Issue:22
Hybrids of phenylsulfonylfuroxan and coumarin as potent antitumor agents.
AID719535Toxicity in athymic mouse xenografted with human SW620 cells assessed as body weight loss at 100 mg/kg, iv tid for 4 days2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Discovery of 3-alkoxyamino-5-(pyridin-2-ylamino)pyrazine-2-carbonitriles as selective, orally bioavailable CHK1 inhibitors.
AID687148Induction of apoptosis in multidrug-resistant human MIAPaCa2 cells assessed as necrotic cells after 48 hrs using AnnexinV-FITC conjugated 7- AAD staining by flow cytometry (Rvb = 0.17%)2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
A novel bitriazolyl acyclonucleoside endowed with dual antiproliferative and immunomodulatory activity.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1066255Cytostatic activity against human HeLa cells after 4 days by coulter counter analysis2014Journal of medicinal chemistry, Jan-09, Volume: 57, Issue:1
Synthesis and cytostatic evaluation of 4-N-alkanoyl and 4-N-alkyl gemcitabine analogues.
AID1689972Antiproliferative activity against human Capan-1 cells assessed as reduction in cell growth incubated for 72 hrs by SRB assay2020European journal of medicinal chemistry, Mar-01, Volume: 189Imidazo[2,1-b] [1,3,4]thiadiazoles with antiproliferative activity against primary and gemcitabine-resistant pancreatic cancer cells.
AID770695Cytotoxicity against human COLO205 cells after 48 hrs by MTT assay2013Bioorganic & medicinal chemistry letters, Oct-01, Volume: 23, Issue:19
Design, synthesis and ex vivo evaluation of colon-specific azo based prodrugs of anticancer agents.
AID1480631Terminal half-life in Wistar rat at 50 mg/kg, po administered as single dose by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID1908805Induction of apoptosis in human MIA PaCa-2 cells assessed as late apoptotic cells at 0.1 uM incubated for 48 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 0.8%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID445378Antimitotic activity in human CCRF-CEM cells assessed as decrease in mitotic histone H3 at 1 x GIC502010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1486083Antiproliferative activity against gefitinib-resistant human NCI-H1975 cells harboring FAK after 72 hrs by CCK8 assay2017Bioorganic & medicinal chemistry, 08-01, Volume: 25, Issue:15
Design, synthesis and biological evaluation of sulfonamide-substituted diphenylpyrimidine derivatives (Sul-DPPYs) as potent focal adhesion kinase (FAK) inhibitors with antitumor activity.
AID1693842Cytotoxicity against human MDA-MB-231 cells expressing CD73 assessed as reduction in cell viability by CCK8 assay2021Bioorganic & medicinal chemistry letters, 02-15, Volume: 34Discovery of natural product ellagic acid as a potent CD73 and CD39 dual inhibitor.
AID1724227Antitumor activity against human MIAPaCa2 cells xenografted in mouse assessed as mean tumor volume at 15 mg/kg, iv administered twice per week for 28 days and measured at day 28 by Caliper method (Rvb = 0.45 +/- 0.18 cm3)2020ACS medicinal chemistry letters, Aug-13, Volume: 11, Issue:8
Asymmetrically Substituted Quadruplex-Binding Naphthalene Diimide Showing Potent Activity in Pancreatic Cancer Models.
AID1358348Cytotoxicity against human PANC1 cells after 72 hrs under hypoxic condition by MTT assay2018European journal of medicinal chemistry, May-10, Volume: 151Syntheses and anti-pancreatic cancer activities of rakicidin A analogues.
AID1203907Cytotoxicity against human T24 cells after 48 hrs by SRB assay2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID648692Growth inhibition of human ACHN cells at 500 nM after 48 hrs by WST-8 assay2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
One pot synthesis and anticancer activity of dimeric phloroglucinols.
AID1075464Prodrug activation in human BxPC3 cells assessed as formation of dFdCTP after 24 hrs in presence of dCK inhibitor 2T2D2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID1602101Drug level in C57BL/6N mouse blood at 10 mg/kg, ip measured after 30 mins by LC-MS/MS analysis2019European journal of medicinal chemistry, Mar-15, Volume: 166Development of bioactive gemcitabine-D-Lys
AID1298309Reduction in dATP level in human U373-MAGI cells at 25 nM after 6 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1358795Cell cycle arrest in human HT-29 cells assessed as accumulation at G2 phase at 25 nM after 48 hrs by propidium iodide/RNase staining-based flow cytometric analysis (Rvb = 7.0%)2018European journal of medicinal chemistry, May-10, Volume: 151Synthesis and biological evaluation of 2,6-disubstituted-9H-purine, 2,4-disubstitued-thieno[3,2-d]pyrimidine and -7H-pyrrolo[2,3-d]pyrimidine analogues as novel CHK1 inhibitors.
AID1908849Induction of apoptosis in human MIA PaCa-2 cells assessed as live cells at 0.1 uM incubated for 48 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 96.3%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID611470Cytotoxicity against human NCI-H146 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1222323Activity of human recombinant N-terminal His-SUMO fused wild type CDA expressed in Escherichia coli BL21(DE3) cells assessed as 2',2'-difluorodeoxyuridine formation by liquid chromatography-tandem mass spectrometry2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1441781Cytotoxicity against human K562 cells assessed as cell growth inhibition after 72 hrs by MTS assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID1480618Drug transport in OCTN2 (unknown origin) expressing HEK293 cells assessed as transporter-mediated drug uptake at 25 uM after 15 mins by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID1222322Activity of human recombinant N-terminal His-SUMO fused CDA Lys27Gln mutant expressed in Escherichia coli BL21(DE3) cells assessed as 2',2'-difluorodeoxyuridine formation by liquid chromatography-tandem mass spectrometry2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1489777Toxicity in NOD/SCID mouse xenografted with human MIAPaCa2 cells assessed as body weight loss at 15 mg/kg administered twice a week for 15 days2018Journal of medicinal chemistry, 02-22, Volume: 61, Issue:4
Design and Synthesis of Novel Reactive Oxygen Species Inducers for the Treatment of Pancreatic Ductal Adenocarcinoma.
AID1298398Reduction in dCTP level in human U373-MAGI cells at 25 nM preincubated for 2 hrs followed by 5-aza-dC addition measured after 4 hrs by LC-MS/MS analysis relative to 5-aza-dC2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1549846Antitumor activity against human PANC1 cells xenografted in nude mouse assessed as reduction in tumor size at 30 mg/kg, ip administered every 3 days for 4 weeks post tumor inoculation2019European journal of medicinal chemistry, May-15, Volume: 170Synthesis and evaluation of tetrahydroquinolin-2(1H)-one derivatives as novel anti-pancreatic cancer agents via targeting autophagy.
AID611457Cytotoxicity against mouse EL4 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID427701Cytotoxicity against human HCT116 cells by sulforhodamine B method2009Journal of medicinal chemistry, Sep-10, Volume: 52, Issue:17
Discovery of a new template for anticancer agents: 2'-deoxy-2'-fluoro-4'-selenoarabinofuranosyl-cytosine (2'-F-4'-seleno-ara-C).
AID312866Cytotoxicity against multidrug-resistant human HCT15 cells by thymidine incorporation assay2008Journal of medicinal chemistry, Feb-14, Volume: 51, Issue:3
Comprehensive study of sansalvamide A derivatives and their structure-activity relationships against drug-resistant colon cancer cell lines.
AID460611Anticancer activity against human HCT116 cells at 500 nM after 48 hrs by propidium iodide fluorescence assay2010Bioorganic & medicinal chemistry, Mar-01, Volume: 18, Issue:5
Synthesis and biological screening of a combinatorial library of beta-chlorovinyl chalcones as anticancer, anti-inflammatory and antimicrobial agents.
AID1472807Growth inhibition of human MDA-MB-231 cells after 72 hrs by Hoechst 33258 dye based fluorescence assay2018Journal of medicinal chemistry, 02-08, Volume: 61, Issue:3
Structure-Guided Synthesis and Mechanistic Studies Reveal Sweetspots on Naphthyl Salicyl Hydrazone Scaffold as Non-Nucleosidic Competitive, Reversible Inhibitors of Human Ribonucleotide Reductase.
AID1062071Induction of apoptosis in human 8305C cells assessed as caspase-3 positive cells at 5 uM after 24 hrs by immunohistochemical analysis2013Bioorganic & medicinal chemistry, Dec-15, Volume: 21, Issue:24
Synthesis and biological evaluation of 3-hydroxymethyl-5-(1H-1,2,3-triazol) isoxazolidines.
AID1489702Cytotoxicity against human MIAPaCa2 cells assessed as decrease in cell proliferation after 72 hrs by MTT assay2018Journal of medicinal chemistry, 02-22, Volume: 61, Issue:4
Design and Synthesis of Novel Reactive Oxygen Species Inducers for the Treatment of Pancreatic Ductal Adenocarcinoma.
AID117643In vivo activity against transplanted Mam-16/C/Adr tumors of mice; Not active2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID611456Cytotoxicity against mouse L1210 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1216058Cytotoxicity against human PANC1 cells by crystal violet staining2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Drug efflux transporter multidrug resistance-associated protein 5 affects sensitivity of pancreatic cancer cell lines to the nucleoside anticancer drug 5-fluorouracil.
AID687151Induction of apoptosis in multidrug-resistant human MIAPaCa2 cells assessed as increase in caspase-3/7 activity after 48 hrs by caspase-Glo 3/7 assay2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
A novel bitriazolyl acyclonucleoside endowed with dual antiproliferative and immunomodulatory activity.
AID1689975Antiproliferative activity against gemicitabine-resistant human Panc-1R cells incubated for 72 hrs by SRB assay2020European journal of medicinal chemistry, Mar-01, Volume: 189Imidazo[2,1-b] [1,3,4]thiadiazoles with antiproliferative activity against primary and gemcitabine-resistant pancreatic cancer cells.
AID1416686Cytostatic activity against human K562 cells after 3 days by MTS assay2017MedChemComm, Sep-01, Volume: 8, Issue:9
Sugar modified pyrimido[4,5-
AID1222331Drug metabolism assessed as intrinsic clearance for 2',2'-difluorodeoxycytidine formation incubated for 1 min in presence of human recombinant N-terminal His-tagged DCK Ala119Gly mutant expressed in Escherichia coli BL21(DE3) cells by liquid chromatograph2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1533382Antiproliferative activity against human K562-TAX cells after 3 days by MTS assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID1827443Antiproliferative activity against human HCT-116 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2022ACS medicinal chemistry letters, Mar-10, Volume: 13, Issue:3
Rational Design of an Orally Active Anticancer Fluoropyrimidine, Pencitabine, a Hybrid of Capecitabine and Gemcitabine.
AID1066254Cytostatic activity against human MCF7 cells after 2 days by coulter counter analysis2014Journal of medicinal chemistry, Jan-09, Volume: 57, Issue:1
Synthesis and cytostatic evaluation of 4-N-alkanoyl and 4-N-alkyl gemcitabine analogues.
AID1412573Induction of apoptosis in mouse B16F10 cells assessed as necrotic cells at IC50 after 72 hrs by annexin V-FITC/propidium iodide staining-based flow cytometric method relative to control2018MedChemComm, May-01, Volume: 9, Issue:5
Development of a peptide-based bifunctional chelator conjugated to a cytotoxic drug for the treatment of melanotic melanoma.
AID611454Cytotoxicity against human BV173 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1457453Antitumor activity against human A2780 cells xenografted in CD-1 Foxn1 nude mouse assessed as delay in tumor growth at 100 umol/kg, ip four times for every three days after 100 to 120 days2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
Influence of a Basic Side Chain on the Properties of Hypoxia-Selective Nitro Analogues of the Duocarmycins: Demonstration of Substantial Anticancer Activity in Combination with Irradiation or Chemotherapy.
AID1222343Activity of human recombinant N-terminal His-tagged wild type DCK expressed in Escherichia coli BL21(DE3) cells assessed as enzyme-mediated 2',2'-difluorodeoxycytidine formation incubated for 1 min by liquid chromatography-tandem mass spectrometry2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1480615Drug transport assessed as OCTN2 transporter mediated drug uptake in human Caco2 cells at 1 to 800 uM at 37 degC incubated for 10 mins2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID124264In vivo activity against transplanted Squam lung-LC12 tumors of mice2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID680888TP_TRANSPORTER: drug resistance in MRD1-expressing SWI573/SI(I.I) cells2003British journal of cancer, Jun-16, Volume: 88, Issue:12
Increased sensitivity to gemcitabine of P-glycoprotein and multidrug resistance-associated protein-overexpressing human cancer cell lines.
AID1216057Cytotoxicity against human Aspc-1 cells by crystal violet staining2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Drug efflux transporter multidrug resistance-associated protein 5 affects sensitivity of pancreatic cancer cell lines to the nucleoside anticancer drug 5-fluorouracil.
AID1355098Antiproliferative activity against human MDA-MB-231/Gem cells after 48 hrs by MTT assay
AID500355Induction of cell cycle arrest in human U2OS cells expressing p53 gene assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1075465Prodrug activation in human MIAPaCa2 cells assessed as formation of dFdCTP after 24 hrs in presence of hENT1 inhibitor NBTI2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID1298273Cytotoxicity against human U373-MAGI cells at 2.5 nM measured at 72 hrs by Celltiter-Glo luminescent cell viability assay2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1730405Cytotoxicity against human Huh-7 cells assessed as reduction in cell viability measured after 48 hrs by celltiter-glo assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1468426Antitumor activity against human MIAPaCa2 cells xenografted in CD-1 nude mouse assessed as change in tumor volume at 15 mg/kg, iv administered twice weekly for 4 weeks measured on day 29 relative to control2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
Targeting Multiple Effector Pathways in Pancreatic Ductal Adenocarcinoma with a G-Quadruplex-Binding Small Molecule.
AID1807089Cytotoxicity against human KG-1a cells assessed as viable cells at 0.5 uM for 48 hrs by FITC-PE analysis (Rvb = 3.9%)2021Journal of medicinal chemistry, 06-24, Volume: 64, Issue:12
Single Diastereomers of the Clinical Anticancer ProTide Agents NUC-1031 and NUC-3373 Preferentially Target Cancer Stem Cells
AID1713612Antitumor activity against mouse H22 cells transplanted in Kunming mouse assessed as tumor growth inhibition at 25 mg/kg, ip administered every 4 days for 4 doses2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID1441788Cytotoxicity against human A549 cells assessed as cell growth inhibition after 72 hrs by MTS assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID526359Antiproliferative activity against human MCF7 cells expressing p53 after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1533379Antiproliferative activity against human HCT116 cells after 3 days by MTS assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID1694959Cytotoxicity against human MCF7 cells assessed as inhibition of cell growth measured after 72 hrs by MTT assay2020RSC medicinal chemistry, Feb-01, Volume: 11, Issue:2
Development of potent CPP6-gemcitabine conjugates against human prostate cancer cell line (PC-3).
AID1457447Antitumor activity against human SiHa cells xenografted in CD-1 Foxn1 nude mouse assessed as tumor regrowth at 237 umol/kg, ip four times for every three days after 100 to 120 days2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
Influence of a Basic Side Chain on the Properties of Hypoxia-Selective Nitro Analogues of the Duocarmycins: Demonstration of Substantial Anticancer Activity in Combination with Irradiation or Chemotherapy.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1525955Cytotoxicity against human U87 cells assessed as reduction in cell viability incubated for 72 hrs by AlamarBlue assay2019Journal of medicinal chemistry, 10-24, Volume: 62, Issue:20
Cyanine-Gemcitabine Conjugates as Targeted Theranostic Agents for Glioblastoma Tumor Cells.
AID1908822Cytotoxicity against human HFF-1 cells assessed as inhibition of cell growth incubated for 72 hrs by MTT assay2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1730423Ratio of IC50 for antiviral activity against HCV infected in human Huh-7 cells assessed as reduction in viral replication preincubated for 2 hrs followed by replacement with fresh culture medium and measured after 46 hrs by luciferase reporter gene assay 2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1713590Antiproliferative activity against human U266 cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID1630176Cytotoxicity against gemcitabine-sensitive human BxPC3 cells assessed as cell viability at 0.1 uM after 48 hrs by trypan blue exclusion assay relative to control2016Journal of medicinal chemistry, 09-22, Volume: 59, Issue:18
Discovery and Optimization of N-(4-(3-Aminophenyl)thiazol-2-yl)acetamide as a Novel Scaffold Active against Sensitive and Resistant Cancer Cells.
AID1742798Induction of apoptosis in human T-24 cells assessed as early apoptotic cells at 3 uM incubated for 8 hrs by annexin V-FITC and PI staining based flow cytometry analysis (Rvb = 3.37 %)2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID445359Cytotoxicity against human NCI-H23 cells after 5 days by SRB assay2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1688178Antiproliferative activity against human T47D cells assessed as reduction in cell viability at 1 to 5 uM after 72 hrs by MTS assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Minor chemical modifications of the aminosteroid derivative RM-581 lead to major impact on its anticancer activity, metabolic stability and aqueous solubility.
AID1908839Induction of cell cycle arrest in human MIA PaCa-2 cells assessed as accumulation of cells in G0/G1 phase at 0.1 uM incubated for 48 hrs by RNase/propidium iodide staining based flow cytometry analysis (Rvb = 70.4%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1325407Antitumor activity against human PANC1 cells xenografted in non-obese diabetic DB17 SCID mouse assessed as tumor growth inhibition at 40 mg/kg, iv administered 2 times per week for 4 weeks2016Bioorganic & medicinal chemistry letters, 11-15, Volume: 26, Issue:22
Discovery of ursolic acid prodrug (NX-201): Pharmacokinetics and in vivo antitumor effects in PANC-1 pancreatic cancer.
AID1850290Selectivity index, ratio IC50 for antiproliferative activity against human HCV-29 cells over IC50 for antiproliferative activity against human T24 cells
AID1684812Cytotoxicity against human HEL cells assessed as reduce in cell growth incubated for 3 days by coulter counter analysis2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID426607Cytotoxicity against human Bel7402 cells after 72 hrs by MTT assay2009Bioorganic & medicinal chemistry letters, May-15, Volume: 19, Issue:10
Synthesis and cytotoxicities of icogenin analogues with disaccharide residues.
AID1867123Cytotoxicity against human PANC-1 cells assessed as inhibition of cell growth incubated for 72 hrs by SRB assay2022Journal of natural products, 04-22, Volume: 85, Issue:4
Cytotoxic Nitrobenzoyl Sesquiterpenoids from an Antarctica Sponge-Derived
AID503808Antiproliferative activity against human U2OS cells expressing p53 gene after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1862938Antiproliferative activity against human Huh-7 cells assessed as inhibition of cell growth2022Bioorganic & medicinal chemistry letters, 09-15, Volume: 72Design, synthesis and antitumor activity study of a gemcitabine prodrug conjugated with a HDAC6 inhibitor.
AID445373Cell cycle arrest in human CCRF-CEM assessed as accumulation at G1 phase at 5 x GIC50 after 24 hrs by flow cytometry2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1356956Antitumor activity against human OVCAR5 cells xenografted in chronic cortisol treated nude mouse assessed as reduction in tumor volume at 100 mg/kg dosed every 3 days for 4 doses2018Journal of medicinal chemistry, 09-13, Volume: 61, Issue:17
Discovery of a Potent and Selective Steroidal Glucocorticoid Receptor Antagonist (ORIC-101).
AID1871324Cytotoxicity against human BEAS-2B cells assessed as reduction in cell viability after 48 hrs by MTT assay2021European journal of medicinal chemistry, Dec-15, Volume: 226A gulose moiety contributes to the belomycin (BLM) disaccharide selective targeting to lung cancer cells.
AID342008Antibacterial activity against deoxyribonucleotide kinase-deficient Escherichia coli KY895 expressing Streptococcus pyogenes recombinant deoxyadenosine kinase2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID716221Antiproliferative activity at human DMS53 cells after 72 hrs by MTT assay2012Journal of medicinal chemistry, Aug-23, Volume: 55, Issue:16
Novel second-generation di-2-pyridylketone thiosemicarbazones show synergism with standard chemotherapeutics and demonstrate potent activity against lung cancer xenografts after oral and intravenous administration in vivo.
AID1416679Cytostatic activity against human BJ cells after 3 days by MTS assay2017MedChemComm, Sep-01, Volume: 8, Issue:9
Sugar modified pyrimido[4,5-
AID1203898Cytotoxicity against human A549 cells treated at 2:1 and 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1467157Growth inhibition of human HT-29 cells after 48 hrs by sulforhodamine B assay relative to control2017Bioorganic & medicinal chemistry letters, 07-01, Volume: 27, Issue:13
Gemcitabine anti-proliferative activity significantly enhanced upon conjugation with cell-penetrating peptides.
AID1824953Inhibition of cell growth in human WM266-4 cells measured after 24 hrs2022Journal of medicinal chemistry, 01-13, Volume: 65, Issue:1
Integrin-Mediated Targeted Cancer Therapy Using c(RGDyK)-Based Conjugates of Gemcitabine.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID666080Cytotoxicity against human ACHN cells at 1000 nM after 48 hrs by WST-1 assay2012Bioorganic & medicinal chemistry letters, Jun-15, Volume: 22, Issue:12
Simple, fast and efficient synthesis of β-keto esters from the esters of heteroaryl compounds, its antimicrobial study and cytotoxicity towards various cancer cell lines.
AID1200782Cytotoxicity against human MDA-MB-231 cells after 24 hrs by MTT colorimetric assay2015European journal of medicinal chemistry, Mar-26, Volume: 93Novel 1-(2-aryl-2-adamantyl)piperazine derivatives with antiproliferative activity.
AID1575531Antiproliferative activity against human MiaPaCa cells assessed as reduction in cell growth incubated for 72 hrs by MTS assay2019MedChemComm, May-01, Volume: 10, Issue:5
Dual inhibitors of LSD1 and spermine oxidase.
AID1129037Inhibition of RRM1 in human U2OS cells assessed as gammaH2AX induction at 0.5 to 125 uM after 2 hrs by FITC/propidium iodide-staining based flow cytometry in absence of SCH9007762014Bioorganic & medicinal chemistry, Apr-01, Volume: 22, Issue:7
The identification of novel 5'-amino gemcitabine analogs as potent RRM1 inhibitors.
AID1203901Cytotoxicity against human A549 cells treated at LA + compound sequent. LA for 24 hrs), LA + GEM (24 hrs additional, total 48 hrs) 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1203925Cytotoxicity against human A549 cells assessed as dose reduction index ratio treated at sequential combination at 2:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1713605Induction of apoptosis in human PLC-PRF-5 cells assessed as late apoptotic cells at 2 uM after 48 hrs by Annexin V-FITC/propidium iodide staining-based flow cytometric analysis (Rvb = 8.7 %)2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID145212In vitro cytotoxic activity against nonsmall cell lung carcinoma (NCI-H460) cells assayed by inhibition of [3H]-labeled thymidine incorporation2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
O-Phosphonatomethylcholine, its analogues, alkyl esters, and their biological activity.
AID1508791Antimigratory activity against human PANC1 cells measured after 18 hrs in presence of mitomycin C using crystal violet staining by inverted microscopy-based transwell assay2019Journal of medicinal chemistry, 05-23, Volume: 62, Issue:10
Modification and Biological Evaluation of a Series of 1,5-Diaryl-1,2,4-triazole Compounds as Novel Agents against Pancreatic Cancer Metastasis through Targeting Myoferlin.
AID1468428Antitumor activity against human MIAPaCa2 cells xenografted in CD-1 nude mouse assessed as change in tumor volume at 15 mg/kg, iv administered twice weekly for 4 weeks measured on day 62 relative to control2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
Targeting Multiple Effector Pathways in Pancreatic Ductal Adenocarcinoma with a G-Quadruplex-Binding Small Molecule.
AID1355092Antiproliferative activity against human MDA-MB-231 cells after 48 hrs by MTT assay
AID1412575Antitumor activity against mouse B16F10 cells allografted in Balb/c mouse assessed as tumor growth inhibition at 25 mg/kg, iv administered thrice weekly for 21 days starting on day 10 post tumor implantation relative to control2018MedChemComm, May-01, Volume: 9, Issue:5
Development of a peptide-based bifunctional chelator conjugated to a cytotoxic drug for the treatment of melanotic melanoma.
AID329308Antitumor activity against human MIAPaCa2 cells xenografted mouse assessed as tumor growth inhibition at 200 mg/kg, ip administered weekly once for 3 weeks2008Journal of medicinal chemistry, Apr-24, Volume: 51, Issue:8
Potent and highly selective hypoxia-activated achiral phosphoramidate mustards as anticancer drugs.
AID1298386Effect on dRGU-TP level in human U373-MAGI cells at 2.5 nM preincubated for 2 hrs followed by 5-aza-dC addition measured after 4 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1724231Antitumor activity against human MIAPaCa2 cells xenografted in mouse assessed as change in tumor volume at 15 mg/kg, iv administered twice per week for 28 days and measured at day 28 by Caliper method relative to control2020ACS medicinal chemistry letters, Aug-13, Volume: 11, Issue:8
Asymmetrically Substituted Quadruplex-Binding Naphthalene Diimide Showing Potent Activity in Pancreatic Cancer Models.
AID739333Cytotoxicity against human PANC1 cells after 72 hrs by MTT assay2013Bioorganic & medicinal chemistry letters, Apr-15, Volume: 23, Issue:8
Cytotoxic scalarane sesterterpenes from a Korean marine sponge Psammocinia sp.
AID1862958Antitumor activity against mouse 4T1 cells implanted in mouse assessed as tumor growth inhibition at 10 mg/kg administered for 15 days relative to control2022Bioorganic & medicinal chemistry letters, 09-15, Volume: 72Design, synthesis and antitumor activity study of a gemcitabine prodrug conjugated with a HDAC6 inhibitor.
AID426604Cytotoxicity against human Capan2 cells after 72 hrs by MTT assay2009Bioorganic & medicinal chemistry letters, May-15, Volume: 19, Issue:10
Synthesis and cytotoxicities of icogenin analogues with disaccharide residues.
AID1862945Antiproliferative activity against human SGC-7901 cells assessed as inhibition of cell growth2022Bioorganic & medicinal chemistry letters, 09-15, Volume: 72Design, synthesis and antitumor activity study of a gemcitabine prodrug conjugated with a HDAC6 inhibitor.
AID1910314Induction of apoptosis in human PDAC-3 cells assessed as increase in caspase-3 level at IC50 measured after 72 hrs by immunoassay2022Journal of medicinal chemistry, 05-26, Volume: 65, Issue:10
Reversible Monoacylglycerol Lipase Inhibitors: Discovery of a New Class of Benzylpiperidine Derivatives.
AID1416684Cytostatic activity against human HCT116 cells after 3 days by MTS assay2017MedChemComm, Sep-01, Volume: 8, Issue:9
Sugar modified pyrimido[4,5-
AID500356Induction of cell cycle arrest in human A2780 cells expressing p53 gene assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID249690Ability (9 umol/kg) tested for inhibition of BxPC-3 human pancreatic tumor growth (n=8)2005Bioorganic & medicinal chemistry letters, May-16, Volume: 15, Issue:10
Synthesis and biological evaluation of gemcitabine-lipid conjugate (NEO6002).
AID1203931Cytotoxicity against human MRC5 cells assessed as dose reduction index ratio treated at sequential combination at 2:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID503809Antiproliferative activity against human A2780 cells expressing p53 gene after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1508830Toxicity in Balb/c nude mouse xenografted with PANC1 cells assessed as pathological changes in spleen at 25 mg/kg/day, ip by H and E staining-based microscopic analysis2019Journal of medicinal chemistry, 05-23, Volume: 62, Issue:10
Modification and Biological Evaluation of a Series of 1,5-Diaryl-1,2,4-triazole Compounds as Novel Agents against Pancreatic Cancer Metastasis through Targeting Myoferlin.
AID1416688Cytostatic activity against human U2OS cells after 3 days by MTS assay2017MedChemComm, Sep-01, Volume: 8, Issue:9
Sugar modified pyrimido[4,5-
AID292205Growth inhibition of CEM cells by SRB assay2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID342000Antimicrobial activity against Staphylococcus aureus CCM 885 after 20 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID445375Cell cycle arrest in human CCRF-CEM assessed as accumulation at S phase at 5 x GIC50 after 24 hrs by flow cytometry2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1294505Cytotoxicity against human Ramos cells assessed as reduction in cell viability after 72 hrs by MTS assay2016Bioorganic & medicinal chemistry letters, May-01, Volume: 26, Issue:9
L-Aspartic and l-glutamic acid ester-based ProTides of anticancer nucleosides: Synthesis and antitumoral evaluation.
AID500357Induction of cell cycle arrest in human PC3 cells expressing p53 gene assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1533380Antiproliferative activity against p53 gene knocked out human HCT116 cells after 3 days by MTS assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID1772130Induction of gamma-H2A.X in human HT-29 cells at 40 nM incubated for 24 hrs by Western blot analysis2021Journal of medicinal chemistry, 10-28, Volume: 64, Issue:20
Discovery and Development of a Potent, Selective, and Orally Bioavailable CHK1 Inhibitor Candidate: 5-((4-((3-Amino-3-methylbutyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)picolinonitrile.
AID1222340Drug metabolism assessed as 2',2'-difluorodeoxycytidine formation incubated for 1 min in presence of human recombinant N-terminal His-tagged DCK Pro122Ser mutant expressed in Escherichia coli BL21(DE3) cells by liquid chromatography-tandem mass spectromet2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1203932Cytotoxicity against human MRC5 cells assessed as dose reduction index ratio treated at sequential combination at 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1713596Antiproliferative activity against human HeLa cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID1416682Cytostatic activity against human CCRF-CEM cells after 3 days by MTS assay2017MedChemComm, Sep-01, Volume: 8, Issue:9
Sugar modified pyrimido[4,5-
AID1441780Cytotoxicity against p53 deficient human HCT116 cells assessed as cell growth inhibition after 72 hrs by MTS assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID1730430Stability in pH 8 aqueous buffer assessed as parent compound remaining at 200 uM measured after 4 hrs by UV spectrophotometry2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1124960Cytotoxicity against human HeLa cells assessed as reduction of cell survival after 96 hrs by MTT assay2014Bioorganic & medicinal chemistry, Apr-01, Volume: 22, Issue:7
N-Acyl-phosphoramidates as potential novel form of gemcitabine prodrugs.
AID1910315Induction of apoptosis in human PDAC-2 cells assessed as increase in caspase-3 level at IC50 measured after 72 hrs by immunoassay (Rvb = 0.35 ng/ml)2022Journal of medicinal chemistry, 05-26, Volume: 65, Issue:10
Reversible Monoacylglycerol Lipase Inhibitors: Discovery of a New Class of Benzylpiperidine Derivatives.
AID1203919Cytotoxicity against human A549 cells assessed as inhibition fraction treated at sequential combination LA + compound sequent. compound for 24 hrs, LA + compound for 24 hrs additional, total 48 hrs 2:1 and 5:1 alpha-lipoic acid to compound ratio after 48 2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1066257Cytostatic activity against human CEM cells after 3 days by coulter counter analysis2014Journal of medicinal chemistry, Jan-09, Volume: 57, Issue:1
Synthesis and cytostatic evaluation of 4-N-alkanoyl and 4-N-alkyl gemcitabine analogues.
AID1656953Antiproliferative activity against human Capan2 cells harboring wild type TP53 and G12V KRAS mutation assessed as inhibition of cell growth incubated for 96 hrs by cell-titer-Glo 2.0 assay relative to control2020Bioorganic & medicinal chemistry letters, 03-15, Volume: 30, Issue:6
Identification of a C3'-nitrile nucleoside analogue inhibitor of pancreatic cancer cell line growth.
AID1550510Cytotoxicity against human CFPAC-1 cells incubated for 24 hrs by MTT assay2019European journal of medicinal chemistry, May-15, Volume: 170Multi-target compounds acting in cancer progression: Focus on thiosemicarbazone, thiazole and thiazolidinone analogues.
AID445361Cytotoxicity against human HCT15 cells after 5 days by SRB assay2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID292199Growth inhibition of A549 cells by SRB assay2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID1298382Reduction in 5-aza-dCTP level in human U373-MAGI cells at 25 nM preincubated for 2 hrs followed by 5-aza-C addition measured after 4 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID341995Antimicrobial activity against Escherichia coli ATCC 25922 after 20 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID1480621Drug transport assessed as OCTN2 transporter mediated drug uptake in human Caco2 cells at 100 uM after 10 mins in presence of L-carnitine by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID680891TP_TRANSPORTER: drug resistance in 2780AD cells cells2003British journal of cancer, Jun-16, Volume: 88, Issue:12
Increased sensitivity to gemcitabine of P-glycoprotein and multidrug resistance-associated protein-overexpressing human cancer cell lines.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID445380Inhibition of RNA synthesis in human CCRF-CEM assessed as assessed as BrdU incorporation at 1 x GIC50 after 24 by flow cytometry2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1441785Cytotoxicity against human HepG2 cells assessed as reduction in cell viability after 72 hrs by XTT assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1298325Reduction in dCTP level in human U373-MAGI cells at 25 nM preincubated for 2 hrs followed by 5-aza-C addition measured after 4 hrs by LC-MS/MS analysis relative to 5-aza-C2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID103941Inhibitory activity against MCF-7/WT-2'' (human, breast carcinoma) cell line2003Journal of medicinal chemistry, Sep-11, Volume: 46, Issue:19
Synthesis and cytotoxic activity of two novel 1-dodecylthio-2-decyloxypropyl-3-phosphatidic acid conjugates with gemcitabine and cytosine arabinoside.
AID1267266Cytotoxicity against human Bel7402 cells assessed as viable cells at 50 uM2016European journal of medicinal chemistry, Jan-01, Volume: 107Structure-activity relationship study of anticancer thymidine-quinoxaline conjugates under the low radiance of long wavelength ultraviolet light for photodynamic therapy.
AID500346Induction of cell cycle arrest in p53 deficient human COLO205 cells assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID345887Antiproliferative activity against human MIAPaCa2 cells after 2 days by MTT assay2009Journal of medicinal chemistry, Feb-26, Volume: 52, Issue:4
Discovery of novel arylethynyltriazole ribonucleosides with selective and effective antiviral and antiproliferative activity.
AID1151330Cytotoxicity against mouse RAW264.7 cells assessed as cell viability after 24 hrs by WST-1 assay2014Journal of natural products, May-23, Volume: 77, Issue:5
Cytotoxic alkylated hydroquinone, phenol, and cyclohexenone derivatives from Aspergillus violaceofuscus Gasperini.
AID1294506Cytotoxicity against human U87 cells assessed as reduction in cell viability after 72 hrs by MTS assay2016Bioorganic & medicinal chemistry letters, May-01, Volume: 26, Issue:9
L-Aspartic and l-glutamic acid ester-based ProTides of anticancer nucleosides: Synthesis and antitumoral evaluation.
AID445360Cytotoxicity against human PC3 cells after 5 days by SRB assay2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID117783In vivo activity against transplanted Panc-02 tumors of mice; Not active2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID1233456Cytotoxicity against human MDA-MB-231 cells after 72 hrs by MTT assay2015Bioorganic & medicinal chemistry letters, Jul-15, Volume: 25, Issue:14
New indole-isoxazolone derivatives: Synthesis, characterisation and in vitro SIRT1 inhibition studies.
AID301993Cell cycle arrest in MDA-MB-231 cells assessed as accumulation at S phase by FACS analysis2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Structure-based design and synthesis of (5-arylamino-2H-pyrazol-3-yl)-biphenyl-2',4'-diols as novel and potent human CHK1 inhibitors.
AID1713597Antiproliferative activity against human MDA-MB-231 cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID312869Cytotoxicity against human WS1 cells by thymidine incorporation assay2008Journal of medicinal chemistry, Feb-14, Volume: 51, Issue:3
Comprehensive study of sansalvamide A derivatives and their structure-activity relationships against drug-resistant colon cancer cell lines.
AID666078Cytotoxicity against human NCI-H460 cells at 1000 nM after 48 hrs by WST-1 assay2012Bioorganic & medicinal chemistry letters, Jun-15, Volume: 22, Issue:12
Simple, fast and efficient synthesis of β-keto esters from the esters of heteroaryl compounds, its antimicrobial study and cytotoxicity towards various cancer cell lines.
AID1812917Cytotoxicity against human BXPC-3 assessed as cell viability measured for 72 hrs by cell titer glo luminescent assay2021Journal of natural products, 08-27, Volume: 84, Issue:8
Monomeric, Dimeric, and Trimeric Tropane Alkaloids from
AID1298300Reduction in dCTP level in human U373-MAGI cells at 25 nM after 6 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID676694Cytotoxicity against human PANC1 cells grown in nutrient-deprived medium after 24 hrs by WST8 assay2012Journal of natural products, Jun-22, Volume: 75, Issue:6
Antiausterity agents from Uvaria dac and their preferential cytotoxic activity against human pancreatic cancer cell lines in a nutrient-deprived condition.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1298287Reduction in dGTP level in human U373-MAGI cells at 2.5 nM after 6 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1385955Antimetastatic activity against human PSC xenografted in BALB/c nu/nu mouse co-implanted with human AsPC1 cells assessed as reduction in metastasis lesions in liver at 75 mg/kg, po administered twice per week via gavage measured after 28 days post first d2018Journal of medicinal chemistry, 09-27, Volume: 61, Issue:18
6-Substituted Hexamethylene Amiloride (HMA) Derivatives as Potent and Selective Inhibitors of the Human Urokinase Plasminogen Activator for Use in Cancer.
AID1696863Inhibition of cell migration in human ASPC1 cells assessed as wound healing rate at 0.2 uM incubated for 24 hrs by wound healing assay (Rvb = 63%)2020Journal of medicinal chemistry, 10-08, Volume: 63, Issue:19
DPAGT1 Inhibitors of Capuramycin Analogues and Their Antimigratory Activities of Solid Tumors.
AID124266In vivo activity against transplanted colon-38 tumors of mice2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID770684Cytotoxicity against human COLO320DM cells after 48 hrs by MTT assay2013Bioorganic & medicinal chemistry letters, Oct-01, Volume: 23, Issue:19
Design, synthesis and ex vivo evaluation of colon-specific azo based prodrugs of anticancer agents.
AID1850287Antiproliferative activity against human MGC-803 cells measured after 48 hrs by MTT assay
AID696880Cytotoxicity against human PANC1 cells grown in DMEM medium after 24 hrs by WST8 assay2012Journal of natural products, Nov-26, Volume: 75, Issue:11
Uvaridacols E-H, highly oxygenated antiausterity agents from Uvaria dac.
AID611474Cytotoxicity against human SK-MEL-2 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1862939Antiproliferative activity against human HeLa cells assessed as inhibition of cell growth2022Bioorganic & medicinal chemistry letters, 09-15, Volume: 72Design, synthesis and antitumor activity study of a gemcitabine prodrug conjugated with a HDAC6 inhibitor.
AID124265In vivo activity against transplanted colon-26 tumors of mice2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID340165Decrease in intracellular dCTP pool in human HL60 cells at 40 nM relative to control2008Journal of medicinal chemistry, Jul-24, Volume: 51, Issue:14
Ribose-modified purine nucleosides as ribonucleotide reductase inhibitors. Synthesis, antitumor activity, and molecular modeling of N6-substituted 3'-C-methyladenosine derivatives.
AID1589121Cytotoxicity in human HepG2 cells assessed as reduction in cell viability incubated for 72 hrs by SRB assay2019Bioorganic & medicinal chemistry letters, 09-15, Volume: 29, Issue:18
Synthesis and in vitro anticancer activity of new gemcitabine-nucleoside analogue dimers containing methyltriazole or ester-methyltriazole linker.
AID426609Cytotoxicity against human HCT8 cells after 72 hrs by MTT assay2009Bioorganic & medicinal chemistry letters, May-15, Volume: 19, Issue:10
Synthesis and cytotoxicities of icogenin analogues with disaccharide residues.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1908852Induction of apoptosis in human MIA PaCa-2 cells assessed as viable cells at 0.5 uM incubated for 48 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 96.3%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID611475Cytotoxicity against human HPAC cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID500344Induction of cell cycle arrest in p53 deficient human HeLa cells assessed as assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1684813Cytotoxicity against human HEL cells assessed as alteration in cell morphology incubated for 3 days by microscopic analysis2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1385962Antimetastatic activity against human AsPC1 cells xenografted in BALB/c nu/nu mouse co-implanted with human PSC assessed as reduction in metastasis lesions in liver at 75 mg/kg, po administered twice per week via gavage measured after 28 days post first d2018Journal of medicinal chemistry, 09-27, Volume: 61, Issue:18
6-Substituted Hexamethylene Amiloride (HMA) Derivatives as Potent and Selective Inhibitors of the Human Urokinase Plasminogen Activator for Use in Cancer.
AID1416681Cytostatic activity against human A549 cells after 3 days by MTS assay2017MedChemComm, Sep-01, Volume: 8, Issue:9
Sugar modified pyrimido[4,5-
AID1684798Antiviral activity against MERS-CoV Hu/Jordan-N3/2012 infected in African green monkey Vero E6 cells assessed as inhibition of viral replication treated for 1 hr prior to viral infection and measured after 48 hrs by ELISA2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID342006Antibacterial activity against deoxyribonucleotide kinase-deficient Escherichia coli KY895 expressing Staphylococcus aureus recombinant deoxyadenosine kinase2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID765201Antitumor activity against human MIAPaCa2 cells xenografted in Ncr mouse assessed as tumor growth inhibition at 80 mg/kg, ip administered daily for 22 days measured on day 25 relative to vehicle-treated control2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Identification of novel HDAC inhibitors through cell based screening and their evaluation as potential anticancer agents.
AID1730422Antiviral activity against HCV infected in human Huh-7 cells assessed as reduction in viral replication preincubated for 2 hrs followed by replacement with fresh culture medium and measured after 46 hrs by luciferase reporter gene assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1684808Antiviral activity against SARS-CoV-2 UC-1075 infected in African green monkey Vero cells assessed as reduction in virus plaque formation measured on day 5 post-viral infection by microscopic analysis2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1468421Growth inhibition of human Capan1 cells after 96 hrs by SRB assay2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
Targeting Multiple Effector Pathways in Pancreatic Ductal Adenocarcinoma with a G-Quadruplex-Binding Small Molecule.
AID503811Antiproliferative activity against NHDF expressing p53 gene after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1730414Antiviral activity against HCV infected in human Huh-7 cells assessed as reduction in viral replication at 25 to 1000 nM measured after 48 hrs in presence of cytidine by luciferase reporter gene assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1730406Therapeutic index, ratio of IC50 for antiviral activity against HCV infected in human Huh-7 cells assessed as reduction in viral replication to TC50 for cytotoxicity against human Huh-7 cells2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1294502Cytotoxicity against human Jurkat cells assessed as reduction in cell viability after 72 hrs by MTS assay2016Bioorganic & medicinal chemistry letters, May-01, Volume: 26, Issue:9
L-Aspartic and l-glutamic acid ester-based ProTides of anticancer nucleosides: Synthesis and antitumoral evaluation.
AID1062074Cytotoxicity against human FTC-133 cells after 24 hrs by MTT assay2013Bioorganic & medicinal chemistry, Dec-15, Volume: 21, Issue:24
Synthesis and biological evaluation of 3-hydroxymethyl-5-(1H-1,2,3-triazol) isoxazolidines.
AID1575533Antiproliferative activity against human BxPC3 cells assessed as reduction in cell growth at 10 to 100 uM incubated for 72 hrs by MTS assay relative to control2019MedChemComm, May-01, Volume: 10, Issue:5
Dual inhibitors of LSD1 and spermine oxidase.
AID342001Antimicrobial activity against Streptococcus pyogenes AP1 after 20 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID500342Induction of cell cycle arrest in p53 deficient human SF268 cells assessed as accumulation at subG1 phase at 0.1 uM after 24 hrs FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1694960Cytotoxicity against human PC-3 cells assessed as inhibition of cell growth measured after 72 hrs by MTT assay2020RSC medicinal chemistry, Feb-01, Volume: 11, Issue:2
Development of potent CPP6-gemcitabine conjugates against human prostate cancer cell line (PC-3).
AID1066251Metabolic stability in human serum assessed as dFdU formation at 100 uM up to 240 mins by HPLC analysis2014Journal of medicinal chemistry, Jan-09, Volume: 57, Issue:1
Synthesis and cytostatic evaluation of 4-N-alkanoyl and 4-N-alkyl gemcitabine analogues.
AID1203909Cytotoxicity against human T24 cells treated at LA + compound sequent. compound for 24 hrs, LA + compound for 24 hrs additional, total 48 hrs 2:1 and 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1129033Inhibition of RRM1 in human U2OS cells assessed as gammaH2AX induction at 0.5 to 125 uM after 2 hrs by FITC/propidium iodide-staining based flow cytometry in presence of SCH9007762014Bioorganic & medicinal chemistry, Apr-01, Volume: 22, Issue:7
The identification of novel 5'-amino gemcitabine analogs as potent RRM1 inhibitors.
AID341998Antimicrobial activity against Streptococcus sp. 07686-2 after 20 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID1684805Antiviral activity against SARS-CoV-2 infected in African green monkey Vero E6 cells assessed as reduction in viral RNA copy number incubated for 24 hrs by real time RT-PCR analysis2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1075458Antitumor activity against human MIAPaCa2 cells xenografted in Balb/c nude mouse assessed as tumor growth inhibition at 0.076 mmol/kg, ip measured on day 72014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID1441782Cytotoxicity against human K562-TAX cells assessed as cell growth inhibition after 72 hrs by MTS assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID1055758Cytotoxic activity against human SW1990 cells2013Journal of natural products, Nov-22, Volume: 76, Issue:11
Sulfur-containing cytotoxic curvularin macrolides from Penicillium sumatrense MA-92, a fungus obtained from the rhizosphere of the mangrove Lumnitzera racemosa.
AID611472Cytotoxicity against human HeLa cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1486084Antiproliferative activity against human LO2 cells after 72 hrs by CCK8 assay2017Bioorganic & medicinal chemistry, 08-01, Volume: 25, Issue:15
Design, synthesis and biological evaluation of sulfonamide-substituted diphenylpyrimidine derivatives (Sul-DPPYs) as potent focal adhesion kinase (FAK) inhibitors with antitumor activity.
AID445363Cytotoxicity against human BT549 cells after 5 days by SRB assay2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID503796Antiproliferative activity against p53 deficient human K562 cells after 72 hrs2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID500358Induction of cell cycle arrest in NHDF expressing p53 gene assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID680890TP_TRANSPORTER: drug resistance in 2RI60 cells2003British journal of cancer, Jun-16, Volume: 88, Issue:12
Increased sensitivity to gemcitabine of P-glycoprotein and multidrug resistance-associated protein-overexpressing human cancer cell lines.
AID1222321Activity of human recombinant N-terminal His-SUMO fused CDA Ala70Thr mutant expressed in Escherichia coli BL21(DE3) cells assessed as 2',2'-difluorodeoxyuridine formation by liquid chromatography-tandem mass spectrometry2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1224153Cytotoxicity against human MIAPaCa2 cells after 5 days by PrestoBlue assay relative to gemcitabine2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
Development and bioorthogonal activation of palladium-labile prodrugs of gemcitabine.
AID1399697Toxicity in Balb/c mouse assessed as mortality at 20 to 40 mg/kg, iv administered three times in a day every 2 days for 15 consecutive days2018Bioorganic & medicinal chemistry, 09-01, Volume: 26, Issue:16
In vitro and in vivo pharmacokinetic and pharmacodynamic study of MBRI-001, a deuterium-substituted plinabulin derivative as a potent anti-cancer agent.
AID1508831Toxicity in Balb/c nude mouse xenografted with PANC1 cells assessed as pathological changes in kidney at 25 mg/kg/day, ip by H and E staining-based microscopic analysis2019Journal of medicinal chemistry, 05-23, Volume: 62, Issue:10
Modification and Biological Evaluation of a Series of 1,5-Diaryl-1,2,4-triazole Compounds as Novel Agents against Pancreatic Cancer Metastasis through Targeting Myoferlin.
AID1767451Antitumor activity against human MIA PaCa-2 cells xenografted in Foxn1nu athymic nude mouse assessed as reduction in tumor weight at 15 mg/kg, ip administered every 3 days for 4 weeks by digital caliper method2021European journal of medicinal chemistry, Oct-15, Volume: 222Structure activity relationship (SAR) study identifies a quinoxaline urea analog that modulates IKKβ phosphorylation for pancreatic cancer therapy.
AID1589125Selectivity index, ratio of IC50 for cytotoxicity in human NHDF cells to IC50 for cytotoxicity in human A549 cells2019Bioorganic & medicinal chemistry letters, 09-15, Volume: 29, Issue:18
Synthesis and in vitro anticancer activity of new gemcitabine-nucleoside analogue dimers containing methyltriazole or ester-methyltriazole linker.
AID1222352Activity of human recombinant N-terminal His-SUMO fused CDA Ala70Thr mutant expressed in Escherichia coli BL21(DE3) cells assessed as intrinsic clearance for 2',2'-difluorodeoxyuridine formation by liquid chromatography-tandem mass spectrometry2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1713594Antiproliferative activity against human 3AO cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID666082Cytotoxicity against human PANC1 cells at 1000 nM after 48 hrs by WST-1 assay2012Bioorganic & medicinal chemistry letters, Jun-15, Volume: 22, Issue:12
Simple, fast and efficient synthesis of β-keto esters from the esters of heteroaryl compounds, its antimicrobial study and cytotoxicity towards various cancer cell lines.
AID1508828Toxicity in Balb/c nude mouse xenografted with PANC1 cells assessed as pathological changes in lung at 25 mg/kg/day, ip by H and E staining-based microscopic analysis2019Journal of medicinal chemistry, 05-23, Volume: 62, Issue:10
Modification and Biological Evaluation of a Series of 1,5-Diaryl-1,2,4-triazole Compounds as Novel Agents against Pancreatic Cancer Metastasis through Targeting Myoferlin.
AID1508792Antiinvasive activity against human PANC1 cells measured after 18 hrs in presence of mitomycin C using crystal violet staining by inverted microscopy-based matrigel coated transwell assay2019Journal of medicinal chemistry, 05-23, Volume: 62, Issue:10
Modification and Biological Evaluation of a Series of 1,5-Diaryl-1,2,4-triazole Compounds as Novel Agents against Pancreatic Cancer Metastasis through Targeting Myoferlin.
AID1054191Antiviral activity against HIV1 infected in human U373-MAGI cells assessed as A to G mutation at 20 nM (Rvb = 22%)2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
5,6-Dihydro-5-aza-2'-deoxycytidine potentiates the anti-HIV-1 activity of ribonucleotide reductase inhibitors.
AID1862946Antiproliferative activity against mouse 4T1 cells assessed as inhibition of cell growth2022Bioorganic & medicinal chemistry letters, 09-15, Volume: 72Design, synthesis and antitumor activity study of a gemcitabine prodrug conjugated with a HDAC6 inhibitor.
AID1730407Toxicity in human Huh-7 cells assessed as reduction in cell viability measured after 96 hrs by celltiter-glo assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1713595Antiproliferative activity against human ES2 cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID1298342Increase in 5-aza-dCTP/dCTP ratio in human U373-MAGI cells at 25 nM preincubated for 2 hrs followed by 5-aza-dC addition measured after 4 hrs by LC-MS/MS analysis relative to 5-aza-dC2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID292210Growth inhibition of SW1573 cells by SRB assay in presence of dipyridamole2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID1203897Cytotoxicity against human A549 cells after 48 hrs by SRB assay2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1871323Cytotoxicity against human A549 cells assessed as reduction in cell viability after 48 hrs by MTT assay2021European journal of medicinal chemistry, Dec-15, Volume: 226A gulose moiety contributes to the belomycin (BLM) disaccharide selective targeting to lung cancer cells.
AID1589117Cytotoxicity in human HeLa cells assessed as reduction in cell viability incubated for 72 hrs by SRB assay2019Bioorganic & medicinal chemistry letters, 09-15, Volume: 29, Issue:18
Synthesis and in vitro anticancer activity of new gemcitabine-nucleoside analogue dimers containing methyltriazole or ester-methyltriazole linker.
AID611462Cytotoxicity against human U87MG cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1075463Prodrug activation in human MIAPaCa2 cells assessed as formation of dFdCTP after 24 hrs in presence of dCK inhibitor 2T2D2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID500347Induction of cell cycle arrest in p53 deficient human HCT116-E6 cells assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1772128Inhibition of CHK1 in human HT-29 cells assessed as increase in phosphorylation at S296 residue at 40 nM incubated for 24 hrs by Western blot analysis2021Journal of medicinal chemistry, 10-28, Volume: 64, Issue:20
Discovery and Development of a Potent, Selective, and Orally Bioavailable CHK1 Inhibitor Candidate: 5-((4-((3-Amino-3-methylbutyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)picolinonitrile.
AID1730411Cytotoxicity against human BXPC-3 cells assessed as reduction in cell viability measured after 96 hrs by celltiter-glo assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1684800Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) expressing NS116-GFP infected in human RPE cells assessed as inhibition of viral replication measured after 24 hrs by luminescence based assay2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1684814Antiviral activity against Human cytomegalovirus Davis infected in human HEL cells assessed as reduction in virus plaque formation measured on 6 to 7 post-viral infection2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1908811Cytotoxicity against human MIA PaCa-2 cells assessed as inhibition of cell growth incubated for 72 hrs by MTT assay2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID526194Antiproliferative activity against human A2780 cells expressing p53 after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1713591Antiproliferative activity against human PC-3 cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID1807083Cytotoxicity against human BXPC-3 cells assessed as cell death incubated for 72 hrs by MTS assay2021Journal of medicinal chemistry, 06-24, Volume: 64, Issue:12
Single Diastereomers of the Clinical Anticancer ProTide Agents NUC-1031 and NUC-3373 Preferentially Target Cancer Stem Cells
AID1533377Antiproliferative activity against human CCRF-CEM cells after 3 days by MTS assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID1730408Cytotoxicity against human HepG2 cells assessed as reduction in cell viability measured after 96 hrs by celltiter-glo assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1216059Cytotoxicity against human Patu-02 cells by crystal violet staining2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Drug efflux transporter multidrug resistance-associated protein 5 affects sensitivity of pancreatic cancer cell lines to the nucleoside anticancer drug 5-fluorouracil.
AID1772135Antitumor activity against human HT-29 cells xenografted in mouse assessed as reduction in tumor growth by measuring T/C ratio at 100 mg/kg, iv dosed once a week for 22 days measured twice every week2021Journal of medicinal chemistry, 10-28, Volume: 64, Issue:20
Discovery and Development of a Potent, Selective, and Orally Bioavailable CHK1 Inhibitor Candidate: 5-((4-((3-Amino-3-methylbutyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)picolinonitrile.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1358357Inhibition of cancer stem cell population of human PANC1 cells assessed as CD24+/CD44+/ESA+ cell population level at 0.15 uM after 48 hrs by flow cytometric analysis (Rvb = 1.7%)2018European journal of medicinal chemistry, May-10, Volume: 151Syntheses and anti-pancreatic cancer activities of rakicidin A analogues.
AID1151328Cytotoxicity against human MOLT4 cells assessed as cell viability after 24 hrs by WST-1 assay2014Journal of natural products, May-23, Volume: 77, Issue:5
Cytotoxic alkylated hydroquinone, phenol, and cyclohexenone derivatives from Aspergillus violaceofuscus Gasperini.
AID739332Cytotoxicity against human MiaPaCa cells after 72 hrs by MTT assay2013Bioorganic & medicinal chemistry letters, Apr-15, Volume: 23, Issue:8
Cytotoxic scalarane sesterterpenes from a Korean marine sponge Psammocinia sp.
AID1862940Antiproliferative activity against human MDA-MB-231 cells assessed as inhibition of cell growth2022Bioorganic & medicinal chemistry letters, 09-15, Volume: 72Design, synthesis and antitumor activity study of a gemcitabine prodrug conjugated with a HDAC6 inhibitor.
AID1908842Induction of apoptosis in human MIA PaCa-2 cells assessed as early apoptotic cells at 0.1 uM incubated for 24 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 5.1%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID340156Antitumor activity against human MCF7 cells after 48 hrs by MTS assay2008Journal of medicinal chemistry, Jul-24, Volume: 51, Issue:14
Ribose-modified purine nucleosides as ribonucleotide reductase inhibitors. Synthesis, antitumor activity, and molecular modeling of N6-substituted 3'-C-methyladenosine derivatives.
AID117640In vivo activity against iv transplanted AML Leukemia 1498 tumors of mice; Not active2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID1508821Toxicity in Balb/c nude mouse xenografted with PANC1 cells assessed as body weight loss at 25 mg/kg/day, ip2019Journal of medicinal chemistry, 05-23, Volume: 62, Issue:10
Modification and Biological Evaluation of a Series of 1,5-Diaryl-1,2,4-triazole Compounds as Novel Agents against Pancreatic Cancer Metastasis through Targeting Myoferlin.
AID1410089Antiproliferative activity against human PANC1 cells at 500 nM after 48 hrs by propidium iodide staining based fluorometry relative to control2018ACS medicinal chemistry letters, Mar-08, Volume: 9, Issue:3
Synthesis and Biological Screening of Pyrano[3,2-
AID500348Induction of cell cycle arrest in p53 deficient human Jurkat cells assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1428349Cytotoxicity against human SW1990 cells assessed as reduction in cell viability after 48 hrs by MTT assay2016Journal of natural products, Dec-23, Volume: 79, Issue:12
Diterpenoids of the Cassane Type from Caesalpinia decapetala.
AID1713606Induction of apoptosis in human PLC-PRF-5 cells assessed as necrotic cells at 2 uM after 48 hrs by Annexin V-FITC/propidium iodide staining-based flow cytometric analysis (Rvb = 6.1 %)2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID1744348Antitumor activity against luciferase-tagged rat DSL-6A/C1 cells and GFP-tagged LTC-14-GFP cells co-inoculated in orthotropic xenograft BALB/c nude mouse model of pancreatic cancer assessed as reduction in tumor volume at 100 mg/kg, ip administered once e2021Journal of medicinal chemistry, 01-14, Volume: 64, Issue:1
Novel Nonsecosteroidal Vitamin D Receptor Modulator Combined with Gemcitabine Enhances Pancreatic Cancer Therapy through Remodeling of the Tumor Microenvironment.
AID1908845Induction of apoptosis in human MIA PaCa-2 cells assessed as live cells at 0.5 uM incubated for 24 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 90.2%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1656950Antiproliferative activity against human BxPC3 cells harboring wild type KRAS and TP53 mutation assessed as maximal inhibition of cell growth at 2.5 uM incubated for 96 hrs by cell-titer-Glo assay2020Bioorganic & medicinal chemistry letters, 03-15, Volume: 30, Issue:6
Identification of a C3'-nitrile nucleoside analogue inhibitor of pancreatic cancer cell line growth.
AID1124981Drug metabolism in human K562 cell lysate assessed as HINT-1-mediated compound formation by measuring retention time at 1 mM after 22 hrs by RP-HPLC analysis relative to control2014Bioorganic & medicinal chemistry, Apr-01, Volume: 22, Issue:7
N-Acyl-phosphoramidates as potential novel form of gemcitabine prodrugs.
AID1298313Effect on 5-aza-dCTP level in human U373-MAGI cells at 2.5 nM preincubated for 2 hrs followed by 5-aza-dC addition measured after 4 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1222342Drug metabolism assessed as 2',2'-difluorodeoxycytidine formation incubated for 1 min in presence of human recombinant N-terminal His-tagged DCK Ala119Gly mutant expressed in Escherichia coli BL21(DE3) cells by liquid chromatography-tandem mass spectromet2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1298317Effect on 5-aza-dCTP level in human U373-MAGI cells at 25 nM preincubated for 2 hrs followed by 5-aza-dC addition measured after 4 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1550509Cytotoxicity against human Capan2 cells incubated for 24 hrs by MTT assay2019European journal of medicinal chemistry, May-15, Volume: 170Multi-target compounds acting in cancer progression: Focus on thiosemicarbazone, thiazole and thiazolidinone analogues.
AID1910313Induction of apoptosis in human PDAC-2 cells assessed as fold change in apoptotic rate at IC50 measured after 72 hrs by Annexin-V/FITC staining based assay relative to control2022Journal of medicinal chemistry, 05-26, Volume: 65, Issue:10
Reversible Monoacylglycerol Lipase Inhibitors: Discovery of a New Class of Benzylpiperidine Derivatives.
AID1824954Antiproliferative activity against human A549 cells assessed as inhibition of cell growth measured after 72 hrs by MTT assay2022Journal of medicinal chemistry, 01-13, Volume: 65, Issue:1
Integrin-Mediated Targeted Cancer Therapy Using c(RGDyK)-Based Conjugates of Gemcitabine.
AID739331Cytotoxicity against african green monkey CV1 cells after 72 hrs by MTT assay2013Bioorganic & medicinal chemistry letters, Apr-15, Volume: 23, Issue:8
Cytotoxic scalarane sesterterpenes from a Korean marine sponge Psammocinia sp.
AID1203923Cytotoxicity against human A549 cells assessed as dose reduction index ratio treated at simultaneous combination at 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1533381Antiproliferative activity against human K562 cells after 3 days by MTS assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID1325409Toxicity in non-obese diabetic DB17 SCID mouse xenografted with human PANC1 cells assessed as change in body weight at 40 mg/kg, iv administered 2 times per week for 4 weeks2016Bioorganic & medicinal chemistry letters, 11-15, Volume: 26, Issue:22
Discovery of ursolic acid prodrug (NX-201): Pharmacokinetics and in vivo antitumor effects in PANC-1 pancreatic cancer.
AID611476Cytotoxicity against mouse P388D1 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1224152Cytotoxicity against human BxPC3 cells after 5 days by PrestoBlue assay relative to gemcitabine2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
Development and bioorthogonal activation of palladium-labile prodrugs of gemcitabine.
AID683840Cytotoxicity against human HeLa cells after 72 hrs by resazurin assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
Comparison of the cytotoxic effects of enantiopure PPAPs, including nemorosone and clusianone.
AID117780In vivo activity against transplanted Mam-17 tumors of mice; Not active2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID342007Antibacterial activity against deoxyribonucleotide kinase-deficient Escherichia coli KY895 expressing Staphylococcus aureus recombinant deoxyguanosine kinase2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID1233458Cytotoxicity against human HT-29 cells after 72 hrs by MTT assay2015Bioorganic & medicinal chemistry letters, Jul-15, Volume: 25, Issue:14
New indole-isoxazolone derivatives: Synthesis, characterisation and in vitro SIRT1 inhibition studies.
AID1203913Cytotoxicity against human A549 cells assessed as inhibition fraction treated at 2:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1403763Half life in human plasma2018European journal of medicinal chemistry, Feb-10, Volume: 145Biotin conjugated organic molecules and proteins for cancer therapy: A review.
AID342003Antibacterial activity against exponentially growing Streptococcus pyogenes AP1 at 0.2 ug/ml after 3 hrs by viable count susceptibility assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID676698Cytotoxicity against human PANC1 cells grown in nutrient-rich medium after 24 hrs by WST8 assay2012Journal of natural products, Jun-22, Volume: 75, Issue:6
Antiausterity agents from Uvaria dac and their preferential cytotoxic activity against human pancreatic cancer cell lines in a nutrient-deprived condition.
AID1410091Antiproliferative activity against human HCT116 cells at 500 nM after 48 hrs by propidium iodide staining based fluorometry relative to control2018ACS medicinal chemistry letters, Mar-08, Volume: 9, Issue:3
Synthesis and Biological Screening of Pyrano[3,2-
AID341996Antimicrobial activity against Streptococcus sp. 07941-1 after 20 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1075481Cytostatic activity against mouse L1210 cells after 48 hrs by coulter counter analysis2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID1508817Antimetastatic activity against human PANC1 cells harboring luciferase reporter gene xenografted in Balb/c nude mouse assessed as mouse survival at 25 mg/kg/day, ip (Rvb = 25%)2019Journal of medicinal chemistry, 05-23, Volume: 62, Issue:10
Modification and Biological Evaluation of a Series of 1,5-Diaryl-1,2,4-triazole Compounds as Novel Agents against Pancreatic Cancer Metastasis through Targeting Myoferlin.
AID1467154Antiproliferative activity against human MKN28 cells after 48 hrs by sulforhodamine B assay2017Bioorganic & medicinal chemistry letters, 07-01, Volume: 27, Issue:13
Gemcitabine anti-proliferative activity significantly enhanced upon conjugation with cell-penetrating peptides.
AID214391Inhibitory activity against U373-MG (human, glioblastoma) cell line2003Journal of medicinal chemistry, Sep-11, Volume: 46, Issue:19
Synthesis and cytotoxic activity of two novel 1-dodecylthio-2-decyloxypropyl-3-phosphatidic acid conjugates with gemcitabine and cytosine arabinoside.
AID1298377Increase in 5-aza-dCTP/dCTP ratio in human U373-MAGI cells at 2.5 nM preincubated for 2 hrs followed by 5-aza-C addition measured after 4 hrs by LC-MS/MS analysis relative to 5-aza-C2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1654142Antiproliferative activity against human PANC1 cells assessed as reduction in cell viability after 72 hrs by WST-8 assay
AID460602Anticancer activity against human PANC1 cells at 500 nM after 48 hrs by propidium iodide fluorescence assay2010Bioorganic & medicinal chemistry, Mar-01, Volume: 18, Issue:5
Synthesis and biological screening of a combinatorial library of beta-chlorovinyl chalcones as anticancer, anti-inflammatory and antimicrobial agents.
AID526353Antiproliferative activity against human p53 deficient COLO205 cells after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1062072Induction of apoptosis in human FTC-133 cells assessed as caspase-3 positive cells at 5 uM after 24 hrs by immunohistochemical analysis2013Bioorganic & medicinal chemistry, Dec-15, Volume: 21, Issue:24
Synthesis and biological evaluation of 3-hydroxymethyl-5-(1H-1,2,3-triazol) isoxazolidines.
AID1908855Induction of apoptosis in human MIA PaCa-2 cells assessed as necrotic cells at 0.5 uM incubated for 48 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 1.07%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1441787Cytotoxicity against daunorubicin resistant human CCRF-CEM cells assessed as cell growth inhibition after 72 hrs by MTS assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID1694957Cytotoxicity against human BXPC-3 cells assessed as inhibition of cell growth measured after 72 hrs by SRB assay2020RSC medicinal chemistry, Feb-01, Volume: 11, Issue:2
Development of potent CPP6-gemcitabine conjugates against human prostate cancer cell line (PC-3).
AID648697Cytotoxicity against human ACHN cells after 48 hrs by WST-8 assay2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
One pot synthesis and anticancer activity of dimeric phloroglucinols.
AID1311653Antiproliferative activity against mouse B16-F10-Luc-G5 cells assessed as cell growth inhibition measured after 24 hrs by luciferase gene assay2016Bioorganic & medicinal chemistry letters, 08-01, Volume: 26, Issue:15
An evaluation of Minor Groove Binders as anti-lung cancer therapeutics.
AID81476Inhibitory activity against HL-60 (human, promyelocytic leukemia) cell line2003Journal of medicinal chemistry, Sep-11, Volume: 46, Issue:19
Synthesis and cytotoxic activity of two novel 1-dodecylthio-2-decyloxypropyl-3-phosphatidic acid conjugates with gemcitabine and cytosine arabinoside.
AID1054210Antiviral activity against HIV1 infected in human U373-MAGI cells incubated for 2 hrs prior to viral infection followed by compound washout after 24 hrs measured 72 hrs post-infection by flow cytometry2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
5,6-Dihydro-5-aza-2'-deoxycytidine potentiates the anti-HIV-1 activity of ribonucleotide reductase inhibitors.
AID1075472Cytotoxicity against human RT112 cells assessed as cell viability by MTT assay in absence of dCK substrate deoxycytidine2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID1602091Antiproliferative activity against human DU145 cells measured after 72 hrs by MTT assay2019European journal of medicinal chemistry, Mar-15, Volume: 166Development of bioactive gemcitabine-D-Lys
AID312865Cytotoxicity against multidrug-resistant human HCT116 cells by thymidine incorporation assay2008Journal of medicinal chemistry, Feb-14, Volume: 51, Issue:3
Comprehensive study of sansalvamide A derivatives and their structure-activity relationships against drug-resistant colon cancer cell lines.
AID1696861Inhibition of cell migration in human PANC-1 cells assessed as wound healing rate at 0.2 uM incubated for 24 hrs by wound healing assay (Rvb = 63%)2020Journal of medicinal chemistry, 10-08, Volume: 63, Issue:19
DPAGT1 Inhibitors of Capuramycin Analogues and Their Antimigratory Activities of Solid Tumors.
AID1772140Induction of S345 phosphorylation in tumor of mouse xenografted with human HT-29 cells at 100 mg/kg, iv dosed once a week for 22 days by Western blot analysis2021Journal of medicinal chemistry, 10-28, Volume: 64, Issue:20
Discovery and Development of a Potent, Selective, and Orally Bioavailable CHK1 Inhibitor Candidate: 5-((4-((3-Amino-3-methylbutyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)picolinonitrile.
AID445379Antimitotic activity in human CCRF-CEM cells assessed as decrease in mitotic histone H3 at 5 x GIC502010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1694956Half life of the compound2020RSC medicinal chemistry, Feb-01, Volume: 11, Issue:2
Development of potent CPP6-gemcitabine conjugates against human prostate cancer cell line (PC-3).
AID1222333Drug metabolism assessed as intrinsic clearance for 2',2'-difluorodeoxycytidine formation incubated for 1 min in presence of human recombinant N-terminal His-tagged DCK Pro122Ser mutant expressed in Escherichia coli BL21(DE3) cells by liquid chromatograph2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1467124Growth inhibition of human PANC1 cells after 72 hrs by WST8 assay2017Bioorganic & medicinal chemistry letters, 07-01, Volume: 27, Issue:13
Phytochemical and cytotoxic studies on the leaves of Calotropis gigantea.
AID1062073Cytotoxicity against human 8305C cells after 24 hrs by MTT assay2013Bioorganic & medicinal chemistry, Dec-15, Volume: 21, Issue:24
Synthesis and biological evaluation of 3-hydroxymethyl-5-(1H-1,2,3-triazol) isoxazolidines.
AID648764Cytotoxicity against human NCI-H460 cells after 48 hrs by WST-8 assay2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
One pot synthesis and anticancer activity of dimeric phloroglucinols.
AID1066256Cytostatic activity against human dCK-deficient CEM cells after 3 days by coulter counter analysis2014Journal of medicinal chemistry, Jan-09, Volume: 57, Issue:1
Synthesis and cytostatic evaluation of 4-N-alkanoyl and 4-N-alkyl gemcitabine analogues.
AID438541Inhibition of chemoresistant human MIAPaCa2 cell proliferation after 48 hrs by MTT assay2009Journal of medicinal chemistry, Oct-08, Volume: 52, Issue:19
Novel triazole ribonucleoside down-regulates heat shock protein 27 and induces potent anticancer activity on drug-resistant pancreatic cancer.
AID1908846Induction of apoptosis in human MIA PaCa-2 cells assessed as early apoptotic cells at 0.5 uM incubated for 24 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 5.1%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID253427Ability (36 umol/kg) tested on mortality of non-diseased CD2F1 mice at day 8 (n=8)2005Bioorganic & medicinal chemistry letters, May-16, Volume: 15, Issue:10
Synthesis and biological evaluation of gemcitabine-lipid conjugate (NEO6002).
AID1294503Cytotoxicity against human A549 cells assessed as reduction in cell viability after 72 hrs by MTS assay2016Bioorganic & medicinal chemistry letters, May-01, Volume: 26, Issue:9
L-Aspartic and l-glutamic acid ester-based ProTides of anticancer nucleosides: Synthesis and antitumoral evaluation.
AID1776703Antiproliferative activity against human MDA-MB-231 cells assessed as reduction in cell viability after 48 hrs by MTT assay2021Bioorganic & medicinal chemistry letters, 07-15, Volume: 44New indenopyrazole linked oxadiazole conjugates as anti-pancreatic cancer agents: Design, synthesis, in silico studies including 3D-QSAR analysis.
AID537478Growth inhibition of human MDA-MB-231 cells at 0.2 uM after 96 hrs by sulforhodamine B assay relative to control2010Bioorganic & medicinal chemistry, Nov-15, Volume: 18, Issue:22
Synthesis and anticancer activity of new 1-[(5 or 6-substituted 2-alkoxyquinoxalin-3-yl)aminocarbonyl]-4-(hetero)arylpiperazine derivatives.
AID611460Cytotoxicity against human MDA-MB-231 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID526355Antiproliferative activity against human p53 deficient SF268 cells after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID611477Cytotoxicity against human BJ cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1607708Antiproliferative activity against human HeLa cells at 15 mM after 24 hrs by MTT assay relative to control2019European journal of medicinal chemistry, Sep-15, Volume: 178Anti-cancer effects of cinnamon: Insights into its apoptosis effects.
AID1222320Activity of human recombinant N-terminal His-SUMO fused wild type CDA expressed in Escherichia coli BL21(DE3) cells assessed as intrinsic clearance for 2',2'-difluorodeoxyuridine formation by liquid chromatography-tandem mass spectrometry2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1713588Antiproliferative activity against human PLC-PRF-5 cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID526352Antiproliferative activity against human p53 deficient SW480 cells after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1730428Stability in pH 4 aqueous buffer assessed as parent compound remaining at 200 uM measured after 4 hrs by UV spectrophotometry2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1200783Cytotoxicity against human MIAPaCa2 cells after 24 hrs by MTT colorimetric assay2015European journal of medicinal chemistry, Mar-26, Volume: 93Novel 1-(2-aryl-2-adamantyl)piperazine derivatives with antiproliferative activity.
AID106322In vitro cytotoxic activity against uterine sarcoma (MES-SA) cells assayed by inhibition of [3H]-labeled thymidine incorporation2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
O-Phosphonatomethylcholine, its analogues, alkyl esters, and their biological activity.
AID1871666Anticancer activity against human ASPC1 cells assessed as cell growth inhibition measured after 72 hrs by Cell-Titre Glo luminescent cell viability assay2022European journal of medicinal chemistry, Feb-05, Volume: 229Current status of carbazole hybrids as anticancer agents.
AID292207Growth inhibition of A549 cells by SRB assay in presence of dipyridamole2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID1489774Antitumor activity against human MIAPaCa2 cells xenografted in NOD/SCID mouse assessed as tumor volume at 15 mg/kg administered once a week for 48 days (Rvb = 1503 +/- 189 mm'3)2018Journal of medicinal chemistry, 02-22, Volume: 61, Issue:4
Design and Synthesis of Novel Reactive Oxygen Species Inducers for the Treatment of Pancreatic Ductal Adenocarcinoma.
AID648696Growth inhibition of human HCT116 cells at 500 nM after 48 hrs by WST-8 assay2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
One pot synthesis and anticancer activity of dimeric phloroglucinols.
AID526357Antiproliferative activity against human HCT15 cells expressing p53 after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1862944Antiproliferative activity against human HCT-116 cells assessed as inhibition of cell growth2022Bioorganic & medicinal chemistry letters, 09-15, Volume: 72Design, synthesis and antitumor activity study of a gemcitabine prodrug conjugated with a HDAC6 inhibitor.
AID1908854Induction of apoptosis in human MIA PaCa-2 cells assessed as late apoptotic cells at 0.5 uM incubated for 48 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 0.8%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1203903Cytotoxicity against human MRC5 cells treated at 2:1 and 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1224150Cytotoxicity against human BxPC3 cells after 5 days by PrestoBlue assay2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
Development and bioorthogonal activation of palladium-labile prodrugs of gemcitabine.
AID460599Anticancer activity against human ACHN cells at 500 nM after 48 hrs by propidium iodide fluorescence assay2010Bioorganic & medicinal chemistry, Mar-01, Volume: 18, Issue:5
Synthesis and biological screening of a combinatorial library of beta-chlorovinyl chalcones as anticancer, anti-inflammatory and antimicrobial agents.
AID1358372Antitumor activity against human PANC1 cells xenografted in zebrafsh yolk assessed as tumor growth inhibition at 66.7 uM after 2 days by fluorescence microscopy2018European journal of medicinal chemistry, May-10, Volume: 151Syntheses and anti-pancreatic cancer activities of rakicidin A analogues.
AID648695Growth inhibition of human NCI-H460 cells at 500 nM after 48 hrs by WST-8 assay2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
One pot synthesis and anticancer activity of dimeric phloroglucinols.
AID1151326Cytotoxicity against human MCF7 cells assessed as cell viability after 24 hrs by WST-1 assay2014Journal of natural products, May-23, Volume: 77, Issue:5
Cytotoxic alkylated hydroquinone, phenol, and cyclohexenone derivatives from Aspergillus violaceofuscus Gasperini.
AID1684810Selectivity index, ratio of CC50 for human HEL cells to EC50 for antiviral activity against thymidine kinase deficient Varicella zoster virus 07-1 infected in human HEL cells2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1480664Oral bioavailability in Wistar rat at 50 mg/kg administered as single dose by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID611453Cytotoxicity against human paclitaxel resistant K562 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1727433Antiproliferative activity against human PDAC-3 cells assessed as inhibition of cell growth incubated for 72 hrs by SRB assay2021European journal of medicinal chemistry, Jan-01, Volume: 209Design, synthesis and biological evaluation of second-generation benzoylpiperidine derivatives as reversible monoacylglycerol lipase (MAGL) inhibitors.
AID1298394Reduction in dCTP level in human U373-MAGI cells at 2.5 nM preincubated for 2 hrs followed by 5-aza-dC addition measured after 4 hrs by LC-MS/MS analysis relative to 5-aza-dC2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1233457Cytotoxicity against human MCF7 cells after 72 hrs by MTT assay2015Bioorganic & medicinal chemistry letters, Jul-15, Volume: 25, Issue:14
New indole-isoxazolone derivatives: Synthesis, characterisation and in vitro SIRT1 inhibition studies.
AID1694315Anticancer activity against human SMMC-7721 cells assessed as inhibition of cell proliferation at 1 uM measured after 72 hrs by MTT assay2021Bioorganic & medicinal chemistry, 02-15, Volume: 32Novel penta-1,4-diene-3-one derivatives containing quinazoline and oxime ether fragments: Design, synthesis and bioactivity.
AID201650Inhibitory activity against SK-LU-1 (human,lung,adenocarcinoma) cell line2003Journal of medicinal chemistry, Sep-11, Volume: 46, Issue:19
Synthesis and cytotoxic activity of two novel 1-dodecylthio-2-decyloxypropyl-3-phosphatidic acid conjugates with gemcitabine and cytosine arabinoside.
AID689616Induction of apoptosis in multidrug-resistant human MIAPaCa2 cells assessed as increase in DNA/histone nucleosome release after 48 hrs by ELISA relative to control2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
A novel bitriazolyl acyclonucleoside endowed with dual antiproliferative and immunomodulatory activity.
AID1889903Cytotoxicity against human MIA PaCa-2 cells assessed as inhibition of cell growth incubated for 72 hrs by CCK-8 assay2022Bioorganic & medicinal chemistry, 04-01, Volume: 59Discovery and optimization of betulinic acid derivatives as novel potent CD73 inhibitors.
AID46041Inhibitory activity against CEM-SS (human T-4 lymphoblastoid clone) cell line2003Journal of medicinal chemistry, Sep-11, Volume: 46, Issue:19
Synthesis and cytotoxic activity of two novel 1-dodecylthio-2-decyloxypropyl-3-phosphatidic acid conjugates with gemcitabine and cytosine arabinoside.
AID445382Inhibition of DNA synthesis in human CCRF-CEM assessed as assessed as BrdU incorporation at 1 x GIC50 after 24 by flow cytometry2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1549857Antitumor activity against human PANC1 cells xenografted in nude mouse assessed as reduction in tumor weight at 30 mg/kg, ip administered every 3 days for 4 weeks post tumor inoculation2019European journal of medicinal chemistry, May-15, Volume: 170Synthesis and evaluation of tetrahydroquinolin-2(1H)-one derivatives as novel anti-pancreatic cancer agents via targeting autophagy.
AID696881Cytotoxicity against human PANC1 cells grown in nutrient-deprived medium after 24 hrs by WST8 assay2012Journal of natural products, Nov-26, Volume: 75, Issue:11
Uvaridacols E-H, highly oxygenated antiausterity agents from Uvaria dac.
AID1908851Induction of apoptosis in human MIA PaCa-2 cells assessed as necrotic cells at 0.1 uM incubated for 48 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 1.07%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1216055Cytotoxicity against human Patu-T cells by crystal violet staining2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Drug efflux transporter multidrug resistance-associated protein 5 affects sensitivity of pancreatic cancer cell lines to the nucleoside anticancer drug 5-fluorouracil.
AID1730409Cytotoxicity against HEK293 cells assessed as reduction in cell viability measured after 96 hrs by celltiter-glo assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID340153Antitumor activity against human K562 cells after 48 hrs by MTS assay2008Journal of medicinal chemistry, Jul-24, Volume: 51, Issue:14
Ribose-modified purine nucleosides as ribonucleotide reductase inhibitors. Synthesis, antitumor activity, and molecular modeling of N6-substituted 3'-C-methyladenosine derivatives.
AID1298370Selectivity index, ratio of 5-Aza-C CC50 for human U373-MAGI cells to 5-Aza-C EC50 for VSV-G pseudotyped HIV-1 NL4-3 in presence of 2.5 nM compound (Rvb = 2.8 No_unit)2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID611473Cytotoxicity against human SKOV3 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1908823Cytotoxicity against HEK293 cells assessed as inhibition of cell growth incubated for 72 hrs by MTT assay2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1892541Antiproliferative activity against human MDA-MB-231 cells assessed as cell growth inhibition measured after 48 hrs by MTS assay
AID1533383Antiproliferative activity against human U2OS cells after 3 days by MTS assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID1054213Antiviral activity against HIV1 infected in human U373-MAGI cells assessed as G to A mutation at 20 nM (Rvb = 27%)2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
5,6-Dihydro-5-aza-2'-deoxycytidine potentiates the anti-HIV-1 activity of ribonucleotide reductase inhibitors.
AID1742875Induction of mitochondrial membrane potential disruption in human T-24 cells assessed as ratio of green/red fluorescence intensity at 8 uM by JC-1 dye based confocal laser scanning microscopic analysis2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID1203939Induction of H2O2 level in human A549 cells at 1 uM after 5 to 30 mins by flow cytometry2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID729742Cytotoxicity against human MiaPaCa cells assessed as inhibition of cell viability after 6 days by MTT assay2013Journal of natural products, Feb-22, Volume: 76, Issue:2
Bioactive sesterterpenoids from a Korean sponge Monanchora sp.
AID1684817Antiviral activity against thymidine kinase positive Varicella zoster virus OKA infected in human HEL cells assessed as reduction in virus plaque formation measured on day 5 post-viral infection2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1200784Cytotoxicity against human NCI-H1975 cells after 24 hrs by MTT colorimetric assay2015European journal of medicinal chemistry, Mar-26, Volume: 93Novel 1-(2-aryl-2-adamantyl)piperazine derivatives with antiproliferative activity.
AID1222332Drug metabolism assessed as intrinsic clearance for 2',2'-difluorodeoxycytidine formation incubated for 1 min in presence of human recombinant N-terminal His-tagged DCK Ile24Val mutant expressed in Escherichia coli BL21(DE3) cells by liquid chromatography2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID345891Induction of apoptosis in human MIAPaCa2 cells assessed as increase in caspase 3/7 activation after 48 hrs2009Journal of medicinal chemistry, Feb-26, Volume: 52, Issue:4
Discovery of novel arylethynyltriazole ribonucleosides with selective and effective antiviral and antiproliferative activity.
AID1480614Drug transport assessed as OCTN2 transporter mediated drug uptake in human Caco2 cells at 1 to 800 uM in presence of Na+2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID1054208Selectivity index, ratio of CC50 for human U373-MAGI cells to EC50 for HIV1 infected in human U373-MAGI cells2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
5,6-Dihydro-5-aza-2'-deoxycytidine potentiates the anti-HIV-1 activity of ribonucleotide reductase inhibitors.
AID1298260Potentiation of 5-Aza-C-induced antiviral activity against VSV-G pseudotyped HIV-1 NL4-3 infected in human U373-MAGI cells assessed as decrease in 5-Aza-C EC50 at 2.5 nM preincubated for 2 hrs followed by 5-Aza-C addition for 2 hrs and subsequent viral in2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1412576Toxicity in mouse B16F10 cells allografted Balb/c mouse assessed as effect on body weight at 25 mg/kg, iv administered thrice weekly for 21 days starting on day 10 post tumor implantation (Rvb = 30.52 +/- 2.9 g)2018MedChemComm, May-01, Volume: 9, Issue:5
Development of a peptide-based bifunctional chelator conjugated to a cytotoxic drug for the treatment of melanotic melanoma.
AID1480604AUC (0 to 24 hrs) in Wistar rat at 7.5 mg/kg, iv administered as single dose by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID427703Cytotoxicity against human SNU638 cells by sulforhodamine B method2009Journal of medicinal chemistry, Sep-10, Volume: 52, Issue:17
Discovery of a new template for anticancer agents: 2'-deoxy-2'-fluoro-4'-selenoarabinofuranosyl-cytosine (2'-F-4'-seleno-ara-C).
AID1489704Cytotoxicity against HPDEC assessed as decrease in cell proliferation after 72 hrs by MTT assay2018Journal of medicinal chemistry, 02-22, Volume: 61, Issue:4
Design and Synthesis of Novel Reactive Oxygen Species Inducers for the Treatment of Pancreatic Ductal Adenocarcinoma.
AID1807084Cytotoxicity against human MIA PaCa-2 cells assessed as cell death incubated for 72 hrs by MTS assay2021Journal of medicinal chemistry, 06-24, Volume: 64, Issue:12
Single Diastereomers of the Clinical Anticancer ProTide Agents NUC-1031 and NUC-3373 Preferentially Target Cancer Stem Cells
AID1908833Induction of cell cycle arrest in human MIA PaCa-2 cells assessed as accumulation of cells in G2/M phase at 0.1 uM incubated for 24 hrs by RNase/propidium iodide staining based flow cytometry analysis (Rvb = 8.11%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1298283Reduction in dTTP level in human U373-MAGI cells at 25 nM after 6 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1480630Terminal half-life in Wistar rat at 7.5 mg/kg, iv administered as single dose by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID1358349Cytotoxicity against human PANC1 cells after 72 hrs under normoxic condition by MTT assay2018European journal of medicinal chemistry, May-10, Volume: 151Syntheses and anti-pancreatic cancer activities of rakicidin A analogues.
AID1468422Growth inhibition of human BxPC3 cells after 96 hrs by SRB assay2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
Targeting Multiple Effector Pathways in Pancreatic Ductal Adenocarcinoma with a G-Quadruplex-Binding Small Molecule.
AID526350Antiproliferative activity against human HCT116-E6 cells expressing p53 after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1533384Antiproliferative activity against human HL60 cells after 72 hrs by XTT assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID1908853Induction of apoptosis in human MIA PaCa-2 cells assessed as early apoptotic cells at 0.5 uM incubated for 48 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 1.8%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1480633Cmax in Wistar rat at 50 mg/kg, po administered as single dose by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID526360Antiproliferative activity against NHDF expressing p53 after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1730399Antiviral activity against HCV infected in human Huh-7 cells assessed as reduction in viral replication measured after 48 hrs by luciferase reporter gene assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID342013Ratio of kcat to Km for Staphylococcus aureus CCM 885 recombinant deoxyadenosine kinase2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID427702Cytotoxicity against human A549 cells by sulforhodamine B method2009Journal of medicinal chemistry, Sep-10, Volume: 52, Issue:17
Discovery of a new template for anticancer agents: 2'-deoxy-2'-fluoro-4'-selenoarabinofuranosyl-cytosine (2'-F-4'-seleno-ara-C).
AID1298269Antiviral activity against VSV-G pseudotyped HIV-1 NL4-3 infected in human U373-MAGI cells assessed as reduction in viral infectivity at 2.5 nM incubated for 4 hrs prior to viral infection measured at 72 hrs post infection by flow cytometric analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID680889TP_TRANSPORTER: drug resistance in MDR1-expressing BROmdr cells2003British journal of cancer, Jun-16, Volume: 88, Issue:12
Increased sensitivity to gemcitabine of P-glycoprotein and multidrug resistance-associated protein-overexpressing human cancer cell lines.
AID1742800Induction of apoptosis in human T-24 cells assessed as necrotic cells at 3 uM incubated for 8 hrs by annexin V-FITC and PI staining based flow cytometry analysis (Rvb = 0.84 %)2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID500353Induction of cell cycle arrest in human HCT15 cells expressing p53 gene assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID611466Cytotoxicity against mouse CT26 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1862943Antiproliferative activity against human PANC-1 cells assessed as inhibition of cell growth2022Bioorganic & medicinal chemistry letters, 09-15, Volume: 72Design, synthesis and antitumor activity study of a gemcitabine prodrug conjugated with a HDAC6 inhibitor.
AID503797Antiproliferative activity against p53 deficient human HeLa cells after 72 hrs2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1124985Drug level in human K562 cell lysate treated with 1 mM gemcitabine 5'-phosphoramidate assessed as HINT-1-mediated compound formation after 22 hrs by RP-HPLC analysis relative to control2014Bioorganic & medicinal chemistry, Apr-01, Volume: 22, Issue:7
N-Acyl-phosphoramidates as potential novel form of gemcitabine prodrugs.
AID500345Induction of cell cycle arrest in p53 deficient human SW480 cells assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1812916Cytotoxicity against human ASPC1 assessed as cell viability measured for 72 hrs by cell titer glo luminescent assay2021Journal of natural products, 08-27, Volume: 84, Issue:8
Monomeric, Dimeric, and Trimeric Tropane Alkaloids from
AID1064234Cytotoxicity against human PANC1 cells after 24 hrs by WST-8 assay in presence of DMEM2014Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2
Discovery of 2-pyridineformamide thiosemicarbazones as potent antiausterity agents.
AID1489775Antitumor activity against human MIAPaCa2 cells xenografted in NOD/SCID mouse at 15 mg/kg administered twice a week for 15 days2018Journal of medicinal chemistry, 02-22, Volume: 61, Issue:4
Design and Synthesis of Novel Reactive Oxygen Species Inducers for the Treatment of Pancreatic Ductal Adenocarcinoma.
AID1697253Cytotoxicity against human PANC1 cells assessed as reduction in cell viability measured after 48 hrs by MTS assay2020Bioorganic & medicinal chemistry letters, 11-15, Volume: 30, Issue:22
Synthesis of indole-tethered [1,3,4]thiadiazolo and [1,3,4]oxadiazolo[3,2-a]pyrimidin-5-one hybrids as anti-pancreatic cancer agents.
AID526356Antiproliferative activity against human p53 deficient OVCAR8 cells after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1200781Cytotoxicity against human HeLa cells after 24 hrs by MTT colorimetric assay2015European journal of medicinal chemistry, Mar-26, Volume: 93Novel 1-(2-aryl-2-adamantyl)piperazine derivatives with antiproliferative activity.
AID1410087Antiproliferative activity against human ACHN cells at 500 nM after 48 hrs by propidium iodide staining based fluorometry relative to control2018ACS medicinal chemistry letters, Mar-08, Volume: 9, Issue:3
Synthesis and Biological Screening of Pyrano[3,2-
AID292204Growth inhibition of AG6000 cells by SRB assay2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID1724282Effect on hTERT expression in mouse xenografted with human MIAPaCa2 cells at 15 mg/kg, iv administered twice per week for 28 days and measured on day 28 by Western blot analysis2020ACS medicinal chemistry letters, Aug-13, Volume: 11, Issue:8
Asymmetrically Substituted Quadruplex-Binding Naphthalene Diimide Showing Potent Activity in Pancreatic Cancer Models.
AID611465Cytotoxicity against human HCT116 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID648766Cytotoxicity against human MCF10A cells after 48 hrs by WST-8 assay2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
One pot synthesis and anticancer activity of dimeric phloroglucinols.
AID1684801Antiviral activity against Polio virus Mahoney infected in human HeLa cells assessed as inhibition of viral replication incubated for 2 days by luminescence analysis2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1467155Antiproliferative activity against human Caco2 cells after 48 hrs by sulforhodamine B assay2017Bioorganic & medicinal chemistry letters, 07-01, Volume: 27, Issue:13
Gemcitabine anti-proliferative activity significantly enhanced upon conjugation with cell-penetrating peptides.
AID676699Cytotoxicity against human PSN1 cells grown in nutrient-rich medium after 24 hrs by WST8 assay2012Journal of natural products, Jun-22, Volume: 75, Issue:6
Antiausterity agents from Uvaria dac and their preferential cytotoxic activity against human pancreatic cancer cell lines in a nutrient-deprived condition.
AID1533378Antiproliferative activity against human CEM-DNR-bulk cells after 3 days by MTS assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID1684804Antiviral activity against Zika virus infected in human RPE cells assessed as inhibition of virus-induced cytopathic effect measured at 48 hrs post-viral infection by CellTiter Glo assay2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1298390Effect on dRGU-TP level in human U373-MAGI cells at 25 nM preincubated for 2 hrs followed by 5-aza-dC addition measured after 4 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1075482Cytostatic activity against human MIAPaCa2 cells after 72 hrs by MTS assay2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1602094Antiproliferative activity against human MCF7 cells measured after 72 hrs by MTT assay2019European journal of medicinal chemistry, Mar-15, Volume: 166Development of bioactive gemcitabine-D-Lys
AID1467125Cytotoxicity against human PANC1 cells at >25 uM measured after 72 hrs by WST8 assay2017Bioorganic & medicinal chemistry letters, 07-01, Volume: 27, Issue:13
Phytochemical and cytotoxic studies on the leaves of Calotropis gigantea.
AID1689971Antiproliferative activity against human SUIT-2 cells assessed as reduction in cell growth incubated for 72 hrs by SRB assay2020European journal of medicinal chemistry, Mar-01, Volume: 189Imidazo[2,1-b] [1,3,4]thiadiazoles with antiproliferative activity against primary and gemcitabine-resistant pancreatic cancer cells.
AID292213Growth inhibition of CEM cells by SRB assay in presence of dipyridamole2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID493448Antiviral activity against HCV 1a infected in human HB-1 cells assessed as inhibition of viral RNA replication after 24 hrs2010Bioorganic & medicinal chemistry letters, Aug-01, Volume: 20, Issue:15
Synthesis and anti-HCV activity of 3',4'-oxetane nucleosides.
AID1355101Resistance ratio of IC50 for human MDA-MB-231/Gem cells to IC50 for human MDA-MB-231 cells
AID1908843Induction of apoptosis in human MIA PaCa-2 cells assessed as late apoptotic cells at 0.1 uM incubated for 24 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 2.04%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1908831Induction of cell cycle arrest in human MIA PaCa-2 cells assessed as accumulation of cells at S phase at 0.1 uM incubated for 48 hrs by RNase/propidium iodide staining based flow cytometry analysis (Rvb =26.9 %)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1066258Cytostatic activity against mouse L1210 cells after 2 days by coulter counter analysis2014Journal of medicinal chemistry, Jan-09, Volume: 57, Issue:1
Synthesis and cytostatic evaluation of 4-N-alkanoyl and 4-N-alkyl gemcitabine analogues.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1776702Antiproliferative activity against human MCF7 cells assessed as reduction in cell viability after 48 hrs by MTT assay2021Bioorganic & medicinal chemistry letters, 07-15, Volume: 44New indenopyrazole linked oxadiazole conjugates as anti-pancreatic cancer agents: Design, synthesis, in silico studies including 3D-QSAR analysis.
AID1589126Selectivity index, ratio of IC50 for cytotoxicity in human NHDF cells to IC50 for cytotoxicity in human U87 cells2019Bioorganic & medicinal chemistry letters, 09-15, Volume: 29, Issue:18
Synthesis and in vitro anticancer activity of new gemcitabine-nucleoside analogue dimers containing methyltriazole or ester-methyltriazole linker.
AID1850286Antiproliferative activity against human HepG2 cells measured after 48 hrs by MTT assay
AID1724239Antitumor activity against human MIAPaCa2 cells xenografted in mouse assessed as change in tumor volume at 15 mg/kg, iv administered twice per week for 28 days and measured at day 53 by Caliper method relative to control2020ACS medicinal chemistry letters, Aug-13, Volume: 11, Issue:8
Asymmetrically Substituted Quadruplex-Binding Naphthalene Diimide Showing Potent Activity in Pancreatic Cancer Models.
AID292203Growth inhibition of A2780 cells by SRB assay2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID459131Growth inhibition of human ACHN cells at 500 nM after 24 hrs by propidium iodide assay2010Bioorganic & medicinal chemistry, Feb, Volume: 18, Issue:3
Synthesis and biological evaluation of simple methoxylated chalcones as anticancer, anti-inflammatory and antioxidant agents.
AID445381Inhibition of RNA synthesis in human CCRF-CEM assessed as assessed as BrdU incorporation at 5 x GIC50 after 24 by flow cytometry2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1689974Antiproliferative activity against human PDAC-3 cells assessed as inhibition of cell growth incubated for 72 hrs by SRB assay2020European journal of medicinal chemistry, Mar-01, Volume: 189Imidazo[2,1-b] [1,3,4]thiadiazoles with antiproliferative activity against primary and gemcitabine-resistant pancreatic cancer cells.
AID1755780Drug uptake in C57BL/6N mouse blood at 10 mg/kg, IP measured after 30 mins of dosing by LC-MS/MS analysis
AID1684797Antiviral activity against SARS-CoV MA15 infected in African green monkey Vero E6 cells assessed as inhibition of virus-induced cytopathic effect treated for 2 hrs prior to viral infection and measured after 48 hrs by CellTiter Glo assay2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1684806Cytotoxicity against African green monkey Vero cells assessed as reduction in cell growth by coulter counter analysis2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1713589Antiproliferative activity against human U937 cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID1203933Cytotoxicity against human MRC5 cells assessed as dose reduction index ratio treated at simultaneous combination at 2:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1486080Antiproliferative activity against human PANC1 cells after 72 hrs by CCK8 assay2017Bioorganic & medicinal chemistry, 08-01, Volume: 25, Issue:15
Design, synthesis and biological evaluation of sulfonamide-substituted diphenylpyrimidine derivatives (Sul-DPPYs) as potent focal adhesion kinase (FAK) inhibitors with antitumor activity.
AID1416680Cytostatic activity against human MCR5 cells after 3 days by MTS assay2017MedChemComm, Sep-01, Volume: 8, Issue:9
Sugar modified pyrimido[4,5-
AID1862941Antiproliferative activity against human SK-OV-3 cells assessed as inhibition of cell growth2022Bioorganic & medicinal chemistry letters, 09-15, Volume: 72Design, synthesis and antitumor activity study of a gemcitabine prodrug conjugated with a HDAC6 inhibitor.
AID1742794Antiproliferative activity against human MGC-803 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID1124958Cytotoxicity against HUVEC assessed as cell after 48 hrs by MTT assay2014Bioorganic & medicinal chemistry, Apr-01, Volume: 22, Issue:7
N-Acyl-phosphoramidates as potential novel form of gemcitabine prodrugs.
AID460608Anticancer activity against human H460 cells at 500 nM after 48 hrs by propidium iodide fluorescence assay2010Bioorganic & medicinal chemistry, Mar-01, Volume: 18, Issue:5
Synthesis and biological screening of a combinatorial library of beta-chlorovinyl chalcones as anticancer, anti-inflammatory and antimicrobial agents.
AID666079Cytotoxicity against human HCT116 cells at 1000 nM after 48 hrs by WST-1 assay2012Bioorganic & medicinal chemistry letters, Jun-15, Volume: 22, Issue:12
Simple, fast and efficient synthesis of β-keto esters from the esters of heteroaryl compounds, its antimicrobial study and cytotoxicity towards various cancer cell lines.
AID1589115Drug level in human HeLa cells treated with 1-(3'-Deoxythymidin-3'-yl)-4-[methyloxycarbonyl-(2'-deoxy-2',2'-difluorocytidin-4N-yl)]-1H-1,2,3-triazole assessed as compound release incubated for 12 hrs by HPLC/MS method2019Bioorganic & medicinal chemistry letters, 09-15, Volume: 29, Issue:18
Synthesis and in vitro anticancer activity of new gemcitabine-nucleoside analogue dimers containing methyltriazole or ester-methyltriazole linker.
AID1203911Cytotoxicity against human T24 cells treated at LA + compound sequent. LA for 24 hrs), LA + GEM (24 hrs additional, total 48 hrs) 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1075467Drug degradation assessed as recombinant human cytidine deaminase-mediated dFdU formation at 100 uM measured within 2 mins by UV absorption spectroscopic analysis2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1222353Activity of human recombinant N-terminal His-SUMO fused CDA Lys27Gln mutant expressed in Escherichia coli BL21(DE3) cells assessed as intrinsic clearance for 2',2'-difluorodeoxyuridine formation by liquid chromatography-tandem mass spectrometry2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1742804Induction of apoptosis in human T-24 cells assessed as early apoptotic cells at 3 uM in presence of zVAD incubated for 8 hrs by annexin V-FITC and PI staining based flow cytometry analysis (Rvb = 3.37 %)2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID1054186Antiviral activity against HIV1 infected in human U373-MAGI cells assessed as T to C mutation at 20 nM (Rvb = 18%)2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
5,6-Dihydro-5-aza-2'-deoxycytidine potentiates the anti-HIV-1 activity of ribonucleotide reductase inhibitors.
AID1694316Anticancer activity against human SMMC-7721 cells assessed as inhibition of cell proliferation at 10 uM measured after 72 hrs by MTT assay2021Bioorganic & medicinal chemistry, 02-15, Volume: 32Novel penta-1,4-diene-3-one derivatives containing quinazoline and oxime ether fragments: Design, synthesis and bioactivity.
AID1222330Drug metabolism assessed as intrinsic clearance for 2',2'-difluorodeoxycytidine formation incubated for 1 min in presence of human recombinant N-terminal His-tagged wild type DCK expressed in Escherichia coli BL21(DE3) cells by liquid chromatography-tande2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1441778Cytotoxicity against mrp-1/mdr-1 overexpressing human CEM-DNR-bulk cells assessed as cell growth inhibition after 72 hrs by MTS assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID503810Antiproliferative activity against human PC3 cells expressing p53 gene after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID342016Antibacterial activity against 2.5 x 10'6 CFU Streptococcus pyogenes AP1-infected BALB/c mouse assessed as protection against bacterial dissemination in spleen at 100 ug, ip administered 6 hrs after bacterial infection and measured after 24 hrs postinfect2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID526358Antiproliferative activity against human p53 deficient Jurkat cells after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1713593Antiproliferative activity against human A549 cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID1124961Cytotoxicity against human CFPAC-1 cells assessed as reduction of cell survival after 72 hrs by MTT assay2014Bioorganic & medicinal chemistry, Apr-01, Volume: 22, Issue:7
N-Acyl-phosphoramidates as potential novel form of gemcitabine prodrugs.
AID503801Antiproliferative activity against p53 deficient human Jurkat cells after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID659006Antitumor activity against human MIAPaCa2 cells xenografted in SCID mouse assessed as tumor weight at 70 mg/kg, ip twice a week (Rvb = 1225 +/- 308 mg)2012Bioorganic & medicinal chemistry, May-15, Volume: 20, Issue:10
Synthesis, σ₁, σ₂-receptors binding affinity and antiproliferative action of new C1-substituted adamantanes.
AID1889904Cytotoxicity against human MDA-MB-231 cells assessed as inhibition of cell growth incubated for 72 hrs by CCK-8 assay2022Bioorganic & medicinal chemistry, 04-01, Volume: 59Discovery and optimization of betulinic acid derivatives as novel potent CD73 inhibitors.
AID426602Cytotoxicity against human SW1990 cells after 72 hrs by MTT assay2009Bioorganic & medicinal chemistry letters, May-15, Volume: 19, Issue:10
Synthesis and cytotoxicities of icogenin analogues with disaccharide residues.
AID117784In vivo activity against transplanted Panc-03 tumors of mice; Not active2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID1684799Antiviral activity against Human rhinovirus 1B infected in human HeLa cells assessed as inhibition of virus-induced cytopathicity measured after 2 days by SRB method2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID342004Antibacterial activity against deoxyribonucleotide kinase-deficient Escherichia coli KY895 expressing Staphylococcus aureus recombinant thymidine kinase2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID329310Toxicity against human MIAPaCa2 cells xenografted mouse assessed as survival time at 200 mg/kg, ip administered weekly once for 3 weeks2008Journal of medicinal chemistry, Apr-24, Volume: 51, Issue:8
Potent and highly selective hypoxia-activated achiral phosphoramidate mustards as anticancer drugs.
AID1630178Cytotoxicity against gemcitabine-resistant human MIAPaCa2 cells assessed as cell viability at 0.1 uM after 48 hrs by trypan blue exclusion assay relative to control2016Journal of medicinal chemistry, 09-22, Volume: 59, Issue:18
Discovery and Optimization of N-(4-(3-Aminophenyl)thiazol-2-yl)acetamide as a Novel Scaffold Active against Sensitive and Resistant Cancer Cells.
AID445383Inhibition of DNA synthesis in human CCRF-CEM assessed as assessed as BrdU incorporation at 5 x GIC50 after 24 by flow cytometry2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID124254In vivo activity against iv transplanted Leukemia L1210 tumors of mice2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID1713614Antitumor activity against human PLC-PRF-5 cells xenografted in BALB/c nude mouse assessed as inhibition of tumor growth by measuring T/C ratio at 25 mg/kg, ip2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1755772Antiproliferative activity against human PC-3 cells measured after 72 hrs by MTT assay
AID1817881Toxicity in BALB/c nude mouse xenografted with human MCF7 cells assessed as effect on spleen at 10 mg/kg, iv administered every 2 days for 2 weeks2021European journal of medicinal chemistry, Dec-15, Volume: 226Design, synthesis and bioevaluation of 6-aryl-1-(3,4,5-trimethoxyphenyl)-1H-benzo[d]imidazoles as tubulin polymerization inhibitors.
AID1298367Increase of 5-Aza-C-mediated cytotoxicity against human U373-MAGI cells at 2.5 nM preincubated for 2 hrs followed by 5-Aza-C addition for 2 hrs measured after 72 hrs by Celltiter-Glo luminescent cell viability assay (Rvb = 387 uM)2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1075459Antitumor activity against human MIAPaCa2 cells xenografted in Balb/c nude mouse assessed as tumor growth inhibition at 0.19 mmol/kg, ip administered every week for 3 weeks2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID1298305Reduction in dATP level in human U373-MAGI cells at 2.5 nM after 6 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1480636Drug level in Wistar rat portal blood at 50 mg/kg administered as single dose at 2 hrs by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID1812918Cytotoxicity against human PANC-1 assessed as cell viability measured for 72 hrs by cell titer glo luminescent assay2021Journal of natural products, 08-27, Volume: 84, Issue:8
Monomeric, Dimeric, and Trimeric Tropane Alkaloids from
AID1684802Antiviral activity against HIV-1 infected in HEK293T cells assessed as inhibition of viral replication treated with compound 2 hrs prior to viral infection and measured after 24 hrs by flow cytometry2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID676701Cytotoxicity against human KLM1 cells grown in nutrient-rich medium after 24 hrs by WST8 assay2012Journal of natural products, Jun-22, Volume: 75, Issue:6
Antiausterity agents from Uvaria dac and their preferential cytotoxic activity against human pancreatic cancer cell lines in a nutrient-deprived condition.
AID1689973Antiproliferative activity against human Panc-1 cells assessed as reduction in cell growth incubated for 72 hrs by SRB assay2020European journal of medicinal chemistry, Mar-01, Volume: 189Imidazo[2,1-b] [1,3,4]thiadiazoles with antiproliferative activity against primary and gemcitabine-resistant pancreatic cancer cells.
AID1724277Antitumor activity in KPC-induced PDAC mouse model expressing active KRASG12D and mutant p53R172H assessed as median survival time at 100 mg/kg, ip administered twice weekly (Rvb = 12 days)2020ACS medicinal chemistry letters, Aug-13, Volume: 11, Issue:8
Asymmetrically Substituted Quadruplex-Binding Naphthalene Diimide Showing Potent Activity in Pancreatic Cancer Models.
AID1730425Ratio of TC50 for cytotoxicity against human Huh-7 cells assessed as reduction in cell viability measured after 48 hrs in presence of ENT1 inhibitor NBTI to TC50 for cytotoxicity against human Huh-7 cells assessed as reduction in cell viability measured a2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1916530Half life in human2021European journal of medicinal chemistry, Dec-15, Volume: 226Novel strategies to improve tumour therapy by targeting the proteins MCT1, MCT4 and LAT1.
AID648693Growth inhibition of human PANC1 cells at 500 nM after 48 hrs by WST-8 assay2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
One pot synthesis and anticancer activity of dimeric phloroglucinols.
AID427704Cytotoxicity against human T47D cells by sulforhodamine B method2009Journal of medicinal chemistry, Sep-10, Volume: 52, Issue:17
Discovery of a new template for anticancer agents: 2'-deoxy-2'-fluoro-4'-selenoarabinofuranosyl-cytosine (2'-F-4'-seleno-ara-C).
AID426610Cytotoxicity against human MCF7 cells after 72 hrs by MTT assay2009Bioorganic & medicinal chemistry letters, May-15, Volume: 19, Issue:10
Synthesis and cytotoxicities of icogenin analogues with disaccharide residues.
AID44589Inhibitory activity against BxPC3 (human,pancreas,adenocarcinoma) cell line2003Journal of medicinal chemistry, Sep-11, Volume: 46, Issue:19
Synthesis and cytotoxic activity of two novel 1-dodecylthio-2-decyloxypropyl-3-phosphatidic acid conjugates with gemcitabine and cytosine arabinoside.
AID1075468Cytotoxicity against human PANC1 cells assessed as cell viability by MTT assay in presence of hENT1 inhibitor dipyridamole2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID1742840Induction of ferroptosis in human T-24 cells assessed as downregulation of xCT at 2 to 12 uM by Western blot analysis2020European journal of medicinal chemistry, Nov-01, Volume: 205Synthesis and in vitro anti-bladder cancer activity evaluation of quinazolinyl-arylurea derivatives.
AID500352Induction of cell cycle arrest in human HCT116 cells expressing p53 gene assessed as accumulation at subG1 phase at 0.1 uM after 24hrs by FACS analysis2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1203934Cytotoxicity against human MRC5 cells assessed as dose reduction index ratio treated at simultaneous combination at 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID342017Antibacterial activity against 1 x 10'7 CFU Streptococcus pyogenes AP1-infected BALB/c mouse assessed as survival at 100 ug, ip after 5 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID340154Antitumor activity against human CaCo2 cells after 48 hrs by MTS assay2008Journal of medicinal chemistry, Jul-24, Volume: 51, Issue:14
Ribose-modified purine nucleosides as ribonucleotide reductase inhibitors. Synthesis, antitumor activity, and molecular modeling of N6-substituted 3'-C-methyladenosine derivatives.
AID1508829Toxicity in Balb/c nude mouse xenografted with PANC1 cells assessed as pathological changes in liver at 25 mg/kg/day, ip by H and E staining-based microscopic analysis2019Journal of medicinal chemistry, 05-23, Volume: 62, Issue:10
Modification and Biological Evaluation of a Series of 1,5-Diaryl-1,2,4-triazole Compounds as Novel Agents against Pancreatic Cancer Metastasis through Targeting Myoferlin.
AID1066252Activity at recombinant dCK (unknown origin) at 100 uM by HPLC analysis2014Journal of medicinal chemistry, Jan-09, Volume: 57, Issue:1
Synthesis and cytostatic evaluation of 4-N-alkanoyl and 4-N-alkyl gemcitabine analogues.
AID1684807Cytotoxicity against African green monkey Vero cells assessed as alteration in cell morphology by microscopic analysis2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Influence of 4'-Substitution on the Activity of Gemcitabine and Its ProTide Against VZV and SARS-CoV-2.
AID1170036Antiproliferative activity against human MDA-MB-231 cells after 48 hrs by MTT assay2014Journal of medicinal chemistry, Nov-26, Volume: 57, Issue:22
Hybrids of phenylsulfonylfuroxan and coumarin as potent antitumor agents.
AID659005Antitumor activity against human MIAPaCa2 cells xenografted in SCID mouse assessed as reduction in tumor volume at 70 mg/kg, ip twice a week2012Bioorganic & medicinal chemistry, May-15, Volume: 20, Issue:10
Synthesis, σ₁, σ₂-receptors binding affinity and antiproliferative action of new C1-substituted adamantanes.
AID1525967Toxicity in Fox1nu mouse xenografted with luciferase and RFP reporter expressing human U87 cells assessed as effect on body weight at 10 mg/kg, iv administered at day 4 and day 8 post inoculation and six injections weekly measured after 5 weeks2019Journal of medicinal chemistry, 10-24, Volume: 62, Issue:20
Cyanine-Gemcitabine Conjugates as Targeted Theranostic Agents for Glioblastoma Tumor Cells.
AID1508827Toxicity in Balb/c nude mouse xenografted with PANC1 cells assessed as pathological changes in heart at 25 mg/kg/day, ip by H and E staining-based microscopic analysis2019Journal of medicinal chemistry, 05-23, Volume: 62, Issue:10
Modification and Biological Evaluation of a Series of 1,5-Diaryl-1,2,4-triazole Compounds as Novel Agents against Pancreatic Cancer Metastasis through Targeting Myoferlin.
AID460605Anticancer activity against human Calu1 cells at 500 nM after 48 hrs by propidium iodide fluorescence assay2010Bioorganic & medicinal chemistry, Mar-01, Volume: 18, Issue:5
Synthesis and biological screening of a combinatorial library of beta-chlorovinyl chalcones as anticancer, anti-inflammatory and antimicrobial agents.
AID1075462Prodrug activation in human BxPC3 cells assessed as formation of dFdCTP after 24 hrs in presence of hENT1 inhibitor NBTI2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID1549860Toxicity in human PANC1 cells xenografted in nude mouse assessed as pathological changes in kidney at 30 mg/kg, ip administered every 3 days for 4 weeks post tumor inoculation by hematoxylin and eosin staining based assay2019European journal of medicinal chemistry, May-15, Volume: 170Synthesis and evaluation of tetrahydroquinolin-2(1H)-one derivatives as novel anti-pancreatic cancer agents via targeting autophagy.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1203918Cytotoxicity against human A549 cells assessed as combination index treated at sequential combination LA + compound sequent. compound for 24 hrs, LA + compound for 24 hrs additional, total 48 hrs 2:1 and 5:1 alpha-lipoic acid to compound ratio after 48 hr2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID427705Cytotoxicity against human PC3 cells by sulforhodamine B method2009Journal of medicinal chemistry, Sep-10, Volume: 52, Issue:17
Discovery of a new template for anticancer agents: 2'-deoxy-2'-fluoro-4'-selenoarabinofuranosyl-cytosine (2'-F-4'-seleno-ara-C).
AID342002Antibacterial activity against exponentially growing Staphylococcus aureus ATCC 29213 at 0.002 ug/ml after 3 hrs by viable count susceptibility assay2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Deoxyribonucleoside kinases activate nucleoside antibiotics in severely pathogenic bacteria.
AID1850288Antiproliferative activity against human T24 cells measured after 48 hrs by MTT assay
AID83750Inhibitory activity against HT-29 (human,colon,adenocarcinoma) cell line2003Journal of medicinal chemistry, Sep-11, Volume: 46, Issue:19
Synthesis and cytotoxic activity of two novel 1-dodecylthio-2-decyloxypropyl-3-phosphatidic acid conjugates with gemcitabine and cytosine arabinoside.
AID445371Cell cycle arrest in human CCRF-CEM assessed as accumulation at subG1 phase at 5 x GIC50 after 24 hrs by flow cytometry2010Journal of medicinal chemistry, Jan-14, Volume: 53, Issue:1
6-(Het)aryl-7-deazapurine ribonucleosides as novel potent cytostatic agents.
AID1203905Cytotoxicity against human MRC5 cells treated at LA + compound sequent. LA for 24 hrs), LA + GEM (24 hrs additional, total 48 hrs) 2:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID503802Antiproliferative activity against p53 deficient human A2780/E6 cells after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1412572Induction of apoptosis in mouse B16F10 cells at IC50 after 72 hrs by annexin V-FITC/propidium iodide staining-based flow cytometric method relative to control2018MedChemComm, May-01, Volume: 9, Issue:5
Development of a peptide-based bifunctional chelator conjugated to a cytotoxic drug for the treatment of melanotic melanoma.
AID1203899Cytotoxicity against human A549 cells treated at LA + compound sequent. compound for 24 hrs, LA + compound for 24 hrs additional, total 48 hrs 2:1 and 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1233459Inhibition of SIRT1 (unknown origin) using AMC-Arg-His-Lys-Lys(Ac) substrate assessed as deacetylation of substrate by fluorimetric enzyme assay2015Bioorganic & medicinal chemistry letters, Jul-15, Volume: 25, Issue:14
New indole-isoxazolone derivatives: Synthesis, characterisation and in vitro SIRT1 inhibition studies.
AID1525968Antitumor activity against luciferase and RFP reporter expressing human U87 cells xenografted in Fox1nu mouse assessed as decrease in tumor size at 10 mg/kg, iv administered at day 4 and day 8 post inoculation and six injections weekly measured after 5 we2019Journal of medicinal chemistry, 10-24, Volume: 62, Issue:20
Cyanine-Gemcitabine Conjugates as Targeted Theranostic Agents for Glioblastoma Tumor Cells.
AID1682881Downregulation of Ki67 expression in BALB/c mouse allografted with mouse Panc02 cells assessed as effect on body weight at 100 mg/kg, ip administered every day measured after 20 days by immunohistochemical analysis2021Bioorganic & medicinal chemistry, 01-01, Volume: 29Design, synthesis and biological evaluation of imidazolopyridone derivatives as novel BRD4 inhibitors.
AID719536Toxicity in athymic mouse xenografted with human Calu6 cells assessed as body weight loss at 100 mg/kg, iv tid for 7 days2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Discovery of 3-alkoxyamino-5-(pyridin-2-ylamino)pyrazine-2-carbonitriles as selective, orally bioavailable CHK1 inhibitors.
AID1767449Antitumor activity against human MIA PaCa-2 cells xenografted in Foxn1nu athymic nude mouse assessed as reduction in tumor volume at 15 mg/kg, ip administered every 3 days for 4 weeks by digital caliper method relative to control2021European journal of medicinal chemistry, Oct-15, Volume: 222Structure activity relationship (SAR) study identifies a quinoxaline urea analog that modulates IKKβ phosphorylation for pancreatic cancer therapy.
AID1441783Cytotoxicity against human U2OS cells assessed as cell growth inhibition after 72 hrs by MTS assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID1298330Reduction in dRGU-TP level in human U373-MAGI cells at 2.5 nM preincubated for 2 hrs followed by 5-aza-C addition measured after 4 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1908848Induction of apoptosis in human MIA PaCa-2 cells assessed as necrotic cells at 0.5 uM incubated for 24 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 2.7%)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1713603Antiproliferative activity against human HL7702 cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID1203916Cytotoxicity against human A549 cells assessed as inhibition fraction treated at 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1426827Cytotoxicity against human MCF7 cells incubated for 72 hrs under normoxic condition by MTT assay2017Journal of medicinal chemistry, 02-09, Volume: 60, Issue:3
Total Syntheses and Biological Activities of Vinylamycin Analogues.
AID526363Antiproliferative activity against human U2OS cells expressing p53 after 72 hrs by celltiter-glo assay2010Journal of medicinal chemistry, Oct-28, Volume: 53, Issue:20
Cdc7 kinase inhibitors: 5-heteroaryl-3-carboxamido-2-aryl pyrroles as potential antitumor agents. 1. Lead finding.
AID1216054Cytotoxicity against human Colo-357 cells by crystal violet staining2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Drug efflux transporter multidrug resistance-associated protein 5 affects sensitivity of pancreatic cancer cell lines to the nucleoside anticancer drug 5-fluorouracil.
AID1075457Antitumor activity against human BxPC3 cells xenografted in Balb/c nude mouse assessed as tumor growth inhibition at 0.19 mmol/kg, ip administered every week for 3 weeks2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID687147Cell cycle arrest in multidrug-resistant human MIAPaCa2 cells assessed as accumulation at sub-G0/G1 phase after 48 hrs by propidium iodide staining based FACS flow cytometry (Rvb = 1.17%)2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
A novel bitriazolyl acyclonucleoside endowed with dual antiproliferative and immunomodulatory activity.
AID1696866Inhibition of cell migration in human PD002 cells at 0.1 uM incubated for 0.5 hrs by crystal violet staining based Boyden chamber assay2020Journal of medicinal chemistry, 10-08, Volume: 63, Issue:19
DPAGT1 Inhibitors of Capuramycin Analogues and Their Antimigratory Activities of Solid Tumors.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1455107Antiproliferative activity against human SW620 cells2018Journal of medicinal chemistry, 02-08, Volume: 61, Issue:3
Adventures in Scaffold Morphing: Discovery of Fused Ring Heterocyclic Checkpoint Kinase 1 (CHK1) Inhibitors.
AID611459Cytotoxicity against human BT549 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1075471Cytotoxicity against human RT112 cells assessed as cell viability by MTT assay in presence of dCK substrate deoxycytidine2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID1862948Antiproliferative activity against human MDA-MB-231 cells assessed as inhibition of cell growth incubated in presence of 10 uM imatinib2022Bioorganic & medicinal chemistry letters, 09-15, Volume: 72Design, synthesis and antitumor activity study of a gemcitabine prodrug conjugated with a HDAC6 inhibitor.
AID1298379Reduction in 5-aza-dCTP level in human U373-MAGI cells at 2.5 nM preincubated for 2 hrs followed by 5-aza-C addition measured after 4 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID1807077Cytotoxicity against human KG-1a cells assessed as cell death incubated for 72 hrs by flow cytometry based Annexin V/7-AAD assay2021Journal of medicinal chemistry, 06-24, Volume: 64, Issue:12
Single Diastereomers of the Clinical Anticancer ProTide Agents NUC-1031 and NUC-3373 Preferentially Target Cancer Stem Cells
AID719545Antitumor activity against human HT-29 cells xenografted in athymic mouse assessed as tumor growth delay at 100 mg/kg, iv tid for 7 days (Rvb = 8.8 4.8)2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Discovery of 3-alkoxyamino-5-(pyridin-2-ylamino)pyrazine-2-carbonitriles as selective, orally bioavailable CHK1 inhibitors.
AID1730424Cytotoxicity against human Huh-7 cells assessed as reduction in cell viability measured after 48 hrs in presence of ENT1 inhibitor NBTI by celltiter-glo assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1075480Cytostatic activity against human CEM cells after 72 hrs by coulter counter analysis2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID124255In vivo activity against transplanted Mam-16/C tumors of mice2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID1203926Cytotoxicity against human A549 cells assessed as dose reduction index ratio treated at sequential combination at 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID476697Antiproliferative activity against human Capan2 cells assessed as cell viability at 50 uM after 48 hrs by MTT assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
N-aryltriazole ribonucleosides with potent antiproliferative activity against drug-resistant pancreatic cancer.
AID1575532Antiproliferative activity against human BxPC3 cells assessed as reduction in cell growth incubated for 72 hrs by MTS assay2019MedChemComm, May-01, Volume: 10, Issue:5
Dual inhibitors of LSD1 and spermine oxidase.
AID1589118Cytotoxicity in human KB cells assessed as reduction in cell viability incubated for 72 hrs by SRB assay2019Bioorganic & medicinal chemistry letters, 09-15, Volume: 29, Issue:18
Synthesis and in vitro anticancer activity of new gemcitabine-nucleoside analogue dimers containing methyltriazole or ester-methyltriazole linker.
AID1075470Ratio of EC50 for human RT112 cells in presence of dCK substrate deoxycytidine to EC50 for human RT112 cells in absence of dCK substrate deoxycytidine2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID292212Growth inhibition of AG6000 cells by SRB assay in presence of dipyridamole2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID1827444Antiproliferative activity against human KG-1 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2022ACS medicinal chemistry letters, Mar-10, Volume: 13, Issue:3
Rational Design of an Orally Active Anticancer Fluoropyrimidine, Pencitabine, a Hybrid of Capecitabine and Gemcitabine.
AID1730426Stability in pH 1 aqueous buffer assessed as parent compound remaining at 200 uM measured after 4 hrs by UV spectrophotometry2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID611464Cytotoxicity against human HT-29 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID719534Toxicity in athymic mouse xenografted with human HT-29 cells assessed as body weight loss at 100 mg/kg, iv tid for 7 days2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Discovery of 3-alkoxyamino-5-(pyridin-2-ylamino)pyrazine-2-carbonitriles as selective, orally bioavailable CHK1 inhibitors.
AID1441784Cytotoxicity against human HL60 cells assessed as reduction in cell viability after 72 hrs by XTT assay2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Synthesis and Cytostatic and Antiviral Profiling of Thieno-Fused 7-Deazapurine Ribonucleosides.
AID1298334Reduction in dRGU-TP level in human U373-MAGI cells at 25 nM preincubated for 2 hrs followed by 5-aza-C addition measured after 4 hrs by LC-MS/MS analysis2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
Synergistic reduction of HIV-1 infectivity by 5-azacytidine and inhibitors of ribonucleotide reductase.
AID459134Growth inhibition of human PANC1 cells at 500 nM after 24 hrs by propidium iodide assay2010Bioorganic & medicinal chemistry, Feb, Volume: 18, Issue:3
Synthesis and biological evaluation of simple methoxylated chalcones as anticancer, anti-inflammatory and antioxidant agents.
AID716220Antiproliferative activity at human A549 cells after 72 hrs by MTT assay2012Journal of medicinal chemistry, Aug-23, Volume: 55, Issue:16
Novel second-generation di-2-pyridylketone thiosemicarbazones show synergism with standard chemotherapeutics and demonstrate potent activity against lung cancer xenografts after oral and intravenous administration in vivo.
AID1489776Toxicity in NOD/SCID mouse xenografted with human MIAPaCa2 cells assessed as body weight loss at 15 mg/kg administered once a week for 48 days2018Journal of medicinal chemistry, 02-22, Volume: 61, Issue:4
Design and Synthesis of Novel Reactive Oxygen Species Inducers for the Treatment of Pancreatic Ductal Adenocarcinoma.
AID1713598Antiproliferative activity against human K562 cells after 48 hrs by MTT assay2016Bioorganic & medicinal chemistry, 11-15, Volume: 24, Issue:22
Discovery of a novel chimeric ubenimex-gemcitabine with potent oral antitumor activity.
AID1533386Antiproliferative activity against human HeLaS3 cells after 72 hrs by XTT assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID278932Activity of human dCK expressed in HepG2 cells assessed as phosphorylation by coupled enzyme assay2007Antimicrobial agents and chemotherapy, Feb, Volume: 51, Issue:2
Mechanism of activation of beta-D-2'-deoxy-2'-fluoro-2'-c-methylcytidine and inhibition of hepatitis C virus NS5B RNA polymerase.
AID1730429Stability in pH 6 aqueous buffer assessed as parent compound remaining at 200 uM measured after 4 hrs by UV spectrophotometry2021European journal of medicinal chemistry, Mar-05, Volume: 213Design, synthesis, and evaluation of liver-specific gemcitabine prodrugs for potential treatment of hepatitis C virus infection and hepatocellular carcinoma.
AID1910312Induction of apoptosis in human PDAC-3 cells at IC50 measured after 72 hrs by Annexin-V/FITC staining based assay2022Journal of medicinal chemistry, 05-26, Volume: 65, Issue:10
Reversible Monoacylglycerol Lipase Inhibitors: Discovery of a New Class of Benzylpiperidine Derivatives.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1525966Antitumor activity against luciferase and RFP reporter expressing human U87 cells xenografted in Fox1nu mouse assessed as decrease in tumor burden at 10 mg/kg, iv administered at day 4 and day 8 post inoculation and six injections weekly measured after 5 2019Journal of medicinal chemistry, 10-24, Volume: 62, Issue:20
Cyanine-Gemcitabine Conjugates as Targeted Theranostic Agents for Glioblastoma Tumor Cells.
AID611455Cytotoxicity against human CEM-DNR-bulk cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID503804Antiproliferative activity against human MCF7 cells expressing p53 gene after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1224151Cytotoxicity against human MIAPaCa2 cells after 5 days by PrestoBlue assay2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
Development and bioorthogonal activation of palladium-labile prodrugs of gemcitabine.
AID85754In vitro cytotoxic activity against colon adenocarcinoma (HT-29) cells assayed by inhibition of [3H]-labeled thymidine incorporation2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
O-Phosphonatomethylcholine, its analogues, alkyl esters, and their biological activity.
AID1216053Cytotoxicity against human T3M4 cells by crystal violet staining2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Drug efflux transporter multidrug resistance-associated protein 5 affects sensitivity of pancreatic cancer cell lines to the nucleoside anticancer drug 5-fluorouracil.
AID1724235Antitumor activity against human MIAPaCa2 cells xenografted in mouse assessed as mean tumor volume at 15 mg/kg, iv administered twice per week for 28 days and measured at day 53 by Caliper method (Rvb = 1.60 +/- 0.44 cm3)2020ACS medicinal chemistry letters, Aug-13, Volume: 11, Issue:8
Asymmetrically Substituted Quadruplex-Binding Naphthalene Diimide Showing Potent Activity in Pancreatic Cancer Models.
AID117786In vivo activity against transplanted colon-51 tumors of mice; Not active2001Journal of medicinal chemistry, May-24, Volume: 44, Issue:11
Design, synthesis, and biological evaluation of analogues of the antitumor agent, 2-(4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy)propionic acid (XK469).
AID1480619Drug uptake in HEK293 cells at 25 uM after 15 mins by UPLC-MS/MS method2017Journal of medicinal chemistry, 03-23, Volume: 60, Issue:6
Combination of l-Carnitine with Lipophilic Linkage-Donating Gemcitabine Derivatives as Intestinal Novel Organic Cation Transporter 2-Targeting Oral Prodrugs.
AID88676Inhibitory activity against HeLa (human, epitheloid carcinoma, cervix) cell line2003Journal of medicinal chemistry, Sep-11, Volume: 46, Issue:19
Synthesis and cytotoxic activity of two novel 1-dodecylthio-2-decyloxypropyl-3-phosphatidic acid conjugates with gemcitabine and cytosine arabinoside.
AID648765Cytotoxicity against human HCT116 cells after 48 hrs by WST-8 assay2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
One pot synthesis and anticancer activity of dimeric phloroglucinols.
AID292211Growth inhibition of A2780 cells by SRB assay in presence of dipyridamole2007Journal of medicinal chemistry, Jul-26, Volume: 50, Issue:15
Synthesis and biological activity of a gemcitabine phosphoramidate prodrug.
AID1410095Antiproliferative activity against human Calu1 cells at 500 nM after 48 hrs by propidium iodide staining based fluorometry relative to control2018ACS medicinal chemistry letters, Mar-08, Volume: 9, Issue:3
Synthesis and Biological Screening of Pyrano[3,2-
AID611468Cytotoxicity against human LNCAP cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1812920Cytotoxicity against human MRC5 assessed as cell viability measured for 72 hrs by cell titer glo luminescent assay2021Journal of natural products, 08-27, Volume: 84, Issue:8
Monomeric, Dimeric, and Trimeric Tropane Alkaloids from
AID1696865Inhibition of cell migration in human HCT-116 cells assessed as wound healing rate at 0.2 uM incubated for 24 hrs by wound healing assay (Rvb = 63%)2020Journal of medicinal chemistry, 10-08, Volume: 63, Issue:19
DPAGT1 Inhibitors of Capuramycin Analogues and Their Antimigratory Activities of Solid Tumors.
AID1602092Antiproliferative activity against human PC3 cells measured after 72 hrs by MTT assay2019European journal of medicinal chemistry, Mar-15, Volume: 166Development of bioactive gemcitabine-D-Lys
AID1589127Selectivity index, ratio of IC50 for cytotoxicity in human NHDF cells to IC50 for cytotoxicity in human HepG2 cells2019Bioorganic & medicinal chemistry letters, 09-15, Volume: 29, Issue:18
Synthesis and in vitro anticancer activity of new gemcitabine-nucleoside analogue dimers containing methyltriazole or ester-methyltriazole linker.
AID1489703Cytotoxicity against gemcitabine-resistant human MIAPaCa2 cells assessed as decrease in cell proliferation after 72 hrs by MTT assay2018Journal of medicinal chemistry, 02-22, Volume: 61, Issue:4
Design and Synthesis of Novel Reactive Oxygen Species Inducers for the Treatment of Pancreatic Ductal Adenocarcinoma.
AID503803Antiproliferative activity against p53 deficient human OVCAR8 cells after 72 hrs by proliferative assay2008Nature chemical biology, Jun, Volume: 4, Issue:6
A Cdc7 kinase inhibitor restricts initiation of DNA replication and has antitumor activity.
AID1075483Cytostatic activity against human BxPC3 cells after 72 hrs by MTS assay2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Application of ProTide technology to gemcitabine: a successful approach to overcome the key cancer resistance mechanisms leads to a new agent (NUC-1031) in clinical development.
AID611469Cytotoxicity against rat MAT-LyLu cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1203908Cytotoxicity against human T24 cells treated at 2:1 and 5:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1203912Cytotoxicity against human A549 cells assessed as combination index treated at 2:1 alpha-lipoic acid to compound ratio after 48 hrs by SRB assay in presence of alpha-lipoic acid2015European journal of medicinal chemistry, , Volume: 96Regioselective chemical and rapid enzymatic synthesis of a novel redox – Antiproliferative molecular hybrid.
AID1908829Induction of cell cycle arrest in human MIA PaCa-2 cells assessed as accumulation of cells at S phase at 0.1 uM incubated for 24 hrs by RNase/propidium iodide staining based flow cytometry analysis (Rvb =27.6 %)2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
Induction of Genes Implicated in Stress Response and Autophagy by a Novel Quinolin-8-yl-nicotinamide QN523 in Pancreatic Cancer.
AID1222336Ratio of intrinsic clearance for human recombinant N-terminal His-tagged DCK Ile24Val mutant expressed in Escherichia coli BL21(DE3) cells to intrisic clerance for human recombinant N-terminal His-tagged wild type DCK expressed in Escherichia coli BL21(DE2013Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 41, Issue:3
Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase.
AID1533385Antiproliferative activity against human HepG2 cells after 72 hrs by XTT assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Cytotoxic and Antiviral Profiling of Pyrrolo- and Furo-Fused 7-Deazapurine Ribonucleosides.
AID1508819Antimetastatic activity against human PANC1 cells harboring luciferase reporter gene xenografted in Balb/c nude mouse at 25 mg/kg/day, ip measured every 10 days by bioluminescence imaging analysis2019Journal of medicinal chemistry, 05-23, Volume: 62, Issue:10
Modification and Biological Evaluation of a Series of 1,5-Diaryl-1,2,4-triazole Compounds as Novel Agents against Pancreatic Cancer Metastasis through Targeting Myoferlin.
AID611463Cytotoxicity against rat C6 cells after 3 days by MTT assay2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Synthesis and significant cytostatic activity of 7-hetaryl-7-deazaadenosines.
AID1607709Antiproliferative activity against human HeLa cells after 24 hrs by MTT assay relative to control2019European journal of medicinal chemistry, Sep-15, Volume: 178Anti-cancer effects of cinnamon: Insights into its apoptosis effects.
AID1426829Selectivity index, ratio of IC50 for human MCF7 cells under hypoxic condition to IC50 for human MCF7 cells under normoxic condition2017Journal of medicinal chemistry, 02-09, Volume: 60, Issue:3
Total Syntheses and Biological Activities of Vinylamycin Analogues.
AID1347172Secondary qRT-PCR qHTS assay for selected Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347171Orthogonal mCherry assay for qRT-PCR qHTS of selected Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347159Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347170Vero cells viability counterscreen for qRT-PCR qHTS assay of selected Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347160Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347151Optimization of GU AMC qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347168HepG2 cells viability qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347169Tertiary RLuc qRT-PCR qHTS assay for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347167Vero cells viability qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID686947qHTS for small molecule inhibitors of Yes1 kinase: Primary Screen2013Bioorganic & medicinal chemistry letters, Aug-01, Volume: 23, Issue:15
Identification of potent Yes1 kinase inhibitors using a library screening approach.
AID1347155Optimization screen NINDS Rhodamine qHTS for Zika virus inhibitors: Linked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347149Furin counterscreen qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347150Optimization screen NINDS AMC qHTS for Zika virus inhibitors: Linked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID977608Experimentally measured binding affinity data (IC50) for protein-ligand complexes derived from PDB2009Biochemical and biophysical research communications, May-01, Volume: 382, Issue:2
Drosophila melanogaster deoxyribonucleoside kinase activates gemcitabine.
AID1346042Human ribonucleotide reductase catalytic subunit M1 (Nucleoside synthesis and metabolism)1990Molecular pharmacology, Oct, Volume: 38, Issue:4
Inhibition of ribonucleotide reduction in CCRF-CEM cells by 2',2'-difluorodeoxycytidine.
AID1346136Human ribonucleotide reductase regulatory subunit M2 (Nucleoside synthesis and metabolism)1990Molecular pharmacology, Oct, Volume: 38, Issue:4
Inhibition of ribonucleotide reduction in CCRF-CEM cells by 2',2'-difluorodeoxycytidine.
AID1745854NCATS anti-infectives library activity on HEK293 viability as a counter-qHTS vs the C. elegans viability qHTS2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1745855NCATS anti-infectives library activity on the primary C. elegans qHTS viability assay2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1804127No assay is provided from Article 10.1002/med.21724: \\The recent outbreaks of human coronaviruses: A medicinal chemistry perspective.\\2021Medicinal research reviews, 01, Volume: 41, Issue:1
The recent outbreaks of human coronaviruses: A medicinal chemistry perspective.
AID977611Experimentally measured binding affinity data (Kd) for protein-ligand complexes derived from PDB2014eLife, Jul-31, Volume: 3Structural basis of nucleoside and nucleoside drug selectivity by concentrative nucleoside transporters.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (11,995)

TimeframeStudies, This Drug (%)All Drugs %
pre-19901 (0.01)18.7374
1990's543 (4.53)18.2507
2000's3966 (33.06)29.6817
2010's5819 (48.51)24.3611
2020's1666 (13.89)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 89.68

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index89.68 (24.57)
Research Supply Index9.66 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index163.83 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (89.68)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials3,208 (25.62%)5.53%
Reviews1,388 (11.08%)6.00%
Case Studies1,272 (10.16%)4.05%
Observational65 (0.52%)0.25%
Other6,590 (52.62%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (2460)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 1b/2 Study With Gemcitabine and LY2157299 for Patients With Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2) [NCT01373164]Phase 1/Phase 2170 participants (Actual)Interventional2011-06-30Completed
Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study [NCT04917250]Phase 215 participants (Anticipated)Interventional2020-03-20Recruiting
Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043) [NCT04846634]Phase 290 participants (Anticipated)Interventional2021-08-31Not yet recruiting
A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study) [NCT05096663]Phase 2/Phase 382 participants (Actual)Interventional2022-03-15Active, not recruiting
Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma: a Multicentric Single-arm Phase II Study [NCT03364530]Phase 240 participants (Anticipated)Interventional2018-06-11Recruiting
A Phase 3, Randomized, Global Trial of Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in First-line Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) [NCT03348904]Phase 32 participants (Actual)Interventional2017-12-27Terminated(stopped due to Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.)
Pixantrone (BBR 2778) Versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma: A Randomized, Controlled, Phase III Comparative Trial [NCT00088530]Phase 3140 participants (Actual)Interventional2004-07-31Completed
Phase II, Randomized, Open-Label Trial of Biweekly Pemetrexed Plus Gemcitabine vs. Pemetrexed or Pemetrexed Plus Carboplatin in Relapsed Non Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy [NCT00356525]Phase 241 participants (Actual)Interventional2006-09-30Terminated(stopped due to Stopped early due to low enrollment)
[NCT01125020]150 participants (Anticipated)Interventional2008-12-31Recruiting
A Phase II Study of Neoadjuvant Cisplatin and Gemcitabine Plus Sorafenib for Patients With Transitional-Cell Carcinoma of the Bladder [NCT01222676]Phase 245 participants (Anticipated)Interventional2010-10-31Recruiting
Randomized Phase II Trial of Gemcitabine and Imatinib Mesylate Versus Gemcitabine Alone in Patients With Previously Treated Locally Advanced or Metastatic Breast Cancer [NCT00323063]Phase 249 participants (Actual)Interventional2006-05-01Terminated(stopped due to Slow accrual)
Phase I/II Trial of Gemcitabine/Pemetrexed Combination in Patients With Advanced Cutaneous T-Cell Lymphoma [NCT00369629]Phase 114 participants (Actual)Interventional2006-08-28Terminated(stopped due to This was planned as a phase I/II study originally, but due to a lack of funding, the phase II portion was never conducted.)
Phase Ib Study of Preoperative Chemotherapy With Paclitaxel, Gemcitabine, and Lapatinib (Tykerb®) (PGT) in Patients With HER2 Positive Operable Breast Cancer [NCT01133912]Phase 113 participants (Actual)Interventional2009-03-31Completed
A Phase I Study of R04929097 in Combination With Gemcitabine in Patients With Advanced Solid Tumors [NCT01145456]Phase 118 participants (Actual)Interventional2010-06-30Completed
A Randomized Phase II Clinical Trial of Nab-Paclitaxel and Carboplatin Compared With Gemcitabine and Carboplatin as First-line Therapy in Advanced Squamous Cell Carcinoma of Lung [NCT01236716]Phase 2126 participants (Actual)Interventional2010-11-30Completed
A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator's Choice in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were R [NCT02049905]Phase 3433 participants (Actual)Interventional2014-01-31Completed
Phase II Study of Gemcitabine-Paclitaxel 3-Weekly Schedule as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure [NCT00316199]Phase 260 participants (Actual)Interventional2006-04-30Completed
A Phase II Study of Triapine in Combination With Gemcitabine in Adenocarcinoma of the Biliary Ducts and Gall Bladder [NCT00075504]Phase 233 participants (Actual)Interventional2003-11-30Completed
Liposomal Doxorubicin(LD) Plus Gemcitabine Versus Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma(HCC) [NCT02527772]Phase 2/Phase 30 participants (Actual)Interventional2015-09-30Withdrawn(stopped due to It doesn't meet the requirements of randomized trials)
Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma [NCT01149122]Phase 3266 participants (Actual)Interventional2009-01-31Completed
Overcoming Resistance to Immunotherapy Combining Gemcitabine With Atezolizumab in Advanced NSCLC and Mesothelioma Progressing Under Immune-checkpoint Inhibitors or Gemcitabine. A Multicenter, Single-arm, Open Label Phase II Trial With Two Cohorts [NCT04480372]Phase 268 participants (Actual)Interventional2021-03-17Active, not recruiting
Phase I Study of ABT-888 in Combination With Gemcitabine in Patients With Advanced Malignancies [NCT01154426]Phase 131 participants (Actual)Interventional2010-05-31Completed
Phase II Study of Fixed Dose Rate Gemcitabine Plus Capecitabine in Locally Advanced Pancreatic Cancer [NCT01268384]Phase 243 participants (Actual)Interventional2006-04-30Completed
Cisplatin With Either Alimta or Gemcitabine in Long Infusion for Mesothelioma: A Randomised Phase II Trial (AGILI Trial) [NCT01281800]Phase 272 participants (Anticipated)Interventional2008-08-31Recruiting
A Phase I Clinical Trial of Oral Calcitriol With Fixed Dose of Cisplatin and Gemcitabine in Patients With Advanced Solid Tumors [NCT01093092]Phase 114 participants (Actual)Interventional2011-09-30Terminated(stopped due to Study transferring to INOVA Health)
Pilot Study of Antiviral Treatment in Combination With Low-dose Gemcitabine in EBV-associated Gastric Cancer (EBVaGC) [NCT05431244]0 participants (Actual)Interventional2022-07-01Withdrawn(stopped due to Research withdrawal before patient registration due to difficulty in continuing research)
A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma [NCT00033540]Phase 257 participants (Actual)Interventional2003-09-30Completed
Phase I/II Radiotherapy Dose Escalation Study in Locally Advanced Pancreatic Cancer, Using a Simultaneous Intensity Modulated Boost With Concurrent Gemcitabine [NCT00878657]Phase 18 participants (Actual)Interventional2009-04-30Terminated(stopped due to Slow accrual)
Panitumumab in Combination With Cisplatin/Gemcitabine Chemotherapy in Patients With Cholangiocarcinomas - a Randomized Clinical Phase II Study [NCT01320254]Phase 293 participants (Actual)Interventional2011-06-30Completed
Maintenance Gemcitabine or Best Supportive Care for the Chinese Advanced NSCLC Patients Without Progression Disease After Given Four Cycles of the Induction Chemotherapy With Gemcitabine Plus Cisplatin [NCT01336192]Phase 4240 participants (Anticipated)Interventional2011-04-30Recruiting
A Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Chemotherapy With DoceTaxel(Doxotel) and Gemcitabine(Gemcibine)in Locally Advanced Breast Cancer [NCT01352494]Phase 299 participants (Anticipated)Interventional2011-05-31Not yet recruiting
A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Urothelial Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin With Molecular Correlates [NCT00045630]Phase 277 participants (Actual)Interventional2003-01-31Completed
A Phase I Study of the PI3-Kinase Inhibitor BKM120 in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors [NCT01971489]Phase 10 participants (Actual)Interventional2015-09-30Withdrawn
A Phase 2 Study Using Chemoimmunotherapy With Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC) [NCT06064097]Phase 250 participants (Anticipated)Interventional2023-12-20Not yet recruiting
Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer [NCT06018883]Phase 3100 participants (Anticipated)Interventional2023-08-20Recruiting
A Phase 2a Study With Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Tumors [NCT05318573]Phase 210 participants (Anticipated)Interventional2022-06-01Recruiting
A Randomized, Open-Label, Multicenter Phase III Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin in Comparison With Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Re [NCT05171647]Phase 3222 participants (Anticipated)Interventional2022-04-25Recruiting
A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cyste [NCT04658862]Phase 3550 participants (Anticipated)Interventional2020-12-07Recruiting
Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-G [NCT04640623]Phase 2200 participants (Anticipated)Interventional2020-12-18Recruiting
A Phase III Randomized Trial of Eribulin (NSC #707389) With or Without Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy [NCT04579224]Phase 3465 participants (Anticipated)Interventional2021-06-28Suspended(stopped due to Other - New treatment available, eliminating Arm 2)
A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients With Previously Treated Non-Squamous NSCLC [NCT04310007]Phase 2117 participants (Anticipated)Interventional2020-07-13Active, not recruiting
An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer [NCT04223856]Phase 3990 participants (Anticipated)Interventional2020-03-30Recruiting
A Phase IB and Randomized Open-Label Phase II Study of Berzosertib (M6620, VX-970) in Combination With Carboplatin/Gemcitabine/Pembrolizumab in Patients With Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer of Squamous Cell Histology [NCT04216316]Phase 1/Phase 2106 participants (Anticipated)Interventional2021-04-14Active, not recruiting
Phase II Study of Bladder-SparIng ChemoradiatioN With Durvalumab in Clinical Stage III, Node PosItive BladdeR CancEr (INSPIRE) [NCT04216290]Phase 295 participants (Anticipated)Interventional2021-03-17Active, not recruiting
A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions [NCT04172675]Phase 2107 participants (Actual)Interventional2020-02-28Active, not recruiting
A Pilot Phase I Study of Atezolizumab (MPDL3280A) in Combination With Immunogenic Chemotherapy (Gemcitabine-Oxaliplatin) and Rituximab for Transformed Diffuse Large B-Cell Lymphoma [NCT03321643]Phase 124 participants (Anticipated)Interventional2018-09-18Active, not recruiting
Phase I Study of Combination With TBI-1401(HF10), a Replication-competent HSV-1 Oncolytic Virus, and Chemotherapy in Patients With Stage III or IV Unresectable Pancreatic Cancer. [NCT03252808]Phase 136 participants (Anticipated)Interventional2017-09-25Active, not recruiting
A Randomized Phase II Trial Evaluating an Organ-conserving Strategy With Radiotherapy + CDDP + Gemcitabine vs Radiotherapy + CDDP in Muscle-infiltrative Bladder Cancer [NCT01495676]69 participants (Actual)Interventional2011-07-06Active, not recruiting
A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma [NCT01013649]Phase 2/Phase 3545 participants (Anticipated)Interventional2009-11-17Active, not recruiting
A Phase II Study of Weekly Oxaliplatin and Gemcitabine Combination Chemotherapy for Recurrent or Metastatic Head and Neck Cancer [NCT00256295]Phase 28 participants (Actual)Interventional2005-04-30Terminated(stopped due to Low accrual)
The Efficacy of Bendamustine, Gemcytabine, Dexamethasone (BGD) Salvage Chemotherapy With Autologous Stem Cell Transplantation (ASCT) Consolidation in Advanced Classical Hodgkin Lymphoma Patients Not Responding to ABVD Therapy- Multicentre Phase II Clinica [NCT03615664]Phase 2115 participants (Actual)Interventional2017-11-06Active, not recruiting
PD-1 Inhibitor or PD-1 Inhibitor Plus GVD(Gemcitabine, Vinorelbine and Doxorubicin Liposome) Regimen for Relapsed/Refractory Classical Hodgkin Lymphoma (R/R CHL): a Single Arm, Open Label, Phase II Study [NCT04624984]Phase 242 participants (Anticipated)Interventional2021-04-01Recruiting
Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer [NCT01375972]Phase 292 participants (Actual)Interventional2008-03-31Completed
A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer [NCT03929094]Phase 2120 participants (Anticipated)Interventional2019-03-01Recruiting
Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer : a Multicenter, Double-blind, Placebo-controlled, Phase 3 Trial [NCT04722978]Phase 3228 participants (Anticipated)Interventional2021-04-20Recruiting
A Multicenter, One-arm Phase II Clinical Study of Utidelone Injection Combined With Gemcitabine in First-line Chemotherapy for Unresectable Advanced Pancreatic Cancer [NCT05795920]Phase 292 participants (Anticipated)Interventional2023-03-08Recruiting
A Single-Arm Feasibility Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma [NCT03579771]Phase 231 participants (Actual)Interventional2018-09-26Active, not recruiting
Avatar-Directed Chemotherapy in Platinum-Resistant Ovarian, Primary Peritoneal and Fallopian Tube Cancers [NCT02312245]Phase 213 participants (Actual)Interventional2015-07-21Completed
A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial [NCT03773302]Phase 348 participants (Actual)Interventional2019-12-27Terminated(stopped due to The sponsor has decided to close the study due to the discontinuation of infigratinib development in oncology within the sponsor's territory. The discontinuation of the study was not due to safety issues.)
Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer [NCT03366766]Phase 214 participants (Actual)Interventional2017-12-20Completed
"A Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Pembrolizumab and Gemcitabine in Patients With HER2-negative Advanced Breast Cancer (ABC) PANGEA-Breast" [NCT03025880]Phase 236 participants (Actual)Interventional2017-06-28Completed
A RANDOMIZED PHASE 2 STUDY OF THE ANTI-ANGIOGENESIS AGENT AG-013736 IN COMBINATION WITH GEMCITABINE IN PATIENTS WITH CHEMOTHERAPY-NAIVE ADVANCED PANCREATIC CANCER PRECEDED BY A PHASE 1 PORTION [NCT00219557]Phase 2111 participants (Actual)Interventional2005-07-05Completed
Tratamiento Individualizado en función de Las Mutaciones en EGFR y Del Nivel de expresión de BRCA1 en Pacientes Con Adenocarcinoma de pulmón Avanzado [NCT00883480]153 participants (Actual)Interventional2005-06-30Completed
Induction Chemotherapy Combined With Low-dose Radiation Plus Cadonilimab in Loco-regionally Advanced Nasopharyngeal Carcinoma: a Multi-center, Open-label, Randomized Controlled Phase III Clinical Trial [NCT05941741]Phase 3380 participants (Anticipated)Interventional2023-12-31Not yet recruiting
A Multicenter and Prospective Clinical Trial of Gemcitabine-based Induction Chemotherapy Combined With Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma [NCT04522050]Phase 165 participants (Anticipated)Interventional2018-10-01Recruiting
Randomised Phase II Study of the Combination of Oral Vinorelbine With Capecitabine Versus Gemcitabine in Combination With Paclitaxel Versus Gemcitabine in Combination With Docetaxel as First Line Chemotherapy in Patients With Metastatic Breast Cancer [NCT03887130]Phase 2152 participants (Actual)Interventional2006-03-31Completed
Phase 1 Study of HLA-A*0201 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer [NCT01266720]Phase 16 participants (Actual)Interventional2008-04-30Active, not recruiting
A Phase I Study of Nab-paclitaxel (Abraxane), Gemcitabine, and Capecitabine (Xeloda) (AGX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma [NCT01161186]Phase 115 participants (Actual)Interventional2010-07-31Completed
A Randomized Phase II Study of Gemcitabine Plus Oxaliplatin (GEMOX) With or Without Cetuximab in Locally Advanced and Metastatic Biliary Tract Cancer (BTC) [NCT01267344]Phase 2122 participants (Actual)Interventional2010-12-31Completed
Switch-Maintenance Gemcitabine After First-Line Chemotherapy (Pemetrexed-Platinum) In Patients With Malignant Pleural Mesothelioma In Ain Shams University Hospitals [NCT05660616]Phase 240 participants (Anticipated)Interventional2023-04-01Recruiting
Open Label Randomized Phase II Trial of Nivolumab + Cabiralizumab (BMS-986227, FPA008) + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial). [NCT03697564]Phase 240 participants (Anticipated)Interventional2019-10-31Suspended(stopped due to Working on getting accurate information for patients interested in the study.)
A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer [NCT01167738]Phase 260 participants (Actual)Interventional2010-07-31Terminated(stopped due to concern of detrimental effect)
A Phase III, Multicenter, Open-Label, Randomized Study of Gemcitabine Plus Cisplatin (GP) Versus Gemcitabine Plus Paclitaxel (GT) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer [NCT01287624]Phase 3240 participants (Actual)Interventional2011-01-31Completed
A Multi-Center Randomized Phase II Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer [CA209-9FC] [NCT03101566]Phase 275 participants (Actual)Interventional2017-09-08Completed
Phase I Trial of Gemcitabine and Split-Dose Cisplatin Plus Everolimus (RAD001) in Patients With Advanced Solid Tumor Malignancies [NCT01182168]Phase 112 participants (Actual)Interventional2010-08-31Completed
A Phase IIB/III Randomized, Double-blind, Placebo Controlled Study Comparing First Line Therapy With or Without TG4010 Immunotherapy Product in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) [NCT01383148]Phase 2/Phase 3222 participants (Actual)Interventional2012-04-30Terminated
A Randomized, Two Arm Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC) [NCT01201044]80 participants (Anticipated)Interventional2010-01-31Recruiting
A Single-arm Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma in Korea [NCT04546828]Phase 20 participants (Actual)Interventional2021-02-01Withdrawn(stopped due to problem of sponsor)
A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus Cisplatin in Patients With Biliary Tract Cancer Undergoing Curative Resection Without Major Hepatectomy [NCT01297998]Phase 124 participants (Actual)Interventional2011-01-31Completed
Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients With Advanced Liposarcoma or Leiomyosarcoma [NCT03810976]Phase 237 participants (Actual)Interventional2018-03-27Completed
Pilot Study of GC. (Gemcitabine-Rituximab-Oxaliplatin Combination) Given Every 14 Days With Maintenance Lenalidomide for the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma [NCT01307592]Phase 270 participants (Anticipated)Interventional2011-02-28Recruiting
IntenSify: An Open-label Phase I Trial of the CYP3A Inhibitor Cobicistat and the Cytostatics Gemcitabine and Nab-Paclitaxel in Patients With Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma to Evaluate the Combination's Pharmacokinetics, Safe [NCT05494866]Phase 118 participants (Anticipated)Interventional2022-12-07Recruiting
Hepatic Arterial Infusion Chemotherapy of Irinotecan, Oxaliplatin, 5-Fluorouracil and Leucovorin Versus Systemic Chemotherapy of Gemcitabine and Oxaliplatin for Unresectable Intrahepatic Cholangiocarcinoma [NCT03771846]Phase 3188 participants (Anticipated)Interventional2018-08-01Recruiting
A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisp [NCT04003610]Phase 27 participants (Actual)Interventional2020-05-14Terminated(stopped due to The reason this study was terminated was due to a business decision. There were no safety concerns that contributed to this decision.)
Effects and Safety of GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma:a Prospective, Single-arm, Single-center Phase II Study [NCT05668884]Phase 235 participants (Anticipated)Interventional2022-10-18Recruiting
Adjuvant Gemcitabine and Capecitabine Chemotherapy in Resected Pancreatic Cancer Following Neoadjuvant Chemotherapy [NCT05415917]Phase 275 participants (Anticipated)Interventional2022-07-29Recruiting
A Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of Pertuzumab (rhuMAb 2C4) in Combination With Gemcitabine and the Effect of Tumor-Based HER2 Activation in Subjects With Platinum-Resistant Ovarian, Primary Peritonea [NCT00096993]Phase 2131 participants (Actual)Interventional2005-01-31Completed
A Phase 1b, Dose Escalation Study to Determine the Recommended Phase 2 Dose of TAK-659 in Combination With Bendamustine (±Rituximab), Gemcitabine, Lenalidomide, or Ibrutinib for the Treatment of Patients With Advanced Non-Hodgkin Lymphoma After At Least 1 [NCT02954406]Phase 143 participants (Actual)Interventional2017-03-05Terminated(stopped due to Business decision, insufficient enrollment, no safety or efficacy concerns.)
A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix [NCT00064077]Phase 3513 participants (Actual)Interventional2003-05-31Completed
a Single-arm Study of Combined Therapy Using Oxaliplatin and Gemcitabine Chemotherapy, Lenvatinib and Programmed Cell Death Protein 1 Antibody (JS001) for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma [NCT03951597]Phase 230 participants (Anticipated)Interventional2019-05-10Active, not recruiting
Phase 2 Study of M6620 (VX-970) in Combination With Gemcitabine Versus Gemcitabine Alone in Subjects With Platinum-Resistant Recurrent Ovarian or Primary Peritoneal Fallopian Tube Cancer [NCT02595892]Phase 270 participants (Actual)Interventional2016-08-25Active, not recruiting
International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma [NCT01327521]Phase 30 participants (Actual)Interventional2011-02-28Withdrawn(stopped due to Accrual below target levels)
[NCT02529579]Phase 1/Phase 2187 participants (Anticipated)Interventional2015-06-30Recruiting
A Phase II, Randomized, Placebo Controlled Study to Evaluate the Efficacy of the Combination of Gemcitabine, Erlotinib and Metformin in Patients With Locally Advanced and Metastatic Pancreatic Cancer [NCT01210911]Phase 2120 participants (Actual)Interventional2010-08-31Completed
A Phase II Study of Gemcitabine and Bexarotene (Gembex) in the Treatment of Cutaneous T-cell Lymphoma [NCT00660231]Phase 236 participants (Actual)Interventional2008-03-31Completed
Phase I Dose Escalation Study of Gemcitabine and ON 01910.Na in Patients With Advanced or Metastatic Solid Tumors [NCT01125891]Phase 139 participants (Actual)Interventional2009-01-31Completed
Sensitivity Detection and Drug Resistance Mechanism of Breast Cancer Therapeutic Drugs Based on Organ-like Culture [NCT03925233]300 participants (Anticipated)Observational2019-01-02Enrolling by invitation
A Phase II Trial of Gemcitabine Plus Bevacizumab in Patients With Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer [NCT01131039]Phase 20 participants (Actual)Interventional2011-01-31Withdrawn(stopped due to PI left Emory)
A Multicenter, Open-Label, Randomized, Phase II Trial of Adjuvant Dasatinib Plus Gemcitabine Versus Single-Agent Gemcitabine in Patients With Resected Pancreatic Adenocarcinoma [NCT01234935]Phase 28 participants (Actual)Interventional2011-01-13Completed
A Phase 1 Study of an ERK1/2 Inhibitor (LY3214996) Administered Alone or in Combination With Other Agents in Advanced Cancer [NCT02857270]Phase 1210 participants (Actual)Interventional2016-09-29Completed
Phase II Study of Hypofractionated Radio-chemotherapy With Gemcitabine Plus Oxaliplatin for Unresectable Nonmetastatic Locally Advanced Pancreatic Cancer. [NCT02035072]Phase 240 participants (Actual)Interventional2010-11-30Completed
PHASE 1B/PHASE 3 MULTICENTER STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION REGIMENS THAT INCLUDE AN IMMUNE AGONIST, EPIGENETIC MODULATOR, CD20 ANTAGONIST AND/OR CONVENTIONAL CHEMOTHERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHO [NCT02951156]Phase 329 participants (Actual)Interventional2016-12-16Terminated(stopped due to Study was terminated due to closure of study arms following futility analysis and difficulty in enrolling participants due to evolving treatment landscape)
Phase I Dose Escalation Study of Gemcitabine and 24 Hour Infusion of ON 01910.Na in Patients With Advanced or Metastatic Solid Tumors [NCT01165905]Phase 110 participants (Actual)Interventional2010-01-31Completed
A Phase II Study of Gemcitabine and TS-1 in Patients With Previously Untreated Metastatic or Recurrent Biliary Tract Cancer [NCT01171755]Phase 219 participants (Actual)Interventional2008-02-29Terminated(stopped due to The objective response rate by more than two people are confirmed.)
Selective Transvenous Chemoembolization of Primary Pancreatic Tumors [NCT03865563]Phase 10 participants (Actual)Interventional2019-07-31Withdrawn(stopped due to We need to make significant adjustments to proposed drug and its delivery method)
A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL) [NCT04442022]Phase 2/Phase 3501 participants (Anticipated)Interventional2020-09-03Recruiting
Phase III Study Of Gemcitabine, Dexamethasone, And Cisplatin Compared To Dexamethasone, Cytarabine, And Cisplatin Plus/Minus Rituximab [(R)-GDP vs (R)-DHAP] As Salvage Chemotherapy For Patients With Relapsed Or Refractory Aggressive Histology Non-Hodgkin' [NCT00078949]Phase 3849 participants (Actual)Interventional2003-08-27Completed
A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma. [NCT01196559]Phase 244 participants (Actual)Interventional2011-01-31Completed
A Phase 1b Study of Gemcitabine and Demcizumab (OMP-21M18) With or Without Abraxane® as 1st-line Treatment in Subjects With Locally Advanced or Metastatic Pancreatic Cancer [NCT01189929]Phase 157 participants (Actual)Interventional2010-08-31Completed
A Phase I Study of Oral Sodium Bicarbonate in Patients With Unresectable Pancreatic Carcinoma Treated With Gemcitabine [NCT01198821]Phase 18 participants (Actual)Interventional2010-08-31Completed
An Open Label, Multiple Centers Phase Ib/II Study of APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma [NCT04643405]Phase 1/Phase 244 participants (Anticipated)Interventional2021-03-17Recruiting
A Phase II Trial of ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma Osteosarcoma, Ewing's Sarcoma, and Small Cell Lung Cancer [NCT03449901]Phase 298 participants (Actual)Interventional2018-05-09Completed
A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab With or Without Platinum-Based Combination Chemotherapy Versus Chemotherapy in Subjects With Advanced or Metastatic Urothelial Carcinoma [NCT02853305]Phase 31,010 participants (Actual)Interventional2016-09-15Completed
An Open-Label Randomized Phase II Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Phase I Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin [NCT01333137]Phase 111 participants (Actual)Interventional2011-08-31Terminated
A Phase II Study of SHR6390 Plus Nab-paclitaxel and Gemcitabine in Unresectable Advanced/Metastatic Pancreatic Ductal Adenocarcinoma [NCT05185869]Phase 258 participants (Anticipated)Interventional2022-01-31Not yet recruiting
An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma [NCT01359696]Phase 140 participants (Actual)Interventional2011-07-11Completed
A Phase 1b (Open-Label)/Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma [NCT02659020]Phase 1/Phase 2310 participants (Actual)Interventional2016-03-01Completed
A Phase II Randomised, Open-label Study of Gemcitabine/Carboplatin First-line Chemotherapy in Combination With or Without the Antisense Oligonucleotide Apatorsen (OGX-427) in Advanced Squamous Cell Lung Cancers [NCT02423590]Phase 2140 participants (Anticipated)Interventional2014-06-30Active, not recruiting
A Randomized, Phase 3 Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment of Patients With Pancreatic Adenocarcinoma [NCT03665441]Phase 3512 participants (Actual)Interventional2018-09-15Completed
A Randomized Open-Label Phase III Trial of Pembrolizumab Versus Platinum Based Chemotherapy in 1L Subjects With PD-L1 Strong Metastatic Non-Small Cell Lung Cancer [NCT02142738]Phase 3305 participants (Actual)Interventional2014-08-25Completed
A Phase III, Randomized, Double-Blind, Multi-center Study to Investigate the Efficacy and Safety of Camrelizumab+Gemcitabine+Cisplatin Versus Placebo+Gemcitabine+Cisplatin in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma [NCT03707509]Phase 3263 participants (Actual)Interventional2018-11-13Active, not recruiting
Phase Ib / II Study of Anlotinib Combined With Gemcitabine/Cisplatin in Previous Untreated Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma [NCT03639467]Phase 1/Phase 240 participants (Anticipated)Interventional2018-09-18Recruiting
A Phase III, Randomised, Open-label,, Multi-Center Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1 Monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL) [NCT06170489]Phase 3185 participants (Anticipated)Interventional2023-12-22Not yet recruiting
A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects With Platinum-resistant, High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer [NCT06161025]Phase 2/Phase 3650 participants (Anticipated)Interventional2024-02-29Not yet recruiting
A Phase III Randomized Controlled Trial to Compare BL-B01D1 With Physician's Choice of Chemotherapy (Last Line) in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Previously Treated With PD-1/PD-L1 Monoclonal Antibody and at Least Two [NCT06118333]Phase 3368 participants (Anticipated)Interventional2023-12-04Recruiting
A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination With Other Anti-Cancer Therapies in Patient [NCT05389462]Phase 1196 participants (Anticipated)Interventional2022-07-13Recruiting
A Phase I/II b (Randomized Controlled) Study of Atezolizumab Combined to BEGEV Regimen as First Salvage Treatment in Patients With Relapsed or Refractory Hodgkin's Lymphoma Candidate to Autologous Stem-Cell Transplantation [NCT05300282]Phase 1/Phase 2140 participants (Anticipated)Interventional2022-08-03Recruiting
A Phase III, Open-Label, Multicenter, Randomized, Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GEMOX) Versus R-GEMOX Alone in Patients With Relapsed/Refractory Diffuse L [NCT04182204]Phase 3267 participants (Actual)Interventional2020-02-07Active, not recruiting
A Phase Ib/II, Open-Label, Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and Subsequent [NCT03421353]Phase 176 participants (Actual)Interventional2018-02-07Active, not recruiting
Vorinostat With Gemcitabine/Clofarabine/Busulfan for Allogeneic Transplantation for Aggressive Lymphomas [NCT04220008]Phase 230 participants (Anticipated)Interventional2023-06-01Not yet recruiting
A Multicentre Randomised Phase III Trial Comparing Pembrolizumab Versus Standard Chemotherapy for Advanced Pre-treated Malignant Pleural Mesothelioma [NCT02991482]Phase 3144 participants (Actual)Interventional2017-09-12Completed
Phase III Multicenter Randomized Study Comparing the Effect of Adjuvant Chemotherapy for Six Months With Gemcitabine-Oxaliplatin 85 mg/m2 (GEMOX 85) to Observation in Patients Who Underwent Surgery for Cancer of the Bile Ducts [NCT01313377]Phase 3190 participants (Actual)Interventional2009-07-31Completed
Translation of in Vitro and in Vivo Ascorbate Research Into a New Treatment Option for Pancreatic Cancer: Phase I/IIa Clinical Trial [NCT01364805]Phase 114 participants (Actual)Interventional2011-04-30Completed
Comparison of Gemcitabine, Oxaliplatin and Pegaspargase and Etoposide, Vincristine, Doxorubicin, Cyclophosphamide and Prednisone as First-line Chemotherapy in Patients With NK/T-cell Lymphoma:a Prospective Randomized Phase III Study [NCT02359162]Phase 350 participants (Actual)Interventional2015-05-31Terminated(stopped due to The study is out of date)
A Phase 1/2, Open-Label, Safety, Tolerability, and Efficacy Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723) [NCT03085914]Phase 1/Phase 270 participants (Actual)Interventional2017-05-02Completed
An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination With Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenoca [NCT02981342]Phase 2106 participants (Actual)Interventional2017-01-12Completed
A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas [NCT00685763]13 participants (Actual)Interventional2008-03-31Completed
Randomized Controlled Trial of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy [NCT02039518]Phase 2160 participants (Anticipated)Interventional2013-12-31Recruiting
A Randomized Pilot/Pharmacodynamic/Genomic Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer [NCT02030860]15 participants (Actual)Interventional2014-01-31Completed
Phase II Open-Label Multi-Cohort Study Evaluating CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Patients With Advanced Chemorefractory Colorectal, Pancreatic, or Other Solid Cancers [NCT05733000]Phase 294 participants (Anticipated)Interventional2023-03-08Recruiting
Neoadjuvant Sintilimab (PD-1 Antibody)-Chemotherapy and Concurrent Sintilimab-chemoradiation in Locoregionally-advanced Nasopharyngeal Carcinoma: a Single-arm, Phase 2 Clinical Trial [NCT03619824]Phase 240 participants (Anticipated)Interventional2019-01-31Not yet recruiting
Phase III Randomized Prospective Clinical Study of Neoadjuvant Chemotherapy With Gemcitabine and Cisplatin(GP) Versus Definite Cisplatin Combined Weekly Chemoradiotherapy for Locally Advanced Bulk Cervical Cancer [NCT05189028]Phase 3290 participants (Anticipated)Interventional2021-07-01Recruiting
A Phase I Open Label Study of GSK3359609 Administered Alone and in Combination With Anticancer Agents in Subjects With Selected Advanced Solid Tumors [NCT02723955]Phase 1829 participants (Actual)Interventional2016-06-23Completed
Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) in Patients With Resected Pancreatic Adenocarcinoma [NCT01526135]Phase 3493 participants (Actual)Interventional2012-04-16Completed
Xenotransplantation of Primary Cancer Samples in Zebrafish Embryos [NCT03668418]120 participants (Anticipated)Observational2018-06-01Recruiting
A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in Combination With Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX as Neoadjuvant Treatment in Patients With Locally Advanced, Unresectable Pancreatic Cancer [NCT03941093]Phase 3284 participants (Actual)Interventional2019-05-10Active, not recruiting
Epidemiological, Observational, Retrospective and Multicenter Study to Evaluate the Characteristics of Treatment With Gemcitabine and Nab-paclitaxel in Patients With Metastatic Pancreatic Adenocarcinoma Treated in the First Line in Routine Clinical Practi [NCT03620461]210 participants (Actual)Observational2013-12-01Completed
A Phase III, Open Label, Multicentre Randomised Clinical Study Comparing Acelarin (NUC-1031) With Gemcitabine in Patients With Metastatic Pancreatic Carcinoma [NCT03610100]Phase 2/Phase 3328 participants (Anticipated)Interventional2015-12-31Suspended(stopped due to Suspended to recruitment following TSC review on efficacy and toxicities)
An Open-label, Single-group, Multi-center, Phase II Clinical Trial Evaluating the Effect of Maintenance DCVAC/OvCa After Standard-of-care Therapy in Women With First Relapse of Platinum-sensitive Epithelial Ovarian Cancer [NCT03657966]Phase 233 participants (Actual)Interventional2017-11-23Completed
A Multi-Center, Double Blind, Placebo-Controlled, Randomized Phase II Trial of Gemcitabine Plus GDC-0449 (NSC 747691), a Hh Pathway Inhibitor, in Patients With Metastatic Pancreatic Cancer (10052747) [NCT01064622]Phase 1/Phase 2118 participants (Actual)Interventional2009-09-30Completed
A Phase II Pilot Trial Of Paclitaxel Protein Bound and Gemcitabine Based Chemotherapy and the Addition Of Paricalcitol Upon Attainment of Stable or Progressive Disease in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma [NCT04054362]Phase 214 participants (Anticipated)Interventional2018-11-29Recruiting
A Single Center, Open-label, Non-comparative, Phase I/II Clinical Trial to Assess the MTD, Safety and Efficacy of BEY1107 in Monotherapy and in Combination With Gemcitabine in Patient With Locally Advanced or Metastatic Pancreatic Cancer [NCT03579836]Phase 1/Phase 275 participants (Anticipated)Interventional2018-05-01Recruiting
Perioperative Chemotherapy Prior To and After Reoperation for Incidental Gallbladder Cancer - An International, Randomized Phase III Trial [NCT03579758]Phase 30 participants (Actual)Interventional2019-04-03Withdrawn(stopped due to This trial will open as an NCTN trial.)
A Phase IIb Randomized Study to Evaluate the Efficacy of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer [NCT01303029]Phase 2120 participants (Actual)Interventional2011-02-28Completed
A Randomised Phase II Study Comparing LEnalidomide Plus Rituximab, GEmcitabine and Methylprednisolone (LR-GEM) to Rituximab, Gemcitabine, Methylprednisolone and cisplatiN (R-GEM-P) in Second-line Treatment of Diffuse Large B-cell Lymphoma (DLBCL). [NCT02060656]Phase 292 participants (Anticipated)Interventional2013-09-30Active, not recruiting
Combination of Gemcitabine, Oxaliplatin, and Asparaginase (GELOX) With Concurrent Involved-Field Radiation Therapy for Patients With Stage IE/IIE Extranodal Natural Killer/T-Cell Lymphoma:a Phase II Study [NCT02080234]Phase 240 participants (Anticipated)Interventional2014-03-31Recruiting
Sequential Use of Nab-paclitaxel Plus Gemcitabine and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer: A Randomized Control Study [NCT03750669]Phase 2416 participants (Anticipated)Interventional2018-10-20Recruiting
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Multicenter Study of Immediate Postoperative Instillation of Gemcitabine in Patients With Superficial Transitional Cell Carcinoma of the Bladder [NCT00191477]Phase 3355 participants (Actual)Interventional2004-01-31Terminated(stopped due to The study was stopped early for futility reasons.)
A Phase I Trial of MEK Inhibitor MEK 162 Combined Sequentially With Gemcitabine-Oxaliplatin (GEMOX) in Patients With Advanced Biliary Cancer [NCT02105350]Phase 10 participants (Actual)Interventional2015-06-30Withdrawn(stopped due to Study was never initiated)
A Phase I/II Study of CX-4945 in Combination With Gemcitabine and Cisplatin in the Frontline Treatment of Patients With Cholangiocarcinoma [NCT02128282]Phase 1/Phase 2127 participants (Actual)Interventional2014-06-30Completed
Cadonilimab (PD-1/CTLA-4 Bi-specific Antibody) Combined With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial [NCT05587374]Phase 3418 participants (Anticipated)Interventional2023-08-01Recruiting
A Pilot Study: Phase II Study of Histology-based Consolidation Chemotherapy Following Concurrent Chemo-radiotherapy for Inoperable Stage III Non-small Cell Lung Cancer [NCT01336543]Phase 20 participants (Actual)Interventional2011-03-31Withdrawn(stopped due to Low accrual, small patient population at center.)
A Dose-Escalation Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-9722 (a PARP 1 and PARP 2 Inhibitor) in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors or Mantle Cell Lymphoma [NCT01345357]Phase 124 participants (Actual)Interventional2011-05-31Completed
QUILT-3.088 NANT Pancreatic Cancer Vaccine: Phase II Randomized Trial of the NANT Pancreatic Cancer Vaccine vs. Standard-of-Care as First- Line Treatment for Patients With Metastatic Pancreatic Cancer [NCT03563144]Phase 20 participants (Actual)Interventional2018-08-31Withdrawn(stopped due to Trial not initiated)
A Phase 1b Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer [NCT02050178]Phase 126 participants (Actual)Interventional2013-11-30Completed
A Phase I, Open-Label Study to Assess the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Administered Intravenously as a Single Agent or in Combination With Chemotherapy in Chinese Patients With Locally Advanced or Metastatic Solid Tumors [NCT02825940]Phase 1120 participants (Actual)Interventional2016-08-04Completed
Anlotinib-based Combination as First-line Treatment in Advanced Non-small Cell Lung Cancer: a Single Center, Three Arms and Exploratory Study [NCT03628521]Phase 180 participants (Anticipated)Interventional2018-07-20Recruiting
[NCT02099396]Phase 2/Phase 3100 participants (Anticipated)Interventional2014-04-30Not yet recruiting
An Open Single-center Phase II Clinical Study of Fruquintinib Combined With Chemotherapy in Patients With Liver Metastases From Pancreatic Cancer [NCT05168527]Phase 230 participants (Anticipated)Interventional2021-09-03Recruiting
Phase II Study of Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma [NCT01261728]Phase 257 participants (Anticipated)Interventional2010-12-14Active, not recruiting
An Open-label, Randomized, Multi-center, Phase III Clinical Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Urothelial Cancer Previously Treated With [NCT05754853]Phase 3290 participants (Anticipated)Interventional2023-04-06Recruiting
CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: a Prospective, Randomized, Double-blind, Multi-center Clinical Trial [NCT03085004]Phase 3100 participants (Anticipated)Interventional2019-04-12Recruiting
Phase II Trial of Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Chinese Patients With Advanced Pancreatic Cancer [NCT02135822]Phase 230 participants (Anticipated)Interventional2014-05-31Recruiting
Phase 1A/1B Dose Escalation and Expansion Study of SBP-101 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma [NCT03412799]Phase 150 participants (Actual)Interventional2018-06-04Completed
Neoadjuvant CCRT With Gemcitabine/Durvalumab (MEDI4736) Followed by Adjuvant Gemcitabine/Durvalumab(MEDI4736) in Resectable or Borderline Resectable Pancreatic Cancer [NCT03572400]Phase 271 participants (Anticipated)Interventional2018-11-29Recruiting
Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma [NCT00109928]Phase 234 participants (Actual)Interventional2005-09-30Completed
A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors [NCT04396821]Phase 1/Phase 2150 participants (Anticipated)Interventional2020-05-28Recruiting
Randomized Phase II Trial of Single Agent Chemotherapy Plus Nivolumab or Single Agent Chemotherapy Alone in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor [NCT03041181]Phase 23 participants (Actual)Interventional2017-01-27Terminated(stopped due to Funder decision - lack of accrual)
A Novel Therapy for Locally Advanced and Metastatic Pancreatic Cancer Based on Nanoparticle Albumin-bound Paclitaxel and Gemcitabine: Circulating Tumor Cells as a Potential Biomarker for Treatment Monitoring, -Response and Survival [NCT02707159]Phase 270 participants (Actual)Interventional2014-11-30Completed
Phase 2 Single Arm Trial Testing Adavosertib and Gemcitabine in Platinum-Resistant Advanced Pancreatic Adenocarcinoma [NCT05212025]Phase 20 participants (Actual)Interventional2022-06-30Withdrawn(stopped due to manufacturer choice)
Phase III, Multicenter, Open-label, Randomized Trial of Tarceva® vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR [NCT00446225]Phase 3174 participants (Actual)Interventional2007-02-28Completed
Open-label, Randomized, Comparative Phase 2 Study of Combination Immunotherapy Plus Standard-of-care Chemotherapy Versus Standard-of-care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer [NCT04390399]Phase 2328 participants (Anticipated)Interventional2020-07-21Recruiting
A Randomized, Multi-center Phase III Trial of Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine Alone in Curatively Resected Biliary Tract Cancer [NCT04401709]Phase 3490 participants (Anticipated)Interventional2021-04-01Recruiting
A Phase I Trial With Cohort Expansion of BYL719 in Combination With Gemcitabine and (Nab)-Paclitaxel in Locally Advanced and Metastatic Pancreatic Cancer [NCT02155088]Phase 115 participants (Actual)Interventional2014-10-30Completed
An Early Phase 1 Trial of Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma [NCT04051047]Early Phase 10 participants (Actual)Interventional2019-11-30Withdrawn(stopped due to Withdrawn by Principal Investigator)
Gemcitabine and Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology as a Sole Metastatic Site, a Pilot Study [NCT03703089]Phase 121 participants (Anticipated)Interventional2018-05-01Recruiting
A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer [NCT03086369]Phase 1/Phase 2184 participants (Actual)Interventional2017-06-22Completed
Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have No Prior Therapy for Their Metastatic Pancreatic Cancer [NCT03697239]Phase 1/Phase 20 participants (Actual)Interventional2019-06-30Withdrawn(stopped due to FDA indicated the same study could not be conducted under multiple INDs)
Randomized Phase III Trial Comparing Gemcitabine/Cisplatin/S-1 With Gemcitabine/Cisplatin for Unresectable Biliary Tract Cancer [NCT02182778]Phase 3246 participants (Actual)Interventional2014-07-09Completed
A Multicenter Phase I Dose-finding and Preliminary Efficacy Study of the Histone Deacetylase Inhibitor Romidepsin (Istodax) in Combination With Gemcitabine (Gemzar), Oxaliplatin (Eloxatin), and Dexamethasone for the Treatment of Adults With Relapsed/Refra [NCT02181218]Phase 124 participants (Actual)Interventional2015-02-04Completed
Phase II Trial of Avelumab in Combination With Gemcitabine in Advanced Leiomyosarcoma as a Second-line Treatment [NCT03536780]Phase 238 participants (Anticipated)Interventional2018-10-01Recruiting
A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer [NCT01251640]Phase 1/Phase 290 participants (Actual)Interventional2011-01-01Completed
Phase 3 Randomized Comparison of Concurrent Gemcitabine, Cisplatin, and Radiation Followed by Adjuvant Gemcitabine and Cisplatin Versus Concurrent Cisplatin and Radiation in Cancer of the Cervix Stages IIB to IVA [NCT00191100]Phase 3515 participants (Actual)Interventional2002-05-31Completed
Randomized Phase II-III Trial of Peri- or Post-Operative Chemotherapy in Resectable Pancreatic Adenocarcinoma [NCT01150630]Phase 298 participants (Actual)Interventional2010-05-31Completed
Hepatic Artery Infusion Gemcitabine and Floxuridine in Patients With Nasopharyngeal Carcinoma Liver Metastases [NCT03876574]Phase 116 participants (Actual)Interventional2011-01-01Completed
A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Can [NCT02542293]Phase 3953 participants (Actual)Interventional2015-11-03Active, not recruiting
A Randomized Phase II Trial of Carboplatin and Gemcitabine +/- Vandetanib in First Line Treatment of Advanced Urothelial Cell Cancer in Patients Who Are Not Suitable to Receive Cisplatin [NCT01191892]Phase 282 participants (Actual)Interventional2010-06-30Completed
Analysis of T Cells to Tetanus Toxoid Antigens in Patients With Pancreatic Cancer Treated With Gemcitabine [NCT03848182]Phase 29 participants (Actual)Interventional2017-07-21Terminated(stopped due to Slow accrual)
Phase II Trial Evaluating the Combination of Gemcitabine, Trastuzumab and Erlotinib as First-line Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma [NCT01204372]Phase 263 participants (Actual)Interventional2010-06-30Completed
An Open-label, Multicenter, Phase 1b Study of CNTO 888 (an Anti-CCL 2 Monoclonal Antibody) in Combination With Chemotherapies for the Treatment of Subjects With Solid Tumors [NCT01204996]Phase 153 participants (Actual)Interventional2010-05-31Completed
Phase II Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas [NCT03779464]Phase 2132 participants (Anticipated)Interventional2019-08-01Recruiting
Guidance of Adjuvant Instillation in Intermediate Risk Non-muscle Invasive Bladder Cancer by Drug Screens in Patient Derived Organoids. A Single Center, Open-label, Phase II Trial With a Feasibility Endpoint. (GAIN-INST-TRIAL) [NCT05024734]Phase 233 participants (Anticipated)Interventional2022-11-17Recruiting
A Phase II Trial of Pemetrexed in Combination With Gemcitabine as First Line Treatment in Extensive-Stage Small Cell Lung Carcinoma [NCT00129974]Phase 21 participants (Actual)Interventional2005-08-31Terminated(stopped due to failure to accrue)
A Phase II Evaluation of Gemcitabine (NSC #613327) and Docetaxel (NSC # 628503) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus [NCT00114218]Phase 228 participants (Actual)Interventional2005-03-31Completed
Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer [NCT00110084]Phase 250 participants (Actual)Interventional2005-08-31Completed
Randomized Phase 2 Study of Gemcitabine/Cisplatin With or Without SAR240550 (BSI-201), a PARP1 Inhibitor, in Patients With Stage IV Non-small Cell Lung Cancer [NCT01086254]Phase 2119 participants (Actual)Interventional2010-05-31Completed
A Phase I/II Trial of the HIV Protease Inhibitor Nelfinavir and Concurrent Radiation and Chemotherapy in Patients With Locally Advanced Pancreatic Cancer [NCT01086332]Phase 17 participants (Actual)Interventional2009-05-31Terminated(stopped due to Toxicities, lack of funding)
Gemcitabine and High-dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease [NCT00388349]Phase 2146 participants (Actual)Interventional2001-09-30Completed
A Randomized Phase II Study of Bevacizumab (NSC# 704865) and Gemcitabine in Combination With Either Cetuximab (NSC# 714692) or OSI-774 (NSC# 718781) in Patients With Advanced Pancreatic Cancer [NCT00091026]Phase 2143 participants (Actual)Interventional2004-07-31Completed
A Phase I/II Single-Arm Trial to Evaluate the Combination of Cisplatin and Gemcitabine With the mTOR Inhibitor Temsirolimus for First-Line Treatment of Patients With Advanced Transitional Cell Carcinoma of the Urothelium [NCT01090466]Phase 1/Phase 215 participants (Actual)Interventional2008-02-29Completed
GALLANT: A Phase 2 Study Using Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab as Second/Third Line Therapy for Advanced Sarcoma [NCT04535713]Phase 2260 participants (Anticipated)Interventional2020-09-30Recruiting
Camrelizumab Combined With Induction Chemotherapy and Intensity Modulated Radiotherapy for the Treatment of Locally Advanced Nasopharyngeal Carcinoma:a Randomized, Multicenter, Phase II Trial [NCT05097209]Phase 2200 participants (Anticipated)Interventional2022-04-06Recruiting
A Phase 1, Single Arm Investigator-initiated Study to Investigate the Safety of Combining the Antibody Magrolimab With Standard First Line Platinum-based Chemotherapy (With Cisplatin / Gemcitabine) in Advanced Urothelial Carcinoma [NCT05738161]Phase 126 participants (Anticipated)Interventional2023-06-21Recruiting
A Phase I, Multi-Center, Open Label, Dose De-Escalation and Expansion Study of Gemcitabine and Cisplatin With AG120 or Pemigatinib for Advanced Cholangiocarcinoma [NCT04088188]Phase 18 participants (Actual)Interventional2021-01-25Active, not recruiting
Pilot Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma [NCT02921022]110 participants (Anticipated)Interventional2016-10-31Active, not recruiting
A Phase I Trial of Dendritic Cell Vaccination for Children and Adults With Sarcoma [NCT01803152]Phase 119 participants (Actual)Interventional2014-01-06Active, not recruiting
A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer [NCT00057876]Phase 374 participants (Actual)Interventional2003-08-29Completed
Phase II-III, Factorial Multicenter Randomized Trial Evaluating the Addition of Rofecoxib to Polycht With Cispatin and Gemcitabine and Fixed Dose Rate Infusion of Gem in Association With Cisplatin in 1st-line for Advanced NSCLC [NCT00385606]Phase 2/Phase 3400 participants (Actual)Interventional2003-01-31Completed
A Phase III Randomized, Open-Label Clinical Study of Napabucasin (GB201) in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic PANCreatic Cancer Following Front-Line Chemotherapy Failure [NCT03721744]Phase 3230 participants (Anticipated)Interventional2018-10-25Recruiting
A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women With Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed By DD Paclitaxel (DD AC→P); DD AC Followed By [NCT00093795]Phase 34,894 participants (Actual)Interventional2004-10-31Completed
Randomized Phase II AGO-Study Comparing Combined Liposomal Doxorubicin (Myocet) and Gemcitabine (Gemzar) With Liposomal Doxorubicin (Myocet) Monotherapy in Platinum-Refractory and Platinum-Resistant Epithelial Cancer of the Ovary, Fallopian Tube and the P [NCT01100372]Phase 2154 participants (Anticipated)Interventional2009-07-31Recruiting
Phase II Study Of Sequential Gemcitabine Followed By Docetaxel For Recurrent Ewing's Sarcoma, Osteosarcoma, Or Unresectable Or Locally Recurrent Chondrosarcoma [SARC Study] [NCT00073983]Phase 254 participants (Actual)Interventional2006-10-31Completed
Feasibility Trial of MK3475 + Docetaxel or Gemcitabine in Platinum Pre-treated Urothelial Cancer [NCT02437370]Phase 132 participants (Actual)Interventional2015-09-01Completed
An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Subjects With Advanced Cancer [NCT00101907]Phase 141 participants (Actual)Interventional2004-12-31Terminated(stopped due to Study terminated per recommendation of Data Review Team)
Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer [NCT00100815]Phase 250 participants (Actual)Interventional2004-08-31Completed
A Phase I/II Trial of the Carboplatin/Gemcitabine Combination as First Line Treatment for Elderly Patients With Stage IV NSCLC. [NCT02175381]Phase 1/Phase 269 participants (Actual)Interventional2011-02-28Completed
A Multi-center, Open-label Phase II Study to Evaluate the Safety and Efficacy of YH003 in Combination With Toripalimab (Anti-PD-1 mAb) in Patients With Unresectable/Metastatic Melanoma and Pancreatic Ductal Adenocarcinoma (PDAC) [NCT05031494]Phase 2129 participants (Anticipated)Interventional2021-12-08Active, not recruiting
A Phase II Trial for the Use of Intravesical Gemcitabine and Docetaxel (GEMDOCE) in the Treatment of BCG naïve Non-muscle Invasive Urothelial Carcinoma of the Bladder [NCT04386746]Phase 227 participants (Actual)Interventional2020-07-29Active, not recruiting
A Randomized Phase II Trial Comparing the Activity of trabectedIn vs Gemcitabine in Patients With Metastatic or Locally Advanced Leiomyosarcoma Pretreated With Conventional Chemotherapy [NCT04383119]Phase 2100 participants (Anticipated)Interventional2021-10-29Recruiting
A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Synovial Sarcoma [NCT04145700]Phase 1/Phase 223 participants (Actual)Interventional2020-03-04Terminated(stopped due to Study terminated for meeting protocol specified futility criteria.)
A Phase II Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 Inhibitor in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma: HCRN GU17-295 [NCT03737123]Phase 26 participants (Actual)Interventional2018-12-19Terminated(stopped due to Lack of accrual)
Pilot Safety and Feasibility Study of an In Vivo Sensitivity Screen Using a Direct Tumor Microinjection Technique and FDG-PET [NCT03432741]Phase 139 participants (Anticipated)Interventional2018-03-27Suspended(stopped due to funding - sponsor filing of Chapter 11 bankruptcy)
Localized High-Risk Soft Tissue Sarcomas Of The Extremities And Trunk Wall In Adults: An Integrating Approach Comprising Standard Vs Histotype-Tailored Neoadjuvant Chemotherapy [NCT01710176]Phase 3550 participants (Actual)Interventional2011-06-01Active, not recruiting
A Phase 1 Study of Gemcitabine, Dasatinib and Erlotinib in Patients With Advanced Pancreatic Carcinoma [NCT01660971]Phase 119 participants (Actual)Interventional2012-07-30Active, not recruiting
Open Labeled Phase II Study Evaluating Efficacy and Safety of Chemotherapy With Gemcitabine - Oxaliplatin Combination for Advanced Refractory Thyroid Cancer Patients [NCT02472080]Phase 221 participants (Actual)Interventional2016-04-07Terminated(stopped due to inefficiency)
A Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, Combined With Chemotherapy in Advanced Soft Tissue and Bone Sarcomas [NCT05116800]Phase 20 participants (Actual)Interventional2022-03-01Withdrawn(stopped due to IND withdrawn)
A Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP [NCT02741388]Phase 139 participants (Actual)Interventional2016-10-31Completed
Toripalimab Combined With Gemcitabine in Recurrent or Metastatic Nasopharyngeal Carcinoma [NCT04405622]Phase 221 participants (Actual)Interventional2020-05-30Active, not recruiting
A Randomized, Controlled Phase Ⅲ Study of Paclitaxel Polymeric Micelles for Injection Versus Physician's Choice(TPC) in Human Epidermal Growth Factor Receptor 2-negative (HER2-) Metastatic Breast Cancer (MBC) Subjects Who Have Failed at Least Two Previous [NCT06143553]Phase 3168 participants (Anticipated)Interventional2023-10-30Recruiting
A Phase Ib/II, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antineoplastic Activity of CT-707 in Combination With Toripalimab and Gemcitabine in Advanced Pancreatic Cancer [NCT05580445]Phase 1/Phase 2114 participants (Anticipated)Interventional2022-08-11Recruiting
Intravesical Recombinant BCG (Bacillus Calmette Guérin) Followed by Perioperative Chemo-immunotherapy for Patients With Muscle-invasive Bladder Cancer (MIBC). A Multicenter, Single-arm Phase II Trial [NCT04630730]Phase 25 participants (Anticipated)Interventional2022-06-24Recruiting
A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN) [NCT03800134]Phase 3826 participants (Actual)Interventional2018-12-06Active, not recruiting
Phase 1 Safety and Tolerability Study of Human Monoclonal Antibody 5B1 (MVT-5873) With Expansion in Subjects With Pancreatic Cancer or Other CA19-9 Positive Malignancies [NCT02672917]Phase 1264 participants (Anticipated)Interventional2016-01-31Recruiting
Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer [NCT01815242]Phase 2336 participants (Anticipated)Interventional2013-06-30Active, not recruiting
Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line [NCT01802749]Phase 3406 participants (Actual)Interventional2013-11-30Active, not recruiting
A Factorial Study Comparing Pemetrexed With Gemcitabine and Testing the Efficacy of the Addition of Cisplatin in Elderly Patients With Non Squamous Advanced, Metastatic or Recurrent NSCLC. [NCT01656551]Phase 3232 participants (Actual)Interventional2012-08-31Active, not recruiting
Randomized Phase III Study of the Addition of Cisplatin in Combination With Gemcitabine as First-line Therapy for Elderly Patients With Advanced Non Small Cell Lung Cancer. [NCT01405586]Phase 3299 participants (Actual)Interventional2011-03-31Active, not recruiting
A Phase 1B Study Repurposing ATRA as Stromal Targeting Agent Along With Gemcitabine and Nab-Paclitaxel for Pancreatic Cancer (STAR_PAC) [NCT03307148]Phase 129 participants (Actual)Interventional2016-01-15Completed
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas [NCT01231347]Phase 3800 participants (Actual)Interventional2011-04-30Terminated(stopped due to Planned independent DMC Interim review: ended for futility w/no safety concerns)
An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic Non-small Cell Lung Cancer [NCT00701558]Phase 220 participants (Actual)Interventional2008-08-31Completed
A Multicenter, Phase 1/2 Study of Selinexor in Combination With Backbone Treatments or Novel Therapies in Patients With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL) [NCT04607772]Phase 1/Phase 2350 participants (Anticipated)Interventional2020-11-18Suspended(stopped due to Sponsor decision)
A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib 9 mg/kg/Day in Combination With Gemcitabine Compared to Placebo in Combination With Gemcitabine in Trea [NCT00789633]Phase 3353 participants (Actual)Interventional2008-11-25Completed
Induction Treatment With Nab-paclitaxel/Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer Followed by Either Alternating Application of Gemcitabine Monotherapy and Nab-paclitaxel/Gemcitabine or Continuing Application of Nab-paclitaxel/G [NCT02564146]Phase 2325 participants (Actual)Interventional2016-12-31Completed
A Study in Cancer Patients to Evaluate the Ability of LY2603618 to Act as an Inhibitor of CYP2D6 Using Desipramine as a Probe Substrate [NCT01358968]Phase 120 participants (Actual)Interventional2011-06-30Completed
A Prospective Phase III Randomized Clinical Trial Comparing the Effectiveness of Immediate Postoperative Intravesical Instillation With Either Gemcitabine Hydrochloride or Epirubicin Hydrochloride in Patients With Urinary Bladder Cancer (Gemcitabine Epiru [NCT04947059]Phase 3180 participants (Anticipated)Interventional2021-12-14Recruiting
A Phase 2, Single-Arm, Open-label, Study of RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy [NCT02452970]Phase 24 participants (Actual)Interventional2015-07-16Terminated(stopped due to Resensitization or clinical benefit was not observed)
A Phase Ⅲ, Randomized Controlled Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine Versus mFOLFIRINOX in Treating Patients With Borderline Reseactable and Locally Advanced Pancreatic Cancer [NCT04617821]Phase 3300 participants (Anticipated)Interventional2021-09-01Recruiting
Evaluation of an Open, Single Arm, Multicenter Phase II Clinical Study on the Neoadjuvant Treatment of HER2 Expressing Myometrial Invasive Bladder Cancer With Disitamab Vedotin for Injection and Gemcitabine [NCT05723991]Phase 436 participants (Anticipated)Interventional2022-09-28Recruiting
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of Combined Therapy With ATR Inhibitor AZD6738 and Gemcitabine, Using a Model Based Design. [NCT03669601]Phase 155 participants (Anticipated)Interventional2019-10-15Recruiting
A Prospective, Randomized, Controlled, Double-blind, Multi-center Clinical Study of Nimotuzumab Combinated With Gemcitabine Contrast to Placebo Combinated With Gemcitabine in K-RAS Wild-type,Locally Advanced and Metastatic Pancreatic Cancer [NCT02395016]Phase 3276 participants (Anticipated)Interventional2015-03-31Recruiting
PAXG Out in the Country [NCT04480268]Phase 4175 participants (Anticipated)Interventional2020-07-08Recruiting
A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer [NCT02694536]Phase 380 participants (Actual)Interventional2006-08-01Completed
Phase IV/II Open-label Study to Evaluate Prompt Response to Treatment With Cisplatin, Gemcitabine and Bevacizumab in Patients With Non-small Lung Cancer. [NCT02316327]Phase 419 participants (Actual)Interventional2013-07-31Completed
PHASE IA/IB, OPEN-LABEL, MULTICENTER, MULTIPLE ASCENDING DOSE STUDY FOLLOWED BY AN EXTENSION PHASE TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND ACTIVITY OF RO6927005, AN ANTI-MESOTHELIN (MSLN) RECOMBINANT CYTOLYTIC FUSION PROTEIN (cFP), ADMI [NCT02317419]Phase 115 participants (Actual)Interventional2014-12-31Terminated(stopped due to The study was prematurely terminated because the emerging benefit:risk ratio did not justify continuing dosing patients.)
Pancreatic Locally Advanced Irresectable Cancer Ablation; a Randomized Controlled Superiority Phase III Multicenter Trial [NCT03690323]228 participants (Anticipated)Interventional2015-04-07Recruiting
A Phase III, Randomized, Three-arm, Double-blind, Placebo-controlled, International Multi-center Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Lenvatinib and Gemcitabine-based Chemotherapy Compared With Gemcitabine-based Che [NCT05342194]Phase 3480 participants (Anticipated)Interventional2022-10-01Not yet recruiting
An Open-Label, Multicenter, Randomized Phase Ib/II Study of Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer [NCT01126749]Phase 1/Phase 292 participants (Actual)Interventional2010-04-16Terminated(stopped due to Study was terminated as per sponsor's decision)
A Phase II Study of Nab-paclitaxel and Gemcitabine, in Elderly Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma [NCT02391662]Phase 280 participants (Actual)Interventional2015-06-23Completed
Phase II Trial Comparing Nab-paclitaxel Plus S-1 Versus Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Patients With Advanced Pancreatic Cancer [NCT03636308]Phase 240 participants (Anticipated)Interventional2018-07-17Recruiting
Combination Chemotherapy Using Cisplatin, Gemcitabine, Ifosfamide, Etoposide, L-asparaginase and Dexamethasone (SIMPLE) for Newly Diagnosed and Relapsed/Refractory NK/T Cell Malignancies [NCT03623087]Phase 368 participants (Anticipated)Interventional2017-07-01Recruiting
Peri-operative S-1/Leucovorin, Oxaliplatin and Gemcitabine (SLOG) for Localized Pancreatic Cancer [NCT05048524]Phase 240 participants (Anticipated)Interventional2021-09-03Recruiting
Prospective Randomized Controlled Study of the Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy [NCT03423849]Phase 2/Phase 3200 participants (Anticipated)Interventional2018-02-08Not yet recruiting
Phase II Multi-Center Study of Nab-paclitaxel, Gemcitabine and Cisplatin (NGC-Triple Regimen as Preoperative Therapy in Patients With Potentially Resectable and Borderline Resectable Pancreatic Cancer [NCT03392571]Phase 20 participants (Actual)Interventional2018-08-15Withdrawn(stopped due to Study was stopped due to lack of funding)
Randomized Double-Blind, Placebo-Controlled Parallel Multi-Center Study to Assess the Efficacy of Cannabidiol (BRCX014) Combined With Standard-Of-Care Treatment in Subjects With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies [NCT03607643]Phase 1/Phase 2160 participants (Anticipated)Interventional2019-01-15Not yet recruiting
Chidamide Combined With Cladribine/Gemcitabine/Busulfan (ChiCGB) With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma [NCT03602131]Phase 230 participants (Anticipated)Interventional2019-01-01Not yet recruiting
A Phase IB/II Clinical Study to Assess the Efficacy and Safety of QLS31905 in Combination With Chemotherapy as First-line Treatment in Patients With Claudin 18.2 (CLDN18.2) Positive Advanced Malignant Solid Tumors [NCT06041035]Phase 1/Phase 2115 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Phase I Study of Proglumide With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic DuctalAdenocarcinoma [NCT06017323]Phase 10 participants (Actual)Interventional2023-10-31Withdrawn(stopped due to STUDY00006987)
Local Consolidative Therapy (LCT) and Durvalumab (MEDI4736) for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy (ENDURE) [NCT04892953]Phase 251 participants (Anticipated)Interventional2021-07-07Recruiting
A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Mus [NCT03732677]Phase 31,063 participants (Actual)Interventional2018-11-16Active, not recruiting
A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects With Muscle-Invasive Transitional Cell Carcinoma of the Bladder [NCT02722538]Phase 123 participants (Actual)Interventional2016-05-31Completed
The Safety and Tolerance of Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in Subjects With Locally Advanced and Metastatic Pancreatic Adenocarcinoma: an Open, One-Armed, Single-Center, Phase Ⅱ Study. [NCT05947825]Phase 230 participants (Anticipated)Interventional2023-07-30Not yet recruiting
Sequential Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma [NCT05825066]Phase 264 participants (Anticipated)Interventional2023-08-01Recruiting
A Multi-Center, Open Label Phase 1/2 Study of CYT-0851 in Patients With Relapsed/Refractory B-Cell Malignancies and Advanced Solid Tumors [NCT03997968]Phase 1/Phase 2170 participants (Anticipated)Interventional2019-10-09Active, not recruiting
Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Untreated Advanced Non-small-cell Lung Cancer: a Randomized, Open-label Study [NCT02194556]Phase 4100 participants (Anticipated)Interventional2014-07-31Active, not recruiting
Phase II, Randomized, Controlled, Clinical Trial Exploring Efficacy and Safety of ERY001 (L-asparaginase Encapsulated in Red Blood Cells) in Association With Gemcitabine or FOLFOX4 in Second-line Therapy for Patients With Progressive Metastatic Pancreatic [NCT02195180]Phase 2141 participants (Actual)Interventional2014-07-31Completed
An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments [NCT02574455]Phase 3529 participants (Actual)Interventional2017-11-07Completed
Significance of Chemoradiation Following Induction Chemotherapy in Locally Advanced,Unresectable Pancreatic Cancer -a Randomised Phase 3 Trial: Chemoradiation Following Induction Chemotherapy Compared With Chemotherapy Alone [NCT01827553]Phase 3830 participants (Anticipated)Interventional2013-04-04Active, not recruiting
A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selecti [NCT00777491]Phase 270 participants (Actual)Interventional2008-12-31Completed
Pazopanib vs. Pazopanib Plus Gemcitabine in Patients With Relapsed or Metastatic Uterine Leiomyosarcomas or Uterine Carcinosarcomas: a Multi-center, Randomized Phase-II Clinical Trial of the NOGGO and AGO - PazoDoble - [NCT02203760]Phase 2107 participants (Anticipated)Interventional2019-10-16Recruiting
Phase II/III of Randomized Controlled Clinical Research on Irreversible Electroporation Synchronous Chemotherapy for Locally Advanced Pancreatic Adenocarcinoma [NCT03673137]Phase 2/Phase 3120 participants (Actual)Interventional2019-09-01Completed
A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer [NCT02213744]Phase 2/Phase 3113 participants (Actual)Interventional2014-07-31Terminated(stopped due to Felt not to show benefit over control per DMC and confirmed via futility analysis)
Phase 2/3 Study of Masitinib in Combination With Gemcitabine Versus Gemcitabine Alone in Advanced/Metastatic Epithelial Ovarian Cancer Patients in Second Line Being Refractory to First Line Platinum Treatment or in Third Line [NCT02490488]Phase 2/Phase 3248 participants (Actual)Interventional2014-04-30Completed
A Cancer Research UK Phase I Trial of an Oral Notch Inhibitor (MK-0752) in Combination With Gemcitabine in Patients With Stage III and IV Pancreatic Cancer [NCT01098344]Phase 144 participants (Actual)Interventional2010-04-30Completed
A Phase 1 Study of Gemcitabine, Nab-Paclitaxel, and Bosentan in Patients With Unresectable Pancreatic Cancer [NCT04158635]Phase 121 participants (Anticipated)Interventional2021-09-01Recruiting
A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma [NCT01472198]Phase 2250 participants (Actual)Interventional2011-11-30Completed
[NCT00813956]Phase 280 participants (Actual)Interventional2008-12-31Completed
Phase Ib Clinical Study to Evaluate the Safety and Efficacy of TQB2858 Injection to the Subjects With Recurrent/Metastatic Nasopharyngeal Cancer [NCT05198531]Phase 1/Phase 290 participants (Anticipated)Interventional2022-01-31Recruiting
The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer and Biological Markers Exploration. [NCT02283476]Phase 3200 participants (Anticipated)Interventional2014-11-30Not yet recruiting
Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer [NCT00625664]Phase 3337 participants (Actual)Interventional2008-02-29Completed
A Multi-Regional, Randomized, Double-blind, Phase 3 Study of the Efficacy and Safety of Sintilimab Plus Chemotherapy vs Placebo Plus Chemotherapy Before Surgery and Sintilimab vs Placebo After Surgery for Resectable Non-small Cell Lung Cancer [NCT05116462]Phase 3800 participants (Anticipated)Interventional2021-11-11Not yet recruiting
Phase 2 Open-Label Study of Volociximab (M200) in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer Not Previously Treated With Chemotherapy [NCT00401570]Phase 240 participants (Actual)Interventional2005-03-31Completed
A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-f [NCT03598270]Phase 3414 participants (Anticipated)Interventional2018-11-21Active, not recruiting
A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma [NCT02107950]Phase 271 participants (Actual)Interventional2013-11-30Completed
Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Myeloma [NCT02114502]Phase 20 participants (Actual)Interventional2014-09-30Withdrawn
A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell [NCT04313608]Phase 123 participants (Actual)Interventional2020-06-04Completed
A Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC) (MAGELLAN) [NCT03819465]Phase 1175 participants (Actual)Interventional2018-12-27Active, not recruiting
A Phase 2 Multi-Cohort, Open-Label Study of Intratumoral Tavokinogene Telseplasmid Plus Electroporation in Combination With Pembrolizumab +/- Chemotherapy in Patients With Inoperable Locally Advanced/Metastatic Triple-Negative Breast Cancer [NCT03567720]Phase 265 participants (Anticipated)Interventional2018-10-11Active, not recruiting
Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer [NCT03498326]Phase 2480 participants (Anticipated)Interventional2018-04-02Recruiting
A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma [NCT04833582]Phase 1/Phase 284 participants (Anticipated)Interventional2021-08-01Active, not recruiting
An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of VX-970/M6620 in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors [NCT02157792]Phase 1200 participants (Actual)Interventional2012-12-10Completed
Adjuvant Treatment of Resectable Cholangiocellular Carcinoma (CCC) With Cisplatin Plus Gemcitabine. A Prospective Single Center Phase Ib-II Study. [NCT01073839]Phase 1/Phase 233 participants (Actual)Interventional2008-08-31Completed
A Randomized Trial Comparing Intravesical Gemcitabine to Continuous Bladder Irrigation With Sterile Water to Prevent Bladder Cancer Implantation in Patients Undergoing Excision of Upper Tract Urothelial Carcinoma [NCT04865939]Phase 3132 participants (Anticipated)Interventional2021-11-29Recruiting
A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304) [NCT04700124]Phase 3784 participants (Anticipated)Interventional2021-04-21Active, not recruiting
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors [NCT03314935]Phase 1/Phase 2149 participants (Actual)Interventional2017-11-21Completed
An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer ( [NCT02477826]Phase 32,748 participants (Actual)Interventional2015-08-05Active, not recruiting
MITO27: Randomized Phase II Study on MK-3475 Plus Chemotherapy Versus Chemotherapy Alone in Recurrent, Platinum-resistant Ovarian Cancer [NCT03539328]Phase 2138 participants (Anticipated)Interventional2018-06-30Not yet recruiting
Alternating Neoadjuvant Gemcitabine-Nab-Paclitaxel and Nanoliposomal Irinotecan (Nal-IRI) With 5-Fluorouracil and Folinic Acid (Leucovorin) Regimens in Resectable and Borderline Resectable Pancreatic Cancer [NCT03703063]Phase 130 participants (Anticipated)Interventional2018-09-17Recruiting
Trabectedin/PLD Versus Continuation of Platinum-based Chemo-therapy in Patients With Disease Stabilization and no Symptom Benefit Under Platinum-based Chemotherapy for Recurrent Ovarian Cancer [NCT03690739]Phase 39 participants (Actual)Interventional2019-08-09Terminated(stopped due to Insufficient Recruitment)
Phase II Study of Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer or Those With Progression on First Line Therapy [NCT02769832]Phase 232 participants (Actual)Interventional2016-08-29Active, not recruiting
Phase 1/2 Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer [NCT02324543]Phase 1/Phase 247 participants (Actual)Interventional2015-02-28Completed
Weight Loss in Patients With Advanced Stage Pancreatic Cancer: Role of Serotonin and Effects of Telotristat Ethyl [NCT03910387]Phase 222 participants (Anticipated)Interventional2019-04-17Active, not recruiting
AflacST1603: A Phase 1 Study Using Nab-paclitaxel (Abraxane®) in Combination With Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors [NCT03507491]Phase 124 participants (Actual)Interventional2018-08-27Active, not recruiting
A MULTICENTER, OPEN-LABEL, PHASE 1B/2 STUDY TO EVALUATE SAFETY AND EFFICACY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH CHEMOTHERAPY WITH OR WITHOUT OTHER ANTI-CANCER IMMUNOTHERAPIES AS FIRST-LINE TREATMENT IN PATIENTS WITH ADVANCED MALIGNANCIES [NCT03317496]Phase 1/Phase 267 participants (Actual)Interventional2017-12-21Terminated(stopped due to The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522).)
Phase Ib/II Study of Neoadjuvant Pembrolizumab With Gemcitabine-Cisplatin (Cisplatin-Eligible) or Gemcitabine (Cisplatin-Ineligible) in Subjects With T2-4aN0M0 Urothelial Cancer: HCRN GU14-188 [NCT02365766]Phase 1/Phase 283 participants (Actual)Interventional2015-05-27Active, not recruiting
Efficacy and Safety of Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma [NCT04432402]124 participants (Anticipated)Interventional2020-06-14Recruiting
A Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas [NCT04906876]Phase 20 participants (Actual)Interventional2021-09-30Withdrawn(stopped due to IND withdrawn)
A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 as a Single Agent and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors [NCT04666688]Phase 1/Phase 280 participants (Anticipated)Interventional2020-12-15Recruiting
A Phase Ib Study of Dovitinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Solid Tumors and Pancreatic Cancer [NCT02048943]Phase 10 participants (Actual)Interventional2015-03-31Withdrawn(stopped due to Lack of funding)
A Double-blind, Placebo Controlled, Randomized Multicenter Phase II Study Evaluating Gemcitabine With or Without Ramucirumab as II Line Treatment for Advanced Malignant Pleural Mesothelioma [NCT03560973]Phase 2164 participants (Actual)Interventional2016-12-22Active, not recruiting
A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients With Advanced Solid Tumours [NCT06059001]Phase 118 participants (Anticipated)Interventional2023-08-31Recruiting
Targeting ATR in Soft-tissue Sarcomas: a Randomized Phase II Study. TARSARC Study [NCT04807816]Phase 272 participants (Anticipated)Interventional2022-02-09Recruiting
A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GP-2250 in Combination With Gemcitabine in Subjects With Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma Who Have Progressed on Prior Treatme [NCT03854110]Phase 164 participants (Anticipated)Interventional2019-01-14Recruiting
A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic [NCT02453282]Phase 31,118 participants (Actual)Interventional2015-07-21Active, not recruiting
Phase I Two-Dimensional Dose-Finding Study of Bortezomib in Combination With Gemcitabine/Doxorubicin in Metastatic Surgically Unresectable Urothelial Cancer or Other Solid Tumors [NCT00479128]Phase 180 participants (Actual)Interventional2006-09-28Active, not recruiting
A Phase Ib, Open-label Trial to Investigate the Safety and Tolerability of SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma [NCT04282070]Phase 191 participants (Actual)Interventional2020-03-27Active, not recruiting
A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination With Chemotherapy for the First Line Treatment for Patients With Advanced Biliary Tract Cancers (TOURMALINE) [NCT05771480]Phase 3140 participants (Anticipated)Interventional2023-08-16Recruiting
Combined Therapy Using D-TACE, Gemcitabine and Cisplatin Chemotherapy, and PD1 Antibody for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma: a Single-center, Single-arm Trial [NCT05738057]Phase 222 participants (Anticipated)Interventional2023-06-30Recruiting
Systemic Therapy With a Loco-regional Treatment in Patients With Locally Advanced Pancreatic Cancer: The SMART Study [NCT04276857]27 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Phase I Trial Study of Gemcitabine and Docetaxel With Radiation in Adult Patients With High Grade and Greater Than 5 cm Soft Tissue Sarcoma of the Extremities [NCT04037527]Phase 127 participants (Anticipated)Interventional2020-08-18Recruiting
A Randomized Placebo-Controlled Phase II Trial Comparing Gemcitabine Monotherapy to Gemcitabine in Combination With AZD 1775 (MK 1775) in Women With Recurrent, Platinum Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers [NCT02101775]Phase 2124 participants (Actual)Interventional2014-07-21Active, not recruiting
MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-metastatic Pancreatic Cancer [NCT01972919]Phase 223 participants (Actual)Interventional2015-12-10Active, not recruiting
Phase II Trial of Pemetrexed-Based Induction Chemotherapy Followed by Concomitant Chemoradiotherapy in Previously Irradiated Head and Neck Cancer Patients [NCT01172470]Phase 234 participants (Actual)Interventional2005-06-30Completed
International, Multi-Center, Open-label, Treatment Extension Study of Iniparib as Monotherapy or in Combination Chemotherapeutic Regimens in Cancer Patients Who Have Derived Clinical Benefit From Iniparib Following Completion of a Phase 1, 2 or 3 Parental [NCT01593228]Phase 337 participants (Actual)Interventional2012-05-31Completed
A Phase 1b/2 Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer [NCT01130142]Phase 1/Phase 2122 participants (Actual)Interventional2010-04-30Completed
Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma (ALIX) [NCT03974854]Phase 290 participants (Anticipated)Interventional2019-07-08Recruiting
[NCT00862524]Phase 1/Phase 220 participants (Actual)Interventional2009-03-31Completed
A Phase 3, Multi-Center, Open-Label, Randomized Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer [NCT00938652]Phase 3519 participants (Actual)Interventional2009-07-31Completed
A Randomized Phase 2/3 Multi-Center Study of SM-88 in Subjects With Pancreatic Cancer Whose Disease Has Progressed or Recurred [NCT03512756]Phase 2/Phase 3132 participants (Actual)Interventional2018-03-27Completed
Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies [NCT03102320]Phase 1173 participants (Actual)Interventional2017-05-26Completed
A Phase II Randomized Study of SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer [NCT03443492]Phase 2130 participants (Anticipated)Interventional2018-03-26Enrolling by invitation
A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Chemotherapy as Second-line Treatment in Subjects With Advanced Biliary Cancer [NCT04809142]Phase 3392 participants (Anticipated)Interventional2021-02-04Recruiting
Prospective Phase I Study of Nab-Paclitaxel Plus Gemcitabine With Concurrent MR-Guided IMRT in Patients With Locally Advanced Pancreatic Cancer [NCT02283372]Phase 130 participants (Actual)Interventional2015-01-21Completed
A Phase Ib, Multicenter, Open-label, Dose-escalation and Dose-expansion Study of the Safety, Tolerability and Pharmacokinetics of HB002.1T in Combination With Chemotherapy in Patients With Advanced Solid Tumors. [NCT04802980]Phase 172 participants (Anticipated)Interventional2020-04-28Recruiting
A Multi-Center Randomised Open-Label Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in [NCT04099888]Phase 241 participants (Actual)Interventional2019-05-23Terminated(stopped due to Recent results from a Phase 3 study are expected to change the standard of care for patients with inoperable CCA, rendering the RELEASE study challenging to complete and potentially inadequate for NDA approval.)
Phase I-II Study of Palliative Treatment With Nimotuzumab as a Second, Third Line or More of Treatment for Advanced or Metastatic Cervical Cancer [NCT02095119]Phase 1/Phase 215 participants (Anticipated)Interventional2008-07-31Completed
Pancreatic Resectability in Cancers With Known Limited Extension (PRICKLE) - A Single-centre Phase 2a Study of Gemcitabine Plus Nab-paclitaxel for Borderline Unresectable Locally Advanced Pancreatic Cancer [NCT02124369]Phase 29 participants (Actual)Interventional2014-07-31Terminated(stopped due to Poor accrual)
International, Randomized, Open-Label, Phase 3 Trial of Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer [NCT00254904]Phase 3839 participants (Actual)Interventional2005-11-30Terminated(stopped due to See Termination Reason in Detailed Description)
PM-01: Phase 1b Study of PGG Beta Glucan (Imprime PGG®) in Combination With Anti-MUC1 Antibody (BTH1704) and Gemcitabine (Gemzar®) for the Treatment of Advanced Pancreatic Cancer [NCT02132403]Phase 13 participants (Actual)Interventional2014-08-31Terminated(stopped due to Drug Recall)
A Randomized, Open, Multicenter Phase II/III Trial to Compare the Efficacy and Safety of QL1706 and Carrilizumab Combined With Gemcitabine and Cisplatin in First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma [NCT05576272]Phase 2/Phase 3460 participants (Anticipated)Interventional2022-05-19Active, not recruiting
A Randomized,Open-label, Multi-Center, Phase II Clinical Trial to Assess the Efficacy and Safety of SHR-1210± SHR-1020 Versus Physician's Choice Chemotherapy in the Treatment of Recurrent or Metastatic Cervical Cancer Patients [NCT04680988]Phase 2194 participants (Actual)Interventional2021-04-05Active, not recruiting
A Phase Ib Study of hPV19, a Novel Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF),in Combination With Chemotherapy in Patients With Advanced Solid Tumors Refractory to Standard Therapy. [NCT03503604]Phase 118 participants (Anticipated)Interventional2018-05-01Not yet recruiting
Safety and Efficacy of Gemcitabine Based Neoadjuvant Chemotherapy Followed by Chemoradiation in Locally Advanced Cervical Cancer Patients and Association With Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression [NCT02309658]Phase 250 participants (Actual)Interventional2013-09-30Completed
A Pilot Study Targeting Angiogenesis Using Bevacizumab Combined With Chemotherapy and Histone Deacetylase Inhibitor (Valproic Acid) in Advanced Sarcomas [NCT01106872]Phase 147 participants (Actual)Interventional2010-09-30Completed
A Phase I Clinical Trial of Vorinostat in Combination With Gemcitabine Plus Platinum in Patients With Advanced Non-Small Cell Lung Cancer [NCT00423449]Phase 161 participants (Actual)Interventional2007-03-31Completed
Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer [NCT02172976]Phase 2/Phase 340 participants (Actual)Interventional2014-11-30Completed
Open Label Randomized Clinical Study of Plasmid Encoding p62/SQSTM1 (ELenagen) in in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer [NCT05979298]Phase 240 participants (Actual)Interventional2019-11-15Active, not recruiting
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Penpulimab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma [NCT05563480]Phase 290 participants (Anticipated)Interventional2022-10-27Recruiting
A Phase II Randomized Trial for Patients With Muscle-Invading Bladder Cancer Evaluating Transurethral Surgery and BID Irradiation Plus Either Paclitaxel and Cisplatin or 5-Fluorouracil and Cisplatin Followed by Selective Bladder Preservation and Gemcitabi [NCT00055601]Phase 297 participants (Actual)Interventional2002-12-31Completed
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of AMG 479 or Placebo in Combination With Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcinoma of the Pancreas [NCT01318642]Phase 210 participants (Actual)Interventional2012-05-31Terminated(stopped due to NCT01318642: Planned independent DMC Interim review: ended for futility w/no safety concerns)
Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients [NCT01096745]Phase 278 participants (Anticipated)Interventional2010-07-31Terminated(stopped due to Planning for randomized phase III trial for this issue.)
A Phase 2 Study of BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously With Gemcitabine as 2nd/3rdline Therapy in Advanced Pancreatic Cancer Patients [NCT02650804]Phase 249 participants (Actual)Interventional2016-07-06Completed
Multi-center, Phase I Clinical Study to Evaluate the Safety and Tolerability of Multi-antigen Autologous Immune Cell Injection (MASCT-I) in Patients With Advanced Solid Tumor, and to Preliminarily Evaluate the Anti-tumor Efficacy of MASCT-I Alone, in Comb [NCT03034304]Phase 1193 participants (Anticipated)Interventional2017-01-31Recruiting
Phase II Study of Second-line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma [NCT03618550]Phase 269 participants (Anticipated)Interventional2018-08-01Recruiting
A Phase 2 Study of Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma [NCT01333124]Phase 223 participants (Actual)Interventional2011-09-28Terminated(stopped due to Recruitment delay)
A Phase II Study of Gemcitabine, Oxaliplatin and Bevacizumab Followed by 5-Fluorouracil, Oxaliplatin, Bevacizumab and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer [NCT00602602]Phase 219 participants (Actual)Interventional2007-03-31Completed
A Phase 2, Multi-center, Open-Label, Randomized Trial of Gemcitabine/ Carboplatin, With or Without BSI-201, in Patients With ER, PR and HER2-negative Metastatic Breast Cancer [NCT00540358]Phase 2123 participants (Actual)Interventional2007-10-31Completed
Neoadjuvant Afatinib Combination With Chemotherapy for Stage Ⅱa-Ⅲb Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutation [NCT04470076]Phase 230 participants (Anticipated)Interventional2020-07-10Not yet recruiting
An Open-Label Phase I/II Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer [NCT05981001]Phase 1/Phase 2170 participants (Anticipated)Interventional2023-08-01Recruiting
A Randomized, Controlled, Open-label, Multi-center Phase III Clinical Trial of SKB264 for Injection Versus Investigator Selected Regimens in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer Who Have Failed [NCT05347134]Phase 3254 participants (Anticipated)Interventional2022-06-10Active, not recruiting
KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinic [NCT05294172]Phase 3295 participants (Actual)Interventional2022-06-16Active, not recruiting
A Phase II Trial of Pharmacological Ascorbate, Gemcitabine, and Nab-Paclitaxel for Metastatic Pancreatic Cancer (PACMAN 2.1) [NCT02905578]Phase 265 participants (Anticipated)Interventional2018-11-28Active, not recruiting
A Phase II Study of Second-Line Therapy With Regorafenib Plus Gemcitabine in Metastatic Pancreatic Cancer [NCT02383433]Phase 22 participants (Actual)Interventional2016-06-14Terminated(stopped due to PI discretion based on low accrual)
Gemcitabine, Ascorbate, Radiation Therapy for Pancreatic Cancer, Phase I [NCT01852890]Phase 116 participants (Actual)Interventional2014-01-31Active, not recruiting
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) [NCT04663347]Phase 1/Phase 2662 participants (Anticipated)Interventional2020-11-03Recruiting
GEMINI: An Open-Label, Single-Arm, Phase II Study of Intraoperative Gemcitabine Intravesical Instillation in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma [NCT04398368]Phase 225 participants (Actual)Interventional2020-06-05Terminated(stopped due to Focus research efforts on other projects.)
A Phase 1b, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0482 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors. [NCT03918278]Phase 1230 participants (Anticipated)Interventional2019-06-19Active, not recruiting
Single Arm, Non Randomized Phase II Trial of Gemcitabine and Oxaliplatin (GEM-OX) for Hepatocellular Carcinoma (HCC) Patients With Platelet Counts Greater Than 100,000 Per Microliter. [NCT00250822]Phase 211 participants (Actual)Interventional2005-10-31Completed
A Phase I Study Evaluating the Safety and Pharmacokinetics of SAR240550 Administered Twice Weekly in Patients With Advanced Solid Tumors. [NCT01213381]Phase 118 participants (Actual)Interventional2010-09-30Completed
Cetuximab Plus Gemcitabine-Oxaliplatin (GEMOX) in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer: a Phase II Study [NCT01216345]Phase 230 participants (Actual)Interventional2006-10-31Completed
St. Jude ELIOT: Phase 1 Evaluation of LY2606368, a Molecularly-Targeted CHK1/2 Inhibitor Therapy, in Combination With Cyclophosphamide or Gemcitabine for Children and Adolescents With Refractory or Recurrent Group 3/Group 4 or SHH Medulloblastoma Brain Tu [NCT04023669]Phase 121 participants (Actual)Interventional2019-08-08Active, not recruiting
Randomized Phase 3 Study Evaluating the Efficacy and the Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patient With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma [NCT03593018]Phase 386 participants (Actual)Interventional2018-11-09Active, not recruiting
A Phase 1b Study to Evaluate HMBD-001 With or Without Chemotherapy in Participants With Advanced Solid Tumors Harboring NRG1 Gene Fusions or Selected HER3 Mutations [NCT05919537]Phase 168 participants (Anticipated)Interventional2023-09-06Recruiting
Phase II, Multicenter, Non-randomized, Single-arm, Open-label Trial of Atezolizumab in Combination of Split-doses of Gemcitabine Plus Cisplatin in Patients With Locally Advanced or Metastatic Urothelial Carcinoma [NCT04602078]Phase 266 participants (Actual)Interventional2020-12-23Active, not recruiting
A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers [NCT03768414]Phase 3452 participants (Actual)Interventional2019-02-07Active, not recruiting
Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) [NCT03533582]Phase 2/Phase 3537 participants (Anticipated)Interventional2018-05-24Recruiting
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (≥ 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC) [NCT00324805]Phase 31,501 participants (Actual)Interventional2007-06-01Active, not recruiting
A Phase I Dose-Escalation Safety and Tolerability Study of MirvetuximabSoravtansine (IMGN853) and Gemcitabine in Patients With FRa-positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial Cancer, or Triple Negative Breast Cancer (TNBC) [NCT02996825]Phase 144 participants (Actual)Interventional2017-03-22Active, not recruiting
A Multicenter Study of TAR-200 in Combination With Nivolumab (OPDIVO) in Subjects With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy [NCT03518320]Phase 113 participants (Actual)Interventional2019-01-02Terminated(stopped due to Business objectives have changed)
A Phase 1b Combination Study of INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105) [NCT03920839]Phase 10 participants (Actual)Interventional2019-07-15Withdrawn(stopped due to As of November 4, 2019 the study was halted prematurely and will not resume.)
A Phase II Clinical Trial to Evaluate the Potential of Concomitant Chemoradiotherapy With Gemcitabine in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease [NCT03101995]Phase 218 participants (Anticipated)Interventional2018-01-16Recruiting
A Randomized, Open-label, Dose-escalation to Rash Study to Assess the Effect of Tarceva in Combination With Gemcitabine on Overall Survival in Patients With Metastatic Pancreatic Cancer. [NCT00652366]Phase 2467 participants (Actual)Interventional2008-05-31Completed
A Multicenter, Randomized Phase II Study Evaluating the Feasibility and Activity of Two Different Combinations of Docetaxel and Gemcitabine and of Cisplatin/Gemcitabine Followed by Docetaxel as First Line Therapy for Locally Advanced Unresectable or Metas [NCT00425191]Phase 2165 participants (Actual)Interventional2002-07-31Completed
A Multicentre, Randomized, Open Label, Phase III Study of Gemcitabine Versus FOLFOX in the First Line Setting for Metastatic Pancreatic Cancer Patients Using Human Equilibrative Nucleoside Transporter 1 (hENT1) Biomarker Testing. [NCT01586611]Phase 3175 participants (Anticipated)Interventional2012-06-30Recruiting
Phase I Study of Veliparib (ABT-888) in Combination With Cisplatin Plus Gemcitabine in Advanced Biliary, Pancreatic, Urothelial, and Non-small Cell Lung Cancer [NCT01282333]Phase 144 participants (Actual)Interventional2011-01-31Terminated
A Randomized, Multicenter, Open-label Phase Ib/II Study of RO5083945 in Combination With Cisplatin and Gemcitabine/Pemetrexed Versus Cisplatin and Gemcitabine/Pemetrexed in Patients With Advanced or Recurrent Non Small Cell Lung Cancer Who Have Not Receiv [NCT01185847]Phase 290 participants (Actual)Interventional2010-11-30Completed
Randomized Phase II Trial of Pre-Operative Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine With or Without Avelumab (PGHA vs. PGH) [NCT03344172]Phase 232 participants (Actual)Interventional2017-12-13Terminated(stopped due to Suspected Serious Adverse Events related to treatment)
Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer [NCT01291615]Phase 16 participants (Actual)Interventional2010-12-31Completed
Phase II Study of Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations [NCT01109615]Phase 240 participants (Actual)Interventional2010-04-30Terminated(stopped due to Lacking effect of treatment)
A Phase IB/II Single-arm Study of M7824 (MSB0011359C) in Combination With Gemcitabine in Adults With Previously Treated Advanced Adenocarcinoma of the Pancreas [NCT03451773]Phase 1/Phase 27 participants (Actual)Interventional2018-05-17Terminated(stopped due to Study was closed after one treatment related death.)
A Multicenter, Phase I-II Trial of Gemcitabine Plus Oxaliplatin and Nab-paclitaxel in Subjects With Advanced (Unresectable or Metastatic) Biliary Tract Cancer [NCT03943043]Phase 1/Phase 285 participants (Anticipated)Interventional2017-07-21Recruiting
Prospective, Single-center, Phase II Clinical Study of Anlotinib in Combination With Rituximab,Gemcitabine and Oxaliplatin (A-RGEMOX) in the Treatment of Early Relapsed/Refractory Diffuse Large B-cell Lymphoma [NCT06086197]Phase 241 participants (Anticipated)Interventional2023-01-01Recruiting
A Phase 1b/2 Randomized Study of AVB-S6-500 Plus Nab-paclitaxel and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma [NCT04983407]Phase 1/Phase 234 participants (Actual)Interventional2021-07-28Terminated(stopped due to Due to business reasons)
A Phase 3 Asian Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (MBC) Who Have Fail [NCT04639986]Phase 3331 participants (Actual)Interventional2020-11-23Active, not recruiting
A Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma [NCT04161248]Early Phase 118 participants (Anticipated)Interventional2020-09-02Recruiting
BLASST-1 (Bladder Cancer Signal Seeking Trial): Phase II Trial of Neoadjuvant Nivolumab With Cisplatin and Gemcitabine in Muscle-Invasive Bladder Cancer (MIBC) Patients Undergoing Radical Cystectomy [NCT03294304]Phase 243 participants (Actual)Interventional2018-01-29Completed
Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations [NCT01206049]Phase 288 participants (Actual)Interventional2010-09-30Completed
A Phase I Study of Induction AMG 479 and Gemcitabine, Followed by AMG 479, Capecitabine, and 3D-Conformal Radiation Therapy (3D-CRT) With Subsequent Maintenance Therapy for Locally Advanced Pancreatic Cancer [NCT01298401]Phase 18 participants (Actual)Interventional2012-02-29Completed
A Pilot Phase II Multi Center Study of Gemcitabine and Nab-paclitaxel (Abraxane) as Preoperative Therapy for Potentially Operable Pancreatic Cancer [NCT01298011]Phase 225 participants (Actual)Interventional2011-05-31Completed
Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone (R2-GOD) in Treatment of Relapse/Refractory DLBCL:A Phase I Study [NCT03795571]Phase 112 participants (Anticipated)Interventional2019-01-01Recruiting
Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Had No Prior Therapy for Their Metastatic Pancreatic Cancer [NCT03797443]Phase 1/Phase 20 participants (Actual)Interventional2019-01-01Withdrawn(stopped due to Regulatory Review needed)
Phase II Open-label Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Systemic Therapy for Locally Advanced or Metastatic Nasopharyngeal Carcinoma (NPC) [NCT01309633]Phase 280 participants (Actual)Interventional2011-09-02Completed
A Phase II, Open-Label, Multi-Cohort Study to Investigate the Preliminary Antitumor Activity, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Combination With Chemotherapy as First-Line Treatment in Chinese Subjects With Loca [NCT03432598]Phase 254 participants (Actual)Interventional2017-08-24Completed
Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine for Biliary Tract Cancer After Curative Resection [NCT03779035]Phase 3460 participants (Anticipated)Interventional2018-12-15Recruiting
PHASE 1B/2 STUDY OF PF-04136309 IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA [NCT02732938]Phase 222 participants (Actual)Interventional2016-05-04Terminated(stopped due to Pfizer made a business-related decision on 04May2017 to terminate study based on change in portfolio prioritization, and is not due to safety or efficacy.)
A Prospective, Single-center, One-arm Clinical Study of Apatinib Combined With Chemotherapy for Patients Who Progressed After First Line EGFR-TKI Treatment Without T790M Mutation [NCT03758677]Phase 230 participants (Anticipated)Interventional2020-08-01Not yet recruiting
ABC-04 a Phase 1B Study of Cisplatin, Gemcitabine and Selumetinib in Patients With Advanced Biliary Tract Cancer [NCT01242605]Phase 113 participants (Actual)Interventional2012-02-29Completed
A Multi-centre Phase II Randomized-controlled Study on Addition of Durvalumab (MEDI4736) to Induction Chemotherapy and Concurrent Chemoradiation and Followed by Maintenance Durvalumab for Locoregionally Advanced Nasopharyngeal Carcinoma [NCT04447612]Phase 2118 participants (Anticipated)Interventional2020-06-01Recruiting
Depletion of Myeloid Derived Suppressor Cells to Enhance Anti PD-1 Therapy [NCT03302247]Phase 23 participants (Actual)Interventional2018-01-15Terminated(stopped due to Unable to accrue subjects)
Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study (NEOPAC Study) [NCT01314027]Phase 338 participants (Actual)Interventional2009-09-30Terminated(stopped due to low recruitment)
Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have No Prior Therapy for Their Metastatic Pancreatic Cancer [NCT03908333]Phase 1/Phase 20 participants (Actual)Interventional2019-05-01Withdrawn(stopped due to Request to close per funding sponsor. Site not moving forward with trial.)
A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) With Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer [NCT02177695]Phase 2237 participants (Actual)Interventional2014-08-28Completed
An Open-label Phase Ib Prospective Clinical Trial to Investigate Safety, Tolerability and Maximum Tolerated Dose for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients. [NCT04652206]Phase 1/Phase 218 participants (Anticipated)Interventional2020-10-27Recruiting
Phase I/II Study of Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer [NCT01284413]Phase 1/Phase 268 participants (Actual)Interventional2010-12-31Completed
A Phase 1 Study of LY2801653 in Patients With Advanced Cancer [NCT01285037]Phase 1190 participants (Actual)Interventional2009-09-09Completed
Multicenter Randomized Controlled Trial of Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable Nasopharyngeal Carcinoma [NCT05352321]264 participants (Anticipated)Interventional2022-06-01Recruiting
Intraperitoneal (IP) Cisplatin Combined With Intravenous Gemcitabine + Nab-paclitaxel in Patients With Pancreatic Cancer With Peritoneal Metastasis [NCT05222204]Phase 244 participants (Anticipated)Interventional2021-07-02Recruiting
Addition of Gemcitabine to the Standard Reduced Busulfan and Cyclophosphamide (BUCY2) Pre Allogeneic Hematopoietic Stem Cell Transplantation Conditioning for Acute Lymphoblastic Leukemia [NCT03339700]Phase 215 participants (Anticipated)Interventional2018-09-15Recruiting
Phase III Trial for Primary Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in PET/CT Defined Poor-Prognostic Cervical Cancer Patients [NCT00842660]Phase 3172 participants (Anticipated)Interventional2009-02-28Enrolling by invitation
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Subjects With Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma [NCT03488251]Phase 28 participants (Actual)Interventional2018-08-20Terminated(stopped due to Sponsor decision)
Exploratory Trial of Immunochemoradiotherapy for Locally Advanced Pancreatic Adenocarcinoma [NCT01342224]Phase 111 participants (Actual)Interventional2011-01-31Completed
Optimizing Ultrasound Enhanced Delivery of Therapeutics [NCT04821284]Phase 1/Phase 2120 participants (Anticipated)Interventional2021-12-06Recruiting
PIONEER-Panc: Phase II Investigations of New and Emerging Therapies for Pancreatic Cancer [NCT04481204]Phase 2105 participants (Actual)Interventional2023-04-18Active, not recruiting
A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) With or Without Durvalumab in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma [NCT03611556]Phase 1/Phase 2213 participants (Actual)Interventional2018-06-21Completed
A Phase I/II Study of Nab-paclitaxel (Abraxane) and Gemcitabine Followed by Modified FOLFOX (AG-mFOLFOX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma [NCT02504333]Phase 1/Phase 2168 participants (Actual)Interventional2015-07-31Completed
A Multicentre Phase II Study of Adavosertib Plus Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer [NCT02272790]Phase 295 participants (Actual)Interventional2015-01-30Completed
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Gemcitabine Versus Vinorelbine Plus Cisplatin [NCT02544243]Phase 2200 participants (Anticipated)Interventional2015-09-30Not yet recruiting
PEXG (Cisplatin, Epirubicin, Capecitabine, Gemcitabine) Versus PDXG (Cisplatin, Docetaxel, Capecitabine, Gemcitabine) in Locally Advanced or Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial [NCT00966706]Phase 2105 participants (Actual)Interventional2005-06-30Completed
A Phase I Study of the Combination of Gemcitabine Plus Dasatinib in Patients With Refractory Solid Tumors With an Expanded Cohort in Advanced Pancreatic Cancer [NCT00598091]Phase 130 participants (Actual)Interventional2007-04-30Terminated(stopped due to Low accrual, unable to meet endpoint in timely manner)
Phase Ⅱ Study of Induction Erlotinib Therapy in Stage III A(N2) Non-small Cell Lung Cancer Proceeding to Mediastinoscopy/PET and Thoracotomy/Radiotherapy [NCT00600587]Phase 224 participants (Actual)Interventional2007-09-30Completed
A Phase I Study, With Expanded Cohort, of Biweekly Fixed-dose Rate Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic and Biliary Carcinomas [NCT00626158]Phase 145 participants (Actual)Interventional2008-02-29Completed
A Phase Ib/II Clinical Study on the Safety, Pharmacokinetic Characteristics, and Preliminary Efficacy of SC0191 Combination Chemotherapy in Patients With Advanced Ovarian Cancer. [NCT06055348]Phase 1/Phase 2112 participants (Anticipated)Interventional2023-10-30Not yet recruiting
Phase I/II Study of Gemcitabine and Docetaxel Combined With Immune Checkpoint Blockade (Retifanlimab) in Patients With Advanced Soft Tissue Sarcoma [NCT04577014]Phase 1/Phase 274 participants (Anticipated)Interventional2020-09-29Recruiting
A Randomized, Double-Blind Placebo-Controlled Phase II Study of the MEK Inhibitor GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Subjects With Metastatic Pancreatic Cancer [NCT01231581]Phase 2160 participants (Actual)Interventional2010-08-31Completed
A Dose-Escalation, Single Arm, Combination Study of Cabazitaxel With Gemcitabine to Determine The Safety, And Pharmacokinetics In Subjects With Advanced Solid Malignancies [NCT01001221]Phase 1/Phase 219 participants (Actual)Interventional2009-11-30Terminated(stopped due to Maximum tolerated dose not able to be determined)
Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial [NCT01294358]Phase 17 participants (Actual)Interventional2011-01-26Completed
Open-label Pilot Phase I / II Study on Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Macroscopically Complete Resection (R0/R1) of Adenocarcinomas of the Pancreas (PanHIPEC) [NCT02863471]Phase 1/Phase 216 participants (Anticipated)Interventional2016-01-31Recruiting
Phase I Study of Bortezomib and Gemcitabine in Elderly Patients With Solid Tumors (X05227) [NCT00620295]Phase 117 participants (Actual)Interventional2007-03-31Completed
A Multicenter Phase II Study of Gemcitabine, Capecitabine and Bevacizumab for Locally Advanced or Metastatic Adenocarcinoma of the Gall Bladder or Biliary Ducts. [NCT01007552]Phase 250 participants (Actual)Interventional2009-12-31Completed
A Phase 1 Dose-Escalation Study of SCH 900776 as Monotherapy and in Combination With Gemcitabine in Subjects With Advanced Solid Tumors or Lymphoma [NCT00779584]Phase 145 participants (Actual)Interventional2008-10-17Completed
Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT141 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients [NCT04683939]Phase 1/Phase 213 participants (Actual)Interventional2022-01-18Terminated(stopped due to Sponsor decision)
Phase II Pilot Study of Subsequent Line Gemcitabine and Nivolumab for Advanced SCLC [NCT03662074]Phase 214 participants (Actual)Interventional2018-11-07Terminated(stopped due to After interim analysis decided not to move forward with continuing the trial.)
A Dose-Escalation Study to Evaluate the Safety and Tolerability of SCH 717454 in Combination With Different Treatment Regimens in Subjects With Advanced Solid Tumors (Phase 1B/2; Protocol No. P04722) [NCT00954512]Phase 1/Phase 215 participants (Actual)Interventional2009-09-25Terminated(stopped due to This study was terminated for business reasons.)
Phase 2 Trial Of AG-013736 As First-Line Treatment For Patients With Squamous Non-Small Cell Lung Cancer Receiving Treatment With Cisplatin And Gemcitabine [NCT00735904]Phase 238 participants (Actual)Interventional2008-12-31Completed
Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study [NCT00747097]Phase 243 participants (Anticipated)Interventional2008-09-30Completed
Docetaxel, Gemcitabine and Bevacizumab as Salvage Therapy for Metastatic Breast Cancer [NCT00754351]Phase 248 participants (Actual)Interventional2008-09-30Completed
A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer. [NCT00919282]Phase 278 participants (Actual)Interventional1997-09-30Completed
A Randomized, Open-Label, Multiple-center, Phase II Study to Evaluate the Efficacy and Safety of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ Metastatic Breast Cancer Who Have Received Pri [NCT04262804]Phase 2123 participants (Actual)Interventional2020-01-13Active, not recruiting
A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma [NCT00434642]Phase 3484 participants (Actual)Interventional2007-04-30Completed
Atezolizumab in Combination With Gemcitabine and Cisplatin As First-Line Treatment in Metastatic Urothelial Cancer: A Multicenter Randomized Phase II Study of Two Alternative Dosing Schedules [NCT03093922]Phase 232 participants (Actual)Interventional2017-03-22Active, not recruiting
An Open-label Window of Opportunity Trial to Evaluate the Activity of Durvalumab (MEDI4736) and Tremelimumab With Platinum-based Chemotherapy (Gemcitabine and Cisplatin) in Intrahepatic Cholangiocarcinoma (ICC) [NCT04989218]Phase 1/Phase 220 participants (Anticipated)Interventional2023-01-30Recruiting
Open-label, Multicentric Phase I-II Trial to Evaluate the Efficacy and Safety of the Combination of Sorafenib (BAY 43-9006), Gemcitabine and Concurrent Radiotherapy, in Locally Advanced Pancreatic Carcinoma [NCT00789763]Phase 112 participants (Actual)Interventional2007-12-31Completed
BCG vs. Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer: A Randomized Prospective Study [NCT00696579]Phase 1/Phase 264 participants (Actual)Interventional2004-01-31Completed
A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC [NCT00806923]Phase 31,044 participants (Actual)Interventional2005-02-28Completed
An Open Label Study to Assess the Effect of First Line Treatment With Avastin in Combination With Paclitaxel and Gemcitabine in Progression-free Survival in Patients With HER-2 Negative Breast Cancer [NCT00846027]Phase 290 participants (Actual)Interventional2009-01-31Completed
Phase Ib Study To Evaluate The Safety Of Combining IGF-1R Antagonist R1507 With Multiple Standard Chemotherapy Drug Treatments In Patients With Advanced Malignancies [NCT00811993]Phase 1104 participants (Actual)Interventional2009-02-28Terminated
A One-Arm Exploratory Clinical Trial of Apatinib Plus Gemcitabine in Patients With Advanced Metastatic Pancreatic Cancer [NCT02863367]Phase 230 participants (Anticipated)Interventional2016-08-31Not yet recruiting
A Multicenter, Open Label, Single Arm, Phase II Study to Investigate the Efficacy and Safety of Sorafenib (Nexavar) in Combination With Gemcitabine in Patients With Advanced Hepatocellular Carcinoma (HCC) [NCT00703365]Phase 245 participants (Actual)Interventional2008-02-29Completed
Perioperative Therapy for Resectable Pancreatic Adenocarcinoma and Borderline Resectable Pancreatic Adenocarcinoma With Molecular Correlates [NCT02723331]Phase 250 participants (Actual)Interventional2016-12-30Active, not recruiting
A Phase 2 Study of Gemcitabine and Bevacizumab as First-Line Treatment in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer Previously Treated With Taxanes [NCT00623233]Phase 252 participants (Actual)Interventional2008-03-31Completed
Role of Neoadjuvant Chemotherapy in the Conservative Management of Non-muscle Invasive Bladder Cancer (NMIBC) T1b [NCT04245618]50 participants (Anticipated)Observational2020-07-31Not yet recruiting
Oxaliplatin Plus Gemcitabine Versus Capecitabine Alone as Adjuvant Treatment in the Prevention of Recurrence of Intrahepatic Cholangiocarcinoma [NCT02548195]Phase 3286 participants (Anticipated)Interventional2015-07-31Recruiting
Feasibility and Efficacy of Molecular Analysis-Directed Individualized Therapy Based of Tumoral mRNA Levels of ERCC1, RRM1 and BRCA1 in Advanced Non-Small-Cell Lung Cancer [NCT00705549]Phase 288 participants (Actual)Interventional2008-02-29Terminated(stopped due to Due to poor accrual)
A Multicenter Phase 4 Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients [NCT02812992]Phase 432 participants (Actual)Interventional2016-06-30Completed
Concurrent Chemoradiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Low-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial [NCT05979961]Phase 3424 participants (Anticipated)Interventional2023-08-31Not yet recruiting
Efficacy and Safety of Cadonilimab Combined With Gemcitabine and Cisplatin in the First-line Treatment of Unresectable Locally Advanced or Metastatic Biliary Malignancies [NCT05978609]Phase 265 participants (Anticipated)Interventional2023-07-01Recruiting
Pembrolizumab in Combination With Gemcitabine for Previously Treated Mycosis Fungoides and Sézary Syndrome: Efficacy and Characterization of Immune Response [NCT04960618]Phase 228 participants (Anticipated)Interventional2021-10-01Recruiting
A Phase I/II Study of Combination of Gemcitabine, Oxaliplatin and Sorafenib (GEMOX-Sorafenib) in Patients With Advanced Biliary Tract Cancer [NCT00955721]Phase 1/Phase 29 participants (Actual)Interventional2009-08-31Terminated(stopped due to Lack of Funding)
Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma [NCT04040491]Phase 4100 participants (Anticipated)Interventional2019-09-01Recruiting
An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greate [NCT05911295]Phase 3700 participants (Anticipated)Interventional2023-09-22Recruiting
A Phase II Study of RP-6306 in Patients With Advanced Cancer [NCT05605509]Phase 278 participants (Anticipated)Interventional2023-04-17Recruiting
A Randomized Phase II Study of Pembrolizumab and Brentuximab Vedotin Versus GDP, Followed by High Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed/Refractory Classical Hodgkin Lymphoma [NCT05180097]Phase 284 participants (Anticipated)Interventional2022-11-01Recruiting
A Randomized, Double-blind, Multi-center Phase III Study of Penpulimab (AK105) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma [NCT04974398]Phase 3298 participants (Anticipated)Interventional2021-08-16Recruiting
An Open-label, Multicenter, Phase 1a/1b Study of IGM-8444 as a Single Agent and in Combination in Subjects With Relapsed, Refractory, or Newly Diagnosed Cancers [NCT04553692]Phase 1430 participants (Anticipated)Interventional2020-09-23Recruiting
Phase 1/2a Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-3500 Alone or in Combination With Talazoparib or Gemcitabine in Advanced Solid Tumors With ATR Inhibitor Sensitizing Mutations (TRESR Study) [NCT04497116]Phase 1/Phase 2273 participants (Actual)Interventional2020-07-22Active, not recruiting
GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma:a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial [NCT03840421]Phase 3468 participants (Anticipated)Interventional2019-04-03Active, not recruiting
A Phase I/II Study to Evaluate the Tolerability and Efficacy of BMS-813160 (CCR2/5 Inhibitor) With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) [NCT03496662]Phase 1/Phase 240 participants (Actual)Interventional2018-08-31Active, not recruiting
A Multi-Stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma [NCT02436707]Phase 2320 participants (Anticipated)Interventional2015-10-27Recruiting
A Pilot Study of Nivolumab in Combination With GDP (Gemcitabine, Dexamethasone, Cisplatin)/ L-asparaginase in Patients With Advanced Stage or Relapsed/ Refractory Natural-killer/ T-cell Lymphoma [NCT04230330]Phase 10 participants (Actual)Interventional2019-12-12Withdrawn(stopped due to PI has left the institution.)
An Exploratory Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody) Combined With Chemotherapy in Patients With Advanced Solid Tumors. [NCT03577704]Phase 1/Phase 256 participants (Actual)Interventional2018-08-08Completed
A Phase I Study of Romidepsin, Gemcitabine, Dexamethasone and Cisplatin Combination Therapy in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma [NCT01846390]Phase 121 participants (Actual)Interventional2013-10-01Completed
A Phase III Study of Gemcitabine Plus Capecitabine (GEMCAP) Versus Gemcitabine Alone in Advanced Biliary Cancer [NCT00658593]Phase 319 participants (Actual)Interventional2008-10-10Terminated(stopped due to due to poor accrual)
An Open-Label, Multicenter Study of IBI308 in Subjects With Selected Advanced Solid Tumors [NCT02937116]Phase 1233 participants (Actual)Interventional2016-10-19Completed
A Phase II Study of Bortezomib and Gemcitabine in Patients With Relapsed Mantle Cell Lymphoma [NCT00377052]Phase 229 participants (Actual)Interventional2007-01-16Completed
A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination With Selected Standard Chemotherapy Regimens (CT) in Patients With Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer [NCT00343408]Phase 131 participants (Actual)Interventional2005-11-29Completed
A Phase I/II Study of AZD0530 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer [NCT00265876]Phase 1/Phase 234 participants (Actual)Interventional2006-04-26Completed
A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors [NCT00079079]Phase 234 participants (Actual)Interventional2003-10-27Completed
Phase II Trial of Gemcitabine and S-1 for Patients With Advanced Biliary Tract Cancer [NCT02146703]Phase 238 participants (Actual)Interventional2005-08-31Completed
A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer [NCT01621243]Phase 1/Phase 2128 participants (Actual)Interventional2012-05-31Terminated(stopped due to The study was terminated after a pre-planned futility analyses showed an insufficient level of efficacy in the study population to warrant continuation.)
Phase I Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC) [NCT04046887]Phase 114 participants (Actual)Interventional2019-09-11Active, not recruiting
A Phase II, Multicenter, Randomized Trial of Eribulin Plus Gemcitabine (EG) vs.Paclitaxel Plus Gemcitabine (PG) in Patients With HER2-Negative Metastatic Breast Cancer as First -Line Chemotherapy [NCT02263495]Phase 2118 participants (Actual)Interventional2014-12-19Completed
A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without Algenpantucel-L (HyperAcute®-Pancreas) Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer [NCT01072981]Phase 3722 participants (Actual)Interventional2010-04-30Completed
EGFR-TKI With Chemotherapy as First Line Treatment in Stage IIIB/IV NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism [NCT02859077]Phase 3100 participants (Anticipated)Interventional2016-08-31Not yet recruiting
A Phase 1, Multicenter, Open-label, Dose-escalation Study to Investigate the Safety and Pharmacokinetics of Nab®-Paclitaxel (ABI-007) Plus Gemcitabine in Subjects With Advanced Pancreatic Cancer Who Have Cholestatic Hyperbilirubinemia Secondary to Bile Du [NCT02267707]Phase 11 participants (Actual)Interventional2015-05-27Terminated(stopped due to Study population more infrequent than estimated. No study-related safety issues and no safety concerns were identified for the study.)
A Phase I, Open-label, Dose Escalation Study of Gemcitabine and Pulse Dose Erlotinib in Second Line Treatment of Advanced Pancreatic Cancer [NCT02154737]Phase 124 participants (Anticipated)Interventional2013-07-31Completed
A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplat [NCT00389155]Phase 2/Phase 334 participants (Actual)Interventional2007-01-31Completed
A Phase I-II Study of Induction Chemotherapy With Carboplatin and Gemcitabine, Followed by Chemoradiotherapy With Paclitaxel and Vinorelbine for Patients With Locally Advanced Non-Small Cell Lung Cancer [NCT00004093]Phase 1/Phase 236 participants (Actual)Interventional1999-08-31Terminated(stopped due to Original Principal Investigator left the institution.)
A Phase I/II Study of Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma [NCT03739619]Phase 1/Phase 254 participants (Anticipated)Interventional2018-11-26Active, not recruiting
Phase III Randomized Trial of Anlotinib Plus Gemcitabine/Cisplatin Vesus Placebo Plus Gemcitabine/Cisplatin in Previous Untreated Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma [NCT03601975]Phase 3336 participants (Anticipated)Interventional2018-08-27Recruiting
A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent With Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva (NCT #01595061) [NCT01595061]Phase 257 participants (Actual)Interventional2012-07-02Active, not recruiting
Neoadjuvant Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy (SBRT) for Patients With Locally Advanced Pancreatic Cancer [NCT03600623]Early Phase 125 participants (Actual)Interventional2017-09-25Terminated(stopped due to PI left the institution; no further accruals)
YY-20394 Combined With GEMOX in the Treatment of Patients With Relapsed and/or Refractory Diffuse Large B-cell Lymphoma With a Single Arm, Open, Multicentrized Phase 1b/2 Clinical Trial [NCT04500561]Phase 1/Phase 228 participants (Anticipated)Interventional2020-08-20Not yet recruiting
A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Advanced Breast Cancer [NCT02514681]Phase 3370 participants (Anticipated)Interventional2015-08-01Active, not recruiting
A Phase 3, Open-Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination With Celecoxib and Gemcitabine in Patients With Malignant Pleur [NCT03710876]Phase 353 participants (Actual)Interventional2019-01-21Active, not recruiting
Phase I Study of Neoadjuvant Chemotherapy of Gemcitabine Plus Nab-paclitaxel for Patients With Borderline Resectable Pancreatic Cancer. [NCT02506803]Phase 110 participants (Anticipated)Interventional2015-07-31Recruiting
A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of PD-1 Antibody Camrelizumab in Combination With Nab-paclitaxel Plus Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer [NCT04498689]Phase 2117 participants (Anticipated)Interventional2019-08-01Recruiting
EndostarTM Injection Combined With Gemcitabine+Platinum (GP)/Navelbine+Platinum (NP)/Gemcitabine+Xeloda (GX)/Navelbine+Xeloda (NX) in Treatment of Recurrent Metastatic Breast Cancer: A Randomized, Opened and Controlled Clinical Study [NCT02489409]Phase 2120 participants (Anticipated)Interventional2015-10-31Recruiting
A Phase 1 Dose-Escalation Study of LY2603618 in Combination With Gemcitabine in Japanese Patients With Solid Tumors [NCT01341457]Phase 117 participants (Actual)Interventional2011-05-31Completed
Phase 1b Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer [NCT03316599]Phase 126 participants (Actual)Interventional2018-01-17Completed
Preoperative Treatment With mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for Borderline Resectable Pancreatic Adenocarcinoma: a Randomised Phase II Study (STEREOPAC) [NCT05083247]Phase 2256 participants (Anticipated)Interventional2023-03-24Recruiting
A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma [NCT01554410]Phase 135 participants (Actual)Interventional2010-08-31Completed
A Phase 1 Study of Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors [NCT02071537]Phase 124 participants (Actual)Interventional2014-05-13Completed
Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer [NCT02074189]Phase 3200 participants (Anticipated)Interventional2014-03-31Enrolling by invitation
A Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma [NCT05254171]Phase 2/Phase 3150 participants (Anticipated)Interventional2022-08-08Recruiting
A First in Human, Phase 1/2a, Multicentre, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of PBP1510 in Patients With Advanced/Metastatic Pancreatic Cancer [NCT05141149]Phase 1/Phase 280 participants (Anticipated)Interventional2023-06-05Recruiting
A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) as First-line Treatment of Biliary Tract Cancer [NCT04066491]Phase 2/Phase 3309 participants (Actual)Interventional2019-09-20Terminated(stopped due to Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this study as the study was unlikely to achieve the primary objective of overall survival.)
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) [NCT03869190]Phase 1/Phase 2645 participants (Anticipated)Interventional2019-06-01Recruiting
Molecularly-Driven Doublet Therapy for All Children With Refractory or Recurrent CNS Malignant Neoplasms and Young Adults With Refractory or Recurrent SHH Medulloblastoma [NCT03434262]Phase 168 participants (Actual)Interventional2018-03-05Active, not recruiting
A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNO [NCT03425643]Phase 3797 participants (Actual)Interventional2018-04-24Active, not recruiting
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung) [NCT03337698]Phase 1/Phase 2470 participants (Anticipated)Interventional2018-01-02Recruiting
A Phase II Trial of MK3475 in Combination With Gemcitabine and Concurrent Hypofractionated Radiation Therapy as Bladder Sparing Treatment for Muscle-Invasive Urothelial Cancer of the Bladder [NCT02621151]Phase 260 participants (Actual)Interventional2016-08-11Active, not recruiting
Liposomal Doxorubicin Versus Carboplatin/Paclitaxel in Patients With Ovarian Cancer Recurrence Between 6 and 12 Months After Previous Platinum Based Therapy: Phase III Randomized Multicenter Study Amendment Title Protocol Version 2.0: Phase III Internatio [NCT00657878]Phase 3215 participants (Actual)Interventional2008-11-30Active, not recruiting
PA-Gemox Regimen Followed by Thalidomide Versus AspaMetDex Regimen in NKTCL Patients:a Randomized, Open-label, Phase 3 Study [NCT02085655]Phase 3264 participants (Anticipated)Interventional2013-04-25Recruiting
Combination Chemotherapy Including Cisplatin, Ifosfamide, Gemcitabine, L-asparaginase, Etoposide and Dexamethasone (PIGLETS Regimen) as Treatment of Newly Diagnosed and Relapsed/Refractory Peripheral T Cell Lymphomas (PTCLs) [NCT03071822]Phase 450 participants (Anticipated)Interventional2017-02-24Recruiting
A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC) [NCT02435680]Phase 250 participants (Actual)Interventional2015-08-10Completed
A Phase I Trial With Cohort Expansion of Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer [NCT02138383]Phase 125 participants (Actual)Interventional2014-05-22Completed
A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination With Nivolumab (BMS-936558) With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer [NCT03336216]Phase 2206 participants (Actual)Interventional2017-12-19Completed
Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features [NCT00068393]Phase 239 participants (Actual)Interventional2004-02-24Completed
Phase 2 Evaluation of a Community-Based Multi-modality Management Algorithm for Clinically Non-metastatic Ductal Adenocarcinoma of the Exocrine Pancreas or Ampulla [NCT02626520]Phase 211 participants (Actual)Interventional2016-05-11Terminated(stopped due to Study team felt toxicity of study regimen outweighed potential benefit.)
A Phase I Two-Dimensional Dose-Finding Study of Ixazomib in Combination With Gemcitabine and Doxorubicin, Followed by a Phase II Extension to Assess the Efficacy of This Combination in Metastatic, Surgically Unresectable Urothelial Cancer [NCT02420847]Phase 1/Phase 257 participants (Anticipated)Interventional2015-07-03Active, not recruiting
Phase I Study of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer [NCT03236883]Phase 130 participants (Anticipated)Interventional2016-04-30Recruiting
Induction Versus Adjuvant Gemcitabine/Cisplatin in Locally Advanced Non-metastatic Nasopharyngeal Carcinoma: A Randomized Phase III Trial [NCT04898374]Phase 3120 participants (Anticipated)Interventional2021-05-01Recruiting
Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo Plus Cisplatin and Gemcitabine as First-Line Treatment in Patients With Advanced or Metastatic Biliary Tract Cancer [NCT02711553]Phase 2309 participants (Actual)Interventional2016-05-19Active, not recruiting
Multicenter and Prospective Phase II Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma [NCT02429973]Phase 233 participants (Actual)Interventional2012-07-31Completed
A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer [NCT02425137]Phase 251 participants (Actual)Interventional2015-04-30Completed
Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (OLAparib) Followed by Adjuvant Combination of DuRvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With BreAst Cancer [NCT04711824]Phase 1/Phase 241 participants (Anticipated)Interventional2022-03-09Recruiting
A Phase II Pilot Trial Of Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and the Addition Of Paricalcitol Upon Disease Progression in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (NABPLAGEMD) [NCT03415854]Phase 211 participants (Actual)Interventional2018-01-31Completed
A Phase I Study of Ceritinib (LDK378), a Novel ALK Inhibitor, in Combination With Gemcitabine-Based Chemotherapy in Patients With Advanced Solid Tumors [NCT02227940]Phase 138 participants (Anticipated)Interventional2015-01-08Completed
Phase 1b/2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells in Advanced GD2-expressing Breast Cancers (DiG NKs) [NCT06026657]Phase 1/Phase 242 participants (Anticipated)Interventional2023-12-31Recruiting
Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA) [NCT02135042]Phase 2/Phase 3685 participants (Actual)Interventional2014-04-21Active, not recruiting
Phase II Trial of 5-FU, Leucovorin, Gemcitabine, and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant [NCT00082706]Phase 246 participants (Actual)Interventional2003-04-23Active, not recruiting
Phase II Study of Neoadjuvant Intraperitoneal Gemcitabine and Intravenous Gemcitabine With Radiotherapy Followed by Surgery and Adjuvant Intraperitoneal Gemcitabine, Intravenous Gemcitabine, and Fluorouracil in Patients With Advanced Adenocarcinoma of the [NCT00020345]Phase 20 participants Interventional2000-09-30Completed
A Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) [NCT00100789]Phase 267 participants (Actual)Interventional2005-01-31Completed
A Unicentric, Open Label, Mechanism of Action Trial, on the Biological Effect of Nab-paclitaxel Combined to Gemcitabine, in Patients With Metastatic Pancreatic Adenocarcinoma [NCT02174887]Phase 119 participants (Actual)Interventional2014-09-30Completed
Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial) [NCT03945357]Phase 3250 participants (Actual)Interventional2019-05-15Completed
A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma [NCT02562716]Phase 2147 participants (Actual)Interventional2016-01-06Completed
A Multicenter Randomized Phase Ⅲ Clinical Trial of Gemcitabine in Combination With Capecitabine Versus Gemcitabine Plus Carboplatin as First-line Treatment in Triple-negative Recurrent or Metastatic Breast Cancer [NCT02207335]Phase 3120 participants (Anticipated)Interventional2013-12-31Recruiting
CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research [NCT05999994]Phase 2105 participants (Anticipated)Interventional2020-01-22Recruiting
Phase II Study Evaluating the Efficacy of M9241 in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer or Intrahepatic Cholangiocarcinoma [NCT05286814]Phase 248 participants (Anticipated)Interventional2022-10-24Recruiting
A Phase II Pilot Study of Disulfiram and Copper Gluconate in Patients With Metastatic Pancreatic Cancer and Rising CA-19-9 Levels While Receiving Abraxane-Gemcitabine or FOLFIRINOX or Single-Agent Gemcitabine [NCT03714555]Phase 21 participants (Actual)Interventional2019-10-17Terminated(stopped due to Study was closed due to low subject enrollment at site.)
Phase II Multicentre, Randomized, Open-label Study to Evaluate the Safety and Efficacy of Avelumab With Gemcitabine/Carboplatin Versus Gemcitabine/Carboplatin Alone in Patients With Unresectable or Metastatic Urothelial Carcinoma (UC) Who Have Not Receive [NCT03390595]Phase 285 participants (Actual)Interventional2018-05-17Completed
A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer [NCT03288545]Phase 1/Phase 2348 participants (Actual)Interventional2017-10-11Active, not recruiting
An Open Label, Dose Escalation Followed by Dose Expansion, Safety and Tolerability Trial of CAN04, a Fully Humanized Monoclonal Antibody Against IL1RAP, in Subjects With Solid Malignant Tumors [NCT03267316]Phase 1/Phase 2167 participants (Actual)Interventional2017-09-19Active, not recruiting
A Double-Blind, Randomized Phase 2b Study of Sorafenib Compared to Placebo When Administered in Combination With Chemotherapy for Patients With Locally Advanced or MBC That Has Progressed During or After Bevacizumab Therapy [NCT00493636]Phase 2160 participants (Actual)Interventional2007-06-30Completed
Gemcitabine Combined With Nimotuzumab and Toripalimab as Induction Treatment Followed by Chemoradiotherapy for Locally Advanced Nasopharyngeal carcinoma-a Multicenter, Randomized Controlled Study [NCT06026878]Phase 3228 participants (Anticipated)Interventional2023-09-01Recruiting
Phase I/II Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma: Analysis of Prognostic Factors and Determinants of Response: A Pilot Study [NCT00184093]Phase 1/Phase 235 participants (Actual)Interventional1999-06-30Completed
A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without MK-0646 as First-Line Therapy in Advanced Squamous Non-Small Cell Lung Carcinoma [NCT00951444]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to The study was not activated.)
Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma [NCT00713687]Phase 20 participants (Actual)Interventional2008-08-31Withdrawn(stopped due to recruiting failed)
A Phase I/II Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Gemcitabine in Cancer Patients [NCT00907166]Phase 1/Phase 26 participants (Actual)Interventional2009-05-31Terminated(stopped due to Suspended trial was not restarted.)
A Phase II Trial of 17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Combination With Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma [NCT00577889]Phase 221 participants (Actual)Interventional2008-03-31Completed
A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory Solid Malignancies [NCT00733031]Phase 175 participants (Anticipated)Interventional2008-08-31Terminated(stopped due to PK results demonstrate low and variable plasma concentrations so that achieving therapeutic concentrations is unlikely.)
A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma [NCT05823311]Phase 380 participants (Anticipated)Interventional2023-10-31Recruiting
A Single Arm Phase 2 Study of Y-90 SIRT in Combination With Durvalumab (MEDI 4736) and Gemcitabine/Cisplatin in Locally Advanced, Unresectable or Metastatic Intrahepatic Cholangiocarcinoma [NCT05655949]Phase 230 participants (Anticipated)Interventional2023-12-31Recruiting
Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial [NCT05615818]Phase 3800 participants (Anticipated)Interventional2024-01-31Not yet recruiting
A Phase Ⅱ, Open Label, Single-center Study of Lenvatinib and Tirelizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma [NCT05532059]Phase 2100 participants (Anticipated)Interventional2022-01-31Recruiting
A Phase II Trial Evaluating the Efficacy of Polatuzumab Vedotin With Rituximab, Gemcitabine, Dexamethasone, and Cisplatin (PV-RGDP) Chemotherapy for Relapsed or Refractory Diffuse Large B-cell Lymphoma [NCT05498220]Phase 244 participants (Anticipated)Interventional2023-02-17Recruiting
A Phase 1b Study of Gemcitabine and Nab-paclitaxel in Combination With IM156 in Patients With Advanced Pancreatic Cancer. [NCT05497778]Phase 125 participants (Anticipated)Interventional2022-10-21Recruiting
Modified FOLFIRINOX Alternated With Biweekly Gemcitabine Plus Nab-Paclitaxel in Untreated Metastatic Adenocarcinoma of the Pancreas [NCT04672005]Phase 230 participants (Anticipated)Interventional2021-01-06Recruiting
A Phase II, Randomized, Active-Controlled, Multi-Center Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Guided by Genomic Profiling Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site Who [NCT03498521]Phase 2790 participants (Anticipated)Interventional2018-07-10Active, not recruiting
Phase II Single Arm Study of Gemcitabine and Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer [NCT02690558]Phase 239 participants (Actual)Interventional2016-05-31Active, not recruiting
A Phase Ib Clinical Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Metastatic Pancreatic Adenocarcinoma [NCT02231723]Phase 1139 participants (Actual)Interventional2014-08-31Completed
A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies [NCT00937664]Phase 124 participants (Actual)Interventional2009-07-31Terminated(stopped due to Termination of the study was made after a full review of program data and assessment of the current risk-benefit profile.)
A Multi-center, Phase IB/II, Open Label, Single Arm Study of Inotuzumab Ozogamicin Plus Rituximab (R-CMC544) Alternating With Gemcitabine-oxaliplatin Plus Rituximab(R-GEMOX)in Patients Aged From 18 to 80 Years With CD20 and CD22 Positive Diffuse Large B-c [NCT01562990]Phase 1/Phase 211 participants (Actual)Interventional2012-12-31Completed
Vinorelbine Plus Gemcitabine (VG) Versus Vinorelbine Plus Carboplatin (VC) in Advanced Non-small Cell Lung Cancer. An Open Randomized Multicenter Phase III Trial From Norwegian Lung Cancer Study Group (NLCG) [NCT00737867]Phase 3444 participants (Anticipated)Interventional2007-09-30Completed
Randomised Phase II Trial of Cediranib (AZD2171) Versus Placebo in Addition to Cisplatin/Gemcitabine Chemotherapy for Patients With Advanced Biliary Tract Cancers [NCT00939848]Phase 2/Phase 3124 participants (Actual)Interventional2011-04-30Completed
An Open-label, Phase II Study of Capecitabine Plus Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer [NCT02565641]Phase 263 participants (Actual)Interventional2003-03-31Completed
A Phase 2 Study of Transarterial Chemoperfusion Treatment With Cisplatin, Methotrexate and Gemcitabine in Patients With Unresectable Pleural Mesothelioma [NCT02611037]Phase 234 participants (Actual)Interventional2016-03-04Active, not recruiting
Randomized Phase II-III Trial of Post-operative Treatment of Pancreatic Adenocarcinoma: Gemcitabine Versus PEFG Followed by Radiochemotherapy With Concomitant Continuous Infusion of 5-fluorouracil [NCT00960284]Phase 2/Phase 3102 participants (Actual)Interventional2003-06-30Completed
A Phase Ib/II Trial of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer [NCT01326871]Phase 1/Phase 290 participants (Anticipated)Interventional2011-06-30Active, not recruiting
A Phase II Randomized Study of the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Physician Choice Chemotherapy in Premenopausal or Perimenopausal Patients With Hormone Receptor-positive/ HER2-negative Inoperable Locally Adv [NCT03839823]Phase 2223 participants (Actual)Interventional2019-02-25Completed
Phase II Safety and Efficacy Study of Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Metastatic or Unresectable Sarcomatoid Renal Cell Carcinoma [NCT00496587]Phase 234 participants (Actual)Interventional2007-07-31Completed
An Open-label Phase I/II Clinical Trial of PT-112 Combine With Gemcitabine Injection for Advanced Solid Tumors [NCT05357196]Phase 1/Phase 268 participants (Anticipated)Interventional2020-04-13Recruiting
A Phase II Study of Gemcitabine and Nab-Paclitaxel in Combination With GDC-0449 (Hedgehog Inhibitor) in Patients With Previously Untreated Metastatic Adenocarcinoma of the Pancreas [NCT01088815]Phase 298 participants (Actual)Interventional2010-09-17Completed
A Phase I/II, Open-label, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Local Advanced/Metastatic Biliary Tract Cancer [NCT04004234]Phase 1/Phase 220 participants (Anticipated)Interventional2019-03-01Recruiting
A Phase II Study of the Combination of Fixed Dose Rate Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer [NCT00417976]Phase 242 participants (Actual)Interventional2006-12-31Completed
A Phase I Trial of GSK1120212 and GSK1120212 in Combination With Gemcitabine in Japanese Subjects With Solid Tumors [NCT01324258]Phase 119 participants (Actual)Interventional2011-01-24Completed
A Phase I Trial of Gemcitabine (Gemzar) Plus ABI-007 (ABRAXANE) In Patients With Advanced Metastatic Pancreatic Cancer [NCT00398086]Phase 1/Phase 267 participants (Actual)Interventional2006-11-01Completed
A Phase 2 Randomized, Placebo-controlled, Double-blind Study of the Efficacy of MORAb-009 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer. [NCT00570713]Phase 2155 participants (Actual)Interventional2007-12-31Completed
Phase II Trial of Albumin-Bound Paclitaxel in Combination With Gemcitabine and Bevacizumab in Patients With Metastatic Breast Cancer [NCT00662129]Phase 250 participants (Actual)Interventional2008-11-30Completed
Multicenter Non-interventional Study to Investigate Safety, Tolerability and Efficacy of Nab-paclitaxel in Clinical Routine Treatment of First-line Pancreatic Cancer Patients [NCT02555813]317 participants (Actual)Observational2015-05-08Completed
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Plitidepsin in Combination With Sorafenib or Gemcitabine in Patients With Advanced Solid Tumors or Lymphomas [NCT00788099]Phase 145 participants (Actual)Interventional2008-12-31Completed
A Phase II Study of Sorafenib With Gemcitabine/Cisplatin in Advanced Hepatocellular Carcinoma [NCT00808145]Phase 20 participants (Actual)Interventional2009-02-28Withdrawn(stopped due to Lack of enrollment, many screen failures and non eligible study participants)
Phase II Randomized Trial of Gemcitabine and Cisplatin With or Without Cetuximab in Patients With Urothelial Carcinoma [NCT00645593]Phase 289 participants (Actual)Interventional2008-03-31Completed
Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (and in a Cohort of Patients Younger Than 60 Years) [NCT00022633]Phase 265 participants (Actual)Interventional2001-07-31Terminated(stopped due to Permanently Closed Due to Poor Accrual)
A Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin in Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma [NCT00536874]Phase 239 participants (Actual)Interventional2007-10-31Completed
A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-metastatic Pancreatic Adenocarcinoma [NCT00424827]Phase 211 participants (Actual)Interventional2006-06-30Completed
A Randomized Open-Label, Phase II Study of Lapatinib-capecitabine or Lapatinib-vinorelbine or Lapatinib/Gemcitabine in Subjects With Her2/Neu Amplified Metastatic Breast Cancer Patients Progression After Taxanes Treatment [NCT01050322]Phase 2142 participants (Actual)Interventional2009-11-30Completed
A Phase 2 Study of REOLYSIN in Combination With Gemcitabine for Patients With Advanced Pancreatic Adenocarcinoma [NCT00998322]Phase 234 participants (Actual)Interventional2009-10-31Completed
A Multi-Center Randomized Phase II Study of Induction Chemotherapy Followed by Gemcitabine or Capecitabine Based Chemoradiotherapy for Locally Advanced Non-Metastatic Pancreatic Cancer [NCT01032057]Phase 2114 participants (Actual)Interventional2009-07-31Completed
Intermediate-size Patient Population IND for Treatment of KRAS G12V-mutant Tumors With Gene-engineered KRAS G12V-reactive T Cells [NCT05389514]0 participants Expanded AccessAvailable
LAPTOP: Phase 1/2 Study in Borderline Resectable, Locally Advanced or Metastatic Pancreatic Cancer to Assess Safety and Potential Efficacy of Dual Checkpoint Inhibition in Combination With Gemcitabine and Nab-paclitaxel Followed by Immune-chemoradiation. [NCT04247165]Phase 1/Phase 240 participants (Anticipated)Interventional2020-06-02Recruiting
A Randomized, Open-Label Phase 2 Study of 2 Regimens, Gemcitabine Plus Enzastaurin and Single-Agent Gemcitabine, in Patients With Locally Advanced or Metastatic Pancreatic Cancer [NCT00267020]Phase 2130 participants (Actual)Interventional2005-12-31Completed
A Phase II Trial of Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer: Hoosier Oncology Group GU04-75 [NCT00234494]Phase 245 participants (Actual)Interventional2005-11-30Completed
A Phase I, Dose-escalation Study of a Combination AS703569 and Gemcitabine Given to Subjects With Advanced Malignancies [NCT01097512]Phase 166 participants (Actual)Interventional2007-06-30Completed
A Phase 1 Dose-Finding Study Of The Anti-Angiogenesis Agent, AG-013736, In Combinations Of Paclitaxel/Carboplatin, Weekly Paclitaxel, Docetaxel, Capecitabine, Gemcitabine/Cisplatin and Pemetrexed/Cisplatin In Patients With Advanced Solid Tumors [NCT00454649]Phase 1102 participants (Actual)Interventional2005-12-31Completed
A Dose Tolerability and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer [NCT01028495]Phase 231 participants (Actual)Interventional2009-05-31Completed
A Study of Endostar in Combination With Chemotherapy Followed by Endostar Maintenance Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) [NCT01028729]Phase 4120 participants (Anticipated)Interventional2009-09-30Recruiting
A Phase 1-2 Study of the VEGF Receptor Tyrosine Kinase Inhibitor PTK787/ZK 222584 and Gemcitabine in Patients With Advanced Pancreatic Cancer [NCT00185588]Phase 1/Phase 233 participants (Actual)Interventional2004-10-31Completed
A Phase II Single-Arm Trial to Evaluate Cisplatin and Gemcitabine Chemotherapy in Combination With Sunitinib for First-Line Treatment of Patients With Advanced Transitional Carcinoma of the Urothelium [NCT01089088]Phase 263 participants (Actual)Interventional2009-04-30Completed
Focused Ultrasound With Low-Dose Gemcitabine to Augment Immune Control of Early Stage Breast Cancer [NCT04796220]Phase 148 participants (Anticipated)Interventional2022-01-27Recruiting
A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 - Claudin18.2 Monoclonal Antibody in the Treatment of Locally Advanced or Metastatic Solid Tumors [NCT04495296]Phase 1/Phase 2320 participants (Anticipated)Interventional2020-08-13Recruiting
Phase 2 Gene Therapy Trial of Locally Advanced Pancreatic Adenocarcinoma Using Intratumoral Injection of CYL-02 in Combination With Gemcitabine [NCT02806687]Phase 268 participants (Actual)Interventional2017-01-30Completed
Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Optional Postoperative Normothermic Intraperitoneal (IP) Chemotherapy to Treat Primary or Recurrent Carcinoma of Ovarian, Fallopian Tube, Uterine, or Peritoneal Origin [NCT01970722]Phase 140 participants (Anticipated)Interventional2014-05-19Active, not recruiting
A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Gemcitabine (GEM) and Capecitabine (CAP) With or Without T-ChOS as Adjuvant Therapy in Patients With Surgically Resected Pancreatic Cancer. [NCT02767752]Phase 221 participants (Actual)Interventional2016-11-30Terminated(stopped due to Poor accrual and change of SOC (FOLFIRINOX in adjuvant setting))
Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma [NCT02767674]Phase 3258 participants (Anticipated)Interventional2016-05-31Recruiting
Randomized, Controlled Study of the Safety and Efficacy of DC-CTL Immune Cell for Non-Small Cell Lung Cancer [NCT02766348]Phase 260 participants (Anticipated)Interventional2016-05-31Not yet recruiting
A Phase II Study of the Efficacy and Safety of Bortezomib Plus GDP in the Treatment of Refractory and Relapsed Non-GCB Diffuse Large B-cell Lymphoma [NCT02542111]Phase 230 participants (Anticipated)Interventional2015-05-31Recruiting
Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma [NCT00286013]Phase 224 participants (Actual)Interventional2004-05-01Completed
Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients. [NCT00905983]Phase 248 participants (Actual)Interventional2007-10-31Active, not recruiting
Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2 [NCT00906061]Phase 276 participants (Anticipated)Interventional2007-10-31Recruiting
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes [NCT02754180]Phase 2110 participants (Anticipated)Interventional2016-03-31Recruiting
Pilot Study of Obinutuzumab in Combination With GDP Chemotherapy for the Treatment of Relapsed or Refractory CD20+ Aggressive Non-Hodgkin Lymphoma [NCT02750670]Phase 230 participants (Actual)Interventional2017-03-15Completed
Phase IIb Randomised Clinical Trial Repurposing ATRA as a Stromal Targeting Agent in a Novel Drug Combination for Pancreatic Cancer [NCT04241276]Phase 2170 participants (Anticipated)Interventional2020-04-30Not yet recruiting
An Exploratory Clinical Trial of Nab-Paclitaxel and Gemcitabine Compared With Gemcitabine and Tegafur in Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer [NCT04216758]Phase 2300 participants (Anticipated)Interventional2020-01-01Recruiting
An Open-lable, Single Arm, Phase 2 Study of Camrelizumab(SHR-1210) Combined With GEMOX in Patients With Relapsed or Refractory Hodgkin Lymphoma Who Will Receive ASCT [NCT04239170]Phase 284 participants (Anticipated)Interventional2020-01-31Recruiting
Feasibility of Total Neoadjuvant Therapy in Resectable Biliary Adenocarcinoma [NCT04480190]Phase 10 participants (Actual)Interventional2021-02-04Withdrawn(stopped due to Difficulty accruing)
Prospective, Open-label, Multicentric, ph. II Study of R-GemOx and Dexametasone in Patients With Agressive Lymphomas Refractory or Relapsed to Previous Treatment and Non Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplanted [NCT01562977]Phase 282 participants (Actual)Interventional2011-04-30Completed
Adjuvant Chemotherapy in Cell-free Human Papillomavirus Deoxyribonucleic Acid (cfHPV-DNA) Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer (CC) [NCT05764044]Phase 350 participants (Anticipated)Interventional2023-04-01Not yet recruiting
A Phase II Randomized Trial Comparing a Combination of Abraxane and Gemcitabine Versus Gemcitabine Alone as First Line Treatment in Locally Advanced Unresectable Pancreatic Cancer. GAP (Gemcitabine Abraxane Pancreas) Trial [NCT02043730]Phase 2124 participants (Actual)Interventional2014-01-31Completed
Sintilimab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma: a Randomized, Multicenter, Phase 3 Trial [NCT03700476]Phase 3425 participants (Actual)Interventional2018-12-21Active, not recruiting
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine [NCT00480597]Phase 2141 participants (Actual)Interventional2002-10-31Completed
SBRT Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Nasopharyngeal Carcinoma With Oligometastasis: A Prospective, Multicenter, Single-arm, Phase II Clinical Trial [NCT05524168]Phase 241 participants (Anticipated)Interventional2022-11-25Recruiting
A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features [NCT01164228]Phase 287 participants (Actual)Interventional2010-09-17Completed
A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer [NCT00041314]Phase 20 participants Interventional2002-10-04Completed
A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients [NCT00006004]Phase 20 participants Interventional2000-08-22Completed
A Phase II Study of Gemcitabine and Docetaxel in Pancreatic Adenocarcinoma [NCT00003810]Phase 20 participants Interventional1999-08-11Completed
FDG-PET Based Chemotherapy Selection for Metastatic Non-Small Cell Lung Cancer [NCT00564733]Phase 255 participants (Actual)Interventional2007-10-31Completed
A Phase 1b Study of Intratumoral REOLYSIN® in Combination With Gemcitabine and Cisplatin as Neoadjuvant Therapy in Muscle-invasive Transitional Cell Carcinoma of the Bladder [NCT02723838]Phase 10 participants (Actual)Interventional2017-02-28Withdrawn(stopped due to Company has reprioritized clinical plans to focus on later-stage studies.)
[NCT02798510]Phase 3140 participants (Anticipated)Interventional2016-04-30Recruiting
Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy [NCT04258163]760 participants (Actual)Observational2019-01-01Completed
GAIN-1 Study: Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma [NCT01470417]Phase 210 participants (Actual)Interventional2011-10-31Completed
A Randomized, Multicentre, Phase II, Parallel-Group Trial of Vandetanib Monotherapy or Vandetanib in Combination With Gemcitabine Versus Gemcitabine Plus Vandetanib Matching Placebo in Subjects With Advanced Biliary Tract Cancer (Gallbladder Cancer, Cance [NCT00753675]Phase 2174 participants (Actual)Interventional2008-10-31Completed
A Phase III, Multicenter, Randomized Study of ABX Plus Cisplatin (AP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer [NCT02546934]Phase 3254 participants (Anticipated)Interventional2016-03-31Completed
A Phase II Study of Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naïve to Systemic Therapy [NCT00919061]Phase 239 participants (Actual)Interventional2009-08-31Completed
"A Randomized Non-comparative Open-label Phase 1b/2 Study of Nadunolimab in Combination With Gemcitabine Plus Carboplatin in Patients With Advanced Triple Negative Breast Cancer. TRIFOUR Study" [NCT05181462]Phase 1/Phase 2116 participants (Anticipated)Interventional2022-01-11Recruiting
Randomized Controlled Trial Comparing Adjuvant Chemotherapy Vs. no Chemotherapy for Patients With Carcinoma of Gallbladder Undergoing Curative Resection. [NCT02778308]100 participants (Actual)Interventional2012-01-31Completed
Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Ibrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone Followed by Ibrutinib Maintenance in Patients With Refractory/Relapsed Non-GCB Diffuse Large B-cell Lymp [NCT02692248]Phase 262 participants (Actual)Interventional2016-04-07Active, not recruiting
A Dose Escalation Trial of Stereotactic Body Radiotherapy (SBRT) After Induction Chemotherapy for Locally Advanced Pancreatic Cancer [NCT02873598]Phase 114 participants (Actual)Interventional2016-11-17Completed
Sequential High Dose MVAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin), Followed by Gemcitabine Plus Cisplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer [NCT00635726]Phase 241 participants (Actual)Interventional2008-02-29Terminated(stopped due to Due to poor accrual)
Phase 2 Study of Neoadjuvant Modified FOLFIRINOX in Patients With Borderline Resectable Pancreas Adenocarcinoma [NCT02749136]Phase 244 participants (Actual)Interventional2016-05-31Completed
Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer [NCT03724994]180 participants (Anticipated)Observational [Patient Registry]2018-10-30Recruiting
The Efficacy and Safety of Gemcitabine, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (GELAD) With Sandwiched Radiotherapy in the Treatment of Stage IE/II Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study [NCT02733458]52 participants (Actual)Interventional2016-03-31Completed
Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma [NCT02718482]Phase 27 participants (Actual)Interventional2016-04-06Terminated(stopped due to Not adequate enrollment (sample size not possible to reach))
A Phase 1 Study of VS-4718, a Focal Adhesion Kinase Inhibitor, in Combination With Nab-paclitaxel and Gemcitabine in Subjects With Advanced Cancer [NCT02651727]Phase 113 participants (Actual)Interventional2015-09-30Terminated(stopped due to the company's decision to de-prioritize 4718 development)
Phase I/Ⅱ Sturdy on Antiangiogenic Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer [NCT00655785]Phase 1/Phase 217 participants (Actual)Interventional2007-09-30Completed
Phase I Study To Establish Maximum Tolerated Dose (MTD) of Cyberknife in Patients With Un-Resectable Pancreas Cancer (TL002) [NCT02707328]Phase 130 participants (Anticipated)Interventional2015-01-31Terminated(stopped due to Closed after being on administrative hold)
A Randomized, Placebo-controlled, Double-blind Phase III Study of the Effect of First-line Treatment With Intercalated Tarceva Versus Placebo in Combination With Gemcitabine/Platinum on Progression-free Survival in Patients With Stage IIIB/IV Non-small Ce [NCT00883779]Phase 3451 participants (Actual)Interventional2009-04-30Completed
A Randomized Controlled Phase II Study on Intra-arterial Versus Intravenous Chemotherapy Infusion With Gemcitabine and Oxaliplatin for Locally Advanced Pancreatic Cancer [NCT02635971]Phase 2168 participants (Anticipated)Interventional2015-12-31Recruiting
A Multicentre, Open-label Phase II Study of Nab-paclitaxel in Combination With Gemcitabine + Cisplatin as First Line Treatment in Patients With Unresectable Biliary Tract Cancer [NCT02632305]Phase 245 participants (Anticipated)Interventional2016-07-13Recruiting
A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors [NCT00615446]Phase 144 participants (Actual)Interventional2005-03-31Completed
Adjuvant vs. Progression-Triggered Treatment With Gemcitabine After Radical Cystectomy for Locally Advanced Transitional Cell Carcinoma of the Bladder in Patients Not Suitable for Cisplatin-Based Chemotherapy - A Phase 3 Study [NCT00146276]Phase 3178 participants Interventional2000-07-31Recruiting
Clinical Study of Low Dose of Decitabine Combined With Gemcitabine in First-line Treatment of Locally Advanced, Unresectable or Metastatic Pancreatic Cancer [NCT02685228]20 participants (Anticipated)Interventional2016-03-31Not yet recruiting
A 2-part Trial Comparing Overall Survival of Patients With Metastatic Ewing's Sarcoma Treated With Vigil Versus Gemcitabine and Docetaxel and to Determine Safety Profile of Vigil in Combination With Irinotecan and Temozolomide. [NCT02511132]Phase 222 participants (Actual)Interventional2016-02-10Completed
A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies [NCT00649584]Phase 144 participants (Actual)Interventional2008-03-31Terminated(stopped due to Sponsor decision not to enroll cohorts of combined SGN-35 and gemcitabine therapy.)
A Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase 3-beta (GSK-3β) Inhibitor, Combined With Retifanlimab, a PD-1 Inhibitor, Plus Gemcitabine/Nab-Paclitaxel as Frontline Therapy for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY) [NCT05239182]Phase 232 participants (Anticipated)Interventional2022-01-26Active, not recruiting
A Phase 1 Study to Evaluate the Safety and Tolerability of AB680 Combination Therapy in Participants With Gastrointestinal Malignancies [NCT04104672]Phase 1165 participants (Actual)Interventional2019-11-06Active, not recruiting
A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer [NCT03088540]Phase 3712 participants (Actual)Interventional2017-05-29Active, not recruiting
A Phase 1 Study of LY3200882 in Patients With Solid Tumors [NCT02937272]Phase 1223 participants (Anticipated)Interventional2016-11-21Active, not recruiting
Phase I Study of Gemcitabine With Antiangiogenic Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 Derived From VEGFR2 in Patients With Unresectable, Locally Advanced, Recurrent or Metastatic Pancreatic Cancer [NCT00622622]Phase 121 participants (Actual)Interventional2006-11-30Completed
GUided Treatment Based on Mini-PDX in metastaTIc refractOry Triple Negative Breast Cancer(GUMPTION):a Prospective Randomized Controlled Single Center Clinical Trial [NCT04745975]Phase 2100 participants (Anticipated)Interventional2021-02-01Recruiting
Randomized phase2 Study of IP vs. GP as the First-line Therapy Followed by Two Different Sequences as the 2nd or 3rd-line Therapy for Patients With Advanced NSCLC; [NCT01003964]Phase 2289 participants (Actual)Interventional2009-02-28Completed
Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus Gemcitabine HCl in Chemonaive Pancreatic Cancer Patients [NCT00005869]Phase 30 participants Interventional1998-11-30Active, not recruiting
Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy Versus Gemcitabine Alone in Patients With Locally Advanced Pancreatic Cancer [NCT00644618]Phase 3120 participants (Actual)Interventional2003-01-31Completed
[NCT02789189]Phase 260 participants (Anticipated)Interventional2016-06-30Terminated
A Randomized Evaluation of Vinorelbine Versus Gemcitabine for Mobilization of Peripheral Stem Cells in Myeloma Patients Undergoing Autologous Stem Cell Transplantation. [NCT02791373]Phase 2136 participants (Actual)Interventional2014-03-31Completed
A Phase II Trial Of Adjuvant Chemoradiation Following Pancreatic Resection For Adenocarcinomas Of The Pancreas Using 3-D Conformal Radiation With Cisplatin, 5FU, And Alpha-Interferon As Radiosensitizing Agents Followed By Gemcitabine [NCT00660270]Phase 253 participants (Actual)Interventional2002-05-31Completed
P-Gemoxd Regimen Followed by Radiotherapy Versus P-CHOP Regimen Followed by Radiotherapy in ENKTL With Early Stage: a Randomized, Multicenter, Open-label, Phase 2 Study [NCT02918747]Phase 2100 participants (Actual)Interventional2016-09-30Active, not recruiting
Phase I Study Of Oxaliplatin, Gemcitabine And Capecitabine In Advanced Gastrointestinal Malignancies And Other Solid Tumors [NCT00660426]Phase 130 participants (Actual)Interventional2005-03-31Completed
PD-1 Inhibitor and Bevacizumab Replace Cisplatin in Induction, Concurrent, and/or Adjuvant Therapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma. [NCT05341193]Phase 1/Phase 232 participants (Anticipated)Interventional2022-04-30Not yet recruiting
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101) [NCT02393248]Phase 1/Phase 2201 participants (Actual)Interventional2015-02-27Terminated
A Multicentre, Open-label, Randomised, Controlled Study of Target Therapy Based on Tumor Molecular Profiling With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA. [NCT04183712]Phase 2102 participants (Anticipated)Interventional2020-06-01Recruiting
Dynamic Changes of the Serum Level of Immunoglobulin G4(IgG4) and Interleukin-10(IL-10) in the Patients of Pancreatic Cancer After Gemcitabine-based Chemotherapy [NCT02654288]300 participants (Anticipated)Observational2016-01-31Recruiting
Prospectively Randomized Phase III Trial, Studying the Benefits of Adjuvant Sequential vs. Combined Taxane Based Chemotherapy, Followed by Different Biological Treatment Strategies in Early, HER2-positive Breast Cancer [NCT00670878]Phase 3799 participants (Anticipated)Interventional2008-06-30Completed
Liposomal Mitoxantrone Hydrochloride, Gemcitabine, Vinorelbine With or Without Rituximab (GVM±R) in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma [NCT05299164]Phase 124 participants (Anticipated)Interventional2022-05-15Not yet recruiting
A Phase I Combination Study of AZD2281 and Cisplatin Plus Gemcitabine in Adults With Solid Tumors [NCT00678132]Phase 123 participants (Actual)Interventional2008-04-24Completed
IGEV +/- Bortezomib (Velcade) as Induction Before High Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma After First Line Treatment: a Randomized Phase II Trial. On Behalf of Intergruppo Italiano Linfomi [NCT00636311]Phase 213 participants (Actual)Interventional2008-02-29Completed
A Multicenter Study of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as First-line Therapy in Patients (Pts) With Metastatic Pancreatic Cancer: PAAG. [NCT05493995]Phase 266 participants (Anticipated)Interventional2022-06-01Recruiting
A Randomized, Placebo-controlled, Blinded Phase II Study of Huachansu & Gemcitabine in Pancreatic Cancer [NCT00837239]Phase 280 participants (Actual)Interventional2007-06-30Completed
Phase I Study of Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer [NCT02546531]Phase 143 participants (Actual)Interventional2016-02-03Completed
Phase II Trial of Intravesical Gemcitabine in Patients With Nonmuscle Invasive Bladder Cancer With or Without Prior Bacillus Calmette-Guérin Therapy [NCT05644041]Phase 225 participants (Anticipated)Interventional2023-03-01Recruiting
A Phase 1 Study of SRF617 in Patients With Advanced Solid Tumors [NCT04336098]Phase 185 participants (Actual)Interventional2020-03-16Completed
A Randomized Phase II Trial of Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma [NCT02879318]Phase 2180 participants (Actual)Interventional2016-11-07Active, not recruiting
Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) in Japanese Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A Phase 1/2, Open-Label, Dose-Escalation Trial With Expansion Cohorts [NCT04542824]Phase 1/Phase 2102 participants (Anticipated)Interventional2020-08-20Active, not recruiting
Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy [NCT01104350]Phase 119 participants (Actual)Interventional2010-04-30Active, not recruiting
Randomized Phase III Trial Comparing Vinorelbine vs. Gemcitabine Plus Vinorelbine in Patients With Advanced Breast Cancer, Previously Treated With Anthracyclines and Taxanes [NCT00128310]Phase 3252 participants (Actual)Interventional2001-01-18Completed
A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma [NCT00881387]Phase 20 participants (Actual)Interventional2009-02-28Withdrawn
Phase II Study of Neoadjuvant Durvalumab (MEDI4736) and Tremelimumab in Combination With Gemcitabine and Cisplatin in Patients With Intrahepatic Cholangiocarcinoma That is Borderline Resectable/Resectable But With High Risk for Recurrence. [NCT06017297]Phase 228 participants (Anticipated)Interventional2024-01-31Recruiting
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in [NCT05382299]Phase 3540 participants (Anticipated)Interventional2022-07-20Recruiting
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Who [NCT05382286]Phase 3440 participants (Anticipated)Interventional2022-07-25Recruiting
A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003) [NCT05139017]Phase 2/Phase 3420 participants (Anticipated)Interventional2022-01-14Recruiting
A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors [NCT05007106]Phase 2610 participants (Anticipated)Interventional2021-09-16Recruiting
Discovery of Molecular Biomarkers for Predicting Response Through RNA Sequencing in Patients With Advanced Biliary Tract Cancer Who Received Nab-paclitaxel Plus Gemcitabine-cisplatin [NCT04871321]120 participants (Anticipated)Observational [Patient Registry]2021-04-14Recruiting
A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II [NCT04832854]Phase 250 participants (Actual)Interventional2021-04-23Active, not recruiting
A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma [NCT04003636]Phase 31,069 participants (Actual)Interventional2019-09-24Active, not recruiting
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Treatment Combinations In Patients With Metastatic Breast Cancer (Morpheus-panBC) [NCT03424005]Phase 1/Phase 2242 participants (Anticipated)Interventional2018-04-02Recruiting
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage [NCT02516241]Phase 31,126 participants (Actual)Interventional2015-11-02Active, not recruiting
mFOLFIRINOX or Gemcitabine / Nab-paclitaxel Followed by Pancreatectomy for Patients With Borderline Resectable Pancreatic Adenocarcinoma. A Pilot Feasibility Study. [NCT04452461]Phase 230 participants (Anticipated)Interventional2021-03-01Recruiting
A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy [NCT06081959]Phase 3376 participants (Anticipated)Interventional2023-11-30Not yet recruiting
A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors [NCT03440450]Phase 190 participants (Anticipated)Interventional2018-03-22Recruiting
Phase II Study of Nab-Paclitaxel in Combination With Gemcitabine for Treatment of Recurrent/Refractory Sarcoma in Teenagers and Young Adults [NCT02945800]Phase 272 participants (Anticipated)Interventional2016-10-25Recruiting
A Multinational, Randomized, Phase II Study of the Combination of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab, an IL-6R Inhibitor, as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Cancer. [NCT02767557]Phase 2147 participants (Actual)Interventional2017-01-26Completed
A Phase I Study of Hepatic Arterial Infusion (HAI) of Abraxane in Combination With Gemcitabine and Bevacizumab for Patients With Advanced Cancers Metastatic to the Liver [NCT01057264]Phase 178 participants (Actual)Interventional2010-01-31Completed
A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma [NCT00523640]Phase 230 participants (Actual)Interventional2005-03-31Terminated(stopped due to Too slow accrual)
Phase II Trial of the Effect of Gemcitabine With Intravenous Omega-3 Fish Oil Infusion in Patients With Unresectable Pancreatic Adenocarcinoma [NCT01019382]Phase 250 participants (Actual)Interventional2009-10-31Completed
A Phase 1 Study of Veliparib in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors [NCT01063816]Phase 179 participants (Actual)Interventional2010-01-31Completed
A Phase II Study of Abraxane, Avastin and Gemcitabine for First Line Metastatic Breast Cancer [NCT00503906]Phase 230 participants (Actual)Interventional2007-06-30Completed
A Phase I/II Study of Induction Conatumumab and Gemcitabine, Followed by Conatumumab, Capecitabine and 3-D Conformal Radiation Therapy (3D-CRT) With Subsequent Maintenance Therapy for Locally Advanced Pancreatic Cancer [NCT01017822]Phase 1/Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to This study was withdrawn due to study agent availability.)
Phase II Prospective Study Evaluating the Role of Personalized Chemotherapy Regimens for Chemo-Naive Select Stage IIIB and IV Non-Small Cell Lung Cancer (NSCLC) in Patients Using a Genomic Predictor of Platinum Resistance to Guide Therapy [NCT00509366]Phase 2101 participants (Actual)Interventional2007-05-31Terminated(stopped due to Study terminated due to reproducibility issues with genomics prediction model.)
A Phase 1b, Parallel Arm, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Two Different Chemotherapy Regimens in Women With Platinum Resistant or Platinum Sensitive Ovarian Cancer [NCT01016054]Phase 14 participants (Actual)Interventional2009-10-31Terminated(stopped due to Trial was terminated to allow sponsors to evaluate the future development of the drug program)
Phase 2, Randomized, Double Blind, Placebo-Controlled Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 For Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Advanced Non-Small Cell Lung Cancer Already Receiv [NCT00413283]Phase 263 participants (Actual)Interventional2006-12-31Completed
Phase I Trial of Everolimus, Gemcitabine, and Cisplatin for Patients With Solid Tumors Refractory to Standard Therapy [NCT00949949]Phase 138 participants (Actual)Interventional2009-09-30Completed
A Randomized Phase II Trial of Pemetrexed/Gemcitabine/Bevacizumab or Pemetrexed/Carboplatin/Bevacizumab in the First-Line Treatment of Elderly Patients With Advanced Non-Small Cell Lung Cancer [NCT00456261]Phase 2110 participants (Actual)Interventional2007-03-31Completed
Phase 1, Dose Escalation Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer [NCT00560573]Phase 146 participants (Actual)Interventional2007-11-30Completed
Multicentric Phase I/II Study for the Efficacy of a Combination of Rituximab, Gemcitabine and Oxaliplatin in Relapsed/Refractory Indolent Lymphoma [NCT00954005]Phase 1/Phase 256 participants (Actual)Interventional2003-01-31Terminated(stopped due to Predefined termination criterion of > 10 patients without CR or PR was matched.)
Phase II Study of Adjuvant Gemcitabine Started One Week After Laparoscopic [NCT01045941]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to The study was never initiated)
A Phase II Randomized Study of Induction Chemotherapy Followed by Concurrent Chemo-radiotherapy in Locally Advanced Pancreatic Cancer [NCT01063192]Phase 273 participants (Anticipated)Interventional2009-11-30Enrolling by invitation
A Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer [NCT00383331]Phase 219 participants (Actual)Interventional2007-02-28Terminated(stopped due to Trial was stopped early due to low enrollment)
A Randomized Phase II Study of Two Chemotherapy Regimens, Pemetrexed-Carboplatin, and Gemcitabine-Vinorelbine, in Anthracycline and Taxanes Pretreated Advanced Breast Cancer Patients [NCT00325234]Phase 2135 participants (Actual)Interventional2006-06-30Completed
A Phase II, Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer [NCT00378573]Phase 217 participants (Actual)Interventional2007-01-31Terminated(stopped due to Incidence of GI Perforation)
Gemcitabine Plus Oxaliplatin (GEMOX) Versus Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma(HCC) [NCT02534337]Phase 2/Phase 30 participants (Actual)Interventional2015-09-30Withdrawn(stopped due to It doesn't meet the requirements of randomized trials)
Phase 2 Trial of Pegaspargase-Gemox Chemotherapy in Newly Diagnosed, Nasal Type, Extranodal Natural Killer/T-cell Lymphoma [NCT02533323]Phase 250 participants (Actual)Interventional2012-01-31Terminated
Phase II Multi-Institutional Study to Evaluate the Efficacy of Gemcitabine and Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma [NCT01146054]Phase 259 participants (Actual)Interventional2009-10-31Completed
A Phase 1b Study of LY2157299 in Combination With Gemcitabine in Patients With Advanced or Metastatic Unresectable Pancreatic Cancer [NCT02154646]Phase 16 participants (Actual)Interventional2014-05-31Completed
09.017 - A Phase I Study of Tolfenamic Acid With Gemcitabine and Radiation in Patients With Locally Advanced or Metastatic Pancreatic Cancer Requiring Definitive or Palliative Radiation Therapy [NCT02159248]Phase 10 participants (Actual)Interventional2014-03-31Withdrawn(stopped due to The study closed prior to enrolling any participants.)
Phase I/II Trial of Bacillus Calmette-Guérin (BCG) and Intravesical Gemcitabine for Patients With BCG-Relapsing High-Grade Non-Muscle Invasive Bladder Cancer [NCT04179162]Phase 1/Phase 268 participants (Anticipated)Interventional2019-11-22Recruiting
A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors [NCT04083599]Phase 1/Phase 21,287 participants (Anticipated)Interventional2019-09-17Recruiting
A Phase 3, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of Either Cisplatin or Carboplatin +Gemcitabine + Tislelizumab Compared With Either Cisplatin or Carboplatin + Gemcitabine + Placebo as First-line Treatment for Patients With Loca [NCT03967977]Phase 3420 participants (Anticipated)Interventional2019-05-29Recruiting
A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Sma [NCT03164616]Phase 31,186 participants (Actual)Interventional2017-06-01Active, not recruiting
Phase II Study of Nanoparticle Albumin-bound Paclitaxel Plus Gemcitabine as First-line Therapy for the Treatment of Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma [NCT02887248]Phase 23 participants (Actual)Interventional2017-01-12Terminated(stopped due to Enrollment issues)
Phase 1 Dose Escalation and Expansion Cohort of Carboplatin and Gemcitabine With or Without M6620 (VX-970) in First or Second Recurrence Platinum-Sensitive Epithelial Ovarian, Peritoneal, and Fallopian Tube Cancer [NCT02627443]Phase 131 participants (Anticipated)Interventional2017-05-16Active, not recruiting
Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma (ACTICCA-1 Trial) [NCT02170090]Phase 3789 participants (Actual)Interventional2014-04-30Active, not recruiting
A Phase II Trial of Preoperative FOLFIRINOX Followed by Gemcitabine Based Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma [NCT01897454]Phase 223 participants (Actual)Interventional2012-01-27Terminated(stopped due to Study was terminated due to slower than anticipated accrual)
Phase II Trial Evaluating Efficacy of a Strategy Employing Combination Gemcitabine and Carboplatin Chemotherapy Followed by EBV-Specific Cytotoxic T-Lymphocytes in Patients With Metastatic or Locally Recurrent EBV-Positive Nasopharyngeal Carcinoma [NCT00690872]Phase 235 participants (Anticipated)Interventional2008-07-31Recruiting
A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer [NCT00622349]Phase 3707 participants (Actual)Interventional2004-02-29Completed
Phase II Study for Inoperable Non-Metastatic Pancreatic Cancer (Stage IVA) With Neoadjuvant Gemzar, Taxotere and Xeloda (GTX), and Radiation With Gemzar [NCT00869258]Phase 232 participants (Actual)Interventional2005-06-30Completed
A Single-arm, Single-center, Exploratory Study of Adbelizumab Combined With Chemotherapy for Neoadjuvant Therapy in Resectable Pancreatic Cancer [NCT06177522]Phase 230 participants (Anticipated)Interventional2023-12-31Recruiting
A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas [NCT00844649]Phase 3861 participants (Actual)Interventional2009-03-01Completed
SHR- 1210 Combined With Paclitaxel (Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer [NCT04181645]20 participants (Anticipated)Interventional2019-06-29Recruiting
A Phase I Adaptive Design Trial of Talazoparib in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors [NCT02537561]Phase 10 participants (Actual)Interventional2015-12-31Withdrawn(stopped due to The pharmaceutical company did not want to follow through with support for the study.)
A Phase Ib, Open-label, Multicenter, Dose-escalation, Safety and Tolerability Study of LDE225 in Combination With Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma [NCT01487785]Phase 118 participants (Actual)Interventional2012-03-31Completed
Oxaliplatin (Eloxatin®) Plus Gemcitabine as First or Second-line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial [NCT00859469]Phase 229 participants (Actual)Interventional2004-04-30Completed
A Phase II Study of Adjuvant Gemcitabine/Capecitabine and Bevacizumab for Patients Treated Neoadjuvantly Chemotherapy for Early Stage Breast Cancer With High Risk for Relapse [NCT00462865]Phase 218 participants (Actual)Interventional2007-11-30Terminated(stopped due to DSMB determined toxicity of regimen more than originally thought. Slow accrual.)
An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer [NCT05500092]Phase 252 participants (Anticipated)Interventional2023-01-25Recruiting
A Multi-center, Single-arm, Open Label Study to Assess the Efficacy and Safety of Anti-PD-1 Antibody (Penpulimab) Plus Lenalidomide, Rituximab, Gemcitabine and Oxaliplatin (R2-GemOx) in Patients With Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLB [NCT05186558]Phase 254 participants (Anticipated)Interventional2022-05-15Not yet recruiting
A Single-arm Phase II Study of Envafolimab Combined With Endostar and Nab-paclitaxel Plus Gemcitabine for First-line Treatment of Advanced Pancreatic Cancer [NCT05298020]Phase 220 participants (Anticipated)Interventional2022-04-01Not yet recruiting
Randomized, Controlled Study of the Safety and Efficacy of D-CIK Immune Cell Combined With Chemotherapy for Non-Small Cell Lung Cancer [NCT02651441]Phase 1/Phase 260 participants (Anticipated)Interventional2016-02-29Recruiting
Efficacy and Safety Study of TA(E)C-GP Versus A(E)C-T for the High Risk Triple-negative Breast Cancer Patients Predicted by the Messenger RNA (mRNA)-Long Non-coding RNA (lncRNA) Signature and Validation of the Signature's Efficacy [NCT02641847]Phase 2/Phase 3503 participants (Anticipated)Interventional2015-07-31Recruiting
Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study [NCT00744640]Phase 1/Phase 246 participants (Actual)Interventional2005-10-31Completed
Phase II, Randomised, Double-blind, Two-arm, Parallel Study of Vandetanib (ZACTIMA™ , ZD6474) Plus Gemcitabine (Gemzar® ) or Gemcitabine Plus Placebo as First Line Treatment of Advanced (Stage IIIB or IV) Non Small Cell Lung Cancer (NSCLC) Elderly Patient [NCT00753714]Phase 2124 participants (Actual)Interventional2008-10-31Completed
A Clinical Study of Adoptive Cellular Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen in Treating Patients With Advanced Malignant Tumor of Biliary Tract [NCT02632019]Phase 1/Phase 240 participants (Anticipated)Interventional2015-09-30Recruiting
The Efficacy of Sequential Intravesical Gemcitabine and Docetaxel Therapy (GEM/DOCE) in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer (NMIBC) [NCT05671900]70 participants (Anticipated)Interventional2020-04-01Active, not recruiting
An Open Label Phase I Study of Gemcitabine/Oxaliplatin (GEMOX) and Vandetanib (ZACTIMA; ZD6474) Combination in Patients With Advanced Solid Malignancy (IRUSZACT0070) (UPCI 07-025) [NCT00660725]Phase 122 participants (Actual)Interventional2009-02-28Completed
Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma [NCT00821327]Phase 236 participants (Actual)Interventional2008-08-31Completed
Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer [NCT00345059]Phase 384 participants (Actual)Interventional2005-05-31Terminated(stopped due to slow accrual)
Prospective Non-inferiority Randomized Trial Comparing Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation and Traditional Clinical Target Volume in Radiotherapy for Nasopharyngeal Carcinoma [NCT02627807]386 participants (Actual)Interventional2015-12-31Active, not recruiting
A Phase I, Open-label, Study of the Safety, Tolerability and Pharmacokinetics of Pazopanib in Combination With Gemcitabine and Gemcitabine Plus Cisplatin for Advanced Solid Tumors [NCT00678977]Phase 122 participants (Actual)Interventional2008-04-03Completed
Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Cilengitide Regimens in Combination With Cetuximab and Platinum-based Chemotherapy (Cisplatin/Vinorelbine or Cisplatin/Gemcitabine) Compared to Cetuximab and Platinum-based Che [NCT00842712]Phase 2232 participants (Actual)Interventional2009-02-28Completed
AdvanTIG-211: A Randomized, Double-blind, Placebo-controlled, Phase II Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118) Combined With Tislelizumab (VDT482) Plus Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Chemotherapy as F [NCT05809895]Phase 20 participants (Actual)Interventional2023-09-15Withdrawn(stopped due to Business decision, not driven by safety concerns; no new safety signals have been observed in the ociperlimab program.)
Evaluating the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for First-line Treatment of Patient With Advanced Endometrial Cancer or Sarcoma of Uterus: a Multi-center, Open-label, Randomized Control [NCT05481645]Phase 279 participants (Anticipated)Interventional2022-08-22Recruiting
Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma [NCT04557020]Phase 3200 participants (Anticipated)Interventional2020-12-30Recruiting
A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer [NCT00922896]Phase 222 participants (Actual)Interventional2009-06-30Completed
An Open Labeled Phase 2 Study of Gemcitabine in Combination With Cisplatin, 5-FU (24h CI) and Folinic Acid in Patients With Inoperable Esophageal Cancer [NCT00759226]Phase 292 participants (Actual)Interventional2002-07-31Completed
A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma [NCT00733746]Phase 2123 participants (Actual)Interventional2009-04-30Completed
A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC) [NCT00589667]Phase 226 participants (Actual)Interventional2006-09-30Completed
OGF & Gemcitabine: Novel Treatment for Pancreatic Cancer Phase I, A Safety and Toxicity Study [NCT00783172]Phase 14 participants (Actual)Interventional2009-01-31Terminated(stopped due to Problems with IRB)
Phase II ERCC1 and RRM1-Based Adjuvant Therapy Trial in Patients With Stage I Non-Small Cell Lung Cancer (NSCLC) [NCT00792701]Phase 285 participants (Actual)Interventional2008-11-30Completed
Phase I Study of PF-00477736 With Gemcitabine In Patients With Advanced Solid Malignancies [NCT00437203]Phase 143 participants (Actual)Interventional2006-12-31Terminated(stopped due to See termination reason in detailed description.)
Explore the Efficacy and Safety of Sintilimab Plus Bevacizumab Combined With Gemcitabine and Albumin-paclitaxel (AG Regimen) in First-line Treatment of Initial Unresectable Gallbladder Cancer: a Phase II Clinical Study [NCT05757336]Phase 250 participants (Anticipated)Interventional2022-12-22Recruiting
A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma [NCT00820898]Phase 224 participants (Actual)Interventional2009-02-28Completed
Phase II Study of Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma [NCT00714948]Phase 22 participants (Actual)Interventional2008-07-31Terminated(stopped due to Lack of accrual)
A Phase I Study Evaluating the Safety and Efficacy of TGR 1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors [NCT02574663]Phase 166 participants (Actual)Interventional2015-09-11Completed
Phase II Trial of Paricalcitol and Hydroxychloroquine (PH) Combination With Gemcitabine and Nab-Paclitaxel in Advanced or Metastatic Pancreatic Cancer [NCT04524702]Phase 221 participants (Anticipated)Interventional2020-09-14Recruiting
Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma [NCT00588666]Phase 251 participants (Actual)Interventional2006-05-31Completed
Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin Compared With Gemcitabine +Cisplatin as First-line Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer: A Randomized, Controlled, Multicenter Phase II Clinical [NCT04300959]Phase 280 participants (Anticipated)Interventional2020-01-01Recruiting
[NCT02707315]Early Phase 115 participants (Anticipated)Interventional2013-01-31Recruiting
A Phase II Protocol in Borderline Resectable Pancreatic Cancer Using Gemcitabine/Docetaxel Chemotherapy and An Oxaliplatin-Based Chemoradiation. [NCT00761241]Phase 240 participants (Anticipated)Interventional2008-09-30Completed
Outpatient Chemotherapy in Pediatric Osteosarcoma: Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy [NCT00673179]7 participants (Actual)Interventional2008-05-31Terminated(stopped due to Low accrual.)
Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX) [NCT00996333]Phase 246 participants (Actual)Interventional2003-06-30Completed
Phase I Sturdy on Antiangiogenic Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer [NCT00639925]Phase 15 participants (Actual)Interventional2007-03-31Active, not recruiting
High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic Cell Support for Patients With Relapsed/Refractory Hodgkin's Disease [NCT01200329]Phase 281 participants (Actual)Interventional2011-06-30Completed
Phase II Trial Of Induction Gemcitabine/CPT-11 Followed By Twice-Weekly Infusion Gemcitabine And Concurrent External Beam Radiation For The Treatment Of Locally Advanced Pancreatic Cancer [NCT00025168]Phase 220 participants (Actual)Interventional2001-11-01Completed
Cancer Stem Cells and Inhibition of Hedgehog Pathway Signaling in Advanced Pancreas Cancer: A Pilot Study of GDC-0449 in Combination With Gemcitabine [NCT01195415]Phase 225 participants (Actual)Interventional2010-06-30Completed
Systemic Chemotherapy Combined With Thoracic Cavity Perfusion of Recombinant Human Adenovirus Type 5 and Endostatin Injections Versus Cisplatin for Treatment Malignant Hydrothorax in Non Small Cell Lung Cancer (NSCLC) Patients: A Multi-center, Randomized, [NCT02579564]Phase 3134 participants (Anticipated)Interventional2016-10-31Not yet recruiting
A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT) [NCT00785421]Phase 2/Phase 3312 participants (Actual)Interventional2004-04-30Completed
Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC) [NCT00030433]Phase 285 participants (Actual)Interventional2002-01-31Completed
Phase II Trial Of Adjuvant 2'2'-Difluoro-2'-Deoxycytidine (Gemcitabine) And External Beam Radiation For The Treatment Of Resectable Pancreatic Cancer [NCT00010166]Phase 226 participants (Actual)Interventional2000-12-01Completed
An Open-Label, Multicenter Phase 1/2 Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors [NCT05093322]Phase 1/Phase 213 participants (Actual)Interventional2021-11-30Active, not recruiting
A Phase II Trial of Pre-operative Chemotherapy (With Gemcitabine and Nab- Paclitaxel) and Stereotactic Body Radiotherapy Followed by Surgery and Chemotherapy in Patients With Resectable Pancreatic Adenocarcinoma [NCT03492671]Phase 230 participants (Anticipated)Interventional2019-07-17Recruiting
Phase 2 Trial of PEG-ASP Combined With Etoposide and Gemcitabine (PEG) as First-line Chemotherapy to Treat NK/T-cell Lymphoma [NCT02705508]Phase 235 participants (Anticipated)Interventional2016-02-29Recruiting
A Feasibility Phase II Study of Gemcitabine With Docetaxel With Concurrent 3-D Conformal Radiation Plus Continuous Infusion 5-Fluorouracil in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers [NCT00660699]Phase 250 participants (Actual)Interventional2002-09-30Completed
A Multicenter, Randomized Phase II Trial of Vinflunine/Gemcitabine vs Carboplatin/Gemcitabine as First Line Treatment in Patients With Metastatic Urothelial Carcinoma Unfit for Cisplatin Based Chemotherapy Due to Impaired Renal Function. [NCT02665039]Phase 262 participants (Actual)Interventional2014-04-30Completed
Phase I/II Study of the Combination Therapy With NC-6004 and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer in Asian Countries [NCT00910741]Phase 1/Phase 240 participants (Actual)Interventional2009-05-31Completed
Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy [NCT01121406]Phase 2110 participants (Actual)Interventional2010-04-30Completed
Randomized Phase 3 Trial Comparing FOLFOX to Gemcitabine in Metastatic First-line in Patients With Pancreatic Adenocarcinoma and Non-fit for FOLFIRINOX [NCT04167007]Phase 3400 participants (Anticipated)Interventional2020-07-20Recruiting
Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-doxorubicin-paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer [NCT00128856]Phase 246 participants (Actual)Interventional2003-03-31Completed
Biomarker-oriented Study of Pembrolizumab in Combination With Chemotherapy in Chemotherapy -naïve Advanced Pancreatic Cancer [NCT04447092]Phase 277 participants (Anticipated)Interventional2020-07-01Active, not recruiting
Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors [NCT04306900]Phase 1185 participants (Anticipated)Interventional2020-03-30Active, not recruiting
Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepat [NCT02807181]Phase 2/Phase 389 participants (Actual)Interventional2017-01-31Completed
A Phase II Trial of Biweekly Gemcitabine, Paclitaxel, and Avastin as Frontline Therapy for Metastatic Breast Cancer [NCT00618826]Phase 214 participants (Actual)Interventional2006-11-30Completed
PhaseⅡ Study of Weekly Docetaxel and Fixed-Dose Rate Gemcitabine in Patient With Previously Treated Advanced Soft Tissue and Bone Sarcoma Prospective, Open Label, Multi-Institutional [NCT00807261]Phase 230 participants (Anticipated)Interventional2008-09-30Enrolling by invitation
A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection Plus Gemcitabine (G+K) Versus Gemcitabine in Patients With Advanced Pancreatic Cancer [NCT00733850]Phase 285 participants (Actual)Interventional2008-08-31Completed
Phase II Study Of Neoadjuvant Chemotherapy With Gemcitabine, Oxaliplatin And Erlotinib (Gemoxt) In Borderline Resectable Pancreatic Adenocarcinoma [NCT00728000]Phase 20 participants (Actual)Interventional2008-08-31Withdrawn(stopped due to study withdrawn due to lack of enrollment)
Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer [NCT06017284]Phase 3100 participants (Anticipated)Interventional2023-11-01Recruiting
Improvement of Outcome in Elderly Patients or Patients Not Eligible for High-dose Chemotherapy With Aggressive NHL in First Relapse/Progression by Adding Nivolumab to Gemcitabine, Oxaliplatin Plus Rituximab in Case of B-cell Lymphoma [NCT03366272]Phase 2/Phase 3348 participants (Actual)Interventional2017-12-05Active, not recruiting
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) [NCT03193190]Phase 1/Phase 2340 participants (Anticipated)Interventional2017-07-05Active, not recruiting
Biomarker-oriented Study of Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer [NCT03046862]Phase 231 participants (Actual)Interventional2017-02-25Active, not recruiting
A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer [NCT02446600]Phase 3579 participants (Actual)Interventional2016-03-28Active, not recruiting
Genotype-driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy [NCT00736814]Phase 2117 participants (Anticipated)Interventional2008-06-30Recruiting
A Phase Ib Study of SGN-40 in Combination With Rituximab and Gemcitabine for the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) [NCT00655837]Phase 133 participants (Actual)Interventional2008-04-30Completed
A Phase 1 Dose Escalation Study of ARQ 197 Administered in Combination With Gemcitabine in Adult Patients With Advanced Solid Tumors [NCT00874042]Phase 174 participants (Actual)Interventional2009-03-31Completed
Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer [NCT00881296]Phase 260 participants (Actual)Interventional2008-03-31Completed
A Phase II Study of Gemcitabine and Erlotinib Plus Sorafenib (GES) in Metastatic Pancreatic Cancer [NCT00696696]Phase 245 participants (Actual)Interventional2007-09-30Completed
A Pilot Study of Gemcitabine, Nab-Paclitaxel, Cisplatin and Anakinra Treatment on Patients With Resectable or Potentially Resectable Pancreatic Adenocarcinoma (PDAC) [NCT02550327]Early Phase 120 participants (Actual)Interventional2016-01-31Completed
A Phase 1b Study of Pembrolizumab (KEYTRUDA®) in Combination With REOLYSIN® (Pelareorep) and Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma [NCT02620423]Phase 111 participants (Actual)Interventional2015-12-31Completed
Neoadjuvant Chemotherapy Plus Nephroureterectomy for Locally Advanced Upper Tract Transitional Cell Cancer [NCT00696007]Phase 20 participants (Actual)Interventional2008-04-30Withdrawn(stopped due to Study was unable to recruit subjects meeting the study requirements.)
Multicenter Retrospective Analysis for Efficacy and Safety of Second-Line Nab-Paclitaxel Plus Gemcitabine After Progression on 1st-line FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma [NCT04133155]103 participants (Actual)Observational2019-09-16Completed
Randomized Phase II Study of Gemcitabine (GEM) Versus GEM+TS-1 for Advanced Pancreatic Cancer [NCT00514163]Phase 2110 participants (Anticipated)Interventional2007-06-30Completed
Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan [NCT02777788]Phase 2/Phase 3120 participants (Anticipated)Interventional2014-09-30Active, not recruiting
A Randomized, Open-label Study of the Effect of First Line Treatment With Tarceva in Sequential Combination With Gemcitabine, Compared to Gemcitabine Monotherapy, on Progression-free Survival in Elderly or ECOG PS of 2 Patients With Advanced Non-small Cel [NCT00940875]Phase 254 participants (Actual)Interventional2009-06-30Terminated(stopped due to Study was stopped due to slower than expected recruitment.)
Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer [NCT00907504]Phase 30 participants (Actual)Interventional2010-07-31Withdrawn
Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer [NCT00366457]Phase 232 participants (Actual)Interventional2006-08-31Completed
A Phase I/II Study of Combination Therapy of CG200745 PPA With Gemcitabine and Erlotinib to Determine the Maximum Tolerated Dose (MTD) and Evaluate the Safety and Efficacy for Locally Advanced Unresectable, or Metastatic Pancreatic Cancer [NCT02737228]Phase 1/Phase 224 participants (Anticipated)Interventional2016-03-31Active, not recruiting
[NCT00832689]Phase 239 participants (Actual)Interventional2008-06-30Completed
Phase II Study of Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer [NCT00847015]Phase 218 participants (Actual)Interventional2009-02-28Completed
Open-label Multicenter Multiple Ascending Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Quisinostat, a Histone Deacetylase Inhibitor, in Combination With Gemcitabine + Cisplatin Chemotherapy (Second Line for Patients With Non-small C [NCT02728492]Phase 151 participants (Actual)Interventional2013-08-31Completed
A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer [NCT00574275]Phase 3546 participants (Actual)Interventional2007-12-31Terminated(stopped due to Data Monitoring Committee concluded after a planned interim analysis that aflibercept added to gemcitabine would be unable to demonstrate improved survival)
A Phase Ⅱ Single-arm, Open-labelled, Multi-center, Clinical Trial of Gemcitabine Combined With Eribulin for the Treatment of Second-line and Above in Patients With Recurrent HER2 Negative Breast Cancer [NCT05263882]Phase 258 participants (Anticipated)Interventional2022-03-31Not yet recruiting
AN OPEN-LABEL, PHASE 1 STUDY OF R-CVP OR R-GDP IN COMBINATION WITH INOTUZUMAB OZOGAMICIN IN SUBJECTS WITH CD22-POSTIVE NON-HODGKIN'S LYMPHOMA [NCT01055496]Phase 1103 participants (Actual)Interventional2010-03-31Completed
Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer [NCT00193414]Phase 272 participants (Actual)Interventional2005-05-31Completed
Trials of Primary Excision Combined With Preoperative Neoadjuvant Therapy and Adjuvant Therapy Was Used as a First-line Comprehensive Therapy for Oligometastasis of Urothelial Carcinoma(UC). [NCT04570410]Phase 215 participants (Anticipated)Interventional2020-10-01Recruiting
An Open-label, Multicenter, Randomized, Phase 2 Study of a Recombinant Human Anti-VEGFR-2 Monoclonal Antibody, IMC-1121B in Combination With Platinum-based Chemotherapy Versus Platinum-based Chemotherapy Alone as First-line Treatment of Patients With Recu [NCT01160744]Phase 2280 participants (Actual)Interventional2010-09-30Completed
A Phase II Study of Gemzar, Taxotere, and Xeloda (GTX) for Adjuvant Pancreatic Cancer [NCT00882310]Phase 237 participants (Actual)Interventional2006-09-30Completed
Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic [NCT00550004]Phase 2153 participants (Anticipated)Interventional2007-09-30Terminated
A Phase I Study of Gemcitabine, Capecitabine and ZD6474 (ZACTIMA) in Patients With Advanced Solid Tumors With an Expanded Cohort of Patients With Biliary or Pancreatic Malignancies. [NCT00551096]Phase 123 participants (Actual)Interventional2007-10-31Completed
A Phase II Study of the Association of Glivec® (Imatinib Mesylate, Formerly Known as STI 571) Plus Gemzar® (Gemcitabine) in Patients With Unresectable, Refractory, Malignant Mesothelioma Expressing Either PDGFR-Beta or C-Kit [NCT00551252]Phase 256 participants (Anticipated)Interventional2008-01-31Not yet recruiting
Phase II Study of the Response Rate of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small Cell Lung Cancer Before Surgery [NCT00563160]Phase 250 participants (Anticipated)Interventional2005-05-31Recruiting
Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy. [NCT01850303]Phase 3632 participants (Actual)Interventional2013-05-16Completed
Phase I Study of Combination of SOM 230 Long Acting Release (LAR) + Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer [NCT01385956]Phase 120 participants (Actual)Interventional2011-06-30Completed
Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer [NCT00361231]Phase 235 participants (Actual)Interventional2006-05-31Completed
PROVE A Randomized Phase II Trial of Standard Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer [NCT01388621]Phase 2140 participants (Anticipated)Interventional2011-10-31Recruiting
Phase II, Open-label, Randomized Clinical Trial of Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX) Versus GEMOX Alone as First Line Treatment in Advanced Biliary Tract Adenocarcinoma [NCT01389414]Phase 289 participants (Actual)Interventional2010-05-31Completed
Phase II Study Open, Not Randomized to Evaluate the Efficacy and Safety of Neoadjuvant Treatment With Gemcitabine and Erlotinib Followed by Gemcitabine, Erlotinib and Radiotherapy in Patients With Resectable Pancreatic Adenocarcinoma [NCT01389440]Phase 224 participants (Actual)Interventional2011-05-31Completed
A Randomized, Open-label, Multi-center Phase III Study of Erlotinib Versus Gemcitabine/Carboplatin in Chemo-naive Stage IIIB/IV Non-Small Cell Lung Cancer Patients With EGFR Exon 19 or 21 Mutation (Optimal) [NCT00874419]Phase 3165 participants (Actual)Interventional2008-08-31Completed
Phase Ⅱ Trial of Fixed Dose Rate Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Capecitabine in Patients With Locally Advanced Pancreatic Cancer [NCT01396668]Phase 235 participants (Anticipated)Interventional2004-12-31Completed
Phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer [NCT01396681]Phase 270 participants (Anticipated)Interventional2004-12-31Completed
A Phase II Study Combining PEGPH20 With Concurrent Gemcitabine and Radiotherapy in Patients With Localized, Unresectable Pancreatic Adenocarcinoma [NCT02910882]Phase 24 participants (Actual)Interventional2017-01-03Terminated(stopped due to Safety)
A Multicenter, Open-label, ExploRatory Platform Trial to EValuate ImmunOtherapy Combinations With Chemotherapy for the Treatment of Patients With PreviousLy UnTreated MetastatIc Pancreatic AdenOcarciNoma (REVOLUTION) [NCT04787991]Phase 145 participants (Anticipated)Interventional2021-08-09Active, not recruiting
Neoadjuvant Chemotherapy in Upper Tract Urothelial Cancer: A Multicentre, Feasibility Pilot Trial [NCT04574960]Phase 314 participants (Anticipated)Interventional2021-02-08Recruiting
A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment With Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB [NCT03456063]Phase 3453 participants (Actual)Interventional2018-04-24Active, not recruiting
A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HMPL-453 (FGFR Inhibitor) Combined With Chemotherapy or Anti-PD-1 Antibody in Patients With Advanced Solid Tumors [NCT05173142]Phase 1/Phase 2141 participants (Anticipated)Interventional2022-01-22Recruiting
A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer [NCT05814354]Phase 3530 participants (Anticipated)Interventional2023-06-30Recruiting
SAMSUNG MEDICAL CENTER [NCT03061630]Phase 249 participants (Actual)Interventional2017-02-15Active, not recruiting
BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreaticobiliary Cancer: A Phase I Study #108181 [NCT00447122]Phase 125 participants (Actual)Interventional2007-03-31Terminated(stopped due to slow enrollment and lack of funding)
A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma [NCT04891289]Phase 2164 participants (Anticipated)Interventional2021-05-07Recruiting
A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer [NCT01401192]Phase 2304 participants (Anticipated)Interventional2011-07-31Recruiting
A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Gemzar® (Gemcitabine) in the Treatment of Subjects With Solid Tumors [NCT00887757]Phase 146 participants (Actual)Interventional2009-09-30Completed
A Phase I/II Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors. [NCT00379639]Phase 136 participants (Actual)Interventional2006-07-01Completed
Phase I Dose Escalating Trial Evaluating the Combination of Gemcitabine and Trabectedin in Patients With Advanced and/or Metastatic Leiomyosarcoma or Liposarcoma [NCT01426633]Phase 15 participants (Actual)Interventional2011-11-30Completed
Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary [NCT02590055]Phase 229 participants (Anticipated)Interventional2015-10-31Recruiting
Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrence at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma [NCT00920153]Phase 3442 participants (Actual)Interventional2008-05-31Terminated(stopped due to Other new drugs)
a Single-arm Study of Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma [NCT04077983]Phase 240 participants (Anticipated)Interventional2019-09-01Not yet recruiting
The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer: The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) Study [NCT05178628]Phase 3450 participants (Anticipated)Interventional2022-02-10Recruiting
A Phase I/II Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Combination in Metastatic Pancreatic Cancer [NCT03535727]Phase 1/Phase 286 participants (Anticipated)Interventional2018-06-21Recruiting
A Phase I/II Study to Evaluate Safety and Efficacy of P276-00 in Combination With Gemcitabine in Patients With Cancer of Pancreas [NCT00898287]Phase 1/Phase 223 participants (Actual)Interventional2009-05-31Completed
A Randomized Two-armed Open Study on the Adjuvant Therapy in Patients With R0/R1 Resected Pancreatic Carcinoma With Gemcitabine Plus Capecitabine (Arm GC) vs. Gemcitabine Plus Cisplatin With Regional Hyperthermia (Arm GPH) [NCT01077427]Phase 3336 participants (Anticipated)Interventional2012-03-31Recruiting
Phase II, Multi-center, Open-label, Single-Arm Study Using Gemcitabine and Panitumumab in the First-line Treatment of Subjects With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas [NCT00613730]Phase 23 participants (Actual)Interventional2007-01-31Terminated(stopped due to APPRISE closure prompted by SWOG S0205 not meeting primary endpoint-improving OS. APPRISE enrollment closure due to similar design;no unexpected safety data)
A Phase II Trial of Neoadjuvant AGEN1884 Plus AGEN2034 in Combination With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer Prior to Radical Cystectomy [NCT04430036]Phase 24 participants (Actual)Interventional2020-10-14Active, not recruiting
Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer. [NCT00987766]Phase 128 participants (Actual)Interventional2009-11-30Completed
Weekly Administration of Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer [NCT00429559]Phase 1/Phase 231 participants (Actual)Interventional2006-06-30Completed
Prospective Randomized Phase II Trial With Gemcitabine Plus Sunitinib Versus Gemcitabine Alone in First-line Therapy of Metastatic or Locally Advanced Pancreatic Cancer [NCT00673504]Phase 2105 participants (Actual)Interventional2008-04-30Completed
A Phase 1/2, Open-label, Multi-center Study to Evaluate theSafety and Efficacy of Selinexor Combined With Chemotherapy orTislelizumab in Relapsed or Refractory Mature T and NK Cell Lymphoma [NCT04425070]Phase 1/Phase 297 participants (Anticipated)Interventional2020-08-18Recruiting
A Randomized Phase III Trial of Adjuvant Chemotherapy in Patients With Early Stage Non-Small Cell Lung Cancer Associated With Banking of Frozen Tumor Specimens and Collection of Gene Expression Profile Data [NCT00863512]Phase 334 participants (Actual)Interventional2009-03-31Terminated
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma [NCT00779454]Phase 272 participants (Actual)Interventional2008-09-30Completed
Phase II Trial of Gemcitabine and Cisplatin/Carboplatin (GC) Plus Erlotinib in Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer [NCT00603915]Phase 220 participants (Actual)Interventional2006-06-30Completed
A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour [NCT00778128]Phase 126 participants (Actual)Interventional2008-10-31Completed
A Randomized, Double-blind, Multicenter Phase II Trial With Gemcitabine Plus Sorafenib Versus Gemcitabine Plus Placebo in Patients With Chemo-naive Advanced or Metastatic Adenocarcinoma of the Biliary Tract [NCT00661830]Phase 2103 participants (Actual)Interventional2008-05-31Completed
Clinical Study to Assess Entry of Chemotherapeutic Agents Into Brain Metastases in Women With Breast Cancer [NCT00795678]10 participants (Actual)Observational2008-09-30Completed
Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian [NCT02822157]Phase 2160 participants (Actual)Interventional2016-08-31Active, not recruiting
A Phase II, Randomized, Open-Label Study of Cetuximab and Bevacizumab Alone or in Combination With Fixed-Dose Rate Gemcitabine as First-Line Therapy of Patients With Metastatic Adenocarcinoma of the Pancreas [NCT00326911]Phase 261 participants (Actual)Interventional2006-05-31Terminated(stopped due to The planned enrollment was 130 patients and the study was halted prematurely due to lack of efficacy in both arms. Enrolled patients continued treatment.)
A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer [NCT00326599]Phase 2101 participants (Actual)Interventional2007-06-30Completed
ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers [NCT05616624]Phase 1/Phase 2108 participants (Anticipated)Interventional2023-04-05Recruiting
A Phase I/ Randomized Phase II Study of Gemcitabine Plus Erlotinib Plus MK-0646; Gemcitabine Plus MK-0646 and Gemcitabine Plus Erlotinib for Patients With Advanced Pancreatic Cancer (IISP#33337) [NCT00769483]Phase 1/Phase 281 participants (Actual)Interventional2008-11-13Completed
Escalating Irinotecan (CPT-11) Administered 24 Hours Prior To Gemcitabine In Patients With Refractory Solid Tumors [NCT00054288]Phase 10 participants Interventional2001-08-31Completed
A Phase II, Single-center, Open-Label, Randomized Study of Gemcitabine Plus Cisplatin (GP) Versus Gemcitabine Plus Carboplatin (GC) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer [NCT02341911]Phase 2150 participants (Anticipated)Interventional2015-01-31Recruiting
A Phase 1b Study of LY3039478 in Combination With Other Anticancer Agents in Patients With Advanced or Metastatic Solid Tumors [NCT02784795]Phase 194 participants (Actual)Interventional2016-11-04Completed
Phase II Study of Irinotecan and Gemcitabine (IrinoGem) Combined With 3-D Conformal Radiation Therapy for Locally Advanced Pancreatic Cancer [NCT00192712]Phase 2/Phase 320 participants Interventional2002-11-30Completed
A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Gemcitabine in Patients With Pancreatic Cancer [NCT00839332]Phase 1/Phase 2157 participants (Actual)Interventional2009-02-28Completed
Randomized Multicenter Phase III Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas: Gemcitabine With or Without Chemoradiotherapy and With or Without Erlotinib. Intergroup Study [NCT00634725]Phase 3820 participants (Anticipated)Interventional2008-02-29Completed
Phase II Trial of Bevacizumab in Combination With Gemcitabine and Carboplatin in Patients With Newly Diagnosed Non-Small Cell Lung Cancer (Excluding Squamous Cell Carcinoma) [NCT00323869]Phase 248 participants (Actual)Interventional2006-06-30Completed
Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas [NCT02739633]Phase 247 participants (Anticipated)Interventional2016-04-30Recruiting
Phase Ib/II Study of ALT-803 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Pancreatic Cancer [NCT02559674]Phase 18 participants (Actual)Interventional2016-07-31Completed
Role of Cholecystokinin Receptor Blockade on the Tumor Microenvironment in Pancreatic Cancer [NCT05827055]Phase 230 participants (Anticipated)Interventional2024-01-31Recruiting
A Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel With CEND-1 or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma [NCT05042128]Phase 2158 participants (Actual)Interventional2022-04-13Active, not recruiting
Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV) [NCT00813696]Phase 3400 participants (Actual)Interventional2002-04-30Active, not recruiting
A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarc [NCT03656536]Phase 3434 participants (Anticipated)Interventional2019-06-03Recruiting
An Open-Label, Multicenter Phase Ib Study of The Safety and Efficacy of Atezolizumab (Anti-PD-L1 Antibody) Administered in Combination With Bevacizumab and/or Other Treatments in Patients With Solid Tumors [NCT02715531]Phase 1243 participants (Actual)Interventional2016-04-06Completed
A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma [NCT04924062]Phase 3158 participants (Actual)Interventional2020-07-10Active, not recruiting
Phase II Study of Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer [NCT02717091]Phase 250 participants (Anticipated)Interventional2015-07-31Active, not recruiting
A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer [NCT03003962]Phase 3669 participants (Actual)Interventional2017-01-02Active, not recruiting
A Phase II, Randomized, Multicenter Study to Assess the Efficacy of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP): The AGNOSTOS Trial [NCT02607202]Phase 2120 participants (Anticipated)Interventional2015-03-31Recruiting
A Pilot Study of Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus [NCT00614835]25 participants (Actual)Interventional2001-08-31Completed
PD-1 Immune Checkpoint Inhibitors and Immune-Related Adverse Events: a Cohort Study [NCT04115410]4,724 participants (Anticipated)Observational2020-07-01Not yet recruiting
A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC) [NCT00789958]Phase 2105 participants (Actual)Interventional2008-12-31Completed
Prospective Phase II Study to Investigate the Efficacy and Safety of Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Solid Tumor [NCT04215159]Phase 242 participants (Anticipated)Interventional2019-12-30Not yet recruiting
A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients With Treatment Naïve Metastatic Pancreatic Cancer (GIANT) [NCT04233866]Phase 2176 participants (Actual)Interventional2020-08-26Active, not recruiting
Phase II Study of Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab- or Pertuzumab-Based Therapy [NCT02252887]Phase 245 participants (Actual)Interventional2015-01-12Active, not recruiting
Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma [NCT01854203]Phase 2/Phase 3300 participants (Anticipated)Interventional2013-07-31Recruiting
Phase II Single-arm Study of First Line Treatment With Gemcitabine and Pazopanib in Patients With Inoperable Locally Advanced or Metastatic Biliary Tree Cancer (Cholangiocarcinoma or Gallbladder Carcinoma) [NCT01855724]Phase 229 participants (Actual)Interventional2013-06-28Terminated
A Multicenter, Phase 3 Clinical Trial of Gemcitabine and Camrelizumab Plus Apatinib Versus Cisplatin in First-line Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma [NCT05854849]Phase 3244 participants (Anticipated)Interventional2023-05-01Recruiting
Phase II Study With Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients Before High Dose Chemotherapy With Autologous Hematopoietic Stem Cells Transplant [NCT01884441]Phase 259 participants (Anticipated)Interventional2011-07-31Recruiting
A Pilot Study of Molecularly Tailored Therapy for Patients With Metastatic Pancreatic Cancer [NCT01888978]Phase 219 participants (Actual)Interventional2012-12-31Completed
Phase 2 Multicenter, Open-Label Study of CS-1008, A Humanized Monoclonal Antibody Targeting Death Receptor 5 (DR5), In Combination With Gemcitabine in Chemotherapy Naive Subjects With Unresectable or Metastatic Pancreatic Cancer [NCT00521404]Phase 265 participants (Actual)Interventional2007-08-15Completed
Sequential Neoadjuvant Chemoradiotherapy (CRT) Followed by Curative Surgery vs. Primary Surgery Alone for Resectable, Non-metastasized Pancreatic Adenocarcinoma [NCT01900327]Phase 332 participants (Actual)Interventional2014-02-28Terminated(stopped due to Recruitment failure)
Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients [NCT00944463]Phase 2106 participants (Actual)Interventional2008-10-31Completed
A Prospective,Randomized,Controlled,Multicenter,Phase III Study of Stage Ⅲ Study of Gemcitabine Plus Cisplatin With or Without Endostatin to the Metastatic Nasopharyngeal Carcinoma [NCT01915134]Phase 3362 participants (Anticipated)Interventional2013-08-31Recruiting
Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer [NCT00954525]Phase 114 participants (Actual)Interventional2009-07-31Completed
Phase I Trial of the Proapoptotic Agonist, LCL161, and Gemcitabine Plus Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer [NCT01934634]Phase 124 participants (Anticipated)Interventional2014-03-31Active, not recruiting
A Randomised Feasibility Study of Extended Chemotherapy With Neoadjuvant Carboplatin, Then Surgery Followed by Adjuvant Paclitaxel and Gemcitabine Verses Neoadjuvant Gemcitabine and Carboplatin, Then Surgery, Followed by Adjuvant Paclitaxel [NCT00838656]Phase 288 participants (Anticipated)Interventional2007-10-31Active, not recruiting
Role of Early 18F-FDG-PET/CT Scan in Predicting Mediastinal Downstaging With Neoadjuvant Chemotherapy in Resectable Stage III A NSCLC [NCT02607423]Phase 20 participants (Actual)Interventional2015-11-19Withdrawn(stopped due to The study failed to meet its accrual targets.)
Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study) [NCT05147272]Phase 1104 participants (Anticipated)Interventional2021-12-16Recruiting
Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Icotinib Combined With Gemcitabine as First-line Treatment in Locally Advanced, Unresectable or Metastatic Pancreatic Cancer [NCT02024633]Phase 124 participants (Anticipated)Interventional2013-12-31Recruiting
A Phase III, Open-label, Randomized Study of the Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Patients With Locally Advanced or Metastatic Pancreatic Cancer [NCT02043288]Phase 3310 participants (Actual)Interventional2014-01-31Completed
A Phase I, Multicenter, Open-label, Dose Escalation Study of Intratumoral Injections of VCN-01 Oncolytic Adenovirus With Intravenous Gemcitabine and Abraxane® in Advanced Pancreatic Cancer [NCT02045589]Phase 18 participants (Actual)Interventional2014-01-31Completed
A Phase I, Multicenter, Open-label, Dose Escalation Study of Intravenous Administration of VCN-01 Oncolytic Adenovirus With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors [NCT02045602]Phase 142 participants (Actual)Interventional2014-01-31Completed
Carboplatin, Gemcitabine, and Mifepristone for Advanced Breast Cancer and Recurrent or Persistent Epithelial Ovarian Cancer [NCT02046421]Phase 131 participants (Actual)Interventional2013-11-30Completed
Phase II Study of Gemcitabine for Relapsed B-Cell Chronic Lymphocytic Leukemia [NCT00005829]Phase 222 participants (Actual)Interventional2000-02-29Completed
Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): A Phase II Pilot Study to Improve Quality of Life During Chemotherapy [NCT00005850]Phase 221 participants (Actual)Interventional2001-08-31Completed
Treatment of Patients With Transitional-Cell Carcinoma of the Urothelial Tract With Gemcitabine, Docetaxel and Filgrastim [NCT00005958]Phase 20 participants Interventional1999-10-31Active, not recruiting
Phase I/II Study of Gemcitabine and Doxil Combination Chemotherapy in Patients With Advanced Solid Tumors (Phase I)/Breast Cancer (Phase II) [NCT00005991]Phase 276 participants (Actual)Interventional1997-08-25Completed
A Phase I/IB Study of Avelumab in Combination With Gemcitabine for Advanced Renal Cell Carcinoma With Sarcomatoid Differentiation [NCT03483883]Phase 16 participants (Actual)Interventional2018-03-19Terminated(stopped due to The study was terminated due to protracted accrual and limited patient engagement in the setting of rapidly changing treatment paradigms for advanced RCC with sarcomatoid features and/or intermediate/poor risk clinical features.)
A Randomized, Double Blind, Phase III Comparative Trial of 2 Doses of ZD1839 (IRESSA) in Combination With Gemcitabine and Cisplatin Versus Placebo in Combination With Gemcitabine and Cisplatin in Chemotherapy Naive Patients With Advanced (Stage III or IV) [NCT00006048]Phase 30 participants Interventional2000-05-31Active, not recruiting
Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer [NCT00006105]Phase 237 participants (Actual)Interventional2000-06-30Completed
Phase II Study of Gemcitabine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Pancreatic Cancer [NCT00006117]Phase 20 participants Interventional1999-09-30Active, not recruiting
A Phase II Trial of Gemcitabine, Herceptin, and Radiation for Regionally Confined Adenocarcinoma of the Pancreas [NCT00005926]Phase 250 participants Interventional2000-06-30Completed
A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer [NCT00006007]Phase 259 participants (Actual)Interventional2000-12-31Completed
Phase I Trial of Combination Pegylated Liposomal Doxorubicin (Doxil), Vinorelbine, and Gemcitabine [NCT00006372]Phase 110 participants (Actual)Interventional2000-02-29Completed
A Phase II Multicentre Trial of Gemcitabine, CVP, and Rituximab (R-GCVP) for the Treatment of Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma, Considered Unsuitable for R-CHOP Chemotherapy [NCT00971763]Phase 262 participants (Actual)Interventional2006-03-31Completed
A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia [NCT00006462]Phase 232 participants (Actual)Interventional2001-04-30Completed
A Phase I Study of Weekly Gemcitabine in Combination With Infusional Fluorodeoxyuridine and Oral Calcium Leucovorin in Adult Cancer Patients [NCT00001449]Phase 160 participants Interventional1995-09-30Completed
A Phase I Trial Of Gemcitabine Followed By Flavopiridol In Patients With Solid Tumors [NCT00007917]Phase 158 participants (Actual)Interventional2001-01-31Completed
Phase I Study Of Gemcitabine, Docetaxel And Carboplatin, With And Without Filrastim Support, Combination Chemotherapy In Patients With Advanced Non-Hematological Malignancies [NCT00008125]Phase 125 participants (Actual)Interventional1998-03-31Completed
An Open-label, Multi-center, Phase II Umbrella Study to Assess Efficacy of Targeted Therapy or Immunotherapy Directed by Next Generation Sequencing (NGS) in Chinese Patients With Advanced NSCLC (TRUMP) [NCT03574402]Phase 2400 participants (Anticipated)Interventional2018-07-09Recruiting
Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer [NCT00005831]Phase 240 participants (Anticipated)Interventional2000-03-31Completed
A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer [NCT00012220]Phase 2259 participants (Actual)Interventional2001-01-31Completed
Phase II Trial of Gemcitabine/Irinotecan as Second Line Therapy for Small Cell Lung Cancer [NCT00005972]Phase 273 participants (Actual)Interventional2000-05-31Completed
A Phase II Study Of Gemcitabine, Dexamethasone, And Cisplatin (GDP) In Patients With Either Hodgkin's Disease Or Aggressive Histology Non-Hodgkin's Lymphoma Which Is Relapsed Or Refractory [NCT00014209]Phase 277 participants (Actual)Interventional2000-12-12Completed
Intravesical Gemcitabine Therapy for BCG-Refractory Superficial Bladder Cancer: A Phase I and Pharmacokinetic Study [NCT00014287]Phase 10 participants (Actual)Interventional2000-09-30Withdrawn
A Phase I Study of Gemcitabine, Carboplatin or Gemcitabine, Paclitaxel and Radiation Therapy Followed by Adjuvant Chemotherapy for Patients With Favorable Prognosis Inoperable Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC) [NCT00016315]Phase 135 participants (Actual)Interventional2001-05-31Completed
An Open-Label, Phase I Dose Escalation Trial of TH-302 in Combination With Gemcitabine and Nab-Paclitaxel in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma [NCT02047500]Phase 119 participants (Actual)Interventional2014-01-31Terminated(stopped due to The trial has been terminated earlier following the company decision to discontinue the clinical development of Evofosfamide)
A Phase I/II Study of Gemcitabine (GEMZAR)/Vinorelbine (NAVELBINE)/Liposomal Doxorubicin (DOXIL) in Relapsed/Refractory Hodgkin's Disease [NCT00006029]Phase 1/Phase 291 participants (Actual)Interventional2000-07-31Completed
A Single Arm Phase 2 Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic Adenocarcinoma. [NCT04045730]Phase 20 participants (Actual)Interventional2019-11-15Withdrawn(stopped due to Halozyme isn't allowing this trial to move forward until their current clinical trial results are released.)
Phase 2 Single-Arm Studies of Gemcitabine in Combination With Oxaliplatin Refractory and Relapsed Pediatric Solid Tumors [NCT00407433]Phase 2156 participants (Anticipated)InterventionalCompleted
A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436) [NCT00656084]Phase 216 participants (Actual)Interventional2004-12-31Completed
A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma [NCT00173862]Phase 218 participants (Actual)Interventional2000-05-31Completed
Pilot Phase II Study of Metronomic Chemotherapy in Combination With Avastin in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer [NCT00655850]Phase 239 participants (Actual)Interventional2008-03-31Completed
Pilot Study of Gemcitabine and Cisplatin Plus AGS-003-BLD in Patients With Muscle-Invasive Bladder Cancer Undergoing Neoadjuvant Cisplatin-Based Chemotherapy [NCT02944357]0 participants (Actual)Interventional2016-11-30Withdrawn
Randomized Phase II Study to Compare a Combination Therapy With Gemcitabine and Treosulfan Versus a Monotherapy as First-Line Chemotherapy for Patients With Metastatic Ocular Melanoma [NCT00168870]Phase 248 participants (Anticipated)Interventional2003-02-28Recruiting
PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma [NCT00147875]Phase 1/Phase 260 participants (Actual)Interventional2004-03-31Completed
Phase II Study of Neoadjuvant Chemotherapy of Gemcitabine+Nab-paclitaxel Therapy for Patients With Borderline Resectable Pancreatic Cancer [NCT02926183]Phase 260 participants (Anticipated)Interventional2016-10-31Recruiting
A Randomized Phase III Trial of Gemcitabine and Docetaxel Versus Gemcitabine and Paclitaxel in Patients With Metastatic Breast Cancer: A Comparison of Different Schedules [NCT00236899]Phase 3241 participants (Actual)Interventional2005-09-30Completed
Infusional Gemcitabine and High-dose Melphalan (HDM) Conditioning Prior to (ASCT) Autologous Stem Cell Transplantation for Patients With Relapsed/Refractory Lymphoma [NCT02295722]Phase 1/Phase 2100 participants (Actual)Interventional2015-04-30Terminated(stopped due to It did not show a significant benefit to justify completing the full target accrual.)
Phase II Study of Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer [NCT00532285]Phase 244 participants (Actual)Interventional2005-09-30Terminated(stopped due to terminated)
Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer [NCT00151034]Phase 233 participants (Actual)Interventional2000-09-30Completed
A Phase Two Trial of Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Patients With Locally Advanced Carcinoma of the Bladder [NCT00585689]Phase 229 participants (Actual)Interventional2007-12-31Completed
A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma [NCT00609336]Phase 235 participants (Actual)Interventional2008-01-31Completed
A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma [NCT00536770]Phase 2132 participants (Anticipated)Interventional2007-09-30Suspended(stopped due to DSMB)
[NCT00540280]Phase 310 participants (Anticipated)Interventional2003-10-31Suspended(stopped due to Follow up only)
Phase II Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer [NCT00159458]Phase 27 participants (Actual)Interventional2003-07-31Terminated(stopped due to Insufficient Accrual)
Phase III Randomized, Double-blind Study Comparing Gemcitabine and Sorafenib or a Placebo in Patients With Locally Advanced or Metastatic Cancer of the Pancreas. [NCT00541021]Phase 3104 participants (Anticipated)Interventional2006-12-31Recruiting
15xxGCC: PHASE II TRIAL OF THE EP4 RECEPTOR ANTAGONIST, AAT-007 (RQ-07; CJ-023,423) IN ADVANCED SOLID TUMORS [NCT02538432]Phase 20 participants (Actual)Interventional2017-06-30Withdrawn(stopped due to PI No Longer at University of Maryland. Now at Fox Chase)
Randomized Phase II Trial to Outline the Efficacy of Gemcitabine Containing Regimens (Gemcitabine/Carboplatin and Gemcitabine/Paclitaxel) When Used as Preoperative Chemotherapy In Patients With Stage I and II NSCLC [NCT00191256]Phase 277 participants Interventional2001-06-30Completed
Phase II Study of Gemcitabine and Trastuzumab Therapy in Patients With HER2 Overexpressing Metastatic Breast Cancer [NCT00191373]Phase 266 participants Interventional2002-03-31Completed
Gemcitabine and Nab-Paclitaxel Combined With the Oral Irreversible ErbB Family Blocker Afatinib in Patients With Metastatic Pancreatic Cancer: A Phase Ib Trial [NCT02975141]Phase 112 participants (Actual)Interventional2016-09-30Active, not recruiting
Pancreatic Adenocarcinoma Signature Stratification for Treatment [NCT04469556]Phase 2150 participants (Anticipated)Interventional2020-10-14Recruiting
A Phase II Trial of Adjuvant Treatment With Gemcitabine and Oxaliplatin Followed by Concomitant Gemcitabine and Radiation Therapy in Patients With Resected Pancreatic Adenocarcinoma [NCT00191568]Phase 245 participants Interventional2002-10-31Completed
NGR014: Randomized Phase II Study of NGR-hTNF in Combination With Standard Chemotherapy Versus Standard Chemotherapy Alone in Previously Untreated Patients With Advanced Non-small Cell Lung Cancer (NSCLC) [NCT00994097]Phase 2121 participants (Actual)Interventional2009-07-31Completed
A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer. [NCT00471146]Phase 3630 participants (Actual)Interventional2007-07-31Completed
An Open Label Study of Tarceva in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas : Relationship Between Skin Rash and Survival [NCT00461708]Phase 2153 participants (Actual)Interventional2007-05-31Completed
A Study Evaluating Safety and Efficacy of Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Adenocarcinoma [NCT01025570]Phase 13 participants (Actual)Interventional2010-05-31Terminated(stopped due to Terminated due to slow accrual)
A Randomized Phase II Trial of Paclitaxel and Bevacizumab Versus Gemcitabine, Paclitaxel, and Bevacizumab as First Line Treatment for Locally Advanced or Metastatic Breast Cancer [NCT00320541]Phase 2187 participants (Actual)Interventional2006-05-31Completed
Phase I Study of Margin-Intense Combination Therapy for Patients With Potentially Resectable Pancreatic Adenocarcinoma [NCT01025882]Phase 15 participants (Actual)Interventional2009-10-31Terminated(stopped due to DSMC closed due to patient deaths)
Individualized Management of Pancreatic Cancer With Targeted Therapeutics (IMPACTT): A Phase II Clinical Trial [NCT00429858]Phase 221 participants (Actual)Interventional2007-01-22Terminated(stopped due to Study accrual rate is very slow, it was mandated by NCI to be terminated.)
An Open-label, Single Arm, Phase 2 Study of Rituximab, Gemcitabine and Oxaliplatin Plus Enzastaurin as Treatment for Patients With Relapsed Diffuse Large B-Cell Lymphoma [NCT00436280]Phase 268 participants (Actual)Interventional2007-02-28Completed
A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Wit [NCT00408408]Phase 31,206 participants (Actual)Interventional2006-11-30Active, not recruiting
A Randomized Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer [NCT00407550]Phase 219 participants (Actual)Interventional2006-11-30Completed
An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination With Gemcitabine and in Combination With Chemoradiation (Capecitabine and Radiation) in Patients With Completely-Resected Pancreatic Carcinoma [NCT00305877]Phase 2137 participants (Actual)Interventional2006-02-28Completed
Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial [NCT00282087]Phase 247 participants (Actual)Interventional2006-01-31Completed
A Phase II Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection [NCT01043172]Phase 272 participants (Actual)Interventional2009-07-20Completed
Phase II Open Label Study of Gemcitabine, Paclitaxel and Bevacizumab Combination as First Line Treatment for Metastatic Breast Cancer [NCT00403130]Phase 231 participants (Actual)Interventional2006-02-28Completed
A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer [NCT01049880]Phase 115 participants (Actual)Interventional2009-12-31Completed
A Phase I Study of Gemcitabine Plus Oxaliplatin in Combination With Imatinib Mesylate (Glivec) in Patients With Gemcitabine-refractory Advanced Adenocarcinoma of the Pancreas [NCT01048320]Phase 136 participants (Anticipated)Interventional2006-07-31Completed
A Phase I/II, Open-label, One-arm, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Local Advanced/Metastatic Pancreatic Cancer [NCT03989310]Phase 1/Phase 250 participants (Anticipated)Interventional2019-03-01Recruiting
A Pilot Study of Full Dose Gemcitabine and Hypofractionated Stereotactic Radiosurgery in the Treatment of Unresectable Pancreatic Cancer [NCT01051284]Phase 114 participants (Actual)Interventional2009-11-30Completed
INST 0601C: A Non-Randomized Phase II Protocol of Erlotinib for Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung [NCT00391586]Phase 245 participants (Actual)Interventional2006-07-31Terminated(stopped due to PI left institution.)
A Phase II Study of Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer [NCT00388154]Phase 221 participants (Actual)Interventional2004-08-31Completed
A Randomized Phase II Study of BAY 43-9006 in Combination With Gemcitabine in Metastatic Pancreatic Carcinoma [NCT00114244]Phase 252 participants (Actual)Interventional2004-12-31Completed
A Randomized Double-Blinded Placebo Controlled Phase II Study of the Anti-CD30 Antibody, SGN-30 (NSC #731636), in Combination With Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin (GVD) for Patients With Relapsed/Refractory Hodgkin Lymphoma [NCT00337194]Phase 230 participants (Actual)Interventional2006-04-30Completed
Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG [NCT00234039]Phase 258 participants (Actual)Interventional2006-11-30Completed
A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Platinum-doublet Chemotherapy and Bevacizumab in Women With Platinum-Resistant/Refractory Ovarian Cancer (OnPr [NCT05281471]Phase 3186 participants (Anticipated)Interventional2022-08-31Recruiting
A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lym [NCT03456076]Phase 3257 participants (Actual)Interventional2018-08-16Active, not recruiting
A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma [NCT02807636]Phase 31,213 participants (Actual)Interventional2016-06-30Active, not recruiting
Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Myeloma [NCT02506959]Phase 283 participants (Actual)Interventional2015-09-14Active, not recruiting
Multicenter, Randomized, Open Label Study Evaluating a Poly(ADP-ribose) Polymerase-1(PARP-1) Inhibitor, SAR240550 (BSI-201), Administered Twice Weekly or Weekly, in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Brea [NCT01045304]Phase 2163 participants (Actual)Interventional2010-02-28Completed
Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer [NCT00227721]Phase 230 participants (Actual)Interventional2004-02-29Completed
A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer [NCT00380588]Phase 284 participants (Actual)Interventional2006-09-30Completed
A Phase Ib Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer [NCT01010945]Phase 119 participants (Actual)Interventional2010-02-03Completed
Phase II Trial of Pemetrexed Plus Gemcitabine in Patients With Advanced Non-Clear Cell Renal Cell Cancer [NCT00491075]Phase 216 participants (Actual)Interventional2005-12-31Terminated(stopped due to Closed early for poor accrual.)
Clinical Study of Toripalimab Monoclonal Antibody Combined With Gemcitabine/5--fluoropyrimidine in the Treatment of Advanced Cholangiocarcinoma [NCT03982680]Phase 230 participants (Anticipated)Interventional2019-07-13Recruiting
Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-adjuvant/Adjuvant Chemotherapy With Anthracycline [NCT00334802]Phase 262 participants (Actual)Interventional2006-06-30Completed
A Phase 1/2a Open-label Study of Pralatrexate and Gemcitabine With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Lymphoproliferative Malignancies [NCT00481871]Phase 1/Phase 2119 participants (Actual)Interventional2007-05-31Completed
A Phase I/II Trial of Combination Bortezomib (VELCADE) and Gemcitabine Therapy for Patients With Relapsed or Refractory Aggressive B- and T-cell Non-Hodgkin's Lymphoma [NCT00290706]Phase 1/Phase 232 participants (Actual)Interventional2006-04-07Terminated(stopped due to Closed per Data Monitoring Committee due to lack of efficacy)
Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma [NCT01065870]Phase 2/Phase 364 participants (Anticipated)Interventional2009-12-31Recruiting
Phase II Trial of Gemcitabine and Curcumin in Patients With Advanced Pancreatic Cancer [NCT00192842]Phase 217 participants (Actual)Interventional2004-07-31Completed
Phase Ib/II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Sunitinib in Patients With HER2-negative Stage II/III Breast Cancer [NCT01070706]Phase 1/Phase 215 participants (Actual)Interventional2009-03-31Completed
A Phase II Study of Gemcitabine/ Mitoxantrone in Patients With Acute Myeloid Leukemia in First Relapse [NCT00268242]Phase 224 participants (Actual)Interventional2006-01-31Terminated(stopped due to If
A Feasibility Study for Individualized Treatment of Patients With Advanced Pancreatic Cancer [NCT00276744]Phase 2249 participants (Actual)Interventional2005-10-31Terminated(stopped due to Because there was no longer an active laboratory component to this study.)
A Phase I, Open-Label, Multi-center, Competitive Enrollment and Dose-escalation Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors [NCT01325558]Phase 130 participants (Anticipated)Interventional2011-05-31Completed
A Phase II Trial Of Gemcitabine in Combination With 17-Allylaminogeldamycin (17-AAG) In Advanced Epithelial Ovarian And Primary Peritoneal Carcinoma [NCT00093496]Phase 229 participants (Actual)Interventional2007-10-31Completed
A Randomized, Open-Label Phase II Study Of ZD1839 (IRESSA™) Versus Gemcitabine And Carboplatin In Chemotherapy-Naive Patients With Advanced (Stage IIIB OR IV) Non-Small Cell Lung Cancer And ECOG Performance Status 2 [NCT00264498]Phase 238 participants (Actual)Interventional2004-10-31Completed
Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma [NCT00262860]Phase 218 participants (Actual)Interventional2005-04-30Completed
A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Ce [NCT00449033]Phase 3904 participants (Actual)Interventional2007-02-28Completed
A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer [NCT00456599]Phase 271 participants (Actual)Interventional2007-04-30Completed
A Phase III Blinded Study of Immediate Post TURBT Instillation of Gemcitabine Versus Saline in Patients With Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer [NCT00445601]Phase 3406 participants (Actual)Interventional2007-09-30Completed
Randomized Phase II Study of First-Line Treatment With Gemcitabine vs. Erlotinib vs. Gemcitabine and Erlotinib in Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer [NCT00283244]Phase 2147 participants (Actual)Interventional2006-03-31Completed
A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer [NCT00193076]Phase 296 participants (Anticipated)Interventional2003-11-30Completed
Phase I, Prospective, Open-label, Multi-centric, Dose Finding Trial of Combination of IGEV and Panobinostat Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma [NCT01884428]Phase 124 participants (Anticipated)Interventional2011-07-31Recruiting
Pilot Trial of Sirolimus, Gemcitabine and Cisplatin for Patients With High Risk for Cholangiocarcinoma Recurrence [NCT01888302]Phase 11 participants (Actual)Interventional2013-09-30Completed
A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability and Efficacy of Amphinex®-Induced Photochemical Internalisation (PCI) of Gemcitabine in Patients With Advanced Inoperable Cholangiocarcinomas [NCT01900158]Phase 124 participants (Actual)Interventional2013-05-31Completed
Phase I Trial of Chemoimmunotherapy and Hypofractionated Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma. [NCT01903083]Phase 110 participants (Actual)Interventional2013-07-31Completed
Ph 2 Trial of G-FLIP (Low Doses Gemcitabine, 5FU, Leucovorin, Irinotecan & Oxaliplatin), Followed by G-FLIP-DM (G-FLIP + Low Doses Docetaxel & MitomycinC), When Used in Combination With Vitamin C, in Patients With Advanced Pancreatic Cancer [NCT01905150]Phase 234 participants (Actual)Interventional2014-07-31Completed
A Phase I Study of Veliparib (ABT-888) in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With Locally Advanced, Unresectable Pancreatic Cancer [NCT01908478]Phase 134 participants (Actual)Interventional2013-10-02Completed
An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Ca [NCT00061308]Phase 275 participants Interventional2002-12-31Completed
An Open-label, Multicenter, Phase II Trial, to Evaluate the Efficacy of Intra-hepatic Administration of Yttrium 90-labelled Microspheres (Therasphere®, Nordion) in Association With Intravenous Chemotherapy With Gemcitabine and Cisplatin for the Treatment [NCT01912053]Phase 241 participants (Actual)Interventional2013-09-30Completed
The Feasibility Study of Oral Rehydration Therapy for Short Hydration in Chemotherapy With Cisplatin Plus Gemcitabine for Biliary Tract Cancer [NCT01917617]Phase 250 participants (Actual)Interventional2013-05-22Completed
Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant (TASUC-Neo): A Pilot Study of Degarelix in Combination With Neoadjuvant Gemcitabine and Cisplatin in Muscle-Invasive Urothelial Cell Carcinoma of the Bladder [NCT05839119]Phase 132 participants (Anticipated)Interventional2023-10-02Recruiting
A Randomized Phase III Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary and a Predicted Favorable Prognosis [NCT00126269]Phase 3192 participants Interventional2003-05-31Recruiting
A Multicenter Phase II Trial of Weekly Gemcitabine, Paclitaxel, and Hyperfractionated External Irradiation (63.80 GY) for Locally Advanced Pancreatic Cancer [NCT00226746]Phase 20 participants (Actual)Interventional2003-03-31Withdrawn
Phase I Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma [NCT01938729]Phase 18 participants (Actual)Interventional2013-09-05Completed
A Phase Ib Trial of Gemcitabine and Cisplatin With RAD001 in Patients With Metastatic Triple Negative Breast Cancer Proceeding to an Open Label Randomized Phase II Trial Comparing Gemcitabine/Cisplatin With or Without RAD001. [NCT01939418]Phase 1/Phase 223 participants (Actual)Interventional2013-08-31Terminated(stopped due to slow recruitment)
Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin [NCT00210041]Phase 250 participants (Anticipated)Interventional2004-02-29Completed
Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma [NCT00316420]Phase 120 participants (Actual)Interventional2003-12-31Completed
Serum Protein Profiling as a Predictor of Gemcitabine Sensitivity in Breast Cancer With Prior Exposure to Anthracyclines and Taxanes [NCT00212069]Phase 230 participants (Anticipated)Interventional2004-03-31Completed
Prospective, Multicenter, Open-labeled, Phase I/II Study of the Efficacy and Safety of Copanlisib (BAY 80-6946) and Gemcitabine Combination in Patients With Relapsed/Refractory Peripheral T-cell or NK/T-cell Lymphoma [NCT03052933]Phase 1/Phase 228 participants (Actual)Interventional2018-02-01Completed
Phase 1-2 Study of the Association of Gemzar ® - Cisplatin-concurrent Radiotherapy in Patients With Non-metastatic Tumors of the Bladder [NCT00556621]Phase 1/Phase 214 participants (Actual)Interventional2005-06-30Completed
Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Lymphoma [NCT02961816]Phase 20 participants (Actual)Interventional2017-06-30Withdrawn(stopped due to Lack of funding)
A Multicentre, Randomized Study of Trastuzumab Combined With Chemotherapy or Endocrine Therapy as the First Line Treatment for Patients With Metastatic Luminal B2 Breast Cancer Subtype [NCT01950182]Phase 3392 participants (Actual)Interventional2013-09-16Completed
Phase II Study of Rituximab and Gemcitabine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Hoosier Oncology Group LYM03-64 [NCT00216164]Phase 28 participants (Actual)Interventional2005-04-30Terminated(stopped due to Study terminated due to lack of response at the first efficacy analysis)
Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer [NCT00242190]Phase 1/Phase 240 participants Interventional2004-06-30Completed
Phase Ib, IIa Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer [NCT01004731]Phase 1/Phase 27 participants (Actual)Interventional2001-06-30Completed
[NCT00436423]Phase 238 participants (Actual)Interventional2006-03-31Completed
Phase I Study to Determine the Safety, Maximum Tolerated Dose, and Efficacy of Biweekly Oxaliplatin (Eloxatin) in Combination With Gemcitabine, Irinotecan, and 5-FU/Leucovorin (G-Flie) in Patients With Metastatic Solid Tumors or Adenocarcinoma of the Exoc [NCT00220649]Phase 125 participants (Actual)Interventional2004-03-31Completed
A Pilot Safety and Toxicity Trial of Adjuvant Chemotherapy With Gemcitabine and Docetaxel and Radiation Therapy for Completely Resected Uterine Leiomyosarcoma [NCT01958580]3 participants (Actual)Interventional2013-09-17Terminated(stopped due to Study terminated due to low accrual. PI left the institution)
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01) [NCT06109779]Phase 3750 participants (Anticipated)Interventional2023-12-04Recruiting
Phase 2 Single Arm Trial Testing the ZN-c3 WEE1 Inhibitor in Combination With Gemcitabine in Second-Line Advanced Pancreatic Adenocarcinoma [NCT06015659]Phase 234 participants (Anticipated)Interventional2023-11-16Recruiting
Phase I-II Trial of Gemcitabine Plus Nab-paclitaxel (GemBrax) Followed by Folfirinox as First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma. [NCT01964287]Phase 1/Phase 278 participants (Actual)Interventional2013-09-24Completed
A Phase I Clinical Trial of CA-4948 in Combination With Gemcitabine and Nab-Paclitaxel in Metastatic or Unresectable Pancreatic Ductal Carcinoma [NCT05685602]Phase 136 participants (Anticipated)Interventional2023-06-12Recruiting
A Phase 1b/2a Study of Gemcitabine and Nab-paclitaxel in Combination With Avutometinib (VS-6766) and Defactinib in Patients With Previously Untreated Metastatic Adenocarcinoma of the Pancreas [NCT05669482]Phase 1/Phase 240 participants (Anticipated)Interventional2023-03-22Recruiting
Randomized Phase II Study of Weekly ABI-007 Plus Gemcitabine or Simplified LV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer [NCT01964534]Phase 2114 participants (Actual)Interventional2013-12-12Active, not recruiting
A Phase I Protocol for Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination With Chemotherapy [NCT05101551]Phase 134 participants (Anticipated)Interventional2023-02-23Recruiting
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination With Gemcitabine in Non-heavily Pretreated Patients With Selected Advanced Solid Tumors [NCT01970553]Phase 147 participants (Actual)Interventional2011-05-31Completed
A Phase II Study of TTFields (150 kHz) Concomitant With Gemcitabine and TTFields Concomitant With Gemcitabine Plus Nab-paclitaxel for Front-line Therapy of Advanced Pancreatic Adenocarcinoma [NCT01971281]Phase 1/Phase 240 participants (Actual)Interventional2013-11-30Active, not recruiting
Phase II, Prospective, Randomized, Non-comparative Study of Treatment With Induction Chemotherapy With Cisplatin and Gemcitabine Followed by Chemoradiation or Definitive Chemoradiation in Invasive Locally Advanced Carcinomas of Uterine Cervix. [NCT01973101]Phase 2120 participants (Anticipated)Interventional2012-06-30Recruiting
The Role of the Tumor Microenvironment of Pancreatic Cancer to Predict Treatment Outcome [NCT01989000]47 participants (Actual)Interventional2013-11-30Completed
A Phase I Study of Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer [NCT00251355]Phase 140 participants (Anticipated)Interventional1998-01-31Completed
An Open, Single-center, Phase II Clinical Trial for Treatment of Untreated Extranodal NK/T Cell Lymphoma With High Dose of Methotrexate in Combination With Gemcitabine, Pegaspargase and Dexamethasone (GAD-M Regimen) [NCT01991158]Phase 230 participants (Anticipated)Interventional2013-11-30Active, not recruiting
A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer [NCT01993979]Phase 3261 participants (Actual)Interventional2012-05-31Active, not recruiting
A Randomized, Open-label Phase III Study of First-line Treatment With Erlotinib Intercalated With Gemcitabine/ Cisplatin or Carboplatin Therapy Versus Erlotinib in Stage IIIB/IV NSCLC Patients With EGFR Mutation [NCT02001896]Phase 360 participants (Anticipated)Interventional2013-12-31Not yet recruiting
A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer [NCT02005315]Phase 130 participants (Actual)Interventional2013-09-30Completed
A Phase II, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of the Combination of Gemcitabine and Metformin in Treating Patients With Pancreatic Cancer After Curative Resection [NCT02005419]Phase 2300 participants (Actual)Interventional2013-12-31Completed
A Phase II Trial of Stanford VI ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease With 3+ Risk Factors: the G6 Study [NCT00225173]Phase 245 participants (Anticipated)Interventional2001-10-31Terminated
A Single-center, Randomized Controlled Phase II Study of Sufantinib Combined With Gemcitabine and Abraxane (AG)Versus AG in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer [NCT05969171]Phase 265 participants (Anticipated)Interventional2023-08-31Not yet recruiting
A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma [NCT05967182]Phase 224 participants (Anticipated)Interventional2024-01-31Not yet recruiting
A Pilot Safety Study and Single Arm Phase II Study of Gemcitabine and Cisplatin With Atezolizumab (MPDL3280A) in Patients With Metastatic and Muscle Invasive Bladder Cancer, Respectively [NCT02989584]Phase 1/Phase 254 participants (Actual)Interventional2016-12-20Active, not recruiting
A Phase II Study of Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC) [NCT01862315]Phase 255 participants (Actual)Interventional2013-05-31Active, not recruiting
Phase II Study of Neoadjuvant Gemcitabine/Oxaliplatin and Cetuximab Followed by Surgery or Concurrent External Beam Radiation With Capecitabine for Patients With Locally Advanced Unresectable Nonmetastatic Pancreatic Cancer [NCT00408564]Phase 239 participants (Actual)Interventional2006-01-31Completed
Whole-course Concurrent and Adjuvant Nivolumab Combined With Induction Chemotherapy Followed by Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 2, Multi-center, Single-arm Clinical Trial [NCT03984357]Phase 2152 participants (Anticipated)Interventional2020-03-16Active, not recruiting
A Pilot Study of Gemcitabine, Abraxane, Metformin and a Standardized Dietary Supplement (DS) in Patients With Unresectable Pancreatic Cancer [NCT02336087]Phase 121 participants (Actual)Interventional2016-01-14Active, not recruiting
A Phase I/II Study of VELCADE in Combination With Gemcitabine in Relapsed B-Cell Non-Hodgkin's Lymphoma [NCT00863369]Phase 1/Phase 233 participants (Actual)Interventional2005-06-29Active, not recruiting
AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR'S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NON-HODGKIN LYMPHOMA WHO ARE NO [NCT01232556]Phase 3338 participants (Actual)Interventional2011-04-04Terminated(stopped due to The study was terminated prematurely on May 16, 2013, for futility. No new or unexpected safety issues were identified.)
Phase II Study Comparing Gemcitabine Plus Cisplatin to Docetaxel, Cisplatin, and Fluorouracil Induction Chemotherapy Followed by Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma [NCT02016417]Phase 2120 participants (Anticipated)Interventional2014-05-31Not yet recruiting
A Phase Ib, Open-label, Dose Escalation Study of the Safety, Tolerability and Efficacy of LY2780301 (a p70/AKT Inhibitor) in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer [NCT02018874]Phase 152 participants (Actual)Interventional2013-09-30Completed
A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy With or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL) [NCT04365036]Phase 3207 participants (Anticipated)Interventional2020-05-31Recruiting
A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients With Pancreatic Cancer After Curative Resection [NCT02023021]Phase 280 participants (Anticipated)Interventional2014-01-31Completed
A Multi-centre Randomised Study of Induction Chemotherapy Followed by Capecitabine (+/-Nelfinavir) With High or Standard Dose Radiotherapy for Locally Advanced Non-metastatic Pancreatic Cancer [NCT02024009]Phase 1/Phase 2289 participants (Anticipated)Interventional2016-03-31Recruiting
A Prospective Phase II Trial of Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery for Patients With High Grade Upper Tract Urothelial Carcinoma [NCT02412670]Phase 236 participants (Actual)Interventional2015-08-27Completed
Efficacy and Safety of Surufatinib Combined With Gemcitabine and Albumin-bound Paclitaxel in the Peri-operative Treatment of Locally Advanced or Borderline Resectable Pancreatic Cancer: An Exploratory Study [NCT05908747]Phase 229 participants (Anticipated)Interventional2023-05-31Recruiting
A Phase I Study of Whole Pelvic Radiation Therapy With Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis [NCT00068549]Phase 113 participants (Actual)Interventional2003-10-31Completed
Phase II Study on SCH 66336 (Farnesyl Protein Transferase Inhibitor) and Gemcitabine as Second Line Treatment in Advanced Metastatic Urothelial Cancer - EORTC Study 16997 [NCT00006351]Phase 234 participants (Actual)Interventional2000-06-30Completed
Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable or Metastatic Hepatocellular Carcinoma [NCT00006010]Phase 225 participants (Actual)Interventional2001-09-30Completed
Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer [NCT00006028]Phase 20 participants Interventional2001-01-31Completed
A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy [NCT00006453]Phase 30 participants Interventional1999-09-30Completed
Phase III Study of Gemcitabine Plus Paclitaxel Versus Paclitaxel in Patients With Unresectable, Locally Recurrent or Metastatic Breast Cancer [NCT00006459]Phase 30 participants Interventional2000-07-31Completed
First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine [NCT00006118]Phase 20 participants Interventional1999-07-31Active, not recruiting
Organoid-Guided Functional Precision Therapy Versus Treatment of Physician's Choice in Previously Treated HER2-negative Advanced Breast Cancer: A Phase II, Multicenter, Open-label, Randomized Controlled Trial [NCT06102824]Phase 2252 participants (Anticipated)Interventional2024-01-20Recruiting
A Phase 3 Randomized Clinical Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008) [NCT05508867]Phase 3360 participants (Anticipated)Interventional2022-10-18Recruiting
Phase 1 Trial of Gemcitabine Combined With the Elimusertib (BAY 1895344) ATR Inhibitor With Expansion Cohorts in Advanced Pancreatic and Ovarian Cancer [NCT04616534]Phase 164 participants (Anticipated)Interventional2021-06-01Active, not recruiting
Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO) [NCT04267848]Phase 31,210 participants (Anticipated)Interventional2020-06-16Recruiting
Phase II Trial of Intravesical Gemcitabine and MK-3475 (Pembrolizumab) in the Treatment of Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer [NCT04164082]Phase 2161 participants (Anticipated)Interventional2020-03-18Recruiting
A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer [NCT03547973]Phase 2643 participants (Anticipated)Interventional2018-08-13Recruiting
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) [NCT02194738]8,300 participants (Anticipated)Interventional2014-09-26Recruiting
Multimodality Management of Head and Neck Cancer: A Phase II Trial of Induction Chemotherapy, Organ Preservation Surgery, and Concurrent Chemoradiotherapy [NCT00544414]Phase 231 participants (Actual)Interventional2000-06-07Active, not recruiting
A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine Versus Paclitaxel(Albumin Bound) and Gemcitabine as Fi [NCT04674956]Phase 3401 participants (Anticipated)Interventional2021-01-01Not yet recruiting
Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer [NCT00564720]Phase 2140 participants (Actual)Interventional2006-12-31Terminated(stopped due to Due to poor accrual of the study)
Phase III, Multicenter, Randomized Trial of Maintenance Versus Observation After Achieving Clinical Response in Pts With Metastatic or Recurrent Breast Cancer Who Received 6 Cycles of Gemcitabine Plus Paclitaxel(GP) as 1st-line Chemotherapy [NCT00561119]Phase 3326 participants (Actual)Interventional2007-05-31Completed
A Phase Ib/II Trial of SHR-1701 Combined With Gemcitabine and Albumin Paclitaxel in First-line Treatment of Subjects With Advanced/Metastatic Pancreatic Cancer [NCT04624217]Phase 1/Phase 256 participants (Actual)Interventional2020-11-24Active, not recruiting
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to [NCT04611776]Phase 20 participants (Actual)Interventional2021-07-01Withdrawn(stopped due to The positive results from IMpower010 demonstrated benefit by adding atezolizumab as adjuvant therapy in early stage NSCLC. These results raised ethical concerns of enrolling pts to best supportive care over checkpoint inhibition in this setting.)
A Phase 2 Study of Saltikva (Attenuated Salmonella Typhimurium Containing the Human Gene for Interleukin-2) in Patients With Metastatic Pancreatic Cancer [NCT04589234]Phase 260 participants (Anticipated)Interventional2020-10-20Recruiting
Dynamic Positron Emission Tomography/Computed Tomography Evaluated the Response of Neoadjuvant Anti-programmed Cell Death Protein 1 Combination With Chemotherapy for Stage Ⅱa-Ⅲb Non-small Cell Lung Cancer [NCT04586465]Phase 223 participants (Anticipated)Interventional2020-10-10Recruiting
A Phase I Trial of Extrapleural Pneumonectomy/Pleurectomy Decortication, Intrathoracic/Intraperitoneal Hyperthermic (IOHC) Cisplatin and Gemcitabine With Intravenous Amifostine and Sodium Thiosulfate Cytoprotection for Patients With Resectable Malignant P [NCT00571298]Phase 1141 participants (Actual)Interventional2007-11-30Completed
Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer [NCT00193206]Phase 2123 participants (Actual)Interventional2005-09-30Completed
Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients [NCT00193050]Phase 2110 participants (Actual)Interventional2001-11-30Completed
A Multicenter, Randomized Phase II Trial of Avastin Plus Gemcitabine Plus 5FU/Folinic Acid (A + FFG) vs. Avastin Plus Oxaliplatin Plus 5FU/Folinic Acid (A + FOLFOX 4) as Therapy for Patients With Metastatic Colorectal Cancer [NCT00192075]Phase 284 participants (Actual)Interventional2003-06-30Completed
Multicenter Phase II Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer [NCT00192036]Phase 249 participants (Actual)Interventional2004-08-31Completed
Phase III Randomized Trial of Induction Chemotherapy With Gemcitabine and Carboplatin Followed by Elective Paclitaxel Consolidation Versus Paclitaxel and Carboplatin Followed by Elective Paclitaxel Consolidation in Patients With Primary Epithelial Ovarian [NCT00191646]Phase 3919 participants (Actual)Interventional2002-10-31Completed
Phase II Trial of Gemzar Plus Paraplatin (Plus Herceptin in HER2+ Patients) in Metastatic Breast Cancer [NCT00191451]Phase 2150 participants (Actual)Interventional2004-04-30Completed
Phase II Study of Gemcitabine Plus Cisplatin as First-Line Therapy in Patients With Epithelial Ovarian Cancer [NCT00191334]Phase 250 participants (Actual)Interventional2004-12-31Completed
A Randomized Study of Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation Therapy in Stage III Unresectable NSCLC [NCT00191139]Phase 264 participants (Actual)Interventional2003-03-31Completed
Exploratory Clinical Trial of Sintilimab Combined With Gemcitabine/Carboplatin Regimen in the Treatment of Advanced Primary Pulmonary Lymphoepithelioma-like Carcinoma(LELC) [NCT04312204]Phase 230 participants (Anticipated)Interventional2020-03-31Recruiting
A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) in Combination With Standard Chemotherapy Versus Placebo in Combination With Standard Chemotherapy [NCT04568304]Phase 3364 participants (Anticipated)Interventional2020-11-30Not yet recruiting
Neoadjuvant Administration of Gemcitabine Plus Doxorubicin Followed by Gemcitabine Plus Cisplatin in Large or Locally Advanced Operable Breast Cancer: A Phase II Study [NCT00191789]Phase 265 participants (Actual)Interventional2003-02-28Completed
Gimatecan (ST1481) as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer: an Open-label, Randomized, Controlled Phase II Study [NCT04571489]Phase 260 participants (Anticipated)Interventional2020-12-01Not yet recruiting
Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC) [NCT01082549]Phase 3780 participants (Actual)Interventional2010-03-31Completed
Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Icotinib Combined With Gemcitabine as First-line Treatment in Locally Advanced, Unresectable or Metastatic Pancreatic Cancer [NCT02278458]Phase 124 participants (Anticipated)Interventional2014-10-31Active, not recruiting
A Phase I Open-label Dose-finding Study of Intravenous BI 2536 Administered in Repeated 4-week Cycles as Repeated Doses on Day 1 and Day 15 in Combination With Gemcitabine Administered on Day 1, Day 8 and Day 15 in Patients With Locally Advanced or Metast [NCT02215044]Phase 112 participants (Actual)Interventional2007-06-30Terminated
A Phase II Study to Evaluate Activity and Toxicity of Gemcitabine in Combination With Pemetrexed Long Term Infusion in the Treatment of Pretreated Metastatic Colorectal Cancer Patients [NCT01909830]Phase 218 participants (Actual)Interventional2012-07-31Completed
Detecting Chemosensitivity and Predicting Treatmemt Efficacy With Circulating Tumour Cells From Peripheral Blood in Metastatic Nasopharyngeal Carcinoma Patients [NCT04544969]50 participants (Anticipated)Observational [Patient Registry]2020-04-01Recruiting
Phase 1/2, Randomized, Multicenter, Prospective Study of Gemcitabine and Rapamycin (Sirolimus) Combination Versus Gemcitabine Only to Treat Advanced Soft Tissue Sarcoma [NCT01684449]Phase 1/Phase 228 participants (Actual)Interventional2010-01-31Completed
A Phase I Open-Label, Ascending Dose Cohort Study of Gemcitabine Elaidate and Cisplatin in Patients With Advanced Solid Tumors Followed by an Expanded Cohort of Patients With Stage IIIb/IV NSCLC. [NCT01641575]Phase 18 participants (Actual)Interventional2012-07-31Terminated(stopped due to Registrational study did not meet endpoint so entire program (including CO-101-011) was terminated.)
A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy and in Combination With Various Anticancer Therapies in Patients With Advanced Solid Tumors [NCT05525247]Phase 1/Phase 2420 participants (Anticipated)Interventional2022-12-21Recruiting
A Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LBL-007 in Combination With Tislelizumab in the Treatment of Malignancies [NCT05516914]Phase 1/Phase 2490 participants (Anticipated)Interventional2022-09-01Recruiting
A Phase 1b Study of ZN-c3 in Combination With Chemotherapy in Patients With Platinum-Resistant Ovarian, Peritoneal or Fallopian Tube Cancer [NCT04516447]Phase 1140 participants (Anticipated)Interventional2020-10-26Recruiting
A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5) [NCT04384484]Phase 3350 participants (Anticipated)Interventional2020-09-16Recruiting
Efficacy and Safety of AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer [NCT06080854]Phase 2108 participants (Anticipated)Interventional2023-11-10Not yet recruiting
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects [NCT06079983]Phase 3400 participants (Anticipated)Interventional2023-12-01Not yet recruiting
A Randomized Phase II Study of Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy for Patients With Resectable Adenocarcinoma of the Pancreas [NCT00766636]Phase 25 participants (Actual)Interventional2008-09-30Terminated(stopped due to Slow Accrual)
A Phase I Dose Escalation Study Evaluating MK-1775 in Both Monotherapy and in Combination With Either Gemcitabine, Cisplatin, or Carboplatin in Adult Subjects With Advanced Solid Tumors [NCT00648648]Phase 1206 participants (Actual)Interventional2008-02-25Completed
Chidamide Combined With R-GemOx(Rituximab、Gemcitabine Plus Oxaliplatin) Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Multi-center, Single Arm, Phase II Study [NCT04022005]Phase 254 participants (Actual)Interventional2019-06-19Completed
Phase 2 Open Label Study of Durvalumab With Neoadjuvant Chemotherapy in Variant Histology Bladder Cancer [NCT03912818]Phase 27 participants (Actual)Interventional2019-04-10Terminated(stopped due to Difficulty with enrollment)
An Open-Label Phase 2 Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002 [NCT01608711]Phase 22 participants (Actual)Interventional2012-08-07Completed
[NCT01648517]Phase 260 participants (Actual)Interventional2012-07-27Completed
Phase I Study of Cisplatin, Gemcitabine and Lapatinib as First Line Treatment in Advanced/Metastatic Urothelial Cancer [NCT00623064]Phase 118 participants (Actual)Interventional2007-11-30Completed
Clinical Transformation of Organoid Model to Predict the Efficacy of GC in the Treatment of Intrahepatic Cholangiocarcinoma [NCT05644743]40 participants (Anticipated)Observational2023-01-31Not yet recruiting
A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer [NCT01303172]Phase 2110 participants (Actual)Interventional2011-06-30Completed
A Phase II Trial of Gemcitabine Plus UFTE Combination Chemotherapy as Salvage Treatment in Oxaliplatin, Irinotecan and Fluoropyrimidine-Refractory Metastatic Colorectal Cancer [NCT01409005]Phase 241 participants (Actual)Interventional2011-06-30Completed
Safety of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Biliary Tract Cancer Patients With Peritoneal Metastases [NCT05285358]Phase 112 participants (Anticipated)Interventional2022-09-19Recruiting
Randomized Pilot Study of Supplemental Iscar in Combination With Gemcitabine vs. Gemcitabine Alone as Second Line Treatment for Advanced Non-Small Cell Lung Cancer. [NCT00283478]20 participants (Anticipated)Interventional2004-05-31Completed
Randomized Phase II Trial Assessing the Combination of Nexavar® (Sorafenib), and Gemcitabine/Oxaliplatin in Patients Treated for Advanced (Unresectable/Metastatic) Hepatocellular Carcinoma. [NCT00941967]Phase 278 participants (Actual)Interventional2008-12-31Completed
A Single-arm, Multi-center Phase II Clinical Study on Pegaspargase Combined With Gemcitabine, Etoposide, Liposomal Mitoxantrone Hydrochloride and Dexamethasone (P-GEMD) in the Treatment of Untreated Early Non-upper Respiratory Tract or Advanced Extranodal [NCT05774028]Phase 250 participants (Anticipated)Interventional2023-04-30Not yet recruiting
Second Line Erlitinib Combination With Gemcitabine Cisplatinum in Non-small Cell Lung Cancer Patients Who Harbored EGFR Sensitive Mutation Developed Resistance After First Line TKI Treatment [NCT02098954]Phase 240 participants (Anticipated)Interventional2014-07-01Recruiting
Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers [NCT00885066]Phase 130 participants (Actual)Interventional2008-05-31Completed
Open-label, Multicenter, Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of CD40 Agonistic Monoclonal Antibody (APX005M) Administered Together With Gemcitabine and Nab-Paclitaxel With or Without PD-1 Blocking Antibody (Nivolumab) in Patients [NCT03214250]Phase 1/Phase 2129 participants (Actual)Interventional2017-07-21Completed
An Open Labeled, Multicentre, Randomized Phase II Trial of Combination Gemcitabine and Carboplatin Chemotherapy in Patients With Metastatic or Recurrent Nasopharyngeal Carcinoma [NCT00697905]Phase 218 participants (Actual)Interventional2008-01-31Completed
Prospective Cohort Study of Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy to Prevent Moderate-high Recurrence and Progression Risks of Muscle-invasive Bladder Cancer [NCT02716961]208 participants (Anticipated)Interventional2016-01-31Recruiting
Stereotactic Body Radiation Therapy Plus Pembrolizumab and Trametinib vs. Stereotactic Body Radiation Therapy Plus Gemcitabine for Locally Recurrent Pancreatic Cancer After Surgical Resection: an Open-label, Randomized, Controlled, Phase 2 Trial [NCT02704156]Phase 2170 participants (Actual)Interventional2016-10-31Completed
Phase II Study of the Gemzar, Taxotere and Xeloda Regimen (GTX) for Inoperable or Metastatic Adenocarcinoma of the Biliary System [NCT00868998]Phase 24 participants (Actual)Interventional2005-08-31Terminated(stopped due to Poor patient accrual)
Randomized, Open Label, Stratified Phase 2 Trial of Gemcitabine, Carboplatin, and Cetuximab With Vs. Without IMC-A12 in Chemotherapy-Naive Patients With Advanced/Metastatic Non-Small Cell Lung Cancer [NCT00870870]Phase 264 participants (Actual)Interventional2009-03-31Completed
Phase I Study of Soluble LAG-3 (IMP321) and Gemcitabine in Patients With Advanced Pancreas Cancer [NCT00732082]Phase 118 participants (Actual)Interventional2009-02-28Terminated(stopped due to Company manufacturing study drug was unable to continue production.)
UPCC 10219: Phase II Study Of Stromal Changes Detected By DCE- and DW-MRI In Response To PEGPH20 Combined With Chemotherapy In Subjects With Locally-Advanced Pancreatic Cancer [NCT04134468]Phase 20 participants (Actual)Interventional2020-01-31Withdrawn(stopped due to Halozyme halted development of PEGPH20 following Phase 3 failure.)
The Effect of Pharmacogenetics on Treatment Toxicities and Outcomes in East Asian and Caucasian Patients Undergoing Docetaxel or Gemcitabine-based Chemotherapy [NCT00695994]Phase 2300 participants (Actual)Interventional2006-10-31Completed
A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer [NCT00518011]Phase 217 participants (Actual)Interventional2007-08-31Completed
A Phase II Study of Gemcitabine and Carboplatin in the Treatment of Metastatic or Recurrent Cholangiocarcinoma/Gallbladder Cancer [NCT00660140]Phase 249 participants (Actual)Interventional2002-03-31Completed
A Open-label, Randomized Study of S-1 and and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer [NCT02131493]Phase 280 participants (Anticipated)Interventional2015-01-31Completed
Phase II Trial of Preoperative (Neo-adjuvant) Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer [NCT00193427]Phase 275 participants (Actual)Interventional2004-04-30Completed
Belinostat Combined With Azacitidine/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Refractory or Relapsed Lymphoma [NCT02701673]Phase 1/Phase 20 participants (Actual)Interventional2016-06-30Withdrawn
A Clinical Trial Trial of Gemcitabine in Children With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) [NCT02992015]Early Phase 110 participants (Anticipated)Interventional2016-09-23Recruiting
A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer [NCT00312650]Phase 224 participants Interventional2006-04-30Terminated
A Phase Ib, Open-Label, Multicenter Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Patients With Locally Advanced or Metas [NCT05867121]Phase 1120 participants (Anticipated)Interventional2023-10-02Recruiting
A Randomized Non Comparative Phase II Study of Lacutamab With GemOx Versus GemOx Alone in Relapsed/Refractory Patients With Peripheral T-cell Lymphoma [NCT04984837]Phase 256 participants (Anticipated)Interventional2021-10-05Recruiting
Phase I Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma [NCT02761291]Phase 118 participants (Anticipated)Interventional2016-05-31Recruiting
A Phase II, Multicentre, Randomised Trial Comparing Combination Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC) [NCT02722369]Phase 272 participants (Actual)Interventional2017-03-14Terminated(stopped due to Low recruitment, lack of efficacy and increased adverse events in investigational arm.)
Oxaliplatin, Gemcitabine, and Erlotinib Study in Patients With Advanced Chemo-naïve Pancreatic Cancer [NCT00636883]Phase 29 participants (Actual)Interventional2008-01-31Terminated(stopped due to slow accrual rate)
A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer [NCT00619021]Phase 14 participants (Actual)Interventional2003-01-31Terminated(stopped due to Funding and study drugs unavailable)
Sequential Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus Cisplatin/Docetaxel/Bevacizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer [NCT00620971]Phase 277 participants (Actual)Interventional2008-01-31Completed
A Multi Centre, Pilot Phase II Trial Assessing the Efficacy and Safety of Bevacizumab + Gemcitabine + Carboplatin as First Line Treatment for Patients Diagnosed With Triple Negative Metastatic Breast Cancer [NCT01201265]Phase 240 participants (Actual)Interventional2011-02-28Completed
Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium [NCT00004223]Phase 20 participants Interventional2000-02-24Completed
An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Overall Survival and Disease Progression in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer [NCT00642733]Phase 46 participants (Actual)Interventional2007-08-31Terminated(stopped due to poor recruitment)
A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard Chemotherapy in Metastatic Pancreatic Cancer Patients [NCT02862015]Phase 2100 participants (Anticipated)Interventional2016-08-31Recruiting
A Multicenter Phase Ib Trial to Measure [18F]-Fluorodeoxyglucose Uptake by Positron Emission Tomography in Stage IIIB and IV Non-Small Cell Lung Cancer Before and After Chemotherapy With Gemcitabine and Cisplatin or Carboplatin [NCT00599755]Phase 168 participants (Actual)Interventional2009-01-01Completed
Phase Ib/II Study of Combination of Vorinostat, Carboplatin and Gemcitabine + Vorinostat Maintenance in Women With Recurrent, Platinum-Sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer [NCT00910000]Phase 1/Phase 215 participants (Actual)Interventional2009-06-30Terminated(stopped due to Terminated due to unacceptable toxicity)
Phase I Study of the Tumor-targeting Human L19IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer [NCT01198522]Phase 128 participants (Actual)Interventional2007-06-30Terminated(stopped due to lack of recruitment)
A Phase 2/3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid ®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma [NCT01197560]Phase 2/Phase 3111 participants (Actual)Interventional2010-09-02Completed
Phase 2 Randomized Study Evaluating the Efficacy of Gemcitabine With or Without Oxaliplatin in Patients With Advanced Urothelial Cancer That Cannot be Treated With Cisplatin-based Chemotherapy [NCT00627432]Phase 2100 participants (Anticipated)Interventional2004-07-31Suspended
LUX-Lung 6: A Randomized, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation [NCT01121393]Phase 3364 participants (Actual)Interventional2010-04-19Completed
Multicenter Phase III, Randomized Study to Evaluate Treatment Customized According to RAP80 and BRCA1 Assessment in Patients With Advanced Non-small-cell Lung Cancer [NCT00617656]Phase 3400 participants (Actual)Interventional2008-02-29Terminated(stopped due to No safety reasons. Interim analysis shows that the hypothesis superiority of the experimental arm over the control arm- would not be confirmed.)
Phase 1 Study of Gemcitabine With Vaccine Therapy Targeting Tumor Antigen, URLC10, For The Patients With Unresectable or Recurrent Bile Duct Cancer [NCT00624182]Phase 19 participants (Anticipated)Interventional2008-02-29Suspended
A Multi-Center Randomized Phase IB/II Study of Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04) [NCT04203160]Phase 1/Phase 278 participants (Anticipated)Interventional2020-06-23Recruiting
A Phase Ib Study to Evaluate the Safety and Tolerability of Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Patients With Advanced Solid Tumors. [NCT02658214]Phase 132 participants (Actual)Interventional2016-04-28Completed
A Phase I Dose Escalation Trial of Once Daily Oral Treatment Using Afatinib (BIBW2992) Plus Gemcitabine or Docetaxel in Patients With Relapsed or Refractory Solid Tumors. [NCT01251653]94 participants (Actual)Observational2010-11-30Completed
Randomised Phase II Trial of Bevacizumab (AVASTIN®) in Combination With Gemcitabine or Attenuated Doses of Cisplatin and Gemcitabine as First-line Treatment of Elderly Patients With Advanced Non-squamous Non-small Cell Lung Cancer - EAGLES [NCT01077713]Phase 286 participants (Actual)Interventional2010-02-28Completed
A Two-arm, Open-label, Randomized Phase III Study of Pembrolizumab (MK-3475) Monotherapy Versus Standard Chemotherapy in Platinum Pre-treated, Recurrent or Metastatic Nasopharyngeal Cancer (NPC) (Keynote-122) [NCT02611960]Phase 3233 participants (Actual)Interventional2016-04-18Completed
Toripalimab Combined With Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 3, Multi-center, Randomized Controlled Trial [NCT04907370]Phase 3540 participants (Actual)Interventional2021-08-01Active, not recruiting
Phase I/II Study of Preoperative Gemcitabine in Combination With Oral Hydroxychloroquine (GcHc) in Subjects With High Risk Stage IIb or III Adenocarcinoma of the Pancreas [NCT01128296]Phase 1/Phase 235 participants (Actual)Interventional2010-10-31Completed
Prospective Phase II Trial of a Combination of Gemcitabine and UFT as First-Line Treatment in Elderly Patients With Advanced Non-Small Cell Carcinoma [NCT00625352]Phase 248 participants (Anticipated)Interventional2008-02-29Recruiting
A Randomised Phase II Trial of Inotuzumab Ozogamicin Plus Rituximab & CVP (IO-R-CVP) vs Gemcitabine Plus Rituximab & CVP (Gem-R-CVP) for the First Line Treatment of Patients With DLBCL Who Are Not Suitable for Anthracycline Containing Chemotherapy [NCT01679119]Phase 2129 participants (Actual)Interventional2013-10-31Completed
A Phase 1 Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab in Adults With Advanced Solid Tumors [NCT02628574]Phase 1109 participants (Actual)Interventional2016-01-31Completed
A Phase II Study of Bevacizumab Plus Docetaxel and Gemcitabine in Subjects With Advanced, Previously Untreated, Non-Squamous Non-Small Cell Lung Cancer [NCT00970684]Phase 213 participants (Actual)Interventional2009-09-30Completed
Phase II Trial Of Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes [NCT00887809]Phase 247 participants (Actual)Interventional2009-04-30Completed
Randomized Phase III Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment: NItCHE Trial (MITO 33) [NCT04679064]Phase 3427 participants (Anticipated)Interventional2020-12-01Recruiting
A Prospective, Randomized, Open-label, Multicenter, Parallel Design, Phase III Study to Assess the Efficacy and Safety of GV1001 Concurrent With Gemcitabine/Capecitabine Versus Gemcitabine/Capecitabine Alone in Treating Locally Advanced and Metastatic Pan [NCT02854072]Phase 3148 participants (Anticipated)Interventional2015-11-30Recruiting
A Phase Ib, Open-Label, Dose- Escalation Trial of ACY-1215 in Combination With Gemcitabine and Cisplatin in Patients With Unresectable or Metastatic Cholangiocarcinoma [NCT02856568]Phase 10 participants (Actual)Interventional2017-05-01Withdrawn(stopped due to Site dropped study)
Pilot Study of Gemcitabine and IORT/EBRT in Locally Advanced Upper Gastrointestinal Malignancies [NCT00544193]Phase 116 participants (Actual)Interventional1997-12-31Completed
A Prospective, Open-label Randomized Clinical Trial of a Single Bladder Instillation of Mitomycin C vs. Gemcitabine vs. No Additional Treatment Immediately After Transurethral Resection of Bladder Tumor (TURBT) [NCT02695771]Phase 3101 participants (Actual)Interventional2016-04-19Completed
A Phase I Study of LBH589 in Combination With Gemcitabine in the Treatment of Solid Tumors [NCT00550199]Phase 117 participants (Actual)Interventional2007-11-30Terminated(stopped due to Study terminated due to LBH589 toxicity.)
An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Le [NCT01956812]Phase 3334 participants (Actual)Interventional2013-12-31Terminated(stopped due to The DSMB conducted an interim analysis on overall survival, which showed that the treatment arm did not demonstrate a sufficient improvement in OS vs. placebo.)
Official Title: A Phase 1B/2 Study of the Safety and Tolerability of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors [NCT01858883]Phase 1/Phase 255 participants (Actual)Interventional2013-06-30Completed
A Randomized Phase I/II Study With Gemcitabine and RTA 402 or Gemcitabine and Placebo for Patients With Unresectable Pancreatic Cancer [NCT00529113]Phase 133 participants (Actual)Interventional2007-09-30Terminated(stopped due to To pursue other indications)
Induction Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma A Prospective Evaluation in Patients With Locally Advanced Pancreas Cancer [NCT01360593]Phase 235 participants (Actual)Interventional2011-07-25Completed
A National, Multi Center, Randomized, Open-label, Phase II Trial of Erlotinib Versus Combination of GC as (Neo)Adjuvant Treatment in Stage IIIA-N2 NSCLC With Sensitizing EGFR Mutation in Exon 19 or 21(EMERGING) [NCT01407822]Phase 2/Phase 372 participants (Actual)Interventional2011-12-05Active, not recruiting
Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer [NCT01411072]20 participants (Anticipated)Interventional2011-09-30Recruiting
Phase I/II Trial of Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in Metastatic Pancreatic Adenocarcinoma [NCT01415713]Phase 1/Phase 273 participants (Actual)Interventional2012-03-31Completed
Pharmacogenetics of Gemcitabine: Study of the Impact of Genetic Polymorphism of Cytidine Deaminase (CDA) on Toxicity in Resected Pancreatic Adenocarcinomas [NCT01416662]Phase 2120 participants (Actual)Interventional2011-06-30Completed
Randomized Phase Ⅱ Trial of Induction Chemotherapy Using Gemcitabine and Cisplatin in Concurrence With Intensity-modulated Radiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma [NCT01417390]Phase 280 participants (Anticipated)Interventional2011-11-30Recruiting
Sequential Administration of Docetaxel/Gemcitabine Followed by Concurrent Chemo-radiotherapy, With or Without Consolidation Chemotherapy, as First Line Treatment in Patients With Unresectable Stage IIIA/IIIB NSCLC. A Randomized Phase II Study [NCT00431613]Phase 238 participants (Actual)Interventional2006-03-31Terminated(stopped due to Due to Poor Accrual)
Vorinostat (SAHA) Combined With High-Dose Gemcitabine, Busulfan, and Melphalan With Autologous Hematopoietic Cell Support for Patients With Relapsed or Refractory Lymphoid Malignancies [NCT01421173]Phase 178 participants (Actual)Interventional2011-08-31Completed
Phase I/II Multicentre Trial of Salvage Chemotherapy With Gem-TIP for Relapsed Germ Cell Cancer [NCT00551122]Phase 1/Phase 223 participants (Anticipated)Interventional2006-11-30Recruiting
Phase II Study of Gemcitabine and Epirubicin for the Treatment of Mesothelioma [NCT00017186]Phase 269 participants (Actual)Interventional2001-07-31Completed
Individualized 1st Line Chemotherapy Based on BRCA1 and RRM1 mRNA Expression Levels for Advanced Non-small Cell Lung Cancer [NCT01424709]Phase 2120 participants (Anticipated)Interventional2010-12-31Active, not recruiting
A Phase IB Combination Study of MEK Inhibitor GSK1120212 With Gemcitabine in Subjects With Solid Tumors [NCT01428427]Phase 131 participants (Actual)Interventional2009-08-12Completed
Randomized Phase II Study Comparing Gemcitabine/S-1 Combination Chemoradiotherapy With Gemcitabine/S-1 Combination Chemotherapy for Unresectable Locally Advanced Pancreatic Cancer. [NCT01430052]Phase 2110 participants (Actual)Interventional2009-04-30Completed
Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study [NCT03478488]Phase 3480 participants (Anticipated)Interventional2018-04-16Recruiting
Phase II Randomized Trial of S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) vs Gemcitabine and Cisplatin (GC) in Locally Advanced or Metastatic Biliary Tract Cancer [NCT03406299]Phase 292 participants (Actual)Interventional2018-04-19Active, not recruiting
Phase IB Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma [NCT00276055]Phase 138 participants (Actual)Interventional2005-11-30Completed
A Pilot Study of Outpatient Vinorelbine and Gemcitabine With Filgrastim Support for Patients With Relapsed or Refractory Lymphoma. [NCT00163748]Phase 240 participants Interventional2001-02-28Completed
A Randomized Phase III Comparison of Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Elderly or Poor Performance Status Patients With Advanced Non-Small Cell Lung Cancer [NCT00193323]Phase 2346 participants Interventional2001-08-31Completed
Phase III Randomized Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine as First-Line Chemotherapy for Stage IIIB and IV Non-Small Cell Lung Cancer [NCT00193362]Phase 3200 participants Interventional2004-06-30Completed
A Phase I Trial of Biweekly Gemcitabine & Paclitaxel & Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent Head & Neck Cancer [NCT00176241]Phase 17 participants (Actual)Interventional2005-12-31Terminated(stopped due to Slow accrual)
A Prospective, Single Arm, Multicenter, Phase II Trial of Gemcitabine Plus Cisplatin in the Treatment of Patients With Non-pCR Triple Negative Breast Cancer Following Neoadjuvant Chemotherapy [NCT04297267]Phase 2100 participants (Anticipated)Interventional2017-02-07Active, not recruiting
First Line Treatment of Stage IIIb/IV Non Small Cell (NSC) Lung Cancer With a Bimonthly Administration of a Combination of Cisplatin-Gemcitabine [NCT00006116]Phase 20 participants Interventional1999-04-30Active, not recruiting
A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) Versus Carboplatin/Paclitaxel (CP) as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT00087802]Phase 3383 participants (Actual)Interventional2004-03-31Completed
A Randomized Phase III Trial Of Gemcitabine Plus Bevacizumab (NSC#704865 IND#7621) Versus Gemcitabine Plus Placebo In Patients With Advanced Pancreatic Cancer [NCT00088894]Phase 3590 participants (Actual)Interventional2004-06-30Completed
Evaluation of Gemcitabine in Persistent or Recurrent Non-Squamous Cell Carcinoma of the Cervix [NCT00006224]Phase 20 participants Interventional2000-09-30Terminated
A Phase II Clinical Trial of Cisplatin + Gemcitabine HCl (GEM) + Low-Dose Metronomic Interferon-a (IFN-a) Combined With Fever-Range Whole-Body Thermal Therapy (FR-WB-TT) in Patients With Metastatic/or Locally Advanced Malignancies (Small-Cell Lung Cancer, [NCT00178698]Phase 236 participants (Anticipated)Interventional2002-07-31Recruiting
A Phase I/II Study Of Lenalidomide (Revlimid ) In Combination With Gemcitabine In Patients With Untreated Advanced Carcinoma Of The Pancreas [NCT00179751]Phase 1/Phase 250 participants Interventional2005-04-30Terminated
Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External Beam Radiation Followed by Gemcitabine in Patients With Locally Advanced Pancreatic Cancer [NCT00096070]Phase 250 participants (Actual)Interventional2004-12-31Completed
Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC [NCT00198354]Phase 3530 participants (Actual)Interventional2001-05-31Completed
Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV [NCT00198393]Phase 2126 participants (Actual)Interventional2004-11-30Completed
A Phase I Study of Halichondrin B Analog E7389 in Combination With Gemcitabine in Patients With Refractory or Advanced Solid Tumors [NCT00410553]Phase 145 participants (Actual)Interventional2006-11-14Completed
XACT-Pancreas 2: Pharmacological Ascorbate, Gemcitabine, and Radiation Therapy for Pancreatic Cancer, Phase 2 [NCT03541486]Phase 260 participants (Anticipated)Interventional2025-12-31Not yet recruiting
An Open-label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0575 Administered Alone and in Combination With Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma [NCT01564251]Phase 1104 participants (Actual)Interventional2012-03-23Completed
A Phase II Feasibility Study of Sorafenib and Gemcitabine Combination Treatment in Patients With Advanced Hepatocellular Carcinoma [NCT00844688]Phase 230 participants (Anticipated)Interventional2008-09-30Recruiting
Phase III Randomized Trial of High Dose Chemoradiation and Systemic Chemotherapy vs Systemic Chemotherapy Alone in Patients With Unresectable Nonmetastatic Cholangiocarcinoma [NCT02773485]Phase 3155 participants (Anticipated)Interventional2015-05-31Recruiting
A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer [NCT00173888]Phase 215 participants (Actual)Interventional2003-07-31Completed
A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First-Line Treatment in Patients With Metastatic Pancreatic Cancer [NCT00617708]Phase 1/Phase 2134 participants (Actual)Interventional2008-03-31Completed
Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Chemotherapy for Pancreatic Cancer Peritoneal Metastases - A Single-arm, Open-label, Phase II Trial: Nab-PIPAC Trial [NCT05371223]Phase 238 participants (Anticipated)Interventional2022-03-01Recruiting
Open-Label, Cooperative, Randomized, Multicenter Phase III Study on the Use of Cisplatin Resistant Genotype (ERCC1 Over-Expression) in Tumor RNA to Customize Chemotherapy in Stage IV-IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer Patients [NCT00174629]Phase 3449 participants (Actual)Interventional2001-06-30Completed
Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy [NCT02844114]Phase 260 participants (Anticipated)Interventional2016-01-31Recruiting
A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy [NCT04628767]Phase 2/Phase 3249 participants (Anticipated)Interventional2021-11-12Recruiting
A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects With Non-Muscle-Invasive Urothelial Carcinoma of the Bladder [NCT02720367]Phase 112 participants (Actual)Interventional2016-01-31Completed
A Phase 1, First in Human, Dose-Escalation Study of UCT-01-097 in Participants With Advanced Solid Tumors [NCT04761601]Phase 1106 participants (Anticipated)Interventional2021-03-03Recruiting
Prospective Phase I Study of Gax (Gemcitabine, ABRAXANE, and Xeloda) for Metastatic Pancreatic Cancer Protocol # TSH - APG - 2015-01 [NCT02581501]Phase 10 participants (Actual)Interventional2016-02-29Withdrawn(stopped due to Due to no enrollment, Celgene (sponsor) withdrew funding)
A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer. [NCT00199758]Phase 2227 participants Interventional2003-09-30Completed
Randomized Phase II Study Assessing the Combination of Vinflunine With Gemcitabine and Vinflunine With Carboplatin in Patients Ineligible to Cisplatin With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium [NCT01599013]Phase 269 participants (Actual)Interventional2011-02-28Completed
Gemcitabine Combined With Busulfan and Melphalan, With Hematopoietic Cell Transplantation, for Patients With Poor-prognosis Advanced Lymphoid Malignancies [NCT00410982]Phase 1145 participants (Actual)Interventional2006-12-31Completed
A Randomized Phase 3 Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin as First-Line Treatment in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer. [NCT01005680]Phase 3256 participants (Actual)Interventional2009-11-30Completed
Phase II Study of Gemcitabine, Cisplatin, and Celecoxib in the Treatment of Metastatic Pancreatic Cancer [NCT00176813]Phase 25 participants (Actual)Interventional2003-03-31Completed
Phase II Clinical Trial of Cisplatin + Gemcitabine in Combination With Mild, Fever-Range Whole-Body Hyperthermia to Treat Patients With Advanced, Inoperable Pancreatic Cancer [NCT00178763]Phase 236 participants (Anticipated)Interventional2003-09-30Recruiting
A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPD [NCT04935359]Phase 3511 participants (Actual)Interventional2021-09-30Active, not recruiting
Phase Ib/IIa Study to Evaluate Safety and Efficacy of Treatment With the Hedgehog Inhibitor NLM-001 and Chemotherapy (Gemcitabine and Nab-Paclitaxel) Plus Zalifrelimab as First Line Treatment in Patients With Advanced Pancreatic Cancer [NCT04827953]Phase 1/Phase 228 participants (Anticipated)Interventional2021-09-01Active, not recruiting
Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer [NCT03775265]Phase 3475 participants (Anticipated)Interventional2019-06-03Recruiting
A Phase I Study of ADH-1 and Gemcitabine Plus Cisplatin in Patients With Unresectable or Metastatic Pancreatic and Biliary Tract Cancers [NCT01825603]Phase 117 participants (Actual)Interventional2013-04-09Completed
Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer [NCT00150657]Phase 245 participants Interventional2004-11-30Recruiting
A Randomized Phase II Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Patients With Intermediate Stage Hodgkin's Lymphoma [NCT00512980]Phase 20 participants Interventional2008-08-31Terminated(stopped due to lower recruitment rates as expected)
Multicenter Phase II Trial of Gefitinib (Iressa™) First Line Therapy Followed by Chemotherapy in Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT00217698]Phase 263 participants (Actual)Interventional2003-11-30Completed
A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 in Combination With Gemcitabine in the Treatment of Patients With Advanced Solid Tumours [NCT00515866]Phase 168 participants (Actual)Interventional2007-08-31Completed
Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma [NCT00212043]Phase 274 participants Interventional2000-07-31Completed
Phase II Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Losartan Followed by Stereotactic Radiotherapy for Locally Advanced Pancreatic Cancer: OVERPASS Trial [NCT05861336]Phase 234 participants (Anticipated)Interventional2023-05-31Not yet recruiting
A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer. [NCT00220155]Phase 216 participants (Actual)Interventional2004-05-31Completed
A Multicenter, Open-label, Phase II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Combination With Chemotherapy as First-line Treatment in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer [NCT05859750]Phase 260 participants (Anticipated)Interventional2023-05-31Not yet recruiting
Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages(T2N0, T1 - 2N1, T3N0 AND T3N1) Non-Small Cell Lung Cancer (NSCLC) [NCT00191126]Phase 3263 participants (Actual)Interventional2000-09-30Completed
A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer [NCT00191243]Phase 2237 participants (Actual)Interventional2002-03-31Completed
Phase I Study of Precision CRT for Liver-Dominant Metastatic Pancreatic Cancer With Homologous Recombination Deficiency (PreCISeRT) [NCT05182112]Phase 11 participants (Actual)Interventional2021-12-20Active, not recruiting
1911GCCC:Two Parallel, Single-arm, Open Label, Phase 2 Trials of Galeterone Alone or Galeterone Combined With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Standard Chemotherapy [NCT04098081]Phase 258 participants (Anticipated)Interventional2019-12-12Recruiting
A Randomized Phase II Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer [NCT00192049]Phase 290 participants Interventional2003-12-31Completed
A Phase 2 Evaluation of the Monoclonal Antibody, RAV12, in Combination With Standard Gemcitabine in the Treatment of Patients With Metastatic Pancreatic Cancer Who Have Not Been Previously Treated for Metastatic Disease [NCT00625586]Phase 22 participants (Actual)Interventional2008-04-15Terminated(stopped due to Corporate decision)
GAMBIT Trial: A Randomized,Non-comparative, Open-label Clinical Trial Evaluating Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer [NCT01859728]Phase 248 participants (Anticipated)Interventional2013-01-31Recruiting
Phase III Study of Docetaxel in Combination With Gemcitabine Versus Docetaxel in Combination With Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer [NCT00191438]Phase 3300 participants Interventional2002-10-31Completed
Phase II Study of 6 Weeks Intravesical Gemcitabine Instillation Followed By Transurethral Resection in Patients Affected By Superficial Bladder Cancer at Low Risk [NCT00191711]Phase 243 participants Interventional2004-02-29Completed
A Phase II Trial of Gemcitabine (Gemzar) Combined With Vinorelbine as First Line Chemotherapy for Metastatic Breast Cancer [NCT00192062]Phase 280 participants Interventional2004-07-31Completed
Randomized Phase II Study of the Combination of Gemcitabine (Gemzar) Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines an/or Taxanes [NCT00192101]Phase 2100 participants Interventional2004-10-31Completed
A Phase II Randomized Study of Induction Chemotherapy Followed by Concurrent Chemo-radiotherapy in Locally Advanced Pancreatic Cancer [NCT01867892]Phase 286 participants (Anticipated)Interventional2013-06-30Enrolling by invitation
Phase II Study of Six Hours, Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma. [NCT01869023]Phase 226 participants (Anticipated)Interventional2010-11-30Active, not recruiting
Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy With or Without Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT01872962]Phase 3480 participants (Actual)Interventional2013-11-30Active, not recruiting
PhAse 1/2 StuDy of Modern ImmunotherApy in BCG-Unresponsive, BCG-RelaPsing, and High-Risk BCG-Naive Non-muscle Invasive UroThelial Carcinoma of the BLADDER [NCT03317158]Phase 1/Phase 255 participants (Anticipated)Interventional2017-11-21Recruiting
Multi-agent Low Dose Chemotherapy (Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, Irinotecan) Followed by Maintenance Olaparib and Pembrolizumab in Untreated Metastatic Pancreatic Ductal Adenocarcinoma. [NCT04753879]Phase 238 participants (Anticipated)Interventional2021-09-29Recruiting
Phase 2 Study of Preoperative Chemotherapy With Abraxane and Gemcitabine Followed by Chemoradiation for Borderline Resectable or Node-Positive Pancreatic Cancer [NCT02427841]Phase 220 participants (Actual)Interventional2016-01-21Completed
Prospective Exploratory Study of Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Postoperative Recurrence of Pancreatic Cancer [NCT04902261]Phase 2140 participants (Anticipated)Interventional2020-11-20Recruiting
A Muti-center, Open-label, Randomized, Phase III Study of Camrelizumab Plus Treatment of Physician Choice Versus Treatment of Physician Choice for Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Systemic Chemotherapy Regimens for [NCT05134194]Phase 3104 participants (Anticipated)Interventional2021-11-30Not yet recruiting
Definitive Chemoradiation With Gemcitabine and Continuous 5- FU (Fluorouracil)Followed by High Dose Rate Brachytherapy or Stereotactic Body Radiation Therapy Boost in Locally Advanced Intra or Extrahepatic Cholangiocarcinoma [NCT00983541]Phase 21 participants (Actual)Interventional2009-09-30Terminated(stopped due to Low enrollment)
A Prospective, Multicenter, Randomized Controlled Clinical Study of Blue Laser-5ALA-photodynamic Therapy (PDT) in the Prevention of Postoperative Tumor Recurrence in High-risk Non-muscle-invasive Bladder Cancer [NCT05547516]140 participants (Anticipated)Interventional2022-09-13Not yet recruiting
A Prospective Phase II Study of Risk-stratification Based Bladder-sparing Modalities for Muscle-invasive Bladder Cancer After Chemotherapy Combined With PD-1 Antibody(Rebirth) [NCT05531123]Phase 230 participants (Anticipated)Interventional2022-09-10Recruiting
Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC [NCT02998528]Phase 3505 participants (Actual)Interventional2017-03-04Active, not recruiting
A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma [NCT00942331]Phase 3506 participants (Actual)Interventional2009-07-15Completed
A Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the First Line Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer [NCT01851174]Phase 215 participants (Actual)Interventional2013-02-28Terminated(stopped due to PI Leaving Site)
A Phase II Study of Induction Consolidation and Maintenance Approach for Patients With Advanced Pancreatic Cancer [NCT01488552]Phase 1/Phase 260 participants (Actual)Interventional2011-11-30Completed
Phase I Trial of Dose-Dense Gemcitabine, Doxorubicin, Then Paclitaxel Plus Carboplatin In Patients With Transitional Cell Carcinoma of the Urothelium and Impaired Renal Function [NCT00003342]Phase 130 participants (Anticipated)Interventional1997-12-31Completed
A Phase I Feasibility Trial of Carboplatin, Paclitaxel, and Gemcitabine in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal Carcinoma [NCT00003378]Phase 145 participants (Anticipated)Interventional1998-08-31Terminated
Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol [NCT00003540]Phase 230 participants (Anticipated)Interventional1998-06-30Completed
Phase II Chemoradiation Trial Using Gemcitabine in Patients With Locoregional Adenocarcinoma of the Pancreas [NCT00003546]Phase 243 participants (Actual)Interventional1998-09-30Completed
An Open Label Randomized Trial Comparing the Safety and Efficacy of Systemic Chemotherapy (Gemcitabine) to Immunotherapy (CYTOIMPLANT - Intra Tumor Implants of Allogeneic Peripheral Blood Mononuclear Cells Sensitized Against Patient Alloantigens by Mixed [NCT00003780]Phase 2150 participants (Anticipated)Interventional1998-12-31Active, not recruiting
Phase I Study of Oxaliplatin in Combination With 5-Fluorouracil and Gemcitabine in Patients With Solid Tumors [NCT00004242]Phase 130 participants (Actual)Interventional1999-10-31Completed
Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer [NCT00247416]Phase 260 participants (Actual)Interventional2005-08-31Completed
Randomized Phase III Multicenter Trial of Customized Chemotherapy Versus Standard of Care for1st Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer [NCT03402048]Phase 3567 participants (Anticipated)Interventional2012-07-31Recruiting
A Phase 1b/2 Dose Escalation and Expansion Trial of NC-6004 (Nanoparticle Cisplatin) Plus Gemcitabine in Patients With Advanced Solid Tumors or Non-Small Cell Lung, Biliary Tract, and Bladder Cancer [NCT02240238]Phase 1/Phase 2209 participants (Anticipated)Interventional2014-05-31Completed
A Neoadjuvant Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer [NCT02243358]Phase 224 participants (Actual)Interventional2014-02-28Completed
A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small C [NCT02352948]Phase 3597 participants (Actual)Interventional2015-01-13Completed
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer [NCT01472770]Phase 249 participants (Actual)Interventional2011-10-31Completed
Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma [NCT00337259]Phase 243 participants (Actual)Interventional2006-06-30Terminated(stopped due to poor accrual and response less than expected on interim analysis)
Gemcitabine Plus Carboplatin in Patients With Pretreated Metastatic Breast Cancer [NCT00450762]Phase 20 participants Interventional2004-03-31Completed
A Randomized Discontinuation Trial to Determine the Clinical Benefit of Continuation of Sorafenib Following Disease Progression in Patients With Advanced Renal Cell Carcinoma [NCT00352859]Phase 42 participants (Actual)Interventional2006-08-31Terminated
A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer [NCT01550848]Phase 284 participants (Anticipated)Interventional2012-01-31Completed
A Phase II Randomized Study of Chemo-Anticoagulation (Gemcitabine-Dalteparin) Versus Chemotherapy Alone (Gemcitabine) for Locally Advanced and Metastatic Pancreatic Adenocarcinoma [FRAGEM] [NCT00462852]Phase 2120 participants (Anticipated)Interventional2003-04-30Completed
A Multicenter Phase II Study of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation in Patients With Non-resectable Stage III Non-Small-Cell-Lung Cancer [NCT00463515]Phase 277 participants Interventional2003-01-31Completed
Efficacy and Safety of Concurrent Chemoradiotherapy Combined With Immunotherapy in Patients With Potentially Resectable Pancreatic Cancer [NCT05634564]Phase 262 participants (Anticipated)Interventional2020-06-01Recruiting
Chidamide Combined With Cladribine/Gemcitabine/Busulfan (ChiCGB) With Autologous Stem-Cell Transplantation in Relapsed and Refractory Diffuse Large B Cell Lymphoma [NCT03151876]Phase 293 participants (Anticipated)Interventional2017-06-12Recruiting
A Phase II Randomized Trial Assessing the Combination of Gemcitabine and Pemetrexed in the First Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer [NCT00434135]Phase 2180 participants (Anticipated)Interventional2006-05-31Completed
Phase I Evaluation Of Carboplatin And Gemcitabine [NCT00021346]Phase 18 participants (Actual)Interventional1997-11-30Completed
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered as a Single Agent and in Combination With Gemcitabine in Subjects With Advanced Malignancies [NCT00475917]Phase 128 participants (Actual)Interventional2007-05-31Terminated
Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial [NCT00441740]Phase 3419 participants (Actual)Interventional2004-04-30Completed
A Multicenter Randomized Phase III Study of Gemcitabine Plus Herceptin Combination Versus the Capecitabine Plus Herceptin Combination in Pretreated Patients With HER-2 Positive Metastatic Breast Cancer [NCT00440622]Phase 390 participants (Actual)Interventional2003-04-30Terminated(stopped due to Due to poor accrual)
Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients [NCT03278015]Phase 290 participants (Anticipated)Interventional2017-10-01Not yet recruiting
A Multicenter Randomized Phase III Study of the Docetaxel and Gemcitabine Combination Versus Monotherapy With Gemcitabine as First-line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC) [NCT00442026]Phase 3106 participants (Actual)Interventional2006-12-31Terminated(stopped due to Due to poor accrual)
Randomized Fase II Trial: Comparing Cisplatin, Paclitaxel and Gemcitabine Versus Cisplatin, Paclitaxel, Gemcitabine and Avastin in Patients With Unknown Primary Tumors [NCT00458315]Phase 20 participants (Actual)Interventional2007-05-31Withdrawn(stopped due to never been started)
A Phase Ib, Multi-Center, Open-Label, Dose Escalation Trial of Intravenous PR-104 Given in Combination With Docetaxel or Gemcitabine in Subjects With Solid Tumors [NCT00459836]Phase 142 participants (Actual)Interventional2007-02-28Completed
A Phase II Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer [NCT01570582]Phase 2314 participants (Anticipated)Interventional2010-03-31Active, not recruiting
A Multicenter, Randomized Trial Comparing a Combined Gemcitabine and Cisplatin 3-Week Regimen With a 4-Week Regimen in Non-Small Cell Lung Cancer Patients [NCT00489996]Phase 2100 participants (Actual)Interventional2003-01-31Completed
A Phase II Trial of Perioperative Chemotherapy (Gemcitabine and Cisplatin) and Adjuvant Chemoradiotherapy (-With Weekly Low-Dose Gemcitabine) in the Treatment of Nodes Positive NSCLC Patients [NCT00490659]Phase 213 participants (Actual)Interventional2003-09-30Completed
Phase II Study of Cisplatin With Gemcitabine in Fixed Dose Rate Infusion and Dexamethasone in Second-Line in Patients With Aggressive Non-Hodgkin's Lymphoma [NCT00491127]Phase 210 participants (Actual)Interventional2003-04-30Completed
Randomized Phase III Study of Gemcitabine Versus TS-1 Versus Gemcitabine Plus TS-1 in Unresectable Advanced Pancreatic Cancer (With Local Progression or Metastasis) [NCT00498225]Phase 3834 participants (Actual)Interventional2007-07-31Completed
A Phase II Trial of Low-dose Gemcitabine in Prolonged Infusion and Cisplatin in Treatment of Malignant Pleural Mesothelioma [NCT01243632]Phase 278 participants (Actual)Interventional2002-12-31Completed
Clinical Study of Tumor Treating Fields Combined With Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer [NCT05653453]Phase 3512 participants (Anticipated)Interventional2022-12-20Not yet recruiting
ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial [NCT00061477]Phase 248 participants Interventional2002-12-31Completed
Phase II Trial of Enzastaurin Plus Carboplatin and Gemcitabine (ECoG) in Bevacizumab-Ineligible Patients and Enzastaurin Plus Carboplatin, Gemcitabine and Bevacizumab (B-ECoG) in Bevacizumab-Eligible Patients With Advanced Non-Small Cell Lung Cancer (NSCL [NCT00469976]Phase 20 participants (Actual)Interventional2007-06-30Withdrawn(stopped due to ECOG will not proceed with activation)
A Phase II Study of Carboplatin in Combination With Gemcitabine as a Dose Dense Schedule in Patients With Locally Advanced or Metastatic Breast Cancer That Are Resistant to Anthracyclines & Taxanes [NCT00470249]Phase 25 participants (Actual)Interventional2006-07-15Terminated(stopped due to Due to difficulty in recruitment)
Phase Ⅱ Study of Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC [NCT00601159]Phase 270 participants (Actual)Interventional2007-09-30Completed
Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Gemcitabine and Capecitabine in Combination With Cetuximab in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma. A Phase II Trial. [NCT01247337]Phase 256 participants (Actual)Interventional2011-02-02Completed
A Phase I Trial of GemCap-T, Capecitabine in Combination With Gemcitabine and Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma [NCT00480584]Phase 120 participants (Actual)Interventional2007-04-30Completed
A Phase II, Single-center, Randomized Study of Eribulin Plus Cisplatin (EP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer [NCT04517292]Phase 2160 participants (Anticipated)Interventional2020-10-08Not yet recruiting
A Multicenter Phase 2 Randomized Trial of Single-Agent ALIMTA or ALIMTA With Sequentially Administered GEMZAR as First-Line Chemotherapy in Elderly Patients or Patients Who Are Not Eligible for Platinum-Based Chemotherapy With Advanced NSCLC [NCT00489983]Phase 291 participants (Actual)Interventional2003-07-31Completed
A Dose-Escalation Trial Of The Combination Of Docetaxel, Gemcitabine And Filgrastim (NEUPOGEN) For The Treatment Of Patients With Advanced Solid Tumors [NCT00014456]Phase 135 participants (Actual)Interventional2000-03-31Completed
The Evaluation of Efficacy and Toxicity of Combined Treatment: Neoadjuvant Chemotherapy (Gemcitabine and Cisplatin) With Radical Cystectomy or Radiotherapy in Patients With Bladder Cancer Stage T2b-T3 NO/Nx M0 [NCT00490880]Phase 22 participants (Actual)Interventional2003-11-30Completed
Phase II Clinical Trial, Non-Randomized, Multicentre, on the Combination of Gemcitabine, Capecitabine and Sorafenib (Bay 43-9006) in Treatment of Patients With Unresectable and/or Metastatic Renal Cell Carcinoma (RCC) [NCT00496301]Phase 240 participants (Anticipated)Interventional2006-11-30Completed
Disposition of [14C]LY2603618 Following Intravenous Administration in Patients With Advanced and/or Metastatic Solid Tumors [NCT01296568]Phase 13 participants (Actual)Interventional2011-02-28Completed
A Randomized, Open Label, Phase II Proof of Concept Study of WX-671 in Combination With Gemcitabine vs.Gemcitabine Alone in Patients With Locally Advanced, Non Resectable Pancreatic Cancer in Order to Evaluate the Anti-Tumor Activity of the Combination Th [NCT00499265]Phase 295 participants (Actual)Interventional2007-04-30Completed
IIT2020-02-Gong-GlutaPanc: Phase I Trial of First-line L-glutamine With Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer (GlutaPanc) [NCT04634539]Phase 118 participants (Actual)Interventional2021-05-13Active, not recruiting
An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma [NCT04083235]Phase 3770 participants (Actual)Interventional2020-02-11Active, not recruiting
A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Panc [NCT03816163]Phase 2369 participants (Anticipated)Interventional2019-03-15Recruiting
Phase I Trial of Intra-tumoral Gemcitabine Therapy for Locally Advanced Pancreatic Carcinoma [NCT01893294]Phase 11 participants (Actual)Interventional2013-04-30Completed
A Phase II Study of Gemcitabine in Combination With Oxaliplatin as First Line Chemotherapy in Patients With Inoperable Biliary Tract Adenocarcinoma [NCT00504192]Phase 240 participants (Actual)Interventional2006-09-30Completed
Phase I Study of the Combination of MLN8237 and Gemcitabine in Advanced Solid Tumors With Emphasis on Pancreatic Cancer [NCT01924260]Phase 126 participants (Actual)Interventional2013-08-09Completed
Phase II Trial of Alimta (Pemetrexed) and Gemzar (Gemcitabine) in Metastatic Breast Cancer Patients Who Have Received Prior Taxane Therapy [NCT00063570]Phase 273 participants (Actual)Interventional2003-07-31Completed
[NCT02940990]Phase 250 participants (Anticipated)Interventional2016-11-30Not yet recruiting
Phase II Study of Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer [NCT00159445]Phase 253 participants (Anticipated)Interventional2004-03-31Completed
A Pilot Study of Bevacizumab Based Peri-Operative Therapy for Operable Pancreatic Adenocarcinoma [NCT00524069]0 participants (Actual)Interventional2007-01-31Withdrawn(stopped due to Withdrawn due to no accrual)
A Randomized, Double Blinding, Placebo-Controlled Clinical Trials of CD8+NKG2D+ AKT Cell Immunotherapy to the Pancreatic Cancer Patients Treated With Adjuvant Chemotherapy [NCT02929797]Early Phase 172 participants (Anticipated)Interventional2016-08-31Recruiting
Gemcitabine Versus Cisplatin and Gemcitabine in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer in Poor Physical Condition (Performance Status 2) [NCT00526643]Phase 357 participants (Actual)Interventional2007-11-30Terminated(stopped due to scarce enrolment and presentation of positive results of similar study in June 2012.)
A Multicenter, Phase 2 Study of Gemcitabine-Carboplatin Plus Necitumumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) [NCT02941601]Phase 20 participants (Actual)Interventional2016-11-30Withdrawn(stopped due to This was a strategic decision for business planning purposes and not out of concern for patient safety.)
Randomized Phase II Study on Decitabine Plus Carboplatin Versus Physician's Choice Chemotherapy in Recurrent, Platinum-resistant Ovarian Cancer. [NCT03467178]Phase 2119 participants (Anticipated)Interventional2018-07-30Recruiting
Phase II Study of Neo-adjuvant Chemoradiotherapy Using Infusional Gemcitabine Followed by Surgery for Locally Advanced (T3 and T4 or Node Positive) Rectal Adenocarcinoma [NCT02919878]Phase 225 participants (Anticipated)Interventional2014-12-31Recruiting
A Phase II Study of Gemcitabine in Combination With Vinorelbine vs. Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer [NCT00532623]Phase 282 participants (Actual)Interventional2004-05-31Completed
Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab in Patients With HER2 Positive Operable Breast Cancer [NCT00532857]Phase 253 participants (Actual)Interventional2007-03-31Completed
Inoperable Non-Squamous NSCLC Stage III/IV: A Randomised Phase II Study With Bevacizumab Plus Erlotinib Or Gemcitabin/Cisplatin Plus Bevacizumab [NCT00536640]Phase 2224 participants (Actual)Interventional2007-11-30Completed
Phase I Study of Dovitinib (TKI258) in Combination With Gemcitabine and Capecitabine in Advanced Solid Tumors, Pancreatic Cancer and Biliary Cancers [NCT01497392]Phase 126 participants (Actual)Interventional2012-03-29Completed
PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples [NCT04683315]Phase 287 participants (Anticipated)Interventional2021-04-01Recruiting
A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab Plus Olaparib Combination Therapy Compared With Durvalumab Monotherapy as Maintenance Therapy in Patients Whose Disease Has Not Progressed F [NCT03775486]Phase 2401 participants (Actual)Interventional2018-12-21Active, not recruiting
A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTI [NCT05092360]Phase 3376 participants (Anticipated)Interventional2022-01-10Recruiting
A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations [NCT04521686]Phase 1200 participants (Anticipated)Interventional2020-10-16Active, not recruiting
Multicenter, Open-label Clinical Study of PD-L1/CTLA4 BsAb Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer [NCT04324307]Phase 1/Phase 260 participants (Anticipated)Interventional2019-11-26Recruiting
Comparisons of Different Neoadjuvant Chemotherapy Regimens With or Without Stereotactic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer: Study Protocol of a Prospective, Randomized Phase II Trial [NCT03777462]Phase 2150 participants (Anticipated)Interventional2019-04-01Recruiting
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Che [NCT05104866]Phase 3733 participants (Actual)Interventional2021-10-18Active, not recruiting
High-dose Gemcitabine, Busulfan and Melphalan With Autologous Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma [NCT01237951]Phase 275 participants (Actual)Interventional2010-11-08Completed
A Phase II Single-arm Clinical Trial of Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer [NCT04681911]Phase 271 participants (Anticipated)Interventional2020-09-09Recruiting
Randomized Phase III Trial on Trabectedin (ET-743) vs Clinician's Choice Chemotherapy in Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancers of BRCA Mutated or BRCAness Phenotype Patients [NCT02903004]Phase 3242 participants (Actual)Interventional2016-04-11Completed
Pilot Study of Gemcitabine, Oxaliplatin, and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer [NCT00448838]42 participants (Actual)Interventional2006-05-31Completed
Phase II Trial of Pulsed Paclitaxel With Concurrent Radiotherapy,and Adjuvant Chemotherapy in Stage III Non-Small Cell Lung Cancer [NCT00449657]Phase 224 participants (Actual)Interventional2007-02-28Terminated(stopped due to Poor accrual, change in standard of care.)
Study of Chinese Medicine Plus Chemotherapy Maintenance Versus Chemotherapy Maintenance in Advanced Non Small Cell Lung Cancer: A Randomized Double-blind Controlled Clinical Trial [NCT02900742]Phase 371 participants (Actual)Interventional2013-03-31Completed
Combination of Gefitinib With Chemotherapy or Anti-angiogenesis as 1st Line Treatment in Advanced NSCLC Patients Detected With Bim Deletion or Low EGFR Activating Mutation Abundance [NCT02930954]Phase 2180 participants (Anticipated)Interventional2016-11-30Not yet recruiting
A Phase I/II Study of Indoximod in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Adenocarcinoma of the Pancreas [NCT02077881]Phase 1/Phase 2157 participants (Actual)Interventional2014-08-31Completed
A Phase 1 Dose Escalation Trial Of CP-675,206 In Combination With Gemcitabine In Patients With Chemotherapy Naive Metastatic Pancreatic Cancer [NCT00556023]Phase 137 participants (Actual)Interventional2008-06-30Completed
An Open-label, Randomized Phase IIB/III Active Control Study of Second-line Tergenpumatucel-L (Hyper-Acute(R)-Lung ) Immunotherapy Versus Docetaxel in Progressive or Relapsed Non-Small Cell Lung Cancer [NCT01774578]Phase 2/Phase 3135 participants (Actual)Interventional2013-02-28Terminated
A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements FOENIX-CCA3 [NCT04093362]Phase 3216 participants (Anticipated)Interventional2020-03-01Active, not recruiting
A Phase 1 Study of AG-270 in the Treatment of Subjects With Advanced Solid Tumors or Lymphoma With Homozygous Deletion of MTAP [NCT03435250]Phase 1123 participants (Actual)Interventional2018-03-04Terminated(stopped due to Strategic reasons)
Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Metastatic or Locally Advanced Unresectable Adenocarcinoma of The Pancreas: A Phase II Randomized Study [NCT03807999]Phase 2125 participants (Actual)Interventional2015-02-19Completed
A Phase 2 Study of the Safety and Efficacy of BIO-11006 in the Treatment of Recurrent Osteosarcoma and Ewing's Sarcoma in Patients With Lung Metastases [NCT04183062]Phase 210 participants (Anticipated)Interventional2019-10-04Active, not recruiting
A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma [NCT02512692]6 participants (Actual)Interventional2015-07-21Active, not recruiting
Randomized Phase 3 Study Evaluation the Efficacy and Safety of Oral Azacitidine(CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma [NCT03703375]Phase 322 participants (Actual)Interventional2018-11-06Active, not recruiting
A PHASE Ib/IIa STUDY OF COMBINATION THERAPY WITH GEMCITABINE AND ATU027 IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC ADENOCARCINOMA [NCT01808638]Phase 1/Phase 229 participants (Actual)Interventional2013-03-31Completed
Whole-target Consolidation Therapy After Standard Chemotherapy for Initial Diagnosed Distant Metastatic Nasopharyngeal Carcinoma Under Full-course Immunotherapy: An Open-Label, Single Center, Nonrandomized, Phase 2 Study [NCT05431764]Phase 238 participants (Anticipated)Interventional2022-06-20Recruiting
A Multi-center Prospective Randomized Phase III Trial to Determine the Benefit of Adjuvant Chemotherapy Using Gemcitabine and Cisplatin in Nasopharyngeal Carcinoma Patients With Residual EBV DNA Following Primary Radiotherapy With or Without Concurrent Ci [NCT00370890]Phase 3104 participants (Actual)Interventional2006-09-04Completed
[NCT01929421]Phase 236 participants (Actual)Interventional2009-12-31Completed
Treatment of Peripheral T-cell Lymphoma With Aggressive Induction Chemotherapy Followed by Autologous Stem Cell Transplant Using Denileukin Diftitox (Ontak) for In-vivo Purging and Post-Transplant Therapy: A Multicenter Phase II Clinical Trial [NCT00632827]Phase 221 participants (Actual)Interventional2008-07-01Terminated(stopped due to Manufacturing shortage of both Diftitox and Doxil)
A Prospective Clinical Study of Ruxolitinib Phosphate Tablets and Etoposide Combined With DDGP Regimen (RUE-DDGP) in Induction Therapy of T/NK Cell Lymphoma-associated Hemophagocytic Syndrome. [NCT04999878]Phase 430 participants (Anticipated)Interventional2021-05-30Recruiting
A Phase I Pilot Study of B Cell Depletion With Rituximab Following by Chemotherapy With Cisplatin Plus Gemcitabine for Recurrent Unresectable or Metastatic Head and Neck Cancer Squamous Cell Carcinoma Patients. [NCT04361409]Phase 110 participants (Actual)Interventional2013-05-31Completed
A Phase Ib, Open-label, Dose Escalation Trial Investigating Different Doses and Schedules of Sym004 in Combination With Platinum-doublets in Subjects With Stage IV Non-small Cell Lung Cancer [NCT02083679]Phase 115 participants (Actual)Interventional2014-07-31Terminated(stopped due to Sponsor the return rights of the compound to the collaboration partner for further clinical development)
A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma [NCT02539537]Phase 3171 participants (Actual)Interventional2015-10-23Active, not recruiting
A Phase Ib, Multi-center, Open-label Study of Z650 and Gemcitabine in Advanced Pancreatic Cancer [NCT04131192]Phase 113 participants (Actual)Interventional2019-11-11Terminated(stopped due to Combined with the analysis of the existing data of the trial, there was no obvious advantage compared with the clinical standard treatments, and the clinical trial was decided to be terminated based on the benefit of the subjects.)
A Randomized Phase III Trial of Vinorelbine Versus Gemcitabine and Carboplatin for Elderly Patients With Advanced Non-Small Cell Lung Cancer [NCT00265694]Phase 30 participants InterventionalRecruiting
A Feasibility and Biomarker Study to Evaluate Necitumumab in the Neoadjuvant Setting With Gemcitabine and Cisplatin in Surgically Resectable Squamous Lung Cancer [NCT03574818]Phase 21 participants (Actual)Interventional2018-05-29Terminated(stopped due to Poor accrual)
Phase I Study of Concurrent Nab-Paclitaxel + Gemcitabine With Hypofractionated, Ablative Proton Therapy for Locally Advanced Pancreatic Cancer [NCT03652428]Phase 1/Phase 224 participants (Anticipated)Interventional2019-04-02Recruiting
Phase I Study of Amifostine (Ethyol) as a Cytoprotector of Gemcitabine/Cisplatin Combination [NCT00003144]Phase 144 participants (Anticipated)Interventional1997-08-31Completed
A Phase III Study of Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation Gemcitabine for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma [NCT00003216]Phase 3518 participants (Anticipated)Interventional1998-07-31Completed
Phase II Evaluation of Weekly Cisplatin and Gemcitabine in the Treatment of Advanced (Recurrent or Metastatic) Carcinoma of the Head and Neck [NCT00003264]Phase 222 participants (Actual)Interventional1997-10-31Completed
A Phase I Trial of Combined Modality Gemcitabine Plus Radiation Therapy for Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma [NCT00003426]Phase 10 participants Interventional1998-04-30Completed
Gemcitabine for Advanced Salivary Cancer: A Phase II Study [NCT00003744]Phase 216 participants (Actual)Interventional1998-11-30Completed
Randomized Phase II Study of Docetaxel and Gemcitabine for Stage IIIB/IV Non-Small Cell Lung Cancer [NCT00003762]Phase 2106 participants (Actual)Interventional1999-02-28Completed
A Phase I/II Trial in Patients With Muscle-Invading Bladder Cancer of Transurethral Surgery Plus Taxol, Cisplatin and Bid Irradiation Followed by Either Selective Bladder Preservation or Radical Cystectomy and Adjuvant Chemotherapy [NCT00003930]Phase 1/Phase 284 participants (Actual)Interventional1999-09-30Completed
Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar) [NCT00004144]Phase 136 participants (Actual)Interventional2000-05-31Completed
Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma [NCT00004884]Phase 296 participants (Actual)Interventional1999-07-31Completed
Phase II Protocol: Gemcitabine for Metastatic Cancer With Unknown Primary Site - Analysis of Symptom Benefit [NCT00357630]Phase 252 participants (Anticipated)Interventional2006-06-30Completed
"Primovax - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer." [NCT00358566]Phase 3360 participants (Actual)Interventional2006-06-30Terminated(stopped due to Preliminary data showed no survival benefit in the GV1001 group compared to the gemcitabine group.)
A Phase II Trial of Intravenous Gemcitabine (NSC #613327) and Intraperitoneal Carboplatin (NSC # 241240) in the Treatment of Patients With Platinum-Sensitive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma With Non-Measurable Disease [NCT00369954]Phase 20 participants (Actual)Interventional2006-04-30Withdrawn(stopped due to Trial was never activated)
A Phase 1B, Open-Label, Dose Escalation Study Evaluating the Safety of BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors [NCT00422682]Phase 1136 participants (Actual)Interventional2007-01-31Completed
A Multicenter, Randomized, Open-label, Parallel-group Study of Paclitaxel Liposome and Cisplatin Compared With Gemcitabine and Cisplatin as First-line Therapy in Advanced Squamous Non-Small-Cell Lung Cancer [NCT02996214]Phase 4536 participants (Anticipated)Interventional2016-11-30Active, not recruiting
EUS-guided Intratumoral Gemcitabine Therapy in Locally Advanced Unresectable Pancreatic Cancer: A Phase 1 Study [NCT01834170]Phase 112 participants (Actual)Interventional2013-04-30Completed
A Phase III Study of Chemotherapy With or Without Algenpantucel-L (HyperAcute®-Pancreas) Immunotherapy in Subjects With Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer [NCT01836432]Phase 3302 participants (Actual)Interventional2013-05-31Terminated(stopped due to Company decision)
Randomized Phase II Trial of Panitumumab, Erlotinib and Gemcitabine vs. Erlotinib and Gemcitabine in Patients With Untreated, Metastatic Pancreatic Adenocarcinoma [NCT00550836]Phase 2104 participants (Actual)Interventional2009-03-31Completed
A Phase 1 Study of Hypofractionated Stereotactic Radiotherapy and Concurrent HIV Protease Inhibitor Nelfinavir as Part of a Neoadjuvant Regimen in Patients With Locally Advanced Pancreatic Cancer [NCT01068327]Phase 146 participants (Actual)Interventional2007-11-05Completed
Phase II Study of Docetaxel and Gemcitabine in Previously Treated Metastatic Esophageal Squamous Cell Cancer [NCT01469598]Phase 224 participants (Actual)Interventional2011-08-31Completed
A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors [NCT03184870]Phase 1/Phase 2332 participants (Actual)Interventional2017-08-08Completed
A Phase I Study of OSI-774 in Combination With Gemcitabine and Radiation in Locally Advanced, Non-Operable Pancreatic Cancer [NCT00063947]Phase 128 participants (Actual)Interventional2003-05-31Completed
A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Metastatic Non-Small Cell Lung Cancer [NCT00064064]Phase 20 participants Interventional2003-01-31Completed
A Phase I Open Label Multi Center Dose Escalation Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose Gemcitabine in Patients With Advanced Solid Mal [NCT00413686]Phase 142 participants (Actual)Interventional2006-12-31Completed
A Phase 1 Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Gemcitabine in Patients With Epithelial Tumors [NCT00243100]Phase 121 participants (Actual)Interventional2005-11-30Completed
A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer [NCT00068432]Phase 228 participants (Actual)Interventional2003-12-31Completed
Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study of Gemcitabine-Cisplatin Combined With Two Different Doses of LY293111 or Placebo in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer [NCT00069875]Phase 2195 participants Interventional2003-09-30Completed
A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease [NCT00070304]Phase 233 participants (Actual)Interventional2004-07-31Completed
A Phase II, Randomized Study With Docetaxel-gemcitabine Followed by Radiotherapy vs Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) Followed by Docetaxel-gemcitabine Versus Docetaxel-gemcitabine Followed by Concomitant Treatment (Radiother [NCT00258739]Phase 2140 participants (Actual)Interventional2001-10-31Completed
A Phase II Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus [NCT00101127]Phase 20 participants Interventional2003-12-31Completed
Treatment of Stages IIIB and IV, Non Small Cell Lung Cancer With Alternating Cycles of Carboplatin/Taxol and Carboplatin/Gemcitabine. [NCT00259675]Phase 2100 participants (Anticipated)Interventional2004-05-31Completed
A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy [NCT00102414]Phase 3356 participants Interventional1999-09-30Completed
Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX] [NCT00268411]Phase 380 participants (Anticipated)Interventional2004-09-30Active, not recruiting
National Trial Phase II to Study the Combination of Gemcitabine and Docetaxel in Patients With Locally Advanced or Metastatic Pancreatic or Biliary Adenocarcinoma That Cannot be Removed by Surgery [NCT00268840]Phase 245 participants (Actual)Interventional2001-08-31Completed
A Phase III Study of Delayed vs. Immediate Second-Line Therapy With Docetaxel After Gemcitabine + Carboplatin in Advanced Non-Small Cell Lung Cancer [NCT00074204]Phase 317 participants (Actual)Interventional2003-10-31Completed
A Phase I Study of CT-2103 in Combination With Gemcitabine in Metastatic Breast Cancer [NCT00270907]Phase 113 participants (Actual)Interventional2005-12-31Completed
Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma [NCT00075452]Phase 30 participants Interventional2003-11-30Active, not recruiting
A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine As First-Line Therapy Of Patients With Advanced Pancreas Cancer [NCT00075686]Phase 3766 participants (Actual)Interventional2004-01-31Completed
A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mg/m Versus Gemcitabine Plus Carboplatin At 50 mg/m Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) [NCT00112710]Phase 31,350 participants (Anticipated)Interventional2005-03-31Recruiting
Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables [NCT00275119]Phase 20 participants Interventional2003-11-30Active, not recruiting
A Phase I Pharmacokinetics and Pharmacodynamic Study of GTI2040 in Combination With Gemcitabine in Patients With Solid Tumors [NCT00078962]Phase 140 participants (Actual)Interventional2004-01-31Completed
A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer [NCT00079352]Phase 124 participants (Actual)Interventional2004-04-30Completed
A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer Not Progressing on First Line Cisplatin-gemcitabine Chemotherapy Maintenance Chemotherapy With Gemcitabine or Sequential Treatment With Erlotinib [NCT00300586]Phase 3842 participants (Actual)Interventional2006-06-30Completed
Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer [NCT00080795]Phase 265 participants (Actual)Interventional2001-07-31Completed
Randomized Phase II-III Study of Chemoradiation With Fluorouracil and Cisplatin Versus Chemotherapy (Gemcitabine/Oxaliplatin) in Non Resectable But Non Metastatic Cancer of the Biliary Tract [NCT00304135]Phase 2/Phase 334 participants (Actual)Interventional2005-10-31Completed
A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer [NCT00087711]Phase 31,713 participants (Actual)Interventional2004-07-31Completed
Phase II Trial of PS-341 (Bortezomib, NSC-681239) Followed by the Addition of Gemcitabine at Progression in Recurrent or Metastatic Nasopharyngeal Carcinoma [NCT00305734]Phase 250 participants (Actual)Interventional2006-08-31Completed
A Phase II Clinical Trial of a Timing/Schedule Optimized Combined-Modality Regimen: Cisplatin + Metronomic Low-Dose Interferon-α (IFN-α) Followed by Gemcitabine HCl (GEMZAR) in Combination With Mild, Fever-Range Whole-Body Hyperthermia (FR-WBH) in Patient [NCT00082862]Phase 248 participants (Anticipated)Interventional2002-07-31Recruiting
Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors [NCT00307255]Phase 118 participants (Actual)Interventional2006-08-31Completed
A Tolerability and Efficacy Study of the Angiogenesis Inhibitor Bevacizumab in Combination With 5-Fluorouracil, Oxaliplatin, and External Beam Radiation Therapy Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer [NCT00307723]Phase 1/Phase 252 participants (Actual)Interventional2006-05-31Terminated(stopped due to poor accrual)
A Randomized Phase III Study Comparing Concomitant Docetaxel Plus Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine in Anthracycline-Pretreated Metastatic or Locally Recurrent Breast Cancer Patients [NCT00294385]Phase 3430 participants (Actual)Interventional2002-06-30Completed
Topotecan-Monotherapy Vs. Topotecan + Etoposide Vs. Topotecan + Gemcitabine in Therapy in Patients With Recurrent Ovarian Cancer [NCT00312988]Phase 3450 participants Interventional2000-01-31Completed
Tumor Microenvironment Features of Response to Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers [NCT06001658]Phase 227 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin [NCT01434459]Phase 19 participants (Actual)Interventional2011-09-30Terminated(stopped due to PI moved to different institution)
A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-301 (Zalifrelimab) Administered Intravesically as Monotherapy and in Combination With Other Agents in Patients With Recurrent NMIBC [NCT05375903]Phase 160 participants (Anticipated)Interventional2022-06-01Recruiting
A Pilot Study of Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel in Metastatic Pancreatic Adenocarcinoma [NCT04115163]Phase 253 participants (Anticipated)Interventional2020-06-24Suspended(stopped due to Drug shortage)
Evaluation of Oxaliplatin and Gemcitabine in Patients With Metastatic Bladder Cancer [NCT04039867]Phase 217 participants (Actual)Interventional2005-01-20Terminated(stopped due to Trial was terminated due to halt in funding.)
A Phase Ib/II, Open-Label Study of M7824 in Combination With Chemotherapy in Participants With Stage IV Non-small Cell Lung Cancer [NCT03840915]Phase 1/Phase 270 participants (Actual)Interventional2019-04-02Completed
Randomized Phase II Study Comparing 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI Followed by Two Months of Gemcitabine+Nab-paclitaxel, in Metastatic Pancreatic Cancer [NCT03693677]Phase 2288 participants (Anticipated)Interventional2018-11-16Recruiting
Phase II Trial of Ixazomib Combined With Gemcitabine and Doxorubicin in Patients With Renal Medullary Carcinoma [NCT03587662]Phase 230 participants (Anticipated)Interventional2018-08-17Recruiting
A Phase II Study Of Gemcitabine, Cisplatin, and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma [NCT00090909]Phase 21 participants (Actual)Interventional2003-06-30Completed
A Phase 3 Trial of Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer After Platinum-Based Chemotherapy (BRAVA) [NCT04943627]Phase 30 participants (Actual)Interventional2021-08-02Withdrawn(stopped due to Strategic Business Decision)
Phase II Multicenter Study to Determine the Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas [NCT01442662]Phase 2106 participants (Actual)Interventional2011-09-30Completed
A Phase II Trial of Gemcitabine and Cisplatin In Unresectable Or Metastatic Biliary Tract and Gallbladder Cancer [NCT00123825]Phase 230 participants Interventional2002-07-31Completed
A Phase II Trial of Gemzar (Gemcitabine) and Gleevec (Imatinib Mesylate) in Patients With Metastatic Renal Cell Carcinoma [NCT00323791]Phase 2100 participants (Anticipated)Interventional2006-04-30Terminated(stopped due to slow accrual)
Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma [NCT00086801]Phase 2104 participants (Actual)Interventional2004-05-31Completed
A Study of Fixed-Dose Rate Gemcitabine, Cisplatin, and Bevacizumab in Previously Untreated Patients With Metastatic Pancreatic Cancer [NCT00126633]Phase 253 participants (Actual)Interventional2004-04-30Completed
An Open-label, Randomized, Controlled Phase III Trial Evaluating the Efficacy and Safety of EndoTAG®-1 in Combination With Paclitaxel and Gemcitabine Compared With Paclitaxel and Gemcitabine as First-line Therapy in Patients With Visceral Metastatic Tripl [NCT03002103]Phase 3420 participants (Anticipated)Interventional2016-11-23Suspended(stopped due to study design reconsideration)
Stage IB2 to IVA Uterine Cervical Cancer: Phase 2 Study to Assess a New Therapeutic Sequence Associating a Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine [NCT00421096]Phase 219 participants (Actual)Interventional2005-05-31Terminated(stopped due to Problems of recruitment)
A Phase II Trial Of Gemcitabine And Triapine In Refractory Metastatic Breast Cancer [NCT00095888]Phase 268 participants (Actual)Interventional2004-10-31Terminated(stopped due to Administratively complete.)
A Phase II Study of BAY 43-9006/Gemcitabine for Advanced Pancreatic Cancer [NCT00095966]Phase 235 participants (Actual)Interventional2004-09-30Completed
A Phase 2 Study of BAY 43-9006 in Combination With Gemcitabine in Recurrent Epithelial Ovarian Cancer [NCT00096395]Phase 233 participants (Actual)Interventional2004-09-30Completed
A Phase 1/2 Dose-Escalation Study of the Safety, Efficacy and Pharmacokinetics of Glufosfamide in Combination With Gemcitabine in Advanced Solid Tumors and Pancreatic Adenocarcinoma [NCT00102752]Phase 1/Phase 247 participants Interventional2004-12-31Completed
Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Patients With Hepatocellular Carcinoma [NCT00142467]Phase 233 participants (Actual)Interventional2004-04-30Completed
Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer [NCT00440167]Phase 3280 participants (Anticipated)Interventional2006-06-30Active, not recruiting
Improvement of Locally Advanced Cervical Cancer Radiotherapy Efficacy by Use of Volumetric Arc Therapy, Individualized Polyradiosensitization and Interstitial Brachytherapy [NCT02957266]Phase 3400 participants (Anticipated)Interventional2015-03-31Recruiting
A Randomized Phase II Study Adjuvant Gemcitabine And Oxaliplatin Versus Gemcitabine and Cisplatin for Completely Resected Stage IB, II or IIIA Non-Small Cell Lung Cancer [NCT00452881]Phase 2151 participants (Actual)Interventional2006-05-31Active, not recruiting
A Phase II Study of Gemcitabine Plus Oxaliplatin for Patients With Advanced Stage IIIB or IV Non-Small Cell Lung Cancer [NCT00453115]Phase 243 participants (Actual)Interventional2006-01-31Active, not recruiting
Phase II Study of Chemotherapy With Gemcitabine in Prolonged Infusion or With Schedules With Cisplatin in Non-small Cell Lung Cancer Elderly Patients [NCT00401492]Phase 2159 participants (Actual)Interventional2002-06-30Completed
An International Randomized Phase III Study of First-line Erlotinib Followed by Second-line Cisplatin + Gemcitabine Versus First-line Cisplatin + Gemcitabine Followed by Second-line Erlotinib in Advanced Non Small Cell Lung Cancer [NCT00349219]Phase 3760 participants (Actual)Interventional2006-12-31Completed
Evaluation of Activity and Toxicity of Polychemotherapy With 2-drug Combinations Containing Gemcitabine as First Line Treatment of Elderly Patients With Small Cell Lung Cancer [NCT00401609]Phase 1/Phase 285 participants Interventional2000-11-30Completed
A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab Versus Gemcitabine/Platinum as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer [NCT00112346]Phase 2120 participants Interventional2005-01-31Completed
Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients [NCT00112658]Phase 2/Phase 3342 participants (Actual)Interventional2004-11-30Completed
A Phase II Study of Bevacizumab With Concurrent Capecitabine and Radiation Followed by Maintenance Gemcitabine and Bevacizumab For Locally Advanced Pancreatic Cancer [NCT00114179]Phase 282 participants (Actual)Interventional2005-01-31Completed
A Phase I/II Study With Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer [NCT00115635]Phase 1/Phase 260 participants (Actual)Interventional2005-03-31Completed
A Phase II Trial of Weekly Gemcitabine Hydrochloride and Bevacizumab in Combination With Abdominal Radiation Therapy in Patients With Localized Pancreatic Cancer [NCT00460174]Phase 231 participants (Actual)Interventional2005-10-10Completed
A Phase I Study of Sunitinib Malate and Standard Infusion Gemcitabine in Solid Tumors [NCT00462553]Phase 137 participants (Actual)Interventional2007-03-31Completed
Phase III, Open, Multicenter and Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA Non-Small-Cell Lung Cancer Patients [NCT00478699]Phase 3500 participants (Actual)Interventional2007-06-30Completed
[NCT00486460]Phase 30 participants Interventional2005-06-30Recruiting
Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head [NCT00490360]Phase 22,007 participants (Actual)Interventional2001-10-31Completed
A Phase II Trial of GEMZAR Combined With Cisplatin in Patients With Inoperable Biliary Tract Carcinomas [NCT00490399]Phase 239 participants (Actual)Interventional2003-03-31Completed
Phase II Study of Sequential Therapy With Paclitaxel Plus Carboplatin Followed by Gemzar Plus Carboplatin in the Treatment of Patients With Epithelial Ovarian Cancer FIGO Stages III-IV [NCT00490711]Phase 27 participants (Actual)Interventional2003-07-31Completed
A Prospective Multicenter Phase II Trial of Gemcitabine, Cisplatin, and Ifosfamide (GIP) in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors (NSGCT) and a Predicted Favorable Prognosis [NCT00127049]Phase 237 participants Interventional2004-12-31Recruiting
A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE) [NCT05538663]Phase 3870 participants (Anticipated)Interventional2023-02-07Recruiting
A Phase II Monocentric Study of Oxaliplatin in Combination With Gemcitabine in Patients With Advanced/Metastatic Transitional Cell Carcinoma of the Urothelial Tract [NCT00127595]Phase 228 participants Interventional2002-01-31Terminated
Phase I Study of a Combination of Doxil, Velcade, and Gemcitabine in Advanced Cancer [NCT00500422]Phase 1134 participants (Actual)Interventional2005-01-31Completed
A Phase I Study of a p53MVA Vaccine in Combination With Gemcitabine in Ovarian Cancer [NCT02275039]Phase 112 participants (Actual)Interventional2015-01-31Completed
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory [NCT04408638]Phase 3270 participants (Anticipated)Interventional2021-02-23Recruiting
[NCT00139971]Phase 3600 participants Interventional2001-12-31Recruiting
Phase II Trial of Paclitaxel, Carboplatin and Gemcitabine in Patients With Locally Advanced Transitional Cell Carcinoma of the Bladder [NCT00136175]Phase 268 participants (Actual)Interventional1999-11-30Completed
A Pilot Trial of Germline Polymorphisms as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer. [NCT00159471]1 participants (Actual)Interventional2005-02-28Terminated(stopped due to Insufficient Accrual)
Phase I/II Trial of Biweekly Gemcitabine, Oxaliplatin, and 48-Hour Infusion of High-Dose 5-FU/Leucovorin (GOFL) in Advanced Pancreatic Adenocarcinoma [NCT00154791]Phase 1/Phase 245 participants Interventional2003-03-31Completed
Ph III Random Trial of 120-Min Infusion Gemcitabine v. 90-Min Infusion Gemcitabine + Docetaxel in Unresectable Soft Tissue Sarcoma: A Multi-Disciplinary Trial of the North Amer. Sarcoma Study Group of the Connective Tissue Oncology Society [NCT00142571]Phase 3120 participants Interventional2003-01-31Completed
Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy. [NCT00148395]Phase 3280 participants Interventional2002-06-30Completed
A Phase I Study of Erbitux and Gemcitabine With Radiation Therapy for Locally Advanced Pancreas Cancer [NCT00467116]Phase 19 participants (Actual)Interventional2005-10-31Completed
A Phase I/Ib Trial of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, in Combination With Gemcitabine and Nab-paclitaxel for Advanced Pancreatic Cancer [NCT06182072]Phase 128 participants (Anticipated)Interventional2023-12-29Not yet recruiting
A Single-arm Prospective Clinical Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin for the Neoadjuvant Treatment of Biliary Tract Malignancies [NCT06181032]Phase 135 participants (Anticipated)Interventional2023-12-23Not yet recruiting
Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma [NCT00089102]Phase 29 participants (Actual)Interventional2003-09-30Terminated(stopped due to Low accrual)
A Phase 2a, Double-blind, Placebo-controlled, Multi-center, Randomized Study Evaluating LSTA1 When Added to Standard of Care (SoC) Versus Standard of Care Alone in Subjects With Advanced Solid Tumors [NCT05712356]Phase 280 participants (Anticipated)Interventional2023-08-24Recruiting
A Phase IIb, Open-label, Randomized Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer [NCT05673811]Phase 296 participants (Anticipated)Interventional2023-01-10Recruiting
A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants With Previously Treated RAS-Mutated Advanced or Metastatic Solid Tumors [NCT05585320]Phase 1/Phase 2210 participants (Anticipated)Interventional2022-10-31Recruiting
A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination With Gemcitabine in Adult Subjects With Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature® Status [NCT05548296]Phase 1/Phase 2390 participants (Anticipated)Interventional2022-08-29Recruiting
Optimal Preoperative Therapy for Intrahepatic Cholangiocarcinoma (OPTIC) [NCT05514912]Phase 20 participants (Actual)Interventional2024-03-01Withdrawn(stopped due to PI has decided to terminate this study due to study supporter pulling support on this study.)
Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine Vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer [NCT03606967]Phase 270 participants (Anticipated)Interventional2021-04-13Recruiting
A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: [NCT03178552]Phase 2/Phase 31,000 participants (Anticipated)Interventional2017-09-22Recruiting
A Phase I Study of Gemcitabine, Carboplatin and Lenalidomide (GCL) for Treatment of Patients With Advanced/Metastatic Urothelial Carcinoma (UC) and Other Solid Tumors [NCT01352962]Phase 118 participants (Actual)Interventional2011-09-26Completed
Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease [NCT00385788]Phase 252 participants (Actual)Interventional2005-07-31Completed
Multimodality Therapy for Stages II and III Non-Small Cell Lung Cancer: Surgical Resection Followed by Sequential Administration of Gemcitabine Plus Cisplatin Chemotherapy and Radiation Therapy [NCT00530634]Phase 23 participants (Actual)Interventional1999-08-31Terminated(stopped due to Poor accrual)
A Phase II Trial of Pemetrexed, Gemcitabine, and Bevacizumab Every Two Weeks in Chemotherapy-Naive Patients With Stages IIIB/IV Non- Squamous, Non-Small Cell Lung Cancer (NSCLC) [NCT00438204]Phase 239 participants (Actual)Interventional2006-05-31Terminated(stopped due to All data collection has completed.)
A Randomized, Phase IIB, Multicenter, Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in Patients With Relapse or Refractory Peripheral T-cell Lymphoma (PTCL) [NCT04747236]Phase 250 participants (Anticipated)Interventional2021-02-19Recruiting
A Multi-Center and Randomized Control Trial of Cisplatin, Carboplatin, Oxaliplatin, Docetaxel and Gemcitabine Plus Surgery as Treatment for Relapsed and Refractory Non-Small Cell Lung Cancer [NCT02889666]Phase 1500 participants (Anticipated)Interventional2008-01-31Recruiting
WCC# 44: A Pilot Study of CerviPrep, a Novel Drug Delivery Device for the Cervix, in the Local Administration of Gemcitabine, a Radiation Sensitizer [NCT00610740]Phase 218 participants (Actual)Interventional2006-07-31Completed
A Phase 1 Study of SY 5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors [NCT04247126]Phase 1105 participants (Actual)Interventional2020-01-23Completed
Nivolumab as add-on to Gemcitabine/S-1 in Metastatic Pancreatic Cancer: a Phase II Trial [NCT04377048]Phase 238 participants (Anticipated)Interventional2020-07-01Not yet recruiting
EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism [NCT03002844]Phase 250 participants (Anticipated)Interventional2016-12-31Not yet recruiting
A Multi-center Phase II Randomized Study of Customized Neoadjuvant Therapy Versus Standard Chemotherapy in Non-small Cell Lung Cancer (NSLC) Patients With Resectable Stage IIIA (N2) Disease (CONTEST-TRIAL) [NCT01784549]Phase 2168 participants (Anticipated)Interventional2012-07-31Recruiting
A Phase II Trial of Panitumumab, Gemcitabine, and Carboplatin in Triple-Negative Metastatic Breast Cancer [NCT00894504]Phase 271 participants (Actual)Interventional2010-02-28Completed
Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer Patients Receiving Treatment With Gemcitabine [NCT01020006]Phase 242 participants (Actual)Interventional2009-11-30Completed
Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma (BTC): a Single Arm, Prospective, Interventional Clinical Study [NCT05822453]Phase 220 participants (Anticipated)Interventional2023-04-30Not yet recruiting
A Prospective Clinical Study of Chemotherapy Plus Programmed Death-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T Cell Lymphoma Not Otherwise Specified and Angioimmunoblastic T-cell Lymphoma. [NCT05821192]34 participants (Anticipated)Interventional2023-03-23Recruiting
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV07/ ENGOT-OV80 Study) [NCT06023862]Phase 2198 participants (Anticipated)Interventional2023-09-25Not yet recruiting
Phase II Study of Gemcitabine, Oxaliplatin in Combination With Panitumumab in Kras/B-raf Wild-Type Unresectable or Metastatic Biliary Track and Gallbladder Cancer [NCT01308840]Phase 231 participants (Actual)Interventional2010-12-31Completed
A Prospective Phase II Clinical Trial on Pre-operative Immunotherapy and Stereotactic Body Radiotherapy Followed by Metastasectomy in Patients With Pulmonary Resectable Recurrence of Osteosarcoma [NCT06114225]Phase 243 participants (Anticipated)Interventional2023-06-01Recruiting
Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcomas [NCT06114004]Phase 288 participants (Anticipated)Interventional2023-09-28Recruiting
Tislelizumab Combined With GEMOX (GOT) Applied as Neoadjuvant Regimen for Patients of Resectable Intrahepatic Cholangiocarcinoma With High-risk Factors of Recurrence: a Single Arm, Single Center, Prospective, Explorative Clinical Trail. [NCT05557578]Phase 220 participants (Anticipated)Interventional2023-05-05Recruiting
A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE- [NCT03924856]Phase 3907 participants (Actual)Interventional2019-06-13Active, not recruiting
A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA No [NCT02486718]Phase 31,280 participants (Actual)Interventional2015-10-31Active, not recruiting
Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus Most Appropriate Therapy in Refractory Pancreatic Cancer Patients [NCT00005870]Phase 30 participants Interventional1999-03-31Active, not recruiting
A Phase I Study of SU5416 in Combination With Gemcitabine/Cisplatin in Patients With Advanced Solid Tumors [NCT00005996]Phase 10 participants InterventionalActive, not recruiting
A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma [NCT00163761]Phase 290 participants (Actual)Interventional2002-12-31Completed
Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma and Osteosarcoma [NCT04595994]Phase 114 participants (Anticipated)Interventional2020-09-02Active, not recruiting
A Phase II Randomized Trial of Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin in Stage IIIB/IV Non-Small Cell Lung Cancer [NCT00154739]Phase 286 participants (Anticipated)Interventional1998-10-31Completed
A Randomized Phase III Trial of Paraplatin (Carboplatin) + Gemzar Versus Gemzar Alone in Patients With Advanced Non-Small Cell Lung Cancer [NCT00190710]Phase 3242 participants Interventional2004-03-31Completed
A Phase I/II Trial of Intratumoral Dendritic Cell Immunotherapy in Combination With Gemcitabine and Stereotactic Radiosurgery in Unresectable Pancreatic Cancer [NCT00547144]Phase 12 participants (Actual)Interventional2005-10-31Completed
A Multicenter Randomized Phase II Study Evaluating the Feasibility and Activity of Two Different Combinations of Docetaxel (RP56976, TAXOTERE *) and Gemcitabine and of Cisplatin/Gemcitabine Followed by Docetaxel as First Line Therapy for Locally Advanced [NCT00191490]Phase 2162 participants Interventional2002-07-31Completed
A Randomized Phase III Trial of Gemzar Versus Doxil With Crossover Treatment Option for Patients With Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer Undergoing Second or Third-Line Chemotherapy [NCT00191607]Phase 3162 participants Interventional2002-07-31Completed
Phase II Trial of Gemcitabine and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Non-Small Cell Lung Cancer [NCT00191763]Phase 252 participants Interventional2002-11-30Completed
Gemcitabine Plus Cisplatin as Neoadjuvant Chemotherapy in Operable Non Small Cell Lung Cancer [NCT00191841]Phase 250 participants Interventional2002-12-31Completed
A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus [NCT00476086]Phase 220 participants (Actual)Interventional2006-08-31Completed
Phase II/III Second-Line NABPLAGEM vs. Nab-Paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Mutant Metastatic Pancreatic Ductal Adenocarcinoma (PLATINUM) [NCT06115499]Phase 2/Phase 3100 participants (Anticipated)Interventional2024-04-09Not yet recruiting
Open-label First Line, Single-arm Phase II Study of CisGem Combined With Pembrolizumab in Patients With Advanced or Metastatic Biliary Tract Cancer [NCT03260712]Phase 250 participants (Actual)Interventional2020-01-07Completed
A Phase II Randomized Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Patients With Metastatic Breast Cancer [NCT00191672]Phase 2120 participants Interventional2003-12-31Completed
A Phase I/II Study of Fixed-Dose Rate Gemcitabine and Bevacizumab for Postoperative Adjuvant Treatment of Patients With Resected Pancreatic Cancer [NCT00410774]Phase 1/Phase 220 participants (Anticipated)Interventional2006-07-31Terminated(stopped due to low accrual-no data available)
A Pilot Protocol Evaluating Safety of the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Advanced Colorectal Carcinoma or Cholangiocarcinoma [NCT04668976]Phase 2100 participants (Anticipated)Interventional2020-11-25Recruiting
Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence [NCT06167057]264 participants (Anticipated)Interventional2023-04-17Recruiting
A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer [NCT03036098]Phase 31,290 participants (Anticipated)Interventional2017-03-24Active, not recruiting
Pemetrexed Plus Gemcitabine Or Carboplatin In Patients With Advanced Malignant Mesothelioma: A Randomized Phase II Trial [NCT00101283]Phase 232 participants (Actual)Interventional2006-02-23Completed
A Phase I Study of Preoperative Concomitant Gemcitabine and External-Beam Radiation Therapy and Surgical Resection for Patients With Extremity and Trunk Soft Tissue Sarcomas [NCT02046304]Phase 141 participants (Actual)Interventional2001-12-31Completed
Phase II Study of Gemcitabine, Carboplatin and VELIPARIB (ABT-888) in Refractory Testicular Germ Cell Cancer [NCT02860819]Phase 215 participants (Actual)Interventional2016-08-01Completed
A Prospective Randomized Controlled Trial for Postoperative Adjuvant Chemotherapy for pTanyN0M0 Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion [NCT04255771]Phase 3200 participants (Anticipated)Interventional2020-03-01Not yet recruiting
Phase I Open-Labeled Trial of Gemcitabine and Dasatinib in Advanced Solid Tumors [NCT00429234]Phase 154 participants (Actual)Interventional2007-01-31Completed
Randomized Phase II Study of Cetuximab in Combination With Gemcitabine or Gemcitabine Followed by Cetuximab in Advanced Non Small-cell Lung Cancer Patients Who Are Not Candidates for Platinum Based Therapy. [NCT00330746]Phase 2100 participants (Actual)Interventional2005-11-30Completed
A Multicenter Randomized Phase III Study of Combination Treatment With Vinorelbine and Gemcitabine Versus Capecitabine Monotherapy in Metastatic Breast Cancer Patients Following Treatment Failure With the Combination of a Taxane and an Anthracycline [NCT00431106]Phase 3144 participants (Anticipated)Interventional2002-04-30Completed
Gemcitabine and Oxaliplatin in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma (NPC) [NCT00436800]Phase 241 participants (Actual)Interventional2005-03-31Completed
Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis [NCT00335543]Phase 2254 participants (Anticipated)Interventional2003-06-30Completed
Arterial LIPIODOLISED Chemotherapy Versus Systemic Chemotherapy With Gemcitabine Plus Oxaliplatin (GEMOX) Versus no Treatment Following Surgical Resection or Local Ablation of Hepatocellular Carcinoma in Cirrhotic Patients [NCT00470340]Phase 3263 participants (Actual)Interventional2007-06-30Terminated(stopped due to during the study)
A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) [NCT00496275]Phase 117 participants (Actual)Interventional2006-08-31Completed
A Phase I/II Study to Determine the Safety and Efficacy of Second-Line Treatment With XELOX Plus Gemcitabine in Irinotecan Pre-Treated Advanced Colorectal Cancer Patients [NCT00496704]Phase 1/Phase 256 participants (Anticipated)Interventional2007-01-31Recruiting
A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer [NCT00593008]Phase 15 participants (Actual)Interventional2007-10-31Terminated
A Phase I Study of Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for the Treatment of High-risk Hematologic Malignancies [NCT00477035]Phase 122 participants (Actual)Interventional2006-05-31Completed
Phase II Study of Comparing Toripalimab Combined With GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic Nasopharyngeal Carcinoma [NCT04517214]Phase 2126 participants (Anticipated)Interventional2020-11-01Recruiting
Intravesical Gemcitabine Therapy in Intermediate Risk Superficial Bladder Cancer: A Phase II Study With the Marker Lesion [NCT00491114]Phase 28 participants (Actual)Interventional2003-07-31Completed
An Integrated Phase II/III, Open Label, Randomized and Controlled Study of the Safety and Efficacy of CG0070 Adenovirus Vector Expressing GM-CSF in Patients With NMIBC With Carcinoma In Situ Disease Who Have Failed BCG [NCT01438112]Phase 2/Phase 322 participants (Actual)Interventional2014-03-31Terminated(stopped due to Change in study design)
A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer [NCT04692051]Phase 2100 participants (Anticipated)Interventional2019-09-01Recruiting
Phase II Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer [NCT00531687]Phase 28 participants (Actual)Interventional2007-09-30Terminated(stopped due to slow accrual)
A Phase I/ II Study of SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma in Adults [NCT04948788]Phase 2102 participants (Anticipated)Interventional2021-10-31Recruiting
Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer [NCT04894643]10 participants (Anticipated)Interventional2020-09-14Recruiting
Phase II Study of Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1 (Excision Repair Cross-complementation Group 1) [NCT01524575]Phase 20 participants (Actual)Interventional2012-01-31Withdrawn(stopped due to the trial was never opened and then withdrawn permanently)
Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine (PAAG) as First-line Treatment for Advanced Metastatic Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Phase 2 Study [NCT06051851]Phase 2177 participants (Anticipated)Interventional2023-07-01Recruiting
A Randomized, Multicenter Phase III Clinical Trial Comparing Gemcitabine and Cisplatin With 5-Fluorouracil and Cisplatin in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) [NCT01528618]Phase 3362 participants (Actual)Interventional2012-02-21Completed
Phase II Study of Neoadjuvant Treatment With Gemcitabine, Tarceva and Oxaliplatin Followed by Chemotherapy With Tarceva and Gemcitabine in Patients With Pancreas Adenocarcinoma With Borderline Resectability. [NCT01531712]Phase 26 participants (Actual)Interventional2011-02-10Terminated(stopped due to Due to a low recruitment rate since start of recruitment period.)
A Phase 2 Study of Neoadjuvant Chemotherapy With Gemcitabine, Epirubicin and Paclitaxel (Taxol)[GET] in Locally Advanced Breast Cancer [NCT00378313]Phase 276 participants Interventional2001-11-30Completed
Phase II Evaluation Of GROC (Gemcitabine- Rituximab-Oxaliplatin Combination) Given Every 14 Days For The Treatment Of Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma [NCT01538641]Phase 243 participants (Actual)Interventional2003-10-31Completed
A Randomized, Open Label, Controlled Study About Endostar Continued Pumping or Injecting Into Vein Combining With Gemcitabine-Carboplatin Versus Gemcitabine-Carboplatin Alone to Treat Non-Small Cell Lung Cancer (NSCLC) [NCT01549093]Phase 290 participants (Anticipated)Interventional2011-08-31Recruiting
A Phase II Trial of Postoperative Proton Radiotherapy With Concomitant Chemotherapy for Patients With Resected Pancreatic Adenocarcinoma [NCT01553019]Phase 22 participants (Actual)Interventional2011-10-31Completed
Gemcitabine and R115777 Combination Therapy for Metastatic Breast Cancer [NCT00100750]Phase 1/Phase 231 participants (Actual)Interventional2005-09-30Completed
Phase I/II Study of Gemzar and Platinol Followed by Alimta and Gemzar in Patients With Advanced or Metastatic Bladder Cancer [NCT00101842]Phase 1/Phase 261 participants Interventional2004-12-31Completed
A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma [NCT00102700]Phase 266 participants Interventional2005-01-31Completed
Phase II Study With Gefitinib (Sequentially) Following Gemcitabine/Cisplatin as Induction Regimen for Patients With Stage IIIA N2 NSCLC [NCT00103051]Phase 20 participants Interventional2004-12-31Completed
Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma [NCT00401128]Phase 29 participants (Actual)Interventional2004-05-31Completed
Phase II Trial of Gemcitabine and ISIS 2503 in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma [NCT00006467]Phase 248 participants (Actual)Interventional2001-02-28Completed
A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix [NCT00006482]Phase 20 participants Interventional2000-10-31Terminated
Sequential Gemcitabine, Doxorubicin, Then Paclitaxel Plus Cisplatin Adjuvant Chemotherapy After Complete Resection of Locally Advanced Transitional Cell Carcinoma of the Urothelium [NCT00003133]Phase 130 participants (Anticipated)Interventional1997-09-30Completed
A Phase I-II Clinical Trial of Cisplatin (Platinol) Followed by Gemcitabine HCl (Gemzar) in Combination With Mild, Fever-Range Whole Body Hyperthermia (LL-WBH) at 40C in Patients With Advanced Malignancies [NCT00004063]Phase 1/Phase 230 participants (Anticipated)Interventional1999-08-31Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CI-994 Capsules Plus Gemcitabine Infusion Versus Placebo Capsules Plus Gemcitabine Infusion in the Treatment of Patients With Advanced Pancreatic Cancer [NCT00004861]Phase 20 participants Interventional1999-10-31Completed
Phase II Trial of Bevacizumab, Gemcitabine, Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma [NCT00112528]Phase 253 participants (Actual)Interventional2005-06-30Completed
A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer [NCT00007943]Phase 215 participants (Anticipated)Interventional2000-09-01Completed
An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas [NCT00116389]Phase 260 participants InterventionalTerminated(stopped due to FDA Hold May 2007)
Carcinoma Unknown Primary: Treatment With Gemcitabine, Docetaxel and Capecitabine (GTX) an Evaluation and Treatment Study of The Cancer Institute of New Jersey Oncology Group [NCT00119314]Phase 20 participants (Actual)Interventional2004-07-31Withdrawn(stopped due to slow accrual)
A Phase I Study of Weekly Gemcitabine in Combination With Infusional 5-Fluorouracil and Oral Calcium Leucovorin in Adult Cancer Patients [NCT00019513]Phase 1108 participants (Anticipated)Interventional1998-08-31Completed
Phase I Study of Continuous Infusion Gemcitabine [NCT00020644]Phase 10 participants Interventional2000-03-31Active, not recruiting
Phase I/II Randomized Trial Comparing Two Treatment Schedules Of Gemcitabine In Poor Prognosis Status Patients With Advanced Non-Small Cell Lung Cancer [NCT00022009]Phase 2/Phase 30 participants Interventional2001-07-31Active, not recruiting
Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma [NCT00024271]Phase 20 participants Interventional2001-05-31Active, not recruiting
An Open Label, Randomized, Controlled, Phase III, Multi-center, Clinical Trial Of PN401 With High Dose 5-Fluorouracil (5FU) Versus Gemcitabine For Treatment Of Patients With Advanced Pancreatic Cancer [NCT00024427]Phase 3250 participants (Actual)Interventional2001-02-28Completed
A Randomized Phase II Trial of Weekly Gemcitabine, Paclitaxel and External Irradiation (50.4 GY) Followed by the Farnesyl Transferase Inhibitor R115777 (NSC #702818) for Locally Advanced Pancreatic Cancer [NCT00026104]Phase 2154 participants (Actual)Interventional2001-11-30Completed
A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer [NCT00026338]Phase 3569 participants (Actual)Interventional2001-10-29Completed
A Double Blind, Placebo Controlled Randomized Phase II Trial Of Gemcitabine And Cisplatin With Or Without The VEGF Inhibitor Bevacizumab (NSC #704865) In Patients With Malignant Mesotheloma [NCT00027703]Phase 2106 participants (Actual)Interventional2001-10-31Completed
Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients With pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder [NCT00028756]Phase 3285 participants (Actual)Interventional2001-10-31Completed
Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II [NCT00012363]Phase 261 participants (Actual)Interventional2001-04-30Completed
A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer [NCT00028834]Phase 250 participants (Actual)Interventional2002-02-28Completed
Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer [NCT00281827]Phase 222 participants (Actual)Interventional2002-05-31Terminated(stopped due to Due to drug unavailability)
Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura [NCT00030745]Phase 261 participants (Actual)Interventional2000-06-30Completed
A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer [NCT00031837]Phase 3400 participants (Anticipated)Interventional2002-10-31Terminated
A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV [NCT00031954]Phase 2105 participants (Actual)Interventional2001-08-31Completed
A Phase Ib Multicenter Trial To Determine The Safety, Tolerance And Preliminary Antineoplastic Activity Of Gemcitabine Administered In Combination With Escalating Oral Doses Of OSI-774 To Patient Cohorts With Recently Diagnosed, Gemcitabine-Naive, Advance [NCT00033241]Phase 10 participants Interventional2001-07-23Completed
Induction/Concurrent Chemotherapy and Dose-Escalated Three Dimensional Thoracic Radiation for Patients With Stage III Non Small Cell Lung Cancer: A Randomized Phase II Study [NCT00033553]Phase 269 participants (Actual)Interventional2002-03-31Completed
A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer. [NCT00034489]Phase 20 participants InterventionalCompleted
[NCT00034606]Phase 20 participants InterventionalCompleted
Randomized Phase II/III Study Assessing Gemcitabine/Carboplatin And Methotrexate/Carboplatin/Vinblastine In Previously Untreated Patients With Advanced Urothelial Cancer Ineligible For Cisplatin Based Chemotherapy [NCT00014274]Phase 2/Phase 3238 participants (Actual)Interventional2001-01-31Completed
A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas. [NCT00035035]Phase 30 participants InterventionalCompleted
A Phase I Study Of UCN-01 In Combination With Gemcitabine In Unresectable Or Metastatic Pancreatic Carcinoma [NCT00039403]Phase 130 participants (Actual)Interventional2002-04-30Completed
A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer. [NCT00042679]Phase 20 participants Interventional2002-06-30Completed
A Phase I Trial Of Gemcitabine, 17-Allylaminogeldanamycin (17-AAG) And Cisplatin In Advanced Solid Tumor Patients [NCT00047047]Phase 178 participants (Anticipated)Interventional2002-08-31Completed
Phase II, Single-arm, Exploratory Study to Evaluate the Safety and Effectiveness of Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer [NCT05640791]Phase 240 participants (Anticipated)Interventional2022-12-01Recruiting
A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV [NCT00052468]Phase 31,742 participants (Actual)Interventional2002-08-31Completed
[NCT00055432]Phase 20 participants InterventionalTerminated
Envofolimab and Lenvatinib in Combination With Gemcitabine Plus Cisplatin for Patients With Advanced Biliary Tract Cancer as First-Line Treatment: A Single-arm, Open-label, Phase II Study [NCT05410197]Phase 243 participants (Anticipated)Interventional2022-10-10Recruiting
Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix [NCT00057928]Phase 30 participants (Actual)Interventional2003-04-30Withdrawn(stopped due to lack of accrual)
European Study Group For Pancreatic Cancer - Trial 3 [NCT00058201]Phase 31,030 participants (Anticipated)Interventional2001-07-31Completed
A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer [NCT00058318]Phase 243 participants (Actual)Interventional2004-12-31Completed
A Phase I Study of Oblimersen (Genasense™, G3139) in Combination With Gemcitabine in Advanced Malignancies [NCT00060112]Phase 115 participants (Actual)Interventional2003-03-31Terminated(stopped due to Administratively complete.)
A Phase II, Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Anti-TNF a Monoclonal Antibody (Infliximab) to Treat Cancer-Related Cachexia in Subjects With Pancreatic Cancer. [NCT00060502]Phase 273 participants (Actual)Interventional2003-04-30Completed
Hyperthermic Intraperitoneal Chemotherapy as Neoadjuvant Treatment for Resectable Pancreatic Adenocarcinoma: A Prospective, Phase II, Proof-of-concept Study [NCT02850874]Phase 20 participants (Actual)Interventional2016-02-29Withdrawn(stopped due to no accrual rate)
A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer [NCT00064051]Phase 20 participants Interventional2003-01-31Completed
Randomized Phase II/III Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation (50.4 Gy) Versus Control After Curative Pancreaticoduodenectomy for Pancreatic Head Cancer [NCT00064207]Phase 2/Phase 397 participants (Actual)Interventional2003-05-31Completed
Randomized Phase II Study of Eicosanoid Pathway Modulators and Cytotoxic Chemotherapy in Advanced Non-Small Cell Lung Cancer [NCT00070486]Phase 2140 participants (Actual)Interventional2003-12-31Completed
A Phase I Trial of Gemcitabine Followed by a Short Infusion of Flavopiridol in Patients With Solid Tumors [NCT00072436]Phase 158 participants (Actual)Interventional2003-09-30Completed
Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer [NCT00075517]Phase 20 participants Interventional2003-09-30Active, not recruiting
A Phase II Trial of Gemcitabine, Carboplatin and PS-341 (NSC-681239) in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT00075751]Phase 299 participants (Actual)Interventional2004-01-31Completed
A Phase II Trial of Triapine® (NSC #663249) in Combination With Gemcitabine as Second Line Treatment of Non-Small Cell Lung Cancer [NCT00077350]Phase 248 participants (Actual)Interventional2004-07-31Completed
Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma [NCT00079261]Phase 225 participants (Actual)Interventional2004-01-31Completed
Randomized Phase 2 Study of Capecitabine vs Gemcistabine Plus Cisplatin in Patients With Resected Extrahepatic Cholangiocarcinoma With Regional Lymph Node Metastasis [NCT03079427]Phase 2101 participants (Actual)Interventional2017-05-15Completed
High-dose Alkylating Chemotherapy in Oligo-metastatic Breast Cancer Harboring Homologous Recombination Deficiency [NCT01646034]Phase 374 participants (Actual)Interventional2014-09-30Active, not recruiting
Phase II Trial Of Gemcitabine, 5-Fluorouracil, And Leucovorin In Patients With Measurable Unresectable Or Metastatic Biliary Tract Carcinoma (Intrahepatic, Extrahepatic, Ampulla Of Vater) And Gallbladder Carcinoma [NCT00009893]Phase 242 participants (Actual)Interventional2001-05-31Completed
Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas [NCT00010088]Phase 20 participants Interventional1999-01-31Active, not recruiting
Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer [NCT00276861]Phase 210 participants (Actual)Interventional2005-09-30Terminated(stopped due to Low Accrual)
Phase II Trial of Gemcitabine/Paraplatin® (Carboplatin) Followed by Taxol® (Paclitaxel) in Patients With Performance Status = 2,3 or Other Significant Co-Morbidity (HIV Infection or s/p Organ Transplantation) in Advanced Non-Small Cell Lung Cancer [NCT00276588]Phase 246 participants (Anticipated)Interventional2005-07-31Completed
Phase II Trial of Gemcitabine And Docetaxel In Androgen-Independent Metastatic Prostate Cancer [NCT00276549]Phase 235 participants (Actual)Interventional2005-10-31Completed
Phase III Study Comparing Sequential Chemotherapy (AG-ITP) To Cisplatin And Gemcitabine As Adjuvant Treatment After Cystectomy For Transitional Cell Carcinoma Of The Bladder [NCT00014534]Phase 342 participants (Actual)Interventional2004-03-31Completed
INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma. [NCT00276003]Phase 222 participants (Actual)Interventional2002-08-31Completed
Phase II Multidose, Single Arm, Multicenter Clinical Trial of Cisplatin and Gemcitabine in Combination With Recombinant Humanized Anti-p185HER2 Monoclonal Antibody (Herceptin) in Patients Who Have Untreated p185HER2 Overexpressing Advanced Local Stage (St [NCT00016367]Phase 222 participants (Actual)Interventional1999-05-13Completed
Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma Of The Head And Neck [NCT00017498]Phase 221 participants (Actual)Interventional2001-02-28Completed
Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy [NCT00022191]Phase 3608 participants (Actual)Interventional2001-05-31Completed
A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma [NCT00026130]Phase 281 participants (Actual)Interventional2001-09-30Completed
A Phase II Study of Gemcitabine, Cisplatin and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer [NCT00026403]Phase 248 participants (Actual)Interventional2001-09-30Completed
A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium [NCT00028860]Phase 20 participants Interventional2001-10-31Completed
Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial [NCT00030732]Phase 3319 participants (Actual)Interventional2001-06-30Completed
A Phase II Evaluation of Docetaxel and Gemcitabine Plus G-CSF in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus [NCT00031629]Phase 251 participants (Actual)Interventional2005-01-31Completed
A Phase I and Randomized Phase II Study of Nab-Paclitaxel/Gemcitabine With or Without AZD1775 for Treatment of Metastatic Adenocarcinoma of the Pancreas [NCT02194829]Phase 1/Phase 28 participants (Actual)Interventional2014-08-19Completed
A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer [NCT00032175]Phase 3508 participants (Anticipated)Interventional2002-04-30Completed
[NCT00034593]Phase 20 participants InterventionalCompleted
A Phase 2 Study of Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma [NCT01206296]Phase 29 participants (Actual)Interventional2010-08-31Terminated(stopped due to Study suspended)
ARIEL4 (Assessment of Rucaparib In Ovarian CancEr TriaL): A Phase 3 Multicenter, Randomized Study of Rucaparib Versus Chemotherapy in Patients With Relapsed, BRCA Mutant, High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer [NCT02855944]Phase 3349 participants (Actual)Interventional2017-03-01Completed
A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV No [NCT02409342]Phase 3572 participants (Actual)Interventional2015-07-20Completed
'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer [NCT00039546]Phase 30 participants Interventional2001-08-31Active, not recruiting
A Phase IB Clinical Study Of The Farnesyltransferase Inhibitor SCH 66336 And Gemcitabine In Patients With Resectable Primary Liver Neoplasms [NCT00020774]Phase 20 participants (Actual)Interventional1998-10-31Withdrawn
Phase II Study Of Cisplatin, Gemcitabine, And ZD 1839 (IRESSA) (IND #61187; NSC 715055) For The Treatment Of Advanced Urothelial Tract Carcinoma [NCT00041106]Phase 250 participants (Actual)Interventional2002-05-31Completed
A Phase I Study Of The Effect Of Mistletoe Extract, A Complementary Medicine Botanical, On Pharmacokinetics, Pharmacodynamics And Safety Of Gemcitabine In Patients With Advanced Solid Tumors [NCT00049608]Phase 151 participants (Anticipated)Interventional2002-07-31Terminated(stopped due to Principal investigator [PI] has left institution.)
A Phase II Clinical Trial Evaluating Three Schedules Of ALIMTA Plus Gemcitabine As Frontline Chemotherapy For Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer [NCT00022646]Phase 2157 participants (Actual)Interventional2001-08-31Completed
A Randomized, Open-Label, Multicenter Phase III Study Comparing the Efficacy and Safety of a Combination of Intravenous DX-8951f (Exatecan Mesylate) Plus Gemcitabine to Gemcitabine Alone in Patients With Locally Advanced or Metastatic Cancer of the Exocri [NCT00023972]Phase 30 participants Interventional2001-07-31Completed
A Phase I Study Of PS-341 In Combination With Gemcitabine And Carbloplatin In Selected Stage IIIB Or IV Non-Small Cell Lung Cancer [NCT00052338]Phase 134 participants (Actual)Interventional2002-09-30Completed
Multicenter Phase II-trial to Investigate Safety and Efficacy of an Adjuvant Therapy With Gemcitabine and Erbitux® in Patients With R0 or R1 Resected Pancreatic Cancer [NCT00395252]Phase 276 participants (Actual)Interventional2006-10-31Completed
A Randomized Phase II Trial of PS-341 and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma [NCT00052689]Phase 288 participants (Anticipated)Interventional2002-12-31Completed
A Randomized Phase II Study of Preoperative Versus Postoperative Gemcitabine and Cisplatin for Patients With Stage IB-II Non-Small Cell Lung Cancer [NCT00398385]Phase 2170 participants (Anticipated)Interventional2005-05-31Recruiting
A Phase III Randomized, Open-Label Comparative Study of Induction Chemotherapy Followed by Thoracic Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Patients With Locally Advanced Unresectable (Stage IIIA/IIIB [NCT00055887]Phase 30 participants (Actual)Interventional2002-11-30Withdrawn(stopped due to Study never started. No patients were enrolled.)
A Pragmatic, Randomised Study To Compare The Hospitalisation Rates Of Two Platinum-Based Outpatient Regimens (Gemcitabine/Cisplatin vs. Gemcitabine/Carboplatin) In Non-Small Cell Lung Cancer (NSCLC) [NCT00055965]Phase 3400 participants (Anticipated)Interventional2002-11-30Active, not recruiting
An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer [NCT00027989]Phase 20 participants Interventional2001-12-31Active, not recruiting
Molecular And Genetic Changes In Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Vinorelbine And Gemcitabine - Phase II Study [NCT00057798]Phase 221 participants (Actual)Interventional2000-03-31Completed
A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma [NCT00058149]Phase 30 participants Interventional2003-03-31Completed
Phase I/II Trial Of Gemcitabine And ALIMTA In Patients With Measurable Or Evaluable, Unresectable Or Metastatic Biliary Tract Carcinoma (Intrahepatic, Extrahepatic, Ampulla Or Vater) And Gallbladder Carcinoma [NCT00059865]Phase 1/Phase 268 participants (Actual)Interventional2004-01-31Completed
ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase II Clinical Trial [NCT00061464]Phase 248 participants Interventional2003-02-28Completed
Phase 1 Trial of the Combination of Perifosine and Gemcitabine [NCT00398697]Phase 119 participants Interventional2004-08-31Completed
A Phase III Randomized Neoadjuvant Study of Sequential Epirubicin/Cyclophosphamide and Paclitaxel + - Gemcitabine in Poor Risk Early Breast Cancer [NCT00070278]Phase 3800 participants (Anticipated)Interventional2005-01-31Active, not recruiting
A Pilot Study of Low Dose Suramin as Modulator of Docetaxel and Gemcitabine in Patients With Previously Treated Non-Small Cell Lung Cancer (NSCLC) [NCT00066768]Phase 124 participants (Actual)Interventional2003-07-31Completed
Phase 1/2 Dose-Escalating Study of Biweekly Alimta and Gemcitabine in Patients With Advanced Cancer [NCT00071136]Phase 1/Phase 248 participants Interventional2003-12-31Completed
Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors [NCT00072228]Phase 10 participants InterventionalWithdrawn
Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer [NCT00209677]Phase 1/Phase 240 participants (Anticipated)Interventional2004-12-31Suspended(stopped due to "Unfortunately, other Phase III clinical Study (GEM+S-1 vs GEM vs S-1) have been started in Japan.~h")
Phase II Trial OF Oxaliplatin and Gemcitabine With Bevacizumab in Advanced Non-Small Cell Lung Cancer [NCT00217282]Phase 245 participants (Actual)Interventional2004-06-30Completed
An Open Label, Dose Escalation Study of Paricalcitol (Zemplar™) [19-NOR-1 ALPHA, 25-(OH) D] in Combination With Gemcitabine [2', 2' -Difluorodeoxycytidine] in Patients With Advanced Malignancies [NCT00217477]Phase 134 participants (Actual)Interventional2004-08-31Completed
Phase II Trial for the Treatment of Recurrent or Persistent Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With Gemcitabine and Topotecan [NCT00217555]Phase 20 participants Interventional2002-07-31Completed
A Randomized Phase II Study Of Triapine® Alone Versus Triapine and Gemcitabine As Second-Line Treatment Of Advanced Non-Small-Cell-Lung Cancer In Patients Who Had Prior Gemcitabine With Evaluation Of The Effect Of Triapine® On Gemcitabine Pharmacokinetics [NCT00077415]Phase 231 participants (Anticipated)Interventional2004-04-30Completed
A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma [NCT00042965]Phase 260 participants (Actual)Interventional2002-10-31Completed
Capecitabine And Gemcitabine In Patients With Advanced Or Metastatic Biliary Tract Cancer, A Multicenter Phase II Trial [NCT00073905]Phase 244 participants (Actual)Interventional2003-04-30Completed
Intrathecal Gemcitabine Therapy for Neoplastic Meningitis: A Phase I and Pharmacokinetic Study [NCT00074607]Phase 110 participants (Actual)Interventional2001-12-31Terminated
A Phase II Study of Triapine in Combination With Gemcitabine in Recurrent/Unresectable/Metastatic Pancreatic Carcinoma [NCT00078975]Phase 226 participants (Actual)Interventional2004-04-30Completed
Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer [NCT00079287]Phase 30 participants Interventional2001-03-31Completed
A Randomized Trial Comparing 5-Fluorouracil, External Beam Radiation, and Gemcitabine With or Without P Radiopharmaceutical Therapy As A First Line Therapy in Patients With Locally/Regionally Advanced Non-Resectable Adenocarcinoma of the Pancreas [NCT00079365]0 participants Interventional2001-05-31Active, not recruiting
A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in Advanced Soft Tissue Sarcoma [NCT00134641]Phase 240 participants Interventional2003-02-28Completed
A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab Combination (BeGeRN) in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma [NCT03259529]Phase 1/Phase 230 participants (Actual)Interventional2017-03-27Completed
A Phase I Trial of BMS 247550 (NSC# 710428) and Gemcitabine in Patients With Advanced Solid Tumor Malignancies [NCT00043095]Phase 10 participants Interventional2002-06-30Completed
A Phase II Trial Evaluating the Combination of Carboplatin, Gemcitabine, and Capecitabine in Patients With Carcinoma of Unknown Primary Site [NCT00148135]Phase 20 participants Interventional2001-05-31Terminated(stopped due to recruitment goals met)
A Phase II Study of Induction Chemotherapy Followed by Concurrent Chemotherapy With Radiotherapy in Locally Advanced Pancreatic Cancer [NCT00149578]Phase 245 participants (Anticipated)Interventional2004-10-31Recruiting
A Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Gemzar® Versus Single-Agent Gemzar® in Patients With Advanced Ovarian Cancer [NCT00051584]Phase 260 participants InterventionalTerminated
A Phase I Study of CDK4/6 Inhibitor LEE011 Combined With Gemcitabine in Patients With Advanced Solid Tumors or Lymphoma [NCT02414724]Phase 110 participants (Actual)Interventional2015-05-31Terminated(stopped due to PI left institute)
CT-2103 vs Gemcitabine or Vinorelbine for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study [NCT00054197]Phase 30 participants Interventional2003-01-31Terminated
A Randomized, Phase III Multicenter Trial Of Gemcitabine In Combination With Carboplatin Or Paclitaxel Plus Carboplatin In Patients With Metastatic (Stage IIIB, IV) Non-Small Cell Lung Cancer [NCT00054392]Phase 30 participants (Actual)Interventional2001-09-30Withdrawn(stopped due to Not opened at Fox Chase Cancer Center)
Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer [NCT00054626]Phase 3700 participants (Anticipated)Interventional2001-09-30Active, not recruiting
Gemcitabine-oxaliplatin Plus Rituximab (R-GEMOX) in Refractory/Relapsed Patients With CD 20 Positive Diffuse Large B-cell Lymphoma, Non Eligible for High-dose Chemotherapy Followed by Autotransplantation [NCT00169195]Phase 249 participants (Actual)Interventional2003-04-30Completed
A Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of Gemcitabine Plus LY293111 Compared to Gemcitabine Plus Placebo in Patients With Locally Advanced or Metastatic Pancreatic Cancer [NCT00055250]Phase 2130 participants Interventional2003-01-31Completed
A Phase II Trial of R115777, a Farnesyl Transferase Inhibitor, in Combination With Gemcitabine and Cisplatin in Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT00055757]Phase 248 participants (Actual)Interventional2003-10-31Completed
Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients With Locally Advanced or Recurrent Urothelial Malignancy [NCT00055835]Phase 27 participants (Actual)Interventional2002-11-30Completed
Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy [NCT00182806]Phase 238 participants (Actual)Interventional2004-09-30Completed
A Phase II Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma [NCT00183820]Phase 230 participants (Actual)Interventional2004-11-30Completed
A Phase 1 Study of Alvocidib (Flavopiridol) in Combination With Radiation in Locally Advanced, Non-Operable Pancreatic and Extrahepatic Bile Duct Cancers [NCT00047307]Phase 146 participants (Actual)Interventional2002-08-31Completed
A Randomized Phase II Trial of Gemcitabine Containing Regimens (Gemcitabine/Carboplatin and Gemcitabine/ Cisplatin)When Used as Preoperative Chemotherapy for Patients With Stage I and II NSCLC [NCT00191230]Phase 270 participants Interventional2001-09-30Completed
A Phase II Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer [NCT00191347]Phase 230 participants Interventional2004-10-31Completed
Phase II Study of Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma [NCT00191503]Phase 230 participants Interventional2005-01-31Completed
Randomized Phase II Study of Cisplatin + Gemcitabine Administered Either as Short Infusion or at a Fixed Dose Rate in Non-Small Cell Lung Cancer [NCT00191620]Phase 264 participants Interventional2004-03-31Completed
A Phase II Study of Gemcitabine in Transitional Cell Carcinoma of the Urothelium [NCT00191971]Phase 240 participants Interventional2004-01-31Completed
A Phase II Study of OSI-774 (Tarceva) and Gemcitabine for Patients With Metastatic Breast Cancer [NCT00059852]Phase 261 participants (Actual)Interventional2003-06-30Completed
A Randomised Phase II Study of Two Regimens of Palliative Chemoradiation Therapy in the Management of Locally Advanced Non Small Cell Lung Cancer [NCT00193921]Phase 282 participants (Actual)Interventional2003-02-28Completed
Activity of Regorafenib in Combination With Modified Gemcitabine - Oxaliplatin Chemotherapy (mGEMOX) in Patients With Advanced Biliary Tract Cancer (BTC): A Phase Ib-II Trial (BREGO) [NCT02386397]Phase 1/Phase 266 participants (Actual)Interventional2014-09-30Completed
A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma [NCT00084942]Phase 20 participants Interventional2002-10-31Completed
Phase I/II Study of LDE225 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Locally Advanced or Metastasized Pancreatic Cancer [NCT02358161]Phase 1/Phase 278 participants (Actual)Interventional2015-09-30Completed
ALIMTA Plus Gemcitabine as Front-line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer: A Phase II Clinical Trial [NCT00061451]Phase 248 participants Interventional2002-12-31Completed
A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer [NCT00222469]Phase 250 participants (Actual)Interventional2005-08-31Completed
Neoadjuvant Chemoradiotherapy (Gemcitabine/Cisplatin and Taxotere) With or Without Co-Administration of ZD 1839 (Iressa) for Stage IIIA (N2) and Selective Stage IIIB Non-Small Cell Lung Cancer: Phase I-II Study [NCT00062270]Phase 1/Phase 20 participants Interventional2003-05-31Completed
A Dose Escalating (Phase I) Study Looking at the Biomodulation of Capecitabine by Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer [NCT00320749]Phase 121 participants (Actual)Interventional2005-12-31Completed
A Phase 1, Open-Label Dose Escalation First-in-Human Study to Evaluate the Tolerability, Safety, Maximum Tolerated Dose, Preliminary Clinical Activity and Pharmacokinetics of AM0010 in Patients With Advanced Solid Tumors [NCT02009449]Phase 1350 participants (Actual)Interventional2013-11-15Active, not recruiting
Induction Cetuximab (IM-C225), Gemcitabine and Oxaliplatin, Followed by Radiotherapy With Concurrent Capecitabine, and Cetuximab, Followed by Maintenance Cetuximab and Gemcitabine for Patients With Locally Advanced Pancreatic Cancer [NCT00338039]Phase 269 participants (Actual)Interventional2005-09-30Completed
A Randomized Phase 2 Study of ARQ 197 Versus Gemcitabine in Treatment-Naïve Patients With Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma [NCT00558207]Phase 243 participants (Actual)Interventional2007-11-30Completed
A Phase II Evaluation of Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma [NCT00418093]Phase 219 participants (Actual)Interventional2006-09-30Terminated(stopped due to THe study was terminated early due to a lack of accural)
A Phase II, Multicenter Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma [NCT00461851]Phase 217 participants (Actual)Interventional2007-03-31Completed
A Phase 1b Study: Treatment of Refractory Pancreatic Adenocarcinoma and Advanced Soft Tissue or Bone Sarcomas Using Decitabine Combined With Gemcitabine [NCT02959164]Phase 136 participants (Actual)Interventional2016-12-05Completed
A Phase 2 Randomized Open-label Study of Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Previously Treated KRAS Mutation Positive Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer [NCT01395758]Phase 296 participants (Actual)Interventional2011-07-31Completed
A Phase 2 Study of AGEN1423, an Anti-CD73-TGFβ-Trap Bifunctional Antibody, in Combination With Balstilimab, With or Without Chemotherapy in Subjects With Advanced Pancreatic Cancer. [NCT05632328]Phase 224 participants (Anticipated)Interventional2023-04-30Not yet recruiting
The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer [NCT01797913]Phase 270 participants (Actual)Interventional2008-08-31Completed
A Phase II Study of Gemcitabine in Combination With Doxorubicin for Patients With Head and Neck Cancer [NCT00509665]Phase 218 participants (Actual)Interventional2005-06-30Completed
Phase I/IIa Trial Evaluating Safety of LOAd703, an Armed Oncolytic Adenovirus for Pancreatic Cancer [NCT02705196]Phase 1/Phase 255 participants (Anticipated)Interventional2016-11-30Recruiting
MC1365, A Randomized Phase II Trial of a Genetically Engineered NIS-Expressing Strain of Measles Virus Versus Investigator's Choice Chemotherapy for Patients With Platinum-Resistant Ovarian, Fallopian, or Peritoneal Cancer [NCT02364713]Phase 266 participants (Anticipated)Interventional2015-03-13Active, not recruiting
A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Cadonilimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma [NCT05898256]Phase 1/Phase 220 participants (Anticipated)Interventional2023-08-01Not yet recruiting
High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors [NCT00936936]Phase 264 participants (Actual)Interventional2009-06-02Active, not recruiting
A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency [NCT00478361]Phase 240 participants (Actual)Interventional2007-04-30Completed
A phase1b/2 Clinical Trial of Chemotherapy and the AXL-inhibitor Bemcentinib for Patients With Metastatic Pancreatic Cancer [NCT03649321]Phase 1/Phase 29 participants (Actual)Interventional2019-01-03Terminated(stopped due to Funding was terminated early because research interests were going in a different direction.)
Randomized Phase III Multicenter Trial of RRM1 & ERCC1 Directed Customized Chemotherapy Versus Standard of Care for 1st Line Treatment of Patients With Advanced Non-Small-Cell Lung Cancer [NCT00499109]Phase 3275 participants (Actual)Interventional2007-05-31Completed
Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma [NCT00556049]Phase 272 participants (Actual)Interventional2007-12-31Completed
Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma [NCT00630409]Phase 25 participants (Actual)Interventional2004-09-30Completed
A Phase II Study of Pemetrexed and Gemcitabine Plus Bevacizumab as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer [NCT00517595]Phase 248 participants (Actual)Interventional2007-08-31Completed
Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial [NCT04559139]Phase 2/Phase 3186 participants (Anticipated)Interventional2021-02-24Recruiting
A Multicenter Randomized Phase II Study to Determine the Optimal First-line Chemotherapy Regimen in Patients With Metastatic Pancreatic Cancer [NCT03487016]Phase 2270 participants (Actual)Interventional2019-02-15Active, not recruiting
Phase II Study of Panitumumab, Chemotherapy, and External Beam Radiation in Patients With Locally Advanced Pancreatic Cancer [NCT00601627]Phase 252 participants (Actual)Interventional2009-06-30Completed
A Phase 1/2 Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination With Gemcitabine Plus Cisplatin or Gemcitabine Alone in Subjects With Advanced Cancer [NCT02797977]Phase 1/Phase 2153 participants (Actual)Interventional2016-07-31Completed
A Phase 1b/2 Pilot Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine (Nabplagem) in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA) [NCT01893801]Phase 1/Phase 225 participants (Actual)Interventional2013-05-31Completed
Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency [NCT00005644]Phase 20 participants Interventional2001-01-02Completed
A Prospective, Single-arm, Exploratory Clinical Study of Sintilimab Injection in Combination With Paclitaxel (Albumin-bound) and Gemcitabine in Translational Therapy in Patients With Unresectable Locally Advanced Pancreatic Cancer. [NCT05346146]Phase 220 participants (Anticipated)Interventional2021-07-01Recruiting
Phase 1 Study of Anti-HB-EGF Monoclonal Antibody KHK2866 as Monotherapy in Subjects With Advanced Solid Tumors and in Combination With Chemotherapy in Ovarian Cancer [NCT01279291]Phase 122 participants (Actual)Interventional2011-01-31Terminated(stopped due to The study was stopped due to the inability to determine an acceptable dose with the potential for further study)
A Phase 2 Randomized, Double-Blind, Multicenter Trial of Amplimexon® Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy Naïve Pancreatic Adenocarcinoma (Stage IV) [NCT00637247]Phase 2142 participants (Actual)Interventional2008-04-30Completed
Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas [NCT01276613]Early Phase 118 participants (Actual)Interventional2011-01-31Terminated(stopped due to Per memo from study team)
GCC 0319: Low Dose Upper Abdominal Radiation Therapy (LD-UART) + Gemcitabine in Patients With Advanced, Unresectable Pancreatic Cancer (PC) [NCT00390182]Phase 1/Phase 238 participants (Actual)Interventional2003-10-31Completed
A Randomized, Open-Label, Phase 2 Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer [NCT01272791]Phase 270 participants (Actual)Interventional2011-01-31Completed
Phase I Study of Low-Dose Fractionated Radiotherapy as a Chemosensitizer for Gemcitabine and Erlotinib in Patients With Locally Advanced or Limited Metastatic Pancreatic Cancer [NCT00761345]Phase 127 participants (Actual)Interventional2008-09-30Completed
A Randomized Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic Pancreatic Cancer at First Line Therapy [NCT03417921]Phase 1/Phase 260 participants (Anticipated)Interventional2021-04-26Suspended(stopped due to We opened another study.)
Phase II Study of Gemcitabine and Intermittent Erlotinib in Advanced Pancreatic Cancer [NCT00810719]Phase 230 participants (Actual)Interventional2009-04-30Completed
A Multi-Center Randomized Phase 2b Study of Cetuximab (Erbitux) in Combination With Platinum-Based Chemotherapy as First Line Treatment of Patients With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT00828841]Phase 2601 participants (Actual)Interventional2008-12-31Completed
Alimta Plus Gemcitabine as Chemotherapy for Patients With Advanced Sarcoma: A Phase II Clinical [NCT00860015]Phase 212 participants (Actual)Interventional2005-08-31Completed
A Phase II Trial of Neoadjuvant Cisplatin, Gemcitabine and Sunitinib Malate Followed by Radical Cystectomy for Transitional Cell Carcinoma (TCC) of the Bladder: Hoosier Oncology Group GU07-123 [NCT00859339]Phase 29 participants (Actual)Interventional2009-03-31Terminated(stopped due to Patient Toxicities)
A Phase II Study of Lenalidomide in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas [NCT00837031]Phase 272 participants (Actual)Interventional2009-02-28Completed
A Pilot Protocol Evaluating Safety of Using the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Colorectal Carcinoma or Cholangiocarcinoma [NCT03693807]Phase 235 participants (Actual)Interventional2018-10-18Active, not recruiting
A Phase II and Biomarker Study of Tivozanib With Gemcitabine Addition Upon Progression in Patients With Metastatic Refractory Renal Cell Carcinoma [NCT01834183]Phase 20 participants (Actual)Interventional2013-06-30Withdrawn(stopped due to Sponsor Aveo has withdrawn support for this trial.)
Gemcitabine and Cisplatin With Erlotinib in Hepatocellular Carcinoma (HCC) and Biliary Tree Cancer (BTC) (Intra- and Extra-hepatic Cholangiocarcinoma, Bile Duct Cancer, Adenocarcinoma of the Ampulla of Vater and Gallbladder Carcinoma) [NCT00832637]Phase 233 participants (Actual)Interventional2007-08-31Terminated(stopped due to Low accrual)
Efficacy and Safety of the Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Initially Unresectable Biliary Tract Cancer [NCT04984980]Phase 237 participants (Actual)Interventional2020-08-01Active, not recruiting
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in First Line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Stage II Randomized Controlled Trials [NCT01810367]Phase 284 participants (Actual)Interventional2011-12-31Completed
A Trial of Cabozantinib (XL184) and Gemcitabine in Advanced Pancreatic Cancer [NCT01663272]Phase 112 participants (Actual)Interventional2012-07-31Completed
Nivolumab in Combination With Cisplatin and 5-Fluorouracil as Induction Therapy in Children and Adults With EBV-positive Nasopharyngeal Carcinoma [NCT06019130]Phase 257 participants (Anticipated)Interventional2023-01-10Recruiting
Randomized Phase III Trial of Chemotherapy vs. Pembrolizumab Plus Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma [NCT05711628]Phase 30 participants (Actual)Interventional2023-08-10Withdrawn(stopped due to Other - Protocol moved to Withdrawn)
Olaparib Combined With High-Dose Chemotherapy for Refractory Lymphomas [NCT03259503]Phase 150 participants (Actual)Interventional2019-09-13Active, not recruiting
A Japanese Single Center, Open-label, Phase I Trial of TH-302 Given Intravenously to Subjects With Solid Tumors as Monotherapy or to Subjects With Advanced Pancreatic Cancer in Combination With Gemcitabine [NCT01833546]Phase 120 participants (Actual)Interventional2013-04-18Completed
Study to Investigate Outcome of Individualized Treatment Based on Pharmacogenomic Profiling & Ex Vivo Drug Sensitivity Testing of Patient-derived Organoids in Patients With Metastatic Colorectal Cancer [NCT05725200]Phase 240 participants (Anticipated)Interventional2022-09-27Recruiting
BrUOG 300: Neoadjuvant Gemcitabine and Fractionated, Weekly Cisplatin For Muscle Invasive Bladder Cancer and Patients Not Candidates For High Dose Cisplatin [NCT02030574]Phase 22 participants (Actual)Interventional2014-07-31Terminated(stopped due to The study is being closed to accrual secondary to low accrual and an interest in opening up a different trial.)
Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation and Adjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma [NCT05717790]288 participants (Anticipated)Interventional2022-12-01Recruiting
A Phase 1 / 2 Study of CAN04, a Fully Humanized Monoclonal Antibody Against IL1RAP, in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumours [NCT05116891]Phase 1/Phase 240 participants (Actual)Interventional2021-09-22Completed
Antiangiogenic Therapy or Chemotherapy Combined With PD-1 Inhibitor Versus Standard Chemotherapy for PD-1 Inhibitor Refractory R/M NPC [NCT05549466]Phase 284 participants (Anticipated)Interventional2022-10-08Recruiting
A Phase Ib/II Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of KRAS p. G12C Mutated Advanced Pancreatic Cancer [NCT05251038]Phase 1/Phase 20 participants (Actual)Interventional2022-09-13Withdrawn(stopped due to Funder Decision)
Phase II Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Urothelial Cancer [NCT02560038]Phase 23 participants (Actual)Interventional2015-10-31Terminated(stopped due to slow enrollment; resource re-allocation)
An Open-Label, Single Center, Nonrandomized, Phase 1 Study to Evaluate Safety and Efficacy of Using the Combination Treatment of SHR-1210, Gemcitabine and Cis-platinum by Recurrent and Metastatic NPC [NCT03121716]Phase 123 participants (Actual)Interventional2017-04-26Completed
Randomized Phase II Study Evaluating the Efficacy of Gemcitabine Versus the Gemcitabine/Docetaxel Combination as Second Line Treatment in Metastatic or Relapsed and Inoperable Uterine or Soft Tissue Leiomyosarcomas [NCT00227669]Phase 290 participants (Actual)Interventional2005-10-31Completed
Phase II Trial of Weekly Gemcitabine and Herceptin in the Treatment of Patients With HER-2 Overexpressing Metastatic Breast Cancer [NCT00193063]Phase 241 participants (Actual)Interventional2001-07-31Completed
Randomized Phase II Study of Biweekly Gemcitabine-Paclitaxel, Biweekly Gemcitabine-Carboplatin and Biweekly Gemcitabine-Cisplatin as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure [NCT00191854]Phase 2147 participants (Actual)Interventional2005-03-31Completed
Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer [NCT00191815]Phase 270 participants (Actual)Interventional2002-10-31Completed
A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer [NCT00191269]Phase 268 participants (Actual)Interventional2005-06-30Completed
Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd [NCT00191152]Phase 3475 participants (Actual)Interventional2002-02-28Completed
Prospective Phase II Randomized Trial-Weekly Gemcitabine Plus High-Dose 5-Fluorouracil/ Leucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract [NCT00201305]Phase 250 participants Interventional2002-07-31Completed
A Two-Part Phase I Study of the Addition of Oxaliplatin to Gemcitabine, and Then Erlotinib Plus Oxaliplatin to Gemcitabine as Radiosensitizers for Pancreatic and Biliary Adenocarcinoma [NCT00266097]Phase 123 participants (Actual)Interventional2004-08-31Completed
A Phase I-II Dose Finding and Early Efficacy Study of Combination Therapy With Erlotinib (Tarceva), Gemcitabine, Bevacizumab (Avastin), and Capecitabine in Advanced Pancreatic Cancer [NCT00260364]Phase 1/Phase 244 participants (Actual)Interventional2005-11-30Completed
Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Gemcitabine for the Treatment of Patients With Newly Diagnosed, Relapsed or Chemotherapy Resistant Mantle Cell Lymphoma [NCT00234026]Phase 20 participants Interventional2005-06-30Completed
A Trial to Evaluate ZD1839 (IRESSA) in Combination With Radiotherapy & Gemcitabine as First-Line Treatment in Patients With Locally Advanced Pancreatic Cancer [NCT00234416]Phase 1/Phase 245 participants Interventional2002-08-31Completed
Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01 [NCT00235235]80 participants (Actual)Observational2005-09-30Terminated(stopped due to Funding terminated)
A Randomized Phase 2 Trial of Cisplatin/Gemcitabine With or Without M6620 (VX-970) in Metastatic Urothelial Carcinoma [NCT02567409]Phase 287 participants (Actual)Interventional2016-08-19Active, not recruiting
A Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin and Gemcitabine for Regionally Advanced or Metastatic Urothelial Cancer [NCT00237575]Phase 3100 participants Interventional2005-11-30Terminated
A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas [NCT00225784]Phase 237 participants (Actual)Interventional2005-02-28Completed
An Open Randomised Phase II Study Of Gemcitabine Plus Cisplatin +/- Concomitant or Sequential ZD1839 in Patients With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium [NCT00246974]Phase 2125 participants (Anticipated)Interventional2003-05-31Completed
A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer [NCT00278460]Phase 249 participants (Actual)Interventional2000-11-30Completed
A Pilot Study of Rituximab in Combination With Out-patient Based VGF/F-GIV Salvage Therapies for Relapsed/Refractory CD20+ Lymphomas [NCT00280878]Phase 212 participants (Anticipated)Interventional2006-01-31Completed
Phase II Randomized Study of Surgical Resection and Adjuvant Gemcitabine Hydrochloride With Versus Without Bevacizumab in Patients With Adenocarcinoma of the Pancreas [NCT00253526]Phase 20 participants (Actual)InterventionalWithdrawn
Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer [NCT00376948]Phase 220 participants (Actual)Interventional2005-05-31Completed
Phase I/II Trial of OSI-906 in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Ductal Adenocarcinoma of the Pancreas [NCT01600807]Phase 1/Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to Study was pending major changes and was on hold, pending activation; administratively withdrawn; will be submitted as a new protocol if study is revised.)
A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine vs. Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-Small Cell Lung Cancer [NCT00270582]Phase 258 participants (Anticipated)Interventional2005-11-30Recruiting
A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus Nab-paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma [NCT02272738]Phase 154 participants (Actual)Interventional2013-08-31Completed
Randomized Phase II Trial of Two Sequential Schedules of Docetaxel and Cisplatin Followed by Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer. [NCT00424853]Phase 288 participants (Actual)Interventional2005-05-31Completed
Gemcitabine, Alone or in Combination With Cisplatin, in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumors: A Multicentre, Randomized Phase III Study [NCT00262769]Phase 3324 participants (Actual)Interventional2005-05-31Completed
An Intention-to-Treat Study of Salvage Chemotherapy Followed by Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of High-Risk or Relapsed Hodgkin Lymphoma [NCT00574496]Phase 225 participants (Actual)Interventional2007-11-13Completed
Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary Cancer [NCT00271271]Phase 240 participants Interventional2003-06-30Completed
Non Resectable But Non Metastatic Adenocarcinoma of the Exocrine Pancreas Non Resecables. Randomised Phase III: Initial Radiochimiotherapy (5-FU, Cisplatine, 60 GY Radiotherapy) Followed by Gemcitabine Versus Gemcitabine Alone [NCT00416507]Phase 3190 participants (Anticipated)Interventional2000-03-31Completed
Multicenter Phase II Study Evaluating Gemcitabine and Oxaliplatin in the Treatment of Patients Suffering From Metastatic Breast Cancer Who Are Not Candidates For Treatment With Antracyclines and Taxanes [NCT00274859]Phase 245 participants (Anticipated)Interventional2005-08-31Active, not recruiting
A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium [NCT00310011]Phase 271 participants (Anticipated)Interventional1998-06-30Completed
Phase I/II Study of Gleevec (Imatinib Mesylate, Formerly Known as STI571) and Gemcitabine for Advanced Pancreas Cancer [NCT00281996]Phase 119 participants (Actual)Interventional2005-03-31Terminated(stopped due to Closed to accrual to allow enrollment on another more promising trial.)
A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JS015 Combination Therapy in Patients With Advanced Solid Tumors [NCT06139211]Phase 1/Phase 2186 participants (Anticipated)Interventional2023-11-30Not yet recruiting
A Phase I Study to Evaluate the Safety and Efficacy of RP72 Monotherapy and in Combination With Gemcitabine in Patients With Pancreatic Cancer [NCT04338763]Phase 148 participants (Anticipated)Interventional2021-04-19Recruiting
Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Lea [NCT03901339]Phase 3543 participants (Actual)Interventional2019-05-08Completed
A Phase 1b, Multicenter Study to Determine the Dose, Safety, Efficacy and Pharmacokinetics of TRK-950 When Used in Combinations With Selected Anti-Cancer Treatment Regimens in Patients With Selected Advanced Solid Tumors [NCT03872947]Phase 1169 participants (Anticipated)Interventional2019-04-26Recruiting
A Phase 1b/2 Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation [NCT03684811]Phase 1/Phase 293 participants (Actual)Interventional2018-11-01Completed
A Phase 1/2 Study of Gemcitabine and Docetaxel in Combination With Hydroxychloroquine (Autophagy Inhibitor) in Patients With Recurrent Osteosarcoma [NCT03598595]Phase 1/Phase 231 participants (Actual)Interventional2019-01-28Active, not recruiting
Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma [NCT03484299]Phase 120 participants (Anticipated)Interventional2018-05-30Recruiting
A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- [NCT03661320]Phase 3861 participants (Anticipated)Interventional2018-11-06Active, not recruiting
A Phase Ib, Open-Label, Sequential, Dose-Finding, Study of AMG 706 in Combination With Gemcitabine to Treat Subjects With Solid Tumors [NCT00324597]Phase 118 participants (Anticipated)Interventional2005-10-31Active, not recruiting
A Phase I Study of a Prolonged Infusion of Triapine in Combination With a Fixed Dose Rate of Gemcitabine in Patients With Advanced Solid Tumors and Lymphomas [NCT00293345]Phase 130 participants (Actual)Interventional2006-06-30Completed
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma [NCT00327327]Phase 1105 participants (Actual)Interventional2004-02-29Completed
Phase III Study of Monotherapy by Gemcitabine or Vinorelbine Comparing to Doublet by Carboplatin and Paclitaxel Among Elderly Patients With Stage IIIB/IV NSCLC (Obligatory Second-line by Erlotinib) [NCT00298415]Phase 3451 participants (Actual)Interventional2006-03-31Completed
A Phase 2 Double-Blind, Placebo Controlled, Multi-center Adjuvant Trial of the Efficacy, Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein Combined With a Gemcitabine Regimen Versus a [NCT00300950]Phase 2176 participants (Actual)Interventional2006-01-31Completed
[NCT00301301]39 participants ObservationalCompleted
Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression [NCT00303758]Phase 3202 participants (Actual)Interventional2005-10-31Completed
Randomized Phase III Trial of Neoadjuvant Chemotherapy Followed by Surgery Plus Adjuvant Chemotherapy Versus Surgery Plus Adjuvant Chemotherapy in Stage IB, IIA, IIB and T3N1 Non-small Cell Lung Cancer (ICON) [NCT00329472]Phase 30 participants (Actual)Interventional2006-04-30Withdrawn(stopped due to poor enrollment)
Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease [NCT00305786]Phase 230 participants (Actual)Interventional2005-08-31Completed
A Phase II Study of Weekly Paclitaxel and Gemcitabine as Second-line Therapy in Patients With Metastatic or Recurrence Small Cell Lung Cancer [NCT00453167]Phase 235 participants (Actual)Interventional2005-12-31Completed
A Phase II Pilot Study of Preoperative Gemcitabine and Bevacizumab-Based Chemoradiation for Patients With Resectable Adenocarcinoma of the Pancreas [NCT00336648]Phase 211 participants (Actual)Interventional2006-06-30Completed
A Multicenter Randomized Phase II Trial in NSCLC Stage IV et IIIB in Elderly Dependent Patients With Evaluation of the Sequence Gemcitabine First Line Followed by Erlotinib When Progression Versus Erlotinib First Line Followed by Gemcitabine When Progress [NCT00419042]100 participants (Actual)Observational2006-07-31Completed
A Phase I/II Study Of Gemcitabine And Bendamustine In Patients With Relapsed Or Refractory Hodgkin's Lymphoma [NCT01535924]Phase 1/Phase 226 participants (Actual)Interventional2012-02-09Completed
A Multicenter, Open Phase Ib Study of the Safety and Efficacy of BEBT-908 Combined With Drugs in the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma [NCT06164327]Phase 175 participants (Anticipated)Interventional2023-12-01Recruiting
Evaluation of Concomitant Chemo-radiotherapy With Cisplatin vs Gemcitabine as the First Line of Treatment in Patients With Locally Advanced Cervical Cancer, With Comorbidities and Preserved Renal Function, is a Phase III Clinical Trial. [NCT06156514]Phase 3140 participants (Anticipated)Interventional2019-11-06Recruiting
A Phase II Trial of Durvalumab With Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma [NCT06050252]Phase 227 participants (Anticipated)Interventional2024-02-16Not yet recruiting
A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharynge [NCT06029270]Phase 2156 participants (Anticipated)Interventional2024-02-16Not yet recruiting
A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage I/II NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone) [NCT01501136]Phase 4200 participants (Anticipated)Interventional2011-01-31Recruiting
A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage Ⅲ/Ⅳ NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone) [NCT01501149]Phase 480 participants (Anticipated)Interventional2011-01-31Recruiting
Phase 2 Study of GEMOX-T in Previously Untreated Patients With Advanced Pancreatic Cancer [NCT01505413]Phase 233 participants (Actual)Interventional2011-01-31Completed
[NCT01509911]Phase 299 participants (Actual)Interventional2012-01-31Active, not recruiting
A Ph Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies. [NCT01510561]Phase 10 participants (Actual)Interventional2012-03-31Withdrawn(stopped due to no subjects enrolled)
Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors [NCT01511146]Phase 2100 participants (Anticipated)Interventional2011-07-31Recruiting
An Open-label Randomized Phase II Trial of Gemcitabine and Cisplatin With or Without Bevacizumab in EGFR Wild-type Non-squamous Non-small-cell Lung Cancer Patients [NCT01623102]Phase 240 participants (Anticipated)Interventional2013-02-28Recruiting
Phase I/II BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients in First or Second Relapse [NCT01624493]Phase 1/Phase 20 participants (Actual)Interventional2012-10-31Withdrawn(stopped due to Phase I was conducted Australia. Phase II not conducted and no US pts enrolled.)
A Phase Ib/II Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-muscle Invasive Bladder Cancer [NCT01625260]Phase 1/Phase 252 participants (Anticipated)Interventional2012-04-30Active, not recruiting
Clofarabine, Gemcitabine, and Busulfan Followed by Allogeneic Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL) [NCT01629511]Phase 1/Phase 215 participants (Actual)Interventional2012-11-21Terminated
Phase III Study Evaluating Two Strategies of Maintenance, One With Pemetrexed in Continuous Strategy and One According to the Response of Induction Chemotherapy, in Non Squamous Non Small Cell Lung Cancer of Advanced Stage [NCT01631136]Phase 3932 participants (Actual)Interventional2012-07-31Completed
Phase II/III Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy in Stage IIIb-IV Squamous Non-Small-Cell Lung Cancer [NCT01631357]Phase 2/Phase 396 participants (Actual)Interventional2014-12-31Completed
A Phase II, Open-Label Trial of Bortezomib (VELCADE®) in Combination With Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer [NCT01633645]Phase 253 participants (Actual)Interventional2009-06-30Completed
Randomized Phase II Trial Of Adjuvant Chemotherapy For Urothelial Carcinoma Comparing GC To Dose-Dense MVAC [NCT01639521]Phase 20 participants (Actual)Interventional2013-05-31Withdrawn(stopped due to Lack of funding)
A Phase 1 Study of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Body Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer [NCT01652794]Phase 112 participants (Actual)Interventional2012-05-31Completed
Randomized Phase II Trial Using Concomitant Chemoradiation Plus Induction or Consolidation Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer Patients [NCT01652820]Phase 2140 participants (Actual)Interventional2001-10-31Completed
Autologous Cytokine-Induced Killer Cell Transfusion in Combination With Gemcitabine Plus Cisplatin Regimen Chemotherapy for Metastatic Nasopharyngeal Carcinoma [NCT01655628]Phase 240 participants (Anticipated)Interventional2012-07-31Recruiting
A Phase I/II Study of MK-3475 With Gemcitabine in Patients With Previously-Treated Advanced Non-small Cell Lung Cancer (NSCLC) [NCT02422381]Phase 1/Phase 216 participants (Actual)Interventional2015-07-20Active, not recruiting
A Single-armed Multicenter Phase Ib / II Study of HX008 (a Recombinant Humanized Anti-PD-1 Monoclonal Antibody) Combined With GP Regimen as the First-line Treatment in Patients With Metastatic Triple Negative Breast Cancer [NCT04750382]Phase 1/Phase 231 participants (Actual)Interventional2019-07-15Active, not recruiting
A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of R-GemOx Regimen as First-line Treatment in Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL). [NCT01670370]Phase 260 participants (Anticipated)Interventional2012-08-31Active, not recruiting
Treatment of Pancreatic Adenocarcinoma by Combining Contrast Agent and Gemitabine Under Sonification [NCT01674556]Phase 125 participants (Actual)Interventional2012-02-29Completed
A Phase 1 Clinical Trial of CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Exocrine Pancreatic Cancer [NCT03517176]Phase 130 participants (Actual)Interventional2018-07-31Completed
A Multicenter, Phase I/II Study of Sequential Epigenetic and Immune Targeting in Combination With Nab-Paclitaxel/Gemcitabine in Patients With Advanced Pancreatic Ductal Adenocarcinoma. [NCT04257448]Phase 1/Phase 275 participants (Anticipated)Interventional2020-05-25Active, not recruiting
A Phase 1, Open-label, Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies [NCT02376699]Phase 1159 participants (Actual)Interventional2015-02-28Terminated(stopped due to Study closed due to portfolio prioritization)
Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin [NCT00003925]Phase 136 participants (Anticipated)Interventional1998-05-31Completed
Downstaging of Unresectable Intrahepatic or Hilar Cholangiocellular Carcinoma by Selective Intra-arterial Floxuridine and Systemic Cisplatin and Gemcitabine. A Dose Finding Single Center Phase IIa Study [NCT01692704]Phase 1/Phase 212 participants (Actual)Interventional2012-04-30Completed
Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer [NCT01693276]Phase 1/Phase 23 participants (Actual)Interventional2012-09-30Terminated(stopped due to Slow accrual)
A Phase II Study of S-1 in Combination With Gemcitabine and Erlotinib in Patients With Advanced or Metastatic Pancreatic Cancer [NCT01693419]Phase 237 participants (Actual)Interventional2011-08-31Completed
A Multi-institutional Open Label, Trial Evaluating the Efficacy of Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Metastatic Colorectal Adenocarcinoma With Methylated CHFR and/or Microsatellite Instability Phenotype [NCT01639131]Phase 26 participants (Actual)Interventional2012-09-10Terminated
A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection [NCT03770299]Phase 20 participants (Actual)Interventional2021-01-15Withdrawn(stopped due to Business objectives have changed)
Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients With Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy [NCT02978716]Phase 2102 participants (Actual)Interventional2017-02-02Terminated(stopped due to Primary Analysis and survival follow up completed per protocol. Not stopped due to safety concerns)
A Phase II Study of Pembrolizumab With Cisplatin and Gemcitabine Treatment in Patients With Recurrent Platinum-resistant Ovarian Cancer [NCT02608684]Phase 221 participants (Actual)Interventional2016-02-08Completed
A Phase 3 Study to Evaluate the Efficacy and Safety of 250 µg G17DT or 1000 µg/m^2 Gemcitabine in Subjects With Advanced Pancreatic Cancer [NCT03200821]Phase 3103 participants (Actual)Interventional2000-08-14Completed
The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus-Calmette Guerin (BCG) Instillation Therapy on the Quality of Life in Non-muscle-invasive Bladder Cancer (NMIBC) Patients: Results of a Prospective, Randomised Phase II Trial. [NCT01697306]Phase 2120 participants (Actual)Interventional2006-09-30Completed
A MULTICENTER, OPEN-LABEL PHASE IB STUDY OF RO5083945 IN COMBINATION WITH CISPLATIN AND GEMCITABINE OR CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH ADVANCED OR RECURRENT NON SMALL CELL LUNG CANCER OF SQUAMOUS HISTOLOGY WHO HAVE NOT RECEIVED PRIOR CHEMOTHER [NCT01702714]Phase 10 participants (Actual)Interventional2014-07-31Withdrawn(stopped due to Project Team decision)
Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples. [NCT01703910]Phase 229 participants (Actual)Interventional2012-11-30Completed
Effect of Intravesical B.C.G and Gemcitabine on Semen Quality and Testicular Volume in Patients With Non-muscle Invasive Bladder Cancer Patients [NCT05701332]Phase 425 participants (Anticipated)Interventional2023-04-01Not yet recruiting
Randomized Phase 2 Trial of Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer [NCT03451331]Phase 248 participants (Actual)Interventional2018-05-10Active, not recruiting
Evaluation of Tumoral Perfusion Modification by Dynamic Imaging After Neoadjuvant Chemotherapy Combining Gemcitabine and a Hedgehog Inhibitor (Vismodegib) in Patients With Resectable Pancreatic Adenocarcinoma [NCT01713218]Early Phase 121 participants (Anticipated)Interventional2012-12-31Not yet recruiting
A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus S-1 in Patients With Biliary Tract Cancer Undergoing Curative Resection Without Major Hepatectomy [NCT01713387]Phase 138 participants (Actual)Interventional2012-04-30Completed
A Phase I-II Evaluation of the Safety and Efficacy of the Oral HSP90 Inhibitor Debio 0932 in Combination With Standard of Care in first-and Second-line Therapy of Patients With Stage IIIb or IV Non-small Cell Lung Cancer-the HALO Study (HSP90 Inhibition A [NCT01714037]Phase 182 participants (Actual)Interventional2012-08-31Terminated
Evaluation of Tumoral Perfusion Modification by Dynamic Imaging After Chemotherapy Combining Gemcitabine and Nab-paclitaxel (Abraxane) in Patients With Potentially Operable, Locally Advanced or Metastatic Pancreatic Adenocarcinoma [NCT01715142]Early Phase 123 participants (Actual)Interventional2013-03-21Completed
Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma [NCT01719302]Phase 1/Phase 26 participants (Actual)Interventional2012-10-31Completed
CHEMO-T: Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (CHOP) Versus Gemcitabine, Cisplatin and Methyl Prednisolone (GEM-P) in the First Line Treatment Of T-cell Lymphoma,a Multicentre Randomised Phase II Study [NCT01719835]Phase 287 participants (Actual)Interventional2012-03-31Active, not recruiting
A Phase I-II Study of PAXG in Stage III-IV Pancreatic Adenocarcinoma [NCT01730222]Phase 1/Phase 2137 participants (Actual)Interventional2012-11-30Completed
Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer [NCT01734798]Phase 3198 participants (Actual)Interventional2002-12-31Completed
RT-054: A Phase I Study of Neoadjuvant Hypofractionated Chemoradiation Plus Radiosurgical Boost for Patients With Borderline Resectable and Locally Advanced Unresectable Pancreatic Cancer [NCT01739439]Phase 16 participants (Actual)Interventional2013-05-31Terminated(stopped due to Slow accrual)
A 3-Arm Phase 2 Double-Blind Randomized Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma [NCT02289898]Phase 2207 participants (Actual)Interventional2015-04-20Completed
Study of Gemcitabine, Cisplatin, Quemliclustat (AB680) and Zimberelimab (AB122) During First Line Treatment of Advanced Biliary Tract Cancers (BTC). [NCT06048133]Phase 239 participants (Anticipated)Interventional2023-12-31Recruiting
A Single-arm, Phase II Clinical Trial to Treat Muscle-invasive Bladder Cancer With Induction Chemotherapy Plus Anti-PD-1 Therapy Followed by Radiotherapy Plus Concurrent Anti-PD-1 Therapy [NCT05975307]Phase 264 participants (Anticipated)Interventional2023-12-01Recruiting
A Multi-Institution Study of TGFβ Imprinted, Ex Vivo Expanded Universal Donor NK Cell Infusions as Adoptive Immunotherapy in Combination With Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Pediatric Bone and Soft Tissue [NCT05634369]Phase 1/Phase 250 participants (Anticipated)Interventional2022-11-14Recruiting
A Randomized Phase II Trial Evaluating Chemotherapy Plus Atezolizumab vs Chemotherapy Plus Bevacizumab and Atezolizumab in Advanced Combined Hepatocellular Carcinoma-Cholangiocarcinoma [NCT05211323]Phase 288 participants (Anticipated)Interventional2022-12-07Recruiting
Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined With Chemotherapy, in Patients With Refractory Hematologic Malignancies or Solid Tumors [NCT03678883]Phase 2350 participants (Anticipated)Interventional2019-01-04Recruiting
Vitamin D Receptor Agonist Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Patients With Metastatic Pancreatic Cancer [NCT03520790]Phase 1/Phase 236 participants (Actual)Interventional2018-12-05Active, not recruiting
A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma [NCT02953509]Phase 1/Phase 2178 participants (Actual)Interventional2016-11-21Active, not recruiting
Sorafenib Combined With Cisplatin and Gemcitabine for the Treatment of Patients With Advanced Renal Collecting Duct Carcinoma:A Pilot, Open Study [NCT01762150]Phase 226 participants (Actual)Interventional2011-06-30Completed
An Open-Label, Multicenter, Phase 1b/2 Study to Evaluate Necitumumab in Combination With Gemcitabine and Cisplatin in the First-Line Treatment of Patients With Advanced (Stage IV) Squamous Non-Small Cell Lung Cancer (NSCLC) [NCT01763788]Phase 1/Phase 2192 participants (Actual)Interventional2013-05-07Completed
A Multi-center, Phase Ib Study of MEK (Mitogen Activated Protein Kinase/ERK Kinase) Inhibitor BAY86-9766 Plus Gemcitabine in Asian Patients With Advanced or Refractory Solid Tumors [NCT01764828]Phase 123 participants (Actual)Interventional2013-02-05Completed
Open-label, Single-center, Non-randomized, Phase I, Dose-ranging Study of Endoscopic Ultrasound (EUS) Guided Photodynamic Therapy (PDT) With Photofrin® in Locally Advanced Pancreatic Cancer [NCT01770132]Phase 112 participants (Anticipated)Interventional2013-04-19Completed
A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer [NCT01770795]Phase 245 participants (Actual)Interventional2011-01-31Completed
Gemcitabine Combined With Chloroquine in Patients With Metastatic or Unresectable Pancreatic Cancer. A Dose Finding Single Center Phase I Study [NCT01777477]Phase 19 participants (Actual)Interventional2012-07-31Completed
Randomized Double-blind Controlled Clinical Study of Chemotherapy Combined With or Without Traditional Chinese Medicine on Survival Affect of Elderly Patients With Advanced Non-small-cell Lung Cancer [NCT01780181]82 participants (Actual)Observational2012-12-31Completed
The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1/RRM1/TS Expression [NCT01781988]Phase 2128 participants (Actual)Interventional2009-06-30Completed
An Open Label, Phase 1, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Clinical Activity of Gemcitabine Hydrochloride Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lym [NCT01800630]Phase 137 participants (Actual)Interventional2013-04-30Completed
Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer [NCT01801644]60 participants (Actual)Interventional2007-04-30Completed
An Open-label, Single Arm, Single Center Phase 2 Study of RC48-ADC (IV) in Combination With Gemcitabine(Intravesical) in High Risk NMIBC Subjects (BCG Naïve or BCG Unresponsive) That Expresses HER2 (IHC 1+ and Greater) [NCT05943379]Phase 285 participants (Anticipated)Interventional2023-06-08Recruiting
A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers [NCT04910386]Phase 2126 participants (Anticipated)Interventional2024-06-01Not yet recruiting
An Open-label, Single-arm, Phase II Study to Assess the Efficacy and Safety of Endostar® (Recombinant Human Endostatin Injection) Plus Gemcitabine and Docetaxel in Treatment of Soft Tissue Sarcoma Patients With Pulmonary Metastases [NCT01812018]Phase 230 participants (Anticipated)Interventional2012-11-30Recruiting
Randomized Phase III Study of Gemcitabine/Cisplatine (GC) Versus High-dose Intensity Methotrexate, Vinblastine, Doxorubicine and Cisplatin (HD-MVAC) in the Perioperative Setting for Patients With Locally Advanced Transitional Cell Cancer of the Bladder [NCT01812369]Phase 3500 participants (Actual)Interventional2013-02-28Active, not recruiting
A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma [NCT02256982]3 participants (Actual)Interventional2014-10-31Terminated(stopped due to Slow accrual.)
Randomized Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer [NCT01815307]Phase 270 participants (Actual)Interventional2013-01-31Completed
A Multicenter Phase II Trial of Preoperative Chemotherapy With Gemcitabine/ Cisplatin /S-1 (GCS) for Biliary Tract Cancers With Lymph Node Metastasis Diagnosed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) [NCT01821248]Phase 225 participants (Anticipated)Interventional2013-07-23Active, not recruiting
Neoadjuvant FOLFIRINOX and Chemoradiation Followed by Definitive Surgery and Postoperative Gemcitabine for Patients With Borderline Resectable Pancreatic Adenocarcinoma: An Intergroup Single-Arm Pilot Study [NCT01821612]Early Phase 123 participants (Actual)Interventional2013-05-31Completed
Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression [NCT01828736]Phase 261 participants (Actual)Interventional2004-02-09Completed
A Phase II Randomized Study of Nab-paclitaxel With Gemcitabine at Two Different Dose Combinations to Determine Efficacy in Patients With Advanced Non- Squamous Non-small Cell Lung Cancer (NSCLC). [NCT02405910]Phase 20 participants (Actual)Interventional2015-03-15Withdrawn(stopped due to PI Left Institution)
Pharmacological Ascorbate for the Control of Metastatic and Node-Positive Pancreatic Cancer (PACMAN): A Phase II Trial [NCT01515046]Phase 21 participants (Actual)Interventional2012-09-30Terminated(stopped due to Standard of care changed to FOLFIRINOX; poor accrual.)
A Phase IIa Exploratory Study of OCZ103-OS in Combination With Platinum-Gemcitabine Based Doublet First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC) Patients [NCT01844791]Phase 225 participants (Actual)Interventional2012-09-30Completed
A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma [NCT01124786]Phase 2367 participants (Actual)Interventional2010-05-31Completed
A Phase 1b Study of Talimogene Laherparepvec (T-VEC) in Combination With Chemotherapy or Endocrine Therapy in Patients With Metastatic, Unresectable, or Locoregionally Recurrent HER2-negative Breast Cancer [NCT03554044]Phase 120 participants (Actual)Interventional2020-02-05Active, not recruiting
Phase Ib/II Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs) in Combination With Low Dose IL-2 and GM-CSF [NCT02620865]Phase 1/Phase 22 participants (Actual)Interventional2015-12-31Completed
A Phase I/II Study of CC-4047 in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas [NCT00540579]Phase 1/Phase 223 participants (Actual)Interventional2007-11-30Completed
A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer [NCT02242409]Phase 24 participants (Actual)Interventional2014-09-30Terminated(stopped due to Testing of combination no longer relevant)
Intercalating and Maintenance Use of Iressa vs. Chemotherapy in Selected Advanced NSCLC: a Randomised Study [NCT01404260]Phase 3219 participants (Actual)Interventional2011-06-30Completed
A Multicentre, Randomized, Open-Label, Phase III Clinical Trial Of Gemcitabine And Carboplatin Followed By Epstein-Barr Virus-Specific Autologous Cytotoxic T Lymphocytes Versus Gemcitabine And Carboplatin As First Line Treatment For Advanced Nasopharyngea [NCT02578641]Phase 3330 participants (Actual)Interventional2014-07-31Completed
Perioperative Therapy Preoperative Chemotherapy Versus Chemoradiotherapy in Locally Advanced Gall Bladder Cancers [NCT02867865]Phase 2/Phase 3314 participants (Anticipated)Interventional2016-09-06Recruiting
Neoadjuvant Chemotherapy Plus Tislelizumab Followed by Concurrent Chemoradiotherapy and Maintenance Therapy With Tislelizumab in Patients With Stage IVA Nasopharyngeal Carcinoma: A Single-arm, Phase II Trial [NCT05448885]Phase 250 participants (Anticipated)Interventional2021-09-01Recruiting
A Single-arm, Open-label, Multi-center Phase II Clinical Study to Evaluate the Safety and Efficacy of Toripalimab Injection Combined With TACE in the Treatment of Extrahepatic Cholangiocarcinoma [NCT05448183]Phase 245 participants (Anticipated)Interventional2022-06-15Recruiting
Phase 1/2 Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma. [NCT01431794]Phase 1/Phase 223 participants (Actual)Interventional2011-12-27Terminated(stopped due to Study was terminated due to cease in manufacturing of study drug.)
Using PERS(PErsonalized Regimen Selection) Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer Multicentric, Prospective, Randomized Controlled Phase III Clinical Study [NCT03006614]Phase 3320 participants (Anticipated)Interventional2016-04-30Recruiting
A Phase II Randomized Trial Evaluating the Addition of High or Standard Intensity Radiation to Gemcitabine and Nab-paclitaxel for Locally Advanced Pancreatic Cancer [NCT01921751]Phase 220 participants (Actual)Interventional2013-08-31Terminated(stopped due to Trial would not be completed in a reasonable timeframe per CTEP guidelines)
Phase II Trial of Neoadjuvant Dose Dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer [NCT01611662]Phase 232 participants (Actual)Interventional2012-05-29Terminated(stopped due to Extreme Toxicity)
A Phase II Randomized - Non Comparative - Study on the Activity of Trabectedin or Gemcitabine + Docetaxel in Metastatic or Locally Relapsed Uterine Leiomyosarcoma Pretreated With Conventional Chemotherapy [NCT02249702]Phase 2168 participants (Actual)Interventional2010-04-30Completed
A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers [NCT01661114]Phase 239 participants (Actual)Interventional2011-07-31Completed
A Randomized Phase II Open Label Study to Assess the Efficacy & Safety of Gemcitabine + Abraxane® With or Without ODSH (2-0, 3-0 Desulfated Heparin) as First Line Treatment of Metastatic Pancreatic Cancer [NCT01461915]Phase 260 participants (Actual)Interventional2011-11-30Terminated
A Phase II Trial of Gemcitabine and Erlotinib (GE) Plus Proton-chemotherapy (PCT) and Capox for Locally Advanced Pancreatic Cancer (LAPC) [NCT01683422]9 participants (Actual)Interventional2013-01-02Terminated(stopped due to Updated chemotherapy regimens currently evaluated in clinical trials due to lack of progress in treating this condition; analysis continues in the realm of patterns of failure and increasing quality of life)
Induction Chemotherapy Plus Radiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial [NCT04414566]Phase 3562 participants (Anticipated)Interventional2020-06-01Not yet recruiting
A Phase II Trial of Gemcitabine Plus High-Dose Ascorbate in Locally Advanced Unresectable or Metastatic Soft Tissue and Bone Sarcomas in Adults [NCT03468075]Phase 210 participants (Actual)Interventional2018-07-11Terminated(stopped due to Stopping rules met)
A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in Combination With First Line Chemotherapy Regimens in Patients With Non-Small Cell Lung Cancer ( [NCT01809210]Phase 155 participants (Actual)Interventional2013-04-04Completed
Phase IIa Study on the Role of Gemcitabine Plus Romidepsin (GEMRO Regimen) in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma Patients. [NCT01822886]Phase 220 participants (Actual)Interventional2013-01-31Completed
A Phase II Study of Mocetinostat Administered With Gemcitabine for Patients With Metastatic Leiomyosarcoma With Progression or Relapse Following Prior Treatment With Gemcitabine-Containing Therapy [NCT02303262]Phase 220 participants (Actual)Interventional2015-11-12Completed
Phase II Study of the Anti-Vascular Endothelial Growth Factor (α-VEGF) Monoclonal Antibody Bevacizumab in Combination With Fixed Dose Rate (FDR) Gemcitabine and Rapid-Fractionation Radiotherapy in the Pre-operative Treatment of Potentially- Resectable Pan [NCT00557492]Phase 259 participants (Actual)Interventional2006-12-31Completed
A Two-Part, Randomized Phase III, Double-Blind, Multicenter Trial Assessing The Efficacy And Safety of Pertuzumab In Combination With Standard Chemotherapy Vs. Placebo Plus Standard Chemotherapy In Women With Recurrent Platinum-Resistant Epithelial Ovaria [NCT01684878]Phase 3208 participants (Actual)Interventional2012-10-22Completed
A Phase I/1b Study of Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer [NCT02300610]Phase 110 participants (Actual)Interventional2015-02-11Completed
DOSE ESCALATION TRIAL OF THE Wee1 INHIBITOR AZD1775, IN COMBINATION WITH GEMCITABINE (+RADIATION) FOR PATIENTS WITH UNRESECTABLE ADENOCARCINOMA OF THE PANCREAS [NCT02037230]Phase 1/Phase 234 participants (Actual)Interventional2014-01-31Completed
Phase II Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin in Subjects With Metastatic Pancreatic Cancer [NCT01459614]Phase 244 participants (Actual)Interventional2011-11-30Completed
A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer [NCT00833859]Phase 22 participants (Actual)Interventional2009-03-31Terminated(stopped due to Abandoned - Lack of funding after only 2 patients enrolled)
A Pivotal Phase II Randomised, Multi-centre, Open-label Study to Evaluate the Efficacy and Safety of MB-CART2019.1 Compared to SoC Therapy in Participants With r/r DLBCL, Who Are Not Eligible for HDC and ASCT [NCT04844866]Phase 2168 participants (Anticipated)Interventional2021-08-18Recruiting
Multiple Centers, Prospective, Phase II Trial of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Locally Advanced/Metastatic Soft Tissue Sarcoma or Imatinib Mesylate Refractory Advanced/Metastatic Malignant Gastrointestinal Stromal Tum [NCT00359333]Phase 258 participants (Actual)Interventional2006-12-31Completed
A Randomized Phase II Study of Gemcitabine, Cisplatin +/- Veliparib in Patients With Pancreas Adenocarcinoma and a Known BRCA/ PALB2 Mutation (Part I) and a Phase II Single Arm Study of Single-Agent Veliparib in Previously Treated Pancreas Adenocarcinoma [NCT01585805]Phase 2107 participants (Anticipated)Interventional2012-05-15Active, not recruiting
A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas [NCT00001431]Phase 120 participants Interventional1995-02-28Completed
Phase II Trial of Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN) [NCT01443078]Phase 242 participants (Actual)Interventional2011-10-31Completed
Evaluation of the Safety and Efficacy of Standard Dose Gemcitabine Combined With High Dose Intravenous Vitamin C (HDIVC) Treatment for Patients With Metastatic Adenocarcinoma of the Pancreas. [NCT01654861]Phase 13 participants (Actual)Interventional2012-06-30Terminated(stopped due to recruiting or enrolling participants has halted prematurely and will not resume)
GVD±R (Gemcitabine, Oral Vinorelbine and Doxorubicin Liposome, With or Without Rituximab) Regimen for Autologous Hematopoietic Stem Cell Transplantation(ASCT)-Eligible Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma:a Multi-center, Single [NCT04021992]Phase 248 participants (Anticipated)Interventional2019-07-15Recruiting
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Carboplatin Versus Gemcitabine Plus Carboplatin [NCT04143906]Phase 2200 participants (Anticipated)Interventional2019-10-25Not yet recruiting
Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer [NCT01442974]15 participants (Actual)Interventional2011-01-31Completed
A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients With Non-resectable Pancreatic Cancer [NCT05841420]Phase 298 participants (Anticipated)Interventional2023-06-12Recruiting
A Phase I/IIa Study of IAH0968 in Patients With HER2-positive Advanced Solid Tumors [NCT04934514]Phase 1/Phase 297 participants (Anticipated)Interventional2021-07-06Recruiting
An Adaptive Approach to Neoadjuvant Therapy to Maximize Resection Rates for Pancreatic Adenocarcinoma: A Phase II Trial [NCT04594772]Phase 232 participants (Anticipated)Interventional2021-03-17Recruiting
A Multicentre, Open-label, Three-arm Randomised Phase II Trial Assessing the Safety and Efficacy of the HSP90 Inhibitor Ganetespib in Combination With Carboplatin Followed by Maintenance Treatment With Niraparib Versus Ganetespib Plus Carboplatin Followed [NCT03783949]Phase 2122 participants (Actual)Interventional2018-11-30Completed
Phase 1 Study of Preoperative Gemcitabine Plus CP-870,893 Followed by Addition of CP-870,893 to Standard -Of-care Adjuvant Chemoradiation for Patient With Newly Diagnosed Resectable Pancreatic Carcinoma [NCT01456585]Phase 110 participants (Anticipated)Interventional2012-04-30Completed
A Phase 1 Study of Copanlisib(Phosphatidylinositol-3 Kinase Inhibitor) in Combination With Gemcitabine (Treatment A) or Cisplatin Plus Gemcitabine (Treatment B) in Subjects With Advanced Solid Malignancy [NCT01460537]Phase 150 participants (Actual)Interventional2011-11-18Completed
A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobilia [NCT05775159]Phase 2180 participants (Anticipated)Interventional2023-04-24Recruiting
A Phase II Study of Oral CHK1 Inhibitor LY2880070 in Combination With Low-Dose Gemcitabine in Patients With Relapsed or Refractory Ewing Sarcoma, Ewing-like Sarcoma, and Desmoplastic Small Round Cell Tumor [NCT05275426]Phase 224 participants (Anticipated)Interventional2022-03-02Recruiting
Phase II Study of Neoadjuvant Gemcitabine, Cisplatin and Bevacizumab in Stage IIIA (N2), Non-Squamous Cell Non-Small Cell Lung Cancer [NCT00924209]Phase 27 participants (Actual)Interventional2009-03-31Terminated(stopped due to Study was terminated due to poor accrual.)
A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Bevacizumab (NSC #704865) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Placebo in the Treatment of Recurrent or Adva [NCT01012297]Phase 3107 participants (Actual)Interventional2009-11-30Terminated(stopped due to The study was targeted to accrue 130 patients, but closed early for futility.)
A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer [NCT05026905]Phase 286 participants (Anticipated)Interventional2021-12-28Recruiting
Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer [NCT02981719]61 participants (Actual)Interventional2016-10-01Completed
Phase I Study of Gemcitabine With Novel RAF Kinase-Vascular Endothelial Growth Factor Receptor Inhibitor Sorafenib (BAY 43-9006) and Radiotherapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma [NCT00375310]Phase 127 participants (Actual)Interventional2006-09-30Completed
Duvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk, Phase II, Single Center, Randomized Controlled Study [NCT05672537]Phase 270 participants (Anticipated)Interventional2023-01-20Recruiting
An Open-Label, Uncontrolled, Single Centered Phase Ⅱ Study of Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone (Avastin+ GemAOD) As First-Line Treatment in Patients With Untreated NK/T Cell Lymphoma [NCT01921790]Phase 230 participants (Anticipated)Interventional2013-08-31Recruiting
Phase II Trial of Gemcitabine-Eribulin (GE) in Cisplatin Ineligible Patients With Advanced or Unresectable Urothelial Carcinoma of the Bladder [NCT02178241]Phase 226 participants (Actual)Interventional2014-12-11Completed
Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma [NCT00948935]Phase 235 participants (Actual)Interventional2009-04-30Completed
A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and niv [NCT02574078]Phase 1/Phase 2341 participants (Actual)Interventional2015-11-23Completed
A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer [NCT01041781]Phase 3313 participants (Actual)Interventional2010-02-28Terminated(stopped due to DSMB recommendation)
Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study [NCT05254899]Phase 254 participants (Anticipated)Interventional2021-10-01Recruiting
Phase II Study of Combined Targeted p53 Gene Therapy (SGT-53) Plus Gemcitabine/Nab-Paclitaxel for Treatment of Metastatic Pancreatic Cancer [NCT02340117]Phase 228 participants (Anticipated)Interventional2015-01-31Recruiting
A Phase II Study of the Combination of Gemcitabine and Imatinib Mesylate in Pemetrexed-pretreated Patients With Malignant Pleural Mesothelioma [NCT02303899]Phase 222 participants (Actual)Interventional2014-11-30Completed
Phase II Randomized Trial of MEK Inhibitor MSC1936369B or Placebo Combined With Gemcitabine in Metastatic Pancreas Cancer Subjects [NCT01016483]Phase 1/Phase 2141 participants (Actual)Interventional2009-11-30Completed
A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Micoenvironment in Resectable Pancreatic Cancer [NCT03519308]Early Phase 19 participants (Actual)Interventional2020-07-29Terminated(stopped due to The accrual goal could not be met and the drug manufacturer pulled support)
Ensayo Fase II de selección Individualizada Del Tratamiento de Quimioterapia en Pacientes Con Carcinoma de páncreas Avanzado en función de la determinación de Dianas terapéuticas en el Tejido Tumoral [NCT01454180]Phase 231 participants (Actual)Interventional2011-10-31Completed
Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of Excision Repair Cross Complementation Gene 1 (ERCC1) in Treatment Decision [NCT01188109]Phase 225 participants (Actual)Interventional2010-07-31Terminated(stopped due to Slow accrual)
A Pilot Study to Test the Feasibility of the Combination of Gemcitabine and Anti-PD1 Monoclonal Antibody (CT-011) in the Treatment of Resected Pancreatic Cancer [NCT01313416]Phase 22 participants (Actual)Interventional2012-09-30Terminated(stopped due to Drug supply issues)
A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients With Pancreatic Cancer [NCT05984602]Phase 110 participants (Anticipated)Interventional2023-07-14Recruiting
A Phase II Study of Neo-Adjuvant Cisplatin, Gemcitabine & Bevacizumab, Followed by Radical Cystectomy for Patients With Muscle Invasive, Resectable, Non-Metastatic Transitional Cell Carcinoma (TCC) of the Bladder [NCT00268450]Phase 221 participants (Actual)Interventional2005-09-21Terminated
Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer [NCT00089128]Phase 216 participants (Actual)Interventional2001-11-30Terminated(stopped due to Low accrual)
Phase II Study of Stereotactic Body Radiotherapy (SBRT) and Chemotherapy for Unresectable Cholangiocarcinoma Followed by Liver Transplantation [NCT01151761]Phase 22 participants (Actual)Interventional2011-01-31Terminated(stopped due to Poor accrual)
HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Advanced Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial. [NCT05751850]Phase 3522 participants (Anticipated)Interventional2023-06-13Recruiting
First-line Trastuzumab Plus Chemoimmunotherapy for Biliary Tract Cancer (HERBOT Trial) [NCT05749900]Phase 1/Phase 244 participants (Anticipated)Interventional2023-03-31Not yet recruiting
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors [NCT02533674]Phase 157 participants (Actual)Interventional2014-12-12Completed
A Phase I Study Evaluating Copanlisib in Combination With R-GCD (Gemcitabine, Carboplatin, Dexamethasone, and Rituximab) With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and High-Risk Follicular Lymphoma [NCT04156828]Phase 112 participants (Actual)Interventional2020-03-31Terminated(stopped due to Terminated due to low accrual)
A Randomized Phase II Study of Progression Free Survival Comparing Gemcitabine (1000 mg/m2 Infusion) Versus Carboplatin (AUC5 Infusion) Plus Alimta (500 mg/m2 Infusion) as First-line Chemotherapy in Elderly Patients With Locally Advanced (Stage IIIb) or M [NCT00754364]Phase 2108 participants (Actual)Interventional2008-10-31Terminated(stopped due to low enrollment rate)
Phase II Study of Gemcitabine (GEMZAR) and Cisplatin (CDDP) in Advanced Breast Cancer [NCT00002998]Phase 259 participants (Actual)Interventional1997-08-31Completed
Combination Chemobiotherapy With Gemcitabine, 5-Fluorouracil, Interleukin-2 and Alpha Interferon in Patients With Metastatic or Unresectable Renal Cell Cancer. A Phase II Study [NCT00003664]Phase 230 participants (Anticipated)Interventional1998-10-31Active, not recruiting
Alternating Phase I/II Trials of Twice-Weekly Infusion Gemcitabine (2'2'-Difluoro-2'-Deoxycytidine) and Concurrent Thoracic Radiation Alone - Or Following 2 Cycles of Cisplatin/Gemcitabine Induction Chemotherapy for the Treatment of Stage IIIA/IIIB Non Sm [NCT00003202]Phase 1/Phase 240 participants (Actual)Interventional1998-01-31Completed
Evaluation of Gemcitabine in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus [NCT00003316]Phase 20 participants Interventional1998-08-31Terminated
Phase I Trial Intraperitoneal Cisplatin With Intraperitoneal Gemcitabine in Patients With Epithelial Ovarian Carcinoma [NCT00003358]Phase 124 participants (Anticipated)Interventional1998-01-31Completed
A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma [NCT00004066]Phase 282 participants (Anticipated)Interventional1999-06-30Completed
A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube [NCT00003382]Phase 10 participants Interventional1998-05-31Terminated
An Open-Label, Phase III Study of Platinum-Gemcitabine With or Without Nivolumab in the First-Line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma [NCT04458909]Phase 315 participants (Actual)Interventional2020-12-09Terminated(stopped due to External information)
Gemcitabine (10 mg/m2/Min) and Cisplatin: A Phase I Study [NCT00004090]Phase 10 participants Interventional1999-08-31Completed
Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma [NCT03377491]Phase 3556 participants (Anticipated)Interventional2018-02-10Active, not recruiting
A Phase 1 Study to Investigate the Safety and Pharmacokinetics of Cemiplimab (Anti-PD-1) and Other Agents in Japanese Patients With Advanced Malignancies [NCT03233139]Phase 1145 participants (Anticipated)Interventional2017-06-21Recruiting
A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma [NCT00003928]Phase 232 participants (Actual)Interventional1999-01-31Completed
"A Phase II Trial of Sequential Doublets Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer" [NCT00005086]Phase 26 participants (Actual)Interventional1999-08-31Completed
Management of Metastatic Breast Cancer in Frail Patients [NCT00005614]Phase 20 participants (Actual)Interventional1999-08-31Withdrawn(stopped due to no accrual)
A Dose Escalation and Cohort Expansion Study of DKN-01 in Combination With Gemcitabine and Cisplatin in Patients With Advanced Carcinoma Primary to the Intra- or Extra-hepatic Biliary System or Gallbladder [NCT02375880]Phase 151 participants (Actual)Interventional2015-06-30Completed
An Open Labelled Phase III Adjuvant Trial of Disease-free Survival in Patients With Resected Pancreatic Ductal Adenocarcinoma Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic T [NCT05314998]Phase 3394 participants (Anticipated)Interventional2023-07-01Not yet recruiting
A Phase 2,Open-label Study of First Line Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non Small Cell Lung Cancer and Biomarker Study [NCT01194453]Phase 2288 participants (Actual)Interventional2009-11-30Completed
An Exploratory Phase 2 Study of Neoadjuvant Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT) With Algenpantucel-L (HyperAcute®-Pancreas) Immunotherapy in Subjects With Borderline Resectable Pancreatic Cancer [NCT02405585]Phase 210 participants (Actual)Interventional2015-04-30Terminated
A Randomized Cross-over Phase 2 Study of the Safety and Efficacy of Two Dose Levels of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Locally Advanced Unresectable or Metastatic Pancreatic Aden [NCT01144455]Phase 2214 participants (Actual)Interventional2010-06-30Completed
A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers [NCT02392637]Phase 262 participants (Actual)Interventional2015-04-02Completed
A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB047986 in Subjects With Advanced Malignancies [NCT01929941]Phase 15 participants (Actual)Interventional2013-09-30Terminated(stopped due to Business decision.)
A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer [NCT01647828]Phase 1/Phase 2217 participants (Actual)Interventional2012-10-31Completed
Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-Fluorouracil and Leucovorin Versus Systemic Chemotherapy of Gemcitabine and Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma [NCT04961970]Phase 3188 participants (Anticipated)Interventional2021-07-09Recruiting
A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination With OGX-427 or Placebo in Patients With Advanced Transitional Cell Carcinoma [NCT01454089]Phase 2183 participants (Actual)Interventional2011-10-31Completed
Phase I Study of Neo-adjuvant RO7009789 Alone or Neo-adjuvant RO7009789 Plus Nab-Paclitaxel and Gemcitabine Followed by Adjuvant RO7009789 Plus Nab-Paclitaxel and Gemcitabine for Patients With Newly Diagnosed Resectable Pancreatic Carcinoma [NCT02588443]Phase 119 participants (Actual)Interventional2015-10-31Completed
A Randomized Open-Label Phase 2b Study of Hepatic Infusions of Anti-CEA CAR-T Cells Alternating With Systemic Chemotherapy Versus Chemotherapy Alone In Patients With Liver Metastases Due To CEA-Expressing Pancreatic Adenocarcinoma [NCT04037241]Phase 2/Phase 30 participants (Actual)Interventional2021-11-01Withdrawn(stopped due to Sponsor terminated)
Randomised Phase II Study in Metastatic Pancreatic Cancer Evaluating FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem in First-line [NCT02352337]Phase 2276 participants (Actual)Interventional2014-12-23Completed
Phase II Randomised Multicenter Trial Evaluating a Sequential Treatment With Nab-paclitaxel+Gemcitabine /FOLFIRI.3 vs Nab-paclitaxel + Gemcitabine in First Line Metastatic Pancreatic Cancer [NCT02827201]Phase 2127 participants (Actual)Interventional2015-11-30Completed
A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer [NCT04163900]Phase 3773 participants (Actual)Interventional2019-12-24Terminated(stopped due to A pre-planned futility analysis concluded that NUC-1031 plus cisplatin was unlikely to achieve its primary objective of improving overall survival. Based on the IDMC's recommendation, NuCana has closed the study.)
Clinical Study of Capeline Combined With Gemcitabine in the Treatment of Pancreatic Cancer [NCT05903703]20 participants (Anticipated)Interventional2023-10-01Not yet recruiting
Randomized Phase 2 Study of Valproic Acid combinEd With Simvastatin and Gemcitabine/Nab-paclitaxel-based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients (The VESPA Trial). [NCT05821556]Phase 2240 participants (Anticipated)Interventional2023-06-12Recruiting
A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects [NCT03734029]Phase 3557 participants (Actual)Interventional2018-12-27Active, not recruiting
A Randomized Phase II Trial of Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine and Cisplatin Compared to Gemcitabine and Cisplatin in Treatment-naïve Patients With Cholangio- and Gallbladder Carcinoma (IMMUCHEC) [NCT03473574]Phase 2128 participants (Actual)Interventional2018-05-02Completed
Durvalumab (MEDI4736) in Frail and Elder Patients With Metastatic NSCLC (DURATION) [NCT03345810]Phase 2200 participants (Actual)Interventional2017-12-14Completed
Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer - An Open Label, Non-comparative, Randomized, Multicenter Phase II Trial [NCT03044587]Phase 293 participants (Actual)Interventional2018-01-24Active, not recruiting
Expansion Cohort Study of Disulfiram and Chemotherapy in Pancreas Cancer Patients [NCT02671890]Phase 116 participants (Actual)Interventional2016-02-25Active, not recruiting
A Randomized Phase II Trial of MEK Inhibitor Selumetinib (AZD6244) Combined Continuously or Sequentially With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Patients With Advanced Biliary Cancer [NCT02151084]Phase 257 participants (Actual)Interventional2014-11-30Active, not recruiting
Neoadjuvant Plus Adjuvant or Only Adjuvant Nab-Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer: A Prospective, Randomized, Controlled, Phase II Study of the AIO (Working Group for Medical Oncology From the German Cancer Society) Pancreatic Ca [NCT02047513]Phase 2127 participants (Actual)Interventional2015-07-31Completed
A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma [NCT01878617]Phase 2660 participants (Actual)Interventional2013-06-23Active, not recruiting
A Randomized Phase II Study Of Gemcitabine Plus Radiotherapy Vs. Gemcitabine, 5-Fluorouracil And Cisplatin Followed By Radiotherapy And 5-Fluoraracil For Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma [NCT00049348]Phase 20 participants Interventional2003-10-13Completed
A Randomized, Open-label, Multicentre, Phase II/III Study of Low-dose Long-term Continuous Intravenous Infused 5-fluorouracil Versus Gemcitabine Combined With Cisplatin and JS001 as First-line Therapy for Metastatic Nasopharyngeal Carcinoma [NCT04890522]Phase 2/Phase 3622 participants (Anticipated)Interventional2021-07-01Not yet recruiting
Pilot Study of Hepatic Arterial Infusion Therapy in Patients With Unresectable or Borderline Resectable Intrahepatic Cholangiocarcinoma [NCT01525069]Phase 127 participants (Actual)Interventional2012-04-03Terminated(stopped due to Equipment that was used in the study was discontinued)
A Phase IB/II Study of Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS) [NCT01418001]Phase 1/Phase 25 participants (Actual)Interventional2011-08-31Terminated(stopped due to Lack of accrual)
Phase II Trial of Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer (SCCHN) [NCT00394147]Phase 217 participants (Actual)Interventional2006-10-31Terminated(stopped due to stopped for lack of efficacy)
Adjuvant Toripalimab Versus Placebo Combined With Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) Non-small-cell Lung Cancer (LungMate-008): a Randomised, Double-blind, Controlled, Phase 3 Trial [NCT04772287]Phase 3341 participants (Anticipated)Interventional2021-03-31Not yet recruiting
A Phase II Study Of Gemcitabine (GEMZAR) And Irinotecan (CPT-11) In Previously Untreated Patients With Measurable Disease With Unknown Primary Carcinoma [NCT00066781]Phase 231 participants (Actual)Interventional2004-02-29Completed
A Phase III, Multicenter, Prospective, Randomized, Patients With Resectable Pancreatic Cancer With Elevated Serum CA125 Were Compared With Those Who Did Not Receive Neoadjuvant Chemotherapy. [NCT04835064]Phase 3600 participants (Anticipated)Interventional2021-04-01Not yet recruiting
Safety and Efficacy of Scheduled Intravesical Gemcitabine Versus Intravesical BCG for Intermediate and High Risk Non Muscle Invasive Bladder Cancer: A Prospective, Randomized Study [NCT05626101]280 participants (Anticipated)Interventional2021-01-01Recruiting
A Multi-arm Phase I Safety Study of Nivolumab in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Canc [NCT01454102]Phase 1472 participants (Actual)Interventional2011-12-16Completed
A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma [NCT01533207]Phase 338 participants (Actual)Interventional2012-06-04Terminated
A Phase II Study to Evaluate the Safety and Efficacy of Sintilimab Combined With Nab-paclitaxel and Gemcitabine for Neoadjuvant and Adjuvant Therapy of Patients With Resectable and Borderline Resectable Pancreatic Cancer [NCT05562297]Phase 250 participants (Anticipated)Interventional2023-07-01Not yet recruiting
ChiCGB Versus BEAM With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma - A Prospective, Multi-centered, Randomized Clinical Trial [NCT05466318]Phase 3306 participants (Anticipated)Interventional2022-07-01Recruiting
A Phase II Trial of First-Line Therapy With Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Stage III or IV Non-Small Cell Lung Cancer [NCT00193453]Phase 269 participants (Actual)Interventional2005-07-31Completed
Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine Versus Cisplatin/Gemcitabine in Patients With IntraHepatic Cholangiocarcinoma [NCT03086993]Phase 2/Phase 3295 participants (Anticipated)Interventional2018-04-10Active, not recruiting
A Single Arm Phase II Trial Evaluating the Efficacy and Safety of Bevacizumab, Carboplatin, Gemcitabine and Atezolizumab in Early Relapsing Metastatic Triple Negative Breast Cancer [NCT04739670]Phase 231 participants (Anticipated)Interventional2021-03-01Recruiting
A Study of Pembrolizumab (MK-3475) Plus Platinum and Gemcitabine as First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (PIPER) [NCT05286619]Phase 263 participants (Anticipated)Interventional2022-09-22Recruiting
Phase 1b/2 Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma [NCT01879085]Phase 1/Phase 237 participants (Actual)Interventional2013-09-24Completed
A Multicenter Phase II Trial of Induction Nimotuzumab Plus Gemcitabine and Carboplatin Followed by Surgery in Patients With Unresectable Stage III Squamous Cell Lung Carcinoma [NCT02428764]Phase 237 participants (Anticipated)Interventional2015-04-30Recruiting
Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer [NCT02243007]Phase 27 participants (Actual)Interventional2014-09-30Terminated(stopped due to Slow Accrual)
Phase I Clinical Trial to Evaluate the Tolerability and Safety of TQB2858 Injection in Subjects With Metastatic Pancreatic Cancer [NCT05193604]Phase 129 participants (Actual)Interventional2022-03-24Terminated(stopped due to Terminated due to the adjustment of sponsor's development strategies and pipeline.)
Phase II Evaluation of Ifosfamide Plus Doxorubicin & Filgrastim Versus Gemcitabine Plus Docetaxel & Filgrastim in the Treatment of Localized Poor Prognosis Soft Tissue Sarcoma [NCT00189137]Phase 284 participants (Actual)Interventional2004-08-31Completed
A Randomized, Open-label, Phase II, Multi-center Trial of Gemcitabine (G) With Pazopanib (P) or Gemcitabine (G) With Docetaxel (T) in Previously Treated Subjects With Advanced Soft Tissue Sarcoma [NCT01593748]Phase 290 participants (Actual)Interventional2012-09-27Completed
Phase II Study of Neoadjuvant Chemotherapy With Gemcitabine and Pemetrexed in Resectable Non-Small-Cell Lung Cancer (NSCLC) With Pharmacogenomic Correlates. [NCT00226577]Phase 252 participants (Actual)Interventional2004-02-29Completed
A Study of the Safety, Immunopharmacodynamics and Anti-tumor Activity of Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Adenocarcinoma [NCT02562898]Phase 1/Phase 218 participants (Actual)Interventional2015-10-12Completed
Non-inferiority Prospective Randomized Trial Comparing Sequential Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT03366415]Phase 3420 participants (Anticipated)Interventional2018-01-01Recruiting
Tislelizumab Plus Gemcitabine and Cisplatin for Relapsed or Refractory Hodgkin Lymphoma Followed by Tislelizumab Consolidation in Patients in Metabolic Complete Remission (TIGERR-HL). An Open Label Phase II Trial [NCT05502250]Phase 275 participants (Anticipated)Interventional2023-07-14Recruiting
A Phase 2 Study to Evaluate the Safety and Efficacy of Nab-pacliatxel Plus Gemcitabine in Korean Patients With Metastatic Pancreatic Ductal Adenocarcinoma [NCT02426281]Phase 2111 participants (Actual)Interventional2015-06-04Completed
A Phase II Multi-Strata Study of PM01183 as a Single Agent or in Combination With Conventional Chemotherapy in Metastatic and/or Unresectable Sarcomas [NCT02448537]Phase 242 participants (Actual)Interventional2015-08-31Completed
Phase Ib Clinical Study of Toripalimab Combined With Gemcitabine and Cisplatin Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma [NCT04947241]Phase 120 participants (Anticipated)Interventional2020-12-15Recruiting
Feasibility of Assessing Drug Response to Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma Patients Undergoing Surgery. [NCT03056599]Phase 123 participants (Actual)Interventional2016-12-15Completed
Phase 2 Trial of Nab-paclitaxel Plus S-1 vs Gemcitabine Plus Cisplatin as 1-line Chemotherapy of Patients With Local Advanced and/or Metastatic Transitional Cell Carcinoma of Urothelial Tract [NCT03051373]Phase 2108 participants (Actual)Interventional2017-04-01Completed
An Open-label, Dose-finding, Phase Ib Study to Assess the Safety, Tolerability of JPI-547, a Dual Inhibitor of PARP/Tankyrase, in Combination With Modified FOLFIRINOX (mFOLFIRINOX) or Gemcitabine-nab-paclitaxel (GemAbraxne) in Patients With Locally Advanc [NCT05257993]Phase 124 participants (Anticipated)Interventional2022-03-31Not yet recruiting
Phase II Study of Gemcitabine With Oxaliplatin in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment [NCT05517239]Phase 232 participants (Actual)Interventional2015-05-01Completed
A Phase 2, Randomized, Proof-of-Concept Study of Nab-Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Previously Untreated Metastatic Pancreatic Cancer [NCT02570711]Phase 23 participants (Actual)Interventional2015-10-13Terminated(stopped due to Sponsor Decision)
A Phase II Study of RRx-001 in Platinum Refractory/Resistant Small Cell Carcinoma, EGFR TKI Resistant EGFR+ T790M Negative Non-Small Cell Lung Cancer, High Grade Neuroendocrine Tumors and Resistant/Refractory Ovarian Cancer Prior to Re-administration of P [NCT02489903]Phase 2139 participants (Actual)Interventional2015-06-30Completed
A Multicenter Study Evaluating Safety and Efficacy of TAR-200 in Subjects With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy [NCT03404791]Phase 135 participants (Actual)Interventional2017-11-20Completed
Randomized, Multicenter, Phase II/III Study, Evaluating Fractionated Cisplatin Chemotherapy/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function. [NCT02240017]Phase 2/Phase 346 participants (Actual)Interventional2015-01-21Completed
A Multicenter Phase I/II Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel With or Without NPC-1C in Patients With Metastatic or Locally Advanced Pancreatic Cancer Previously Treated With FOLFIRINOX [NCT01834235]Phase 1/Phase 281 participants (Actual)Interventional2013-04-30Terminated(stopped due to DSMB terminated the trial for futility.)
A Dose Escalation Safety Study of Locally-Delivered (Intra-Arterial) Gemcitabine in Unresectable Adenocarcinoma of the Pancreas [NCT02237157]Phase 120 participants (Actual)Interventional2015-03-31Completed
The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer [NCT03401827]Phase 440 participants (Anticipated)Interventional2018-03-01Recruiting
Phase II Study to Evaluatate the Efficacy of Gemcitabine Plus Erlotinib for RASH-positive Patients With Metastatic Pancreatic Cancer and Friendly Risk Circumstances [NCT01729481]Phase 2150 participants (Actual)Interventional2012-07-31Active, not recruiting
A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage [NCT03403829]Phase 3360 participants (Anticipated)Interventional2018-01-01Recruiting
A Prospective Phase I Clinical Trial of Carbon Ion Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer [NCT03403049]Phase 114 participants (Actual)Interventional2016-04-01Completed
A Randomized Phase III Prospective Study of Induction Chemotherapy Combined With Concurrent Chemoradiotherapy Versus Induction Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma [NCT05527470]Phase 3440 participants (Anticipated)Interventional2022-11-11Recruiting
A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2) [NCT04799249]Phase 3194 participants (Actual)Interventional2021-04-15Active, not recruiting
A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1+GEM vs GEM Alone in Patients With Measurable Locally Advanced/Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment [NCT03126435]Phase 3218 participants (Actual)Interventional2018-10-16Completed
An Exploratory Clinical Study of Low-dose Gemcitabine Combined With Nivolumab for Second-line and Higher-line Treatment of Driving Gene-negative Non-small Cell Lung Cancer [NCT04331626]Phase 450 participants (Anticipated)Interventional2020-04-30Not yet recruiting
Phase I Study of Combination of Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies [NCT01113476]Phase 1176 participants (Actual)Interventional2010-04-27Completed
Phase II Study to Evaluate the Efficacy and Safety of HAIC Combined With Toripalimab and Donafenib in Patients With Advanced Biliary Tract Cancer [NCT05350943]Phase 270 participants (Anticipated)Interventional2022-03-01Enrolling by invitation
A Randomized, Phase II Trial Comparing Induction Chemotherapy Gemcitabine Plus Cisplatin With Docetaxel Plus Cisplatin Followed by Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma in Northwest China [NCT01596868]Phase 260 participants (Anticipated)Interventional2012-05-31Completed
A Phase II/III Prospective Randomized Placebo-control Trail Compare Mirtazapine Plus Gemcitabine With Gemcitabine in Metastasis Pancreatic Cancer [NCT01598584]Phase 2/Phase 30 participants (Actual)Interventional2012-06-30Withdrawn(stopped due to Gemcitabine is not the first choice for most pancreatic cancer patients nowdays)
A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma [NCT01746173]Phase 25 participants (Actual)Interventional2013-07-31Terminated(stopped due to Slow accrual and futility)
Phase I Study of CDK4/6 Inhibitor Ribociclib (LEE011) Combined With Gemcitabine in Patients With Advanced Solid Tumors [NCT03237390]Phase 143 participants (Actual)Interventional2018-01-04Completed
Phase Ib, Multicenter, Open Label Study of PDR001 in Combination With Platinum Doublet Chemotherapy and Other Immunooncology Agents in PD-L1 Unselected, Metastatic NSCLS Patients (ElevatION:NSCLC-101 Trial) [NCT03064854]Phase 1111 participants (Actual)Interventional2017-05-24Terminated(stopped due to Recruitment halted prematurely due to competitive landscape for lung cancer therapies)
An Open-Label, Single Center, Nonrandomized, Phase 1 Study to Evaluate Safety and Efficacy of Gemcitabine Combined With Apatinib and Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma [NCT04073784]Phase 141 participants (Actual)Interventional2019-06-08Active, not recruiting
A Phase I, Open-Label, Multi-Center Study to Assess the Safety and Tolerability of Selumetinib (AZD6244, ARRY-142886) in Combination With Cisplatin/Gemcitabine in Japanese Patients With Inoperable Locally Advanced or Metastatic Biliary Tract Cancer (BTC) [NCT01949870]Phase 16 participants (Actual)Interventional2013-10-31Terminated(stopped due to change in the development strategy)
A Randomized, Phase III Comparison of Gemcitabine/Irinotecan Followed by IRESSA Versus Paclitaxel/Carboplatin/Etoposide Followed by IRESSA in the First-Line Treatment of Patients With Carcinoma of Unknown Primary Site [NCT00193596]Phase 3198 participants (Actual)Interventional2003-09-30Completed
A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients. [NCT00267696]Phase 245 participants (Actual)Interventional2005-11-30Completed
Phase II Trial of Induction Gemcitabine and Carboplatin Followed by Paclitaxel and Carboplatin With Concurrent Thoracic Radiation for Patients With Unresectable Stage IIIA/IIIB Non-Small Cell Lung Cancer [NCT00226590]Phase 239 participants (Actual)Interventional2003-04-30Completed
Phase II Study to Evaluate the Efficacy of Trilogy Stereotactic Radiosurgery for Pancreatic Cancer [NCT00350142]Phase 220 participants (Actual)Interventional2006-04-30Completed
A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer [NCT03983226]Phase 2167 participants (Anticipated)Interventional2019-10-18Recruiting
Pamiparib and Low Dose Temozolomide In Patients With Platinum Sensitive Biliary Tract Cancer [NCT04796454]Phase 20 participants (Actual)Interventional2022-05-31Withdrawn(stopped due to Company decision)
Open-label, Multi-cohort, Phase 2 Trial, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine (SAR408701) Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors [NCT04659603]Phase 294 participants (Anticipated)Interventional2021-03-29Recruiting
A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer [NCT04222972]Phase 3226 participants (Anticipated)Interventional2020-07-24Recruiting
Adjuvant Doxorubicin, Cyclophosphamide Followed by Avastin Given With Paclitaxel and Gemcitabine for Stage II and III Breast Cancer That Does Not Over-express Human Epidermal Growth Factor Receptor 2 (HER-2)/Neu [NCT00679029]Phase 215 participants (Actual)Interventional2008-05-02Terminated(stopped due to drug toxicity)
Phase I-II Study of bi-Weekly Fixed Dose Rate Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma [NCT00350961]Phase 1/Phase 239 participants (Anticipated)Interventional2004-06-30Completed
A Phase II Study to Evaluate the Efficacy and Toxicity of Oxaliplatin in Combination With Gemcitabine as First and Second Line Therapy in Unknown Primary Cancer [NCT00353145]Phase 229 participants (Actual)Interventional2004-02-29Completed
Bevacizumab and Erlotinib First-Line Therapy in Advanced Non-Squamous Non-Small-Cell Lung Cancer (Stage IIIB/IV) Followed by Platinum-Based Chemotherapy at Disease Progression. A Multicenter Phase II Trial [NCT00354549]Phase 2104 participants (Actual)Interventional2006-01-31Completed
Lokal Fortgeschrittenes Pankreas-Karzinom: Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie [NCT00425841]Phase 229 participants (Anticipated)Interventional2006-05-31Completed
Phase II Trial of Gemcitabine, Cisplatin, Plus Ipilimumab as First-line Treatment for Patients With Metastatic Urothelial Carcinoma: Hoosier Cancer Research Network GU10-148 [NCT01524991]Phase 236 participants (Actual)Interventional2012-01-31Completed
Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases [NCT03093909]Phase 144 participants (Anticipated)Interventional2017-11-22Recruiting
A Preoperative Phase 1B Study to Assess the Safety and the Immunological Effect of Pembrolizumab (Keytruda®) in Combination With Paricalcitol With or Without Chemotherapy in Patients With Resectable Pancreatic Cancer [NCT02930902]Phase 19 participants (Actual)Interventional2017-02-20Completed
An Open, Single-arm Prospective Clinical Study Evaluating the Efficacy of Systemic Venous Gemcitabine-based Chemotherapy Combined With Immunocheckpoint Inhibitors in First-line Treatment of Advanced Biliary Malignancies [NCT05487443]Phase 2/Phase 350 participants (Anticipated)Interventional2022-08-01Not yet recruiting
A Novel Phase I/IIa Open Label Study of IMM 101 in Combination With Selected Standard of Care (SOC) Regimens in Patients With Metastatic Cancer or Unresectable Cancer at Study Entry [NCT03009058]Phase 1/Phase 22 participants (Actual)Interventional2017-05-24Terminated(stopped due to Commercial reasons)
Bladder Sparing Treatment of Tislelizumab Combined With Gemcitabine and Cisplatin for Patients With PD-L1 Positive Muscle Invasive Bladder Cancer (T2-3N0M0): a Phase II Prospective Study [NCT05401279]Phase 220 participants (Anticipated)Interventional2022-06-01Recruiting
A Phase I/II Study Evaluating the Feasibility and Safety of Neoadjuvant Gemcitabine/Nab-paclitaxel (GA) and Concurrent Gemcitabine and Radiation Therapy Followed By Pancreatic Resection and Major Arterial Resection for Adenocarcinoma of the Pancreas (ARCA [NCT02481635]Phase 1/Phase 230 participants (Anticipated)Interventional2016-07-31Active, not recruiting
Lenalidomide Combined With Vorinostat/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Diffuse Large B-Cell Lymphoma of the ABC Subtype [NCT02589145]Phase 1/Phase 28 participants (Actual)Interventional2016-06-22Terminated(stopped due to Closed due to very slow accrual)
Perioperative Stromal Depletion Strategies in Pancreatic Ductal Adenocarcinoma [NCT02487277]Phase 23 participants (Actual)Interventional2015-07-14Terminated(stopped due to Low accrual)
Phase II Clinical Trial Of Neoadjuvant Chemotherapy (NAC)In Upper Tract Urothelial Carcinoma (UTUC) [NCT01663285]Phase 21 participants (Actual)Interventional2012-09-30Terminated(stopped due to Low study participant enrollment.)
A Phase II Safety and Tolerability Study of Avastin When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain [NCT00476827]Phase 216 participants (Actual)Interventional2007-05-31Terminated(stopped due to Slow accrual)
A Phase I Study of Docetaxel (Taxotere), Carboplatin, and Gemcitabine (DoCaGem) as First-Line Therapy for Patients With High-Risk Epithelial Tumors of Mullerian Origin [NCT00004082]Phase 10 participants Interventional1999-07-31Completed
Gemcitabine and Vinorelbine vs Standard Chemotherapy Containing Cisplatin for Stage IIIB/IV Non-Small Cell Lung Cancer [NCT00004100]Phase 30 participants Interventional1998-11-30Active, not recruiting
Sequential and Concomitant Chemoradiotherapy With Gemcitabine-Based Chemotherapy for Inoperable Stage IIIa and IIIb Non-Small Cell Lung Cancer: A Phase I/IIa Study [NCT00004160]Phase 1/Phase 272 participants (Actual)Interventional2000-02-29Completed
A Phase I(Limited)/Phase II Study of Oxaliplatin (OXAL) and Gemcitabine (GEMZAR) in Patients With Metastatic Pancreatic Carcinoma [NCT00004190]Phase 259 participants (Actual)Interventional1999-10-31Completed
A Phase I Study of Oxaliplatin in Combination With Gemcitabine [NCT00004220]Phase 10 participants Interventional1999-10-31Completed
A Phase III, Double-Blind, Placebo Controlled Trial of Gemcitabine Plus Placebo Versus Gemcitabine Plus R115777 in Patients With Advanced Pancreatic Cancer [NCT00005648]Phase 3688 participants (Actual)Interventional1999-11-30Completed
Autologous Stem Cell Transplantation for Poor Prognosis, Relapsed, or Refractory Intermediate-High Grade B-Cell Lymphoma Using Gemcitabine Plus High Dose BCNU and Melphalan Followed by Anti-CD20 Moab (IDEC C2B8, Rituximab, Rituxan) and Consolidative Chemo [NCT00003397]Phase 225 participants (Anticipated)Interventional1998-09-30Completed
Phase I/II Study of 5-Fluorouracil/Folinic Acid/Gemcitabine in Patients With Advanced Colorectal Carcinoma [NCT00003001]Phase 1/Phase 263 participants (Anticipated)Interventional1997-04-30Active, not recruiting
Randomized Study With New Combination Chemotherapies in Advanced Non-Small Cell Lung Cancer [NCT00003589]Phase 3450 participants (Anticipated)Interventional1998-08-31Completed
A Study of Gemcitabine, Cisplatin, and 5-Fluorouracil in the Treatment of Advanced Pancreatic Cancer [NCT00004003]Phase 230 participants (Anticipated)Interventional1999-04-30Completed
Autotransplantation for Chronic Myelogenous Leukemia (CML) Followed by Immunotherapy With Ex-Vivo Expanded Autologous T Cells [NCT00003727]Phase 222 participants (Anticipated)Interventional1999-03-31Completed
A Phase I Study of Gemcitabine, Cisplatin, and Radiation Therapy in Patients With Locally Advanced Pancreatic and Gastric Cancer [NCT00003157]Phase 126 participants (Actual)Interventional1998-02-28Completed
Biweekly Gemcitabine and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer and Solid Tumors: A Phase I/IIa Study [NCT00004159]Phase 1/Phase 254 participants (Actual)Interventional2000-02-29Terminated
A Randomized Phase II Trial of Cisplatin or Carboplatin With Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer [NCT00004201]Phase 20 participants InterventionalCompleted
A Pilot Trial of Platinum, Gemcitabine, or Pemetrexed Single- or Multi-Agent Therapy With Serial Tumor Specimen Collection in Patients With Advanced Non-Small-Cell Lung Cancer [NCT02145078]4 participants (Actual)Interventional2014-06-30Terminated(stopped due to Slow accrual.)
Multicenter, Open-label, Randomized, Controlled Phase III Clinical Study of the Efficacy and Safety of Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Unresectable Advanced Perihilar Cholangiocarcinoma [NCT02082522]Phase 328 participants (Actual)Interventional2014-11-12Terminated(stopped due to Accrual rate remaining too low)
A Phase 1b Study of LY2835219 in Combination With Multiple Single Agent Options for Patients With Stage IV NSCLC [NCT02079636]Phase 1142 participants (Actual)Interventional2014-03-28Completed
A Pilot Study of Gemcitabine Plus High-Dose Ascorbate in Locally Advanced Unresectable or Metastatic Soft Tissue and Bone Sarcomas Including Adolescents [NCT04877587]Early Phase 10 participants (Actual)Interventional2023-01-31Withdrawn(stopped due to Unable to enroll)
Platinum-Gemcitabine-Avastin (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma [NCT01936974]Phase 27 participants (Actual)Interventional2013-09-30Terminated(stopped due to PI Decision)
A Phase II Trial of Systemic Chemotherapy (Gemcitabine and Cisplatin) in Combination With Conventional Transarterial Chemoembolization (cTACE) in Patients With Advanced Intra-Hepatic Cholangiocarcinoma (ICC) [NCT02994251]Phase 21 participants (Actual)Interventional2017-06-21Terminated(stopped due to Study terminated due to low enrollment making it unlikely to meet recruitment goals.)
A Phase 1b Study of the Safety and Tolerability of Ruxolitinib in Combination With Gemcitabine With or Without Nab-Paclitaxel in Subjects With Advanced Solid Tumors [NCT01822756]Phase 142 participants (Actual)Interventional2013-04-30Terminated(stopped due to Dose escalation ended after Cohort B1, RUX 10 mg BID - GCSF in October 2014.)
A Randomized Open Label Phase II Study of Weekly Gemcitabine Plus Pazopanib Versus Weekly Gemcitabine Alone in the Treatment of Patients With Persistent or Relapsed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma [NCT01610206]Phase 2148 participants (Actual)Interventional2012-09-30Completed
An Open-label Pilot Study Evaluating the Effect of a Combination Regimen of Herceptin, Cisplatin, and Gemcitabine on Time to Disease Progression in Patients With Metastatic Urothelial Cancer [NCT02006667]Phase 213 participants (Actual)Interventional2001-01-31Completed
Phase II, Neoadjuvant Study of Parasympathetic Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Borderline Resectable Pancreatic Adenocarcinoma [NCT05241249]Phase 237 participants (Anticipated)Interventional2022-02-01Recruiting
A Randomized, Open-label Study of the Effect of Omnitarg in Combination With Carboplatin-based Chemotherapy Versus Carboplatin-based Therapy Alone on Treatment Response in Patients With Platinum-sensitive Recurrent Ovarian Cancer [NCT02004093]Phase 2149 participants (Actual)Interventional2005-12-31Completed
ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC) [NCT06027268]Phase 236 participants (Anticipated)Interventional2023-12-31Not yet recruiting
A Randomized, Open-Label, Phase II Trial of Nab-paclitaxel + Gemcitabine With or Without Botensilimab (AGEN1181) in Patients With Metastatic Pancreatic Cancer Who Have Progressed on Prior 5FU + Leucovorin + Irinotecan + Oxaliplatin (FOLFIRINOX) [NCT05630183]Phase 278 participants (Anticipated)Interventional2023-03-27Recruiting
A Phase II Study of Peri-Operative NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma [NCT05624918]Phase 238 participants (Anticipated)Interventional2023-12-31Recruiting
A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and C [NCT02915744]Phase 3178 participants (Actual)Interventional2016-11-30Completed
A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Pe [NCT00565851]Phase 31,052 participants (Actual)Interventional2007-12-06Active, not recruiting
Phase I/II Trial of Sequential Doxorubicin/Gemcitabine (AG) and Ifosfamide, Paclitaxel, and Cisplatin (ITP) Chemotherapy (AG-ITP) in Patients With Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium [NCT00003105]Phase 1/Phase 230 participants (Anticipated)Interventional1997-09-30Completed
A Randomized, Open Label, Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer [NCT02210559]Phase 1/Phase 237 participants (Actual)Interventional2014-07-31Completed
A Phase 1B Study to Determine the Safety and Tolerability and Confirm the Dose of Canakinumab and Spartalizumab in Combination With Nab-paclitaxel and Gemcitabine for Patients With Metastatic Pancreatic Cancer [NCT04581343]Phase 110 participants (Actual)Interventional2020-11-02Active, not recruiting
A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancre [NCT01746979]Phase 3693 participants (Actual)Interventional2012-12-31Completed
Validation of a Radiation Response Signature in Borderline Resectable Pancreatic Cancer Patients Treated With Induction Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT) [NCT01754623]Phase 29 participants (Actual)Interventional2013-02-28Terminated(stopped due to Lack of pre-treatment tissue to make the study plan feasible.)
A Phase 1-2 Study of Rapamycin and Cisplatin/Gemcitabine for Treatment of Patients With Bladder Cancer [NCT01938573]Phase 1/Phase 221 participants (Actual)Interventional2013-10-31Completed
A Study to Evaluate the Efficacy of Propranolol in Boosting Immunotherapy in Hepatocellular Carcinoma, Cholangiocarcinoma and Pancreatic Adenocarcinoma [NCT05451043]Phase 262 participants (Anticipated)Interventional2023-03-01Not yet recruiting
Phase II Study of Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer [NCT01916109]Phase 24 participants (Actual)Interventional2013-08-31Terminated(stopped due to Lack of accrual)
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer [NCT02041533]Phase 3541 participants (Actual)Interventional2014-03-27Completed
A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma [NCT01839799]Phase 232 participants (Actual)Interventional2013-04-30Completed
The Effectiveness and Safety of Intravesical Gemcitabine Instillation During Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy in Upper Urinary Tract Urothelial Carcinoma: Prospective, Phase II Study [NCT03062059]Phase 2134 participants (Anticipated)Interventional2018-03-01Recruiting
Phase Ib Study of BVD-523 Plus Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer [NCT02608229]Phase 118 participants (Actual)Interventional2016-06-06Terminated(stopped due to Adverse events)
A Phase II Trial of Flouro-Gem as a First Line Treatment of Metastatic Adenocarcinoma of the Pancreas (GEFLUPAN) [NCT04769414]Phase 248 participants (Actual)Interventional2021-02-20Completed
A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma [NCT01574716]Phase 2209 participants (Actual)Interventional2012-08-07Completed
Nab-Paclitaxel and Gemcitabine Plus Camrelizumab and Radiotherapy Versus Nab-Paclitaxel and Gemcitabine Alone for Locally Advanced Pancreatic Adenocarcinoma [NCT04365049]100 participants (Anticipated)Observational [Patient Registry]2020-04-01Recruiting
Phase II Study of Abraxane and Gemicitabine in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer Progressing After First-Line Platinum-Based Chemotherapy [NCT02303977]Phase 237 participants (Actual)Interventional2015-06-26Completed
A Phase IIa, Single-arm, Multicenter Study to Investigate the Clinical Activity and Safety of Avelumab in Combination With Cetuximab Plus Gemcitabine and Cisplatin in Participants With Advanced Squamous NSCLC [NCT03717155]Phase 243 participants (Actual)Interventional2018-10-30Completed
A Randomized, Three-Arm, Open-Label Phase 3b Clinical Trial of Aumolertinib, Versus Aumolertinib With Chemotherapy, Versus Osimertinib for Patients With Metastatic NSCLC and an EGFR Mutation (TREBLE) [NCT05493501]Phase 38 participants (Actual)Interventional2022-12-14Terminated(stopped due to The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with aumolertinib.)
Randomized Phase II Trial of Gemcitabine, Avelumab and Carboplatin vs. No Neoadjuvant Therapy Preceding Surgery for Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma: SWOG GAP TRIAL [NCT04871529]Phase 2196 participants (Anticipated)Interventional2022-08-10Suspended(stopped due to undergoing nrevision)
Phase 2 Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Gemcitabine Followed by Systemic Adjuvant Chemotherapy With Dacarbazine for Locally Recurrent Uterine Leiomyosarcoma (LMS) [NCT04727242]Phase 225 participants (Anticipated)Interventional2021-01-28Recruiting
A Phase II Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin+ Hydroxychlororoquine as Preoperative Treatment in Patients With Untreated Resectable, Borderline Resectable and Locally Advanced Adenocarcinoma of the Pancreas [NCT04669197]Phase 219 participants (Actual)Interventional2020-12-01Active, not recruiting
Phase 2 Study of ZW25 Plus First-line Combination Chemotherapy in HER2-Expressing Gastrointestinal (GI) Cancers, Including Gastroesophageal Adenocarcinoma (GEA), Biliary Tract Cancer (BTC), and Colorectal Cancer (CRC) [NCT03929666]Phase 2362 participants (Anticipated)Interventional2019-08-29Recruiting
A Phase II Pilot Trial of Nivolumab + Albumin-Bound Paclitaxel + Paricalcitol + Cisplatin + Gemcitabine (NAPPCG) In Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma [NCT02754726]Phase 210 participants (Actual)Interventional2016-04-30Active, not recruiting
A Prospective Phase II Trial of Molecular Profiling to Guide Neoadjuvant Therapy for Resectable and Borderline Resectable Adenocarcinoma of the Pancreas [NCT01726582]Phase 2229 participants (Actual)Interventional2011-11-30Completed
Gemcitabine/Clofarabine/Busulfan and Allogeneic Transplantation for Aggressive Lymphomas [NCT01701986]Phase 1/Phase 280 participants (Anticipated)Interventional2012-10-25Active, not recruiting
Phase II Study of Imatinib Mesylate and Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer [NCT00161213]Phase 244 participants (Actual)Interventional2005-09-30Completed
Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage [NCT00003159]Phase 3600 participants (Anticipated)Interventional1997-08-31Completed
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies [NCT02265510]Phase 1/Phase 283 participants (Actual)Interventional2014-09-10Terminated
A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Surufatinib in Combination With KN046 and AG Regimen Chemotherapy for the First-Line Treatment of Unresectable Advanced Pancreatic Cancer [NCT05832892]Phase 1/Phase 241 participants (Anticipated)Interventional2023-10-31Recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma Preceded by a Dose-finding, Lead-in Phase [NCT02101021]Phase 325 participants (Actual)Interventional2014-06-02Terminated
A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma [NCT01964430]Phase 3866 participants (Actual)Interventional2014-03-28Completed
A Study of Nivolumab Combination Gemcitabine and S1 as the First-Line Treatment in Patients With Advanced Biliary Tract Cancer [NCT04172402]Phase 248 participants (Anticipated)Interventional2019-12-27Active, not recruiting
Vinorelbine Versus Gemcitabine Versus Gemcitabine and Vinorelbine in Elderly Patients With Stage IIIB-IV Non-Small Cell Lung Cancer [NCT00003447]Phase 3630 participants (Anticipated)Interventional1998-07-31Active, not recruiting
Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With Solid Tumors [NCT00004095]Phase 138 participants (Actual)Interventional1999-08-31Completed
Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma [NCT00003723]Phase 257 participants (Actual)Interventional1999-02-28Completed
A PEDIATRIC PHASE I STUDY OF GEMCITABINE (NSC# 613327) IN SOLID TUMORS [NCT00005577]Phase 130 participants (Actual)Interventional1996-08-31Completed
A Phase II Trial of Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers [NCT02525653]Phase 240 participants (Actual)Interventional2015-08-31Completed
A Randomized, Multicenter, Double-blind, Placebo-controlled, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine, in the Fir [NCT02436668]Phase 3430 participants (Actual)Interventional2015-05-31Completed
Chemotherapy-based Split Stereotactic Body Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer: Study Protocol of a Prospective, Single-arm Phase II Trial [NCT04289792]Phase 227 participants (Anticipated)Interventional2020-05-09Recruiting
Phase II Study of Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma [NCT02631590]Phase 224 participants (Actual)Interventional2016-07-05Completed
Phase I/II Study of LY2090314 and Chemotherapy in Metastatic Pancreatic Cancer Patients With Metastases Amenable to Biopsy [NCT01632306]Phase 1/Phase 213 participants (Actual)Interventional2013-03-31Terminated(stopped due to Study has been terminated due to slow enrollment.)
Phase I/II Clinical Study of Mitoxantrone Hydrochloride Liposomes in Combination With Gemcitabine, Dexamethasone, and Cisplatin in Relapsed/Refractory Peripheral T-cell Lymphoma [NCT05441761]Phase 1/Phase 260 participants (Anticipated)Interventional2022-05-01Recruiting
Camrelizumab Plus Apatinib Combined With GEMOX (Gemcitabine and Oxaliplatin ) in the Perioperative Treatment of Locally Advanced Biliary Tract Malignancies: A Prospective, Multicenter, Phase Ⅱ Study [NCT05451290]Phase 230 participants (Anticipated)Interventional2022-09-01Not yet recruiting
A Prospective, Phase III, Controlled, Multicentre, Randomised Clinical Trial Comparing Combination Gemcitabine and Capecitabine Therapy With Concurrent and Sequential Chemoimmunotherapy Using a Telomerase Vaccine in Locally Advanced and Metastatic Pancrea [NCT00425360]Phase 31,110 participants (Anticipated)Interventional2006-09-30Completed
A Phase Ib/II, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018+Standard Chemotherapy and IN10018+Standard Chemotherapy+KN046 in Subjects With Advanced Pancreatic Cancer [NCT05827796]Phase 1/Phase 270 participants (Anticipated)Interventional2022-12-08Recruiting
Carboplatin-gemcitabine Versus Cisplatin-gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer: a Prospective Randomized Trial [NCT05822934]Phase 320 participants (Anticipated)Interventional2022-11-01Recruiting
From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection [NCT04966663]Phase 266 participants (Anticipated)Interventional2022-03-28Recruiting
A Phase II Study of Penpulimab Combined With Chemotherapy ± Anlotinib Hydrochloride in Patients With Advanced Nasopharyngeal Carcinoma [NCT04736810]Phase 290 participants (Anticipated)Interventional2021-02-28Recruiting
A Controlled, Randomized, Open Label Phase II Trial to Evaluate Safety and Efficacy of a 1st Line Combination Treatment With Weekly Infusions of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG-1) in Three Dose Levels Com [NCT00377936]Phase 2212 participants (Actual)Interventional2005-09-30Completed
A Phase II Study to Assess the Efficacy and Safety of Preoperative Chemotherapy With Radiation Therapy for Patients With Borderline Unresectable Adenocarcinoma of the Pancreas [NCT01240304]Phase 210 participants (Actual)Interventional2010-11-30Terminated(stopped due to no subjects enrolled)
Efficacy and Safety of Conventional and Low-dose Platinum Gemcitabine Combined With Cindilimab With Delayed Administration in First-line Treatment of Advanced Squamous Non-small Cell Lung Cancer [NCT05312840]Phase 460 participants (Anticipated)Interventional2022-01-01Recruiting
A Feasibility Study to Discern the Tolerability of 5-FU/Gemcitabine Based Chemotherapy Concurrent With Upper Abdominal Radiation and the Utility of Aprepitant/5HT-3 Antagonist (EMEND) for the Prevention of ChemoRadiation-Induced Nausea and Vomiting (CRINV [NCT01534637]Phase 222 participants (Actual)Interventional2006-08-31Completed
A Randomized, Double-Blind Phase II, Study of Gemcitabine Alone or in Combination With Pazopanib for Refractory Soft Tissue Sarcoma [NCT01532687]Phase 254 participants (Actual)Interventional2012-03-13Completed
A Phase II Study of Preoperative Systemic Chemotherapy (Modified FOLFIRINOX) Followed by Radiation Therapy for Patients With High Risk Resectable and Borderline Resectable Adenocarcinoma of the Pancreas [NCT01560949]Phase 234 participants (Actual)Interventional2012-06-14Completed
Phase II Study of Neoadjuvant Toripalimab With Gemcitabine-Cisplatin in Subjects With T2-4aN0M0 Bladder Cancer: GZZJU-2021NB [NCT04861584]Phase 241 participants (Anticipated)Interventional2021-06-03Recruiting
Phase II Study of Dose Attenuated Chemotherapy in Patients With Lung Cancer and Age > 70 and/or Comorbidities [NCT05800587]Phase 2280 participants (Anticipated)Interventional2023-02-22Recruiting
Phase II Study of Biweekly Carboplatin and Gemcitabine With Bevacizumab as 1st Line Treatment in Patients With Advanced, Inoperable Stage IIIb/IV NSCLC [NCT00400803]Phase 238 participants (Actual)Interventional2007-03-31Completed
A Phase I Study of Anetumab Ravtansine in Combination With Either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic Adenocarcinoma [NCT03816358]Phase 174 participants (Anticipated)Interventional2019-12-09Active, not recruiting
A Phase 1b/2 Multicenter, International, Randomized, Double Blind, Placebo-Controlled, Study of Gemcitabine Combined With PEGPH20 Compared to Gemcitabine Combined With Placebo in Patients With Stage IV Previously Untreated Pancreatic Cancer [NCT01453153]Phase 1/Phase 228 participants (Actual)Interventional2011-09-30Completed
A Pilot Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Patients With Advanced Unresectable or Metastatic Biliary Tract Cancers [NCT03311789]Phase 1/Phase 230 participants (Anticipated)Interventional2017-05-01Recruiting
A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies [NCT02711137]Phase 1/Phase 2137 participants (Actual)Interventional2016-05-18Terminated(stopped due to Study terminated due to safety issues.)
Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer - A Norwegian Population Based Observational Study [NCT04423731]251 participants (Actual)Observational2018-01-01Active, not recruiting
A Multi-Institutional, Single Arm, Two-Stage Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma [NCT02181634]Phase 274 participants (Actual)Interventional2014-12-09Completed
A Phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma [NCT02583477]Phase 1/Phase 223 participants (Actual)Interventional2016-03-25Completed
A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Treated With Gemcitabine Followed by Brentuximab Vedotin Maintenance [NCT03496779]Phase 271 participants (Actual)Interventional2018-04-10Completed
A Phase I/II Study Using Cisplatin and Gemcitabine (Gemzar) for Advanced Head and Neck Cancer (Squamous Cell Carcinoma) [NCT00003182]Phase 1/Phase 240 participants (Anticipated)Interventional1997-03-31Active, not recruiting
Phase I/II Study of Induction Chemotherapy With Gemcitabine and Cisplatin Followed by Combined Chemo-radiation and/or Surgical Resection for Locally Advanced Pancreatic Cancer [NCT00003332]Phase 1/Phase 236 participants (Anticipated)Interventional1997-07-31Completed
A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study of LY2228820, a p38 MAPK Inhibitor, Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin for Women With Platinum-Sensitive Ovarian Cancer [NCT01663857]Phase 1/Phase 2118 participants (Actual)Interventional2012-07-31Completed
A Randomized, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Sintilimab (IBI308) in Combination With Gemcitabine and Platinum-Based Chemotherapy vs. Placebo in Combination With Gemcitabine and Platinum-Based Chemotherapy as First-Line [NCT03629925]Phase 3357 participants (Actual)Interventional2018-09-28Completed
A Phase 2 Study With Combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), Chemokine (C-X-C) Motif Receptor 4 Inhibitor (BL-8040), and Immune Checkpoint Blockade (Cemiplimab) in METastatic Treatment naïve PANCreas Adenocarcinoma [NCT04543071]Phase 210 participants (Anticipated)Interventional2020-11-09Recruiting
Phase I/II Study to Assess the Efficacy and Safety of Nab-paclitaxel in Combination With Gemcitabine for the Treatment of Fragile Patients With Advanced or Metastatic Pancreatic Cancer [NCT02382263]Phase 1/Phase 2224 participants (Actual)Interventional2013-04-30Completed
Phase III Italian Multicenter Study Comparing the Combination of 5-fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan (Folfoxiri) Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer [NCT02355119]Phase 3310 participants (Anticipated)Interventional2015-01-31Recruiting
A Phase Ib/II Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus) [NCT02331251]Phase 1/Phase 281 participants (Actual)Interventional2014-12-31Terminated(stopped due to PI not longer at site.)
Phase I/II Trial of the Combination of Docetaxel, Gemcitabine and Cisplatin (DGP) as Induction Chemotherapy in Patients With Stage III Non-Small Cell Lung Cancer [NCT00003037]Phase 1/Phase 20 participants Interventional1997-04-30Completed
A Randomized Phase II Trial Comparing Stem Cell Mobilization With Chemotherapy and Cytokine (G-CSF) Versus Cytokine (G-CSF) Alone in Myeloma Patients (MOCCCA-trial). [NCT03442673]Phase 2137 participants (Actual)Interventional2018-09-17Active, not recruiting
A Phase 1b Study to Assess the Safety and Anti-tumour Activity of Dexanabinol Monotherapy and Dexanabinol in Combination With Chemotherapy in Patients With Advanced Tumours [NCT02423239]Phase 1112 participants (Anticipated)Interventional2015-04-30Active, not recruiting
Open-label, Uncontrolled, Multicenter Phase I/Ib Trial to Investigate Safety and Efficacy of BIBW 2992 and Standard Gemcitabine/Cisplatin in Chemo-naïve Patients With Advanced Biliary Tract Adenocarcinoma [NCT01679405]Phase 19 participants (Actual)Interventional2012-08-31Terminated(stopped due to No sufficient clinical or molecular signals for efficacy were observed.)
A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine Versus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer [NCT02399137]Phase 288 participants (Actual)Interventional2015-05-31Completed
A Combined Phase 1 and Phase 2 Study of Albumin-bound Rapamycin Nanoparticles (Nab-rapamycin, ABI-009) in the Treatment of BCG Refractory or Recurrent Nonmuscle Invasive Transitional Cell Bladder Cancer [NCT02009332]Phase 1/Phase 221 participants (Actual)Interventional2014-04-09Completed
A Randomized Phase II Clinical Trial Assessing the Efficacy and Safety of MK-3475 (Pembrolizumab) in Combination With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer [NCT02755272]Phase 287 participants (Anticipated)Interventional2016-05-31Active, not recruiting
A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC [NCT02576574]Phase 31,214 participants (Actual)Interventional2015-10-29Active, not recruiting
Phase Ib Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330), Gemcitabine and Nab-Paclitaxel and Phase II Study of Gemcitabine and Selinexor in Patients With Metastatic Pancreatic Cancer [NCT02178436]Phase 1/Phase 215 participants (Actual)Interventional2014-10-31Completed
Phase II Study of Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Stage II-IIIB Bladder Cancer [NCT04553939]Phase 250 participants (Anticipated)Interventional2021-01-04Recruiting
A Phase I Dose-Escalation Study of CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma [NCT05325281]Phase 124 participants (Anticipated)Interventional2022-10-31Recruiting
A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase II Study to Evaluate the Differences of Safety and Efficacy of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated [NCT05047991]Phase 2153 participants (Anticipated)Interventional2021-10-31Not yet recruiting
Phase Ib/II Clinical Study of IAH0968 in Combination With Gemcitabine and Cisplatin for the Treatment of HER2-Positive Unresectable Advanced/Metastatic Malignant Tumors and Cholangiocarcinoma [NCT05991518]Phase 1/Phase 2136 participants (Anticipated)Interventional2023-04-25Recruiting
A Pilot Multi-arm Study of sEphB4-HSA in Combination With Different Chemotherapy Regimens in Patients With Specific Advanced or Metastatic Solid Tumors [NCT02495896]Phase 161 participants (Actual)Interventional2015-09-03Terminated(stopped due to Lack of funding)
A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer [NCT05776524]Phase 246 participants (Anticipated)Interventional2023-06-13Recruiting
An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metas [NCT04191135]Phase 2462 participants (Actual)Interventional2019-12-19Active, not recruiting
Neoadjuvant Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing [NCT03558087]Phase 276 participants (Anticipated)Interventional2018-07-13Active, not recruiting
[NCT01454934]Phase 3540 participants (Actual)Interventional2011-12-09Completed
An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125. [NCT01133756]Phase 1/Phase 27 participants (Actual)Interventional2010-03-31Terminated(stopped due to poor accrual)
Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays [NCT00244933]Phase 219 participants (Actual)Interventional2004-02-29Completed
Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer [NCT00053209]Phase 246 participants (Actual)Interventional2004-08-10Completed
Phase II Study of Paclitaxel Plus Gemcitabine in Refractory Germ Cell Tumors [NCT00003518]Phase 244 participants (Anticipated)Interventional1999-01-25Completed
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5745 as Monotherapy and in Combination With Chemotherapy in Subjects With Advanced Solid Tumors [NCT01803282]Phase 1236 participants (Actual)Interventional2013-03-29Completed
MASTERPLAN: A Randomised Phase II Study of MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease [NCT04089150]Phase 2120 participants (Anticipated)Interventional2019-10-01Recruiting
Phase II Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma [NCT00183794]Phase 220 participants (Actual)Interventional2002-11-30Completed
A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors [NCT01447225]Phase 143 participants (Actual)Interventional2011-10-31Completed
Phase II Study on the Use of Molecular Analyses-Based Customized Chemotherapy in Patients With Stage IV/IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer (NSCLC) [NCT00215930]Phase 253 participants (Actual)Interventional2004-02-29Completed
Gemcitabine in Combination With the Oral Irreversible ErbB Inhibitor Afatinib Versus Gemcitabine Alone in Patients With Metastatic Pancreatic Cancer: an Explorative Randomized Phase II Trial [NCT01728818]Phase 2119 participants (Actual)Interventional2013-04-30Active, not recruiting
A Phase II Study of Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer [NCT01080248]Phase 22 participants (Actual)Interventional2010-08-31Terminated(stopped due to Closed due to delay by GSK)
A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Me [NCT01881230]Phase 2/Phase 3191 participants (Actual)Interventional2013-09-26Completed
A Phase I/II Study of First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma [NCT01828034]Phase 1/Phase 242 participants (Actual)Interventional2013-04-30Completed
A Study of Gemcitabine, L- Asparaginase, Ifosfamide, Dexamethasone and Etoposide Chemotherapy Followed by ASCT for Newly Diagnosed Stage IV, Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma, Nasal Type [NCT03154918]Phase 260 participants (Anticipated)Interventional2017-06-01Recruiting
An Open-Label Phase 1b Study to Investigate the Preliminary Safety and Activity of Aldoxorubicin Plus Gemcitabine in Subjects With Metastatic Solid Tumors [NCT02235688]Phase 130 participants (Anticipated)Interventional2014-08-31Completed
A Randomized Phase 2/3 Study of Eryaspase in Combination With Gemcitabine and Carboplatin Chemotherapy Versus Chemotherapy Alone for the Treatment of Patients With Metastatic or Locally Recurrent Triple-Negative Breast Cancer [NCT03674242]Phase 2/Phase 327 participants (Actual)Interventional2019-06-13Terminated(stopped due to sponsor decision)
Neoadjuvant Chemotherapy With Gemcitabine Plus Cisplatin Followed by Radical Liver Resection Versus Immediate Radical Liver Resection Alone With or Without Adjuvant Chemotherapy in Incidentally Detected Gallbladder Carcinoma After Simple Cholecystectomy o [NCT03673072]Phase 3300 participants (Anticipated)Interventional2019-07-01Recruiting
Phase II Trial of Biweekly S-1, Leucovorin and Gemcitabine in Elderly Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma [NCT03559348]Phase 249 participants (Actual)Interventional2018-04-03Completed
An Open-Label, Exploratory, Limited Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors [NCT01678690]Early Phase 111 participants (Actual)Interventional2012-08-31Completed
Combination of Anti-PD-1 Antibody and Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma: A Exploratory Clinical Trial [NCT04413734]Phase 2120 participants (Anticipated)Interventional2020-04-22Recruiting
CNCT19 Following Autologous Stem Cell Transplantation in Patients With Relapsed or Refractory Aggressive B-cell Lymphoma [NCT04690192]Phase 1/Phase 220 participants (Anticipated)Interventional2021-01-01Recruiting
Phase 3, Double-Blind, Randomized Study to Compare the Efficacy and Safety of Tislelizumab Combined With Chemotherapy Versus Chemotherapy as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer [NCT03924986]Phase 3256 participants (Anticipated)Interventional2019-04-18Active, not recruiting
A Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With Untreated Pancreatic Cancer [NCT03825328]Phase 230 participants (Anticipated)Interventional2019-01-30Not yet recruiting
A Phase 1/1b Dose Escalation Study Evaluating Iniparib (BSI201/SAR240550) as a Single Agent and in Combination With Chemotherapeutic Regimens in Patients With Solid Tumors [NCT01455532]Phase 159 participants (Actual)Interventional2011-11-30Completed
Paediatric Hepatic International Tumour Trial [NCT03017326]Phase 3450 participants (Anticipated)Interventional2017-08-24Recruiting
A Phase I Study of TL32711 In Combination With Gemcitabine in Patients With Advanced Solid Tumors [NCT01573780]Phase 121 participants (Actual)Interventional2012-04-30Terminated(stopped due to Sponsor did not have funds to continue study)
Phase I/II Study of Lenalidomide and Gemcitabine as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Cancer [NCT01547260]Phase 1/Phase 234 participants (Actual)Interventional2009-10-31Completed
A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies [NCT00072514]Phase 255 participants (Actual)Interventional2003-08-31Completed
A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma [NCT00011986]Phase 34,312 participants (Actual)Interventional2001-01-31Completed
A Randomized Phase II Study of Gemcitabine/ Trastuzumab and Gemcitabine/ Cisplatin/ Trastuzumab in Patients With Metastatic Breast Cancer [NCT00201760]Phase 210 participants (Actual)Interventional2005-02-25Completed
A Phase I/II Study of Etanercept and Gemcitabine in Patients With Advanced Stage and Chemotherapy Naive Pancreatic Adenocarcinoma [NCT00201838]Phase 1/Phase 238 participants (Actual)Interventional2001-07-31Completed
A Phase II Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma [NCT03915444]Phase 242 participants (Actual)Interventional2019-07-15Active, not recruiting
A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC) [NCT03790111]Phase 253 participants (Actual)Interventional2019-03-13Terminated(stopped due to Did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis)
Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have No Prior Therapy for Their Metastatic Pancreatic Cancer [NCT03410030]Phase 1/Phase 227 participants (Actual)Interventional2017-12-15Completed
A Phase II Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Paricalcitol as Pre-operative Treatment in Patients With Untreated Resectable, Borderline Resectable and Locally Advanced Adenocarcinoma of the Pancreas [NCT03138720]Phase 224 participants (Actual)Interventional2017-05-23Active, not recruiting
A Phase II/III Randomized Clinical Trial of CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence: PURITY Study [NCT06037980]Phase 2/Phase 3300 participants (Anticipated)Interventional2023-11-07Recruiting
A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CM24 in Combination With Nivolumab in Adults With Advanced Solid Tumors [NCT04731467]Phase 1/Phase 279 participants (Anticipated)Interventional2021-03-19Recruiting
A Multicenter, Open-Label, Non-Comparative, Three-Arm, Phase IIa Trial of Ipatasertib (GDC-0068) in Combination With Non-Taxane Chemotherapy Agents for Taxane-Pretreated Unresectable Locally Advanced or Metastatic TNBC Patients [NCT04464174]Phase 254 participants (Actual)Interventional2020-10-08Completed
A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma [NCT02993731]Phase 31,134 participants (Actual)Interventional2016-12-31Completed
An Open-Label, Non-controlled, Non-randomized Sequential Design, Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin in Patients With Advanced Solid Cancers [NCT01606748]Phase 235 participants (Actual)Interventional2012-08-31Completed
A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [NCT01788566]Phase 261 participants (Actual)Interventional2013-03-31Completed
Phase II Study of Gemcitabine and Docetaxel (GEMDOC) Combination in Patients With Previously Treated Recurrent or Metatstatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) [NCT00248560]Phase 236 participants (Actual)Interventional2005-01-31Completed
A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer [NCT00336700]Phase 225 participants (Actual)Interventional2006-06-30Terminated(stopped due to Study published November 2010 and no further work will be done)
Phase II Study of Imatinib Mesylate and Gemcitabine for Recurrent/Metastatic Non-small Cell Lung Cancer (NSCLC) [NCT00323362]Phase 217 participants (Actual)Interventional2006-04-30Terminated(stopped due to Toxicity)
A Phase 2 Study of Low-Dose Fractionated Radiation Therapy to the Whole Liver in Combination With Gemcitabine and Cisplatin in Locally Advanced Mass-Forming Intrahepatic Cholangiocarcinoma [NCT02254681]Phase 26 participants (Actual)Interventional2014-09-30Terminated(stopped due to lack of funding)
Sintilimab With P-GemOx (Pegaspargase, Gemcitabine and Oxaliplatin) Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type (ENKTL): a Single Arm, Open, Multicenter, Phase II Study [NCT04127227]Phase 234 participants (Anticipated)Interventional2019-10-09Recruiting
LS1781: Phase 2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed / Refractory Lymphoma and Patients With Clonal Cytopenia of Undetermined Significance [NCT03418038]Phase 255 participants (Anticipated)Interventional2018-03-23Recruiting
A Phase II Study Of Neo-Adjuvant Chemotherapy And Radiation In Patients With Locally Advanced Pancreatic Cancer [NCT00089024]Phase 229 participants (Actual)Interventional2004-02-25Completed
A Randomised Phase II/III Study of Concurrent Cisplatin-Radiotherapy With or Without Induction Chemotherapy Using Gemcitabine, Carboplatin and Paclitaxel in Locally Advanced Nasopharyngeal Cancer [NCT00997906]Phase 2/Phase 3172 participants (Actual)Interventional2009-09-15Active, not recruiting
A Phase I Trial for the Use of Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment of BCG-Refractory Non-muscle Invasive Urothelial Carcinoma of the Bladder Cancer [NCT02202772]Phase 1/Phase 251 participants (Anticipated)Interventional2014-12-01Recruiting
Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer [NCT02139358]Phase 1/Phase 215 participants (Actual)Interventional2014-09-05Completed
A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer [NCT00593866]Phase 1/Phase 250 participants (Actual)Interventional2006-06-30Completed
A Phase II Trial of Gemcitabine and Oxaliplatin for ER-, PR-, HER2NEU- (Triple Negative) Metastatic Breast Cancer [NCT00674206]Phase 26 participants (Actual)Interventional2008-10-31Terminated(stopped due to Sponsor funding stopped)
A Phase I Open Label, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Dose Limiting Toxicity, Safety and Pharmacokinetics of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab o [NCT00705874]Phase 1172 participants (Actual)Interventional2006-05-31Completed
A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined With Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer [NCT01839487]Phase 2279 participants (Actual)Interventional2013-05-14Completed
Ensure Extension Study to Assess the PFS of First-Line Erlotinib (Tarceva®) and Erlotinib After the Time of Disease Progression in Chinese Population Enrolled in the Ensure Trial [NCT02000531]Phase 445 participants (Actual)Interventional2014-01-31Completed
A Prospective, Multinational, Multi-Center, Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy, Safety and Tolerability of siG12D-LODER in Combination With Standard of Care Chemotherapy in the Treatment of Patients With Locally Advanced Pancrea [NCT01676259]Phase 280 participants (Anticipated)Interventional2018-03-07Recruiting
A Randomized Phase II Trial of Cytotoxic Chemotherapy With or Without Epigenetic Priming in Patients With Advanced Non-Small Cell Lung Cancer [NCT01935947]Phase 217 participants (Actual)Interventional2013-05-31Terminated
A Randomized-Controlled Three-arm Phase II Study of Lurbinectedin (PM01183) Alone or In Combination With Gemcitabine and a Control Arm With Docetaxel as Second-Line Treatment in Unresectable Non-Small Cell Lung Cancer (NSCLC) Patients [NCT01951157]Phase 269 participants (Actual)Interventional2013-09-11Completed
A Phase II Open-Label Clinical Trial of CPI-613 Given Alone, or in Combination With Gemcitabine, in Patients With Metastatic Pancreatic Cancer [NCT01830322]Phase 20 participants (Actual)Interventional2014-01-31Withdrawn
A Phase II Trial of Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer Who Have Failed at Least Two Prior Therapies [NCT00928642]Phase 28 participants (Actual)Interventional2009-06-30Completed
A Phase II Study of Atezolizumab With Rituximab, Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Who Are Not Candidates for High-dose Therapy [NCT03422523]Phase 253 participants (Actual)Interventional2018-05-09Terminated(stopped due to Failure to reach pre-specified futility boundary)
A Phase III, Multicenter, Open-Label, Randomized Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablated Intra-Hepatic Cholangiocarcinoma [NCT03081039]Phase 30 participants (Actual)Interventional2017-08-21Withdrawn(stopped due to Competing study)
A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL) [NCT05700448]Phase 3150 participants (Anticipated)Interventional2024-07-31Not yet recruiting
TAGGED: A Phase 2 Study Using Low Dose/Metronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd/3rd/4th Line Therapy for Advanced Leiomyosarcoma [NCT04535271]Phase 280 participants (Anticipated)Interventional2021-09-09Recruiting
A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355) [NCT02819518]Phase 3882 participants (Actual)Interventional2016-07-27Completed
NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma. A Multicenter Open-label Single Arm Phase Ib/IIa Trial [NCT03524898]Phase 1/Phase 239 participants (Actual)Interventional2018-10-02Terminated(stopped due to As Last patient last visit (LPLV) took place on 15/02/2022, the trial was ended prematurely on this date in accordance with SAKK/CI.)
Safety and Efficacy of GEMOX Combined With Donafenib and Tislelizumab as First-line Treatment in Biliary Tract Cancer [NCT04979663]Phase 1/Phase 210 participants (Anticipated)Interventional2020-12-01Recruiting
A Multicenter Randomized Double Blind Study Examining the Efficacy and Safety of Denosumab in Combination With First Line Platinum-based Chemotherapy for Patients With Bone Metastasis Secondary to Metastatic Urothelial Cancer [NCT03520231]Phase 26 participants (Actual)Interventional2018-09-04Completed
A Prospective, Single Center Clinical Study to Examine Cisplatin-based Chemotherapy Combined With Tislelizumab as Bladder Sparing Treatment for Patients With Muscle Invasive Bladder Cancer [NCT04909775]Phase 240 participants (Anticipated)Interventional2021-07-31Not yet recruiting
A Phase 1B/2 Randomized, Multicenter, Open-Label Study Of Iberdomide (CC-220) In Combination With Polatuzumab Vedotin Plus Rituximab Or Tafasitamab Or Rituximab Plus Chemotherapy For Subjects With Relapsed Or Refractory Aggressive B-Cell Lymphoma [NCT04882163]Phase 1/Phase 20 participants (Actual)Interventional2021-10-10Withdrawn(stopped due to Business objectives have changed)
Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer [NCT03257033]Phase 3320 participants (Anticipated)Interventional2018-03-12Recruiting
Phase II, Open Label Clinical Trial of Paricalcitol in Combination With Gemcitabine/ Nab-Paclitaxel Therapy in Advanced Pancreatic Cancer [NCT04617067]Phase 215 participants (Actual)Interventional2020-10-16Active, not recruiting
A Phase I/II/Pharmacodynamic Study of Hydroxychloroquine in Combination With Gemcitabine/Abraxane to Inhibit Autophagy in Pancreatic Cancer [NCT01506973]Phase 1/Phase 2119 participants (Actual)Interventional2011-12-31Completed
A Phase I/Ib, Single-Arm, Open-Label, Multi-Center Trial Using ARQ-761 (Beta-Lapachone) Treatment With Gemcitabine/Nab-Paclitaxel Chemotherapy In Metastatic, Unresectable, Or Recurrent Pancreatic Cancer [NCT02514031]Phase 117 participants (Actual)Interventional2016-03-24Terminated(stopped due to The study placed on temporarily hold to enrollment due to quality testing necessary for the study drug.)
Non-inferiority Study of Albumin-bound Paclitaxel Combined With Gemcitabine for Three Weeks Versus Four Weeks for First-line Inoperable Locally Advanced or Metastatic Pancreatic Cancer [NCT05035147]Phase 4934 participants (Anticipated)Interventional2021-03-25Recruiting
A Single-arm, Phase II Study of Anlotinib Combined With Platinum/Gemcitabine for First Line Treatment of Advanced Urothelial Carcinoma [NCT05030077]Phase 253 participants (Anticipated)Interventional2021-10-01Not yet recruiting
Single-arm Intervention Trial of the Feasibility of Endoscopic Ultrasound-guided Pancreatic Cyst Chemoablation (EUS-PCA) Using Gemcitabine and Paclitaxel for Intraductal Papillary Mucinous Neoplasms (IPMN) in Two New Zealand Tertiary Interventional Endosc [NCT06162468]20 participants (Anticipated)Interventional2024-03-31Not yet recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Participants With Muscle-invasive Bladder Cancer (MIBC) (KEY [NCT04241185]Phase 3636 participants (Anticipated)Interventional2020-05-19Recruiting
A Phase II Randomized Study of Ramucirumab Plus MK3475 (Pembrolizumab) Versus Standard of Care for Patients Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study) [NCT03971474]Phase 2166 participants (Actual)Interventional2019-05-28Active, not recruiting
Maintenance Systemic Therapy Versus Local Consolidative Therapy (LCT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial [NCT03137771]Phase 2218 participants (Actual)Interventional2017-04-07Active, not recruiting
Autologous Transplantation With Gemcitabine and High Dose BCNU Plus Melphalan Followed by Consolidation With DCEP Plus Gemcitabine and Taxol/Cisplatin in Patients With Multiple Myeloma and >12 Months of Standard Therapy [NCT00003401]Phase 20 participants Interventional1999-01-31Completed
Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer [NCT00003449]Phase 235 participants (Actual)Interventional1998-05-31Completed
Randomized Phase II Trial of Carboplatin/Gemcitabine Followed By Paclitaxel or Cisplatin/Vinorelbine Followed by Docetaxel in Advanced Non-Small Cell Lung Cancer [NCT00003587]Phase 2204 participants (Actual)Interventional1998-10-31Completed
A Phase I Study of Concomitant Chemoradiotherapy With Gemcitabine, Paclitaxel, and 5-FU for Patients With Advanced and/or Recurrent Cancer of the Head and Neck [NCT00004097]Phase 10 participants Interventional1999-08-31Active, not recruiting
Phase II Randomized Trial of Gemcitabine/Docetaxel and Gemcitabine/Irinotecan in Stage IIIB/IV Non-Small Cell Lung Cancer [NCT00004139]Phase 280 participants (Actual)Interventional1999-09-30Completed
A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Matrix Metalloprotease Inhibitor Prinomastat (AG3340) in Combination With Gemcitabine and Cisplatin in Patients Having Advanced Non-Small Cell Lung Cancer [NCT00004199]Phase 30 participants Interventional1999-03-31Completed
A Randomized Double-Blind, Placebo-Controlled, Multicenter Study of CI-994 Capsules Plus Gemcitabine Infusion Versus Placebo Capsules Plus Gemcitabine Infusion as Second-Line Treatment of Patients With Advanced Nonsmall Cell Lung Cancer [NCT00005093]Phase 30 participants Interventional1999-12-31Completed
Phase II Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody C225 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer [NCT00005591]Phase 20 participants (Actual)Interventional1999-10-31Withdrawn
A Phase I, Maximum Tolerated Dose (MTD) Trial to Determine the Safety and Pharmacokinetics of Chronic Oral Administration of Farnesyl Transferase Inhibitor R115777 in Combination With Gemcitabine in Subjects With Advanced Incurable Cancer [NCT00003707]Phase 122 participants (Actual)Interventional1998-10-31Completed
Herceptin (NSC #688097) and Gemcitabine for Metastatic Pancreatic Cancers That Overexpress HER-2/NEU [NCT00003797]Phase 241 participants (Anticipated)Interventional1999-03-31Active, not recruiting
A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage [NCT00003803]Phase 3158 participants (Actual)Interventional1999-02-28Terminated(stopped due to low accrual)
Evaluation of Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support Versus Gemcitabine Chemotherapy in the Treatment of Inoperable Pancreatic Adenocarcinoma [NCT00003851]90 participants (Anticipated)Interventional1999-03-31Terminated(stopped due to Approval lapse)
A Phase 1b, Open-Label, Dose Escalation, Multi-arm Study of MLN4924 Plus Docetaxel, Gemcitabine, or Combination of Carboplatin and Paclitaxel in Patients With Solid Tumors [NCT01862328]Phase 164 participants (Actual)Interventional2013-06-10Completed
A Phase 1 Trial of the ATR Inhibitor BAY 1895344 in Combination With Cisplatin and With Cisplatin Plus Gemcitabine in Advanced Solid Tumors With an Emphasis on Urothelial Carcinoma [NCT04491942]Phase 174 participants (Anticipated)Interventional2021-08-25Active, not recruiting
Phase 2 Trial of Neoadjuvant Nivolumab + Platinum-based Chemotherapy + Certolizumab in Patients With Resectable Stages II-III Lung Cancers [NCT04991025]Phase 260 participants (Anticipated)Interventional2022-10-19Recruiting
A Open-Label, Multicenter, Randomised, Controlled Phase 3 Study of RC48-ADC Plus Toripalimab Versus Chemotherapy Alone in Previously Untreated Unresectable Locally Advanced or Metastatic Urothelial Carcinoma With HER2-Expressing [NCT05302284]Phase 3452 participants (Anticipated)Interventional2022-06-14Recruiting
Bevacizumab Combined With High-Dose Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Patients With Advanced Epithelial Ovarian Cancer [NCT00583622]Phase 213 participants (Actual)Interventional2007-12-31Terminated(stopped due to Slow Accrual)
A Phase I/II Trial of Radioimmunotherapy (Y-90 cT84.66), Gemcitabine and Hepatic Arterial Infusion of Fudr for Metastatic Colorectal Carcinoma to the Liver [NCT00645710]Phase 1/Phase 216 participants (Actual)Interventional2005-02-11Completed
A Phase 1 Multicenter, Dose-escalation Study of LY573636-sodium in Combination With 1) Gemcitabine HCl or 2) Docetaxel or 3) Temozolomide or 4) Cisplatin, or 5) Erlotinib in Patients With Advanced Solid Tumors [NCT01284335]Phase 1234 participants (Actual)Interventional2008-07-31Terminated(stopped due to Study was terminated due to the termination of tasisulam development.)
A Phase II Clinical Trial of Induction Chemotherapy Regimen Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) Followed by a Single Cycle of High Dose Chemotherapy (HDC) and Autologous Hematopoietic Stem Cell Rescue (AuHSCR) for Patients With Recurrent or P [NCT01270724]Phase 210 participants (Actual)Interventional2010-08-31Completed
APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer [NCT00709826]Phase 2109 participants (Actual)Interventional2008-08-31Completed
A Multicentre, Phase 1B/2 Study of Varlitinib in Combination With Gemcitabine and Cisplatin for Treatment naïve Advanced or Metastatic Biliary Tract Cancer. [NCT02992340]Phase 1/Phase 2204 participants (Anticipated)Interventional2016-12-13Terminated(stopped due to Sponsor decided to terminate the study and not proceed to Phase 2.)
Neoadjuvant Soft Tissue Ablation Utilizing Aliya™ Pulsed Electric Fields With Systemic Therapy in Early-Stage Resectable Non-Small Cell Lung Cancer (NSCLC) [NCT05583188]Phase 415 participants (Anticipated)Interventional2023-02-01Recruiting
Phase I/II Study of RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder [NCT01259063]Phase 1/Phase 233 participants (Actual)Interventional2010-12-31Completed
A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Tran [NCT01321541]Phase 3312 participants (Actual)Interventional2011-04-20Completed
Pilot Trial of Type I-Polarized Autologous Dendritic Cell Vaccine Incorporating Tumor Blood Vessel Antigen-Derived Peptides in Patients With Metastatic Breast Cancer [NCT02479230]Phase 118 participants (Actual)Interventional2015-07-17Completed
A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC). [NCT01998919]Phase 2154 participants (Actual)Interventional2006-08-31Completed
Tissue Pharmacokinetics of Intraoperative Gemcitabine in Adenocarcinoma of the Pancreas After Preoperative Chemoradiation Therapy [NCT01938716]12 participants (Actual)Interventional2012-03-31Terminated(stopped due to Early termination due to low accrual)
A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination With an Anti-PD-1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancrea [NCT04060342]Phase 161 participants (Actual)Interventional2019-08-13Terminated(stopped due to No clear benefit of GB1275 was observed either as monotherapy or in combination with pembrolizumab.)
A Phase I Study to Assess the Safety and Tolerability of Pembrolizumab in Combination With Fixed Rate Gemcitabine Chemotherapy in Patients With Leiomyosarcoma and Undifferentiated Pleomorphic Sarcoma [NCT03123276]Phase 1/Phase 224 participants (Anticipated)Interventional2017-11-29Active, not recruiting
Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL) [NCT01626664]Phase 271 participants (Actual)Interventional2012-06-30Completed
MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors or Leukemia [NCT01376310]Phase 2159 participants (Actual)Interventional2010-11-02Terminated(stopped due to Company Decision)
A Prospective, Multi-centric, Phase Ⅲ, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine (AG) Versus Oxaliplatin Plus Folinic Acid and Fluorouracil (OFF) for Gemcitabine-R [NCT02506842]Phase 3300 participants (Anticipated)Interventional2015-06-30Recruiting
Gemox Combined With Anlotinib and Sintilimab in Advanced Combined Hepatocellular-cholangiocarcinoma: an Exploratory Study [NCT06033118]Phase 1/Phase 225 participants (Anticipated)Interventional2023-10-01Not yet recruiting
A Liquid-biopsy Informed Platform Trial to Evaluate Treatment in CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer [NCT05601440]Phase 2484 participants (Anticipated)Interventional2023-06-13Recruiting
A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered With First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients With Untreated, Locally Advanced or Metastatic Urothelial Carcinoma (PRESERVE 3) [NCT04887831]Phase 292 participants (Actual)Interventional2021-06-04Active, not recruiting
A Randomized Phase II Trial of Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer Eligible for Platinum-based Chemotherapy. Supported by: DIAGNOSTIC PROTOCOL for the VENTANA FOLR1 (FOLR1-2.1) CDx Assay Ventan [NCT04274426]Phase 2136 participants (Anticipated)Interventional2021-10-13Recruiting
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Car [NCT03682068]Phase 31,292 participants (Anticipated)Interventional2018-09-27Recruiting
A Phase 1b/2a Three-Part Open-Label Multicenter Study to Evaluate the Safety and Efficacy of LY2880070 as Monotherapy and in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer [NCT02632448]Phase 1/Phase 2229 participants (Anticipated)Interventional2016-05-16Recruiting
Phase I Study of Imatinib, Gemcitabine and Capecitabine in Patients With Solid Tumors [NCT00483366]Phase 113 participants (Actual)Interventional2006-08-15Completed
Pilot Study of Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas [NCT01783054]Early Phase 12 participants (Actual)Interventional2012-07-31Terminated(stopped due to Study terminated due to low accrual)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Subjects Wit [NCT02715804]Phase 3492 participants (Actual)Interventional2016-03-14Terminated(stopped due to Sponsor decision)
A Phase 1 Study of Neoadjuvant Chemotherapy, Followed by Concurrent Chemoradiation With Gemcitabine, Sorafenib, and Vorinostat in Pancreatic Cancer [NCT02349867]Phase 123 participants (Actual)Interventional2015-01-29Completed
A Randomized Phase II Study of SUBATM-itraconazole With Cisplatin/Gemcitabine in Patients With Previously Untreated Metastatic Squamous Non-Small Cell Lung Cancer. [NCT01752023]Phase 23 participants (Actual)Interventional2013-03-31Terminated(stopped due to Low Accrual)
A Multicenter, Open-Label Phase II Study To Evaluate The Efficacy And Safety Of ABSK021 In Combination With Chemotherapy With Or Without Toripalimab In Patients With Advanced Pancreatic Cancer [NCT06111274]Phase 282 participants (Anticipated)Interventional2023-10-17Recruiting
Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer : a Phase II Randomized Controlled PILOT Study (SAGE) [NCT05988372]Phase 250 participants (Anticipated)Interventional2023-10-23Not yet recruiting
Phase II Study of Neoadjuvant Gemcitabine, Nab-paclitaxel, Durvalumab (MEDI4736) (Anti-PD-L1), and Oleclumab (Anti-CD73) in the Treatment of Resectable/Borderline Resectable Primary Pancreatic Adenocarcinoma [NCT04940286]Phase 230 participants (Anticipated)Interventional2021-09-28Recruiting
Precision Promise Platform Trial for Metastatic Pancreatic Cancer [NCT04229004]Phase 3825 participants (Anticipated)Interventional2020-01-31Active, not recruiting
A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients With Muscle-invasive Bladder Cancer With Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations [NCT03609216]Phase 2271 participants (Anticipated)Interventional2018-08-01Recruiting
Impact on Survival of Cutaneous Reactions in Erlotinib Plus Gemcitabine Treated Patients With Metastatic Pancreatic Cancer Under Conditions of Daily Routine Practice [NCT01782690]338 participants (Actual)Observational2012-03-31Completed
A Phase 1/2 Study of Brentuximab Vedotin (SGN35) in Combination With Gemcitabine for Pediatric and Young Adult Patients With Relapsed or Refractory Hodgkin Lymphoma [NCT01780662]Phase 1/Phase 246 participants (Actual)Interventional2013-01-31Completed
A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer [NCT01696032]Phase 2120 participants (Actual)Interventional2012-09-30Completed
Phase II Study of Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer [NCT01589094]Phase 251 participants (Actual)Interventional2012-04-30Completed
An Open-Labeled, Randomized Phase II Trial of Adjuvant Chemotherapy in Combination With Stereotactic Body Radiation Therapy (SBRT) Versus Adjuvant Chemotherapy Alone for Patients After Radical Resection of Pancreatic Cancer With Advanced Stages (T3 or N1) [NCT02461836]Phase 2513 participants (Anticipated)Interventional2015-08-31Recruiting
A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer [NCT04697628]Phase 3556 participants (Anticipated)Interventional2021-02-22Recruiting
Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study [NCT04405375]Phase 229 participants (Anticipated)Interventional2020-03-21Recruiting
"Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma: A Feasibility Phase II Randomized Clinical Trial (URANUS)" [NCT02969083]Phase 2200 participants (Anticipated)Interventional2018-05-28Recruiting
Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma [NCT02233205]Phase 1/Phase 218 participants (Anticipated)Interventional2014-10-31Recruiting
A Prospective, Multicenter, Double-randomized, Double-blind, 2-parallel Groups, Phase 3 Study to Compare as First Line Therapy Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Gemcitabine in Combination With Placebo, in the Treatment o [NCT03766295]Phase 3377 participants (Actual)Interventional2014-07-31Completed
A Randomized, Open-label, Multiple-centre Study of Intercalating and Maintenance Gefitinib in Combination With Chemotherapy for Advanced NSCLC With EGFR Mutation Positive [NCT02299765]Phase 461 participants (Actual)Interventional2014-12-31Terminated(stopped due to the research data is not statistically significant)
A Phase III, Multi-center, Randomized, Controlled Study to Compare the Efficacy and Safety of Gemcitabine Alone vs. ON 01910.Na Combined With Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Cancer [NCT01360853]Phase 3160 participants (Actual)Interventional2011-05-31Completed
A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer [NCT00902291]Phase 2205 participants (Actual)Interventional2009-04-30Completed
Phase II Multicenter Trial of Neoadjuvant Cisplatin and Nab-paclitaxel for (N2) Defined Stage IIIA Non-Small Cell Lung Cancer (NSCLC) [NCT02276560]Phase 21 participants (Actual)Interventional2015-01-31Terminated(stopped due to This study was terminated due to lack of funding.)
A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic S [NCT04657068]Phase 1/Phase 2242 participants (Anticipated)Interventional2020-12-13Recruiting
Phase II Clinical Study of Hydroxychloroquine Combined With Gemcitabine in the Treatment of Advanced Non-small Cell Lung Cancer [NCT05647330]Phase 255 participants (Anticipated)Interventional2022-12-15Not yet recruiting
Pilot Study of Celecoxib Combined With Gemcitabine and Cisplatin for Neoadjuvant Treatment of Localized, Muscle-Invasive Bladder Cancer [NCT02885974]Phase 115 participants (Anticipated)Interventional2016-12-31Recruiting
A Phase I/II Study of MGCD0103 (MG-0103) in Combination With Gemcitabine [NCT00372437]Phase 1/Phase 247 participants (Actual)Interventional2006-09-30Completed
Randomised Phase II Trial to Investigate Two Different Schedules of Nab-paclitaxel (Abraxane) Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma [NCT03529175]Phase 2146 participants (Actual)Interventional2014-01-31Completed
An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination With Atezolizum [NCT03386721]Phase 2256 participants (Actual)Interventional2018-02-19Terminated(stopped due to The Sponsor discontinued the development of Simlukafusp alfa due to portfolio prioritization, not due to any safety, efficacy, or quality issues.)
A Phase 1, Open-label, Multicenter, Safety Study of Nivolumab (Bms-936558) in Combination With Nab-pacitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-paclitaxel/Carboplatin in Stage Iiib/iv Non-small Cell Lung Cancer or Nab-paclitaxel in Metast [NCT02309177]Phase 1114 participants (Actual)Interventional2015-01-12Completed
Efficacy and Safety of Modified Nab-Paclitaxel Plus Gemcitabine Chemotherapy for Metastatic Pancreatic Cancer: A Single-arm Phase II Clinical Trial [NCT03502343]Phase 252 participants (Anticipated)Interventional2018-04-01Recruiting
A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119) [NCT02555657]Phase 3622 participants (Actual)Interventional2015-10-13Completed
A Phase I Study of CPI-613 in Combination With Gemcitabine and Nab-paclitaxel (Abraxane) for Patients With Locally Advanced or Metastatic Pancreatic Cancer [NCT03435289]Phase 124 participants (Anticipated)Interventional2017-10-19Recruiting
The Efficacy and Safety of Continuous Administration of Endostar Combined With Chemotherapy for Patients With Advanced no Small Cell Lung Cancer: An Open-label, no Randomized Controlled Multicenter Phase II Study [NCT03123445]Phase 2150 participants (Anticipated)Interventional2017-04-30Not yet recruiting
An Open-label, Randomized, Multi-center, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Immuncell-LC Therapy Combined With Gemcitabine Versus Adjuvant Gemcitabine Single Therapy After Resection in Patients With Pancreat [NCT04969731]Phase 3408 participants (Anticipated)Interventional2021-09-07Recruiting
Phase II Randomised Trial of Induction Gemcitabine and Cisplatin Versus Gemcitabine, Cisplatin, Pembrolizumab and Bevacizumab (GPPB) in Nasopharyngeal Cancer [NCT05305131]Phase 250 participants (Anticipated)Interventional2022-03-28Not yet recruiting
An Open-Label Multicenter 3-Arm Randomized Phase 2 Study to Assess the Efficacy and Safety of TTX-030 and Chemotherapy With or Without Budigalimab, Compared to Chemotherapy Alone, for the Treatment of Patients Not Previously Treated for Metastatic Pancrea [NCT06119217]Phase 2180 participants (Anticipated)Interventional2023-12-31Not yet recruiting
A Phase II Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumours [NCT04999969]Phase 2126 participants (Actual)Interventional2021-12-10Active, not recruiting
A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Napabucasin Protocols [NCT04299880]Phase 17 participants (Actual)Interventional2020-02-24Completed
A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma [NCT03943667]Phase 3211 participants (Actual)Interventional2019-05-23Completed
DURVA+ : Evaluation of the Safety and Pharmacodynamics of Anti-PD-L1 Antibody Durvalumab in Combination With Chemotherapy in Patients With Advanced Solid Tumors [NCT03907475]Phase 2115 participants (Anticipated)Interventional2019-07-16Recruiting
An Open-label, Multi-center, Phase 1b Study to Investigate the Safety and Tolerability of SLC-0111 (WBI-5111) in Combination With Gemcitabine in Metastatic Pancreatic Ductal Adenocarcinoma Subjects Positive for Carbonic Anhydrase IX [NCT03450018]Phase 1/Phase 230 participants (Anticipated)Interventional2019-01-10Recruiting
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab Compared With Chemotherapy in Patients With Treatment Naïve Advanced or Recurrent (Stage IIIb Not Amenable for Multimodality Treatment) or Metast [NCT03191786]Phase 3453 participants (Actual)Interventional2017-09-11Completed
Phase I Trial of the Combination of Vismodegib GDC-0449 and Erlotinib +/- Gemcitabine [NCT00878163]Phase 155 participants (Actual)Interventional2009-03-31Active, not recruiting
A Phase I Study of Merestinib Monotherapy or in Combination With Other Anti-Cancer Agents in Japanese Patients With Advanced and/or Metastatic Cancer [NCT03027284]Phase 119 participants (Actual)Interventional2017-02-03Completed
Progression-free Survival After Minimally Invasive Surgical Microwave Ablation Plus Durvalumab (MEDI4736) and Tremelimumab for Unresectable Non-metastatic Locally Advanced Pancreatic Cancer: MIMIPAC Trial [NCT04156087]Phase 212 participants (Actual)Interventional2020-05-09Active, not recruiting
A Phase I/II Trial of BAY 43-9006 Plus Gemcitabine and Capecitabine in the Treatment of Patients With Advanced Renal Cell Carcinoma [NCT00121251]Phase 1/Phase 217 participants (Actual)Interventional2005-06-03Completed
A Single Arm,Phase Ib/II Study of the Combination of Lenalidomide and Gemcitabine in Relapsed or Refractory Peripheral T-cell Lymphomas (PTCL) [NCT05105412]Phase 1/Phase 233 participants (Anticipated)Interventional2021-10-31Not yet recruiting
A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma [NCT01482962]Phase 3271 participants (Actual)Interventional2012-06-11Completed
Phase II Study of Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer [NCT02241551]Phase 22 participants (Actual)Interventional2014-12-31Terminated(stopped due to Study was terminated with the IRB ended early as logistical concerns of the SBRT)
Ipilimumab and Gemcitabine for Advanced Pancreas Cancer: A Phase Ib Study [NCT01473940]Phase 121 participants (Actual)Interventional2012-06-11Completed
PHASE 1/2 STUDY OF PF-03084014 IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA [NCT02109445]Phase 23 participants (Actual)Interventional2014-09-03Terminated(stopped due to The study was terminated on 24JUN15 due to change in strategy of PF-03084014 development.No safety/efficacy concerns were behind the reason of trial termination)
A Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS-110) in Combination With Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients With Non-Small Cell Lung Adenocarcinoma After Failu [NCT02117024]Phase 266 participants (Actual)Interventional2014-07-31Terminated(stopped due to Sponsor Decision; strategic - based on changing treatment landscape)
Randomized Crossover Trial to Assess the Effects and Quality of Life in Patients With Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine in Combination With Nab-paclitaxel: QOLINPAC [NCT02106884]Phase 2146 participants (Actual)Interventional2014-04-30Completed
Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer [NCT00202800]Phase 240 participants (Anticipated)Interventional2002-03-31Completed
Phase II Study of Gemcitabine and Pazopanib in Chemotherapy Naïve Patients With Advanced/Metastatic Urothelial Carcinoma Ineligible for Cisplatin-based Chemotherapy [NCT01622660]Phase 22 participants (Actual)Interventional2012-06-30Terminated(stopped due to Safety reasons)
A PHASE 2, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ABI-007 PLUS GEMCITABINE IN CHINESE PATEINTS WITH METASTATIC PANCREATIC ADENOCARCINOMA [NCT02017015]Phase 283 participants (Actual)Interventional2013-12-24Completed
Randomized Phase II Trial of Pre-Operative Gemcitabine and Nab Paclitacel With or With Out Hydroxychloroquine [NCT01978184]Phase 2104 participants (Actual)Interventional2013-11-30Completed
A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Pa [NCT06103864]Phase 3625 participants (Anticipated)Interventional2023-11-23Recruiting
A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer [NCT03371017]Phase 3572 participants (Anticipated)Interventional2018-01-11Active, not recruiting
A Randomized Trial Comparing Induction Gemcitabine and Cisplatin Plus Intensity-modulated Radiotherapy With Concurrent Cisplatin Plus Intensity-modulated Radiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT02460887]Phase 3236 participants (Anticipated)Interventional2015-06-30Active, not recruiting
Evaluation of Safety and Efficacy of Electrochemotherapy in the Treatment of Pancreatic Adenocarcinoma [NCT02514421]Phase 16 participants (Actual)Interventional2015-07-31Completed
PERSONALIZED MEDICINE GROUP / UCBG UC-0105/1304: SAFIR02_Breast - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer [NCT02299999]Phase 21,460 participants (Actual)Interventional2014-04-07Active, not recruiting
Neoadjuvant Chemotherapy for Non-metastatic Non-small Cell Lung Cancer [NCT01860040]Phase 21 participants (Actual)Interventional2013-04-30Terminated(stopped due to Poor accrual, no data to analyze)
Intrabdominal Hyperthermic Chemotherapy Using Gemcitabine to Treat Pancreatic Carcinomatosis [NCT03251365]Phase 2/Phase 342 participants (Anticipated)Interventional2017-07-27Recruiting
A Phase 1b, Open Label, Dose Escalation Study of IOA-289, an Orally Bioavailable, Selective Autotaxin (ENPP2) Inhibitor Alone and in Combination With Gemcitabine/Nab-paclitaxel in Patients With Metastatic Pancreatic Cancer [NCT05586516]Phase 1/Phase 224 participants (Anticipated)Interventional2022-10-10Recruiting
Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies [NCT03884556]Phase 156 participants (Actual)Interventional2019-04-10Completed
Phase III Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Unresectable, Locally Recurrent or Metastatic Breast Cancer After Prior Anthracycline-based Adjuvant Chemotherapy [NCT02054338]Phase 31,004 participants (Actual)Interventional2006-06-30Terminated(stopped due to Study was stopped before progressive disease or death of alive subjects.)
A Phase II, Randomized, Double-Blind Placebo-Controlled Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer [NCT04677504]Phase 2162 participants (Actual)Interventional2021-02-23Completed
A Phase II, Open Label, Randomized, Parallel Arm Study of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy Gemcitabine/Nab-paclitaxel, and Gemcitabine/Nab-paclitaxel Alone in First-line Metastatic Pancreatic Ductal Adenocarcino [NCT04390763]Phase 2151 participants (Actual)Interventional2020-10-16Active, not recruiting
A Phase II Study of Neoadjuvant Chemotherapy With and Without Immunotherapy to CA125 (Oregovomab) Followed by Hypofractionated Stereotactic Radiotherapy & Concurrent HIV Protease Inhibitor Nelfinavir in Locally Advanced Pancreatic Cancer [NCT01959672]Phase 211 participants (Actual)Interventional2013-09-06Completed
A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Gemcitabine+Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer [NCT02409355]Phase 38 participants (Actual)Interventional2015-05-07Terminated(stopped due to The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342.)
Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer: a Prospective, Randomized Controlled Clinical Trial [NCT05218889]Phase 1/Phase 283 participants (Anticipated)Interventional2021-08-04Recruiting
Feasibility Study of Neoadjuvant Gemcitabine/Nab-Paclitaxel and Hypofractionated Image-Guided Intensity Modulated Radiotherapy in Resectable and Borderline Resectable Pancreatic Cancer [NCT02318095]40 participants (Actual)Interventional2015-02-17Completed
Azacitidine/Vorinostat/GemBuMel With Autologous Stem-Cell Transplant (SCT) in Patients With Refractory Lymphomas [NCT01983969]Phase 1/Phase 261 participants (Actual)Interventional2013-11-07Completed
A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer [NCT00981058]Phase 31,093 participants (Actual)Interventional2010-01-07Active, not recruiting
Milciclib in Combination With Gemcitabine in Advanced Non-Small Cell Lung Cancer [NCT05651269]Phase 228 participants (Anticipated)Interventional2023-03-15Not yet recruiting
TIGER-3: A Phase 3, Open-label, Multicenter, Randomized Study of Oral Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC) After Failure of at Least 1 Previous EGFR-di [NCT02322281]Phase 3149 participants (Actual)Interventional2015-02-28Terminated(stopped due to Sponsor discontinued development of CO-1686 for NSCLC)
Nab-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT). [NCT02301143]Phase 2107 participants (Actual)Interventional2015-04-21Completed
A Multicenter, Open-Label, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of YH003 in Combination With Toripalimab (Anti-PD-1 mAb) in Subjects With Advanced Solid Tumors [NCT04481009]Phase 1/Phase 226 participants (Actual)Interventional2020-08-04Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00011986 (3) [back to overview]Overall Survival
NCT00011986 (3) [back to overview]Progression-free Survival
NCT00011986 (3) [back to overview]Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0
NCT00022633 (8) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00022633 (8) [back to overview]Progression-free Survival in Patients Aged 70 Years and Older
NCT00022633 (8) [back to overview]Overall Survival (OS) in Patients Aged 70 Years and Older
NCT00022633 (8) [back to overview]Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols
NCT00022633 (8) [back to overview]Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)
NCT00022633 (8) [back to overview]Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required
NCT00022633 (8) [back to overview]Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate
NCT00022633 (8) [back to overview]Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms
NCT00033540 (5) [back to overview]Accrual of Patients With This Disease Site
NCT00033540 (5) [back to overview]Overall Survival
NCT00033540 (5) [back to overview]Median Survival Time for Participants With Relevant Biologic Markers
NCT00033540 (5) [back to overview]Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
NCT00033540 (5) [back to overview]Response
NCT00045630 (3) [back to overview]Overall Survival (OS)
NCT00045630 (3) [back to overview]Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy
NCT00045630 (3) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00055601 (3) [back to overview]Treatment Completion Rate
NCT00055601 (3) [back to overview]Complete Response After Induction
NCT00055601 (3) [back to overview]Bladder-intact Survival Rate (5 Years)
NCT00057876 (3) [back to overview]Overall Response
NCT00057876 (3) [back to overview]Progression-free Survival Time
NCT00057876 (3) [back to overview]Overall Survival Time
NCT00063570 (5) [back to overview]Overall Tumor Response
NCT00063570 (5) [back to overview]Time to Treatment Failure
NCT00063570 (5) [back to overview]Time to Progressive Disease
NCT00063570 (5) [back to overview]Overall Survival
NCT00063570 (5) [back to overview]Duration of (Confirmed) Complete Response or Partial Response
NCT00064077 (5) [back to overview]Pain, Assessed by Brief Pain Inventory
NCT00064077 (5) [back to overview]Duration of Progression-free Survival (PFS)
NCT00064077 (5) [back to overview]Duration of Overall Survival (OS)
NCT00064077 (5) [back to overview]Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)
NCT00064077 (5) [back to overview]Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).
NCT00066781 (3) [back to overview]Time to Disease Progression
NCT00066781 (3) [back to overview]Confirmed Response Rate (Partial or Complete Response for 2 Consecutive Evaluations at Least 4 Weeks Apart) as Measured by RECIST Criteria
NCT00066781 (3) [back to overview]Overall Survival
NCT00068393 (3) [back to overview]Overall Survival
NCT00068393 (3) [back to overview]Progression-free Survival
NCT00068393 (3) [back to overview]Response Rate by Solid Tumor Response Criteria (RECIST)
NCT00072514 (4) [back to overview]Overall and Complete Response Rates
NCT00072514 (4) [back to overview]Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules
NCT00072514 (4) [back to overview]Hematologic and Non-hematologic Adverse Events.
NCT00072514 (4) [back to overview]Peripheral Blood Stem Cell Collection
NCT00073983 (2) [back to overview]Objective Response Rate
NCT00073983 (2) [back to overview]Toxicity as Assessed by NCI CTCAE v3.0
NCT00075504 (3) [back to overview]Overall Survival
NCT00075504 (3) [back to overview]Progression Free Survival
NCT00075504 (3) [back to overview]Response Rate According to RECIST Criteria
NCT00078949 (4) [back to overview]Toxic Effect
NCT00078949 (4) [back to overview]Transplantation Rate of Patients After 2 Courses of Chemotherapy
NCT00078949 (4) [back to overview]Response Rate of Patients After 2 Courses of Chemotherapy
NCT00078949 (4) [back to overview]Event-free Survival of Patients on Maintenance Randomization (Period 2)
NCT00088530 (4) [back to overview]Overall Survival
NCT00088530 (4) [back to overview]Overall Response Rate (ORR) Lasting at Least 4 Months
NCT00088530 (4) [back to overview]Complete Response (CR) and Complete Response Unconfirmed (CRu)
NCT00088530 (4) [back to overview]Progression-Free Survival (PFS)
NCT00089024 (2) [back to overview]Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment
NCT00089024 (2) [back to overview]Surgical Exploration
NCT00091026 (3) [back to overview]Progression-free Survival
NCT00091026 (3) [back to overview]Overall Survival
NCT00091026 (3) [back to overview]Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00093496 (4) [back to overview]Toxicity
NCT00093496 (4) [back to overview]Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.
NCT00093496 (4) [back to overview]Times to Progression
NCT00093496 (4) [back to overview]Overall Survival
NCT00093795 (5) [back to overview]Toxicity
NCT00093795 (5) [back to overview]Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer
NCT00093795 (5) [back to overview]Overall Survival
NCT00093795 (5) [back to overview]Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence
NCT00093795 (5) [back to overview]Distant Recurrence-free Interval: the Time to Distant Disease Recurrence Only
NCT00096993 (5) [back to overview]Progression-free Survival
NCT00096993 (5) [back to overview]Percentage of Participants With an Objective Response
NCT00096993 (5) [back to overview]Duration of the Objective Response
NCT00096993 (5) [back to overview]Duration of Survival
NCT00096993 (5) [back to overview]Percentage of Participants Free From Disease Progression at 4 Months
NCT00100789 (4) [back to overview]Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
NCT00100789 (4) [back to overview]Progression-free Survival
NCT00100789 (4) [back to overview]Overall Survival
NCT00100789 (4) [back to overview]Response
NCT00100815 (5) [back to overview]Overall Survival
NCT00100815 (5) [back to overview]Percentage of Participants With Improved Quality of Life
NCT00100815 (5) [back to overview]Progression-free Survival
NCT00100815 (5) [back to overview]Clinical Response
NCT00100815 (5) [back to overview]Percentage of Participants With Grades 3-5 Treatment Related Toxicities
NCT00101283 (3) [back to overview]Overall Survival
NCT00101283 (3) [back to overview]Best Overall Response by RECIST Criteria (Version 1.0)
NCT00101283 (3) [back to overview]Progression-Free Survival
NCT00101907 (6) [back to overview]Cmax
NCT00101907 (6) [back to overview]Number of Participants With an Objective Tumor Response
NCT00101907 (6) [back to overview]Participant Incidence of Adverse Events
NCT00101907 (6) [back to overview]Tmax
NCT00101907 (6) [back to overview]AUC0-inf
NCT00101907 (6) [back to overview]AUC0-24
NCT00109928 (4) [back to overview]2-year Overall Survival Rate
NCT00109928 (4) [back to overview]2-year Progression-free Survival Rate
NCT00109928 (4) [back to overview]Response Rate
NCT00109928 (4) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00110084 (3) [back to overview]Progression-free Survival
NCT00110084 (3) [back to overview]Adverse Event
NCT00110084 (3) [back to overview]Proportion of Patients With Confirmed Responses
NCT00114218 (2) [back to overview]Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0
NCT00114218 (2) [back to overview]Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
NCT00114244 (3) [back to overview]Progression-free Survival
NCT00114244 (3) [back to overview]Overall Survival
NCT00114244 (3) [back to overview]Objective Response (OR = CR or PR) as Determined by the RECIST Criteria
NCT00121251 (3) [back to overview]Median Number of Months of Progression Free Survival (PFS)
NCT00121251 (3) [back to overview]Number of Participants Who Survived (Overall Survival)
NCT00121251 (3) [back to overview]Objective Response for BAY 43-9006 in Combination With Gemcitabine and Capecitabine Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00161213 (4) [back to overview]Response Rate
NCT00161213 (4) [back to overview]1-year Survival Rate
NCT00161213 (4) [back to overview]Overall Survival
NCT00161213 (4) [back to overview]Progression-free Survival
NCT00183794 (2) [back to overview]Tumor Response Type: CR, PR, SD or PD
NCT00183794 (2) [back to overview]Median Time to Progression (Months)
NCT00184093 (2) [back to overview]Toxicity (Number of Participants With Serious Adverse Events)
NCT00184093 (2) [back to overview]Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)
NCT00185588 (2) [back to overview]Time-to-Progression, Evaluable Patients
NCT00185588 (2) [back to overview]Time-to-Treatment Failure (Intent-To-Treat Analysis)
NCT00189137 (2) [back to overview]The Percentage of Patients Alive Without Disease at 2 Years
NCT00189137 (2) [back to overview]Percentage of Patients Hospitalized in Each Arm.
NCT00191100 (6) [back to overview]Local Failure Rate
NCT00191100 (6) [back to overview]Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years
NCT00191100 (6) [back to overview]Number of Participants Who Died From Any Cause at Various Time Points
NCT00191100 (6) [back to overview]Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
NCT00191100 (6) [back to overview]Tumor Response
NCT00191100 (6) [back to overview]Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
NCT00191139 (5) [back to overview]Progression-Free Survival
NCT00191139 (5) [back to overview]Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization
NCT00191139 (5) [back to overview]Number of Patients With Overall Tumor Response
NCT00191139 (5) [back to overview]2-Year Survival
NCT00191139 (5) [back to overview]Overall Survival
NCT00191152 (13) [back to overview]Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)
NCT00191152 (13) [back to overview]Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)
NCT00191152 (13) [back to overview]Progression-Free Survival (Crossover Treatment)
NCT00191152 (13) [back to overview]Time to Disease Progression (Crossover Treatment)
NCT00191152 (13) [back to overview]Progression-Free Survival (Initial Treatment)
NCT00191152 (13) [back to overview]Time to Disease Progression (Initial Treatment)
NCT00191152 (13) [back to overview]Best Overall Response (Crossover Treatment)
NCT00191152 (13) [back to overview]Best Overall Response (Initial Treatment)
NCT00191152 (13) [back to overview]Duration of Response (Crossover Treatment)
NCT00191152 (13) [back to overview]Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)
NCT00191152 (13) [back to overview]Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)
NCT00191152 (13) [back to overview]Overall Survival
NCT00191152 (13) [back to overview]Duration of Response (Initial Treatment)
NCT00191269 (6) [back to overview]Tumor Response
NCT00191269 (6) [back to overview]Pharmacokinetics - Normalized Cmax
NCT00191269 (6) [back to overview]Pharmacokinetics - Normalized Area Under the Curve
NCT00191269 (6) [back to overview]Time to Progressive Disease
NCT00191269 (6) [back to overview]Survival at 1 Year
NCT00191269 (6) [back to overview]Duration of Response
NCT00191334 (5) [back to overview]Duration of Response
NCT00191334 (5) [back to overview]Time to Progressive Disease
NCT00191334 (5) [back to overview]Time to Treatment Failure
NCT00191334 (5) [back to overview]Best Overall Tumor Response
NCT00191334 (5) [back to overview]Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
NCT00191451 (5) [back to overview]Duration of Response
NCT00191451 (5) [back to overview]Overall Tumor Response
NCT00191451 (5) [back to overview]Percentage of Patients With Overall Survival at 1 Year and 2 Years
NCT00191451 (5) [back to overview]Time to Disease Progression (TTP)
NCT00191451 (5) [back to overview]Number of Patients Who Experienced Alopecia
NCT00191477 (4) [back to overview]Recurrence-Free Survival (RFS)
NCT00191477 (4) [back to overview]Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
NCT00191477 (4) [back to overview]Percentage of Participants Without Tumor Recurrence
NCT00191477 (4) [back to overview]Tumor Recurrence Type
NCT00191646 (4) [back to overview]Time to Treatment Failure
NCT00191646 (4) [back to overview]Overall Survival
NCT00191646 (4) [back to overview]Progression Free Survival (PFS)
NCT00191646 (4) [back to overview]Proportion of Participants With Response (Response Rate)
NCT00191789 (6) [back to overview]Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study
NCT00191789 (6) [back to overview]Number of Participants With Time to Treatment Failure at Various Time Points
NCT00191789 (6) [back to overview]Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery
NCT00191789 (6) [back to overview]Summary of Deaths During Study
NCT00191789 (6) [back to overview]Number of Participants Who Died From Any Cause at Various Time Points
NCT00191789 (6) [back to overview]Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)
NCT00191815 (9) [back to overview]Duration of Response
NCT00191815 (9) [back to overview]Survival Time
NCT00191815 (9) [back to overview]Time to Progressive Disease
NCT00191815 (9) [back to overview]Time to Treatment Failure
NCT00191815 (9) [back to overview]Number of Participants With Adverse Events Leading to Discontinuation
NCT00191815 (9) [back to overview]Number of Deaths
NCT00191815 (9) [back to overview]Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
NCT00191815 (9) [back to overview]Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
NCT00191815 (9) [back to overview]Objective Tumor Response
NCT00191854 (5) [back to overview]Best Overall Response
NCT00191854 (5) [back to overview]Progression Free Survival (PFS)
NCT00191854 (5) [back to overview]Overall Survival
NCT00191854 (5) [back to overview]Duration of Response
NCT00191854 (5) [back to overview]Number of Participants With a Time to Treatment Failure (TTTF) Event
NCT00192036 (5) [back to overview]Tumor Response at End of Treatment
NCT00192036 (5) [back to overview]Time to Progressive Disease
NCT00192036 (5) [back to overview]Safety of Induction Chemotherapy
NCT00192036 (5) [back to overview]Safety of Chemo-radiotherapy
NCT00192036 (5) [back to overview]Overall Survival
NCT00192075 (11) [back to overview]Tumor Response - Avastin Subgroup
NCT00192075 (11) [back to overview]Progression-Free Survival
NCT00192075 (11) [back to overview]Duration of Response
NCT00192075 (11) [back to overview]Progression-Free Survival - Avastin Subgroup
NCT00192075 (11) [back to overview]Time to Progressive Disease - Avastin Subgroup
NCT00192075 (11) [back to overview]Survival at 12 Months and 24 Months - Avastin Subgroup
NCT00192075 (11) [back to overview]Toxicity - Avastin Subgroup
NCT00192075 (11) [back to overview]Time to Progressive Disease
NCT00192075 (11) [back to overview]Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
NCT00192075 (11) [back to overview]Overall Survival
NCT00192075 (11) [back to overview]Duration of Response - A+FOLFOX4 - Avastin Subgroup
NCT00193050 (3) [back to overview]Overall Survival (OS)
NCT00193050 (3) [back to overview]Pathologic Complete Response (pCR)
NCT00193050 (3) [back to overview]Time to Treatment Failure (TTF)
NCT00193063 (3) [back to overview]Overall Survival (OS)
NCT00193063 (3) [back to overview]Progression Free Survival (PFS)
NCT00193063 (3) [back to overview]Overall Response Rate (ORR)
NCT00193206 (4) [back to overview]Pathologic Complete Response
NCT00193206 (4) [back to overview]Rates of Breast Preservation
NCT00193206 (4) [back to overview]Time to Disease Progression
NCT00193206 (4) [back to overview]Clinical Response Rates
NCT00193414 (3) [back to overview]Progression-free Survival (PFS)
NCT00193414 (3) [back to overview]Overall Survival (OS)
NCT00193414 (3) [back to overview]Overall Response Rate
NCT00193427 (4) [back to overview]Progression Free Survival (PFS)
NCT00193427 (4) [back to overview]Pathologic Complete Response Rate
NCT00193427 (4) [back to overview]Overall Survival (OS)
NCT00193427 (4) [back to overview]Overall Response Rate (ORR)
NCT00193453 (3) [back to overview]Overall Clinical Response Rate
NCT00193453 (3) [back to overview]Progression Free Survival (PFS)
NCT00193453 (3) [back to overview]Response Duration
NCT00193596 (2) [back to overview]Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
NCT00193596 (2) [back to overview]Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
NCT00201760 (3) [back to overview]Disease Progression
NCT00201760 (3) [back to overview]Measure Response Rate of Each Drug Combination
NCT00201760 (3) [back to overview]Number of Participants With Grades 3 and Grade 4 Toxicity Profiles of the Drug Combinations
NCT00201838 (5) [back to overview]Percentage of Patients With Clinical Benefit Response
NCT00201838 (5) [back to overview]Number of Patients With Response
NCT00201838 (5) [back to overview]Anti-tumor Effect as Measured by the Proportion of Patients Free of Disease-progression at Six Months After Treatment Initiation
NCT00201838 (5) [back to overview]Median Overall Survival Rates for Patients
NCT00201838 (5) [back to overview]Serial Levels of TNF (Tumor Necrosis Factor) and Other Inflammatory Cytokines
NCT00215930 (3) [back to overview]Best Disease Response After a Maximum of Six Cycles.
NCT00215930 (3) [back to overview]Progression Free Survival (PFS)
NCT00215930 (3) [back to overview]Overall Survival (OS)
NCT00219557 (18) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)
NCT00219557 (18) [back to overview]Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
NCT00219557 (18) [back to overview]Overall Survival (OS)
NCT00219557 (18) [back to overview]Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
NCT00219557 (18) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine
NCT00219557 (18) [back to overview]Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)
NCT00219557 (18) [back to overview]Duration of Response (DR)
NCT00219557 (18) [back to overview]Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study
NCT00219557 (18) [back to overview]Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study
NCT00219557 (18) [back to overview]Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study
NCT00219557 (18) [back to overview]Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study
NCT00219557 (18) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)
NCT00219557 (18) [back to overview]Progression-free Survival (PFS)
NCT00219557 (18) [back to overview]Plasma Decay Half-life (t1/2) of Gemcitabine
NCT00219557 (18) [back to overview]Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)
NCT00219557 (18) [back to overview]Percentage of Participants With Overall Response (OR)
NCT00219557 (18) [back to overview]One Year Survival Probability
NCT00219557 (18) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Gemcitabine
NCT00225784 (7) [back to overview]Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy
NCT00225784 (7) [back to overview]Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.
NCT00225784 (7) [back to overview]Objective Response of Tumor by RECIST 1.0 Criteria
NCT00225784 (7) [back to overview]Pattern of Failure After Therapy
NCT00225784 (7) [back to overview]Disease-Free Survival After Therapy
NCT00225784 (7) [back to overview]Number of Participants Assessed for Adverse Events
NCT00225784 (7) [back to overview]Overall Length of Survival After Therapy
NCT00226577 (5) [back to overview]Disease Response - Pathologic
NCT00226577 (5) [back to overview]Survival - Disease Free
NCT00226577 (5) [back to overview]Survival - Overall
NCT00226577 (5) [back to overview]Disease Response - Radiographic
NCT00226577 (5) [back to overview]Toxicity
NCT00226590 (4) [back to overview]Treatment Completion
NCT00226590 (4) [back to overview]Progression Free Survival
NCT00226590 (4) [back to overview]Overall Survival
NCT00226590 (4) [back to overview]Number of Participants Whose Response Allowed Them to Proceed to Chemoradiation
NCT00227721 (2) [back to overview]Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.
NCT00227721 (2) [back to overview]Progression-free Survival
NCT00234039 (4) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00234039 (4) [back to overview]Recurrence-free Survival (RFS)
NCT00234039 (4) [back to overview]Overall Survival (OS)
NCT00234039 (4) [back to overview]Complete Response Rate at the End of Induction
NCT00234494 (3) [back to overview]Estimate Response Rates
NCT00234494 (3) [back to overview]Progression Free Survival
NCT00234494 (3) [back to overview]Overall Survival Time
NCT00236899 (9) [back to overview]Overall Response Rate (ORR) by Treatment Schedule
NCT00236899 (9) [back to overview]Time to Progressive Disease (TTPD) by Treatment Schedule
NCT00236899 (9) [back to overview]Time to Progressive Disease (TTPD) by Treatment Drug
NCT00236899 (9) [back to overview]Overall Survival (OS) by Treatment Schedule
NCT00236899 (9) [back to overview]Number of Participants With Serious and Nonserious Adverse Events (AEs)
NCT00236899 (9) [back to overview]Overall Survival (OS) by Treatment Drug
NCT00236899 (9) [back to overview]Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle
NCT00236899 (9) [back to overview]Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit
NCT00236899 (9) [back to overview]Overall Response Rate(ORR) by Treatment Drug
NCT00244933 (1) [back to overview]Objective Response Rate by RECIST Criteria Following
NCT00247416 (4) [back to overview]Percentage of Participants With Reduction in Grade 3/4 Neutropenia
NCT00247416 (4) [back to overview]Progression-free Survival
NCT00247416 (4) [back to overview]Effect of Dexamethasone Pre-treatment on Overall Survival.
NCT00247416 (4) [back to overview]Effect of Dexamethasone Pre-treatment on Response Rate.
NCT00248560 (4) [back to overview]Response Duration
NCT00248560 (4) [back to overview]Survival
NCT00248560 (4) [back to overview]Toxicity as Measured by Number and Grade of Adverse Events
NCT00248560 (4) [back to overview]Response (Complete Response [CR] + Partial Response [PR])
NCT00262860 (3) [back to overview]Response Rate After 2 Courses of Therapy
NCT00262860 (3) [back to overview]Change in Proteasome Activity Compared to Baseline (Cycle 2)
NCT00262860 (3) [back to overview]Change in Proteasome Activity Compared to Baseline (Cycle 1)
NCT00264498 (1) [back to overview]Progression Free Survival (PFS)
NCT00267020 (9) [back to overview]Overall Survival (OS)
NCT00267020 (9) [back to overview]Relationship of Steady-state Drug Levels to Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Disease Control)
NCT00267020 (9) [back to overview]Duration of Response
NCT00267020 (9) [back to overview]Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate)
NCT00267020 (9) [back to overview]Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) (Toxicity)
NCT00267020 (9) [back to overview]Change in Scores From Baseline (Improved, Stable or Worsened) to End of Study in Functional Assessment of Cancer Therapy Hepatobiliary Version 4 ( FACT-Hep v.4) (Quality of Life (QOL))
NCT00267020 (9) [back to overview]Carbohydrate Antigen 19-9 (CA 19-9) Concentration in the Blood
NCT00267020 (9) [back to overview]Progression Free Survival (PFS)
NCT00267020 (9) [back to overview]Relationship of Steady-State Drug Levels to Clinical Outcomes of Overall Survival (OS)
NCT00267696 (2) [back to overview]Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.
NCT00267696 (2) [back to overview]Overall Survival for Patients Treated With the Regimen.
NCT00268242 (6) [back to overview]Complete Response Rate
NCT00268242 (6) [back to overview]Percentage of Patients Making it to Bone Marrow Transplant.
NCT00268242 (6) [back to overview]White Blood Cell Count at Time of Relapse
NCT00268242 (6) [back to overview]Disease-free and Overall Survival
NCT00268242 (6) [back to overview]Laboratory Correlates: Immunohistochemistry
NCT00268242 (6) [back to overview]Duration of the First Complete Response
NCT00276549 (2) [back to overview]Objective PSA Response Rate (Number of Patients With a PSA Response)
NCT00276549 (2) [back to overview]Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).
NCT00276744 (1) [back to overview]6-month Overall Survival
NCT00276861 (2) [back to overview]Response Rate as Measured by RECIST Criteria
NCT00276861 (2) [back to overview]Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment
NCT00281827 (6) [back to overview]Number of Patients Alive at 56 Months (End of Study)
NCT00281827 (6) [back to overview]Number of Patients Disease-free at 1 Year
NCT00281827 (6) [back to overview]Number of Patients Disease-free at 2 Years
NCT00281827 (6) [back to overview]Number of Patients Alive at 2 Years (Survival)
NCT00281827 (6) [back to overview]Number of Patients Alive at 1 Year (Survival)
NCT00281827 (6) [back to overview]Number of Patients Reporting Clinical Response
NCT00282087 (10) [back to overview]Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)
NCT00282087 (10) [back to overview]Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
NCT00282087 (10) [back to overview]Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)
NCT00282087 (10) [back to overview]Correlation Between Age and Tumor Response to Treatment (PFS)
NCT00282087 (10) [back to overview]Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)
NCT00282087 (10) [back to overview]Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)
NCT00282087 (10) [back to overview]Tolerability/Toxicity of This Regimen
NCT00282087 (10) [back to overview]Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)
NCT00282087 (10) [back to overview]Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)
NCT00282087 (10) [back to overview]Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)
NCT00283244 (5) [back to overview]Quality of Life (QOL)- Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Trial Outcome Index-L (TOI-L)
NCT00283244 (5) [back to overview]Response Rate
NCT00283244 (5) [back to overview]Progression-free Survival
NCT00283244 (5) [back to overview]Toxicity
NCT00283244 (5) [back to overview]Overall Survival
NCT00290706 (1) [back to overview]Response Rate in Patients With Relapsed or Refractory B- and T-cell NHL With Gemcitabine and Bortezomib Combination Treatment.
NCT00305877 (3) [back to overview]Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy
NCT00305877 (3) [back to overview]Two-year Disease-free Survival (DFS)
NCT00305877 (3) [back to overview]Two-year Overall Survival Rate
NCT00316199 (5) [back to overview]Overall Survival Probability
NCT00316199 (5) [back to overview]Best Overall Tumor Response
NCT00316199 (5) [back to overview]Time to Treatment Failure
NCT00316199 (5) [back to overview]Progression-Free Survival
NCT00316199 (5) [back to overview]Duration of Response
NCT00320541 (10) [back to overview]Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy
NCT00320541 (10) [back to overview]Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy
NCT00320541 (10) [back to overview]Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy
NCT00320541 (10) [back to overview]Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy
NCT00320541 (10) [back to overview]Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy
NCT00320541 (10) [back to overview]Overall Response Rate (ORR)
NCT00320541 (10) [back to overview]Overall Survival
NCT00320541 (10) [back to overview]Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy
NCT00320541 (10) [back to overview]Progression-free Survival (PFS)
NCT00320541 (10) [back to overview]Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy
NCT00320749 (3) [back to overview]Common Toxicities
NCT00320749 (3) [back to overview]Therapeutic Response
NCT00320749 (3) [back to overview]Maximum Tolerated Dose (MTD)
NCT00323063 (2) [back to overview]Response Rate (Complete and Partial Response)
NCT00323063 (2) [back to overview]Time to Progression
NCT00323362 (3) [back to overview]1-year Survival
NCT00323362 (3) [back to overview]Percentage of Patients Who Meet Critieria for Response
NCT00323362 (3) [back to overview]Time to Progression
NCT00323869 (9) [back to overview]Time-to-First Event
NCT00323869 (9) [back to overview]Progression-free Survival (PFS)
NCT00323869 (9) [back to overview]Partial Response (PR)
NCT00323869 (9) [back to overview]Overall Survival (OS) at 12 Months
NCT00323869 (9) [back to overview]Overall Survival (OS)
NCT00323869 (9) [back to overview]Response Rate (CR + PR + SD)
NCT00323869 (9) [back to overview]Stable Disease (SD)
NCT00323869 (9) [back to overview]Overall Survival (OS) at 24 Months
NCT00323869 (9) [back to overview]Complete Response (CR)
NCT00324805 (2) [back to overview]Overall Survival
NCT00324805 (2) [back to overview]Disease-free Survival
NCT00325234 (6) [back to overview]Tumor Response Rate
NCT00325234 (6) [back to overview]Duration of Response (DOR)
NCT00325234 (6) [back to overview]Time to Progressive Disease (PD)
NCT00325234 (6) [back to overview]Time to Response
NCT00325234 (6) [back to overview]Time To Treatment Failure (TTTF)
NCT00325234 (6) [back to overview]Number of Participants With Adverse Events (AE)
NCT00326599 (7) [back to overview]Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)
NCT00326599 (7) [back to overview]Time to Treatment Failure (Phase II Patients Only)
NCT00326599 (7) [back to overview]Overall Survival (Phase II Patients Only)
NCT00326599 (7) [back to overview]Overall Survival at 1 Year After Randomization (Phase II Patients Only)
NCT00326599 (7) [back to overview]Dose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)
NCT00326599 (7) [back to overview]Progression-free Survival (Phase II Patients Only)
NCT00326599 (7) [back to overview]Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)
NCT00326911 (23) [back to overview]Change From Baseline in QoL Assessment Using LASA, Legal Concerns, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Progression-free Survival (PFS)
NCT00326911 (23) [back to overview]Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Overall Survival (OS)
NCT00326911 (23) [back to overview]Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Percentage of Patients With Carbohydrate Antigen 19-9 (CA19-9) Response at End of Cycle 2 in Patients With Elevated Baseline Values (Equal or Greater Than 2 x Upper Limit of Normal).
NCT00326911 (23) [back to overview]Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00326911 (23) [back to overview]The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)
NCT00326911 (23) [back to overview]Time to Progression (TTP)
NCT00326911 (23) [back to overview]Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4
NCT00326911 (23) [back to overview]Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4
NCT00334802 (7) [back to overview]Pharmacokinetics - Maximum Plasma Concentration (Cmax)
NCT00334802 (7) [back to overview]Duration of Response
NCT00334802 (7) [back to overview]Number of Participants Alive at One Year (1-Year Survival)
NCT00334802 (7) [back to overview]Pharmacokinetics - Area Under the Concentration Curve (AUC)
NCT00334802 (7) [back to overview]Pharmacokinetics - Half Life (t½)
NCT00334802 (7) [back to overview]Time to Progressive Disease
NCT00334802 (7) [back to overview]Tumor Response
NCT00336700 (6) [back to overview]Recurrence Free Survival (RFS)
NCT00336700 (6) [back to overview]KRAS Mutational Status
NCT00336700 (6) [back to overview]2-year Recurrence Free Survival (RFS)
NCT00336700 (6) [back to overview]Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)
NCT00336700 (6) [back to overview]Estimated 1&2 Year Overall Survival (OS)
NCT00336700 (6) [back to overview]1-year Recurrence Free Survival (RFS)
NCT00337194 (6) [back to overview]sCD30 Levels
NCT00337194 (6) [back to overview]Event Free Survival (EFS)
NCT00337194 (6) [back to overview]Number of Participants With Overall Response (OR)
NCT00337194 (6) [back to overview]Overall Survival (OS) At 1 Year
NCT00337194 (6) [back to overview]Peak Serum Level of Monoclonal Antibody SGN-30
NCT00337194 (6) [back to overview]Fc Gamma Receptor Polymorphisms
NCT00338039 (2) [back to overview]Overall Survival Rate
NCT00338039 (2) [back to overview]Median Overall Survival
NCT00350142 (2) [back to overview]Rate of Local Control
NCT00350142 (2) [back to overview]Median Overall Survival Time
NCT00356525 (2) [back to overview]Overall Survival
NCT00356525 (2) [back to overview]Objective Tumor Response
NCT00361231 (2) [back to overview]Overall Response Rate
NCT00361231 (2) [back to overview]Median Progression Free Survival
NCT00366457 (3) [back to overview]Time to Tumor Progression
NCT00366457 (3) [back to overview]Toxicity Profile
NCT00366457 (3) [back to overview]Overall Survival
NCT00369629 (1) [back to overview]Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort.
NCT00376948 (7) [back to overview]Time to Treatment Failure
NCT00376948 (7) [back to overview]Time to Progression
NCT00376948 (7) [back to overview]Response Duration
NCT00376948 (7) [back to overview]Patients Alive
NCT00376948 (7) [back to overview]Overall Objective Response Rate (Complete and Partial Response)
NCT00376948 (7) [back to overview]Median Overall Survival Estimate
NCT00376948 (7) [back to overview]Grade 3 or Higher Toxicity Evaluation
NCT00378573 (1) [back to overview]Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00379639 (3) [back to overview]Number of Participants With a Dose-limiting Toxicity (DLT)
NCT00379639 (3) [back to overview]Best Overall Response
NCT00379639 (3) [back to overview]Number of Participants With Adverse Events (AEs)
NCT00380588 (4) [back to overview]Tumor Response
NCT00380588 (4) [back to overview]Progression Free Survival
NCT00380588 (4) [back to overview]Percentage of Patients Alive at 1 Year (1-Year Survival Rate)
NCT00380588 (4) [back to overview]Survival Time
NCT00383331 (3) [back to overview]Overall Survival
NCT00383331 (3) [back to overview]Best Overall Tumor Response
NCT00383331 (3) [back to overview]Progression Free Survival
NCT00385788 (1) [back to overview]Transplant Related Mortality Rate
NCT00388154 (2) [back to overview]Overall Objective Response Rate (CR + PR)
NCT00388154 (2) [back to overview]Participant Responses
NCT00388349 (5) [back to overview]Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity
NCT00388349 (5) [back to overview]Relapse Post-transplant
NCT00388349 (5) [back to overview]Pulmonary Toxicity (BCNU Pneumonitis)
NCT00388349 (5) [back to overview]Overall Survival (OS)
NCT00388349 (5) [back to overview]Survival Measures
NCT00390182 (3) [back to overview]Percentage of Participants With Distant Mestastases - Liver
NCT00390182 (3) [back to overview]Overall Response
NCT00390182 (3) [back to overview]Time of Advanced/Recurrent Disease Without Distant Metastases.
NCT00391586 (1) [back to overview]Toxicity Profile
NCT00394147 (3) [back to overview]Time to Progression
NCT00394147 (3) [back to overview]Objective Response Rate
NCT00394147 (3) [back to overview]Overall Survival
NCT00398086 (9) [back to overview]Maximal Degree of Anemia
NCT00398086 (9) [back to overview]Number of Participants With Adverse Events (AE)
NCT00398086 (9) [back to overview]Maximal Degree of Myelosuppression
NCT00398086 (9) [back to overview]Progression-free Survival
NCT00398086 (9) [back to overview]Percentage of Participants With Disease Control
NCT00398086 (9) [back to overview]Percentage of Participants Who Achieved an Objective Confirmed Overall Response
NCT00398086 (9) [back to overview]Overall Survival
NCT00398086 (9) [back to overview]Number of Participants With Dose-limiting Toxicities
NCT00398086 (9) [back to overview]Duration of Response
NCT00400803 (5) [back to overview]Best Overall Response by Cycle
NCT00400803 (5) [back to overview]Overall Survival Time
NCT00400803 (5) [back to overview]Time to Best Response
NCT00400803 (5) [back to overview]Time to Progression
NCT00400803 (5) [back to overview]Duration of Response
NCT00403130 (4) [back to overview]Overall Survival (OS), Confirmed
NCT00403130 (4) [back to overview]Response Rates
NCT00403130 (4) [back to overview]Overall Survival (OS), All Participants
NCT00403130 (4) [back to overview]Time-to-Progression (TTP)
NCT00407550 (4) [back to overview]Progression-free Survival
NCT00407550 (4) [back to overview]Overall Survival
NCT00407550 (4) [back to overview]Number of Patients With Confirmed Responses
NCT00407550 (4) [back to overview]Adverse Event
NCT00408408 (9) [back to overview]Disease-free Survival (DFS)
NCT00408408 (9) [back to overview]Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens
NCT00408408 (9) [back to overview]Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy
NCT00408408 (9) [back to overview]Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy
NCT00408408 (9) [back to overview]Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens
NCT00408408 (9) [back to overview]Pathologic Complete Response (pCR) of the Primary Tumor in the Breast
NCT00408408 (9) [back to overview]pCR in the Breast and Nodes
NCT00408408 (9) [back to overview]Surgical Complication
NCT00408408 (9) [back to overview]Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone
NCT00408564 (4) [back to overview]Overall Survival
NCT00408564 (4) [back to overview]Progression-free Survival at 6 Months
NCT00408564 (4) [back to overview]Response Rate
NCT00408564 (4) [back to overview]Number of Participants With Grade 3-4 Adverse Events Reported
NCT00413283 (6) [back to overview]Number of Participants With Platelet Transfusions
NCT00413283 (6) [back to overview]Number of Participants With Adverse Events
NCT00413283 (6) [back to overview]Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.
NCT00413283 (6) [back to overview]Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle
NCT00413283 (6) [back to overview]Platelet Count on Day 22
NCT00413283 (6) [back to overview]Duration of Grade 3 or 4 Thrombocytopenia
NCT00417976 (2) [back to overview]Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy
NCT00417976 (2) [back to overview]Response Rates Defined by RECIST 1.0
NCT00418093 (4) [back to overview]Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.
NCT00418093 (4) [back to overview]Overall Survival
NCT00418093 (4) [back to overview]Progression Free Survival
NCT00418093 (4) [back to overview]Partial Response Rate
NCT00423449 (4) [back to overview]Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin
NCT00423449 (4) [back to overview]Number of Participants With Clinical Adverse Experiences (Safety and Tolerability)
NCT00423449 (4) [back to overview]Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease
NCT00423449 (4) [back to overview]Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability)
NCT00424827 (5) [back to overview]Toxicity Associated With This Regimen.
NCT00424827 (5) [back to overview]Biomarker Response to Chemoradiation Therapy
NCT00424827 (5) [back to overview]Overall Survival
NCT00424827 (5) [back to overview]Progression-free Survival of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy.
NCT00424827 (5) [back to overview]Resection Rate
NCT00434642 (6) [back to overview]Overall Survival
NCT00434642 (6) [back to overview]Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
NCT00434642 (6) [back to overview]Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)
NCT00434642 (6) [back to overview]Percentage of Patients Who Had at Least 1 Adverse Event
NCT00434642 (6) [back to overview]Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
NCT00434642 (6) [back to overview]Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
NCT00436280 (11) [back to overview]Pharmacokinetics (PK): Maximum Observed Drug Concentration During a Dosing Interval at Steady State(Cmax,ss) for Total Analyte [Characterization of Pharmacokinetics of Enzastaurin and Its Metabolites]
NCT00436280 (11) [back to overview]Percent of Participants With Progression Free Survival (PFS) After 1 Year Treatment
NCT00436280 (11) [back to overview]Duration of Tumor Response (DOR)
NCT00436280 (11) [back to overview]Progression-Free Survival (PFS ) of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-Center B-cells (GCB) Versus Non-GCB Molecular Subtypes (Assessment of Biomarkers Relevant for Enzastaurin)
NCT00436280 (11) [back to overview]PFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C Beta 2 (PKCB2) Expression (Assessment of Biomarkers Relevant for Enzastaurin)
NCT00436280 (11) [back to overview]Percent of Participants With Progression-Free Survival (PFS) After 2 Years and 4 Years of Treatment
NCT00436280 (11) [back to overview]Percent of Participants With Overall Survival (OS) After 1 Year, 2 Years and 4 Years
NCT00436280 (11) [back to overview]Percent of Participants With Event Free Survival (EFS) After 1 Year, 2 Years and 4 Years
NCT00436280 (11) [back to overview]Percent of Participants With Disease-Free Survival (DFS) at 1 Year, 2 Years and 4 Years
NCT00436280 (11) [back to overview]Overall Response Rate (ORR) - Percentage of Participants Achieving Complete Response (CR) or Complete Response Unconfirmed (CRu) or Partial Response (PR) (Response)
NCT00436280 (11) [back to overview]PK: Area Under the Concentration vs. Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) for Total Analyte
NCT00437203 (2) [back to overview]Number of Participants With Objective Response (OR)
NCT00437203 (2) [back to overview]Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine
NCT00438204 (5) [back to overview]Overall Survival
NCT00438204 (5) [back to overview]Number of Participants With Response
NCT00438204 (5) [back to overview]Number of Participants With Grade 3 or Grade 4 Toxicity
NCT00438204 (5) [back to overview]Time to Treatment Failure
NCT00438204 (5) [back to overview]Progression-free Survival (PFS)
NCT00445601 (3) [back to overview]Disease Recurrence Rate
NCT00445601 (3) [back to overview]Compare Qualitative and Quantitative Toxicities Between the Treatment Arms
NCT00445601 (3) [back to overview]Rate of Progression to Muscle Invasive Disease at 4 Years
NCT00447122 (1) [back to overview]Overall Survival for Patients With Metastatic Pancreatic Cancer.
NCT00449033 (15) [back to overview]Time to Response (TTR) in the ITT (Non-squamous) Population
NCT00449033 (15) [back to overview]Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population
NCT00449033 (15) [back to overview]Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population
NCT00449033 (15) [back to overview]Disease Control (DC) in the ITT (Non-squamous) Population
NCT00449033 (15) [back to overview]Duration of Response in the ITT (Non-squamous) Population
NCT00449033 (15) [back to overview]Duration of Stable Disease (SD) in the ITT (Non-squamous) Population
NCT00449033 (15) [back to overview]OS in the ITT (Both Squamous and Non-squamous) Population
NCT00449033 (15) [back to overview]OS in the ITT (Squamous) Population
NCT00449033 (15) [back to overview]Overall Survival (OS) in the ITT (Non-squamous) Population
NCT00449033 (15) [back to overview]Progression-free Survival (PFS) in the ITT (Non-squamous) Population
NCT00449033 (15) [back to overview]Time to Progression (TTP) in the ITT (Non-squamous) Population
NCT00449033 (15) [back to overview]Time to Symptomatic Deterioration (TSD) in the ITT (Non-squamous) Population
NCT00449033 (15) [back to overview]EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population
NCT00449033 (15) [back to overview]Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population
NCT00449033 (15) [back to overview]Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population
NCT00454649 (34) [back to overview]Plasma Clearance (CL) for Cisplatin
NCT00454649 (34) [back to overview]Plasma Clearance (CL) for Carboplatin
NCT00454649 (34) [back to overview]Percentage of Participants With Objective Response
NCT00454649 (34) [back to overview]Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Pemetrexed
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Paclitaxel
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Gemcitabine
NCT00454649 (34) [back to overview]Plasma Clearance (CL) for Paclitaxel
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Cisplatin
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Docetaxel
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin
NCT00454649 (34) [back to overview]Apparent Oral Clearance (CL/F) for Capecitabine
NCT00454649 (34) [back to overview]Apparent Oral Clearance (CL/F) for Axitinib (AG-013736)
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736)
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine
NCT00454649 (34) [back to overview]Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Capecitabine
NCT00454649 (34) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Carboplatin
NCT00454649 (34) [back to overview]Plasma Clearance (CL) for Gemcitabine
NCT00454649 (34) [back to overview]Plasma Clearance (CL) for Docetaxel
NCT00454649 (34) [back to overview]Plasma Clearance (CL) for Pemetrexed
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Pemetrexed
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Paclitaxel
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Gemcitabine
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Docetaxel
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Cisplatin
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Carboplatin
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Capecitabine
NCT00454649 (34) [back to overview]Plasma Decay Half Life (t1/2) for Axitinib (AG-013736)
NCT00456261 (3) [back to overview]Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
NCT00456261 (3) [back to overview]Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
NCT00456261 (3) [back to overview]Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
NCT00456599 (3) [back to overview]Overall Survival
NCT00456599 (3) [back to overview]Two-year Disease Free Survival.
NCT00456599 (3) [back to overview]Time to Treatment Failure
NCT00461708 (10) [back to overview]Percentage of Participants With Disease Control According to RECIST
NCT00461708 (10) [back to overview]PFS
NCT00461708 (10) [back to overview]OS At 6 Months
NCT00461708 (10) [back to overview]Number of Participants Who Died at 6 Months
NCT00461708 (10) [back to overview]Number of Participants Who Died During the Study
NCT00461708 (10) [back to overview]Number of Participants Who Died During the Study By Rash Grade
NCT00461708 (10) [back to overview]Number of Participants With Disease Progression or Death
NCT00461708 (10) [back to overview]OS By Rash Grade
NCT00461708 (10) [back to overview]Overall Survival (OS) During the Study
NCT00461708 (10) [back to overview]Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST
NCT00461851 (2) [back to overview]Dose Ruction (Toxicity)
NCT00461851 (2) [back to overview]Progression Free Survival (PFS)
NCT00462865 (2) [back to overview]Number of Participants With Recurrent Disease
NCT00462865 (2) [back to overview]Toxicity Related to Treatment
NCT00471146 (9) [back to overview]Progression Free Survival (PFS)
NCT00471146 (9) [back to overview]Percentage of Participants With Objective Response (OR)
NCT00471146 (9) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
NCT00471146 (9) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
NCT00471146 (9) [back to overview]Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score
NCT00471146 (9) [back to overview]Overall Survival (OS)
NCT00471146 (9) [back to overview]Duration of Response (DR)
NCT00471146 (9) [back to overview]Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile
NCT00471146 (9) [back to overview]Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score
NCT00476086 (2) [back to overview]Chemotherapy Completion Rate
NCT00476086 (2) [back to overview]Radiation Therapy Completion Rate
NCT00478361 (3) [back to overview]Safety and Efficacy of Same-day Pegfilgrastim
NCT00478361 (3) [back to overview]Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease
NCT00478361 (3) [back to overview]Objective Response Rate
NCT00481871 (3) [back to overview]Duration of Response
NCT00481871 (3) [back to overview]Objective Responses Assessed by International Workshop Criteria (IWC)
NCT00481871 (3) [back to overview]Progression-free Survival (PFS) Time
NCT00491075 (1) [back to overview]Overall Response
NCT00493636 (5) [back to overview]Duration of Overall Response
NCT00493636 (5) [back to overview]Overall Survival
NCT00493636 (5) [back to overview]Time to Progression
NCT00493636 (5) [back to overview]Progression Free Survival
NCT00493636 (5) [back to overview]Overall Response Rate
NCT00496587 (3) [back to overview]Objective Response Rate (ORR)
NCT00496587 (3) [back to overview]Progression Free Survival (PFS)
NCT00496587 (3) [back to overview]Time to Treatment Failure (TTF)
NCT00499109 (3) [back to overview]Response Rate (RR)
NCT00499109 (3) [back to overview]Progression Free Survival (PFS)
NCT00499109 (3) [back to overview]Overall Survival (OS)
NCT00503906 (4) [back to overview]Median Progression-Free Survival
NCT00503906 (4) [back to overview]Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants
NCT00503906 (4) [back to overview]Rate of Toxicity in Study Participants
NCT00503906 (4) [back to overview]Rate of Overall Survival in Study Participants
NCT00509366 (3) [back to overview]Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)
NCT00509366 (3) [back to overview]Median Time to Progressive Disease
NCT00509366 (3) [back to overview]1-year Progression Free Survival Rate in Chemo-naive Select Stage IIIB or Stage IV NSCLC Patients
NCT00509665 (4) [back to overview]Number of Patients Who Had Greater Than Grade 2 Toxicity
NCT00509665 (4) [back to overview]Overall Survival
NCT00509665 (4) [back to overview]Response Rate
NCT00509665 (4) [back to overview]Progression-free Survival
NCT00517595 (6) [back to overview]Time to Progression (TTP)
NCT00517595 (6) [back to overview]Progression Free Survival (PFS)
NCT00517595 (6) [back to overview]Overall Survival (OS)
NCT00517595 (6) [back to overview]Progression Free Survival (PFS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
NCT00517595 (6) [back to overview]Overall Survival (OS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
NCT00517595 (6) [back to overview]Overall Response
NCT00518011 (8) [back to overview]Disease Control Rate
NCT00518011 (8) [back to overview]Mean Change in Pulse Rate From Baseline
NCT00518011 (8) [back to overview]Duration of Response
NCT00518011 (8) [back to overview]Mean Change in Body Temperature From Baseline
NCT00518011 (8) [back to overview]Progression Free Survival
NCT00518011 (8) [back to overview]Mean Change in Blood Pressure From Baseline
NCT00518011 (8) [back to overview]Objective Response Rate
NCT00518011 (8) [back to overview]Overall Survival
NCT00521404 (6) [back to overview]Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
NCT00521404 (6) [back to overview]Progression-Free Survival Rate at 16 Weeks Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
NCT00521404 (6) [back to overview]Kaplan-Meier (Non-Parametric) Analysis of Progression-Free Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
NCT00521404 (6) [back to overview]Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term
NCT00521404 (6) [back to overview]Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term
NCT00521404 (6) [back to overview]Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
NCT00523640 (3) [back to overview]Objective Response Rate
NCT00523640 (3) [back to overview]Overall Survival
NCT00523640 (3) [back to overview]Progression-free Survival
NCT00530634 (1) [back to overview]Two-year Progression-free Survival From the Date of Surgery
NCT00536874 (7) [back to overview]Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy
NCT00536874 (7) [back to overview]Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy
NCT00536874 (7) [back to overview]RECIST Radiologic Response to Neoadjuvant Therapy
NCT00536874 (7) [back to overview]Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy
NCT00536874 (7) [back to overview]Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy
NCT00536874 (7) [back to overview]Overall Survival at 18 Months
NCT00536874 (7) [back to overview]Overall Survival (Follow-Up Time)
NCT00540579 (2) [back to overview]Determination of Maximum Tolerated Dose (MTD), The Dose of Study Drug(s) Which Causes <33% of Patients Treated to Experience Unacceptable Side Effects
NCT00540579 (2) [back to overview]The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0
NCT00544414 (2) [back to overview]Overall Response
NCT00544414 (2) [back to overview]Progression-free Survival
NCT00550836 (5) [back to overview]Time to Treatment Failure
NCT00550836 (5) [back to overview]Confirmed Response Rate
NCT00550836 (5) [back to overview]Frequency and Severity of Observed Adverse Effects
NCT00550836 (5) [back to overview]Overall Survival
NCT00550836 (5) [back to overview]Progression-free Survival
NCT00556049 (1) [back to overview]To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy.
NCT00557492 (7) [back to overview]Radiographic Tumor Response
NCT00557492 (7) [back to overview]Rate of Surgical Resection
NCT00557492 (7) [back to overview]Rate of Pathologic Complete Response (pCR)
NCT00557492 (7) [back to overview]Rate of Margin Negative Surgical Resection (R0 Resection Rate)
NCT00557492 (7) [back to overview]Progression-free Survival (PFS)
NCT00557492 (7) [back to overview]Ca 19-9 Level (in Serum) - Biomarker Response
NCT00557492 (7) [back to overview]Overall Survival (OS)
NCT00560573 (16) [back to overview]Maximum Tolerated Dose (MTD)
NCT00560573 (16) [back to overview]Serum Total Circulating Insulin-like Growth Factor (IGF-1) Levels
NCT00560573 (16) [back to overview]Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab
NCT00560573 (16) [back to overview]Recommended Phase 2 Dose (RP2D)
NCT00560573 (16) [back to overview]Progression-Free Survival (PFS)
NCT00560573 (16) [back to overview]Percentage of Participants With Objective Response or Prolonged Stabilization
NCT00560573 (16) [back to overview]Number of Participants With Dose-limiting Toxicities (DLT)
NCT00560573 (16) [back to overview]Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab
NCT00560573 (16) [back to overview]Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab
NCT00560573 (16) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Gemcitabine
NCT00560573 (16) [back to overview]Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Gemcitabine
NCT00560573 (16) [back to overview]Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Pemetrexed
NCT00560573 (16) [back to overview]Concentration at the End of Infusion (Cinf) for Figitumumab
NCT00560573 (16) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Cisplatin
NCT00560573 (16) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Pemetrexed
NCT00560573 (16) [back to overview]Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Cisplatin
NCT00564733 (1) [back to overview]Overall Response Rate (Patients That Achieve a CR or PR)
NCT00565851 (9) [back to overview]To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer
NCT00565851 (9) [back to overview]To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer
NCT00565851 (9) [back to overview]Patient Reported Quality of Life (Chemotherapy Analysis)
NCT00565851 (9) [back to overview]Summary of Adverse Events (CTCAE Version 4.0)
NCT00565851 (9) [back to overview]Patient Reported Physical Functioning (Surgery Analysis)
NCT00565851 (9) [back to overview]Patient Reported Physical Function (Chemotherapy Analysis)
NCT00565851 (9) [back to overview]Patient Reported Quality of Life (Surgery Analysis)
NCT00565851 (9) [back to overview]Progression Free Survival (Surgery Analysis)
NCT00565851 (9) [back to overview]Progression-free Survival (Chemotherapy Analysis)
NCT00570713 (3) [back to overview]Best Overall Response Rate
NCT00570713 (3) [back to overview]Progression-free Survival
NCT00570713 (3) [back to overview]Overall Survival (OS)
NCT00574275 (4) [back to overview]Progression Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors [RECIST] Criteria
NCT00574275 (4) [back to overview]Number of Participants With Anti-drug Antibodies
NCT00574275 (4) [back to overview]Overall Survival (OS)
NCT00574275 (4) [back to overview]Safety-Number of Participants With Adverse Events (AE)
NCT00574496 (3) [back to overview]Disease Relapse or Progression as Measured by CT Scan or PET
NCT00574496 (3) [back to overview]Overall Survival
NCT00574496 (3) [back to overview]Progression-free Survival at 1 Year
NCT00577889 (4) [back to overview]Overall Survival Time
NCT00577889 (4) [back to overview]Six Month Survival Rate
NCT00577889 (4) [back to overview]Time to Disease Progression
NCT00577889 (4) [back to overview]Confirmed Response Rate
NCT00583622 (1) [back to overview]Participant Response
NCT00585689 (1) [back to overview]Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment
NCT00588666 (2) [back to overview]Evaluate the Time to Disease Progression
NCT00588666 (2) [back to overview]The Response Rate of Combination Therapy With Bevacizumab, Gemcitabine, and Carboplatin in Patients With Advanced/Metastatic TCC.
NCT00589667 (2) [back to overview]Overall Objective Response
NCT00589667 (2) [back to overview]Median Overall Survival
NCT00593866 (2) [back to overview]The Maximum Tolerated Radiation Dose
NCT00593866 (2) [back to overview]The Percentage of Participants Free From Local Progression at 2 Years
NCT00599755 (6) [back to overview]Change in FGD-PET Uptake From Baseline to Week 6
NCT00599755 (6) [back to overview]Repeatability of FDG SUVmean at Baseline
NCT00599755 (6) [back to overview]Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy At a Threshold of a 30% Decrease in SUVmean
NCT00599755 (6) [back to overview]Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean
NCT00599755 (6) [back to overview]Change in FDG-PET Uptake From Week 3 to Week 6
NCT00599755 (6) [back to overview]Change in FDG-PET Uptake From Baseline to Week 3
NCT00601627 (5) [back to overview]One Year Survival Rate
NCT00601627 (5) [back to overview]Overall Survival
NCT00601627 (5) [back to overview]Progression Free Survival (PFS)
NCT00601627 (5) [back to overview]Time to Treatment Failure
NCT00601627 (5) [back to overview]Confirmed Response Rate
NCT00603915 (2) [back to overview]Number of Participants With the Responses Outlined
NCT00603915 (2) [back to overview]Progression Free Survival.
NCT00609336 (7) [back to overview]Surgical Completion Rate and Complication Rate
NCT00609336 (7) [back to overview]Median Overall Survival of Patients With Adenocarcinoma of the Pancreas
NCT00609336 (7) [back to overview]Median Recurrence Free Survival Following Pancreaticoduodenectomy
NCT00609336 (7) [back to overview]Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy
NCT00609336 (7) [back to overview]Percent of Patients Surviving at 5 Years
NCT00609336 (7) [back to overview]Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
NCT00609336 (7) [back to overview]Percent of Patients Surviving at Annual Intervals
NCT00610740 (3) [back to overview]Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)
NCT00610740 (3) [back to overview]Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)
NCT00610740 (3) [back to overview]Number of Patients With Measurable Peripheral Vein Concentration of dFdC
NCT00617708 (5) [back to overview]Progression-Free Survival
NCT00617708 (5) [back to overview]Maximum Tolerated Dose Determination
NCT00617708 (5) [back to overview]Overall Survival
NCT00617708 (5) [back to overview]Toxicity
NCT00617708 (5) [back to overview]Response
NCT00618826 (2) [back to overview]Overall Response Rate
NCT00618826 (2) [back to overview]Progression-free Survival
NCT00623233 (4) [back to overview]Number of Participants With Adverse Events (AEs); Pharmacology Toxicities
NCT00623233 (4) [back to overview]Progression Free Survival (PFS) Time
NCT00623233 (4) [back to overview]Overall Tumor Response Rate (ORR)
NCT00623233 (4) [back to overview]1-Year Overall Survival (OS) Rate
NCT00625586 (6) [back to overview]Number of Patients Alive at 8 Months
NCT00625586 (6) [back to overview]Partial Response and Complete Response Rates
NCT00625586 (6) [back to overview]Participants With Adverse Events
NCT00625586 (6) [back to overview]Cmax
NCT00625586 (6) [back to overview]Median Overall Survival
NCT00625586 (6) [back to overview]Median Progression-free Survival
NCT00630409 (2) [back to overview]Time to Progression
NCT00630409 (2) [back to overview]Response Rate
NCT00632827 (4) [back to overview]Complete Response Rate
NCT00632827 (4) [back to overview]Median Time to Response
NCT00632827 (4) [back to overview]Progression Free Survival
NCT00632827 (4) [back to overview]Overall Survival Rate
NCT00637247 (4) [back to overview]Objective Response Rates of the Two Treatment Arms
NCT00637247 (4) [back to overview]Overall Survival for the Intent to Treat Population
NCT00637247 (4) [back to overview]Progression Free Survival
NCT00637247 (4) [back to overview]To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events
NCT00645593 (4) [back to overview]The Number of Grade 3 to 5 Adverse Events Experienced by Arm 1 and Arm 2
NCT00645593 (4) [back to overview]Median Progression-free Survival Time in Months
NCT00645593 (4) [back to overview]Percentage of Participants That Respond to Treatment in Arm 1 and Arm 2
NCT00645593 (4) [back to overview]Median Overall Survival in Months
NCT00645710 (4) [back to overview]Overall Survival
NCT00645710 (4) [back to overview]Number of Participants With at Least One Dose Limiting Toxicity
NCT00645710 (4) [back to overview]Progression-free Survival
NCT00645710 (4) [back to overview]Recommended Phase II Dose
NCT00648648 (7) [back to overview]Percentage of Total pCDC2 in Skin Cells at Baseline and 24 Hours After MK-1775 Dosing
NCT00648648 (7) [back to overview]Mean Urine Excretion of MK-1775 24 Hours After the Day 1 Monotherapy Dose
NCT00648648 (7) [back to overview]Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
NCT00648648 (7) [back to overview]Plasma Concentration of MK-1775 at 8 Hours After Administration (C8hr) of Single or Multiple Oral Doses
NCT00648648 (7) [back to overview]Best Overall Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
NCT00648648 (7) [back to overview]Percentage of Total Cyclin-dependent Kinase (CDC2)-Positive Cells That Were Phosphorylated (pCDC2) in Skin Cells at Baseline and 8 Hours After MK-1775 Dosing
NCT00648648 (7) [back to overview]Percentage of Total pCDC2 in Skin Cells at Baseline and 48 Hours After MK-1775 Dosing
NCT00652366 (11) [back to overview]Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST
NCT00652366 (11) [back to overview]Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In
NCT00652366 (11) [back to overview]Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In
NCT00652366 (11) [back to overview]Percentage of Participants Who Died Assessed From Point of Randomization
NCT00652366 (11) [back to overview]OS Assessed From Start of 4-Week Run-In
NCT00652366 (11) [back to overview]Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST
NCT00652366 (11) [back to overview]Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization
NCT00652366 (11) [back to overview]PFS Assessed From Point of Randomization
NCT00652366 (11) [back to overview]Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST
NCT00652366 (11) [back to overview]PFS Assessed From the Start of 4-Week Run-In
NCT00652366 (11) [back to overview]OS Assessed From Point of Randomization
NCT00655850 (4) [back to overview]Number of Participants With Adverse Events
NCT00655850 (4) [back to overview]Objective Response Rate
NCT00655850 (4) [back to overview]Overall Survival (OS)
NCT00655850 (4) [back to overview]Progression-Free Survival (PFS)
NCT00656084 (4) [back to overview]Progression-free Survival Rate at 1 Year.
NCT00656084 (4) [back to overview]Overall Survival (OS) Rate at 1 Year
NCT00656084 (4) [back to overview]Objective Response Rate (CR + PR)
NCT00656084 (4) [back to overview]Duration of Response
NCT00660699 (8) [back to overview]Toxicities Associated With Treatment (Grade 1-2)
NCT00660699 (8) [back to overview]Overall Survival (OS) - Median
NCT00660699 (8) [back to overview]Overall Survival (OS)
NCT00660699 (8) [back to overview]Overall Survival (OS)
NCT00660699 (8) [back to overview]Disease Free Survival (DFS) - Median
NCT00660699 (8) [back to overview]Incidence of Disease Recurrence
NCT00660699 (8) [back to overview]Incidence of Severe Toxicities
NCT00660699 (8) [back to overview]Toxicities Associated With Treatment (Grade 3-4)
NCT00661830 (4) [back to overview]Overall Survival
NCT00661830 (4) [back to overview]Progression-free Survival (PFS)
NCT00661830 (4) [back to overview]Time to Objective Response
NCT00661830 (4) [back to overview]Best Overall Response
NCT00662129 (7) [back to overview]Time to Treatment Failure
NCT00662129 (7) [back to overview]Quality of Life, as Measure by the Mean Change in FACT-B TOI Score at Cycle 8
NCT00662129 (7) [back to overview]PFS Time
NCT00662129 (7) [back to overview]Overall Survival Time
NCT00662129 (7) [back to overview]Confirmed Response (Complete or Partial Response) Rate
NCT00662129 (7) [back to overview]6-month Progression-free Survival (PFS) Rate
NCT00662129 (7) [back to overview]Duration of Response
NCT00674206 (2) [back to overview]Overall Survival From Time of Study Entry
NCT00674206 (2) [back to overview]Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.
NCT00679029 (4) [back to overview]Overall Survival as Assessed by the Kaplan and Meier Method
NCT00679029 (4) [back to overview]Percentage of Participants With Study Drug-associated Adverse Events Leading to Dose Holds or Reductions
NCT00679029 (4) [back to overview]Disease-free Survival
NCT00679029 (4) [back to overview]Count of Participants With Related Serious Adverse Events (SAEs) by NCI Common Toxicity Criteria v3.0
NCT00685763 (1) [back to overview]Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start)
NCT00696696 (3) [back to overview]Median Overall Survival (mOS)
NCT00696696 (3) [back to overview]Objective Response Rate
NCT00696696 (3) [back to overview]4-month Progression Free Survival (PFS) Rate
NCT00701558 (3) [back to overview]Overall Response Rate (ORR)
NCT00701558 (3) [back to overview]Overall Survival
NCT00701558 (3) [back to overview]Time to Disease Progression
NCT00705874 (1) [back to overview]Maximum Tolerated Dose (MTD)
NCT00709826 (2) [back to overview]Overall Survival
NCT00709826 (2) [back to overview]Progression Free Survival
NCT00733746 (5) [back to overview]Overall Survival at 2 Years
NCT00733746 (5) [back to overview]Response Rate
NCT00733746 (5) [back to overview]Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI's Common Toxicity Criteria for Adverse Events
NCT00733746 (5) [back to overview]Relapse/Progression-free Survival
NCT00733746 (5) [back to overview]Resection Rate
NCT00735904 (4) [back to overview]Overall Survival (OS)
NCT00735904 (4) [back to overview]Percentage of Participants With Objective Response (OR)
NCT00735904 (4) [back to overview]Progression Free Survival (PFS)
NCT00735904 (4) [back to overview]Duration of Response (DR)
NCT00753675 (5) [back to overview]Duration of Response (DOR)
NCT00753675 (5) [back to overview]Overall Survival
NCT00753675 (5) [back to overview]Disease Control Rate (CR+PR+SD)
NCT00753675 (5) [back to overview]Progression Free Survival
NCT00753675 (5) [back to overview]Objective Tumor Response Rate (CR+PR),
NCT00753714 (5) [back to overview]Progression Free Survival
NCT00753714 (5) [back to overview]Overall Survival
NCT00753714 (5) [back to overview]Overall Objective Response
NCT00753714 (5) [back to overview]Duration of Response
NCT00753714 (5) [back to overview]The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine
NCT00761345 (1) [back to overview]To Determine the Dose Limiting Toxicities
NCT00769483 (5) [back to overview]Progression Free Survival
NCT00769483 (5) [back to overview]Treatment Toxicity
NCT00769483 (5) [back to overview]MK-0646 Maximum Tolerable Dose
NCT00769483 (5) [back to overview]Overall Response Rate
NCT00769483 (5) [back to overview]Overall Survival
NCT00777491 (6) [back to overview]Percentage of Patients With Grade 3 or Higher Genitourinary, Gastrointestinal, or Hematologic Adverse Events
NCT00777491 (6) [back to overview]Percentage of Patients Who Completed Treatment Per Protocol
NCT00777491 (6) [back to overview]Change in American Urological Association Symptom Index (AUASI) Score at 3 Years
NCT00777491 (6) [back to overview]Number of Participants With Progression or Removal of Bladder Five Years After Therapy
NCT00777491 (6) [back to overview]Number of Patients Experiencing Complete Response of the Primary Tumor After Induction Therapy
NCT00777491 (6) [back to overview]Percentage of Patients Without Distant Metastases by Three Years
NCT00779584 (7) [back to overview]Number of Participants Who Discontinued Study Treatment Due to an AE
NCT00779584 (7) [back to overview]Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) During Cycle 0 and Cycle 1 Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v 3.0)
NCT00779584 (7) [back to overview]Number of Participants Who Experienced an Adverse Event (AE)
NCT00779584 (7) [back to overview]MK-8776 Area Under the Curve of the Plasma Concentration Versus Time From Time Zero to the Time of the Last Analytically Quantifiable Concentration (AUC0-last)
NCT00779584 (7) [back to overview]Time of MK-8776 Cmax (Tmax)
NCT00779584 (7) [back to overview]MK-8776 Terminal Phase Half-Life (t1/2)
NCT00779584 (7) [back to overview]MK-8776 Maximum Plasma Concentration (Cmax)
NCT00789958 (7) [back to overview]2-year Stratum-specific Local Relapse Rate
NCT00789958 (7) [back to overview]Stratum-specific (R0 and R1) 2-year Overall Survival
NCT00789958 (7) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00789958 (7) [back to overview]2-year Disease-free Survival in All Patients
NCT00789958 (7) [back to overview]2-year Overall Local Relapse Rate
NCT00789958 (7) [back to overview]2-year Overall Survival for All Patients
NCT00789958 (7) [back to overview]2-year Stratum-specific Disease-free Survival
NCT00792701 (5) [back to overview]Two-year Disease-free Survival
NCT00792701 (5) [back to overview]Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0
NCT00792701 (5) [back to overview]Relationship Between RNA and Protein Expression of RRM1 and ERCC1
NCT00792701 (5) [back to overview]Relationship Between RRM1 and ERCC1 Expression in the Formalin-fixed and Paraffin-embedded Tumor Specimens.
NCT00792701 (5) [back to overview]Feasibility of Pharmacogenomics-based Treatment Assignment in the Cooperative Group Setting
NCT00810719 (3) [back to overview]Progression Free Survival
NCT00810719 (3) [back to overview]Overall Survival
NCT00810719 (3) [back to overview]Response Rate
NCT00820898 (2) [back to overview]Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
NCT00820898 (2) [back to overview]Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
NCT00821327 (3) [back to overview]Progression-free Survival
NCT00821327 (3) [back to overview]Ovarall Survival (OS)
NCT00821327 (3) [back to overview]Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib.
NCT00828841 (3) [back to overview]Overall Survival by Treatment Arm
NCT00828841 (3) [back to overview]Overall Survival by Histology
NCT00828841 (3) [back to overview]1-year Survival by Treatment Arm
NCT00832637 (5) [back to overview]Toxicity
NCT00832637 (5) [back to overview]Overall Response Rate
NCT00832637 (5) [back to overview]Tumor Control Rate
NCT00832637 (5) [back to overview]Time to Tumor Progression (TTP)
NCT00832637 (5) [back to overview]Median Survival Time (MST)
NCT00837031 (3) [back to overview]Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
NCT00837031 (3) [back to overview]Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
NCT00837031 (3) [back to overview]Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment
NCT00839332 (13) [back to overview]Number of Deaths During the Phase 1 Post-study Period
NCT00839332 (13) [back to overview]Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618
NCT00839332 (13) [back to overview]Phase 1: Electrocardiogram QTc Prolongation
NCT00839332 (13) [back to overview]Phase 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618
NCT00839332 (13) [back to overview]Phase 2: Maximum Plasma Concentration (Cmax) of Gemcitabine, dFdU, and LY2603618
NCT00839332 (13) [back to overview]Phase 1: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618
NCT00839332 (13) [back to overview]Phase 1: Determine the Recommended Phase 2 Dose for LY2603618 When Administered After Gemcitabine
NCT00839332 (13) [back to overview]Phase 2: Clinical Benefit Rate
NCT00839332 (13) [back to overview]Phase 2: Duration of Response
NCT00839332 (13) [back to overview]Phase 2: Overall Response Rate
NCT00839332 (13) [back to overview]Phase 2: Overall Survival (OS)
NCT00839332 (13) [back to overview]Phase 2: Progression-free Survival (PFS)
NCT00839332 (13) [back to overview]Phase 2: Electrocardiogram QTc Prolongation
NCT00842712 (6) [back to overview]Randomized Part: Progression Free Survival (PFS) Time - Independent Read
NCT00842712 (6) [back to overview]Randomized Part: Progression Free Survival (PFS) Time - Investigator Read
NCT00842712 (6) [back to overview]Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)
NCT00842712 (6) [back to overview]Randomized Part: Time to Treatment Failure
NCT00842712 (6) [back to overview]Randomized Part: Overall Survival (OS) Time
NCT00842712 (6) [back to overview]Randomized Part: Best Overall Response (BOR) Rate
NCT00844649 (7) [back to overview]Number of Participants With Dose Reductions
NCT00844649 (7) [back to overview]Number of Participants With Dose Interruptions
NCT00844649 (7) [back to overview]Progression-free Survival (PFS) by Independent Radiological Review (IRR)
NCT00844649 (7) [back to overview]Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)
NCT00844649 (7) [back to overview]Overall Survival (OS)
NCT00844649 (7) [back to overview]Number of Participants With Dose Delays/Doses Not Given
NCT00844649 (7) [back to overview]Participants With Treatment Emergent Adverse Events (AE)
NCT00846027 (4) [back to overview]Overall Survival
NCT00846027 (4) [back to overview]Progression-free Survival
NCT00846027 (4) [back to overview]Percentage of Participants With an Objective Response
NCT00846027 (4) [back to overview]Duration of the Objective Response
NCT00847015 (3) [back to overview]The Pathologic Response Rate (
NCT00847015 (3) [back to overview]The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy.
NCT00847015 (3) [back to overview]The Pathologic Complete Response Rate (
NCT00859339 (2) [back to overview]Safety Profile
NCT00859339 (2) [back to overview]Pathological Complete Response (pCR) Rate.
NCT00859469 (3) [back to overview]Best Response
NCT00859469 (3) [back to overview]Progression-free Survival
NCT00859469 (3) [back to overview]Overall Survival
NCT00860015 (1) [back to overview]Tumor Best Response Rate
NCT00863369 (3) [back to overview]Number of Subject With Complete Response
NCT00863369 (3) [back to overview]Number of Participants With at Least One Dose Limiting Toxicity (DLT)
NCT00863369 (3) [back to overview]Recommended Phase II Dose
NCT00870870 (6) [back to overview]Overall Survival (OS)
NCT00870870 (6) [back to overview]Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
NCT00870870 (6) [back to overview]Progression-Free Survival (PFS)
NCT00870870 (6) [back to overview]Time To Progression (TTP)
NCT00870870 (6) [back to overview]Duration of Response
NCT00870870 (6) [back to overview]Number of Participants With Adverse Events (AEs) or Deaths
NCT00883779 (16) [back to overview]Percentage of Participants Alive at the End of Study-Overall and Among Different Subgroups
NCT00883779 (16) [back to overview]Time to Deterioration in TOI Using FACT-L Version 4.0
NCT00883779 (16) [back to overview]Median Overall Survival (OS) Time-Overall and Among Different Subgroups
NCT00883779 (16) [back to overview]Duration of Response
NCT00883779 (16) [back to overview]Median Follow-up Time During the Study
NCT00883779 (16) [back to overview]Median Progression Free Survival (PFS) Time
NCT00883779 (16) [back to overview]Time to Progression
NCT00883779 (16) [back to overview]Time to Deterioration in QOL Using FACT-L Version 4.0
NCT00883779 (16) [back to overview]Non-Progression Rate: Percentage of Participants With a Confirmed Best Overall Response of Either Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for At Least 16 Weeks
NCT00883779 (16) [back to overview]Objective Response Rate: Percentage of Participants With a Confirmed Best Overall Response of CR or PR
NCT00883779 (16) [back to overview]Percentage of Participants Alive and Free From Disease Progression
NCT00883779 (16) [back to overview]Percentage of Participants With Deterioration in Quality of Life (QOL) Using FACT-L Version 4.0
NCT00883779 (16) [back to overview]Percentage of Participants With Deterioration in Trial Outcome Index (TOI) Using FACT-L Version 4.0
NCT00883779 (16) [back to overview]Percentage of Participants With Symptomatic Progression Assessed Using the Lung Cancer Subscale (LCS)
NCT00883779 (16) [back to overview]Time to Symptomatic Progression
NCT00883779 (16) [back to overview]Median PFS Time Based on Different Subgroups
NCT00887809 (1) [back to overview]Overall Objective Response
NCT00894504 (4) [back to overview]Progression-free Survival (PFS)
NCT00894504 (4) [back to overview]Number of Treatment-related Toxicities Occurring in ≥10% of Patients as a Measure of Tolerability and Toxicity
NCT00894504 (4) [back to overview]Objective Response Rate and Clinical Benefit Rate
NCT00894504 (4) [back to overview]Correlation of Biomarker Expressions of EGFR, K-ras, p53, PTEN Expression, and PI3K in Triple-negative Breast Cancer With Response to Treatment With the Combination of Gemcitabine, Carboplatin, and Panitumumab
NCT00910000 (3) [back to overview]Vorinostat Maximum Tolerated Dose (MTD) [Phase Ib]
NCT00910000 (3) [back to overview]Response
NCT00910000 (3) [back to overview]Dose Limiting Toxicity (DLT) [Phase Ib]
NCT00919061 (2) [back to overview]Median PFS
NCT00919061 (2) [back to overview]Progression-Free Survival
NCT00924209 (1) [back to overview]Number of Participants With Serious and Non-Serious Adverse Events
NCT00928642 (5) [back to overview]Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment.
NCT00928642 (5) [back to overview]To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial)
NCT00928642 (5) [back to overview]To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria
NCT00928642 (5) [back to overview]To Determine the Distribution of the Overall Survival
NCT00928642 (5) [back to overview]The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma.
NCT00940875 (6) [back to overview]Percentage of Participants With Non-Progression at Weeks 8 and 16
NCT00940875 (6) [back to overview]PFS
NCT00940875 (6) [back to overview]Percentage of Participants With Disease Progression or Death
NCT00940875 (6) [back to overview]Percentage of Participants Who Died
NCT00940875 (6) [back to overview]Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
NCT00940875 (6) [back to overview]Overall Survival (OS)
NCT00942331 (4) [back to overview]Overall Survival (OS)
NCT00942331 (4) [back to overview]Number of Patients Experiencing Grade 3+ Toxicity
NCT00942331 (4) [back to overview]Objective Response
NCT00942331 (4) [back to overview]Progression-free Survival (PFS)
NCT00948935 (2) [back to overview]Progression Free Survival Rate at Five Months
NCT00948935 (2) [back to overview]Response Rate From Combination Chemotherapy
NCT00954512 (2) [back to overview]Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response
NCT00954512 (2) [back to overview]Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)
NCT00955721 (1) [back to overview]Phase I: Recommended Phase II Dose (RPTD) of the Combination of Sorafenib and GEMOX in Patients With Advanced Biliary Tract Cancer (BTC).
NCT00970684 (3) [back to overview]Median Time to Progression
NCT00970684 (3) [back to overview]Progression Free Survival(PFS)
NCT00970684 (3) [back to overview]Best Response
NCT00981058 (9) [back to overview]Progression-Free Survival (PFS)
NCT00981058 (9) [back to overview]Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])
NCT00981058 (9) [back to overview]Time to Treatment Failure (TTF)
NCT00981058 (9) [back to overview]Overall Survival Time (OS)
NCT00981058 (9) [back to overview]Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)
NCT00981058 (9) [back to overview]Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)
NCT00981058 (9) [back to overview]Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
NCT00981058 (9) [back to overview]Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
NCT00981058 (9) [back to overview]Number of Participants With a Serum Anti-Necitumumab Antibody Assessment
NCT00983541 (1) [back to overview]Number of Participants Experiencing Toxicity Treated With Gemcitabine Every Two Weeks & 5-FU Given Concurrently With External Beam Radiation Therapy , Followed by Brachytherapy or SBRT Boost.
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance (CL)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Terminal Half-life (t1/2z)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State (Vss)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance (CL)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Terminal Half-life (t1/2z)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC)
NCT01001221 (41) [back to overview]Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)
NCT01001221 (41) [back to overview]Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State (Vss)
NCT01001221 (41) [back to overview]Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)
NCT01001221 (41) [back to overview]Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance (CL)
NCT01001221 (41) [back to overview]Pharmacokinetic of Cabazitaxel on Cycle 1: Time to Maximum Concentration (Tmax)
NCT01001221 (41) [back to overview]Pharmacokinetic of Cabazitaxel on Cycle 1: Terminal Half-life (t1/2z)
NCT01001221 (41) [back to overview]Pharmacokinetic of Cabazitaxel on Cycle 1: Maximum Plasma Concentration Observed (Cmax)
NCT01001221 (41) [back to overview]Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)
NCT01001221 (41) [back to overview]Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve (AUC)
NCT01001221 (41) [back to overview]Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax)
NCT01001221 (41) [back to overview]Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Terminal Half-life (t1/2z)
NCT01001221 (41) [back to overview]Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax)
NCT01001221 (41) [back to overview]Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)
NCT01001221 (41) [back to overview]Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC)
NCT01001221 (41) [back to overview]Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax)
NCT01001221 (41) [back to overview]Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Terminal Half-life (t1/2z)
NCT01001221 (41) [back to overview]Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax)
NCT01001221 (41) [back to overview]Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)
NCT01001221 (41) [back to overview]Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC)
NCT01001221 (41) [back to overview]Participants With Dose Limiting Toxicities During Dose Escalation
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1: Ratio Day 1/Day 8 for AUClast and AUC
NCT01001221 (41) [back to overview]Participants With Adverse Events
NCT01001221 (41) [back to overview]Participant Best Response as Per the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)
NCT01001221 (41) [back to overview]Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State (Vss)
NCT01005680 (9) [back to overview]Risk/Benefit Ratio
NCT01005680 (9) [back to overview]Survival Without Toxicity (SWT)
NCT01005680 (9) [back to overview]Overall Survival (OS)
NCT01005680 (9) [back to overview]Tumor Response Rate
NCT01005680 (9) [back to overview]Time to Treatment Failure (TtTF)
NCT01005680 (9) [back to overview]Time to Progressive Disease (TtPD)
NCT01005680 (9) [back to overview]Progression Free Survival (PFS)
NCT01005680 (9) [back to overview]Duration of Response (DoR)
NCT01005680 (9) [back to overview]Disease Control Rate (DCR)
NCT01007552 (6) [back to overview]Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers.
NCT01007552 (6) [back to overview]The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers.
NCT01007552 (6) [back to overview]Assess the Toxicity of the Regimen.
NCT01007552 (6) [back to overview]Estimate the Proportion of Patients With Clinical Response
NCT01007552 (6) [back to overview]Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43
NCT01007552 (6) [back to overview]Assess Overall Survival (OS)
NCT01012297 (4) [back to overview]Progression-free Survival
NCT01012297 (4) [back to overview]Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0
NCT01012297 (4) [back to overview]Overall Survival
NCT01012297 (4) [back to overview]Objective Response Rate as Measured by RECIST 1.1 Criteria
NCT01016483 (26) [back to overview]Phase II: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation
NCT01016483 (26) [back to overview]Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 2
NCT01016483 (26) [back to overview]Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 1
NCT01016483 (26) [back to overview]Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
NCT01016483 (26) [back to overview]Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
NCT01016483 (26) [back to overview]Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
NCT01016483 (26) [back to overview]Safety Run-In Part: Area Under Curve (AUC:0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) Regimen 2
NCT01016483 (26) [back to overview]Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 1
NCT01016483 (26) [back to overview]Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 2
NCT01016483 (26) [back to overview]Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) for Regimen 1
NCT01016483 (26) [back to overview]Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2
NCT01016483 (26) [back to overview]Safety Run-In Part: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation
NCT01016483 (26) [back to overview]Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 1
NCT01016483 (26) [back to overview]Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 2
NCT01016483 (26) [back to overview]Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
NCT01016483 (26) [back to overview]Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 2
NCT01016483 (26) [back to overview]Phase II: Time to Progression (TTP)
NCT01016483 (26) [back to overview]Phase II: Overall Survival (OS) Time
NCT01016483 (26) [back to overview]Phase II: Percentage of Subjects With Clinical Benefit
NCT01016483 (26) [back to overview]Phase II: Progression-Free Survival (PFS) Time
NCT01016483 (26) [back to overview]Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 1
NCT01016483 (26) [back to overview]Safety Run-In Part: Number of Subjects With Dose Limiting Toxicities (DLTs)
NCT01016483 (26) [back to overview]Safety Run-In Part: Area Under Curve (AUC: 0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1
NCT01016483 (26) [back to overview]Phase II: Percentage of Subjects With Best Overall Response (BOR)
NCT01016483 (26) [back to overview]Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 1
NCT01016483 (26) [back to overview]Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 2
NCT01020006 (1) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs)
NCT01041781 (7) [back to overview]Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1)
NCT01041781 (7) [back to overview]Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Median Quartile (Q2)
NCT01041781 (7) [back to overview]Progression-free Survival
NCT01041781 (7) [back to overview]Response Rate
NCT01041781 (7) [back to overview]Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0
NCT01041781 (7) [back to overview]Overall Survival
NCT01041781 (7) [back to overview]Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Third Quartile (Q3)
NCT01055496 (17) [back to overview]Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts
NCT01055496 (17) [back to overview]Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2
NCT01055496 (17) [back to overview]Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1
NCT01055496 (17) [back to overview]Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts
NCT01055496 (17) [back to overview]Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy
NCT01055496 (17) [back to overview]Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy
NCT01055496 (17) [back to overview]Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts
NCT01055496 (17) [back to overview]Mean Inotuzumab Ozogamicin Serum Concentrations
NCT01055496 (17) [back to overview]Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts
NCT01055496 (17) [back to overview]Mean Inotuzumab Ozogamicin Serum Concentrations
NCT01055496 (17) [back to overview]Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts.
NCT01055496 (17) [back to overview]Percentage of Participants With a Treatment Emergent AE
NCT01055496 (17) [back to overview]Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts
NCT01064622 (5) [back to overview]Objective Response Rate
NCT01064622 (5) [back to overview]Overall Survival
NCT01064622 (5) [back to overview]Incidence of Adverse Events
NCT01064622 (5) [back to overview]Progression-free Survival
NCT01064622 (5) [back to overview]Activity (Overall Response Rate) in Crossover Patients
NCT01077713 (10) [back to overview]Percentage of Participants With Disease Control
NCT01077713 (10) [back to overview]Percentage of Participants With Disease Progression or Death
NCT01077713 (10) [back to overview]Duration of Response (DoR)
NCT01077713 (10) [back to overview]Overall Survival (OS)
NCT01077713 (10) [back to overview]Percentage of Participants Alive and Without Progressive Disease at Month 6
NCT01077713 (10) [back to overview]Percentage of Participants Alive at 12 Months After Randomization
NCT01077713 (10) [back to overview]Percentage of Participants Who Died
NCT01077713 (10) [back to overview]Progression Free Survival (PFS)
NCT01077713 (10) [back to overview]Percentage of Participants by Best Overall Response
NCT01077713 (10) [back to overview]Percentage of Participants With an Objective Response
NCT01080248 (4) [back to overview]Response Rate by RECIST Criteria.
NCT01080248 (4) [back to overview]Progression-free Survival (PFS)
NCT01080248 (4) [back to overview]Median Survival
NCT01080248 (4) [back to overview]Overall Survival
NCT01088815 (5) [back to overview]Progression Free Survival With the Combination of GDC-0449 With Gemcitabine and Nab-paclitaxel.
NCT01088815 (5) [back to overview]Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Tumor Response
NCT01088815 (5) [back to overview]Safety of Combination Therapy in Patients With Metastatic Adenocarcinoma of the Pancreas as Assessed by Number of Grade 3 or 4 Adverse Events
NCT01088815 (5) [back to overview]Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Changes in Pancreatic Cancer Stem Cell
NCT01088815 (5) [back to overview]Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Overall Survival
NCT01121393 (18) [back to overview]Tumour Shrinkage
NCT01121393 (18) [back to overview]Change From Baseline in Body Weight
NCT01121393 (18) [back to overview]Time to Objective Response (OR)
NCT01121393 (18) [back to overview]Health Related Quality of Life (HRQOL): Time of Deterioration in Dyspnoea
NCT01121393 (18) [back to overview]Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing
NCT01121393 (18) [back to overview]Duration of Objective Response
NCT01121393 (18) [back to overview]Duration of Disease Control
NCT01121393 (18) [back to overview]Disease Control (DC)
NCT01121393 (18) [back to overview]Health Related Quality of Life (HRQOL): Time of Deterioration in Pain
NCT01121393 (18) [back to overview]Pharmacokinetics of Afatinib at Day 22
NCT01121393 (18) [back to overview]Overall Survival (OS)
NCT01121393 (18) [back to overview]Objective Response (OR)
NCT01121393 (18) [back to overview]Pharmacokinetics of Afatinib at Day 29
NCT01121393 (18) [back to overview]Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events
NCT01121393 (18) [back to overview]Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
NCT01121393 (18) [back to overview]Pharmacokinetics of Afatinib at Day 43
NCT01121393 (18) [back to overview]Progression-free Survival
NCT01121393 (18) [back to overview]Changes in Safety Laboratory Parameters
NCT01121406 (26) [back to overview]Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria
NCT01121406 (26) [back to overview]CL; Total Clearance of BI 6727 BS in Plasma After Intravenous Administration
NCT01121406 (26) [back to overview]Cmax; Maximum Measured Concentration of BI 6727 BS in Plasma
NCT01121406 (26) [back to overview]Cmax; Maximum Measured Concentration of CD 10899 BS in Plasma
NCT01121406 (26) [back to overview]Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
NCT01121406 (26) [back to overview]MRT; Mean Residence Time of BI 6727 BS in the Body
NCT01121406 (26) [back to overview]Overall Survival (OS)
NCT01121406 (26) [back to overview]Progression Free Survival (PFS)
NCT01121406 (26) [back to overview]t1/2; Terminal Half-life of BI 6727 BS in Plasma
NCT01121406 (26) [back to overview]t1/2; Terminal Half-life of CD 10899 BS in Plasma
NCT01121406 (26) [back to overview]Time to Deterioration in Abdominal Bloating/ Quality of Life (QOL)
NCT01121406 (26) [back to overview]Time to Deterioration in Global Health Status/Quality of Life (QOL)
NCT01121406 (26) [back to overview]Time to Deterioration in Pain/ Quality of Life (QOL)
NCT01121406 (26) [back to overview]Time to Deterioration in the Three Most Troublesome Disease Specific Symptoms/ Quality of Life (QOL)
NCT01121406 (26) [back to overview]Tmax; Time From Dosing to Maximum Measured Concentration of BI 6727 BS in Plasma
NCT01121406 (26) [back to overview]Tmax; Time From Dosing to Maximum Measured Concentration of CD 10899 BS in Plasma
NCT01121406 (26) [back to overview]Vss;Apparent Volume of Distribution at Steady State Following Intravenous Administration for BI 6727 BS
NCT01121406 (26) [back to overview]Best Overall Response
NCT01121406 (26) [back to overview]Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria
NCT01121406 (26) [back to overview]Clinically Relevant Changes in Laboratory and ECG Data
NCT01121406 (26) [back to overview]Incidence and Intensity of Adverse Events According to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
NCT01121406 (26) [back to overview]Time to Deterioration in Fatigue/Quality of Life (QOL)
NCT01121406 (26) [back to overview]AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for BI 6727 BS
NCT01121406 (26) [back to overview]AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for CD 10899 BS
NCT01121406 (26) [back to overview]AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for BI 6727 BS
NCT01121406 (26) [back to overview]AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for CD 10899 BS
NCT01124786 (1) [back to overview]Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression
NCT01126749 (4) [back to overview]Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
NCT01126749 (4) [back to overview]Phase 2: Percentage of Participants With Overall Response
NCT01126749 (4) [back to overview]Phase 2: Overall Survival (OS)
NCT01126749 (4) [back to overview]Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
NCT01128296 (10) [back to overview]Disease-free Survival (DFS) by Response to HCQ Treatment
NCT01128296 (10) [back to overview]Overall Survival (OS)
NCT01128296 (10) [back to overview]R0 Resection Rate
NCT01128296 (10) [back to overview]Disease-free Survival (DFS) by CA 19-9 Response
NCT01128296 (10) [back to overview]Disease-free Survival by p53 Genetic Status
NCT01128296 (10) [back to overview]Overall Survival (OS) by CA 19-9 Response
NCT01128296 (10) [back to overview]Overall Survival (OS) by Response to HCQ Treatment
NCT01128296 (10) [back to overview]Overall Survival (OS) by p53 Mutant Status
NCT01128296 (10) [back to overview]Disease-free Survival (DFS)
NCT01128296 (10) [back to overview]Number of Participants That Experienced a Dose Limiting Toxicity (DLT)
NCT01133756 (1) [back to overview]Number of Participants With Dose Limiting Toxicity (DLT)
NCT01144455 (1) [back to overview]Progression-free Survival (PFS)
NCT01146054 (5) [back to overview]To Determine the Overall Survival in Pancreatic Cancer Patients Treated With Gemcitabine and SBRT for up to 5 Years of Follow up.
NCT01146054 (5) [back to overview]Proportion of Participants Achieving Freedom From Local Progression (FFLP) in Patients Treated With Gemcitabine Followed by Fractionated Stereotactic Body Radiotherapy (SBRT) for up to 5 Years of Follow up.
NCT01146054 (5) [back to overview]Evaluate Acute Gastrointestinal Toxicity up to 3 Months of Treatment.
NCT01146054 (5) [back to overview]To Determine the Rate of (Grade 2 or Greater) Gastrointestinal Toxicity Attributable to Gemcitabine and Fractionated SBRT at One Year.
NCT01146054 (5) [back to overview]To Evaluate Progression Free Survival Following Gemcitabine and SBRT for up to 5 Years of Follow up .
NCT01151761 (8) [back to overview]Serum CA 19-9 Levels
NCT01151761 (8) [back to overview]Overall Survival at 12 Months
NCT01151761 (8) [back to overview]Liver Transplant Conversion Rate
NCT01151761 (8) [back to overview]Progression-free Survival at 12 Months
NCT01151761 (8) [back to overview]Liver Transplant Rate
NCT01151761 (8) [back to overview]Freedom From Local Progression at 12 Months
NCT01151761 (8) [back to overview]Median Time to Overall Survival
NCT01151761 (8) [back to overview]Pathologic Complete Response Rate
NCT01160744 (7) [back to overview]Progression-Free Survival (PFS)
NCT01160744 (7) [back to overview]Change in Tumor Size (CTS)
NCT01160744 (7) [back to overview]Duration of Response (DOR)
NCT01160744 (7) [back to overview]Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
NCT01160744 (7) [back to overview]Percentage of Participants With CR, PR, or Stable Disease (SD) [Disease Control Rate (DCR)]
NCT01160744 (7) [back to overview]Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Who Died
NCT01160744 (7) [back to overview]Overall Survival (OS)
NCT01164228 (3) [back to overview]Overall Survival
NCT01164228 (3) [back to overview]Proportion of Patients With Response
NCT01164228 (3) [back to overview]Progression-free Survival
NCT01188109 (2) [back to overview]Recurrence-free Survival as Measured by CT Scan
NCT01188109 (2) [back to overview]Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression
NCT01194453 (2) [back to overview]Progression Free Survival (PFS)
NCT01194453 (2) [back to overview]Response Rate
NCT01195415 (4) [back to overview]Percentage of Treated Patients Experiencing Grade 3+ Toxicity Per National Cancer Institute Common Toxicity Criteria (CTC) Version 3.0
NCT01195415 (4) [back to overview]Median Progression Free Survival
NCT01195415 (4) [back to overview]The Number of Participants With an Objective Best Response (CR + PR)
NCT01195415 (4) [back to overview]Median Percent at Baseline and 3 Weeks in CD44+/ CD24+/ ESA+ Cells From Needle Biopsy Calculated Using FACS
NCT01197560 (9) [back to overview]Stage 1: Percentage of Participants With a Complete Response According to the IWG Response Criteria as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase
NCT01197560 (9) [back to overview]Number of Participants With Treatment Emergent Events (TEAEs) in the Overall Treatment Phase by Initial Treatment Assignment
NCT01197560 (9) [back to overview]Stage 1: Kaplan Meier Estimates of Overall Survival As Assessed by the Investigators at the Final Data Cut During The Core Treatment Phase
NCT01197560 (9) [back to overview]Stage 1: Kaplan Meier Estimates of Duration of Overall Response (DoR) as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase
NCT01197560 (9) [back to overview]Stage 1: Percentage of Participants With a Durable Overall Response (dORR) According to the IWG Response Criteria as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase
NCT01197560 (9) [back to overview]Stage 1: Kaplan Meier Estimates of Progression-Free Survival As Assessed By The Investigators At The Final Data Cut During The Core Treatment Phase
NCT01197560 (9) [back to overview]Stage 1: Kaplan Meier Estimates of Duration of Complete Response (DoCR) as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase
NCT01197560 (9) [back to overview]Stage 1: Percentage of Participants With an Overall Response According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 and Evaluated by the Independent Response Adjudication Committee (IRAC)
NCT01197560 (9) [back to overview]Stage 1: Percentage of Participants With an Overall Response According to the IWG Response Criteria Based on the Investigators Assessment at the Final Data Cut During the Core Treatment Phase
NCT01200329 (2) [back to overview]Event-free Survival (EFS) of Patients
NCT01200329 (2) [back to overview]Overall Survival (OS) of These Patients.
NCT01201265 (9) [back to overview]Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)
NCT01201265 (9) [back to overview]Change From Baseline in Systolic Blood Pressure (SBP)
NCT01201265 (9) [back to overview]Change From Baseline in Diastolic Blood Pressure (DBP)
NCT01201265 (9) [back to overview]Time to Progression (TTP)
NCT01201265 (9) [back to overview]Progression-free Survival (PFS)
NCT01201265 (9) [back to overview]Percentage of Participants Achieving an Overall Response
NCT01201265 (9) [back to overview]Percentage of Participants Achieving a Clinical Benefit Response (CBR)
NCT01201265 (9) [back to overview]Overall Survival (OS)
NCT01201265 (9) [back to overview]Number of Participants With an Adverse Event (AE)
NCT01231581 (7) [back to overview]Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
NCT01231581 (7) [back to overview]Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR)
NCT01231581 (7) [back to overview]Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements
NCT01231581 (7) [back to overview]Overall Survival
NCT01231581 (7) [back to overview]Progression-free Survival (PFS) as Assessed by the Investigator
NCT01231581 (7) [back to overview]Investigator-Assessed Duration of Response
NCT01231581 (7) [back to overview]Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters
NCT01232556 (8) [back to overview]Duration of Response
NCT01232556 (8) [back to overview]Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) Questionnaire
NCT01232556 (8) [back to overview]Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) Questionnaire
NCT01232556 (8) [back to overview]Overall Survival
NCT01232556 (8) [back to overview]Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL
NCT01232556 (8) [back to overview]Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL
NCT01232556 (8) [back to overview]Progression-Free Survival (PFS)
NCT01232556 (8) [back to overview]Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
NCT01237951 (4) [back to overview]Overall Survival
NCT01237951 (4) [back to overview]Participants Who Had Measurable Disease at Time of Transplant and Achieved a Stringent Complete Remission
NCT01237951 (4) [back to overview]Percent of Participants Dying From Treatment-Related Complications
NCT01237951 (4) [back to overview]Progression-free Survival (PFS)
NCT01251653 (20) [back to overview]Objective Response According to RECIST v1.1
NCT01251653 (20) [back to overview]The Incidence and Intensity of AEs With Grading According to CTCAE.
NCT01251653 (20) [back to overview]Time to Objective Response According to RECIST v1.1
NCT01251653 (20) [back to overview]Cmax of Docetaxel
NCT01251653 (20) [back to overview]AUC 0-tz of Gemcitabine
NCT01251653 (20) [back to overview]AUC 0-24 of Docetaxel
NCT01251653 (20) [back to overview]Area Under the Concentration-time Curve (AUC) Tau,ss of Afatinib
NCT01251653 (20) [back to overview]Cmax of Gemcitabine
NCT01251653 (20) [back to overview]Total Clearance (CL) of Gemcitabine
NCT01251653 (20) [back to overview]Total Clearance (CL) of Docetaxel
NCT01251653 (20) [back to overview]Progression Free Survival (PFS)
NCT01251653 (20) [back to overview]Overall Survival (OS)
NCT01251653 (20) [back to overview]Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).
NCT01251653 (20) [back to overview]Duration of Objective Response According to RECIST v1.1
NCT01251653 (20) [back to overview]Duration of Disease Control According to RECIST v1.1
NCT01251653 (20) [back to overview]Cmax,ss of Afatinib
NCT01251653 (20) [back to overview]Volume of Distribution at Steady State (Vss) of Docetaxel
NCT01251653 (20) [back to overview]Volume of Distribution at Steady State (Vss) of Gemcitabine
NCT01251653 (20) [back to overview]Best Overall Response According to RECIST v1.1 Criteria
NCT01251653 (20) [back to overview]Disease Control According to RECIST v1.1
NCT01259063 (5) [back to overview]Phase I - Dose-limiting Toxicity (DLT)
NCT01259063 (5) [back to overview]Complete Response (CR) Rate
NCT01259063 (5) [back to overview]Survival of Patients Treated
NCT01259063 (5) [back to overview]Phase II - Patients Who Are Free of Disease at 1 Year
NCT01259063 (5) [back to overview]Phase I - Maximum Tolerated Dose (MTD)
NCT01284335 (8) [back to overview]Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
NCT01284335 (8) [back to overview]Number of Participants With a Clinically Significant Effects
NCT01284335 (8) [back to overview]Pharmacokinetic (PK): Concentration Maximum (Cmax)
NCT01284335 (8) [back to overview]Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
NCT01284335 (8) [back to overview]Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
NCT01284335 (8) [back to overview]Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
NCT01284335 (8) [back to overview]PK: Area Under the Curve Albumin (AUCalb)
NCT01284335 (8) [back to overview]Number of Participants With Dose-Limiting Toxicities Cycle 1
NCT01294358 (8) [back to overview]Median Overall Survival (OS)
NCT01294358 (8) [back to overview]Number of Participants With Dose Limiting Toxicity (DLT )
NCT01294358 (8) [back to overview]Response Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
NCT01294358 (8) [back to overview]Response Using Computed Tomography (CT) Perfusion Criteria European Association for the Study of the Liver (EASL1)
NCT01294358 (8) [back to overview]Number of Participants With Serious and Non-Serious Adverse Events
NCT01294358 (8) [back to overview]Number of Participants Who Converted From Unresectable or Borderline Resectable To Potentially Resectable Pancreatic Cancer
NCT01294358 (8) [back to overview]Median Time to Progression
NCT01294358 (8) [back to overview]MTD (Maximum Tolerated Dose)
NCT01296568 (10) [back to overview]Relative Abundance of LY2603618 and the Metabolites of LY2603618 in Urine
NCT01296568 (10) [back to overview]Urinary and Fecal Excretion of LY2603618 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
NCT01296568 (10) [back to overview]The Number of Participants With a Tumor Response
NCT01296568 (10) [back to overview]Plasma Pharmacokinetics of Radioactivity: Area Under the Concentration Time Curve From Time Zero to Time t [AUC(0-tlast)]
NCT01296568 (10) [back to overview]Relative Abundance of LY2603618 and the Metabolites of LY2603618 in Feces
NCT01296568 (10) [back to overview]Plasma Pharmacokinetics of Radioactivity: Maximum Observed Drug Concentration (Cmax)
NCT01296568 (10) [back to overview]Plasma Pharmacokinetics of Radioactivity: Area Under the Concentration Time Curve From Time Zero to Infinity [AUC(0-infinity)]
NCT01296568 (10) [back to overview]Plasma Pharmacokinetics of LY2603618: Maximum Observed Drug Concentration (Cmax)
NCT01296568 (10) [back to overview]Plasma Pharmacokinetics of LY2603618: Area Under the Concentration Time Curve From Time Zero to Time t [AUC(0-tlast)]
NCT01296568 (10) [back to overview]Plasma Pharmacokinetics of LY2603618: Area Under the Concentration Time Curve From Time Zero to Infinity [AUC(0-infinity)]
NCT01303172 (4) [back to overview]Safety and Tolerability.
NCT01303172 (4) [back to overview]Overall Response Rate (ORR).
NCT01303172 (4) [back to overview]Survival
NCT01303172 (4) [back to overview]Overall Survival in Metastatic Patients Only
NCT01308840 (4) [back to overview]The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
NCT01308840 (4) [back to overview]The Number of Participants Who Experience an Adverse Event
NCT01308840 (4) [back to overview]Median Progression Free Survival
NCT01308840 (4) [back to overview]Median Overall Survival
NCT01321541 (5) [back to overview]Overall Response Rate
NCT01321541 (5) [back to overview]Progression Free Survival (PFS)
NCT01321541 (5) [back to overview]Complete Response Rate
NCT01321541 (5) [back to overview]Number of Treatment Emergent Adverse Events (TEAE) Related to Study Drug
NCT01321541 (5) [back to overview]Overall Survival
NCT01341457 (8) [back to overview]PK: Cmax of Gemcitabine Metabolite Deoxydifluorouridine (dFdU)
NCT01341457 (8) [back to overview]Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Best Overall Response)
NCT01341457 (8) [back to overview]Number of Participants With Dose Limiting Toxicity (DLT)
NCT01341457 (8) [back to overview]Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618
NCT01341457 (8) [back to overview]PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2603618
NCT01341457 (8) [back to overview]PK: AUC(0-∞) of Gemcitabine
NCT01341457 (8) [back to overview]PK: AUC(0-∞) of Gemcitabine Metabolite dFdU
NCT01341457 (8) [back to overview]PK: Cmax of Gemcitabine
NCT01358968 (7) [back to overview]Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]
NCT01358968 (7) [back to overview]Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of Desipramine [AUC(0-tlast)]
NCT01358968 (7) [back to overview]Plasma Pharmacokinetics of LY2603618: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of LY2603618 [AUC(0-tlast)]
NCT01358968 (7) [back to overview]Number of Participants With a Tumor Response
NCT01358968 (7) [back to overview]Plasma Pharmacokinetics of Desipramine: the Maximum Concentration of Desipramine in the Plasma (Cmax)
NCT01358968 (7) [back to overview]Plasma Pharmacokinetics of LY2603618: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]
NCT01358968 (7) [back to overview]Plasma Pharmacokinetics of LY2603618: the Maximum Concentration of LY2603618 in the Plasma (Cmax)
NCT01360593 (9) [back to overview]Time to Progression (TTP)
NCT01360593 (9) [back to overview]Overall Survival (OS)
NCT01360593 (9) [back to overview]Objective Response Rate (ORR) (Surgery After Chemotherapy and SBRT)
NCT01360593 (9) [back to overview]Objective Response Rate (ORR) (Neoadjuvant Chemotherapy)
NCT01360593 (9) [back to overview]Number of Participants Able to Undergo a Margin-negative Resection After Neoadjuvant Therapy
NCT01360593 (9) [back to overview]Local Progression-free Survival (LPFS)
NCT01360593 (9) [back to overview]Late Toxicities Associated With SBRT
NCT01360593 (9) [back to overview]Acute Toxicities Associated With SBRT
NCT01360593 (9) [back to overview]The Functional Assessment of Cancer Therapy - General (FACT-G)
NCT01373164 (12) [back to overview]Phase 1b: Recommended Phase 2 Dose
NCT01373164 (12) [back to overview]Phase 2: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) at Study Completion
NCT01373164 (12) [back to overview]Phase 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA19-9) Level at First Study Completion Follow-up
NCT01373164 (12) [back to overview]Phase 2: Overall Survival (OS)
NCT01373164 (12) [back to overview]Phase 2: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])
NCT01373164 (12) [back to overview]Phase 2: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24])
NCT01373164 (12) [back to overview]Phase 2: Population PK: Maximum Concentration (Cmax) of Galunisertib
NCT01373164 (12) [back to overview]Phase 2: Progression Free Survival (PFS)
NCT01373164 (12) [back to overview]Phase 1b: Number of Participants With Tumor Response
NCT01373164 (12) [back to overview]Phase 1b: Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 24 Hours (AUC[0-24], ss) and Time Zero to Infinity (AUC[0-∞], ss)
NCT01373164 (12) [back to overview]Phase 2: Percentage Change From Baseline in Tumor Size (CTS)
NCT01373164 (12) [back to overview]Phase 1b: Pharmacokinetics: Maximum Plasma Drug Concentration at Steady State (Cmax,ss)
NCT01376310 (1) [back to overview]Number of Participants With Adverse Events
NCT01395758 (4) [back to overview]Progression-free Survival (PFS) Among Subjects With KRAS Mutation Positive NSCLC (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Single Agent Chemotherapy.
NCT01395758 (4) [back to overview]Overall Survival (OS) Among All Eligible Subjects (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Chemotherapy.
NCT01395758 (4) [back to overview]ORR Among Subjects in the Crossover Period Treated With Erlotinib Plus Tivantinib
NCT01395758 (4) [back to overview]Objective Response Rate (ORR) Among All Eligible Subjects (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Chemotherapy.
NCT01404260 (1) [back to overview]Progression Free Survival
NCT01418001 (1) [back to overview]Overall Objective Response
NCT01431794 (3) [back to overview]Overall Survival
NCT01431794 (3) [back to overview]Overall Tumor Response as Determined by Number of Participants With Complete or Partial Response
NCT01431794 (3) [back to overview]Phase I - Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy as Measured by Number of Participants Who Tolerated the Maximal Dose of LDE-225
NCT01443078 (2) [back to overview]PERCIST Partial Metabolic Response
NCT01443078 (2) [back to overview]Pathologic Response Rate
NCT01447225 (11) [back to overview]Pharmacokinetics
NCT01447225 (11) [back to overview]Objective Response Rate
NCT01447225 (11) [back to overview]Immunogenicity
NCT01447225 (11) [back to overview]To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies
NCT01447225 (11) [back to overview]To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed
NCT01447225 (11) [back to overview]To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine
NCT01447225 (11) [back to overview]To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin
NCT01447225 (11) [back to overview]To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel
NCT01447225 (11) [back to overview]To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies
NCT01447225 (11) [back to overview]Pharmacokinetics (AUClast)
NCT01447225 (11) [back to overview]To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses
NCT01453153 (29) [back to overview]Number of Participants With a Dose-limiting Toxicity (DLT)
NCT01453153 (29) [back to overview]Objective Response Rate
NCT01453153 (29) [back to overview]Observed Maximum Plasma Concentration (Cmax) Following Single PEGPH20 Doses
NCT01453153 (29) [back to overview]Overall Survival
NCT01453153 (29) [back to overview]Progression-free Survival (PFS)
NCT01453153 (29) [back to overview]Recommended Phase 2 Dose (RP2D)
NCT01453153 (29) [back to overview]Time to Reach Cmax (Tmax) Following Single PEGPH20 Doses
NCT01453153 (29) [back to overview]Tmax Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks
NCT01453153 (29) [back to overview]Change From Baseline in CA19-9 in Participants Classified as Responders and Non-responders
NCT01453153 (29) [back to overview]Change From Baseline in CA19-9 in Participants Classified as Responders and Non-responders
NCT01453153 (29) [back to overview]Change From Baseline in CA19-9 in Participants With a Baseline Value >=59 U/ml
NCT01453153 (29) [back to overview]Change From Baseline in Carbohydrate Antigen 19-9 or Sialylated Lewis(a) Antigen (CA19-9)
NCT01453153 (29) [back to overview]Change From Baseline in Carbohydrate Antigen 19-9 or Sialylated Lewis(a) Antigen (CA19-9)
NCT01453153 (29) [back to overview]Change From Baseline in Carbohydrate Antigen 19-9 or Sialylated Lewis(a) Antigen (CA19-9)
NCT01453153 (29) [back to overview]H-scores, as an Assessment of HA Staining Changes in Tumor Biopsies
NCT01453153 (29) [back to overview]Mean Extravascular-Extracellular Volume Fraction (Ve) for Scans Across Tissue Sites
NCT01453153 (29) [back to overview]Mean Volume Transfer Constant (Ktrans) for Scans Across Tissue Sites
NCT01453153 (29) [back to overview]Number of Participants With the Indicated Best Response, Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1
NCT01453153 (29) [back to overview]Plasma Hyaluronan (HA) Concentration at Baseline and After PEGPH20 Administration
NCT01453153 (29) [back to overview]Percent Change in in the Maximum Standardized Uptake Value (SUVmax), as an Assessment of Total Lesion Metabolic Activity
NCT01453153 (29) [back to overview]t1/2 Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks
NCT01453153 (29) [back to overview]Apparent Half-life (t1/2) Following Single PEGPH20 Doses
NCT01453153 (29) [back to overview]Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Measurable Plasma Concentration (AUC0-T) Following Single PEGPH20 Doses
NCT01453153 (29) [back to overview]AUC0-T Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks
NCT01453153 (29) [back to overview]Cmax Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks
NCT01453153 (29) [back to overview]Cmin Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks
NCT01453153 (29) [back to overview]Disease Control Rate
NCT01453153 (29) [back to overview]Last Measurable Observed Plasma Concentration (Cmin) Following Single PEGPH20 Doses
NCT01453153 (29) [back to overview]Change From Baseline in CA19-9 in Participants With a Baseline Value >=59 U/ml
NCT01454102 (6) [back to overview]Progression-Free Survival Rate (PFSR) at Week 24
NCT01454102 (6) [back to overview]Number of Participants Who Experienced Selected Adverse Events
NCT01454102 (6) [back to overview]Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death
NCT01454102 (6) [back to overview]Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests
NCT01454102 (6) [back to overview]Objective Response Rate (ORR)
NCT01454102 (6) [back to overview]Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests
NCT01454934 (3) [back to overview]Objective Response Rate (ORR)
NCT01454934 (3) [back to overview]Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)
NCT01454934 (3) [back to overview]Overall Survival (OS)
NCT01459614 (5) [back to overview]Percentage of Participants Without Disease Progression (Progression-Free Survival) at 6 Months
NCT01459614 (5) [back to overview]Progression-free Survival (PFS)
NCT01459614 (5) [back to overview]Overall Survival (OS)
NCT01459614 (5) [back to overview]Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
NCT01459614 (5) [back to overview]Disease Control Rate (DCR)
NCT01470417 (4) [back to overview]Pathologic Downstaging and Margin Status
NCT01470417 (4) [back to overview]Radiographic Response Rate
NCT01470417 (4) [back to overview]90 Day Post-operative Mortality
NCT01470417 (4) [back to overview]Biochemical Response Rate
NCT01473940 (4) [back to overview]Progression Free Survival (PFS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination
NCT01473940 (4) [back to overview]Number of Dose Limiting Toxicities (DLTs) Seen in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination in Order to Define the Maximum Tolerated Dose (MTD)
NCT01473940 (4) [back to overview]Duration of Response in Patients Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination
NCT01473940 (4) [back to overview]Overall Survival (OS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination
NCT01482962 (12) [back to overview]Overall Survival (OS)
NCT01482962 (12) [back to overview]Progression-Free Survival (PFS) Based on IRC Assessment
NCT01482962 (12) [back to overview]Time to Disease Progression (TTP)
NCT01482962 (12) [back to overview]Time to Response
NCT01482962 (12) [back to overview]Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms
NCT01482962 (12) [back to overview]Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs
NCT01482962 (12) [back to overview]Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs
NCT01482962 (12) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
NCT01482962 (12) [back to overview]Time to Subsequent Antineoplastic Therapy
NCT01482962 (12) [back to overview]Complete Response (CR) Rate
NCT01482962 (12) [back to overview]Duration of Response (DOR)
NCT01482962 (12) [back to overview]Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
NCT01515046 (3) [back to overview]Overall Survival
NCT01515046 (3) [back to overview]Progression Free Survival
NCT01515046 (3) [back to overview]Number of Drug-related Adverse Events Per Cycle
NCT01524991 (2) [back to overview]Median Overall Survival
NCT01524991 (2) [back to overview]Progression-Free Survival
NCT01532687 (4) [back to overview]Overall Survival
NCT01532687 (4) [back to overview]Progression-free Survival (PFS)
NCT01532687 (4) [back to overview]Percentage of Participants Achieving Best Overall Objective Response (CR+PR)
NCT01532687 (4) [back to overview]Progression-free Survival (PFS) for a Sub-group of Patients Treated With Open-label Pazopanib Hydrochloride Following Administration of Gemcitabine Hydrochloride in the Cross-over Portion of This Study
NCT01533207 (3) [back to overview]Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
NCT01533207 (3) [back to overview]Number of Participants Who Experienced Death
NCT01533207 (3) [back to overview]Number of Participants With Recurrence
NCT01534637 (3) [back to overview]Number of Patients With Gastrointestinal Toxicities (Grade 3 and 4 Nausea and Vomiting) Associated With Delivering Fluorouracil/Gemcitabine Hydrochloride-based Chemotherapy With Upper Abdominal Radiation
NCT01534637 (3) [back to overview]Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs
NCT01534637 (3) [back to overview]Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs
NCT01535924 (2) [back to overview]Overall Response Rate (ORR) of Bendamustine Hydrochloride and Gemcitabine Hydrochloride in Patients With Relapsed or Refractory Hodgkin Lymphoma (Phase II)
NCT01535924 (2) [back to overview]Adverse Events in Terms of Dose-limiting Toxicity (DLT) and MTD of Bendamustine Hydrochloride (Phase I)
NCT01560949 (8) [back to overview]Number of Participants Correlative Studies Including DPC4 (SMAD4) Staining and Circulating Tumor Cells (CTC) Post-Surgery
NCT01560949 (8) [back to overview]Number of Participants Correlative Studies Including DPC4 (SMAD4) Staining and Circulating Tumor Cells (CTC) Pre-Surgery
NCT01560949 (8) [back to overview]Overall Survival
NCT01560949 (8) [back to overview]Number of Participants With Resectability Rate
NCT01560949 (8) [back to overview]Number of Participants With R0 Margin Resection
NCT01560949 (8) [back to overview]Disease Free Survival (DFS)
NCT01560949 (8) [back to overview]Number of Participants With Local and Distant Failure
NCT01560949 (8) [back to overview]Number of Participants That Were SMAD4 Positive Before and After Surgery
NCT01574716 (6) [back to overview]Part 2: Overall Response Rate (ORR)
NCT01574716 (6) [back to overview]Part 2: Overall Survival (OS)
NCT01574716 (6) [back to overview]Part 2: Radiologic Progression-free Survival (PFS)
NCT01574716 (6) [back to overview]Part 2: Radiologic Progression-free Survival Rate (PFR)
NCT01574716 (6) [back to overview]Part 2: Symptomatic Progression-free Survival
NCT01574716 (6) [back to overview]Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels
NCT01589094 (4) [back to overview]Pathologic Response Rate
NCT01589094 (4) [back to overview]Number of Participants With Toxicity
NCT01589094 (4) [back to overview]2 Year Recurrence Free Survival (RFS) Rate for Nonresponders
NCT01589094 (4) [back to overview]2 Year Recurrence Free Survival (RFS) Rate for Responders
NCT01593748 (4) [back to overview]Rate of Participants With Grade 3 or Higher Toxicity
NCT01593748 (4) [back to overview]Hazard Ratio
NCT01593748 (4) [back to overview]Average Number of Months of Progression-free Survival
NCT01593748 (4) [back to overview]Average Score of Quality of Life
NCT01595061 (4) [back to overview]Progression-free Survival (PFS)
NCT01595061 (4) [back to overview]Complete Clinical Response
NCT01595061 (4) [back to overview]Complete Pathologic Response
NCT01595061 (4) [back to overview]Adverse Events (Grade 3 or Higher) During Treatment Period
NCT01606748 (12) [back to overview]PK: Dose-Normalized Cmax of Gemcitabine
NCT01606748 (12) [back to overview]Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of Necitumumab in Combination With Gemcitabine-cisplatin Chemotherapy)
NCT01606748 (12) [back to overview]Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab
NCT01606748 (12) [back to overview]PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab
NCT01606748 (12) [back to overview]PK: AUC(0-∞) of Necitumumab After Administration of Process C and Process D Drug Product
NCT01606748 (12) [back to overview]PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab
NCT01606748 (12) [back to overview]PK: Cmax of Necitumumab After Administration of Process C and Process D Drug Product
NCT01606748 (12) [back to overview]PK: Dose-Normalized AUC(0-24) of Gemcitabine
NCT01606748 (12) [back to overview]PK: Dose-Normalized AUC(0-5) of Cisplatin
NCT01606748 (12) [back to overview]PK: Dose-Normalized Cmax of Cisplatin
NCT01606748 (12) [back to overview]Number of Participants With Anti-Necitumumab Antibodies
NCT01606748 (12) [back to overview]PK: Dose Normalized AUC(0-∞) of Gemcitabine
NCT01610206 (2) [back to overview]Progression-free Survival
NCT01610206 (2) [back to overview]Number of Participants With Adverse Events
NCT01611662 (1) [back to overview]Pathological Complete Response Rate Following Chemotherapy Before Surgery
NCT01622660 (1) [back to overview]Progression Free Survival (PFS)
NCT01626664 (4) [back to overview]Progression Free Survival
NCT01626664 (4) [back to overview]Change in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score
NCT01626664 (4) [back to overview]Overall Response Rate
NCT01626664 (4) [back to overview]Overall Survival
NCT01629511 (3) [back to overview]Time-to-engraftment
NCT01629511 (3) [back to overview]100 Day Treatment Related Mortality (TRM)
NCT01629511 (3) [back to overview]Overall Survival
NCT01632306 (4) [back to overview]Progression Free Survival (PFS)
NCT01632306 (4) [back to overview]Percentage of Participants Who Survived at 6 Months
NCT01632306 (4) [back to overview]Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
NCT01632306 (4) [back to overview]Overall Survival (OS)
NCT01639131 (3) [back to overview]Progression-free Survival (PFS)
NCT01639131 (3) [back to overview]Response Rate
NCT01639131 (3) [back to overview]Overall Survival With Gemcitabine and Docetaxel Combination Therapy
NCT01647828 (3) [back to overview]Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT)
NCT01647828 (3) [back to overview]Phase 2: Median OS by Notch 3 Percentile (ITT Population)
NCT01647828 (3) [back to overview]Phase 2: Overall Survival (ITT Population)
NCT01654861 (1) [back to overview]Adverse Events as a Measure of Safety and Tolerability
NCT01661114 (2) [back to overview]The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment
NCT01661114 (2) [back to overview]Median Overall Survival of Previously Treated and Previously Untreated Patients
NCT01663272 (2) [back to overview]Maximum Tolerated Dose
NCT01663272 (2) [back to overview]Median Progression-free Survival (PFS)
NCT01663857 (7) [back to overview]Phase 2: Overall Survival
NCT01663857 (7) [back to overview]Phase 2: Percentage of Participants Who Achieve Complete Response or Partial Response (Overall Response Rate)
NCT01663857 (7) [back to overview]Phase 2: Progression-free Survival (PFS) in Participants Treated With LY2228820 Plus Gemcitabine and Carboplatin Versus Placebo Plus Gemcitabine and Carboplatin
NCT01663857 (7) [back to overview]Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820
NCT01663857 (7) [back to overview]Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820
NCT01663857 (7) [back to overview]Phase 2: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) Total Score
NCT01663857 (7) [back to overview]Phase 1b: Recommended Phase 2 Dose of LY2228820 in Combination With Gemcitabine and Carboplatin (Maximum Tolerated Dose [MTD])
NCT01679405 (5) [back to overview]Tumor Control Rate
NCT01679405 (5) [back to overview]Number of Adverse Events
NCT01679405 (5) [back to overview]Objective Response Rate
NCT01679405 (5) [back to overview]Overall Survival (OS)
NCT01679405 (5) [back to overview]Time to Progress (TTP)
NCT01683422 (1) [back to overview]One-year Survival Rate
NCT01684878 (9) [back to overview]Part 1: PFS Assessed by the Investigator
NCT01684878 (9) [back to overview]Part 2- Objective Response Rate (ORR)
NCT01684878 (9) [back to overview]Part 2: Overall Survival
NCT01684878 (9) [back to overview]Part 2: Percentage of Participants With Adverse Events (AEs)
NCT01684878 (9) [back to overview]Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO)
NCT01684878 (9) [back to overview]Part 2: Progression-free Survival (PFS) Assessed by the Investigator
NCT01684878 (9) [back to overview]Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score
NCT01684878 (9) [back to overview]Part 1- Objective Response Rate (ORR)
NCT01684878 (9) [back to overview]Part 1: Percentage of Participants With Adverse Events (AEs)
NCT01696032 (11) [back to overview]Duration of Response
NCT01696032 (11) [back to overview]Stage 1: Pharmacokinetic Parameter AUC0-8
NCT01696032 (11) [back to overview]Clinical Benefit Rate
NCT01696032 (11) [back to overview]Stage 1: Dose Limiting Toxicities
NCT01696032 (11) [back to overview]Stage 1: Pharmacokinetic Parameter Tmax
NCT01696032 (11) [back to overview]Stage 1: Pharmacokinetic Parameter Cmax
NCT01696032 (11) [back to overview]Stage 2: Progression Free Survival
NCT01696032 (11) [back to overview]CA-125 Levels
NCT01696032 (11) [back to overview]Progression Free Survival at 6 Months
NCT01696032 (11) [back to overview]Overall Survival
NCT01696032 (11) [back to overview]Objective Response Rate
NCT01726582 (4) [back to overview]Use of Biomarkers to Determine Course of Treatment
NCT01726582 (4) [back to overview]Number of Subjects Completing Therapy Including Surgical Resection.
NCT01726582 (4) [back to overview]Overall Survival in Months
NCT01726582 (4) [back to overview]Progression-free Survival
NCT01746173 (2) [back to overview]Induction Response
NCT01746173 (2) [back to overview]24-month Progression-Free Survival Rate
NCT01746979 (2) [back to overview]Overall Survival
NCT01746979 (2) [back to overview]Progression Free Survival
NCT01754623 (2) [back to overview]Margin-negative (R0) Resection Rate
NCT01754623 (2) [back to overview]Overall Survival (OS) Rate
NCT01763788 (17) [back to overview]Phase 1b: Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])
NCT01763788 (17) [back to overview]Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
NCT01763788 (17) [back to overview]Phase 1b: PK: Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Necitumumab
NCT01763788 (17) [back to overview]Phase 1b: PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Gemcitabine and Cisplatin
NCT01763788 (17) [back to overview]Phase 2: Change From Baseline in EuroQol 5-Dimensional 3 Level (EuroQol-5D-3L) Visual Analog Scale (VAS)
NCT01763788 (17) [back to overview]Phase 2: Change From Baseline in EuroQol 5-Dimensional 3 Level (EuroQol-5D-3L) Index Score
NCT01763788 (17) [back to overview]Phase 1b: PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Gemcitabine and Cisplatin
NCT01763788 (17) [back to overview]Phase 1b: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab
NCT01763788 (17) [back to overview]Phase 2: Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])
NCT01763788 (17) [back to overview]Phase 2: Time to Treatment Failure (TTF)
NCT01763788 (17) [back to overview]Phase 2: Progression Free Survival (PFS)
NCT01763788 (17) [back to overview]Phase 2: Overall Survival (OS)
NCT01763788 (17) [back to overview]Phase 2: Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)
NCT01763788 (17) [back to overview]Phase 2: Change From Baseline in Lung Cancer Symptom Scale (LCSS)
NCT01763788 (17) [back to overview]Phase 2: PK: Minimum Concentration (Ctrough) of Necitumumab
NCT01763788 (17) [back to overview]Phase 1b: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab
NCT01763788 (17) [back to overview]Phase 1b: PK: Cmax of Gemcitabine and Cisplatin
NCT01780662 (8) [back to overview]Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
NCT01780662 (8) [back to overview]The Number of Patients Who Had Successful Peripheral Blood Stem Cell (PBSC) Collection
NCT01780662 (8) [back to overview]The Number of Patients Who Had Disease Response Assessed by Deauville Scales Among Those in Phase I With Dose Level 2.
NCT01780662 (8) [back to overview]Percentage of Patients Who Achieved Overall Response (OR) as Measured by Complete Response (CR) and Partial Response (PR)
NCT01780662 (8) [back to overview]Maximum Tolerated Dose (MTD) for Brentuximab Vedotin
NCT01780662 (8) [back to overview]The Number of Patients With Relapsed or Refractory HL Who Achieved Complete Response (CR)
NCT01780662 (8) [back to overview]Number of Patients With FcyRIIIa-158 V/F (Valine/Phenylalanine) Polymorphism
NCT01780662 (8) [back to overview]Plasma Level of Thymus and Activation-Regulated Chemokine (TARC)
NCT01782690 (13) [back to overview]Number of Participants With Rash by Severity
NCT01782690 (13) [back to overview]Score in Participant Questionnaire: Quality of Life
NCT01782690 (13) [back to overview]Score in Patient Questionnaire: Possible Side Effects
NCT01782690 (13) [back to overview]Score in Participant Questionnaire: What to Do in Case of Side Effect
NCT01782690 (13) [back to overview]Number of Dose Modifications and Dose Withdrawals of Erlotinib
NCT01782690 (13) [back to overview]Number of Dose Modifications and Dose Withdrawals of Gemcitabine
NCT01782690 (13) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01782690 (13) [back to overview]Percentage of Participants With Best Overall Response
NCT01782690 (13) [back to overview]Time to Disease Progression
NCT01782690 (13) [back to overview]Time of Onset of Rash After Start Erlotinib Treatment
NCT01782690 (13) [back to overview]Overall Survival Stratified by Rash
NCT01782690 (13) [back to overview]Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
NCT01782690 (13) [back to overview]Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation
NCT01783054 (4) [back to overview]Number of Participants With R0 Resection Status.
NCT01783054 (4) [back to overview]Estimate Median Time to Recurrence.
NCT01783054 (4) [back to overview]Estimate Median Overall Survival
NCT01783054 (4) [back to overview]Number of Adverse Events Reported in Subjects Enrolled.
NCT01788566 (7) [back to overview]Overall Survival (OS)
NCT01788566 (7) [back to overview]Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)
NCT01788566 (7) [back to overview]Progression Free Survival (PFS)
NCT01788566 (7) [back to overview]Number of Participants With Anti-Necitumumab Antibodies
NCT01788566 (7) [back to overview]Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab
NCT01788566 (7) [back to overview]Number of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]
NCT01788566 (7) [back to overview]Percent Change in Tumor Size (CTS)
NCT01803282 (2) [back to overview]Percentage of Participants Experiencing Laboratory Abnormalities
NCT01803282 (2) [back to overview]Percentage of Participants Experiencing Treatment-Emergent Adverse Events
NCT01809210 (9) [back to overview]CL/F
NCT01809210 (9) [back to overview]Cmax,ss
NCT01809210 (9) [back to overview]Percentage Change From Baseline at 6 Weeks in Target Lesion Size
NCT01809210 (9) [back to overview]Tmax,ss
NCT01809210 (9) [back to overview]Best Objective Response
NCT01809210 (9) [back to overview]Dose Limiting Toxicity (DLT) Events in Chemotherapy in Combination With Selumetinib
NCT01809210 (9) [back to overview]Objective Response Rate (ORR)
NCT01809210 (9) [back to overview]AUC (0-tau)
NCT01809210 (9) [back to overview]Best Percentage Change From Baseline in Target Lesion Size
NCT01822756 (4) [back to overview]Duration of Response
NCT01822756 (4) [back to overview]Percentage of Participants With a Best Response by RECIST Criteria
NCT01822756 (4) [back to overview]Percentage of Participants With Adverse Events That Are Defined as Dose Limiting Toxicities (DLTs)
NCT01822756 (4) [back to overview]Percentage of Responders
NCT01822886 (5) [back to overview]Safety - Frequency of Toxicities Grade 3 and 4
NCT01822886 (5) [back to overview]Percentage of Participants With Progression-Free Survival
NCT01822886 (5) [back to overview]Overall Survival is Measured From the Date of Study Entry to the Date of Patient's Death
NCT01822886 (5) [back to overview]Complete Remission (CR) Rate
NCT01822886 (5) [back to overview]Overall Response Rate (ORR)
NCT01828034 (4) [back to overview]MTD of MEK162 - Phase I
NCT01828034 (4) [back to overview]Median PFS
NCT01828034 (4) [back to overview]Median Overall Survival
NCT01828034 (4) [back to overview]Objective Response Rate (ORR)
NCT01833546 (31) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Death
NCT01833546 (31) [back to overview]Number of Participants With Clinical Significant Laboratory Abnormalities and Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events
NCT01833546 (31) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])
NCT01833546 (31) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])
NCT01833546 (31) [back to overview]Cumulative Amount of Evofosfamide Excreted From Time Zero to Time After Dosing (Ae0-t)
NCT01833546 (31) [back to overview]Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])
NCT01833546 (31) [back to overview]Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])
NCT01833546 (31) [back to overview]Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])
NCT01833546 (31) [back to overview]Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Sampling Time With Concentration at or Above the Lower Limit of Quantitation (AUC[0-t]) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])
NCT01833546 (31) [back to overview]Apparent Terminal Half-life (t1/2) of of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])
NCT01833546 (31) [back to overview]Apparent Volume of Distribution During Terminal Phase (Vz) of Gemcitabine
NCT01833546 (31) [back to overview]Apparent Volume of Distribution During Terminal Phase (Vz) of Evofosfamide
NCT01833546 (31) [back to overview]Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Sampling Time With Concentration at or Above the Lower Limit of Quantitation (AUC[0-t]) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])
NCT01833546 (31) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])
NCT01833546 (31) [back to overview]Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as Treatment Emergent Adverse Events (TEAEs)
NCT01833546 (31) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])
NCT01833546 (31) [back to overview]Terminal Rate Constant Associated With the Terminal Elimination Phase (λz) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])
NCT01833546 (31) [back to overview]Terminal Rate Constant Associated With the Terminal Elimination Phase (λz) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])
NCT01833546 (31) [back to overview]Number of Participants With Disease Control
NCT01833546 (31) [back to overview]Terminal Rate Constant Associated With the Terminal Elimination Phase (λz) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])
NCT01833546 (31) [back to overview]Renal Clearance (CL) for Evofosfamide
NCT01833546 (31) [back to overview]Apparent Volume of Distribution at Steady State (Vss) of Gemcitabine
NCT01833546 (31) [back to overview]Apparent Volume of Distribution at Steady State (Vss) of Evofosfamide
NCT01833546 (31) [back to overview]Apparent Total Body Clearance of (CL) of Gemcitabine
NCT01833546 (31) [back to overview]Apparent Total Body Clearance of (CL) of Evofosfamide
NCT01833546 (31) [back to overview]Best Overall Response (BOR)
NCT01833546 (31) [back to overview]Apparent Terminal Half-life (t1/2) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])
NCT01833546 (31) [back to overview]Number of Participants With Objective Response
NCT01833546 (31) [back to overview]Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 2 or Higher Than 2
NCT01833546 (31) [back to overview]Number of Participants Who Experienced Any Dose-Limiting Toxicity (DLT) During First Cycle - Day 1 to 28
NCT01833546 (31) [back to overview]Apparent Terminal Half-life (t1/2) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])
NCT01839487 (9) [back to overview]Overall Survival
NCT01839487 (9) [back to overview]Percentage of Participants in the PAG Arm Who Experienced Any Thromboembolic (TE) Event in Stage 2 of the Study
NCT01839487 (9) [back to overview]Percentage of Participants With AEs
NCT01839487 (9) [back to overview]Progression-Free Survival (PFS)
NCT01839487 (9) [back to overview]Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of PEGPH20
NCT01839487 (9) [back to overview]Maximum Observed Plasma Concentration (Cmax) of PEGPH20
NCT01839487 (9) [back to overview]PFS in Relation to Tumor Hyaluronan (HA) Levels
NCT01839487 (9) [back to overview]Time to Reach Cmax (Tmax) of PEGPH20
NCT01839487 (9) [back to overview]Objective Response Rate (ORR): Percentage of Participants With Objective Response
NCT01839799 (1) [back to overview]Number of Participants With Relapse-free Survival
NCT01862328 (8) [back to overview]Duration of Response
NCT01862328 (8) [back to overview]Dose-escalation Phase: Plasma Concentrations-time Data of MLN4924
NCT01862328 (8) [back to overview]MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924
NCT01862328 (8) [back to overview]MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924
NCT01862328 (8) [back to overview]Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
NCT01862328 (8) [back to overview]Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings
NCT01862328 (8) [back to overview]Number of Participants With TEAEs Related to Clinically Significant Vital Sign Findings
NCT01862328 (8) [back to overview]Percentage of Participants With Objective Response
NCT01879085 (8) [back to overview]Progression-free Survival (PFS)
NCT01879085 (8) [back to overview]Six-month Overall Survival (OS)
NCT01879085 (8) [back to overview]Six-month Progression-free Survival (PFS)
NCT01879085 (8) [back to overview]Objective Response Rate (ORR)
NCT01879085 (8) [back to overview]One-year Overall Survival (OS)
NCT01879085 (8) [back to overview]One-year Progression-free Survival (PFS)
NCT01879085 (8) [back to overview]Overall Survival (OS)
NCT01879085 (8) [back to overview]Phase I: Recommended Phase II Dose of Vorinostat
NCT01881230 (7) [back to overview]Kaplan-Meier Estimates of Overall Survival
NCT01881230 (7) [back to overview]Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.
NCT01881230 (7) [back to overview]Percentage of Participants Who Discontinued From All Study Treatment Due to TEAEs
NCT01881230 (7) [back to overview]Percentage of Participants Experiencing Dose Modifications (Reductions and Interruptions)
NCT01881230 (7) [back to overview]Percentage of Participants Who Initiated Cycle 6 Receiving Doublet Combination Therapy
NCT01881230 (7) [back to overview]Percentage of Participants With an Objective Complete or Partial Overall Response by Investigator Assessment.
NCT01881230 (7) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs)
NCT01893801 (3) [back to overview]Progression-Free Survival
NCT01893801 (3) [back to overview]Percentage Change in CA 19-9
NCT01893801 (3) [back to overview]Overall Survival
NCT01897454 (7) [back to overview]Toxicities Associated With Chemotherapy and Radiotherapy
NCT01897454 (7) [back to overview]Progression Free Survival (PFS)
NCT01897454 (7) [back to overview]Percentage of Patients Able to Undergo Resection
NCT01897454 (7) [back to overview]Percentage of Participants Achieving R0 Resection (R0 Resection Rate)
NCT01897454 (7) [back to overview]Overall Survival (OS)
NCT01897454 (7) [back to overview]Overall Response Rate
NCT01897454 (7) [back to overview]Vascular Reconstruction
NCT01916109 (1) [back to overview]Pathologic Complete Response Rate (
NCT01921751 (2) [back to overview]Overall Survival
NCT01921751 (2) [back to overview]Patterns of Failure (Local and Metastatic Failure)
NCT01938573 (3) [back to overview]Patients With Dose Limiting Toxicity
NCT01938573 (3) [back to overview]Percent of Patients With Pathologic Complete Response (Phase II)
NCT01938573 (3) [back to overview]Incidence of Adverse Events Including Any Unfavorable and Unintended Sign, Symptom, Diagnosis, or Disease Temporally Associated With the Use of a Medicinal Product, Whether or Not Related to the Medicinal Product (Phase I and II)
NCT01949870 (1) [back to overview]The Number of Dose-limiting Toxicities
NCT01951157 (8) [back to overview]Overall Response Rate
NCT01951157 (8) [back to overview]Duration of Response
NCT01951157 (8) [back to overview]Overall Survival (OS)
NCT01951157 (8) [back to overview]Information on Quality of Life (QoL)
NCT01951157 (8) [back to overview]Information on Quality of Life (QoL)
NCT01951157 (8) [back to overview]Progression-free Survival Rate at Six Months (PFS6)
NCT01951157 (8) [back to overview]Progression-free Survival Rate at Four Months (PFS4)
NCT01951157 (8) [back to overview]Progression-free Survival
NCT01959672 (5) [back to overview]Distant Failure-free Survival
NCT01959672 (5) [back to overview]Surgical Complete Resection (Negative Margin) Rate
NCT01959672 (5) [back to overview]Overall Survival
NCT01959672 (5) [back to overview]Number of Participants With Progressive Disease,
NCT01959672 (5) [back to overview]Number of Participants With CA-125-Specific T-cell Signal.
NCT01964430 (4) [back to overview]The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)
NCT01964430 (4) [back to overview]Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee
NCT01964430 (4) [back to overview]Kaplan Meier Estimate of Overall Survival (OS)
NCT01964430 (4) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAE's)
NCT01978184 (11) [back to overview]Evans Grade Histopathologic Response
NCT01978184 (11) [back to overview]Type of Surgical Procedure (Operation)
NCT01978184 (11) [back to overview]Carbohydrate Antigen 19-9 (CA19-9) Response
NCT01978184 (11) [back to overview]Age at Diagnosis
NCT01978184 (11) [back to overview]Robotic Resection Surgery
NCT01978184 (11) [back to overview]Rate of R0 Resection
NCT01978184 (11) [back to overview]Cancer Diagnosis Stage
NCT01978184 (11) [back to overview]Age-Adjusted Charlson Comorbidity Index
NCT01978184 (11) [back to overview]Positive Lymph Node Involvement
NCT01978184 (11) [back to overview]CT Tumor Size
NCT01978184 (11) [back to overview]Carbohydrate Antigen 19-9 (CA19-9) Response
NCT01983969 (2) [back to overview]Frequency of DLT
NCT01983969 (2) [back to overview]Participants With Event-free Survival (EFS)
NCT01998919 (7) [back to overview]Duration of Response
NCT01998919 (7) [back to overview]Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST
NCT01998919 (7) [back to overview]Time to Progression
NCT01998919 (7) [back to overview]Progression-Free Survival (PFS)
NCT01998919 (7) [back to overview]Percentage of Participants With Confirmed CR or PR as Assessed by RECIST
NCT01998919 (7) [back to overview]Overall Survival
NCT01998919 (7) [back to overview]Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
NCT02000531 (2) [back to overview]Participants With Adverse Events
NCT02000531 (2) [back to overview]Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events
NCT02004093 (13) [back to overview]Kaplan-Meier Probability of Being Progression Free at 1 Year
NCT02004093 (13) [back to overview]Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year
NCT02004093 (13) [back to overview]Overall Survival
NCT02004093 (13) [back to overview]Duration of Response
NCT02004093 (13) [back to overview]Time to Progressive Disease
NCT02004093 (13) [back to overview]Kaplan-Meier Probability of No Disease or Progression at 1 Year
NCT02004093 (13) [back to overview]Kaplan-Meier Probability of Being Alive at 1 Year
NCT02004093 (13) [back to overview]Percentage of Participants Who Died
NCT02004093 (13) [back to overview]Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements
NCT02004093 (13) [back to overview]Percentage of Participants With Disease Progression
NCT02004093 (13) [back to overview]Percentage of Participants With Disease Progression or Death
NCT02004093 (13) [back to overview]Progression-Free Survival
NCT02004093 (13) [back to overview]Time To Response
NCT02006667 (7) [back to overview]Overall Survival - Time to Event
NCT02006667 (7) [back to overview]Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
NCT02006667 (7) [back to overview]Overall Survival (OS) - Percentage of Participants With an Event
NCT02006667 (7) [back to overview]Progression-Free Survival - Time to Event
NCT02006667 (7) [back to overview]Progression-Free Survival (PFS) - Percentage of Participants With an Event
NCT02006667 (7) [back to overview]Percentage of Participants Surviving at 12 and 24 Months
NCT02006667 (7) [back to overview]Percentage of Participants Who Were Progression Free at 12 and 24 Months
NCT02009332 (3) [back to overview]Phase 1: Dose Limiting Toxicities (DLT) Following Intravesical Administration of ABI-009
NCT02009332 (3) [back to overview]Phase 1: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009
NCT02009332 (3) [back to overview]Phase 2: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009 and Gemcitabine
NCT02017015 (4) [back to overview]Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)
NCT02017015 (4) [back to overview]Kaplan-Meier Estimate of Overall Survival (OS)
NCT02017015 (4) [back to overview]Overall Response Rate (ORR) Based on Independent Radiological Review (IRR)
NCT02017015 (4) [back to overview]Duration of Response (DoR) Based on IRR According to RECIST Guidelines
NCT02030574 (2) [back to overview]Number of Participants Experiencing Toxicities With Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Bladder Cancer
NCT02030574 (2) [back to overview]Pathologic Complete Response Rate of Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Muscle Invasive Bladder Cancer Whom Are Not Candidates for High Dose Cisplatin.
NCT02037230 (4) [back to overview]Overall Survival
NCT02037230 (4) [back to overview]Time From Date of Registration to Date of Documented Disease Progression
NCT02037230 (4) [back to overview]Number of Patients With Phosphorylation Inhibition of Greater Than 0
NCT02037230 (4) [back to overview]Maximum Tolerated Dose (MTD) of AZD1775 (MK-1775) When Used Concurrently With Gemcitabine and Radiation Therapy.
NCT02041533 (6) [back to overview]Progression-Free Survival in All Randomized Participants
NCT02041533 (6) [back to overview]Disease-related Symptom Improvement Rate by Week 12
NCT02041533 (6) [back to overview]Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%
NCT02041533 (6) [back to overview]Overall Survival in All Randomized Participants
NCT02041533 (6) [back to overview]Overall Survival in Participants With PD-L1 Expression >= 5%
NCT02041533 (6) [back to overview]Progression-Free Survival in Participants With PD-L1 Expression >= 5%
NCT02047500 (1) [back to overview]Number of Subjects Experiencing Dose Limiting Toxicity (DLT)
NCT02054338 (3) [back to overview]Overall Survival
NCT02054338 (3) [back to overview]Overall Response Rate & Disease Control Rate
NCT02054338 (3) [back to overview]Progression Free Survival
NCT02079636 (15) [back to overview]PK: Area Under the Concentration Curve (AUC) of Abemaciclib in Part A, B, C, D and E
NCT02079636 (15) [back to overview]PK: Area Under the Concentration Curve (AUC) of Abemaciclib in Part A, B, C, D and E
NCT02079636 (15) [back to overview]PK: Area Under the Concentration Curve (AUC) of Active Gemcitabine Metabolite: 2',2'-Difluorodeoxyuridine (dFdU) on Day 1 and at Steady State (Cycle 2 Day 1) in Part B
NCT02079636 (15) [back to overview]PK: Area Under the Concentration Curve (AUC) of LY3023414 in Part D
NCT02079636 (15) [back to overview]PK: Dose-normalized Maximum Concentration (Cmax) of Active Gemcitabine Metabolite: 2',2'-Difluorodeoxyuridine (dFdU) on Day 1 and at Steady State (Cycle 2 Day 1) in Part B
NCT02079636 (15) [back to overview]PK: Maximum Concentration (Cmax) of LY3023414 in Part D
NCT02079636 (15) [back to overview]PK: Maximum Concentration (Cmax) of Ramucirumab at 1 Hour Post-End-of-Infusion in Part C
NCT02079636 (15) [back to overview]Pharmacokinetics: Maximum Concentration (Cmax) of Pemetrexed at Steady State in Part A
NCT02079636 (15) [back to overview]Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) in Part A, B, C, D and E
NCT02079636 (15) [back to overview]Number of Participants With Dose-Limiting Toxicities (DLT) or DLT-equivalent in Part A, B, C, D and E
NCT02079636 (15) [back to overview]PK: Area Under the Concentration Curve (AUC) of Pemetrexed at Steady State in Part A
NCT02079636 (15) [back to overview]Progression Free Survival Time in Part A, B, C, D and E
NCT02079636 (15) [back to overview]Change From Baseline in MD Anderson Symptom Inventory Scale-Lung Cancer (MDASI-LC) in Part A, B, C, D and E
NCT02079636 (15) [back to overview]Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib on Day 1 and at Steady State (Cycle 2 Day 1) in Part A , B, C, D and E
NCT02079636 (15) [back to overview]Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib on Day 1 and at Steady State (Cycle 2 Day 1) in Part A , B, C, D and E
NCT02082522 (15) [back to overview]Change From Baseline in Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
NCT02082522 (15) [back to overview]Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Change From Baseline on Karnofsky Performance Scale (KPS)
NCT02082522 (15) [back to overview]Overall Survival Time
NCT02082522 (15) [back to overview]Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
NCT02082522 (15) [back to overview]Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
NCT02082522 (15) [back to overview]Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
NCT02082522 (15) [back to overview]Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
NCT02082522 (15) [back to overview]Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
NCT02082522 (15) [back to overview]Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors)
NCT02083679 (2) [back to overview]Number of Subjects With Dose Limiting Toxicities (DLTs)
NCT02083679 (2) [back to overview]Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
NCT02101021 (4) [back to overview]Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events
NCT02101021 (4) [back to overview]Lead-In Phase: Overall Survival (OS)
NCT02101021 (4) [back to overview]Lead-In Phase: Overall Response Rate (ORR)
NCT02101021 (4) [back to overview]Lead-In Phase: Progression-Free Survival (PFS)
NCT02101775 (8) [back to overview]TP53 Mutations
NCT02101775 (8) [back to overview]Progression Free Survival
NCT02101775 (8) [back to overview]p53 Protein Expression
NCT02101775 (8) [back to overview]Overall Survival
NCT02101775 (8) [back to overview]Patient Reported Outcomes
NCT02101775 (8) [back to overview]Objective Response
NCT02101775 (8) [back to overview]Response According to CA125 Criteria
NCT02101775 (8) [back to overview]Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
NCT02106884 (6) [back to overview]Duration of Response (in Responders)
NCT02106884 (6) [back to overview]Overall Survival
NCT02106884 (6) [back to overview]Progression Free Survival
NCT02106884 (6) [back to overview]QOL Global Health Status Deterioration-free Median Survival
NCT02106884 (6) [back to overview]Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos)
NCT02106884 (6) [back to overview]Laboratory Safety Assessment
NCT02109445 (12) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 1
NCT02109445 (12) [back to overview]Systemic Clearance (CL) of Nab-paclitaxel in Phase 1
NCT02109445 (12) [back to overview]Systemic Clearance (CL) of Gemcitabine in Phase 1
NCT02109445 (12) [back to overview]Plasma Decay Half-life (t1/2) for Nab-P and GEM in Phase 1
NCT02109445 (12) [back to overview]Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 1
NCT02109445 (12) [back to overview]Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1
NCT02109445 (12) [back to overview]Number of Participants With Worsening QTc Results in Phase 1
NCT02109445 (12) [back to overview]Number of Participants With Objective Response (OR) in Phase 1
NCT02109445 (12) [back to overview]Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1
NCT02109445 (12) [back to overview]Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1
NCT02109445 (12) [back to overview]Volume of Distribution at Steady State (Vss) for Nab-P and GEM in Phase 1
NCT02109445 (12) [back to overview]Number of Participants With Laboratory Abnormalities in Phase 1
NCT02117024 (6) [back to overview]Survival at 6 Months
NCT02117024 (6) [back to overview]Survival at 12 Months
NCT02117024 (6) [back to overview]Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
NCT02117024 (6) [back to overview]Overall Survival (OS)
NCT02117024 (6) [back to overview]Time to Progression (TTP)
NCT02117024 (6) [back to overview]Progression-Free Survival (PFS)
NCT02139358 (4) [back to overview]Phase II: Objective Response Rate (ORR)
NCT02139358 (4) [back to overview]Phase II: Progression Free Survival (PFS)
NCT02139358 (4) [back to overview]Phase I: Recommended Phase II Dose (RP2D)
NCT02139358 (4) [back to overview]Overall Survival (OS)
NCT02142738 (3) [back to overview]Progression Free Survival (PFS) Rate at Month 6
NCT02142738 (3) [back to overview]Overall Survival (OS) Rate
NCT02142738 (3) [back to overview]Objective Response Rate (ORR)
NCT02145078 (2) [back to overview]Progression-free Survival (PFS)
NCT02145078 (2) [back to overview]Overall Survival (OS)
NCT02177695 (7) [back to overview]Pathologic T0 Rate Evaluation: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)
NCT02177695 (7) [back to overview]Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate
NCT02177695 (7) [back to overview]Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC
NCT02177695 (7) [back to overview]Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate
NCT02177695 (7) [back to overview]Correlation Between GC-and ddMVAC-COXEN Score
NCT02177695 (7) [back to overview]Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
NCT02177695 (7) [back to overview]Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)
NCT02178241 (4) [back to overview]Observed Overall Response Rate
NCT02178241 (4) [back to overview]Overall Survival
NCT02178241 (4) [back to overview]Progression-free Survival
NCT02178241 (4) [back to overview]Incidence of Adverse Events.
NCT02178436 (5) [back to overview]Proportion of Patients With a Response
NCT02178436 (5) [back to overview]Progression Free Survival (Phase II)
NCT02178436 (5) [back to overview]Maximum Tolerated Dose (MTD) of Selinexor, Gemcitabine Hydrochloride, and Paclitaxel Albumin-stabilized Nanoparticle Formulation Combination (Phase Ib)
NCT02178436 (5) [back to overview]Overall Survival (Phase II)
NCT02178436 (5) [back to overview]Proportion of Patients With a Toxic Event, Graded According to NCI CTCAE Version 4.03
NCT02181634 (8) [back to overview]Time To Progression (TTP)
NCT02181634 (8) [back to overview]Association Between OS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline
NCT02181634 (8) [back to overview]Association Between PFS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline
NCT02181634 (8) [back to overview]Progression-Free Survival (PFS) Rate at 6 Months (Proportion of Participants Alive and Progression-Free at 6 Months)
NCT02181634 (8) [back to overview]Overall Response Rate (ORR)
NCT02181634 (8) [back to overview]Disease Control Rate (DCR)
NCT02181634 (8) [back to overview]Overall Survival (OS)
NCT02181634 (8) [back to overview]Progression-free Survival (PFS)
NCT02194829 (1) [back to overview]Number of Participants With Dose Limiting Toxicities (DLT)
NCT02210559 (8) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
NCT02210559 (8) [back to overview]Median Progression-Free Survival
NCT02210559 (8) [back to overview]Number of Participants in Whom R0 or R1 Resection Was Achieved
NCT02210559 (8) [back to overview]Median Overall Survival
NCT02210559 (8) [back to overview]Number of Participants in Whom R0 Resection Was Achieved
NCT02210559 (8) [back to overview]Number of Participants Who Became Eligible for Surgery
NCT02210559 (8) [back to overview]Number of Participants Who Had Surgical Complications Post-Resection
NCT02210559 (8) [back to overview]Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
NCT02237157 (1) [back to overview]Determine the Maximum Tolerated Dose of Gemcitabine to be Delivered Locally to the Pancreas
NCT02243007 (8) [back to overview]Local Control Rate
NCT02243007 (8) [back to overview]Pathologic Complete Response Rate (pCR).
NCT02243007 (8) [back to overview]Correlation of Biomarkers With PFS
NCT02243007 (8) [back to overview]Rate of Pathologic Downstaging
NCT02243007 (8) [back to overview]30-day Post-operative Mortality Rate
NCT02243007 (8) [back to overview]Survival Rate at 18 Month
NCT02243007 (8) [back to overview]Surgical Morbidity Rate
NCT02243007 (8) [back to overview]Number of Participants With Serious and Non-Serious Adverse Events
NCT02254681 (3) [back to overview]Number of Participants With Post-operative Complications After Partial Hepatectomy After Antecedent Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.
NCT02254681 (3) [back to overview]Number of Participants With Intrahepatic Recurrence After Partial Hepatectomy With Antecedent Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.
NCT02254681 (3) [back to overview]Number of Participants With Intrahepatic Disease Progression After Treatment With Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.
NCT02256982 (1) [back to overview]Number of Participants Post Operative/Radiation Therapy Complications
NCT02265510 (10) [back to overview]Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
NCT02265510 (10) [back to overview]Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration of Itacitinib
NCT02265510 (10) [back to overview]Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment
NCT02265510 (10) [back to overview]Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
NCT02265510 (10) [back to overview]Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for Itacitinib
NCT02265510 (10) [back to overview]Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
NCT02265510 (10) [back to overview]Phase 2: Objective Response Rate (ORR) in Hematological Malignancies
NCT02265510 (10) [back to overview]Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
NCT02265510 (10) [back to overview]Phase 2: Number of Participants With at Least One TEAE and SAE
NCT02265510 (10) [back to overview]Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib
NCT02272790 (23) [back to overview]Single Dose Adavosertib Cmax
NCT02272790 (23) [back to overview]Progression Free Survival (Median, 80% CI)
NCT02272790 (23) [back to overview]Overall Survival (Median, 95% CI)
NCT02272790 (23) [back to overview]Overall Survival (Median, 80% CI)
NCT02272790 (23) [back to overview]Objective Response Rate (ORR)
NCT02272790 (23) [back to overview]Multiple Dose Adavosertib Tmax
NCT02272790 (23) [back to overview]Multiple Dose Adavosertib Cmax
NCT02272790 (23) [back to overview]Gynecologic Cancer Intergroup (GCIG) CA-125 Response
NCT02272790 (23) [back to overview]Duration of Response (DoR)
NCT02272790 (23) [back to overview]Disease Control Rate (DCR)
NCT02272790 (23) [back to overview]The Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) by Maximum CTCAE Grade.
NCT02272790 (23) [back to overview]The Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) Related to Adavosertib by Maximum CTCAE Grade
NCT02272790 (23) [back to overview]Progression Free Survival (Median, 95% CI)
NCT02272790 (23) [back to overview]Serious Adverse Events
NCT02272790 (23) [back to overview]Treatment-Related Adverse Events Related to Chemotherapy Leading to Treatment Interruption
NCT02272790 (23) [back to overview]Serious Adverse Events Leading to Death
NCT02272790 (23) [back to overview]Treatment-Related Adverse Events Related to Chemotherapy Leading to Treatment Discontinuation
NCT02272790 (23) [back to overview]Treatment-Related Adverse Events Related to Chemotherapy Leading to Dose Reduction
NCT02272790 (23) [back to overview]Treatment-Related Adverse Events Related to Adavosertib Leading to Treatment Interruption
NCT02272790 (23) [back to overview]Treatment-Related Adverse Events Related to Adavosertib Leading to Treatment Discontinuation
NCT02272790 (23) [back to overview]Treatment-Related Adverse Events Related to Adavosertib Leading to Dose Reduction
NCT02272790 (23) [back to overview]Single Dose Adavosertib Tmax
NCT02272790 (23) [back to overview]The Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) Related to Chemotherapy by Maximum CTCAE Grade
NCT02300610 (4) [back to overview]Progression Free Survival (PFS)
NCT02300610 (4) [back to overview]Overall Response Rate (ORR): Complete Response (CR) + Partial Response (PR)
NCT02300610 (4) [back to overview]Recommended Dose of Enzalutamide
NCT02300610 (4) [back to overview]Overall Survival (OS)
NCT02301143 (11) [back to overview]Disease Control Rate (DCR): Percentage of Participants With Complete (CR) or Partial Response (PR), or Stable Disease (SD) for ≥ 16 Weeks According to RECIST Version 1.1
NCT02301143 (11) [back to overview]Kaplan-Meier Estimate of Progression-Free Survival (PFS)
NCT02301143 (11) [back to overview]Kaplan-Meier Estimates for Overall Survival (OS)
NCT02301143 (11) [back to overview]Kaplan-Meier Estimates for Time to Treatment Failure (TTF)
NCT02301143 (11) [back to overview]Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1
NCT02301143 (11) [back to overview]Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Global Health Status and 5 Functioning Scales
NCT02301143 (11) [back to overview]Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Symptom Scales and Single Symptom Items
NCT02301143 (11) [back to overview]Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): 10 Individual Item Scores
NCT02301143 (11) [back to overview]Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Satisfaction With Health Care Scale
NCT02301143 (11) [back to overview]Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Six Summary Scales
NCT02301143 (11) [back to overview]Participants With Treatment Emergent Adverse Events (TEAEs)
NCT02303262 (3) [back to overview]Progression Free Survival (PFS)
NCT02303262 (3) [back to overview]Duration of Response
NCT02303262 (3) [back to overview]Response Rate (Per RECIST 1.1)
NCT02303977 (4) [back to overview]Progression-free Survival
NCT02303977 (4) [back to overview]Disease Control Rate
NCT02303977 (4) [back to overview]Overall Response Rate
NCT02303977 (4) [back to overview]Overall Survival
NCT02318095 (4) [back to overview]Feasibility as Measured by Number of Participants Who Complete the Neoadjuvant Gemcitabine/Nab-paclitaxel and HIGRT Regimen
NCT02318095 (4) [back to overview]Number of Participants Who Underwent Surgical Resection
NCT02318095 (4) [back to overview]Number of Participants Who Received an R0 Resection
NCT02318095 (4) [back to overview]Number of Participants Experiencing Grade >/=2 Acute Toxicity
NCT02322281 (5) [back to overview]Plasma PK for Patients Treated With Rociletinib Based on Sparse Sampling
NCT02322281 (5) [back to overview]Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
NCT02322281 (5) [back to overview]Percentage of Participants With Confirmed Response
NCT02322281 (5) [back to overview]Overall Survival (OS)
NCT02322281 (5) [back to overview]Duration of Response (DOR) According to RECIST Version 1.1 as Determined by Investigator Assessment
NCT02324543 (10) [back to overview]Maximum Tolerated Dose (MTD) of Capecitabine
NCT02324543 (10) [back to overview]Maximum Tolerated Dose (MTD) of Cisplatin
NCT02324543 (10) [back to overview]Overall Survival (OS)
NCT02324543 (10) [back to overview]Maximum Tolerated Dose (MTD) of Gemcitabine
NCT02324543 (10) [back to overview]Maximum Tolerated Dose (MTD) of Docetaxel
NCT02324543 (10) [back to overview]Maximum Tolerated Dose (MTD) of Irinotecan
NCT02324543 (10) [back to overview]Response Rate (RR) Using RECIST 1.1 Criteria
NCT02324543 (10) [back to overview]Progression-free Survival (PFS) Using RECIST 1.1 Criteria
NCT02324543 (10) [back to overview]Overall Survival (OS) Rate at 9 Months
NCT02324543 (10) [back to overview]Disease Control Rate (DCR) Using RECIST 1.1 Criteria
NCT02352948 (10) [back to overview]OS, Contribution of the Components Analysis of Sub-study B
NCT02352948 (10) [back to overview]Objective Response Rate (ORR)
NCT02352948 (10) [back to overview]Duration of Response (DoR)
NCT02352948 (10) [back to overview]Overall Survival (OS)
NCT02352948 (10) [back to overview]Percentage of Participants Alive and Progression Free at 12 Months (APF12)
NCT02352948 (10) [back to overview]Percentage of Participants Alive and Progression Free at 6 Months (APF6)
NCT02352948 (10) [back to overview]Percentage of Participants Alive at 12 Months (OS12)
NCT02352948 (10) [back to overview]PFS, Contribution of the Components Analysis of Sub-study B
NCT02352948 (10) [back to overview]Progression-Free Survival (PFS)
NCT02352948 (10) [back to overview]Time From Randomisation to Second Progression (PFS2) of Sub-study B
NCT02392637 (3) [back to overview]Median Progression Free Survival (PFS)
NCT02392637 (3) [back to overview]Median Overall Survival (OS)
NCT02392637 (3) [back to overview]Number of Participants With Treatment Response Rate
NCT02393248 (39) [back to overview]Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
NCT02393248 (39) [back to overview]Part 3: Accumulation Ratio of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
NCT02393248 (39) [back to overview]Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
NCT02393248 (39) [back to overview]Part 3: t1/2 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
NCT02393248 (39) [back to overview]Part 3: ORR
NCT02393248 (39) [back to overview]Parts 1 and 2: Tmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
NCT02393248 (39) [back to overview]Part 3: Number of Participants With Any TEAE
NCT02393248 (39) [back to overview]Part 2: Overall Response Rate (ORR)
NCT02393248 (39) [back to overview]EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
NCT02393248 (39) [back to overview]Emax Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
NCT02393248 (39) [back to overview]Parts 1 and 2: Cmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
NCT02393248 (39) [back to overview]Parts 1 and 2: Cmin After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
NCT02393248 (39) [back to overview]Parts 1 and 2: Cmin Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
NCT02393248 (39) [back to overview]Parts 1 and 2: t1/2 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
NCT02393248 (39) [back to overview]Parts 1 and 2: t1/2 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
NCT02393248 (39) [back to overview]Part 3: Cmin of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
NCT02393248 (39) [back to overview]Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
NCT02393248 (39) [back to overview]Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
NCT02393248 (39) [back to overview]Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
NCT02393248 (39) [back to overview]Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
NCT02393248 (39) [back to overview]Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
NCT02393248 (39) [back to overview]Parts 1 and 2: CL/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
NCT02393248 (39) [back to overview]Parts 1 and 2: AUClast After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
NCT02393248 (39) [back to overview]Parts 1 and 2: AUC0-24 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
NCT02393248 (39) [back to overview]Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
NCT02393248 (39) [back to overview]Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
NCT02393248 (39) [back to overview]Parts 1 and 2: Accumulation Ratio After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
NCT02393248 (39) [back to overview]Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
NCT02393248 (39) [back to overview]Parts 1 and 2: Vz/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
NCT02393248 (39) [back to overview]Parts 1 and 2: CL/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
NCT02393248 (39) [back to overview]Parts 1 and 2: Vz/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
NCT02393248 (39) [back to overview]Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
NCT02393248 (39) [back to overview]Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2
NCT02393248 (39) [back to overview]E0 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
NCT02393248 (39) [back to overview]Part 3: CL/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
NCT02393248 (39) [back to overview]Part 3: AUClast of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
NCT02393248 (39) [back to overview]Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
NCT02393248 (39) [back to overview]Part 3: Vz/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
NCT02393248 (39) [back to overview]Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
NCT02409342 (24) [back to overview]Maximum Observed Serum Concentration (Cmax) of Atezolizumab
NCT02409342 (24) [back to overview]Duration of Response (DOR) in the TC3 or IC3-WT Populations
NCT02409342 (24) [back to overview]Percentage of Participants With Anti-therapeutic Antibodies (ATAs)
NCT02409342 (24) [back to overview]OS in Participants With PD-L1 Expression
NCT02409342 (24) [back to overview]Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
NCT02409342 (24) [back to overview]Percentage of Participants Who Are Alive at 1 Year in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
NCT02409342 (24) [back to overview]Percentage of Participants Who Are Alive at 2 Years in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
NCT02409342 (24) [back to overview]OS in Participants With Blood Tumor Mutational Burden (bTMB)
NCT02409342 (24) [back to overview]Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
NCT02409342 (24) [back to overview]Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
NCT02409342 (24) [back to overview]Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations
NCT02409342 (24) [back to overview]TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations
NCT02409342 (24) [back to overview]Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations
NCT02409342 (24) [back to overview]Percentage of Participants With at Least One Adverse Event
NCT02409342 (24) [back to overview]Percentage of Participants Who Are Alive at 2 Years in the TC3 or IC3-WT Populations
NCT02409342 (24) [back to overview]Percentage of Participants Who Are Alive at 1 Year in the TC3 or IC3-WT Populations
NCT02409342 (24) [back to overview]Overall Survival (OS) in the TC3 or IC3-WT Populations
NCT02409342 (24) [back to overview]Progression-free Survival (PFS) in the TC3 or IC3-WT Populations
NCT02409342 (24) [back to overview]Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
NCT02409342 (24) [back to overview]Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
NCT02409342 (24) [back to overview]Duration of Response (DOR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
NCT02409342 (24) [back to overview]Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1
NCT02409342 (24) [back to overview]Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1
NCT02409342 (24) [back to overview]Minimum Observed Serum Concentration (Cmin) of Atezolizumab
NCT02412670 (7) [back to overview]Cumulative Incidence of Cancer-specific Death at 24 Months
NCT02412670 (7) [back to overview]Complete Pathologic Response Rate
NCT02412670 (7) [back to overview]Event-free Survival
NCT02412670 (7) [back to overview]Proportion of Patients With Renal Insufficiency at Completion of Chemotherapy
NCT02412670 (7) [back to overview]Recurrence-free Survival
NCT02412670 (7) [back to overview]Bladder Cancer-free Survival
NCT02412670 (7) [back to overview]Proportion of Patients With Renal Insufficiency at Completion of Surgery
NCT02427841 (6) [back to overview]Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0
NCT02427841 (6) [back to overview]Overall Survival Rate Defined as the Percentage of Subjects Alive at the 2 Year Time Point
NCT02427841 (6) [back to overview]Overall Survival Rate Defined as the Percentage of Subjects Alive at the One Year Time Point
NCT02427841 (6) [back to overview]R0 Resection Rate Defined as Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins by Pathologic Assessment
NCT02427841 (6) [back to overview]Relapse-free Survival Rate Defined as the Percentage of Subjects Who Are Without Recurrence or Death at One Year From Surgical Resection of the Primary Tumor
NCT02427841 (6) [back to overview]Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Defined as the Percent of Subjects With Complete or Partial Disease Response as Confirmed Through Tumor Imaging With Computed Tomography (CT)
NCT02435680 (13) [back to overview]Tumor Response Per RECIST v1.1 (by Local Investigator Assessment) Duration of Response
NCT02435680 (13) [back to overview]Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)
NCT02435680 (13) [back to overview]Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)
NCT02435680 (13) [back to overview]MCS110 Dose Intensity
NCT02435680 (13) [back to overview]Free MCS110 : Derived Pharmacokinetics (PK) Parameters: Cmax
NCT02435680 (13) [back to overview]Free MCS110 : Derived Pharmacokinetics (PK) Parameters: AUCtau
NCT02435680 (13) [back to overview]Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
NCT02435680 (13) [back to overview]Circulating Monocytes Cells in Blood
NCT02435680 (13) [back to overview]Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
NCT02435680 (13) [back to overview]AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
NCT02435680 (13) [back to overview]Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
NCT02435680 (13) [back to overview]Tumor Associated Macrophage (TAM) and Tumor Infiltrating Lymphocyte (TIL) Content in Pre- and Post-dose Tumor Biopsies.
NCT02435680 (13) [back to overview]Number of Patients With at Least One MCS110 Dose Reduction, and Number of Patients With at Least One MCS110 Dose Interruption
NCT02436668 (8) [back to overview]Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.
NCT02436668 (8) [back to overview]Clinical Benefit Response
NCT02436668 (8) [back to overview]Rate of Venous Thromboembolic Events (VTE)
NCT02436668 (8) [back to overview]Progression Free Survival (PFS)
NCT02436668 (8) [back to overview]Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
NCT02436668 (8) [back to overview]Overall Survival (OS)
NCT02436668 (8) [back to overview]Overall Response Rate
NCT02436668 (8) [back to overview]Carbohydrate Antigen 19-9 (CA19-9) Response
NCT02446600 (4) [back to overview]Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
NCT02446600 (4) [back to overview]Frequency and Severity of Adverse Effects
NCT02446600 (4) [back to overview]Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria
NCT02446600 (4) [back to overview]Overall Survival
NCT02448537 (3) [back to overview]Treatment Related Serious Adverse Events
NCT02448537 (3) [back to overview]Disease Control Rate
NCT02448537 (3) [back to overview]Overall Response Rate
NCT02453282 (29) [back to overview]Number of Participants With ADA Response to Tremelimumab
NCT02453282 (29) [back to overview]Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at 12 Months
NCT02453282 (29) [back to overview]Cmax_ss of Tremelimumab
NCT02453282 (29) [back to overview]Trough Serum Concentration at Steady State (Ctrough_ss) of Durvalumab
NCT02453282 (29) [back to overview]Time From Randomization to Second Progression (PFS2); PD-L1 (TC >=25%) Analysis Set Population
NCT02453282 (29) [back to overview]Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy
NCT02453282 (29) [back to overview]PFS2; FAS Population
NCT02453282 (29) [back to overview]PFS; PD-L1 (TC >=1%) Analysis Set Population
NCT02453282 (29) [back to overview]Ctrough_ss of Tremelimumab
NCT02453282 (29) [back to overview]Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population
NCT02453282 (29) [back to overview]DoR; FAS Population
NCT02453282 (29) [back to overview]PFS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs Durvalumab Monotherapy
NCT02453282 (29) [back to overview]PFS2; PD-L1 (TC >=1%) Analysis Set Population
NCT02453282 (29) [back to overview]Serum Concentrations of Tremelimumab
NCT02453282 (29) [back to overview]Serum Concentrations of Durvalumab
NCT02453282 (29) [back to overview]Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab
NCT02453282 (29) [back to overview]PFS; FAS Population
NCT02453282 (29) [back to overview]Percentage of Participants APF12; PD-L1 (TC >=1%) Analysis Set Population
NCT02453282 (29) [back to overview]Percentage of Participants APF12; FAS Population
NCT02453282 (29) [back to overview]Percentage of Participants Alive and Progression Free at 12 Months (APF12); PD-L1 (TC >=25%) Analysis Set Population
NCT02453282 (29) [back to overview]Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy
NCT02453282 (29) [back to overview]OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy
NCT02453282 (29) [back to overview]OS; PD-L1 (TC >=1%) Analysis Set Population
NCT02453282 (29) [back to overview]OS; FAS Population
NCT02453282 (29) [back to overview]ORR; PD-L1 (TC >=1%) Analysis Set Population
NCT02453282 (29) [back to overview]ORR; FAS Population
NCT02453282 (29) [back to overview]Maximum Serum Concentration at Steady State (Cmax_ss) of Durvalumab
NCT02453282 (29) [back to overview]Duration of Response (DoR); PD-L1 (TC >=25%) Analysis Set Population
NCT02453282 (29) [back to overview]DoR; PD-L1 (TC >=1%) Analysis Set Population
NCT02511132 (3) [back to overview]Progression Free Survival
NCT02511132 (3) [back to overview]Overall Survival
NCT02511132 (3) [back to overview]Number of Participants With Adverse Events Determined by Laboratory Assessments and Physical Examinations
NCT02516241 (40) [back to overview]Alive at 24 Months (OS24), PD-L1-Low/Negative Analysis Set
NCT02516241 (40) [back to overview]PFS2, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
NCT02516241 (40) [back to overview]To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set
NCT02516241 (40) [back to overview]Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
NCT02516241 (40) [back to overview]PFS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
NCT02516241 (40) [back to overview]Alive and Progression-free at 12 Months (APF12), Full Analysis Set
NCT02516241 (40) [back to overview]Alive and Progression-free at 12 Months (APF12), PD-L1-High Analysis Set
NCT02516241 (40) [back to overview]Alive and Progression-free at 12 Months (APF12), PD-L1-Low/Negative Analysis Set
NCT02516241 (40) [back to overview]Alive at 24 Months (OS24), Full Analysis Set
NCT02516241 (40) [back to overview]Alive at 24 Months (OS24), PD-L1-High Analysis Set
NCT02516241 (40) [back to overview]Duration of Response (DoR), PD-L1-Low/Negative Analysis Set
NCT02516241 (40) [back to overview]Improvement in Fatigue and Deterioration in Pain Per FACT-BL, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
NCT02516241 (40) [back to overview]Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
NCT02516241 (40) [back to overview]Disease Control Rate (DCR) at 12 Months, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
NCT02516241 (40) [back to overview]Disease Control Rate (DCR) at 12 Months, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
NCT02516241 (40) [back to overview]Disease Control Rate (DCR) at 6 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
NCT02516241 (40) [back to overview]Disease Control Rate (DCR) at 6 Months, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
NCT02516241 (40) [back to overview]Disease Control Rate (DCR) at 6 Months, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
NCT02516241 (40) [back to overview]Disease Control Rate (DCR) at 12 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
NCT02516241 (40) [back to overview]Duration of Response (DoR), Full Analysis Set
NCT02516241 (40) [back to overview]Duration of Response (DoR), PD-L1-High Analysis Set
NCT02516241 (40) [back to overview]Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
NCT02516241 (40) [back to overview]Objective Response Rate (ORR) Based on BICR Assessment According to RECIST 1.1 - Responses Are Confirmed - Durvalumab Cisplatin Ineligible Population
NCT02516241 (40) [back to overview]Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
NCT02516241 (40) [back to overview]Objective Response Rate (ORR), PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
NCT02516241 (40) [back to overview]Objective Response Rate (ORR), PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
NCT02516241 (40) [back to overview]OS, Full Analysis Set - Durvalumab Monotherapy vs SoC
NCT02516241 (40) [back to overview]Serum Concentrations of Tremelimumab, Pharmacokinetic Analysis Set
NCT02516241 (40) [back to overview]Serum Concentrations of Durvalumab, Pharmacokinetic Analysis Set
NCT02516241 (40) [back to overview]Number of Participants With Anti-Drug Antibody (ADA) Response to Tremelimumab, Safety Analysis Set - ADA Evaluable Patients
NCT02516241 (40) [back to overview]Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab, Safety Analysis Set - ADA Evaluable Patients
NCT02516241 (40) [back to overview]OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
NCT02516241 (40) [back to overview]PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
NCT02516241 (40) [back to overview]PFS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
NCT02516241 (40) [back to overview]To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set
NCT02516241 (40) [back to overview]OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC
NCT02516241 (40) [back to overview]PFS2, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
NCT02516241 (40) [back to overview]PFS2, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
NCT02516241 (40) [back to overview]Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
NCT02516241 (40) [back to overview]Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
NCT02525653 (1) [back to overview]Overall Response Rate
NCT02533674 (2) [back to overview]Number of Participants With Clinical Benefit
NCT02533674 (2) [back to overview]Number of Participants With Dose Limiting Toxicities
NCT02542293 (20) [back to overview]Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]Serum Concentrations of Durvalumab
NCT02542293 (20) [back to overview]Serum Concentrations of Tremelimumab
NCT02542293 (20) [back to overview]DoR; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets
NCT02542293 (20) [back to overview]APF12; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets
NCT02542293 (20) [back to overview]OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set
NCT02542293 (20) [back to overview]Time From Randomization to Second Progression or Death (PFS2); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set
NCT02542293 (20) [back to overview]Alive and Progression-Free at 12 Months (APF12); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]Duration of Response (DoR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]Number of Participants With ADA Response to Tremelimumab
NCT02542293 (20) [back to overview]Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab
NCT02542293 (20) [back to overview]Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]ORR; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets
NCT02542293 (20) [back to overview]OS at Months 12, 18 and 24; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets
NCT02542293 (20) [back to overview]OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]OS; Global and China Cohorts: FAS, PD-L1 Tumor Cell (TC) ≥25%, and PD-L1 TC ≥50% Analysis Sets
NCT02542293 (20) [back to overview]OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets
NCT02542293 (20) [back to overview]PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets
NCT02542293 (20) [back to overview]PFS2; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets
NCT02555657 (17) [back to overview]Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10
NCT02555657 (17) [back to overview]Overall Survival in All Participants
NCT02555657 (17) [back to overview]Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 Who Had a Confirmed Response
NCT02555657 (17) [back to overview]Overall Survival in Participants With PD-L1 CPS ≥1
NCT02555657 (17) [back to overview]Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
NCT02555657 (17) [back to overview]Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥10
NCT02555657 (17) [back to overview]Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 Who Had a Confirmed Response
NCT02555657 (17) [back to overview]Duration of Response Per RECIST 1.1 in All Participants Who Had a Confirmed Response
NCT02555657 (17) [back to overview]Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
NCT02555657 (17) [back to overview]Disease Control Rate Per RECIST 1.1 in All Participants
NCT02555657 (17) [back to overview]Overall Response Rate Per RECIST 1.1 in All Participants
NCT02555657 (17) [back to overview]Overall Response Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
NCT02555657 (17) [back to overview]Number of Participants Who Experienced One or More Adverse Events
NCT02555657 (17) [back to overview]Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥10
NCT02555657 (17) [back to overview]Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
NCT02555657 (17) [back to overview]Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10
NCT02555657 (17) [back to overview]Progression-Free Survival Per RECIST 1.1 in All Participants
NCT02560038 (3) [back to overview]Safety of Drug Regimen as Measured by Number of Adverse Events
NCT02560038 (3) [back to overview]Efficacy as Measured by Number Who Progressed
NCT02560038 (3) [back to overview]Efficacy as Measured by the Objective Response Rate (ORR).
NCT02562716 (6) [back to overview]Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1.
NCT02562716 (6) [back to overview]Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy.
NCT02562716 (6) [back to overview]Number of Patients Achieving R0 Resection After Preoperative Chemotherapy.
NCT02562716 (6) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT02562716 (6) [back to overview]Disease-free Survival From the Time of R0 or R1 Resection.
NCT02562716 (6) [back to overview]Overall Survival (OS)
NCT02562898 (6) [back to overview]CA19-9 Clinical Response Rate
NCT02562898 (6) [back to overview]Maximum Tolerated Dose (MTD)
NCT02562898 (6) [back to overview]Median Overall Survival (OS)
NCT02562898 (6) [back to overview]Median Progression-free Survival (PFS)
NCT02562898 (6) [back to overview]Median Time-to-progression (TTP)
NCT02562898 (6) [back to overview]Number of Patients Who Experienced a Dose-Limiting Toxicity (DLT)
NCT02567409 (4) [back to overview]Treatment Limiting Adverse Events
NCT02567409 (4) [back to overview]Confirmed Objective Response Rate
NCT02567409 (4) [back to overview]Progression-free Survival (PFS)
NCT02567409 (4) [back to overview]Overall Survival (OS)
NCT02570711 (1) [back to overview]Overall Response Rate (ORR)
NCT02574078 (7) [back to overview]Progression-Free Survival (PFS), Group E Only
NCT02574078 (7) [back to overview]Duration of Response (DOR), Groups A-D Only
NCT02574078 (7) [back to overview]Progression-Free Survival (PFS), Groups A-D Only
NCT02574078 (7) [back to overview]Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only
NCT02574078 (7) [back to overview]Overall Survival (OS), Groups A-C Only
NCT02574078 (7) [back to overview]Overall Survival (OS), Group D Only
NCT02574078 (7) [back to overview]Objective Response Rate (ORR), Groups A-E
NCT02574455 (14) [back to overview]Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug
NCT02574455 (14) [back to overview]Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Overall Survival (OS) in BM-ve Population
NCT02574455 (14) [back to overview]Progression-Free Survival (PFS) by IRC Assessment in the ITT Population
NCT02574455 (14) [back to overview]Time to Objective Response by the IRC Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Time to Progression (TTP) by Investigator Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Time to Progression (TTP) by IRC Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Overall Survival (OS) in ITT Population
NCT02574455 (14) [back to overview]Time to Objective Response by the Investigator Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population
NCT02574455 (14) [back to overview]Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline
NCT02574455 (14) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score
NCT02576574 (32) [back to overview]Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
NCT02576574 (32) [back to overview]Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Modified Full Analysis Set
NCT02576574 (32) [back to overview]Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Full Analysis Set
NCT02576574 (32) [back to overview]Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Modified Full Analysis Set
NCT02576574 (32) [back to overview]Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set
NCT02576574 (32) [back to overview]Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
NCT02576574 (32) [back to overview]Number of Participants With At Least One Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab
NCT02576574 (32) [back to overview]Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score
NCT02576574 (32) [back to overview]Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase
NCT02576574 (32) [back to overview]Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease
NCT02576574 (32) [back to overview]Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)
NCT02576574 (32) [back to overview]Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS)
NCT02576574 (32) [back to overview]Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)
NCT02576574 (32) [back to overview]Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Full Analysis Set
NCT02576574 (32) [back to overview]Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters
NCT02576574 (32) [back to overview]Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Weight Increase/Decrease
NCT02576574 (32) [back to overview]Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease
NCT02576574 (32) [back to overview]Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease
NCT02576574 (32) [back to overview]Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set
NCT02576574 (32) [back to overview]Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
NCT02576574 (32) [back to overview]Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03
NCT02576574 (32) [back to overview]Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High PD-L1+ Health-related Quality of Life (HRQoL) Analysis Set at End of Treatment
NCT02576574 (32) [back to overview]Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)
NCT02576574 (32) [back to overview]Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
NCT02576574 (32) [back to overview]Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
NCT02576574 (32) [back to overview]Overall Survival (OS) in Full Analysis Set (FAS)
NCT02576574 (32) [back to overview]Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)
NCT02576574 (32) [back to overview]Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
NCT02576574 (32) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and AEs of Special Interest (AESIs)
NCT02576574 (32) [back to overview]Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)
NCT02576574 (32) [back to overview]Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
NCT02576574 (32) [back to overview]Overall Survival (OS) in Modified Full Analysis Set (mFAS)
NCT02578641 (2) [back to overview]Progression-free Survival (PFS) of Subjects With Advanced Nasopharyngeal Carcinoma.
NCT02578641 (2) [back to overview]Overall Survival (OS) of Subjects With Advanced Nasopharyngeal Carcinoma.
NCT02583477 (14) [back to overview]Objective Response Rate (ORR) in Cohort 2
NCT02583477 (14) [back to overview]Mean Plasma Concentrations of MEDI4736 in Cohort 2
NCT02583477 (14) [back to overview]Number of Participants With Dose-Limiting Toxicities (DLT)
NCT02583477 (14) [back to overview]Median Progression-Free Survival (PFS) in Cohort 2
NCT02583477 (14) [back to overview]Median Overall Survival (OS) in Cohort 2
NCT02583477 (14) [back to overview]Number of Participants With AEs
NCT02583477 (14) [back to overview]Number of Participants With Anti-Drug Antibody (ADAs) for MEDI4736 in Cohort 2
NCT02583477 (14) [back to overview]Duration of Response (DoR) in Cohort 2
NCT02583477 (14) [back to overview]Progression-Free Survival Rate at 3 Months (PFS3) in Cohort 2
NCT02583477 (14) [back to overview]Overall Survival at 6 Months (OS6) in Cohort 2
NCT02583477 (14) [back to overview]Overall Survival at 12 Months (OS12) in Cohort 2
NCT02583477 (14) [back to overview]Disease Control Rate (DCR) in Cohort 2
NCT02583477 (14) [back to overview]Mean Plasma Concentrations of AZD5069 in Cohort 2
NCT02583477 (14) [back to overview]Progression-Free Survival Rate at 6 Months (PFS6) in Cohort 2
NCT02595892 (10) [back to overview]Duration of Response
NCT02595892 (10) [back to overview]Progression Free Survival at 6 Months (PFS-6)
NCT02595892 (10) [back to overview]Progression Free Survival (PFS)
NCT02595892 (10) [back to overview]Percentage of Patients With a Reduction in CA-125
NCT02595892 (10) [back to overview]Overall Survival (OS)
NCT02595892 (10) [back to overview]Objective Response Rate (ORR)
NCT02595892 (10) [back to overview]Number of Participants With Serious Adverse Events (SAEs)
NCT02595892 (10) [back to overview]Clinical Benefit Rate (CBR)
NCT02595892 (10) [back to overview]Duration of Response
NCT02595892 (10) [back to overview]Objective Response Rate by Platinum Free Status
NCT02608229 (7) [back to overview]Overall Survival (OS)
NCT02608229 (7) [back to overview]Progression-free Survival (PFS)
NCT02608229 (7) [back to overview]Time to Tumor Progression (TTP)
NCT02608229 (7) [back to overview]Safety and Toxicity Profile of Treatment Regimen as Measured by Grade and Frequency of Adverse Events
NCT02608229 (7) [back to overview]Response Rate
NCT02608229 (7) [back to overview]Biochemical Response of Treatment Regimen
NCT02608229 (7) [back to overview]Maximum Tolerated Dose (MTD) of BVD-523
NCT02608684 (7) [back to overview]Time to Progression
NCT02608684 (7) [back to overview]Overall Survival (OS)
NCT02608684 (7) [back to overview]Duration of Response
NCT02608684 (7) [back to overview]Progression-free Survival (PFS) at 6 Months and at 12 Months
NCT02608684 (7) [back to overview]Overall Response Rate by iRECIST
NCT02608684 (7) [back to overview]Overall Response Rate (ORR)
NCT02608684 (7) [back to overview]Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation
NCT02611037 (4) [back to overview]Disease Control Rate (DCR)
NCT02611037 (4) [back to overview]Progression Free Survival (PFS)
NCT02611037 (4) [back to overview]Overall Survival (OS)
NCT02611037 (4) [back to overview]Occurrence of Treatment Related Toxicity
NCT02611960 (10) [back to overview]Overall Survival (OS)
NCT02611960 (10) [back to overview]Percentage of Participants Who Experience One or More Adverse Events (AEs)
NCT02611960 (10) [back to overview]Percentage of Participants Who Discontinue Study Treatment Due to an AE
NCT02611960 (10) [back to overview]Percentage of Participants Surviving (OS Rate) at 24 Months
NCT02611960 (10) [back to overview]Percentage of Participants Surviving (OS Rate) at 12 Months
NCT02611960 (10) [back to overview]Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
NCT02611960 (10) [back to overview]Objective Response Rate (ORR) Per RECIST 1.1
NCT02611960 (10) [back to overview]Duration of Response (DOR) Per RECIST 1.1
NCT02611960 (10) [back to overview]Percentage of Participants With PFS (PFS Rate) at 12 Months
NCT02611960 (10) [back to overview]Percentage of Participants With PFS (PFS Rate) at 6 Months
NCT02620865 (3) [back to overview]Incidence of Toxicity (CTCAE Version 4.0)
NCT02620865 (3) [back to overview]Progression Free Survival (PFS)
NCT02620865 (3) [back to overview]Median Overall Survival (OS)
NCT02631590 (3) [back to overview]Overall Survival (OS)
NCT02631590 (3) [back to overview]Response Rate
NCT02631590 (3) [back to overview]Progression Free Survival (PFS)
NCT02659020 (18) [back to overview]Phase 1b: PK: Elimination Half-Life (T1/2) of Olaratumab
NCT02659020 (18) [back to overview]Phase 1b/2: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Docetaxel
NCT02659020 (18) [back to overview]Phase 1b: PK: Minimum Serum Concentration (Cmin) of Olaratumab
NCT02659020 (18) [back to overview]Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab
NCT02659020 (18) [back to overview]Phase 2: Progression Free Survival (PFS)
NCT02659020 (18) [back to overview]Phase 2: Percentage of Participants With a Complete or Partial Response (Objective Response Rate [ORR])
NCT02659020 (18) [back to overview]Phase 2: Overall Survival (OS) (Olaratumab-Naive)
NCT02659020 (18) [back to overview]Phase 2: Overall Survival (Olaratumab Pre-Treated)
NCT02659020 (18) [back to overview]Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
NCT02659020 (18) [back to overview]Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
NCT02659020 (18) [back to overview]Phase 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD)
NCT02659020 (18) [back to overview]Phase 1b/2: Population PK: Volume of Distribution at Steady State (Vss) of Olaratumab
NCT02659020 (18) [back to overview]Phase 1b/2: PK: Cmax of Gemcitabine
NCT02659020 (18) [back to overview]Phase 1b/2: PK: Cmax of Docetaxel
NCT02659020 (18) [back to overview]Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)
NCT02659020 (18) [back to overview]"Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) Worst Pain Score"
NCT02659020 (18) [back to overview]Phase 1b/2: Population PK: Clearance of Olaratumab
NCT02659020 (18) [back to overview]Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.
NCT02690558 (3) [back to overview]Number of Participants With Treatment Related Adverse Events.
NCT02690558 (3) [back to overview]Percentage of Subjects That Reach Complete Pathologic Response (pT0) at the Time of Cystectomy
NCT02690558 (3) [back to overview]Percentage of Subjects That Reach Pathological Downstaging (Response) at the Time of Cystectomy
NCT02694536 (6) [back to overview]Overall Survival (OS)
NCT02694536 (6) [back to overview]Percentage of Participants Who Died
NCT02694536 (6) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT02694536 (6) [back to overview]Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)
NCT02694536 (6) [back to overview]European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
NCT02694536 (6) [back to overview]Progression-Free Survival (PFS) According to RECIST
NCT02695771 (2) [back to overview]Freedom From Bladder Stones/Dystrophic Calcification
NCT02695771 (2) [back to overview]Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03
NCT02704156 (6) [back to overview]One- and Two-year Progression Survival Rate Will be Determined. Will be Determined.
NCT02704156 (6) [back to overview]The Quality of Life Will be Analyzed.
NCT02704156 (6) [back to overview]Treatment-related Adverse Effects Will be Determined.
NCT02704156 (6) [back to overview]The Median Progression Free Survival Time Will be Determined.
NCT02704156 (6) [back to overview]The Median Survival Time Will be Determined.
NCT02704156 (6) [back to overview]One- and Two-year Overall Survival Rate Will be Determined.
NCT02711137 (17) [back to overview]AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy
NCT02711137 (17) [back to overview]AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy
NCT02711137 (17) [back to overview]Objective Response Rate (ORR) With INCB057643 in Solid Tumors
NCT02711137 (17) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAE's).
NCT02711137 (17) [back to overview]Percent Inhibition of Total Cellular Myc Protein Concentrations Before and After Administration of INCB057643 When Administered as Monotherapy in an Ex-vivo Assay
NCT02711137 (17) [back to overview]Part 2 - Cmax: Maximum Observed Plasma Concentration of INCB057643.
NCT02711137 (17) [back to overview]Tmax: Time to Maximum Plasma Concentration of INCB057643
NCT02711137 (17) [back to overview]Part 2-Tmax: Time to Maximum Plasma Concentration of INCB057643
NCT02711137 (17) [back to overview]Objective Response Rate (ORR) With INCB057643 in Solid Tumors
NCT02711137 (17) [back to overview]Cmax: Maximum Observed Plasma Concentration of INCB057643.
NCT02711137 (17) [back to overview]Objective Response Rate (ORR) With INCB057643 in Solid Tumors
NCT02711137 (17) [back to overview]AUC0-t: Area Under the Single-dose Plasma Concentration-time Curve of INCB057643
NCT02711137 (17) [back to overview]Objective Response Rate (ORR) With INCB057643 in Solid Tumors
NCT02711137 (17) [back to overview]Objective Response Rate (ORR) With INCB057643 in Solid Tumors
NCT02711137 (17) [back to overview]Objective Response Rate (ORR) With INCB057643 in Solid Tumors
NCT02711137 (17) [back to overview]Objective Response Rate (ORR) With INCB057643 in Solid Tumors
NCT02711137 (17) [back to overview]Objective Response Rate (ORR) With INCB057643 in Solid Tumors
NCT02711553 (9) [back to overview]Progression Free Survival (PFS)
NCT02711553 (9) [back to overview]Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
NCT02711553 (9) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep)
NCT02711553 (9) [back to overview]Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
NCT02711553 (9) [back to overview]Overall Survival (OS)
NCT02711553 (9) [back to overview]Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)
NCT02711553 (9) [back to overview]Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
NCT02711553 (9) [back to overview]Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
NCT02711553 (9) [back to overview]Change From Baseline in Participant-Reported EQ-5D-5L Visual Analog Scale (VAS) Score
NCT02715804 (8) [back to overview]Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
NCT02715804 (8) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs)
NCT02715804 (8) [back to overview]Duration of Response (DOR)
NCT02715804 (8) [back to overview]Number of Participants With Worst Post-Baseline Hematology and Chemistry (Clinical Laboratory Parameters) Severity Grade During the Study
NCT02715804 (8) [back to overview]Number of Participants With Clinically Significant Abnormalities in Vital Signs
NCT02715804 (8) [back to overview]Progression-Free Survival (PFS)
NCT02715804 (8) [back to overview]Overall Survival
NCT02715804 (8) [back to overview]Objective Response Rate (ORR): Percentage of Participants With Objective Response
NCT02732938 (20) [back to overview]PF-04136309 Minimum Observed Plasma Concentration (Cmin) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]
NCT02732938 (20) [back to overview]PF-04136309 Maximum Observed Plasma Concentration (Cmax) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]
NCT02732938 (20) [back to overview]PF-04136309 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]
NCT02732938 (20) [back to overview]PF-04136309 Maximum Observed Plasma Concentration (Cmax) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]
NCT02732938 (20) [back to overview]Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b]
NCT02732938 (20) [back to overview]PF-04136309 Time to Reach Maximum Observed Plasma Concentration (Tmax) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]
NCT02732938 (20) [back to overview]PF-04136309 Minimum Observed Plasma Concentration (Cmin) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]
NCT02732938 (20) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Phase 1b]
NCT02732938 (20) [back to overview]PF-04136309 Apparent Oral Clearance (CL/F) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]
NCT02732938 (20) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity [Phase 1b]
NCT02732938 (20) [back to overview]Number of Participants With Urinalysis Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b]
NCT02732938 (20) [back to overview]Objective Response Rate (ORR) [Phase 1b]
NCT02732938 (20) [back to overview]PF-04136309 Apparent Oral Clearance (CL/F) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]
NCT02732938 (20) [back to overview]PF-04136309 Apparent Volume of Distribution (Vz/F) for Cycle 1 Day 15 [Phase 1b]
NCT02732938 (20) [back to overview]PF-04136309 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]
NCT02732938 (20) [back to overview]Number of Participants With Dose-Limiting Toxicities (DLTs) [Phase 1b]
NCT02732938 (20) [back to overview]Number of Participants With Hematology Laboratory Abnormalities by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Phase 1b]
NCT02732938 (20) [back to overview]PF-04136309 Time to Reach Maximum Observed Plasma Concentration (Tmax) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]
NCT02732938 (20) [back to overview]PF-04136309 Plasma Decay Half-Life (t1/2) for Cycle 1 Day 15 [Phase 1b]
NCT02732938 (20) [back to overview]Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b]
NCT02769832 (3) [back to overview]Time to Progression
NCT02769832 (3) [back to overview]Progression-Free Survival
NCT02769832 (3) [back to overview]Overall Survival
NCT02807636 (19) [back to overview]Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
NCT02807636 (19) [back to overview]Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
NCT02807636 (19) [back to overview]Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
NCT02807636 (19) [back to overview]Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
NCT02807636 (19) [back to overview]Investigator-Assessed Progression-Free Survival (INV-PFS) in Participants Treated With Atezolizumab Monotherapy Arm Compared With Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
NCT02807636 (19) [back to overview]OS Event Free Rate in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
NCT02807636 (19) [back to overview]Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
NCT02807636 (19) [back to overview]Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
NCT02807636 (19) [back to overview]Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
NCT02807636 (19) [back to overview]Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
NCT02807636 (19) [back to overview]Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
NCT02807636 (19) [back to overview]Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs)
NCT02807636 (19) [back to overview]Minimum Atezolizumab Serum Concentration
NCT02807636 (19) [back to overview]PFS Event Free Rate
NCT02807636 (19) [back to overview]Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
NCT02807636 (19) [back to overview]Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
NCT02807636 (19) [back to overview]IRF-PFS
NCT02807636 (19) [back to overview]Maximum Atezolizumab Serum Concentration
NCT02807636 (19) [back to overview]OS Event Free Rate Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
NCT02819518 (25) [back to overview]Part 2: DOR - Participants With PD-L1 CPS ≥10 Tumors
NCT02819518 (25) [back to overview]Part 2: Duration of Response (DOR) - All Participants
NCT02819518 (25) [back to overview]Part 2: Objective Response Rate (ORR) - All Participants
NCT02819518 (25) [back to overview]Part 2: ORR - Participants With PD-L1 CPS ≥1 Tumors
NCT02819518 (25) [back to overview]Part 2: ORR - Participants With PD-L1 CPS ≥10 Tumors
NCT02819518 (25) [back to overview]Part 2: OS - Participants With PD-L1 CPS ≥1 Tumors
NCT02819518 (25) [back to overview]Part 2: OS - Participants With PD-L1 CPS ≥10 Tumors
NCT02819518 (25) [back to overview]Part 2: Overall Survival (OS) - All Participants
NCT02819518 (25) [back to overview]Part 2: Percentage of Participants Who Discontinued Study Drug Due to an AE- All Participants
NCT02819518 (25) [back to overview]Part 2: Percentage of Participants Who Experienced an AE- All Participants
NCT02819518 (25) [back to overview]Part 2: PFS - Participants With PD-L1 CPS ≥10 Tumors
NCT02819518 (25) [back to overview]Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors
NCT02819518 (25) [back to overview]Part 2: Progression-Free Survival (PFS) - All Participants
NCT02819518 (25) [back to overview]Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants
NCT02819518 (25) [back to overview]Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants
NCT02819518 (25) [back to overview]Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score - Participants With PD-L1 CPS ≥1 Tumors
NCT02819518 (25) [back to overview]Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score-Participants With PD-L1 CPS ≥10 Tumors
NCT02819518 (25) [back to overview]Part 2: Change From Baseline to Week 15 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score- All Participants
NCT02819518 (25) [back to overview]Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)-All Participants
NCT02819518 (25) [back to overview]Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 - Participants With PD-L1 CPS ≥1 Tumors
NCT02819518 (25) [back to overview]Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23- Participants With PD-L1 CPS ≥10 Tumors
NCT02819518 (25) [back to overview]Part 2: DCR - Participants With PD-L1 CPS ≥1 Tumors
NCT02819518 (25) [back to overview]Part 2: Disease Control Rate (DCR) - All Participants
NCT02819518 (25) [back to overview]Part 2: DCR - Participants With PD-L1 CPS ≥10 Tumors
NCT02819518 (25) [back to overview]Part 2: DOR - Participants With PD-L1 CPS ≥1 Tumors
NCT02853305 (20) [back to overview]Pembro Combo vs Chemo: Duration of Response (DOR) Using RECIST 1.1 as Assessed by BICR
NCT02853305 (20) [back to overview]Pembro vs Chemo: PFS Using RECIST 1.1 as Assessed by BICR
NCT02853305 (20) [back to overview]Pembro vs Chemo: TTD in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score
NCT02853305 (20) [back to overview]PFS Using RECIST 1.1 as Assessed by BICR at 12 Months
NCT02853305 (20) [back to overview]Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10%
NCT02853305 (20) [back to overview]Pembro Combo vs Chemo: Objective Response Rate (ORR) Using RECIST 1.1 as Assessed by BICR
NCT02853305 (20) [back to overview]Number of Participants Who Discontinue Study Drug Due to an AE
NCT02853305 (20) [back to overview]Number of Participants Who Experience an Adverse Event (AE)
NCT02853305 (20) [back to overview]PFS Using RECIST 1.1 as Assessed by BICR at 18 Months
NCT02853305 (20) [back to overview]Pembro Combo vs Chemo: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
NCT02853305 (20) [back to overview]Pembro Combo vs Chemo: Disease Control Rate (DCR) Using RECIST 1.1 as Assessed by BICR
NCT02853305 (20) [back to overview]Pembro Combo vs Chemo: Overall Survival (OS)
NCT02853305 (20) [back to overview]Pembro Combo vs Chemo: Progression-free Survival (PFS) Using Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
NCT02853305 (20) [back to overview]Pembro Combo vs Chemo: Time to Deterioration (TTD) in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score
NCT02853305 (20) [back to overview]Pembro vs Chemo: Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score
NCT02853305 (20) [back to overview]Pembro vs Chemo: DCR Using RECIST 1.1 as Assessed by BICR
NCT02853305 (20) [back to overview]Pembro vs Chemo: DOR Using RECIST 1.1 as Assessed by BICR
NCT02853305 (20) [back to overview]Pembro vs Chemo: ORR Using RECIST 1.1 as Assessed by BICR
NCT02853305 (20) [back to overview]Pembro vs Chemo: OS
NCT02853305 (20) [back to overview]PFS Using RECIST 1.1 as Assessed by BICR at 6 Months
NCT02855944 (12) [back to overview]Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population)
NCT02855944 (12) [back to overview]Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (Efficacy Population)
NCT02855944 (12) [back to overview]Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (ITT Population)
NCT02855944 (12) [back to overview]Overall Survival (Efficacy Population)
NCT02855944 (12) [back to overview]Overall Survival (ITT Population)
NCT02855944 (12) [back to overview]Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (Efficacy Population)
NCT02855944 (12) [back to overview]Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (ITT Population)
NCT02855944 (12) [back to overview]Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (Efficacy Population)
NCT02855944 (12) [back to overview]Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (ITT Population)
NCT02855944 (12) [back to overview]Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (ITT Population)
NCT02855944 (12) [back to overview]Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (Efficacy Population)
NCT02855944 (12) [back to overview]Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (ITT Population)
NCT02873598 (1) [back to overview]The Maximum Tolerated Dose (MTD) of Stereotactic Body Radiotherapy (SBRT) in Locally Advanced Pancreatic Cancer (LAPC) Patients Who Have Not Developed Distant Progression After Induction Chemotherapies.
NCT02879318 (2) [back to overview]Progression Free Survival
NCT02879318 (2) [back to overview]Overall Survival
NCT02887248 (1) [back to overview]The Number of Participants With Grade 3/4/5 Adverse Events (AEs) as a Measure of Safety.
NCT02915744 (11) [back to overview]Compare Health-Related Quality of Life (HRQoL) Using the European Organisation for Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30) Module With the Brain Neoplasms 20-question (BN-20) Subscale.
NCT02915744 (11) [back to overview]Compare Health-Related Quality of Life (HRQoL) Using the the EuroQoL 5D (EQ-5D-5L™)
NCT02915744 (11) [back to overview]Overall Survival (OS) of Patients
NCT02915744 (11) [back to overview]Duration of Response (DoR)
NCT02915744 (11) [back to overview]Magnitude of Clinical Benefit Assessed by ESMO-MCBS Derived From Overall Survival
NCT02915744 (11) [back to overview]Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3
NCT02915744 (11) [back to overview]Progression-Free Survival (Outside the Central Nervous System)
NCT02915744 (11) [back to overview]Progression-Free Survival (Overall)
NCT02915744 (11) [back to overview]Progression-Free Survival in Brain Metastasis (PFS-BM)
NCT02915744 (11) [back to overview]Clinical Benefit Rate (CBR)
NCT02915744 (11) [back to overview]Compare Health-Related Quality of Life (HRQoL) Using the Brief Fatigue Inventory (BFI)
NCT02937116 (13) [back to overview]Volume of Distribution of IBI308 in Plasma After Single Dose Administration
NCT02937116 (13) [back to overview]Clearance of IBI308 in Plasma After Single Dose Administration
NCT02937116 (13) [back to overview]Number of All Study Participants Who Demonstrate a Tumor Response
NCT02937116 (13) [back to overview]DOR According to RECIST 1.1 as Assessed by Investigator
NCT02937116 (13) [back to overview]Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator
NCT02937116 (13) [back to overview]Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
NCT02937116 (13) [back to overview]PFS According to RECIST 1.1 as Assessed by Investigator
NCT02937116 (13) [back to overview]Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants
NCT02937116 (13) [back to overview]TTR According to RECIST 1.1 as Assessed by Investigator
NCT02937116 (13) [back to overview]Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants
NCT02937116 (13) [back to overview]The Half-life (t1/2) of IBI308 in Plasma After Single Dose Administration
NCT02937116 (13) [back to overview]Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t)
NCT02937116 (13) [back to overview]OS for Participants
NCT02951156 (18) [back to overview]Progression-Free Survival (PFS) as Assessed by the Investigator Per Lugano Response Classification Criteria
NCT02951156 (18) [back to overview]Overall Survival
NCT02951156 (18) [back to overview]Objective Response Rate (ORR) as Assessed by Investigator Per Lugano Response Classification Criteria
NCT02951156 (18) [back to overview]Number of Participants With Dose Limiting Toxicities (DLT)
NCT02951156 (18) [back to overview]Duration of Response (DOR) as Assessed by Investigator Per Lugano Response Classification Criteria
NCT02951156 (18) [back to overview]Disease Control Rate as Assessed by the Investigator Per Lugano Response Classification Criteria
NCT02951156 (18) [back to overview]Number of Participants With Laboratory Abnormalities As Per National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.03
NCT02951156 (18) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Greater Than or Equal to (>=) Grade 3, As Per National Cancer Institute Common Terminology Criteria For Adverse Events (NCI-CTCAE), Version 4.03
NCT02951156 (18) [back to overview]Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor and Immune Cells as Assessed by Immunohistochemistry (IHC) at Baseline
NCT02951156 (18) [back to overview]Number of Participants With Neutralizing Antibodies (nAb) Against Utomilumab by Never and Ever Positive Status
NCT02951156 (18) [back to overview]Number of Participants With Minimal Residual Disease Burden (MRD) Positive, Negative and Not Evaluable (NE) Status
NCT02951156 (18) [back to overview]Number of Participants With Electrocardiogram (ECG) Abnormalities
NCT02951156 (18) [back to overview]Number of Participants With Anti-Drug Antibodies (ADA) Against Utomilumab by Never and Ever Positive Status
NCT02951156 (18) [back to overview]Number of Participants With Anti-Drug Antibodies (ADA) Against Rituximab by Never and Ever Positive Status
NCT02951156 (18) [back to overview]Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status
NCT02951156 (18) [back to overview]Concentration Verses Time Summary of Avelumab
NCT02951156 (18) [back to overview]Concentration Verses Time Summary of Avelumab
NCT02951156 (18) [back to overview]Time to Tumor Response (TTR) as Assessed by Investigator Per Lugano Response Classification Criteria
NCT02954406 (8) [back to overview]Dose Escalation Phase: Maximum Tolerated Dose (MTD) of TAK-659
NCT02954406 (8) [back to overview]AUCtau: Area Under the Plasma Concentration-time Curve During Dosing Interval
NCT02954406 (8) [back to overview]Duration of Response (DOR)
NCT02954406 (8) [back to overview]Tmax: Time to Reach the Maximum Plasma Concentration for TAK-659
NCT02954406 (8) [back to overview]Cmax: Maximum Observed Plasma Concentration for TAK-659
NCT02954406 (8) [back to overview]Time to Progression (TTP)
NCT02954406 (8) [back to overview]Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of TAK-659
NCT02954406 (8) [back to overview]Overall Response Rate (ORR)
NCT02978716 (28) [back to overview]Terminal Elimination Half-Life (t1/2) of Trilaciclib
NCT02978716 (28) [back to overview]Duration of Severe (Grade 4) Neutropenia (DSN) During Cycle 1
NCT02978716 (28) [back to overview]Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
NCT02978716 (28) [back to overview]Relative Dose Intensity of Gemcitabine and Carboplatin
NCT02978716 (28) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
NCT02978716 (28) [back to overview]Number of Participants With Grade 3 and 4 Hematologic Toxicities
NCT02978716 (28) [back to overview]Dose Modifications: Number of Participants With Any Dose Interruptions
NCT02978716 (28) [back to overview]Dose Modifications - Number of Participants With Dose Reductions
NCT02978716 (28) [back to overview]Volume of Distribution at Steady State (Vss) of Free Carboplatin
NCT02978716 (28) [back to overview]Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Gemcitabine
NCT02978716 (28) [back to overview]Terminal Elimination Half-Life (t1/2) of Free Carboplatin
NCT02978716 (28) [back to overview]Progression Free Survival (PFS) as Per RECIST v1.1 as Determined by Investigator
NCT02978716 (28) [back to overview]Overall Survival (OS)
NCT02978716 (28) [back to overview]Number of Participants With Febrile Neutropenia (FN)
NCT02978716 (28) [back to overview]Number of Cycles Participants Received Treatment in Each Treatment Arm
NCT02978716 (28) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Trilaciclib
NCT02978716 (28) [back to overview]Major Adverse Hematologic Event (MAHE) Rate
NCT02978716 (28) [back to overview]Duration of Objective Response (DOR) as Per RECIST v1.1 as Determined by Investigator
NCT02978716 (28) [back to overview]Number of Participants With Grade 3 or 4 Thrombocytopenia
NCT02978716 (28) [back to overview]Dose Modifications: Number of Participants With Cycle Delays
NCT02978716 (28) [back to overview]Dose Modifications - Number of Participants With Skipped Doses
NCT02978716 (28) [back to overview]Duration of Exposure
NCT02978716 (28) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Gemcitabine
NCT02978716 (28) [back to overview]Cumulative Dose of Gemcitabine
NCT02978716 (28) [back to overview]Cumulative Dose of Carboplatin
NCT02978716 (28) [back to overview]Clearance (CL) of of Free Carboplatin
NCT02978716 (28) [back to overview]Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Trilaciclib
NCT02978716 (28) [back to overview]All-cause Dose Reductions, Event Rate (Per Cycle)
NCT02981342 (11) [back to overview]Stage 2: Overall Survival (OS)
NCT02981342 (11) [back to overview]Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months
NCT02981342 (11) [back to overview]Stage 2: Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
NCT02981342 (11) [back to overview]Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
NCT02981342 (11) [back to overview]Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level
NCT02981342 (11) [back to overview]Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414
NCT02981342 (11) [back to overview]Stage 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
NCT02981342 (11) [back to overview]Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose
NCT02981342 (11) [back to overview]Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR
NCT02981342 (11) [back to overview]Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))
NCT02981342 (11) [back to overview]Stage 2: Progression Free Survival (PFS)
NCT02991482 (6) [back to overview]Percentage of Patients Experienced AEs/SAEs
NCT02991482 (6) [back to overview]Progression Free Survival (PFS) Assessed by Investigator
NCT02991482 (6) [back to overview]Progression Free Survival (PFS) as Assessed by Independent Radiological Review
NCT02991482 (6) [back to overview]Overall Survival.
NCT02991482 (6) [back to overview]Time to Treatment Failure.
NCT02991482 (6) [back to overview]Objective Response Rate by Independent Radiological Review
NCT02993731 (10) [back to overview]Overall Response Rate in Biomarker Positive Patients
NCT02993731 (10) [back to overview]Overall Survival
NCT02993731 (10) [back to overview]Overall Response Rate
NCT02993731 (10) [back to overview]Number of Patients With Adverse Events
NCT02993731 (10) [back to overview]Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks.
NCT02993731 (10) [back to overview]Disease Control Rate in Biomarker Positive Patients
NCT02993731 (10) [back to overview]Disease Control Rate
NCT02993731 (10) [back to overview]Progression Free Survival in Biomarker Positive Patients
NCT02993731 (10) [back to overview]Progression Free Survival
NCT02993731 (10) [back to overview]Overall Survival in Biomarker Positive Patients
NCT02998528 (4) [back to overview]Event-Free Survival (EFS)
NCT02998528 (4) [back to overview]Time to Death or Distant Metastases (TTDM)
NCT02998528 (4) [back to overview]Pathologic Complete Response (pCR) Rate
NCT02998528 (4) [back to overview]Major Pathologic Response (MPR) Rate
NCT03003962 (44) [back to overview]OS at 24 Months
NCT03003962 (44) [back to overview]OS in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]Time to Deterioration of EORTC QLQ-C30 in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Time to Deterioration of EORTC QLQ-LC13
NCT03003962 (44) [back to overview]Time to Deterioration of EORTC QLQ-LC13 in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Percentage of Participants With Antidrug Antibody (ADA) Response to Durvalumab
NCT03003962 (44) [back to overview]OS at 18 Months in PD-L1 TC > = 25% LREM Analysis Set
NCT03003962 (44) [back to overview]PFS2 in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Overall Survival (OS)
NCT03003962 (44) [back to overview]PFS Based on Investigator Assessment According to RECIST 1.1 in LREM Analysis Set
NCT03003962 (44) [back to overview]Percentage of Participants With ADA Response to Durvalumab in LREM Analysis Set
NCT03003962 (44) [back to overview]Time to Deterioration of EORTC QLQ-C30
NCT03003962 (44) [back to overview]OS in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]OS at 18 Months in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]OS at 18 Months in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]OS at 18 Months
NCT03003962 (44) [back to overview]ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Objective Response Rate (ORR) as Per RECIST 1.1 Using Investigator Assessment
NCT03003962 (44) [back to overview]Duration of Response (DoR) as Per RECIST 1.1 Using Investigator Assessment
NCT03003962 (44) [back to overview]DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=50% LREM Analysis Set
NCT03003962 (44) [back to overview]DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=50% Analysis Set
NCT03003962 (44) [back to overview]OS at 24 Months in PD-L1 TC > = 25% LREM Analysis Set
NCT03003962 (44) [back to overview]OS at 24 Months in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]OS at 24 Months in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]OS in Participants With LREM
NCT03003962 (44) [back to overview]PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) 30-Item Core Quality of Life Questionnaire Version 3 (QLQ-C30)
NCT03003962 (44) [back to overview]PFS2 in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]PFS2 in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]Progression Free Survival (PFS) Based on Investigator Assessment According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
NCT03003962 (44) [back to overview]Time From Randomization to Second Progression (PFS2)
NCT03003962 (44) [back to overview]DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=25% LREM Analysis Set
NCT03003962 (44) [back to overview]APF12 in PD-L1 TC >= 50% LREM Analysis Set
NCT03003962 (44) [back to overview]Change From Baseline in EORTC 13-Item Lung Cancer Quality of Life Questionnaire (QLQ-LC13)
NCT03003962 (44) [back to overview]APF12 in PD-L1 TC >= 50% Analysis Set
NCT03003962 (44) [back to overview]APF12 in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Alive and Progression-Free at 12 Months (APF12)
NCT03003962 (44) [back to overview]Change From Baseline in EORTC QLQ-C30 in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Change From Baseline in EORTC QLQ-LC13 in PD-L1 TC >= 25% LREM Analysis Set
NCT03003962 (44) [back to overview]Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
NCT03003962 (44) [back to overview]Number of Participants With ECOG Performance Status in PD-L1 TC >=25% LREM Analysis Set
NCT03025880 (14) [back to overview]Immune Related Response Duration (irRD)
NCT03025880 (14) [back to overview]Immune-related Objective Response Rate (irORR)
NCT03025880 (14) [back to overview]Immune-related Progression-Free Survival (irPFS)
NCT03025880 (14) [back to overview]Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle
NCT03025880 (14) [back to overview]Objective Response Rate (ORR)
NCT03025880 (14) [back to overview]Overall Survival (OS)
NCT03025880 (14) [back to overview]Clinical Benefit Rate (CBR)
NCT03025880 (14) [back to overview]Clinical Benefit Rate (CBR) at Least 24 Weeks
NCT03025880 (14) [back to overview]Progression-Free Survival (PFS)
NCT03025880 (14) [back to overview]Immune Related Clinical Benefit Rate (irCBR)
NCT03025880 (14) [back to overview]The Number of Participants Who Experienced Adverse Events (AE) Related to Study Treatment
NCT03025880 (14) [back to overview]Response Duration (RD)
NCT03025880 (14) [back to overview]Recommended Phase II Dose (RP2D) of Gemcitabine in Combination With Pembrolizumab
NCT03025880 (14) [back to overview]Immune Related Clinical Benefit Rate (irCBR) at Least 24 Weeks
NCT03041181 (1) [back to overview]Number of Participants With Grade 3 or Grade 4 Adverse Events
NCT03085914 (3) [back to overview]Phases 1 and 2: Objective Response Rate (ORR)
NCT03085914 (3) [back to overview]Phases 1 & 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
NCT03085914 (3) [back to overview]Phases 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
NCT03086369 (10) [back to overview]"Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) Worst Pain Score"
NCT03086369 (10) [back to overview]Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
NCT03086369 (10) [back to overview]Phase 1b/2: Duration of Response (DoR)
NCT03086369 (10) [back to overview]Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.
NCT03086369 (10) [back to overview]Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
NCT03086369 (10) [back to overview]Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab
NCT03086369 (10) [back to overview]Phase 2: Progression-Free Survival (PFS)
NCT03086369 (10) [back to overview]Phase 2: Overall Survival (OS)
NCT03086369 (10) [back to overview]Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
NCT03086369 (10) [back to overview]Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
NCT03101566 (4) [back to overview]The Percentage of Patients Alive and Without Progression at 6 Months Following the Initiation of Treatment
NCT03101566 (4) [back to overview]Overall Response Rate (ORR)
NCT03101566 (4) [back to overview]Median Progression Free Survival Time
NCT03101566 (4) [back to overview]Median Overall Survival Time
NCT03126435 (8) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
NCT03126435 (8) [back to overview]Percentage of Subjects With Objective Response
NCT03126435 (8) [back to overview]Percentage of Subjects With Disease Control According to RECIST v.1.1
NCT03126435 (8) [back to overview]Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate
NCT03126435 (8) [back to overview]Overall Survival
NCT03126435 (8) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
NCT03126435 (8) [back to overview]Duration of Response
NCT03126435 (8) [back to overview]Progression Free Survival (PFS)
NCT03164616 (13) [back to overview]Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)
NCT03164616 (13) [back to overview]Duration of Response (DoR)
NCT03164616 (13) [back to overview]Objective Response Rate (ORR)
NCT03164616 (13) [back to overview]PK of Tremelimumab; Peak and Trough Serum Concentrations
NCT03164616 (13) [back to overview]OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC
NCT03164616 (13) [back to overview]Overall Survival (OS); D + SoC Compared With SoC Alone
NCT03164616 (13) [back to overview]PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC
NCT03164616 (13) [back to overview]Progression-Free Survival (PFS); D + SoC Compared With SoC Alone
NCT03164616 (13) [back to overview]Time From Randomization to Second Progression (PFS2)
NCT03164616 (13) [back to overview]Number of Patients With ADA Response to Tremelimumab
NCT03164616 (13) [back to overview]Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab
NCT03164616 (13) [back to overview]Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations
NCT03164616 (13) [back to overview]Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13)
NCT03191786 (14) [back to overview]Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
NCT03191786 (14) [back to overview]Duration of Response (DOR), as Determined by the Investigator Using RECIST v1.1
NCT03191786 (14) [back to overview]Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1 in Participants With PD-L1 Positive Status
NCT03191786 (14) [back to overview]Overall Survival (OS)
NCT03191786 (14) [back to overview]Overall Survival in Participants With PD-L1 Positive Status
NCT03191786 (14) [back to overview]Percentage of Participants With At Lease One Adverse Event
NCT03191786 (14) [back to overview]Percentage of Participants With Objective Response Rate, as Determined by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (v1.1)
NCT03191786 (14) [back to overview]Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
NCT03191786 (14) [back to overview]Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
NCT03191786 (14) [back to overview]Time to Deterioration in Patient-Reported Lung Cancer Symptoms As Assessed by EORTC QLQ-LC13 Score
NCT03191786 (14) [back to overview]Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC QLQ-C30 Score
NCT03191786 (14) [back to overview]Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1
NCT03191786 (14) [back to overview]OS Rates at the 6, 12, 18, 24-Months Timepoints
NCT03191786 (14) [back to overview]Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
NCT03214250 (8) [back to overview]Disease Control Rate (DCR)
NCT03214250 (8) [back to overview]Phase 1b Primary Safety Outcome
NCT03214250 (8) [back to overview]Progression-free Survival (PFS)
NCT03214250 (8) [back to overview]Objective Response Rate (ORR): Efficacy Population
NCT03214250 (8) [back to overview]Objective Response Rate (ORR): DLT-Evaluable Population
NCT03214250 (8) [back to overview]Duration of Response (DOR): Efficacy Population
NCT03214250 (8) [back to overview]Duration of Response (DOR): DLT-Evaluable Population
NCT03214250 (8) [back to overview]1-year Overall Survival Rate
NCT03294304 (12) [back to overview]Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)
NCT03294304 (12) [back to overview]Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)
NCT03294304 (12) [back to overview]Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)
NCT03294304 (12) [back to overview]Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)
NCT03294304 (12) [back to overview]Safety of Nivolumab With Gemcitabine/Cisplatin
NCT03294304 (12) [back to overview]Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)
NCT03294304 (12) [back to overview]Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)
NCT03294304 (12) [back to overview]Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)
NCT03294304 (12) [back to overview]Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)
NCT03294304 (12) [back to overview]Safety of Nivolumab With Gemcitabine/Cisplatin
NCT03294304 (12) [back to overview]Pathologic Response Rate (PaR) at Time of Radical Cystectomy. PaR is Defined as Absence of Residual MIBC at Cystectomy in the Surgical Specimen (Pathologic Down-staging to ≤pT1pN0 Which Includes pT0, pT1, pTa and pTis)
NCT03294304 (12) [back to overview]Count of Participants Experiencing Progression Free Survival (PFS)
NCT03314935 (13) [back to overview]Phases 1 and 2: Duration of Response
NCT03314935 (13) [back to overview]Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
NCT03314935 (13) [back to overview]AUC0-t of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
NCT03314935 (13) [back to overview]Phase 2: Objective Response Rate (ORR)
NCT03314935 (13) [back to overview]Cmin of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy on Cycle 2 Day 1 Following Repeated Dose Administration
NCT03314935 (13) [back to overview]Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)
NCT03314935 (13) [back to overview]Tmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
NCT03314935 (13) [back to overview]Tlast of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
NCT03314935 (13) [back to overview]Cmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
NCT03314935 (13) [back to overview]Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen
NCT03314935 (13) [back to overview]Phase 1: ORR
NCT03314935 (13) [back to overview]Phases 1 and 2: Progression-free Survival
NCT03314935 (13) [back to overview]Phases 1 and 2: Disease Control Rate
NCT03317496 (13) [back to overview]Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment
NCT03317496 (13) [back to overview]Overall Survival (OS)
NCT03317496 (13) [back to overview]Number of Participants With Treatment Related TEAEs
NCT03317496 (13) [back to overview]Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v 4.03
NCT03317496 (13) [back to overview]Serum Concentration of Avelumab
NCT03317496 (13) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
NCT03317496 (13) [back to overview]Absolute Value of Tumor Mutational Burden (TMB) in Tumor Tissue
NCT03317496 (13) [back to overview]Duration of Response (DOR) as Per RECIST v 1.1 by Investigator Assessment
NCT03317496 (13) [back to overview]Number of Participants With Programmed Death-Ligand 1 (PD-L1) Expression
NCT03317496 (13) [back to overview]Number of Participants With Grade 3 or Higher Laboratory Abnormalities by CTCAE Grade
NCT03317496 (13) [back to overview]Time-to-Tumor Response (TTR) as Per RECIST v 1.1 by Investigator Assessment
NCT03317496 (13) [back to overview]Progression Free Survival (PFS) as Per RECIST v 1.1 by Investigator Assessment
NCT03317496 (13) [back to overview]Phase 1b Lead-in: Number of Participants With Dose-Limiting Toxicities (DLT)
NCT03344172 (4) [back to overview]Change in CA19-9 Levels
NCT03344172 (4) [back to overview]Proportion of Grade IIb or Higher Histolopathologic Responses
NCT03344172 (4) [back to overview]Worst Grade of Adverse Event Experienced At Least Possibly Related to Treatment
NCT03344172 (4) [back to overview]Worst Grade of Adverse Event Experienced At Least Probably Related to Treatment
NCT03386721 (5) [back to overview]Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1
NCT03386721 (5) [back to overview]Progression-Free Survival (PFS) According to RECIST Version 1.1
NCT03386721 (5) [back to overview]Overall Survival (OS)
NCT03386721 (5) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT03386721 (5) [back to overview]Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
NCT03449901 (5) [back to overview]Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
NCT03449901 (5) [back to overview]Progression-free Survival (PFS) (Cohort 1 Only)
NCT03449901 (5) [back to overview]Number of Participants With Cancer-related Mortality (Cohort 1 Only)
NCT03449901 (5) [back to overview]Clinical Benefit Rate (CBR) (Cohort 1 Only)
NCT03449901 (5) [back to overview]Overall Survival (OS) (Cohort 1 Only)
NCT03451773 (10) [back to overview]Overall Progression Free Survival
NCT03451773 (10) [back to overview]Percentage of Participants Who Have Not Progressed at 3 Months
NCT03451773 (10) [back to overview]Duration of Treatment-related Adverse Events (AEs)
NCT03451773 (10) [back to overview]Duration of Treatment-related Adverse Events (AEs)
NCT03451773 (10) [back to overview]Percentage of Evaluable Participants Alive at 6 Months and 9 Months
NCT03451773 (10) [back to overview]Phase IB: Number and Severity of Grade 1-2 Adverse Events Possibly, Probably, or Definitely Related to Treatment
NCT03451773 (10) [back to overview]Phase II: Number of Participants With a Best Overall Response (BOR)
NCT03451773 (10) [back to overview]Phase IB: Number and Severity of Grade 3-5 Adverse Events Possibly, Probably, or Definitely Related to Treatment
NCT03451773 (10) [back to overview]Overall Median Survival
NCT03451773 (10) [back to overview]Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
NCT03468075 (4) [back to overview]Overall Survival
NCT03468075 (4) [back to overview]Progression Free Survival
NCT03468075 (4) [back to overview]Tumor Response
NCT03468075 (4) [back to overview]Incidence of Adverse Events (AE) Per CTCAE 4.03
NCT03488251 (12) [back to overview]Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
NCT03488251 (12) [back to overview]Part 1 and 2: Number of Participants With Anti-drug Antibody Titer
NCT03488251 (12) [back to overview]Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
NCT03488251 (12) [back to overview]Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range
NCT03488251 (12) [back to overview]Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724
NCT03488251 (12) [back to overview]Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724
NCT03488251 (12) [back to overview]Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies
NCT03488251 (12) [back to overview]Part 1 and 2: Objective Response Rate
NCT03488251 (12) [back to overview]Part 1 and 2: Disease Control Rate
NCT03488251 (12) [back to overview]Part 1 and 2: Duration of Response
NCT03488251 (12) [back to overview]Part 1 and 2: Progression-free Survival
NCT03488251 (12) [back to overview]Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724
NCT03496662 (3) [back to overview](Part B and Part A Experimental Dose Level 0 Only): Objective Response Rate
NCT03496662 (3) [back to overview](Part B and Part A Experimental Dose Level 0 Only): Percentage of Patients Whose Disease Becomes Resectable After Treatment
NCT03496662 (3) [back to overview](Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
NCT03574818 (1) [back to overview]Surgically Resectable
NCT03611556 (31) [back to overview]Serum Concentrations of Durvalumab
NCT03611556 (31) [back to overview]Serum Concentrations of Durvalumab
NCT03611556 (31) [back to overview]Plasma Concentrations of Nab-paclitaxel
NCT03611556 (31) [back to overview]Plasma Concentrations of Gemcitabine and Metabolite 2',2'-Difluorodeoxyuridine (dFdU)
NCT03611556 (31) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase
NCT03611556 (31) [back to overview]Number of Participants With Positive ADA to Durvalumab
NCT03611556 (31) [back to overview]Number of Participants With TEAEs and TESAEs in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Positive Anti-drug Antibodies (ADA) to Oleclumab
NCT03611556 (31) [back to overview]Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase
NCT03611556 (31) [back to overview]Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase
NCT03611556 (31) [back to overview]Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase
NCT03611556 (31) [back to overview]Progression-free Survival According to RECIST v1.1 in Dose Expansion Phase
NCT03611556 (31) [back to overview]Progression-free Survival According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
NCT03611556 (31) [back to overview]Percentage of Participants With OR According to RECIST v1.1 in Dose Escalation Phase
NCT03611556 (31) [back to overview]Percentage of Participants With OR According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
NCT03611556 (31) [back to overview]Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose Expansion Phase
NCT03611556 (31) [back to overview]Percentage of Participants With Disease Control (DC) According to RECIST v1.1 in Dose Escalation Phase
NCT03611556 (31) [back to overview]Percentage of Participants With DC According to RECIST v1.1 in Dose Expansion Phase
NCT03611556 (31) [back to overview]Overall Survival in Dose Expansion Phase
NCT03611556 (31) [back to overview]Overall Survival by CD73 Expression at Baseline in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Progression-free Survival Events According to RECIST v1.1 in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Progression-free Survival Events According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Overall Survival Events in Dose Expansion Phase
NCT03611556 (31) [back to overview]Serum Concentrations of Oleclumab
NCT03611556 (31) [back to overview]Serum Concentrations of Oleclumab
NCT03611556 (31) [back to overview]Number of Participants With Overall Survival Events by CD73 Expression at Baseline in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase
NCT03611556 (31) [back to overview]Duration of Response (DoR) According to RECIST v1.1 in Dose Expansion Phase
NCT03629925 (6) [back to overview]DOR (Duration of Response)
NCT03629925 (6) [back to overview]DCR (Disease Control Rate)
NCT03629925 (6) [back to overview]PFS(Progression Free Survival)
NCT03629925 (6) [back to overview]TTR (Time to Response)
NCT03629925 (6) [back to overview]OS (Overall Survival)
NCT03629925 (6) [back to overview]ORR(Objective Response Rate)
NCT03649321 (4) [back to overview]Number of Participants With an Adverse Event of Grade 3 or Higher
NCT03649321 (4) [back to overview]Overall Response Rate (ORR)
NCT03649321 (4) [back to overview]Clinical Benefit Rate
NCT03649321 (4) [back to overview]Complete Response Rate (CR)
NCT03662074 (6) [back to overview]Number of Participants With Positive Responses to Therapy Per Response Evaluation Criteria in Solid Tumors (RECIST)
NCT03662074 (6) [back to overview]Progression-free Survival (PFS) - Months
NCT03662074 (6) [back to overview]Overall Survival (OS) - Months
NCT03662074 (6) [back to overview]Number of Adverse Events
NCT03662074 (6) [back to overview]Progression-free Survival (PFS) - Number of Participants
NCT03662074 (6) [back to overview]Overall Survival (OS) - Number of Participants
NCT03665441 (7) [back to overview]Disease Control Rate (DCR)
NCT03665441 (7) [back to overview]Time to Quality of Life Questionnaire EORTC QLQ-C30 First Worsening in Global Health Status Analysis
NCT03665441 (7) [back to overview]Duration of Response (DoR)
NCT03665441 (7) [back to overview]Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0
NCT03665441 (7) [back to overview]Objective Response Rate (ORR)
NCT03665441 (7) [back to overview]Overall Survival (OS)
NCT03665441 (7) [back to overview]Progression Free Survival (PFS)
NCT03684811 (14) [back to overview]Overall Response Rate (ORR)
NCT03684811 (14) [back to overview]Overall Survival (OS)
NCT03684811 (14) [back to overview]Progression-Free Survival (PFS)
NCT03684811 (14) [back to overview]Rate of Drug Distribution Within the Blood Stream (Vd/F)
NCT03684811 (14) [back to overview]Time for Half of the Drug to be Absent in Blood Stream Following Dose (T 1/2)
NCT03684811 (14) [back to overview]Time to Progression (TTP)
NCT03684811 (14) [back to overview]Time to Response (TTR)
NCT03684811 (14) [back to overview]Area Under the Plasma Concentration Versus Time Curve (AUC)
NCT03684811 (14) [back to overview]Peak Plasma Concentration (Cmax)
NCT03684811 (14) [back to overview]Time of Peak Plasma Concentration (Tmax)
NCT03684811 (14) [back to overview]Number of Participants With a Dose Limiting Toxicity (DLT)
NCT03684811 (14) [back to overview]Apparent Clearance (CL/F)
NCT03684811 (14) [back to overview]Duration of Response (DOR)
NCT03684811 (14) [back to overview]Olutasidenib Concentration Within Cerebro-spinal Fluid (CSF)
NCT03717155 (11) [back to overview]Number of Participants With Positive Anti-Drug Antibody (ADA) of Cetuximab
NCT03717155 (11) [back to overview]Progression-Free Survival (PFS) Time Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
NCT03717155 (11) [back to overview]Percentage of Participants With Confirmed Best Objective Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 Assessed by Investigator
NCT03717155 (11) [back to overview]Overall Survival (OS)
NCT03717155 (11) [back to overview]Duration of Response (DOR)
NCT03717155 (11) [back to overview]Number of Participants With Positive Anti-Drug Antibody (ADA) of Avelumab
NCT03717155 (11) [back to overview]Serum Trough Concentration Levels (Ctrough) of Cetuximab
NCT03717155 (11) [back to overview]Serum Trough Concentration Levels (Ctrough) of Avelumab
NCT03717155 (11) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (AEs), Treatment-Related Grade >=3 TEAEs and Immune-related Treatment Emergent AEs (irTEAEs)
NCT03717155 (11) [back to overview]Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Cetuximab
NCT03717155 (11) [back to overview]Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Avelumab
NCT03734029 (12) [back to overview]Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status
NCT03734029 (12) [back to overview]Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
NCT03734029 (12) [back to overview]Overall Survival (OS) in All Patients
NCT03734029 (12) [back to overview]Number of Overall Survival Events (Deaths)
NCT03734029 (12) [back to overview]Duration of Response in Participants With HER2-low Breast Cancer (All Patients)
NCT03734029 (12) [back to overview]Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
NCT03734029 (12) [back to overview]Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients)
NCT03734029 (12) [back to overview]Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
NCT03734029 (12) [back to overview]Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
NCT03734029 (12) [back to overview]All-Cause Mortality
NCT03734029 (12) [back to overview]Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
NCT03734029 (12) [back to overview]Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients)
NCT03737123 (10) [back to overview]Clinical Benefit Rate (CBR) With irRECIST
NCT03737123 (10) [back to overview]Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Carboplatin + Gemcitabine or Docetaxel
NCT03737123 (10) [back to overview]Clinical Benefit Rate (CBR) With RECIST 1.1
NCT03737123 (10) [back to overview]Progression Free Survival (PFS) for Atezolizumab + Carboplatin and Gemcitabine
NCT03737123 (10) [back to overview]Progression Free Survival (PFS) Compared to Historical Controls
NCT03737123 (10) [back to overview]Overall Survival (OS)
NCT03737123 (10) [back to overview]PFS by irRECIST
NCT03737123 (10) [back to overview]Progression Free Survival (PFS)
NCT03737123 (10) [back to overview]Objective Response Rate (ORR) With RECIST 1.1
NCT03737123 (10) [back to overview]Objective Response Rate (ORR) With irRECIST
NCT03775486 (11) [back to overview]Presence of Anti-drug Antibodies (ADAs) for Durvalumab
NCT03775486 (11) [back to overview]Progression-free Survival
NCT03775486 (11) [back to overview]Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population
NCT03775486 (11) [back to overview]Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30
NCT03775486 (11) [back to overview]Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13
NCT03775486 (11) [back to overview]Number of Participants With Treatment-Related Adverse Events
NCT03775486 (11) [back to overview]Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30
NCT03775486 (11) [back to overview]Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13
NCT03775486 (11) [back to overview]Concentration of Durvalumab
NCT03775486 (11) [back to overview]Overall Survival
NCT03775486 (11) [back to overview]Duration of Response
NCT03790111 (32) [back to overview]Change From Baseline in Serum Albumin
NCT03790111 (32) [back to overview]Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
NCT03790111 (32) [back to overview]Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
NCT03790111 (32) [back to overview]Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
NCT03790111 (32) [back to overview]Median Progression Free Survival
NCT03790111 (32) [back to overview]Weight Change From Baseline
NCT03790111 (32) [back to overview]Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Overall (Objective) Response Rate (ORR), Local Reader's Assessment
NCT03790111 (32) [back to overview]Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Overall (Objective) Response Rate, Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Weight Change From Baseline
NCT03790111 (32) [back to overview]Weight Change From Baseline
NCT03790111 (32) [back to overview]Summary of Duration of Progression Free Survival, Local Radiologist's Assessment
NCT03790111 (32) [back to overview]Project Overall Survival Rate at Month 6
NCT03790111 (32) [back to overview]Overall (Objective) Response Rate, Local Read
NCT03790111 (32) [back to overview]Project Overall Survival Rate at Month 12
NCT03790111 (32) [back to overview]Progression Free Survival, Local Radiologist's Assessment
NCT03790111 (32) [back to overview]Change From Baseline in Serum Albumin
NCT03790111 (32) [back to overview]Progression Free Survival, Local Radiologist's Assessment
NCT03790111 (32) [back to overview]Overall Survival (OS)
NCT03790111 (32) [back to overview]Overall (Objective) Response Rate, Local Reader's Assessment
NCT03790111 (32) [back to overview]Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)
NCT03790111 (32) [back to overview]Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)
NCT03790111 (32) [back to overview]Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)
NCT03790111 (32) [back to overview]Change From Baseline in Serum Albumin
NCT03790111 (32) [back to overview]Disease Control Rate (DCR), Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Disease Control Rate (DCR), Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Disease Control Rate (DCR), Central Radiologist's Assessment
NCT03790111 (32) [back to overview]Disease Control Rate (DCR), Local Reviewer
NCT03790111 (32) [back to overview]Disease Control Rate (DCR), Local Reviewer
NCT03790111 (32) [back to overview]Disease Control Rate End of Study, Local Reviewer
NCT03840915 (7) [back to overview]Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
NCT03840915 (7) [back to overview]Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator (IRC)
NCT03840915 (7) [back to overview]Overall Survival (OS)
NCT03840915 (7) [back to overview]Number of Participants With Positive Antidrug Antibodies (ADA)
NCT03840915 (7) [back to overview]Number of Participants With Dose-Limiting Toxicities (DLTs)
NCT03840915 (7) [back to overview]Duration of Response (DOR)
NCT03840915 (7) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
NCT03912818 (2) [back to overview]Incidence of Grade 3-5 Adverse Events
NCT03912818 (2) [back to overview]Proportion of Subjects Who Initiate Study Treatment and Achieve Tumor Stage of pT2 N0 M0 or Better (e.g., pT0, pT1 N0) at Cystectomy
NCT03945357 (2) [back to overview]Incidence of SSI Requiring Intervention
NCT03945357 (2) [back to overview]Surgical Site Infection
NCT03971474 (8) [back to overview]Overall Survival (OS), Subgroup Analysis by Stratification Factors
NCT03971474 (8) [back to overview]Disease Control Rate (DCR)
NCT03971474 (8) [back to overview]Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
NCT03971474 (8) [back to overview]Investigator-Assessed Progression-Free Survival (IA-PFS), Subgroup Analysis by Stratification Factors
NCT03971474 (8) [back to overview]Response Rate (RR)
NCT03971474 (8) [back to overview]Investigator Assessed-progression-free Survival (IA-PFS)
NCT03971474 (8) [back to overview]Duration of Response (DOR)
NCT03971474 (8) [back to overview]Overall Survival (OS)
NCT04003610 (10) [back to overview]Number of Participants With the Indicated EQ-5D-5L Dimension Scores
NCT04003610 (10) [back to overview]EORTC QLQ-C30 Score
NCT04003610 (10) [back to overview]Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score
NCT04003610 (10) [back to overview]Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score
NCT04003610 (10) [back to overview]Change From Baseline in the EORTC QLQ-C30 Score
NCT04003610 (10) [back to overview]Progression-free Survival (PFS)
NCT04003610 (10) [back to overview]Overall Survival (OS)
NCT04003610 (10) [back to overview]Objective Response Rate (ORR)
NCT04003610 (10) [back to overview]Number of Participants With Treatment-emergent Adverse Events
NCT04003610 (10) [back to overview]EORTC QLQ-C30 Score
NCT04003636 (6) [back to overview]Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
NCT04003636 (6) [back to overview]Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)
NCT04003636 (6) [back to overview]Overall Survival (OS)
NCT04003636 (6) [back to overview]Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
NCT04003636 (6) [back to overview]Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
NCT04003636 (6) [back to overview]Number of Participants Who Experience One or More Adverse Events (AE)
NCT04039867 (3) [back to overview]Number of Participants With Treatment-emergent Adverse Events to Evaluate Tolerability of Oxaliplatin With Gemcitabine
NCT04039867 (3) [back to overview]Overall Survival of Patients Who Received Gemcitabine and Oxaliplatin
NCT04039867 (3) [back to overview]Overall Response Rate as Assessed by RECIST Criteria of Patients Who Received Gemcitabine and Oxaliplatin
NCT04066491 (8) [back to overview]Safety Run-in Part: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
NCT04066491 (8) [back to overview]Double-blind Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), Treatment Related TEAEs and Adverse Events of Special Interest (AESIs) According to NCI-CTCAE Version 5.0
NCT04066491 (8) [back to overview]Safety Run-in Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs) and Treatment Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
NCT04066491 (8) [back to overview]Safety Run-in Part: Number of Participants With Grade Greater Than or Equal (>=) 3 Laboratory Abnormalities
NCT04066491 (8) [back to overview]Double-blind Part: Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
NCT04066491 (8) [back to overview]Double-blind Part: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
NCT04066491 (8) [back to overview]Double-blind Part: Overall Survival
NCT04066491 (8) [back to overview]Double-blind Part: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
NCT04099888 (11) [back to overview]Maximum Observed Concentration (Cmax) Was Performed for Patients in Arm A.
NCT04099888 (11) [back to overview]Overall Disease Control Rate (DCR)
NCT04099888 (11) [back to overview]Time to Cmax (Tmax) Was Performed for Patients in Arm A.
NCT04099888 (11) [back to overview]Duration of Response (DoR)
NCT04099888 (11) [back to overview]Area Under the Plasma Concentration Curve (AUC) Was Performed for Patients in Arm A.
NCT04099888 (11) [back to overview]Progression-free Survival (PFS)
NCT04099888 (11) [back to overview]Adverse Events (AEs)/Serious Adverse Events (SAEs)
NCT04099888 (11) [back to overview]Change in Tumor Size
NCT04099888 (11) [back to overview]Loco-regional Tumour-related Events and Biliary Complications
NCT04099888 (11) [back to overview]Objective Response Rate (ORR)
NCT04099888 (11) [back to overview]Overall Survival (OS)
NCT04145700 (7) [back to overview]Complete Response (CR): Percentage of Participants Who Achieve CR
NCT04145700 (7) [back to overview]Duration of Response (DoR)
NCT04145700 (7) [back to overview]PK: Minimum Serum Concentration of Ramucirumab (Cmin)
NCT04145700 (7) [back to overview]Progression Free Survival (PFS)
NCT04145700 (7) [back to overview]Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax)
NCT04145700 (7) [back to overview]Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
NCT04145700 (7) [back to overview]Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA)
NCT04163900 (2) [back to overview]Objective Response Rate (ORR)
NCT04163900 (2) [back to overview]Overall Survival (OS)
NCT04386746 (1) [back to overview]3-Month Complete Response Rate
NCT04398368 (6) [back to overview]Time to Death
NCT04398368 (6) [back to overview]Time to Development of Muscle-invasive Bladder Cancer
NCT04398368 (6) [back to overview]Incidence of Adverse Events
NCT04398368 (6) [back to overview]Incidence of Muscle-invasive Bladder Cancer
NCT04398368 (6) [back to overview]Urothelial Carcinoma Relapse-free Survival
NCT04398368 (6) [back to overview]Time to Recurrence
NCT04677504 (6) [back to overview]Time to Confirmed Deterioration (TTCD)
NCT04677504 (6) [back to overview]Confirmed Objective Response Rate (ORR)
NCT04677504 (6) [back to overview]Duration of Response (DOR)
NCT04677504 (6) [back to overview]Progression Free Survival (PFS)
NCT04677504 (6) [back to overview]Serum Concentration of Atezolizumab
NCT04677504 (6) [back to overview]Disease Control Rate (DCR)
NCT04924062 (6) [back to overview]Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
NCT04924062 (6) [back to overview]Overall Survival (OS)
NCT04924062 (6) [back to overview]Number of Participants Who Experience One or More Adverse Events (AE)
NCT04924062 (6) [back to overview]Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by BICR
NCT04924062 (6) [back to overview]Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
NCT04924062 (6) [back to overview]Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

Overall Survival

Proportion of participants whose overall survival exceeded 5 years. (NCT00011986)
Timeframe: Up to 9 years

InterventionProportion of participants (Number)
Carbo/Taxol0.35
Carbo/Taxol/Gemcitabine0.34
Carbo/Taxol/Doxil0.39
Carbo/Topotecan - Carbo/Taxol0.34
Carbo/Gemcitabine - Carbo/Taxol0.30

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Progression-free Survival

Median duration in months of progression free survival. (NCT00011986)
Timeframe: From the date of enrollment to first progression or death or last contact, if alive and progression free.

Interventionmonths (Median)
Carbo/Taxol16.0
Carbo/Taxol/Gemcitabine16.3
Carbo/Taxol/Doxil16.4
Carbo/Topotecan - Carbo/Taxol15.4
Carbo/Gemcitabine - Carbo/Taxol15.4

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Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0

(NCT00011986)
Timeframe: Up to 9 years

,,,,
InterventionParticipants (Count of Participants)
LeukopeniaNeutropeniaThrombocytopeniaAnemiaOther HematologicAllergyAuditoryCardiovascularCoagulationConstitutionalDermatologicEndocrineGastrointestinalGenitourinary/RenalHemorrhageHepaticInfection/FeverMetabolicMusculoskeletalNeurologicPeripheral NeurologicOcular/VisualPainPulmonarySexualSecond Primary
Grade 3 and Above on Carbo/Gemcitabine - Carbo/Taxol51376148620331526123757819293025824510352435237057
Grade 3 and Above on Carbo/Taxol/Doxil595782320160244283344841121241320111345513434517539151
Grade 3 and Above on Carbo/Taxol/Gemcitabine68679852019633820236109664145829321385518475937537066
Grade 3 and Above on Carbo/Topotecan - Carbo/Taxol4767793031672462121797361105681384378283536621141
Grade 3 and Above on ToxicityCarbo/Taxol4387491931021563852055413090981376617344515319034

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Progression-free Survival in Patients Aged 70 Years and Older

Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment. (NCT00022633)
Timeframe: 0-5 years

Interventionmonths (Median)
Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)6

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Overall Survival (OS) in Patients Aged 70 Years and Older

Measured from date of registration to date of death due to any cause. (NCT00022633)
Timeframe: 0-5 years

Interventionmonths (Median)
Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)11

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Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols

Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population. (NCT00022633)
Timeframe: 66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)

Interventionparticipants (Number)
Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)55

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Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)

Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. (NCT00022633)
Timeframe: every week for the first 4 weeks and then every 3 weeks for up to 19 weeks

Interventionpercentage of participants (Number)
Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)22

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Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required

Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included. (NCT00022633)
Timeframe: at study entry (prior to administration of any treatment)

Interventionpercentage of participants (Number)
Medical Conditions QuestionnaireInstrumental Activities of Daily Living FormFeelings Questionnaire
Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)284234

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Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate

Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included. (NCT00022633)
Timeframe: at study entry (prior to administration of any treatment)

Interventionpercentage of participants (Number)
Medical Conditions QuestionnaireInstrumental Activities of Daily Living FormFeelings Questionnaire
Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)989898

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Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms

Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included. (NCT00022633)
Timeframe: at study entry (prior to administration of any treatment)

Interventionminutes (Median)
Medical Conditions QuestionnaireInstrumental Activities of Daily Living FormFeelings Questionnaire
Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)532

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Accrual of Patients With This Disease Site

Only eligible patients who received treatment were evaluable for response and survival outcomes. (NCT00033540)
Timeframe: 1-20 months

Interventionparticipants (Number)
EligibleEligible and Analyzable
Capecitabine + Gemcitabine5452

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Overall Survival

Measured from time of registration to death, or last contact date (NCT00033540)
Timeframe: All patients will be followed until death or three years after registration, whichever is first.

Interventionmonths (Median)
Capecitabine + Gemcitabine7

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Median Survival Time for Participants With Relevant Biologic Markers

To evaluate in a preliminary fashion relevant prognostic markers in gallbladder and cholangiocarcinoma which may have prognostic implications as predictors of survival. Overall survival measured from time of registration to death, or last contact date. (NCT00033540)
Timeframe: All patients will be followed until death or three years after registration, whichever is first.

Interventionmonths (Median)
TS 3' +/+ (N=14)TS 3' +/- (N=6)TS 3' -/- (N=2)TS 5' Low functional significance (N=16)TS 5' Intermediate functional significance (N=16)MTHFR C677T - C/C (N=11)MTHFR C677T - C/T (N=11)MTHFR A1298C - A/A (N=11)MTHFR A1298C - A/C (N=8)MTHFR A1298C - C/C (N=3)RRMI G/A - G/G (N=9)RRMI G/A - G/A (N=10)RRMI G/A - A/A (N=3)CDA A79C - A/A (N=8)CDA A79C - A/C (N=12)CDA A79C - C/C (N=1)
Capecitabine + Gemcitabine779976774979547NA

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Response

Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. (NCT00033540)
Timeframe: Patients assessed at least every six weeks while on protocol treatment

Interventionparticipants (Number)
Confirmed Partial ResponseUnconfirmed Partial ResponseStable DiseaseProgressionSymptomatic DeteriorationEarly DeathInadequate Assessment
Capecitabine + Gemcitabine761215318

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Overall Survival (OS)

Overall survival is defined from the date of registration to date of death from any cause (NCT00045630)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery59

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Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy

Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration. (NCT00045630)
Timeframe: up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )

Interventionpercentage of participants (Number)
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery46

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Treatment Completion Rate

Radiation therapy and chemotherapy per protocol or within acceptable variation guidelines based on central review. The study was designed for a two-sided binomial test with 87% power and a significance level of 0.05 with a null hypothesis of a 70% completion rate against the alternative 90% completion rate. For each arm, more than 34 out of 43 evaluable patients completing the treatment, would indicate to reject the null hypothesis for a better treatment completion rate. Fewer than 24 out 43 evaluable patients completing the treatment would indicate to reject the null hypothesis for a worse treatment completion rate. Otherwise, the conclusion would be that there is not enough evidence to reject the null hypothesis of a 70% completion rate in either direction. (NCT00055601)
Timeframe: From randomization to 11 weeks

Interventionpercentage of participants (Number)
Pelvic RT + Paclitaxel + Cisplatin67
Pelvic RT + Fluorouracil + Cisplatin53

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Complete Response After Induction

Complete response requires the absence of any tumor in the tumor-site biopsy specimen or elsewhere and a bimanual exam that does not indicate the presence of a tumor mass. (NCT00055601)
Timeframe: From randomization to eight weeks

Interventionpercentage of participants (Number)
Pelvic RT + Paclitaxel + Cisplatin72
Pelvic RT + Fluorouracil + Cisplatin62

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Bladder-intact Survival Rate (5 Years)

Bladder-intact survival was measured from the date of randomization to occurrence of cystectomy or death. Five-year rates were estimated using the Kaplan-Meier method. (NCT00055601)
Timeframe: From the date of randomization to five years.

Interventionpercentage of participants (Number)
Pelvic RT + Paclitaxel + Cisplatin67
Pelvic RT + Fluorouracil + Cisplatin71

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Overall Response

Response was assessed per Response Evaluation Criteria In Solid Tumors (RECIST) by CT. Overall response included complete response (CR) and partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as CR of target lesions and persistence of one or more non-target lesions or at least a 30% decrease in the sum of the longest diameters of target lesions and non-progressive disease in the non-target lesions. The 71 eligible, treated participants were included in the analysis. (NCT00057876)
Timeframe: assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3

Interventionparticipants (Number)
Gemcitabine2
Gemcitabine + Radiation2

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Progression-free Survival Time

Time from randomization (registration) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the baseline sum longest diameter), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients who received treatment beyond 3 years were also followed for survival. (NCT00057876)
Timeframe: assessed every 3 months for 2 years, then every 6 months for year 3

InterventionMonths (Median)
Gemcitabine6.7
Gemcitabine + Radiation6.0

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Overall Survival Time

Overall survival was defined as the time from randomization (registration) to death from any cause. Patients alive at last follow-up were censored. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients received treatment beyond 3 years were also followed for survival. (NCT00057876)
Timeframe: assessed every 3 months for 2 years, then every 6 months for year 3

InterventionMonths (Median)
Gemcitabine9.2
Gemcitabine + Radiation11.0

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Overall Tumor Response

Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria. (NCT00063570)
Timeframe: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated

,
Interventionparticipants (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseUnknown
21-Day Schedule051060
Bi-Weekly Schedule2826142

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Time to Treatment Failure

Time to treatment failure is calculated as (Date of First Disease Progression, Death as a Result of any Cause, or Early Discontinuation of Treatment Due to Adverse Event or Physician Perception of Lack of Efficacy or Patient and Physician Perception of Lack of Efficacy, whichever Comes First - First Dose Date + 1)/ (365.25/12) (NCT00063570)
Timeframe: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated

Interventionmonths (Median)
Bi-Weekly Schedule2.79
21-Day Schedule2.56

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Time to Progressive Disease

Time to progressive disease is calculated as (Date of First Disease Progression or Death Due to Disease under Study whichever Comes First - First Dose Date + 1)/(365.25/12). (NCT00063570)
Timeframe: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated

Interventionmonths (Median)
Bi-Weekly Schedule3.19
21-Day Schedule4.01

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Overall Survival

Overall survival time is calculated as (Date of Death as a Result of any Cause - First Dose Date + 1)/ (365.25/12). (NCT00063570)
Timeframe: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated

Interventionmonths (Median)
Bi-Weekly Schedule13.44
21-Day Schedule16.20

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Duration of (Confirmed) Complete Response or Partial Response

Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed CR or PR + 1)/(365.25/12). (NCT00063570)
Timeframe: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated

Interventionmonths (Median)
Bi-Weekly Schedule5.85
21-Day Schedule4.17

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Pain, Assessed by Brief Pain Inventory

"Single item from the Brief Pain Inventory (BPI) assessing worst pain in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score." (NCT00064077)
Timeframe: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

,,,
Interventionunits on a scale (Mean)
BaselinePre-cycle 2Pre-cycle 59 months post cycle 1
Arm I (Paclitaxel, Cisplatin)4.03.53.62.3
Arm II (Vinorelbine, Cisplatin)3.93.54.03.2
Arm III (Gemcitabine, Cisplatin)3.33.43.53.7
Arm IV (Topotecan, Cisplatin)3.63.62.52.9

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Duration of Progression-free Survival (PFS)

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. (NCT00064077)
Timeframe: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Interventionmonths (Median)
Arm I (Paclitaxel, Cisplatin)5.82
Arm II (Vinorelbine, Cisplatin)3.98
Arm III (Gemcitabine, Cisplatin)4.70
Arm IV (Topotecan, Cisplatin)4.57

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Duration of Overall Survival (OS)

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. (NCT00064077)
Timeframe: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Interventionmonths (Median)
Arm I (Paclitaxel, Cisplatin)12.87
Arm II (Vinorelbine, Cisplatin)9.99
Arm III (Gemcitabine, Cisplatin)10.28
Arm IV (Topotecan, Cisplatin)10.25

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Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)

The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL. (NCT00064077)
Timeframe: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

,,,
Interventionunits on a scale (Mean)
BaselinePre-cycle 2Pre-cycle 59 months post cycle 1
Arm I (Paclitaxel, Cisplatin)66.665.270.571.9
Arm II (Vinorelbine, Cisplatin)69.165.566.669.9
Arm III (Gemcitabine, Cisplatin)67.965.364.568.6
Arm IV (Topotecan, Cisplatin)68.166.268.470.9

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Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).

The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity. (NCT00064077)
Timeframe: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

,,,
Interventionunits on a scale (Mean)
BaselinePre-cycle 2Pre-cycle 59 months post cycle 1
Arm I (Paclitaxel, Cisplatin)14.414.113.111.1
Arm II (Vinorelbine, Cisplatin)13.513.313.111.4
Arm III (Gemcitabine, Cisplatin)14.213.714.112.3
Arm IV (Topotecan, Cisplatin)14.114.214.413.1

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Time to Disease Progression

Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Time to disease progression will be calculated for all evaluable patients combined and by group (ie. for patients with or without the UGT1A1*28 polymorphism). (NCT00066781)
Timeframe: Up to 2 years

InterventionMonths (Median)
Cohort I3.7
Cohort II3.4

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Confirmed Response Rate (Partial or Complete Response for 2 Consecutive Evaluations at Least 4 Weeks Apart) as Measured by RECIST Criteria

The primary endpoint is confirmed response rate. If measurable disease is present, a confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. All registered patients meeting the eligibility criteria that have signed a consent form and have begun treatment will be evaluable for response. (NCT00066781)
Timeframe: Up to 2 years

Interventionpercentage of patients with response (Number)
Cohort I9
Cohort II13

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Overall Survival

Overall survival time is defined as the time from registration to death due> to any cause. The distribution of survival time will be estimated using> the method of Kaplan-Meier . Overall survival will be calculated for> all evaluable patients combined and by group (ie. for patients with or> without the UGT1A1*28 polymorphism). (NCT00066781)
Timeframe: Up to 2 years

InterventionMonths (Median)
Cohort I4
Cohort II9.3

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Overall Survival

Overall survival is defined as the time from study entry until death from any cause. (NCT00068393)
Timeframe: Every 2 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

InterventionMonths (Median)
Doxorubicin/Gemcitabine8.8

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Progression-free Survival

Progression-free survival is defined as time from study entry until disease progression or death from any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions. (NCT00068393)
Timeframe: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

InterventionMonths (Median)
Doxorubicin/Gemcitabine3.5

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Response Rate by Solid Tumor Response Criteria (RECIST)

Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR (NCT00068393)
Timeframe: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

InterventionPercentage of Participants (Number)
Doxorubicin/Gemcitabine16

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Overall and Complete Response Rates

Response was assessed per standard criteria (Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria fornon-Hodgkin's lymphomas. J Clin Oncol 1999;17:1244-1253.) (NCT00072514)
Timeframe: 3-4 weeks after completion of study treatment

Interventionpercentage of participants (Number)
OverallComplete
Treatment6731

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Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules

Count of participants that received the investigational therapy without incurring the protocol suspension rules. A stopping rule for safety was employed such that the study would be suspended if sufficient evidence indicated that the true grade 4-5 non-hematologic toxicity rate exceeded 10%. (NCT00072514)
Timeframe: At 3-4 weeks after completion of study treatment

InterventionParticipants (Count of Participants)
Treatment51

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Hematologic and Non-hematologic Adverse Events.

Count of participants with grade 3/4 hematologic and non-hematologic adverse events. (NCT00072514)
Timeframe: 3-4 weeks after completion of study treatment

InterventionParticipants (Count of Participants)
Hematologic Grade 3Hematologic Grade 4Non-Hematologic Grade 3Non-Hematologic Grade 4
Treatment1039232

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Peripheral Blood Stem Cell Collection

Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection. (NCT00072514)
Timeframe: Up to 12 weeks

InterventionParticipants (Count of Participants)
Attempted PBSC CollectionSuccessful PBSC Collection
Treatment1717

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Objective Response Rate

Patients will be evaluated up to 4 time points(after 2,4,8 and 12 cycles of therapy), each cycle is 21 days. Per RECIST 1.0 and assessed by CT/MRI disease status will be categorized as R=CR/PR(response), F=progressive disease or death(failure), or S(stable disease=neither R nor F) based on the change from baseline. A patient with outcome R or F at any stage is scored as having that overall outcome, a patient with outcome S is re-evaluated after subsequent cycles of therapy. Patients who receive more than 14 cycles of therapy will be scored as the outcome at completion of cycle 14. (NCT00073983)
Timeframe: After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days

Interventionparticipants (Number)
Ewing's Sarcoma6
Osteosarcoma5
Chondrosarcoma14

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Toxicity as Assessed by NCI CTCAE v3.0

Toxicity was graded according to Common Terminology Criteria for Adverse Events v.3.0 (CTCAE v.3.0). For gemcitabine or docetaxel related grade 3 or 4 non-hematological toxicities or hematological toxicities (grade 3 or 4 neutropenia for ≥ 7 days, grade 4 thrombocytopenia, or any platelet transfusion), both agents were withheld until the toxicity was ≤ grade 1. If the toxicity recovered to ≤ grade 1 by cycle day 35, the dose of both agents was reduced for all subsequent cycles. If the toxicity did not resolve by day 35, protocol therapy was discontinued. (NCT00073983)
Timeframe: Throughout the study

,,
Interventionparticipants (Number)
ToxicityNo Toxicity
Chondrosarcoma520
Ewing's Sarcoma410
Osteosarcoma311

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Overall Survival

(NCT00075504)
Timeframe: Up to 2 years

Interventionmonths (Median)
Stratum A Normal Liver Function Triapine, Gemcitabine10.3
Stratum B Abnormal Liver Function Triapine, Gemcitabine3.6

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Progression Free Survival

PFS will be measured from the time of the patient's initial best response (PR or CR) until documented progression. (NCT00075504)
Timeframe: Up to 2 years

Interventionmonths (Median)
Stratum A Normal Liver Function Triapine, Gemcitabine3.7
Stratum B Abnormal Liver Function Triapine, Gemcitabine3.6

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Response Rate According to RECIST Criteria

Tumor response was assessed every eight weeks by CT scan using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR+PR. (NCT00075504)
Timeframe: Up to 2 years

Interventionparticipants (Number)
Stratum A Normal Liver Function Triapine, Gemcitabine3
Stratum B Abnormal Liver Function Triapine, Gemcitabine0

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Toxic Effect

Number of patients affected by adverse events graded according to CTC Version 2.0. See adverse event (others) for details. (NCT00078949)
Timeframe: 48 months

InterventionParticipants (Count of Participants)
Salvage GDP36
Salvage DHAP26
Maintenance16
Observation8

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Transplantation Rate of Patients After 2 Courses of Chemotherapy

Transplantation rate is defined as the number of patients who respond sufficiently to protocol salvage chemotherapy to be planned for transplantation minus those who do not meet the endpoint of successful transplantation, divided by the number of all randomized patients (NCT00078949)
Timeframe: During period 1 (salvage chemotherapy)

Interventionpercentage of transplantation (Number)
Salvage GDP51.0
Salvage DHAP48.9

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Response Rate of Patients After 2 Courses of Chemotherapy

The overall response rate by arm is calculated as total number of responders (CR + CRu + PR) / (all patients in the ITT analysis population). (NCT00078949)
Timeframe: After 2 cycle of treatment

Interventionpercentage of response (Number)
Salvage GDP45.2
Salvage DHAP44.0

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Event-free Survival of Patients on Maintenance Randomization (Period 2)

Number of patients who develop EFS event during maintenance randomization (period 2) (NCT00078949)
Timeframe: during the period 2 (up to10 years)

Interventionparticipants (Number)
Maintenance53
Observation65

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Overall Survival

The time between the date of randomization and the date of death due to any cause. (NCT00088530)
Timeframe: 18 months after 6 cycles of treatment; approximately 24 months

InterventionMonths (Median)
Experimental Group10.2
Comparator Group7.6

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Overall Response Rate (ORR) Lasting at Least 4 Months

The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months. (NCT00088530)
Timeframe: approximately 24 months

Interventionparticipants (Number)
Experimental Group12
Comparator Group6

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Complete Response (CR) and Complete Response Unconfirmed (CRu)

Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT) (NCT00088530)
Timeframe: EOT; approximately 6 months

,
Interventionpercentage of randomized patients (Number)
END OF TREATMENT: CR/CRu, n (%)END OF STUDY: CR/CRu, n (%)
Comparator Group5.77.1
Experimental Group20.024.3

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Progression-Free Survival (PFS)

The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause. (NCT00088530)
Timeframe: 18 months after 6 cycles of treatment; approximately 24 months

Interventionmonths (Median)
Experimental Group5.3
Comparator Group2.6

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Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment

Toxicity event collected during Induction chemotherapy (CT) - two 3-week cycles, Concurrent CT and Radiation Therapy (CRT) (approximately 5.5 weeks), post CRT (4 weeks after the end of CRT), 2-3 months post CRT (8-12 weeks after the end of CRT) (NCT00089024)
Timeframe: From time of first dose until 30 days following final treatment, approximately 24 weeks

InterventionParticipants (Count of Participants)
Induction CT, grade 3Induction CT, grade 4CRT, grade 3CRT, grade 4Within 1 mo. post CRT, grade 3Within 1 mo. post CRT, grade 42-3 mos. post CRT, grade 32-3 mos. post CRT, grade 4
Treatment4511012190

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Surgical Exploration

Patients who completed chemotherapy & chemo-radiation had restaging imaging studies 4 weeks after completion of chemo-radiation. If there were no contraindications for surgical resection, surgical exploration was performed 6-8 weeks after completing chemo-radiation (NCT00089024)
Timeframe: After 6 weeks of chemotherapy and then after 4 weeks of chemo-radiation.

InterventionParticipants (Count of Participants)
unresectable diseaseintra-abdominal metastasisresection of the primary tumor
Treatment469

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Progression-free Survival

Median progression-free survival time (time from randomization to disease progression or death from any cause). Analyzed using the Kaplan-Meier (1958) estimator and their associated 95% confidence intervals determined using the method described in Brookmeyer and Crowley. (NCT00091026)
Timeframe: 36 months

Interventionmonths (Median)
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)5.0
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)5.1

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Overall Survival

Time from randomization until death from any cause. Analyzed using the Kaplan-Meier (1958) estimator and their associated 5% confidence intervals determined using the method described in Brookmeyer and Crowley. (NCT00091026)
Timeframe: 36 months

InterventionMonths (Median)
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)7.9
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)7.1

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Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)

(NCT00091026)
Timeframe: Up to 6 months

Interventionpercentage of participants (Number)
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)21
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)21

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Toxicity

Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as an adverse event classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. (NCT00093496)
Timeframe: Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)

,
Interventionevents (Number)
Grade 3Grade 4 or Higher
Cohort 1 (No Prior Gemcitabine Exposure)90
Cohort 2 (Prior Gemcitabine Exposure)70

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Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.

"Objective response will be measured using the modified RECIST criteria. A confirmed response requires an objective status of complete or partial response on 2 consecutive evaluations occurring 4 or more weeks apart.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.~Partial Response (PR): At least a 30% decrease in the sum of the target lesions from the baseline." (NCT00093496)
Timeframe: Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).

,
Interventionproportion of participants (Number)
Confirmed Partial Response (PR)Confirmed Complete Response (CR)
Cohort 1 (No Prior Gemcitabine Exposure)0.0710
Cohort 2 (Prior Gemcitabine Exposure)00

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Times to Progression

Defined as the time from registration to the date of progression or last follow-up, whichever comes first. Estimated using the method of Kaplan-Meier (NCT00093496)
Timeframe: Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.

Interventionmonths (Median)
Cohort 1 (No Prior Gemcitabine Exposure)1.6
Cohort 2 (Prior Gemcitabine Exposure)2.7

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Overall Survival

Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier. (NCT00093496)
Timeframe: Every 3 months until disease progression and then every 6 months for up to 5 years.

Interventionmonths (Median)
Cohort 1 (No Prior Gemcitabine Exposure)18.3
Cohort 2 (Prior Gemcitabine Exposure)11.5

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Toxicity

Percentage of patients who ever experienced grade 2 or higher toxicities. (NCT00093795)
Timeframe: 30 days after the last dose of study therapy (about 7 months after study entry)

Interventionpercentage of patients (Number)
Group 1: TAC X 682.7
Group 2: AC X 4 Then P X 487.5
Group 3: AC X 4 Then PG X 488.4

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Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer

The percentage of patients alive and cancer-free. (NCT00093795)
Timeframe: 5 years

Interventionpercentage of patients (Number)
Group 1: TAC X 680.1
Group 2: AC X 4 Then P X 482.2
Group 3: AC X 4 Then PG X 480.6

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Overall Survival

Percentage of participants alive at 5 years (NCT00093795)
Timeframe: 5 years

Interventionpercentage of patients alive (Number)
Group 1: TAC X 689.6
Group 2: AC X 4 Then P X 489.1
Group 3: AC X 4 Then PG X 490.8

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Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence

Percentage of patients recurrence-free (no first local, regional, or distant recurrence) (NCT00093795)
Timeframe: 5 years

Interventionpercentage of patients (Number)
Group 1: TAC X 685.1
Group 2: AC X 4 Then P X 486.2
Group 3: AC X 4 Then PG X 484.8

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Distant Recurrence-free Interval: the Time to Distant Disease Recurrence Only

Percentage of patients distant recurrence-free (no distant disease recurrence only) (NCT00093795)
Timeframe: 5 years

Interventionpercentage of patients (Number)
Group 1: TAC X 686.6
Group 2: AC X 4 Then P X 487.4
Group 3: AC X 4 Then PG X 486.6

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Progression-free Survival

Progression-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as >=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR. (NCT00096993)
Timeframe: Baseline to the end of the study (up to 1 year)

Interventionmonths (Median)
Placebo + Gemcitabine2.6
Pertuzumab + Gemcitabine2.9

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Percentage of Participants With an Objective Response

An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions. (NCT00096993)
Timeframe: Baseline to the end of the study (up to 1 year)

Interventionpercentage of participants (Number)
Placebo + Gemcitabine4.6
Pertuzumab + Gemcitabine13.8

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Duration of the Objective Response

Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause. (NCT00096993)
Timeframe: Baseline to the end of the study (up to 1 year)

Interventionmonths (Median)
Placebo + GemcitabineNA
Pertuzumab + Gemcitabine6.9

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Duration of Survival

Duration of survival was defined as the time from randomization until death from any cause. (NCT00096993)
Timeframe: Baseline to the end of the study (up to 1 year)

Interventionmonths (Median)
Placebo + Gemcitabine13.1
Pertuzumab + Gemcitabine13.0

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Percentage of Participants Free From Disease Progression at 4 Months

Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT00096993)
Timeframe: Baseline to Month 4

Interventionpercentage of participants (Number)
Placebo + Gemcitabine37.3
Pertuzumab + Gemcitabine47.6

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Progression-free Survival

Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00100789)
Timeframe: 0 - 3 years

Interventionmonths (Median)
Gemcitabine and Paclitaxel4

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Overall Survival

Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00100789)
Timeframe: 0 - 3 years

Interventionmonths (Median)
Gemcitabine and Paclitaxel8

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Response

Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. (NCT00100789)
Timeframe: 9 weeks - 3 years

Interventionparticipants (Number)
Complete ResponsePartial ResponseUnconfirmed Complete ResponseUnconfirmed Partial ResponseStable/No ResponseIncreasing DiseaseAssessment Inadequate
Gemcitabine and Paclitaxel161811219

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Overall Survival

(NCT00100815)
Timeframe: every 2-4 months for 1 year and then every 6 months for 5 years

Interventionmonths (Median)
GEMCITABINE, CAPECITABINE and AVASTIN9.8

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Percentage of Participants With Improved Quality of Life

Quality of Life was assessed using EORTC QLQ-PAN26. All measures range in score from 1 to 4 as lower scores indicate better outcomes. The improved Quality of Life is defined as a greater than 5% decrease in 2 consecutive scores compared with the baseline score. (NCT00100815)
Timeframe: assessed at baseline then weekly for 3 weeks

Interventionpercentage of participants (Number)
GEMCITABINE, CAPECITABINE and AVASTIN56.0

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Progression-free Survival

Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT00100815)
Timeframe: every 2-4 months for 1 year and then every 6 months for 5 years

Interventionmonths (Median)
GEMCITABINE, CAPECITABINE and AVASTIN5.7

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Clinical Response

Response was evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Overall Response (OR) = CR + PR. (NCT00100815)
Timeframe: Pre-treatment and every 6 weeks from treatment.

Interventionpercentage of participants (Number)
GEMCITABINE, CAPECITABINE and AVASTIN22.0

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Overall Survival

Time from randomization to death. Patients alive at last follow-up were censored. (NCT00101283)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 1 year

InterventionMonths (Median)
Pemetrexed/Carboplatin13.0
Pemetrexed/Gemcitabine6.0

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Best Overall Response by RECIST Criteria (Version 1.0)

Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression. (NCT00101283)
Timeframe: Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression

,
Interventioneligible, treated participants (Number)
Partial ResponseStable DiseaseProgressionUnevaluable
Pemetrexed/Carboplatin3751
Pemetrexed/Gemcitabine0652

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Progression-Free Survival

Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. (NCT00101283)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 1 year

InterventionMonths (Median)
Pemetrexed/Carboplatin4.1
Pemetrexed/Gemcitabine3.3

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Cmax

The maximum observed plasma concentration after AMG 706 dosing (NCT00101907)
Timeframe: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.

Interventionng/mL (Mean)
50 mg QD AMG 706 + Panitumumab + Gem/Cis152
75 mg QD AMG 706 + Panitumumab + Gem/Cis186
100 mg QD AMG 706 + Panitumumab + Gem/Cis278
125 mg QD AMG 706 + Panitumumab + Gem/Cis458
75 mg BID AMG 706 + Panitumumab + Gem/Cis268

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Number of Participants With an Objective Tumor Response

The number of participants with a confirmed objective tumor response, defined as a complete response (CR) or partial response (PR) throughout based on modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Any CR or PR was to be confirmed 4 to 6 weeks after the initial CR or PR. (NCT00101907)
Timeframe: From enrollment until date of last follow-up visit. The median follow-up time was 24 weeks, with a range of 3 to 73 weeks.

Interventionparticipants (Number)
Panitumumab + Gem/Cis2
50 mg QD AMG 706 + Panitumumab + Gem/Cis0
75 mg QD AMG 706 + Panitumumab + Gem/Cis1
100 mg QD AMG 706 + Panitumumab + Gem/Cis4
125 mg QD AMG 706 + Panitumumab + Gem/Cis2
75 mg BID AMG 706 + Panitumumab + Gem/Cis1

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Participant Incidence of Adverse Events

The number of participants who experienced at least one treatment-emergent adverse event. Additional details regarding specfic adverse events are provided in the Adverse Event section of this posting. (NCT00101907)
Timeframe: From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days.

InterventionParticipants (Number)
Panitumumab + Gem/Cis8
50 mg QD AMG 706 + Panitumumab + Gem/Cis8
75 mg QD AMG 706 + Panitumumab + Gem/Cis6
100 mg QD AMG 706 + Panitumumab + Gem/Cis6
125 mg QD AMG 706 + Panitumumab + Gem/Cis11
75 mg BID AMG 706 + Panitumumab + Gem/Cis2

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Tmax

Time after dosing when maximum plasma concentration was observed for AMG 706 (NCT00101907)
Timeframe: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.

Interventionhours (Median)
50 mg QD AMG 706 + Panitumumab + Gem/Cis1.00
75 mg QD AMG 706 + Panitumumab + Gem/Cis1.00
100 mg QD AMG 706 + Panitumumab + Gem/Cis1.38
125 mg QD AMG 706 + Panitumumab + Gem/Cis1.00
75 mg BID AMG 706 + Panitumumab + Gem/Cis1.00

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AUC0-inf

Area under the concentration-time curve from time 0 to infinite time (AUC0-inf) postdose with AMG 706. AUC0-inf was estimated using the linear/log trapezoidal method. AUC0-inf was not calculated for the BID cohort. (NCT00101907)
Timeframe: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.

Interventionμg*hr/mL (Mean)
50 mg QD AMG 706 + Panitumumab + Gem/Cis1.12
75 mg QD AMG 706 + Panitumumab + Gem/Cis1.64
100 mg QD AMG 706 + Panitumumab + Gem/Cis2.59
125 mg QD AMG 706 + Panitumumab + Gem/Cis3.05

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AUC0-24

Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC0-24) with AMG 706. AUC0-24 was estimated using the linear/log trapezoidal method. For the BID cohort, AUC0 24 was estimated as 2 times the AUC from time 0 to 12 hours post the first daily dose (AUC0-12) using the linear/log trapezoidal method. (NCT00101907)
Timeframe: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.

Interventionμg*hr/mL (Mean)
50 mg QD AMG 706 + Panitumumab + Gem/Cis1.03
75 mg QD AMG 706 + Panitumumab + Gem/Cis1.31
100 mg QD AMG 706 + Panitumumab + Gem/Cis2.38
125 mg QD AMG 706 + Panitumumab + Gem/Cis2.82
75 mg BID AMG 706 + Panitumumab + Gem/Cis2.54

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2-year Overall Survival Rate

The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause. (NCT00109928)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
PEGS31

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2-year Progression-free Survival Rate

Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed. (NCT00109928)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
PEGS12

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Response Rate

Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00109928)
Timeframe: up to 3 years or time of disease progression

Interventionparticipants (Number)
Complete ResponseUnconfirmed Complete ResponsePartial ResponseNo Response
PEGS62520

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Progression-free Survival

Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation. (NCT00110084)
Timeframe: Time from registration to progression or death (up to 5 years)

Interventionmonths (Median)
Nab-paclitaxel/Gemcitabine7.9

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Adverse Event

Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0 (NCT00110084)
Timeframe: Every 6 weeks

Interventionparticipants (Number)
NeutropeniaFatigueAnemiaDyspneaThrombocytopeniaArthralgiaVomitingNeuropathyMyalgiaNauseaPain-abdominalAspartate aminotransferase (AST)
Nab-paclitaxel/Gemcitabine27147764433333

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Proportion of Patients With Confirmed Responses

"Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.~Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions." (NCT00110084)
Timeframe: Two consecutive evaluations at least 6 weeks apart

Interventionparticipants (Number)
Confirmed responseAssessable
Nab-paclitaxel/Gemcitabine2550

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Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0

RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate. (NCT00114218)
Timeframe: CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.

InterventionPercentage of participants (Number)
Treatment (Gemcitabine Hydrochloride, Docetaxel)8

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Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0

Count of participants with Toxicities maximum grade greater than or equal to grade 3 (NCT00114218)
Timeframe: Assessed every 28 days (28 days=1 cycle) while on study treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

InterventionParticipants (Count of Participants)
Treatment (Gemcitabine Hydrochloride, Docetaxel)18

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Progression-free Survival

Estimated using the product-limit method of Kaplan and Meier by arm. The probability of progression-free survival at 3 months and overall survival at 6 months, and their Greenwood's standard errors will be summarized by arm. (NCT00114244)
Timeframe: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 3 months

InterventionMonths (Median)
Arm I (Sorafenib Tosylate)2.3
Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)2.9

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Overall Survival

Estimated using the product-limit method of Kaplan and Meier by arm. (NCT00114244)
Timeframe: From first day of treatment to time of death due to any cause, assessed up to 6 months

InterventionMonths (Median)
Arm I (Sorafenib Tosylate)4.3
Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)6.5

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Objective Response (OR = CR or PR) as Determined by the RECIST Criteria

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan, MRI, X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00114244)
Timeframe: Every 6 weeks.

Interventionparticipants (Number)
Arm I (Sorafenib Tosylate)0
Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)1

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Median Number of Months of Progression Free Survival (PFS)

PFS will be measured from the time of the patient's initial best response (PR or CR) until documented progression. (NCT00121251)
Timeframe: From the time of the patient's initial best response (PR or CR) until documented progression, assessed up to 9 years

InterventionMonths (Median)
Sorafenib + Gemcitabine + Capecitabine5

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Number of Participants Who Survived (Overall Survival)

Overall survival (OS) is defined as the time from start of treatment to death from any cause. (NCT00121251)
Timeframe: Up to 9 years

InterventionParticipants (Count of Participants)
Sorafenib + Gemcitabine + Capecitabine6

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Objective Response for BAY 43-9006 in Combination With Gemcitabine and Capecitabine Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR (NCT00121251)
Timeframe: Up to 9 years

InterventionParticipants (Count of Participants)
Sorafenib + Gemcitabine + Capecitabine5

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Response Rate

"Response rate as defined by a best response of Stable Disease or better." (NCT00161213)
Timeframe: 5 years

Interventionpercentage of total evaluable subjects (Number)
Gemcitabine and Imatinib48.6

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1-year Survival Rate

Percentage of subjects who survive up to 1 year (NCT00161213)
Timeframe: 5 years

Interventionpercentage of total evaluable subjects (Number)
Gemcitabine and Imatinib25.6

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Overall Survival

(NCT00161213)
Timeframe: 5 years

Interventionmonths (Median)
Gemcitabine and Imatinib6.23

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Progression-free Survival

Progression-free survival in months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00161213)
Timeframe: 4 years

Interventionmonths (Median)
Gemcitabine and Imatinib3.9

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Tumor Response Type: CR, PR, SD or PD

Tumor response will be based on the RECIST v1.0 criteria. CR (complete response)= disappearance of all target lesions, PR (partial response)= greater or equal to 30% decrease in sum of longest diameter of target lesions, SD (stable disease)= <30% decrease or <20% increase, PD (progressive disease)= greater or equal to 20% increase in longest diameter of target lesions. For patients with an elevated CA-125 as the only evidence of disease, a PR was defined as a decrease of 50% or more lasting at least 8 weeks (Rustin et al. JCO 14:1545-51, 1996). Disease assessment performed every 2 cycles (1 cycle = 21 days). Responders included CR and PR. (NCT00183794)
Timeframe: 6 months after enrollment of last participant

InterventionParticipants (Number)
CRPRSDPD
Gemcitabine and Docetaxel1496

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Median Time to Progression (Months)

Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression based on RECIST v1.0 criteria for measurable disease, and on CA-125 for patients with an elevated CA-125 as the only evidence of disease (Rustin et al. JCO 14:1545-51, 1996) (NCT00183794)
Timeframe: 6 months after enrollment of last patient

InterventionMonths (Median)
Gemcitabine and Docetaxel3

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Toxicity (Number of Participants With Serious Adverse Events)

Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35) (NCT00184093)
Timeframe: Every 3 weeks from start of study until 30 days after the last dose of treatment

InterventionParticipants (Count of Participants)
Gemcitabine Weekly x 6 Wks With Concurrent External Radiation10

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Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)

"Participants who complete the 6 weeks of chemotherapy and radiation or who experience dose limiting toxicity or who progress at any time prior to completion of the 6 weeks of chemotherapy and radiation will be evaluable for response.~Complete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No disease related symptoms. No evidence of nonevaluable disease, including normalization of markers and other abnormal lab values. All measurable, evaluable, and nonevaluable lesions and sites must be assessed using the same technique as baseline.~Partial response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline." (NCT00184093)
Timeframe: Baseline to response (up to 24 months)

InterventionParticipants (Count of Participants)
Gemcitabine Weekly x 6 Wks With Concurrent External Radiation32

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Time-to-Progression, Evaluable Patients

Represents the evaluable subset of subjects that terminated from the study due to disease progression (endpoint). Does not include any other form of treatment failure, nor lost-to-follow-up. (NCT00185588)
Timeframe: 12 months

Interventionmonths (Median)
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 12504.4
Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 12506.0
Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x5003.2

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Time-to-Treatment Failure (Intent-To-Treat Analysis)

"For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death.~Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)." (NCT00185588)
Timeframe: 12 months

Interventionmonths (Median)
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 12504.9
Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 12502.7
Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x5002.2
Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x5003.7

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The Percentage of Patients Alive Without Disease at 2 Years

Disease-free survival (NCT00189137)
Timeframe: 2 years

Interventionpercentage of patients (Number)
Doxorubicin and Ifosfamide57
Gemcitabine and Docetaxel74

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Percentage of Patients Hospitalized in Each Arm.

To contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma. (NCT00189137)
Timeframe: 12 weeks

Interventionpercentage of patients hospitalized (Number)
Doxorubicin and Ifosfamide35
Gemcitabine and Docetaxel26

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Local Failure Rate

Local failure rate (LFR) was defined as the the proportion of per-protocol participants who had progressive disease (PD) in the cervix or pelvis. LFR = The number of (a) participants who progressed in the cervix or pelvis divided by (b) the number of participants in each arm. (LFR=a/b). (NCT00191100)
Timeframe: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively

Interventionproportion of participants with PD (Number)
Gemcitabine/Cisplatin/Radiation0.113
Cisplatin/Radiation0.166

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Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years

"Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted Measure Type, so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented." (NCT00191100)
Timeframe: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively

,
Interventionparticipants (Number)
3 Years: Number of Patients with Event3 Years: Number of Patients at Risk
Cisplatin/Radiation83141
Gemcitabine/Cisplatin/Radiation55149

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Number of Participants Who Died From Any Cause at Various Time Points

Original outcome was Overall Survival, which was defined as time from baseline to death from any cause. (NCT00191100)
Timeframe: baseline to date of death from any cause (includes 60 month follow-up period)

,
Interventionparticipants (Number)
3 Months: Number of Patients with Event3 Months: Number of Patients at Risk6 Months: Number of Patients with Event6 Months: Number of Patients at Risk12 Months: Number of Patients with Event12 Months: Number of Patients at Risk18 Months: Number of Patients with Event18 Months: Number of Patients at Risk24 Months: Number of Patients with Event24 Months: Number of Patients at Risk36 Months: Number of Patients with Event36 Months: Number of Patients at Risk
Cisplatin/Radiation0254424825222461955818275158
Gemcitabine/Cisplatin/Radiation3253924122226332073920053175

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Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points

Original outcome was Time to Progressive Disease (TTPD), which is the time from baseline to event (progressive disease or death due to study disease). The median TTPD was not achieved and therefore the cumulative number of participants with event (and those still at risk) at various time points are presented. (NCT00191100)
Timeframe: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively

,
Interventionparticipants (Number)
3 Months: Number of Patients with Event3 Months: Number of Patients at Risk6 Months: Number of Patients with Event6 Months: Number of Patients at Risk12 Months: Number of Patients with Event12 Months: Number of Patients at Risk18 Months: Number of Patients with Event18 Months: Number of Patients at Risk24 Months: Number of Patients with Event24 Months: Number of Patients at Risk36 Months: Number of Patients with Event36 Months: Number of Patients at Risk
Cisplatin/Radiation82382521844195621706915878141
Gemcitabine/Cisplatin/Radiation52211020421186241763116740149

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Tumor Response

Tumor response rate (TRR) defined as number of qualified responder patients with confirmed complete or partial response. (NCT00191100)
Timeframe: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively

,
Interventionparticipants (Number)
Complete ResponsePartial Response
Cisplatin/Radiation21720
Gemcitabine/Cisplatin/Radiation22322

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Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points

Original outome was Progression-Free Survival, which was defined as time from baseline to progressive disease or death due to any cause. (NCT00191100)
Timeframe: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively

,
Interventionparticipants (Number)
3 Months: Number of Patients with Event3 Months: Number of Patients at Risk6 Months: Number of Patients with Event6 Months: Number of Patients at Risk12 Months: Number of Patients with Event12 Months: Number of Patients at Risk18 Months: Number of Patients with Event18 Months: Number of Patients at Risk24 Months: Number of Patients with Event24 Months: Number of Patients at Risk36 Months: Number of Patients with Event36 Months: Number of Patients at Risk
Cisplatin/Radiation82382521845195631707215883141
Gemcitabine/Cisplatin/Radiation82211420429186341764216755149

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Progression-Free Survival

Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed. (NCT00191139)
Timeframe: baseline to measured progressive disease up to 2057 days

Interventiondays (Median)
Gemcitabine162.5
Gemcitabine Plus Docetaxel408.0

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Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization

LCSS measures physical & functional dimensions. The patient scale contains 9 items, 3 summation & 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met. (NCT00191139)
Timeframe: baseline to 3 months after last dose of study treatment (three 21-day cycles)

,
Interventionparticipants (Number)
ImprovementStableWorse
Gemcitabine8102
Gemcitabine Plus Docetaxel598

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Number of Patients With Overall Tumor Response

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR). (NCT00191139)
Timeframe: randomization and every 3 months up to 2 years of post-study followup

Interventionparticipants (Number)
Gemcitabine24
Gemcitabine Plus Docetaxel27

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2-Year Survival

Percentage of participants alive at 2 years. (NCT00191139)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Gemcitabine40.6
Gemcitabine Plus Docetaxel55.7

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Overall Survival

Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact. (NCT00191139)
Timeframe: baseline to date of death from any cause up to 2057 days

Interventiondays (Median)
Gemcitabine492.5
Gemcitabine Plus Docetaxel899.0

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Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)

RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL]. (NCT00191152)
Timeframe: Baseline until crossover treatment began (up to 82 months)

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline
Docetaxel Plus Capecitabine72.32-2.68
Gemcitabine Plus Docetaxel68.092.42

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Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)

RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL]. (NCT00191152)
Timeframe: First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline
Capecitabine75.00-2.78
Gemcitabine76.39-0.69

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Progression-Free Survival (Crossover Treatment)

For crossover treatment, progression-free survival (PFS) was defined as the number of months between first dose date of crossover treatment and date of documented disease progression or date of death due to any cause, whichever came first. PFS for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for participants with documented disease progression. (NCT00191152)
Timeframe: First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)

Interventionmonths (Median)
Capecitabine4.51
Gemcitabine2.34

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Time to Disease Progression (Crossover Treatment)

For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression. (NCT00191152)
Timeframe: Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)

Interventionmonths (Median)
Capecitabine4.51
Gemcitabine2.34

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Progression-Free Survival (Initial Treatment)

For initial treatment, progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. Time to PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for progression; or 3) first dose date of crossover treatment. (NCT00191152)
Timeframe: Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)

Interventionmonths (Median)
Gemcitabine Plus Docetaxel9.01
Docetaxel Plus Capecitabine8.88

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Time to Disease Progression (Initial Treatment)

Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment. (NCT00191152)
Timeframe: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)

Interventionmonths (Median)
Gemcitabine Plus Docetaxel9.28
Docetaxel Plus Capecitabine8.88

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Best Overall Response (Crossover Treatment)

Best overall response was the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response assessed using RECIST criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria. (NCT00191152)
Timeframe: Best response from start of treatment until disease progression/recurrence (up to 82 months)

,
Interventionparticipants (Number)
Complete Response (confirmed)Partial Response (confirmed)Stable DiseaseProgressive DiseaseUnknown
Capecitabine110193413
Gemcitabine16203618

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Best Overall Response (Initial Treatment)

Best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria. (NCT00191152)
Timeframe: Best response from start of treatment until disease progression/recurrence (up to 82 months)

,
Interventionparticipants (Number)
Complete Response (confirmed)Partial Response (confirmed)Stable DiseaseProgressive DiseaseUnknown
Docetaxel Plus Capecitabine679902734
Gemcitabine Plus Docetaxel671963234

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Duration of Response (Crossover Treatment)

At crossover treatment, duration of response was measured from the time criteria were met for complete response (CR) or partial response (PR), until first date that recurrent or progressive disease was objectively documented or date of death due to any cause, whichever came first. This definition only applied to those who crossed over & achieved CR or PR in crossover treatment. Duration of response censored at earliest of: 1) date of last contact for those alive without disease progression; or 2) start date of other anti-tumor therapy for documented disease progression. (NCT00191152)
Timeframe: Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)

Interventionmonths (Median)
Capecitabine25.89
Gemcitabine42.50

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Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)

KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100). (NCT00191152)
Timeframe: First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline
Capecitabine89.09-0.30
Gemcitabine87.94-1.27

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Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)

KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100). (NCT00191152)
Timeframe: Baseline until crossover treatment began (up to 82 months)

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline
Docetaxel Plus Capecitabine90.09-3.27
Gemcitabine Plus Docetaxel90.85-3.30

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Overall Survival

Overall survival time was defined as the number of months between the date of randomization and the date of death due to any cause. The overall survival time was censored at the date of last contact for participants who were still alive. (NCT00191152)
Timeframe: Date of randomization to date of death from any cause (up to 82 months)

Interventionmonths (Median)
Gemcitabine Plus Docetaxel22.99
Docetaxel Plus Capecitabine23.29

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Duration of Response (Initial Treatment)

Among tumor responders, duration of tumor response was measured from the date of response (complete response [CR] or partial response [PR] until the first date of documented progression or death from any cause. Duration of response was censored at the earliest of: 1) date of last contact for participants alive without disease progression (DP); or 2) start date of other anti-tumor therapy for DP; or 3) dose date of crossover treatment. (NCT00191152)
Timeframe: Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)

Interventionmonths (Median)
Gemcitabine Plus Docetaxel9.11
Docetaxel Plus Capecitabine10.39

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Tumor Response

"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment." (NCT00191269)
Timeframe: baseline to measured progressive disease

,
Interventionparticipants (Number)
Complete ResponsePartial ResponseLong Stable DiseaseStable DiseaseProgressive DiseaseNot Evaluable
Dose Level 1001122
Dose Level 214416325

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Pharmacokinetics - Normalized Cmax

maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine. (NCT00191269)
Timeframe: cycle 1

Interventionnanograms per milliliter (ng/mL) (Geometric Mean)
Dose Normalized to 1250 Milligrams Per Square Meter29,036

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Pharmacokinetics - Normalized Area Under the Curve

Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter. (NCT00191269)
Timeframe: cycle 1

Interventionnanograms times hour per milliliter (Geometric Mean)
Dose Normalized to 1250 Milligrams Per Square Meter15,999

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Time to Progressive Disease

Time from study enrollment to first date of disease progression. Time to disease progression was censored at date of death if death was due to other cause. The minimum and maximum of this parameter were summarized, and the median time to progression and its 95% confidence interval were calculated using the Kaplan-Meier estimation. (NCT00191269)
Timeframe: baseline to measured progressive disease

Interventiondays (Median)
Dose Level 1137
Dose Level 292

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Survival at 1 Year

Results are reported as number of participants alive at one year. (NCT00191269)
Timeframe: baseline to date of death from any cause, evaluate at 1 year

Interventionparticipants (Number)
Dose Level 14
Dose Level 242

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Duration of Response

For responders, the minimum and maximum of the duration of complete response, duration of partial response, and duration of overall response were summarized, and the median of response duration and its 95% confidence interval were calculated using the Kaplan-Meier estimation. (NCT00191269)
Timeframe: time of response to progressive disease

Interventionmonths (Median)
Dose Level 210.07

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Duration of Response

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. (NCT00191334)
Timeframe: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up

Interventionweeks (Median)
Gemcitabine + Cisplatin37.0

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Time to Progressive Disease

Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. (NCT00191334)
Timeframe: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up

Interventionweeks (Median)
Gemcitabine + Cisplatin45.1

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Time to Treatment Failure

Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. (NCT00191334)
Timeframe: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up

Interventionweeks (Median)
Gemcitabine + Cisplatin38.4

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Best Overall Tumor Response

Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). (NCT00191334)
Timeframe: every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up

Interventionparticipants (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseNot Assessed
Gemcitabine + Cisplatin6251054

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Duration of Response

Among tumor responders, the duration of tumor response is measured from the date of response (complete response [CR] or partial response [PR]) until the first date of documented progression or death from any cause. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed. (NCT00191451)
Timeframe: date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years)

Interventionmonths (Median)
HER2+6.9
HER2- (Taxane-)6.4
HER2- (Taxane+)5.6

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Overall Tumor Response

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. (NCT00191451)
Timeframe: baseline to disease progression/recurrence (up to 3.5 years)

,,
Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)Not Evaluable (NE)
HER2- (Taxane-)01320122
HER2- (Taxane+)11513171
HER2+6261242

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Percentage of Patients With Overall Survival at 1 Year and 2 Years

Kaplan-Meier estimates of overall survival (percentage of patients surviving) at 1 year and 2 years. (NCT00191451)
Timeframe: 1 Year, 2 Years

,,
Interventionpercentage of participants (Number)
1 Year Overall Survival2 Year Overall Survival
HER2- (Taxane-)67.541.4
HER2- (Taxane+)47.820.5
HER2+90.073.3

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Time to Disease Progression (TTP)

If a patient is lost to follow-up, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient died due to reason other than study disease, and patient has not progressed or received any new treatment, TTP is censored at the date of death. (NCT00191451)
Timeframe: randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years)

Interventionmonths (Median)
HER2+7.2
HER2- (Taxane-)5.6
HER2- (Taxane+)4.6

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Number of Patients Who Experienced Alopecia

(NCT00191451)
Timeframe: Baseline to 3.5 years

Interventionparticipants (Number)
HER2+21
HER2- (Taxane-)17
HER2- (Taxane+)16

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Recurrence-Free Survival (RFS)

Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression. (NCT00191477)
Timeframe: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)

InterventionMonths (Median)
Gemcitabine37.2
Placebo40.2

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Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months

RFS rate was estimated using Kaplan-Meier method. RFS was analyzed in different subgroups based on risk, disease status, and concomitant Bacillus Calmette-Guerin (BCG) instillations. Risk: Grading (G1,G2,G3) was performed according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer. Newly diagnosed disease: Initial diagnosis at study entry. Recurrent disease: history of at least one superficial bladder tumor that was surgically treated and relapsed prior to study entry. With BCG: received at least one instillation of BCG during study. Without BCG: didn't receive BCG. (NCT00191477)
Timeframe: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)

,
Interventionpercentage of participants (Number)
Low Risk (G1/G2) - 12 Months (N=106, N=109)Low Risk (G1/G2) - 24 Months (N=106, N=109)High Risk (G3) - 12 Months (N=13, N=14)High Risk (G3) - 24 Months (N=13, N=14)Newly Diagnosed Disease - 12 Months (N=94, N=98)Newly Diagnosed Disease - 24 Months (N=94, N=98)Recurrent Disease - 12 Months (N=30, N=26)Recurrent Disease - 24 Months (N=30, N=26)With BCG - 12 Months (N=13, N=21)With BCG - 24 Months (N=13, N=21)Without BCG - 12 Months (N=111, N=103)Without BCG - 24 Months (N=111, N=103)
Gemcitabine78.563.966.757.179.365.472.259.561.549.279.965.8
Placebo78.464.342.431.879.863.658.950.579.463.574.560.1

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Percentage of Participants Without Tumor Recurrence

Because median time to recurrence was not reached, percentage of participants without event was estimated using Kaplan-Meier method. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence. (NCT00191477)
Timeframe: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)

,
Interventionpercentage of participants (Number)
Recurrence-Free at 12 MonthsRecurrence-Free at 24 Months
Gemcitabine78.466.3
Placebo76.963.7

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Tumor Recurrence Type

Tumor recurrence type (superficial, stage pTA or pT1; or muscle-invasive, stage≥pT2) was classified according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer (AJCC Cancer Staging Manual, 6th edition). (NCT00191477)
Timeframe: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)

,
Interventionparticipants (Number)
No Tumor RecurrenceSuperficial Tumor - Stage pTa or pT1Muscle-Invasive Tumor - Any Stage ≥pT2pTx - Tumor Cannot be Assessed
Gemcitabine764431
Placebo784510

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Time to Treatment Failure

Time to treatment failure was defined as the duration from date of randomization to the date of the first of the following events: early discontinuation of study therapy; progression of disease, or death due to any cause. Time to treatment failure will be censored at the date of the last follow-up visit for participants who did not discontinue early, who are still alive, and who have not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies. (NCT00191646)
Timeframe: Baseline to stopping treatment up to 82 months

Interventionmonths (Median)
Gemcitabine/Carboplatin13.0
Paclitaxel/Carboplatin13.1

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Overall Survival

Overall survival is defined as the duration from baseline to death. For participants who are still alive at the data cut-off date, survival will be censored at the last contact date. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies. (NCT00191646)
Timeframe: Baseline to death from any cause up to 82 months

Interventionmonths (Median)
Gemcitabine/Carboplatin43.8
Paclitaxel/Carboplatin57.3

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Progression Free Survival (PFS)

Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies. (NCT00191646)
Timeframe: Baseline to measured progressive disease or death up to 82 months

InterventionMonths (Median)
Gemcitabine/Carboplatin20.0
Paclitaxel/Carboplatin22.2

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Proportion of Participants With Response (Response Rate)

Response rate (RR) = proportion of participants with best overall Complete Response (CR: disappearance of all target lesions [TL]) or Partial Response (PR: 30% decrease in sum of longest diameter of TL). Induction therapy RR = number of participants with CR or PR during induction divided by number of participants with measurable disease at baseline (TL measurement during screening). Crossover therapy RR = number of participants with CR or PR during crossover divided by number of participants with measurable disease at baseline (latest TL measurement by first dose date of crossover therapy). (NCT00191646)
Timeframe: Baseline to measured progressive disease up to 82 months

Interventionproportion of responders (Mean)
Gemcitabine/Carboplatin (Induction)0.676
Paclitaxel/Carboplatin (Induction)0.711
Gemcitabine (Crossover)0.357
Paclitaxel (Crossover)0.303

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Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study

The cumulative number of participants with an event (either progressive disease or death) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without progressive disease or still alive at the beginning of each time point. (NCT00191789)
Timeframe: baseline up to 68 months

Interventionparticipants (Number)
3 Months: Number of Patients with Event3 Months: Number of Patients at Risk6 Months: Number of Patients with Event6 Months: Number of Patients at Risk12 Months: Number of Patients with Event12 Months: Number of Patients at Risk24 Months: Number of Patients with Event24 Months: Number of Patients at Risk48 Months: Number of Patients with Event48 Months: Number of Patients at Risk68 Months: Number of Patients with Event68 Months: Number of Patients at Risk
Gemcitabine+Doxorubicin+Cisplatin+Surgery559850114115362123211

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Number of Participants With Time to Treatment Failure at Various Time Points

This outcome is in place of the time to treatment failure outcome. The cumulative number of participants with an event (disease progression, death as a result of any cause, or early discontinuation of treatment) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without disease progression, are alive, or did not discontinue treatment early at the beginning of each time point. (NCT00191789)
Timeframe: baseline to stopping treatment (up to 68 months)

Interventionparticipants (Number)
3 Months: Number of Patients with Event3 Months: Number of Patients at Risk6 Months: Number of Patients with Event6 Months: Number of Patients at Risk12 Months: Number of Patients with Event12 Months: Number of Patients at Risk24 Months: Number of Patients with Event24 Months: Number of Patients at Risk48 Months: Number of Patients with Event48 Months: Number of Patients at Risk68 Months: Number of Patients with Event68 Months: Number of Patients at Risk
Gemcitabine+Doxorubicin+Cisplatin+Surgery11591950254129363523351

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Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery

The extent and type of surgery was guided by the tumor size, physician and/or patient decision. It was either conservation surgery or mastectomy with axillary lymph node dissection. Results are reported on the number of patients who underwent breast conservation surgery. (NCT00191789)
Timeframe: baseline, after eight 21-day cycles of study drug

Interventionparticipiants (Number)
Eligible for Surgery at BaselineUnderwent Surgery
Gemcitabine+Doxorubicin+Cisplatin+Surgery018

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Summary of Deaths During Study

(NCT00191789)
Timeframe: baseline through last cycle on study drug (eight 21-day cycles)

Interventionparticipants (Number)
Study DiseaseStudy Drug Toxicity: Cardiac arrestStudy Drug Toxicity: Infection with neutropeniaStudy Drug Toxicity: Neutropenic sepsisMyocardial infarction
Gemcitabine+Doxorubicin+Cisplatin+Surgery01121

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Number of Participants Who Died From Any Cause at Various Time Points

The cumulative number of participants with an event (death from any cause) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants still alive at the beginning of each time point. (NCT00191789)
Timeframe: baseline up to 68 months

Interventionparticipants (Number)
3 Months: Number of Patients With Event3 Months: Number of Patients at Risk6 Months: Number of Patients With Event6 Months: Number of Patients at Risk12 Months: Number of Patients With Event12 Months: Number of Patients at Risk26 Months: Number of Patients With Event26 Months: Number of Patients at Risk48 Months: Number of Patients With Event48 Months: Number of Patients at Risk68 Months: Number of Patients With Event68 Months: Number of Patients at Risk
Gemcitabine+Doxorubicin+Cisplatin+Surgery36055174311371424151

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Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)

Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified. (NCT00191789)
Timeframe: tumor assessment at baseline and during surgery after eight 21-day treatment cycles

Interventionparticipants (Number)
Gemcitabine+Doxorubicin+Cisplatin+Surgery13

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Duration of Response

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. (NCT00191815)
Timeframe: first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)

Interventionweeks (Median)
Gemcitabine + Cisplatin32.7

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Survival Time

Overall survival is the duration from enrollment to death due to any cause. (NCT00191815)
Timeframe: first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)

Interventionweeks (Median)
Gemcitabine + Cisplatin84.0

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Time to Progressive Disease

Defined as the time from study enrollment to the first date of disease progression. (NCT00191815)
Timeframe: first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)

Interventionweeks (Median)
Gemcitabine + Cisplatin33.9

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Time to Treatment Failure

Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. (NCT00191815)
Timeframe: first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)

Interventionweeks (Median)
Gemcitabine + Cisplatin26.2

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Number of Participants With Adverse Events Leading to Discontinuation

(NCT00191815)
Timeframe: Baseline through eight 21-day cycles

Interventionparticipants (Number)
Patients with >=1 AE leading to discontinuationPneumoniaToxic skin eruption
Gemcitabine + Cisplatin211

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Number of Deaths

(NCT00191815)
Timeframe: Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)

Interventionparticipants (Number)
Disease ProgressionVentricular FibrillationCirculatory Arrest
Gemcitabine + Cisplatin3511

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Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination

The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). (NCT00191815)
Timeframe: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)

Interventionparticipants (Number)
Allergic reaction/hypersensivity - Grade 1Allergic reaction/hypersensivity - Grade 2Allergic reaction/hypersensivity - Grade 3Allergic reaction/hypersensivity - Grade 4Allergic rhinitis - Grade 1Allergic rhinitis - Grade 2Allergic rhinitis - Grade 3Allergic rhinitis - Grade 4Other auditory/hearing - Grade 1Other auditory/hearing - Grade 2Other auditory/hearing - Grade 3Other auditory/hearing - Grade 4Blood/Bone marrow - other - Grade 1Blood/Bone marrow - other - Grade 2Blood/Bone marrow - other - Grade 3Blood/Bone marrow - other - Grade 4Cardiac- ischemia/infarction - Grade 1Cardiac- ischemia/infarction - Grade 2Cardiac- ischemia/infarction - Grade 3Cardiac- ischemia/infarction - Grade 4Hypertension - Grade 1Hypertension - Grade 2Hypertension - Grade 3Hypertension - Grade 4Hypotension - Grade 1Hypotension - Grade 2Hypotension - Grade 3Hypotension - Grade 4Fatigue - Grade 1Fatigue - Grade 2Fatigue - Grade 3Fatigue - Grade 4Fever - Grade 1Fever - Grade 2Fever - Grade 3Fever - Grade 4Rigors, chills - Grade 1Rigors, chills - Grade 2Rigors, chills - Grade 3Rigors, chills - Grade 4Weight loss - Grade 1Weight loss - Grade 2Weight loss - Grade 3Weight loss - Grade 4Alopecia - Grade 1Alopecia - Grade 2Alopecia - Grade 3Alopecia - Grade 4Rash/desquamation - Grade 1Rash/desquamation - Grade 2Rash/desquamation - Grade 3Rash/desquamation - Grade 4Anorexia - Grade 1Anorexia - Grade 2Anorexia - Grade 3Anorexia - Grade 4Constipation - Grade 1Constipation - Grade 2Constipation - Grade 3Constipation - Grade 4Mucositis due to radiation - Grade 1Mucositis due to radiation - Grade 2Mucositis due to radiation - Grade 3Mucositis due to radiation - Grade 4Nausea - Grade 1Nausea - Grade 2Nausea - Grade 3Nausea - Grade 4Vomiting - Grade 1Vomiting - Grade 2Vomiting - Grade 3Vomiting - Grade 4SGPT (ALT) - Grade 1SGPT (ALT) - Grade 2SGPT (ALT) - Grade 3SGPT (ALT) - Grade 4Infection without neutropenia - Grade 1Infection without neutropenia - Grade 2Infection without neutropenia - Grade 3Infection without neutropenia - Grade 4Insomnia - Grade 1Insomnia - Grade 2Insomnia - Grade 3Insomnia - Grade 4Abdominal pain or cramping - Grade 1Abdominal pain or cramping - Grade 2Abdominal pain or cramping - Grade 3Abdominal pain or cramping - Grade 4Headache - Grade 1Headache - Grade 2Headache - Grade 3Headache - Grade 4Pain - Other - Grade 1Pain - Other - Grade 2Pain - Other - Grade 3Pain - Other - Grade 4Renal/Genitourinary - Other - Grade 1Renal/Genitourinary - Other - Grade 2Renal/Genitourinary - Other - Grade 3Renal/Genitourinary - Other - Grade 4
Gemcitabine + Cisplatin11001000001000010010010000016100010010001100130000104000100020001082047100100100000101100001000101010

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Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades

Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death). (NCT00191815)
Timeframe: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)

Interventionparticipants (Number)
Hemoglobin (g/L) - Grade 1Hemoglobin (g/L) - Grade 2Hemoglobin (g/L) - Grade 3Hemoglobin (g/L) - Grade 4Neutrophils (x10E9/L) - Grade 1Neutrophils (x10E9/L) - Grade 2Neutrophils (x10E9/L) - Grade 3Neutrophils (x10E9/L) - Grade 4Platelets (x10E9/L) - Grade 1Platelets (x10E9/L) - Grade 2Platelets (x10E9/L) - Grade 3Platelets (x10E9/L) - Grade 4White Blood Cells (x10E9/L) - Grade 1White Blood Cells (x10E9/L) - Grade 2White Blood Cells (x10E9/L) - Grade 3White Blood Cells (x10E9/L) - Grade 4
Gemcitabine + Cisplatin3520516251310432101627183

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Objective Tumor Response

"Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment." (NCT00191815)
Timeframe: baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)

Interventionparticipants (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseNot Assessable
Gemcitabine + Cisplatin7191954

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Best Overall Response

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. (NCT00191854)
Timeframe: baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)

,,
Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)Early Death from Other CausesUnknown
Gemcitabine + Carboplatin08251121
Gemcitabine + Cisplatin17291103
Gemcitabine + Paclitaxel112171414

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Progression Free Survival (PFS)

PFS was defined as the time from randomizaton to the date of documented disease progression or death on study, whichever occurred first. PFS for participants who discontinued from the study or who had not progressed at the time of analysis were treated as censored at the date of the last tumor assessment. (NCT00191854)
Timeframe: baseline to measured progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)

Interventionmonths (Median)
Gemcitabine + Paclitaxel4.8
Gemcitabine + Carboplatin4.3
Gemcitabine + Cisplatin4.8

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Overall Survival

Overall survival time is defined as the time from the date of randomization to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow-up. (NCT00191854)
Timeframe: baseline to date of death from any cause (up to 34 months)

Interventionmonths (Median)
Gemcitabine + Paclitaxel15.5
Gemcitabine + Carboplatin22.8
Gemcitabine + Cisplatin20.1

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Duration of Response

Duration of response was measured from time of first documentation of complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions), until date of PFS. Duration of response was censored on day of last tumor assessment for patients who had not progressed or who had discontinued study at time of analysis, and for cases where investigator determined patient had progressive disease and discontinued study therapy and/or started a new, non-protocol-specified anti-cancer therapy before documented disease progression. (NCT00191854)
Timeframe: time of response to progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)

Interventionmonths (Median)
Gemcitabine + Paclitaxel5.8
Gemcitabine + Carboplatin3.2
Gemcitabine + Cisplatin5.1

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Number of Participants With a Time to Treatment Failure (TTTF) Event

TTTF event was defined as documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity. TTTF for patients who were still participating in study without treatment failure at time of analysis were treated as censored at date of last tumor assessment. TTTF for patients who had discontinued from therapy for reasons other than toxicity and who did not experience treatment failure prior to therapy discontinuation were treated as censored on day of study discontinuation. (NCT00191854)
Timeframe: randomization to date of documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity, whichever occurred first (up to 6 months)

Interventionparticipants (Number)
Gemcitabine + Paclitaxel15
Gemcitabine + Carboplatin21
Gemcitabine + Cisplatin21

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Tumor Response at End of Treatment

Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. (NCT00192036)
Timeframe: baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)

Interventionparticipants (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseUnknownMissing
Gemcitabine + Cisplatin11831224

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Time to Progressive Disease

Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included. (NCT00192036)
Timeframe: Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years);

Interventionmonths (Median)
PreliminaryFinal
Gemcitabine + Cisplatin10.911.4

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Safety of Induction Chemotherapy

A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening. (NCT00192036)
Timeframe: every cycle (21 days) for 3 cycles (up to 10 weeks)

Interventionparticipants (Number)
Neutropenia - Grade 3Neutropenia - Grade 4Thrombocytopenia - Grade 3Thrombocytopenia - Grade 4
Gemcitabine + Cisplatin9841

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Safety of Chemo-radiotherapy

A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to NCI-CTC Version 2.0 grading scales. For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported. Grade 3 events are severe and Grade 4 events are life-threatening. (NCT00192036)
Timeframe: Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy

Interventionparticipants (Number)
Neutropenia - Grade 3Neutropenia - Grade 4Thrombocytopenia - Grade 3Thrombocytopenia - Grade 4Radiation Esophagitis - Grade 3Radiation Esophagitis - Grade 4Radiation Pneumonitis - Grade 3Radiation Pneumonitis - Grade 4
Gemcitabine + Cisplatin62714010

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Overall Survival

Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. (NCT00192036)
Timeframe: Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years)

Interventionmonths (Median)
PreliminaryFinal
Gemcitabine + Cisplatin27.921.8

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Tumor Response - Avastin Subgroup

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. (NCT00192075)
Timeframe: baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

,
Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)Overall Response Rate (CR+PR)Stable Disease (SD)Disease Control Rate (CR+PR+SD)Progressive DiseaseUnknown
A + FOLFOX 4 - Avastin Subgroup18981710
A+FFG - Avastin Subgroup000111161

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Progression-Free Survival

Defined as the time from randomization to the first observation of disease progression, or death due to any cause. (NCT00192075)
Timeframe: randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A+FFG8.6
A + FOLFOX 49.5

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Duration of Response

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. (NCT00192075)
Timeframe: date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A+FFG12.7
A + FOLFOX 47.9

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Progression-Free Survival - Avastin Subgroup

Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. (NCT00192075)
Timeframe: randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A+FFG - Avastin Subgroup13.7
A + FOLFOX 4 - Avastin Subgroup11.5

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Time to Progressive Disease - Avastin Subgroup

Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. (NCT00192075)
Timeframe: randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A+FFG - Avastin Subgroup13.7
A + FOLFOX 4 - Avastin Subgroup13.8

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Survival at 12 Months and 24 Months - Avastin Subgroup

Percentage of participants who were alive at 12 months and 24 months. (NCT00192075)
Timeframe: randomization to the date of death from any cause (up to 24 months)

,
Interventionpercentage of participants alive (Number)
12-Month Survival24-Month Survival
A + FOLFOX 4 - Avastin Subgroup83.366.7
A+FFG - Avastin Subgroup75.650.4

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Toxicity - Avastin Subgroup

Includes all Grade 3-4 hematologic toxicities and all non-hematologic toxicities with either >=1 Grade 4 or >=2 Grade 3 adverse events (NCT00192075)
Timeframe: every cycle (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

,
Interventionparticipants (Number)
Neutropenia (Grade 3)Neutropenia (Grade 4)Thrombocytopenia (Grade 3)Thrombocytopenia (Grade 4)Leukopenia (Grade 3)Leukopenia (Grade 4)Anemia (Grade 3)Anemia (Grade 4)Febrile neutropenia (Grade 3)Febrile neutropenia (Grade 4)Diarrhea (Grade 3)Diarrhea (Grade 4)Small intestinal obstruction (Grade 3)Small intestinal obstruction (Grade 4)Fatigue (Grade 3)Fatigue (Grade 4)Cerebral infarction (Grade 3)Cerebral infarction (Grade 4)Hyperglycemia (Grade 3)Hyperglycemia (Grade 4)Dehydration (Grade 3)Dehydration (Grade 4)Deep vein thrombosis (Grade 3)Deep vein thrombosis (Grade 4)Myocardial infarction (Grade 3)Myocardial infarction (Grade 4)Subdural hematoma (Grade 3)Subdural hematoma (Grade 4)Perirectal abscess (Grade 3)Perirectal abscess (Grade 4)Hypoxia (Grade 3)Hypoxia (Grade 4)
A + FOLFOX 4 - Avastin Subgroup51000000100110200000102002000000
A+FFG - Avastin Subgrouup35103100001010000000000000001000

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Time to Progressive Disease

Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. (NCT00192075)
Timeframe: randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A+FFG8.6
A + FOLFOX 49.7

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Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. (NCT00192075)
Timeframe: baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

,
Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)Overall Response Rate (CR+PR)Stable Disease (SD)Disease Control Rate (CR+PR+SD)Progressive DiseaseUnknown
A + FOLFOX 421517163372
A+FFG1342125143

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Overall Survival

Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. (NCT00192075)
Timeframe: randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A+FFG20.6
A + FOLFOX 419.7

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Duration of Response - A+FOLFOX4 - Avastin Subgroup

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. (NCT00192075)
Timeframe: date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A + FOLFOX 4 - Avastin Subgroup5.2

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Overall Survival (OS)

Number of participants that are alive at 48th months (NCT00193050)
Timeframe: 48 months

InterventionParticipants (Count of Participants)
Intervention72

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Pathologic Complete Response (pCR)

For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported. (NCT00193050)
Timeframe: 18 Months

Interventionpercentage of participants (Number)
Intervention18

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Time to Treatment Failure (TTF)

"Time to Treatment Failure (TTF) is defined as the minimum of the time from first date of treatment to the either of the following dates:~disease progression date (RECIST or clinical)~death date~treatment discontinuation" (NCT00193050)
Timeframe: 69 months

Interventionmonths (Median)
Intervention13

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Overall Survival (OS)

The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death (NCT00193063)
Timeframe: 24 months

Interventionmonths (Median)
Gemcitabine/Trastuzumab21

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Progression Free Survival (PFS)

The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00193063)
Timeframe: 21 Months

Interventionmonths (Median)
Gemcitabine/Trastuzumab4

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Overall Response Rate (ORR)

The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00193063)
Timeframe: 18 Months

Interventionpercentage of participants (Number)
Gemcitabine/Trastuzumab30

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Pathologic Complete Response

For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection. Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported. (NCT00193206)
Timeframe: 18 months

InterventionParticipants (Count of Participants)
Intervention23

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Rates of Breast Preservation

Number of patients who underwent breast conservation after neo adjuvant chemotherapy (NCT00193206)
Timeframe: 18 months

InterventionParticipants (Count of Participants)
Intervention26

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Time to Disease Progression

Time to progression is the length of time from the start of treatment until the disease progressed. Progressive disease is defined as an increase of >25% in the total calculated product of the tumor's measurements or development of a new lesion. Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST) (NCT00193206)
Timeframe: 36 months

Interventionmonths (Median)
Intervention13.7

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Clinical Response Rates

Clinical response rate is defined as percentage of patients whose disease decreased (Partial response - PR) and/or disappeared (Complete response - CR) after treatment). Clinical tumor response was defined as complete if there was no clinical evidence of palpable tumor in either the breast or axilla at the time of surgery. Reduction of total tumor size >50 % at the time surgery was considered a clinical partial response. Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST) (NCT00193206)
Timeframe: 18 months

InterventionParticipants (Count of Participants)
Intervention109

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Progression-free Survival (PFS)

PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause. (NCT00193414)
Timeframe: 18 months

InterventionMonths (Median)
Intervention6.2

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Overall Survival (OS)

OS was measured from the date of study entry until the date of death. (NCT00193414)
Timeframe: 18 months

InterventionMonths (Median)
Intervention8.5

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Overall Response Rate

Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. (NCT00193414)
Timeframe: 18 months

InterventionPercentage of participants (Number)
Intervention26

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Progression Free Survival (PFS)

Progression-free survival was calculated as the elapsed time between the date of study registration and the date of recurrence or death from any cause. (NCT00193427)
Timeframe: 19 months

InterventionMonths (Median)
Intervention9.9

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Pathologic Complete Response Rate

A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review. (NCT00193427)
Timeframe: 18 months

InterventionPercentage of participants (Number)
Intervention0

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Overall Survival (OS)

Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death. (NCT00193427)
Timeframe: 18 months

InterventionMonths (Median)
Intervention18

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Overall Response Rate (ORR)

Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. (NCT00193427)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Intervention30

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Overall Clinical Response Rate

Overall response rate was defined as the proportion of treated patients whose best response was a complete or partial response after completing at least two courses of treatment. (NCT00193453)
Timeframe: 18 months

InterventionPercentage of participants (Number)
Intervention17

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Progression Free Survival (PFS)

Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disase or death from any cause. (NCT00193453)
Timeframe: 18 months

InterventionMonths (Median)
Intervention4.0

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Response Duration

The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease. (NCT00193453)
Timeframe: 18 months

InterventionMonths (Median)
Intervention7.0

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Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease (NCT00193596)
Timeframe: 12 months

Interventionmonths (Median)
Paclitaxel/Carboplatin/Etoposide/Gefitinib3.3
Irinotecan/Gemcitabine/Gefitinib5.3

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Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

Length of time, in months, that patients were alive from their first date of protocol treatment until death. (NCT00193596)
Timeframe: 24 months

Interventionmonths (Median)
Paclitaxel/Carboplatin/Etoposide/Gefitinib7.4
Irinotecan/Gemcitabine/Gefitinib8.5

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Disease Progression

Proportion of patients with metastatic breast cancer free of disease progression at 6 months following treatment (NCT00201760)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Arm 1 Gemcitabine/Cisplatin/Trastuzumab1
Arm 2 Gemcitabine / Trastuzumab0

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Measure Response Rate of Each Drug Combination

Response rate of the of the triple drug combination therapy and the double drug combination therapy regimens. (NCT00201760)
Timeframe: Up to 24 months

Interventionpatients (Number)
Arm 1 Gemcitabine/Cisplatin/Trastuzumab1
Arm 2 Gemcitabine / Trastuzumab0

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Number of Participants With Grades 3 and Grade 4 Toxicity Profiles of the Drug Combinations

Adverse Events will be graded in accordance with the CTCAE Version 3.0 Toxicity grading criteria (NCT00201760)
Timeframe: Up to 24 months

,
Interventionpatients (Number)
Leukocytes (total WBC)Neutrophils/granulocytesPlatelets (Thrombocytopenia)Fatigue
Arm 1 Gemcitabine/Cisplatin/Trastuzumab2211
Arm 2 Gemcitabine / Trastuzumab1201

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Percentage of Patients With Clinical Benefit Response

A clinical benefit was defined by the improvement of at least one parameter over at least 4 weeks, without worsening of any other parameter (change in weight, ECOG performance status, Quality of life). (NCT00201838)
Timeframe: Up to 12 months

Interventionpercentage of patients (Number)
Experimental Group33
Control Group0

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Number of Patients With Response

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00201838)
Timeframe: up to 12 months

,
Interventionpercentage of patients (Number)
Partial ResponseStable Disease
Control Group1750
Experimental Group1232

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Anti-tumor Effect as Measured by the Proportion of Patients Free of Disease-progression at Six Months After Treatment Initiation

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Percentages were calculated by a Kaplan Meier analysis. (NCT00201838)
Timeframe: up to 6 months

Interventionpercent of patients with PFS (Number)
Experimental Group28
Control Group14

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Median Overall Survival Rates for Patients

Median survival is defined as the time of initiation of the first dose of intervention to the date of death (NCT00201838)
Timeframe: up to 1 year

Interventionmonths (Median)
Experimental Group5.43
Control Group8.1

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Serial Levels of TNF (Tumor Necrosis Factor) and Other Inflammatory Cytokines

(NCT00201838)
Timeframe: up to 6 months

,
Interventiondelta Ct values (Mean)
IL-10IL-1bNFkBIL-12TNFIFNIL-6
Non Responders26.8513.074.3836.1127.2628.6329.29
Responders28.0416.26.0335.6626.6628.729.25

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Best Disease Response After a Maximum of Six Cycles.

Determine the number of participants for each category of response rates (RR) in newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) who are treated with a chemotherapeutic regimen assigned to them on the basis of expression of the genes ribonucleotide reductase subunit 1 (ERCC1) and excision repair cross-complementing group 1 gene (RRM1) expression. Prior to treatment we measured the level of ERCC1 and RRM1 expression in the patients tumor, on the basis of which the patient would be assigned a specific doublet chemotherapy. (NCT00215930)
Timeframe: 24 Months

InterventionParticipants (Number)
Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)Not Assessible
Double Agent Chemotherapy0232361

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Progression Free Survival (PFS)

PFS was recorded as the time elapsed from the date of first treatment to the date of first evidence for disease progression or death. OS and PFS probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes. (NCT00215930)
Timeframe: 24 Months

InterventionMonths (Median)
Double Agent Chemotherapy6.6

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Overall Survival (OS)

Median Overall Survival of Participants. OS and Progression Free Survival (PFS) probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes. (NCT00215930)
Timeframe: 24 Months

InterventionMonths (Median)
Double Agent Chemotherapy13.3

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Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)

(NCT00219557)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) post-dose on Day 15 of Phase 1 Cycle 1

Interventionnanogram/milliliter (ng/mL) (Mean)
Axitinib + Gemcitabine (Phase 1 Lead-In)45.08

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Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)

Dose of gemcitabine was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or non hematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity. (NCT00219557)
Timeframe: Phase 1 Baseline up to Week 4

Interventionparticipants (Number)
Axitinib + Gemcitabine (Phase 1 Lead-In)0

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Overall Survival (OS)

Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the date of randomization plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). (NCT00219557)
Timeframe: Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant

InterventionDays (Median)
Axitinib + Gemcitabine210
Gemcitabine171

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Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)

Dose of axitinib (AG-013736) was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or non hematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity. (NCT00219557)
Timeframe: Phase 1 baseline up to Week 4

Interventionparticipants (Number)
Axitinib + Gemcitabine (Phase 1 Lead-In)0

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine

AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). (NCT00219557)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1

Interventionng*hr/mL (Mean)
Axitinib + Gemcitabine (Phase 1 Lead-In)13656.00

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Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)

AUC (0-24) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 24 hours (0-24). (NCT00219557)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1

Interventionng*hr/mL (Mean)
Axitinib + Gemcitabine (Phase 1 Lead-In)282.34

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Duration of Response (DR)

Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. (NCT00219557)
Timeframe: Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks

InterventionDays (Median)
Axitinib + Gemcitabine379
Gemcitabine155

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Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score. (NCT00219557)
Timeframe: Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).

Interventionunits on a scale (Mean)
Global QoL: BaselinePhysical Functioning: BaselineRole Functioning: BaselineEmotional Functioning: BaselineCognitive Functioning: BaselineSocial Functioning: BaselineFatigue: BaselineNausea and Vomiting: BaselinePain: BaselineDyspnea: BaselineInsomnia: BaselineAppetite loss: BaselineConstipation: BaselineDiarrhea: BaselineFinancial Difficulties: BaselineGlobal QoL: Change at C2 D1Physical Functioning: Change at C2 D1Role Functioning: Change at C2 D1Emotional Functioning: Change at C2 D1Cognitive Functioning: Change at C2 D1Social Functioning: Change at C2 D1Fatigue: Change at C2 D1Nausea and Vomiting: Change at C2 D1Pain: Change at C2 D1Dyspnea: Change at C2 D1Insomnia: Change at C2 D1Appetite loss: Change at C2 D1Constipation: Change at C2 D1Diarrhea: Change at C2 D1Financial Difficulties: Change at C2 D1Global QoL: Change at C3 D1Physical Functioning: Change at C3 D1Role Functioning: Change at C3 D1Emotional Functioning: Change at C3 D1Cognitive Functioning: Change at C3 D1Social Functioning: Change at C3 D1Fatigue: Change at C3 D1Nausea and Vomiting: Change at C3 D1Pain: Change at C3 D1Dyspnea: Change at C3 D1Insomnia: Change at C3 D1Appetite loss: Change at C3 D1Constipation: Change at C3 D1Diarrhea: Change at C3 D1Financial Difficulties: Change at C3 D1Global QoL: Change at C4 D1Physical Functioning: Change at C4 D1Role Functioning: Change at C4 D1Emotional Functioning: Change at C4 D1Cognitive Functioning: Change at C4 D1Social Functioning: Change at C4 D1Fatigue: Change at C4 D1Nausea and Vomiting: Change at C4 D1Pain: Change at C4 D1Dyspnea: Change at C4 D1Insomnia: Change at C4 D1Appetite loss: Change at C4 D1Constipation: Change at C4 D1Diarrhea: Change at C4 D1Financial Difficulties: Change at C4 D1Global QoL: Change at C5 D1Physical Functioning: Change at C5 D1Role Functioning: Change at C5 D1Emotional Functioning: Change at C5 D1Cognitive Functioning: Change at C5 D1Social Functioning: Change at C5 D1Fatigue: Change at C5 D1Nausea and Vomiting: Change at C5 D1Pain: Change at C5 D1Dyspnea: Change at C5 D1Insomnia: Change at C5 D1Appetite loss: Change at C5 D1Constipation: Change at C5 D1Diarrhea: Change at C5 D1Financial Difficulties: Change at C5 D1Global QoL: Change at C6 D1Physical Functioning: Change at C6 D1Role Functioning: Change at C6 D1Emotional Functioning: Change at C6 D1Cognitive Functioning: Change at C6 D1Social Functioning: Change at C6 D1Fatigue: Change at C6 D1Nausea and Vomiting: Change at C6 D1Pain: Change at C6 D1Dyspnea: Change at C6 D1(n=18,2)Insomnia: Change at C6 D1Appetite loss: Change at C6 D1(n=19,2)Constipation: Change at C6 D1Diarrhea: Change at C6 D1Financial Difficulties: Change at C6 D1Global QoL: Change at C7 D1Physical Functioning: Change at C7 D1Role Functioning: Change at C7 D1Emotional Functioning: Change at C7 D1Cognitive Functioning: Change at C7 D1Social Functioning: Change at C7 D1Fatigue: Change at C7 D1Nausea and Vomiting: Change at C7D1Pain: Change at C7 D1Dyspnea: Change at C7 D1Insomnia: Change at C7 D1Appetite loss: Change at C7 D1Constipation: Change at C7 D1Diarrhea: Change at C7 D1Financial Difficulties: Change at C7 D1Global QoL: Change at C8 D1Physical Functioning Change at C8 D1Role Functioning: Change at C8 D1Emotional Functioning: Change at C8 D1Cognitive Functioning: Change at C8 D1Social Functioning: Change at C8 D1Fatigue: Change at C8 D1Nausea and Vomiting: Change at C8 D1Pain: Change at C8 D1Dyspnea: Change at C8 D1Insomnia: Change at C8 D1Appetite loss: Change at C8 D1Constipation: Change at C8 D1Diarrhea: Change at C8 D1Financial Difficulties: Change at C8 D1Global QoL: Change at C9 D1Physical Functioning: Change at C9 D1Role Functioning: Change at C9 D1Emotional Functioning: Change at C9 D1Cognitive Functioning: Change at C9 D1Social Functioning: Change at C9 D1Fatigue: Change at C9 D1Nausea and Vomiting: Change at C9 D1Pain: Change at C9 D1Dyspnea: Change at C9 D1Insomnia: Change at C9 D1Appetite loss: Change at C9 D1Constipation: Change at C9 D1Diarrhea: Change at C9 D1Financial Difficulties: Change at C9 D1Global QoL: Change at C10 D1Physical Functioning: Change at C10 D1Role Functioning: Change at C10 D1Emotional Functioning: Change at C10 D1Cognitive Functioning: Change at C10 D1Social Functioning: Change at C10 D1Fatigue: Change at C10 D1Nausea and Vomiting: Change at C10 D1Pain: Change at C10 D1Dyspnea: Change at C10 D1Insomnia: Change at C10 D1Appetite loss: Change at C10 D1Constipation: Change at C10 D1Diarrhea: Change at C10 D1Financial Difficulties: Change at C10 D1Global QoL: Change at C11 D1Physical Functioning: Change at C11 D1Role Functioning: Change at C11 D1Emotional Functioning: Change at C11 D1Cognitive Functioning: Change at C11 D1Social Functioning: Change at C11 D1Fatigue: Change at C11 D1Nausea and Vomiting: Change at C11 D1Pain: Change at C11 D1Dyspnea: Change at C11 D1Insomnia: Change at C11 D1Appetite loss: Change at C11 D1Constipation: Change at C11 D1Diarrhea: Change at C11 D1Financial Difficulties: Change at C11 D1Global QoL: Change at C12 D1Physical Functioning: Change at C12 D1Role Functioning: Change at C12 D1Emotional Functioning: Change at C12 D1Cognitive Functioning: Change at C12 D1Social Functioning: Change at C12 D1Fatigue: Change at C12 D1Nausea and Vomiting: Change at C12 D1Pain: Change at C12 D1Dyspnea: Change at C12 D1Insomnia: Change at C12 D1Appetite loss: Change at C12 D1Constipation: Change at C12 D1Diarrhea: Change at C12 D1Financial Difficulties: Change at C12 D1Global QoL: Change at C13 D1Physical Functioning: Change at C13 D1Role Functioning: Change at C13 D1Emotional Functioning: Change at C13 D1Cognitive Functioning: Change at C13 D1Social Functioning: Change at C13 D1Fatigue: Change at C13 D1Nausea and Vomiting: Change at C13 D1Pain: Change at C13 D1Dyspnea: Change at C13 D1Insomnia: Change at C13 D1Appetite loss: Change at C13 D1Constipation: Change at C13 D1Diarrhea: Change at C13 D1Financial Difficulties: Change at C13 D1Global QoL: Change at C14 D1Physical Functioning: Change at C14 D1Role Functioning: Change at C14 D1Emotional Functioning: Change at C14 D1Cognitive Functioning: Change at C14 D1Social Functioning: Change at C14 D1Fatigue: Change at C14 D1Nausea and Vomiting: Change at C14 D1Pain: Change at C14 D1Dyspnea: Change at C14 D1Insomnia: Change at C14 D1Appetite loss: Change at C14 D1Constipation: Change at C14 D1Diarrhea: Change at C14 D1Financial Difficulties: Change at C14 D1Global QoL: Change at EoSPhysical Functioning: Change at EoSRole Functioning: Change at EoSEmotional Functioning: Change at EoSCognitive Functioning: Change at EoSSocial Functioning: Change at EoSFatigue: Change at EoSNausea and Vomiting: Change at EoSPain: Change at EoSDyspnea: Change at EoSInsomnia: Change at EoSAppetite loss: Change at EoSConstipation: Change at EoSDiarrhea: Change at EoSFinancial Difficulties: Change at EoS
Axitinib + Gemcitabine55.6076.9062.5667.2282.8267.4443.5019.7440.0012.5031.2841.0334.8720.0010.42-5.10-5.070.333.21-3.53-4.171.42-5.88-9.299.33-9.15-0.65-9.62-1.280.67-9.17-8.13-5.56-1.69-4.88-4.077.41-4.37-6.753.25-10.3211.11-10.577.323.33-6.67-6.67-7.81-3.23-6.99-8.607.47-4.69-16.670.00-11.466.25-24.447.531.15-9.29-8.57-8.93-3.87-2.38-15.489.720.00-5.369.52-19.050.00-21.437.140.00-14.22-6.32-9.652.19-0.88-2.636.73-4.39-8.77-1.85-7.02-3.51-10.53-1.751.75-4.63-3.33-15.00-8.331.67-15.00-2.221.67-3.3316.67-10.00-10.00-13.333.33-6.67-12.50-10.67-13.33-7.500.00-11.674.440.00-8.3314.81-20.00-3.33-3.336.67-3.33-17.71-6.67-29.17-3.13-2.08-6.2518.06-8.330.0019.05-4.178.33-8.3312.50-4.17-16.67-19.05-23.81-20.24-9.52-21.4325.400.0011.9022.224.7623.81-19.059.52-4.76-38.89-24.44-38.89-25.00-27.78-38.8937.0427.7822.2222.2222.2244.440.0011.11-11.11-11.11-6.67-11.11-2.780.00-5.567.4116.67-5.560.00-11.1122.22-22.2222.22-11.11-50.00-23.33-41.67-8.330.00-8.3333.33-8.3341.670.000.0033.33-16.6716.67-16.67-16.67-6.67-33.33-8.3316.670.0022.220.0016.6733.33-33.330.000.0033.33-33.33-54.17-70.00-33.33-66.67-66.67-83.3355.5633.3341.6783.3366.6750.00-16.6733.33-16.67

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Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score. (NCT00219557)
Timeframe: Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).

Interventionunits on a scale (Mean)
Global QoL: BaselinePhysical Functioning: BaselineRole Functioning: BaselineEmotional Functioning: BaselineCognitive Functioning: BaselineSocial Functioning: BaselineFatigue: BaselineNausea and Vomiting: BaselinePain: BaselineDyspnea: BaselineInsomnia: BaselineAppetite loss: BaselineConstipation: BaselineDiarrhea: BaselineFinancial Difficulties: BaselineGlobal QoL: Change at C2 D1Physical Functioning: Change at C2 D1Role Functioning: Change at C2 D1Emotional Functioning: Change at C2 D1Cognitive Functioning: Change at C2 D1Social Functioning: Change at C2 D1Fatigue: Change at C2 D1Nausea and Vomiting: Change at C2 D1Pain: Change at C2 D1Dyspnea: Change at C2 D1Insomnia: Change at C2 D1Appetite loss: Change at C2 D1Constipation: Change at C2 D1Diarrhea: Change at C2 D1Financial Difficulties: Change at C2 D1Global QoL: Change at C3 D1Physical Functioning: Change at C3 D1Role Functioning: Change at C3 D1Emotional Functioning: Change at C3 D1Cognitive Functioning: Change at C3 D1Social Functioning: Change at C3 D1Fatigue: Change at C3 D1Nausea and Vomiting: Change at C3 D1Pain: Change at C3 D1Dyspnea: Change at C3 D1Insomnia: Change at C3 D1Appetite loss: Change at C3 D1Constipation: Change at C3 D1Diarrhea: Change at C3 D1Financial Difficulties: Change at C3 D1Global QoL: Change at C4 D1Physical Functioning: Change at C4 D1Role Functioning: Change at C4 D1Emotional Functioning: Change at C4 D1Cognitive Functioning: Change at C4 D1Social Functioning: Change at C4 D1Fatigue: Change at C4 D1Nausea and Vomiting: Change at C4 D1Pain: Change at C4 D1Dyspnea: Change at C4 D1Insomnia: Change at C4 D1Appetite loss: Change at C4 D1Constipation: Change at C4 D1Diarrhea: Change at C4 D1Financial Difficulties: Change at C4 D1Global QoL: Change at C5 D1Physical Functioning: Change at C5 D1Role Functioning: Change at C5 D1Emotional Functioning: Change at C5 D1Cognitive Functioning: Change at C5 D1Social Functioning: Change at C5 D1Fatigue: Change at C5 D1Nausea and Vomiting: Change at C5 D1Pain: Change at C5 D1Dyspnea: Change at C5 D1Insomnia: Change at C5 D1Appetite loss: Change at C5 D1Constipation: Change at C5 D1Diarrhea: Change at C5 D1Financial Difficulties: Change at C5 D1Global QoL: Change at C6 D1Physical Functioning: Change at C6 D1Role Functioning: Change at C6 D1Emotional Functioning: Change at C6 D1Cognitive Functioning: Change at C6 D1Social Functioning: Change at C6 D1Fatigue: Change at C6 D1Nausea and Vomiting: Change at C6 D1Pain: Change at C6 D1Dyspnea: Change at C6 D1(n=18,2)Insomnia: Change at C6 D1Appetite loss: Change at C6 D1(n=19,2)Constipation: Change at C6 D1Diarrhea: Change at C6 D1Financial Difficulties: Change at C6 D1Global QoL: Change at C7 D1Physical Functioning: Change at C7 D1Role Functioning: Change at C7 D1Emotional Functioning: Change at C7 D1Cognitive Functioning: Change at C7 D1Social Functioning: Change at C7 D1Fatigue: Change at C7 D1Nausea and Vomiting: Change at C7D1Pain: Change at C7 D1Dyspnea: Change at C7 D1Insomnia: Change at C7 D1Appetite loss: Change at C7 D1Constipation: Change at C7 D1Diarrhea: Change at C7 D1Financial Difficulties: Change at C7 D1Global QoL: Change at C8 D1Physical Functioning Change at C8 D1Role Functioning: Change at C8 D1Emotional Functioning: Change at C8 D1Cognitive Functioning: Change at C8 D1Social Functioning: Change at C8 D1Fatigue: Change at C8 D1Nausea and Vomiting: Change at C8 D1Pain: Change at C8 D1Dyspnea: Change at C8 D1Insomnia: Change at C8 D1Appetite loss: Change at C8 D1Constipation: Change at C8 D1Diarrhea: Change at C8 D1Financial Difficulties: Change at C8 D1Global QoL: Change at C9 D1Physical Functioning: Change at C9 D1Role Functioning: Change at C9 D1Emotional Functioning: Change at C9 D1Cognitive Functioning: Change at C9 D1Social Functioning: Change at C9 D1Fatigue: Change at C9 D1Nausea and Vomiting: Change at C9 D1Pain: Change at C9 D1Dyspnea: Change at C9 D1Insomnia: Change at C9 D1Appetite loss: Change at C9 D1Constipation: Change at C9 D1Diarrhea: Change at C9 D1Financial Difficulties: Change at C9 D1Global QoL: Change at C10 D1Physical Functioning: Change at C10 D1Role Functioning: Change at C10 D1Emotional Functioning: Change at C10 D1Cognitive Functioning: Change at C10 D1Social Functioning: Change at C10 D1Fatigue: Change at C10 D1Nausea and Vomiting: Change at C10 D1Pain: Change at C10 D1Dyspnea: Change at C10 D1Insomnia: Change at C10 D1Appetite loss: Change at C10 D1Constipation: Change at C10 D1Diarrhea: Change at C10 D1Financial Difficulties: Change at C10 D1Global QoL: Change at C11 D1Physical Functioning: Change at C11 D1Role Functioning: Change at C11 D1Emotional Functioning: Change at C11 D1Cognitive Functioning: Change at C11 D1Social Functioning: Change at C11 D1Fatigue: Change at C11 D1Nausea and Vomiting: Change at C11 D1Pain: Change at C11 D1Dyspnea: Change at C11 D1Insomnia: Change at C11 D1Appetite loss: Change at C11 D1Constipation: Change at C11 D1Diarrhea: Change at C11 D1Financial Difficulties: Change at C11 D1Global QoL: Change at EoSPhysical Functioning: Change at EoSRole Functioning: Change at EoSEmotional Functioning: Change at EoSCognitive Functioning: Change at EoSSocial Functioning: Change at EoSFatigue: Change at EoSNausea and Vomiting: Change at EoSPain: Change at EoSDyspnea: Change at EoSInsomnia: Change at EoSAppetite loss: Change at EoSConstipation: Change at EoSDiarrhea: Change at EoSFinancial Difficulties: Change at EoS
Gemcitabine54.3282.2260.2666.9882.1070.5142.8013.5837.0416.0539.5133.3338.2716.0528.403.330.959.657.941.59-0.83-8.99-1.59-16.67-3.17-19.05-14.29-14.290.00-4.766.673.4413.1012.222.225.56-8.73-2.56-23.33-7.14-11.90-5.13-13.334.44-2.22-1.03-1.039.729.030.00-1.52-3.426.41-11.54-5.13-5.13-2.78-25.005.56-8.3310.710.007.1420.247.144.76-15.28-6.25-25.00-12.50-29.17-20.83-33.33-4.760.00-5.566.6716.678.3311.11-16.67-16.67-8.33-33.330.00-16.67-16.67-33.330.00-22.22-16.67-22.2233.33-7.41-5.56-25.0014.8116.67-11.1133.3311.1122.22-66.670.000.00-33.33-20.00-33.330.00-16.67-16.672.2216.67-16.6733.330.0033.330.00-66.670.00-33.33-40.00-33.33-8.33-33.33-33.3333.3316.670.0033.330.0033.330.00-66.670.00-33.33-46.67-50.00-16.67-33.33-50.0055.5616.6716.6733.330.0033.330.00-66.670.00-33.33-40.00-66.67-8.33-33.33-66.6722.2216.67-16.6733.330.000.000.00-66.670.000.000.000.00-25.000.000.00-11.110.0016.670.0033.330.000.000.000.00

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Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study

QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100. Higher scores on functioning scales=better functioning; higher scores on the symptom scales=more symptoms. (NCT00219557)
Timeframe: Phase 2 baseline [Day (D) 1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).

Interventionunits on a scale (Mean)
Pancreatic Pain: BaselineEating Related Items: BaselineAltered Bowel Habits: BaselineJaundice: BaselineBody Image: BaselineHealth Care Satisfaction: BaselineSexual Functioning: BaselineAscites: BaselineIndigestion: BaselineFlatulence: BaselineCachexia: BaselineSide Effects: BaselineFear of Future Health: BaselineAbility to Plan Future: BaselinePancreatic Pain: Change at C2 D1Eating Related Items: Change at C2 D1Altered Bowel Habits: Change at C2 D1Jaundice: Change at C2 D1Body Image: Change at C2 D1Health Care Satisfaction: Change at C2 D1Sexual Functioning: Change at C2 D1Ascites: Change at C2 D1Indigestion: Change at C2 D1Flatulence: Change at C2 D1Cachexia: Change at C2 D1Side Effects: Change at C2 D1Fear of Future Health: Change at C2 D1Ability to Plan Future: Change at C2 D1Pancreatic Pain: Change at C3 D1Eating Related Items: Change at C3 D1Altered Bowel Habits: Change at C3 D1Jaundice: Change at C3 D1Body Image: Change at C3 D1Health Care Satisfaction: Change at C3 D1Sexual Functioning: Change at C3 D1Ascites: Change at C3 D1Indigestion: Change at C3 D1Flatulence: Change at C3 D1Cachexia: Change at C3 D1Side Effects: Change at C3 D1Fear of Future Health: Change at C3 D1Ability to Plan Future: Change at C3 D1Pancreatic Pain: Change at C4 D1Eating Related Items: Change at C4 D1Altered Bowel Habits: Change at C4 D1Jaundice: Change at C4 D1Body Image: Change at C4 D1Health Care Satisfaction: Change at C4 D1Sexual Functioning: Change at C4 D1Ascites: Change at C4 D1Indigestion: Change at C4 D1Flatulence: Change at C4 D1Cachexia: Change at C4 D1Side Effects: Change at C4 D1Fear of Future Health: Change at C4 D1Ability to Plan Future: Change at C4 D1Pancreatic Pain: Change at C5 D1Eating Related Items: Change at C5 D1Altered Bowel Habits: Change at C5 D1Jaundice: Change at C5 D1Body Image: Change at C5 D1Health Care Satisfaction: Change at C5 D1Sexual Functioning: Change at C5 D1Ascites: Change at C5 D1Indigestion: Change at C5 D1Flatulence: Change at C5 D1Cachexia: Change at C5 D1Side Effects: Change at C5 D1Fear of Future Health: Change at C5 D1Ability to Plan Future: Change at C5 D1Pancreatic Pain: Change at C6 D1Eating Related Items: Change at C6 D1Altered Bowel Habits: Change at C6 D1Jaundice: Change at C6 D1Body Image: Change at C6 D1Health Care Satisfaction: Change at C6 D1Sexual Functioning: Change at C6 D1Ascites: Change at C6 D1Indigestion: Change at C6 D1Flatulence: Change at C6 D1Cachexia: Change at C6 D1Side Effects: Change at C6 D1Fear of Future Health: Change at C6 D1Ability to Plan Future: Change at C6 D1Pancreatic Pain: Change at C7 D1Eating Related Items: Change at C7 D1Altered Bowel Habits: Change at C7 D1Jaundice: Change at C7 D1Body Image: Change at C7 D1Health Care Satisfaction: Change at C7 D1Sexual Functioning: Change at C7 D1Ascites: Change at C7 D1Indigestion: Change at C7 D1Flatulence: Change at C7 D1Cachexia: Change at C7 D1Side Effects: Change at C7 D1Fear of Future Health: Change at C7 D1Ability to Plan Future: Change at C7 D1Pancreatic Pain: Change at C8 D1Eating Related Items: Change at C8 D1Altered Bowel Habits: Change at C8 D1Jaundice: Change at C8 D1Body Image: Change at C8 D1Health Care Satisfaction: Change at C8 D1Sexual Functioning: Change at C8 D1Ascites: Change at C8 D1Indigestion: Change at C8 D1Flatulence: Change at C8 D1Cachexia: Change at C8 D1Side Effects: Change at C8 D1Fear of Future Health: Change at C8 D1Ability to Plan Future: Change at C8 D1Pancreatic Pain: Change at C9 D1Eating Related Items: Change at C9 D1Altered Bowel Habits: Change at C9 D1Jaundice: Change at C9 D1Body Image: Change at C9 D1Health Care Satisfaction: Change at C9 D1Sexual Functioning: Change at C9 D1Ascites: Change at C9 D1Indigestion: Change at C9 D1Flatulence: Change at C9 D1Cachexia: Change at C9 D1Side Effects: Change at C9 D1Fear of Future Health: Change at C9 D1Ability to Plan Future: Change at C9 D1Pancreatic Pain: Change at C10 D1Eating Related Items: Change at C10 D1Altered Bowel Habits: Change at C10 D1Jaundice: Change at C10 D1Body Image: Change at C10 D1Health Care Satisfaction: Change at C10 D1Sexual Functioning: Change at C10 D1Ascites: Change at C10 D1Indigestion: Change at C10 D1Flatulence: Change at C10 D1Cachexia: Change at C10 D1Side Effects: Change at C10 D1Fear of Future Health: Change at C10 D1Ability to Plan Future: Change at C10 D1Pancreatic Pain: Change at C11 D1Eating Related Items: Change at C11 D1Altered Bowel Habits: Change at C11 D1Jaundice: Change at C11 D1Body Image: Change at C11 D1Health Care Satisfaction: Change at C11 D1Sexual Functioning: Change at C11 D1Ascites: Change at C11 D1Indigestion: Change at C11 D1Flatulence: Change at C11 D1Cachexia: Change at C11 D1Side Effects: Change at C11 D1Fear of Future Health: Change at C11 D1Ability to Plan Future: Change at C11 D1Pancreatic Pain: Change at C12 D1Eating Related Items: Change at C12 D1Altered Bowel Habits: Change at C12 D1Jaundice: Change at C12 D1Body Image: Change at C12 D1Health Care Satisfaction: Change at C12 D1Sexual Functioning: Change at C12 D1Ascites: Change at C12 D1Indigestion: Change at C12 D1Flatulence: Change at C12 D1Cachexia: Change at C12 D1Side Effects: Change at C12 D1(n=3,0)Fear of Future Health: Change at C12 D1Ability to Plan Future: Change at C12 D1Pancreatic Pain: Change at C13 D1Eating Related Items: Change at C13 D1Altered Bowel Habits: Change at C13 D1Jaundice: Change at C13 D1Body Image: Change at C13 D1Health Care Satisfaction: Change at C13 D1Sexual Functioning: Change at C13 D1Ascites: Change at C13 D1Indigestion: Change at C13 D1Flatulence: Change at C13 D1Cachexia: Change at C13 D1Side Effects: Change at C13 D1Fear of Future Health: Change at C13 D1Ability to Plan Future: Change at C13 D1Pancreatic Pain: Change at C14 D1Eating Related Items: Change at C14 D1Altered Bowel Habits: Change at C14 D1Jaundice: Change at C14 D1Body Image: Change at C14 D1Health Care Satisfaction: Change at C14 D1Sexual Functioning: Change at C14 D1Ascites: Change at C14 D1Indigestion: Change at C14 D1Flatulence: Change at C14 D1Cachexia: Change at C14 D1Side Effects: Change at C14 D1Fear of Future Health: Change at C14 D1Ability to Plan Future: Change at C14 D1Pancreatic Pain: Change at EoSEating Related Items: Change at EoSAltered Bowel Habits: Change at EoSJaundice: Change at EoSBody Image: Change at EoSHealth Care Satisfaction: Change at EoSSexual Functioning: Change at EoSAscites: Change at EoSIndigestion: Change at EoSFlatulence: Change at EoSCachexia: Change at EoSSide Effects: Change at EoSFear of Future Health: Change at EoSAbility to Plan Future: Change at EoS
Axitinib + Gemcitabine37.5240.4022.329.8931.6479.3844.3537.2924.8635.5933.6227.7863.2239.55-11.05-0.388.330.007.950.39-2.56-10.85-4.655.309.477.70-2.334.55-8.923.0710.532.1913.51-5.41-3.13-2.63-4.509.6514.4711.55-2.869.01-18.30-7.4716.091.7212.82-1.92-5.30-6.90-9.521.159.2011.88-2.7810.26-7.260.0013.463.8514.00-2.67-1.75-5.13-3.85-1.3310.2610.040.0020.00-3.76-4.9013.731.9623.96-11.46-7.69-1.963.921.964.9016.34-4.4412.50-3.70-14.815.565.5616.675.56-9.520.00-7.41-3.705.568.644.1714.81-1.543.7014.819.2622.223.70-7.14-3.70-7.41-11.1111.1111.114.1711.110.0014.2923.819.5228.572.38-13.33-11.114.7614.2923.8131.75-16.6719.058.3325.0027.782.7825.0013.89-13.330.0027.7816.6725.0037.040.0033.335.5638.8950.0016.6750.0027.78-33.3322.2211.1111.1155.5655.560.0044.44-5.5616.6727.780.0016.67-5.560.00-22.220.000.0033.3333.330.000.0020.8358.338.3325.0041.67-16.67-50.0016.670.0016.6733.3316.670.0016.67-8.3316.6733.3333.3333.330.00-33.330.000.0033.3350.000.000.000.0058.3325.0083.338.3366.670.000.0033.3333.3383.3366.6719.4433.3366.67

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Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study

QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100. Higher scores on functioning scales=better functioning; higher scores on the symptom scales=more symptoms. (NCT00219557)
Timeframe: Phase 2 baseline [Day (D) 1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).

Interventionunits on a scale (Mean)
Pancreatic Pain: BaselineEating Related Items: BaselineAltered Bowel Habits: BaselineJaundice: BaselineBody Image: BaselineHealth Care Satisfaction: BaselineSexual Functioning: BaselineAscites: BaselineIndigestion: BaselineFlatulence: BaselineCachexia: BaselineSide Effects: BaselineFear of Future Health: BaselineAbility to Plan Future: BaselinePancreatic Pain: Change at C2 D1Eating Related Items: Change at C2 D1Altered Bowel Habits: Change at C2 D1Jaundice: Change at C2 D1Body Image: Change at C2 D1Health Care Satisfaction: Change at C2 D1Sexual Functioning: Change at C2 D1Ascites: Change at C2 D1Indigestion: Change at C2 D1Flatulence: Change at C2 D1Cachexia: Change at C2 D1Side Effects: Change at C2 D1Fear of Future Health: Change at C2 D1Ability to Plan Future: Change at C2 D1Pancreatic Pain: Change at C3 D1Eating Related Items: Change at C3 D1Altered Bowel Habits: Change at C3 D1Jaundice: Change at C3 D1Body Image: Change at C3 D1Health Care Satisfaction: Change at C3 D1Sexual Functioning: Change at C3 D1Ascites: Change at C3 D1Indigestion: Change at C3 D1Flatulence: Change at C3 D1Cachexia: Change at C3 D1Side Effects: Change at C3 D1Fear of Future Health: Change at C3 D1Ability to Plan Future: Change at C3 D1Pancreatic Pain: Change at C4 D1Eating Related Items: Change at C4 D1Altered Bowel Habits: Change at C4 D1Jaundice: Change at C4 D1Body Image: Change at C4 D1Health Care Satisfaction: Change at C4 D1Sexual Functioning: Change at C4 D1Ascites: Change at C4 D1Indigestion: Change at C4 D1Flatulence: Change at C4 D1Cachexia: Change at C4 D1Side Effects: Change at C4 D1Fear of Future Health: Change at C4 D1Ability to Plan Future: Change at C4 D1Pancreatic Pain: Change at C5 D1Eating Related Items: Change at C5 D1Altered Bowel Habits: Change at C5 D1Jaundice: Change at C5 D1Body Image: Change at C5 D1Health Care Satisfaction: Change at C5 D1Sexual Functioning: Change at C5 D1Ascites: Change at C5 D1Indigestion: Change at C5 D1Flatulence: Change at C5 D1Cachexia: Change at C5 D1Side Effects: Change at C5 D1Fear of Future Health: Change at C5 D1Ability to Plan Future: Change at C5 D1Pancreatic Pain: Change at C6 D1Eating Related Items: Change at C6 D1Altered Bowel Habits: Change at C6 D1Jaundice: Change at C6 D1Body Image: Change at C6 D1Health Care Satisfaction: Change at C6 D1Sexual Functioning: Change at C6 D1Ascites: Change at C6 D1Indigestion: Change at C6 D1Flatulence: Change at C6 D1Cachexia: Change at C6 D1Side Effects: Change at C6 D1Fear of Future Health: Change at C6 D1Ability to Plan Future: Change at C6 D1Pancreatic Pain: Change at C7 D1Eating Related Items: Change at C7 D1Altered Bowel Habits: Change at C7 D1Jaundice: Change at C7 D1Body Image: Change at C7 D1Health Care Satisfaction: Change at C7 D1Sexual Functioning: Change at C7 D1Ascites: Change at C7 D1Indigestion: Change at C7 D1Flatulence: Change at C7 D1Cachexia: Change at C7 D1Side Effects: Change at C7 D1Fear of Future Health: Change at C7 D1Ability to Plan Future: Change at C7 D1Pancreatic Pain: Change at C8 D1Eating Related Items: Change at C8 D1Altered Bowel Habits: Change at C8 D1Jaundice: Change at C8 D1Body Image: Change at C8 D1Health Care Satisfaction: Change at C8 D1Sexual Functioning: Change at C8 D1Ascites: Change at C8 D1Indigestion: Change at C8 D1Flatulence: Change at C8 D1Cachexia: Change at C8 D1Side Effects: Change at C8 D1Fear of Future Health: Change at C8 D1Ability to Plan Future: Change at C8 D1Pancreatic Pain: Change at C9 D1Eating Related Items: Change at C9 D1Altered Bowel Habits: Change at C9 D1Jaundice: Change at C9 D1Body Image: Change at C9 D1Health Care Satisfaction: Change at C9 D1Sexual Functioning: Change at C9 D1Ascites: Change at C9 D1Indigestion: Change at C9 D1Flatulence: Change at C9 D1Cachexia: Change at C9 D1Side Effects: Change at C9 D1Fear of Future Health: Change at C9 D1Ability to Plan Future: Change at C9 D1Pancreatic Pain: Change at C10 D1Eating Related Items: Change at C10 D1Altered Bowel Habits: Change at C10 D1Jaundice: Change at C10 D1Body Image: Change at C10 D1Health Care Satisfaction: Change at C10 D1Sexual Functioning: Change at C10 D1Ascites: Change at C10 D1Indigestion: Change at C10 D1Flatulence: Change at C10 D1Cachexia: Change at C10 D1Side Effects: Change at C10 D1Fear of Future Health: Change at C10 D1Ability to Plan Future: Change at C10 D1Pancreatic Pain: Change at C11 D1Eating Related Items: Change at C11 D1Altered Bowel Habits: Change at C11 D1Jaundice: Change at C11 D1Body Image: Change at C11 D1Health Care Satisfaction: Change at C11 D1Sexual Functioning: Change at C11 D1Ascites: Change at C11 D1Indigestion: Change at C11 D1Flatulence: Change at C11 D1Cachexia: Change at C11 D1Side Effects: Change at C11 D1Fear of Future Health: Change at C11 D1Ability to Plan Future: Change at C11 D1Pancreatic Pain: Change at EoSEating Related Items: Change at EoSAltered Bowel Habits: Change at EoSJaundice: Change at EoSBody Image: Change at EoSHealth Care Satisfaction: Change at EoSSexual Functioning: Change at EoSAscites: Change at EoSIndigestion: Change at EoSFlatulence: Change at EoSCachexia: Change at EoSSide Effects: Change at EoSFear of Future Health: Change at EoSAbility to Plan Future: Change at EoS
Gemcitabine38.8933.9525.3115.3826.5469.7557.9725.9330.8639.5131.4827.3559.2641.98-13.64-3.79-11.36-12.70-7.14-3.9718.63-3.03-10.61-9.09-3.03-3.170.00-1.67-23.78-10.42-8.33-9.38-5.215.21-4.44-4.17-15.566.255.21-7.64-2.22-12.50-14.105.133.85-11.118.97-8.97-2.782.56-2.56-2.56-3.85-3.245.13-5.13-18.52-7.41-14.81-20.37-11.117.411.85-11.11-25.93-11.11-5.56-11.7314.81-11.11-12.508.33-8.33-16.670.00-25.00-20.83-8.33-16.67-8.33-20.83-22.220.0016.67-16.678.3325.00-41.67-25.00-33.33-41.670.000.00-16.67-8.33-22.22-16.6733.33-25.0016.67-33.33-83.3316.67-33.330.000.000.00-33.33-16.670.0033.3366.67-16.670.00-50.00-66.670.00-33.330.0033.330.000.000.000.0033.3333.33-16.670.00-50.00-83.330.00-33.33-33.3333.330.000.0016.6711.1133.3333.33-8.3333.33-16.67-83.3316.67-16.67-33.3333.330.000.0016.6711.1133.3366.670.000.000.000.00-16.6733.3333.3333.3333.330.000.00-11.11-33.3333.33

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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)

Tmax was based on the actual time points when the samples were collected. (NCT00219557)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1

Interventionhr (Median)
Axitinib + Gemcitabine (Phase 1 Lead-In)1.52

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Progression-free Survival (PFS)

"Time in days from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of randomization plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)." (NCT00219557)
Timeframe: Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks

InterventionDays (Number)
Axitinib + Gemcitabine116
Gemcitabine113

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Plasma Decay Half-life (t1/2) of Gemcitabine

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT00219557)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1

Interventionhr (Mean)
Axitinib + Gemcitabine (Phase 1 Lead-In)0.310

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Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT00219557)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1

Interventionhr (Mean)
Axitinib + Gemcitabine (Phase 1 Lead-In)2.97

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Percentage of Participants With Overall Response (OR)

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non-target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions. (NCT00219557)
Timeframe: Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks

InterventionPercentage of Participants (Number)
Axitinib + Gemcitabine7.2
Gemcitabine2.9

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One Year Survival Probability

One year survival probability was defined as the probability of survival at one year after the date of randomization based on the Kaplan Meier estimate. (NCT00219557)
Timeframe: Phase 2 baseline to disease progression or death due to any cause or at least 1 year after the first dose for the last participant

InterventionPercent chance of survival (Number)
Axitinib + Gemcitabine36.81
Gemcitabine23.53

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Maximum Observed Plasma Concentration (Cmax) of Gemcitabine

(NCT00219557)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1

Interventionng/mL (Mean)
Axitinib + Gemcitabine (Phase 1 Lead-In)27280.0

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Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy

Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA). (NCT00225784)
Timeframe: 1 month after completion of treatment

Interventionparticipants (Number)
Cetuximab, Gemcitabine, Radiotherapy26

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Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.

Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment. (NCT00225784)
Timeframe: One month post-therapy

Interventionpercent (Number)
Cetuximab, Gemcitabine, Radiotherapy in EGFR (-) Tumors33
Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors29

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Objective Response of Tumor by RECIST 1.0 Criteria

Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. (NCT00225784)
Timeframe: one month post-therapy

Interventionparticipants (Number)
partial responsestable diseaseprogressive disease
Cetuximab, Gemcitabine, Radiotherapy10203

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Pattern of Failure After Therapy

Local recurrence, distant recurrence, or both. (NCT00225784)
Timeframe: Five years post treatment

Interventionparticipants (Number)
number of participants with local recurrence onlynumber of ppts. with local and distant recurrencenumber of ppts. with distant disease recurrencenumber of ppts. without recurrence or unknown
Cetuximab, Gemcitabine, Radiotherapy21175

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Disease-Free Survival After Therapy

Time to disease progression after therapy. (NCT00225784)
Timeframe: Five years post treatment

Interventionmonths (Median)
Cetuximab, Gemcitabine, Radiotherapy9.1

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Number of Participants Assessed for Adverse Events

Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0 (NCT00225784)
Timeframe: Participants were followed during treatment and for 30 days after completion of treatment

Interventionparticipants (Number)
Cetuximab, Gemcitabine, Radiotherapy37

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Overall Length of Survival After Therapy

Length of survival after therapy in all participants enrolled. (NCT00225784)
Timeframe: Five years post treatment

Interventionmonths (Median)
Cetuximab, Gemcitabine, Radiotherapy17.3

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Disease Response - Pathologic

Number of participants with Pathologic Complete Response. Pathologic complete response (pCR) is defined by a surgical pathology specimen, which consists of equal to or more than 95% fibrosis and necrosis. (NCT00226577)
Timeframe: 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006

Interventionparticipants (Number)
Pre-Surgery Chemotherapy13

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Survival - Disease Free

Disease-free survival (DFS) is defined as the period of time from surgery to the time when disease recurrence is clearly documented. A histologic confirmation is required in equivalent cases. (NCT00226577)
Timeframe: 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006

Interventionmonths (Median)
Pre-Surgery Chemotherapy33.7

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Survival - Overall

Median range of number of participants with Overall Survival. Overall survival (OS) will be defined as the period of time from the first day of drug treatment to the date of death of the patient. Patients taken off study will be followed quarterly until death for survival data. (NCT00226577)
Timeframe: 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006

Interventionmonths (Median)
Pre-Surgery Chemotherapy27.8

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Disease Response - Radiographic

"Number of participants with partial or Complete Response. Complete response (CR) is defined as the total disappearance of all malignant and evaluable clinical evidence of cancer without the development of any new malignant lesions documented on the post chemotherapy chest CT and PET scan.~Partial response (PR) (measurable disease only): When compared with pre-treatment measurements, a reduction of >30% in the sum of the largest diameters of all measurable lesions and absence of new lesions." (NCT00226577)
Timeframe: 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006

Interventionparticipants (Number)
Complete RemissionPartial Remission
Pre-Surgery Chemotherapy116

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Toxicity

Number of participants with toxicity ≥ Grade 3 after gemcitabine plus pemetrexed induction chemotherapy. (NCT00226577)
Timeframe: 06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006

Interventionparticipants (Number)
Pre-Surgery Chemotherapy18

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Treatment Completion

The number of participants who completed all treatment on schedule without dose reductions or delays. (NCT00226590)
Timeframe: Ranging from 2 weeks up to 4 years, 9 months

Interventionparticipants (Number)
Combination Therapy19

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Progression Free Survival

To determine median Progression Free Survival rate. Progression-free survival (PFS) is defined as the interval between the date of the first chemotherapy administration and the date of objective progression or death. Progression was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. (NCT00226590)
Timeframe: Ranging from 2 weeks up to 4 years, 9 months

Interventionmonths (Median)
Combination Therapy22.7

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Overall Survival

To determine median Overall Survival rate (NCT00226590)
Timeframe: Ranging from 2 weeks up to 4 years, 9 months

Interventionmonths (Median)
Combination Therapy14.3

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Number of Participants Whose Response Allowed Them to Proceed to Chemoradiation

Response Rates - Complete Response (CR) + Partial Response (PR): We determined the number of participants whose response (both CT and PET assessment) to two cycles of induction chemotherapy with gemcitabine and carboplatin allowed them to proceed to chemoradiation. Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. (NCT00226590)
Timeframe: Ranging from 2 weeks up to 4 years, 9 months

Interventionparticipants (Number)
Induction Therapy38

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Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.

(NCT00227721)
Timeframe: Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first).

Interventionpercentage of participants with CR or PR (Number)
Docetaxel & Gemcitabine Hydrochloride62

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Progression-free Survival

Progression-free survival estimated using Kaplan-Meier's product-limit method. (NCT00227721)
Timeframe: Every two cycles until disease progression or death, assessed up to 5 years

Interventionmonths (Median)
Docetaxel & Gemcitabine Hydrochloride7.2

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Recurrence-free Survival (RFS)

Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause. (NCT00234039)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Intravesical Gemcitabine28

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Overall Survival (OS)

Measured from the day of registration to death due to any cause. Survival is censored at date of last contact. (NCT00234039)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Intravesical Gemcitabine98

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Complete Response Rate at the End of Induction

Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy (NCT00234039)
Timeframe: Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5

Interventionpercentage of participants (Number)
Intravesical Gemcitabine46

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Estimate Response Rates

To estimate rate of partial response (PR), complete response (CR) and overall response (PR plus CR). (NCT00234494)
Timeframe: 36 months

Interventionpercentage of participants (Number)
complete reponsepartial reponseoverall response
Single Group Assignment195372

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Progression Free Survival

- To determine the progression free survival of patients with metastatic transitional cell cancer treated with cisplatin, gemcitabine and bevacizumab. (NCT00234494)
Timeframe: 36 months

Interventionmonths (Median)
Single Group Assignment8.2

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Overall Survival Time

To estimate overall survival time in months. (NCT00234494)
Timeframe: 36 months

Interventionmonths (Median)
Single Group Assignment19.1

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Overall Response Rate (ORR) by Treatment Schedule

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants. (NCT00236899)
Timeframe: Baseline up to 49.84 months

,
Interventionpercentage of responses (Number)
ORR (Complete Response or Partial Response)Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseNot AvailableNot Assessed
Treatment Schedule (3 Weekly)33.065.6527.4240.3212.901.6112.10
Treatment Schedule (Weekly)50.436.8443.5923.9321.370.853.42

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Time to Progressive Disease (TTPD) by Treatment Schedule

"TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions." (NCT00236899)
Timeframe: Baseline up to 49.84 months

Interventionmonths (Median)
Treatment Schedule (Weekly)8.33
Treatment Schedule (3 Weekly)7.51

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Time to Progressive Disease (TTPD) by Treatment Drug

"TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions." (NCT00236899)
Timeframe: Baseline up to 49.84 months

Interventionmonths (Median)
Treatment Drug (Docetaxel)7.74
Treatment Drug (Paclitaxel)7.80

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Overall Survival (OS) by Treatment Schedule

OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit). (NCT00236899)
Timeframe: Baseline up to 51.64 months

Interventionmonths (Mean)
Treatment Schedule (Weekly)21.11
Treatment Schedule (3 Weekly)20.95

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Number of Participants With Serious and Nonserious Adverse Events (AEs)

Summary tables of serious adverse events (SAEs) and all other nonserious AEs are located in the Reported Adverse Event Module. (NCT00236899)
Timeframe: Baseline up to 51.64 months

,,,
Interventionparticipants (Number)
SAEsNonserious AEs
Arm A: Docetaxel and Gemcitabine (Tri-weekly)957
Arm B: Paclitaxel and Gemcitabine (Tri-weekly)1058
Arm C: Docetaxel and Gemcitabine (Weekly)753
Arm D: Paclitaxel and Gemcitabine (Weekly)1156

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Overall Survival (OS) by Treatment Drug

OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit). (NCT00236899)
Timeframe: Baseline up to 51.64 months

Interventionmonths (Median)
Treatment Drug (Docetaxel)19.11
Treatment Drug (Paclitaxel)23.80

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Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle

RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL by treatment arm are provided. Arms A (Docetaxel and Gemcitabine 3 Weekly) and B (Paclitaxel and Gemcitabine 3 Weekly) were assessed every 3 weeks. Arms C (Docetaxel and Gemcitabine Weekly) and D (Paclitaxel and Gemcitabine Weekly) were assessed every 4 weeks. (NCT00236899)
Timeframe: Baseline up to 51.64 months

,,,
Interventionparticipants (Number)
1=Excellent2=Good3=Moderately Good4=Neither Good Nor Bad5=Rather Poor6=Poor7=Extremely PoorNo Response
Arm A: Docetaxel and Gemcitabine (Tri-weekly)3136620030
Arm B: Paclitaxel and Gemcitabine (Tri-weekly)1138733326
Arm C: Docetaxel and Gemcitabine (Weekly)299637022
Arm D: Paclitaxel and Gemcitabine (Weekly)459762125

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Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit

RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL (using the 7-point scale) by treatment arm are provided. (NCT00236899)
Timeframe: Baseline up to 51.64 months

,,,
Interventionparticipants (Number)
1=Excellent2=Good3=Moderately Good4=Neither Good Nor Bad5=Rather Poor6=Poor7=Extremely PoorNo Response
Arm A: Docetaxel and Gemcitabine (Tri-weekly)072302145
Arm B: Paclitaxel and Gemcitabine (Tri-weekly)076610044
Arm C: Docetaxel and Gemcitabine (Weekly)023011249
Arm D: Paclitaxel and Gemcitabine (Weekly)042312047

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Overall Response Rate(ORR) by Treatment Drug

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants. (NCT00236899)
Timeframe: Baseline up to 49.84 months

,
Interventionpercentage of responses (Number)
ORR (Complete Response or Partial Response)Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseNot AvailableNot Assessed
Treatment Drug (Docetaxel)43.25.0838.1432.2017.800.855.93
Treatment Drug (Paclitaxel)39.87.3232.5232.5216.261.639.76

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Objective Response Rate by RECIST Criteria Following

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00244933)
Timeframe: every 2 courses until disease progression or death, up to 24 weeks

Interventionparticipants (Number)
Gemcitabine & Genistein0

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Percentage of Participants With Reduction in Grade 3/4 Neutropenia

Reduction grade 3/4 neutropenia (NCT00247416)
Timeframe: continuous throughout treatment, up to 25 weeks

Interventionpercentage of participants (Number)
Arm 1, Control, no Dexamethasone Pretreatment40
Arm 2, Dexamethasone Pretreatment Test Arm13

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Progression-free Survival

progression-free survival (NCT00247416)
Timeframe: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days

Interventiondays (Median)
Arm 1, Control, no Dexamethasone Pretreatment101
Arm 2, Dexamethasone Pretreatment Test Arm122

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Effect of Dexamethasone Pre-treatment on Overall Survival.

Overall survival (NCT00247416)
Timeframe: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days

Interventiondays (Median)
Arm 1, Control, no Dexamethasone Pretreatment291
Arm 2, Dexamethasone Pretreatment Test Arm378

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Effect of Dexamethasone Pre-treatment on Response Rate.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00247416)
Timeframe: Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment

Interventionpercentage of responders out of total (Number)
1 No Dex8
2 Dex26

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Response Duration

Response duration in months (NCT00248560)
Timeframe: Every 8 weeks

Interventionmonths (Median)
Gemcitabine, Docetaxel3.2

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Survival

Overall Survival using the Kaplan-Meier method (NCT00248560)
Timeframe: Every 8 weeks

Interventionmonths (Median)
Gemcitabine, Docetaxel4.2

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Toxicity as Measured by Number and Grade of Adverse Events

Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event (NCT00248560)
Timeframe: Every 2 weeks

Interventionparticipants (Number)
AnemiaNeutropeniaHyponatremiaDehydrationFatigueDyspneaPneumoniaThrombocytopeniaFebrile neutropeniaTachycardiaSyncopeFluid retentionMucositisHyperglycemiaConstipationAnorexiaVomitingOther non-hematologic toxicity
Gemcitabine, Docetaxel131010333321111111111

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Response (Complete Response [CR] + Partial Response [PR])

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00248560)
Timeframe: every 8 weeks for approximately 8 - 48 weeks

Interventionparticipants (Number)
Gemcitabine, Docetaxel6

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Response Rate After 2 Courses of Therapy

Response was evaluated after two cycles of therapy using the 1999 Cheson response criteria. All responses were based on CT scans. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients-especially those with large-cell NHL-who may not have residual disease. For patients who had FDG-PET imaging, metabolic response was defined as a decrease in the standardized uptake value in target lesions (regions of abnormal FDG uptake on pretreatment FDG-PET images) to below three on posttreatment FDG-PET imaging). All PET scans were reviewed and interpreted by a single radiologist (SV). (NCT00262860)
Timeframe: 21 Days/course for up to 2 courses

Interventionparticipants (Number)
Bortezomib, Gemcitabine Hydrochloride4

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Change in Proteasome Activity Compared to Baseline (Cycle 2)

Peripheral blood (40 ml) was collected at baseline and 1-2 weeks after cycle 2, day 11 post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated. (NCT00262860)
Timeframe: baseline and 1-2 weeks after cycle 2, day 11

Interventionpercentage of change in proteosome activ (Median)
Bortezomib, Gemcitabine Hydrochloride-57

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Change in Proteasome Activity Compared to Baseline (Cycle 1)

Peripheral blood (40 ml) was collected on cycle 1, day 1 of prebortezomib at baseline and 2 hrs post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated. (NCT00262860)
Timeframe: baseline to 2 hours

InterventionPercentage of change in proteosome activ (Median)
Bortezomib, Gemcitabine Hydrochloride-50

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Progression Free Survival (PFS)

Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression (NCT00264498)
Timeframe: Date of randomization to earliest date of objective disease progression

InterventionDays (Mean)
Active Comparator131.0
Experimental42.0

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Overall Survival (OS)

OS was the duration from randomization to death. OS was censored at the last contact for participants who were alive, at the cut-off date. (NCT00267020)
Timeframe: Randomization to the date of death from any cause up to 27.7 months

Interventionmonths (Median)
Enzastaurin+Gemcitabine5.6
Gemcitabine5.1

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Relationship of Steady-state Drug Levels to Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Disease Control)

"The overall disease control rate was calculated as percent of participants with overall response of complete response (CR), partial response (PR) or stable disease (SD) over number of per-protocol population. Using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria, CR: disappearance of all target and non-target lesions; PR: as at least a 30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD) was defined as at least 20% increase in sum of LD of target lesions; SD: small changes that did not meet above criteria.~Participants were categorized into 2 groups based on their steady state drug levels of Enzastaurin (total analyte=enzastaurin + LSN326020 [metabolite]): participants below the median and participants above the median [2754.521 nanomoles per liter (nmol/l)].~The steady state drug levels and clinical outcomes were not evaluated for the Gemcitabine only group." (NCT00267020)
Timeframe: Beginning of treatment up to 27.7 months

Interventionpercentage of participants (Number)
CR (Below median)CR (Above median)PR (Below median)PR (Above median)SD (Below median)SD (Above median)PD (Below median)PD (Above median)Disease Control (Below median)Disease Control (Above median)
Enzastaurin+Gemcitabine3.60.017.93.657.139.314.332.178.642.9

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Duration of Response

The duration of a complete response (CR) or partial response (PR) was defined, using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria, as the time from first objective status assessment of CR or PR to the first time of disease progression or death as a result of any cause. Using the Response Evaluation Criteria in Solid Tumors (RECIST V1.0) criteria, CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. Duration of response was censored at the date of the last assessment visit for responders who were still alive at data cut-off and had no documented progressive disease (PD). (NCT00267020)
Timeframe: Time of response to PD or death from any cause up to 19.9 months

Interventionmonths (Median)
Enzastaurin+Gemcitabine4.6
Gemcitabine9.2

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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate)

"Response rate was defined as percentage of responders (best study response recorded as CR or PR) from the qualified number of participants for tumor response analysis. Response defined using Response Evaluation Criteria In Solid Tumors (RECIST, v1.0) criteria: CR was disappearance of all target lesions for at least 4 weeks. PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.~Percentage of participants was calculated as: (The number of responders with CR or PR/ The number of participants qualified for tumor response analysis) × 100." (NCT00267020)
Timeframe: Randomization to measured progressive disease (PD) up to 19.9 months

,
Interventionpercentage of participants (Number)
CRPR
Enzastaurin+Gemcitabine1.27.4
Gemcitabine05.3

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Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) (Toxicity)

Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). Participants who died due to progressive disease (PD), AEs while on treatment or died during the 30 day post-treatment are included. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. (NCT00267020)
Timeframe: Baseline through study completion (Up To 27.7 Months)

,
InterventionParticipants (Count of Participants)
Non-serious AEsSAEsDeaths due to PDDeaths due to AEsDeaths within 30-days after treatment
Enzastaurin+Gemcitabine8049343
Gemcitabine3823111

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Change in Scores From Baseline (Improved, Stable or Worsened) to End of Study in Functional Assessment of Cancer Therapy Hepatobiliary Version 4 ( FACT-Hep v.4) (Quality of Life (QOL))

"FACT-Hep consists of 45 items in five subscales (1) physical well-being (PWB) score rage 0 -28; (2) social well-being (SWB) score range 0-28; (3) emotional well-being (EWB) score range 0-24; (4) functional well-being (FWB) score range 0-28; and (5) the hepatobiliary cancer subscale (HCS) Score range 0-72. The Trial Outcomes Index (TOI) is the sum of the PWB, FWB and Hep subscales with a scores range of 0 to 128. The Total FACT-Hep score was the sum of all questions with a scores range of 0 to 180. The Total FACT-G score was the sum of the 27 questions in the PWB, SFWB, EWB and FWB with a scores range of 0 to 108. The FACT-Hep Symptoms Index with 8 key questions and scores range of 0 to 32 from the Hep Subscale. Higher score in sub-score or total score indicates better QOL and better health state. Participants were classified as Improved if they had positive change from baseline, Worsened if they had negative change from baseline, and Stable otherwise." (NCT00267020)
Timeframe: Baseline through end of study up to 27.7 months

,
Interventionunits on a scale (Mean)
Physical well-being- ImprovedPhysical well-being- StablePhysical well-being- WorsenedSocial well-being- ImprovedSocial well-being- StableSocial well-being- WorsenedEmotional well-being- ImprovedEmotional well-being- StableEmotional well-being- WorsenedFunctional well-being- ImprovedFunctional well-being- StableFunctional well-being- WorsenedHepatobiliary cancer subscale- ImprovedHepatobiliary cancer subscale- StableHepatobiliary cancer subscale- WorsenedTotal Outcome Index- ImprovedTotal outcome index- StableTotal outcome index- WorsenedTotal FACT-Hep score- ImprovedTotal FACT-Hep score- StableTotal FACT-Hep score- WorsenedTotal FACT-G-score- ImprovedTotal FACT-G-score- StableTotal FACT-G-score- WorsenedFACT Hep Symptoms Index- ImprovedFACT Hep Symptoms Index- StableFACT Hep Symptoms Index- Worsened
Enzastaurin+Gemcitabine7.20.3-10.03.80.1-6.56.90-5.86.8-0.2-10.612.70.5-14.621.4-1.6-35.930.0-1.2-37.919.1-0.5-20.17.40.5-7.0
Gemcitabine6.50.8-7.84.7-0.6-5.56.7-0.1-8.26.5-1.1-8.512.00.7-10.019.0-1.3-23.027.50-26.624.1-0.6-21.26.30.1-7.0

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Carbohydrate Antigen 19-9 (CA 19-9) Concentration in the Blood

CA19-9 is a tumor biomarker which was measured in the blood to assess the effect of treatment with enzastaurin. (NCT00267020)
Timeframe: Cycles 1 to 6, and post-treatment (up to 27.7 months)

,
Interventionkilo units/liter (kU/L) (Mean)
Cycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Post-treatment 1st visitPost-treatment 2nd visit
Enzastaurin+Gemcitabine31708.512828.424709.537261.0392.3600.919420.519557.7
Gemcitabine12038.640764.91573.01102.7403.1938.511351.393955.9

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Progression Free Survival (PFS)

PFS was defined as the time from the date of randomization to the first date of documented progressive disease (PD) or death due to any cause, whichever occurred first. PFS was censored at the date of the last assessment visit for participants who were still alive at data cut-off and who had not had documented progressive disease. Participants who started a new treatment before progression were censored as of the date of the start of new treatment. (NCT00267020)
Timeframe: Randomization to measured PD or death from any cause up to 21.6 months

Interventionmonths (Median)
Enzastaurin+Gemcitabine3.4
Gemcitabine3.0

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Relationship of Steady-State Drug Levels to Clinical Outcomes of Overall Survival (OS)

OS was the duration from randomization to death from any cause. For participants who were alive at data cut-off, OS was censored at the last contact. Participants were categorized into 2 groups based on their steady state drug levels of Enzastaurin (total analyte=enzastaurin + LSN326020 [metabolite]): those participants below the median and those participants above the median [2786.042 nanomoles per /liter (nmol/l)]. The steady state drug levels and clinical outcomes were not evaluated for the Gemcitabine only treatment group. (NCT00267020)
Timeframe: Randomization to date of death from any cause up to 27.7 months

Interventionmonths (Median)
Below medianAbove median
Enzastaurin+Gemcitabine7.25.6

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Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.

Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation. (NCT00267696)
Timeframe: up to 6 months

Interventionmonths (Median)
Gemcitabine/Carboplatin/Bevacizumab13.3

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Overall Survival for Patients Treated With the Regimen.

The period of time from study entry until disease progression or date of last contact. (NCT00267696)
Timeframe: To progression of Disease

Interventionmonths (Median)
Gemcitabine/Carboplatin/Bevacizumab36.1

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Complete Response Rate

Assumptions/ hypothesis: A Complete Response (CR) rate of 30% or less is unacceptable, and 50% or more is promising. A two-stage design will be used. Initially, 18 patients will be enrolled. If 5 or fewer achieve CR, the study will be stopped. Otherwise, an additional 22 patients will be accrued. Accrual was not halted while follow-up of the first 18 evaluable patients was under way. Therefore, 24 patients were enrolled. Four weeks is anticipated for observation for response. Only 5 patients (21%) achieved a CR and therefore, the study was terminated. Since response was assessed using the International Working Group criteria, a complete response was determined by Morphologic complete remission: A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL, a cytogenic CR and a morphologic CR with incomplete blood count recovery (CRi). (NCT00268242)
Timeframe: 4 Weeks

Interventionparticipants (Number)
Gemcitabine + Mitoxantrone5

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Percentage of Patients Making it to Bone Marrow Transplant.

Assessing the number of patients who were able to have protocol treatment and have a bone marrow transplant after treatment. (NCT00268242)
Timeframe: After completion of protocol therapy

Interventionpercentage of Patients completed a BMT (Number)
Gemcitabine + Mitoxantrone8

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White Blood Cell Count at Time of Relapse

(NCT00268242)
Timeframe: After a CR is achieved, patient will be followed at 3 month intervals for disease progression, typically for up to 5 years.

Interventioncells per microliter (Median)
Gemcitabine + Mitoxantrone3450

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Disease-free and Overall Survival

(NCT00268242)
Timeframe: After a CR is achieved, patients are followed at 3 month intervals for disease progression and survival. If a patient has disease progression after achieving a CR, survival will be captured at 6 month intervals, typically for up to 5 years.

Interventionparticipants (Number)
Patients dead >30 days post-tx, no relapsePatients alive with no evidence of disease relapsePatient death on Day 1 of Protocol TherapyPatients dead >30 days post-tx, after relapse
Gemcitabine + Mitoxantrone14118

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Laboratory Correlates: Immunohistochemistry

"Percentage of patients who had a moderate-strong (2-3+) expression of multidrug resistance (MDR) genes by immunohistochemistry.~Multidrug resistance gene 1 (MDR1)~Equilibrative nucleoside transporter 2(SLC29A2)" (NCT00268242)
Timeframe: Baseline

Interventionpercentage of participants (Number)
Participants with GSTP1 Gene ExpressionParticipants with SLC29A2 Gene ExpressionParticipants with MRP1 Gene ExpressionParticipants with LRP1 Gene ExpressionParticipants with MDR1 Gene Expression
Gemcitabine + Mitoxantrone7055433522

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Duration of the First Complete Response

(NCT00268242)
Timeframe: After a CR is achieved, patients are followed at 3 month intervals for disease progression and survival. If a patient has disease progression after achieving a CR, survival will be captured at 6 month intervals, typically for up to 5 years.

Interventionmonths (Median)
Gemcitabine + Mitoxantrone7.3

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Objective PSA Response Rate (Number of Patients With a PSA Response)

Decline from a baseline value by ≥ 50% or normalization of PSA (< 0.03) confirmed by a second measurement at least 1 week or more weeks later. Patients must not demonstrate clinical or radiographic evidence of disease progression during this time period. The date of response will be defined as the first date at which the PSA declined from baseline by ≥ 50% or normalized. (NCT00276549)
Timeframe: every 4 weeks

Interventionparticipants (Number)
Number of patients with a response ≥ 50%Number of patients with no response
Gemcitabine (Gemzar) and Docetaxel (Taxotere)1718

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Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).

Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, patients who do not meet the criteria for response or progressive disease for at least 90 days will be categorized as stable disease. (NCT00276549)
Timeframe: at 4 weeks after treatment completion

Interventionparticipants (Number)
Partial ResponseStable Disease
Gemcitabine (Gemzar) and Docetaxel (Taxotere)319

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6-month Overall Survival

Percentage of patients survived at 6 months for patients whose tumors were xenografted and treated in the mouse when treated with the most active agent identified in that model (NCT00276744)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Arm 153

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Response Rate as Measured by RECIST Criteria

Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria. (NCT00276861)
Timeframe: 4 - 6 months

Interventionpercentage of particpants (Number)
Single Arm9.9

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Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment

Number of months from time of enrollment to the date of first documented progression or date of death. (NCT00276861)
Timeframe: 6 months

Interventionmonths (Number)
Oxaliplatin + Gemcitabine4.6

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Number of Patients Alive at 56 Months (End of Study)

Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival). (NCT00281827)
Timeframe: Up to 56 months

InterventionParticipants (Number)
Intent-to-Treat8

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Number of Patients Disease-free at 1 Year

Calculated from date of enrollment to date of recurrence or death, whichever came first (NCT00281827)
Timeframe: 1 year

InterventionParticipants (Number)
Intent-to-Treat14

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Number of Patients Disease-free at 2 Years

Calculated from date of enrollment to date of recurrence or death, whichever came first (NCT00281827)
Timeframe: 2 Years

InterventionParticipants (Number)
Intent-To-Treat8

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Number of Patients Alive at 2 Years (Survival)

Participants who were alive at 2 years from date of enrollment. (NCT00281827)
Timeframe: 24 Months

InterventionParticipants (Number)
Intent-to-Treat16

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Number of Patients Alive at 1 Year (Survival)

Participants who were alive at one year from date of enrollment . (NCT00281827)
Timeframe: 12 Months

InterventionParticipants (Number)
Intent-to-Treat21

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Number of Patients Reporting Clinical Response

Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable. Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy. Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline. Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions. Stable Disease (SD) = Neither PR or PD. (NCT00281827)
Timeframe: At end of 3 -21 day cycles of treatment

InterventionParticipants (Number)
Complete ResponsePathological Complete ResponsePartial ResponseStable DiseaseProgressive Disease
Evaluable Patients001442

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Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)

Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread) (NCT00282087)
Timeframe: 2 years

Interventionparticipants (Number)
FIFO Stage IFIGO Stage IIFIGO Stage III
Women Treated With Adjuvant Regimen for High Risk Uterine LMS3872

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Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS

(NCT00282087)
Timeframe: Every 3 months up to two years

Interventionpercentage of participants (Number)
Women Treated With Adjuvant Regimen for High Risk Uterine LMS78

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Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)

Mitotic rate is measured in mitoses per 10 high-power fields (NCT00282087)
Timeframe: 2 years

Interventionmitoses per 10 high-power fields (Median)
Women Treated With Adjuvant Regimen for High Risk Uterine LMS18

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Correlation Between Age and Tumor Response to Treatment (PFS)

(NCT00282087)
Timeframe: 2 years

Interventionyears (Median)
Women Treated With Adjuvant Regimen for High Risk Uterine LMS53

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Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)

AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only (NCT00282087)
Timeframe: 2 years

Interventionparticipants (Number)
AJCC Stage IAJCC Stage IIAJCC Stage III
Women Treated With Adjuvant Regimen for High Risk Uterine LMS0641

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Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)

(NCT00282087)
Timeframe: 2 years

Interventionparticipants (Number)
Positive StatusNegative Status
Women Treated With Adjuvant Regimen for High Risk Uterine LMS1919

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Tolerability/Toxicity of This Regimen

Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue. (NCT00282087)
Timeframe: Every 28 days during dosing and then every 3 months thereafter until patient comes off study

Interventionnumber of major toxicity events (Number)
Women Treated With Adjuvant Regimen for High Risk Uterine LMS6

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Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)

(NCT00282087)
Timeframe: 2 years

Interventionparticipants (Number)
PostmenopausalPremenopausal
Women Treated With Adjuvant Regimen for High Risk Uterine LMS434

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Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)

(NCT00282087)
Timeframe: 2 years

Interventionparticipants (Number)
Positive StatusNegative Status
Women Treated With Adjuvant Regimen for High Risk Uterine LMS2414

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Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)

(NCT00282087)
Timeframe: 2 years

Interventionparticipants (Number)
ER or PR PositiveER and PR Negative
Women Treated With Adjuvant Regimen for High Risk Uterine LMS3314

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Quality of Life (QOL)- Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Trial Outcome Index-L (TOI-L)

"The FACT-L is the FACT-G and a lung cancer specific (LCS) subscale given at baseline, after each cycle and at end of treatment. The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL. The TOI-L sums the PWB, FWB, and LCS subscale scores.~A best response for TOI-L scores is based on change from baseline and coded as:~a change >=+6 improved, <= -6 worsened and otherwise no change.~A best overall score response is coded as:~Improved (2 visit resp. of improved a min. of 28 days apart w/ no interim worsened) No change (not improved; 2 visit resp. of no change or improved a min. of 28 days apart w/ no interim worsened) Worsened (not improved or no change; 2 consecutive worsened) Other (none of the above)" (NCT00283244)
Timeframe: After each cycle/3 weeks

,,
Interventionparticipants (Number)
ImprovedNo changeWorsenedOther
Arm A (Gemcitabine)5121116
Arm B (Erlotinib)691224
Arm C (Gemcitabine + Erlotinib)79926

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Response Rate

The best overall response (BOR) is the best response recorded from the start of the treatment until disease progression-recurrence (taking as reference for progressive disease the smallest measurement recorded since the treatment started. The response rate was defined as the percentage of patients achieving a BOR of complete response or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00283244)
Timeframe: Six months

Interventionpercentage of participants (Number)
Arm A (Gemcitabine)7
Arm B (Erlotinib)0
Arm C (Gemcitabine + Erlotinib)21

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Progression-free Survival

We would consider the combination of gemcitabine plus erlotinib or single agent erlotinib to be worthy of further study if there was an increased progressed-free survival. We would use an increase to 45% progression-free survival at 6 months as significant. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00283244)
Timeframe: Six months

Interventionmonths (Median)
Arm A (Gemcitabine)3.7
Arm B (Erlotinib)2.8
Arm C (Gemcitabine + Erlotinib)4.1

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Toxicity

Assessments for treatment toxicity will be done with each cycle according to CTCAE v3. Results listed here are grade >=3, treatment related hematologic events (all) and Grade>=3 treatment related non hematologic events that occurred in >=5% of patients in any arm. Adverse events (toxicities) are graded on a 5 point scale from 1 (mild) to 5 (lethal), with grades 3 and higher being severe or life threatening. (NCT00283244)
Timeframe: After each cycle/3 weeks, up to 3 years

,,
Interventionparticipants (Number)
Anemia (Grade>=3; treatment related)Neutropenia (Grade>=3; treatment related)Thrombocyopenia (Grade>=3; treatment related)Dehydration (Grade>=3; treatment related)Diarrhea (Grade>=3; treatment related)Dyspnea (Grade>=3; treatment related)Fatigue (Grade>=3; treatment related)Rash (Grade>=3; treatment related)
Arm A (Gemcitabine)14300241
Arm B (Erlotinib)01133012
Arm C (Gemcitabine + Erlotinib)41223353

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Overall Survival

Survival calculated from start of treatment to death from any cause for up to three years. (NCT00283244)
Timeframe: Up to 3 years

InterventionMonths (Median)
Arm A (Gemcitabine)6.8
Arm B (Erlotinib)5.8
Arm C (Gemcitabine + Erlotinib)5.6

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Response Rate in Patients With Relapsed or Refractory B- and T-cell NHL With Gemcitabine and Bortezomib Combination Treatment.

"Response rate in patients with relapsed or refractory B- and T-cell NHL with Gemcitabine and Bortezomib combination treatment will be defined as the number of patients with Complete Remission [CR] and Partial Remission [PR]. CT scans at screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8 assessed by the Response Criteria for Non-hodgkins Lymphoma will be used to determine response where:~CR=Complete disappearance of all detectable clinical and radiographic evidence of disease PR=> 50% decrease in SPD of the six largest dominant nodes or nodal masses" (NCT00290706)
Timeframe: At screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8

Interventionparticipants (Number)
Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D81
Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D152

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Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy

"Specific toxicities to be monitored pursuant to the primary endpoint include:~Any grade 5 toxicities~Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension~Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis~ECOG performance status decline by 2 or greater for >24 hours~Weight loss >10%" (NCT00305877)
Timeframe: Every 2 weeks while on treatment and for 30 days after the end of treatment

InterventionProportion of patients (Number)
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)0.30
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)0.25

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Two-year Disease-free Survival (DFS)

Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence). (NCT00305877)
Timeframe: Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years

InterventionProportion of patients (Number)
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)0.17
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)0.23

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Two-year Overall Survival Rate

Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival. (NCT00305877)
Timeframe: Assessed every 3 months for 2 years

InterventionProportion of patients (Number)
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)0.38
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)0.37

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Overall Survival Probability

Original outcome was overall survival = time from date of enrollment to date of death due to any cause. Survival time was censored at date of last contact for participants who were still alive or lost to follow-up. Because only 8 participants had documented death while on study, results are reported as 6- and 12-month overall survival probability. (NCT00316199)
Timeframe: baseline to date of death from any cause

Interventionpercent (Number)
6-Month Overall Survival Probability12-Month Overall Survival Probability
Gemcitabine + Paclitaxel9787

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Best Overall Tumor Response

"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment." (NCT00316199)
Timeframe: baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)

Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)Early Death from Malignant DiseaseDeath from ToxicityEarly Death from Other CausesUnknown
Gemcitabine + Paclitaxel2272070002

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Time to Treatment Failure

Defined as time from enrollment to the date of death due to any cause, measured disease progression, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started. (NCT00316199)
Timeframe: baseline to stopping treatment

Interventionmonths (Median)
Gemcitabine + Paclitaxel4.5

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Progression-Free Survival

Defined as the time from enrollment to the date of objective disease progression or death on study, whichever occurs first. Censoring was determined based on US-FDA 2005 draft guidance on clinical endpoints. (NCT00316199)
Timeframe: baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)

Interventionmonths (Median)
Gemcitabine + Paclitaxel7.6

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Duration of Response

Measured from the time of first documentation of complete response (CR) or partial response (PR), whichever status is first recorded, until the date of objective disease progression or death on study, whichever occurs first, with censoring defined in the same way as for progression-free survival. (NCT00316199)
Timeframe: time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)

Interventionmonths (Median)
Gemcitabine + Paclitaxel5.6

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Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy

FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), & additional concerns of breast cancer (BCS). Total FACT-B scores range from 0-144, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for FACT-B is 7-8 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up. (NCT00320541)
Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Interventionunits on a scale (Mean)
Paclitaxel Plus Bevacizumab (PB)-1.0
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)-10.8

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Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy

The TOI-B represents the total of the subscales PWB,FWB, and BCS. Total TOI-B scores range from 0 to 92, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for TOI is 5-6 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up. (NCT00320541)
Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Interventionunits on a scale (Mean)
Paclitaxel Plus Bevacizumab (PB)-2.5
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)-9.1

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Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy

The BCS subscale of FACT-B measures additional concerns of breast cancer . Total BCS scores range from 0 to 36, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for BCS is 2-3 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up. (NCT00320541)
Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Interventionunits on a scale (Mean)
Paclitaxel Plus Bevacizumab (PB)-0.1
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)-1.9

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Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy

The EWB subscale of FACT-B measures emotional well-being. Total EWB scores range from 0 to 24, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up. (NCT00320541)
Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Interventionunits on a scale (Mean)
Paclitaxel Plus Bevacizumab (PB)1.8
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)-0.2

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Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy

The FWB subscale of FACT-B measures functional well-being. Total FWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up. (NCT00320541)
Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Interventionunits on a scale (Mean)
Paclitaxel Plus Bevacizumab (PB)-0.3
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)-3.8

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Overall Response Rate (ORR)

Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population). (NCT00320541)
Timeframe: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)

Interventionproportion of responders (Mean)
Paclitaxel Plus Bevacizumab (PB)0.489
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)0.587

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Overall Survival

Overall survival was measured from date of randomization to date of death from any cause. For participants not known to have died as of data-inclusion cut-off date, overall survival duration was censored at date of last study visit prior to the data cut-off date. (NCT00320541)
Timeframe: baseline to death from any cause (up to 35 months)

Interventionmonths (Median)
Paclitaxel Plus Bevacizumab (PB)25.0
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)24.3

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Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy

The PWB subscale of FACT-B measures physical well-being. Total PWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up. (NCT00320541)
Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Interventionunits on a scale (Mean)
Paclitaxel Plus Bevacizumab (PB)-1.9
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)-4.0

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Progression-free Survival (PFS)

PFS was measured from date of randomization to first date of disease progression or death from any cause. For participants not known to have died or had disease progression as of data-inclusion cut-off date, PFS duration was censored at date of last study visit prior to data-inclusion cut-off date. (NCT00320541)
Timeframe: baseline to measured progressive disease or death up to 35 months (tumor assessments were performed every 2 cycles during study therapy; every 2 months during post-therapy until disease progression or new anticancer treatment initiated)

Interventionmonths (Median)
Paclitaxel Plus Bevacizumab (PB)8.8
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)11.3

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Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy

The SFWB subscale of FACT-B measures social/family well-being. Total SFWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up. (NCT00320541)
Timeframe: Baseline through 30 days post therapy follow-up (up to 35 months)

Interventionunits on a scale (Mean)
Paclitaxel Plus Bevacizumab (PB)0.0
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)-1.9

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Common Toxicities

The NCI Common Terminology Criteria for Adverse Events version 3.0 was used for adverse event reporting and toxicity grading. (NCT00320749)
Timeframe: Weekly up to 24 weeks

Interventionpercent of patients (Number)
leukopenianeutropeniafatigue
Capecitabine, Docetaxel, Gemcitabine292925

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Therapeutic Response

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00320749)
Timeframe: every 8 weeks, up to 24 weeks

Interventionpercent of patients (Number)
Partial ResponseComplete ResponseStable Disease
Capecitabine, Docetaxel, Gemcitabine11072

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Maximum Tolerated Dose (MTD)

MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT). (NCT00320749)
Timeframe: Weekly up to 24 weeks

Interventionmg/m^2 (Number)
docetaxelgemcitabinecapecitabine
Capecitabine, Docetaxel, Gemcitabine36750625

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Response Rate (Complete and Partial Response)

Overall response rate was evaluated every 2 cycles (six weeks) for both groups using international criteria by the Response Evaluation Criteria in Solid Tumors (RECISTv1.0) for target lesions and were assessed by CT or MRI. Response rates were defined as complete response (CR), disappearance of all target lesions; partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response(OR) defined as OR=CR + PR (NCT00323063)
Timeframe: 5 years

Interventionpercentage of participants (Number)
Arm I (Gemcitabine Hydrochloride)9.1
Arm II (Gemcitabine Hydrochloride + Imatinib)9.1

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Time to Progression

Sample size of 40 patients per group was needed to detect an 8 month increase in time to progression with the combination (80% power, alpha =.05, 2-sided). (NCT00323063)
Timeframe: 5 years

Interventionmonths (Median)
Arm I (Gemcitabine Hydrochloride)2
Arm II (Gemcitabine Hydrochloride + Imatinib)2.5

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1-year Survival

Accrual duration is 2 years with an additional year for assessment of 1-year survival. Outcome measure time frame is about 3 years. (NCT00323362)
Timeframe: 3 years

Interventionpercentage of patients (Number)
Gemcitabine Hydrochloride and Imatinib Mesylate35

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Percentage of Patients Who Meet Critieria for Response

"Response is considered Partial Response or Complete Response as per RECIST criteria.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started." (NCT00323362)
Timeframe: 2 years

Interventionpercentage of patients who responded (Number)
Gemcitabine Hydrochloride and Imatinib Mesylate0

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Time to Progression

(NCT00323362)
Timeframe: 2 years

Interventionmonths (Mean)
Gemcitabine Hydrochloride and Imatinib Mesylate2.77

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Time-to-First Event

Median time-to-first event, with events defined as disease progression, death, or toxicity requiring drug discontinuation (NCT00323869)
Timeframe: 18 months

Interventionmonths (Median)
Bevacizumab + Carboplatin + Gemcitabine6.4

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Progression-free Survival (PFS)

Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death. (NCT00323869)
Timeframe: 18 months

Interventionmonths (Median)
Bevacizumab + Carboplatin + Gemcitabine8.7

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Partial Response (PR)

Number of subjects with PR per RECIST criteria (NCT00323869)
Timeframe: 6 weeks

Interventionparticipants (Number)
Bevacizumab + Carboplatin + Gemcitabine7

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Overall Survival (OS) at 12 Months

Number of subjects surviving 1 year after treatment initiation (NCT00323869)
Timeframe: 12 months

Interventionparticipants (Number)
Bevacizumab + Carboplatin + Gemcitabine27

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Overall Survival (OS)

To evaluate the safety of the combination regimen. (NCT00323869)
Timeframe: 36 months

Interventionmonths (Median)
Bevacizumab + Carboplatin + Gemcitabine12.8

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Response Rate (CR + PR + SD)

"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, by computed tomography (CT); bone scan; positron emission tomography (PET) scan; and/or magnetic resonance imaging (MRI) as necessary to assess diseasE~Response determined as the number of subjects with any clinical response (CR + PR + SD) per RECIST criteria.~Complete Response (CR) = disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, or appearance of new cancer lesions~Stable Disease (SD): No significant effect, does not meet criteria for PR or PD." (NCT00323869)
Timeframe: 6 weeks

Interventionparticipants (Number)
Bevacizumab + Carboplatin + Gemcitabine41

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Stable Disease (SD)

Number of subjects with SD per RECIST criteria (NCT00323869)
Timeframe: 6 weeks

Interventionparticipants (Number)
Bevacizumab + Carboplatin + Gemcitabine34

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Overall Survival (OS) at 24 Months

Number of subjects surviving 2 years after treatment initiation (NCT00323869)
Timeframe: 24 months

Interventionparticipants (Number)
Bevacizumab + Carboplatin + Gemcitabine5

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Complete Response (CR)

Number of subjects with CR per RECIST criteria (NCT00323869)
Timeframe: 6 weeks

Interventionparticipants (Number)
Bevacizumab + Carboplatin + Gemcitabine0

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Overall Survival

Overall survival (OS) was defined as the time from randomization to death from any cause, and patients who were thought to be alive at the time of final analysis were censored at the last date of contact. The study failed to meet its primary endpoint. (NCT00324805)
Timeframe: From registration to death, up to 10 years

Interventionmonths (Median)
Arm I (Chemotherapy)NA
Arm II (Chemotherapy, Bevacizumab)85.8

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Disease-free Survival

Disease-free survival (DFS) was defined as the time from randomization to an event. Events include disease recurrence, new primary of lung cancer, second primaries or death, whichever occurred first; however, it should be noted that patients with new primaries at other non-lung sites should have continued followup for recurrence of the original cancer. Patients that have not had an event reported at analysis were censored at their last date of disease assessment. (NCT00324805)
Timeframe: From registration to death, up to 10 years

Interventionmonths (Median)
Arm I (Chemotherapy)42.9
Arm II (Chemotherapy, Bevacizumab)40.6

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Tumor Response Rate

Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR=≥30% size decrease of lesions. Progressive Disease (PD)=≥20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants*100. (NCT00325234)
Timeframe: Baseline up to 30 days of follow-up after 21 cycles of treatment

,
Interventionpercentage of participants (Number)
Overall ResponseComplete ResponsePartial ResponseStable DiseaseProgressive DiseaseUnknown
Gemcitabine/Vinorelbine29.53.326.234.427.98.2
Pemetrexed/Carboplatin26.60.026.635.926.610.9

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Duration of Response (DOR)

DOR-RECIST criteria of (Complete Response [CR =Disappearance of lesions] or Partial Response [PR=≥30% size decrease of lesions]) is defined as time from the date when measurement criteria are met for CR or PR until the date of first observation of progressive disease (PD) or death from study disease. For participants who die from causes other than study disease and without PD, DOR will be censored at the date of death. For participants who have not died as of the data cut-off date who are without PD, DOR was censored at last contact date. (NCT00325234)
Timeframe: Time of response to progressive disease (up to 19 months)

InterventionMonths (Median)
Pemetrexed/Carboplatin7.7
Gemcitabine/Vinorelbine7.5

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Time to Progressive Disease (PD)

Time to PD is defined as the time from the date of study enrollment to the first documented date of PD or death from study disease. For participants who die from causes other than study disease and without PD, time to PD was censored at the date of death. For participants not known to have died as of the data cut-off date and do not have PD, time to PD was censored at the last contact date. For participants who received subsequent chemotherapy (after discontinuation from the study chemotherapy) prior to disease progression, time to PD was censored at the date of subsequent chemotherapy. (NCT00325234)
Timeframe: Baseline to measured PD (up to 25.1 months)

InterventionMonths (Median)
Pemetrexed/Carboplatin5.1
Gemcitabine/Vinorelbine5.6

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Time to Response

Time to response (Complete Response(CR) or Partial Response (PR) is defined as the time from the date of study enrollment to the first date when the measurement criteria are met for complete response or partial response (whichever status is recorded first). CR=Disappearance of target lesions lesions. PR=≥30% size decrease of lesions. (NCT00325234)
Timeframe: Baseline to response (up to 7.8 months)

InterventionMonths (Median)
Pemetrexed/Carboplatin1.8
Gemcitabine/Vinorelbine1.8

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Time To Treatment Failure (TTTF)

TTTF is defined as the time from date of study enrollment to the first documented date of death, PD, or study treatment discontinuation due to adverse event (AE). For participants not known to have discontinued as of the data cut-off date, TTTF is censored at the last contact date. For participants who discontinued for reasons other than death, PD, or AE, TTTF is censored at the date of discontinuation. (NCT00325234)
Timeframe: Baseline to end of treatment (up to 21.9 months)

InterventionMonths (Median)
Pemetrexed/Carboplatin4.8
Gemcitabine/Vinorelbine5.1

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Number of Participants With Adverse Events (AE)

A listing of adverse events is presented in the Reported Adverse Event Module. (NCT00325234)
Timeframe: every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up)

,
Interventionparticipants (Number)
Adverse EventsSerious Adverse Events
Gemcitabine/Vinorelbine6622
Pemetrexed/Carboplatin6418

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Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)

"Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions." (NCT00326599)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)48
Phase II: Arm II (Gemcitabine + Carboplatin)38

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Time to Treatment Failure (Phase II Patients Only)

Time to treatment failure was defined to be the time from date of registration to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or death from any cause. (NCT00326599)
Timeframe: Up to 15 months

Interventionmonths (Median)
Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)2.48
Phase II: Arm II (Gemcitabine + Carboplatin)2.89

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Overall Survival (Phase II Patients Only)

Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up. (NCT00326599)
Timeframe: Up to 5 years

Interventionmonths (Median)
Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)12.0
Phase II: Arm II (Gemcitabine + Carboplatin)9.9

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Overall Survival at 1 Year After Randomization (Phase II Patients Only)

Overall survival was defined as the time from study enrollment to the time of death from any cause. A patient is classified as a success if alive at 1 year. (NCT00326599)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)48
Phase II: Arm II (Gemcitabine + Carboplatin)41

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Dose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)

DLT was defined as an adverse event occurring in cycle 1 only, at least possibly attributed to the study treatment and meeting the following criteria: 1) Grade 4 absolute neutrophil count (ANC) >5 days or of any duration with fever >38.5 degree Celsius; 2) Grade 4 platelet count; 3) Grade 3 or higher non-hematologic toxicities (for nausea, vomiting or diarrhea, grade 3 toxicities will be DLT if they occur despite maximal use of anti-emetic support or anti-diarrhea agents, respectively); 4) Cediranib dose interruption of >14 days for drug-related toxicities. (NCT00326599)
Timeframe: Cycle 1 (up to 3 weeks)

Interventionparticipants (Number)
Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)1

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Progression-free Survival (Phase II Patients Only)

Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression. (NCT00326599)
Timeframe: Up to 5 years

Interventionmonths (Median)
Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)6.3
Phase II: Arm II (Gemcitabine + Carboplatin)4.5

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Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)

"A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions" (NCT00326599)
Timeframe: Up to 5 years

Interventionpercentage of participants (Number)
Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)19
Phase II: Arm II (Gemcitabine + Carboplatin)20

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Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Frequency of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates improvement from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-1.5
Cetuximab + Bevacizumab-2.3

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Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Financial Concerns Question question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-0.1
Cetuximab + Bevacizumab0.9

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Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Worst Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-1.2
Cetuximab + Bevacizumab0.5

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Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Pain Right Now question (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-0.9
Cetuximab + Bevacizumab0.9

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Progression-free Survival (PFS)

Progression-free survival is the time from randomization until the date of progressive disease (PD) or death from any cause whichever is first reported. Patients who die without a reported prior progression were considered to have progresssed on the day of their death. Patients who did not progress were censored at the day of their last tumor assessment. (NCT00326911)
Timeframe: Time from randomization to disease progression or death from any cause (Range: 0 -10 months)

Interventionmonths (Median)
Cetuximab + Bevacizumab + Gemcitabine3.55
Cetuximab + Bevacizumab1.91

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Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Least Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-0.4
Cetuximab + Bevacizumab0.9

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Overall Survival (OS)

This measure is defined as the time from randomization to the date of death due to any cause. Survival of living patients or those who lost to follow-up were censored on the last date the patients were known to be alive. (NCT00326911)
Timeframe: Survival information was collected continuously every 3 months after completion of therapy and/or follow-up (range: 1-19 months).

InterventionMonths (Median)
Cetuximab + Bevacizumab + Gemcitabine5.41
Cetuximab + Bevacizumab4.17

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Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Interference question (change from baseline) to Cycle 2 Week 4 is reported. Complete interference is scored as 10 and no interference is scored as 0. A negative score indicates improvement from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-0.2
Cetuximab + Bevacizumab0.8

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Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Average Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain was 10 and no pain is 0. A negative score indicates improvement from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-0.6
Cetuximab + Bevacizumab-0.2

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Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Physical Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-0.6
Cetuximab + Bevacizumab-0.6

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Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall QoL question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-0.9
Cetuximab + Bevacizumab-0.9

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Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Severity of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-0.5
Cetuximab + Bevacizumab-0.9

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Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Spiritual Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-0.4
Cetuximab + Bevacizumab-0.3

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Percentage of Patients With Carbohydrate Antigen 19-9 (CA19-9) Response at End of Cycle 2 in Patients With Elevated Baseline Values (Equal or Greater Than 2 x Upper Limit of Normal).

CA19-9 is a tumor marker for pancreatic cancer and the level usually increases as the disease is progressing. The CA19-9 response was the percentage of patients whose CA19-9 level was declining, stable or increasing < 10% compared with baseline, divided by the total patients with elevated baseline CA19-9 in that arm. (NCT00326911)
Timeframe: First day of treatment to the end of Cycle 2, Week 1

InterventionPercentage of participants (Number)
Cetuximab + Bevacizumab + Gemcitabine8
Cetuximab + Bevacizumab9

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Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Social Activity question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-1.1
Cetuximab + Bevacizumab0.6

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Reported AEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for regulatory Activities dictionary. The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated). (NCT00326911)
Timeframe: An AE was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.

InterventionParticipants (Number)
Cetuximab + Bevacizumab + Gemcitabine29
Cetuximab + Bevacizumab29

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The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)

The best overall response is the number of patients with a best overall response of CR or PR, as classifed by the investigator according to the RECIST guidelines. A CR is the disappearance of all target lesions and a PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. (NCT00326911)
Timeframe: Tumor evaluations were performed every 8 weeks while on cetuximab therapy until PD or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.

InterventionParticipants (Number)
Cetuximab + Bevacizumab + Gemcitabine4
Cetuximab + Bevacizumab0

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Time to Progression (TTP)

Time to progression was defined as the time from randomization until the date of objectively confirmed tumor progression was first reported. The censoring rule was consistent with PFS except death. Patients who died from any cause were censored at the time of death or at last tumor assessment date if the death date was missing. For patients lost to follow-up, they were censored at the last tumor assessment date. (NCT00326911)
Timeframe: Time from randomization until the date of objective tumor progression was first reported (range: 11 -38 months)

Interventionmonths (Median)
Cetuximab + Bevacizumab + Gemcitabine4.11
Cetuximab + Bevacizumab2.07

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Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Mental Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine0.6
Cetuximab + Bevacizumab-0.8

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Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Emotional Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine-0.2
Cetuximab + Bevacizumab-1.1

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Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Support, Friends and Family question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine0.1
Cetuximab + Bevacizumab-0.8

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Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4

Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Fatigue question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline. (NCT00326911)
Timeframe: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up

InterventionScores on a scale (Mean)
Cetuximab + Bevacizumab + Gemcitabine1.5
Cetuximab + Bevacizumab0.3

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Pharmacokinetics - Maximum Plasma Concentration (Cmax)

Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1. (NCT00334802)
Timeframe: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)

Interventionnanograms per milliliter (ng/mL) (Geometric Mean)
Gemcitabine + Paclitaxcel25800
Gemcitabine25400

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Duration of Response

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. (NCT00334802)
Timeframe: time of response to progressive disease

Interventionmonths (Median)
Dose Level 24.70

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Number of Participants Alive at One Year (1-Year Survival)

(NCT00334802)
Timeframe: baseline to date of death from any cause, evaluated at 1 year

Interventionparticipants (Number)
Dose Level 15
Dose Level 245

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Pharmacokinetics - Area Under the Concentration Curve (AUC)

Area under the concentration curve from time zero to infinity. (NCT00334802)
Timeframe: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)

Interventionnanograms*hour per milliliter (ng*hr/mL) (Geometric Mean)
Gemcitabine + Paclitaxcel16300
Gemcitabine14700

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Pharmacokinetics - Half Life (t½)

Apparent elimination half-life. (NCT00334802)
Timeframe: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)

Interventionhours (Geometric Mean)
Gemcitabine + Paclitaxcel0.282
Gemcitabine0.258

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Time to Progressive Disease

Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. (NCT00334802)
Timeframe: baseline to measured progressive disease

Interventiondays (Median)
Dose Level 1310.5
Dose Level 2194.0

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Tumor Response

"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Responders are patients with complete response or partial response." (NCT00334802)
Timeframe: baseline to measured progressive disease

,
Interventionparticipants (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseNot Evaluable
Dose Level 103111
Dose Level 202517113

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Recurrence Free Survival (RFS)

The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death. (NCT00336700)
Timeframe: Up to 60 months

Interventionmonths (Median)
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)14

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KRAS Mutational Status

KRAS mutation status in resected tumor specimens. (NCT00336700)
Timeframe: Up to 60 months

Interventionpercentage of participants (Number)
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)92

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2-year Recurrence Free Survival (RFS)

(NCT00336700)
Timeframe: Up to 60 months

Interventionpercentage of participants (Number)
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)26

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Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)

Percentage of participants with expression of epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC). (NCT00336700)
Timeframe: Up to 60 months

Interventionpercentage of participants (Number)
EGFR FISH - NegativeEGFR FISH - PositiveEGFR IHC - 1+ (incomplete circumferential)2+ (complete circumferential)3+ (complete strong circumferential)
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)8020223543

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Estimated 1&2 Year Overall Survival (OS)

Time from from date of first study therapy to to death from any cause. (NCT00336700)
Timeframe: Up to 60 months

Interventionpercentage of participants (Number)
Estimated 1-year OSEstimated 2-year OS
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)8453

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1-year Recurrence Free Survival (RFS)

(NCT00336700)
Timeframe: Up to 60 months

Interventionpercentage of participants (Number)
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)56

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sCD30 Levels

A 2-sided t-test with alpha = 0.05 will be used to compare sCD30 levels between responders (OR) and non-responders groups. (NCT00337194)
Timeframe: Up to day 21 of course 6

InterventionU/ml (Median)
Responders174.2
Non-responders76.5

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Event Free Survival (EFS)

Event free survival is the time from trial entry until progression, death, or termination of treatment due to nonresponse. Patients who went on to receive a stem cell transplant (SCT) were not censored from the EFS survival at the time of transplant and were only considered failures at the time of relapse or death from any cause. The median EFS with 95% confidence interval (CI) was estimated using the Kaplan Meier method. (NCT00337194)
Timeframe: Up to 10 years

Interventionmonths (Median)
Arm I (SGN-30, Chemotherapy)11.3
Arm II (Placebo, Chemotherapy)4.1

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Number of Participants With Overall Response (OR)

The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): >= 50% reduction in sum of the product of diameters of indicator lesions. (NCT00337194)
Timeframe: Up to 10 years

Interventionparticipants (Number)
Arm I (SGN-30, Chemotherapy)15
Arm II (Placebo, Chemotherapy)4

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Overall Survival (OS) At 1 Year

Percentage of patients who were alive at 1 year. The 1-year survival rate was estimated using the Kaplan Meier method. (NCT00337194)
Timeframe: 1 year

Interventionpercentage of participants (Median)
Arm I (SGN-30, Chemotherapy)86
Arm II (Placebo, Chemotherapy)30

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Peak Serum Level of Monoclonal Antibody SGN-30

Record the highest serum level of monoclonal antibody SGN-30 achieved. (NCT00337194)
Timeframe: Up to day 21 of course 6

Interventionmg/ml (Median)
Arm I (SGN-30, Chemotherapy)339

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Fc Gamma Receptor Polymorphisms

Fisher's exact test with 2-sided alpha = 0.05 will be used to compare the response probabilities in patients with V/V (valine expression), V/F (heterozygous), and F/F (homozygous for phenylalanine) for each of Fc gamma RIIIa a (NCT00337194)
Timeframe: Baseline

,
Interventionparticipants (Number)
V/VF/FF/V
Non-responders065
Responders0107

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Overall Survival Rate

1-year, 2-year, and 4-year actuarial overall survival (OS) rates defined as number of participants out of total participants alive at 1, 2 or 4 years post baseline treatment. (NCT00338039)
Timeframe: 1 to 4 years

Interventionpercentage of participants (Number)
1-year OS Rate2-year OS Rate4-year OS Rate
Chemotherapy + Chemoradation66.025.0211.3

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Median Overall Survival

Median survival is defined as the time of initiation of the first dose of chemotherapy to the date of death. (NCT00338039)
Timeframe: Baseline to disease progression or death, up to 4 years

InterventionMonths (Median)
Chemotherapy + Chemoradation19.2

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Rate of Local Control

"The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site.~Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression." (NCT00350142)
Timeframe: up to 3 years

Interventionparticipants (Number)
Stereotactic Radiosurgery15

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Median Overall Survival Time

The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves. (NCT00350142)
Timeframe: up to 3 years

Interventionmonths (Median)
Stereotactic Body Radiotherapy11.8

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Overall Survival

Overall survival is the number of participants who were alive when the trial was terminated. (NCT00356525)
Timeframe: baseline to trial termination (17.5 months)

Interventionparticipants alive (Number)
Less Than One Year: Pemetrexed6
Less Than One Year: Pemetrexed + Gemcitabine4
One Year or Greater: Pemetrexed + Carboplatin6
One Year or Greater: Pemetrexed + Gemcitabine7

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Objective Tumor Response

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. (NCT00356525)
Timeframe: baseline to time of response (up to 17.5 months)

,,,
Interventionparticipants (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseUnknown
Less Than One Year: Pemetrexed07322
Less Than One Year: Pemetrexed + Gemcitabine00920
One Year or Greater: Pemetrexed + Carboplatin02500
One Year or Greater: Pemetrexed + Gemcitabine01611

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Overall Response Rate

To assess the overall response rate of GEMOX-B in patients with advanced BTC. Response rate is determined through Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00361231)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Bevacizumab, Gemcitabine, Oxaliplatin0

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Median Progression Free Survival

To assess the median progression free survival in patients with BTC on GEMOX-B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition, death in the absence of radiological disease progression was also categorized as progression. (NCT00361231)
Timeframe: 2 years

Interventionmonths (Median)
Bevacizumab, Gemcitabine, Oxaliplatin7.0

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Time to Tumor Progression

"Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions." (NCT00366457)
Timeframe: all patients will be followed for a minimum of 4 months

Interventionmonths (Median)
Gemcitabine, Bevacizumab and Erlotinib3.5

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Toxicity Profile

Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening (NCT00366457)
Timeframe: during and after first 28-day cycle of treatment

InterventionParticipants (Count of Participants)
NeutrophilsALT-SGPTFatigueLeukocytesRash: acne/acneiformThrombosis/thrombus/embolismAnorexiaAST - SGOTHemoglobinLymphopeniaNonneuropathic generalized weaknessUpper GI-hemorrhage NOSVascular access-Thrombosis/embolismVessel injury - artery - Other NOSWeight loss
Gemcitabine, Bevacizumab and Erlotinib432222111111111

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Overall Survival

overall survival (OS) = time from study entry until death from any cause (NCT00366457)
Timeframe: 5 years

Interventionmonths (Median)
Gemcitabine, Bevacizumab and Erlotinib6.7

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Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort.

"Only dose limiting toxicities (DLT) were collected. DLTs were graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~The occurrence of any of the following toxicities during the first treatment cycle constitutes DLT in this study:~Grade 3 and/or 4 non-hematologic toxicity other than grade 3 nausea or vomiting.~Grade 3 and/or 4 unexpected non-hematologic toxicities. Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and fever during first cycle. Grade 4 neutropenia on Day 1 of 2nd treatment cycle despite growth factor support or grade 4 thrombocytopenia on Day 1 of 2nd treatment cycle." (NCT00369629)
Timeframe: From the day that the first treatment is given through the first 28 day period for each patient.

,,
InterventionDLT (Number)
Perforated sigmoid diverticulitisFebrile neutropenia
Cohort 110
Cohort 200
Cohort 301

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Time to Treatment Failure

Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions. (NCT00376948)
Timeframe: Every 8 weeks

Interventionmonths (Median)
Novasoy®, Gemcitabine & Erlotinib2.04

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Time to Progression

Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions. (NCT00376948)
Timeframe: Every 8 weeks

Interventionmoths (Median)
Novasoy®, Gemcitabine & Erlotinib2.07

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Response Duration

Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions. Partial response is defined as greater than or equal to 30% reduction in the sum of the longest diameteres of target lesions, taking as reference the baseline sum of the longest diameters. (NCT00376948)
Timeframe: Every 8 weeks

Interventiondays (Number)
Novasoy®, Gemcitabine & Erlotinib73

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Patients Alive

(NCT00376948)
Timeframe: at 6 months

Interventionparticipants (Number)
Novasoy®, Gemcitabine & Erlotinib10

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Overall Objective Response Rate (Complete and Partial Response)

Imaging tests (CT scan, CXR [Chest X-Ray], MRI or imaging studies as clinically indicated (NCT00376948)
Timeframe: Every 8 weeks

Interventionproportion of patients (Number)
Novasoy®, Gemcitabine & Erlotinib0.056

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Median Overall Survival Estimate

(NCT00376948)
Timeframe: up to 17 months

Interventionmonths (Median)
Novasoy®, Gemcitabine & Erlotinib6.3

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Grade 3 or Higher Toxicity Evaluation

Toxicity evaluation using NCI-CTC (Common Terminology Criteria) v.3 criteria; CBC (complete blood count) with differential white cell and platelet counts; Serum sodium, potassium, chloride, bicarbonate, AST, ALT, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, and albumin; Serum CA 19-9 (NCT00376948)
Timeframe: First day of each cycle

InterventionParticipants (Count of Participants)
diarrheafatigueinfectionnauseaneutrophilpainplateletstomach mucostisvomitingwbcother toxicity
Novasoy®, Gemcitabine & Erlotinib35174511424

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Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST)

"Complete response is defined as disappearance of all target and nontarget lesions identified and reported at baseline (at or within 4 weeks before the beginning of treatment) by image-based evaluations such as computerized tomography (CT) or magnetic resonance imaging (MRI).~Partial response is defined as persistence of one or more nontarget lesions and at least 30 percent decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters." (NCT00378573)
Timeframe: 1 year from start of treatment

InterventionParticipants (Number)
Complete ResponseConfirmed Partial ResponseUnconfirmed Partial ResponseStable DiseaseProgressive DiseaseNot Evaluable
Docetaxel, Gemcitabine and Bevacizumab061271

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Number of Participants With a Dose-limiting Toxicity (DLT)

"Toxicities were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), V 3.0. A DLT was one of the following, if considered at least possibly related to study treatment:~Grade 4 neutropenia for ≥5 days or febrile neutropenia; Grade 4 thrombocytopenia or need for a platelet transfusion; ≥ Grade 3 nausea and/or emesis despite using optimal antiemetic therapy; ≥ Grade 3 diarrhea despite using maximal supportive therapy; Any clinically significant Grade 3 or 4 nonhematologic toxicity; Inability to administer all doses in cycle 1." (NCT00379639)
Timeframe: 28 days

Interventionparticipants (Number)
Dose Level 13
Dose Level 21
Dose Level 50
Dose Level 62
Dose Level 80

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Best Overall Response

"Disease response was determined by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria using computed tomography or magnetic resonance imaging:~Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of ≥1 new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD." (NCT00379639)
Timeframe: Disease assessments were performed within 4 weeks of first dose and every 8 weeks thereafter (up to 236 days).

,,,,
Interventionparticipants (Number)
Complete ResponsePartial ResponseStable diseaseProgressive disease
Dose Level 10051
Dose Level 20142
Dose Level 50034
Dose Level 60013
Dose Level 80111

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Number of Participants With Adverse Events (AEs)

"AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.~A serious AE is associated with events that pose a threat to a patient's life or functioning, require hospitalization, is a congenital anomaly/birth defect or is an important medical event or condition that may jeopardize the patient and may require medical or surgical intervention to prevent one of the above outcomes." (NCT00379639)
Timeframe: From the date of first dose to 30 days after last dose (up to 236 days).

,,,,
Interventionparticipants (Number)
Any adverse event≥Grade 3 adverse eventGrade 4 adverse eventSerious adverse eventAdverse event leading to discontinuationAdverse event leading to death
Dose Level 1771300
Dose Level 2752200
Dose Level 51053410
Dose Level 6642100
Dose Level 8631211

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Tumor Response

"Response Evaluation Criteria In Solid Tumors - define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria." (NCT00380588)
Timeframe: baseline to measured progressive disease (up to 2 years)

,
Interventionparticipants (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseNot Evaluable
Gemcitabine0516174
Gemcitabine + Cisplatin082094

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Progression Free Survival

The period from study entry until disease progression, death or date of last contact. (NCT00380588)
Timeframe: baseline to measured progressive disease (up to 2 years)

Interventionmonths (Median)
Gemcitabine + Cisplatin5.8
Gemcitabine3.7

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Percentage of Patients Alive at 1 Year (1-Year Survival Rate)

Percentage of patients alive at 1 year. (NCT00380588)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Gemcitabine + Cisplatin39
Gemcitabine31

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Survival Time

Data of patients lost to follow-up were censored at the last date of confirmation of their survival. (NCT00380588)
Timeframe: baseline to date of death due to any cause (up to 2 years)

Interventionmonths (Median)
Gemcitabine + Cisplatin11.2
Gemcitabine7.7

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Overall Survival

Survival time is defined as the time from date of randomization to death due to any cause. (NCT00383331)
Timeframe: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

Interventionmonths (Median)
21-Day Cycle5.1
14-Day Cycle8.1

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Best Overall Tumor Response

"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment." (NCT00383331)
Timeframe: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

,
Interventionparticipants (Number)
Complete ResponsePartial Response
14-Day Cycle00
21-Day Cycle02

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Progression Free Survival

baseline to measured progressive disease (NCT00383331)
Timeframe: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

Interventionmonths (Median)
21-Day Cycle1.66
14-Day Cycle5.04

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Overall Objective Response Rate (CR + PR)

Objective response (OR) defined as percentage of participants with RECIST Complete Response (CR) and Partial Response (PR), defined as CR: Disappearance all target and non-target lesions, no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125, if elevated at baseline, is required; PR: 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD, no unequivocal progression of non-target lesions; no new lesions documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical examination, which is not radiographically measurable, a 50% decrease in the LD is required. 21-day cycle assessments or until either disease progression or adverse effects prohibit further treatment. (NCT00388154)
Timeframe: Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.

Interventionpercentage of participants (Number)
Gemcitabine + Cisplatin50

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Participant Responses

Response Evaluation Criteria In Solid Tumors (RECIST): Complete Response (CR): disappearance all target & nontarget lesions, absence new lesions, documented by 2 disease assessments 4 weeks apart; Partial response (PR): 30% decrease in sum longest diameter (LD) all measurable target lesions (baseline sum LDs as reference) & absence of progression of nontarget lesions or development of new, documented by 2 disease assessments 4 weeks apart. When only target lesion solitary pelvic mass measurable by physical examination but not radiography, a 50% decrease in LD required to be PR; Progressive disease (PD): 20% increase in sum LDs of target lesions (reference smallest sum of LDs at any assessment) or appearance of new lesions within 9 weeks of study entry, and unequivocal progression of existing nontarget lesions, other than pleural effusions without cytological proof of neoplastic origin within 9 weeks of enrollment; Stable disease (SD): any condition not meeting above CR, PR, or PD. (NCT00388154)
Timeframe: Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.

Interventionparticipants (Number)
CRPRPDSD
Gemcitabine + Cisplatin2846

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Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity

Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events. (NCT00388349)
Timeframe: 6 months

Interventionparticipants (Number)
1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue0
1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue3

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Relapse Post-transplant

Reports the percentage of participants that experienced relapse post-transplant. (NCT00388349)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Gemcitabine + High-dose Chemotherapy + PBSC Rescue29

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Pulmonary Toxicity (BCNU Pneumonitis)

Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU). (NCT00388349)
Timeframe: 2 years

Interventionparticipants (Number)
Gemcitabine + High-dose Chemotherapy + PBSC Rescue26

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Overall Survival (OS)

Reports the percentage of participants surviving 6 months after PBSC infusion (transplant). (NCT00388349)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Gemcitabine + High-dose Chemotherapy + PBSC Rescue87

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Survival Measures

"Reports the survival measures:~Freedom from progression (FFP)~Event-free survival (EFS)~Overall survival (OS)~EFS and OS were estimated by Kaplan-Meier method~Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions" (NCT00388349)
Timeframe: 2 years

Interventionpercentage of patients (Number)
Freedom from Progression (FFP)Event-Free Survival (EFS)Overall Survival (OS)
1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue716783

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Percentage of Participants With Distant Mestastases - Liver

Patients with distant mestastases to the liver (NCT00390182)
Timeframe: Participants were followed for an average of 8 years

Interventionpercentage of participants (Number)
Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine63

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Overall Response

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00390182)
Timeframe: 3 weeks

Interventionparticipants (Number)
Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine3

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Time of Advanced/Recurrent Disease Without Distant Metastases.

Locally advanced/recurrent disease without distant metastases. (NCT00390182)
Timeframe: Participants were followed for an average of 8 years

Interventionmonths (Median)
Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine7.5

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Toxicity Profile

Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment. (NCT00391586)
Timeframe: 28 days after last on-study treatment

Interventionparticipants (Number)
AcneAnorexiaConfusionDehydrationDiarrheaDyspneaFatigueNasal hemorrhageInsomniaKidney painLymphocyte count decreasedMuscle weaknessNeutrophil count decreasedDesquamating rashSyncopeThrombosis (clotting)
Erlotinib Followed by Chemotherapy1111238111112111

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Time to Progression

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00394147)
Timeframe: 1 year

Interventionmonths (Median)
Pemetrexed and Gemcitabine5.9

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Objective Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00394147)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Pemetrexed and Gemcitabine2

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Overall Survival

(NCT00394147)
Timeframe: 1 year

Interventionmonths (Median)
Pemetrexed and Gemcitabine5.9

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Maximal Degree of Anemia

The maximal degree of anemia (and myelosuppression) was assessed by the overall (any time after first dose of study drug) nadir of hemoglobin levels based on clinical laboratory measurements. (NCT00398086)
Timeframe: During the treatment phase, up to a maximum of 24 months.

Interventiong/L (Mean)
100 mg/m^295.1
125 mg/m^291.8
150 mg/m^295.3

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Number of Participants With Adverse Events (AE)

"An AE was any untoward medical occurrence, not necessarily having a causal relationship with the patient's treatment, that began or worsened in grade after the start of study drug through 30 days after the last dose.~A serious AE (SAE) is any untoward medical occurrence that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.~Treatment-related AEs (TRAEs) include those assessed by the Investigator as possibly, probably, or definitely related to study treatment.~Severity was graded according to the NCI CTCAE based on the following: Grade 1- Mild; Grade 2 -Moderate; Grade 3 - Severe; Grade 4 - Life-threatening or disabling; Grade 5 - Death related to AE." (NCT00398086)
Timeframe: Up to 25 months

,,
Interventionparticipants (Number)
Patients with at least 1 AEAt least 1 grade 3 or higher AEAt least 1 treatment-related AEAt least 1 treatment-related grade 3 to 5 AEPatients with at least 1 SAEPatients with at least 1 treatment-related SAEAt least 1 AE and drug permanently discontinuedAt least 1 TRAE and drug permanently discontinuedAt least 1 dose reduction due to TRAEAt least 1 dose interruption due to AEAt least 1 treatment-related AE dose interruptionAt least 1 treatment-emergent dose delay due to AEAt least 1 treatment-related dose delay due to AEAt least 1 AE resulting in death
100 mg/m^2201518111043241114130
125 mg/m^2444242382412128100027271
150 mg/m^233331122100331

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Maximal Degree of Myelosuppression

The maximal degree of myelosuppression was assessed by the overall nadir of absolute neutrophil count (ANC), white blood cell count and platelet count based on clinical laboratory measurements. (NCT00398086)
Timeframe: During the treatment phase, up to a maximum of 24 months.

,,
Interventionx10^9/L (Mean)
Absolute neutrophil countWhite blood cell countPlatelet count
100 mg/m^21.382.69120.3
125 mg/m^20.962.1888.3
150 mg/m^20.471.5258.7

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Progression-free Survival

"Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first, assessed by an Independent Radiological Reviewer. Participants who do not have disease progression or have not died were censored at the last known time that the participant was progression free. Progression-free survival was summarized using Kaplan-Meier methods.~Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion." (NCT00398086)
Timeframe: Up to approximately 4 years

Interventionmonths (Median)
100 mg/m^26.1
125 mg/m^26.9
150 mg/m^21.6

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Percentage of Participants With Disease Control

"Disease control is defined as participants with Stable Disease for at least 16 weeks, or confirmed complete or partial overall response, based on RECIST guidelines and assessed by an Independent Radiological Reviewer.~Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease, and no new non-target lesions or unequivocal progression of existing non-target lesions. Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion." (NCT00398086)
Timeframe: Up to approximately 4 years

Interventionpercentage of participants (Number)
100 mg/m^255
125 mg/m^255
150 mg/m^233

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Percentage of Participants Who Achieved an Objective Confirmed Overall Response

"Overall Response is defined as the percent of participants who achieve an objective confirmed complete (CR) or partial response (PR). Response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, assessed by an Independent Radiological Reviewer.~CR: The disappearance of all known disease and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers.~PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation and no new non-target lesions and/or unequivocal progression of existing non-target lesions. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing." (NCT00398086)
Timeframe: Up to approximately 4 years

Interventionpercentage of participants (Number)
100 mg/m^225
125 mg/m^239
150 mg/m^20

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Overall Survival

Overall survival was defined as the time from the date of first dose of study drug to the date of patient death from all causes. Participants who did not die were censored at the last known time the patient was alive. Patient survival was summarized using Kaplan-Meier methods. (NCT00398086)
Timeframe: Up to approximately 4 years

Interventionmonths (Median)
100 mg/m^29.3
125 mg/m^212.2
150 mg/m^26.1

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Number of Participants With Dose-limiting Toxicities

"A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3:~Grade 4 neutropenia lasting >3 days in the absence of growth factor support;~Grade 4 neutropenia associated with fever >38.5°C;~Any other Grade 4 hematological toxicity;~Grade 3 thrombocytopenia with hemorrhage;~Grade 3 or 4 nausea, vomiting or diarrhea despite prophylaxis or treatment with an optimal anti-emetic or anti-diarrhea regimen;~Any other Grade 3 or higher non-hematological toxicity attributable to the study drug, excluding alopecia and fatigue." (NCT00398086)
Timeframe: Cycle 1 (Days 1-28)

Interventionparticipants (Number)
100 mg/m^24
125 mg/m^20
150 mg/m^21

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Duration of Response

Duration of response was assessed by progression-free survival for participants who achieved a confirmed Complete Response or Partial Response, assessed by an Independent Radiological Reviewer. (NCT00398086)
Timeframe: Up to approximately 4 years

Interventionmonths (Median)
100 mg/m^2NA
125 mg/m^27.3

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Best Overall Response by Cycle

Number of patients and their best response recorded from the state of treatment until disease progression. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response-disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria. (NCT00400803)
Timeframe: After Cycle 4, Cycle 6 and Cycle 7 of Therapy

,,,
InterventionParticipants (Number)
Cycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Cycle 7
Intent To Treat - Lung Cancer Patients11324024
Partial Response00015022
Progressive Disease1113000
Stable Disease0026002

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Overall Survival Time

Overall survival is defined as the time from the start of treatment until death due to whatever cause. For subjects alive at study completion, time to death will be censored at the time of last contact. (NCT00400803)
Timeframe: Baseline to Death

InterventionMonths (Mean)
Intent To Treat - Lung Cancer Patients14.3

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Time to Best Response

Time to best response is defined as the time from the start of treatment until first documented evidence of tumor response (30% decrease or complete disappearance of tumor). For subjects who do not show a tumor response, the time will be censored at the time of last contact. (NCT00400803)
Timeframe: From Enrollment to First Tumor Response

InterventionDays (Median)
Intent To Treat - Lung Cancer Patients72

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Time to Progression

Time to progression (progression free survival)is defined as the time from the start of treatment until first documented sign of disease progression or death due to any cause. For subjects who do not progress, time to progression will be censored at the time of last tumor assessment. (NCT00400803)
Timeframe: From Enrollment Through 2 Years

InterventionMonths (Mean)
Intent To Treat - Lung Cancer Patients3.1

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Duration of Response

For subjects who show a response, duration of response is defined to be the time from first documented evidence of response(30% decrease or complete disappearance of tumor) until the first documented sign of disease progression or death due to any cause. For subjects who do not progress or die, duration of response will be censored at the time of last tumor assessment. (NCT00400803)
Timeframe: From Enrollment through Date of First Documented Disease Progression or Date of Death From Any Cause, Whichever Came First, Up to 100 Months

InterventionDays (Median)
Intent To Treat - Lung Cancer Patients105

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Overall Survival (OS), Confirmed

Overall Survival (OS) as determined by confirmed date of death. Participants without documentation as either alive or deceased as of 6 years from the start of treatment were considered lost-to-follow-up. (NCT00403130)
Timeframe: 6 years

Interventionmonths (Median)
Bevacizumab + Gemcitabine + Paclitaxel33.7

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Response Rates

"The best overall response was recorded for each participant from randomization until disease progression/recurrence, using any increase from the smallest measurements recorded since randomization as the indicator of Progressive Disease (PD).~Overall response was determined on the basis of response at the target and non-target lesions, and the appearance of new lesions, as follows.~Target Nontarget New Lesions Overall Response~Complete Complete None Overall Complete Response~Complete Incomplete response/ None Overall Partial Response Stable Disease (SD)~Partial Not PD None Overall Partial Response~SD Not PD None Overall Stable Disease~PD Any Yes/No Overall PD~Any PD Yes/No Overall PD~Any Any Yes Overall PD~Overall Response Rate (ORR) was assessed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate." (NCT00403130)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)Overall Response Rate (ORR)
Bevacizumab + Gemcitabine + Paclitaxel14175

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Overall Survival (OS), All Participants

Overall Survival (OS), based on date of death or last known date alive (NCT00403130)
Timeframe: 6 years

Interventionmonths (Median)
Bevacizumab + Gemcitabine + Paclitaxel14.8

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Time-to-Progression (TTP)

Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans and assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for progressive disease (ie, a 5-mm absolute increase of the sum of the longest diameters of the target lesions in addition to a 20% increase in the sum of the target lesions) (NCT00403130)
Timeframe: 2 years

Interventionmonths (Median)
Bevacizumab + Gemcitabine + Paclitaxel8.9

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Progression-free Survival

Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation. (NCT00407550)
Timeframe: Time from registration to progression or death (up to 2 years)

Interventionmonths (Median)
Gemzar x21.66
Gemzar x15.04

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Overall Survival

Overall survival time was defined as the number of months from registration to the date of death or last follow-up (NCT00407550)
Timeframe: Death or last follow-up (up to 2 years)

Interventionmonths (Median)
Gemzar x25.1
Gemzar x18.1

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Number of Patients With Confirmed Responses

"Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.~>~> Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions." (NCT00407550)
Timeframe: Two consecutive evaluations at least 6 weeks apart (up to 2 years)

Interventionparticipants (Number)
Gemzar x22
Gemzar x10

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Adverse Event

Number of patients that experienced adverse events (grade 4 or more) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0 (NCT00407550)
Timeframe: Gemzar x2 Arm every 21 days, Gemzar x1 Arm every 14 days (up to 2 years)

InterventionParticipants (Count of Participants)
Gemzar x26
Gemzar x14

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Disease-free Survival (DFS)

Percentage of patients free from local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer after 5 years. (NCT00408408)
Timeframe: Measured through 5 years after study enrollment

Interventionpercentage of patients (Number)
Arm 1A: Docetaxel Then AC73.4
Arm 1B Docetaxel + Bev Then AC + Bev72.2
Arm 2A: Docetaxel + Capecitabine Then AC68.5
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev77.1
Arm 3A: Docetaxel + Gem Then AC72.9
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev74.8

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Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens

The percentage of patients assessed by physical exam as Clinical Complete Response according to RECIST. (NCT00408408)
Timeframe: Three to four weeks after the last chemotherapy dose, on average at 6 or 13 months

Interventionpercentage of patients (Number)
Arm 1A: Docetaxel Then AC52.3
Arm 1B Docetaxel + Bev Then AC + Bev64.6
Arm 2A: Docetaxel + Capecitabine Then AC51.3
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev59.1
Arm 3A: Docetaxel + Gem Then AC52.6
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev60

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Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy

Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST. (NCT00408408)
Timeframe: Assessed at cycle 5 of chemotherapy, on average at 15 weeks

Interventionpercentage of patients (Number)
Arm 1A: Docetaxel Then AC30
Arm 1B Docetaxel + Bev Then AC + Bev43.3
Arm 2A: Docetaxel + Capecitabine Then AC29.8
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev34.5
Arm 3A: Docetaxel + Gem Then AC37.9
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev42

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Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy

Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST. (NCT00408408)
Timeframe: Assessed at cycle 5 of chemotherapy, on average at 15 weeks

Interventionpercentage of patients (Number)
Arm 1A: Docetaxel Then AC77
Arm 1B Docetaxel + Bev Then AC + Bev87.6
Arm 2A: Docetaxel + Capecitabine Then AC73.7
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev84
Arm 3A: Docetaxel + Gem Then AC82.6
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev88

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Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens

The percentage of patients assessed by physical exam as Clinical Complete Response or Clinical Partial Response according to RECIST. (NCT00408408)
Timeframe: Three to four weeks after the last chemotherapy dose on average 6 or 13 months

Interventionpercentage of patients (Number)
Arm 1A: Docetaxel Then AC79.9
Arm 1B Docetaxel + Bev Then AC + Bev87.7
Arm 2A: Docetaxel + Capecitabine Then AC75.4
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev90.7
Arm 3A: Docetaxel + Gem Then AC83.3
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev80.5

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Pathologic Complete Response (pCR) of the Primary Tumor in the Breast

Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen. (NCT00408408)
Timeframe: Time of surgery, on average 6 or 13 months

Interventionpercentage of patients (Number)
Arm 1A: Docetaxel Then AC33.7
Arm 1B Docetaxel + Bev Then AC + Bev31.6
Arm 2A: Docetaxel + Capecitabine Then AC23.5
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev36.1
Arm 3A: Docetaxel + Gem Then AC27.6
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev35.8

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pCR in the Breast and Nodes

Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes. (NCT00408408)
Timeframe: Time of surgery, on average 6 or 13 months

Interventionpercentage of patients (Number)
Arm 1A: Docetaxel Then AC27.3
Arm 1B Docetaxel + Bev Then AC + Bev24.4
Arm 2A: Docetaxel + Capecitabine Then AC18.7
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev27.4
Arm 3A: Docetaxel + Gem Then AC22.9
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev30.3

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Surgical Complication

Number of patients with Grade 4 or above surgery-related toxicities (NCT00408408)
Timeframe: 24 months after study entry

Interventionparticipants (Number)
Arm 1A: Docetaxel Then AC1
Arm 1B Docetaxel + Bev Then AC + Bev1
Arm 2A: Docetaxel + Capecitabine Then AC0
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev1
Arm 3A: Docetaxel + Gem Then AC0
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev1

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Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone

The number of patients who experienced Grade 1 or above Adverse Events. Referring to the Adverse Events tables for specifics. (NCT00408408)
Timeframe: 24 months after study entry

Interventionparticipants (Number)
Arm 1A: Docetaxel Then AC180
Arm 1B Docetaxel + Bev Then AC + Bev157
Arm 2A: Docetaxel + Capecitabine Then AC172
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev185
Arm 3A: Docetaxel + Gem Then AC158
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev185

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Overall Survival

(NCT00408564)
Timeframe: up to 46 weeks after the start of study treatment

Interventionpercentage of participants (Number)
Gemcitabine,Oxaliplatin and Cetuximab49

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Progression-free Survival at 6 Months

(NCT00408564)
Timeframe: up to 46 weeks after the start of study treatment

Interventionpercentage of participants (Number)
Gemcitabine,Oxaliplatin and Cetuximab82

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Response Rate

defined as the total number of subjects whose best response is PR or CR. (NCT00408564)
Timeframe: up to 46 weeks after the start of study treatment

InterventionParticipants (Count of Participants)
Gemcitabine,Oxaliplatin and Cetuximab5

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Number of Participants With Grade 3-4 Adverse Events Reported

(NCT00408564)
Timeframe: from start of study treatment until end of study visit, about 30 weeks

Interventionparticipants (Number)
Gemcitabine,Oxaliplatin and Cetuximab9

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Number of Participants With Platelet Transfusions

Number of participants who were administered platelet transfusions during first on study treatment cycle. (NCT00413283)
Timeframe: 3 weeks

InterventionParticipants (Number)
Placebo1
Romiplostim 250 µg4
Romiplostim 500 µg1
Romiplostim 750 µg1

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Number of Participants With Adverse Events

This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study. (NCT00413283)
Timeframe: 4 months

InterventionParticipants (Number)
Placebo12
Romiplostim 250 µg16
Romiplostim 500 µg18
Romiplostim 750 µg14

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Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.

The number of participants in each treatment group with grade 3 or 4 thrombocytopenia during the first on study treatment cycle. Per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0, participants with a platelet count < 50 x 10^9/L, but ≥ 25 x 10^9/L are considered to have Grade 3 thrombocytopenia and participants with a platelet count < 25 x 10^9/L are considered to have Grade 4 thrombocytopenia. Additionally, participants with a platelet transfusion during the first on-study treatment cycle were classified as having Grade 3/4 thrombocytopenia. (NCT00413283)
Timeframe: 3 weeks

InterventionParticipants (Number)
Placebo5
Romiplostim 250 µg7
Romiplostim 500 µg7
Romiplostim 750 µg7

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Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle

Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle. (NCT00413283)
Timeframe: 8 days

InterventionParticipants (Number)
Placebo2
Romiplostim 250 µg4
Romiplostim 500 µg4
Romiplostim 750 µg5

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Platelet Count on Day 22

Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group (NCT00413283)
Timeframe: Day 22

Intervention10^9/L (Mean)
Placebo281.2
Romiplostim 250 µg222.6
Romiplostim 500 µg412.8
Romiplostim 750 µg336.0

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Duration of Grade 3 or 4 Thrombocytopenia

The duration of grade 3 or 4 thrombocytopenia (defined as platelet count <50 x 10^9/L) experienced during the first on study chemotherapy cycle by treatment group. (NCT00413283)
Timeframe: 3 weeks

Interventiondays (Mean)
Placebo2.1
Romiplostim 250 µg3.6
Romiplostim 500 µg2.6
Romiplostim 750 µg2.1

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Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy

(NCT00417976)
Timeframe: 6 months

Interventionpercent of patients (Number)
Bevacizumab49

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Response Rates Defined by RECIST 1.0

The National Cancer Institutes Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 was used in accessing response for patients (NCT00417976)
Timeframe: 6 months

Interventionpatients (Number)
Complete RespsonsePartial ResponseStable DiseaseProgressive Disease
Bevacizumab0121810

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Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.

The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported (NCT00418093)
Timeframe: Toxicities were assessed every cycle and for up to 30 days after being removed from the trial

Interventionpercentage of participants (Number)
Chemotherapy Group94.7

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Overall Survival

Duration of time participants are alive after enrolling on the study. Assessed by clinical records (NCT00418093)
Timeframe: Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months

Interventionweeks (Median)
Chemotherapy Group112.3

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Progression Free Survival

Time participant remains free of progression of her disease. Evaluated by RECIST criteria (NCT00418093)
Timeframe: Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months

Interventionweeks (Median)
Chemotherapy Group36.9

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Partial Response Rate

Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria (NCT00418093)
Timeframe: Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)

Interventionpercentage of patients on study (Number)
Chemotherapy Group68.4

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Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin

DLT = any Common Terminology Criteria for Adverse Events Grade 3/4 drug related non-hematologic toxicity EXCEPT Grade 3 nausea/vomiting responsive to therapy, Grade 3 Fatigue responsive to management, transient electrolyte disorders that were corrected, any Grade 4 drug related hematologic toxicity EXCEPT lymphopenia/neutropenia, unless the neutropenia was febrile and/or was an infection requiring treatment, OR Any Grade 4 neutropenia lasting >=7 days, failure of absolute neutrophil count or platelets to recover, or any drug-related AE that led to a dose reduction of >=1 study drugs. (NCT00423449)
Timeframe: every 21 days (every cycle), up to 126 days (6 cycles)

InterventionParticipants (Number)
Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin0
Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin1
Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin0
Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin0
Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin1

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Number of Participants With Clinical Adverse Experiences (Safety and Tolerability)

"An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.~The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively)." (NCT00423449)
Timeframe: every 21 days (every cycle), up to 126 days (6 cycles)

InterventionParticipants (Number)
Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin4
Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin6
Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin17
Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin27
Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin7

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Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease

"Maximum tolerated dose (MTD) was defined as the highest dose level in which fewer than 2 patients among the first 6 enrolled experience a DLT (as defined in Outcome Measure 1) during the first cycle of treatment.~The MTD was 400 mg for up to 10 days in 21-day cycles." (NCT00423449)
Timeframe: every 21 days (every cycle), up to 126 days (6 cycles)

Interventionmg (Number)
All Participants400

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Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability)

"An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.~The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively)." (NCT00423449)
Timeframe: every 21 days (every cycle), up to 126 days (6 cycles)

InterventionParticipants (Number)
Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin2
Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin4
Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin7
Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin13
Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin2

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Toxicity Associated With This Regimen.

(NCT00424827)
Timeframe: 1-Year

Interventionparticipants (Number)
Gemcitabine/Fluorouracil With External Beam Radiation:2

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Biomarker Response to Chemoradiation Therapy

20% decrease in biomarker (CA19-9) from baseline (NCT00424827)
Timeframe: 1-year

Interventionparticipants (Number)
Gemcitabine/Fluorouracil With External Beam Radiation:7

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Overall Survival

(NCT00424827)
Timeframe: Up to 2 years

Interventionmonths (Median)
Gemcitabine/Fluorouracil With External Beam Radiation:17

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Progression-free Survival of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00424827)
Timeframe: 1-year

Interventionmonths (Median)
Gemcitabine/Fluorouracil With External Beam Radiation:7.17

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Resection Rate

(NCT00424827)
Timeframe: 1-Year

Interventionparticipants (Number)
Gemcitabine/Fluorouracil With External Beam Radiation:4

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Overall Survival

Overall survival was defined as the time from randomization to death from any cause. (NCT00434642)
Timeframe: From randomization through July 19, 2013 (up to 6 years, 3 months)

InterventionMonths (Median)
Carboplatin and Gemcitabine + Bevacizumab33.6
Carboplatin and Gemcitabine + Placebo32.9

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Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)

Duration of OR was analyzed in the subset of patients who achieved an OR. The duration of OR was defined as the time from the initial CR or PR until documented PD or death. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks. (NCT00434642)
Timeframe: From randomization through September 17, 2010 (up to 3 years, 5 months)

InterventionMonths (Median)
Carboplatin and Gemcitabine + Bevacizumab10.4
Carboplatin and Gemcitabine + Placebo7.4

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Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)

A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder. (NCT00434642)
Timeframe: From randomization through September 17, 2010 (up to 3 years, 5 months)

InterventionPercentage of participants (Number)
Carboplatin and Gemcitabine + Bevacizumab0
Carboplatin and Gemcitabine + Placebo0

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Percentage of Patients Who Had at Least 1 Adverse Event

(NCT00434642)
Timeframe: From randomization through July 19, 2013 (up to 6 years, 3 months)

InterventionPercentage of participants (Number)
Carboplatin and Gemcitabine + Bevacizumab100.0
Carboplatin and Gemcitabine + Placebo100.0

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Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)

An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks. (NCT00434642)
Timeframe: From randomization through September 17, 2010 (up to 3 years, 5 months)

InterventionPercentage of participants (Number)
Carboplatin and Gemcitabine + Bevacizumab78.5
Carboplatin and Gemcitabine + Placebo57.4

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Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)

PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks. (NCT00434642)
Timeframe: From randomization through September 17, 2010 (up to 3 years, 5 months)

InterventionMonths (Median)
Carboplatin and Gemcitabine + Bevacizumab12.4
Carboplatin and Gemcitabine + Placebo8.4

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Pharmacokinetics (PK): Maximum Observed Drug Concentration During a Dosing Interval at Steady State(Cmax,ss) for Total Analyte [Characterization of Pharmacokinetics of Enzastaurin and Its Metabolites]

Cmax,ss is defined as the maximum observed drug concentration during a dosing interval at steady state. Non-Compartmental Pharmacokinetic Parameters for Total Analyte (Enzastaurin + LSN326020). LSN326020 is Enzastaurin's major active metabolite. (NCT00436280)
Timeframe: Day 2 of Cycle 2: Predose;1-2 Hours(H);3-4 h;5-6 h;7-8 H Postdose

Interventionnanomoles per litre (nmol/L) (Geometric Mean)
Enzastaurin + R-GEMOX2750

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Percent of Participants With Progression Free Survival (PFS) After 1 Year Treatment

PFS is defined as the rate at 1 year from the date of first dose of study drug to the first date of measured PD or death from any cause and was determined using the distribution of overall PFS times. The PFS rate at 1 year was determined using Kaplan-Meier estimates. For participants not known to have died as of the data cut-off date and who do not have PD, PFS was censored at the date of the last progression-free disease assessment. (NCT00436280)
Timeframe: First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 1 Year

Interventionpercentage of participants (Number)
Enzastaurin + R-GEMOX16.4

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Duration of Tumor Response (DOR)

Duration of tumor response was defined as the time from the date when the measurement criteria were met for CR and CRu or PR (whichever status was recorded first) until the date of first observation of objective disease progression. For responding patients who died without objective PD (including death from study disease), duration of response was censored at the date of the last objective progression-free disease assessment. For responding patients not known to have died as of the data cut-off date and who do not have objective PD, duration of response was censored at the date of the last objective progression-free disease assessment. For responding patients who received subsequent systemic anticancer therapy (after discontinuation from the study chemotherapy) prior to objectively determined disease progression, duration of response was censored at the date of the last objective progression-free disease assessment prior to post-discontinuation therapy. (NCT00436280)
Timeframe: Time from Observed CR and CRu or PR (Up to 4 Years)

Interventionyears (Number)
Enzastaurin + R-GEMOX23.4

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Progression-Free Survival (PFS ) of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-Center B-cells (GCB) Versus Non-GCB Molecular Subtypes (Assessment of Biomarkers Relevant for Enzastaurin)

PFS based on DLBCL molecular subtypes (GCB vs non-GCB) were determined. The molecular characterization of germinal center B-cells (GCBs) vs. non-GCBs was analyzed as separate combination immunohistochemistry (IHC) markers based on the Hans algorithms. Molecular subtype was included as class effect in the analytical models, adjusting for International Prognostic Index (IPI) score. (NCT00436280)
Timeframe: Baseline, Cycles 1-4, End of Study

Interventionmonths (Median)
GCBNon-GCB
Enzastaurin + R-GEMOX7.84.7

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PFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C Beta 2 (PKCB2) Expression (Assessment of Biomarkers Relevant for Enzastaurin)

Reported PFS was based on PKCB2 protein expression assessed by immunohistochemistry (scored in 10% increments for percent of tumor cells). Protein expression levels was grouped into high and low in association with the clinical endpoints. Grouping was based on 1) a pre-specified threshold provided by the pathologist at Cleveland Clinic for the diffuse large B-cell lymphoma (DLBCL)-prognostic markers, and 2) a median cut-point for the enzastaurin-specific markers. (NCT00436280)
Timeframe: Baseline, Cycles 1-4, End of Study

Interventionmonths (Median)
High ExpressionLow Expression
Enzastaurin + R-GEMOX3.66.1

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Percent of Participants With Progression-Free Survival (PFS) After 2 Years and 4 Years of Treatment

"PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s).~PFS rate was defined as the rate of PFS at 2 year from the date of first dose of study drug and was determined using the distribution of overall PFS times.~PFS rate was defined as the rate of PFS at 4 year from the date of first dose of study drug and was determined using the distribution of overall PFS times.~For participants not known to have died as of the data cut-off date and who did not have PD, PFS was censored at the date of the last progression-free disease assessment." (NCT00436280)
Timeframe: First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 2 Years, 4 Years

Interventionpercentage of participants (Number)
2 Years4 Years
Enzastaurin + R-GEMOX12.18.7

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Percent of Participants With Overall Survival (OS) After 1 Year, 2 Years and 4 Years

Overall survival was defined as the time from the date of first dose of study drug to the date of death from any cause. For participants who were not still alive at the time of analysis, survival time was censored at the last contact date. For participants not known to have died as of the cut-off date for analysis,OS was censored at the last contact date for participants in post-discontinuation. (NCT00436280)
Timeframe: First Dose of Study Drug to Death from Any Cause at 1 Year, 2 Years and 4 Years

Interventionpercentage of participants (Number)
1 Year2 Years4 Years
Enzastaurin + R-GEMOX52.329.920.9

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Percent of Participants With Event Free Survival (EFS) After 1 Year, 2 Years and 4 Years

Event-free survival time was defined as the time from the date of first dose of study drug to the first date of measured PD,or start of a new treatment for the lymphoma, or death from any cause. For participants not known to have events as of the data cut-off date, EFS was censored at the date of the last tumor assessment. (NCT00436280)
Timeframe: First Dose of Study Drug to Measured PD, or Start of New Lymphoma Treatment or Death from Any Cause at 1 Year, 2 Years and 4 Years

Interventionpercentage of participants (Number)
1 Year2 Years4 Years
Enzastaurin + R-GEMOX15.010.38.6

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Percent of Participants With Disease-Free Survival (DFS) at 1 Year, 2 Years and 4 Years

DFS was calculated as the duration from date of first dose of study drug to the date of first relapse event after CR or CRu or death from any cause. Participants who have not experienced an event at the time of analysis were censored at the most recent date of disease assessment. Events are relapse after a CR or CRu. Related death or death from unknown cause was considered as an event. Unrelated death was not considered as an event and the participant was censored at the time of death for this analysis. Unrelated death was defined as death from a cause not related to the lymphoma, any examination done for the lymphoma, or any treatment of the lymphoma. (NCT00436280)
Timeframe: First Dose of Study Drug to Relapse after CR or CRu or Death from any Cause at 1 Year, 2 Years and 4 Years

Interventionpercentage of participants (Number)
1 Year2 Years4 Years
Enzastaurin + R-GEMOX69.252.752.7

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Overall Response Rate (ORR) - Percentage of Participants Achieving Complete Response (CR) or Complete Response Unconfirmed (CRu) or Partial Response (PR) (Response)

Assessment of response was based on the International Workshop to Standardize Response criteria for lymphoma (Cheson et al. 1999). CR is the complete disappearance of all detectable clinical and radiologic evidence of disease; all lymph nodes and nodal masses must have regressed to normal size (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy).CRu is as CR but with 1 or more of the following features: A residual lymph node mass >1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameters (SPD) and/or indeterminate bone marrow with normalization of all biologic abnormalities. PR is regression of more than 50% (SPD) of all measurable lesions, disappearance of nonmeasurable lesions and no new lesion. For each response category the number of participants with this response will be divided by the total number of participants treated to achieve the response rate. (NCT00436280)
Timeframe: Baseline to Measured Progressive Disease or Death from Any Cause at End of 4 and 8 Cycles

Interventionpercentage of participants (Number)
End of 4 cyclesEnd of 8 cycles
Enzastaurin + R-GEMOX5052.50

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PK: Area Under the Concentration vs. Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) for Total Analyte

AUCτ,ss is defined as the area under the concentration versus time curve during 1 dosing interval at steady state. (NCT00436280)
Timeframe: Day 2 of Cycle 2: Predose;1-2 hours(h);3-4 h;5-6 h;7-8 h Postdose

Interventionnanomoles*hour per liter(nmol•h/L) (Geometric Mean)
Enzastaurin + R-GEMOX44100

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Number of Participants With Objective Response (OR)

OR based assessment of confirmed complete response(CR)/confirmed partial response(PR)/stable disease(SD)/progressive disease(PD) as per Response Evaluation Criteria in Solid Tumors(RECIST).CR:disappearance of target lesions;PR:at least(>=) 30% decrease in sum of longest dimensions of target lesions(reference:baseline sum of longest dimensions);PD:>=20% increase in sum of longest dimensions of target lesions(reference:smallest sum of longest dimensions recorded since treatment started)/appearance of any new lesions;SD:no adequate shrinkage to qualify for PR/adequate increase to qualify for PD. (NCT00437203)
Timeframe: Baseline, Day 15 of Cycle 2 and 4 and every 4 cycles thereafter up to Week 62

Interventionparticipants (Number)
PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)1
PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)0
PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)1
PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)1
PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)0
PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)0
PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)0
PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)0
PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)1
PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)0

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Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine

(NCT00437203)
Timeframe: Up to Day 21 Cycle 1

Interventionmg (Number)
PF-00477736 + Gemcitabine 750 mg/m^2270
PF-00477736 + Gemcitabine 1000 mg/m^2NA

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Overall Survival

Overall survival using the Kaplan-Meier method. (NCT00438204)
Timeframe: Every 8 weeks, for up to 54 months

Interventionmonths (Median)
Bevacizumab, Gemcitabine Hydrochloride17.5

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Number of Participants With Response

The rate of response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00438204)
Timeframe: Every 8 weeks, for up to 54 months

InterventionParticipants (Count of Participants)
Complete responsePartial responseStable diseaseProgressive diseaseNot response evaluable
Bevacizumab, Gemcitabine Hydrochloride11512101

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Number of Participants With Grade 3 or Grade 4 Toxicity

Grade 3/4 toxicity according to the NCI Common Toxicity Criteria v3.0 . (NCT00438204)
Timeframe: Every two weeks, for up to 54 months

InterventionParticipants (Count of Participants)
NeutropeniaLeukopeniaAnemiaThrombocytopeniaFebrile NeutropeniaElevated ALT/ASTAcute renal insufficiencyAnorexiaThrombosis/embolismDehydrationFatigueHyperglycemiaHypertensionNausea/vomitingBowel PerforationDyspneaDiverticulitisAtaxia
Bevacizumab, Gemcitabine Hydrochloride1131114123179211421

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Time to Treatment Failure

Time to treatment failure using the Kaplan-Meier method. (NCT00438204)
Timeframe: Every 8 weeks, for up to 54 months

Interventionmonths (Median)
Bevacizumab, Gemcitabine Hydrochloride6.2

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Progression-free Survival (PFS)

RECIST criteria for tumor progression of at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). (NCT00438204)
Timeframe: Up to 12 months

Interventionmonths (Median)
Bevacizumab, Gemcitabine Hydrochloride6.1

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Disease Recurrence Rate

Percentage of patients who experienced a recurrence of grade 1 or 2 superficial transitional cell cancer of the bladder between the date of registration and 24 months. Disease recurrence considered to occur at date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence were censored at the time of their last cystoscopy. (NCT00445601)
Timeframe: Up to 2 Years

Interventionpercentage of patients with recurrence (Number)
Arm I27.86
Arm II40

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Compare Qualitative and Quantitative Toxicities Between the Treatment Arms

Number of patients with Grade 3 through Grade 5 adverse events that are related to study drug (NCT00445601)
Timeframe: Up to 4 years after Transurethral Resection of Bladder Tumor (TURBT)

,
InterventionParticipants (Number)
Bladder spasmsHemorrhage, GU - BladderHemorrhage, GU - Urinary NOSInfection-Other (Specify)Pain - BladderPain - UrethraUrinary frequency/urgency
Arm I: Gemcitabine0121000
Arm II: Placebo1010112

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Rate of Progression to Muscle Invasive Disease at 4 Years

From date of registration to date of diagnosis of progressive disease. Censor at date of last disease assessment for those without progression. (NCT00445601)
Timeframe: 4 years

Interventionpercentage of patients with progression (Number)
Arm I2.49
Arm II4.39

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Overall Survival for Patients With Metastatic Pancreatic Cancer.

(NCT00447122)
Timeframe: Date of study entry until the date of death, up to 12 months.

Interventionparticipants (Number)
Arm 13
Arm 210
Arm 36
Arm 45

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Time to Response (TTR) in the ITT (Non-squamous) Population

TTR for patients who achieved a best response (CR or PR) was defined as the time from date of randomization to the earliest date that response was first documented. (NCT00449033)
Timeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first

Interventiondays (Median)
Sorafenib (Nexavar, BAY43-9006) + GC42
Placebo + GC43

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Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population

The FACT-L measures health related quality of life (HRQOL) and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better HRQOL. (NCT00449033)
Timeframe: from randomization of the first patient until 38 months

,
Interventionscores on a scale (Least Squares Mean)
cycle 2 (day 22)cycle 4 (day 64)cycle 6 (day 106)
Placebo + GC94.093.693.1
Sorafenib (Nexavar, BAY43-9006) + GC90.690.189.7

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Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population

LCS is a subscale of FACT-L measuring lung cancer specific symptoms. The LCS scores range from 0 to 28, higher scores represent fewer lung cancer symptoms. (NCT00449033)
Timeframe: from randomization of the first patient to 38 months later or death whatever occurs first.

,
Interventionscores on a scale (Least Squares Mean)
cycle 1 (day 1)cycle 2 (day 22)cycle 3 (day 43)cycle 4 (day 64)cycle 5 (day 85)cycle 6 (day 106)
Placebo + GC20.520.520.420.320.320.2
Sorafenib (Nexavar, BAY43-9006) + GC20.019.919.919.819.719.7

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Disease Control (DC) in the ITT (Non-squamous) Population

DC was defined as the total number of patients whose best response was not PD according to RECIST (version 1.0) by Investigator-assessment (= total number of CR + total number of PR + total number of SD; CR or PR had to be maintained for at least 28 days from the first demonstration of that rating, SD had to be documented at least once more than 6 weeks from baseline). PD: an increase in the sum of tumor lesions sizes or new lesions. (NCT00449033)
Timeframe: from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks

Interventionpercentage of participants (Number)
Sorafenib (Nexavar, BAY43-9006) + GC62.1
Placebo + GC63.1

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Duration of Response in the ITT (Non-squamous) Population

Duration of response was defined as the time from date of first documented objective response of PR or CR, whichever was noted earlier, to date of disease progression or death (if death occurred before progression was documented). Patients without disease progression at the time of analysis or death before progression were censored at the last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions. (NCT00449033)
Timeframe: from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks

Interventiondays (Median)
Sorafenib (Nexavar, BAY43-9006) + GC171
Placebo + GC133

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Duration of Stable Disease (SD) in the ITT (Non-squamous) Population

Duration of SD was defined as the time from date of randomization to date that disease progression (radiological or clinical, whichever was earlier) was first documented. Patients without disease progression at the time of analysis or death before progression were censored at the date of their last tumor assessment.(Disease progression: increase in the sum of tumor lesion sizes or new lesions.) Duration of stable disease was only evaluated in patients failing to achieve a best response of CR or PR. (NCT00449033)
Timeframe: from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks

Interventiondays (Median)
Sorafenib (Nexavar, BAY43-9006) + GC144
Placebo + GC131

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OS in the ITT (Both Squamous and Non-squamous) Population

OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact. (NCT00449033)
Timeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first

Interventiondays (Median)
Sorafenib (Nexavar, BAY43-9006) + GC371
Placebo + GC378

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OS in the ITT (Squamous) Population

OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact. (NCT00449033)
Timeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first

Interventiondays (Median)
Sorafenib (Nexavar, BAY43-9006) + GC254
Placebo + GC374

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Overall Survival (OS) in the ITT (Non-squamous) Population

Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact. (NCT00449033)
Timeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first

Interventiondays (Median)
Sorafenib (Nexavar, BAY43-9006) + GC376
Placebo + GC379

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Progression-free Survival (PFS) in the ITT (Non-squamous) Population

PFS was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0) or death due to any cause, whichever occured first. Patients without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions. (NCT00449033)
Timeframe: from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks

Interventiondays (Median)
Sorafenib (Nexavar, BAY43-9006) + GC183
Placebo + GC168

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Time to Progression (TTP) in the ITT (Non-squamous) Population

TTP was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using RECIST version 1.0). Patients without progression at the time of analysis or death before progression were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions. (NCT00449033)
Timeframe: from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks

Interventiondays (Median)
Sorafenib (Nexavar, BAY43-9006) + GC185
Placebo + GC167

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Time to Symptomatic Deterioration (TSD) in the ITT (Non-squamous) Population

TSD is defined as the time from randomization to the date of symptomatic deterioration (≥3 point decline in the LCS score that is maintained for at least 2 consecutive cycles) or death if death occurs before these 2 consecutive cycles are completed. (NCT00449033)
Timeframe: from randomization of the first patient to 38 months later or death whatever occurs first

Interventionmonths (Median)
Sorafenib (Nexavar, BAY43-9006) + GC6.9
Placebo + GC4.5

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EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population

The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). (NCT00449033)
Timeframe: from randomization of the first patient until 38 months later or death whatever occurs first

,
Interventionscores on a scale (Least Squares Mean)
cycle 1 (day 1)cycle 2 (day 22)cycle 3 (day 43)cycle 4 (day 64)cycle 5 (day 85)cycle 6 (day 106)
Placebo + GC68.9668.9668.9568.9568.9568.95
Sorafenib (Nexavar, BAY43-9006) + GC66.4366.4366.4366.4366.4266.42

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Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population

The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 to 1 when the United Kingdom (UK) weights are applied (0=death, 1=perfect health). Higher index scores represent better health states. (NCT00449033)
Timeframe: from randomization of the first patient until 38 months later or death whatever occurs first

,
Interventionscores on a scale (Least Squares Mean)
cycle 1 (day 1)cycle 2 (day 22)cycle 3 (day 43)cycle 4 (day 64)cycle 5 (day 85)cycle 6 (day 106)
Placebo + GC0.760.750.750.740.730.73
Sorafenib (Nexavar, BAY43-9006) + GC0.700.690.690.680.680.67

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Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population

Tumor response (= Best Overall Response) of a patient was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes or new lesions)) observed during trial period assessed according to the RECIST criteria (version 1.0) based on Investigator-assessment. (NCT00449033)
Timeframe: from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks

,
Interventionpercentage of participants (Number)
CRconfirmed PRSDPDNot assessable
Placebo + GC0.025.837.217.119.9
Sorafenib (Nexavar, BAY43-9006) + GC0.027.834.310.927.0

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Plasma Clearance (CL) for Cisplatin

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9

InterventionL/hr (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)46.31
Axitinib + Pemetrexed + Cisplatin (Cohort 9)46.80

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Plasma Clearance (CL) for Carboplatin

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3

InterventionL/hr (Mean)
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)12.57

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Percentage of Participants With Objective Response

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00454649)
Timeframe: Baseline and thereafter every 2 cycles up to disease progression or discontinuation from study or up to 155 weeks

InterventionPercentage of Participants (Number)
Axitinib + Paclitaxel + Carboplatin (Cohort 1)100.0
Axitinib + Paclitaxel + Carboplatin (Cohort 2)0
Axitinib + Paclitaxel + Carboplatin (Cohort 3)35.0
Axitinib + Paclitaxel (Cohort 4)66.7
Axitinib + Docetaxel (Cohort 5)50.0
Axitinib + Capecitabine (Cohort 6)11.1
Axitinib + Capecitabine (Cohort 7)11.8
Axitinib + Gemcitabine + Cisplatin (Cohort 8)23.8
Axitinib + Pemetrexed + Cisplatin (Cohort 9)0

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Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy

MTD defined as the dose level at which more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 nonhematological toxicities or >=0.5 teaspoon/day hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity. (NCT00454649)
Timeframe: Baseline to withdrawal from study or Day 21 of Cycle 1 [all cohorts except cohort 4 (Day 28 of Cycle 1)]

Interventionmg BID (Number)
Axitinib + Paclitaxel + Carboplatin (Cohort 1)5
Axitinib + Paclitaxel + Carboplatin (Cohort 2)5
Axitinib + Paclitaxel + Carboplatin (Cohort 3)5
Axitinib + Paclitaxel (Cohort 4)5
Axitinib + Docetaxel (Cohort 5)NA
Axitinib + Capecitabine (Cohort 6)5
Axitinib + Capecitabine (Cohort 7)5
Axitinib + Gemcitabine + Cisplatin (Cohort 8)5
Axitinib + Pemetrexed + Cisplatin (Cohort 9)5

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Maximum Observed Plasma Concentration (Cmax) for Pemetrexed

(NCT00454649)
Timeframe: 0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9

Interventionng/mL (Mean)
Axitinib + Pemetrexed + Cisplatin (Cohort 9)83925.00

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Maximum Observed Plasma Concentration (Cmax) for Paclitaxel

(NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4

Interventionng/mL (Mean)
Axitinib + Paclitaxel (Cohort 4)3698.33
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)6105.00

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Maximum Observed Plasma Concentration (Cmax) for Gemcitabine

(NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8

Interventionng/mL (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)20635.29

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Plasma Clearance (CL) for Paclitaxel

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4

InterventionL/hr (Mean)
Axitinib + Paclitaxel (Cohort 4)30.48
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)21.61

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Maximum Observed Plasma Concentration (Cmax) for Cisplatin

(NCT00454649)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9

Interventionng/mL (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)1680.54
Axitinib + Pemetrexed + Cisplatin (Cohort 9)1176.00

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Maximum Observed Plasma Concentration (Cmax) for Docetaxel

(NCT00454649)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5

Interventionng/mL (Mean)
Axitinib + Docetaxel (Cohort 5)3130.00

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4

Interventionng*hr/mL (Mean)
Axitinib + Paclitaxel (Cohort 4)5683.55
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)19959.91

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8

Interventionng*hr/mL (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)10991.16

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5

Interventionng*hr/mL (Mean)
Axitinib + Docetaxel (Cohort 5)3478.49

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3

Interventionng*hr/mL (Mean)
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)55580.26

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Apparent Oral Clearance (CL/F) for Capecitabine

Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7

InterventionLiter/hr (Mean)
Axitinib + Capecitabine (Cohort 6)209.05
Axitinib + Capecitabine (Cohort 7)314.12

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Apparent Oral Clearance (CL/F) for Axitinib (AG-013736)

Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration. (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9

InterventionLiter/hour (L/hr) (Mean)
Axitinib + Paclitaxel + Carboplatin (Cohort 1)49.39
Axitinib + Paclitaxel + Carboplatin (Cohort 2)40.72
Axitinib + Paclitaxel + Carboplatin (Cohort 3)29.73
Axitinib + Paclitaxel (Cohort 4)65.69
Axitinib + Docetaxel (Cohort 5)14.35
Axitinib + Capecitabine (Cohort 6)26.64
Axitinib + Capecitabine (Cohort 7)83.46
Axitinib + Gemcitabine + Cisplatin (Cohort 8)50.05
Axitinib + Pemetrexed + Cisplatin (Cohort 9)25.10

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9

Interventionng*hr/mL (Mean)
Axitinib + Pemetrexed + Cisplatin (Cohort 9)133032.97

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Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736)

AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24). (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9

Interventionnanogram*hour/milliliter (ng*hr/mL) (Mean)
Axitinib + Paclitaxel + Carboplatin (Cohort 1)61.58
Axitinib + Paclitaxel + Carboplatin (Cohort 2)242.41
Axitinib + Paclitaxel + Carboplatin (Cohort 3)475.18
Axitinib + Paclitaxel (Cohort 4)154.43
Axitinib + Docetaxel (Cohort 5)780.99
Axitinib + Capecitabine (Cohort 6)365.95
Axitinib + Capecitabine (Cohort 7)449.99
Axitinib + Gemcitabine + Cisplatin (Cohort 8)416.30
Axitinib + Pemetrexed + Cisplatin (Cohort 9)420.64

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Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine

AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24). (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7

Interventionng*hr/mL (Mean)
Axitinib + Capecitabine (Cohort 6)20534.52
Axitinib + Capecitabine (Cohort 7)22163.88

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Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin

AUC (0-8) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 8 hours (0-8). (NCT00454649)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9

Interventionng*hr/mL (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)2932.43
Axitinib + Pemetrexed + Cisplatin (Cohort 9)2703.92

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Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)

(NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9

Interventionng/mL (Mean)
Axitinib + Paclitaxel + Carboplatin (Cohort 1)5.97
Axitinib + Paclitaxel + Carboplatin (Cohort 2)23.36
Axitinib + Paclitaxel + Carboplatin (Cohort 3)42.58
Axitinib + Paclitaxel (Cohort 4)44.58
Axitinib + Docetaxel (Cohort 5)67.96
Axitinib + Capecitabine (Cohort 6)37.51
Axitinib + Capecitabine (Cohort 7)43.97
Axitinib + Gemcitabine + Cisplatin (Cohort 8)40.97
Axitinib + Pemetrexed + Cisplatin (Cohort 9)31.53

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Maximum Observed Plasma Concentration (Cmax) for Capecitabine

(NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7

Interventionng/mL (Mean)
Axitinib + Capecitabine (Cohort 6)10808.00
Axitinib + Capecitabine (Cohort 7)10588.38

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Maximum Observed Plasma Concentration (Cmax) for Carboplatin

(NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3

Interventionng/mL (Mean)
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)23383.33

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Plasma Clearance (CL) for Gemcitabine

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8

InterventionL/hr (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)224.36

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Plasma Clearance (CL) for Docetaxel

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5

InterventionL/hr (Mean)
Axitinib + Docetaxel (Cohort 5)42.96

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Plasma Clearance (CL) for Pemetrexed

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9

InterventionL/hr (Mean)
Axitinib + Pemetrexed + Cisplatin (Cohort 9)7.26

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Plasma Decay Half Life (t1/2) for Pemetrexed

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9

Interventionhr (Mean)
Axitinib + Pemetrexed + Cisplatin (Cohort 9)2.77

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Plasma Decay Half Life (t1/2) for Paclitaxel

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4

Interventionhr (Mean)
Axitinib + Paclitaxel (Cohort 4)12.51
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)8.36

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Plasma Decay Half Life (t1/2) for Gemcitabine

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8

Interventionhr (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)0.29

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Plasma Decay Half Life (t1/2) for Docetaxel

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5

Interventionhr (Mean)
Axitinib + Docetaxel (Cohort 5)11.49

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Plasma Decay Half Life (t1/2) for Cisplatin

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9

Interventionhr (Mean)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)2.61
Axitinib + Pemetrexed + Cisplatin (Cohort 9)3.91

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Plasma Decay Half Life (t1/2) for Carboplatin

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3

Interventionhr (Mean)
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)2.62

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Plasma Decay Half Life (t1/2) for Capecitabine

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7

Interventionhr (Mean)
Axitinib + Capecitabine (Cohort 6)0.85
Axitinib + Capecitabine (Cohort 7)1.44

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Plasma Decay Half Life (t1/2) for Axitinib (AG-013736)

t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9

Interventionhr (Mean)
Axitinib + Paclitaxel + Carboplatin (Cohort 1)2.75
Axitinib + Paclitaxel + Carboplatin (Cohort 2)2.90
Axitinib + Paclitaxel + Carboplatin (Cohort 3)2.80
Axitinib + Paclitaxel (Cohort 4)1.45
Axitinib + Docetaxel (Cohort 5)4.07
Axitinib + Capecitabine (Cohort 6)3.85
Axitinib + Capecitabine (Cohort 7)3.64
Axitinib + Gemcitabine + Cisplatin (Cohort 8)2.68
Axitinib + Pemetrexed + Cisplatin (Cohort 9)5.02

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Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

OS is defined as the time from the date of study entry until the date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to the last date the participant was known to be alive. (NCT00456261)
Timeframe: From date of study entry until the date of death from any cause or the date the patient was last known alive, up to 18 months

Interventionmonths (Number)
Bevacizumab/Pemetrexed/Gemcitabine7.5
Bevacizumab/Pemetrexed/Carboplatin14.8

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Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

Time to Progression (TTP) is defined as the interval between the date of treatment initiation and the date of progressive disease. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions. (NCT00456261)
Timeframe: From the date of treatment initiation until the date of first documented PD or date of last study contact or date of other therapy begins up to 18 months

Interventionmonths (Median)
Bevacizumab/Pemetrexed/Gemcitabine4.7
Bevacizumab/Pemetrexed/Carboplatin10.2

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Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Overall response rate (ORR) is defined as the percentage of patients who have a partial or complete response to therapy. Responses were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0). Complete Response: Disappearance of all target lesions, and disappearance of all non-target lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions (taking as reference the baseline sum of longest diameters) (NCT00456261)
Timeframe: From date of treatment initiation to end of study treatment up to 18 months

Interventionpercentage of patients (Number)
Bevacizumab/Pemetrexed/Gemcitabine35
Bevacizumab/Pemetrexed/Carboplatin35

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Overall Survival

Percent overall survival was calculated for all evaluable patients. (NCT00456599)
Timeframe: 5 years

Interventionmonths (Median)
Oxaliplatin & Gemcitabine With Radiation18.2

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Two-year Disease Free Survival.

The percent of patients alive and disease-free at two years. (NCT00456599)
Timeframe: two years

Interventionpercentage of patients (Number)
Oxaliplatin & Gemcitabine With Radiation26.1

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Time to Treatment Failure

Median time for disease recurrence after surgery. (NCT00456599)
Timeframe: 2 years

Interventionmonths (Median)
Oxaliplatin & Gemcitabine With Radiation10.4

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Percentage of Participants With Disease Control According to RECIST

Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR. (NCT00461708)
Timeframe: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

Interventionpercentage of participants (Number)
Erlotinib, Gemcitabine: Rash Grade < 242.6
Erlotinib, Gemcitabine: Rash Grade ≥ 284.2

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PFS

The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology. (NCT00461708)
Timeframe: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months

Interventionmonths (Median)
Erlotinib, Gemcitabine: Rash Grade < 22.497
Erlotinib, Gemcitabine: Rash Grade ≥ 26.439

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OS At 6 Months

OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology. (NCT00461708)
Timeframe: Enrollment through Cycle 6 (4-week cycles), up to 6 months.

Interventionmonths (Median)
Erlotinib, Gemcitabine: Rash Grade < 24.468
Erlotinib, Gemcitabine: Rash Grade ≥ 2NA

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Number of Participants Who Died at 6 Months

(NCT00461708)
Timeframe: Enrollment through Cycle 6 (4-week cycles), up to 6 months.

Interventionparticipants (Number)
Erlotinib, Gemcitabine: Rash Grade < 269
Erlotinib, Gemcitabine: Rash Grade ≥ 28

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Number of Participants Who Died During the Study

(NCT00461708)
Timeframe: Enrollment through Cycle 24 (4-week cycles), up to 24 months.

Interventionparticipants (Number)
Erlotinib, Gemcitabine: Rash Grade < 2102
Erlotinib, Gemcitabine: Rash Grade ≥ 227

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Number of Participants Who Died During the Study By Rash Grade

(NCT00461708)
Timeframe: Enrollment through Cycle 24 (4-week cycles), up to 24 months.

Interventionparticipants (Number)
Erlotinib, Gemcitabine: Rash Grade 065
Erlotinib, Gemcitabine: Rash Grade 137
Erlotinib, Gemcitabine: Rash Grade ≥ 227

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Number of Participants With Disease Progression or Death

Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored. (NCT00461708)
Timeframe: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

Interventionparticipants (Number)
Erlotinib, Gemcitabine: Rash Grade < 2110
Erlotinib, Gemcitabine: Rash Grade ≥ 233

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OS By Rash Grade

OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology. (NCT00461708)
Timeframe: Enrollment through Cycle 24 (4-week cycles), up to 24 months.

Interventionmonths (Median)
Erlotinib, Gemcitabine: Rash Grade 03.318
Erlotinib, Gemcitabine: Rash Grade 16.571
Erlotinib, Gemcitabine: Rash Grade ≥ 210.546

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Overall Survival (OS) During the Study

OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology. (NCT00461708)
Timeframe: Enrollment through Cycle 24 (4-week cycles), up to 24 months.

Interventionmonths (Median)
Erlotinib, Gemcitabine: Rash Grade < 24.468
Erlotinib, Gemcitabine: Rash Grade ≥ 210.546

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Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST

As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR. (NCT00461708)
Timeframe: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

Interventionpercentage of participants (Number)
Erlotinib, Gemcitabine: Rash Grade < 27.0
Erlotinib, Gemcitabine: Rash Grade ≥ 221.1

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Dose Ruction (Toxicity)

To determine the toxicity of combination therapy with sorafenib, gemcitabine and carboplatin, dose reductions by drug are reported. The number of patients that were reduced in dosage are reported here. (NCT00461851)
Timeframe: Upon completion of study

InterventionParticipants (Count of Participants)
Dose Reduction: GemcitabineDose Reduction: CarboplatinDose Reduction: Sorafenib
Chemotherapy Plus Sorafenib1559

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Progression Free Survival (PFS)

The primary outcome was the proportion of patients who achieved progression free survival (PFS) of five months. PFS was defined as time to progression or any-cause mortality, whichever came first. (NCT00461851)
Timeframe: Upon completion of study

Interventionmonths (Median)
Chemotherapy Plus Sorafenib9.5

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Number of Participants With Recurrent Disease

(NCT00462865)
Timeframe: 6 months and again at the end of the study (1 year)

InterventionParticipants (Count of Participants)
Gemcitabine, Capectiabine, Avastin4

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Progression Free Survival (PFS)

"Time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)." (NCT00471146)
Timeframe: Baseline until disease progression or at least 1 year after the randomization of last participant

InterventionWeeks (Median)
Axitinib + Gemcitabine19.1
Placebo + Gemcitabine18.9

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Percentage of Participants With Objective Response (OR)

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. (NCT00471146)
Timeframe: Baseline, every 8 weeks until tumor progression or death

InterventionPercentage of participants (Number)
Axitinib + Gemcitabine4.9
Placebo + Gemcitabine1.6

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Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score. (NCT00471146)
Timeframe: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

,
InterventionUnits on a scale (Mean)
Physical functioning: Baseline (n=295, 289)Physical functioning: Change at C2 D1 (n=233, 233)Physical functioning: Change at C3 D1 (n=173, 179)Physical functioning: Change at C4 D1 (n=134, 133)Physical functioning: Change at C5 D1 (n=96, 82)Physical functioning: Change at C6 D1 (n=59, 58)Physical functioning: Change at C7 D1 (n=38, 37)Physical functioning: Change at C8 D1 (n=15, 21)Physical functioning: Change at C9 D1 (n=9, 9)Physical functioning: Change at C10 D1 (n=3, 4)Physical functioning: Change at C11 D1 (n=1, 1)Physical functioning: Change at C12 D1 (n=1, 0)Physical functioning: Change at C13 D1 (n=1, 0)Physical functioning:Change at followup (n=67, 70)Role functioning: Baseline (n=297, 295)Role functioning: Change at C2 D1 (n=239, 242)Role functioning: Change at C3 D1 (n=177, 185)Role functioning: Change at C4 D1 (n=135, 136)Role functioning: Change at C5 D1 (n=99, 81)Role functioning: Change at C6 D1 (n=60, 58)Role functioning: Change at C7 D1 (n=38, 37)Role functioning: Change at C8 D1 (n=16, 21)Role functioning: Change at C9 D1 (n=9, 9)Role functioning: Change at C10 D1 (n=3, 4)Role functioning: Change at C11 D1 (n=1, 1)Role functioning: Change at C12 D1 (n=1, 0)Role functioning: Change at C13 D1 (n=1, 0)Role functioning: Change at follow-up (n=66, 72)Emotional functioning (EF): Baseline (n=294, 287)EF: Change at C2 D1 (n=233, 229)EF: Change at C3 D1 (n=170, 180)EF: Change at C4 D1 (n=134, 131)EF: Change at C5 D1 (n=96, 80)EF: Change at C6 D1 (n=60, 56)EF: Change at C7 D1 (n=37, 34)EF: Change at C8 D1 (n=17, 19)EF: Change at C9 D1 (n=9, 9)EF: Change at C10 D1 (n=3, 4)EF: Change at C11 D1 (n=1, 1)EF: Change at C12 D1 (n=1, 0)EF: Change at C13 D1 (n=1, 0)EF: Change at follow-up (n=65, 71)Cognitive Functioning (CF): Baseline (n=293, 288)CF: Change at C2 D1 (n=234, 234)CF: Change at C3 D1 (n=172, 179)CF: Change at C4 D1 (n=134, 134)CF: Change at C5 D1 (n=97, 80)CF: Change at C6 D1 (n=60, 56)CF: Change at C7 D1 (n=38, 34)CF: Change at C8 D1 (n=17, 17)CF: Change at C9 D1 (n=9, 9)CF: Change at C10 D1 (n=3, 4)CF: Change at C11 D1 (n=1, 1)CF: Change at C12 D1 (n=1, 0)CF: Change at C13 D1 (n=1, 0)CF: Change at follow-up (n=65, 71)Social functioning: Baseline (n=289, 286)Social functioning: Change at C2 D1 (n=232, 230)Social functioning: Change at C3 D1 (n=169, 178)Social functioning: Change at C4 D1 (n=132, 134)Social functioning: Change at C5 D1 (n=95, 80)Social functioning: Change at C6 D1 (n=58, 56)Social functioning: Change at C7 D1 (n=37, 35)Social functioning: Change at C8 D1 (n=17, 19)Social functioning: Change at C9 D1 (n=9, 9)Social functioning: Change at C10 D1 (n=3, 4)Social functioning: Change at C11 D1 (n=1, 1)Social functioning: Change at C12 D1 (n=1, 0)Social functioning: Change at C13 D1 (n=1, 0)Social functioning: Change at follow-up (n=64, 70)Fatigue: Baseline (n=293, 289)Fatigue: Change at C2 D1 (n=227, 228)Fatigue: Change at C3 D1 (n=170, 181)Fatigue: Change at C4 D1 (n=132, 132)Fatigue: Change at C5 D1 (n=97, 80)Fatigue: Change at C6 D1 (n=60, 57)Fatigue: Change at C7 D1 (n=38, 36)Fatigue: Change at C8 D1 (n=17, 20)Fatigue: Change at C9 D1 (n=9, 9)Fatigue: Change at C10 D1 (n=3, 4)Fatigue: Change at C11 D1 (n=1, 1)Fatigue: Change at C12 D1 (n=1, 0)Fatigue: Change at C13 D1 (n=1, 0)Fatigue: Change at follow-up (n=63, 71)Nausea and vomiting: Baseline (n=295, 294)Nausea and vomiting: Change at C2 D1 (n=238, 239)Nausea and vomiting: Change at C3 D1 (n=176, 185)Nausea and vomiting: Change at C4 D1 (n=133, 135)Nausea and vomiting: Change at C5 D1 (n=98, 81)Nausea and vomiting: Change at C6 D1 (n=60, 59)Nausea and vomiting: Change at C7 D1 (n=38, 37)Nausea and vomiting: Change at C8 D1 (n=17, 21)Nausea and vomiting: Change at C9 D1 (n=9, 9)Nausea and vomiting: Change at C10 D1 (n=3, 4)Nausea and vomiting: Change at C11 D1 (n=1, 1)Nausea and vomiting: Change at C12 D1 (n=1, 0)Nausea and vomiting: Change at C13 D1 (n=1, 0)Nausea and vomiting: Change at followup (n=68, 73)Pain: Baseline (n=291, 291)Pain: Change at C2 D1 (n=231, 234)Pain: Change at C3 D1 (n=169, 181)Pain: Change at C4 D1 (n=131, 135)Pain: Change at C5 D1 (n=97, 80)Pain: Change at C6 D1 (n=59, 58)Pain: Change at C7 D1 (n=38, 35)Pain: Change at C8 D1 (n=17, 20)Pain: Change at C9 D1 (n=9, 9)Pain: Change at C10 D1 (n=3, 4)Pain: Change at C11 D1 (n=1, 1)Pain: Change at C12 D1 (n=1, 0)Pain: Change at C13 D1 (n=1, 0)Pain: Change at follow-up (n=66, 72)Dyspnoea: Baseline (n=295, 295)Dyspnoea: Change at C2 D1 (n=238, 240)Dyspnoea: Change at C3 D1 (n=175, 186)Dyspnoea: Change at C4 D1 (n=135, 135)Dyspnoea: Change at C5 D1 (n=98, 82)Dyspnoea: Change at C6 D1 (n=60, 59)Dyspnoea: Change at C7 D1 (n=37, 37)Dyspnoea: Change at C8 D1 (n=16, 21)Dyspnoea: Change at C9 D1 (n=9, 9)Dyspnoea: Change at C10 D1 (n=3, 4)Dyspnoea: Change at C11 D1 (n=1, 1)Dyspnoea: Change at C12 D1 (n=1, 0)Dyspnoea: Change at C13 D1 (n=1, 0)Dyspnoea: Change at follow-up (n=68, 73)Insomnia: Baseline (n=297, 295)Insomnia: Change at C2 D1 (n=240, 241)Insomnia: Change at C3 D1 (n=178, 185)Insomnia: Change at C4 D1 (n=134, 134)Insomnia: Change at C5 D1 (n=99, 82)Insomnia: Change at C6 D1 (n=60, 59)Insomnia: Change at C7 D1 (n=37, 37)Insomnia: Change at C8 D1 (n=17, 21)Insomnia: Change at C9 D1 (n=9, 9)Insomnia: Change at C10 D1 (n=3, 4)Insomnia: Change at C11 D1 (n=1, 1)Insomnia: Change at C12 D1 (n=1, 0)Insomnia: Change at C13 D1 (n=1, 0)Insomnia: Change at follow-up (n=68, 73)Loss of appetite: Baseline (n=297, 295)Loss of appetite: Change at C2 D1 (n=240, 240)Loss of appetite: Change at C3 D1 (n=178, 186)Loss of appetite: Change at C4 D1 (n=135, 135)Loss of appetite: Change at C5 D1 (n=99, 82)Loss of appetite: Change at C6 D1 (n=60, 59)Loss of appetite: Change at C7 D1 (n=38, 37)Loss of appetite: Change at C8 D1 (n=17, 20)Loss of appetite: Change at C9 D1 (n=9, 9)Loss of appetite: Change at C10 D1 (n=3, 4)Loss of appetite: Change at C11 D1 (n=1, 1)Loss of appetite: Change at C12 D1 (n=1, 0)Loss of appetite: Change at C13 D1 (n=1, 0)Loss of appetite: Change at follow-up (n=67, 73)Constipation: Baseline (n=293, 289)Constipation: Change at C2 D1 (n=234, 235)Constipation: Change at C3 D1 (n =173, 181)Constipation: Change at C4 D1 (n=134, 135)Constipation: Change at C5 D1 (n=97, 80)Constipation: Change at C6 D1 (n=60, 58)Constipation: Change at C7 D1 (n=38, 36)Constipation: Change at C8 D1 (n=17, 20)Constipation: Change at C9 D1 (n=9, 9)Constipation: Change at C10 D1 (n=3, 4)Constipation: Change at C11 D1 (n=1, 1)Constipation: Change at C12 D1 (n=1, 0)Constipation: Change at C13 D1 (n=1, 0)Constipation: Change at follow-up (n=66, 71)Diarrhoea: Baseline (n=294, 290)Diarrhoea: Change at C2 D1 (n=235, 235)Diarrhoea: Change at C3 D1 (n=173, 182)Diarrhoea: Change at C4 D1 (n=134, 136)Diarrhoea: Change at C5 D1 (n=96, 81)Diarrhoea: Change at C6 D1 (n=60, 58)Diarrhoea: Change at C7 D1 (n=38, 36)Diarrhoea: Change at C8 D1 (n=17, 20)Diarrhoea: Change at C9 D1 (n=9, 9)Diarrhoea: Change at C10 D1 (n=3, 4)Diarrhoea: Change at C11 D1 (n=1, 1)Diarrhoea: Change at C12 D1 (n=1, 0)Diarrhoea: Change at C13 D1 (n=1, 0)Diarrhoea: Change at follow-up (n=66, 71)Financial difficulties (FD): Baseline (n=292, 285)FD:Change at C2 D1 (n=233, 228)FD: Change at C3 D1 (n=171, 176)FD: Change at C4 D1 (n=133, 133)FD: Change at C5 D1 (n=96, 80)FD: Change at C6 D1 (n=60, 56)FD: Change at C7 D1 (n=37, 34)FD: Change at C8 D1 (n=17, 17)FD: Change at C9 D1 (n=9, 9)FD: Change at C10 D1 (n=3, 4)FD: Change at C11 D1 (n=1, 1)FD: Change at C12 D1 (n=1, 0)FD: Change at C13 D1 (n=1, 0)FD: Change at follow-up (n=65, 70)GHS/Quality of Life (QoL): Baseline (n=292, 288)GHS/QoL:Change at C2 D1 (n=234, 233)GHS/QoL:Change at C3 D1 (n=168, 180)GHS/QoL:Change at C4 D1(n=132, 132)GHS/QoL:Change at C5 D1 (n=96, 81)GHS/QoL:Change at C6 D1 (n=60, 57)GHS/QoL:Change at C7 D1 (n=38, 35)GHS/QoL:Change at C8 D1 (n=17, 19)GHS/QoL:Change at C9 D1 (n=9, 9)GHS/QoL: Change at C10 D1 (n=3, 4)GHS/QoL: Change at C11 D1 (n=1, 1)GHS/QoL: Change at C12 D1 (n=1, 0)GHS/QoL: Change at C13 D1 (n=1, 0)GHS/QoL:Change at follow-up (n=65, 71)
Axitinib + Gemcitabine77.445-2.713-5.897-5.671-2.498-5.193-1.924-4.0000.0336.6670.0000.0000.000-17.71366.3-2.2-4.6-4.3-0.5-4.4-3.1-6.21.95.60.00.00.0-20.070.85.03.73.04.34.00.0-2.93.713.90.00.00.0-7.378.7-1.1-2.1-4.2-1.4-3.1-4.4-8.8-0.0-5.60.00.00.0-12.668.91.3-1.30.12.1-4.9-5.44.9-0.05.60.00.00.0-13.341.02.83.45.6-0.05.01.87.2-6.2-11.10.00.00.013.112.93.71.93.54.66.91.3-4.9-13.0-11.10.00.00.09.840.7-10.1-13.6-12.2-10.5-11.9-14.0-9.8-22.2-33.30.00.00.03.316.15.55.77.74.49.46.34.211.1-11.10.00.00.013.236.8-13.6-13.5-12.7-14.5-8.3-11.75.9-14.811.10.00.00.01.539.6-2.1-1.30.01.72.80.97.8-14.8-22.20.00.00.07.030.7-4.8-7.3-6.5-11.0-5.6-2.60.0-18.5-11.10.00.00.05.114.31.79.47.711.820.014.925.537.022.20.00.00.02.524.7-3.1-7.2-5.5-4.9-3.9-2.72.07.40.00.00.00.06.754.22.2-0.30.11.50.82.6-1.07.422.30.00.00.0-9.1
Placebo + Gemcitabine78.546-3.261-1.565-1.453-0.076-1.7190.0110.014-12.578-1.675-6.600NANA-11.52368.1-2.81.51.2-2.7-2.3-1.30.0-20.4-4.2-50.0NANA-14.171.75.03.45.25.96.73.25.3-4.62.1-16.6NANA-2.780.9-0.3-0.92.01.7-4.50.5-2.9-1.88.30.0NANA-7.569.70.93.20.60.81.52.4-1.7-1.812.533.4NANA-2.640.12.1-0.9-1.11.10.02.24.414.8-5.511.1NANA12.113.12.9-0.40.41.02.82.70.8-5.68.30.0NANA7.536.9-7.9-11.2-7.8-6.9-7.5-9.5-6.7-5.6-4.2-33.3NANA3.514.82.13.94.42.8-0.05.412.714.80.00.0NANA8.732.2-7.3-8.7-11.2-7.3-2.3-2.7-3.2-0.0-0.033.3NANA1.437.5-2.6-5.9-6.7-4.5-4.5-7.2-1.7-7.40.033.3NANA7.829.6-2.8-6.1-10.6-8.7-9.8-13.0-16.7-29.6-50.0-66.7NANA-6.113.70.30.2-1.51.21.72.81.722.216.70.0NANA2.823.0-4.5-3.4-3.31.3-1.8-3.92.03.725.066.7NANA-0.557.11.95.72.82.73.22.11.3-8.3-0.00.0NANA-6.7

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score

QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues. (NCT00471146)
Timeframe: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

,
InterventionUnits on a scale (Mean)
Pancreatic Pain: Baseline (n=246, 250)Pancreatic Pain: Change at C2 D1 (n=191, 197)Pancreatic Pain: Change at C3 D1 (n=141, 153)Pancreatic Pain: Change at C4 D1 (n=99, 111)Pancreatic Pain: Change at C5 D1 (n=67, 64)Pancreatic Pain: Change at C6 D1 (n=41, 43)Pancreatic Pain: Change at C7 D1 (n=25, 25)Pancreatic Pain: Change at C8 D1 (n=11, 11)Pancreatic Pain: Change at C9 D1 (n=6, 6)Pancreatic Pain: Change at C10 D1 (n=2, 3)Pancreatic Pain: Change at C11 D1 (n=1, 1)Pancreatic Pain: Change at C12 D1 (n=1, 0)Pancreatic Pain: Change at C13 D1 (n=1, 0)Pancreatic Pain: Change at follow-up (n=47, 46)Hepatic: Baseline (n=245, 254)Hepatic: Change at C2 D1 (n=193, 205)Hepatic: Change at C3 D1 (n=142, 157)Hepatic: Change at C4 D1 (n=99, 112)Hepatic: Change at C5 D1 (n=68, 64)Hepatic: Change at C6 D1 (n=40, 41)Hepatic: Change at C7 D1 (n=25, 24)Hepatic: Change at C8 D1 (n=11, 12)Hepatic: Change at C9 D1 (n=6, 5)Hepatic: Change at C10 D1 (n=2, 2)Hepatic: Change at C11 D1 (n=1, 1)Hepatic: Change at C12 D1 (n=1, 0)Hepatic: Change at C13 D1 (n=1, 0)Hepatic: Change at follow-up (n=47, 48)Digestive Symptom: Baseline (n=250, 255)Digestive Symptom: Change at C2 D1 (n=195, 206)Digestive Symptom: Change at C3 D1 (n=144, 159)Digestive Symptom: Change at C4 D1 (n=100, 114)Digestive Symptom: Change at C5 D1 (n=69, 65)Digestive Symptom: Change at C6 D1 (n=40, 45)Digestive Symptom: Change at C7 D1 (n=25, 26)Digestive Symptom: Change at C8 D1 (n=11, 14)Digestive Symptom: Change at C9 D1 (n=6, 6)Digestive Symptom: Change at C10 D1 (n=2, 3)Digestive Symptom: Change at C11 D1 (n=1, 1)Digestive Symptom: Change at C12 D1 (n=1, 0)Digestive Symptom: Change at C13 D1 (n=1, 0)Digestive Symptom: Change at follow-up (n=47, 47)Sexuality: Baseline (n=217, 232)Sexuality: Change at C2 D1 (n=157, 181)Sexuality: Change at C3 D1 (n=118, 139)Sexuality: Change at C4 D1 (n=85, 100)Sexuality: Change at C5 D1 (n=55, 58)Sexuality: Change at C6 D1 (n=30, 38)Sexuality: Change at C7 D1 (n=19, 21)Sexuality: Change at C8 D1 (n=8, 10)Sexuality: Change at C9 D1 (n=4, 6)Sexuality: Change at C10 D1 (n=0, 3)Sexuality: Change at C11 D1 (n=0, 1)Sexuality: Change at C12 D1 (n=0, 0)Sexuality: Change at C13 D1 (n=0, 0)Sexuality: Change at follow-up (n=36, 41)Health care(HC)satisfaction: Baseline (n=241, 247)HC satisfaction: Change at C2 D1 (n=182, 194)HC satisfaction: Change at C3 D1 (n=135, 149)HC satisfaction: Change at C4 D1 (n=97, 108)HC satisfaction: Change at C5 D1 (n=66, 59)HC satisfaction: Change at C6 D1 (n=40, 39)HC satisfaction: Change at C7 D1 (n=27, 20)HC satisfaction: Change at C8 D1 (n=12, 11)HC satisfaction: Change at C9 D1 (n=6, 6)HC satisfaction: Change at C10 D1 (n=2, 3)HC satisfaction: Change at C11 D1 (n=1, 1)HC satisfaction: Change at C12 D1 (n=1, 0)HC satisfaction: Change at C13 D1(n=1, 0)HC satisfaction: Change at follow-up (n=46, 45)Body Image: Baseline (n=249, 251)Body Image: Change at C2 D1 (n=189, 200)Body Image: Change at C3 D1 (n=142, 149)Body Image: Change at C4 D1 (n=97, 111)Body Image: Change at C5 D1 (n=70, 62)Body Image: Change at C6 D1 (n=40, 42)Body Image: Change at C7 D1 (n=25, 24)Body Image: Change at C8 D1 (n=11, 12)Body Image: Change at C9 D1 (n=6, 6)Body Image: Change at C10 D1 (n=2, 3)Body Image: Change at C11 D1 (n=1, 1)Body Image: Change at C12 D1 (n=1, 0)Body Image: Change at C13 D1 (n=1, 0)Body Image: Change at follow-up (n=47, 45)Altered Bowel Habit: Baseline (n=250, 255)Altered Bowel Habit: Change at C2 D1 (n=193, 204)Altered Bowel Habit: Change at C3 D1 (n=143, 156)Altered Bowel Habit: Change at C4 D1 (n=98, 114)Altered Bowel Habit: Change at C5 D1 (n=68, 63)Altered Bowel Habit: Change at C6 D1 (n=40, 43)Altered Bowel Habit: Change at C7 D1 (n=25, 25)Altered Bowel Habit: Change at C8 D1 (n=11, 13)Altered Bowel Habit: Change at C9 D1 (n=6, 6)Altered Bowel Habit: Change at C10 D1 (n=2, 3)Altered Bowel Habit: Change at C11 D1 (n=1, 1)Altered Bowel Habit: Change at C12 D1 (n=1, 0)Altered Bowel Habit: Change at C13 D1 (n=1, 0)Altered Bowel Habit: Change at followup (n=47, 48)Ascites: Baseline (n=250, 256)Ascites: Change at C2 D1 (n=197, 207)Ascites: Change at C3 D1 (n=144, 158)Ascites: Change at C4 D1 (n=101, 114)Ascites: Change at C5 D1 (n=71, 65)Ascites: Change at C6 D1 (n=42, 45)Ascites: Change at C7 D1 (n=26, 26)Ascites: Change at C8 D1 (n=11, 14)Ascites: Change at C9 D1 (n=6, 6)Ascites: Change at C10 D1 (n=2, 3)Ascites: Change at C11 D1 (n=1, 1)Ascites: Change at C12 D1 (n=1, 0)Ascites: Change at C13 D1 (n=1, 0)Ascites: Change at follow-up (n=48, 48)Indigestion: Baseline (n=252, 257)Indigestion: Change at C2 D1 (n=198, 208)Indigestion: Change at C3 D1 (n=144, 159)Indigestion: Change at C4 D1 (n=101, 115)Indigestion: Change at C5 D1 (n=71, 65)Indigestion: Change at C6 D1 (n=41, 45)Indigestion: Change at C7 D1 (n=26, 26)Indigestion: Change at C8 D1 (n=11, 14)Indigestion: Change at C9 D1 (n=6, 6)Indigestion: Change at C10 D1 (n=2, 3)Indigestion: Change at C11 D1 (n=1, 1)Indigestion: Change at C12 D1 (n=1, 0)Indigestion: Change at C13 D1 (n=1, 0)Indigestion: Change at follow-up (n=48, 48)Flatulence: Baseline (n=249, 256)Flatulence: Change at C2 D1 (n=197, 206)Flatulence: Change at C3 D1 (n=146, 159)Flatulence: Change at C4 D1 (n=101, 115)Flatulence: Change at C5 D1 (n=70, 65)Flatulence: Change at C6 D1 (n=41, 45)Flatulence: Change at C7 D1 (n=25, 26)Flatulence: Change at C8 D1 (n=10, 14)Flatulence: Change at C9 D1 (n=5, 6)Flatulence: Change at C10 D1 (n=1, 3)Flatulence: Change at C11 D1 (n=0, 1)Flatulence: Change at C12 D1 (n=0, 0)Flatulence: Change at C13 D1 (n=0, 0)Flatulence: Change at follow-up (n=48, 46)Cachexia: Baseline (n=251, 253)Cachexia: Change at C2 D1 (n=197, 205)Cachexia: Change at C3 D1 (n=145, 157)Cachexia: Change at C4 D1 (n=101, 112)Cachexia: Change at C5 D1 (n=70, 64)Cachexia: Change at C6 D1 (n=40, 44)Cachexia: Change at C7 D1 (n=24, 26)Cachexia: Change at C8 D1 (n=10, 14)Cachexia: Change at C9 D1 (n=5, 6)Cachexia: Change at C10 D1 (n=1, 3)Cachexia: Change at C11 D1 (n=0, 1)Cachexia: Change at C12 D1 (n=0, 0)Cachexia: Change at C13 D1 (n=0, 0)Cachexia: Change at follow-up (n=48, 47)Side Effects: Baseline (n=209, 226)Side Effects: Change at C2 D1 (n=159, 181)Side Effects: Change at C3 D1 (n=113, 137)Side Effects: Change at C4 D1 (n=80, 102)Side Effects: Change at C5 D1 (n=54, 59)Side Effects: Change at C6 D1 (n=29, 40)Side Effects: Change at C7 D1 (n=17, 22)Side Effects: Change at C8 D1 (n=8, 11)Side Effects: Change at C9 D1 (n=3, 6)Side Effects: Change at C10 D1 (n=0, 3)Side Effects: Change at C11 D1 (n=0, 1)Side Effects: Change at C12 D1 (n=0, 0)Side Effects: Change at C13 D1 (n=0, 0)Side Effects: Change at follow-up (n=42, 42)Fear of Future Health (FH): Baseline (n=252, 250))Fear of FH: Change at C2 D1 (n=192, 201)Fear of FH: Change at C3 D1 (n=145, 155)Fear of FH: Change at C4 D1 (n=103, 113)Fear of FH: Change at C5 D1 (n=71, 64)Fear of FH: Change at C6 D1 (n=42, 44)Fear of FH: Change at C7 D1 (n=27, 25)Fear of FH: Change at C8 D1 (n=12, 12)Fear of FH: Change at C9 D1 (n=6, 6)Fear of FH: Change at C10 D1 (n=2, 3)Fear of FH: Change at C11 D1 (n=1, 1)Fear of FH: Change at C12 D1 (n=1, 0)Fear of FH: Change at C13 D1 (n=1, 0)Fear of FH:Change at follow-up (n=48, 45)Future Plan ability: Baseline (n=250, 249)Future Plan ability: Change at C2 D1 (n=192, 198)Future Plan ability:Change at C3 D1 (n=142, 153)Future Plan ability:Change at C4 D1 (n=101, 112)Future Plan ability:Change at C5 D1 (n=70, 62)Future Plan ability:Change at C6 D1 (n=42, 42)Future Plan ability: Change at C7 D1 (n=26, 24)Future Plan ability: Change at C8 D1 (n=11, 11)Future Plan ability: Change at C9 D1 (n=5, 6)Future Plan ability: Change at C10 D1 (n=1, 3)Future Plan ability: Change at C11 D1 (n=1, 1)Future Plan ability: Change at C12 D1 (n=1, 0)Future Plan ability: Change at C13 D1 (n=1, 0)Future Plan ability: Change at followup (n=48, 45)
Axitinib + Gemcitabine41.6-10.9-16.3-13.2-15.8-15.9-15.3-7.6-29.2-20.90.00.00.0-3.510.20.3-1.4-2.51.00.4-0.7-4.5-11.1-16.70.00.00.02.834.32.8-1.20.51.43.3-6.04.5-13.9-33.30.00.00.06.056.8-0.5-4.9-4.1-1.512.24.412.525.0NANANANA-3.278.00.10.2-4.31.0-6.7-4.3-16.716.7-33.3-33.3-33.3-33.3-0.728.54.94.96.74.88.312.021.233.3-8.30.00.00.013.120.33.06.26.68.39.66.01.513.9-8.316.716.70.06.038.7-8.6-8.3-5.0-8.5-3.2-14.1-18.2-11.1-16.70.00.00.05.629.4-0.30.2-4.00.51.6-3.80.0-5.6-16.70.00.00.07.637.91.23.2-1.3-1.0-1.6-1.3-10.00.033.3NANANA-0.733.14.24.61.20.5-2.1-0.715.016.70.0NANANA8.024.911.213.010.17.48.115.09.714.8NANANANA18.859.3-3.5-0.9-4.5-0.5-4.8-6.22.816.7-16.70.00.00.05.634.36.13.55.60.94.82.66.10.00.00.00.00.021.5
Placebo + Gemcitabine40.0-10.1-11.2-11.4-13.0-13.0-15.0-9.80.05.60.0NANA-3.610.8-2.0-2.5-2.4-2.6-3.2-4.9-4.2-13.3-8.40.0NANA-1.433.90.6-4.3-4.5-3.60.4-1.317.922.211.166.7NANA2.855.5-4.0-3.03.0-5.2-11.4-7.1-15.00.011.133.3NANA-23.278.31.85.4-0.20.8-0.46.77.6-5.65.60.0NANA-2.228.8-0.22.10.9-0.3-0.8-5.611.18.35.6-50.0NANA11.521.21.52.54.81.32.31.37.7-5.6-16.7-100.0NANA5.932.9-3.4-5.1-0.3-0.5-2.2-12.8-11.9-16.722.233.3NANA-2.124.0-2.4-5.2-4.1-4.6-1.5-1.32.411.122.20.0NANA1.434.02.60.22.31.0-1.5-3.82.45.6-11.10.0NANA2.233.60.6-3.3-6.2-8.3-5.3-5.1-4.72.80.0-16.6NANA6.427.45.84.74.93.6-1.4-1.0-3.0-1.90.0-33.4NANA13.261.1-9.6-11.6-15.9-10.9-14.4-13.35.616.711.10.0NANA-4.438.0-0.30.40.3-3.80.8-7.03.00.0-11.1-66.7NANA5.2

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Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. (NCT00471146)
Timeframe: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

,
InterventionMillimeter (mm) (Mean)
Baseline (n= 277, 281)Change at Cycle 2 Day 1 (n= 223, 226)Change at Cycle 3 Day 1 (n= 161, 171)Change at Cycle 4 Day 1 (n=122, 128)Change at Cycle 5 Day 1 (n= 90, 79)Change at Cycle 6 Day 1 (n= 56, 56)Change at Cycle 7 Day 1 (n= 36, 35)Change at Cycle 8 Day 1 (n= 16, 19)Change at Cycle 9 Day 1 (n= 9, 9)Change at Cycle 10 Day 1 (n= 3, 4)Change at Cycle 11 Day 1 (n= 1, 1)Change at Cycle 12 Day 1 (n= 1, 0)Change at Cycle 13 Day 1 (n= 1, 1)Change at follow-up (n= 62, 68)
Axitinib + Gemcitabine60.61.02.60.5-0.31.02.63.822.220.00.00.00.0-6.3
Placebo + Gemcitabine62.6-0.41.13.21.93.74.19.67.76.330.0NA36.0-4.8

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Overall Survival (OS)

Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). (NCT00471146)
Timeframe: Baseline until death or at least 1 year after the randomization of last participant

InterventionWeeks (Median)
Axitinib + Gemcitabine36.9
Placebo + Gemcitabine35.8

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Duration of Response (DR)

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. (NCT00471146)
Timeframe: Baseline until death or at least 1 year after the randomization of last participant

InterventionWeeks (Median)
Axitinib + Gemcitabine33.1
Placebo + GemcitabineNA

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Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile

"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state." (NCT00471146)
Timeframe: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

,
InterventionUnits on a scale (Mean)
Baseline (n=289, 290)Change at C2 D1 (n=231, 240)Change at C3 D1 (n=171, 178)Change at C4 D1 (n=128, 131)Change at C5 D1 (n=94, 80)Change at C6 D1 (n=57, 57)Change at C7 D1 (n=37, 36)Change at C8 D1 (n=17, 20)Change at C9 D1 (n=9, 9)Change at C10 D1 (n=3, 4)Change at C11 D1 (n=1, 1)Change at C12 D1 (n=1, 0)Change at C13 D1 (n=1, 1)Change at follow-up (n=65, 73)
Axitinib + Gemcitabine0.6650.0500.0530.0100.0100.0010.049-0.0210.0490.1810.0000.0000.000-0.148
Placebo + Gemcitabine0.6900.0200.0280.0500.0440.0580.0750.0710.1210.2080.058NA0.470-0.080

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Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score

BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. (NCT00471146)
Timeframe: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

,
InterventionUnits on a scale (Mean)
Worst Pain: Baseline (n=247, 250)Worst Pain: Change at C2 D1 (n=192, 200)Worst Pain: Change at C3 D1 (n=138, 151)Worst Pain: Change at C4 D1 (n=99, 113)Worst Pain: Change at C5 D1 (n=69, 64)Worst Pain: Change at C6 D1 (n=41, 43)Worst Pain: Change at C7 D1 (n=25, 26)Worst Pain: Change at C8 D1 (n=12, 13)Worst Pain: Change at C9 D1(n=6, 6)Worst Pain: Change at C10 D1 (n=2, 3)Worst Pain: Change at C11 D1 (n=1, 1)Worst Pain: Change at C12 D1 (n=1, 0)Worst Pain: Change at C13 D1 (n=1, 1)Worst Pain: Change at follow-up (n=47, 46)Pain in Last 24 Hours (hrs): Baseline (n=246, 248)Pain in Last 24 hrs: Change at C2 D1 (n=193, 197)Pain in Last 24 hrs: Change at C3 D1 (n=138, 150)Pain in Last 24 hrs: Change at C4 D1 (n=99, 112)Pain in Last 24 hrs: Change at C5 D1 (n=69, 63)Pain in Last 24 hrs: Change at C6 D1 (n=40, 43)Pain in Last 24 hrs: Change at C7 D1 (n=25, 26)Pain in Last 24 hrs: Change at C8 D1 (n=12, 13)Pain in Last 24 hrs: Change at C9 D1 (n=6, 6)Pain in Last 24 hrs: Change at C10 D1 (n=2, 3)Pain in Last 24 hrs: Change at C11 D1 (n=1, 1)Pain in Last 24 hrs: Change at C12 D1 (n=1, 0)Pain in Last 24 hrs: Change at C13 D1 (n=1, 1)Pain in Last 24 hrs: Change at followup (n=48, 45)Pain on the Average: Baseline (n=246, 248)Pain on the Average: Change at C2 D1 (n=195, 198)Pain on the Average: Change at C3 D1 (n=140, 149)Pain on the Average: Change at C4 D1 (n=99, 113)Pain on the Average: Change at C5 D1 (n=69, 63)Pain on the Average: Change at C6 D1 (n=40, 43)Pain on the Average: Change at C7 D1 (n=25, 26)Pain on the Average: Change at C8 D1 (n=12, 13)Pain on the Average: Change at C9 D1 (n=6, 6)Pain on the Average: Change at C10 D1 (n=2, 3)Pain on the Average: Change at C11 D1 (n=1, 1)Pain on the Average: Change at C12 D1 (n=1, 0)Pain on the Average: Change at C13 D1 (n=1, 1)Pain on the Average: Change at followup (n=48, 45)Pain Right Now: Baseline (n=248, 249)Pain Right Now: Change at C2 D1 (n=196, 200)Pain Right Now: Change at C3 D1 (n=140, 150)Pain Right Now: Change at C4 D1 (n=99, 113)Pain Right Now: Change at C5 D1 (n=68, 63)Pain Right Now: Change at C6 D1 (n=40, 43)Pain Right Now: Change at C7 D1 (n=25, 26)Pain Right Now: Change at C8 D1 (n=12, 13)Pain Right Now: Change at C9 D1 (n=6, 6)Pain Right Now: Change at C10 D1 (n=2, 3)Pain Right Now: Change at C11 D1 (n=1, 1)Pain Right Now: Change at C12 D1 (n=1, 0)Pain Right Now: Change at C13 D1 (n=1, 1)Pain Right Now: Change at follow-up (n=48, 46)Relief Pain Treatment (Tx): Baseline (n=226, 221)Relief Pain Tx: Change at C2 D1 (n=164, 165)Relief Pain Tx: Change at C3 D1 (n=122, 124)Relief Pain Tx: Change at C4 D1 (n=88, 92)Relief Pain Tx: Change at C5 D1 (n=59, 51)Relief Pain Tx: Change at C6 D1 (n=34, 33)Relief Pain Tx: Change at C7 D1 (n=21, 18)Relief Pain Tx: Change at C8 D1 (n=10, 8)Relief Pain Tx: Change at C9 D1 (n=5, 5)Relief Pain Tx: Change at C10 D1 (n=1, 2)Relief Pain Tx: Change at C11 D1 (n=0, 1)Relief Pain Tx: Change at C12 D1 (n=0, 0)Relief Pain Tx: Change at C13 D1 (n=0, 0)Relief Pain Tx: Change at follow-up (n=43, 36)General Activity: Baseline (n=243, 243)General Activity: Change at C2 D1 (n=190, 193)General Activity: Change at C3 D1 (n=135, 143)General Activity: Change at C4 D1 (n=97, 109)General Activity: Change at C5 D1 (n=66, 62)General Activity: Change at C6 D1 (n=40, 41)General Activity: Change at C7 D1 (n=25, 25)General Activity: Change at C8 D1 (n=12, 12)General Activity: Change at C9 D1 (n=6, 6)General Activity: Change at C10 D1 (n=2, 3)General Activity: Change at C11 D1 (n=1, 1)General Activity: Change at C12 D1 (n=1, 0)General Activity: Change at C13 D1 (n=1, 1)General Activity: Change at follow-up (n=47, 44)Mood: Baseline (n=243, 241)Mood: Change at C2 D1 (n=191, 191)Mood: Change at C3 D1 (n=135, 141)Mood: Change at C4 D1 (n=98, 106)Mood: Change at C5 D1 (n=66, 61)Mood: Change at C6 D1 (n=40, 41)Mood: Change at C7 D1 (n=25, 25)Mood: Change at C8 D1 (n=12, 12)Mood: Change at C9 D1 (n=6, 6)Mood: Change at C10 D1 (n=2, 3)Mood: Change at C11 D1 (n=1, 1)Mood: Change at C12 D1 (n=1, 0)Mood: Change at C13 D1 (n=1, 1)Mood: Change at follow-up (n=47, 44)Walking Ability: Baseline (n=242, 243)Walking Ability: Change at C2 D1 (n=189, 194)Walking Ability: Change at C3 D1 (n=133, 143)Walking Ability: Change at C4 D1 (n=97, 108)Walking Ability: Change at C5 D1 (n=66, 62)Walking Ability: Change at C6 D1 (n=41, 41)Walking Ability: Change at C7 D1 (n=25, 25)Walking Ability: Change at C8 D1 (n=12, 12)Walking Ability: Change at C9 D1 (n=6, 6)Walking Ability: Change at C10 D1 (n=2, 3)Walking Ability: Change at C11 D1 (n=1, 1)Walking Ability: Change at C12 D1 (n=1, 0)Walking Ability: Change at C13 D1 (n=1, 1)Walking Ability: Change at follow-up (n=47, 45)Normal Work: Baseline (n=240, 240)Normal Work: Change at C2 D1 (n=187, 191)Normal Work: Change at C3 D1 (n=133, 139)Normal Work: Change at C4 D1 (n=96, 107)Normal Work: Change at C5 D1 (n=65, 61)Normal Work: Change at C6 D1 (n=39, 41)Normal Work: Change at C7 D1 (n=25, 24)Normal Work: Change at C8 D1 (n=12, 12)Normal Work: Change at C9 D1 (n=6, 6)Normal Work: Change at C10 D1 (n=2, 3)Normal Work: Change at C11 D1 (n=1, 1)Normal Work: Change at C12 D1 (n=1, 0)Normal Work: Change at C13 D1 (n=1, 1)Normal Work: Change at follow-up (n=46, 43)Relations: Baseline (n=244, 242)Relations: Change at C2 D1 (n=190, 193)Relations: Change at C3 D1 (n=136, 142)Relations: Change at C4 D1 (n=98, 108)Relations: Change at C5 D1 (n=66, 62)Relations: Change at C6 D1 (n=40, 41)Relations: Change at C7 D1 (n=25, 25)Relations: Change at C8 D1 (n=12, 12)Relations: Change at C9 D1 (n=6, 6)Relations: Change at C10 D1 (n=2, 3)Relations: Change at C11 D1 (n=1, 1)Relations: Change at C12 D1 (n=1, 0)Relations: Change at C13 D1 (n=1, 1)Relations: Change at follow-up (n=47, 45)Sleep: Baseline (n=244, 242)Sleep: Change at C2 D1 (n=191, 193)Sleep: Change at C3 D1 (n=136, 142)Sleep: Change at C4 D1 (n=98, 107)Sleep: Change at C5 D1 (n=66, 62)Sleep: Change at C6 D1(n=39, 41)Sleep: Change at C7 D1 (n=25, 25)Sleep: Change at C8 D1 (n=12, 12)Sleep: Change at C9 D1 (n=6, 6)Sleep: Change at C10 D1 (n=2, 3)Sleep: Change at C11 D1 (n=1, 1)Sleep: Change at C12 D1 (n=1, 0)Sleep: Change at C13 D1 (n=1, 1)Sleep: Change at follow-up (n=47, 44)Enjoyment of Life: Baseline (n=242, 240)Enjoyment of Life: Change at C2 D1 (n=191, 191)Enjoyment of Life: Change at C3 D1 (n=134, 142)Enjoyment of Life: Change at C4 D1 (n=98, 107)Enjoyment of Life: Change at C5 D1 (n=66, 62)Enjoyment of Life: Change at C6 D1 (n=40, 41)Enjoyment of Life: Change at C7 D1 (n=25, 25)Enjoyment of Life: Change at C8 D1 (n=12, 12)Enjoyment of Life: Change at C9 D1 (n=6, 6)Enjoyment of Life: Change at C10 D1 (n=2, 3)Enjoyment of Life: Change at C11 D1 (n=1, 1)Enjoyment of Life: Change at C12 D1 (n=1, 0)Enjoyment of Life: Change at C13 D1 (n=1, 1)Enjoyment of Life: Change at follow-up (n=47, 43)Combined Pain Intensity(PI): Baseline (n=248, 251)Combined PI: Change at C2 D1 (n=196, 202)Combined PI: Change at C3 D1 (n=140, 151)Combined PI: Change at C4 D1 (n=99, 114)Combined PI: Change at C5 D1 (n=69, 64)Combined PI: Change at C6 D1 (n=41, 43)Combined PI: Change at C7 D1 (n=25, 27)Combined PI: Change at C8 D1 (n=12, 13)Combined PI: Change at C9 D1 (n=6, 6)Combined PI: Change at C10 D1 (n=2, 3)Combined PI: Change at C11 D1 (n=1, 1)Combined PI: Change at C12 D1 (n=1, 0)Combined PI: Change at C13 D1 (n=1, 1)Combined PI:Change follow-up (n=48, 47)Combined Pain Interference(Pf):Baseline(n=244,243)Combined Pf: Change at C2 D1 (n=191, 194)Combined Pf: Change at C3 D1 (n=136,143)Combined Pf: Change at C4 D1 (n=98,109)Combined Pf: Change at C5 D1 (n=66, 62)Combined Pf: Change at C6 D1 (n=41, 41)Combined Pf: Change at C7 D1 (n=25, 25)Combined Pf: Change at C8 D1 (n=12, 12)Combined Pf: Change at C9 D1 (n=6, 6)Combined Pf: Change at C10 D1 (n=2, 3)Combined Pf: Change at C11 D1 (n=1, 1)Combined Pf: Change at C12 D1 (n=1, 0)Combined Pf: Change at C13 D1 (n=1, 1)Combined Pf: Change at follow-up (n=47, 45)
Axitinib + Gemcitabine3.8-0.7-1.5-1.0-1.1-0.9-0.80.8-1.8-2.00.00.00.00.51.8-0.2-0.6-0.3-0.3-0.20.41.3-0.3-1.50.00.00.00.42.9-0.5-0.8-0.7-0.7-0.5-0.31.0-1.7-2.00.00.00.00.62.1-0.4-0.8-0.6-0.5-0.50.11.1-1.5-2.00.00.00.00.47.80.6-2.1-1.7-2.9-1.61.0-5.0-14.06.0NANANA0.23.2-0.6-1.1-0.4-0.8-0.6-0.50.1-2.2-2.50.00.00.01.03.0-0.6-1.0-0.3-0.7-0.60.00.6-1.3-1.00.00.00.00.92.20.1-0.20.30.10.51.10.7-1.0-2.00.00.00.00.93.5-0.4-0.6-0.2-0.70.20.5-0.3-1.5-0.50.00.00.01.02.3-0.3-0.4-0.2-0.6-0.30.80.6-1.21.00.00.00.00.73.3-1.1-1.6-1.2-1.3-1.5-0.20.6-2.31.00.00.00.00.53.5-0.6-0.7-0.6-0.6-0.40.40.8-0.50.50.00.00.00.22.7-0.4-0.9-0.6-0.6-0.5-0.11.0-1.3-1.90.00.00.00.53.0-0.5-0.8-0.4-0.6-0.40.30.4-1.4-0.50.00.00.00.7
Placebo + Gemcitabine3.7-0.9-0.9-0.9-1.2-1.0-0.9-1.5-1.3-0.30.0NA-4.00.01.7-0.3-0.3-0.0-0.2-0.1-0.0-0.20.20.34.0NA-1.00.82.8-0.5-0.5-0.6-0.6-0.9-0.5-1.4-1.7-1.0-3.0NA-2.00.42.1-0.5-0.6-0.5-0.3-0.5-0.2-0.6-0.30.75.0NA-5.0-0.06.90.40.1-0.91.80.5-3.2-11.6-16.60.00.0NANA-0.43.0-0.7-0.7-0.8-0.5-0.7-0.4-0.80.33.01.0NA-1.00.02.8-0.2-0.5-0.9-0.9-0.8-0.2-1.1-0.83.35.0NA-3.00.22.3-0.1-0.3-0.4-0.3-0.2-0.1-1.30.21.30.0NA-2.00.73.2-0.1-0.4-0.7-0.6-0.2-0.4-0.13.51.32.0NA-2.00.31.90.0-0.0-0.1-0.1-0.1-0.7-0.90.82.72.0NA-2.00.83.2-0.9-1.1-1.2-0.8-0.8-0.6-1.20.30.74.0NA-5.0-0.33.4-0.5-0.7-0.9-0.8-1.0-0.9-0.80.22.3-1.0NA-4.0-0.22.6-0.5-0.6-0.5-0.6-0.6-0.4-0.9-0.8-0.11.5NA-3.00.22.8-0.4-0.5-0.7-0.6-0.6-0.5-0.90.72.11.9NA-2.70.3

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Chemotherapy Completion Rate

Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy. (NCT00476086)
Timeframe: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle

Interventionpercentage of participants (Number)
Oxaliplatin/ Gemcitabine Then Radiation100

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Radiation Therapy Completion Rate

Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease (NCT00476086)
Timeframe: Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.

Interventionpercentage of participants (Number)
Oxaliplatin/ Gemcitabine Then Radiation79

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Safety and Efficacy of Same-day Pegfilgrastim

Determined the number of participants who had either a fever due to abnormally low level of neutrophils, a type of white blood cell, on the day of study drug treatment, or the participants who had the study drug treatment delayed due to an abnormally low level of neutrophils. (NCT00478361)
Timeframe: Up to 3 years

Interventionparticipants (Number)
Neutropenic FeverTreatment Delay
Gemcitabine, Paclitaxel and Doxorubicin40

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Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease

The overall survival was determined by grouping participants based upon their response based on RECIST. The groups are Complete Response(CR): All the cancerous lesion disappear, Partial Response (PR): All the measured lesions decrease by at least 30 percent, and Stable Disease(SD): No significant change in the disease burden. OS of complete response or partial response participants were compared to the reference group of stable disease participants in a Hazard Ratio(HR). If HR is greater than 1, the experimental group has a better outcome than the reference group. If HR is less than 1, the reference group has the better outcome. (NCT00478361)
Timeframe: Registration Date of each participant for up to three years or death whichever came first

InterventionHazard Ratio (Number)
Complete ResponsePartial Response
Gemcitabine, Paclitaxel and Doxorubicin0.251.09

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Objective Response Rate

The percentage of participants with either Complete Response (CR) or Partial Response (PR) in their disease burden based upon the rules of the Response Evaluation Criteria in Solid Tumors (RECIST). A participant with of all of the lesions disappearing is a CR. A participant with at least a 30 percent decrease in the measured lesions is a PR. (NCT00478361)
Timeframe: Up to 12 weeks, or following completion 6 cycles of chemotherapy, respectively; the best response achieved within 6 cycles of starting chemotherapy used to calculate response rate.

Interventionpercentage of participants (Number)
Gemcitabine, Paclitaxel and Doxorubicin56.4

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Duration of Response

Duration of response was defined as the number of days between the date of first tumor response assessment of objective response to the time of the first tumor response assessment of progressive disease (PD) or death due to any cause (date of first PD assessment or death - date of first objective response assessment + 1) (NCT00481871)
Timeframe: Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study

Interventiondays (Median)
Phase 1174
Phase 2 - Group B210
Phase 2 - Group C170

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Objective Responses Assessed by International Workshop Criteria (IWC)

Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done. (NCT00481871)
Timeframe: Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I

Interventionparticipants (Number)
Phase 18
Phase 2 - Group B5
Phase 2 - Group C7

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Progression-free Survival (PFS) Time

PFS time was calculated as the number of days from study day 1 to the date of PD or death, regardless of cause (date of PD or death - study day 1 + 1). (NCT00481871)
Timeframe: Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study

Interventiondays (Median)
Phase 153.0
Phase 2 - Group B59.0
Phase 2 - Group C54.0

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Overall Response

Number of participants with complete or partial response. Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response: disappearance all target lesions; Partial Response: >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: >20% increase sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease: Insufficient shrinkage for partial response, or insufficient increase for progressive disease, reference smallest sum LD since treatment started. (NCT00491075)
Timeframe: Baseline to 8 weeks (after 4 cycles) protocol response at 16 weeks

Interventionpercentage of participants (Number)
Pemetrexed + Gemcitabine6.7

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Duration of Overall Response

Duration of overall response was calculated as the time (days) from first documentation of CR or PR (whichever status is recorded first) until the first date that recurrent or progressive disease (PD) or death is objectively documented. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions. (NCT00493636)
Timeframe: Period measured from the first documentation of complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease or death is objectively documented.

InterventionDays (Median)
A (Sorafenib + Gemcitabine or Capecitabine)94
B (Placebo + Gemcitabine or Capecitabine)147

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Overall Survival

(NCT00493636)
Timeframe: From the date of randomization to date of death due to any cause, assessed up to 56 months.

InterventionDays (Median)
A (Sorafenib + Gemcitabine or Capecitabine)407
B (Placebo + Gemcitabine or Capecitabine)348

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Time to Progression

(NCT00493636)
Timeframe: Calculated as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier), assessed up to 39 months.

InterventionDays (Median)
A (Sorafenib + Gemcitabine or Capecitabine)111
B (Placebo + Gemcitabine or Capecitabine)82

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Progression Free Survival

(NCT00493636)
Timeframe: From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.

InterventionDays (Median)
A (Sorafenib + Gemcitabine or Capecitabine)103
B (Placebo + Gemcitabine or Capecitabine)81

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Overall Response Rate

Overall response rate was defined as the proportion of participants experiencing complete response (CR) and partial response (PR) as best overall response. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions. (NCT00493636)
Timeframe: The overall tumor burden at baseline will be compared with subsequent measurements up to the date of first documented disease progression or the date of death due to any cause, if before progression, assessed up to 39 months.

Interventionpercentage of participants (Number)
A (Sorafenib + Gemcitabine or Capecitabine)19.8
B (Placebo + Gemcitabine or Capecitabine)12.7

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Objective Response Rate (ORR)

Objective response defined as Complete Response + Partial Response, with response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response: The disappearance of all target lesions. Partial Response: >30% decrease in the sum of the longest diameter of target lesions, reference baseline sum longest diameter. Progressive Disease: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since the treatment started. (NCT00496587)
Timeframe: 12 months or until progression of disease

Interventionpercentage of participants (Number)
Capecitabine + Gemcitabine + Bevacizumab20

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Progression Free Survival (PFS)

Event or disease-free survival given as progression free survival (PFS) which was defined as the length of time after primary treatment that the participant survives without disease progression. Evaluation of response will follow the Response Evaluation Criteria in Solid Tumors (RECIST) where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline. (NCT00496587)
Timeframe: 12 months or until progression of disease

InterventionMonths (Median)
Capecitabine + Gemcitabine + Bevacizumab5.5

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Time to Treatment Failure (TTF)

Time to treatment failure, TTF, with failure defined as death or disease progression where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline. (NCT00496587)
Timeframe: 12 months or until progression of disease

InterventionMonths (Median)
Capecitabine + Gemcitabine + Bevacizumab4.2

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Response Rate (RR)

Number of participants per response category. Response to treatment was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (NCT00499109)
Timeframe: 6 months

,
Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)
C. Standard of Care Control Arm031
E. Dual Agent Chemotherapy064

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Progression Free Survival (PFS)

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. The data of first documented disease progression or death, as defined by Response Evaluation Criteria In Solid Tumors (RECIST), was recorded, and the time interval from randomization to that date was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the PFS at 6 months. (NCT00499109)
Timeframe: 6 months

Interventionestimated percentage of participants (Number)
E. Dual Agent Chemotherapy52
C. Standard of Care Control Arm56.5

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Overall Survival (OS)

OS at 12 months, determined from the date of randomization. The time interval from randomization to the date of death was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the overall survival. (NCT00499109)
Timeframe: 12 months

Interventionestimated percentage of participants (Number)
E. Dual Agent Chemotherapy46.1
C. Standard of Care Control Arm46.6

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Median Progression-Free Survival

Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first. (NCT00503906)
Timeframe: Up to 24 months

Interventionmonths (Median)
Abraxane, Avastin and Gemcitabine10.4

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Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants

Rates of partial response (PR), complete response (CR) and overall response (PR+CR = ORR) in study participants according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. (NCT00503906)
Timeframe: After two cycles, about 60 days

Interventionpercentage of participants (Number)
Overall Response Rate (ORR)Complete Response (CR)Partial Response (PR)
Abraxane, Avastin and Gemcitabine75.627.648.3

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Rate of Toxicity in Study Participants

Determination of safety and side effect profile of the protocol therapy including the rate of toxicity in study participants. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting. (NCT00503906)
Timeframe: Over the course of study treatment.

Interventionpercentage of participants (Number)
Alopecia, Grade 1/2Fatigue, Grade 1/2Bone Pain, Grade 1/2Nausea, Grade 1/2Skin rash/lesions, Grade 1/2Neutropenia, Grade 1/2Grade 3/4 Toxicities
Abraxane, Avastin and Gemcitabine65.537.9313127.610.327.6

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Rate of Overall Survival in Study Participants

Rate of overall survival in study participants. Overall survival will be measured from the date of enrollment to the date of death from any cause, or the date of last contact (censored observations.) (NCT00503906)
Timeframe: 18 months

Interventionpercentage of participants (Median)
Abraxane, Avastin and Gemcitabine77.2

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Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)

The outcome measure is mean change in the Trial Outcome Index (TOI) between baseline and each follow-up assessment measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L). The FACT-L instrument consists of 34 items to assess physical (PWB), social and family (SWB), emotional (EWB), functional well-being (FWB) and additional lung specific concerns (LCS). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. The TOI is the sum of PWB (7 items), FWB (7 items) and LCS scores (7 items), which each have a possible range between 0 and 28. Therefore, TOI ranges from 0 to 84. (NCT00509366)
Timeframe: Baseline, Every 21 days for a maximum of 6 cycles

Interventionunits on a scale (Mean)
Change from baseline to Cycle 1Change from baseline to Cycle 2Change from baseline to Cycle 3Change from baseline to Cycle 4Change from baseline to Cycle 5Change from baseline to Cycle 6
Treatment0.15-1.04-1.28-2.62-6.14-0.72

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Median Time to Progressive Disease

Median time to progressive disease was defined as the time from enrollment to the the time at which 50% of patients had experienced disease progression. Enrollment is defined as having successful genomic analysis and start of chemotherapy. Time was censored at date of death for patients who have not had documented disease progression, at first available date of other anti-tumor therapy for patients who were either administered other anti-tumor therapy prior to documented disease progression or administered other anti-tumor therapy without documented disease progression, and at last date of followup if neither non-protocol therapy was administered nor progression documented. (NCT00509366)
Timeframe: 1 Year

Interventionmonths (Number)
Treatment4.60

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1-year Progression Free Survival Rate in Chemo-naive Select Stage IIIB or Stage IV NSCLC Patients

One-year progression-free survival was defined from the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The one-year progression free survival rate is a percentage, representing the fraction of treated patients who, after one-year, are disease free or alive. (NCT00509366)
Timeframe: 1 year

Interventionpercentage of treated patients (Number)
Treatment19.15

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Number of Patients Who Had Greater Than Grade 2 Toxicity

(NCT00509665)
Timeframe: from time of initial treatment until end of study, an average of 6 months

InterventionParticipants (Count of Participants)
Gemcitabine+Doxorubicin10

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Overall Survival

(NCT00509665)
Timeframe: From the time of initial therapy until the time of death.

InterventionMonths (Median)
Gemcitabine+Doxorubicin5.6

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Response Rate

Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above. (NCT00509665)
Timeframe: Every 6 weeks from the time of initial treatment for up to 8 months

Interventionparticipants (Number)
Gemcitabine+Doxorubicin4

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Progression-free Survival

(NCT00509665)
Timeframe: Through the end of follow up, for an average of 8 months

Interventionmonths (Median)
Gemcitabine+Doxorubicin1.6

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Time to Progression (TTP)

Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP. (NCT00517595)
Timeframe: TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), assessed up to 15 months.

InterventionMonths (Median)
Pemetrexed, Gemcitabine, and Bevacizumab5.56

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Progression Free Survival (PFS)

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median progression free survival is the parameter used to describe PFS. (NCT00517595)
Timeframe: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.

InterventionMonths (Median)
Pemetrexed, Gemcitabine, and Bevacizumab4.90

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Overall Survival (OS)

Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. (NCT00517595)
Timeframe: OS was measured from day 1 of treatment until time of death, assessed up to 20 months.

InterventionMonths (Median)
Pemetrexed, Gemcitabine, and Bevacizumab8.78

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Progression Free Survival (PFS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. The median progression free survival is the parameter used to describe PFS. ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment). (NCT00517595)
Timeframe: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.

InterventionMonths (Median)
Baseline ECOG performance status 0 (N=18)Baseline ECOG performance status 1 (N=30)
Pemetrexed, Gemcitabine, and Bevacizumab7.574.67

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Overall Survival (OS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status

Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment). (NCT00517595)
Timeframe: OS was measured from day 1 of treatment until time of death, assessed up to 20 months.

InterventionMonths (Median)
Baseline ECOG performance status 0 (N=18)Baseline ECOG performance status 1 (N=30)
Pemetrexed, Gemcitabine, and Bevacizumab19.876.71

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Overall Response

Response was evaluated via changes from baseline in radiological tumor measurements performed after every 4th treatment cycle and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions. (NCT00517595)
Timeframe: Response to treatment was assessed after every 8 weeks of treatment, up to 50 weeks.

InterventionParticipants (Number)
Complete response (CR)Partial response (PR)Stable disease (SD)Progressive disease (PD)Not evaluable (NE)
Pemetrexed, Gemcitabine, and Bevacizumab0172164

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Disease Control Rate

Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00518011)
Timeframe: Up to 2 years

InterventionPercentage of participants (Number)
Gemcitabine50
Erlotinib + Gemcitabine85.7

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Mean Change in Pulse Rate From Baseline

Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value (NCT00518011)
Timeframe: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)

,
Interventionbeats per minute (Mean)
Cycle 1 (n=8, 8)Cycle 2 (n=7, 6)Cycle 3 (n=4, 5)Cycle 4 (n=1, 5)Cycle 5 (n=1, 3)Cycle 6 (n= 1, 2)
Erlotinib + Gemcitabine3.00-3.00-1.801.80-9.006.00
Gemcitabine2.373.002.7518.00-6.004.00

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Duration of Response

Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death. (NCT00518011)
Timeframe: Up to 2 years

InterventionWeek (Mean)
Erlotinib + Gemcitabine16.3

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Mean Change in Body Temperature From Baseline

Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value. (NCT00518011)
Timeframe: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)

,
InterventionFahrenheit (Mean)
Cycle 1 (n=8, 8)Cycle 2 (n=7, 6)Cycle 3 (n=4, 5)Cycle 4 (n=1, 5)Cycle 5 (n=1, 3)Cycle 6 (n=1, 2)
Erlotinib + Gemcitabine-0.012-0.30-0.32-0.24-0.46-0.20
Gemcitabine-0.020.14-0.07-0.60-0.70-0.20

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Progression Free Survival

Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first. (NCT00518011)
Timeframe: Up to 2 years

InterventionWeek (Median)
Gemcitabine23.3
Erlotinib + Gemcitabine24.4

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Mean Change in Blood Pressure From Baseline

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value. (NCT00518011)
Timeframe: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)

,
Interventionmm Hg (Mean)
SBP at Cycle 1 (n=8, 8)DBP at Cycle 1 (n=8, 8)SBP at Cycle 2 (n=7, 6)DBP at Cycle 2 (n=7, 6)SBP at Cycle 3 (n=4, 5)DBP at Cycle 3 (n=4, 5)SBP at Cycle 4 (n=1, 5)DBP at Cycle 4 (n=1, 5)SBP at Cycle 5 (n=1, 3)DBP at Cycle 5 (n=1, 3)SBP at Cycle 6 (n=1, 2)DBP at Cycle 6 (n=1, 2)
Erlotinib + Gemcitabine-0.87-5.37-17.83-9.50-17.20-9.20-10.20-1.60-1.660.665.00-0.50
Gemcitabine3.00-6.87-4.85-10.71-9.00-8.25-18.00-4.0028.0012.0010.005.00

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Objective Response Rate

Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. (NCT00518011)
Timeframe: Up to 2 years

InterventionPercentage of participants (Number)
Gemcitabine0
Erlotinib + Gemcitabine28.6

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Overall Survival

Overall survival was defined as the interval between the date of randomization to the date of death from any cause. (NCT00518011)
Timeframe: Up to 2 years

InterventionWeek (Median)
Gemcitabine21.1
Erlotinib + Gemcitabine39.0

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Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer

The best overall response the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], unconfirmed CR, unconfirmed PR, stable disease [SD], and progressive disease[PD]) among all overall responses recorded from the start of treatment until the subject withdrew from the study. If there was no tumor assessment after the first infusion of study drug and no clinical disease progression recorded, the best overall response was classified as Unknown. CR was defined as the disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, PD was defined as at least a 20% increase in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease PD according to RECIST guideline (version 1.1). (NCT00521404)
Timeframe: Baseline to up to date of first documented objective response or disease progression (whichever occurs first), up to approximately 36 months post dose.

InterventionParticipants (Count of Participants)
Confirmed CRConfirmed PRObjective Response (confirmed CR or PR)Unconfirmed CRUnconfirmed PRStable Disease (SD)Progressive Disease (PD)Unknown
CS-1008 + Gemcitabine05503281411

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Progression-Free Survival Rate at 16 Weeks Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer

Progression-free survival rate (PFS) was defined as the time from the date of the first administration of the study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first at 16 weeks post-treatment with CS-1008. (NCT00521404)
Timeframe: Baseline to the date of disease progression or death due to any cause (whichever occurs first), up to 16 weeks post dose.

InterventionPercentage of participants (Number)
CS-1008 + Gemcitabine52.5

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Kaplan-Meier (Non-Parametric) Analysis of Progression-Free Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer

PFS (Progression-free survival) was defined as the time from the date of the first administration of study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first. (NCT00521404)
Timeframe: Baseline up to date of disease progression or death due to any cause (whichever occurs first), up to approximately 36 months post dose.

InterventionPercentage of participants (Number)
PFS Rate at 3 Months (%)PFS Rate at 6 Months (%)PFS Rate at 9 Months (%)PFS Rate at 1 Year (%)
CS-1008 + Gemcitabine59.034.421.313.1

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Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer

OS (Overall Survival) was defined as the time from the date of the first administration of study drug (Day 1) to the date of death. If there was no death reported for a subject before the cut-off date for overall survival analysis, overall survival was censored at the last contact date at which the subject was known to be alive. (NCT00521404)
Timeframe: Baseline to death due to any cause, up to approximately 36 months post dose.

InterventionPercentage of participants (Number)
OS Rate at 6 Months (%)OS Rate at 9 Months (%)OS Rate at 1 Year (%)OS Rate at 15 Months (%)
CS-1008 + Gemcitabine55.741.024.613.1

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Objective Response Rate

Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR. (NCT00523640)
Timeframe: 12 weeks

Interventionproportion (Number)
Combination of Gemcitabine, Capecitabine, and Bevacizumab0.24

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Overall Survival

Time from enrollment until death from any cause. (NCT00523640)
Timeframe: 60 months

Interventionmonths (Median)
Combination of Gemcitabine, Capecitabine, and Bevacizumab9.8

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Progression-free Survival

Progression is defined as a measurable increase in the sum of longest diameters of all target lesions, or unequivocable progression of non-target lesions, or the appearance of new lesions, since baseline (NCT00523640)
Timeframe: 60 months

Interventionmonths (Median)
Combination of Gemcitabine, Capecitabine, and Bevacizumab5.3

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Two-year Progression-free Survival From the Date of Surgery

Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 25% increase or an increase of 10 cm2 (whichever is smaller) in the sum of the products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation or death, or deteriorating condition (unless clearly unrelated to this cancer). (NCT00530634)
Timeframe: 2 years post-surgery

Interventionpercentage of participants (Number)
Gemcitabine + Cisplatin67.6

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Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy

(NCT00536874)
Timeframe: Baseline and 2 years

Interventionng/ml (Median)
CEA (Pre-Therapy)CEA (Post-Therapy)
Gemcitabine And Oxaliplatin4.24.2

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Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy

(NCT00536874)
Timeframe: Baseline and 2 years

InterventionU/ml (Median)
Ca 19-9 (Pre-Therapy)Ca 19-9 (Post-Therapy)
Gemcitabine And Oxaliplatin133132

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RECIST Radiologic Response to Neoadjuvant Therapy

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR (NCT00536874)
Timeframe: 2 years

Interventionparticipants (Number)
Partial ResponseStable DiseaseProgression of DiseaseInevaluable
Gemcitabine And Oxaliplatin42833

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Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy

Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy (NCT00536874)
Timeframe: Baseline and 2 years

Interventionpercent change (Median)
Gemcitabine And Oxaliplatin-5.1

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Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy

Percent change in specific tumor marker (Cancer Antigen 19-9, Ca 19-9) levels in response to neoadjuvant therapy (NCT00536874)
Timeframe: Baseline and 2 years

Interventionpercent change (Median)
Gemcitabine And Oxaliplatin-25.6

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Overall Survival at 18 Months

Percentage of participants that were alive or survived at 18 months after randomization (NCT00536874)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Gemcitabine And Oxaliplatin63

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Overall Survival (Follow-Up Time)

(NCT00536874)
Timeframe: From Baseline until 2 Years and Follow-Up, up to 120 months

Interventionmonths (Median)
Gemcitabine And Oxaliplatin39.6

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Determination of Maximum Tolerated Dose (MTD), The Dose of Study Drug(s) Which Causes <33% of Patients Treated to Experience Unacceptable Side Effects

"Unacceptable side effects or dose-limiting toxicities (DLTs) were defined as follows:~Inability to Complete cycle 1 of therapy due to drug-related toxicity.~> Grade 3 non-hematological drug-related toxicity (excluding alopecia) despite optimal supportive care~Febrile neutropenia (absolute neutrophil count [ANC] <1,000/μL and fever >101° F (38.5° C))~Grade 4 neutropenia that occurs prior to day 21. (Grade 4 neutropenia that occurs after day 21 but resolves within 7 days of the scheduled cycle 2, will not be considered DLT)~Platelet count < 25,000/μL~Inability to initiate Cycle 2, Day 1 therapy within 7 days of scheduled start (i.e. cannot delay the start of Cycle 2 by more than 7 days following the normal 7 day recovery period) due to drug-related toxicity." (NCT00540579)
Timeframe: 6 months

Interventionmilligrams (Number)
PomalidomideGemcitabine
Pomalidomide/Gemcitabine101000

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The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0

The relative incidence of Grade 3/4 adverse events from protocol treatment as defined by Common Terminology Criteria for Adverse Events v3.0 (CTCAE) (NCT00540579)
Timeframe: 24 Months

Interventionpercentage of patients (Number)
Pomalidomide/Gemcitabine39

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Overall Response

Complete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial response (PR): Greater than or equal 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline. Overall Response (OR) = CR + PR. (NCT00544414)
Timeframe: 30 days after last course of treatment

InterventionParticipants (Count of Participants)
Treatment28

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Progression-free Survival

Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 50% increase or an increase of 10 cm^2 (whichever is smaller) in the sum of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition. Progression-free survival defined as from first day of treatment until the date of first documented progression or date of death from any cause, whichever came first. If failure has not occurred, failure time is censored at the time of last follow-up. (NCT00544414)
Timeframe: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 171 months

InterventionMonths (Median)
Treatment170.5

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Time to Treatment Failure

Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a nonprotocol failure, the patient will be censored on the date they are removed from treatment. The time to treatment failure will be estimated using the method of Kaplan-Meier. (NCT00550836)
Timeframe: Up to 2 years

Interventionmonths (Median)
Arm A: GE2.0
Arm B: PGE3.8

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Confirmed Response Rate

Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants. (NCT00550836)
Timeframe: Up to 2 years

Interventionrate of confirmed response (Number)
Arm A: GE0.087
Arm B: PGE0.065

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Frequency and Severity of Observed Adverse Effects

"Patients are assessed for Adverse events each cycle using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). The maximum grade for each type of adverse event will be recorded for each patient, and tables will be reviewed to determine adverse event patterns. The number of patients in each arm that reported a grade 3 or higher adverse event and a grade 4 or higher adverse event are reported.~A complete listing of all adverse events is reported in the Adverse Events section." (NCT00550836)
Timeframe: Up to 2 years

,
Interventionparticipants (Number)
Grade 3+ Adverse EventGrade 4+ Adverse Event
Arm A: GE4115
Arm B: PGE4114

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Overall Survival

Overall Survival is defined as the time from registration to death due to any cause. The estimate will be done using the Kaplan-Meier method. The primary goal of this trial is to compare the experimental arm (Arm B) to the standard arm (Arm A). The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves. (NCT00550836)
Timeframe: Up to 2 years

Interventionmonths (Median)
Arm A: GE4.2
Arm B: PGE8.3

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Progression-free Survival

Progression-free survival is defined as the time from randomization to documentation of disease progression or death, whichever comes first. Progression is defined as at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. The progression-free survival curves will be compared between the 2 arms using a log-rank test. (NCT00550836)
Timeframe: Up to 2 years

Interventionmonths (Median)
Arm A: GE2.0
Arm B: PGE3.6

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To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy.

(NCT00556049)
Timeframe: Until disease progression

Interventionpercentage of participants (Number)
Treatment25

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Radiographic Tumor Response

CT scans evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST) (NCT00557492)
Timeframe: Up to 48 months

InterventionParticipants (Number)
metastatic progression (at restaging)stable diseasepartial responseprogressive disease
FDR GEM + BEV +/- BEV/RT439510

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Rate of Surgical Resection

Number of participants that underwent resection / per the total number of evaluable participants (NCT00557492)
Timeframe: Up to 48 months

Interventionpercentage of participants (Number)
FDR GEM + BEV +/- BEV/RT74

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Rate of Pathologic Complete Response (pCR)

Rate of pathologic complete response (pCR) is no residual invasive tumor, in situ carcinoma can be present, and no residual lymph node metastasis. Rate of pCR is the number of participants who underwent laparoscopy and pancreatic resections that experienced complete pathologic response/total number of participants who underwent laparoscopy and pancreatic resections. (NCT00557492)
Timeframe: Up to 48 months

Interventionpercentage of participants (Number)
FDR GEM + BEV +/- BEV/RT2.3

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Rate of Margin Negative Surgical Resection (R0 Resection Rate)

Number of participants who underwent laparoscopy and pancreatic resections that were margin negative/total number of participants who underwent laparoscopy and pancreatic resections. (NCT00557492)
Timeframe: Up to 48 months

Interventionpercentage of participants (Number)
FDR GEM + BEV +/- BEV/RT88

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Progression-free Survival (PFS)

(NCT00557492)
Timeframe: Up to 48 months

Interventionmonths (Median)
FDR GEM + BEV +/- BEV/RT6.6
FDR GEM + BEV +/- BEV/RT12.9

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Ca 19-9 Level (in Serum) - Biomarker Response

Percentage decrease in Ca 19-9 level (in serum) (NCT00557492)
Timeframe: Baseline and up to 48 months

Interventionpercentage decrease in serum Ca19-9 leve (Mean)
FDR GEM + BEV +/- BEV/RT25

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Overall Survival (OS)

(NCT00557492)
Timeframe: Up to 48 months

Interventionmonths (Number)
FDR GEM + BEV +/- BEV/RT16.8
FDR GEM + BEV +/- BEV/RT19.7

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Maximum Tolerated Dose (MTD)

The MTD was defined as the highest dose level below the maximum administered dose which caused 0 or 1 out of 6 participants to experience a DLT in that given cohort at Cycle 1 (NCT00560573)
Timeframe: Cycle 1, up to Day 21

Interventionmg/kg (Number)
Overall Population20

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Serum Total Circulating Insulin-like Growth Factor (IGF-1) Levels

To monitor serum total IGF-1 levels as a potential pharmacodynamic response to figitumumab treatment (NCT00560573)
Timeframe: Baseline, Day 8, end of study

Interventionng/mL (Mean)
BaselineEnd of study
Overall Population124.88543.63

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Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab

Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab (NCT00560573)
Timeframe: 30 min prior to figitumumab infusion in Cycle 1 and Cycle 4, end of study, fourth follow up visit (approximately 150 days after last dose)

,,,,,
InterventionPercentage of participants (Number)
C1D1 - NegativeC1D1 - PositiveC1D1 - Not determinedC4D1 - NegativeC4D1 - PositiveC4D1 - Not determinedEnd of Study - NegativeEnd of Study - PositiveEnd of Study - Not determinedFollow Up - NegativeFollow Up - PositiveFollow Up - Not determined
Figitumumab 10 mg/kg33.3066.7001000010000100
Figitumumab 20 mg/kg Dose Escalation50.0050.050.0050.050.0050.000100
Figitumumab 20 mg/kg Pemetrexed Expansion1000053.8046.246.2053.800100
Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion80.0020.030.0070.020.0080.000100
Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion1000071.4028.642.9051.714.3085.7
Figitumumab 6 mg/kg50.0050.016.7083.383.3016.700100

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Progression-Free Survival (PFS)

Time from the date of enrollment to date of documented disease progression, or death due to any cause (NCT00560573)
Timeframe: Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)

Interventionmonths (Median)
Overall Population5.7
Figitumumab 20 mg/kg With Gemcitabine and Cisplatin6.5
Figitumumab 20 mg/kg Expansion With Pemetrexed5.4

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Percentage of Participants With Objective Response or Prolonged Stabilization

Percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 12 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants with non measurable disease were considered having a clinical benefit response only in the case of achievement of CR. Participants who developed early progressive disease post dosing and prior to response evaluation were considered to have progressed on study. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response (NCT00560573)
Timeframe: Screening, from Cycle 2 onwards computerized tomography (CT) scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)

InterventionPercentage of participants (Number)
Overall Population53.3
Figitumumab 20 mg/kg With Gemcitabine and Cisplatin56.5
Figitumumab 20 mg/kg Expansion With Pemetrexed46.2

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Number of Participants With Dose-limiting Toxicities (DLT)

Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count <500 cells/cubic millimeter [mm^3]) >=7 days, febrile neutropenia (Gr 3, fever >=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet <25,000 cells/mm^3), Gr 3 thrombocytopenia >=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment (NCT00560573)
Timeframe: Start of treatment up to end of Cycle 1, Day 21

Interventionparticipants (Number)
Figitumumab 6 mg/kg0
Figitumumab 10 mg/kg0
Figitumumab 20 mg/kg Dose Escalation1

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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Figitumumab PK data was analyzed using noncompartmental methods (NCT00560573)
Timeframe: 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 1 for dose escation and 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 4 for expansion

Interventionmg*hr/L (Mean)
Figitumumab 6 mg/kg26020
Figitumumab 10 mg/kg21500
Figitumumab 20 mg/kg Dose Escalation84100
Figitumumab 20 mg/kg Expansion121200

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Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab

Concentration at the end of Cycle 4 (NCT00560573)
Timeframe: 0 (pre-dose) in Cycle 5 Day 1

Interventionmg/L (Mean)
Figitumumab 20 mg/kg Expansion113.6

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Maximum Observed Plasma Concentration (Cmax) for Gemcitabine

Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle) 1 and presence (Cycle 2) of figitumumab (NCT00560573)
Timeframe: 0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8

Interventionng/L (Mean)
Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)12.85
Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)23.97

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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Gemcitabine

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab (NCT00560573)
Timeframe: 0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8

Interventionng*hr/L (Mean)
Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)6.665
Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)12.53

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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Pemetrexed

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab (NCT00560573)
Timeframe: 0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2

Interventionng*hr/L (Mean)
Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)132.2
Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)161.6

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Concentration at the End of Infusion (Cinf) for Figitumumab

Figitumumab pharmacokinetic (PK) data was analyzed using noncompartmental methods (NCT00560573)
Timeframe: Cycle 1 for dose escalation and Cycle 4 for dose expansion

Interventionmg/liter (L) (Mean)
Figitumumab 6 mg/kg120.4
Figitumumab 10 mg/kg137.0
Figitumumab 20 mg/kg Dose Escalation435.0
Figitumumab 20 mg/kg Expansion513.4

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Maximum Observed Plasma Concentration (Cmax) for Cisplatin

Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence of (Cycle 2) figitumumab (NCT00560573)
Timeframe: 0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2

Interventionnanogram (ng)/mL (Mean)
Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)3.816
Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)3.880
Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)2.845
Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)3.490

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Maximum Observed Plasma Concentration (Cmax) for Pemetrexed

Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab (NCT00560573)
Timeframe: 0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2

Interventionng/mL (Mean)
Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)72.96
Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)93.13

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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Cisplatin

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab (NCT00560573)
Timeframe: 0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2

Interventionng*hr/L (Mean)
Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)38.23
Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)45.18
Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)37.12
Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)48.29

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Overall Response Rate (Patients That Achieve a CR or PR)

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00564733)
Timeframe: At the end of 4 cycles of treatment, up to 24 weeks.

Interventionparticipants (Number)
Chemotherapy13

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To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer

The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs > 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method. (NCT00565851)
Timeframe: The time frame is 82.5 months (median duration of follow-up)

InterventionMonths (Median)
No Cytoreductive Surgery64.7
Cytoreductive Surgery50.6

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To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer

The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs > 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method. (NCT00565851)
Timeframe: The time frame is 82.5 months (median duration of follow-up).

InterventionMonths (Median)
Paclitaxel and Carboplatin Chemotherapy37.3
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab42.2

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Patient Reported Quality of Life (Chemotherapy Analysis)

Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL. (NCT00565851)
Timeframe: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.

,
Interventionscore on a scale (Least Squares Mean)
Prior to cycle 1 (baseline)Prior to cycle 3Prior to cycle 66 months post cycle 112 months post cycle 1
Paclitaxel and Carboplatin Chemotherapy75.874.273.377.177.0
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab75.373.472.377.277.8

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Summary of Adverse Events (CTCAE Version 4.0)

Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0)) (NCT00565851)
Timeframe: During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months

InterventionParticipants (Count of Participants)
Arm I (no Surgery; Carboplatin and Paclitaxel)304
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)376
Arm III (Surgery; Carboplatin and Paclitaxel)29
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)77
Arm V (no Surgery; Carboplatin and Gemcitabine)3
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))9
Arm VII (Surgery; Carboplatin and Gemcitabine)3
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))9

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Patient Reported Physical Functioning (Surgery Analysis)

Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. This measure was completed by US patients only. (NCT00565851)
Timeframe: 1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgery

,
Interventionscore on a scale (Least Squares Mean)
Prior to surgery (baseline)6 weeks post-surgery15 weeks post-surgery6 months post-surgery12 months post-surgery
Cytoreductive Surgery71.769.864.670.270.7
No Cytoreductive Surgery73.473.271.571.671.8

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Patient Reported Physical Function (Chemotherapy Analysis)

Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning Subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. (NCT00565851)
Timeframe: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.

,
Interventionscore on a scale (Least Squares Mean)
Prior to cycle 1 (baseline)Prior to cycle 3Prior to cycle 66 months post cycle 112 months post cycle 1
Paclitaxel and Carboplatin Chemotherapy71.573.271.571.671.8
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab69.469.864.670.270.7

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Patient Reported Quality of Life (Surgery Analysis)

Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL. (NCT00565851)
Timeframe: 1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery.

,
Interventionscore on a scale (Least Squares Mean)
Prior to surgery6 weeks post-surgery15 weeks post-surgery6 months post-surgery12 months post-surgery
Cytoreductive Surgery74.268.468.873.575.6
No Cytoreductive Surgery74.569.368.772.674.0

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Progression Free Survival (Surgery Analysis)

Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause. (NCT00565851)
Timeframe: Radiographic assessment of disease (in patients with measurable and non-measurable disease) was conducted Every three months for two years and then every 6 months after completion of chemotherapy during the maintenance/surveillance phase.

InterventionMonths (Median)
No Cytoreductive Surgery16.2
Cytoreductive Surgery18.9

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Progression-free Survival (Chemotherapy Analysis)

Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause. (NCT00565851)
Timeframe: Radiographic assessment of disease was conducted during chemotherapy and then every 6 months during the maintenance / surveillance phase

InterventionMonths (Median)
Paclitaxel and Carboplatin Chemotherapy10.4
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab13.8

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Best Overall Response Rate

Best overall response is the number of participants with a Complete Response (CR) or Partial Response (PR), as classified by independent blinded review of the CT or MRI images, based on RECIST 1.0. A CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum longest diameter. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameters of target lesions or the appearance of one or more new lesions. Stable disease (SD) is neither CR, PR or PD. (NCT00570713)
Timeframe: Baseline to response up to 21 months

,
Interventionpercentage of participants (Number)
Complete or Partial ResponseComplete ResponsePartial ResponseStable DiseaseProgressive DiseaseNot Evaluable
MORAb-009 Plus Gemcitabine ('MORAb-009')6.406.447.419.226.9
Placebo Plus Gemcitabine ('Placebo')7.807.855.823.413.0

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Progression-free Survival

Progression-free Survival (PFS) is defined as the time from the date of randomization to the date of the first observation of disease progression (clinical or radiological) or death due to any cause. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. If progression or death is not observed, the PFS time will be censored at the date of the last tumor assessment without evidence of progression prior to the date of initiation of further anticancer treatment. (NCT00570713)
Timeframe: 1-21 Months

InterventionMonths (Median)
MORAb-009 Plus Gemcitabine ('MORAb-009')3.4
Placebo Plus Gemcitabine ('Placebo')3.5

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Overall Survival (OS)

This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up. (NCT00570713)
Timeframe: 1-21 Months

InterventionMonths (Median)
MORAb-009 Plus Gemcitabine ('MORAb-009')6.5
Placebo Plus Gemcitabine ('Placebo')6.9

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Progression Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors [RECIST] Criteria

"PFS was the time interval from the date of registration to the date of progression, or death from any cause if it occurs before tumor progression is documented. Tumor progression was assessed using RECIST criteria, by which progression was a pre-defined increase in the size of existing tumors or appearance of one or more new tumors.~If a participant did not progress or die, the progression was censored to the date of the last valid tumor assessment or data cut-off, whichever was earlier.~Median PFS time was estimated from Kaplan-Meier Plots." (NCT00574275)
Timeframe: From the first randomization until the end of study data cutoff date (approximately 2 years)

Interventionmonths (Median)
Placebo and Gemcitabine3.71
Aflibercept and Gemcitabine3.71

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Number of Participants With Anti-drug Antibodies

Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. The validated lower limit of detection (LLOD) for the assay was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 μg/mL of aflibercept. (NCT00574275)
Timeframe: Up to 90 days post last dose of study drug

Interventionparticipants (Number)
Placebo and Gemcitabine5
Aflibercept and Gemcitabine5

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Overall Survival (OS)

"OS is the time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, data on OS were censored at the earlier of the last date participant was known to be alive, or the study data cutoff date (11 September 2009).~OS time was estimated from Kaplan-Meier Plots." (NCT00574275)
Timeframe: From the first randomization until the end of study data cutoff date (approximately 2 years)

Interventionmonths (Median)
Placebo and Gemcitabine7.75
Aflibercept and Gemcitabine6.54

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Safety-Number of Participants With Adverse Events (AE)

All AEs regardless of seriousness or relationship to study treatment, spanning from the signature of informed consent until 30 days after the last administration of study treatment, were recorded. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported. (NCT00574275)
Timeframe: up to 30 days after treatment discontinuation. SAEs and related AEs were followed till resolved or stabilized.

,
Interventionparticipants (Number)
Treatment Emergent Adverse Event (TEAE)Treatment Emergent Serious Adverse EventTEAE leading to deathTEAE leading to permanent discontinuation
Aflibercept and Gemcitabine2661485576
Placebo and Gemcitabine2571224332

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Disease Relapse or Progression as Measured by CT Scan or PET

(NCT00574496)
Timeframe: 3 years

Interventionmonths (Median)
High-Risk or Relapsed Hodgkin Lymphoma34.3

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Overall Survival

(NCT00574496)
Timeframe: up to 8 years

Interventionmonths (Median)
High-Risk or Relapsed Hodgkin Lymphoma70.3

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Progression-free Survival at 1 Year

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00574496)
Timeframe: 1 year

Interventionproportion of progression-free pts (Number)
High-Risk or Relapsed Hodgkin Lymphoma33.3

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Overall Survival Time

Overall Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier. (NCT00577889)
Timeframe: Assessed up to 2 years from registration

Interventionmonths (Median)
Arm I (Combination Chemotherapy)4.8
Arm II (Combination Chemotherapy)6.9
Arm III (Combination Chemotherapy)4.3

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Six Month Survival Rate

"A patient that is alive at 6 months is considered a treatment success. Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner." (NCT00577889)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Arm I (Combination Chemotherapy)25
Arm II (Combination Chemotherapy)67
Arm III (Combination Chemotherapy)33

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Time to Disease Progression

"The time to disease progression is defined as the time from registration to the time of confirmed disease progression using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA).~Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD." (NCT00577889)
Timeframe: Time from registration to documentation of disease progression, assessed up to 2 years

Interventionmonths (Median)
Arm I (Combination Chemotherapy)2.2
Arm II (Combination Chemotherapy)4.1
Arm III (Combination Chemotherapy)2.3

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Confirmed Response Rate

"A confirmed response is defined as a complete response (CR) or partial response (PR) observed in two consecutive evaluations at least 4 weeks apart using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA).~Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD.Evaluated using RECIST criteria." (NCT00577889)
Timeframe: 2 consecutive evaluations at least 4 weeks, up to 6 courses of treatment

Interventionparticipants (Number)
Arm I (Combination Chemotherapy)0
Arm II (Combination Chemotherapy)0
Arm III (Combination Chemotherapy)0

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Participant Response

Number of participants evaluated using Response to Treatment in Solid Tumors (RECIST) with definitions of Complete Response (CR): disappearance of all target lesions; and, Partial Response: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Maintained Continued CR: participants who entered study in a CR and maintained CR post study treatment. Evaluations once a week till Day +30, then Days 30, 60, and 100 then at 6 months or until disease progression. (NCT00583622)
Timeframe: Up to 6 months

Interventionpercentage of participants (Number)
Complete Response (CR)Maintained Continued CRPartial Response (PR)No ResponseNot Evaluable
Bevacizumab + High-Dose Chemotherapy33.342.08.38.38.3

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Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment

The rate of pathologic complete response (pT0) following three 21 day cycles of neoadjuvant ABI-007, carboplatin and gemcitabine was determined. (NCT00585689)
Timeframe: 63 days (post 3 cycles)

Interventionpercentage of patients (Number)
Neoadjuvant ABI-007, Carboplatin, and Gemcitabine27.3

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Evaluate the Time to Disease Progression

Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI, 92(3):205-216, 2000]. Changes in only the largest diameter (uni-dimensional measurement) are used in the RECIST criteria. (NCT00588666)
Timeframe: 3 years

Interventionmonths (Median)
Time to ProgressionOverall Survival
Treatment6.513.9

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The Response Rate of Combination Therapy With Bevacizumab, Gemcitabine, and Carboplatin in Patients With Advanced/Metastatic TCC.

(NCT00588666)
Timeframe: 3 years

Interventionpercentage of participants (Number)
Treatment49

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Overall Objective Response

"To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." (NCT00589667)
Timeframe: 2 years

Interventionparticipants (Number)
Partial ResponseStable DiseaseProgression of DiseaseResponse not available
Pemetrexed Plus Gemcitabine41821

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Median Overall Survival

To determine the median overall survival for patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma treated with pemetrexed and gemcitabine. (NCT00589667)
Timeframe: 2 years

Interventionmonths (Median)
Pemetrexed Plus Gemcitabine8.8

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The Maximum Tolerated Radiation Dose

The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas. (NCT00593866)
Timeframe: 13 weeks post radiation

InterventionGray (Gy) (Number)
Radiation Dose Escalation With Gemcitabine55

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The Percentage of Participants Free From Local Progression at 2 Years

(NCT00593866)
Timeframe: 2 Years

Interventionpercentage of participants (Number)
Radiation Dose Escalation With Gemcitabine59

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Change in FGD-PET Uptake From Baseline to Week 6

"Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval.~The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass." (NCT00599755)
Timeframe: Baseline and Week 6

InterventionFold change in SUVmean (Number)
Gemcitabine and Cisplatin or Gemcitabine and Carboplatin0.65

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Repeatability of FDG SUVmean at Baseline

Two positron emission tomography (PET) scans are obtained on different days at baseline, as close together as possible, under conditions of no biological change, to measure FDG SUVmean. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass. (NCT00599755)
Timeframe: Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy

InterventionSUVmean (Geometric Mean)
Gemcitabine and Cisplatin or Gemcitabine and Carboplatin3.79

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Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy At a Threshold of a 30% Decrease in SUVmean

Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 30% decrease in SUVmean of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass. (NCT00599755)
Timeframe: Weeks 3 and 6 following chemotherapy

InterventionParticipants (Number)
Gemcitabine and Cisplatin or Gemcitabine and Carboplatin4

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Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean

Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 20% decrease in mean standardized uptake value (SUVmean) of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass. (NCT00599755)
Timeframe: Weeks 3 and 6 following chemotherapy

InterventionParticipants (Number)
Gemcitabine and Cisplatin or Gemcitabine and Carboplatin10

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Change in FDG-PET Uptake From Week 3 to Week 6

Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass. (NCT00599755)
Timeframe: Week 3 and Week 6

InterventionFold change in SUVmean (Number)
Gemcitabine and Cisplatin or Gemcitabine and Carboplatin0.85

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Change in FDG-PET Uptake From Baseline to Week 3

Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass. (NCT00599755)
Timeframe: Baseline and Week 3

InterventionFold Change in SUVmean (Number)
Gemcitabine and Cisplatin or Gemcitabine and Carboplatin0.75

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One Year Survival Rate

The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the exact binomial method. (NCT00601627)
Timeframe: Baseline to 12 months

Interventionproportion of patients (Number)
Panitumumab0.502

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Overall Survival

Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (NCT00601627)
Timeframe: baseline to 2 years

Interventionmonths (Median)
Panitumumab12.1

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Progression Free Survival (PFS)

Progression Free Survival is defined as the time from registration to the earliest documented evidence of disease progression. (NCT00601627)
Timeframe: baseline to 2 years

Interventionmonths (Median)
Panitumumab7.4

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Time to Treatment Failure

Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of survival time will be estimated using the method of Kaplan-Meier. (NCT00601627)
Timeframe: baseline to 2 years

Interventionmonths (Median)
Panitumumab2.71

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Confirmed Response Rate

"A confirmed tumor response is defined to be a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.~A complete response is defined as the disappearance of all target and non-target lesions.~A partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesion from baseline.~Confirmed tumor response will be evaluated using the first 6 cycles of treatment." (NCT00601627)
Timeframe: baseline to 2 years

Interventionrate of confirmed response (Number)
Panitumumab0.059

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Number of Participants With the Responses Outlined

"Complete Response (CR): disappearance of all clinical and radiological evidence of tumour.~Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started. Appearance of new lesions will also constitute progressive disease." (NCT00603915)
Timeframe: Measured every 2 cycles until the participant is off treatment.

InterventionParticipants (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseInevaluable
GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB071111

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Progression Free Survival.

From randomization to the first documented disease progression or death from any cause, whichever came first, assessed until all participants randomized to the study have progressed for died. (NCT00603915)
Timeframe: From the on-study date until the date of first documented progression or date of death from any cause any cause until all participants have progressed or died.

InterventionMonths (Mean)
GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB6.3

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Surgical Completion Rate and Complication Rate

(NCT00609336)
Timeframe: Up to 6 weeks following the completion of chemoradiotherapy

InterventionParticipants (Count of Participants)
Completion rateComplication rate
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)222

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Median Overall Survival of Patients With Adenocarcinoma of the Pancreas

Time at which Kaplan-Meier estimate of overall survival drops below 50% (NCT00609336)
Timeframe: 5 years

Interventionmonths (Median)
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)31.6

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Median Recurrence Free Survival Following Pancreaticoduodenectomy

The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence. (NCT00609336)
Timeframe: From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years

Interventionmonths (Median)
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)31.3

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Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy

The resected pancreaticoduodenectomy specimen and accompanying lymph nodes will be staged according to American Joint Committee on Cancer 6th Edition incorporating the prefix y to indicate a specimen status-post neoadjuvant treatment (ypTNM). Cancer 2012;118:1382-90 (NCT00609336)
Timeframe: Up to 7 years

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)20

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Percent of Patients Surviving at 5 Years

Kaplan-Meier estimate of overall survival at 5 years (NCT00609336)
Timeframe: Up to 5 years

Interventionpercentage of eligible pts alive (Number)
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)31.6

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Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

(NCT00609336)
Timeframe: Up to 26 weeks after surgery (the end of adjuvant chemotherapy)

Interventionoccurrence of toxicities (Number)
Any Grade 2 CTCAE toxicityAny Grade 3 CTCAE toxicityAny Grade 4 CTCAE toxicity
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)2112114

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Percent of Patients Surviving at Annual Intervals

(NCT00609336)
Timeframe: 5 years

Interventionpercentage of participants (Number)
Year 1Year 2Year 3Year 4Year 5
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)8162453731

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Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)

Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by local (uterine vein) gemcitabine hydrochloride concentration levels in blood (NCT00610740)
Timeframe: 30 minutes post administration

InterventionParticipants (Number)
Patients Treated With CerviPrep™3

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Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)

Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by gemcitabine hydrochloride concentration levels in tissue samples. (NCT00610740)
Timeframe: 30 Minutes After Application of Gemcitabine

InterventionParticipants (Number)
Patients Treated With CerviPrep™5

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Number of Patients With Measurable Peripheral Vein Concentration of dFdC

Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by peripheral gemcitabine hydrochloride concentration levels in blood (NCT00610740)
Timeframe: 30, 60, 90 minutes post uterine vein sample

InterventionParticipants (Number)
30 Minutes60 Minutes90 Minutes
Patients Treated With CerviPrep™000

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Progression-Free Survival

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. (NCT00617708)
Timeframe: Up to 3 years

Interventionmonths (Median)
Erlotinib + Gemcitabine + IMC-A123.6
Erlotinib + Gemcitabine3.6

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Maximum Tolerated Dose Determination

Maximum dose of IMC-A12 (in combination with erlotinib and gemcitabine) at which 3/10 or fewer patients have dose-limiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite). (NCT00617708)
Timeframe: 28 days

Interventionmg/kg IMC-A12 (Number)
Ph I: Erlotinib + Gemcitabine + IMC-A126

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Overall Survival

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00617708)
Timeframe: Up to 3 years

Interventionmonths (Median)
Erlotinib + Gemcitabine + IMC-A127.0
Erlotinib + Gemcitabine6.5

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Toxicity

Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT00617708)
Timeframe: Up to 3 years

,,
InterventionParticipants (Number)
ALT, SGPT (serum glutamic pyruvic transaminase)AST, SGOTAcidosis (metabolic or respiratory)Adult respiratory distress syndrome (ARDS)Albumin, serum-low (hypoalbuminemia)Alkaline phosphataseAllergic reaction/hypersensitivityAnorexiaBilirubin (hyperbilirubinemia)Calcium, serum-low (hypocalcemia)Cardiac troponin I (cTnI)Cardiac-ischemia/infarctionCardiopulmonary arrest, cause unknown (non-fatal)DehydrationDiarrheaDizzinessDysphagia (difficulty swallowing)Dyspnea (shortness of breath)Edema: limbEdema: trunk/genitalFatigue (asthenia, lethargy, malaise)GGT (gamma-glutamyl transpeptidase)Glucose, serum-high (hyperglycemia)HemoglobinHypotensionHypoxiaInf (clin/microbio) w/Gr 3-4 neuts - BloodInf (clin/microbio) w/Gr 3-4 neuts - UTIInf w/normal ANC or Gr 1-2 neutrophils - Bil. treeInf w/normal ANC or Gr 1-2 neutrophils - BloodInf w/normal ANC or Gr 1-2 neutrophils - LungInf w/normal ANC or Gr 1-2 neutrophils - PancreasInf w/normal ANC or Gr 1-2 neutrophils - SkinInf w/normal ANC or Gr 1-2 neutrophils - UTIInf w/normal ANC or Gr 1-2 neutrophils -Up aerodigInfection-Other (Specify)Left ventricular systolic dysfunctionLeukocytes (total WBC)Liver dysfunction/failure (clinical)Lymphatics-Other (Specify)LymphopeniaMagnesium, serum-low (hypomagnesemia)Mucositis/stomatitis (functional/symp) - Oral cavMuscle weakness, not d/t neuropathy - Extrem-lowerMuscle weakness, not d/t neuropathy - body/generalNauseaNeuropathy: sensoryNeutrophils/granulocytes (ANC/AGC)Obstruction, GI - DuodenumOpportunistic inf associated w/gt=Gr 2 lymphopeniaPTT (Partial thromboplastin time)Pain - Abdomen NOSPain - EyePain - Head/headachePain - MusclePancreas, exocrine enzyme deficiencyPancreatic endocrine: glucose intolerancePericardial effusion (non-malignant)Personality/behavioralPlateletsPleural effusion (non-malignant)Pneumonitis/pulmonary infiltratesPotassium, serum-low (hypokalemia)Pulmonary/Upper Respiratory-Other (Specify)Rash/desquamationRash: acne/acneiformRash: erythema multiformeSVT and nodal arrhythmia - Atrial fibrillationSodium, serum-low (hyponatremia)Stricture/stenosis (incl anastomotic), StomachSyncope (fainting)Thrombosis/embolism (vascular access-related)Thrombosis/thrombus/embolismTremorUric acid, serum-high (hyperuricemia)Ventricular arrhythmia - Ventricular fibrillationVision-blurred visionVision-photophobiaVomitingWeight loss
Ph I: Erlotinib + Gemcitabine + IMC-A1200000011000003200000402000000100000001001000040301000000000200000000100000000020
Ph II: Erlotinib + Gemcitabine4301030601011520141112018121101210100051150003601010010010010712111200110010000010
Ph II: Erlotinib + Gemcitabine + IMC-A12961034075130063102001611693100101010111900411159121001011016011601110311503141111152

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Response

Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR. (NCT00617708)
Timeframe: Up to 3 years

Interventionpercentage of participants (Number)
Erlotinib + Gemcitabine + IMC-A1213.7
Erlotinib + Gemcitabine15.3

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Overall Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00618826)
Timeframe: maximum 50 months

Interventionproportion of participants (Number)
Arm 10.46

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Progression-free Survival

Time from study entry to disease progression or death (NCT00618826)
Timeframe: maximum 50 months

Interventionmonths (Median)
Treatment43

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Number of Participants With Adverse Events (AEs); Pharmacology Toxicities

A listing of serious adverse events (SAEs) and other non-serious AEs is located in the Reported Adverse Event module. (NCT00623233)
Timeframe: Baseline, every cycle (every 14 days) up to 34 months

Interventionparticipants (Number)
SAEsOther non-serious AEs
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg1851

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Progression Free Survival (PFS) Time

PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date. (NCT00623233)
Timeframe: Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months).

Interventionmonths (Median)
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg4.80

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Overall Tumor Response Rate (ORR)

Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: complete response (CR)=disappearance of all target lesions; partial response (PR)=30% decrease in sum of longest diameter of target lesions; progressive disease (PD)=20% increase in sum of longest diameter of target lesions; stable disease=small changes that do not meet above criteria. ORR=proportion of participants who achieved a confirmed best response of CR or PR (responders). ORR=number of participants with CR or PR /number of participants qualified for tumor response analysis (per protocol population). (NCT00623233)
Timeframe: Baseline to measured PD. Tumor assessments were performed every 8 weeks (q 8 weeks) during therapy and q 2 months during post-therapy until documented PD (up to 34 months).

Interventionproportion of responders (Number)
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg0.214

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1-Year Overall Survival (OS) Rate

OS was measured from the date of first dose to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date for a particular analysis, OS duration was censored for that analysis at the date of participant's last study contact prior to that cut-off date. The 1-year survival rate (percentage of participants who were alive at 1 year) was estimated from OS data. (NCT00623233)
Timeframe: Baseline to death from any cause, 1 year

Interventionpercentage of participants (Number)
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg68.68

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Number of Patients Alive at 8 Months

(NCT00625586)
Timeframe: 8 months

Interventionparticipants (Number)
RAV12 Plus Gemcitabine1

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Partial Response and Complete Response Rates

Based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0; partial response = 30% decrease in sum of longest diameter. complete response = 100% decrease in sum of longest diameter. Rate of response = proportion of complete or partial responses based on number of patients evaluated. (NCT00625586)
Timeframe: 8 months

Interventionparticipants (Number)
RAV12 Plus Gemcitabine0

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Participants With Adverse Events

Frequency of adverse events and serious adverse events (NCT00625586)
Timeframe: Throughout the study, up to 11 months

Interventionparticipants (Number)
RAV12 Plus Gemcitabine2

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Cmax

RAV12 and gemcitabine cmax (NCT00625586)
Timeframe: 29 days

Interventionmcg/mL (Mean)
RAV12 Plus GemcitabineNA

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Median Overall Survival

Time from the first dose date to the date of death from any cause (NCT00625586)
Timeframe: up to 11 months

Interventionmonths (Median)
RAV12 Plus GemcitabineNA

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Median Progression-free Survival

Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first. (NCT00625586)
Timeframe: up to 11 months

Interventionmonths (Median)
RAV12 Plus Gemcitabine4.5

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Time to Progression

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00630409)
Timeframe: Up to 40 months

Interventionparticipants (Median)
Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)NA

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Response Rate

Number of participants that experienced response/total number of participants per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan. Response was defined as Complete Response (CR), the disappearance of all target lesions; Partial Response (PR), a 30% or greater decrease in the sum of the longest diameter of target lesions. (NCT00630409)
Timeframe: Up to 18 weeks for individual; Up to 40 months for cohort

Interventionpercentage of participants (Number)
Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)0

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Complete Response Rate

The complete response rate will be defined as the total number of patients who have defined complete response using study regimen (intensive induction therapy/progressive chemotherapy/stem cell rescue), divided by the number of patients entered in the trial using response-evaluable patients. (NCT00632827)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Treatment Plan14

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Median Time to Response

The time to response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) in months. (NCT00632827)
Timeframe: Up to 2 years

Interventionmonths (Median)
Treatment Plan3.0

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Progression Free Survival

Progression-Free Survival will be defined the percentage of participants alive and progression-free at median follow up of 25 months. Patients will be routinely followed for disease progression and those who die without a reported prior progression will be considered to have progressed on the day of their death. Patients who did not progress or die will be censored at the day of their last treatment assessment. Patients who have not received study regimen or did not have on-study treatment assessments will be censored on the day they entered the trial. Patients who receive chemotherapy for reasons other than documented progression of disease or clinical progression without documented progression will be censored on the earliest date of subsequent therapy (NCT00632827)
Timeframe: Up to 3 years

Interventionpercentage of partcipants (Number)
Treatment Plan65

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Overall Survival Rate

Overall Survival will be defined the percentage of participants alive at median follow up of 25 months. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. The analysis is expected to occur up to 60 months after the first patient is entered the trial. (NCT00632827)
Timeframe: Up to 5 years

Interventionpercentage of participants (Number)
Treatment Plan75

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Objective Response Rates of the Two Treatment Arms

Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response. (NCT00637247)
Timeframe: one year

Interventionpercent of responses (Number)
Amplimexon (Imexon) + Gemcitabine13.2
Imexon Placebo + Gemcitabine16.4

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Overall Survival for the Intent to Treat Population

To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment. (NCT00637247)
Timeframe: up to 2 years

Interventionmonths (Median)
Amplimexon (Imexon) + Gemcitabine5.2
Imexon Placebo + Gemcitabine6.8

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Progression Free Survival

To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria. (NCT00637247)
Timeframe: one year

Interventionmonths (Median)
Amplimexon (Imexon) + Gemcitabine2.8
Imexon Placebo + Gemcitabine3.8

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To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events

Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events (NCT00637247)
Timeframe: Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months

Interventionparticipants (Number)
Imexon + Gemcitabine67
Placebo + Gemcitabine68

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The Number of Grade 3 to 5 Adverse Events Experienced by Arm 1 and Arm 2

"One of the secondary outcomes was to assess the safety and tolerability of treatment for both arms.~The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were utilized for adverse event reporting." (NCT00645593)
Timeframe: 3 years

Interventionadverse events (Number)
Arm 1, Gemcitabine and Cisplatin75
Arm 2, Cetuximab, Gemcitabine and Cisplatin83

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Median Progression-free Survival Time in Months

Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions. (NCT00645593)
Timeframe: 3 years

Interventionmonths (Median)
Arm 1, Gemcitabine and Cisplatin8.5
Arm 2, Cetuximab, Gemcitabine and Cisplatin7.6

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Percentage of Participants That Respond to Treatment in Arm 1 and Arm 2

"The primary objective is to compare the overall response rate of participants with locally advanced or metastatic urothelial carcinoma treated with gemcitabine and cisplatin with or without cetuximab.~Overall response rate is defined as the percentage of participants that experience Complete Response (CR) (Disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest diameter of target lesions)." (NCT00645593)
Timeframe: 3 years

Interventionpercentage of participants (Number)
Arm 1, Gemcitabine and Cisplatin57.1
Arm 2, Cetuximab, Gemcitabine and Cisplatin61.4

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Median Overall Survival in Months

Median overall survival in months is provided. One participant who progressed from chemotherapy in arm 1 received cyclophosphamide and achieved long-term disease control therefore there is no upper limit for the 95% confidence interval. (NCT00645593)
Timeframe: 3 years

InterventionMonths (Median)
Arm 1, Gemcitabine and Cisplatin17.4
Arm 2, Cetuximab, Gemcitabine and Cisplatin14.3

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Overall Survival

Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause. (NCT00645710)
Timeframe: Up to 5 years

InterventionMonths (Median)
Dose Level 1- FUdR 0.10 mg/kg/Day23.2
Dose Level 2 - FUdR 0.15 mg/kg/Day73.2
Dose Level 3 - FUdR 0.20 mg/kg/Day41.2

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Number of Participants With at Least One Dose Limiting Toxicity

Dose Limiting Toxicity (DLT) defined as any treatment-related grade grade 3 nonhematologic toxicity not reversible to grade 2 or less within 24 hours, or any grade 4 toxicity.Up to three cycles of therapy were allowed with DLTs determined based on first cycle tolerance. Toxicity was graded using the National Cancer Institute Common Toxicity Criteria version 2.0. (NCT00645710)
Timeframe: 4 weeks from start of treatment, up to 2 years.

Interventionparticipants with DLTs (Number)
Dose Level 1- FUdR 0.10 mg/kg/Day0
Dose Level 2 - FUdR 0.15 mg/kg/Day0
Dose Level 3 - FUdR 0.20 mg/kg/Day1

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Progression-free Survival

Estimated using the product-limit method of Kaplan and Meier. Progression is defined as a 25% increase in the sum of products of measurable lesions over the smallest sum observed, or appearance of any lesions that had disappeared, or appearance of any new lesion/site. (NCT00645710)
Timeframe: Up to 5 years

InterventionMonths (Median)
Dose Level 1- FUdR 0.10 mg/kg/Day8.3
Dose Level 2 - FUdR 0.15 mg/kg/Day11.5
Dose Level 3 - FUdR 0.20 mg/kg/Day9.6

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Percentage of Total pCDC2 in Skin Cells at Baseline and 24 Hours After MK-1775 Dosing

The pCDC2 level in skin cells was used as a marker to evaluate MK-1775 activity. Analysis was done by immunohistochemistry and the percentage of total pCDC2 at baseline and 24 hours after MK-1775 dosing were reported for participants in the Part 2-B/3 MK-1775 QD x2 Multi Dose plus Gemcitabine treatment groups with available data per protocol. (NCT00648648)
Timeframe: Baseline, 24 hours after first MK-1775 dose

,,,
Interventionpercentage of cells (Geometric Least Squares Mean)
Baseline percentagePercentage after dosing
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^247.529.9
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^227.917.7
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^218.712.7
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^211.66.3

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Mean Urine Excretion of MK-1775 24 Hours After the Day 1 Monotherapy Dose

The mean cumulative amount of MK-1775 excreted unchanged in urine after a single oral dose was measured during the initial monotherapy cycle of the study. For this outcome measure, samples were collected and analyzed only for the MK-1775 monotherapy arms of the study at defined intervals after the Day 1 dose of monotherapy. Part 2 MK-1775 combination arms were not sampled per protocol. (NCT00648648)
Timeframe: At 0-4 hours, 4-8 hours, and 12-24 hours post Day 1 dose of monotherapy

Interventionmg (Mean)
MK-1775 325 mg Single Dose16.7
MK-1775 650 mg Single Dose35.4
MK-1775 1300 mg Single Dose154

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Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

DLTs were adverse events (AEs) considered at least possibly related to study drug that prevented escalation of the drug dose. Hematologic DLTs were any grade (Gr) 4-5 toxicity EXCEPT: Gr 4 anemia and Gr 4 leukopenia, Gr 4 neutropenia lasting for <7 days, Gr 4 thrombocytopenia lasting for <4 days except if a platelet transfusion is required, and Gr 3/Gr 4 neutropenia with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment. Non-hematologic DLT was defined as any Gr 3, 4, or 5 non-hematologic toxicity EXCEPT: nausea, vomiting, diarrhea, or dehydration (all Gr 3) occurring in a setting of inadequate compliance with supportive care measures and lasting for <48 hours, alopecia of any grade, inadequately treated hypersensitivity reactions, and clinically non-significant, treatable or reversible lab abnormalities including liver function tests, uric acid, etc. (NCT00648648)
Timeframe: Part 1: Up to 14 days, Part 2: Up to 28 days

InterventionParticipants (Count of Participants)
MK-1775 325 mg Single Dose0
MK-1775 650 mg Single Dose0
MK-1775 1300 mg Single Dose0
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^20
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^22
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^20
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^22
MK-1775 100 mg Single Dose + Carboplatin AUC 50
MK-1775 200 mg Single Dose + Carboplatin AUC 50
MK-1775 325 mg Single Dose + Carboplatin AUC 50
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^21
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^22
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^25
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^20
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^20
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^22
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^21
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^23
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^20
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^21
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^20
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^20
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^24
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^23
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 50
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 50
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 57
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 56

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Plasma Concentration of MK-1775 at 8 Hours After Administration (C8hr) of Single or Multiple Oral Doses

MK-1775 was measured in the plasma at 8 hours after dosing (Day 1 for single dose of monotherapy, Day 2 of single-dose combination therapy and QD x 2 Combination dosing, and Day 3 dose for BID X 2.5 combination dosing) for participants with available data. (NCT00648648)
Timeframe: 8 hours after MK-1775 dose

InterventionnM (Mean)
MK-1775 325 mg Single Dose585
MK-1775 650 mg Single Dose1130
MK-1775 1300 mg Single Dose2190
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2129
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2235
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2108
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2310
MK-1775 100 mg Single Dose + Carboplatin AUC 5119
MK-1775 200 mg Single Dose + Carboplatin AUC 5262
MK-1775 325 mg Single Dose + Carboplatin AUC 5425
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^241.7
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^265.4
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2138
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2188
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2241
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2355
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2346
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2407
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2113
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2388
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2748
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2920
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^21070
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^22010
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5184
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5295
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5985
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 51960

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Best Overall Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

Best overall response achieved by a participant. Starting at Day 1, participants in Part 2 were evaluated for tumor response every 6-8 weeks until discontinuation from study treatment according to RECIST criteria; which are based on radiographic imaging. Recorded responses were either confirmed by Central Review or unconfirmed (Investigator assessment only), and included complete response (CR; defined as disappearance of all target lesions), partial response (PR; at least a 30% decrease in the sum of the longest diameter [LD] of target lesions, taking as reference the baseline sum LD), stable disease (SD; neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD, taking as reference the smallest sum LD since the treatment started), or progressive disease (PD; ≥20% increase in sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions). (NCT00648648)
Timeframe: From Day 1 up through discontinuation of study treatment (up to ~11.2 months)

,,,,,,,,,,,,,,,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
CRConfirmed PRUnconfirmed PRSDPDNE
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2020120
MK-1775 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2000220
MK-1775 100 mg Single Dose + Carboplatin AUC 5000030
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^2001020
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^2010311
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2000140
MK-1775 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2000220
MK-1775 1300 mg Single Dose000000
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5000310
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2002440
MK-1775 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2000820
MK-1775 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2011830
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2011630
MK-1775 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2001310
MK-1775 200 mg Single Dose + Carboplatin AUC 5000030
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^2010710
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^2000510
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 50021480
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2000410
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2001210
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5000660
MK-1775 325 mg Single Dose000000
MK-1775 325 mg Single Dose + Carboplatin AUC 5011331
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2000410
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2000210
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2000450
MK-1775 650 mg Single Dose000000
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5000220

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Percentage of Total Cyclin-dependent Kinase (CDC2)-Positive Cells That Were Phosphorylated (pCDC2) in Skin Cells at Baseline and 8 Hours After MK-1775 Dosing

The pCDC2 level in skin cells was used as a marker to evaluate MK-1775 activity. Analysis was done by immunohistochemistry and the percentage of total CDC2-positive cells that were pCDC2 positive (% pCDC2-positive cells) at baseline and 8 hours after MK-1775 dosing were reported for participants in Part 1, 2-A, and 2-B/3 treatment groups with available data per protocol. (NCT00648648)
Timeframe: Baseline, 8 hours after first MK-1775 dose

,,,,,,,,,,,,,,,,,,
Interventionpercentage of cells (Geometric Least Squares Mean)
Baseline percentagePercentage after dosing
MK-1775 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^224.114.4
MK-1775 100 mg Single Dose + Carboplatin AUC 534.441.9
MK-1775 100 mg Single Dose + Cisplatin 75 mg/ m^216.114.8
MK-1775 100 mg Single Dose + Gemcitabine 1000 mg/m^253.228.9
MK-1775 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^221.419.9
MK-1775 1300 mg Single Dose36.220.6
MK-1775 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 52716.8
MK-1775 200 mg Single Dose + Carboplatin AUC 517.620.9
MK-1775 200 mg Single Dose + Cisplatin 75 mg/ m^228.622.1
MK-1775 200 mg Single Dose + Gemcitabine 1000 mg/m^240.735.7
MK-1775 225 mg BID x2.5 Multi Dose + Carboplatin AUC 52111.5
MK-1775 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^228.120.1
MK-1775 325 mg Single Dose40.818
MK-1775 325 mg Single Dose + Carboplatin AUC 522.417.1
MK-1775 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^230.816.6
MK-1775 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^216.417.8
MK-1775 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^218.313.7
MK-1775 650 mg Single Dose35.113.4
MK-1775 75 mg BID x2.5 Multi Dose + Carboplatin AUC 515.712.1

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Percentage of Total pCDC2 in Skin Cells at Baseline and 48 Hours After MK-1775 Dosing

The pCDC2 level in skin cells was used as a marker to evaluate MK-1775 activity. Analysis was done by immunohistochemistry and the percentage of total pCDC2 at baseline and at 48 hours after MK-1775 dosing were reported for participants in the Part 2-B/3 MK-1775 (150 mg, 200 mg, 250) BID x 2.5 Multi Dose plus cisplatin 75 mg/m^2 groups and the 325 mg BID x2.5 Multi Dose + Carboplatin group with available data per protocol. (NCT00648648)
Timeframe: Baseline, 48 hours after first MK-1775 dose

,,,
Interventionpercentage of cells (Geometric Least Squares Mean)
Baseline percentagePercentage after dosing
MK-1775 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^228.615.7
MK-1775 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^231.57.4
MK-1775 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^231.511.1
MK-1775 325 mg BID x2.5 Multi Dose + Carboplatin AUC 533.515.1

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Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST

CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. (NCT00652366)
Timeframe: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.

,
Interventionpercentage of participants (Number)
CRPRSDPDMissing (no response assessment)
G+E Escalating Dose: Rash Grade < 21.47.172.912.95.7
G+E Standard Dose: Rash Grade < 20.014.758.725.31.3

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Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In

PFS as assessed from the start of 4-week run-in was defined as the time from BL to the first occurrence of PD according to RECIST or death due to any cause. For TLs, PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. (NCT00652366)
Timeframe: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.

Interventionpercentage of participants (Number)
G+E: Rash ≥ Grade 290.6
G+E Standard Dose: Rash Grade < 290.7
G+E Escalating Dose: Rash Grade < 288.6

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Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In

OS assessed from the start of the 4-week run in period was defined as the time from BL to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. (NCT00652366)
Timeframe: BL and weekly thereafter for up to 46 months.

Interventionpercentage of participants (Number)
G+E: Rash ≥ Grade 284.9
G+E Standard Dose: Rash Grade < 281.3
G+E Escalating Dose: Rash Grade < 285.7

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Percentage of Participants Who Died Assessed From Point of Randomization

Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. (NCT00652366)
Timeframe: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.

Interventionpercentage of participants (Number)
G+E Standard Dose: Rash Grade < 281.3
G+E Escalating Dose: Rash Grade < 285.7

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OS Assessed From Start of 4-Week Run-In

OS assessed from the start of the 4-week run in period was defined as the median time, in months, from BL to the date of death, due to any cause. Participants who were still alive at the time of analysis were censored at the date they were last known to be alive. The 95% CI was determined using Kaplan-Meier methodology. (NCT00652366)
Timeframe: BL and weekly thereafter for up to 46 months.

Interventionmonths (Median)
G+E: Rash ≥ Grade 27.9
G+E Standard Dose: Rash Grade < 29.3
G+E Escalating Dose: Rash Grade < 28.0

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Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST

BOR was defined as a confirmed CR or PR for at least 4 weeks. CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. The 95% CI for one sample binomial was determined using Pearson-Clopper method. (NCT00652366)
Timeframe: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.

Interventionpercentage of participants (Number)
G+E Standard Dose: Rash Grade < 214.7
G+E Escalating Dose: Rash Grade < 28.6

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Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization

Progression-free survival (PFS) as assessed from the point of randomization was defined as the time from randomization to the first occurrence of progressive disease (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause. For target lesions (TLs), PD was defined as at least a 20% increase in the sum of longest diameter (SLD) of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. (NCT00652366)
Timeframe: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.

Interventionpercentage of participants (Number)
G+E Standard Dose: Rash Grade < 290.7
G+E Escalating Dose: Rash Grade < 288.6

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PFS Assessed From Point of Randomization

PFS assessed from the point of randomization was defined as the median time, in weeks, from randomization to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology. (NCT00652366)
Timeframe: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.

Interventionweeks (Median)
G+E Standard Dose: Rash Grade < 219.4
G+E Escalating Dose: Rash Grade < 215.3

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Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST

Disease control was defined as a participant with a response of CR or PR for at least 4 weeks at any time during treatment, or SD that was maintained for at least 8 weeks after the start of treatment. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. (NCT00652366)
Timeframe: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.

Interventionpercentage of participants (Number)
G+E Standard Dose: Rash Grade < 262.7
G+E Escalating Dose: Rash Grade < 247.1

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PFS Assessed From the Start of 4-Week Run-In

PFS assessed from the start of 4-week run-in was defined as the median time, in weeks, from BL to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology. (NCT00652366)
Timeframe: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.

Interventionweeks (Median)
G+E: Rash ≥ Grade 217.1
G+E Standard Dose: Rash Grade < 223.4
G+E Escalating Dose: Rash Grade < 219.3

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OS Assessed From Point of Randomization

OS assessed from the point of randomization was defined as the median time, in months, from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. The 95 percent (%) confidence interval (CI) was determined using Kaplan-Meier methodology. (NCT00652366)
Timeframe: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.

Interventionmonths (Median)
G+E Standard Dose: Rash Grade < 28.4
G+E Escalating Dose: Rash Grade < 27.0

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Number of Participants With Adverse Events

All adverse events will be recorded as to the grade and relationship to the study drug in accordance with the Common Terminology Criteria for Adverse Events (CTCAE v 3.0) (NCT00655850)
Timeframe: Baseline through duration of treatment an average of 1 year

Interventionparticipants (Number)
Paclitaxel and Gemcitabine + Avastin36

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Objective Response Rate

The percentage of patients who achieve a complete response and partial response according to RECIST criteria (v1.0). (NCT00655850)
Timeframe: Baseline up to 12 months

InterventionParticipants (Count of Participants)
Paclitaxel and Gemcitabine + Avastin22

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Overall Survival (OS)

Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences death or lost to follow up. (NCT00655850)
Timeframe: Baseline up to 84 months

Interventionmonths (Median)
Paclitaxel and Gemcitabine + Avastin25.5

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Progression-Free Survival (PFS)

Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences disease progression in accordance with the Response Evaluation Criteria Solid Tumors (RECIST v1.0). The RECIST criteria indicates progression as a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions. (NCT00655850)
Timeframe: Baseline to 24 months

Interventionmonths (Median)
Paclitaxel and Gemcitabine + Avastin8.5

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Progression-free Survival Rate at 1 Year.

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. (NCT00656084)
Timeframe: 1 year.

InterventionProbability of Progression-free Survival (Number)
Gemzar + Novantrone + Rituxan0.54

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Overall Survival (OS) Rate at 1 Year

OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date. (NCT00656084)
Timeframe: 1 year.

InterventionProbability of Survival (Number)
Gemzar + Novantrone + Rituxan0.57

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Objective Response Rate (CR + PR)

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. (NCT00656084)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Gemzar + Novantrone + Rituxan46.7

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Duration of Response

"The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.~CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD." (NCT00656084)
Timeframe: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.

Interventionmonths (Median)
Gemzar + Novantrone + Rituxan7.9

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Toxicities Associated With Treatment (Grade 1-2)

Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome. (NCT00660699)
Timeframe: 30 days after completion of treatment (treatment lasts approximately 19 weeks)

Interventionpercentage of participants (Number)
MucositisNauseaVomitingDiarrheaDehydrationWeight lossFatigueRenal toxicityHepatotoxicityInfectionNeutropeniaAnemiaThrombocytopenia
Arm 131482331172767136913466546

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Overall Survival (OS) - Median

OS was defined as the time from the initiation of treatment to death from any cause or last follow-up. (NCT00660699)
Timeframe: Median follow-up was 24 months (range 3.2-97 months)

Interventionmonths (Median)
Pancreatic cancerBiliary cancer/ampullary cancer
Arm 117.623.824.523.8

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Overall Survival (OS)

OS was defined as the time from the initiation of treatment to death from any cause or last follow-up (NCT00660699)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Pancreatic cancerBiliary/ampullary cancer
Arm 132.149.1

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Overall Survival (OS)

OS was defined as the time from the initiation of treatment to death from any cause or last follow-up (NCT00660699)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Pancreatic cancerBiliary/ampullary cancer
Arm 160.775.078.681.2

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Disease Free Survival (DFS) - Median

DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first. (NCT00660699)
Timeframe: Median follow-up was 24 months (range 3.2-97 months)

Interventionmonths (Median)
Pancreatic cancerBiliary/ampullary cancerBiliary cancer/ampullary cancer
Arm 19.612.712.815.0

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Incidence of Disease Recurrence

(NCT00660699)
Timeframe: Median follow-up was 24 months (range 3.2-97 months)

Interventionpercentage of participants (Number)
Arm 183

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Incidence of Severe Toxicities

Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0 (NCT00660699)
Timeframe: 1 month after completion of treatment (treatment lasts approximately 19 weeks)

Interventionpercentage of participants (Number)
Arm 120

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Toxicities Associated With Treatment (Grade 3-4)

Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome. (NCT00660699)
Timeframe: 30 days after completion of treatment (treatment lasts approximately 19 weeks)

Interventionpercentage of participants (Number)
MucositisNauseaVomitingDiarrheaDehydrationWeight lossFatigueRenal toxicityHepatotoxicityInfectionNeutropeniaAnemiaThrombocytopenia
Arm 12441540804152346

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Overall Survival

Overall Survival (OS) is measured from start of treatment to death due to any cause until end of follow-up period. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored at the date of the last observation. (NCT00661830)
Timeframe: one year

Interventiondays (Median)
Gemcitabine + Sorafenib255
Gemcitabine + Placebo341

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Progression-free Survival (PFS)

The primary endpoint is the progression-free survival (PFS) defined as the time from start of treatment to first documentation of objective tumor progression or to death due to any cause, whichever occurs first during treatment or follow-up period. For patients not known to have died as of the data cut-off date and who do not have objective progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment. For patients who receive subsequent anticancer therapy (after discontinuation from the study drug) prior to objectively determined disease progression or death, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation anti-cancer therapy. Acceptable documentation of objective disease progression status consists of objective assessments using CT scan assessment method. (NCT00661830)
Timeframe: one year

Interventiondays (Median)
Gemcitabine + Sorafenib91
Gemcitabine + Placebo148

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Time to Objective Response

Time to Objective Response (OR) is defined as the time from start of treatment to objective tumor response (CR or PR) is first documented according to the RECIST tumor response criteria during treatment or until 30 days after termination of active therapy. Response must subsequently be confirmed. For subjects failing to achieve an objective response and who did not progress during the trial, time to objective response will be censored at their last date of tumor evaluation. (NCT00661830)
Timeframe: one year

Interventiondays (Median)
Gemcitabine + SorafenibNA
Gemcitabine + PlaceboNA

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Best Overall Response

"Best Overall Response (BOR) is defined as the best tumor response (confirmed partial or complete response, stable disease) that is achieved during treatment or within 30 days after termination of active therapy that is confirmed according to the RECIST tumor response criteria. Best response is determined from the sequence of responses assessed. For complete response (CR) or partial response (PR), best response must be confirmed by a second assessment within 4 -6 weeks.~Two objective status determinations of CR before progression are required for a best response of CR.~Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR.~Best response of Stable Disease (SD) is defined as disease that does not meet the criteria of CR, PR or Progressive Disease (PD) and has been evaluated at least one time, at least 6 weeks after baseline assessment." (NCT00661830)
Timeframe: one year

,
Interventionparticipants (Number)
Complete responsePartial responseStable diseaseProgressive diseaseMissing
Gemcitabine + Placebo0327018
Gemcitabine + Sorafenib0424021

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Time to Treatment Failure

Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier (1958). Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. (NCT00662129)
Timeframe: Up to 5 years

Interventionmonths (Median)
Paclitaxel + Gemcitabine + Bevacizumab6.9

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Quality of Life, as Measure by the Mean Change in FACT-B TOI Score at Cycle 8

"Quality of life (QOL) as measured by the mean change (from baseline) in FACT-B (TOI) Trial Outcome Index at Cycle 8 (24 weeks). FACT-B was scored according to the published scoring (*) criteria with higher scores representing better QOL. The FACT-B TOI was the sum of the following FACT-B subscale/scale scores: physical (score range 0-28), functional (score range 0-28), and Breast Cancer Subscale (score range 0-40); range of the FACT-B TOI is 0-96 (the change scores have a possible range of -96 to 96). The mean change and 95% confidence interval are reported below. A one-sample t-test is used to compare the change from baseline to a value of 0.~(*)= Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality of life instrument. J Clin Oncol 1997;15:974-986." (NCT00662129)
Timeframe: From baseline to end of Cycle 8; Up to 24 weeks

Interventionunits on a scale (Mean)
Paclitaxel + Gemcitabine + Bevacizumab-7.4

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PFS Time

Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. The distribution of time to progression will be estimated using the method of Kaplan-Meier (1958). Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. (NCT00662129)
Timeframe: Up to 5 years

Interventionmonths (Median)
Paclitaxel + Gemcitabine + Bevacizumab11.2

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Overall Survival Time

Overall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958). (NCT00662129)
Timeframe: Up to 5 years

Interventionmonths (Median)
Paclitaxel + Gemcitabine + Bevacizumab24.4

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Confirmed Response (Complete or Partial Response) Rate

A confirmed response is defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 8 weeks apart. The confirmed response rate (percentage) will be estimated by the number of confirmed responses in evaluable patients divided by the total number of evaluable patients multiplied by 100. The appropriate confidence interval will be calculated based on the binomial distribution. (NCT00662129)
Timeframe: Up to 5 years

Interventionpercentage of patients with CR or PR (Number)
Paclitaxel + Gemcitabine + Bevacizumab70.8

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6-month Progression-free Survival (PFS) Rate

The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is 6 months from registration without a documentation of disease progression (note, the patient need not be on study treatment at 6 months to be considered a success). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. (NCT00662129)
Timeframe: at 6 months

Interventionproportion of patients progression-free (Number)
Paclitaxel + Gemcitabine + Bevacizumab0.792

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Duration of Response

Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation. The distribution of duration of response will be estimated using the method of Kaplan-Meier (1958). (NCT00662129)
Timeframe: Up to 5 years

Interventionmonths (Median)
Paclitaxel + Gemcitabine + Bevacizumab9.7

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Overall Survival From Time of Study Entry

"The number of weeks patient survived from the time of patient entry. The time frame reflects the time the first patient was entered into the study to the time till the last patient survived.~Note: Not all patients started the study at the same time so the time frame is different from the full range.~The full range reflects the least number of weeks a patient survived to the most number of weeks a patient survived." (NCT00674206)
Timeframe: 132 weeks

InterventionWeeks (Median)
Gemcitabine and Oxaliplatin62

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Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.

"A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions.~Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started." (NCT00674206)
Timeframe: 8 weeks

Interventionparticipants (Number)
Stable DiseasePartial Response
Gemcitabine and Oxaliplatin42

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Overall Survival as Assessed by the Kaplan and Meier Method

Overall survival as assessed by the Kaplan and Meier method at 5 years (NCT00679029)
Timeframe: Original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years

Interventionpercentage of participants (Number)
Arm I69.1

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Percentage of Participants With Study Drug-associated Adverse Events Leading to Dose Holds or Reductions

This outcome is to measure the feasibility of the of administering two sequential chemotherapy doublets with Avastin in the adjuvant setting in women with stage II and III breast cancer that does not over-express human epidermal growth factor receptor 2 (HER 2)/neu (NCT00679029)
Timeframe: through study completion, an average of 10 months

Interventionpercentage of participants (Number)
Arm I20

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Disease-free Survival

Disease-free survival as assessed by the Kaplan and Meier method (NCT00679029)
Timeframe: From the date of first treatment to the date of disease progression/recurrence, second cancer, or death, whichever came first: Original time frame up to 5 years from date of first treatment; study terminated at 2.5 years

Interventionpercentage of participants (Number)
Arm I70

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Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start)

(NCT00685763)
Timeframe: 1 year following the completion of radiation therapy

Interventionparticipants (Number)
Proton Radiation and Chemotherapy0

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Median Overall Survival (mOS)

Median overall survival is defined as the time when 50% of the patients are alive from the start of the treatment. (NCT00696696)
Timeframe: up to 2 years

Interventiondays (Median)
Combination GES195

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Objective Response Rate

The response rate is the percentage of the patients who have a complete response or partial response based on RECIST from the start of the treatment. The response is evaluated every 2 cycles by radiologic methods (e.g., computer tomography (CT)). (NCT00696696)
Timeframe: up to 1 year

Interventionpercentage of patients (Number)
Combination GES7

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4-month Progression Free Survival (PFS) Rate

The PFS rate at 4 months is defined as the percentage of patients whose disease is progression free at 4 months from the start of treatment. Disease progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al, 2000). Radiological measurements to determine progression is performed every 2 cycles. (NCT00696696)
Timeframe: 4 months

Interventionpercentage of patients (Number)
Combination GES49

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Overall Response Rate (ORR)

Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00701558)
Timeframe: From the time of randomization until disease progression or death (up to 193 weeks)

Interventionpercentage of participants (Number)
Erlotinib + Gemcitabine15.8

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Overall Survival

Overall survival was defined as the interval between the day of randomization and the date of death from any cause. (NCT00701558)
Timeframe: From the time of randomization until death (up to 193 weeks)

Interventionweeks (Median)
Erlotinib + Gemcitabine39

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Time to Disease Progression

Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first. (NCT00701558)
Timeframe: From the time of randomization until disease progression or death (up to 193 weeks)]

Interventionweeks (Median)
Erlotinib + Gemcitabine15

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Maximum Tolerated Dose (MTD)

"The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT).~DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047:~Any nonhematologic toxicity > Grade 3 lasting > 3 days~Grade 4 thrombocytopenia~Grade 4 Anemia on the next scheduled dosing day~Grade 4 Neutropenia (lasting > than 5 days~Any febrile neutropenia (Grade 3 or 4))~Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity" (NCT00705874)
Timeframe: End of Study

Interventionmg (Number)
PG11047/GemcitabineNA
PG11047/DocetaxelNA
PG11047/Bevacizumab590
PG11047/Erlotinib590
PG11047/Cisplatin590
PG11047/5-Flurouracil590
PG11047/SunitinibNA

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Overall Survival

(NCT00709826)
Timeframe: Randomization then every other cycle

InterventionMonths (Median)
Apricoxib/Gemcitabine/Erlotinib5.0
Placebo/Gemcitabine/Erlotinib4.8

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Progression Free Survival

Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. (NCT00709826)
Timeframe: Randomization then every other cycle

InterventionMonths (Median)
Apricoxib/Gemcitabine/Erlotinib3.0
Placebo/Gemcitabine/Erlotinib2.8

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Overall Survival at 2 Years

The primary endpoint of this trial is 2-year overall survival, which will be evaluated as the proportion of treatment successes. A treatment success is defined to be an evaluable patient who is alive at two years from the date of registration. (NCT00733746)
Timeframe: At 2 years post-registration

Interventionproportion of patients (Number)
Neoadjuvant Therapy + Surgery + Adjuvant Therapy0.54

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Response Rate

The response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib and rates of accurate pathologic assessment of the resected tumor specimen according to College of American Pathology guidelines will be estimated with a binomial point estimate and corresponding 95% confidence intervals. (NCT00733746)
Timeframe: Up to 4 years postoperative chemotherapy treatment

Interventionproportion of patients (Number)
Neoadjuvant Therapy + Surgery + Adjuvant Therapy0.06

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Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI's Common Toxicity Criteria for Adverse Events

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. These patterns will be summarized with descriptive statistics. The number of patients reporting grade 3 or higher adverse events as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report. (NCT00733746)
Timeframe: Up to 4 years postoperative chemotherapy treatment

InterventionParticipants (Count of Participants)
Grade 3+ Adverse EventGrade 4+ Adverse Event
Neoadjuvant Therapy + Surgery + Adjuvant Therapy272

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Relapse/Progression-free Survival

Relapse/progression-free survival is defined as the time from date of registration to the date of documentation of disease recurrence/progression. If a patient dies without documentation of disease recurrence/progression, the patient will be considered to have had disease recurrence/progression at the time of their death unless there is sufficient documented evidence to conclude no recurrence/progression occurred prior to death. If a patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation occurred. If a patient is lost to follow-up, s/he will be censored at the data of last contact. The distribution of disease-free survival will be estimated using the method of Kaplan and Meier. (NCT00733746)
Timeframe: At 2 years post-registration

Interventionmonths (Median)
Neoadjuvant Therapy + Surgery + Adjuvant Therapy11.9

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Resection Rate

"The resection rate is defined as the fraction of patients that proceed to planned surgery with removal of primary tumor (R0/R1) following neoadjuvant treatment with gemcitabine plus erlotinib.The resection rate will be estimated by the binomial point estimate, i.e. as the number of patients that undergo the planned surgery with removal of the primary tumor following neoadjuvant treatment with gemcitabine plus erlotinib divided by the number of evaluable patients. This quantity will also be estimated with a 95% binomial confidence interval.~Curative resection (R0) is defined as macroscopically and microscopically complete resection (with microscopic surgical margin assessment according to AJCC Staging Principles).~An R1 resection is defined as macroscopically complete tumor removal with any positive microscopic surgical margin (bile duct, pancreatic parenchyma, or SMA margins)." (NCT00733746)
Timeframe: Up to 4 years postoperative chemotherapy treatment

Interventionproportion of patients (Geometric Least Squares Mean)
Neoadjuvant Therapy + Surgery + Adjuvant Therapy0.76

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Overall Survival (OS)

Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). (NCT00735904)
Timeframe: Baseline until death or assessed every 2 months (up to 28 days after the last dose)

InterventionMonths (Median)
Axitinib + Cisplatin + Gemcitabine14.2

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Percentage of Participants With Objective Response (OR)

Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions. (NCT00735904)
Timeframe: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)

InterventionPercentage of participants (Number)
Axitinib + Cisplatin + Gemcitabine39.5

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Progression Free Survival (PFS)

"Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)." (NCT00735904)
Timeframe: Baseline, assessed every 2 months (up to 28 days after the last dose)

InterventionMonths (Median)
Axitinib + Cisplatin + Gemcitabine6.2

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Duration of Response (DR)

Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. (NCT00735904)
Timeframe: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)

InterventionMonths (Median)
Axitinib + Cisplatin + Gemcitabine5.78

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Duration of Response (DOR)

DOR is defined from the date of first documentation of response until date of PD or death (NCT00753675)
Timeframe: up to 1032 days

InterventionDays (Median)
Arm A Vandetanib 300 mg277
Arm B Vandetanib 100mg + Gemcitab179
ARM C Placebo+ Gemcitabine127

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Overall Survival

OS is defined from the date of randomization to death (NCT00753675)
Timeframe: up to 1032 days

InterventionDays (Median)
Arm A Vandetanib 300 mg228
Arm B Vandetanib 100mg + Gemcitab284
ARM C Placebo+ Gemcitabine307

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Disease Control Rate (CR+PR+SD)

DCR is the sum of patients with a best overall CR, PR or SD (>=8 weeks) by the patient in the analysis (NCT00753675)
Timeframe: up to 1032 days

,,
InterventionPartecipants (Number)
Disease control rate = NODisease control rate = YES
Arm A Vandetanib 300 mg4214
Arm B Vandetanib 100mg + Gemcitab4017
ARM C Placebo+ Gemcitabine3220

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Progression Free Survival

Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s). (NCT00753675)
Timeframe: up to 1032 days

Interventiondays (Median)
Arm A Vandetanib 300 mg105
Arm B Vandetanib 100mg + Gemcitab114
ARM C Placebo+ Gemcitabine148

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Objective Tumor Response Rate (CR+PR),

Objective Tumor Response Rate was defined as complete response (CR) + partial response (PR) evaluated by RECIST. CR was defined as disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of longest diameters (LD) of target lesion(s) taking as reference the baseline sum of LD (NCT00753675)
Timeframe: up to 1032 days

,,
InterventionParticipants (Number)
Objective Response = NOObjective Response = YES
Arm A Vandetanib 300 mg542
Arm B Vandetanib 100mg + Gemcitab4611
ARM C Placebo+ Gemcitabine457

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Progression Free Survival

(NCT00753714)
Timeframe: Oct 2008- dec 2011

Interventiondays (Median)
ZD6474 (Vandetanib),Gemcitabine183
Placebo to Match ZD6474 (Vandetanib),Gemcitabine169

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Overall Survival

(NCT00753714)
Timeframe: Oct 2008- dec 2011

Interventiondays (Median)
ZD6474 (Vandetanib),Gemcitabine262
Placebo to Match ZD6474 (Vandetanib),Gemcitabine305

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Overall Objective Response

(NCT00753714)
Timeframe: Oct 2008- dec 2011

InterventionParticipants (Number)
ZD6474 ( (Vandetanib),Gemcitabine9
Placebo to Match ZD6474 (Vandetanib),Gemcitabine8

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Duration of Response

(NCT00753714)
Timeframe: Oct 2008- dec 2011

Interventiondays (Median)
ZD6474 (Vandetanib),Gemcitabine225
Placebo to Match ZD6474 (Vandetanib),Gemcitabine214

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The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine

The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes (NCT00753714)
Timeframe: Oct 2008- Dec 2011

InterventionAdverse Events (Number)
ZD6474 (Vandetanib),Gemcitabine378
Placebo to Match ZD6474 (Vandetanib),Gemcitabine381

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To Determine the Dose Limiting Toxicities

(NCT00761345)
Timeframe: weekly physician and nurse assessment and in between as needed until 30 days after treatment termination

Interventionparticipants (Number)
Radiotherapy and Chemotherapy27

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Progression Free Survival

Time interval (in months) from date of randomization until the date of first documented progression or date of death from any cause, whichever came first (NCT00769483)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Interventionmonths (Median)
Arm A / Phase II Randomization1.8
Arm B / Phase II Randomization1.8
Arm C / Phase II Randomization1.9
Phase II Expansion2.0

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Treatment Toxicity

Number of patients who developed toxicity from treatment according to the National Cancer Institute's Common Terminology Criteria (NCT00769483)
Timeframe: Through the treatment cycles

InterventionParticipants (Count of Participants)
Arm A / Phase I9
Arm B / Phase I12
Arm A / Phase II Randomization15
Arm B / Phase II Randomization15
Arm C / Phase II Randomization15
Phase II Expansion9

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MK-0646 Maximum Tolerable Dose

MK-0646 10 mg/kg was declared to be the MTD in combination with gemcitabine and 5 mg/kg the MTD in combination with Gemcitabine and erlotinib (NCT00769483)
Timeframe: up to 12 cycles

,
Interventionparticipants (Number)
MK 5mg +G: #DLTMK 10mg +G: # DLT
Arm A / Phase I00
Arm B / Phase I02

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Overall Response Rate

Complete response + Partial response using RECIST (Response Evaluation Criteria in Solid Tumors) (NCT00769483)
Timeframe: From start of the treatment until disease progression/recurrence; or through study completion (average of 1 year)

InterventionParticipants (Count of Participants)
Arm A / Phase I0
Arm B / Phase I0
Arm A / Phase II Randomization2
Arm B / Phase II Randomization1
Arm C / Phase II Randomization2
Phase II Expansion0

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Overall Survival

Time interval (in months) from date of randomization until the date of death from any cause (NCT00769483)
Timeframe: From date of randomization until the date of death from any cause, assessed up to 100 months

Interventionmonths (Median)
Arm A / Phase II Randomization10.4
Arm B / Phase II Randomization7.1
Arm C / Phase II Randomization5.7
Phase II Expansion8.2

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Percentage of Patients With Grade 3 or Higher Genitourinary, Gastrointestinal, or Hematologic Adverse Events

Highest grade adverse event (AE) per subject was counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. All adverse events are counted, regardless of reported relationship to protocol treatment. (NCT00777491)
Timeframe: From start of treatment to 180 days after the end of treatment. Treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges.

,
InterventionParticipants (Count of Participants)
During TreatmentBetween End of Treatment and 180 days after
5-FU and Cisplatin + BID Irradiation198
Gemcitabine + QD Irradiation185

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Percentage of Patients Who Completed Treatment Per Protocol

Treatment administration data was centrally reviewed to determine if patients completed each treatment component per protocol. (NCT00777491)
Timeframe: After each treatment component (induction, consolidation, adjuvant). Timing varies bases on arm, tumor response at multiple time points, and allowed time ranges.

,
InterventionParticipants (Count of Participants)
Induction TherapyConsolidation TherapyAdjuvant Therapy
5-FU and Cisplatin + BID Irradiation322718
Gemcitabine + QD Irradiation312317

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Change in American Urological Association Symptom Index (AUASI) Score at 3 Years

The AUASI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as 3-year score - baseline score such that a negative change indicates improvement. (NCT00777491)
Timeframe: Baseline and 3 years

,
Interventionunits on a scale (Median)
Sensation of Not Emptying BladderUrinate Again < 2 Hours After UrinatingStopped and Started When UrinatingDifficult to Postpone UrinationWeak Urinary StreamPush or Strain to Begin UrinationHow Often Get Up at Night to UrinateAUA Total Symptom Score
5-FU and Cisplatin + BID Irradiation-0.50-2.50-1.00-3.00-0.50-0.50-3.50-9.50
Gemcitabine + QD Irradiation0.0-1.00.00-0.500.000.00-1.50-3.50

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Number of Participants With Progression or Removal of Bladder Five Years After Therapy

Progression is defined as an increase of 50% or more in the largest diameter of the endoscopically appreciable tumor in the tumor-site biopsy specimen, the development of new bladder tumors, or the development of metastatic disease. (NCT00777491)
Timeframe: From start of treatment to five years after the end of therapy. Treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges.

InterventionParticipants (Count of Participants)
5-FU and Cisplatin + BID Irradiation4
Gemcitabine + QD Irradiation5

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Number of Patients Experiencing Complete Response of the Primary Tumor After Induction Therapy

Patients will be considered as having a clinical complete response when all biopsies are negative at the site(s) of the pretreatment tumor(s). (NCT00777491)
Timeframe: 3-4 weeks following induction therapy (approximately maximum 8 weeks from start of treatment depending on treatment arm and allowed time windows)

InterventionParticipants (Count of Participants)
5-FU and Cisplatin + BID Irradiation29
Gemcitabine + QD Irradiation25

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Percentage of Patients Without Distant Metastases by Three Years

Distant metastasis occurrence is defined as the first appearance of disease (with radiographic evidence) in a non-regional lymph node, solid organ or bone. (NCT00777491)
Timeframe: From randomization to three years

Interventionpercentage of participants (Number)
5-FU and Cisplatin + BID Irradiation77.8
Gemcitabine + QD Irradiation84.0

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Number of Participants Who Discontinued Study Treatment Due to an AE

An AE was defined as any untoward medical occurrence in a participant administered study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to study treatment. The number of participants who discontinued study treatment due to an AE is presented. (NCT00779584)
Timeframe: Up to approximatey 66 weeks

InterventionParticipants (Number)
MK-8776 10mg/m^2+Gemcitabine 800mg/m^21
MK-8776 20mg/m^2+Gemcitabine 800mg/m^20
MK-8776 40mg/m^2+Gemcitabine 800mg/m^22
MK-8776 80mg/m^2+Gemcitabine 800mg/m^20
MK-8776 112mg/m^2+Gemcitabine 800mg/m^20
MK-8776 80mg/m^2+Gemcitabine 1000mg/m^20
MK-8776 112mg/m^2+Gemcitabine 1000mg/m^22
MK-8776 150mg/m^2+Gemcitabine 1000mg/m^21
MK-8776 200mg+Gemcitabine 1000mg/m^21

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Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) During Cycle 0 and Cycle 1 Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v 3.0)

During Cycle 0, a DLT was defined as: CTCAE v 3.0 Grade 3 neutropenia or thrombocytopenia lasting ≥3 days; any CTCAE v 3.0 Grade 4 neutropenia or thrombocytopenia; neutropenic fever; any CTCAE v. 3.0 ≥ Grade 3 QT interval corrected by Fridericia (QTcF) prolongation of any duration; any other CTCAE v 3.0 Grade 3 or higher nonhematologic toxicity; or Grade 3 elevation of transaminases that resolved prior to administration of next dose(s) of study drug(s); delay in Cycle 1 Day 1 beyond 3 weeks due to continuing toxicity. During Cycle 1, a DLT was defined as: CTCAE v 3.0 Grade 4 neutropenia that persists for ≥7 days; neutropenic fever; CTCAE v 3.0 Grade 4 thrombocytopenia; CTCAE v 3.0 ≥ Grade 3 thrombocytopenia with bleeding; any CTCAE v 3.0 QTc ≥ Grade 3 QTcF prolongation of any duration; any other CTCAE v 3.0 Grade 3 or higher nonhematologic toxicity; or Grade 3 elevation of transaminases that resolved prior to administration of next dose(s) of study drug(s). (NCT00779584)
Timeframe: Through Cycle 0 and Cycle 1 (Up to 42 days)

InterventionParticipants (Number)
MK-8776 10mg/m^2+Gemcitabine 800mg/m^20
MK-8776 20mg/m^2+Gemcitabine 800mg/m^20
MK-8776 40mg/m^2+Gemcitabine 800mg/m^21
MK-8776 80mg/m^2+Gemcitabine 800mg/m^20
MK-8776 112mg/m^2+Gemcitabine 800mg/m^22
MK-8776 80mg/m^2+Gemcitabine 1000mg/m^20
MK-8776 112mg/m^2+Gemcitabine 1000mg/m^21
MK-8776 150mg/m^2+Gemcitabine 1000mg/m^20
MK-8776 200mg+Gemcitabine 1000mg/m^20

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Number of Participants Who Experienced an Adverse Event (AE)

An AE was defined as any untoward medical occurrence in a participant administered study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to study treatment. The number of participants who experienced an AE is presented. (NCT00779584)
Timeframe: Up to approximately 72 weeks (Up to approximately 6 weeks after last dose of study treatment)

InterventionParticipants (Number)
MK-8776 10mg/m^2+Gemcitabine 800mg/m^23
MK-8776 20mg/m^2+Gemcitabine 800mg/m^23
MK-8776 40mg/m^2+Gemcitabine 800mg/m^27
MK-8776 80mg/m^2+Gemcitabine 800mg/m^26
MK-8776 112mg/m^2+Gemcitabine 800mg/m^27
MK-8776 80mg/m^2+Gemcitabine 1000mg/m^24
MK-8776 112mg/m^2+Gemcitabine 1000mg/m^28
MK-8776 150mg/m^2+Gemcitabine 1000mg/m^23
MK-8776 200mg+Gemcitabine 1000mg/m^22

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MK-8776 Area Under the Curve of the Plasma Concentration Versus Time From Time Zero to the Time of the Last Analytically Quantifiable Concentration (AUC0-last)

AUC0-last was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion. AUC0-last was calculated by the linear trapezoidal method. (NCT00779584)
Timeframe: At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion

,,,,,,,,
Interventionng*hr/mL (Mean)
Cycle 0 (n=3, 3, 7, 6, 7, 4, 8, 3, 2)Cycle 1 (n=3, 3, 7, 5, 6, 4, 6, 1, 2)
MK-8776 10mg/m^2+Gemcitabine 800mg/m^2565539
MK-8776 112mg/m^2+Gemcitabine 1000mg/m^292406900
MK-8776 112mg/m^2+Gemcitabine 800mg/m^2905010300
MK-8776 150mg/m^2+Gemcitabine 1000mg/m^21850013000
MK-8776 200mg+Gemcitabine 1000mg/m^2844016900
MK-8776 20mg/m^2+Gemcitabine 800mg/m^214001570
MK-8776 40mg/m^2+Gemcitabine 800mg/m^222501900
MK-8776 80mg/m^2+Gemcitabine 1000mg/m^240404660
MK-8776 80mg/m^2+Gemcitabine 800mg/m^250604540

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Time of MK-8776 Cmax (Tmax)

The time of Cmax of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion. (NCT00779584)
Timeframe: At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion

,,,,,,,,
Interventionhr (Mean)
Cycle 0 (n=3, 3, 7, 6, 7, 4, 8, 3, 2)Cycle 1 (n=3, 3, 7, 5, 6, 4, 6, 1, 2)
MK-8776 10mg/m^2+Gemcitabine 800mg/m^20.270.26
MK-8776 112mg/m^2+Gemcitabine 1000mg/m^20.230.23
MK-8776 112mg/m^2+Gemcitabine 800mg/m^20.300.28
MK-8776 150mg/m^2+Gemcitabine 1000mg/m^20.480.50
MK-8776 200mg+Gemcitabine 1000mg/m^20.490.57
MK-8776 20mg/m^2+Gemcitabine 800mg/m^20.260.27
MK-8776 40mg/m^2+Gemcitabine 800mg/m^20.290.35
MK-8776 80mg/m^2+Gemcitabine 1000mg/m^20.260.26
MK-8776 80mg/m^2+Gemcitabine 800mg/m^20.240.25

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MK-8776 Terminal Phase Half-Life (t1/2)

The t1/2 of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion. (NCT00779584)
Timeframe: At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion

,,,,,,,,
Interventionhr (Mean)
Cycle 0 (n=3, 3, 7, 6, 7, 4, 8, 3, 2)Cycle 1 (n=3, 3, 6, 6, 7, 4, 7, 1, 2)
MK-8776 10mg/m^2+Gemcitabine 800mg/m^26.296.24
MK-8776 112mg/m^2+Gemcitabine 1000mg/m^27.147.98
MK-8776 112mg/m^2+Gemcitabine 800mg/m^25.947.29
MK-8776 150mg/m^2+Gemcitabine 1000mg/m^29.467.59
MK-8776 200mg+Gemcitabine 1000mg/m^26.309.89
MK-8776 20mg/m^2+Gemcitabine 800mg/m^29.338.57
MK-8776 40mg/m^2+Gemcitabine 800mg/m^28.458.23
MK-8776 80mg/m^2+Gemcitabine 1000mg/m^28.137.87
MK-8776 80mg/m^2+Gemcitabine 800mg/m^27.449.01

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MK-8776 Maximum Plasma Concentration (Cmax)

The Cmax of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion. (NCT00779584)
Timeframe: At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion

,,,,,,,,
Interventionng/mL (Mean)
Cycle 0 (n=3, 3, 7, 6, 7, 4, 8, 3, 2)Cycle 1 (n=3, 3, 7, 5, 6, 4, 6, 1, 2)
MK-8776 10mg/m^2+Gemcitabine 800mg/m^2414445
MK-8776 112mg/m^2+Gemcitabine 1000mg/m^262104690
MK-8776 112mg/m^2+Gemcitabine 800mg/m^252704710
MK-8776 150mg/m^2+Gemcitabine 1000mg/m^262204940
MK-8776 200mg+Gemcitabine 1000mg/m^248603700
MK-8776 20mg/m^2+Gemcitabine 800mg/m^210101650
MK-8776 40mg/m^2+Gemcitabine 800mg/m^21220962
MK-8776 80mg/m^2+Gemcitabine 1000mg/m^229603610
MK-8776 80mg/m^2+Gemcitabine 800mg/m^249703700

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2-year Stratum-specific Local Relapse Rate

Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields). (NCT00789958)
Timeframe: Up to 2 years from registration

Interventionpercentage of participants (Number)
Patients With Negative Margins of Resection (R0)9
Patients w/Microscopically Positive Margin of Resection (R1)16

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Stratum-specific (R0 and R1) 2-year Overall Survival

Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00789958)
Timeframe: Up to 2 years from registration

Interventionpercentage of participants (Number)
Patients With Negative Margins of Resection (R0)67
Patients w/Microscopically Positive Margin of Resection (R1)60

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2-year Disease-free Survival in All Patients

Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00789958)
Timeframe: Up to 2 years from registration

Interventionpercentage of participants (Number)
Adjuvant Chemotherapy + Chemoradiotherapy52

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2-year Overall Local Relapse Rate

Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields). (NCT00789958)
Timeframe: Up to 2 years from registration

Interventionpercentage of participants (Number)
Adjuvant Chemotherapy + Chemoradiotherapy11

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2-year Overall Survival for All Patients

Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00789958)
Timeframe: Up to 2 years from registration

Interventionpercentage of participants (Number)
Adjuvant Chemotherapy + Chemoradiotherapy65

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2-year Stratum-specific Disease-free Survival

Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00789958)
Timeframe: Up to 2 years from registration

Interventionpercentage of participants (Number)
Patients With Negative Margins of Resection (R0)54
Patients w/Microscopically Positive Margin of Resection (R1)48

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Two-year Disease-free Survival

(NCT00792701)
Timeframe: From time of registration to maximum of 2 years

Interventionpercentage of participants (Number)
Active Monitoring71
Gemcitabine Hydrochloride and Cisplatin83

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Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0

Patients in the active monitoring arm were not followed for adverse events. (NCT00792701)
Timeframe: From time of registration to maximum of 2 years

Interventionparticipants (Number)
ALT, SGPT (serum glutamic pyruvic transaminase)AnorexiaDehydrationFatigue (asthenia, lethargy, malaise)Febrile neutropeniaHearing: pts w/o audiogram not enroll monitor prgmHemoglobinMucositis/stomatitis (clinical exam) - Oral cavityNauseaNeutrophils/granulocytes (ANC/AGC)PlateletsPleural effusion (non-malignant)Potassium, serum-low (hypokalemia)Renal failureSVT and nodal arrhythmia - Sinus bradycardiaSodium, serum-low (hyponatremia)Syncope (fainting)Thrombosis/embolism (vascular access-related)Thrombosis/thrombus/embolismVomiting
Gemcitabine Hydrochloride and Cisplatin121221214178111121114

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Relationship Between RNA and Protein Expression of RRM1 and ERCC1

(NCT00792701)
Timeframe: From time of registration to maximum of 2 years

InterventionScores (Median)
RRM1 Protein ScoreERCC1 Protein Score
All Patients39.741.9

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Relationship Between RRM1 and ERCC1 Expression in the Formalin-fixed and Paraffin-embedded Tumor Specimens.

RRM1 and ERCC1 protein levels are expressed as a simple score with no units. (NCT00792701)
Timeframe: From time of registration to maximum of 2 years

InterventionScores (Median)
RRM1 Protein ScoreERCC1 Protein Score
All Patients39.741.9

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Feasibility of Pharmacogenomics-based Treatment Assignment in the Cooperative Group Setting

Feasibility will be assessed both by accrual rate and the percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring. (NCT00792701)
Timeframe: From time of registration to 84 days after surgical resection.

InterventionParticipants (Count of Participants)
All Eligible Patients71

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Progression Free Survival

Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00810719)
Timeframe: Up to 36 months

Interventionmonths (Median)
Gemcitabine and Erlotinib2.07

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Overall Survival

Overall survival will be followed for survival every three months until documented progression, death or study termination. If a participant is still alive, survival time is censored at the time of last follow-up. (NCT00810719)
Timeframe: Up to 36 months

Interventionmonths (Median)
Gemcitabine and Erlotinib5.67

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Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00810719)
Timeframe: Up to 36 months

Interventionpercentage of participants (Number)
Gemcitabine and Erlotinib11

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Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0

RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate. (NCT00820898)
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.

InterventionParticipants (Count of Participants)
Partial responseComplete response
Gemcitabine10

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Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0

(NCT00820898)
Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

,,,,,
InterventionParticipants (Count of Participants)
LeukopeniaThrombocytopeniaNeutropeniaAnemiaHemorrhageNausea/VomitingGastrointestinalAlopeciaDermatologicRenalAlkaline PhosphataseSGOTNeurotoxicityConstitutionalMetabolicPulmonaryLymphaticsInfectionPain
Grade 0651052214719212020201461817212017
Grade 1 (CTCAE v 3.0)611161672013281022105
Grade 2 (CTCAE v 3.0)8577038221011621021
Grade 3 (CTCAE v 3.0)3144001000000110110
Grade 4 (CTCAE v 3.0)0111000001000001000
Grade 5 (CTCAE v 3.0)0000000000000002000

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Progression-free Survival

"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression (PD) is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions." (NCT00821327)
Timeframe: 2 years

InterventionMonth (Median)
Study Arm: Advanced/Metastatic UC8.0

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Ovarall Survival (OS)

OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date. (NCT00821327)
Timeframe: 2 years

Interventionmonths (Median)
Study Arm: Advanced/Metastatic UC13.8

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Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib.

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. (NCT00821327)
Timeframe: 2 years

InterventionPercentage of participants (Number)
Study Arm: Advanced/Metastatic UC48.5

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Overall Survival by Treatment Arm

(NCT00828841)
Timeframe: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

InterventionMonths (Median)
Paclitaxel, Carboplatin, Cetuximab (Arm A)9.5
Platinum, Gemcitabine, Cetuximab (Arm B)8.3
Platinum, Pemetrexed, Cetuximab (Arm C)10.6

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Overall Survival by Histology

(NCT00828841)
Timeframe: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

InterventionMonths (Median)
Squamous Cell Histology8.7
Non-squamous Cell Histology9.9

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1-year Survival by Treatment Arm

(NCT00828841)
Timeframe: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

Interventionpercentage of participants (Number)
Paclitaxel, Carboplatin, Cetuximab (Arm A)39.7
Platinum, Gemcitabine, Cetuximab (Arm B)37.2
Platinum, Pemetrexed, Cetuximab (Arm C)47.3

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Toxicity

Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events). (NCT00832637)
Timeframe: Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition. An average of 24 weeks

Interventionparticipants (Number)
AnemiaNeutropeniaNeutropenic FeverThrombocytopeniaDiarrheaAbdominal PainRenal FailureDermatitis (acneiform)Peripheral neuropathyMetabolic syndromeCerebral hemorrhage
Gemcitabine, Cisplatin, Erlotinib27264213121

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Overall Response Rate

"Overall response rate is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) at 24 weeks following treatment.~Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions." (NCT00832637)
Timeframe: 24 weeks

Interventionpercentage of evaluable participants (Number)
Complete response (CR)Partial response (PR)CR + PR
Gemcitabine, Cisplatin, Erlotinib07.17.1

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Tumor Control Rate

"Rate of tumor control is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) + stable disease (SD) at 24 weeks following treatment.~Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions." (NCT00832637)
Timeframe: 24 weeks

Interventionpercentage of evaluable participants (Number)
Complete response (CR)Partial response (PR)Stable disease (SD)CR + PR + SD
Gemcitabine, Cisplatin, Erlotinib07.153.660.7

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Time to Tumor Progression (TTP)

The time from treatment initiation to disease progression. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00832637)
Timeframe: 2 years

Interventionweeks (Median)
Gemcitabine, Cisplatin, Erlotinib22

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Median Survival Time (MST)

Survival is defined as the time from treatment initiation to death by any cause (NCT00832637)
Timeframe: 2 years

Interventionweeks (Median)
Gemcitabine, Cisplatin, Erlotinib28

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Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

Length of time, in months, that patients were alive from their first date of protocol treatment until death (NCT00837031)
Timeframe: 18 months

Interventionmonths (Median)
Lenalidomide/Gemcitabine4.7

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Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

The length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease (NCT00837031)
Timeframe: 18 months

Interventionmonths (Median)
Lenalidomide/Gemcitabine2.3

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Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment

The percentage of patients who were alive 6 months after beginning treatment (NCT00837031)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Lenalidomide/Gemcitabine37

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Number of Deaths During the Phase 1 Post-study Period

The number of participants who died during the post-study period of Phase 1 does not include the outcomes for the 4 participants who died while on treatment during Phase 2 as captured in the Participant Flow Table. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT00839332)
Timeframe: Phase 1: Time of last dose of study drug through the end of the follow-up period

InterventionParticipants (Count of Participants)
Total deathsDeaths within 30 days of last dose of study drugDeaths during the follow-up period
Phase 1: LY2603618 + Gemcitabine541

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Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618

Plasma samples for pharmacokinetic (PK) analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine and dFdU plasma concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only the LY2603618 plasma Cmax values are reported for each LY2603618 dose level on Cycle (C) 1 /Day (D) 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each dose level and time point. (NCT00839332)
Timeframe: Phase 1: LY2603618 - Predose and 0, 1, 3, 6, 24, 48, and 72 hours after the end of infusion on C1 /D2, C1 /D16, and C2 /D2. Gemcitabine - Predose and 0, 10, 30, 60, and 120 minutes after the end of infusion on C1 /D1, C1 /D15, and C2 /D1.

Interventionnanograms per milliliter (ng/mL) (Geometric Mean)
70 mg/m^2, Cycle 1 /Day 270 mg/m^2, Cycle 1 /Day 1670 mg/m^2, Cycle 2 /Day 2105 mg/m^2, Cycle 1 /Day 2105 mg/m^2, Cycle 1 /Day 16105 mg/m^2, Cycle 2 /Day 2150 mg/m^2, Cycle 1 /Day 2150 mg/m^2, Cycle 1 /Day 16150 mg/m^2, Cycle 2 /Day 2200 mg/m^2, Cycle 1 /Day 2200 mg/m^2, Cycle 1 /Day 16200 mg/m^2, Cycle 2 /Day 2250 mg/m^2, Cycle 1 /Day 2250 mg/m^2, Cycle 1 /Day 16250 mg/m^2, Cycle 2 /Day 2200 mg (flat dose), Cycle 1 /Day 2200 mg (flat dose), Cycle 1 /Day 16200 mg (flat dose), Cycle 2 /Day 2230 mg (flat dose), Cycle 1 /Day 2230 mg (flat dose), Cycle 1 /Day 16230 mg (flat dose), Cycle 2 /Day 2
Phase 1: LY2603618 + Gemcitabine353033603100489051705360428050404370487053605290799079905290344034703640482049803830

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Phase 1: Electrocardiogram QTc Prolongation

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. Twelve-lead electrocardiogram (ECG) data was used to calculate the corrected QT (QTc) based on Fridericia's formula (QTc=QT/RR^0.33, where RR is the interval between two R waves). For each participant, changes in QTc were calculated by subtracting the reading taken before LY2603618 administration from the reading taken after LY2603618 administration on Days 2 and 16 during Cycle 1. The number of participants in which the change in QTc was <=30 milliseconds (msec), >30-60 msec, or >60 msec is presented by dose group and overall. (NCT00839332)
Timeframe: Phase 1: Days 2 and 16 of Cycle 1

InterventionParticipants (Count of Participants)
70 mg/m^2, <=30 msec70 mg/m^2, >30-60 msec70 mg/m^2, >60 msec105 mg/m^2, <=30 msec105 mg/m^2, >30-60 msec105 mg/m^2, >60 msec150 mg/m^2, <=30 msec150 mg/m^2, >30-60 msec150 mg/m^2, >60 msec200 mg/m^2, <=30 msec200 mg/m^2, >30-60 msec200 mg/m^2, >60 msec250 mg/m^2, <=30 msec250 mg/m^2, >30-60 msec250 mg/m^2, >60 msec200 mg (flat dose), <=30 msec200 mg (flat dose), >30-60 msec200 mg (flat dose), >60 msec230 mg (flat dose), <=30 msec230 mg (flat dose), >30-60 msec230 mg (flat dose), >60 msecTotal, <=30 msecTotal, >30-60 msecTotal, >60 msec
Phase 1: LY2603618 + Gemcitabine21020061011006009108204450

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Phase 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618

Plasma samples for PK analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine and dFdU plasma concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only the LY2603618 plasma AUC(0-24), AUC(0-tlast), and AUC(0-inf) values are reported for the 230 mg LY2603618 dose on Cycle 1 /Day 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each time point. (NCT00839332)
Timeframe: Phase 2: LY2603618 - Predose and 0, 1, 3, and 24 hours after the end of infusion on Days 2 and 16 of Cycle 1. Gemcitabine - Predose and 0, 10, 60, and 120 minutes after the end of infusion on Days 1 and 15 of Cycle 1.

Interventionng*h/mL (Geometric Mean)
AUC(0-24), Cycle 1 /Day 2AUC(0-24), Cycle 1 /Day 16AUC(0-24), Cycle 2 /Day 2AUC(0-tlast), Cycle 1 /Day 2AUC(0-tlast), Cycle 1 /Day 16AUC(0-tlast), Cycle 2 /Day 2AUC(0-inf), Cycle 1 /Day 2AUC(0-inf), Cycle 1 /Day 16AUC(0-inf), Cycle 2 /Day 2
Phase 2: LY2603618 + Gemcitabine232002370019800222002080020100294002910023300

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Phase 2: Maximum Plasma Concentration (Cmax) of Gemcitabine, dFdU, and LY2603618

Plasma samples for PK analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine and dFdU plasma concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only the LY2603618 plasma Cmax values are reported at the 230 mg LY2603618 dose level on Cycle 1 /Day 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each time point. (NCT00839332)
Timeframe: Phase 2: LY2603618 - Predose and 0, 1, 3, and 24 hours after the end of infusion on Days 2 and 16 of Cycle 1. Gemcitabine - Predose and 0, 10, 60, and 120 minutes after the end of infusion on Days 1 and 15 of Cycle 1.

Interventionng/mL (Geometric Mean)
Cycle 1 /Day 2Cycle 1 /Day 16Cycle 2 /Day 2
Phase 2: LY2603618 + Gemcitabine317034102390

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Phase 1: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618

Plasma samples for PK analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine plasma and dFdU concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only LY2603618 plasma AUC from time zero to 24 hours (AUC[0-24]), AUC from time zero to the last time point with a measurable concentration (AUC[0-tlast]), and AUC from time zero to infinity (AUC[0-inf]) values are reported for each LY2603618 dose level on Cycle 1 /Day 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each dose level and time point. (NCT00839332)
Timeframe: Phase 1: LY2603618 - Predose and 0, 1, 3, 6, 24, 48, and 72 hours after the end of infusion on C1 /D2, C1 /D16, and C2 /D2. Gemcitabine - Predose and 0, 10, 30, 60, and 120 minutes after the end of infusion on C1 /D1, C1 /D15, and C2 /D1.

Interventionnanogram*hour/milliliter (ng*h/mL) (Geometric Mean)
AUC(0-24), 70 mg/m^2, Cycle 1 /Day 2AUC(0-24), 70 mg/m^2, Cycle 1 /Day 16AUC(0-24), 70 mg/m^2, Cycle 2 /Day 2AUC(0-24), 105 mg/m^2, Cycle 1 /Day 2AUC(0-24), 105 mg/m^2, Cycle 1 /Day 16AUC(0-24), 105 mg/m^2, Cycle 2 /Day 2AUC(0-24), 150 mg/m^2, Cycle 1 /Day 2AUC(0-24), 150 mg/m^2, Cycle 1 /Day 16AUC(0-24), 150 mg/m^2, Cycle 2 /Day 2AUC(0-24), 200 mg/m^2, Cycle 1 /Day 2AUC(0-24), 200 mg/m^2, Cycle 1 /Day 16AUC(0-24), 200 mg/m^2, Cycle 2 /Day 2AUC(0-24), 250 mg/m^2, Cycle 1 /Day 2AUC(0-24), 250 mg/m^2, Cycle 1 /Day 16AUC(0-24), 250 mg/m^2, Cycle 2 /Day 2AUC(0-24), 200 mg (flat), Cycle 1 /Day 2AUC(0-24), 200 mg (flat), Cycle 1 /Day 16AUC(0-24), 200 mg (flat), Cycle 2 /Day 2AUC(0-24), 230 mg (flat), Cycle 1 /Day 2AUC(0-24), 230 mg (flat), Cycle 1 /Day 16AUC(0-24), 230 mg (flat), Cycle 2 /Day 2AUC(0-tlast), 70 mg/m^2, Cycle 1 /Day 2AUC(0-tlast), 70 mg/m^2, Cycle 1 /Day 16AUC(0-tlast), 70 mg/m^2, Cycle 2 /Day 2AUC(0-tlast), 105 mg/m^2, Cycle 1 /Day 2AUC(0-tlast), 105 mg/m^2, Cycle 1 /Day 16AUC(0-tlast), 105 mg/m^2, Cycle 2 /Day 2AUC(0-tlast), 150 mg/m^2, Cycle 1 /Day 2AUC(0-tlast), 150 mg/m^2, Cycle 1 /Day 16AUC(0-tlast), 150 mg/m^2, Cycle 2 /Day 2AUC(0-tlast), 200 mg/m^2, Cycle 1 /Day 2AUC(0-tlast), 200 mg/m^2, Cycle 1 /Day 16AUC(0-tlast), 200 mg/m^2, Cycle 2 /Day 2AUC(0-tlast), 250 mg/m^2, Cycle 1 /Day 2AUC(0-tlast), 250 mg/m^2, Cycle 1 /Day 16AUC(0-tlast), 250 mg/m^2, Cycle 2 /Day 2AUC(0-tlast), 200 mg (flat), Cycle 1 /Day 2AUC(0-tlast), 200 mg (flat), Cycle 1 /Day 16AUC(0-tlast), 200 mg (flat), Cycle 2 /Day 2AUC(0-tlast), 230 mg (flat), Cycle 1 /Day 2AUC(0-tlast), 230 mg (flat), Cycle 1 /Day 16AUC(0-tlast), 230 mg (flat), Cycle 2 /Day 2AUC(0-inf), 70 mg/m^2, Cycle 1 /Day 2AUC(0-inf), 70 mg/m^2, Cycle 1 /Day 16AUC(0-inf), 70 mg/m^2, Cycle 2 /Day 2AUC(0-inf), 105 mg/m^2, Cycle 1 /Day 2AUC(0-inf), 105 mg/m^2, Cycle 1 /Day 16AUC(0-inf), 105 mg/m^2, Cycle 2 /Day 2AUC(0-inf), 150 mg/m^2, Cycle 1 /Day 2AUC(0-inf), 150 mg/m^2, Cycle 1 /Day 16AUC(0-inf), 150 mg/m^2, Cycle 2 /Day 2AUC(0-inf), 200 mg/m^2, Cycle 1 /Day 2AUC(0-inf), 200 mg/m^2, Cycle 1 /Day 16AUC(0-inf), 200 mg/m^2, Cycle 2 /Day 2AUC(0-inf), 250 mg/m^2, Cycle 1 /Day 2AUC(0-inf), 250 mg/m^2, Cycle 1 /Day 16AUC(0-inf), 250 mg/m^2, Cycle 2 /Day 2AUC(0-inf), 200 mg (flat), Cycle 1 /Day 2AUC(0-inf), 200 mg (flat), Cycle 1 /Day 16AUC(0-inf), 200 mg (flat), Cycle 2 /Day 2AUC(0-inf), 230 mg (flat), Cycle 1 /Day 2AUC(0-inf), 230 mg (flat), Cycle 1 /Day 16AUC(0-inf), 230 mg (flat), Cycle 2 /Day 2
Phase 1: LY2603618 + Gemcitabine213002120019900405005010049800322004000031000402003980044300888006100040000229002870023800324003230032500246002750025800658007550079600416005200039800443005530055600140000982006040033100426003240043000519004590024900286002710078600798008880042800546004100060300568006540015300010100070500352004570034400452005770048000

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Phase 2: Clinical Benefit Rate

Clinical benefit rate is the best response CR, PR, or stable disease (SD) as classified by the investigators according to the RECIST v1.1 guidelines. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Overall response rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100. (NCT00839332)
Timeframe: Phase 2: Baseline to measured progressive disease or date of death from any cause

Interventionpercentage of participants (Number)
Phase 2: LY2603618 + Gemcitabine55.4
Phase 2: Gemcitabine64.7

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Phase 2: Duration of Response

Duration of response was defined as the time from the first observation of complete response (CR) or partial response (PR) to the first observation of progressive disease or death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date and who do not have progressive disease, the duration was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent anticancer therapy (systemic, radiologic, or surgery). Participants were also censored at the last valid assessment prior to missing more than 1 consecutive scheduled assessment. Duration of response was summarized using Kaplan-Meier estimates. (NCT00839332)
Timeframe: Phase 2. Baseline to measured progressive disease or date of death from any cause

Interventionmonths (Median)
Phase 2: LY2603618 + Gemcitabine3.5
Phase 2: Gemcitabine6.0

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Phase 2: Overall Response Rate

Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100. (NCT00839332)
Timeframe: Phase 2: Baseline to measured progressive disease or date of death from any cause

Interventionpercentage of participants (Number)
Phase 2: LY2603618 + Gemcitabine21.5
Phase 2: Gemcitabine8.8

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Phase 2: Overall Survival (OS)

Overall survival (OS) time is defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the cut-off date. OS was summarized using Kaplan-Meier estimates. (NCT00839332)
Timeframe: Phase 2: Baseline to date of death

Interventionmonths (Median)
Phase 2: LY2603618 + Gemcitabine7.8
Phase 2: Gemcitabine8.3

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Phase 2: Progression-free Survival (PFS)

Progression-free survival (PFS) time was defined as the time from the date of randomization to the first date of progressive disease (symptomatic or objective) or death due to any cause, whichever occurred first. For participants who were not known to have died or progressed as of the data-inclusion cutoff date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS was summarized using Kaplan-Meier estimates. (NCT00839332)
Timeframe: Phase 2: Baseline to measured progressive disease or date of death from any cause

Interventionmonths (Median)
Phase 2: LY2603618 + Gemcitabine3.5
Phase 2: Gemcitabine5.6

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Phase 2: Electrocardiogram QTc Prolongation

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. Twelve-lead ECG data was used to calculate QTc based on Fridericia's formula (QTc=QT/RR^0.33, where RR is the interval between two R waves). For each participant, changes in QTc were calculated by subtracting the reading taken before LY2603618 administration from the reading taken after LY2603618 administration on Days 2 and 16 during Cycle 1. The number of participants in which the change in QTc was <=30 milliseconds (msec), >30-60 msec, or >60 msec is presented. (NCT00839332)
Timeframe: Phase 2: Days 2 and 16 of Cycle 1

InterventionParticipants (Count of Participants)
<=30 msec>30-60 msec>60 msec
Phase 2: LY2603618 + Gemcitabine5550

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Randomized Part: Progression Free Survival (PFS) Time - Independent Read

The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). (NCT00842712)
Timeframe: Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)

Interventionmonths (Median)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy6.2
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy5.6
Randomized Part: Cetuximab + Chemotherapy5.0

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Randomized Part: Progression Free Survival (PFS) Time - Investigator Read

The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site. (NCT00842712)
Timeframe: Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)

Interventionmonths (Median)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy5.6
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy5.6
Randomized Part: Cetuximab + Chemotherapy5.3

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Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)

(NCT00842712)
Timeframe: Up to Week 3

Interventionparticipants (Number)
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem0
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin0
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem0
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin0

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Randomized Part: Time to Treatment Failure

Time to treatment failure was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: Progressive Disease (PD) assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment. Time to treatment failure was assessed according to modified World Health Organization (WHO) criteria by Independent Review Committee (IRC). (NCT00842712)
Timeframe: Time from randomization until treatment failure or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)

Interventionmonths (Median)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy4.4
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy2.8
Randomized Part: Cetuximab + Chemotherapy4.2

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Randomized Part: Overall Survival (OS) Time

The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. (NCT00842712)
Timeframe: Time from randomization until death or last day known to be alive, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)

Interventionmonths (Median)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy13.6
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy13.6
Randomized Part: Cetuximab + Chemotherapy9.7

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Randomized Part: Best Overall Response (BOR) Rate

The BOR rate is defined as the percentage of participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST]) as assessed by Independent Review Committee (IRC): CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions. (NCT00842712)
Timeframe: Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)

Interventionpercentage of participants (Number)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy37.6
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy27.5
Randomized Part: Cetuximab + Chemotherapy29.8

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Number of Participants With Dose Reductions

The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. (NCT00844649)
Timeframe: Maximum time on treatment was 666 days

,
Interventionparticipants (Number)
At least 1 alumbin bound paclitaxel dose reductionAt least 1 Gemcitabine dose reduction
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)172198
Gemcitabine (Gem)0132

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Number of Participants With Dose Interruptions

The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. (NCT00844649)
Timeframe: Maximum time on treatment was 666 days

,
Interventionparticipants (Number)
≥ 1 Albumin-bound paclitaxel dose interruptionAt least 1 Gemcitabine dose interruption
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine28
Gemcitabine09

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Progression-free Survival (PFS) by Independent Radiological Review (IRR)

Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods. (NCT00844649)
Timeframe: Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.

Interventionmonths (Median)
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine5.5
Gemcitabine3.7

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Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)

Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment. (NCT00844649)
Timeframe: Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months

Interventionpercentage of participants (Number)
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine23
Gemcitabine7

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Overall Survival (OS)

Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods. (NCT00844649)
Timeframe: From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.

Interventionmonths (Median)
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine8.5
Gemcitabine6.7

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Number of Participants With Dose Delays/Doses Not Given

The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy. (NCT00844649)
Timeframe: Up to 666 days

,
Interventionnumber of dose delays (Number)
At least 1 ABI-007 dose delay/Not givenAt least ≥ 1 Gem dose delay/Not given
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine300295
Gemcitabine0230

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Participants With Treatment Emergent Adverse Events (AE)

A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. (NCT00844649)
Timeframe: Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days

,
Interventionparticipants (Number)
At least 1 AE≥ 1 Treatment related AE (TEAE)At least 1 Serious Adverse Event (SAE)≥ 1 treatment related SAE≥ 1 Grade (GR) 3/4 AE≥ 1 Grade 3 or higher AE≥ 1 AE leading to stopping treatment≥ 1 AE leading to death≥ 1 AE leading to dose reduction of ABI-007 or Gem≥ 1 AE related dose interruption of ABI-007 or Gem≥ 1 AE related dose delay of ABI-007 or Gem
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine4174032121213703741491820911276
Gemcitabine39537117253298303951812510192

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Overall Survival

Overall survival is defined as the time from the first dose of study medication until death. (NCT00846027)
Timeframe: Baseline to the end of the study (up to 2 years 10 months)

InterventionMonths (Median)
Bevacizumab + Paclitaxel + Gemcitabine27.39

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Progression-free Survival

Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first. (NCT00846027)
Timeframe: Baseline to the end of the study (up to 2 years 10 months)

InterventionMonths (Median)
Bevacizumab + Paclitaxel + Gemcitabine11.51

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Percentage of Participants With an Objective Response

An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. (NCT00846027)
Timeframe: Baseline to the end of the study (up to 2 years 10 months)

InterventionPercentage of participants (Number)
Bevacizumab + Paclitaxel + Gemcitabine72.37

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Duration of the Objective Response

Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease. (NCT00846027)
Timeframe: Baseline to the end of the study (up to 2 years 10 months)

InterventionMonths (Median)
Bevacizumab + Paclitaxel + Gemcitabine12.39

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The Pathologic Response Rate (

is defined as the absence of muscle invasive carcinoma (NCT00847015)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Gemcitabine, Cisplatin, and Sunitinib33

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The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy.

The time to disease progression is measured from the time of initiation of chemotherapy until the first date that systemic recurrence is objectively documented. Systemic recurrence for this trial is defined as either metastatic or local pelvic recurrence. (NCT00847015)
Timeframe: 2 years

Interventionmonths (Median)
Gemcitabine, Cisplatin, and Sunitinib10

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The Pathologic Complete Response Rate (

Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen. (NCT00847015)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Gemcitabine, Cisplatin, and Sunitinib6.67

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Safety Profile

Evaluate the safety profile of Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy in participants with TCC (NCT00859339)
Timeframe: 18 months

Interventionparticipants (Number)
Perioperative bleedingneutropenianeutropenic feverthrombocytopeniaanemianausea/emesissyncopemyocardial infarctionfatigue
CGS + Radical Cystectomy421113211

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Pathological Complete Response (pCR) Rate.

number of participants with a pCR (NCT00859339)
Timeframe: 18 months

Interventionparticpants with pCR (Number)
CGS + Radical Cystectomy2

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Best Response

Radiologic response by RECIST criteria will be compared between baseline and at 2 months. Disease assessment: Two objective status determinations of CR before progression are required for a best response of CR. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. Two determinations of stable/no response or better before progression, but not qualifying as CR or PR are required for a best response of stable/no response. (NCT00859469)
Timeframe: Two months

Interventionparticipants (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive Disease
Oxaliplatin and Gemcitabine071111

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Progression-free Survival

Time to radiologic disease progression or death (NCT00859469)
Timeframe: 50 months

Interventionmonths (Median)
Oxaliplatin and Gemcitabine5

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Overall Survival

(NCT00859469)
Timeframe: 50 months

Interventionmonths (Median)
Oxaliplatin and Gemcitabine8

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Tumor Best Response Rate

The best response rate will include patients with both Complete Response and Partial Response after 2 months of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00860015)
Timeframe: Two months

InterventionParticipants (Count of Participants)
Alimta/Gemcitabine0

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Number of Subject With Complete Response

Per standard lymphoma response criteria (Cheson): Complete Response (CR), 1. Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy, with normalization of LDH if elevated prior to therapy. 2. All lymph nodes and masses must regress to normal size (<1.5 cm in greatest transverse diameter if >1.5 cm prior to treatment). 3. The spleen, if enlarged prior to therapy, must have regressed to normal size. 3. If bone marrow was involved by lymphoma, it must be cleared as documented by biopsy at the same location. (NCT00863369)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Dose Level 1 Tx Schema I - Velcade 1.0 mg/m2, Gemcitabine 1000 mg/m21
Dose Level Tx Schema I -1 - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m20
Dose Level 3B Tx Schema II - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m20
Dose Level 4B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 800 mg/m20
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m21
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2, Rituximab 375 mg/m21

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Number of Participants With at Least One Dose Limiting Toxicity (DLT)

Adverse events were graded by NCI CTCAE, Version 3.0. DLT defined as grade 4 thrombocytopenia, or grade 3 thrombocytopenia lasting greater than 7 days. Grade 4 neutropenia lasting 7 days or more despite use of growth factors. Febrile neutropenia only is it occurs after 7 days of neutropenia. Any grade 3 or higher non-hematologic toxicity related to the study drug, with the exception of alopecia, inadequately treated nausea, vomiting and/or diarrhea and fatigue. (NCT00863369)
Timeframe: 28 days from start of treatment, up to 2 years.

InterventionParticipants (Count of Participants)
Dose Level 1 Tx Schema I - Velcade 1.0 mg/m2, Gemcitabine 1000 mg/m23
Dose Level Tx Schema I -1 - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m21
Dose Level 3B Tx Schema II - Velcade 1.0 mg/m2, Gemcitabine 800 mg/m20
Dose Level 4B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 800 mg/m20
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m20
Dose Level 5B Tx Schema II - Velcade 1.3 mg/m2, Gemcitabine 1000 mg/m2, Rituximab 375 mg/m20

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Overall Survival (OS)

OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact. (NCT00870870)
Timeframe: Randomization to death due to any cause or censor (up to 30.4 months)

Interventionmonths (Median)
GCiC11.5
GCiC Plus Cixutumumab8.9

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Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated * 100. (NCT00870870)
Timeframe: Randomization to measured progressive disease (PD) (up to 16.9 months)

Interventionpercentage of participants (Number)
Gemcitabine/Cisplatin/Cetuximab (GCiC)31.0
GCiC Plus Cixutumumab20.0

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Progression-Free Survival (PFS)

PFS was defined as the duration from the date of randomization until disease progression or death due to any cause, whichever occurred first. Response was defined using RECIST, v 1.0 criteria. PD was defined as having a ≥20% increase in sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants who were alive and without disease progression, PFS was censored at the date of last objective tumor assessment. For participants who did not experience disease progression and were lost to follow-up, PFS was censored at the date of the last objective tumor assessment or the date of last contact. (NCT00870870)
Timeframe: Randomization to PD or death due to any cause or censor (up to 16.9 months)

Interventionmonths (Median)
GCiC4.2
GCiC Plus Cixutumumab5.6

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Time To Progression (TTP)

TTP was defined as the duration from the date of randomization until the date of disease progression. Response was defined using RECIST v 1.0 criteria. PD was defined as having a ≥20% increase in the sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants without disease progression, TTP was censored at the date of last objective tumor assessment. For participants without disease progression and were subsequently lost to follow-up, TTP was censored at the date of last follow-up visit or at the date of last contact. (NCT00870870)
Timeframe: Randomization to months until PD or censor (up to 16.9 months)

Interventionmonths (Median)
GCiC5.8
GCiC Plus Cixutumumab5.7

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Duration of Response

The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of disease progression or death. Response was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as having at least a 30% decrease in sum of LD of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of disease progression. (NCT00870870)
Timeframe: Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months)

Interventionmonths (Median)
GCiC4.8
GCiC Plus Cixutumumab4.8

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Number of Participants With Adverse Events (AEs) or Deaths

Data presented are the number of participants who experienced 1 or more AEs, serious AEs (SAEs), and AEs that lead to death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report. (NCT00870870)
Timeframe: Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up

,,,
InterventionParticipants (Count of Participants)
AEsSAEsDeaths Due to AEs
GCC Plus Cixutumumab651
GCiC Plus Cixutumumab25151
Gemcitabine/Carboplatin/Cetuximab (GCC)441
Gemcitabine/Cisplatin/Cetuximab (GCiC)29204

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Percentage of Participants Alive at the End of Study-Overall and Among Different Subgroups

(NCT00883779)
Timeframe: Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years])

,
Interventionpercentage of participants (Number)
Overall participants (n=225,226)Adenocarcinoma (n=168,174)Non-adenocarcinoma (n=57,52)Never smoked (n=107,112)Current/former smoker (n=118,114)EGFR mutation (n=48,49)EGFR wild-type (n=67,69)KRAS mutation (n=11,10)KRAS wild-type (n=101,101)EGFR IHC positive (n=36,40)EGFR IHC negative (n=25,12)EGFR FISH positive (n=20,14)EGFR FISH negative (n=23,25)
Erlotinib15.919.53.823.28.830.610.120.017.825.033.342.916.0
Placebo13.314.98.813.113.622.97.50.014.911.18.010.013.0

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Time to Deterioration in TOI Using FACT-L Version 4.0

"Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. TOI is defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 84; higher score indicates better physical aspects of QoL. A clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Participants without deterioration in TOI at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method." (NCT00883779)
Timeframe: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)

Interventionmonths (Median)
Placebo5.6
Erlotinib6.3

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Median Overall Survival (OS) Time-Overall and Among Different Subgroups

OS was defined as the time between the date of randomization and the date of death from any cause. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Participants with no post baseline information were censored at the time of randomization. OS among different subgroups of type of carcinoma, smoking habit, EGFR mutation type, KRAS mutation type, EGFR IHC test result type, and EGFR FISH result type. Analysis was performed using Kaplan-Meier method. (NCT00883779)
Timeframe: Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years])

,
Interventionmonths (Median)
Overall participants (n=225,226)Adenocarcinoma (n=168,174)Non-adenocarcinoma (n=57,52)Never smoked (n=107,112)Current/former smoker (n=118,114)EGFR mutation (n=48,49)EGFR wild-type (n=67,69)KRAS mutation (n=11,10)KRAS wild-type (n=101,101)EGFR IHC positive (n=36,40)EGFR IHC negative (n=25,12)EGFR FISH positive (n=20,14)EGFR FISH negative (n=23,25)
Erlotinib18.220.910.325.913.030.314.917.518.118.621.943.116.7
Placebo15.215.812.417.513.020.612.211.214.115.212.517.712.5

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Duration of Response

Duration of response is defined as the time between the date of first documented response (CR or PR, as determined by the RECIST criteria) and the date of first documented PD or death. Participants who did not progress or die after they had a confirmed response (CR or PR) were censored at the date of their last tumor assessment where non-progression was documented or last date of follow-up for progression of disease, whichever was last. CR and PR are defined in Outcome Measure 7. (NCT00883779)
Timeframe: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])

Interventionmonths (Median)
Placebo5.6
Erlotinib10.3

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Median Follow-up Time During the Study

Median follow-up was calculated using 'Reverse Kaplan-Meier' analysis for Overall survival. (NCT00883779)
Timeframe: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 5.5 years])

Interventionmonths (Median)
Placebo50.3
Erlotinib50.2

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Median Progression Free Survival (PFS) Time

Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. Analysis was performed using Kaplan-Meier method. (NCT00883779)
Timeframe: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])

Interventionmonths (Median)
Placebo6.0
Erlotinib7.6

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Time to Progression

Time to progression is defined as the time between the date of randomization and the date of the first documented disease progression. Participants who have not progressed at the time of study completion (or data cut off) or who were lost to follow up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow-up for progression of disease, whichever was latest. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Participants with no post baseline tumor assessments were censored at the time of randomization. Analysis was performed using Kaplan-Meier method. (NCT00883779)
Timeframe: Randomization until PD (assessed at baseline and every 8 weeks thereafter until PD or end of study [up to approximately 1.5 years])

Interventionmonths (Median)
Placebo6.5
Erlotinib7.9

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Time to Deterioration in QOL Using FACT-L Version 4.0

"Time to deterioration in QoL is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in Total FACT-L or death on study. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 136; higher score indicates better QoL. A clinically meaningful decline used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method." (NCT00883779)
Timeframe: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)

Interventionmonths (Median)
Placebo4.5
Erlotinib5.6

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Non-Progression Rate: Percentage of Participants With a Confirmed Best Overall Response of Either Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for At Least 16 Weeks

Tumor response was evaluated according to RECIST (version 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the screening sum LD; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Responses were confirmed with repeated assessment 4 weeks after initial response was observed. (NCT00883779)
Timeframe: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])

Interventionpercentage of participants (Number)
Placebo64.4
Erlotinib67.3

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Objective Response Rate: Percentage of Participants With a Confirmed Best Overall Response of CR or PR

Tumor response was evaluated according to RECIST (version 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the screening sum LD. Responses were confirmed with repeated assessment 4 weeks after initial response was observed. (NCT00883779)
Timeframe: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])

Interventionpercentage of participants (Number)
Placebo17.8
Erlotinib42.9

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Percentage of Participants Alive and Free From Disease Progression

Tumor response was evaluated according to RECIST (version 1.0). PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. (NCT00883779)
Timeframe: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])

Interventionpercentage of participants (Number)
Placebo6.2
Erlotinib22.6

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Percentage of Participants With Deterioration in Quality of Life (QOL) Using FACT-L Version 4.0

"Total FACT-L score was defined as the sum of the TOI, Social Well Being (SWB) and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 136; higher score indicates better QoL. A clinically meaningful decline used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment." (NCT00883779)
Timeframe: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)

Interventionpercentage of participants (Number)
Placebo79.6
Erlotinib70.4

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Percentage of Participants With Deterioration in Trial Outcome Index (TOI) Using FACT-L Version 4.0

"TOI was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 84; higher score indicates better physical aspects of quality of life (QoL). A clinically meaningful decline used to determine deterioration in TOI was greater than or equal to (≥) 6-point decline from baseline. Participants without deterioration in TOI at the time of analysis were censored at the time of the last FACT-L assessment." (NCT00883779)
Timeframe: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)

Interventionpercentage of participants (Number)
Placebo75.6
Erlotinib65.9

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Percentage of Participants With Symptomatic Progression Assessed Using the Lung Cancer Subscale (LCS)

"LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) (version 4.0). Participants responded to questions such as shortness of breath, cough, tightness in chest, breathing difficulty, appetite loss, weight loss and unclear thinking; on a 5-point scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 (most symptomatic) to 28 (asymptomatic); higher score indicates fewer symptoms. A clinically meaningful decline used to determine symptomatic progression in this study was at least a three point decline in LCS score from baseline. Participants without symptomatic progression at the time of analysis were censored at the time of the last FACT-L assessment." (NCT00883779)
Timeframe: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)

Interventionpercentage of participants (Number)
Placebo72.4
Erlotinib66.4

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Time to Symptomatic Progression

"Time to symptomatic progression was the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. LCS scores were obtained from a 7-item questionnaire from the FACT-L (version 4.0). Participants responded to questions such as shortness of breath, cough, tightness in chest, breathing difficulty, appetite loss, weight loss and unclear thinking; on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 (most symptomatic) to 28 (asymptomatic); higher score indicates fewer symptoms. A clinically meaningful decline used to determine symptomatic progression in this study was at least a three point decline in LCS score from baseline. Participants without symptomatic progression at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method." (NCT00883779)
Timeframe: Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)

Interventionmonths (Mean)
Placebo6.6
Erlotinib7.2

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Median PFS Time Based on Different Subgroups

Tumor response was evaluated according to RECIST (version 1.0). PD was defined in outcome measure 1. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. PFS among different subgroups of type of carcinoma, smoking habit, epidermal growth factor receptor (EGFR) mutation type, KRAS mutation type, EGFR immunohistochemistry (IHC) test result type, and EGFR fluorescent in situ hybridization (FISH) result type. (NCT00883779)
Timeframe: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])

,
Interventionmonths (Median)
Adenocarcinoma (n=168,174)Non-adenocarcinoma (n=57,52)Never smoked (n=107,112)Former/current smoker (n=118,114)EGFR mutation (n=48,49)EGFR wild-type (n=67,69)KRAS mutation (n=11,10)KRAS wild-type (n=101,101)EGFR IHC positive (n=36,40)EGFR IHC negative (n=25,12)EGFR FISH positive (n=20,14)EGFR FISH negative (n=23,25)
Erlotinib8.25.710.95.715.67.16.08.08.110.112.97.5
Placebo6.55.86.65.96.95.94.56.86.06.75.96.0

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Overall Objective Response

Overall Objective Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) (NCT00887809)
Timeframe: 6 months

,
Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progression of Disease (POD)
Gemcitabine, Docetaxel, Bevacizumab09231
Gemcitabine, Docetaxel, Placebo1171

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Progression-free Survival (PFS)

Measured from Day 1 of study drug administration to disease progression - defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as a 20% increase in the sum of the longest diameter of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions (NCT00894504)
Timeframe: every 6 weeks until treatment discontinuation

InterventionMonths (Median)
Panitumumab/Gemcitabine/Carboplatin4.4

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Objective Response Rate and Clinical Benefit Rate

Estimated as the proportion of subjects who meet the criteria for complete or partial response (CR or PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 - for target lesions assessed by MRI: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions. (NCT00894504)
Timeframe: every 6 weeks until treatment discontinuation

InterventionParticipants (Number)
Clinical benefit rate (CR + PR + SD>6 months)Objective response rate (CR + PR)
Panitumumab/Gemcitabine/Carboplatin3230

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Correlation of Biomarker Expressions of EGFR, K-ras, p53, PTEN Expression, and PI3K in Triple-negative Breast Cancer With Response to Treatment With the Combination of Gemcitabine, Carboplatin, and Panitumumab

Median PFS (95% CI), months, reported by biomarker expression/mutation status for: EGFR, p53, PTEN, PIK3CA, KRAS (NCT00894504)
Timeframe: 18 months

Interventionmonths (Median)
EGFR Normal4.57
EGFR Amplified3.42
p53 Normal4.16
p53 Loss5.32
PTEN Normal4.4
PTEN Loss2.91
PIK3CA No Mutation4.37
PIK3CA Mutation(s)4.73

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Vorinostat Maximum Tolerated Dose (MTD) [Phase Ib]

The Vorinostat MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. (NCT00910000)
Timeframe: The DLT observation period in determining the MTD was the 21-day cycle 1 length.

Interventionmg/day (Number)
All Phase Ib ParticipantsNA

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Response

Response was based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD from the smallest LD recorded on treatment. Stable disease (SD) is neither sufficient increase to qualify as PD nor sufficient shrinkage to qualify for PR. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed 4 weeks +/- 2 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Participants who received therapy but did not have their disease re-evaluated were considered unevaluable. (NCT00910000)
Timeframe: Disease was assessed radiographically (CT or MRI scan) every 2 cycles on treatment; Phase Ib participants received up to 8 cycles of treatment. The median number of cycles started was 2 (range 1-8).

,,,,,
Interventionparticipants (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseUnevaluable
Dose Level 1A03000
Dose Level 1B00003
Dose Level 1C01001
Dose Level 1D02001
Dose Level 2A00102
Dose Level 2D00001

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Dose Limiting Toxicity (DLT) [Phase Ib]

"Dose-limiting toxicity was based on the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) and defined as any of the following:~Any CTCAE grade 3 or 4 non-hematologic event except manageable gastrointestinal toxicity and fatigue.~Any of the following hematologic events (excluding neutropenia lasting < 5 days):~i) febrile neutropenia defined as grade 3-4 neutropenia with fever ≥ 38.5°C and/or infection.~ii) any grade 4 neutropenia lasting 5 days or more. iii) grade 4 thrombocytopenia (plt count < 25x 109/L) iv) failure of ANC to recover to ≥ 1000/μL or platelets to recover to ≥ 50,000/μL within 14 days of therapy v) grade 4 anemia~Any clinically significant abnormal laboratory value that results in dose delay of >14 days.~<75% of vorinostat dosing taken by the patient during the first cycle due to any toxicity." (NCT00910000)
Timeframe: The DLT observation period in determining the MTD was the 21-day cycle 1 length.

Interventionparticipants with DLT (Number)
Dose Level 1A0
Dose Level 2A2
Dose Level 1B2
Dose Level 1C2
Dose Level 1D0
Dose Level 2D1

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Median PFS

Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first. (NCT00919061)
Timeframe: 6 mos

Interventionmonths (Median)
Progression Free SurvivalOverall Survival
Gemcitabine and Cisplatin Plus Sorafenib6.514.4

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Progression-Free Survival

Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first. (NCT00919061)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Gemcitabine and Cisplatin Plus Sorafenib51

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Number of Participants With Serious and Non-Serious Adverse Events

Here is the number of participants with adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. For the detailed list of adverse events see the adverse event module. (NCT00924209)
Timeframe: Date treatment consent signed to date off study, approximately 38 months

InterventionParticipants (Count of Participants)
Stage IIIA Lung Cancer Patients7

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Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment.

"Best response to thearpy was assessed using modified SWOG criteria (same as for outcome masure #1). Subjects were assess as complete response, partial response, stable disease, and progressive disease after 2 cycles (6 weeks) of beginning treatment and every 6 weeks afterward until progression of disease, unacceptable toxicity, or subject withdrawl from study.~the measurement reported is the number of patients who met the criteria for partial response." (NCT00928642)
Timeframe: Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified

Interventionparticipants (Number)
Oral Imatinib Plus IV Gemcitabine0

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To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial)

"Using SWOG criteria for response of measurable disease, subject best response was assessed. First assessment was 6 weeks after starting treatment. Subjequent evaluations were every 6 weeks in patients who remained on study.~Repsonse rate was the sum of Complete Repsonse and Partial Response." (NCT00928642)
Timeframe: until disease progression or unacceptable toxicity

Interventionparticipants (Number)
Treatment0

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To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria

Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria (NCT00928642)
Timeframe: Until disease progression or unacceptable toxicity

Interventionparticipants (Number)
Grade 3 toxicityGrade 4 toxicityRed Blood Cell Transfusion
Oral Imatinib Puls IV Gemcitabine311

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To Determine the Distribution of the Overall Survival

All subjects were followed after treatment was complete to assess overall survival. (NCT00928642)
Timeframe: Until death

Interventionmonths (Median)
Treatment9

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The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma.

Progression free survival at six months was assessed for all research subjects. Progression defined by SWOG criteria: Invest New Drugs. 1992 Nov;10(4):239-53. Progression is defined as > 50% increase in the sume of measured cross sectional area of areasa of measurable disease, measured from the lowest measured amount of disease. Progression is also defined as new areas of measurabe disease. (NCT00928642)
Timeframe: Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.

Interventionparticipants (Number)
Oral Imatinib Plus Gemcitabine0

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Percentage of Participants With Non-Progression at Weeks 8 and 16

Non-progression was defined as CR, PR, or stable disease according to RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD recorded since the start of treatment. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above the normal limits. The 95% CI for one-sample binomial was determined using the Pearson-Clopper method. (NCT00940875)
Timeframe: Weeks 8 and 16

,
Interventionpercentage of participants (Number)
Week 8Week 16
Gemcitabine + Erlotinib38.511.5
Gemcitabine Monotherapy50.025.0

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PFS

The median time, in weeks, between randomization and PFS event. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-BL tumor assessment who were known to be alive were censored at the date of randomization. PFS was estimated by using Kaplan-Meier methodology. (NCT00940875)
Timeframe: BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years)

Interventionweeks (Median)
Gemcitabine Monotherapy8.0
Gemcitabine + Erlotinib10.3

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Percentage of Participants With Disease Progression or Death

Progression-free survival (PFS) was defined as the time from randomization to the date of first documentation of progressive disease (PD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.0, or date of death from any cause. PD was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-Baseline (BL) tumor assessment who were known to be alive were censored at the date of randomization. (NCT00940875)
Timeframe: BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).

Interventionpercentage of participants (Number)
Gemcitabine Monotherapy96.4
Gemcitabine + Erlotinib96.2

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Percentage of Participants Who Died

(NCT00940875)
Timeframe: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.

Interventionpercentage of participants (Number)
Gemcitabine Monotherapy92.9
Gemcitabine+ Erlotinib76.9

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Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0

As per RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper Method. (NCT00940875)
Timeframe: BL, Day 22 of Cycle 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).

Interventionpercentage of participants (Number)
Gemcitabine Monotherapy7.1
Gemcitabine + Erlotinib3.8

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Overall Survival (OS)

OS was defined as the median time, in weeks, between randomization and death due to any cause. Participants without documented death were censored at the last date recorded in the drug log, or the last date of follow-up the participant was known to be alive, whichever was last. Participants without a post-BL assessment who were known to be alive were censored at the date of randomization. OS was estimated using Kaplan-Meier methodology. (NCT00940875)
Timeframe: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.

Interventionweeks (Median)
Gemcitabine Monotherapy21.3
Gemcitabine + Erlotinib17.1

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Overall Survival (OS)

Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.The stratified log-rank statistic will be the primary analysis to compare the two treatment arms on OS with the stratification factors: presence of visceral metastases (no, yes) and prior chemotherapy (no, yes). In addition, the proportional hazards model will be used to assess the importance of the treatment arm adjusting on patient characteristics, stratification variables and other important covariates in predicting OS. (NCT00942331)
Timeframe: From date of randomization to date of death due to any cause, assessed up to 7 years

Interventionmonths (Median)
Arm II (GCB)14.5
Arm I (GCP)14.3

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Number of Patients Experiencing Grade 3+ Toxicity

The number of patients experiencing grade 3 or higher toxicity (adverse events considered at least possibly related to treatment) is reported below. (NCT00942331)
Timeframe: Up to 7 years

InterventionParticipants (Count of Participants)
Arm II (GCB)183
Arm I (GCP)163

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Objective Response

"Objective response is defined as confirmed complete and partial responses using Response Evaluation Criteria in Solid Tumors criteria. A complete response (CR) is defined as a disappearance of all target lesions. A partial response (PR) is defined as having at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum.~In each arm, the number of patients reporting a CR or PR was divided by the number of patients evaluable in each arm to obtain the proportion." (NCT00942331)
Timeframe: Up to 7 years

Interventionproportion of participants (Number)
Arm II (GCB)0.4
Arm I (GCP)0.36

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Progression-free Survival (PFS)

The primary analysis of PFS will be a two-sided stratified log-rank test comparing arm A and arm B. The stratification factors will consist of the two stratification factors used for patient randomization: prior nephrectomy (yes vs. no) and Motzer score (0 vs. 1-2 vs. 3+). Results from unstratified log-rank tests will also be provided. Kaplan-Meier methodology will be used to estimate median PFS for each treatment arm. (NCT00942331)
Timeframe: From the date of randomization to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years

Interventionmonths (Median)
Arm II (GCB)8.0
Arm I (GCP)6.7

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Progression Free Survival Rate at Five Months

(NCT00948935)
Timeframe: 5 months

Interventionpercentage of participants (Number)
Chemotherapy69

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Response Rate From Combination Chemotherapy

(NCT00948935)
Timeframe: 5 months

InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseNot Assessable
Chemotherapy291527

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Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response

Overall best response was determined by RECIST criteria. Types of overall response could be: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Assessable (NA) or Incomplete Response/Stable Disease (IR/SD). (NCT00954512)
Timeframe: Up to ~30 days after the final dose of robatumumab (Up to ~14 months)

,,,,
InterventionParticipants (Number)
Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)Not Assessable (NA)Incomplete Response/Stable Disease (IR/SD)
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab000200
Regimen B: Carboplatin + Paclitaxel + Robatumumab002100
Regimen D: Trastuzumab + Robatumumab001100
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab002100
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab001100

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Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to this study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. (NCT00954512)
Timeframe: Up to ~30 days after the final dose of robatumumab (Up to ~14 months)

InterventionParticipants (Number)
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab2
Regimen B: Carboplatin + Paclitaxel + Robatumumab3
Regimen D: Trastuzumab + Robatumumab2
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab4
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab4

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Median Time to Progression

Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm. (NCT00970684)
Timeframe: 1 year

Interventionmonths (Median)
Bevacizumab, Docetaxel, and Gemcitabine5.6

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Progression Free Survival(PFS)

PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression. (NCT00970684)
Timeframe: 1 year

Interventionmonths (Median)
Bevacizumab, Docetaxel, and Gemcitabine5.6

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Best Response

The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease) (NCT00970684)
Timeframe: 1 year

Interventionparticipants (Number)
Stable DiseasePartial ResponseProgressive Disease
Bevacizumab, Docetaxel, and Gemcitabine291

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Progression-Free Survival (PFS)

PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits. (NCT00981058)
Timeframe: Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)

Interventionmonths (Median)
Necitumumab + Gemcitabine + Cisplatin5.7
Gemcitabine + Cisplatin5.5

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Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])

ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions. PR defined as a >=30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100. (NCT00981058)
Timeframe: Baseline to Measured Progressive Disease (Up to 31 Months)

Interventionpercentage of participants (Number)
Necitumumab + Gemcitabine + Cisplatin31.2
Gemcitabine + Cisplatin28.8

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Time to Treatment Failure (TTF)

TTF is defined as the time from the date of randomization until the date of the first radiographic documentation of PD, death from any cause, discontinuation of treatment for any reason, or initiation of new cancer therapy. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study. (NCT00981058)
Timeframe: Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)

InterventionMonths (Median)
Necitumumab + Gemcitabine + Cisplatin4.3
Gemcitabine + Cisplatin3.6

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Overall Survival Time (OS)

Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method. (NCT00981058)
Timeframe: Randomization to Death from Any Cause (Up to 31 Months)

InterventionMonths (Median)
Necitumumab + Gemcitabine + Cisplatin11.5
Gemcitabine + Cisplatin9.9

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Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)

The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). (NCT00981058)
Timeframe: Baseline, Cycle 6 (Cycle = 3 Weeks)

Interventionunits on a scale (Mean)
Necitumumab + Gemcitabine + Cisplatin-0.0053
Gemcitabine + Cisplatin-0.0083

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Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)

The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. (NCT00981058)
Timeframe: Baseline, Cycle 6 (Cycle = 3 Weeks)

,
Interventionmillimeter (mm) (Mean)
Loss of Appetite (n=304, 242)Fatigue (n=302, 242)Cough (n=303, 243)Dyspnea (n=305, 244)Pain (n=302, 243)Overall Symptoms (n=303, 242)Interference (n=306,241)Quality of Life (n=305, 243)Average Symptom Burden Index (ASBI) (n=294, 234)LCSS Total Score (n=290, 228)
Gemcitabine + Cisplatin1.53.5-9.1-1.8-2.2-0.62.2-1.6-1.5-0.8
Necitumumab + Gemcitabine + Cisplatin1.86.3-7.8-2.8-3.3-0.33.8-0.3-1.9-0.8

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Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)

EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess participants with a low EGFR expression defined by a H-score cutoff value of <200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200. (NCT00981058)
Timeframe: 31 Months

,
Interventionparticipants (Number)
0>0<200≥200
Gemcitabine + Cisplatin23473313183
Necitumumab + Gemcitabine + Cisplatin24462295191

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Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab

(NCT00981058)
Timeframe: Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months

Interventionmicrograms/milliliter (ug/mL) (Geometric Mean)
Predose Cycle 2 Day 1 (n=419)Predose Cycle3 Day 1 (n=386)Predose Cycle 4 Day 1 (n=344)Predose Cycle 5 Day 1 (n=297)Predose Cycle 6 Day 1 (n=262)
Necitumumab + Gemcitabine + Cisplatin52.476.694.510198.5

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Number of Participants With a Serum Anti-Necitumumab Antibody Assessment

A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point. (NCT00981058)
Timeframe: Baseline through 31 Months

Interventionparticipants (Number)
Participants with at least 1 positive titerNeutralizing antibody detected
Necitumumab + Gemcitabine + Cisplatin815

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Number of Participants Experiencing Toxicity Treated With Gemcitabine Every Two Weeks & 5-FU Given Concurrently With External Beam Radiation Therapy , Followed by Brachytherapy or SBRT Boost.

(NCT00983541)
Timeframe: Toxicity was assessed for each patient over the course of the study treatment and follow-up stage which together lasted 9 months. Only one patient was enrolled.

Interventionparticipants (Number)
All Patients1

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

InterventionL/hr/m^2 (Mean)
Cabazitaxel + Gemcitabine Dose Level 0157
Cabazitaxel + Gemcitabine Dose Level -162.8
Gemcitabine + Cabazitaxel Dose Level 0143

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance (CL)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

InterventionL/hr (Mean)
Cabazitaxel + Gemcitabine Dose Level 0262
Cabazitaxel + Gemcitabine Dose Level -1110
Gemcitabine + Cabazitaxel Dose Level 0252

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionhours (hr) (Median)
Cabazitaxel + Gemcitabine Dose Level 00.52
Cabazitaxel + Gemcitabine Dose Level -10.45
Gemcitabine + Cabazitaxel Dose Level 00.47

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Terminal Half-life (t1/2z)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionhours (hr) (Mean)
Cabazitaxel + Gemcitabine Dose Level 00.222
Cabazitaxel + Gemcitabine Dose Level -10.282
Gemcitabine + Cabazitaxel Dose Level 00.317

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax)

"Blood samples for gemcitabine assay were collected on Day 8 of cycle 1 at the following timepoints:~Cabazitaxel + Gemcitabine: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of infusion;~Gemcitabine + cabazitaxel: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of infusion;~Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis." (NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionng/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 010200
Cabazitaxel + Gemcitabine Dose Level -134500
Gemcitabine + Cabazitaxel Dose Level 014100

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionng*hr/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 05530
Cabazitaxel + Gemcitabine Dose Level -115300
Gemcitabine + Cabazitaxel Dose Level 07710

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionng*hr/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 06360
Cabazitaxel + Gemcitabine Dose Level -118500
Gemcitabine + Cabazitaxel Dose Level 07780

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

InterventionL/m^2 (Mean)
Cabazitaxel + Gemcitabine Dose Level 066.5
Cabazitaxel + Gemcitabine Dose Level -117.3
Cabazitaxel + Gemcitabine Dose Level -229.9
Gemcitabine + Cabazitaxel Dose Level 028.7

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State (Vss)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

InterventionL (Mean)
Cabazitaxel + Gemcitabine Dose Level 0135
Cabazitaxel + Gemcitabine Dose Level -128.9
Cabazitaxel + Gemcitabine Dose Level -247.0
Gemcitabine + Cabazitaxel Dose Level 051.6

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

InterventionL/hr/m^2 (Mean)
Cabazitaxel + Gemcitabine Dose Level 0159
Cabazitaxel + Gemcitabine Dose Level -149.8
Cabazitaxel + Gemcitabine Dose Level -278.4
Gemcitabine + Cabazitaxel Dose Level 096.4

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance (CL)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

InterventionL/hr (Mean)
Cabazitaxel + Gemcitabine Dose Level 0313
Cabazitaxel + Gemcitabine Dose Level -185.1
Cabazitaxel + Gemcitabine Dose Level -2123
Gemcitabine + Cabazitaxel Dose Level 0174

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionhours (hr) (Median)
Cabazitaxel + Gemcitabine Dose Level 00.49
Cabazitaxel + Gemcitabine Dose Level -10.38
Cabazitaxel + Gemcitabine Dose Level -20.60
Gemcitabine + Cabazitaxel Dose Level 00.42

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Terminal Half-life (t1/2z)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionhours (Mean)
Cabazitaxel + Gemcitabine Dose Level 00.295
Cabazitaxel + Gemcitabine Dose Level -10.254
Cabazitaxel + Gemcitabine Dose Level -20.202
Gemcitabine + Cabazitaxel Dose Level 00.256

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax)

"Blood samples for gemcitabine assay were collected on Day 1 of cycle 1 at the following timepoints:~Cabazitaxel + Gemcitabine: prior the start of cabazitaxel infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of gemcitabine infusion;~Gemcitabine + cabazitaxel: prior the start of gemcitabine infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of cabazitaxel infusion;~Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis." (NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionng/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 014600
Cabazitaxel + Gemcitabine Dose Level -135600
Cabazitaxel + Gemcitabine Dose Level -211400
Gemcitabine + Cabazitaxel Dose Level 019000

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionng*hr/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 07320
Cabazitaxel + Gemcitabine Dose Level -116000
Cabazitaxel + Gemcitabine Dose Level -26120
Gemcitabine + Cabazitaxel Dose Level 09920

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionng*hr/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 06290
Cabazitaxel + Gemcitabine Dose Level -121900
Cabazitaxel + Gemcitabine Dose Level -28530
Gemcitabine + Cabazitaxel Dose Level 09970

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Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)

(NCT01001221)
Timeframe: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion

InterventionL/m^2 (Mean)
Cabazitaxel + Gemcitabine Dose Level 03530
Cabazitaxel + Gemcitabine Dose Level -12690
Cabazitaxel + Gemcitabine Dose Level -21980
Gemcitabine + Cabazitaxel Dose Level 03020

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Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State (Vss)

(NCT01001221)
Timeframe: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion

InterventionL (Mean)
Cabazitaxel + Gemcitabine Dose Level 06780
Cabazitaxel + Gemcitabine Dose Level -14980
Cabazitaxel + Gemcitabine Dose Level -23930
Gemcitabine + Cabazitaxel Dose Level 05570

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Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)

(NCT01001221)
Timeframe: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion

InterventionL/hr/m^2 (Mean)
Cabazitaxel + Gemcitabine Dose Level 032.4
Cabazitaxel + Gemcitabine Dose Level -136.1
Cabazitaxel + Gemcitabine Dose Level -231.9
Gemcitabine + Cabazitaxel Dose Level 049.6

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Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance (CL)

(NCT01001221)
Timeframe: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion

InterventionL/hr (Mean)
Cabazitaxel + Gemcitabine Dose Level 061.0
Cabazitaxel + Gemcitabine Dose Level -164.3
Cabazitaxel + Gemcitabine Dose Level -259.5
Gemcitabine + Cabazitaxel Dose Level 090.8

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Pharmacokinetic of Cabazitaxel on Cycle 1: Time to Maximum Concentration (Tmax)

(NCT01001221)
Timeframe: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion

Interventionhours (hr) (Median)
Cabazitaxel + Gemcitabine Dose Level 01.00
Cabazitaxel + Gemcitabine Dose Level -10.94
Cabazitaxel + Gemcitabine Dose Level -20.94
Gemcitabine + Cabazitaxel Dose Level 00.93

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Pharmacokinetic of Cabazitaxel on Cycle 1: Terminal Half-life (t1/2z)

(NCT01001221)
Timeframe: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion

Interventionhours (hr) (Mean)
Cabazitaxel + Gemcitabine Dose Level 092.1
Cabazitaxel + Gemcitabine Dose Level -188.3
Cabazitaxel + Gemcitabine Dose Level -275.6
Gemcitabine + Cabazitaxel Dose Level 070.3

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Pharmacokinetic of Cabazitaxel on Cycle 1: Maximum Plasma Concentration Observed (Cmax)

"Blood samples for cabazitaxel assay were collected during cycle 1 and cabazitaxel plasma concentrations were determined using a validated liquid chromatography with tandem mass spectometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 1 ng/mL.~Pharmacokinetic (PK) parameters were calculated from plasma concentrations using non-compartmental analysis." (NCT01001221)
Timeframe: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion

Interventionng/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 0123
Cabazitaxel + Gemcitabine Dose Level -1150
Cabazitaxel + Gemcitabine Dose Level -2273
Gemcitabine + Cabazitaxel Dose Level 0118

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Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)

Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 0 to the last measurable concentration at time t. (NCT01001221)
Timeframe: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion

Interventionng*hr/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 0556
Cabazitaxel + Gemcitabine Dose Level -1352
Cabazitaxel + Gemcitabine Dose Level -2344
Gemcitabine + Cabazitaxel Dose Level 0315

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Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve (AUC)

Area under the plasma concentration versus time curve extrapolated to infinity (NCT01001221)
Timeframe: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion

Interventionng*hr/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 0876
Cabazitaxel + Gemcitabine Dose Level -1420
Cabazitaxel + Gemcitabine Dose Level -2462
Gemcitabine + Cabazitaxel Dose Level 0306

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Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionhours (Median)
Cabazitaxel + Gemcitabine Dose Level 00.69
Cabazitaxel + Gemcitabine Dose Level -10.68
Gemcitabine + Cabazitaxel Dose Level 00.72

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Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Terminal Half-life (t1/2z)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionhours (Mean)
Cabazitaxel + Gemcitabine Dose Level 07.29
Cabazitaxel + Gemcitabine Dose Level -18.55
Gemcitabine + Cabazitaxel Dose Level 09.10

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Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax)

"Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).~2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis." (NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionng/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 027400
Cabazitaxel + Gemcitabine Dose Level -134800
Gemcitabine + Cabazitaxel Dose Level 018700

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Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionng*hr/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 0216000
Cabazitaxel + Gemcitabine Dose Level -1287000
Gemcitabine + Cabazitaxel Dose Level 0141000

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Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionng*hr/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 0240000
Cabazitaxel + Gemcitabine Dose Level -1340000
Gemcitabine + Cabazitaxel Dose Level 0168000

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Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionhours (Median)
Cabazitaxel + Gemcitabine Dose Level 00.73
Cabazitaxel + Gemcitabine Dose Level -10.77
Cabazitaxel + Gemcitabine Dose Level -20.65
Gemcitabine + Cabazitaxel Dose Level 00.77

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Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Terminal Half-life (t1/2z)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionhours (Mean)
Cabazitaxel + Gemcitabine Dose Level 09.07
Cabazitaxel + Gemcitabine Dose Level -19.41
Cabazitaxel + Gemcitabine Dose Level -27.96
Gemcitabine + Cabazitaxel Dose Level 012.1

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Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax)

"Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).~2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis." (NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionng/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 032200
Cabazitaxel + Gemcitabine Dose Level -132500
Cabazitaxel + Gemcitabine Dose Level -225500
Gemcitabine + Cabazitaxel Dose Level 021100

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Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionng*hr/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 0227000
Cabazitaxel + Gemcitabine Dose Level -1235000
Cabazitaxel + Gemcitabine Dose Level -2167000
Gemcitabine + Cabazitaxel Dose Level 0168000

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Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

Interventionng*hr/ml (Mean)
Cabazitaxel + Gemcitabine Dose Level 0273000
Cabazitaxel + Gemcitabine Dose Level -1285000
Cabazitaxel + Gemcitabine Dose Level -2191000
Gemcitabine + Cabazitaxel Dose Level 0151000

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Participants With Dose Limiting Toxicities During Dose Escalation

Dose Limiting Toxicities (DLTs) were defined as clinical adverse events (AE) or laboratory abnormalities considered drug-related as assessed by the Investigator or Sponsor, and achieving a Common Terminology Criteria for Adverse Events v3.0 (CTCAE) severity rating of severe (3) or life-threatening (4). (NCT01001221)
Timeframe: Day 1 to Day 21 of the first treatment cycle

Interventionparticipants (Number)
Cabazitaxel + Gemcitabine Dose Level 02
Cabazitaxel + Gemcitabine Dose Level -12
Cabazitaxel + Gemcitabine Dose Level -22
Gemcitabine + Cabazitaxel Dose Level 02

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Pharmacokinetic of Gemcitabine on Cycle 1: Ratio Day 1/Day 8 for AUClast and AUC

Ratio Day 1/Day 8 for AUClast and AUC were calculated to assess the effect of cabazitaxel on gemcitabine exposure. (NCT01001221)
Timeframe: Day 1 (7 to 9 timepoints from start of infusion up to 24h hours after the end of infusion) and Day 8 (7 to 9 timepoints from start of infusion up to 24h hours after the end of infusion)

,,
Interventionratio (Mean)
AUClastAUC
Cabazitaxel + Gemcitabine Dose Level -11.171.24
Cabazitaxel + Gemcitabine Dose Level 01.151.15
Gemcitabine + Cabazitaxel Dose Level 01.111.11

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Participants With Adverse Events

"Summary of participants with adverse events (AEs) according to severity and relationship to study drug as assessed by the investigator. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used to grade the severity of AE.~Treatment-emergent adverse events (TEAEs) are AEs that occurred or worsened from start of treatment up to 30 days after treatment ceased.~NCI CTCAE v.3.0 grade 3 =severe and grade 4= life-threatening or disabling." (NCT01001221)
Timeframe: from first dose of study medication up to 30 days after the last dose of study medication (maximum follow-up of 68 weeks)

,,,
Interventionparticipants (Number)
Any AEAny TEAE- Drug-related TEAEGrade 3-4 TEAE- Grade 3-4 drug-related TEAESerious TEAE- Drug-related serious TEAEAE leading to drug withdrawn- Drug-related AE leading to drug withdrawnAE leading to deathAE leading to dose reductionAE leading to dose delay
Cabazitaxel + Gemcitabine Dose Level -1555552222042
Cabazitaxel + Gemcitabine Dose Level -2222222200021
Cabazitaxel + Gemcitabine Dose Level 0555545320134
Gemcitabine + Cabazitaxel Dose Level 0666664321044

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Participant Best Response as Per the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1

"Participant Best response was assessed by investigator using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1:~Complete response (CR): Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm:~Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion;~Progressive disease (PD): >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions;~Stable disease (SD): not a CR, PR or PD." (NCT01001221)
Timeframe: Up to a maximum of 22 cycles (median 4 cycles)

,,,
Interventionparticipants (Number)
Complete responsePartial responseStable diseaseProgressive diseaseNot evaluable
Cabazitaxel + Gemcitabine Dose Level -101310
Cabazitaxel + Gemcitabine Dose Level -200020
Cabazitaxel + Gemcitabine Dose Level 001211
Gemcitabine + Cabazitaxel Dose Level 001320

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

InterventionL/m^2 (Mean)
Cabazitaxel + Gemcitabine Dose Level 062.2
Cabazitaxel + Gemcitabine Dose Level -120.6
Gemcitabine + Cabazitaxel Dose Level 052.3

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Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State (Vss)

(NCT01001221)
Timeframe: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1

InterventionL (Mean)
Cabazitaxel + Gemcitabine Dose Level 0104
Cabazitaxel + Gemcitabine Dose Level -136.2
Gemcitabine + Cabazitaxel Dose Level 093.3

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Risk/Benefit Ratio

Risk/benefit ratio was calculated as the percentage of participants who experienced a study-drug related toxicity of Common Terminology Criteria for Adverse Events (CTCAE v3.0) Cancer Therapy Evaluation Program (CTEP) Grade 3 or higher, divided by the Kaplan-Meier estimated percentage of participants surviving one year. (NCT01005680)
Timeframe: Randomization to date of death from any cause up to 35.8 months post-randomization

Interventionratio (Number)
Pemetrexed Plus Cisplatin (PC)0.70
Gemcitabine Plus Cisplatin (GC)0.83

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Survival Without Toxicity (SWT)

SWT was defined as the time from randomization to a study-drug related toxicity. Toxicity was defined as Common Terminology Criteria for Adverse Events (CTCAE v3.0) Grade 3 or 4 or death. Participants who do not have a CTCAE Grade 3 or higher toxicity and are alive will be censored at the date of last contact. (NCT01005680)
Timeframe: Randomization to date of toxicity or date of death up to 34.6 months post-randomization

Interventionmonths (Median)
Pemetrexed Plus Cisplatin (PC)5.85
Gemcitabine Plus Cisplatin (GC)2.56

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Overall Survival (OS)

OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact. (NCT01005680)
Timeframe: Randomization to date of death from any cause up to 35.8 months post-randomization

Interventionmonths (Median)
Pemetrexed Plus Cisplatin (PC)17.54
Gemcitabine Plus Cisplatin (GC)15.51

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Tumor Response Rate

Tumor response rate was the percentage of participants with confirmed best tumor response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease (PD) assessed using RECIST v1.0 criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. (NCT01005680)
Timeframe: Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization

Interventionpercentage of participants (Number)
Pemetrexed Plus Cisplatin (PC)24.8
Gemcitabine Plus Cisplatin (GC)20.7

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Time to Treatment Failure (TtTF)

TtTF was defined as date of randomization until the date of discontinuation of study treatment due to adverse event, progressive disease (PD), or death from any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who discontinued study treatment for any other reason were censored at the date of discontinuation of study treatment. Participants still on study drug at data-inclusion cut-off date were censored at the cut-off date. (NCT01005680)
Timeframe: Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization

Interventionmonths (Median)
Pemetrexed Plus Cisplatin (PC)NA
Gemcitabine Plus Cisplatin (GC)NA

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Time to Progressive Disease (TtPD)

TtPD defined as the time from study randomization to the first date of progressive disease (PD). PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who were not known to have PD or who died without PD were censored at the date of last of last tumor assessment. (NCT01005680)
Timeframe: Randomization to first date of PD up to 23.7 months post-randomization

Interventionmonths (Median)
Pemetrexed Plus Cisplatin (PC)5.82
Gemcitabine Plus Cisplatin (GC)5.82

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Progression Free Survival (PFS)

PFS was defined as the date of randomization to date of first observation of clinical or objective progressive disease (PD) or death due to any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of one or more new lesions. Participants who were not known to have died or had PD were censored at the date of last contact. (NCT01005680)
Timeframe: Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization

Interventionmonths (Median)
Pemetrexed Plus Cisplatin (PC)5.88
Gemcitabine Plus Cisplatin (GC)5.85

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Duration of Response (DoR)

DoR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time progressive disease (PD) or death as a result of any cause. Response using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Participants who are not known to have died or to have PD were censored at the date of last contact. PD assessed using RECIST v1.0 and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions (NCT01005680)
Timeframe: Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization

Interventionmonths (Median)
Pemetrexed Plus Cisplatin (PC)4.53
Gemcitabine Plus Cisplatin (GC)4.98

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Disease Control Rate (DCR)

DCR was the percentage of participants with Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Response determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions; SD was defined as small changes that did not meet the above criteria. (NCT01005680)
Timeframe: Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization

Interventionpercentage of participants (Number)
Pemetrexed Plus Cisplatin (PC)78.5
Gemcitabine Plus Cisplatin (GC)75.9

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Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers.

"We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores of the reflect better quality of life.~For a Detailed description see:~Nancy Heffernan, David Cella, Kimberly Webster, Linda Odom, Mary Martone, Steven Passik, Marilyn Bookbinder, Yuman Fong, William Jarnagin, and Leslie Blumgart: Measuring Health-Related Quality of Life in Patients With Hepatobiliary Cancers: The Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire. Journal of Clinical Oncology, Vol 20, No 9 (May 1), 2002: pp 2229-2239.~No subscales were analyzed.~." (NCT01007552)
Timeframe: Baseline, Day 22 and Day 43

Interventionunits on a scale (Mean)
BaselineCycle 2Cycle 3
Gemcitabine, Capecitabine and Bevacizumab136.7135.6139.9

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The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers.

"Progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Note: Lesions are either measurable or non-measurable using the criteria provided below. The term evaluable in reference to measurability will not be used because it does not provide additional meaning or accuracy." (NCT01007552)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Interventionmonths (Median)
Gemcitabine, Capecitabine and Bevacizumab8.1

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Assess the Toxicity of the Regimen.

Number of patients with Serious Adverse Events. Please refer to the adverse event reporting for more detail. (NCT01007552)
Timeframe: up to 5 years

Interventionparticipants (Number)
Gemcitabine, Capecitabine and Bevacizumab30

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Estimate the Proportion of Patients With Clinical Response

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01007552)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Interventionpercentage of participants (Number)
Gemcitabine, Capecitabine and Bevacizumab24

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Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43

Mean number of CTCs in 7.5 ml of whole blood (NCT01007552)
Timeframe: baseline, day 22 and day 43

Interventioncells (Mean)
BaselineDay 22Day 43
Gemcitabine, Capecitabine and Bevacizumab2.31.00.8

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Assess Overall Survival (OS)

(NCT01007552)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Interventionmonths (Mean)
Gemcitabine, Capecitabine and Bevacizumab10.2

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Progression-free Survival

"Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.~Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group." (NCT01012297)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Interventionmonths (Median)
Arm I Gem+Doce+Placebo6.2
Arm II Gem+Doce+Bev4.2

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Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0

"Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse.~Please refer to the adverse event reporting for more detail." (NCT01012297)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Arm I Gem+Doce+Placebo36
Arm II Gem+Doce+Bev46

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Overall Survival

"Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last followup were censored on the date of last CT Scan.~The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group." (NCT01012297)
Timeframe: Up to 5 years

Interventionmonths (Median)
Arm I Gem+Doce+Placebo26.9
Arm II Gem+Doce+Bev23.3

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Objective Response Rate as Measured by RECIST 1.1 Criteria

"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." (NCT01012297)
Timeframe: Up to 5 years

Interventionpercentage of participants (Number)
Arm I Gem+Doce+Placebo31.5
Arm II Gem+Doce+Bev35.8

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Phase II: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation

An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) except AEs recorded with an onset date prior to the first day of drug administration unless a worsening of the event was recorded after the first dosing date, in which case the event was counted as a TEAE. TEAEs include both SAEs and non-SAEs. (NCT01016483)
Timeframe: From the first dose of study drug administration until EOT (6 years)

,
Interventionsubjects (Number)
TEAEsSerious TEAEsTEAEs Leading to Treatment Discontinuation
Phase II: Arm 1402810
Phase II: Arm 2453521

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Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 2

Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. (NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,
Interventionliter/hour (Geometric Mean)
CL: Gemcitabine on Day 1 (n=11, 14)CL: Gemcitabine on Day 22 (n=9, 4)
Regimen 2: 60 mg145.65164.68
Regimen 2: 75 mg221.46183.85

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Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 1

Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. (NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,,,,,
Interventionliter/hour (Geometric Mean)
CL: Gemcitabine on Day 1 (n=4,3,3,3,3,11)CL: Gemcitabine on Day 22 (n=2,2,1,2,2,9)
Regimen 1: 120 mg151.93164.6
Regimen 1: 15 mg60.537163.37
Regimen 1: 30 mg133.88156.93
Regimen 1: 45 mg190.52190.69
Regimen 1: 68 mg95.9625.123
Regimen 1: 90 mg210.25183.97

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Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2

(NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,
Interventionhours (Median)
Tmax: MSC1936369B on Day 1 (n=12,13)Tmax: MSC1936369B on Day 22 (n=10,9)Tmax: Gemcitabine (dFdC) on Day 1 (n=11,14)Tmax: Gemcitabine (dFdC) on Day 22 (n=9,4)Tmax: Metabolite (dFdU) on Day 1 (n=11,13)Tmax: Metabolite (dFdU) on Day 22 (n=10,5)
Regimen 2: 60 mg2.0001.5000.500.250.670.50
Regimen 2: 75 mg1.5832.0000.380.250.670.50

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Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1

(NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,,,,,
Interventionhours (Median)
Tmax: MSC1936369B on Day 1 (n= 4,3,3,3,3,11)Tmax: MSC1936369B on Day 22 (n= 3,3,3 2,3,10)Tmax: Gemcitabine (dFdC) on Day 1 (n=4,3,3,3,3,11)Tmax: Gemcitabine (dFdC) on Day 22 (n=2,3,3,2,3,9)Tmax: Metabolite (dFdU) on Day 1 (n=4,3,3,3,3,11)Tmax: Metabolite (dFdU) on Day 22 (n=2,3,3,2,3,10
Regimen 1: 120 mg1.5002.0000.270.500.500.75
Regimen 1: 15 mg1.2502.0170.380.420.640.54
Regimen 1: 30 mg1.0001.0000.500.500.500.75
Regimen 1: 45 mg1.5331.0000.250.530.501.00
Regimen 1: 68 mg2.0001.7500.251.040.750.67
Regimen 1: 90 mg1.0831.5000.250.250.500.75

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Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,
Interventionhours (Median)
t1/2: MSC1936369B on Day 1 (n=10,11)t1/2: MSC1936369B on Day 22 (n=8,5)t1/2: Gemcitabine (dFdC) on Day 1 (n=11,14)t1/2: Gemcitabine (dFdC) on Day 22 (n=9,4)t1/2: Metabolite (dFdU) on Day 1 (n=11,13)t1/2: Metabolite (dFdU) on Day 22 (n=10,5)
Regimen 2: 60 mg2.7573.4255.2585.5229.47110.68
Regimen 2: 75 mg2.6033.1885.3765.24910.2613.58

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Safety Run-In Part: Area Under Curve (AUC:0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) Regimen 2

AUC:0 to infinity is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. (NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1 of Cycle 1 for MSC1936369B, 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1 for Gemcitabine

,
Interventionhour*nanogram per milliliter (h*ng/mL) (Geometric Mean)
AUC: MSC1936369B on Day 1 (n= 10, 11)AUC: Gemcitabine (dFdC) on Day 1 (n= 11, 14)AUC: Gemcitabine (dFdC) on Day 22 (n= 9, 4)AUC: Metabolite (dFdU) on Day 1 (n= 11, 13)AUC: Metabolite (dFdU) on Day 22 (n= 10, 5)
Regimen 1: 75 mg1427.08065.510102.3234934.8256714.9
Regimen 2: 60 mg704.311932.010719.1189007.0177504.5

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Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 1

ERK phosphoprotein in peripheral blood monocytes (PBMCs) was analyzed from blood samples of all subjects in the SAF analysis set (safety-run part) only. (NCT01016483)
Timeframe: pre-dose on Day 1, 2, 22 of Cycle 1; post-dose on Day 1, 22 of Cycle 1

,,,,,
InterventionFluorescence Intensity (Mean)
Cycle 1 Day 1 Pre-dose (n=3,2,2,3,3,7)Cycle 1 Day 1 Post-dose (n=3,2,2,3,2,6)Cycle 1 Day 2 Pre-dose (n=3,2,1,2,2,6)Cycle 1 Day 22 Pre-dose (n=2,1,2,1,3,5)Cycle 1 Day 22 Post-dose (n=0,0,0,0,2)
Regimen 1: 30 mg6.4762.0616.7196.000NA
Regimen 1: 45 mg4.7670.8373.9021.978NA
Regimen 1: 68 mg6.5093.8812.7688.653NA
Regimen 1: 90 mg4.6081.0594.8744.252NA
Regimen 1:15 mg5.3891.6114.8185.242NA
Regimen1: 120 mg4.2290.9463.6363.4534.130

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Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 2

ERK phosphoprotein in peripheral blood monocytes (PBMCs) was analyzed from blood samples of all subjects in the SAF analysis set (safety-run part) only. (NCT01016483)
Timeframe: pre-dose on Day 1, 2, 22 of Cycle 1; post-dose on Day 1, 22 of Cycle 1

,
InterventionFluorescence Intensity (Mean)
Cycle 1 Day 1 Pre-dose (n=7,4)Cycle 1 Day 1 Post-dose (n=5,3)Cycle 1 Day 2 Pre-dose (n=7,3)Cycle 1 Day 22 Pre-dose (n=6,2)Cycle 1 Day 22 Post-dose (n=3,1)
Regimen 2: 60 mg6.0811.5203.8772.7281.443
Regimen 2: 75 mg5.8741.0482.2632.2951.111

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Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) for Regimen 1

(NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,,,,,
Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
MSC1936369B on Days 1 (n=4,3,3,3,3,11)MSC1936369B on Days 22 (n= 3,3,3,2,3,10)Gemcitabine (dFdC) on Day 1 (n=4,3,3,3,3,11)Gemcitabine (dFdC) on Day 22 (n= 2,3,3,2,3,9)Metabolite (dFdU) on Day 1 (n= 4,3,3,3,3,11)Metabolite (dFdU) on Day 22 (n= 2,3,3,2,3,10)
Regimen 1: 120 mg484.3252.923880.723207.234038.721077.5
Regimen 1: 15 mg32.329.669540.524115.829359.829677.6
Regimen 1: 30 mg131.0174.221207.311799.733171.638265.2
Regimen 1: 45 mg205.8261.817759.9181.934868.910569.2
Regimen 1: 68 mg151.3212.529762.1163196.233804.432869.2
Regimen 1: 90 mg485.3409.115606.3669.537786.417135.0

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Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2

(NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,
Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
MSC1936369B on Day 1 (n= 12,13)MSC1936369B on Day 22 (n=10,9)Gemcitabine (dFdC) on Day 1 (n=11,14)Gemcitabine (dFdC) on Day 22 (n=9,4)Gemcitabine Metabolite (dFdU) on Day 1 (n=11, 10)Gemcitabine Metabolite (dFdU) on Day 22 (n=10,5)
Regimen 2: 60 mg175.7228.227849.221589.733033.313455.5
Regimen 2: 75 mg345.5244.817663.918733.431623.918298.7

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Safety Run-In Part: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation

An adverse event (AE) was any untoward medical occurrence in a subjects who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) except AEs recorded with an onset date prior to the first day of drug administration unless a worsening of the event was recorded after the first dosing date, in which case the event was counted as a TEAE. TEAEs include both SAEs and non-SAEs. (NCT01016483)
Timeframe: From the first dose of study drug administration until EOT (6 years)

,
Interventionsubjects (Number)
TEAEsSerious TEAEsPermanent treatment discontinuation of pimasertibPermanent treatment discontinuation of gemcitabine
Safety Run-in Part: Regimen 127181214
Safety Run-in Part: Regimen 226201615

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Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 1

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. (NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,,,,,
Interventionliter (Geometric Mean)
V/f: MSC1936369B on Day 1 (n=4,3,3,2,3,11)V/f: MSC1936369B on Day 22 (n=2,2,3,2,3,8)
Regimen 1: 120 mg367.25414.38
Regimen 1: 15 mg528.62824.33
Regimen 1: 30 mg369.12366.30
Regimen 1: 45 mg329.80264.31
Regimen 1: 68 mg524.96441.40
Regimen 1: 90 mg362.29284.42

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Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 2

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. (NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,
Interventionliter (Geometric Mean)
V/f: MSC1936369B on Day 1 (n= 10,11)V/f: MSC1936369B on Day 22 (n=8,5)
Regimen 2: 60 mg335.56389.56
Regimen 2: 75 mg213.24319.02

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Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1

Plasma decay half-life was the time measured for the plasma concentration to decrease by one half. (NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,,,,,
Interventionhours (Median)
t1/2: MSC1936369B on Day 1 (n=4,3,3,2,3,11)t1/2: MSC1936369B on Day 22 (n=2,2,3,2,3,8)t1/2: Gemcitabine (dFdC) on Day 1 (n=4,3,3,3,3,11)t1/2: Gemcitabine (dFdC) on Day 22 (n=2,2,1,2,2,9)t1/2: Metabolite (dFdU) on Day 1 (n=4,3,3,3,3,11)t1/2: Metabolite (dFdU) on Day 22(n=2,2,2,2,2,10)
Regimen 1: 120 mg4.5804.8256.2424.68010.9312.17
Regimen 1: 15 mg4.0088.6604.2747.4498.9567.731
Regimen 1: 30 mg3.8076.1002.4614.55310.498.925
Regimen 1: 45 mg3.8333.2542.4210.91529.8368.843
Regimen 1: 68 mg4.2325.7445.3274.49311.5211.14
Regimen 1: 90 mg5.0363.1628.9408.2138.34910.21

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Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 2

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. (NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,
Interventionliter (Geometric Mean)
V: Gemcitabine on Day 1 (n=11,14)V: Gemcitabine on Day 22 (n=9,4)
Regimen 2: 60 mg716.121590.8
Regimen 2: 75 mg1059.0801.90

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Phase II: Time to Progression (TTP)

Time to progression (TTP) is defined as the time (in months) from the randomization date to the date of progression prior to the start of any subsequent therapy for the primary disease, as reported and documented by the Investigator (i.e. radiological progression per RECIST). (NCT01016483)
Timeframe: From randomization every 8 weeks up to EOT (6 years)

Interventionmonths (Median)
Phase II: Arm 13.78
Phase II: Arm 25.09

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Phase II: Overall Survival (OS) Time

Overall survival (OS) time is defined as the time (in months) from randomization to death. (NCT01016483)
Timeframe: Baseline, every 8 weeks up to EOT (6 years)

Interventionmonths (Median)
Phase II: Arm 16.64
Phase II: Arm 29.33

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Phase II: Percentage of Subjects With Clinical Benefit

Clinical Benefit was defined as the presence of at least one CR, PR or Stable Disease (SD) (using RECIST v1.0) during treatment. CR: Disappearance of all target lesions, PR: At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline and SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started. (NCT01016483)
Timeframe: Baseline, every 8 weeks up to end of treatment (EOT i.e. 6 years)

Interventionpercentage of subjects (Number)
Phase II: Arm 145.5
Phase II: Arm 259.1

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Phase II: Progression-Free Survival (PFS) Time

PFS was defined as the time from randomization to the first documentation of objective tumor progression (Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline, Progressive Disease (PD): At least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started) or to death due to any cause, whichever occurred first. PFS calculated as (Months) = Date of first PD or death or censoring date minus date of randomization plus 1) divided by 30.4375. (NCT01016483)
Timeframe: From the time of randomization to every 8 weeks up to end of treatment (EOT) (6 years)

Interventionmonths (Median)
Phase II: Arm 12.83
Phase II: Arm 23.75

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Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 1

Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. (NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,,,,,
Interventionliter (Geometric Mean)
V: Gemcitabine (dFdC) on Day 1 (n= 4,3,3,3,3,11)V: Gemcitabine (dFdC) on Day 22 (n=2,2,1,2,2,9)
Regimen 1: 120 mg1270.1805.15
Regimen 1: 15 mg359.551723.6
Regimen 1: 30 mg531.23908.50
Regimen 1: 45 mg587.64251.79
Regimen 1: 68 mg729.65149.65
Regimen 1: 90 mg2402.12140.8

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Safety Run-In Part: Number of Subjects With Dose Limiting Toxicities (DLTs)

DLT using the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE) v3.0,was defined as any of the following toxicities at any dose level and judged to be possibly or probably related to trial medication by the Investigator and/or the Sponsor and relevant for the combination treatment: Grade 3/more non-hematological toxicity excluding: Subjects with liver involvement: Grade 4 asymptomatic increases in liver function tests and subject without liver involvement: Grade 3 asymptomatic increases in liver function tests reversible within 7 days. Grade 3 vomiting encountered despite adequate therapy. Grade 3 diarrhea encountered despite adequate anti diarrhea therapy. Grade 4 neutropenia greater (>) 5 days duration or febrile neutropenia lasting for more than 1 day. Grade 4 thrombocytopenia > 1 day/Grade 3 with bleeding. Grade 4 anemia: Any treatment delay > 2 weeks due to drug-related adverse effects. (NCT01016483)
Timeframe: Up to 28 days in Cycle 1

Interventionsubjects (Number)
Safety Run-in Part Regimen 1: 15 mg0
Safety Run-in Part Regimen 1: 30 mg0
Safety Run-in Part Regimen 1: 45 mg0
Safety Run-in Part Regimen 1: 68 mg0
Safety Run-in Part Regimen 1: 90 mg0
Safety Run-in Part Regimen 1: 120 mg0
Safety Run-in Part Regimen 2: 60 mg1
Safety Run-in Part Regimen 2: 75 mg2

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Safety Run-In Part: Area Under Curve (AUC: 0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1

AUC:0 to infinity was a measure of the serum concentration of the drug over time. It was used to characterize drug absorption. (NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1 of Cycle 1 for MSC1936369B, 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1 for Gemcitabine

,,,,,
Interventionhour*nanogram per milliliter (h*ng/mL) (Geometric Mean)
AUC: MSC1936369B on Day 1 (n=4,3,3,3,3,11)AUC: Gemcitabine (dFdC) on Day 1(n=4,3,3,3,3,11)AUC: Gemcitabine (dFdC) on Day 22(n=2,2,1,2,2,9)AUC: Metabolite (dFdU) on Day 1 (n=4,3,3,3,3,11)AUC: Metabolite (dFdU) on Day 22 (n=2,2,2,2,2,10)
Regimen 1: 30 mg516.313536.512019.6228032.9376280.5
Regimen 1: 45 mg881.110053.39093.2276968.3217930.8
Regimen 1: 68 mg774.818956.076448.7259816.2327424.8
Regimen 1: 90 mg1729.98178.49604.8239902.9248496.4
Regimen 1:15 mg162.829536.110828.0245795.5190952.6
Regimen1: 120 mg2175.111680.110598.0240293.8247430.7

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Phase II: Percentage of Subjects With Best Overall Response (BOR)

Best overall response was defined as the presence of at least one complete response (CR), partial response (PR) or Stable Disease (SD) (using RECIST v1.0) during treatment. CR: Disappearance of all target lesions, PR: At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline and SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started. (NCT01016483)
Timeframe: Baseline, every 8 weeks up to end of treatment (EOT i.e. 6 years)

,
Interventionpercentage of subjects (Number)
CRPRSDPDMissing
Phase II: Arm 109.136.429.525
Phase II: Arm 209.150.020.520.5

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Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 1

Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed. (NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,,,,,
InterventionLiter per hour (L/h) (Geometric Mean)
CL/f: MSC1936369B on Day 1 (n=4,3,3,2,3,11)CL/f: MSC1936369B on Day 22 (n=2,2,3,2,3,9)
Regimen 1: 120 mg55.17155.723
Regimen 1: 30 mg58.10442.484
Regimen 1: 45 mg51.07244.579
Regimen 1: 68 mg87.76556.502
Regimen 1: 90 mg52.02550.873
Regimen 1:15 mg92.15274.143

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Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 2

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. (NCT01016483)
Timeframe: 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1

,
InterventionLiter per hour (L/H) (Geometric Mean)
CL/f: MSC1936369B on Day 1 (n=10,11)CL/f: MSC1936369B on Day 22 (n=8,5)
Regimen 2: 60 mg85.18670.163
Regimen 2: 75 mg52.55868.312

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Number of Participants With Treatment Emergent Adverse Events (AEs)

Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0 (NCT01020006)
Timeframe: First dose until 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last in the assigned part (A or B).

Interventionparticipants (Number)
(PCI-27483 + Gemcitabine)/Part A8
(PCI-27483 + Gemcitabine)/Part B18
Gemcitabine/Part B16

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Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1)

Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the first quartile (Q1, 10.09). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. (NCT01041781)
Timeframe: Up to 5 years

Interventionmonths (Median)
PGE-M < Q17.7
PGE-M >= Q14.9

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Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Median Quartile (Q2)

prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q2, 15.38). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. (NCT01041781)
Timeframe: Up to 5 years

Interventionmonths (Median)
PGE-M < Q26.2
PGE-M >= Q24.2

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Progression-free Survival

Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. (NCT01041781)
Timeframe: Time between randomization and disease relapse or death from any cause, assessed up to 5 years

Interventionmonths (Median)
Arm I (Arm A: Celecoxib + Standard Chemotherapy)5.16
Arm II (Arm B: Placebo + Standard Chemotherapy)5.26

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Response Rate

The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test (NCT01041781)
Timeframe: Up to 5 years

Interventionpercentage of patients (Number)
Arm I (Arm A: Celecoxib + Standard Chemotherapy)40
Arm II (Arm B: Placebo + Standard Chemotherapy)35

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Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0

The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment (NCT01041781)
Timeframe: Up to 5 years

Interventionpercentage of patients (Number)
Arm I (Arm A: Celecoxib + Standard Chemotherapy)61.04
Arm II (Arm B: Placebo + Standard Chemotherapy)55.06

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Overall Survival

Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. (NCT01041781)
Timeframe: Time between randomization and death from any cause, assessed up to 5 years

Interventionmonths (Median)
Arm I (Arm A: Celecoxib + Standard Chemotherapy)11.4
Arm II (Arm B: Placebo + Standard Chemotherapy)12.5

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Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Third Quartile (Q3)

Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q3, 27.86). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. (NCT01041781)
Timeframe: Up to 5 years

Interventionmonths (Median)
PGE-M < Q36.0
PGE-M >= Q33.0

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Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period

InterventionMonths (Median)
DE Arm 1: (R-CVP) Plus Inotuzumab OzogamicinNA
DE Arm 2: (R-GDP) Plus Inotuzumab OzogamicinNA

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Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts

PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with OR of CR, PR, SD, or PD, but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks

InterventionMonths (Median)
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin14.36
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin6.14

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Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts

PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with overall response of CR, PR, stable disease (SD), or disease progression (PD), but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks

InterventionMonths (Median)
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin16.36
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin10.12

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Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2

DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. (NCT01055496)
Timeframe: From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.

InterventionParticipants (Count of Participants)
Cohort 1, Arm 20
Cohort 2a, Arm 22
Cohort 2b, Arm 21
Cohort 3b, Arm 22
Cohort 4, Arm 20
MTD Confirmation Cohort, Arm 23

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Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1

DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. (NCT01055496)
Timeframe: From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.

InterventionParticipants (Count of Participants)
Cohort 1, Arm 10
Cohort 2, Arm 10
Cohort 3, Arm 11
Cohort 4, Arm 12
MTD Confirmation Cohort, Arm 12

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Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts

OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their GTD for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.

InterventionPercentage of participants (Number)
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin81.3
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin51.9

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Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy

"The following parameters were analyzed for blood chemistry: blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals severe and CTCAE Grade 4 equals life threatening or disabling." (NCT01055496)
Timeframe: Within 3 days prior to the start of each cycle, on Day 8 of each cycle, on Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.

InterventionPercentage of Participants (Number)
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin21.3
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin36.4

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Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy

"The following parameters were analyzed for hematology: lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals severe and CTCAE Grade 4 equals life threatening or disabling." (NCT01055496)
Timeframe: Within 3 days prior to the start of each cycle, Day 8 of each cycle, Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.

InterventionPercentage of Participants (Number)
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin91.7
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin96.4

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Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts

OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 centimeters [cm] in their greatest transverse diameter (GTD) for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.

InterventionPercentage of participants (Number)
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin81.3
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin53.6

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Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts

Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. (NCT01055496)
Timeframe: 6, 12 and 24 months

,
InterventionPercent Probability (Number)
6 months12 months24 months
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin80.0066.6722.22
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin60.9847.9233.54

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Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: 6, 12, and 24 months

,
InterventionPercent Probability (Number)
6 months12 months24 months
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin100.0080.0080.00
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin74.0762.9655.09

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Mean Inotuzumab Ozogamicin Serum Concentrations

Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays. (NCT01055496)
Timeframe: Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8.

,
Interventionng/mL (Mean)
Cycle 1 Day 2, 0hCycle 3 Day 2, 0hCycle 3 Day 2, 1hCycle 3 Day 2, 3hCycle 3 Day 3, 24hCycle 3 Day 8, 168h
Cohort 2b/MTD/EE Arm 2: (R-GDP) Plus Inotuzumab OzogamicinNA25.00283.27280.33154.25NA
Cohort 3/MTD/EE Arm 1: (R-CVP) Plus Inotuzumab OzogamicinNANA189.74213.95110.39NA

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Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: 6, 12, and 24 Months

,
InterventionPercent Probability (Number)
6 months12 months24 months
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin84.3878.1371.61
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin88.0059.1153.74

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Mean Inotuzumab Ozogamicin Serum Concentrations

Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays. (NCT01055496)
Timeframe: Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8.

,,,
Interventionng/mL (Mean)
Cycle 1 Day 2, 0h
Cohort 1, Arm 2NA
Cohort 3b, Arm 2NA
Cohort 4, Arm 1NA
Cohort 4, Arm 2NA

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Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts.

Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. (NCT01055496)
Timeframe: 6, 12, and 24 months

,
InterventionPercent Probability (Number)
6 months12 months24 months
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin61.8551.5444.67
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin54.7424.88NA

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Percentage of Participants With a Treatment Emergent AE

An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event may not necessarily have had a causal relationship with the treatment or usage. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as those occurring on or after the first study drug dose day through and including 56 days post last dose of study drug. The severity of all AEs was graded by the investigator using the National Cancer Institute Common Terminology Criteria for AE Version 3.0 (NCI CTCAE v3.0). (NCT01055496)
Timeframe: SAEs were assessed from informed consent through and including the end of treatment visit (at least 28 calendar days after last study drug administration). Non-SAEs were recorded from time of the first dose of study drug through last participant visit.

,
InterventionPercentage of Participants (Number)
Subjects with AEsSubjects with SAEsSubjects with Grade 3 or 4 AEsSubjects with Grade 5 AEsSubjects discontinued due to AEsSubjects with dose reduced due to AEsSubjects with temporary discontinuation due to AEs
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin10031.389.64.227.116.754.2
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin10045.596.45.536.432.767.3

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Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period

InterventionMonths (Median)
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab OzogamicinNA
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab OzogamicinNA

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Objective Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01064622)
Timeframe: Up to 6 months

Interventionpercentage of participants (Number)
Arm I (Gemcitabine Hydrochloride and Placebo)13.2
Arm II (Gemcitabine Hydrochloride and Vismodegib)7.5

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Overall Survival

Time from randomization to death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test. (NCT01064622)
Timeframe: Up to 3 years

Interventionmonths (Median)
Arm I (Gemcitabine Hydrochloride and Placebo)6.1
Arm II (Gemcitabine Hydrochloride and Vismodegib)6.9

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Incidence of Adverse Events

Details are provided in Adverse Events section below. Reported here are percentage of patients in each arm with any grade 1 or higher adverse event, regardless of attribution. (NCT01064622)
Timeframe: Up to 3 years

Interventionpercentage of participants (Number)
Arm I (Gemcitabine Hydrochloride and Placebo)98.1
Arm II (Gemcitabine Hydrochloride and Vismodegib)98.1
Phase I lead-in Patients100.0

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Progression-free Survival

Time from randomization to disease progression or death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test. (NCT01064622)
Timeframe: Up to 3 years

Interventionmonths (Median)
Arm I (Gemcitabine Hydrochloride and Placebo)2.5
Arm II (Gemcitabine Hydrochloride and Vismodegib)4.0

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Activity (Overall Response Rate) in Crossover Patients

RECIST response rate in patients after crossover from placebo to vismodegib arm. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01064622)
Timeframe: Up to 6 months

Interventionpercentage of participants (Number)
Arm I (Gemcitabine Hydrochloride and Placebo)4.5

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Percentage of Participants With Disease Control

Disease control was defined as having CR/PR/SD as per RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. (NCT01077713)
Timeframe: Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6

,
Interventionpercentage of participants (Number)
Cycle 3Cycle 6Month 6
Bevacizumab + Gemcitabine53.527.925.6
Bevacizumab + Gemcitabine + Cisplatin67.537.530.0

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Percentage of Participants With Disease Progression or Death

Disease progression was assessed according to RECIST criteria v1.1. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. (NCT01077713)
Timeframe: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)

Interventionpercentage of participants (Number)
Bevacizumab + Gemcitabine86.0
Bevacizumab + Gemcitabine + Cisplatin90.0

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Duration of Response (DoR)

DoR was defined for participants who had achieved an objective response (CR/PR) (whichever status was recorded first) as the time period from first documentation of a response to the date of first occurrence of investigator documented disease progression or death. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters or appearance of one or more new lesions. DoR was estimated using Kaplan Meier method. (NCT01077713)
Timeframe: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)

Interventionmonths (Median)
Bevacizumab + Gemcitabine5.23
Bevacizumab + Gemcitabine + Cisplatin5.97

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Overall Survival (OS)

OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method. (NCT01077713)
Timeframe: From randomization to death or end of the study (up to 53 months)

Interventionmonths (Median)
Bevacizumab + Gemcitabine5.66
Bevacizumab + Gemcitabine + Cisplatin12.0

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Percentage of Participants Alive and Without Progressive Disease at Month 6

Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions. (NCT01077713)
Timeframe: Month 6

Interventionpercentage of participants (Number)
Bevacizumab + Gemcitabine25.6
Bevacizumab + Gemcitabine + Cisplatin30.0

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Percentage of Participants Alive at 12 Months After Randomization

(NCT01077713)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Bevacizumab + Gemcitabine37.2
Bevacizumab + Gemcitabine + Cisplatin47.5

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Percentage of Participants Who Died

(NCT01077713)
Timeframe: From randomization to death or end of the study (up to 53 months)

Interventionpercentage of participants (Number)
Bevacizumab + Gemcitabine69.8
Bevacizumab + Gemcitabine + Cisplatin72.5

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Progression Free Survival (PFS)

PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Disease progression was assessed according to RECIST criteria v 1.1. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. (NCT01077713)
Timeframe: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)

Interventionmonths (Median)
Bevacizumab + Gemcitabine4.33
Bevacizumab + Gemcitabine + Cisplatin6.82

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Percentage of Participants by Best Overall Response

Best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence, assessed according to RECIST criteria v 1.1. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions; Progressive Disease (PD): at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (NCT01077713)
Timeframe: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)

,
Interventionpercentage of participants (Number)
CRPRSDPDNot Assessable
Bevacizumab + Gemcitabine0.014.039.516.330.2
Bevacizumab + Gemcitabine + Cisplatin0.035.037.512.515.0

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Percentage of Participants With an Objective Response

Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. (NCT01077713)
Timeframe: Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6

,
Interventionpercentage of participants (Number)
Cycle 3Cycle 6Month 6
Bevacizumab + Gemcitabine11.69.34.7
Bevacizumab + Gemcitabine + Cisplatin27.515.010.0

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Response Rate by RECIST Criteria.

"Response rate = complete response + partial response per RECIST~Complete response - disappearance of all target and non-target lesions.~Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter" (NCT01080248)
Timeframe: Follow-up was approximately 9 weeks

Interventionpercentage of participants (Number)
Arm 1 (Gemcitabine & Pazopanib)0

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Progression-free Survival (PFS)

"PFS is defined as the duration of time from start of treatment to time to progression.~Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions." (NCT01080248)
Timeframe: Follow-up was approximately 9 weeks

Interventionweeks (Number)
Arm 1 (Gemcitabine & Pazopanib)8

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Median Survival

(NCT01080248)
Timeframe: Length of follow-up was 35 weeks

Interventionweeks (Median)
Arm 1 (Gemcitabine & Pazopanib)34

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Overall Survival

(NCT01080248)
Timeframe: 1 year

Interventionparticipants (Number)
Arm 1 (Gemcitabine & Pazopanib)0

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Progression Free Survival With the Combination of GDC-0449 With Gemcitabine and Nab-paclitaxel.

Number of months from time first therapy received to the earliest documented disease progression or death from any cause. (NCT01088815)
Timeframe: 6 years

Interventionmonths (Median)
Gemcitabine, Nab-paclitaxel, GDC-04495.42

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Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Tumor Response

Number of participants with complete (CR) or partial (PR) response as defined by RECIST criteria. (NCT01088815)
Timeframe: 6 years

InterventionParticipants (Count of Participants)
CRPR
Gemcitabine, Nab-paclitaxel, GDC-0449126

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Safety of Combination Therapy in Patients With Metastatic Adenocarcinoma of the Pancreas as Assessed by Number of Grade 3 or 4 Adverse Events

Number of grade 3 or 4 adverse events as defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE v4.0) that occur after Cycle 2, Day 1 (NCT01088815)
Timeframe: 6 years

InterventionGrade 3/4 adverse events (Number)
Gemcitabine, Nab-paclitaxel, GDC-0449104

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Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Changes in Pancreatic Cancer Stem Cell

Change in number of Pancreatic cancer stem cells in tissue and peripheral blood in tissue biopsy and peripheral blood. (NCT01088815)
Timeframe: 6 years

Interventioncells (Mean)
peripheral blood
Gemcitabine, Nab-paclitaxel, GDC-044927.0

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Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Overall Survival

Total number of months alive. (NCT01088815)
Timeframe: 6 years

Interventionmonths (Median)
Gemcitabine, Nab-paclitaxel, GDC-04499.79

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Tumour Shrinkage

"Tumour shrinkage is calculated as the minimum post-baseline sum of longest diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) (SLD), as assessed by central independent review. The mean of these minimum values are presented after adjusting for baseline sum of longest diameters and EGFR mutation category. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered. A negative value means the smallest post-baseline SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline.~The means are adjusted for baseline sum of lesions and EGFR mutation category." (NCT01121393)
Timeframe: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374

Interventionmillimetre (mm) (Mean)
Afatinib 40 Milligram (mg)33.41
Gemcitabine / Cisplatin Chemotherapy47.06

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Change From Baseline in Body Weight

The change from baseline to the lowest and the last body weight recorded or during the the study. (NCT01121393)
Timeframe: Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.

,
Interventionkilogram (kg) (Mean)
Change from baseline at lowest valueChange from baseline at last value
Afatinib 40 Milligram (mg)-3.03-0.76
Gemcitabine / Cisplatin Chemotherapy-1.520.00

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Time to Objective Response (OR)

"OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.~For patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response.~Outcome data are the percentage of patients with OR by each scheduled tumour assessment." (NCT01121393)
Timeframe: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374

,
Interventionpercentage of participants (Number)
By Week 6By Week 12By Week 18By Week 24By Week 30By Week 36By Week 42By Week 48By Week 60By Week 72By Week 84By Week 96By Week 108By Week 120
Afatinib 40 Milligram (mg)49.259.964.064.965.766.166.566.566.966.966.967.467.467.8
Gemcitabine / Cisplatin Chemotherapy13.119.723.023.023.023.023.023.023.023.023.023.023.023.0

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Duration of Objective Response

"OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.~For patients with an objective response, duration of objective response was defined as the time from the first objective response to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates." (NCT01121393)
Timeframe: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374

Interventionmonths (Median)
Afatinib 40 Milligram (mg)9.72
Gemcitabine / Cisplatin Chemotherapy4.27

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Duration of Disease Control

For patients with disease control, duration of disease control was defined as the time from randomisation to progression or death whichever occurs first. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates. (NCT01121393)
Timeframe: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374

Interventionmonths (Median)
Afatinib 40 Milligram (mg)11.07
Gemcitabine / Cisplatin Chemotherapy5.65

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Disease Control (DC)

DC is defined as a patient with objective response (OR) or stable disease (SD) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with DC. (NCT01121393)
Timeframe: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374

Interventionpercentage of participants (Number)
Afatinib 40 Milligram (mg)92.6
Gemcitabine / Cisplatin Chemotherapy76.2

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Pharmacokinetics of Afatinib at Day 22

Outcome data are the trough plasma concentrations of afatinib at day 22 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the Pharmacokinetics (PK) assessment period). (NCT01121393)
Timeframe: Day 22 (course 2, visit 1)

Interventionnanogram/millilitre (ng/mL) (Geometric Mean)
Afatinib 30mg q.d.17.7
Afatinib 40mg q.d.23.1

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Overall Survival (OS)

"OS is defined as the time from randomisation to death. For patients who had not died until 7 December 2017, the date they were last known to be alive was derived from patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.~Median time results from unstratified Kaplan-Meier estimates." (NCT01121393)
Timeframe: From randomisation up to 374 weeks

Interventionmonths (Median)
Afatinib 40 Milligram (mg)23.10
Gemcitabine / Cisplatin Chemotherapy23.46

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Objective Response (OR)

"OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR.~CR is defined as the disappearance of all target lesions and non-target lesions and no new lesions.~PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions.~(Exact 95% Confidence interval by Clopper and Pearson.)" (NCT01121393)
Timeframe: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374

Interventionpercentage of participants (Number)
Afatinib 40 Milligram (mg)67.8
Gemcitabine / Cisplatin Chemotherapy23.0

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Pharmacokinetics of Afatinib at Day 29

Outcome data are the trough plasma concentrations of afatinib at day 29 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period). (NCT01121393)
Timeframe: Day 29 (course 2, visit 2)

Interventionng/mL (Geometric Mean)
Afatinib 30mg q.d.19.5
Afatinib 40mg q.d.23.8
Afatinib 50mg q.d.22.8

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Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events

Safety of Afatinib as indicated by intensity and incidence of adverse events graded according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Presented as the percentage of patients with an Adverse Events during the on-treatment period by highest CTCAE grade. (NCT01121393)
Timeframe: From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.

,
Interventionpercentage of participants (Number)
CTCAE Grade 1CTCAE Grade 2CTCAE Grade 3CTCAE Grade 4CTCAE Grade 5
Afatinib 40 Milligram (mg)13.836.039.34.26.7
Gemcitabine / Cisplatin Chemotherapy8.029.238.121.22.7

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Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

"The last ECOG performance score category recorded during the study. Outcome data are the percentage of patients with an shift of ECOG performance status from baseline to the last ECOG performance status.~ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction;~Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work;~Ambulatory (>50 percent of waking hours), capable of all selfcare, unable to carry out any work activities;~Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours;~Completely disabled, cannot carry on any selfcare, totally confined to bed or chair;~Dead" (NCT01121393)
Timeframe: Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.

,
Interventionpercentage of participants (Number)
ECOG PS 0 (baseline) 0 (last value)ECOG PS 1 (baseline) 0 (last value)ECOG PS 0 (baseline) 1 (last value)ECOG PS 1 (baseline) 1 (last value)ECOG PS 0 (baseline) 2 (last value)ECOG PS 1 (baseline) 2 (last value)ECOG PS 0 (baseline) 3 (last value)ECOG PS 1 (baseline) 3 (last value)ECOG PS 0 (baseline) 4 (last value)ECOG PS 1 (baseline) 4 (last value)
Afatinib 40 Milligram (mg)11.46.88.067.50.42.10.02.10.41.3
Gemcitabine / Cisplatin Chemotherapy21.83.614.551.80.01.80.04.50.01.8

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Pharmacokinetics of Afatinib at Day 43

Outcome data are the trough plasma concentrations of afatinib at day 43 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period). (NCT01121393)
Timeframe: Day 43 (course 3, visit 1)

Interventionng/mL (Geometric Mean)
Afatinib 30mg q.d.21.5
Afatinib 40mg q.d.22.1
Afatinib 50mg q.d.22.9

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Progression-free Survival

"The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS.~Only data collected up until the analysis cut-off date (27 December 2013) were considered. Median time results from unstratified Kaplan-Meier estimates." (NCT01121393)
Timeframe: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168

Interventionmonths (Median)
Afatinib 40 Milligram (mg)11.01
Gemcitabine / Cisplatin Chemotherapy5.59

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Changes in Safety Laboratory Parameters

"Outcome data presented are the percentage of patients by worst CTCAE grade (only Grades 2 to 4 presented) on treatment for the following laboratory parameters: Potassium, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine and Creatine Kinase.~For Potassium; only CTCAE grades resulting from hypokalemia (low values) are presented." (NCT01121393)
Timeframe: From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.

,
Interventionpercentage of participants (Number)
Potassium CTCAE grade 2Potassium CTCAE grade 3Potassium CTCAE grade 4AST CTCAE grade 2AST CTCAE grade 3AST CTCAE grade 4ALT CTCAE grade 2ALT CTCAE grade 3ALT CTCAE grade 4Creatinine CTCAE grade 2Creatinine CTCAE grade 3Creatinine CTCAE grade 4Creatinine Kinase CTCAE grade 2Creatinine Kinase CTCAE grade 3Creatinine Kinase CTCAE grade 4
Afatinib 40 Milligram (mg)NA5.12.65.11.30.08.13.40.02.10.00.03.71.90.0
Gemcitabine / Cisplatin ChemotherapyNA15.60.91.91.90.05.61.90.02.80.00.01.00.00.0

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Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria

"Biological PFS including assessment of CA-125 levels was defined as the time from randomisation until the first occurrence of progressive disease according to CA-125, progressive disease according to radiological evidence, or death.~Also according to the below criterias,~In patients with radiological measurable disease, disease progression during study treatment could not be declared on the basis of CA-125 alone.~Patients with elevated CA-125 pre-treatment and normalization of CA-125 had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart or~Patients with elevated CA-125 pre-treatment, which never normalized, had to show evidence of CA-125 ≥ to two times the nadir value on two occasions at least one week apart or~Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart." (NCT01121406)
Timeframe: At screening and every 6 weeks thereafter (Up to 213 weeks )

Interventionweeks (Median)
Volasertib (BI 6727)13.1
Cytotoxic20.6

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CL; Total Clearance of BI 6727 BS in Plasma After Intravenous Administration

CL; total clearance of BI 6727 BS in plasma after intravenous administration (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

InterventionmL/min (Geometric Mean)
Volasertib801

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Cmax; Maximum Measured Concentration of BI 6727 BS in Plasma

Cmax; maximum measured concentration of BI 6727 BS in plasma (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

Interventionng/mL (Geometric Mean)
Volasertib341

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Cmax; Maximum Measured Concentration of CD 10899 BS in Plasma

Cmax; maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

Interventionng/mL (Geometric Mean)
Volasertib10.8

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Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1

DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD). (NCT01121406)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Volasertib (BI 6727)30.6
Cytotoxic43.1

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MRT; Mean Residence Time of BI 6727 BS in the Body

MRT; Mean residence time of BI 6727 BS in the body (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

Interventionhours (Geometric Mean)
Volasertib118

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Overall Survival (OS)

OS is defined as time from randomisation to death irrespective of the cause of the death. (NCT01121406)
Timeframe: From randomization until death or study discontinuation; Up to 213 weeks

Interventionweeks (Median)
Volasertib (BI 6727)60.1
Cytotoxic68.6

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Progression Free Survival (PFS)

"Progression-free survival of a patient was based on the investigator's assessment; it was defined as the number of days from the date of randomisation until the date of either disease progression or death from any cause, whichever occurred first.~Definition of disease progression according to RECIST version 1.1; Patients with measurable tumour lesions at baseline, Target-lesions: at least a 20% increase in the sum of diameters of target lesions, the sum of diameters must also demonstrate an absolute increase of at least 5 mm,taking as reference the smallest sum on study, or appearance of 1 or more new lesions.~Non-target lesions: unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions Patients with non-measurable tumour lesions at baseline, Non-target lesions: requires unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions" (NCT01121406)
Timeframe: From randomization until disease progression, death or study discontinuation; Up to 213 weeks

Interventionweeks (Median)
Volasertib (BI 6727)13.1
Cytotoxic20.6

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t1/2; Terminal Half-life of BI 6727 BS in Plasma

t1/2; Terminal half-life of BI 6727 BS in plasma (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

Interventionhours (Geometric Mean)
Volasertib143

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t1/2; Terminal Half-life of CD 10899 BS in Plasma

t1/2; Terminal half-life of CD 10899 BS in plasma (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

Interventionhours (Geometric Mean)
Volasertib146

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Time to Deterioration in Abdominal Bloating/ Quality of Life (QOL)

"Time to deterioration in abdominal bloating/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death." (NCT01121406)
Timeframe: Every 6 weeks (Up to 213 weeks )

Interventionweeks (Median)
Volasertib (BI 6727)NA
Cytotoxic47.2

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Time to Deterioration in Global Health Status/Quality of Life (QOL)

"Time to deterioration in global health status/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death." (NCT01121406)
Timeframe: Every 6 weeks (Up to 213 weeks )

Interventionweeks (Median)
Volasertib (BI 6727)NA
Cytotoxic39.6

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Time to Deterioration in Pain/ Quality of Life (QOL)

"Time to deterioration in pain/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death." (NCT01121406)
Timeframe: Every 6 weeks (Up to 213 weeks )

Interventionweeks (Median)
Volasertib (BI 6727)NA
Cytotoxic54.1

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Time to Deterioration in the Three Most Troublesome Disease Specific Symptoms/ Quality of Life (QOL)

"Three most troublesome disease specific symptoms, defined by the patient at baseline.~Patients that have defined more than 3 most troublesome symptoms have not been taken into account in the analysis.~Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death." (NCT01121406)
Timeframe: Every 6 weeks (Up to 213 weeks)

Interventionweeks (Median)
Volasertib (BI 6727)NA
Cytotoxic18.9

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Tmax; Time From Dosing to Maximum Measured Concentration of BI 6727 BS in Plasma

tmax; time from dosing to maximum measured concentration of BI 6727 BS in plasma (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

Interventionhours (Median)
Volasertib2.00

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Tmax; Time From Dosing to Maximum Measured Concentration of CD 10899 BS in Plasma

tmax; time from dosing to maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

Interventionhours (Median)
Volasertib6.07

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Vss;Apparent Volume of Distribution at Steady State Following Intravenous Administration for BI 6727 BS

Vss;apparent volume of distribution at steady state following intravenous administration for BI 6727 BS (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

InterventionLitres (Geometric Mean)
Volasertib5690

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Best Overall Response

"Best overall response (BOR) is defined as the best response recorded at any time from the date of randomisation until the end of treatment.~Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed." (NCT01121406)
Timeframe: time from the date of randomisation until study completion/discontinuation; Up to 213 weeks

,
Interventionparticipants (Number)
CR- Measurable diseasePR- Measurable diseaseSD- Measurable diseasePD- Measurable diseaseMissing- Measurable diseaseCR- Non-measurable diseaseNon-CR/Non-PD- Non-measurable diseasePD- Non-measurable diseaseMissing- Non-measurable disease
Cytotoxic08241021901
Volasertib (BI 6727)07241400630

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Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria

"Patients were to have a pre-treatment CA-125 of at least twice the upper limit of normal to be considered for CA-125 response. Patients were not evaluable by CA-125 if they had received mouse antibodies or if they had undergone medical and/or surgical interference with their peritoneum or pleura during the previous 28 days. In eligible patients, a CA-125 response was defined as the moment the CA- 25 was reduced by 50%, with this being confirmed with a consecutive CA-125 assessment not earlier than 28 days after the previous one.~Biological response rate based on serum CA-125 levels was assessed according to the guidelines by the Gynaecologic Cancer Intergroup. Monitoring of blood levels of the tumour marker CA-125 was performed at screening and every 6 weeks thereafter." (NCT01121406)
Timeframe: At screening and every 6 weeks thereafter (Up to 213 weeks)

,
Interventionparticipants (Number)
YesNoNot evaluableMissing
Cytotoxic1223119
Volasertib (BI 6727)103347

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Clinically Relevant Changes in Laboratory and ECG Data

Clinically relevant changes in laboratory and ECG data (NCT01121406)
Timeframe: From first treatment administration to 21 days after the last drug administration (Up to 1403 days)

,,
Interventionpercentage of participants (Number)
Blood alkaline phosphatase increasedBlood creatinine increasedPlatelet count decreasedAlanine aminotransferase increasedAspartate aminotransferase increasedBlood uric acid increasedGamma-glutamyltransferase increasedAlanine aminotransferase abnormalElectrocardiogram QT prolongedHaemoglobin decreasedNeutrophil count decreasedTroponin I increasedBlood lactate dehydrogenase increasedBlood magnesium decreasedWhite blood cell count decreasedBlood urea increasedAlanine aminotransferase decreasedBlood bilirubin increasedBlood creatine phosphokinase decreasedBlood potassium decreasedHepatic enzyme increasedAspartate aminotransferase abnormalTransaminases increased
Cytotoxic12.73.60.09.15.55.55.50.00.03.60.00.00.00.00.03.60.00.00.00.00.01.81.8
Cytotoxic to Volasertib Switch8.30.08.34.24.20.04.24.24.24.24.24.20.00.00.00.00.00.00.00.00.00.00.0
Volasertib (BI 6727)3.79.39.31.93.71.93.70.00.03.71.90.03.73.73.71.91.91.91.91.91.90.00.0

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Incidence and Intensity of Adverse Events According to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

Incidence and intensity of adverse events according to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (NCT01121406)
Timeframe: From first treatment administration to 21 days after the last drug administration (Up to 1403 days)

,,
Interventionparticipants (Number)
Grade 1Grade 2Grade 3Grade 4Grade 5
Cytotoxic3192553
Cytotoxic to Volasertib Switch13963
Volasertib (BI 6727)4616253

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Time to Deterioration in Fatigue/Quality of Life (QOL)

"Time to deterioration in fatigue/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death." (NCT01121406)
Timeframe: Every 6 weeks (Up to 213 weeks )

Interventionweeks (Median)
Volasertib (BI 6727)NA
Cytotoxic67.1

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AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for BI 6727 BS

AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for BI 6727 BS (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

Interventionng*h/mL (Geometric Mean)
Volasertib2140

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AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for CD 10899 BS

AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for CD 10899 BS (metabolite of Volasertib BI 6727) (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

Interventionng*h/mL (Geometric Mean)
Volasertib204

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AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for BI 6727 BS

AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for BI 6727 BS (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

Interventionng*h/mL (Geometric Mean)
Volasertib6240

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AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for CD 10899 BS

AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for CD 10899 BS (metabolite of Volasertib BI 6727) (NCT01121406)
Timeframe: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration

Interventionng*h/mL (Geometric Mean)
Volasertib1400

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Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression

(NCT01124786)
Timeframe: Monthly follow up after treatment discontinuation until death, up to 1.5 years.

Interventionmonths (Median)
CO-1.015.7
Gemcitabine6.1

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Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. Number of participants with TEAEs were reported based on safety assessments of laboratory tests, physical examination, examining bowel movements, regular measurement of vital signs, eastern cooperative oncology group-performance status and electrocardiogram parameter values. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported. (NCT01126749)
Timeframe: From the first dose of study drug up to approximately 6 years 3 months

,
InterventionParticipants (Count of Participants)
TEAEsSAEs
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^24122
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^23814

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Phase 2: Percentage of Participants With Overall Response

Overall response rate was defined as the percentage of participants with the best confirmed response of complete response (CR) or partial response (PR) based on RECIST v1.1. CR was defined as complete disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline summed longest diameters. (NCT01126749)
Timeframe: From the date of randomization until CR or PR (Up to approximately 6 years 3 months)

Interventionpercentage of participants (Number)
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^252.5
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^246.2

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Phase 2: Overall Survival (OS)

OS was defined as the time from the date of randomization until the date of death due to any cause. (NCT01126749)
Timeframe: From the date of randomization until the date of death (Up to approximately 6 years 3 months)

Interventionweeks (Median)
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^262.9
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^264.6

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Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0

DLTs were clinically significant adverse events within 21 days of treatment judged by investigator at least possibly related to treatment. This included greater than or equal to (>=) Grade 3 (G3) peripheral neuropathy, >=G3 nausea and vomiting despite optimal anti-emetic treatment, any other non-hematologic toxicity of >=G3 (except alopecia, single abnormal laboratory values the Investigator judged unlikely related to study therapy, had no clinical correlate, and resolved within 7 days, and hypersensitivity reaction to any of the compounds), Grade 4 neutropenia lasting over 7 days, febrile neutropenia (defined as fever >=38.5 degrees Celsius with absolute neutrophil count below 1.0*10^9 per liter, G3 thrombocytopenia with nontraumatic bleeding (without therapeutic systemic anticoagulation) requiring platelet transfusion, Grade 4 thrombocytopenia (with or without nontraumatic bleeding), any study drug-related death, any other toxicity the dose escalation committee believed to be DLT. (NCT01126749)
Timeframe: Cycle 1 (Cycle length=21 days)

InterventionParticipants (Count of Participants)
Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^20
Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^21

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Disease-free Survival (DFS) by Response to HCQ Treatment

Median number of months of disease-free survival in participants who did and did not experience response to HCQ treatment. Patients who had >51 % increase in their LC3-II staining were classified as having a response to HCQ. (NCT01128296)
Timeframe: Up to 30 months

Interventionmonths (Median)
Response to HQC treatmentNo response to HQC treatment
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)15.036.9

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Overall Survival (OS)

Median number of months of overall survival for participants receiving study treatment. (NCT01128296)
Timeframe: Up to 35 months

Interventionmonths (Median)
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)34.83

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R0 Resection Rate

Number of participants that underwent a resection with microscopically margin-negative resection in which no gross or microscopic tumor remains in the primary tumor bed (24) / number of that completed treatment (31) (NCT01128296)
Timeframe: Up to 30 months

Interventionpercentage of participants (Number)
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)77

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Disease-free Survival (DFS) by CA 19-9 Response

Median number of months of disease-free survival for participants who experienced Ca 19-9 (surrogate biomarker) response (either an increase or decrease in Ca 19-9), or no Ca 19-9 response. Per participant increases in Ca 19-9 ranged from >0 to 225%. Per participant decreases in Ca 19-9 ranged from >0 to 100%. (NCT01128296)
Timeframe: Up to 30 months

Interventionmonths (Median)
Ca 19-9 ResponseNo Ca 19-9 Response
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)21.46.9

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Disease-free Survival by p53 Genetic Status

(NCT01128296)
Timeframe: Up to 35 months

Interventionmonths (Median)
p53 WTp53 Mutant
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)21.411.8

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Overall Survival (OS) by CA 19-9 Response

Median number of months of overall survival for participants who experienced Ca 19-9 (surrogate biomarker) response (either an increase or decrease in Ca 19-9), or, no Ca 19-9 response. Per participant increases in Ca 19-9 ranged from >0 to 225%. Per participant decreases in Ca 19-9 ranged from >0 to 100%. (NCT01128296)
Timeframe: Up to 35 months

Interventionmonths (Median)
Ca 19-9 Response (increase or decrease)No Ca 19-9 Response
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)34.88.8

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Overall Survival (OS) by Response to HCQ Treatment

Median number of months of overall survival in participants who did and did not experience response to HCQ treatment. Patients who had >51 % increase in their LC3-II staining were classified as having a response to HCQ. (NCT01128296)
Timeframe: Up to 35 months

Interventionmonths (Median)
Response to HQC treatmentNo response to HQC treatment
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)34.8310.83

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Overall Survival (OS) by p53 Mutant Status

(NCT01128296)
Timeframe: Up to 35 months

Interventionmonths (Median)
p53 WTp53 Mutant
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)NA26.1

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Disease-free Survival (DFS)

Median number of months of disease-free survival for participants receiving study treatment. (NCT01128296)
Timeframe: Up to 30 months

Interventionmonths (Median)
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)11.97

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Number of Participants That Experienced a Dose Limiting Toxicity (DLT)

Number of Participants at each dose level of HCQ that experienced a Dose Limiting Toxicity (DLT). (NCT01128296)
Timeframe: Up to 31 days

Interventionparticipants (Number)
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)0
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)0
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)0
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)0
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)0
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)0

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Number of Participants With Dose Limiting Toxicity (DLT)

DLTs were defined as clinically significant adverse events occurring less than or equal to 21 days after commencing study treatment and considered to be possibly or probably related to study treatment by the Investigator. If 1 DLT occurred at any dose level, the cohort was to be expanded to include a maximum of six evaluable subjects. If 2 DLTs occurred at any dose level, the maximum tolerated dose (MTD) was to be either defined as the preceding dose, or an intermediate dose. To evaluate an intermediate dose, an additional dose cohort could be added to more accurately define the MTD. (NCT01133756)
Timeframe: Cycle 1 (21 days)

,,
InterventionParticipants (Number)
Platelet count decreasedThrombocytopenia
Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine10
Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine02
Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine00

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Progression-free Survival (PFS)

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT01144455)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year

Interventiondays (Median)
Gemcitabine111
240 mg/m2 TH-302 + Gemcitabine169
340 mg/m2 TH-302 + Gemcitabine183

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To Determine the Overall Survival in Pancreatic Cancer Patients Treated With Gemcitabine and SBRT for up to 5 Years of Follow up.

Time to death was measured from start of treatment to until death. If death was not observed, the patient was censored at last follow up. (NCT01146054)
Timeframe: Up to 5 years of follow up.

InterventionMonths (Median)
SBRT and Gemzar13.9

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Proportion of Participants Achieving Freedom From Local Progression (FFLP) in Patients Treated With Gemcitabine Followed by Fractionated Stereotactic Body Radiotherapy (SBRT) for up to 5 Years of Follow up.

"Freedom from local progression is defined as the time from start of SBRT treatment to local progression, with death as a competing risk. If the patient neither died nor experienced local progression, then patient was censored at last follow up.~The data was analyzed in a competing risk model and the outcome reported was the 1 year cumulative incidence rate." (NCT01146054)
Timeframe: Up to 5 years of follow up.

InterventionProportion of participants with FFLP (Number)
SBRT and Gemzar0.78

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Evaluate Acute Gastrointestinal Toxicity up to 3 Months of Treatment.

Acute grade 2 or greater gastritis, fistula, enteritis, or ulcer or any other grade 3-4 gastrointestinal toxicity within 3 months of treatment. (NCT01146054)
Timeframe: Within 3 months of treatment.

InterventionNumber of toxicities. (Number)
SBRT and Gemzar14

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To Determine the Rate of (Grade 2 or Greater) Gastrointestinal Toxicity Attributable to Gemcitabine and Fractionated SBRT at One Year.

Grade 2 or greater late gastritis, fistula, enteritis, or ulcer or late grade 3-4 gastrointestinal toxicity at one year. (NCT01146054)
Timeframe: One year.

InterventionNumber of toxicities. (Number)
SBRT and Gemzar5

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To Evaluate Progression Free Survival Following Gemcitabine and SBRT for up to 5 Years of Follow up .

"Time to progression free survival is measured from start of SBRT treatment until first progression event or death, which ever comes first. If the patient did not have an event, then the patient was censored at the last follow up.~The analysis was a Kaplan-Meier curve and the outcome was the median time to progression free survival." (NCT01146054)
Timeframe: Up to 5 years of follow up.

InterventionMonths (Median)
SBRT and Gemzar7.8

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Serum CA 19-9 Levels

Initial level of Cancer antigen 19-9 (NCT01151761)
Timeframe: 12 months

InterventionU/ml (Mean)
SBRT and Chemo3329.1

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Overall Survival at 12 Months

the estimated probability for the percentage of participants with overall survival at 12 months. (NCT01151761)
Timeframe: 12 months

Interventionprobability (Number)
SBRT and Chemo0

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Liver Transplant Conversion Rate

The ability to successfully perform liver transplant among patients who initially have tumor >3 cm (NCT01151761)
Timeframe: 12 months

Interventionparticipants (Number)
SBRT and Chemo0

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Progression-free Survival at 12 Months

Progression free survival is defined to be the time to progression of disease or death. (NCT01151761)
Timeframe: 12 months

Interventionparticipants (Number)
SBRT and Chemo0

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Liver Transplant Rate

The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm (NCT01151761)
Timeframe: 12 months

Interventionparticipants (Number)
SBRT and Chemo0

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Freedom From Local Progression at 12 Months

the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk (NCT01151761)
Timeframe: 12 months

Interventionpercentage of patients (Number)
SBRT and Chemo0

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Median Time to Overall Survival

The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology. (NCT01151761)
Timeframe: 18 months

Interventionmonths (Median)
SBRT and Chemo8.5

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Pathologic Complete Response Rate

Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen. (NCT01151761)
Timeframe: 12 months

Interventionparticipants (Number)
SBRT and Chemo0

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Progression-Free Survival (PFS)

PFS was the time from randomization to the first objective progression as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1) or death from any cause, whichever occurred first. Progressive disease (PD) was defined as ≥20% increase in sum of diameter (SOD) of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 millimeters (mm); appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants alive and without disease progression were censored at the time of the last objective tumor assessment. Participants who did not progress and were lost to follow-up were censored at their last radiographic assessment. If no baseline or post baseline radiologic assessments were available, participants were censored at date of randomization. (NCT01160744)
Timeframe: Randomization to PD or death (up to 24 months)

Interventionmonths (Median)
Pem + Carb or Cis (Non-Squamous)5.6
Ram + Pem + Carb or Cis (Non-Squamous)7.2
Gem + Carb or Cis (Squamous)5.4
Ram + Gem + Carb or Cis (Squamous)5.6

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Change in Tumor Size (CTS)

CTS was defined as the log ratio of tumor size at 6 weeks to tumor size at baseline. CTS at 6 weeks=Log (Sum of Target Lesion Measurements at 6 Weeks)-Log (Sum of Target Lesion Measurements at Baseline). (NCT01160744)
Timeframe: Baseline, 6 weeks

Interventionlog ratio (Mean)
Pem + Carb or Cis (Non-Squamous)-0.2
Ram + Pem + Carb or Cis (Non-Squamous)-0.2
Gem + Carb or Cis (Squamous)-0.3
Ram + Gem + Carb or Cis (Squamous)-0.4

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Duration of Response (DOR)

DOR was measured from the time criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death. Response was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker level of non-target lesions. PR was defined as ≥30% decrease SOD of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment. (NCT01160744)
Timeframe: Time of first response (CR or PR) until PD or death (up to 24 months)

Interventionmonths (Median)
Pem + Carb or Cis (Non-Squamous)4.5
Ram + Pem + Carb or Cis (Non-Squamous)5.5
Gem + Carb or Cis (Squamous)4.3
Ram + Gem + Carb or Cis (Squamous)4.3

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Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

Best overall response of CR or PR was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in SOD of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100. (NCT01160744)
Timeframe: Day 1, Cycle 1 (3-week cycles) and every 6 weeks thereafter to PD (up to 24 months)

Interventionpercentage of participants (Number)
Pem + Carb or Cis (Non-Squamous)38.0
Ram + Pem + Carb or Cis (Non-Squamous)49.3
Gem + Carb or Cis (Squamous)24.6
Ram + Gem + Carb or Cis (Squamous)46.5

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Percentage of Participants With CR, PR, or Stable Disease (SD) [Disease Control Rate (DCR)]

DCR: percentage of participants with CR, PR, or SD using RECIST v 1.1 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in SOD of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100. (NCT01160744)
Timeframe: Day 1, Cycle 1 (3-week cycles) and every 6 weeks thereafter to PD (up to 24 months)

Interventionpercentage of participants (Number)
Pem + Carb or Cis (Non-Squamous)70.4
Ram + Pem + Carb or Cis (Non-Squamous)85.5
Gem + Carb or Cis (Squamous)66.7
Ram + Gem + Carb or Cis (Squamous)73.2

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Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Who Died

Data presented are the number of participants with at least 1 treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (SAE), as well as, the number of participants who died during the study. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). A summary of SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. (NCT01160744)
Timeframe: Day 1, Cycle 1 (3-week cycles) Up to 3 Years

,,,
InterventionParticipants (Count of Participants)
Treatment-Emergent SAETreatment-Emergent Adverse EventDeaths
Gem + Carb or Cis (Squamous)296355
Pem + Carb or Cis (Non-Squamous)386851
Ram + Gem + Carb or Cis (Squamous)397156
Ram + Pem + Carb or Cis (Non-Squamous)446755

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Overall Survival (OS)

OS was defined as the time from the date of randomization to the date of death from any cause. If the participant was alive at the end of the follow-up period or was lost to follow-up, OS was censored on the last date the participant was known to be alive. (NCT01160744)
Timeframe: Randomization to the date of death from any cause (up to 31.3 months)

Interventionmonths (Median)
Pem + Carb or Cis (Non-Squamous)10.4
Ram + Pem + Carb or Cis (Non-Squamous)13.9
Gem + Carb or Cis (Squamous)11.3
Ram + Gem + Carb or Cis (Squamous)10.4

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Overall Survival

Overall survival is defined as the time from randomization to death or date last known alive. (NCT01164228)
Timeframe: Assessed every 3 months for 2 years and every 6 months for year 3.

Interventionmonths (Median)
Arm A (Sunitinib + Gemcitabine)9.4
Arm B (Sunitinib)7.8

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Proportion of Patients With Response

Response is defined as either complete response (CR, disappearance of all lesions) or partial response (PR, at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits). (NCT01164228)
Timeframe: Assessed every 3 months for 2 years and every 6 months for year 3.

Interventionproportion of participants (Number)
Arm A (Sunitinib + Gemcitabine)0.18
Arm B (Sunitinib)0.11

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Progression-free Survival

"Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is defined as follows:~At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions." (NCT01164228)
Timeframe: Assessed every 3 months for 2 years and every 6 months for year 3.

Interventionmonths (Median)
Arm A (Sunitinib + Gemcitabine)4.5
Arm B (Sunitinib)3.6

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Recurrence-free Survival as Measured by CT Scan

Clinical data were prospectively collected. Staging was performed using 7th American Committee on Cancer criteria. Patients were followed by radiologic evaluation (CT or MRI) and carbohydrate antigen 19-9 (CA19-9) every 3 months for the first 3 years after resection to assess for recurrence. Subsequently, patients underwent imaging every 6 months. (NCT01188109)
Timeframe: Every 3 months and then every 6 months for 2 more years after resection

Interventionmonths (Median)
Gemcitabine / Cisplatin16.7

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Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression

To determine the level of ERCC1 expression, formalin-fixed, resected tumors were stained with anti-ERCC1 monoclonal antibody (clone 8F1; Neomarkers, Fremont, CA, USA) using the Dako Autostainer (Ft. Collins, CO). The percentage and intensity of fine granular nuclear staining were graded by a single pathologist. Percentage of staining was categorized into the following groups: 0 ≤ 1%; 1 = 1-10%; 2 = 11-50%; 3 = 51-100%. Staining intensity was scored as follows: 0 = none; 1 = weak; 2 = moderate; 3 = strong. Subsequently, an overall score to dichotomize the expression level to low or high was calculated: [(1+intensity score)/3]*percentage score. An overall score ≤ 2 was considered low ERCC1 expression, and > 2 was high ERCC1 expression. (NCT01188109)
Timeframe: At the time of resection

Interventionpatients (Number)
Low Tumor ERCC1 ExpressionHigh Tumor ERCC1 Expression
Gemcitabine / Cisplatin155

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Progression Free Survival (PFS)

(NCT01194453)
Timeframe: 36months

Interventionday (Median)
Group A168
Group B140

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Response Rate

(NCT01194453)
Timeframe: 6 weeks

Interventionpercentage (Number)
Group A24.41
Group B14.17

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Percentage of Treated Patients Experiencing Grade 3+ Toxicity Per National Cancer Institute Common Toxicity Criteria (CTC) Version 3.0

(NCT01195415)
Timeframe: Up to 4 weeks

Interventionpercentage of patients (Number)
Treatment (Vismodegib, Gemcitabine Hydrochloride)56

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Median Progression Free Survival

Median progression free survival was calculated for all treated patients. Assessed using the Kaplan-Meier method. The 95% confidence interval for this estimate will be computed using the Greenwood's formula. (NCT01195415)
Timeframe: Up to 24 months

Interventionmonths (Median)
Treatment (Vismodegib, Gemcitabine Hydrochloride)2.8

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The Number of Participants With an Objective Best Response (CR + PR)

The number of participants with either a complete response (CR) or a partial response (PR) will be calculated. A CR is defined as the disappearance of all target lesions. A PR is defined as at least a 30% decrease in the sum of the diameters of target lesions. (NCT01195415)
Timeframe: Up to 4 weeks

Interventionparticipants (Number)
Treatment (Vismodegib, Gemcitabine Hydrochloride)5

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Median Percent at Baseline and 3 Weeks in CD44+/ CD24+/ ESA+ Cells From Needle Biopsy Calculated Using FACS

The median percentage of CD44+CD24+ESA+ cells from needle biopsy were calculated at baseline and at 3 weeks using FACS. The difference between the two time points was calculated. (NCT01195415)
Timeframe: 3 weeks

Interventionpercentage of CD44+/ CD24+/ ESA+ cells (Median)
Baseline Median % of CD44+/CD24+/ESA+ CSCs3 Weeks Post Tx Median % of CD44+/CD24+/ESA+ CSCs
Treatment (Vismodegib, Gemcitabine Hydrochloride)4.793.09

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Stage 1: Percentage of Participants With a Complete Response According to the IWG Response Criteria as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase

A complete response was defined as participants with a complete response (CR), or unconfirmed complete response (CRu) based on IWG 1999 Response Criteria for NHL as assessed by the investigator. A CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRu) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. (NCT01197560)
Timeframe: From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

Interventionpercentage of participants (Number)
Lenalidomide13.7
Investigators Choice (IC)3.9

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Number of Participants With Treatment Emergent Events (TEAEs) in the Overall Treatment Phase by Initial Treatment Assignment

"A TEAE was defined as an AE that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug.~A serious adverse event (SAE) is any:~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death" (NCT01197560)
Timeframe: From first dose of study drug to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

,
InterventionParticipants (Count of Participants)
Any TEAEsAny Treatment Related TEAEAny TEAE Grade ≥ 3Any TEAE Grade ≥ 4Any TEAE Grade 5Any TEAE Grade 3 or 4Any Treatment Related TEAE Grade ≥ 3Any Treatment Related TEAEs Grade ≥ 4Any Treatment Related TEAE Grade 5Any Treatment Related TEAE Grade 3 or 4Any Serious Adverse Events (SAEs)Any Treated Related SAEsAny AE leading to stopping of study drugAny drug related AE leading to halt of study drugAny AE leading to dose interruption/reductAny drug related AE leading to interruption/reduct
Investigators Choice (IC)554553361852392123942211743430
Lenalidomide54494329942301503031141153227

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Stage 1: Kaplan Meier Estimates of Overall Survival As Assessed by the Investigators at the Final Data Cut During The Core Treatment Phase

Overall survival was defined as time from randomization until death of any cause. (NCT01197560)
Timeframe: From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

InterventionWeeks (Median)
Lenalidomide31.0
Investigators Choice (IC)24.6

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Stage 1: Kaplan Meier Estimates of Duration of Overall Response (DoR) as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase

Duration of overall response was calculated as the time of initial response (CR+CRu+PR) until documented disease progression determinted by computerized scan CT scan or MRI or death due to lymphoma, whichever occurred earlier, for participants who responded. (NCT01197560)
Timeframe: From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

InterventionWeeks (Median)
Lenalidomide64.7
Investigators Choice (Control Arm)63.1

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Stage 1: Percentage of Participants With a Durable Overall Response (dORR) According to the IWG Response Criteria as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase

Durable overall response rate was defined as the percentage of participants who maintained a response for at least 16 weeks after initial response. (NCT01197560)
Timeframe: From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

Interventionpercentage of participants (Median)
Lenalidomide23.5
Investigators Choice (Control Arm)9.8

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Stage 1: Kaplan Meier Estimates of Progression-Free Survival As Assessed By The Investigators At The Final Data Cut During The Core Treatment Phase

Progression-free survival was defined as the time from randomization to the first documented disease progression or death due to any cause. (NCT01197560)
Timeframe: From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

InterventionWeeks (Median)
Lenalidomide9.6
Investigators Choice (IC)7.1

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Stage 1: Kaplan Meier Estimates of Duration of Complete Response (DoCR) as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase

Duration of complete response was defined as the time from the first documented complete response (CR + CRu) until the first disease progression or death for participants who had a CR. (NCT01197560)
Timeframe: From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

InterventionWeeks (Median)
Lenalidomide66.4
Investigators Choice (Control Arm)179.3

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Stage 1: Percentage of Participants With an Overall Response According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 and Evaluated by the Independent Response Adjudication Committee (IRAC)

An overall response is a complete response (CR), unconfirmed complete response (CRu) or partial response (PR) and was evaluated by the IRAC. A CR = complete disappearance of disease and related symptoms. Lymph nodes and nodal masses regressed on computed tomography to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on exam, normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or for single nodules, in the greatest transverse diameter;no new disease. (NCT01197560)
Timeframe: From the date of randomization to the data cut-off of 4 July 2013; when all patients reached the scheduled 16-week assessment or had progressed/died before the scheduled 16-week assessment); the median study duration was 27.0 and 19.7 weeks, respectively.

,
Interventionpercentage of participants (Number)
ORR for All ParticipantsGCB SubtypeNon-GCB
Investigators Choice (IC)11.812.011.5
Lenalidomide27.526.128.6

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Stage 1: Percentage of Participants With an Overall Response According to the IWG Response Criteria Based on the Investigators Assessment at the Final Data Cut During the Core Treatment Phase

Response was defined as having a CR, CRu or PR, based on IWG 1999 Response Criteria for NHL as evaluated by the investigators. CR = complete disappearance of disease and disease related symptoms. All lymph nodes and nodal masses regressed on computed tomography to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on physical exam, normal size by imaging, and absence of nodules related to lymphoma. If BM was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in the other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. No new disease. (NCT01197560)
Timeframe: From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.

InterventionPercentage of participants (Number)
Lenalidomide29.4
Investigators Choice (IC)13.7

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Event-free Survival (EFS) of Patients

The event-free survival (EFS) of patients with poor prognosis relapse or refractory Hodgkin's disease (HD) after high-dose chemotherapy (HDC) with Gemcitabine/Busulfan/Melphalan (GemBuMel). Event is defined as relapse, tumor progression or death.Progression free survival is the length of time during and after the treatment of disease that a patient lives with the disease but it does not get worse. Toxicity is defined as the treatment related mortality (TRM) rate, which will be evaluated within 30 days post transplant, and this rate will be compared with the 5% maximum rate. For EFS analysis, patients who experience the tumor relapse, disease progression, or death will be considered to be an event. (NCT01200329)
Timeframe: Enrollment up to 2 years post transplant

InterventionParticipants (Count of Participants)
Overall Study Group51

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Overall Survival (OS) of These Patients.

The overall survival is the length of time from the start of treatment (Auto SCT) for the cancer, that patients are diagnosed with are still alive until date of first documented progression or date of death from any cause. It is measured in months and assessed up to 84 months. (NCT01200329)
Timeframe: Beyond 100 days post transplant up to 84 months.

InterventionMonths (Median)
Overall Study Group52

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Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)

The EORTC QLQ-C30 (version 3.0) questionnaire incorporates 9 multi scale items: 5 functional scales (physical, role, cognitive, emotional and social); 3 symptom scales (fatigue, pain and nausea & vomiting); and a global health and quality-of-life scale. It contains 30 questions. The score for each item and the overall score ranges from 0 to 100. A high overall scale and subscale scores represent improved health status. However, in case of symptoms, higher scores suggest increased perception of these symptoms. (NCT01201265)
Timeframe: Baseline, cycle 6

Interventionunits on a scale (Mean)
Baseline; physical (n=40)Change at Cycle 6; physical (n=28)Baseline; role (n=40)Change at Cycle 6; role (n=28)Baseline; cognitive (n=40)Change at Cycle 6; cognitive (n=28)Baseline; emotional (n=40)Change at Cycle 6; emotional (n=28)Baseline; social (n=40)Change at Cycle 6; social (n=28)Baseline; fatigue (n=40)Change at Cycle 6; fatigue (n=28)Baseline; pain (n=40)Change at Cycle 6; pain (n=28)Baseline; nausea and vomiting (n=40)Change at Cycle 6; nausea and vomiting (n=28)Baseline; global health & QOL (n=40)Change at Cycle 6; global health & QOL (n=28)
All Participants69.33-8.8271.26-5.3674.58-4.1761.87-15.7865.42-8.3342.218.3534.5813.0916.672.3858.55-3.86

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Change From Baseline in Systolic Blood Pressure (SBP)

Change from baseline in SBP was analyzed by overall response (CR+PR, SD+PD). (NCT01201265)
Timeframe: Baseline, Cycle 6, 12 of treatment

Interventionmillimetre of mercury (mmHg) (Mean)
Baseline; CR+PR (n= 19)Change at cycle 6; CR+PR (n=14)Change at cycle 12; CR+PR at cycle 12 (n=5)Baseline; SD+PD (n= 18)Change at cycle 6; SD+PD at cycle 6 (n=13)Change at cycle 12; SD+PD at cycle 12 (n=4)
All Participants124.8-4.6-4.0123.60.2-6.3

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Change From Baseline in Diastolic Blood Pressure (DBP)

Change from baseline in DBP was analyzed by overall response (CR+PR, SD+PD). (NCT01201265)
Timeframe: Baseline, Cycle 6, 12 of treatment

InterventionmmHg (Mean)
Baseline; CR+PR (n= 19)Change at cycle 6; CR+PR (n=14)Change at cycle 12; CR+PR (n=5)Baseline; SD+PD (n= 18)Change at cycle 6; SD+PD (n=13)Change at cycle 12; SD+PD (n=4)
All Participants80.4-4.1-2.078.92.37.5

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Time to Progression (TTP)

Duration of time to progression (TTP) was estimated using the Kaplan-Meier method. The time to progression was calculated in days from the date of registration until the earliest date of documented disease progression. (NCT01201265)
Timeframe: From the date of registration until the disease progression (up to 1541 days).

Interventiondays (Median)
All Participants269.0

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Progression-free Survival (PFS)

Progression free survival (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography (CT)/ magnetic resonance imaging (MRI)/bone scans and X-ray and Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. (NCT01201265)
Timeframe: From the date of registration until the disease progression or death (up to 1541 days).

Interventiondays (Median)
All Participants255

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Percentage of Participants Achieving an Overall Response

The overall response rate (ORR) was defined as complete response (CR) + partial response (PR). ORR was summarized using number and percentage along with two-sided 95% Pearson-Clopper CI. The overall response rate was assessed utilizing the RECIST v. 1.1. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. (NCT01201265)
Timeframe: From the date of registration until the disease progression or death (up to 1541 days)

Interventionpercentage of participants (Number)
All Participants50.0

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Percentage of Participants Achieving a Clinical Benefit Response (CBR)

Clinical benefit response was defined as a complete response (CR), partial response (PR) or stable disease (SD). CBR was assessed using Recist v.1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (NCT01201265)
Timeframe: From the date of registration until the disease progression or death (up to 1541 days)

Interventionpercentage of participants (Number)
All Participants92.5

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Overall Survival (OS)

Overall survival was measured from the date of the first study drug dose to the date of death from any cause. The median overall survival time with 95%CI was estimated using Kaplan-Meier method. (NCT01201265)
Timeframe: From the date of registration until the disease progression or death (up to 1541 days)

Interventiondays (Median)
All Participants475.0

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Number of Participants With an Adverse Event (AE)

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01201265)
Timeframe: Up to 28 days after termination of study treatment (approximately 1569 days)

Interventionparticipants (Number)
All Participants24

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Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Per protocol other events were considered SAEs like symptomatic left ventricular ejection fraction (LVEF) decreases or cases of central serous retinopathy (CSR) or retinal vein occlusion (RVO). AE and SAE data were collected from the start of the first dose of study treatment and continued until 28 days following discontinuation of the study treatment or death. Refer to the general AE/SAE module for a complete list of AEs and SAEs. (NCT01231581)
Timeframe: From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 15-March-2013 (up to 21 months)

,
Interventionparticipants (Number)
Any AESAE
Placebo + Gemcitabine8037
Trametinib + Gemcitabine8042

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Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR)

CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). CR and PR were evaluated by the Investigator using standard criteria (RECIST version 1.1). Confirmation of response was not required. (NCT01231581)
Timeframe: From randomization until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months)

,
Interventionparticipants (Number)
CRPR
Placebo + Gemcitabine014
Trametinib + Gemcitabine116

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Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements

A grading (severity) scale is provided for each laboratory toxicity. Grade refers to the severity of the toxicity. The CTCAE version 3.0 displays Grades 1 through 5, with unique clinical descriptions of the severity for each toxicity based on the general guideline: Grade 1, mild toxicity; Grade 2, moderate toxicity; Grade 3, severe toxicity; Grade 4, life-threatening or disabling toxicity; Grade 5, death related to toxicity. (NCT01231581)
Timeframe: From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months)

,
Interventionparticipants (Number)
Hemoglobin (Increased), Grade 3, n=80, 79Hemoglobin (Increased), Grade 4, n=80, 79Hemoglobin (Anemia), Grade 3, n=80, 79Hemoglobin (Anemia), Grade 4, n=80, 79Lymphocytes (Increased), Grade 3, n=80, 79Lymphocytes (Increased), Grade 4, n=80, 79Lymphocytes (Decreased), Grade 3, n=80, 79Lymphocytes (Decreased), Grade 4, n=80, 79Absolute Neutrophil Count, Grade 3, n=80, 79Absolute Neutrophil Count, Grade 4, n=80, 79Platelet count, Grade 3, n=80, 79Platelet count, Grade 4, n=80, 79White Blood Cell count, Grade 3, n=80, 79White Blood Cell count, Grade 4, n=80, 79
Placebo + Gemcitabine00130001262010104144
Trametinib + Gemcitabine302401093237111151

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Overall Survival

Overall survival is defined as the time from randomization until death due to any cause. For the analysis of overall survival, the last date of known contact was used for those participants who were not dead at the time of analysis; such participants were considered censored. (NCT01231581)
Timeframe: From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months)

Interventionmonths (Median)
Trametinib + Gemcitabine8.4
Placebo + Gemcitabine6.7

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Progression-free Survival (PFS) as Assessed by the Investigator

PFS is defined as the time from randomization until the earliest date of radiological PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). PD was also based on unequivocal progression of existing non-target lesions. If the participant received subsequent anti-cancer therapy prior to the date of documented progression or death, or did not have a documented date of progression or death, PFS was censored at the last adequate assessment. (NCT01231581)
Timeframe: From randomization until disease progression (PD) or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months)

Interventionweeks (Median)
Trametinib + Gemcitabine16.1
Placebo + Gemcitabine15.1

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Investigator-Assessed Duration of Response

Duration of response is defined, for the subset of participants with a CR or PR, as the time from the first documented evidence of CR or PR until the first documented disease progression or death due to any cause. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). (NCT01231581)
Timeframe: From the first documented CR or PR until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 13 months)

InterventionWeeks (Median)
Trametinib + Gemcitabine23.9
Placebo + Gemcitabine16.1

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Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters

A grading (severity) scale is provided for each laboratory toxicity. Grade refers to the severity of the toxicity. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 displays Grades 1 through 5 based on the general guideline: Grade 1, mild toxicity; Grade 2, moderate toxicity; Grade 3, severe toxicity; Grade 4, life-threatening or disabling toxicity; Grade 5, death related to toxicity. (NCT01231581)
Timeframe: From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months)

,
Interventionparticipants (Number)
Albumin, Grade 3, n=73, 73Albumin, Grade 4, n=73, 73Alkaline Phosphatase, Grade 3, n=74, 73Alkaline Phosphatase, Grade 4, n=74, 73Alanine Amino Transferase, Grade 3, n=74, 73Alanine Amino Transferase, Grade 4, n=74, 73Aspartate Aminotransferase, Grade 3, n=73, 72Aspartate Aminotransferase, Grade 4, n=73, 72Total Bilirubin, Grade 3, n=74, 73Total Bilirubin, Grade 4, n=74, 73Calcium (hypercalcemia), Grade 3, n=73, 73Calcium (hypercalcemia), Grade 4, n=73, 73Calcium (hypocalcemia), Grade 3, n=73, 73Calcium (hypocalcemia), Grade 4, n=73, 73Creatinine, Grade 3, n=74, 75Creatinine, Grade 4, n=74, 75Glucose (hyperglycemia), Grade 3, n=74, 72Glucose (hyperglycemia), Grade 4, n=74, 72Glucose (hypoglycemia), Grade 3, n=74, 72Glucose (hypoglycemia), Grade 4, n=74, 72Potassium (hyperkalemia), Grade 3, n=74, 72Potassium (hyperkalemia), Grade 4, n=74, 72Potassium (hypokalemia), Grade 3, n=74, 72Potassium (hypokalemia), Grade 4, n=74, 72Sodium (hyponatremia), Grade 3, n=74, 74Sodium (hyponatremia), Grade 4, n=74, 74
Placebo + Gemcitabine404070707110200010100101030
Trametinib + Gemcitabine70707060101010019001204052

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Duration of Response

The duration of overall response is measured from the first date of response until the first date that the progressive disease (PD) or death is objectively documented. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression. (NCT01232556)
Timeframe: Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.

InterventionMonths (Median)
Inotuzumab Ozogamicin+Rituximab11.56
Rituximab+Gemcitabine or Rituximab+Bendamustine6.93

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Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) Questionnaire

EQ-5D consists of a descriptive system and an EQ visual analogue scale. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The scale, the best state is marked 100 and the worst state is marked 0, is to help the participant to say how good or bad a health state is. EQ-5D index, which was reported, was derived based on US weight. The range of EQ-5D index is -0.109 to 1.00. Higher scores mean better outcomes. The average post-baseline scores for EQ-5D index were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12. (NCT01232556)
Timeframe: Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported

InterventionUnit on a scale (Mean)
Inotuzumab Ozogamicin+Rituximab0.79
Rituximab+Gemcitabine or Rituximab+Bendamustine0.77

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Overall Survival

Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. The Kaplan-Meier method was used to determine OS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression. (NCT01232556)
Timeframe: From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.

InterventionMonths (Median)
Inotuzumab Ozogamicin+Rituximab9.5
Rituximab+Gemcitabine or Rituximab+Bendamustine9.5

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Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL

"CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment).~Partial Response (PR) requires the following:~≥50 % decrease in SPD of the six largest dominant nodes or nodal masses.~No increase in the size of other nodes, liver, or spleen.~Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter.~With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.~No new sites of disease. The 95% CI was determined using the exact method based on binomial distribution." (NCT01232556)
Timeframe: Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.

InterventionPercentage of Participants (Number)
Inotuzumab Ozogamicin+Rituximab29.5
Rituximab+Gemcitabine or Rituximab+Bendamustine29.7

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Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL

"CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment).~Partial Response (PR) requires the following:~≥50 % decrease in SPD of the six largest dominant nodes or nodal masses.~No increase in the size of other nodes, liver, or spleen.~Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter.~With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.~No new sites of disease. unCR and unPR means didn't have confirmatory assessment (including bone marrow assessment for CR).~The 95% CI was determined using the exact method based on binomial distribution." (NCT01232556)
Timeframe: Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.

InterventionPercentage of Participants (Number)
Inotuzumab Ozogamicin+Rituximab41.0
Rituximab+Gemcitabine or Rituximab+Bendamustine43.6

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Progression-Free Survival (PFS)

"PFS is defined as time from date of randomization to date of progressive disease (PD, including investigator's claim of clinical progression), date of death from any cause, or initiation of a new treatment for the lymphoma due to persistent/refractory disease. The Kaplan-Meier method was used to determine PFS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.~PD requires the following:~Appearance of any new lesion more than 1.5 cm in any axis during or at the end of treatment, even if other lesions are decreasing in size.~At least a 50% increase from nadir in the sum of the product diameters of any previously involved nodes, or in a single involved node, or the size of other lesions.~At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis." (NCT01232556)
Timeframe: From randomization up to 2 years or final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.

InterventionMonths (Median)
Inotuzumab Ozogamicin+Rituximab3.7
Rituximab+Gemcitabine or Rituximab+Bendamustine3.5

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Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)

Includes all TEAEs: Any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration.. (NCT01232556)
Timeframe: Up to 20 weeks after the first dose of study drug

,
InterventionPercentage of Participants (Number)
% participants with a TEAE% participants with serious TEAE% participants with Grade 3 or 4 TEAE% participants with Grade 5 TEAE% participants for study drug discontinuation% participants with dose reductions due to TEAEs% participants for study drug stopped temporarily
Inotuzumab Ozogamicin+Rituximab98.837.279.914.625.027.431.1
Rituximab+Gemcitabine or Rituximab+Bendamustine100.037.779.613.818.029.346.1

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Overall Survival

Number of participants from ASCT to death or last contact (NCT01237951)
Timeframe: From date of transplant until the date of death from any cause, assessed up to 2 years

InterventionParticipants (Count of Participants)
Gemcitabine/Busulfan/Melphalan49

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Participants Who Had Measurable Disease at Time of Transplant and Achieved a Stringent Complete Remission

Stringent complete remission was defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, 5% or fewer plasma cells in bone marrow, normal free light chain ratio, and the absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. (NCT01237951)
Timeframe: 100 days post-transplant

InterventionParticipants (Count of Participants)
Gemcitabine/Busulfan/Melphalan16

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Progression-free Survival (PFS)

Number of participants remain free of progression or death after ASCT (NCT01237951)
Timeframe: From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.

InterventionParticipants (Count of Participants)
Gemcitabine/Busulfan/Melphalan31

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Objective Response According to RECIST v1.1

Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed. (NCT01251653)
Timeframe: From first drug administration until 28 days after last drug administration, up to 717 days.

,,,,,,,,
InterventionParticipants (Number)
NoYesMissing
Afatinib 30mg and Docetaxel 60mg1710
Afatinib 30mg and Docetaxel 75mg1251
Afatinib 30mg and Gemcitabine 1000mg300
Afatinib 30mg and Gemcitabine 1250mg611
Afatinib 40mg and Docetaxel 75mg741
Afatinib 40mg and Gemcitabine 1000mg1541
Afatinib 40mg and Gemcitabine 1250mg600
Afatinib 50mg and Docetaxel 75mg600
Afatinib 50mg and Gemcitabine 1250mg200

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The Incidence and Intensity of AEs With Grading According to CTCAE.

The incidence and intensity of adverse events with grading according to CTCAE. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE). (NCT01251653)
Timeframe: From first drug administration until 28 days after last drug administration, up to 717 days.

,,,,,,,,
InterventionParticipants (Number)
Grade 1Grade 2Grade 3Grade 4Grade 5
Afatinib 30mg and Docetaxel 60mg13662
Afatinib 30mg and Docetaxel 75mg014112
Afatinib 30mg and Gemcitabine 1000mg02001
Afatinib 30mg and Gemcitabine 1250mg01610
Afatinib 40mg and Docetaxel 75mg00462
Afatinib 40mg and Gemcitabine 1000mg05654
Afatinib 40mg and Gemcitabine 1250mg02211
Afatinib 50mg and Docetaxel 75mg01212
Afatinib 50mg and Gemcitabine 1250mg00110

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Time to Objective Response According to RECIST v1.1

Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Time to objective response is the time from the start of treatment to the date of first documented complete response or partial response. Descriptive analyses has been performed for the time to objective response (N(%) of patients with first occurrence of objective response at 6, 12 and 24 weeks). Onset of objective response is derived for patient with measurable disease. (NCT01251653)
Timeframe: 6 weeks, 12 weeks and 24 weeks

,,,,,,,,
InterventionParticipants (Number)
6 Weeks12 Weeks24 WeeksNot applicable
Afatinib 30mg and Docetaxel 60mg10017
Afatinib 30mg and Docetaxel 75mg41013
Afatinib 30mg and Gemcitabine 1000mg0003
Afatinib 30mg and Gemcitabine 1250mg0107
Afatinib 40mg and Docetaxel 75mg1218
Afatinib 40mg and Gemcitabine 1000mg13016
Afatinib 40mg and Gemcitabine 1250mg0006
Afatinib 50mg and Docetaxel 75mg0006
Afatinib 50mg and Gemcitabine 1250mg0002

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Cmax of Docetaxel

Maximum concentration of docetaxel in plasma. (NCT01251653)
Timeframe: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55

Interventionng/mL (Geometric Mean)
Docetaxel 60mg With Afatinib 30mg1690.0
Docetaxel 60mg Without Afatinib1860.0
Docetaxel 75mg With Afatinib 30mg1790.0
Docetaxel 75mg Without Afatinib2080.0

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AUC 0-tz of Gemcitabine

Area under the concentration-time curve of Gemcitabine in plasma over the time interval from 0 up to the last quantifiable data point (NCT01251653)
Timeframe: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3

Interventionng*h/mL (Geometric Mean)
Gemcitabine 1000mg With Afatinib 40 mg9610.0
Gemcitabine 1000mg Without Afatinib7120.0

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AUC 0-24 of Docetaxel

Area under the concentration-time curve of docetaxel in plasma over the time interval from 0 up to 24 hours (NCT01251653)
Timeframe: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55

Interventionng*h/mL (Geometric Mean)
Docetaxel 60mg With Afatinib 30mg2000.0
Docetaxel 60mg Without Afatinib2210.0
Docetaxel 75mg With Afatinib 30mg2400.0
Docetaxel 75mg Without Afatinib2270.0

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Area Under the Concentration-time Curve (AUC) Tau,ss of Afatinib

Area under the concentration-time curve of Afatinib in plasma over a uniform dosing interval t at steady state. (NCT01251653)
Timeframe: PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55

Interventionng*h/mL (Geometric Mean)
Afatinib 40mg With Gemcitabine 1000 mg1000.0
Afatinib 40mg Without Gemcitabine1230.0
Afatinib 30mg With Docetaxel 60mg642.0
Afatinib 30mg Without Docetaxel 60mg746.0
Afatinib 30mg With Docetaxel 75mg557.0
Afatinib 30mg Without Docetaxel 75mg723.0

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Cmax of Gemcitabine

Maximum concentration of Gemcitabine in plasma. (NCT01251653)
Timeframe: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3

Interventionng/mL (Geometric Mean)
Gemcitabine 1000mg With Afatinib 40 mg16000.0
Gemcitabine 1000mg Without Afatinib13500.0

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Total Clearance (CL) of Gemcitabine

Total Clearance (CL) of Gemcitabine from plasma. (NCT01251653)
Timeframe: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3

InterventionmL/min (Geometric Mean)
Gemcitabine 1000mg With Afatinib 40 mg3020.0
Gemcitabine 1000mg Without Afatinib4090.0

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Total Clearance (CL) of Docetaxel

Total Clearance (CL) of Docetaxel from plasma. (NCT01251653)
Timeframe: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55

InterventionmL/min (Geometric Mean)
Docetaxel 60mg With Afatinib 30mg811.0
Docetaxel 60mg Without Afatinib671.0
Docetaxel 75mg With Afatinib 30mg886.0
Docetaxel 75mg Without Afatinib892.0

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Progression Free Survival (PFS)

Progression-free survival was defined as the time from the first administration of study medication to the time of disease progression or death, whichever occurred first. (NCT01251653)
Timeframe: From the first administration of study medication to the time of disease progression or death

InterventionWeeks (Median)
Afatinib 40mg and Gemcitabine 1000mg23.9
Afatinib 30mg and Docetaxel 60mg18.1
Afatinib 30mg and Docetaxel 75mg23.6

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Overall Survival (OS)

Overall survival was defined as the time from the first administration of study medication to the time of death from any cause. (NCT01251653)
Timeframe: From the first administration of study medication to the time of death

InterventionWeeks (Median)
Afatinib 40mg and Gemcitabine 1000mg52.4
Afatinib 30mg and Docetaxel 60mg38.4
Afatinib 30mg and Docetaxel 75mgNA

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Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).

DLT was based on following criterions: 1. Grade 4 uncomplicated (not associated with fever >38.5° C (Celsius)) neutropenia for ≥7 days. 2. Grade 3 or 4 neutropenia concomitant with fever >38.5º C or Grade ≥3 infection. 3. Platelet count of <25x 10^9/L or <50x 10^9/L with bleeding requiring whole blood transfusion. 4. Grade ≥3 non-haematological toxicity (except untreated nausea, untreated vomiting, or untreated diarrhoea). 5. Grade ≥2 decrease in cardiac left ventricular function. 6. Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria, or a newly developed decrease in glomerular filtration rate. Toxicity grading was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 (NCT01251653)
Timeframe: 3 weeks

InterventionParticipants (Number)
Afatinib 30mg and Gemcitabine 1000mg0
Afatinib 30mg and Gemcitabine 1250mg1
Afatinib 40mg and Gemcitabine 1000mg1
Afatinib 40mg and Gemcitabine 1250mg2
Afatinib 50mg and Gemcitabine 1250mg2
Afatinib 30mg and Docetaxel 60mg4
Afatinib 30mg and Docetaxel 75mg6
Afatinib 40mg and Docetaxel 75mg5
Afatinib 50mg and Docetaxel 75mg1

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Duration of Objective Response According to RECIST v1.1

Duration of objective response was the time from the first documented complete response or partial response to disease progression or death. (NCT01251653)
Timeframe: From the first documented complete response or partial response to the time of disease progression or death

InterventionDays (Mean)
Afatinib 30mg and Gemcitabine 1250mg291.0
Afatinib 40mg and Gemcitabine 1000mg138.3
Afatinib 30mg and Docetaxel 60mg410.0
Afatinib 30mg and Docetaxel 75mg296.0
Afatinib 40mg and Docetaxel 75mg55.5

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Duration of Disease Control According to RECIST v1.1

Duration of disease control according to RECIST v1.1. (NCT01251653)
Timeframe: From the first administration of study medication to the time of disease progression or death

InterventionDays (Mean)
Afatinib 30mg and Gemcitabine 1000mg119.5
Afatinib 30mg and Gemcitabine 1250mg210.0
Afatinib 40mg and Gemcitabine 1000mg119.7
Afatinib 40mg and Gemcitabine 1250mg77.4
Afatinib 30mg and Docetaxel 60mg207.1
Afatinib 30mg and Docetaxel 75mg233.6
Afatinib 40mg and Docetaxel 75mg158.7
Afatinib 50mg and Docetaxel 75mg85.0

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Cmax,ss of Afatinib

Maximum concentration of Afatinib in plasma at steady state. (NCT01251653)
Timeframe: PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55

Interventionng/mL (Geometric Mean)
Afatinib 40mg With Gemcitabine 1000 mg58.1
Afatinib 40mg Without Gemcitabine66.4
Afatinib 30mg With Docetaxel 60mg33.9
Afatinib 30mg Without Docetaxel 60mg45.6
Afatinib 30mg With Docetaxel 75mg33.9
Afatinib 30mg Without Docetaxel 75mg45.7

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Volume of Distribution at Steady State (Vss) of Docetaxel

Apparent volume of distribution at steady state (Vss) of Docetaxel. (NCT01251653)
Timeframe: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55

InterventionL (Geometric Mean)
Docetaxel 60mg With Afatinib 30mg255.0
Docetaxel 60mg Without Afatinib315.0
Docetaxel 75mg With Afatinib 30mg323.0
Docetaxel 75mg Without Afatinib300.0

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Volume of Distribution at Steady State (Vss) of Gemcitabine

Apparent volume of distribution at steady state (Vss) of Gemcitabine. (NCT01251653)
Timeframe: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3

InterventionL (Geometric Mean)
Gemcitabine 1000mg With Afatinib 40 mg90.5
Gemcitabine 1000mg Without Afatinib106.0

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Best Overall Response According to RECIST v1.1 Criteria

Best overall response (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) was the best response recorded at any time from the date of the first administration of afatinib or gemcitabine/docetaxel to the end of treatment (EOT). Partial response is for patients with measurable disease. Missing categories signifies that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed. (NCT01251653)
Timeframe: From first drug administration until 28 days after last drug administration, up to 717 days.

,,,,,,,,
InterventionParticipants (Number)
Complete response (CR)Partial responseStable disease/ Non-CR/Non-PDProgressive disease (PD)Not evaluableMissing
Afatinib 30mg and Docetaxel 60mg019800
Afatinib 30mg and Docetaxel 75mg058401
Afatinib 30mg and Gemcitabine 1000mg002100
Afatinib 30mg and Gemcitabine 1250mg013301
Afatinib 40mg and Docetaxel 75mg045201
Afatinib 40mg and Gemcitabine 1000mg049601
Afatinib 40mg and Gemcitabine 1250mg005100
Afatinib 50mg and Docetaxel 75mg002400
Afatinib 50mg and Gemcitabine 1250mg000200

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Disease Control According to RECIST v1.1

Disease control according to RECIST v1.1 Disease control is complete response, partial response or stable disease for measurable patients and complete response or non-CR/non-PD for non-measurable patients. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed. (NCT01251653)
Timeframe: From first drug administration until 28 days after last drug administration, up to 717 days.

,,,,,,,,
InterventionParticipants (Number)
NoYesMissing
Afatinib 30mg and Docetaxel 60mg8100
Afatinib 30mg and Docetaxel 75mg4131
Afatinib 30mg and Gemcitabine 1000mg120
Afatinib 30mg and Gemcitabine 1250mg341
Afatinib 40mg and Docetaxel 75mg291
Afatinib 40mg and Gemcitabine 1000mg6131
Afatinib 40mg and Gemcitabine 1250mg150
Afatinib 50mg and Docetaxel 75mg420
Afatinib 50mg and Gemcitabine 1250mg200

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Phase I - Dose-limiting Toxicity (DLT)

Everolimus (mg) given in conjunction with intravesical gemcitabine (NCT01259063)
Timeframe: 8 weeks

InterventionDLT (Number)
Pts Who Failed or Relapsed After Intravesical BCG0

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Complete Response (CR) Rate

Complete Response (CR) is defined as no evidence of disease (by cytology and cystoscopy). Partial Response is defined as negative cystoscopy and positive cytology. Progression is defined as the development of invasion or metastasis. If the participant develops a recurrence, they will be considered having failed treatment. Participants will also be considered having failed treatment if there is no response to treatment after two cycles. (NCT01259063)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseDid not achieve CR or PR
Pts Who Failed or Relapsed After Intravesical BCG1788

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Survival of Patients Treated

With Everolimus in combination with intravesical gemcitabine. Overall survival following start of therapy will be estimated using Kaplan-Meier methods. (NCT01259063)
Timeframe: 1 year

Intervention% of pts with CR who relapsed in a year (Number)
Pts Who Failed or Relapsed After Intravesical BCG21

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Phase II - Patients Who Are Free of Disease at 1 Year

following start of therapy. (NCT01259063)
Timeframe: 1 year

Interventionpercentage of pts disease free at 1 year (Number)
Pts Who Failed or Relapsed After Intravesical BCG21

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Phase I - Maximum Tolerated Dose (MTD)

of Everolimus given in conjunction with intravesical gemcitabine (NCT01259063)
Timeframe: 8 weeks

Interventionmg daily of everolimus (Number)
Pts Who Failed or Relapsed After Intravesical BCG10

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Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)

Best overall tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. (NCT01284335)
Timeframe: Baseline to Study Completion (Up to 2 years)

Interventionpercentage of participants (Number)
Other
Arm C Tasisulam + Temozolomide Dose Confirmation0.0

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Number of Participants With a Clinically Significant Effects

Clinically significant effects are reported if a Grade 3 or higher treatment emergent adverse event (TEAE) and observed in ≥10% of participants or a toxicity possibly related to study drug based on Common Terminology Criteria for Adverse Events (CTCAE). A summary of other nonserious AEs and all SAEs, regardless of causality is located in the Reported Adverse Event section. (NCT01284335)
Timeframe: Baseline to Study Completion (Up to 2 years)

,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
TEAE >/= Grade 3Toxicity >/= Grade 3
Arm A Tasisulam + Gemcitabine Dose Confirmation1818
Arm A Tasisulam + Gemcitabine Dose Escalation1513
Arm B* Tasisulam + Docetaxel Dose Escalation04
Arm B1 Tasisulam + Docetaxel Dose Escalation05
Arm B2 Tasisulam + Docetaxel Dose Confirmation1926
Arm B2 Tasisulam + Docetaxel Dose Escalation1618
Arm C Tasisulam + Temozolomide Dose Confirmation66
Arm C Tasisulam + Temozolomide Dose Escalation1113
Arm D Tasisulam + Cisplatin Dose Confirmation3030
Arm D Tasisulam + Cisplatin Dose Escalation87
Arm D* Tasisulam + Cisplatin Dose Escalation01
Arm E Tasisulam + Erlotinib Dose Confirmation77
Arm E Tasisulam + Erlotinib Dose Escalation55

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Pharmacokinetic (PK): Concentration Maximum (Cmax)

Cycle 2: predose,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion. (NCT01284335)
Timeframe: Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.

Interventionmicrograms per milliliter (µg/mL) (Geometric Mean)
Cycle 1Cycle 2
Tasisulam306250

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Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)

Best overall tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. (NCT01284335)
Timeframe: Baseline to Study Completion (Up to 2 years)

Interventionpercentage of participants (Number)
Non-Small Cell Lung Cancer (NSCLC)OtherPancreasSmall Cell Lung Cancer (SCLC)
Arm D Tasisulam + Cisplatin Dose Confirmation5.010.007.1

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Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)

Best overall tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. (NCT01284335)
Timeframe: Baseline to Study Completion (Up to 2 years)

,
Interventionpercentage of participants (Number)
Non-Small Cell Lung Cancer (NSCLC)OtherPancreas
Arm A Tasisulam + Gemcitabine Dose Confirmation0.014.313.3
Arm E Tasisulam + Erlotinib Dose Confirmation0.014.30.0

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Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)

Best overall tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. (NCT01284335)
Timeframe: Baseline to Study Completion (Up to 2 years)

Interventionpercentage of participants (Number)
Non-Small Cell Lung Cancer (NSCLC)Other
Arm B* Tasisulam + Docetaxel Dose Confirmation20.06.3

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PK: Area Under the Curve Albumin (AUCalb)

Cycle 2: predose,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion. (NCT01284335)
Timeframe: Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.

Interventionmicrograms*hour/milliliter (µg*h/mL) (Geometric Mean)
Cycle 1Cycle 2
Tasisulam946648

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Number of Participants With Dose-Limiting Toxicities Cycle 1

A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade 4 neutropenia lasting more than 5 days. Grade 4 neutropenia with fever or Grade 4 thrombocytopenia, regardless of duration; Grade ≥3 thrombocytopenia with bleeding, regardless of duration; Grade ≥3 nonhematologic toxicity (excluding nausea/vomiting or diarrhea that can be controlled with medication, and alopecia). Grade 3 electrolyte toxicity (for example, hypokalemia, hypophosphatemia) will not be considered a DLT unless it is considered related to the study drug or combination and does not resolve with standard replacement treatments within 42 days after Cycle 1 Day 1. A summary of other nonserious AEs and all Serious Adverse Events (SAE), regardless of causality is located in the Reported Adverse Event section. (NCT01284335)
Timeframe: Baseline to Cycle 1 (Up to Day 28)

InterventionParticipants (Count of Participants)
Arm A Tasisulam + Gemcitabine Dose Escalation4
Arm A Tasisulam + Gemcitabine Dose Confirmation0
Arm B* Tasisulam + Docetaxel Dose Escalation4
Arm B1 Tasisulam + Docetaxel Dose Escalation4
Arm B2 Tasisulam + Docetaxel Dose Escalation3
Arm B2 Tasisulam + Docetaxel Dose Confirmation0
Arm C Tasisulam + Temozolomide Dose Escalation3
Arm C Tasisulam + Temozolomide Dose Confirmation0
Arm D* Tasisulam + Cisplatin Dose Escalation0
Arm D Tasisulam + Cisplatin Dose Escalation2
Arm D Tasisulam + Cisplatin Dose Confirmation0
Arm E Tasisulam + Erlotinib Dose Escalation1
Arm E Tasisulam + Erlotinib Dose Confirmation0

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Median Overall Survival (OS)

Overall survival is defined as the time between the first day of treatment to the day of death. (NCT01294358)
Timeframe: Overall survival was assessed through study completion, an average of 3 years.

InterventionMonths (Median)
18 mg/m(2)/24h,NA
36 mg/m(2)/24h9
72 mg/m(2)/24h9
96 mg/m(2)/24h15
115 mg/m(2)/24hNA

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Number of Participants With Dose Limiting Toxicity (DLT )

Here is the number of participants with DLT. DLT is defined as follows: All grade 3 or greater toxicities with the exception of Grade 3 constitutional symptoms that persist for less than 72 hours, Grade 3 and 4 myelosuppression (neutrophils and thrombocytopenia) of less than 5 days duration. Grade 3 metabolic/laboratory events that are correctable within 24 hours. Events that are assessed by the principal investigator as clearly unrelated to the agent will not be considered DLTs (e.g., events directly related to catheter insertion, pain related to underlying disease). (NCT01294358)
Timeframe: Cycle 1 (4 weeks), for up to 6 cycles

InterventionParticipants (Count of Participants)
18 mg/m(2)/24h0
36 mg/m(2)/24h1
72 mg/m(2)/24h0
96 mg/m(2)/24h0
115 mg/m(2)/24h0

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Response Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study. (NCT01294358)
Timeframe: Every 2 cycles (8 weeks), up to 18 weeks

,,,,
InterventionParticipants (Count of Participants)
Complete response (CR)Partial response (PR)Stable diseaseProgressive disease (PD)
115 mg/m(2)/24h0001
18 mg/m(2)/24h,0040
36 mg/m(2)/24h0042
72 mg/m(2)/24h0022
96 mg/m(2)/24h0020

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Response Using Computed Tomography (CT) Perfusion Criteria European Association for the Study of the Liver (EASL1)

Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study. (NCT01294358)
Timeframe: Every 2 cycles (8 weeks), up to 18 weeks

,,,,
InterventionParticipants (Count of Participants)
Complete response (CR)Partial response (PR)Progressive disease (PD)Stable disease (SD)
115 mg/m(2)/24h0001
18 mg/m(2)/24h0004
36 mg/m(2)/24h0042
72 mg/m(2)/24h0022
96 mg/m(2)/24h0020

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Number of Participants With Serious and Non-Serious Adverse Events

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned (NCT01294358)
Timeframe: Date treatment consent signed to date off study, approximately 2 years and 2 months and 21 days

InterventionParticipants (Count of Participants)
18 mg/m(2)/24h4
36 mg/m(2)/24h5
72 mg/m(2)/24h3
96 mg/m(2)/24h2
115 mg/m(2)/24h1

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Number of Participants Who Converted From Unresectable or Borderline Resectable To Potentially Resectable Pancreatic Cancer

Resectability is defined by the MD Anderson Resectability criteria: Resectable is no extension; normal fat plane between the tumor and the artery (superior mesenteric artery (SMA)). No extension (celiac axis/hepatic artery). Patent (superior mesenteric vein/portal vein (SMV/PV)). Borderline resectable is tumor abutment ≤180◦ (one half or less) of the circumference of the artery; periarterial stranding and tumor points of contact forming a convexity against the vessel improve chances of resection (SMA). Short-segment encasement/abutment of the common hepatic artery (typically at the gastroduodenal origin) (celiac axis/hepatic artery). Short-segment occlusion with suitable vessel above and below (SMV/PV). Locally advanced is encased (>180◦) (SMA). Encased and no technical option for reconstruction usually because of extension to the celiac axis/splenic/left gastric junction or the celiac origin (celiac axis/hepatic artery). Occluded and no technical option for reconstruction (SMV/PV). (NCT01294358)
Timeframe: 4 months

InterventionParticipants (Count of Participants)
18 mg/m(2)/24h0
36 mg/m(2)/24h0
72 mg/m(2)/24h0
96 mg/m(2)/24h.1
115 mg/m(2)/24h1

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Median Time to Progression

Time to progression is the time between the first day of treatment to the day of disease progression. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. (NCT01294358)
Timeframe: From first day of treatment to the day of progression, assessed up to 221 months

InterventionMonths (Median)
Gemcitabine Dose Escalation2

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MTD (Maximum Tolerated Dose)

The MTD is the highest dose that induces dose limiting toxicity (DLT) in no more than 2 patients among a cohort of 6 patients. If 1 or fewer patients experience dose limiting toxicity than the dose level will define the MTD. Only DLT's that occurred during cycle 1 of each dose level were used to determine the MTD. (NCT01294358)
Timeframe: Cycle 1 (4 weeks), for up to 6 cycles

Interventionmg/ml/24h (Number)
Gemcitabine Dose Escalation115

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Relative Abundance of LY2603618 and the Metabolites of LY2603618 in Urine

Relative abundance was expressed as the percentage of the dose of study drug administered and calculated as %=[amount of LY2603618 or its metabolites excreted/amount of radioactive dose administered]*100. (NCT01296568)
Timeframe: Day 1 through 7 days postdose

Interventionpercentage of [^14C]LY2603618 (Mean)
LY2603618 (parent)Metabolites
[^14C]LY26036183.33.0

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Urinary and Fecal Excretion of LY2603618 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Urinary and fecal excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in urine and fecal samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in urine and feces. (NCT01296568)
Timeframe: 0 to 6 hours, 6 to 12, 12 to 24, 24 to 48, 48 to 72 and 72 to 96 hours post-dose

Interventionpercentage of total dose (Mean)
FecesUrine
[^14C]LY260361872.211.0

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The Number of Participants With a Tumor Response

Tumor responses were followed and measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete response was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions. Partial response was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir; Stable disease was defined as small changes that did not meet above criteria. (NCT01296568)
Timeframe: Baseline through study completion [Cycle 5 (28 days/cycle) and 21-day safety follow-up]

InterventionParticipants (Count of Participants)
Complete responsePartial responseProgressive diseaseStable disease
Entire Study Population0020

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Plasma Pharmacokinetics of Radioactivity: Area Under the Concentration Time Curve From Time Zero to Time t [AUC(0-tlast)]

Plasma radioactivity AUC(0-tlast) [nanogram equivalents*hours per milliliter (ng Eq*h/mL)] where tlast is the last time point with a measurable concentration following a single dose on Day 1. (NCT01296568)
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Interventionng Eq*h/mL (Geometric Mean)
[^14C]LY260361827700

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Relative Abundance of LY2603618 and the Metabolites of LY2603618 in Feces

Relative abundance was expressed as the percentage of the dose of study drug administered and calculated as %=[amount of LY2603618 or its metabolites excreted/amount of radioactive dose administered]*100. (NCT01296568)
Timeframe: Day 1 through 7 days postdose

Interventionpercentage of [^14C]LY2603618 (Mean)
LY2603618 (parent)Metabolites
[^14C]LY26036185.661.4

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Plasma Pharmacokinetics of Radioactivity: Maximum Observed Drug Concentration (Cmax)

Plasma radioactivity Cmax [nanogram equivalents per milliliter (ng Eq/mL)] following a single dose on Day 1. (NCT01296568)
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Interventionng Eq/mL (Geometric Mean)
[^14C]LY26036185660

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Plasma Pharmacokinetics of Radioactivity: Area Under the Concentration Time Curve From Time Zero to Infinity [AUC(0-infinity)]

Plasma radioactivity AUC(0-infinity) [nanogram equivalents*hours per milliliter (ng Eq*h/mL)] following a single dose on Day 1. (NCT01296568)
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Interventionng Eq*h/mL (Geometric Mean)
[^14C]LY260361832500

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Plasma Pharmacokinetics of LY2603618: Maximum Observed Drug Concentration (Cmax)

Plasma LY2603618 Cmax following a single dose on Day 1. (NCT01296568)
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Interventionnanograms per milliliter (ng/mL) (Geometric Mean)
[^14C]LY26036184750

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Plasma Pharmacokinetics of LY2603618: Area Under the Concentration Time Curve From Time Zero to Time t [AUC(0-tlast)]

Plasma LY2603618 AUC(0-tlast) where tlast is the last time point with a measurable concentration following a single dose on Day 1. (NCT01296568)
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Interventionnanograms*hours per milliliter (ng*h/mL) (Geometric Mean)
[^14C]LY260361822200

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Plasma Pharmacokinetics of LY2603618: Area Under the Concentration Time Curve From Time Zero to Infinity [AUC(0-infinity)]

Plasma LY2603618 AUC(0-infinity) following a single dose on Day 1. (NCT01296568)
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Interventionnanograms*hours per milliliter (ng*h/mL) (Geometric Mean)
[^14C]LY260361822300

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Safety and Tolerability.

"A clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles was judged by:~Local and systemic toxicities.~Number, type and degree of toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.~Adverse events were collected from time of Informed Consent to 30 days post last dose of study medication IMM-101 does not appear to confer an incremental safety burden beyond that associated with chemotherapy and the disease itself. No new safety signals were identified from this study. The numbers of SAEs by preferred term were low, such that no trends could be inferred from these data and no significant SAEs attributable to IMM 101 were observed." (NCT01303172)
Timeframe: From time of Informed Consent to 30 days post last dose of study medication

,
Interventionparticipants (Number)
With Treatment Emergent Adverse Events (TEAEs)Withdrawn due to a TEAEWith TEAEs related to IMM-101With Treatment Emergent Serious Adverse Events (TESAEs)With Treatment Emergent Serious Adverse Events (TESAEs) related to IMM-101
Control3500100
Experimental73443387

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Overall Response Rate (ORR).

A clinically relevant improvement Overall Response Rate (ORR). Overall response rate was defined as the percentage of patients with a complete response or partial response as assessed by RECIST v1.1 criteria. (NCT01303172)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (or longer in the case of patients who entered the long term treatment sub-study).

,
Interventionparticipants (Number)
Complete ResponsePartial Response
Control01
Experimental08

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Survival

Overall and progression free survival (NCT01303172)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (or longer in the case of patients who entered the long term treatment sub-study, up to 5 years).

,
InterventionMonths (Median)
Overall SurvivalProgression Free Survival
Control5.62.4
Experimental6.74.1

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Overall Survival in Metastatic Patients Only

Overall and progression free survival in metastatic patients only (NCT01303172)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (or longer in the case of patients who entered the long term treatment sub-study, up to 5 years).

InterventionMonths (Median)
Experimental7.0
Control4.4

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The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.

Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks. (NCT01308840)
Timeframe: end of cycle 2 of treatment

Interventionparticipants (Number)
complete responsepartial responsestable diseaseprogressive disease
Panitumumab014143

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The Number of Participants Who Experience an Adverse Event

Any adverse event continuing after the study completion and considered potentially related to study treatment will be followed until resolution, stabilization or initiation of treatment that confounds the ability to assess the event (NCT01308840)
Timeframe: baseline to study completion

Interventionparticipants (Number)
Panitumumab31

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Median Progression Free Survival

Progression-free survival was defined as the time from study enrollment to date of cancer progression or death, whichever occurred first. Progression was assessed using CT scans and the Response Evaluation Criteria In Solid Tumors criteria. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT01308840)
Timeframe: time to cancer progression or death

Interventionmonths (Median)
Panitumumab10.6

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Median Overall Survival

Death from any cause was used. (NCT01308840)
Timeframe: enrollment until date of death

Interventionmonths (Median)
Panitumumab20.3

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Overall Response Rate

ORR is defined as the proportion of patients who achieve a CR or PR without additional therapy. (NCT01321541)
Timeframe: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)

Interventionpercentage of patients (Number)
Pixantrone + Rituximab61.9
Gemcitabine + Rituximab43.9

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Progression Free Survival (PFS)

PFS is defined as the time of randomization to the date of disease progression or death due to any cause (whichever occurs first) (NCT01321541)
Timeframe: From the date of randomization to the date of progressive disease or death due to any cause (whichever is first reported) (Up to 100 weeks)

InterventionMonths (Median)
Pixantrone + Rituximab7.3
Gemcitabine + Rituximab6.3

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Complete Response Rate

CRR is defined as the proportion of patients who achieve a Complete Response (CR) without additional therapy. CR is defined as the disappearance of all target lesions. (NCT01321541)
Timeframe: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)

InterventionParticipants (Count of Participants)
Pixantrone + Rituximab55
Gemcitabine + Rituximab34

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Overall Survival

Overall survival is from randomization to death due to any cause (NCT01321541)
Timeframe: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)

InterventionMonths (Median)
Pixantrone + Rituximab13.3
Gemcitabine + Rituximab19.6

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PK: Cmax of Gemcitabine Metabolite Deoxydifluorouridine (dFdU)

(NCT01341457)
Timeframe: Cycle 1 (days 1 and 15) & 2 (day 1): Predose, End of Infusion, 10 minutes (m), 30m, 60m, 120m

Interventionng/mL (Geometric Mean)
Cycle 1 Day 1Cycle 1 Day 15Cycle 2 Day 1
LY2603618 + Gemcitabine401003860038400

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Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Best Overall Response)

Participants achieved disease control if they had a best overall response of PR, CR or SD according to RECIST v1.1 (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD); PR at least 30% decrease and PD at least 20% increase in the sum of diameter of target lesions; CR: disappearance of all target lesions). Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. Best response of SD is defined as disease that does not meet the criteria for CR, PR or PD and has been evaluated at least 6 weeks after the first gemcitabine administration. (NCT01341457)
Timeframe: Baseline to Measured Progressive Disease (Up to 52 Months)

Interventionparticipants (Number)
170 mg LY2603618 + Gemcitabine2
230 mg LY2603618 + Gemcitabine5

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Number of Participants With Dose Limiting Toxicity (DLT)

DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 28) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section. (NCT01341457)
Timeframe: Cycle 1 (28 Days)

InterventionParticipants (Count of Participants)
170 mg LY2603618 + Gemcitabine1
230 mg LY2603618 + Gemcitabine2

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Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618

(NCT01341457)
Timeframe: Cycle 1 (days 2 and 16) & 2 (day 2): Predose, End of Infusion, 1 hour (h), 3h, 6h, 24h (days 3 and 17), 48h (days 4 and 18 cycle 1 only), 72h (days 5 and 19)

,
InterventionNanograms per Milliliter (ng/mL) (Geometric Mean)
Cycle 1 Day 2Cycle 1 Day 16Cycle 2 Day 2
170 mg LY2603618 + Gemcitabine361035103290
230 mg LY2603618 + Gemcitabine392041203570

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PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2603618

(NCT01341457)
Timeframe: Cycle 1 (days 2 and 16) & 2 (day 2): Predose, End of Infusion, 1 hour (h), 3h, 6h, 24h (days 3 and 17), 48h (days 4 and 18 cycle 1 only), 72h (days 5 and 19)

,
Interventionnanograms*hour per milliliter (ng*h/mL) (Geometric Mean)
Cycle 1 Day 1Cycle 1 Day 16Cycle 2 Day 2
170 mg LY2603618 + Gemcitabine439005260047800
230 mg LY2603618 + Gemcitabine372003900035800

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PK: AUC(0-∞) of Gemcitabine

(NCT01341457)
Timeframe: Cycle 1 (days 1 and 15) & 2 (day 1): Predose, End of Infusion, 10 minutes (m), 30m, 60m, 120m

Interventionng*h/mL (Geometric Mean)
Cycle 1 Day 1Cycle 1 Day 15Cycle 2 Day 1
LY2603618 + Gemcitabine11600123009530

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PK: AUC(0-∞) of Gemcitabine Metabolite dFdU

(NCT01341457)
Timeframe: Cycle 1 (days 1 and 15) & 2 (day 1): Predose, End of Infusion, 10 minutes (m), 30m, 60m, 120m

Interventionng*h/mL (Geometric Mean)
Cycle 1 Day 1Cycle 1 Day 15Cycle 2 Day 1
LY2603618 + Gemcitabine126000136000142000

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PK: Cmax of Gemcitabine

(NCT01341457)
Timeframe: Cycle 1 (days 1 and 15) & 2 (day 1): Predose, End of Infusion, 10 minutes (m), 30m, 60m, 120m

Interventionng/mL (Geometric Mean)
Cycle 1 Day 1Cycle 1 Day 15Cycle 2 Day 1
LY2603618 + Gemcitabine230002470018100

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Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]

(NCT01358968)
Timeframe: Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose

Interventionnanograms*hour/milliliter (ng*h/mL) (Geometric Mean)
Period 1Period 2
Desipramine655687

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Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of Desipramine [AUC(0-tlast)]

(NCT01358968)
Timeframe: Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose

Interventionnanogram*hour/milliliter (ng*h/mL) (Geometric Mean)
Period 1Period 2
Desipramine619653

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Plasma Pharmacokinetics of LY2603618: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of LY2603618 [AUC(0-tlast)]

(NCT01358968)
Timeframe: Period 2 only: Predose 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose

Interventionnanograms*hour/milliliter (ng*h/mL) (Geometric Mean)
LY260361853000

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Number of Participants With a Tumor Response

Tumor response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1). CR is the disappearance of all target and non-target lesions and PR is a ≥30% decrease in sum of longest diameter of target lesions. Number of participants with a tumor response is the total number of participants with CR or PR. (NCT01358968)
Timeframe: Baseline to study completion up to 11 cycles of 21-day cycles

InterventionParticipants (Count of Participants)
LY2603618 + Gemcitabine (Continued Access)1
LY2603618 + Pemetrexed (Continued Access)0

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Plasma Pharmacokinetics of Desipramine: the Maximum Concentration of Desipramine in the Plasma (Cmax)

(NCT01358968)
Timeframe: Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose

Interventionnanograms/milliliter (ng/mL) (Geometric Mean)
Period 1Period 2
Desipramine21.222.8

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Plasma Pharmacokinetics of LY2603618: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]

(NCT01358968)
Timeframe: Period 2 only: Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose

Interventionnanograms*hour/milliliter (ng*h/mL) (Geometric Mean)
LY260361853700

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Plasma Pharmacokinetics of LY2603618: the Maximum Concentration of LY2603618 in the Plasma (Cmax)

(NCT01358968)
Timeframe: Period 2 only: Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose

Interventionnanograms/milliliter (ng/mL) (Geometric Mean)
LY26036185950

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Time to Progression (TTP)

The (median) length of time from enrollment to disease progression per Response Evaluation Criteria in Solid Tumors (v1.0). Per RECIST, Progressive Disease (PD) is defined at least a 25% increase in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. For lesions without size response the maintenance of CA 19-9 level above the normal limits indicates disease progression. (NCT01360593)
Timeframe: Up to 5 years

Interventionmonths (Median)
Gem + Xeloda + SBRT16

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Overall Survival (OS)

The (median) length of time from enrollment to confirmed death from any cause. (NCT01360593)
Timeframe: Up to 32 months

Interventionmonths (Median)
Gem + Xeloda + SBRT18.82546

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Objective Response Rate (ORR) (Surgery After Chemotherapy and SBRT)

Percentage of participants with response per RECIST v1.0. Per RECIST v1.0: Complete Response (CR): the disappearance of a lesion; Near Complete Response (NCR): at least an 80% decrease in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. Partial Response (PR): at least a 30% decrease in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. (NCT01360593)
Timeframe: Up to 24 months

Interventionpercentage of participants (Number)
Gem + Xeloda + SBRT20.0

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Objective Response Rate (ORR) (Neoadjuvant Chemotherapy)

Percentage of participants with response per RECIST v1.0. Per RECIST v1.0: Complete Response (CR): the disappearance of a lesion; Near Complete Response (NCR): at least an 80% decrease in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. Partial Response (PR): at least a 30% decrease in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. (NCT01360593)
Timeframe: Up to 24 months

Interventionpercentage of participants (Number)
Gem + Xeloda + SBRT28.13

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Number of Participants Able to Undergo a Margin-negative Resection After Neoadjuvant Therapy

Number of patients that are able to undergo a margin-negative resection after neoadjuvant therapy. Surgical evaluation: pathology records reviewed by operating surgeon to determine margin status as negative (not close (1-2.5mm), microscopically positive, and/or grossly positive). (NCT01360593)
Timeframe: Up to 24 months

InterventionParticipants (Count of Participants)
Gem + Xeloda + SBRT11

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Local Progression-free Survival (LPFS)

LPFS is defined as the time from enrollment to first documentation of progressive disease (PD) in the target lesion. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume. Death or development of distant disease is not regarded as an event. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, progressive disease is defined as at least a 25% increase in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. (NCT01360593)
Timeframe: Up to 32 months

Interventionmonths (Median)
Gem + Xeloda + SBRT22.30801

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Late Toxicities Associated With SBRT

Percentage of patients that experience treatment-related toxicities as graded according to Common Terminology Criteria for Adverse Events (CTCAE v4), greater than 3 months after treatment, by grade. Patients were monitored for potential toxicity throughout treatment. (NCT01360593)
Timeframe: From 3 months following SBRT treatment up to 24 months

Interventionpercentage of participants (Number)
Gem + Xeloda + SBRT0

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Acute Toxicities Associated With SBRT

Percentage of patients that experience treatment-related toxicities as graded according to Common Terminology Criteria for Adverse Events (CTCAE v4), within 3 months after treatment, by grade. Patients were monitored for potential toxicity throughout treatment. (NCT01360593)
Timeframe: Up to 3 months following SBRT treatment

Interventionpercentage of participants (Number)
Grade 1Grade 2Grade 3Grade 4
Gem + Xeloda + SBRT88.2429.4114.712.94

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The Functional Assessment of Cancer Therapy - General (FACT-G)

The Functional Assessment of Cancer Therapy - General (FACT-G) is a self-administered, 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Quality of Life (QOL) evaluation will be administered prior to SBRT, after completion of SBRT, and at each follow-up. Scaling of items: Five-point scale for each questions from 0 (not at all) to 4 (very much); overall scoring 0-108. Higher scores indicated better quality of life. (NCT01360593)
Timeframe: Baseline; 2 - 4 weeks post chemotherapy; 4-6 weeks post SBRT; after surgery (up to 24 months)

Interventionscore on a scale (Median)
Baseline2-4 weeks after Chemo4-6 weeks after SBRTafter Surgery, up to 24 months
Gem + Xeloda + SBRT54.054.051.549.5

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Phase 2: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) at Study Completion

The BPI-SF Pain Severity Subscale was a participant-rated questionnaire that measured the severity of pain. Severity scores could have ranged from 0 (no pain) to 10 (pain as bad as you can imagine) for questions that included assessing average pain in the past 24 hours. (NCT01373164)
Timeframe: Baseline, study treatment completion (up to 1 year)

InterventionUnits on a scale (Mean)
Phase 2: 300 mg Galunisertib + Gemcitabine2.54
Placebo+Gemcitabine1.50

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Phase 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA19-9) Level at First Study Completion Follow-up

Carbohydrate antigen 19-9 (CA 19-9) is a modified Lewis(a) blood group antigen, and has been used as a tumor marker. The outcome measure is the median, minimum and maximum values from participants who had samples collected at baseline and at follow-up (NCT01373164)
Timeframe: Baseline, study treatment completion after first follow up visit (up to 1 year)

InterventionUnits/Milliliter (U/mL) (Median)
Phase 2: 300 mg Galunisertib + Gemcitabine32.7
Phase 2: Placebo + Gemcitabine-33.3

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Phase 2: Overall Survival (OS)

Overall survival is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact. (NCT01373164)
Timeframe: Baseline to date of death from any cause (up to 2 years)

InterventionMonths (Median)
Phase 2: 300 mg Galunisertib + Gemcitabine8.9
Phase 2: Placebo + Gemcitabine7.1

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Phase 2: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])

Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100. (NCT01373164)
Timeframe: Baseline to measured progressive disease (up to 2 years)

InterventionPercentage of Participants (Number)
Phase 2: 300 mg Galunisertib + Gemcitabine10.6
Phase 2: Placebo + Gemcitabine3.8

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Phase 2: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24])

AUC[0-24] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute. (NCT01373164)
Timeframe: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)

Interventionmg*h/L (Mean)
Phase 2: 300 mg Galunisertib + Gemcitabine5.56

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Phase 2: Population PK: Maximum Concentration (Cmax) of Galunisertib

Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported. (NCT01373164)
Timeframe: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)

Interventionng/mL (Mean)
Phase 2: 300 mg Galunisertib + Gemcitabine904

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Phase 2: Progression Free Survival (PFS)

PFS is defined as the date of randomization to the first date of progression of disease or of death from any cause. For each participant who is not known to have died or to have had a progression of disease as of the data-inclusion cut-off date for a particular analysis, PFS will be censored at the date of last prior contact. PFS will be calculated and analyzed twice: (1) including clinical progressions of disease not based on lesion measurements, and (2) excluding clinical progressions. Progression Disease (PD) was defined as having at least a 25% increase in the sum of the longest diameter of target lesions. (NCT01373164)
Timeframe: Baseline to first date of progressive disease or death due to any cause (up to 2 years)

InterventionMonths (Median)
Phase 2: 300 mg Galunisertib + Gemcitabine4.11
Phase 2: Placebo + Gemcitabine2.86

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Phase 1b: Number of Participants With Tumor Response

Response was defined using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. (NCT01373164)
Timeframe: Baseline to end of Phase 1b (up to 1 year)

,,
InterventionParticipants (Number)
Progressive Disease (PD)Stable Disease (SD)Partial Response (PR)Non-Complete Response/Non-Progressive Disease (NC)Not Assessed (NA)
Phase 1b: 160 mg Galunisertib + Gemcitabine12100
Phase 1b: 300 mg Galunisertib + Gemcitabine22010
Phase 1b: 80 mg Galunisertib + Gemcitabine31001

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Phase 1b: Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 24 Hours (AUC[0-24], ss) and Time Zero to Infinity (AUC[0-∞], ss)

AUC[0-24h] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute. AUC0-infinity will take 48h and extrapolation beyond this in addition to earlier time points to be calculated. All mentioned time points are used to calculate the two AUCs. (NCT01373164)
Timeframe: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)

,,
Interventionnanogram*hour per milliliter (ng*h/mL) (Geometric Mean)
AUC(0-24)AUC(0-∞)
Phase 1b: 160 mg Galunisertib + GemcitabineNANA
Phase 1b: 300 mg Galunisertib + Gemcitabine909010600
Phase 1b: 80 mg Galunisertib + Gemcitabine25302740

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Phase 2: Percentage Change From Baseline in Tumor Size (CTS)

Change in tumor size is defined as the maximum percent change from baseline in the sum of target lesions. Change was assessed in each participant using radiographic imaging. (NCT01373164)
Timeframe: Baseline, end of Cycle 2 (up to 56 days)

,
InterventionPercent change in tumor size (Geometric Mean)
Independent Assessor 1Independent Assessor 2
Phase 2: 300 mg Galunisertib + Gemcitabine0.951.03
Phase 2: Placebo + Gemcitabine0.920.98

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Phase 1b: Pharmacokinetics: Maximum Plasma Drug Concentration at Steady State (Cmax,ss)

Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported. (NCT01373164)
Timeframe: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)

Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
Phase 1b: 80 mg Galunisertib + Gemcitabine385
Phase 1b: 160 mg Galunisertib + GemcitabineNA
Phase 1b: 300 mg Galunisertib + Gemcitabine1050

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Number of Participants With Adverse Events

Number of participants with adverse events as a measure of safety and tolerability (NCT01376310)
Timeframe: Until 30 days after the last dose of study treatment. Subjects may have continued to receive study treatment until disease progression, death, unacceptable toxicity or until locally commercially available. The maximum duration of exposure was 76 months.

,
InterventionParticipants (Count of Participants)
Adverse EventsTreatment-Related Adverse EventsSerious Adverse EventsTreatment-Related Serious Adverse Events
Cohort A (GSK1120212 < 24 Weeks)119101268
Cohort B (GSK1120212 >= 24 Weeks)3026134

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Progression-free Survival (PFS) Among Subjects With KRAS Mutation Positive NSCLC (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Single Agent Chemotherapy.

Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) criteria as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or progression of existing non-target lesions are also considered progression. (NCT01395758)
Timeframe: Date of randomization until disease progression per RECIST (v 1.1) or death from any cause, whichever came first, assessed up to 24 months.

Interventionweeks (Median)
Tivantinib Plus Erlotinib Arm7.3
Chemotherapy Arm18.6

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Overall Survival (OS) Among All Eligible Subjects (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Chemotherapy.

OS is calculated from the date of randomization until death from any cause. (NCT01395758)
Timeframe: Date of randomization to the date of death from any cause, assessed up to 24 months

Interventionmonths (Median)
Tivantinib Plus Erlotinib Arm6.8
Chemotherapy Arm8.5

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ORR Among Subjects in the Crossover Period Treated With Erlotinib Plus Tivantinib

Per RECIST v1.1, CR = disappearance of all lesions and PR = at least 30% decrease in the sum of diameters of target lesions. ORR = (CR+PR)/# subjects. (NCT01395758)
Timeframe: Date of randomization to the date of death from any cause or to the date that the subject discontinues from the study, assessed up to 24 months.

InterventionParticipants (Count of Participants)
Tivantinib Plus Erlotinib Crossover Period2

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Objective Response Rate (ORR) Among All Eligible Subjects (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Chemotherapy.

Per RECIST v1.1, Complete Response (CR) = disappearance of all lesions and Partial Response (PR) = at least 30% decrease in the sum of diameters of target lesions. ORR = (CR+PR)/# subjects. (NCT01395758)
Timeframe: Date of randomization to the date of death from any cause or to the date that the subject discontinues from the study, assessed up to 24 months

InterventionParticipants (Count of Participants)
Tivantinib Plus Erlotinib Arm0
Chemotherapy Arm4

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Progression Free Survival

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or progression in existing non-target lesions,or the appearance of one or more new lesions . (NCT01404260)
Timeframe: The evaluation of disease is demanded every two months for the patients receiving maintenance use of Gefitinib or patients in observation after chemotherapy,until disease progression occured

Interventionmonths (Median)
Arm A: Gefitinib+Gemcitabine +Carboplatin9.7
Arm B: Gemcitabine +Carboplatin4.2

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Overall Objective Response

"Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study." (NCT01418001)
Timeframe: Every 6 weeks up to 2 years

Interventionparticipants (Number)
Complete Response (CR)Stable Disease (SD)
Level 1: Pazopanib 400 mg QD32

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Overall Survival

Number of months alive from cycle 1, Day 1 until 5 years post-intervention or death, whichever comes first. (NCT01431794)
Timeframe: 5 years

Interventionmonths (Median)
Phase I: Gem, Nab-paclitaxel, and LDE225-600mg34.3

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Overall Tumor Response as Determined by Number of Participants With Complete or Partial Response

Number of participants who experienced complete response (CR) or partial response (PR), as defined by RECIST v1.0; where CR is a disappearance of all target lesions and PR is ≥30% reduction of target lesions. (NCT01431794)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Phase I: Gem, Nab-paclitaxel, and LDE225-600mg3

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Phase I - Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy as Measured by Number of Participants Who Tolerated the Maximal Dose of LDE-225

Number of participants who tolerated the maximal dose of LDE-225 in combination with gemcitabine, nab-paclitaxel as neoadjuvant therapy in patients with borderline resectable pancreatic adenocarcinoma (PDA). (NCT01431794)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Phase I: Gem, Nab-paclitaxel, and LDE225-600mg13
Phase I: Gem, Nab-paclitaxel, and LDE225-400mg0
Phase I: Gem, Nab-paclitaxel, and LDE225-800mg0

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PERCIST Partial Metabolic Response

"The primary endpoint was partial metabolic response after 2 cycles of switch therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline)." (NCT01443078)
Timeframe: 2 years

Interventionparticipants (Number)
All Patients6

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Pathologic Response Rate

The percentage of patients with a major pathologic response (NCT01443078)
Timeframe: 2 years

Interventionpercentage of patients (Number)
All Patients17

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Pharmacokinetics

Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg). (NCT01447225)
Timeframe: Collections taken at Cycle 1, Week 1 for all patients at start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion

Interventionug/mL (Geometric Mean)
MM-121 + Gemcitabine: 20/12 mg/kg560
MM-121 + Carboplatin: 20/12 mg/kg554.8
MM-121 + Pemetrexed: 20/12 mg/kg900.7
MM-121 + Cisplatin: 20/12 mg/kg677.1
MM-121 + Gemcitabine: 40/20 mg/kg1033.4
MM-121 + Carboplatin: 40/20 mg/kg1107.2
MM-121 + Pemetrexed: 40/20 mg/kg1100.8
MM-121 + Cisplatin: 40/20 mg/kg1087.9

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Objective Response Rate

To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR. (NCT01447225)
Timeframe: patients were assessed for response during their time on study, the longest of which was 88.1 weeks

Interventionparticipants with objective response (Number)
MM-121 Plus Gemcitabine: Cohort 10
MM-121 Plus Gemcitabine: Cohort 22
MM-121 Plus Carboplatin: Cohort 10
MM-121 Plus Carboplatin: Cohort 20
MM-121 Plus Carboplatin: Cohort 30
MM-121 Plus Pemetrexed: Cohort 10
MM-121 Plus Pemetrexed: Cohort 21
MM-121 Plus Cabazitaxel: Cohort 11
MM-121 Plus Cabazitaxel: Cohort 22
MM-121 Plus Cabazitaxel: Cohort 31

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Immunogenicity

Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies). (NCT01447225)
Timeframe: Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 88.1 weeks, and a collection was made post-infusion in any case of infusion reaction

Intervention (Number)
MM-121 Plus Gemcitabine: Cohort 1NA
MM-121 Plus Gemcitabine: Cohort 2NA
MM-121 Plus Carboplatin: Cohort 1NA
MM-121 Plus Carboplatin: Cohort 2NA
MM-121 Plus Carboplatin: Cohort 3NA
MM-121 Plus Pemetrexed: Cohort 1NA
MM-121 Plus Pemetrexed: Cohort 2NA
MM-121 Plus Cabazitaxel: Cohort 1NA
MM-121 Plus Cabazitaxel: Cohort 2NA
MM-121 Plus Cabazitaxel: Cohort 3NA

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To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies

Safety and tolerability data presented in detail in the adverse events and serious adverse events section of the results posting (NCT01447225)
Timeframe: From date of first dose to 30 days after termination, the longest 88.1 weeks

Interventionparticipants reporting adverse events (Number)
MM-121 Plus Gemcitabine: Cohort 13
MM-121 Plus Gemcitabine: Cohort 28
MM-121 Plus Carboplatin: Cohort 15
MM-121 Plus Carboplatin: Cohort 23
MM-121 Plus Carboplatin: Cohort 33
MM-121 Plus Pemetrexed: Cohort 13
MM-121 Plus Pemetrexed: Cohort 27
MM-121 Plus Cabazitaxel: Cohort 14
MM-121 Plus Cabazitaxel: Cohort 23
MM-121 Plus Cabazitaxel: Cohort 34

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To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed

"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Pemetrexed doses tested: 500 mg/m2 Day 1" (NCT01447225)
Timeframe: From date of first dose to 30 days after termination, the longest 88.1 weeks

Interventionmg/m2 (Number)
MM-121 + Pemetrexed500

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To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine

"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8" (NCT01447225)
Timeframe: From date of first dose to 30 days after termination, the longest 88.1 weeks

Interventionmg/m2 (Number)
MM-121 + Gemcitabine1000

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To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin

"Maximum Tolerated Dose reported in Target AUC, as calculated by the Calvert Formula~Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Carboplatin doses tested: 5 or 6 AUC Day 1" (NCT01447225)
Timeframe: From date of first dose to 30 days after termination, the longest 88.1 weeks

Interventiontarget AUC (mg*min/mL) (Number)
MM-121 + Carboplatin5

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To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel

"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3" (NCT01447225)
Timeframe: From date of first dose to 30 days after termination, the longest 88.1 weeks

Interventionmg/m2 (Number)
MM-121 + Cabazitaxel25

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To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies

To establish the safety of escalating doses of MM-121 administered in combination with multiple anti-cancer therapies in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort. (NCT01447225)
Timeframe: From date of first dose to 30 days after termination, the longest 88.1 weeks

Interventionparticipants reporting DLTs (Number)
MM-121 Plus Gemcitabine: Cohort 10
MM-121 Plus Gemcitabine: Cohort 21
MM-121 Plus Carboplatin: Cohort 11
MM-121 Plus Carboplatin: Cohort 20
MM-121 Plus Carboplatin: Cohort 30
MM-121 Plus Pemetrexed: Cohort 10
MM-121 Plus Pemetrexed: Cohort 21
MM-121 Plus Cabazitaxel: Cohort 10
MM-121 Plus Cabazitaxel: Cohort 20
MM-121 Plus Cabazitaxel: Cohort 30

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Pharmacokinetics (AUClast)

Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2). (NCT01447225)
Timeframe: Collections taken at Cycle 1, Week 1 for all patients at the start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion

Interventionhr* ug/mL (Geometric Mean)
MM-121 + Gemcitabine: 20/12 mg/kg39666.4
MM-121 + Carboplatin: 20/12 mg/kg49749.6
MM-121 + Pemetrexed: 20/12 mg/kg59984.1
MM-121 + Cisplatin: 20/12 mg/kg51995.1
MM-121 + Gemcitabine: 40/20 mg/kg72132.1
MM-121 + Carboplatin: 40/20 mg/kg100309.9
MM-121 + Pemetrexed: 40/20 mg/kg92732.9
MM-121 + Cisplatin: 40/20 mg/kg98142.6

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To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses

"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8 Pemetrexed doses tested: 500 mg/m2 Day 1 Carboplatin doses tested: 5 or 6 AUC Day 1 Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3" (NCT01447225)
Timeframe: From date of first dose to 30 days after termination, the longest 88.1 weeks

,,,
Interventionmg/kg (Number)
one-time loading dosemaintenance dose
MM-121 Plus Cabazitaxel4020
MM-121 Plus Carboplatin4020
MM-121 Plus Gemcitabine4020
MM-121 Plus Pemetrexed4020

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Number of Participants With a Dose-limiting Toxicity (DLT)

The safety and tolerability profile of PEGPH20 used in combination with gemcitabine was assessed by measuring the number of participants with a DLT during the dose-escalation phase of the study. A DLT was defined as any treatment-emergent National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE), Version 4.0, Grade 3 or greater event occurring within the first 4 weeks of treatment that was considered related to PEGPH20. Any PEGPH20 treatment-related AE that resulted in a drug interruption or reduction might have been considered a DLT at the Investigator's or Sponsor's discretion. Hypersensitivity/infusion reactions related to PEGPH20 dosing were not considered DLTs. (NCT01453153)
Timeframe: first 4 weeks of Cycle 1

InterventionParticipants (Count of Participants)
PEGPH20 1.0 μg/kg0
PEGPH20 1.6 μg/kg0
PEGPH20 3.0 μg/kg0

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Objective Response Rate

Objective Response Rate is defined as the number of participants with a complete response plus the number of participants with a partial response, per RECIST, Version 1.1. For TLs, CR: Disappearance of all TLs. PR: >=30% decrease in the sum of diameters of TLs, referencing baseline sums. For NTLs, CR: Disappearance of all NTLs and normalization of tumor marker level. All lymph nodes must be nonpathological in size (short axis <10 mm). Incomplete response/SD: Persistence of >=1 NTLs and/or maintenance of tumor marker level above normal limits. (NCT01453153)
Timeframe: up to approximately 2 years 4 months

InterventionParticipants (Count of Participants)
PEGPH20 1.0 μg/kg0
PEGPH20 1.6 μg/kg2
PEGPH20 3.0 μg/kg8

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Observed Maximum Plasma Concentration (Cmax) Following Single PEGPH20 Doses

Cmax is defined as the observed maximum plasma concentration after the first dose. Blood samples were collected for pharmacokinetic assessment. (NCT01453153)
Timeframe: Cycle 1, Week 1, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)

Interventionunits per milliliter (Mean)
PEGPH20 1.0 μg/kg0.604
PEGPH20 1.6 μg/kg1.54
PEGPH20 3.0 μg/kg3.18

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Overall Survival

Overall survival was defined as the time from the time of the first dose of PEGPH20 until death. (NCT01453153)
Timeframe: from the time of the first dose of PEGPH20 until death (up to approximately 2 years 4 months)

Interventiondays (Median)
PEGPH20 1.0 μg/kg109.5
PEGPH20 1.6 μg/kg199.5
PEGPH20 3.0 μg/kg220.0

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Progression-free Survival (PFS)

PFS duration was defined as the time from the first dose of PEGPH20 until objective tumor progression or death. Per RECIST, Version 1.1, for the evaluation of target lesions, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters. Note: the appearance of 1 or more new lesions is also considered progression. For the evaluation of nontarget lesions, progressive disease is defined as the unequivocal progression of existing nontarget lesions. Note: The appearance of 1 or more new lesions is also considered progression. (NCT01453153)
Timeframe: from the first dose of PEGH20 until objective tumor progression or death (up to approximately 2 years 4 months)

Interventiondays (Median)
PEGPH20 1.0 μg/kg47.0
PEGPH20 1.6 μg/kg276.0
PEGPH20 3.0 μg/kg113.0

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Time to Reach Cmax (Tmax) Following Single PEGPH20 Doses

Blood samples were collected for pharmacokinetic assessment. (NCT01453153)
Timeframe: Cycle 1, Week 1, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)

Interventionhours (Median)
PEGPH20 1.0 μg/kg0.250
PEGPH20 1.6 μg/kg0.250
PEGPH20 3.0 μg/kg0.420

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Tmax Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks

Blood samples were collected for pharmacokinetic assessment. The 24-hour sample collected at the first visit was optional. (NCT01453153)
Timeframe: Cycle 1, Week 4, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)

Interventionhours (Median)
PEGPH20 1.0 μg/kg0.330
PEGPH20 1.6 μg/kg0.325
PEGPH20 3.0 μg/kg0.420

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Change From Baseline in CA19-9 in Participants Classified as Responders and Non-responders

CA19-9 is a tumor marker. Blood samples (plasma) were collected for CA19-9 evaluations. Responders are defined as participants who had a complete response or partial response, and non-responders are defined as participants who had stable disease, progressive disease, or an unknown tumor response, per RECIST, Version 1.1. (NCT01453153)
Timeframe: up to the end of Cycle 10 (up to Week 44)

InterventionU/ml (Mean)
Cycle 1, Week 4, Visit 1Cycle 1, Week 8, Visit 1Cycle 2, Week 4, Visit 1Cycle 3, Week 4, Visit 1Cycle 4, Week 4, Visit 1Cycle 5, Week 4, Visit 1Cycle 6, Week 4, Visit 1Cycle 7, Week 4, Visit 1Cycle 8, Week 4, Visit 1Cycle 9, Week 4, Visit 1Cycle 10, Week 4, Visit 1
Responders-15677.1-16367.0-21587.2-28752.7-19976.6-22347.6-39900.5-77482.1-77472.8-154940-154937

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Change From Baseline in CA19-9 in Participants Classified as Responders and Non-responders

CA19-9 is a tumor marker. Blood samples (plasma) were collected for CA19-9 evaluations. Responders are defined as participants who had a complete response or partial response, and non-responders are defined as participants who had stable disease, progressive disease, or an unknown tumor response, per RECIST, Version 1.1. (NCT01453153)
Timeframe: up to the end of Cycle 10 (up to Week 44)

InterventionU/ml (Mean)
Cycle 1, Week 4, Visit 1Cycle 1, Week 8, Visit 1Cycle 2, Week 4, Visit 1Cycle 3, Week 4, Visit 1Cycle 4, Week 4, Visit 1Cycle 5, Week 4, Visit 1
Non-responders675.7-6227.91377.123830.5-32900.0-29200.0

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Change From Baseline in CA19-9 in Participants With a Baseline Value >=59 U/ml

CA19-9 is a tumor marker. Blood samples (plasma) were collected for CA19-9 evaluations. (NCT01453153)
Timeframe: up to the end of Cycle 10 (up to Week 44)

,
InterventionU/ml (Mean)
Cycle 1, Week 4, Visit 1
PEGPH20 1.0 μg/kg19346.2
PEGPH20 1.6 μg/kg-23500.0

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Change From Baseline in Carbohydrate Antigen 19-9 or Sialylated Lewis(a) Antigen (CA19-9)

CA19-9 is a tumor marker. Blood samples (plasma) were collected for CA19-9 evaluations. (NCT01453153)
Timeframe: up to the end of Cycle 10 (up to Week 44)

InterventionUnits per milliliter (U/ml) (Mean)
Cycle 1, Week 4, Visit 1Cycle 1, Week 8, Visit 1Cycle 2, Week 4, Visit 1Cycle 3, Week 4, Visit 1Cycle 4, Week 4, Visit 1Cycle 5, Week 4, Visit 1Cycle 6, Week 4, Visit 1Cycle 7, Week 4, Visit 1Cycle 8, Week 4, Visit 1Cycle 9, Week 4, Visit 1Cycle 10, Week 4, Visit 1
PEGPH20 3.0 μg/kg-11800.3-15464.1-16581.0-12628.0-24089.1-27214.3-53200.6-154964-154946-154940-154937

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Change From Baseline in Carbohydrate Antigen 19-9 or Sialylated Lewis(a) Antigen (CA19-9)

CA19-9 is a tumor marker. Blood samples (plasma) were collected for CA19-9 evaluations. (NCT01453153)
Timeframe: up to the end of Cycle 10 (up to Week 44)

InterventionUnits per milliliter (U/ml) (Mean)
Cycle 1, Week 4, Visit 1Cycle 1, Week 8, Visit 1Cycle 2, Week 4, Visit 1
PEGPH20 1.0 μg/kg12897.50.00.0

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Change From Baseline in Carbohydrate Antigen 19-9 or Sialylated Lewis(a) Antigen (CA19-9)

CA19-9 is a tumor marker. Blood samples (plasma) were collected for CA19-9 evaluations. (NCT01453153)
Timeframe: up to the end of Cycle 10 (up to Week 44)

InterventionUnits per milliliter (U/ml) (Mean)
Cycle 1, Week 4, Visit 1Cycle 1, Week 8, Visit 1Cycle 2, Week 4, Visit 1Cycle 3, Week 4, Visit 1Cycle 4, Week 4, Visit 1Cycle 5, Week 4, Visit 1Cycle 6, Week 4, Visit 1Cycle 7, Week 4, Visit 1Cycle 8, Week 4, Visit 1
PEGPH20 1.6 μg/kg-7833.9-1.9-1.20.00.00.00.00.00.0

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H-scores, as an Assessment of HA Staining Changes in Tumor Biopsies

An H-score approach methodology was developed and used to analyze staining in the tumor pericellular regions and the stroma separately. The H-score calculation was the sum of the products of the percentage of positive staining areas and the staining intensity (0, 1, 2 or 3), and ranged from 0 to 300. For example: [90% * 1 (weak)] + [10% * 2 (moderate)] + [0% * 3 (strong)] = 110. A score of 0 represents the absence of expression, and an H-score of 300 represents maximum expression. A larger decrease in H-score correlated with a greater target engagement of PEGPH20. As HA is a secreted protein, the scoring was performed in the immediate areas surrounding tumor (pericellular areas) as well as in stroma. (NCT01453153)
Timeframe: Screening; Cycle 1 Week 7

Interventionscore on a scale (Number)
Screening pericellular tumor H-scoreScreening stromal H-scorePost-treatment pericellular tumor H-scorePost-treatment stromal tumor H-score
PEGPH20 3.0 μg/kg4026015150

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Mean Extravascular-Extracellular Volume Fraction (Ve) for Scans Across Tissue Sites

DCE-MRI provides a measure of the exchange of small-molecule contrast agents between the intracellular and extracellular spaces. Ve is defined as the extravascular-extracellular volume fraction and is a measure of extracellular, extravascular space. Mean Ve values across scan sites are reported per participant. DCE-MRI was performed before the first dosing visit (Week 1/Day 1), 24 hours after the first dose of PEGPH20 in Cycle 1, and 24 hours after the last dose of PEGPH20 in Cycle 1 (Week 7). Assessment was done for the entire cohort of participants, not per treatment group. (NCT01453153)
Timeframe: Baseline; 24 hours hours; end of Cycle 1 (Week 7)

Interventionmilliliters (Mean)
Participant 1, BaselineParticipant 1, 24 hoursParticipant 1, End of Cycle 1Participant 2, BaselineParticipant 2, 24 hoursParticipant 2, End of Cycle 1Participant 3, BaselineParticipant 3, 24 hoursParticipant 3, End of Cycle 1Participant 4, BaselineParticipant 4, 24 hoursParticipant 4, End of Cycle 1Participant 5, BaselineParticipant 5, 24 hoursParticipant 5, End of Cycle 1Participant 6, BaselineParticipant 6, 24 hoursParticipant 6, End of Cycle 1
PEGPH20 1.0, 1.6, or 3.0 μg/kg0.1620.327NA0.6710.386NA0.4810.389NA0.4580.7880.7510.3800.3950.5500.3550.8250.425

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Mean Volume Transfer Constant (Ktrans) for Scans Across Tissue Sites

Dynamic control enhanced-magnetic resonance imaging (DCE-MRI) provides a measure of the exchange of small-molecule contrast agents between the intracellular and extracellular spaces. Using a 2-compartment pharmacokinetic model, an estimate of tissue (tumor) perfusion can be obtained by determining the exchange rate constant (Ktrans) of contrast exchange. Ktrans is defined as the volume transfer constant between extravascular/extracellular space to plasma space and is a measure of blood flow, vascular permeability, or both. Mean Ktrans values across scan sites are reported per participant. DCE-MRI was performed before the first dosing visit (Week 1/Day 1), 24 hours after the first dose of PEGPH20 in Cycle 1, and 24 hours after the last dose of PEGPH20 in Cycle 1 (Week 7). Assessment was done for the entire cohort of participants, not per treatment group. (NCT01453153)
Timeframe: Baseline; 24 hours hours; end of Cycle 1 (Week 7)

Interventionmilliliters (mL) per minute per 100 mL (Mean)
Participant 1, BaselineParticipant 1, 24 hoursParticipant 1, End of Cycle 1Participant 2, BaselineParticipant 2, 24 hoursParticipant 2, End of Cycle 1Participant 3, BaselineParticipant 3, 24 hoursParticipant 3, End of Cycle 1Participant 4, BaselineParticipant 4, 24 hoursParticipant 4, End of Cycle 1Participant 5, BaselineParticipant 5, 24 hoursParticipant 5, End of Cycle 1Participant 6, BaselineParticipant 6, 24 hoursParticipant 6, End of Cycle 1
PEGPH20 1.0, 1.6, or 3.0 μg/kg0.1240.383NA0.4300.468NA0.4020.331NA0.5640.6720.6460.1350.1970.1330.2490.3760.078

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Number of Participants With the Indicated Best Response, Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1

Target lesions (TLs), complete response (CR): Disappearance of all TLs. Partial response (PR): >=30% decrease in the sum of diameters of TLs, referencing baseline sums. Progressive disease (PD): >= 20% increase in the sum of diameters of TLs, referencing the smallest sum (including baseline sum). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of >=5 mm. (The appearance of >=1 new lesions is considered progression.) Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient to qualify for PD, referencing the smallest sum diameters. For nontarget lesions (NTLs), CR: Disappearance of all NTLs and normalization of tumor marker level. All lymph nodes must be nonpathological in size (short axis <10 mm). Incomplete response/SD: Persistence of >=1 NTLs and/or maintenance of tumor marker level above normal limits. PD: Unequivocal progression of existing NTLs. (The appearance of >=1 new lesions is considered progression.) (NCT01453153)
Timeframe: up to approximately 2 years 4 months

,,
InterventionParticipants (Count of Participants)
CRPRSDPDUnknown
PEGPH20 1.0 μg/kg00130
PEGPH20 1.6 μg/kg02200
PEGPH20 3.0 μg/kg08606

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Plasma Hyaluronan (HA) Concentration at Baseline and After PEGPH20 Administration

The pharmacodynamic activity of PEGPH20 was evaluated by measuring plasma concentrations of HA after PEGPH20 dosing. Peak HA concentrations are the highest concentrations measured after a single dose of PEGPH20. HA samples were collected in Cycle 1 at the following time points: 1) Week 1/Day 1 (first visit) and Week 4 (first visit): predose and 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing (24-hour sample optional for Week 4); 2) all other visits in Cycle 1: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given). HA samples were collected in Cycles 2+ at the following time points: Week 3 of each cycle pre-PEGPH20 dose and 1 to 2 hours post-PEGPH20 dose. (NCT01453153)
Timeframe: Baseline; post-Baseline (average treatment duration of 94.6 days)

,,
Interventionnanograms per milliliter (Mean)
BaselineAfter PEGPH20 administration
PEGPH20 1.0 μg/kg123.77288
PEGPH20 1.6 μg/kg982.327818
PEGPH20 3.0 μg/kg164.7128411

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Percent Change in in the Maximum Standardized Uptake Value (SUVmax), as an Assessment of Total Lesion Metabolic Activity

PEGPH20's effect on the metabolic activities of the tumor was assessed as the percent change in SUVmax (a measure of total lesion metabolic activity) using fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT). Assessment was done for the entire cohort of participants, not per treatment group. (NCT01453153)
Timeframe: Baseline; up to 32 weeks for each individual participant (end of Cycle 7)

Interventionpercent change (Mean)
Cycle 1Cycle 3Cycle 5Cycle 7
PEGPH20 1.0, 1.6, or 3.0 μg/kg-36.7-43.2-39.3-41.2

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t1/2 Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks

The apparent half-life calculated by ln(2)/λ, where λ was the rate constant for the log-linear portion of the terminal phase. A minimum of 3 values in the postdistribution phase of the plasma concentration-time curve were required for calculation of λ. Blood samples were collected for pharmacokinetic assessment. The 24-hour sample collected at the first visit was optional. t1/2 is expressed as harmonic mean and pseudo standard deviation. (NCT01453153)
Timeframe: Cycle 1, Week 4, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)

Interventionhours (Mean)
PEGPH20 1.0 μg/kg5.60
PEGPH20 1.6 μg/kg19.5
PEGPH20 3.0 μg/kg10.7

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Apparent Half-life (t1/2) Following Single PEGPH20 Doses

The apparent half-life calculated by ln(2)/λ, where λ was the rate constant for the log-linear portion of the terminal phase. A minimum of 3 values in the postdistribution phase of the plasma concentration-time curve were required for calculation of λ. Blood samples were collected for pharmacokinetic assessment. t1/2 is expressed as harmonic mean and pseudo standard deviation. (NCT01453153)
Timeframe: Cycle 1, Week 1, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)

Interventionhours (Mean)
PEGPH20 1.6 μg/kg18.6
PEGPH20 3.0 μg/kg8.24

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Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Measurable Plasma Concentration (AUC0-T) Following Single PEGPH20 Doses

Blood samples were collected for pharmacokinetic assessment. AUC0-T was calculated by the linear trapezoidal rule. (NCT01453153)
Timeframe: Cycle 1, Week 1, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)

InterventionUnits*hour/milliliter (Mean)
PEGPH20 1.0 μg/kg1.39
PEGPH20 1.6 μg/kg13.6
PEGPH20 3.0 μg/kg31.5

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AUC0-T Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks

Blood samples were collected for pharmacokinetic assessment. The 24-hour sample collected at the first visit was optional. AUC0-T was calculated by the linear trapezoidal rule. (NCT01453153)
Timeframe: Cycle 1, Week 4, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)

InterventionUnits*hour/milliliter (Mean)
PEGPH20 1.0 μg/kg2.99
PEGPH20 1.6 μg/kg21.5
PEGPH20 3.0 μg/kg35.2

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Cmax Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks

Cmax is defined as the observed maximum plasma concentration after the first dose. Blood samples were collected for pharmacokinetic assessment. The 24-hour sample collected at the first visit was optional. (NCT01453153)
Timeframe: Cycle 1, Week 4, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)

Interventionunits per milliliter (Mean)
PEGPH20 1.0 μg/kg1.08
PEGPH20 1.6 μg/kg2.40
PEGPH20 3.0 μg/kg3.98

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Cmin Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks

Blood samples were collected for pharmacokinetic assessment. The 24-hour sample collected at the first visit was optional. (NCT01453153)
Timeframe: Cycle 1, Week 4, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)

InterventionUnits per milliliter (Mean)
PEGPH20 1.0 μg/kg0.572
PEGPH20 1.6 μg/kg0.976
PEGPH20 3.0 μg/kg1.52

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Disease Control Rate

Disease Control Rate is defined as the sum of the number of participants with a complete response, the number of participants with a partial response, and the number of participants with stable disease per RECIST, Version 1.1. For TLs, CR: Disappearance of all TLs. PR: >=30% decrease in the sum of diameters of TLs, referencing baseline sums. SD: Neither sufficient shrinkage to qualify for PR nor sufficient to qualify for PD, referencing the smallest sum diameters. For NTLs, CR: Disappearance of all NTLs and normalization of tumor marker level. All lymph nodes must be nonpathological in size (short axis <10 mm). Incomplete response/SD: Persistence of >=1 NTLs and/or maintenance of tumor marker level above normal limits. (NCT01453153)
Timeframe: up to approximately 2 years 4 months

InterventionParticipants (Count of Participants)
PEGPH20 1.0 μg/kg1
PEGPH20 1.6 μg/kg4
PEGPH20 3.0 μg/kg14

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Last Measurable Observed Plasma Concentration (Cmin) Following Single PEGPH20 Doses

Blood samples were collected for pharmacokinetic assessment. (NCT01453153)
Timeframe: Cycle 1, Week 1, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)

Interventionunits per milliliter (Mean)
PEGPH20 1.0 μg/kg0.626
PEGPH20 1.6 μg/kg0.651
PEGPH20 3.0 μg/kg0.864

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Change From Baseline in CA19-9 in Participants With a Baseline Value >=59 U/ml

CA19-9 is a tumor marker. Blood samples (plasma) were collected for CA19-9 evaluations. (NCT01453153)
Timeframe: up to the end of Cycle 10 (up to Week 44)

InterventionU/ml (Mean)
Cycle 1, Week 4, Visit 1Cycle 1, Week 8, Visit 1Cycle 2, Week 4, Visit 1Cycle 3, Week 4, Visit 1Cycle 4, Week 4, Visit 1Cycle 5, Week 4, Visit 1Cycle 6, Week 4, Visit 1Cycle 7, Week 4, Visit 1Cycle 8, Week 4, Visit 1Cycle 9, Week 4, Visit 1Cycle 10, Week 4, Visit 1
PEGPH20 3.0 μg/kg-15018.9-18274.5-20724.4-16835.7-27530.1-32656.8-79800.9-154964-154946-154940-154937

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Progression-Free Survival Rate (PFSR) at Week 24

"Progression-Free Survival (PFS) was defined as the time from the date of first dose of study medication to the date of first disease progression or death, if death occurred within 100 days of the final dose of study drug. Among participants without previous RECIST-defined progression, participants who died beyond 100 days and those who remained alive were censored at the last tumor assessment date (before subsequent therapy).~PFSR at week 24 was defined as the proportion of subjects remaining progression free and surviving at 24 weeks. The proportion was calculated by the product-limit method (Kaplan-Meier estimate), which takes into account censored data, and expressed as a percentage." (NCT01454102)
Timeframe: 24 weeks

InterventionPercentage of participants (Number)
Arm A: Nivolumab + Gemcitabine + Cisplatin50.5
Arm B: Nivolumab + Pemetrexed + Cisplatin68.4
Arm C10: Nivolumab + Paclitaxel + Carboplatin34.3
Arm D: Nivolumab + Bevacizumab Maintenance58.3
Arm E: Nivolumab + Erlotinib50.6
Arm F: Nivolumab39.7
Arm GH: Nivolumab + Ipilimumab42.8
Arm IJ: Nivolumab + Ipilimumab37.3
Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)50.0
Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)20.5
Arm M: Nivolumab8.3
Arm N: Nivolumab + Ipilimumab49.1
Arm O: Nivolumab + Ipilimumab48.0
Arm P: Nivolumab + Ipilimumab72.4
Arm Q: Nivolumab + Ipilimumab39.5
Arm C5: Nivolumab + Paclitaxel + Carboplatin59.3

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Number of Participants Who Experienced Selected Adverse Events

"The number of participants who experienced an AE of interest due to any cause is presented. Endocrine, Gastrointestinal, Hepatic, Pulmonary, Renal, Skin, and~Hypersensitivity/Infusion select AEs were identified that are potentially associated with the use of nivolumab, based on the following 4 guiding principles:~AEs that may differ in type, frequency, or severity from AEs caused by non-immunotherapies~AEs that may require immunosuppression (eg, corticosteroids) as part of their management~AEs whose early recognition and management may mitigate severe toxicity~AEs for which multiple event terms may be used to describe a single type of AE, thereby necessitating the pooling of terms for full characterization." (NCT01454102)
Timeframe: From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)

,,,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
EndorcrineGastrointestinalHepaticPulmonaryRenalSkinHypersensitivity/Infusion Reactions
Arm A: Nivolumab + Gemcitabine + Cisplatin3402131
Arm B: Nivolumab + Pemetrexed + Cisplatin2622696
Arm C10: Nivolumab + Paclitaxel + Carboplatin0810177
Arm C5: Nivolumab + Paclitaxel + Carboplatin1601471
Arm D: Nivolumab + Bevacizumab Maintenance2202151
Arm E: Nivolumab + Erlotinib410412162
Arm F: Nivolumab816530274
Arm GH: Nivolumab + Ipilimumab815732151
Arm IJ: Nivolumab + Ipilimumab612220143
Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)3521342
Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)2102020
Arm M: Nivolumab0100020
Arm N: Nivolumab + Ipilimumab412432201
Arm O: Nivolumab + Ipilimumab15131332201
Arm P: Nivolumab + Ipilimumab811156213
Arm Q: Nivolumab + Ipilimumab1213234201

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Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. (NCT01454102)
Timeframe: From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)

,,,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
SAEsAEs leading to discontinuationDeath
Arm A: Nivolumab + Gemcitabine + Cisplatin420
Arm B: Nivolumab + Pemetrexed + Cisplatin1050
Arm C10: Nivolumab + Paclitaxel + Carboplatin810
Arm C5: Nivolumab + Paclitaxel + Carboplatin920
Arm D: Nivolumab + Bevacizumab Maintenance330
Arm E: Nivolumab + Erlotinib1130
Arm F: Nivolumab2392
Arm GH: Nivolumab + Ipilimumab18112
Arm IJ: Nivolumab + Ipilimumab17133
Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)330
Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)441
Arm M: Nivolumab411
Arm N: Nivolumab + Ipilimumab1231
Arm O: Nivolumab + Ipilimumab2141
Arm P: Nivolumab + Ipilimumab25104
Arm Q: Nivolumab + Ipilimumab2582

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Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests

"The number of subjects with selected hepatic laboratory abnormalities is reported.~AST= aspartate aminotransferase; ALT= alanine aminotransferase; ULN= upper limit of normal." (NCT01454102)
Timeframe: From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)

,,,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
ALT OR AST > 3XULNALT OR AST > 5XULNALT OR AST > 10XULNALT OR AST > 20XULNTOTAL BILIRUBIN > 2XULNAST or ALT>3XULN with Bilirubin>2XULN within 1 dayAST or ALT>3XULN with Bilirubin>2XULN within 30day
Arm A: Nivolumab + Gemcitabine + Cisplatin0000000
Arm B: Nivolumab + Pemetrexed + Cisplatin0000000
Arm C10: Nivolumab + Paclitaxel + Carboplatin2000000
Arm C5: Nivolumab + Paclitaxel + Carboplatin2000000
Arm D: Nivolumab + Bevacizumab Maintenance1000000
Arm E: Nivolumab + Erlotinib4210111
Arm F: Nivolumab2200111
Arm GH: Nivolumab + Ipilimumab6421000
Arm IJ: Nivolumab + Ipilimumab0000000
Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)0000000
Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)0000000
Arm M: Nivolumab0000000
Arm N: Nivolumab + Ipilimumab1111000
Arm O: Nivolumab + Ipilimumab2100000
Arm P: Nivolumab + Ipilimumab1000000
Arm Q: Nivolumab + Ipilimumab0000000

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Objective Response Rate (ORR)

ORR was defined as the percentage of all treated participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria as per investigator assessment. This proportion was multiplied by 100 and expressed as a percentage. BOR was defined as the best response designation recorded between the date of randomization and the date of progression, or the date of subsequent anticancer therapy, whichever occurred first. CR or PR determinations included in the BOR assessment were confirmed by a second scan at least 4 weeks after the criteria for responses were first met. For participants without progression or subsequent therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial progression. (NCT01454102)
Timeframe: From first dose until date of progression or subsequent anti-cancer therapy (assessed up to July 2016, approximately 55 months)

InterventionPercentage of participants (Number)
Arm A: Nivolumab + Gemcitabine + Cisplatin41.7
Arm B: Nivolumab + Pemetrexed + Cisplatin46.7
Arm C10: Nivolumab + Paclitaxel + Carboplatin46.7
Arm D: Nivolumab + Bevacizumab Maintenance16.7
Arm E: Nivolumab + Erlotinib19.0
Arm F: Nivolumab23.1
Arm GH: Nivolumab + Ipilimumab20.8
Arm IJ: Nivolumab + Ipilimumab24.0
Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)0
Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)15.4
Arm M: Nivolumab8.3
Arm N: Nivolumab + Ipilimumab22.6
Arm O: Nivolumab + Ipilimumab32.5
Arm P: Nivolumab + Ipilimumab47.4
Arm Q: Nivolumab + Ipilimumab38.5
Arm C5: Nivolumab + Paclitaxel + Carboplatin50.0

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Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests

"The number of subjects with selected thyroid laboratory abnormalities is reported. FT3 and FT4 test abnormalities were considered for a 2-week window after the abnormal TSH test date.~TSH= thyroid-stimulating hormone; FT3= Free T3; FT4= Free T4; LLN= lower limit of normal; ULN= upper limit of normal" (NCT01454102)
Timeframe: From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)

,,,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
TSH > ULNTSH > ULN WITH TSH <= ULN AT BASELINETSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLNTSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLNTSH > ULN WITH FT3/FT4 TEST MISSINGTSH < LLNTSH < LLN WITH TSH >= LLN AT BASELINETSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULNTSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULNTSH < LLN WITH FT3/FT4 TEST MISSING
Arm A: Nivolumab + Gemcitabine + Cisplatin2100221101
Arm B: Nivolumab + Pemetrexed + Cisplatin3212073133
Arm C10: Nivolumab + Paclitaxel + Carboplatin1101051014
Arm C5: Nivolumab + Paclitaxel + Carboplatin5420375205
Arm D: Nivolumab + Bevacizumab Maintenance8410721011
Arm E: Nivolumab + Erlotinib12870577403
Arm F: Nivolumab2113341499414
Arm GH: Nivolumab + Ipilimumab10105141212633
Arm IJ: Nivolumab + Ipilimumab7652099513
Arm K: Nivolumab in Squamous Histology Subjects (NSCLC)5532033210
Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC)5302310100
Arm M: Nivolumab2100264105
Arm N: Nivolumab + Ipilimumab10761399621
Arm O: Nivolumab + Ipilimumab129714109721
Arm P: Nivolumab + Ipilimumab11550666114
Arm Q: Nivolumab + Ipilimumab11842599117

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Objective Response Rate (ORR)

The ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST criteria. The ORR was estimated by study arm based on the tumor response evaluation as determined by the investigator, according to RECIST 1.1. Participants with unknown response were treated as non-responders. The statistical difference in ORR between treatment arms was evaluated using the Cochran-Mantel-Haenszel (CMH) chi-square test with histology, TPC option, and geographic region as strata, tested at an alpha level of 0.05 (2-sided). The 95 percent confidence interval (CI) was calculated using Clopper Pearson method. (NCT01454934)
Timeframe: Randomization (Day 1) to CR or PR

Interventionpercentage of participants (Number)
Arm A: Eribulin Mesylate12.2
Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed15.2

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Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)

PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first. The difference in PFS (based on the tumor response evaluation as determined by the investigator) between eribulin mesylate and TPC was evaluated using the log rank test, stratified by histology, TPC option, and geographic region, tested at an alpha level of 0.05 (2-sided). PFS censoring rules will be defined in the SAP and follow Federal Department of Agriculture (FDA) guidance. (NCT01454934)
Timeframe: Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months

Interventionmonths (Median)
Arm A: Eribulin Mesylate3.0
Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed2.8

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Overall Survival (OS)

The OS was defined as the time in months from the date of randomization to the date of death, regardless of cause. In the absence of confirmation of death, the participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. The two treatment arms were compared using the log-rank test, stratified by histology, TPC option, and geographic region; and the treatment difference between eribulin mesylate and TPC was tested at a significance level of 0.05 (2-sided). Kaplan-Meier (K-M) survival probabilities for each arm were plotted over time. The treatment effect was estimated by fitting a Cox Proportional Hazards model to the OS times including treatment arm as a factor and histology, TPC option and geographic region as strata. (NCT01454934)
Timeframe: Randomization (Day 1) until date of death from any cause, or 37 months

Interventionmonths (Median)
Arm A: Eribulin Mesylate9.5
Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed9.5

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Percentage of Participants Without Disease Progression (Progression-Free Survival) at 6 Months

PFS is defined as the percentage of patients with disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause at 6 months. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve. (NCT01459614)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Primary Cohort (21 Day Cycle)78.6
Expansion Cohort (28 Day Cycle)30

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Progression-free Survival (PFS)

PFS is defined as the the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause . Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve. (NCT01459614)
Timeframe: Up to 21 months

InterventionMonths (Median)
Primary Cohort (21 Day Cycle)8.4
Expansion Cohort (28 Day Cycle)4.1

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Overall Survival (OS)

OS (in months) will be measured from date of first dose until death (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (NCT01459614)
Timeframe: Up to 28 months

InterventionMonths (Median)
Primary Cohort (21 Day Cycle)13.42

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Disease Control Rate (DCR)

DCR is defined as the percentage of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. (NCT01459614)
Timeframe: Up to 22 months

InterventionPercentage of Participants (Number)
Primary Cohort (21 Day Cycle)89

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Pathologic Downstaging and Margin Status

Pathologic stage and margin status after resection. Pathologic downstaging was determined my looking at the rate of R0 (all residual tumor removed during surgery) vs R1 (microscopic tumor present at the resection margin per pathology) resections. (NCT01470417)
Timeframe: At the time of surgery after neoadjuvant therapy

,
Interventionparticipants (Number)
R0 ResectionR1 Resection
Chemotherapy30
Chemotherapy + ChemoRadiotherapy32

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Radiographic Response Rate

Evaluate radiographic response of the measurable disease with repeat imaging at 4 - 8 weeks after therapy. Measurable disease was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 criteria. Per RECIST v1.1 in target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >20% growth in the sum of the longest diameter or target lesions or appearance of new lesions; Stable Disease (SD), change in sum of longest diameter of target lesions does not meet criteria for PR or PD. The number of subjects experiencing Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD) is reported. (NCT01470417)
Timeframe: 4 - 8 weeks after neoadjuvant therapy

,
Interventionparticipants (Number)
Partial ResponseStable DiseaseProgressive Disease
Chemotherapy120
Chemotherapy + ChemoRadiotherapy052

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90 Day Post-operative Mortality

Evaluate mortality in the first 90 days after surgery (NCT01470417)
Timeframe: 90 days after surgery

,
Interventionparticipants (Number)
Number of survivalNumber of mortality
Chemotherapy30
Chemotherapy + ChemoRadiotherapy50

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Biochemical Response Rate

Biochemical response rate (serum CA 19-9). Baseline compared to pre-operative serum CA19-9 values. (NCT01470417)
Timeframe: 4 - 8 weeks after neoadjuvant therapy

,
InterventionU/mL (Mean)
Baseline CA19-9Pre-Operative CA19-9
Chemotherapy38343
Chemotherapy + ChemoRadiotherapy55053

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Progression Free Survival (PFS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination

Median Progression Free Survival (mPFS) was estimated using a Kaplan-Meier curve with 0 censored patients. PFS is defined from the time of treatment initiation until the first documentation of progressive disease. Any patient without the event at the time of analysis will be censored from the last documented contact. (NCT01473940)
Timeframe: Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10

Interventionmonths (Median)
Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kg3.3859
Cohort 2/Expansion Gemcitabine-1,000mg/m2+Ipilimumab-3mg/kg2.5312
Cohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg3.8626

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Number of Dose Limiting Toxicities (DLTs) Seen in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination in Order to Define the Maximum Tolerated Dose (MTD)

"Dose limiting toxicity (DLT) will be monitored by calculating the Bayesian predictive probability of a DLT given the data to date. All toxicities will be summarized in a descriptive manner as to type, frequency, attribution and timing by dose level. Safety will be evaluated for all treated patients using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 where grading is as follows:~Mild (grade 1) Moderate (grade 2) Severe (grade 3) Life-threatening (grade 4) Fatal (grade 5)~In general a DLT will be defined as any any of the following drug-related toxicities:~Febrile neutropenia with grade 3/4 neutropenia Asymptomatic grade 4 neutropenia more than 7 days Grade 3 thrombocytopenia with grade 3-4 hemorrhage or grade 4 thrombocytopenia Non-hematologic toxicity grade 3 or 4 (with some protocol specified exceptions)~DLTs will be used to determine the MTD for the expansion cohort of the study.~*AST = Aspartate transamina" (NCT01473940)
Timeframe: During the 12 weeks of Induction Therapy

,,
InterventionDLTs (Number)
Number of DLTS seen in cohortNumber of AST increase DLTs seen in cohortNumber of diarrhea DLTs seen in cohort
Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kg000
Cohort 2 Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg000
Cohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg211

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Duration of Response in Patients Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination

"Duration of response is shown below for patients who showed a response as defined by immune-related response criteria (irCR) as either of the following:~irComplete Response (irCR)-Complete disappearance of all index lesions or irPartial Response (irPR)-Decrease of 50% or greater in the sum of products of the two largest perpendicular diameters of all index and all new measurable lesions (i.e., percentage change in tumor burden)~Duration of response is defined as the time from first documentation of response to first documentation of progression, with progression defined as:~irProgressive Disease (irPD)-At least 25% increase in the percentage change in tumor burden (i.e., taking sum of all the products of all the index lesions and any new lesions) when compared to the sum of all the product diameters (SPD) at nadir." (NCT01473940)
Timeframe: From the time of response and every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10

Interventionmonths (Number)
Cohort 2 Gemcitabine-1,000mg/m2+Ipilimumab-3mg/kg8.5
Cohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg19.8
Expansion - Gemcitabine-1,000mg/m2+Ipilimumab-3mg/kg11

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Overall Survival (OS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination

Overall Survival (OS) was estimated using a kaplan-meier curve with 0 patients censored. OS is defined from the time of treatment initiation until the time of death from any cause. Any patient without the event at the time of analysis will be censored from the last documented contact. (NCT01473940)
Timeframe: Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10

Interventionmonths (Median)
Cohort 1 Gemcitabine - 750 mg/m2, Ipilimumab 3 mg/kg5.3254
Cohort 2/Expansion Gemcitabine-1,000mg/m2+Ipilimumab-3mg/kg5.7199
Cohort 3 Gemcitabine -1,000 mg/m2, Ipilimumab 6 mg/kg8.9908

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Overall Survival (OS)

OS was defined as the time from the date of randomization to the date of death. Participants without documentation of death were censored at the date last known to be alive. (NCT01482962)
Timeframe: Participants were followed for survival for 2 years from date of last participant off study treatment, or death, whichever occurs first. Contacts were every 4 months (Median follow-up 519 days in the alisertib arm and 586 days in the comparative arm)

Interventiondays (Median)
Alisertib415
Pralatrexate, or Romidepsin, or Gemcitabine367

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Progression-Free Survival (PFS) Based on IRC Assessment

PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurred first. (NCT01482962)
Timeframe: Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years

Interventiondays (Median)
Alisertib115
Pralatrexate, or Romidepsin, or Gemcitabine104

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Time to Disease Progression (TTP)

Time to Progression (TTP) was defined as the time from the date of randomization to the date of first documentation of PD/relapse. (NCT01482962)
Timeframe: At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years

Interventiondays (Median)
Alisertib162
Pralatrexate, or Romidepsin, or Gemcitabine116

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Time to Response

Time to Response is defined as the time from the date of randomization to the date of first documentation of PR or better. (NCT01482962)
Timeframe: At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years

Interventiondays (Median)
Alisertib62
Pralatrexate, or Romidepsin, or Gemcitabine64

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Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms

The FACT-LYM includes the Functional Assessment of Cancer Therapy General Scale (FACT-G) and a 15-item lymphoma-specific subscale (LYM) over the past week. The FACT-G has 27 items that incorporate 4 scales including physical well-being (PWB; 7 items), social/family well-being (SWB, 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). The combined FACT-LYM instrument consists of a total of a 42 item questionnaire. Each question is answered on a 5- point scale of 0 (not at all) to 4 (very much) for a total possible score of 168. Higher scores indicate better well-being and a positive change from Baseline indicates improvement. (NCT01482962)
Timeframe: Baseline and End of Treatment (EOT) (Up to 152 Weeks)

,
Interventionscore on a scale (Mean)
Physical Well-Being, EOTSocial/Family Well-Being, EOTEmotional Well-Being, EOTFunctional Well-Being, EOT
Alisertib-2.4-0.3-1.4-2.4
Pralatrexate, or Romidepsin, or Gemcitabine-1.30.0-0.8-0.3

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Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs

Clinical laboratory tests included chemistry, hematology and urinalysis test. Clinically significant treatment-emergent laboratory abnormalities were reported by the investigator as TEAEs. (NCT01482962)
Timeframe: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)

,
Interventionparticipants (Number)
Neutrophil Count DecreasedWhite Blood Cell Count DecreasedLymphocyte Count DecreasedMonocyte Count DecreasedLymphocyte Count IncreasedMonocyte Count IncreasedWhite Blood Cell Count IncreasedPlatelet Count DecreasedAlanine Aminotransferase IncreasedAspartate Aminotransferase IncreasedGamma-glutamyltransferase IncreasedBlood Bilirubin IncreasedHepatic Enzyme IncreasedLiver Function Test AbnormalTransaminases IncreasedBlood Alkaline Phosphatase IncreasedBlood Lactate Dehydrogenase IncreasedBlood Creatinine IncreasedBlood Creatinine DecreasedBlood Urea IncreasedBlood Potassium DecreasedBlood Magnesium DecreasedBlood Bicarbonate DecreasedBlood Calcium DecreasedBlood Calcium IncreasedBlood Phosphorus DecreasedCalcium Ionised IncreasedHaemoglobin DecreasedHaematocrit IncreasedHaematocrit DecreasedCoagulation Factor XIII Level DecreasedInternational Normalised Ratio IncreasedBlood Albumin DecreasedMyocardial Necrosis Marker IncreasedTroponin IncreasedBlood Glucose IncreasedImmunoglobulins IncreasedBlood Uric Acid IncreasedEnterovirus Test Positive
Alisertib181762111158562200953011100101111110100110
Pralatrexate, or Romidepsin, or Gemcitabine14105100022111131011717104211010320002011001

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Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs

Vital signs included blood pressure, heart rate and temperature. Individual clinically significant changes in vital signs were reported by the investigator as TEAEs. (NCT01482962)
Timeframe: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)

,
Interventionparticipants (Number)
Heart Rate IncreasedBody Temperature IncreasedHypotensionOrthostatic HypotensionHypertensionPyrexia
Alisertib1042548
Pralatrexate, or Romidepsin, or Gemcitabine0161740

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/ birth defect or is a medically important event. (NCT01482962)
Timeframe: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)

,
Interventionparticipants (Number)
TEAESAE
Alisertib13675
Pralatrexate, or Romidepsin, or Gemcitabine12669

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Time to Subsequent Antineoplastic Therapy

Time to subsequent antineoplastic therapy was defined as the time from randomization to the first date of subsequent antineoplastic therapy (excluding transplant). Participants without subsequent antineoplastic therapy were censored at the date of death or last known to be alive. (NCT01482962)
Timeframe: From date of last study drug to date of subsequent antineoplastic therapy, if required; approximately 3 years

Interventiondays (Median)
Alisertib336
Pralatrexate, or Romidepsin, or Gemcitabine233

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Complete Response (CR) Rate

Complete Response (CR) rate is defined as the percentage of participants with CR as assessed by the IRC using IWG criteria (2007 Cheson). CR= Disappearance of all evidence of disease. (NCT01482962)
Timeframe: At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until PD (approximately 3 years)

Interventionpercentage of participants (Number)
Alisertib18
Pralatrexate, or Romidepsin, or Gemcitabine27

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Duration of Response (DOR)

DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease (PD)/relapse for responders as assessed by the IRC using IWG criteria. Responders without documentation of PD/relapse were censored at the date of last response assessment that was stable disease (SD) or better. (NCT01482962)
Timeframe: At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years

Interventiondays (Median)
Alisertib225
Pralatrexate, or Romidepsin, or Gemcitabine172

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Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment

ORR was defined as the percentage of participants who achieve Complete Response (CR) or Partial Response (PR) as assessed by the IRC using International Working Group (IWG) criteria. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites. (NCT01482962)
Timeframe: Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years

Interventionpercentage of participants (Number)
Alisertib33
Pralatrexate, or Romidepsin, or Gemcitabine45

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Overall Survival

Time to event outcome measure (death), measured in days from cycle 1 day 1. (NCT01515046)
Timeframe: up to 5 years

Interventiondays (Number)
Gemcitabine With Escalating IV Ascorbate268

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Progression Free Survival

Time-to-event outcome measure (initial disease progression) measured in days from cycle 1 day 1 to day of first progression as defined by RECIST criteria from NCI. (NCT01515046)
Timeframe: up to 5 years

Interventiondays (Number)
Gemcitabine With Escalating IV Ascorbate80

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Median Overall Survival

To determine the median overall survival of patients with advanced/metastatic urothelial cancer treated with gemcitabine, cisplatin, plus ipilimumab, calculated from the date of registration until the date of final analysis, projected to be 48 months from the start of the study. (NCT01524991)
Timeframe: 48 months

Interventionmonths (Median)
Treatment13.9

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Progression-Free Survival

"To determine the progression-free survival (using irRC and RECIST v1.0) of patients with advanced/metastatic urothelial carcinoma treated with gemcitabine, cisplatin, and ipilimumab.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression is definied by IrRC as at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 wk apart." (NCT01524991)
Timeframe: 12 months

Interventionmonths (Median)
Treatment7.9

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Overall Survival

Two treatment arms will be compared using a one-sided log-rank test stratified by sarcoma subtype and study site. Kaplan-Meier estimates and the survival curves for each treatment arm will be presented with the estimated hazard ratios and their associated confidence interval. (NCT01532687)
Timeframe: From randomization to death due to any cause, or until last patient contact if the patient did not die, assessed up to 3 years

,
Interventionmonths (Median)
All RandomizedLiposarcoma participantsOther Sarcoma participants
Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride11.020.510.2
Gemcitabine Hydrochloride Plus Placebo15.65.717.7

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Progression-free Survival (PFS)

Compared using a one-sided Gehan-Wilcoxon test stratified by sarcoma subtype. Kaplan-Meier estimates for each treatment arm will be presented with the estimated hazard ratios and their associated confidence intervals. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the smallest sum on study) with an absolute increase of at least 5 mm (target lesions), or measurable increase in non-target lesions (unequivocal progression), or appearance of one or more new lesions. (NCT01532687)
Timeframe: Calculated as the time from randomization to the first documented progression or death, whichever occurs first, or until time of last contact if no progression or death occurred, assessed up to 3 years

,
Interventionmonths (Median)
All randomizedLiposarcomaOther Sarcoma
Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride4.58.94.4
Gemcitabine Hydrochloride Plus Placebo1.61.52.2

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Percentage of Participants Achieving Best Overall Objective Response (CR+PR)

Response is evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where RECIST combines assessments for target, non-target and presence of new lesions. Best Overall Objective Response is the sum of all CR+PR divided by all randomized participants, where the strongest recorded response is used for the evaluation (CR>PR>SD>PD). Objective response (CR+PR) requires at least a 30% decrease in the sum of the largest diameter target lesions (with respective to the baseline sum); disappearance of all or persistence of one or more non-target lesions, maintenance of tumor marker levels above normal limits, and no new lesions. Estimated odds ratio of best overall objective response are reported with 95% confidence interval for the two histologic sarcoma subgroups (liposarcoma vs all other eligible soft tissue sarcoma subtypes). One-sided proportions test is used to determine whether best overall objective response is greater for the gemcitabine plus pazopanib group. (NCT01532687)
Timeframe: Best overall objective response recorded from the start of treatment until disease progression/recurrence assessed up to 3 years

,
Interventionpercentage of participants (Number)
All randomized participantsLiposarcoma participantsOther sarcoma participants
Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride6.922.20
Gemcitabine Hydrochloride Plus Placebo8.0011.1

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Progression-free Survival (PFS) for a Sub-group of Patients Treated With Open-label Pazopanib Hydrochloride Following Administration of Gemcitabine Hydrochloride in the Cross-over Portion of This Study

Participants who progress during treatment and are found to be part of the gemcitabine+placebo arm after unblinding are eligible to receive open-label pazopanib with gemcitabine. This is the crossover population. Statistical analysis is exploratory and requires sufficient crossover participants to assess Kaplan-Meier estimated hazard ratio and associated 95% confidence interval. This represents the participants second progression. In both cases progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 as at least a 20% increase in the sum of the longest diameters of target lesions with an absolute increase of at least 5 mm (target lesions), or measurable increase in non-target lesions (unequivocal progression), or appearance of one or more new lesions. First progression uses the smallest sum on study as a reference; progression for the crossover population uses first progression measurements as the reference. (NCT01532687)
Timeframe: Calculated as the time from receiving open-labeled pazopanib hydrochloride to the next documented progression or death whichever occurs first, assessed up to 3 years

Interventionmonths (Median)
Crossover From Gemcitabine + Placebo to Gemcitabine + Open-label Pazopanib3.0

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Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

(NCT01533207)
Timeframe: Approximately 4 years

Interventionparticipants (Number)
Regimen 110
Regimen II1

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Number of Participants Who Experienced Death

The duration of time from study entry to time of death or the date of last contact. (NCT01533207)
Timeframe: Follow-up every 4 months for 3 years, then every 6 months for 2 years.

InterventionParticipants (Number)
Regimen 15
Regimen II1

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Number of Participants With Recurrence

The duration of time from study entry to time of recurrence or death, whichever occurred first, or the date of last contact. (NCT01533207)
Timeframe: Follow-up every 4 months for 3 years, then every 6 months for 2 years.

Interventionparticipants (Number)
Regimen 18
Regimen II8

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Number of Patients With Gastrointestinal Toxicities (Grade 3 and 4 Nausea and Vomiting) Associated With Delivering Fluorouracil/Gemcitabine Hydrochloride-based Chemotherapy With Upper Abdominal Radiation

Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Descriptive statistics (means, standard deviations, frequencies, etc.) will be presented for pretreatment patient characteristics. The rate of grade 3 and 4 nausea will be compared to the cut points during interim and final analyses. (NCT01534637)
Timeframe: Over 10 weeks

Interventionparticipants (Number)
Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)3

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Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs

(NCT01534637)
Timeframe: Week 1

Interventionparticipants (Number)
Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)6

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Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs

(NCT01534637)
Timeframe: Week 5

Interventionparticipants (Number)
Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)5

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Overall Response Rate (ORR) of Bendamustine Hydrochloride and Gemcitabine Hydrochloride in Patients With Relapsed or Refractory Hodgkin Lymphoma (Phase II)

Tested using Simon's two-stage Minimax design. Descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data) and graphical analyses will be used for all correlative laboratory parameters. The associations between correlative laboratory parameters and clinical response will be evaluated using two sample t test or Fisher's exact test, whichever is appropriate. (NCT01535924)
Timeframe: up to 5 years

Interventionpercentage of patients (Number)
Phase 2 (Dose Levels 5)67
Phase 271

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Adverse Events in Terms of Dose-limiting Toxicity (DLT) and MTD of Bendamustine Hydrochloride (Phase I)

Dose limiting toxicity will be defined during cycle 1 only of the phase I trial. Hematologic and Infectious Dose Limiting Toxicities include: Grade 3 febrile neutropenia persisting> 7 days, Grade 4 infection or febrile neutropenia. Treatment delay>14 days due to grade 3-4 neutropenia or thrombocytopenia. Non-Hematological Dose Limiting Toxicities include: any Grade 3 or 4 non-hematologic toxicity related to study treatment with the exception of nausea or vomiting, alopecia, or electrolyte/glucose abnormalities that are correctable within 72 hours. (NCT01535924)
Timeframe: up to 5 years

Interventionnumber of patients (Number)
Phase 1 (Dose Levels 1)0
Phase 1 (Dose Levels 2)0
Phase 1 (Dose Levels 3)0
Phase 1 (Dose Levels 4)0

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Number of Participants Correlative Studies Including DPC4 (SMAD4) Staining and Circulating Tumor Cells (CTC) Post-Surgery

Tumor tissue collected pre-therapy and post-therapy for surgically resected patients was assessed for SMAD4 status and classified as either present or absent based on immunohistochemistry evaluation. (NCT01560949)
Timeframe: 43 months

InterventionParticipants (Count of Participants)
PresentAbsent
Surgery47

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Number of Participants Correlative Studies Including DPC4 (SMAD4) Staining and Circulating Tumor Cells (CTC) Pre-Surgery

Tumor tissue collected pre-therapy and post-therapy for surgically resected patients was assessed for SMAD4 status and classified as either present or absent based on immunohistochemistry evaluation. (NCT01560949)
Timeframe: 43 months

InterventionParticipants (Count of Participants)
PresentAbsent
Surgery42

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Overall Survival

Overall survival (OS) was defined as the time interval from the date of diagnosis to the date of death due to any cause or the date a patient was last known to be alive. Estimated by using the Kaplan-Meier method. (NCT01560949)
Timeframe: 54 months

Interventionmonths (Median)
All Phases(Systematic,Chemoradiation w/ Gemcitabine & Surgery)24

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Number of Participants With Resectability Rate

Patients with borderline resectable treated with preoperative modified FOLFIRINOX chemotherapy, followed by gemcitabine-based chemoradiation therapy. At least 4- 6 weeks after the last dose of gemcitabine if there is no local progression or distant metastasis, patients were scheduled for surgery. (NCT01560949)
Timeframe: 43 months

InterventionParticipants (Count of Participants)
Surgery15

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Number of Participants With R0 Margin Resection

The specimen was designated R0 if no tumor cells were identified at any of the resection margins. (NCT01560949)
Timeframe: 43 months

InterventionParticipants (Count of Participants)
Surgery10

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Disease Free Survival (DFS)

Disease free survival (DFS) was defined as the time interval from the date of surgery to the date of disease recurrence or death or the date of a participant was last known to be alive without disease recurrence. (NCT01560949)
Timeframe: 54 months

Interventionmonths (Median)
All Phases11.1

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Number of Participants With Local and Distant Failure

(NCT01560949)
Timeframe: 43 months

InterventionParticipants (Count of Participants)
Local recurrenceDistant recurrence
Surgery010

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Number of Participants That Were SMAD4 Positive Before and After Surgery

Tumor tissue collected pre-therapy and post-therapy for surgically resected patients was assessed for SMAD4 status and classified as either present or absent based on immunohistochemistry evaluation. (NCT01560949)
Timeframe: 43 months

InterventionParticipants (Count of Participants)
SMAD4 positive before surgerySMAD4 positive after surgery
Surgery44

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Part 2: Overall Response Rate (ORR)

ORR was defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) based on RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. (NCT01574716)
Timeframe: From date of first dose until disease progression (up to approximately 3.5 years)

Interventionpercentage of participants (Number)
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel19.4
Part 2: Placebo + Gemcitabine/Docetaxel20.0

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Part 2: Overall Survival (OS)

OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause. (NCT01574716)
Timeframe: From date of first dose until date of death from any cause (up to approximately 3.5 years)

Interventionmonths (Median)
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel18.3
Part 2: Placebo + Gemcitabine/Docetaxel21.1

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Part 2: Radiologic Progression-free Survival (PFS)

PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause. (NCT01574716)
Timeframe: From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)

Interventionweeks (Median)
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel18.7
Part 2: Placebo + Gemcitabine/Docetaxel24.1

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Part 2: Radiologic Progression-free Survival Rate (PFR)

Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points. (NCT01574716)
Timeframe: Weeks 12, 24, 48 and 52

,
Interventionpercentage of participants (Number)
12 weeks24 weeks48 weeks52 weeks
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel57.643.324.520.8
Part 2: Placebo + Gemcitabine/Docetaxel61.851.025.221.4

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Part 2: Symptomatic Progression-free Survival

PFS including symptomatic progression was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression according to RECIST 1.1, symptomatic progression, or death due to any cause. (NCT01574716)
Timeframe: From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years)

Interventionweeks (Median)
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel18.1
Part 2: Placebo + Gemcitabine/Docetaxel24.0

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Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels

(NCT01574716)
Timeframe: Up to approximately 3 years

Interventionparticipants (Number)
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel0
Part 2: Placebo + Gemcitabine/Docetaxel0

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Pathologic Response Rate

Defined as the absence of muscle invasive carcinoma (NCT01589094)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Gemcitabine and Cisplatin (DD GC)57

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Number of Participants With Toxicity

Toxicity will be graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0. (NCT01589094)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Gemcitabine and Cisplatin (DD GC)51

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2 Year Recurrence Free Survival (RFS) Rate for Nonresponders

Defined as the time from treatment initiation to disease progression, local-regional or metastatic recurrence, or death analyzed using the Kaplan Meier method. (NCT01589094)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Gemcitabine and Cisplatin (DD GC)52

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2 Year Recurrence Free Survival (RFS) Rate for Responders

Defined as the time from treatment initiation to disease progression, local-regional or metastatic recurrence, or death analyzed using the Kaplan Meier method. (NCT01589094)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Gemcitabine and Cisplatin (DD GC)95

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Rate of Participants With Grade 3 or Higher Toxicity

Toxicity is graded according to the CTCAE v 4. (NCT01593748)
Timeframe: 30 days post end of treatment

InterventionParticipants (Count of Participants)
Experimental39
Standard of Care39

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Hazard Ratio

Hazard ratio is defined as the rate of survival in the experimental group versus the standard of care group. A hazard ratio of greater than one or less than one means that survival was better in one of the groups. (NCT01593748)
Timeframe: minimum of 18 months

Interventionhazard ratio (Number)
Experimental1.2
Standard of CareNA

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Average Number of Months of Progression-free Survival

To estimate the PFS of the combination of G+P or G+T in patients with metastatic and/or locally advanced or recurrent STS. Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. (NCT01593748)
Timeframe: minimum of 18 months

Interventionmonths (Median)
Experimental4.1
Standard of Care4.1

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Average Score of Quality of Life

"To estimate the quality of life of patient with metastatic an/or locally advanced recurrent STS using the Quality of Life Questionnaire (QLQ-C30). The QLQ-C30 is scored on a scale from 0-100 with 0 indicating never and 100 indicating always in regard the the participants' experience of fatigue, nausea/vomiting, pain, disponae, insomnia, appetite loss, constipation, diarrhea, financial concerns at 4 time points through the study." (NCT01593748)
Timeframe: Baseline, Cycle 2, Cycle 6 and End of Treatment

,
Interventionscore on a scale (Mean)
Fatigue at baselineNausea/Vommiting at baselinePain at baselineDysponae at baselineInsomnia at baselineAppetite loss at baselineConstipation at baselineDiarrhea at baselineFinancial at baselineFatigue at cycle 2Nausea/Vomitting at cycle 2Pain at cycle 2Dyspnoae at cycle 2Insomnia at cycle 2Appetite loss at cycle 2Constipation at cycle 2Diarrhea at cycle 2Financial at cycle 2Fatigue at cycle 6Nausea/vommiting at cycle 6Pain at cycle 6Dyspnoae at cycle 6Insomnia at cycle 6Appetite loss at cycle 6Constipation at cycle 6Diarrhea at cycle 6Financial at cycle 6Fatigue at end of studyNausea/vomitting at end of studyPain at end of studyDysponae at end of studyInsomnia at end of studyAppetite loss at end of studyConstipation at end of studyDiarrhea at end of studyFinancial at end of study
Experimental61.7991.0661.3822.7645.5322.7614.634.8837.4052.8980.6766.0024.0042.6736.1113.334.8826.6764.4486.6780.0010.0023.3326.6713.3336.6723.3349.8175.8653.4531.0348.2837.9317.2421.4339.60
Standard of Care67.1290.9974.7721.6236.0415.3215.328.1132.4355.0993.7583.3326.3938.8926.3923.618.1122.2251.118.0578.3343.3333.3330.0013.3320.0020.0049.7792.3672.9234.7237.5023.6129.1715.2829.17

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Progression-free Survival (PFS)

Estimate for probability of progression free survival by Kaplan-Meier method, where progression-free survival is defined as the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. PFS is censored in patients who are alive and have not progressed. Progression is assessed by RECIST 1.1 (NCT01595061)
Timeframe: From study entry to disease progression, death or date of last contact, whichever occurs first. The median for observed PFS was 26.2 month with a range from 1.5 months to 82.4 months

Interventionpercentage of participants (Number)
GEM+CIS+IMRT75

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Complete Clinical Response

Percentage of participants with complete clinical response. Complete clinical response is defined as no clinical/radiographic evidence of primary disease (vulva or groin) following primary chemo-radiation therapy. (NCT01595061)
Timeframe: 6-8 weeks after completion of chemo-radiation

Interventionpercentage of participants (Number)
GEM+CIS+IMRT71.7

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Complete Pathologic Response

Percentage of participants with complete pathologic response. Complete pathologic response is defined as negative local core biopsy or FNA specimens following primary chemo-radiation therapy. (NCT01595061)
Timeframe: 6 -8 weeks after completion of chemo-radiation

Interventionpercentage of participants (Number)
GEM+CIS+IMRT73.6

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Adverse Events (Grade 3 or Higher) During Treatment Period

Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0. (NCT01595061)
Timeframe: During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.

InterventionParticipants (Count of Participants)
LeukopeniaThrombocytopeniaNeutropeniaAnemiaOther InvestigationsOther blood and lymphatic disordersCardiac disordersGastrointestinal disordersGeneral disorders and administration site conditionsInfections and infestationsInjury, poisoning and procedural complicationsMetabolism and nutrition disordersMusculoskeletal and connective tissue disordersPeripheral sensory neuropathyOther nervous system disordersRenal and urinary disordersReproductive system and breast disordersRespiratory, thoracic and mediastinal disordersSkin and subcutaneous tissue disordersSurgical and medical proceduresVascular disorders
GEM+CIS+IMRT2720202078210552019212171415

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PK: Dose-Normalized Cmax of Gemcitabine

(NCT01606748)
Timeframe: Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion

Interventionnanogram(ng)/mL/mg (Geometric Mean)
Gemcitabine Cohort 1 Day 1 PK Run-In4.83
Gemcitabine Cohort 1 Day 1, Cycle 1, Combination7.87

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Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of Necitumumab in Combination With Gemcitabine-cisplatin Chemotherapy)

ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100. (NCT01606748)
Timeframe: Baseline to Measured Progressive Disease (Up to 14 Months)

Interventionpercentage of participants (Number)
Necitumumab Cohort 116.7
Necitumumab Cohort 25.9

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Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab

(NCT01606748)
Timeframe: Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 Hour (h) Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion

Interventionmicrogram/milliliter (ug/mL) (Geometric Mean)
Necitumumab Cohort 1 Day 3 Run-in277
Necitumumab Cohort 1 Day 1, Cycle 1, Combination315

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PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab

(NCT01606748)
Timeframe: Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion

Interventionug*hour(h)/mL (Geometric Mean)
Necitumumab Cohort 1 Day 3 Run-In21900
Necitumumab Cohort 1 Day 1, Cycle 1, Combination22900

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PK: AUC(0-∞) of Necitumumab After Administration of Process C and Process D Drug Product

(NCT01606748)
Timeframe: Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion

Interventionug*h/mL (Geometric Mean)
Necitumumab Cohort 133800
Necitumumab Cohort 235500

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PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab

(NCT01606748)
Timeframe: Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1 Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion

Interventionug*h/mL (Geometric Mean)
Necitumumab Cohort 1 Day 3 PK Run-In33800
Necitumumab Cohort 1 Day 1, Cycle 1, Combination26400

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PK: Cmax of Necitumumab After Administration of Process C and Process D Drug Product

(NCT01606748)
Timeframe: Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion

Interventionug/mL (Geometric Mean)
Necitumumab Cohort 1277
Necitumumab Cohort 2300

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PK: Dose-Normalized AUC(0-24) of Gemcitabine

(NCT01606748)
Timeframe: Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion

Interventionng*h/mL/mg (Geometric Mean)
Gemcitabine Cohort 1 Day 1 PK Run-in2.71
Gemcitabine Cohort 1 Day 1, Cycle 1, Combination3.31

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PK: Dose-Normalized AUC(0-5) of Cisplatin

(NCT01606748)
Timeframe: Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion

Interventionng*h/mL/mg (Geometric Mean)
Cisplatin Cohort 1 Day 1 Run-in61.5
Cisplatin Cohort 1 Day 1, Cycle 1, Combination67.3

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PK: Dose-Normalized Cmax of Cisplatin

(NCT01606748)
Timeframe: Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion

Interventionnanogram (ng)/mL/mg (Geometric Mean)
Cisplatin Cohort 1 Day 1 Run-in19.2
Cisplatin Cohort 1 Day 1, Cycle 1, Combination22.1

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Number of Participants With Anti-Necitumumab Antibodies

A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer. (NCT01606748)
Timeframe: Baseline through, 30-Day Follow-Up

,
Interventionparticipants with immunogenicity samples (Number)
ADA PositiveTE AntibodiesNeutralizing Antibodies
Necitumumab Cohort 1310
Necitumumab Cohort 2000

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PK: Dose Normalized AUC(0-∞) of Gemcitabine

(NCT01606748)
Timeframe: Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion

Interventionng*h/mL/mg (Geometric Mean)
Gemcitabine Cohort 1 Day 1 PK Run-in2.72
Gemcitabine Cohort 1 Day 1, Cycle 1, Combination3.32

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Progression-free Survival

Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of recurrence/progression or death from any cause, whichever occurs first. (NCT01610206)
Timeframe: 3 years

Interventionmonths (Median)
Gemcitabine2.9
Gemcitabine + Pazopanib5.3

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Number of Participants With Adverse Events

Adverse events will be evaluated using CTCAE criteria from the start of study treatment until 30 days following the last dose of study treatment (NCT01610206)
Timeframe: 30 days after last dose

InterventionParticipants (Count of Participants)
Gemcitabine73
Gemcitabine + Pazopanib75

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Pathological Complete Response Rate Following Chemotherapy Before Surgery

Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy (NCT01611662)
Timeframe: Up to 5 years

Interventionpercentage of participants (Number)
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)32

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Progression Free Survival (PFS)

Progression Free Survival will be calculated from the start of treatment until progressive disease or death. Patients who die before documented progression will be considered failures at their time of death. If the patient did not progress or die, the patient will be censored on the date of last follow-up. Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Measurable lesions: lesions that can be accurately measured in at least one dimension with longest diameter ≥ 10 mm by clinical exam or with spiral CT scan or MRI (no less than double the slice thickness and a minimum of 10mm). Malignant lymph nodes must be 15 mm in the short axis when assessed by spiral CT scan to be considered measurable. Non-measurable lesions: all other lesions (or sites of disease) including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm u (NCT01622660)
Timeframe: 2 years

Interventiondays (Number)
Gemcitabine and Pazopanib184

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Progression Free Survival

Progression-free survival was defined as the time from the first date of treatment until the date that PD or death was first reported. Disease progression included PD in any compartment per ATL response criteria, clinical progression at the end of the randomized treatment, or disease progression reported during the follow-up period. The date of PD was the earliest date at which disease progression could be declared. (NCT01626664)
Timeframe: From date of randomization until the date of first documented progression, start of alternative therapy, or date of death from any cause, whichever came first, up to 36 months

,
Interventionpercentage of subjects (Median)
PFS Subjects (%) Alive for at Least: 1 MonthPFS Subjects (%) Alive for at Least: 2 MonthsPFS Subjects (%) Alive for at Least: 3 MonthsPFS Subjects (%) Alive for at Least: 4 MonthsPFS Subjects (%) Alive for at Least: 5 MonthsPFS Subjects (%) Alive for at Least: 6 Months
Investigator's Choice44.133.026.413.200
KW-076147.529.824.418.318.312.2

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Change in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score

The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline. (NCT01626664)
Timeframe: From date of randomization until the date of first documented progression, up to 36 months

,
InterventionUnits on a scale (Mean)
BaselineLast Observation Change from Baseline
Investigator's Choice106.8-14.9
KW-0761110.1-12.1

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Overall Response Rate

"Overall Response Rate was determined based on the response in all compartments (lymph nodes, extranodal masses, spleen/liver, skin, peripheral blood, and bone marrow), referencing Tsukasaki, 2009 as follows: Complete Response (CR) = All compartments involved with disease must be CR; Uncertified Complete Response (CRu) = > 75% decrease in lymph nodes and/or extranodal disease with all other compartments involved with disease CR; Partial Response (PR) = If any compartment is CR/PR and all other compartments involved with disease are at least SD; Stable Disease (SD) = All compartments involved with disease are SD; Progressive Disease (PD) = PD in any compartment.~Lymph node and extranodal masses response ≥50% decrease by CT, skin response ≥50% decrease in mSWAT score; blood response ≥50% decrease in malignant cells by flow cytometry; normal bone marrow if abnormal at baseline. PD equals New or ≥50% increase in any compartment." (NCT01626664)
Timeframe: every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first

,
Interventionparticipants (Number)
Complete ResponseUncertified Complete ResponsePartial ResponseStable DiseaseRelapsed Disease or Progressive DiseaseNot AssessableOverall Response Rate (Confirmed and Unconfirmed)Overall Response Rate Confirmed
Investigator's Choice002413520
KW-0761201101618135

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Overall Survival

The estimates and summary statistics for OS were calculated based on Kaplan-Meier method, and the median OS was 4.9 months for subjects randomized to the mogamulizumab group versus 6.87 months for subjects randomized to the Investigator's Choice group. (NCT01626664)
Timeframe: up to 36 months

,
Interventionpercentage of subjects (Median)
Subjects (%) Alive for at Least: 1 MonthSubjects (%) Alive for at Least: 2 MonthsSubjects (%) Alive for at Least: 3 MonthsSubjects (%) Alive for at Least: 4 MonthsSubjects (%) Alive for at Least: 5 MonthsSubjects (%) Alive for at Least: 6 Months
Investigator's Choice91.779.270.866.754.254.2
KW-076187.075.659.154.349.544.3

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Time-to-engraftment

The number of days until participants by dose level reach engraftment. (NCT01629511)
Timeframe: 30 days post transplant

,,
Interventionparticipants (Number)
Day 10Day 11Day 12Day 13Day 15Day 17<10 days - Graft Failure
Gemcitabine Dose Level 11210000
Gemcitabine Dose Level 32401001
Gemcitabine Dose Level 40010110

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Overall Survival

Will be estimated by the method of Kaplan and Meier. Time-to-event distributions as function of patient baseline covariates will be evaluated using Bayesian time-to-event regression modeling. (NCT01629511)
Timeframe: Up to 1 year post transplant

InterventionParticipants (Count of Participants)
Gemcitabine Dose Level 13
Gemcitabine Dose Level 20
Gemcitabine Dose Level 34
Gemcitabine Dose Level 42

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Progression Free Survival (PFS)

PFS was as the time from enrollment to the earliest documented evidence of disease progression or death,whatever comes first. (NCT01632306)
Timeframe: Baseline to Disease Progression Up to 18 Months

InterventionMonths (Median)
LY2090314 + Gemcitabine1.8
LY2090314 + FOLFOX3.4

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Percentage of Participants Who Survived at 6 Months

(NCT01632306)
Timeframe: Baseline to Date of Death to any cause Up to 6 Months

InterventionPercentage of participants (Number)
LY2090314 + Gemcitabine0
LY2090314 + FOLFOX50.0

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Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]

"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.~A CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart." (NCT01632306)
Timeframe: Baseline Up to 6 Months

InterventionPercentage of Participants (Number)
LY2090314 + Gemcitabine0
LY2090314 + FOLFOX10.0

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Overall Survival (OS)

(NCT01632306)
Timeframe: Baseline to Date of Death Due to any Cause Up to 21 Months

InterventionMonths (Median)
LY2090314 + Gemcitabine1.8
LY2090314 + FOLFOX7.7

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Progression-free Survival (PFS)

Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. PFS is defined as the number of months from the date of first dose of study drug to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve. (NCT01639131)
Timeframe: 9 months

Interventionmonths (Median)
Gemcitabine and Docetaxel1.79

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Response Rate

The Response Rate is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. (NCT01639131)
Timeframe: 9 months

Interventionparticipants (Number)
Gemcitabine and Docetaxel0

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Overall Survival With Gemcitabine and Docetaxel Combination Therapy

Overall survival is the time from the start of first dose of study drug to death. OS will be measured from date of first dose of a study drug until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (NCT01639131)
Timeframe: 62 months

Interventionmonths (Median)
Gemcitabine and Docetaxel15.67

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Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT)

Number of participants with dose-limiting toxicities when administered OMP-59R5 every of other week (Days 1 and 15) in combination with nab-paclitaxel (Nab-P) 125 mg/m2 and gemcitabine (Gem) 1000 mg/m2 on Days 1, 8, and 15 of every 28-day cycle in subjects with previously untreated stage IV pancreatic cancer. In the event that no DLTs are observed, maximum tested dose would be considered the Maximum Tolerated Dose (MTD). (NCT01647828)
Timeframe: Up to 1 year in absence of unacceptable toxicity or disease progression.

InterventionParticipants (Count of Participants)
P1B: OMP-59R5 2.5 mg/kg + Gem0
P1B: OMP-59R5 5 mg/kg + Gem0
P1B: OMP-59R5 5 mg/kg + Nab-P + Gem0
P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem0
P1B: OMP-59R5 10 mg/kg + Nab-P + Gem0
P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem0
P1B: OMP-59R5 15 mg/kg + Nab-P + Gem1

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Phase 2: Median OS by Notch 3 Percentile (ITT Population)

To determine the clinical benefit, as measured by OS of the addition of OMP-59R5 to Nab-P+Gem across the 4 subject subsets: subjects with Notch3 ≥ 25th percentile, subjects with Notch3 ≥ 50th percentile, subjects with Notch3 ≥ 75th percentile and all subjects receiving first-line therapy for stage IV pancreatic cancer with Notch3 high expression level. (NCT01647828)
Timeframe: Up to 1 year in absence of unacceptable toxicity or disease progression.

,
InterventionDays (Median)
Notch 3 ≥ 75th percentileNotch 3 ≥ 50th percentileNotch 3 ≥ 25th percentile
P2: OMP-59R5 15 mg/kg + Nab-P + Gem228.0151.0165.0
P2: Placebo + Nab-P + Gem187.5220.5206.0

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Phase 2: Overall Survival (ITT Population)

To determine the clinical benefit, as measured by overall survival (OS) ofthe addition of OMP-59R5 to nab-paclitaxel and gemcitabine in all subjects who are receiving first-line therapy for stage IV pancreatic cancer. (NCT01647828)
Timeframe: Up to 1 year in absence of unacceptable toxicity or disease progression.

,
Interventionparticipants (Number)
Number of subjects who diedNumber of subjects who did not die
P2: OMP-59R5 15 mg/kg + Nab-P + Gem7118
P2: Placebo + Nab-P + Gem6028

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Adverse Events as a Measure of Safety and Tolerability

Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued. Subjects experiencing Grade 4 neutropenia, Grade ≥3 thrombocytopenia, or Grade 2 peripheral neuropathy who do not recover will have treatment protocol discontinued. (NCT01654861)
Timeframe: Weekly for up to 6 months.

Interventionparticipants (Number)
HDIVC0

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The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment

"The primary objective of this clinical trial is to estimate the response rate to treatment with the triplet chemotherapy regimen of gemcitabine, infusional 5-FU, and cisplatin, in untreated and previously treated advanced pancreatic and biliary cancer patients.~Partial Response (PR) is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters." (NCT01661114)
Timeframe: 28 days

Interventionpercentage of patients (Number)
UntreatedReceived Previous Treatment
Gemcitabine, 5-FU and Cisplatin407.1

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Median Overall Survival of Previously Treated and Previously Untreated Patients

To assess the overall survival following treatment with gemcitabine, 5-FU and cisplatin. (NCT01661114)
Timeframe: 1 year

InterventionMonths (Median)
Previously UntreatedPreviously Treated
Gemcitabine, 5-FU and Cisplatin10.34.9

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Maximum Tolerated Dose

The MTD is defined at the highest dose level at which ≤25% of patients experience a dose-limiting toxicity (DLT). (NCT01663272)
Timeframe: 5 weeks

Interventionmg (Number)
Cabozantinib With GemcitabineNA

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Median Progression-free Survival (PFS)

Progression-free survival (PFS, a secondary endpoint) will be calculated from day-7 of cycle 1 of study treatment, until documented disease progression or death. Patients removed from treatment for progression or other reasons will be followed for 30 days after their last dose. (NCT01663272)
Timeframe: day-7 of cycle 1 until 30 days post treatment

Interventionmonths (Median)
Cabozantinib With Gemcitabine4.7

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Phase 2: Overall Survival

Data presented are the median overall survival in months for participants in the Phase 2 treatment arms. (NCT01663857)
Timeframe: Baseline to Date of Death from any cause (up to 5 years)

Interventionmonths (Median)
LY2228820 + Gemcitabine +Carboplatin29.17
Placebo + Gemcitabine + Carboplatin25.10

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Phase 2: Percentage of Participants Who Achieve Complete Response or Partial Response (Overall Response Rate)

Overall Response Rate was estimated as the percentage of participants with best response of Complete Response (CR) or Partial Response (PR), based on RECIST version 1.1 divided by the total number of randomized participants. CR is defined as disappearance of all target lesions. PR is defined as at least 30% disease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT01663857)
Timeframe: Baseline to Disease Progression (up to 3 years)

Interventionpercentage of participants (Number)
LY2228820 + Gemcitabine +Carboplatin46.6
Placebo + Gemcitabine + Carboplatin46.2

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Phase 2: Progression-free Survival (PFS) in Participants Treated With LY2228820 Plus Gemcitabine and Carboplatin Versus Placebo Plus Gemcitabine and Carboplatin

PFS was defined as time from date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01663857)
Timeframe: Randomization to Date of Disease Progression or Death from any cause (up to 3 years)

Interventionmonths (Median)
LY2228820 + Gemcitabine +Carboplatin10.25
Placebo + Gemcitabine + Carboplatin8.44

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Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820

PK parameters after administration of LY2228820 for both Phase 1b and Phase 2. (NCT01663857)
Timeframe: Phase1b:Cycle(C)1 Day(D)1:Predose(PRD),0.5,1,2,4,6,8 hours(hr)postdose(PD); C1D10:PRD,0.5,1,2,8hrPD; C2D10:PRD,0.5,1,2,4,6,8,12hrPD; C7D3:PRD,0.5,1,2,4,6hrPD; Phase 2: C1D3:PRD,0.5,1,2,4,6,8hrPD; C1D10:PRD,0.5,1,2,4,6,8hrPD; C7D3:PRD,0.5,1,2,4,6,8hrPD

Interventionnanograms * hr per milliliter (ng*hr/mL) (Geometric Mean)
Cycle 1 Day 1Cycle 1 Day 10Cycle 2 Day 10Cycle 7 Day 3
300 mg LY22288203560935034907230

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Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820

PK parameters after administration of LY2228820 for both Phase 1b and Phase 2. (NCT01663857)
Timeframe: Phase1b:Cycle(C)1 Day(D)1:Predose(PRD),0.5,1,2,4,6,8 hours(hr)postdose(PD); C1D10:PRD,0.5,1,2,8hrPD; C2D10:PRD,0.5,1,2,4,6,8,12hrPD; C7D3:PRD,0.5,1,2,4,6hrPD; Phase 2: C1D3:PRD,0.5,1,2,4,6,8hrPD; C1D10:PRD,0.5,1,2,4,6,8hrPD; C7D3:PRD,0.5,1,2,4,6,8hrPD

Interventionnanograms * hr per milliliter (ng*hr/mL) (Geometric Mean)
Cycle 1 Day 1Cycle 1 Day 3Cycle 1 Day 10Cycle 2 Day 10
200 mg LY22288203470317042703270

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Phase 2: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) Total Score

"The Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) instrument measures health related quality of life (HRQoL) in participants with ovarian cancer. The instrument is organized into sections of physical, social/family, emotional, functional well-being and ovarian subscales with a 5-point rating scale in which 0 = not at all and 4 = very much. Data presented here are change from baseline at follow-up in the FACT-O Total Score. The total score is the sum of Physical Well Being (PWB) + Social Well-being (SWB) + Emotional Well Being (EWB) + Family Well-being (FWB) + Ovarian Cancer Subscale (OCS). The FACT-O Total score range 0 - 152 with higher scores indicating better quality of life." (NCT01663857)
Timeframe: Baseline, Study Completion (up to 3 years)

Interventionunits on a scale (Mean)
LY2228820 + Gemcitabine +Carboplatin-0.6
Placebo + Gemcitabine + Carboplatin-8.9

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Tumor Control Rate

Tumor control rate is defined as the best tumour response (confirmed partial or complete response, stable disease) that is achieved until end of treatment according to Recist 1.1. (NCT01679405)
Timeframe: Treatment period: up to eight cycles (maximum 8 months).

InterventionParticipants (Count of Participants)
Dose Level 10
Dose Level -14

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Number of Adverse Events

"In part A the maximum tolerated dose (MTD) of BIBW 2992 administered continuously to the standard therapy of Gemcitabine / Cisplatin (Gem/Cis) (administered together on day 1 and 8 of a three-week cycle) will be evaluated in a 2 step dose escalation.~Safety and toxicity will be evaluated as described and considered primary for part B of the study." (NCT01679405)
Timeframe: Treatment period: up to eight cycles (maximum 8 months). 12 months follow-up period.

InterventionParticipants (Count of Participants)
Dose Level 12
Dose Level -11

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Objective Response Rate

Response was assessed by means of RECIST 1.1 criteria for target lesions, non-target lesions and the appearance of new lesions. Objective response was defined as the CR, PR or SD at end of treatment (NCT01679405)
Timeframe: Treatment period: up to eight cycles (maximum 8 months).

InterventionParticipants (Count of Participants)
Dose Level 10
Dose Level -10

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Overall Survival (OS)

Median overall survival time including the 95% confidence interval were determined using Kaplan-Meier estimates. (NCT01679405)
Timeframe: Time from start of treatment to death due to any cause. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored. Estimated time period: up to 76 weeks

Interventiondays (Median)
Dose Level 1163
Dose Level -1260

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Time to Progress (TTP)

Median time to progress (according to RECIST 1.1 criteria) including the 95% confidence intervals were determined using Kaplan-Meier estimates. Time from start of treatment to first documentation of objective tumour progression. Deaths were censored at the time of death. (NCT01679405)
Timeframe: Treatment period: up to eight cycles (maximum 8 months). 12 months follow-up period.

Interventiondays (Median)
Dose Level 1159
Dose Level -1NA

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One-year Survival Rate

Subjects will be followed after treatment completed to determine length of survival rate. The primary study objective was 1-year overall survival (OS, failure: death due to any cause). The Kaplan-Meier method was used to estimate the one-year OS. Secondary Objectives were the frequency of serious adverse events, disease control rate and progression-free survival. (NCT01683422)
Timeframe: One year after treatment completed.

Interventionpercentage of participants (Number)
Proton Radiation55.6

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Part 1: PFS Assessed by the Investigator

PFS as assessed by Investigator was defined as the time from first dose of pertuzumab or chemotherapy in Part 1 of the trial, until disease progression according to RECIST version 1.1, symptomatic deterioration or death from any cause, whichever occurs first. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants were censored at the last tumor assessment. Participants who have no tumor assessments after baseline and who were still alive will be censored at 1 day. (NCT01684878)
Timeframe: Approximately 28 months (assessed at screening and every 9 weeks from randomization until disease progression)

Interventionmonths (Median)
Part 1: Pertuzumab + Topotecan4.07
Part 1: Pertuzumab + Paclitaxel4.24

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Part 2- Objective Response Rate (ORR)

ORR was defined as the number of participants with BOR of CR or PR recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT01684878)
Timeframe: Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)

Interventionpercentage of participants (Number)
Part 2: Pertuzumab+Chemotherapy14.8
Part 2: Placebo+Chemotherapy8.7

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Part 2: Overall Survival

Overall survival was defined as the time from randomization into Part 2 of the trial until death from any cause (NCT01684878)
Timeframe: Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)

Interventionmonths (Median)
Part 2: Pertuzumab+Chemotherapy10.18
Part 2: Placebo+Chemotherapy8.36

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Part 2: Percentage of Participants With Adverse Events (AEs)

An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01684878)
Timeframe: Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)

Interventionpercentage of participants (Number)
Part 2: Pertuzumab+Chemotherapy98.7
Part 2: Placebo+Chemotherapy100

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Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO)

PFS (IRC-Assessed) was defined as the time from randomization into Part 2 of the trial until progressive disease (PD), MBO or death from any cause, whichever occurred first per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. (NCT01684878)
Timeframe: Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)

Interventionmonths (Median)
Part 2: Pertuzumab+Chemotherapy4.27
Part 2: Placebo+Chemotherapy2.74

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Part 2: Progression-free Survival (PFS) Assessed by the Investigator

PFS (Investigator-assessed) is defined as the time from randomization, until disease progression according to RECIST v1.1 including death or MBO, whichever occurs first. Censoring is based on the last tumor assessment. If no tumor assessment post baseline, then censoring is at day 1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. (NCT01684878)
Timeframe: Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)

Interventionmonths (Median)
Part 2: Pertuzumab+Chemotherapy4.22
Part 2: Placebo+Chemotherapy3.94

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Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scores, a higher score represents a more severe level of symptoms. For the global health status scores, a higher score represents a better quality of life. (NCT01684878)
Timeframe: Baseline (assessed at baseline and every 9 weeks from randomization until disease progression)

,
Interventionunits on a scale (Mean)
Functional Scales: Physical (n=71, 74)Functional Scales: Role (n=70, 73)Functional Scales: Emotional (n=71, 73)Functional Scales: Cognitive (n=71, 73)Functional Scales: Social (n=71, 73)Symptomatic Scales: Fatigue (n=71, 74)Symptomatic Scales: Nausea and vomiting (n=72, 74)Symptomatic Scales: Pain (n=72, 74)Symptomatic Scales: Dyspnoea (n=68, 73)Symptomatic Scales: Insomnia (n=69, 74)Symptomatic Scales: Appetite loss (n=71, 73)Symptomatic Scales: Constipation (n=69, 72)Symptomatic Scales: Diarrhoea (n=69, 72)Symptomatic Scales:Financial difficulties(n=70,72Global health status / QoL scale (n=71, 72)
Part 2: Pertuzumab+Chemotherapy71.168.659.581.270.741.210.435.222.535.324.925.614.517.654.1
Part 2: Placebo+Chemotherapy74.969.465.984.968.338.412.431.121.531.521.026.414.413.461.1

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Part 1- Objective Response Rate (ORR)

ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT01684878)
Timeframe: Approximately 28 months (assessed at baseline and every 9 weeks from randomization until disease progression)

Interventionpercentage of participants (Number)
Part 1: Pertuzumab + Topotecan14.3
Part 1: Pertuzumab + Paclitaxel25.0

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Part 1: Percentage of Participants With Adverse Events (AEs)

An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01684878)
Timeframe: Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)

Interventionpercentage of participants (Number)
Part 1: Pertuzumab + Topotecan95.5
Part 1: Pertuzumab + Paclitaxel100.0

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Duration of Response

Duration of response is defined as the time between the date of the first documentation of complete response/full response or partial response, and the date of disease progression or date of death due to any cause, or the last adequate tumor assessment prior to the start of subsequent anti-cancer therapy including crossing over to G+C from TC arm, whichever occurred earlier. Only participants who responded were included in the duration of response calculation. (NCT01696032)
Timeframe: Up to 24 months

InterventionDays (Median)
Stage 1: Guadecitabine+Carboplatin 30 mg/m2225
Stage 1: Guadecitabine+Carboplatin 45 mg/m2195
Stage 2: Guadecitabine+Carboplatin 30 mg/m2186
Stage 2: Treatment Choice173
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2182

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Stage 1: Pharmacokinetic Parameter AUC0-8

Area under the concentration-time curve from 0 to 8 hours (AUC0-8) for guadecitabine, decitabine and carboplatin (NCT01696032)
Timeframe: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)

,
InterventionHours*ng/mL (Mean)
GuadecitabineDecitabineCarboplatin
Stage 1: Guadecitabine+Carboplatin 30 mg/m223971.151200
Stage 1: Guadecitabine+Carboplatin 45 mg/m241612941900

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Clinical Benefit Rate

Clinical benefit rate (CBR) was defined as the proportion of subjects who experienced a best overall response of complete response/full response or partial response (confirmed by a subsequent assessment at least 28 days later), or documented stable disease for at least 3 months after the first dose. Response categories were determined based on RECIST v1.1 criteria, then based on modified Rustin (CA-125) criteria if assessment could not be made using RECIST criteria. (NCT01696032)
Timeframe: Up to 24 months

InterventionPercent of participants (Number)
Stage 1: Guadecitabine+Carboplatin 30 mg/m243
Stage 1: Guadecitabine+Carboplatin 45 mg/m250
Stage 2: Guadecitabine+Carboplatin 30 mg/m241
Stage 2: Treatment Choice29
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m219

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Stage 1: Dose Limiting Toxicities

Number of participants with dose limiting toxicities (DLTs) in Stage 1 (NCT01696032)
Timeframe: Up to 12 months

InterventionParticipants (Count of Participants)
Stage 1: Guadecitabine+Carboplatin 30 mg/m20
Stage 1: Guadecitabine+Carboplatin 45 mg/m24

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Stage 1: Pharmacokinetic Parameter Tmax

Time to last measurable concentration for guadecitabine, decitabine and carboplatin (NCT01696032)
Timeframe: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)

,
InterventionHours (Median)
GuadecitabineDecitabineCarboplatin
Stage 1: Guadecitabine+Carboplatin 30 mg/m21.421.981.03
Stage 1: Guadecitabine+Carboplatin 45 mg/m21.983.951.05

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Stage 1: Pharmacokinetic Parameter Cmax

Time to maximum plasma concentration for guadecitabine, decitabine and carboplatin (NCT01696032)
Timeframe: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)

,
Interventionng/mL (Mean)
GuadecitabineDecitabineCarboplatin
Stage 1: Guadecitabine+Carboplatin 30 mg/m296.222.619600
Stage 1: Guadecitabine+Carboplatin 45 mg/m210926.321900

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Stage 2: Progression Free Survival

Progression free survival (PFS) time was defined as the time interval from the date of the first dose of study medication until the earlier of disease progression or death. Participants were treated with their assigned treatment [guadecitabine+carboplatin (G+C) or treatment choice (TC)] until disease progression or unacceptable treatment-related toxicity occurred. (NCT01696032)
Timeframe: Up to 24 months

InterventionDays (Median)
Stage 2: Guadecitabine+Carboplatin 30 mg/m2114
Stage 2: Treatment Choice64

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CA-125 Levels

Percentage of participants with CA-125 reduction by ≥ 50% from baseline (NCT01696032)
Timeframe: Up to 24 months

InterventionPercent of participants (Number)
Stage 1: Guadecitabine+Carboplatin 30 mg/m227
Stage 1: Guadecitabine+Carboplatin 45 mg/m250
Stage 2: Guadecitabine+Carboplatin 30 mg/m236
Stage 2: Treatment Choice32
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m229

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Progression Free Survival at 6 Months

Progression free survival rate at 6 months is the proportion of participants who were alive and did not have disease progression at 6 months after start of treatment. (NCT01696032)
Timeframe: 6 months

InterventionPercent of participants (Number)
Stage 1: Guadecitabine+Carboplatin 30 mg/m20.36
Stage 1: Guadecitabine+Carboplatin 45 mg/m20.33
Stage 2: Guadecitabine+Carboplatin 30 mg/m20.37
Stage 2: Treatment Choice0.11
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m20.19

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Overall Survival

Overall survival was defined as the number of days from the day the participant was administered the first dose of study treatment to the date of death (regardless of cause). Survival time was censored on the last date the participant was known to be alive or lost to follow-up before reaching the event of death; in the TC group, time was censored at the date of crossover. (NCT01696032)
Timeframe: Up to 24 months

InterventionDays (Median)
Stage 1: Guadecitabine+Carboplatin 30 mg/m2341
Stage 1: Guadecitabine+Carboplatin 45 mg/m2195
Stage 2: Guadecitabine+Carboplatin 30 mg/m2331
Stage 2: Treatment Choice221
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2279

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Objective Response Rate

The objective response rate (ORR) was defined as the proportion of participants who experienced an objective response (best overall response of complete response/full response or partial response, which was confirmed by a subsequent assessment at least 28 days later). Response categories were determined based on RECIST v1.1 criteria, or on modified Rustin (CA-125) criteria if response assessment could not be made using RECIST criteria. (NCT01696032)
Timeframe: Up to 24 months

InterventionPercent (Number)
Stage 1: Guadecitabine+Carboplatin 30 mg/m221
Stage 1: Guadecitabine+Carboplatin 45 mg/m20
Stage 2: Guadecitabine+Carboplatin 30 mg/m216
Stage 2: Treatment Choice8
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m24

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Use of Biomarkers to Determine Course of Treatment

The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment. (NCT01726582)
Timeframe: Initiation of therapy (approximately 4 to 12 weeks after screening) until surgery (approximately 10 to 20 weeks after screening)

InterventionParticipants (Count of Participants)
Milestones Related to Usual Therapy92

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Number of Subjects Completing Therapy Including Surgical Resection.

This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure. (NCT01726582)
Timeframe: At time of surgery (approximately 10 to 20 weeks after screening)

InterventionParticipants (Count of Participants)
Milestones Related to Usual Therapy107

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Overall Survival in Months

This measure is the median time of survival (in months) at five years from the initiation of therapy. Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection. (NCT01726582)
Timeframe: 5 years

InterventionMonths (Median)
Milestones Related to Therapy (Resected)45
Milestones Related to Therapy (Non-Resected)11

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Progression-free Survival

This measure is the number of subjects not experiencing tumor progression at five years from initiating therapy. (NCT01726582)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Milestones Related to Usual Therapy36

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Induction Response

Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Response was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks. (NCT01746173)
Timeframe: Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).

Interventionproportion of patients (Number)
CHOEP + High Dose Therapy + Auto SCT.60

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24-month Progression-Free Survival Rate

24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). (NCT01746173)
Timeframe: Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.

Interventionproportion of patients (Number)
CHOEP + High Dose Therapy + Auto SCT0.0

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Overall Survival

Overall survival is defined as time from randomization to death or last day known to be alive. (NCT01746979)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Interventionmonths (Median)
Gemcitabine Plus TH-3028.9
Gemcitabine Plus Placebo7.6

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Progression Free Survival

Progression Free Survival is defined as the time from randomization to either first observation of progressive disease or occurrence of death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT01746979)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Interventionmonths (Median)
Gemcitabine Plus TH-3025.5
Gemcitabine Plus Placebo3.7

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Margin-negative (R0) Resection Rate

R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement. (NCT01754623)
Timeframe: Up to 3 years

Interventionpercentage of participants (Number)
Chemotherapy Followed by Radiation Treatment67

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Overall Survival (OS) Rate

OS at time of analysis, calculated from date of enrollment to date of death from any cause. (NCT01754623)
Timeframe: 12 months

Interventionpercentage of participants (Number)
All Participants -Chemotherapy Followed by Radiation Treatment33
Resection Group -Chemotherapy Followed by Radiation Treatment100

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Phase 1b: Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])

ORR was the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of nontarget lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. (NCT01763788)
Timeframe: Baseline to Measured Progressive Disease (Up To 39 Months)

Interventionpercentage of participants (Number)
Phase 1b: Cohort 10.0
Phase 1b: Cohort 283.3

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Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)

DLT was defined as any of the following events graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, when the event occurred within 21 days from Day 1 in Cycle 1 and was considered to be definitely or probably related to necitumumab and/or gemcitabine-cisplatin chemotherapy: Grade 4 neutropenia ≥ 7 days, Grade ≥ 3 febrile neutropenia except for transient febrile neutropenia (Grade 3 neutropenia with fever ≥ 38.5 degrees Celsius (°C) for ≤ 24 hours), Grade 3 thrombocytopenia requiring platelet substitution, Grade 4 thrombocytopenia, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, arthralgia, myalgia, asthenia, fatigue, diarrhea, constipation, anorexia), any toxicity leading to the omission of necitumumab on Day 8 or 15 (for participants for whom necitumumab was delayed from Days 8 to 15) during the Cycle 1. (NCT01763788)
Timeframe: Day 1 to Day 21 in Cycle 1 (Up To 21 days)

InterventionParticipants (Count of Participants)
Phase 1b: Cohort 10
Phase 1b: Cohort 20

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Phase 1b: PK: Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Necitumumab

The AUC(0-infinity) is area under the serum concentration-time curve from time zero to infinite time. (NCT01763788)
Timeframe: Cycle 1 (C1) Day 1 (D1) and C3 D1: Predose, End-of-infusion and 1, 3, 6, 24, 96, 168 h post-end-of-infusion

,
Interventionmicrogram*hour per milliliter (µg*h/mL) (Geometric Mean)
Cycle 1
Phase 1b: Cohort 1NA
Phase 1b: Cohort 238900

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Phase 1b: PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Gemcitabine and Cisplatin

The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time. (NCT01763788)
Timeframe: Gemcitabine: C1D1: Predose, End-of-infusion and 0.5, 1, 2 h post-end-of-infusion; Cisplatin:C1D1: Predose, End-of-infusion and 3, 21, 93, 165 h post-end-of-infusion

Interventionnanogram*hour per milliliter (ng*h/mL) (Geometric Mean)
GemcitabineCisplatin
Phase 1b: Cohort 213300NA

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Phase 2: Change From Baseline in EuroQol 5-Dimensional 3 Level (EuroQol-5D-3L) Visual Analog Scale (VAS)

EQ-5D VAS allowed participants to rate their present health condition. Possible scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). One Cycle = 3 weeks and it can be delayed up to 6 weeks. (NCT01763788)
Timeframe: Baseline, Cycle 4 (Cycle = 3 weeks)

Interventionunits on a scale (Mean)
Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)7.81
Phase 2: GC (Gemcitabine, Cisplatin)11.10

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Phase 2: Change From Baseline in EuroQol 5-Dimensional 3 Level (EuroQol-5D-3L) Index Score

EQ-5D measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. The index score was calculated from a set of item weights to derive a score on a theoretical scale of 0 to 1, with 1 representing the best health status and zero representing death based on item weights for the Japanese population. One Cycle = 3 weeks and it can be delayed up to 6 weeks. (NCT01763788)
Timeframe: Baseline, Cycle 4 (Cycle = 3 weeks)

InterventionScore on a scale (Mean)
Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)0.04
Phase 2: GC (Gemcitabine, Cisplatin)0.03

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Phase 1b: PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Gemcitabine and Cisplatin

The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time. (NCT01763788)
Timeframe: Gemcitabine: C1D1: Predose, End-of-infusion and 0.5, 1, 2 h post-end-of-infusion; Cisplatin:C1D1: Predose, End-of-infusion and 3, 21, 93, 165 h post-end-of-infusion

Interventionnanogram*hour per milliliter (ng*h/mL) (Geometric Mean)
Gemcitabine
Phase 1b: Cohort 18710

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Phase 1b: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab

The Cmax is observed maximum serum concentration, taken directly from the serum concentration-time profile. (NCT01763788)
Timeframe: Cycle 1 (C1) Day 1 (D1) and C3 D1: Predose, End-of-infusion and 1, 3, 6, 24, 96, 168 h post-end-of-infusion

Interventionmicrograms/milliliter (µg/ml) (Geometric Mean)
Cycle 1Cycle 3
Phase 1b: Cohort 2371372

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Phase 2: Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])

ORR was the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of nontarget lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. (NCT01763788)
Timeframe: Baseline to Measured Progressive Disease (Up To 39 Months)

Interventionpercentage of participants (Number)
Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)51.1
Phase 2: GC (Gemcitabine, Cisplatin)20.9

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Phase 2: Time to Treatment Failure (TTF)

TTF was time from the date of randomization until the date of the first observation of radiographically documented progressive disease (PD), death due to any cause, discontinuation of treatment for any reason, or initiation of new anticancer therapy. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Time to treatment failure was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed. (NCT01763788)
Timeframe: From Date of Randomization to Measured Progressive Disease, Death Due to Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up To 39 Months)

InterventionMonths (Median)
Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)4.16
Phase 2: GC (Gemcitabine, Cisplatin)3.75

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Phase 2: Progression Free Survival (PFS)

PFS defined as time from date of randomization until first radiographic documentation of measured progressive disease(PD) defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. PD was at least 20% increase in sum of diameters of target lesions with reference being smallest sum on study and an absolute increase of at least 5 mm,or unequivocal progression of non-target lesions,or 1 or more new lesions.If participant does not have complete baseline disease assessment,PFS time censored at date of randomization,regardless of whether or not objectively determined disease progression or death observed for participant.If participant was not known to have died or have objective progression as of data inclusion cutoff date for analysis,the PFS time censored at last adequate tumor assessment date.The use of new anticancer therapy prior to occurrence of PD resulted in censoring at the date of last radiographic assessment prior to initiation of new therapy. (NCT01763788)
Timeframe: From Date of Randomization to Measured Progressive Disease or Death Due to Any Cause (Up To 39 Months)

InterventionMonths (Median)
Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)4.21
Phase 2: GC (Gemcitabine, Cisplatin)4.01

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Phase 2: Overall Survival (OS)

OS defined as the time from the date of randomization to the date of death due to any cause. Participants who are alive at the time of study completion or are lost to follow-up will be censored at the time they were last known to be alive. (NCT01763788)
Timeframe: From Date of Randomization until Death Due to Any Cause (Up To 39 Months)

InterventionMonths (Median)
Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)14.92
Phase 2: GC (Gemcitabine, Cisplatin)10.84

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Phase 2: Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)

A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point. (NCT01763788)
Timeframe: Baseline up to 30 Days Post Last Infusion (estimated up to 39 months)

InterventionParticipants (Count of Participants)
Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)4

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Phase 2: Change From Baseline in Lung Cancer Symptom Scale (LCSS)

The LCSS is a validated and reliable instrument to assess lung cancer-specific symptoms and their impact on QOL.The LCSS total score was defined as the mean of the 9 items of the scale and the average symptom burden index (ASBI) is defined as the mean of 6 symptom-specific lung cancer questions. Each of the 9 symptom or summary items is assessed on a 100-mm visual analogue scale (VAS), with 0 representing no symptoms or better QOL. (NCT01763788)
Timeframe: Baseline, Cycle 4 (Cycle = 3 weeks)

,
Interventionunits on a scale (Mean)
Loss of AppetiteFatigueCoughDyspneaHemoptysisPainOverall SymptomsInterferenceQuality of LifeAverage Symptom Burden Index (ASBI)LCSS Total Score
Phase 2: GC (Gemcitabine, Cisplatin)-9.03-4.02-15.82-5.08-4.10-12.38-9.56-5.93-15.43-8.40-9.04
Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)-4.48-5.42-18.00-5.14-4.75-10.68-11.62-6.92-5.10-8.08-8.01

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Phase 2: PK: Minimum Concentration (Ctrough) of Necitumumab

The minimum observed serum concentration (Ctrough) of Necitumumab was evaluated. (NCT01763788)
Timeframe: Predose Day 1 of Cycle 1, 2, 3, 4, and every 2 cycles after Cycle 5

Interventionmicrogram per milliliter (µg/mL) (Geometric Mean)
Dose 3Dose 5Dose 7Dose 9Dose 13Dose 17Dose 21
Phase 2: GC+N (Gemcitabine, Cisplatin + Necitumumab)77.9110130137145120194

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Phase 1b: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab

The Cmax is observed maximum serum concentration, taken directly from the serum concentration-time profile. (NCT01763788)
Timeframe: Cycle 1 (C1) Day 1 (D1) and C3 D1: Predose, End-of-infusion and 1, 3, 6, 24, 96, 168 h post-end-of-infusion

Interventionmicrograms/milliliter (µg/ml) (Geometric Mean)
Cycle 1
Phase 1b: Cohort 1454

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Phase 1b: PK: Cmax of Gemcitabine and Cisplatin

The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile. (NCT01763788)
Timeframe: Gemcitabine: Cycle 1(C1) Day1(D1): Predose, End-of-infusion and 0.5, 1, 2 h post-end-of-infusion; Cisplatin:C1 D1: Predose, End-of-infusion and 3, 21, 93, 165 h post-end-of-infusion

,
Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
GemcitabineCisplatin
Phase 1b: Cohort 1174003740
Phase 1b: Cohort 2260003980

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Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

The number of eligible patients assigned to receive brentuximab vedotin in combination with gemcitabine that experienced CTC Version 4, grade 3 or higher adverse events during Phase 1 and Phase 2. (NCT01780662)
Timeframe: 13 months from first dose

,
InterventionParticipants (Count of Participants)
Abdominal painAdrenal insufficiencyAlanine aminotransferase increasedAnemiaAnorexiaAspartate aminotransferase increasedDehydrationDental cariesDiarrheaFebrile neutropeniaGGT increasedHemolytic uremic syndromeHypophosphatemiaHypotensionInfections and infestations - Other- SpecifyInvestigations - Other- SpecifyLung infectionLymphocyte count decreasedMyositisNauseaNeutrophil count decreasedNon-cardiac chest painPain in extremityPericardial effusionPlatelet count decreasedPneumonitisPruritusRash maculo-papularSkin infectionUrinary tract infectionWhite blood cell decreased
Dose 1.4mg/kg (Phase I)0011010000000000030030000110003
Dose 1.8mg/kg (Phase I + Phase II)111341101132112411281228111130031115

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The Number of Patients Who Had Successful Peripheral Blood Stem Cell (PBSC) Collection

Successful PBSC collection was defined as a collection of more than 2x10^6 CD34 positive cells. (NCT01780662)
Timeframe: From 1 to 5 cycles

InterventionParticipants (Count of Participants)
Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)24

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The Number of Patients Who Had Disease Response Assessed by Deauville Scales Among Those in Phase I With Dose Level 2.

The Deauville five-point scale was used to assess the number of participants with complete response (CR) and partial response (PR). A lower score indicates a better outcome. Scores of 1-3 represent CR and 4-5 represent PR. (NCT01780662)
Timeframe: Up to 13 months from first dose

InterventionParticipants (Count of Participants)
Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)8

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Percentage of Patients Who Achieved Overall Response (OR) as Measured by Complete Response (CR) and Partial Response (PR)

The percentage of patients who experienced complete Response (CR) within the first four cycles.By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores <=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study. (NCT01780662)
Timeframe: After 4 cycles (21 days per cycle) of protocol therapy

Interventionpercentage of participants (Number)
Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)74

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Maximum Tolerated Dose (MTD) for Brentuximab Vedotin

MTD was determined as the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicities (DLT) as assessed by National Cancer Institute (NCI) CTCAE v 4.0 during Cycle 1 of therapy. Gemcitabine was administered on days 1 and 8 of a 21 day cycle at a fixed dose. Brentuximab vedotin was investigated at a starting dose of 1.4 mg/kg administered on day 1 and escalated if tolerated. (NCT01780662)
Timeframe: During cycle 1 of protocol therapy (21 days)

Interventionmg/kg (Number)
Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)1.8

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The Number of Patients With Relapsed or Refractory HL Who Achieved Complete Response (CR)

The number of patients who experienced complete Response (CR) within the first four cycles. By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores <=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study. (NCT01780662)
Timeframe: After 4 cycles (21 days per cycle) of protocol therapy

InterventionParticipants (Count of Participants)
Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)28

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Number of Patients With FcyRIIIa-158 V/F (Valine/Phenylalanine) Polymorphism

Among patients who received 1.8mg/kg dose, the frequency of the FcγRIIIa-158 V/F polymorphism are described. (NCT01780662)
Timeframe: From the end of first dose to the end of last dose (Up to 13 Months)

InterventionParticipants (Count of Participants)
Homozygous FF- PhenylalanineHeterozygous FV- Valine/PhenylalanineHomozygous VV- Valine
Dose 1.8mg/kg22145

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Plasma Level of Thymus and Activation-Regulated Chemokine (TARC)

Limit to 41 evaluable patients who received dose 1.8 mg/kg (NCT01780662)
Timeframe: From baseline to time prior to cycle 2

Interventionpg/ml (Median)
BaselinePrior to Cycle 2
Dose 1.8mg/kg5700668

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Number of Participants With Rash by Severity

Reported is the total number of participants with rash as well as the number of participants with specific forms of rash, including paronychia, dry skin and papulopustulous eczema. Severity was reported according to Common Terminology Criteria for Adverse Events version 4.0 (CTC AE 4.0): Grade 1 = mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. (NCT01782690)
Timeframe: Up to 12 months

Interventionparticipants (Number)
Total number with rashParonychia Grade 1Paronychia Grade 2Paronychia Grade 3Dry skin Grade 1Dry skin Grade 2Papulopustulous eczema Grade 1Papulopustulous eczema Grade 2Papulopustulous eczema Grade 3
Erlotinib Plus Gemcitabine1741072622689696

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Score in Participant Questionnaire: Quality of Life

Participant assessment of life quality under therapy. Assessment ranged from 1 (very good) to 6 (very bad). Questionnaire scores were assessed at several time points during the study. (NCT01782690)
Timeframe: At Weeks 4, 8, 9 and 16

Interventionscores on a scale (Mean)
Week 4Week 8Week 9Week 16
Erlotinib Plus Gemcitabine2.92.91.02.9

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Score in Patient Questionnaire: Possible Side Effects

Participant questionnaire regarding satisfaction with the information about possible side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study. (NCT01782690)
Timeframe: At Weeks 4, 8, 9 and 16

Interventionscores on a scale (Mean)
Week 4Week 8Week 9Week 16
Erlotinib Plus Gemcitabine1.91.91.01.9

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Score in Participant Questionnaire: What to Do in Case of Side Effect

Participant questionnaire regarding satisfaction with the information about what one should do in case of side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study. (NCT01782690)
Timeframe: At Weeks 4, 8, 9 and 16

Interventionscores on a scale (Mean)
Week 4Week 8Week 9Week 16
Erlotinib Plus Gemcitabine1.92.01.01.9

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Number of Dose Modifications and Dose Withdrawals of Erlotinib

Reported is the total number of dose modifications/withdrawals for erlotinib. (NCT01782690)
Timeframe: Up to 12 months

Interventiondose modifications/withdrawals (Number)
Erlotinib Plus Gemcitabine152

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Number of Dose Modifications and Dose Withdrawals of Gemcitabine

Reported is the number of dose modifications/withdrawals for gemcitabine. (NCT01782690)
Timeframe: Up to 12 months

Interventiondose modifications/withdrawals (Number)
Erlotinib Plus Gemcitabine738

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Number of Participants With Adverse Events (AEs)

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT01782690)
Timeframe: Up to 12 months

Interventionparticipants (Number)
Erlotinib Plus Gemcitabine310

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Percentage of Participants With Best Overall Response

Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice. (NCT01782690)
Timeframe: Up to 12 months

Interventionpercentage of participants (Number)
Erlotinib Plus Gemcitabine24.74

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Time to Disease Progression

Disease progression was defined in accordance with daily routine practice. (NCT01782690)
Timeframe: Up to 12 months

Interventionmonths (Median)
Erlotinib Plus Gemcitabine4.3726

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Time of Onset of Rash After Start Erlotinib Treatment

Reported is the number of days from first erlotinib treatment to first rash onset. (NCT01782690)
Timeframe: Up to 12 months

Interventiondays (Mean)
Erlotinib Plus Gemcitabine18.4

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Overall Survival Stratified by Rash

Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by rash status. Participants with rash: rash = yes. Participants without rash: rash = no. (NCT01782690)
Timeframe: Up to 12 months

Interventionmonths (Median)
Rash = YesRash = No
Erlotinib Plus Gemcitabine9.92888.6795

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Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)

Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by ECOG-PS at baseline (0-1 versus 2). ECOG-PS 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours. (NCT01782690)
Timeframe: Up to 12 months

Interventionmonths (Median)
ECOG-PS grade 0-1ECOG-PS grade 2
Erlotinib Plus Gemcitabine9.83016.3452

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Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation

Participant questionnaire regarding the actual side effects of therapy compared to what one expected before therapy. Assessment ranged from 1 (less than expected) to 6 (more than expected). Questionnaire scores were assessed at several time points during the study. (NCT01782690)
Timeframe: At Weeks 4, 8, 9 and 16

Interventionscores on a scale (Mean)
Week 4Week 8Week 9Week 16
Erlotinib Plus Gemcitabine2.62.66.02.7

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Number of Participants With R0 Resection Status.

R0 resection status is a macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. (NCT01783054)
Timeframe: at time of surgery

Interventionparticipants (Number)
Chemotherapy, Surgery2

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Estimate Median Time to Recurrence.

Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact. (NCT01783054)
Timeframe: 2 years

Interventiondays (Number)
Chemotherapy, Surgery329

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Estimate Median Overall Survival

Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact. (NCT01783054)
Timeframe: 2 years

Interventiondays (Number)
Chemotherapy, Surgery465

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Number of Adverse Events Reported in Subjects Enrolled.

Assess the safety profile of this neoadjuvant regimen in patients with localized pancreatic adenocarcinoma. All toxicities will be reported by type and grade and tabulated. All adverse events will be reported via case report forms. The intensity of any adverse event should be reported according to the NCI Common Terminology Criteria for Adverse Events v4.0. (NCT01783054)
Timeframe: First study drug administration until end of study

Interventionadverse events (Number)
Chemotherapy, Surgery60

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Overall Survival (OS)

Overall survival (OS) duration is defined from the date of first dose of study drug to the date of death from any cause. OS was estimated by the Kaplan-Meier method. For participants who were not known to have died as of the data cut-off date, OS was censored at the date of last contact prior to the data cutoff date. (NCT01788566)
Timeframe: Baseline to Death from Any Cause (up to 17 Months)

Interventionmonths (Median)
Gemcitabine + Cisplatin + Necitumumab11.7

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Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)

ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%. (NCT01788566)
Timeframe: Baseline to Measured Progressive Disease (up to 17 Months)

InterventionPercentage of participants (Number)
Gemcitabine + Cisplatin + Necitumumab48.1

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Progression Free Survival (PFS)

PFS is defined as the time from the date of first dose of study drug until objective progressive disease (PD) or death for any cause. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions was also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment. (NCT01788566)
Timeframe: Baseline to Measured Progressive Disease or Death from Any Cause (up to 17 Months)

Interventionmonths (Median)
Gemcitabine + Cisplatin + Necitumumab5.6

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Number of Participants With Anti-Necitumumab Antibodies

A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer. (NCT01788566)
Timeframe: Baseline up to 30 Days Post Last Infusion (up to 17 Months)

Interventionparticipants (Number)
Number of Participants with 1 Positive TiterTreatment Emergent Antibody PositiveNeutralizing Antibody Detected
Gemcitabine + Cisplatin + Necitumumab943

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Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab

Pre-infusion Minimum Concentration (Cmin) and post-infusion (Cmax) necitumumab serum concentration (NCT01788566)
Timeframe: Predose Cycle 1 Day 8; Cycle 2 through 6 Day 1; End of Infusion (EOI) Cycle 1, 3, 5 Day 1

Interventionmicrograms/milliliter (ug/ml) (Geometric Mean)
Predose Cycle 1 Day 8Predose Cycle 2 Day 1Predose Cycle 3 Day 1Predose Cycle 4 Day 1Predose Cycle 5 Day 1Predose Cycle 6 Day 1EOI Cycle 1 Day 1EOI Cycle 3 Day 1EOI Cycle 5 Day 1
Gemcitabine + Cisplatin + Necitumumab70.867.5106115141126266352360

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Number of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]

DCR is best overall response of SD, PR or CR. According to RECIST v1.1, PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Percentage of participants who achieved disease control = (those participants counted in the denominator with a best tumor response of SD, PR, or CR)/(the same denominator as for ORR)*100. (NCT01788566)
Timeframe: Baseline to Measured Progressive Disease or Participants Stops Study (up to 17 Months)

Interventionpercentage of participants (Number)
Gemcitabine + Cisplatin + Necitumumab81.5

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Percent Change in Tumor Size (CTS)

CTS is defined as maximum percent improvement from baseline in the sum of target lesions. (NCT01788566)
Timeframe: Baseline until Measured Progressive Disease (up to 17 Months)

Interventionpercent change (Mean)
Gemcitabine + Cisplatin + Necitumumab39.68

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Percentage of Participants Experiencing Laboratory Abnormalities

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported. (NCT01803282)
Timeframe: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days

,,,,,,,,,,,
Interventionpercentage of participants (Number)
Any Laboratory abnormalities: HematologyAny Laboratory abnormalities: Serum ChemistryAny Laboratory abnormalities: Coagulation
Part A: ADX 1800 mg33.383.333.3
Part A: ADX 200 mg0.0100.025.0
Part A: ADX 600 mg33.366.70.0
Part B: BRCA, ADX 800 mg86.766.740.0
Part B: EGC, ADX 800 mg87.587.535.0
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg90.981.836.4
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg84.495.637.8
Part B: LAC, ADX 1200 mg90.060.010.0
Part B: LSC, ADX 1200 mg80.070.010.0
Part B: PAC, ADX 800 mg97.288.938.9
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg100.087.537.5
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg95.586.445.5

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Percentage of Participants Experiencing Treatment-Emergent Adverse Events

(NCT01803282)
Timeframe: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days

Interventionpercentage of participants (Number)
Part A: ADX 200 mg100.0
Part A: ADX 600 mg100.0
Part A: ADX 1800 mg83.3
Part B: PAC, ADX 800 mg100.0
Part B: LAC, ADX 1200 mg100.0
Part B: LSC, ADX 1200 mg100.0
Part B: EGC, ADX 800 mg100.0
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg100.0
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg100.0
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg100.0
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg100.0
Part B: BRCA, ADX 800 mg100.0

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CL/F

Apparent oral plasma clearance (NCT01809210)
Timeframe: Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose

InterventionL/h (Mean)
Cohort 1 sel50, Gem, CisNA
Cohort 2 sel50, Gem, Carb14.72
Cohort 3 sel75, Gem, Cis22.64
Cohort 4 sel150, Pem, Carb10.72
Cohort 5 sel75, Pem, Carb18.82
Cohort 6 sel75, Pem, Cis19.08
Cohort 7 sel100, Pem, Carb21.02

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Cmax,ss

Maximum plasma concentration at steady state (NCT01809210)
Timeframe: Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose

Interventionng/mL (Geometric Mean)
Cohort 1 sel50, Gem, Cis476.7
Cohort 2 sel50, Gem, Carb1222
Cohort 3 sel75, Gem, Cis1487
Cohort 4 sel150, Pem, Carb1615
Cohort 5 sel75, Pem, Carb1375
Cohort 6 sel75, Pem, Cis1364
Cohort 7 sel100, Pem, Carb2309

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Percentage Change From Baseline at 6 Weeks in Target Lesion Size

The percentage change in the sum of the diameters of target lesions (NCT01809210)
Timeframe: Week 6

Intervention% change (Mean)
Cohort 1 sel50, Gem, Cis-7.5
Cohort 2 sel50, Gem, Carb-29.3
Cohort 3 sel75, Gem, Cis-10.4
Cohort 4 sel150, Pem, Carb-14.7
Cohort 5 sel75, Pem, Carb-24.4
Cohort 6 sel75, Pem, Cis-18.9
Cohort 7 sel100, Pem, Carb-18.4

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Tmax,ss

Time to reach maximum plasma concentration at steady state (NCT01809210)
Timeframe: Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose

Interventionh (Median)
Cohort 1 sel50, Gem, Cis1.00
Cohort 2 sel50, Gem, Carb1.25
Cohort 3 sel75, Gem, Cis1.00
Cohort 4 sel150, Pem, Carb1.00
Cohort 5 sel75, Pem, Carb1.75
Cohort 6 sel75, Pem, Cis1.48
Cohort 7 sel100, Pem, Carb1.50

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Best Objective Response

The best response a patient has had during their time in the study up until RECIST progression or last valuable assessment in the absence of RECIST progression. Per Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions, the sum must also demonstrate an absolute increase of >=5mm; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm (NCT01809210)
Timeframe: Screening, week 6 and week 12

,,,,,,
Interventionparticipants (Number)
Complete responsePartial responseUnconfirmed complete or partial responseStable diseaseRECIST progressionDeathIncomplete post-baseline assessments
Cohort 1 sel50, Gem, Cis0100200
Cohort 2 sel50, Gem, Carb0231003
Cohort 3 sel75, Gem, Cis0202102
Cohort 4 sel150, Pem, Carb0102000
Cohort 5 sel75, Pem, Carb0123000
Cohort 6 sel75, Pem, Cis0227112
Cohort 7 sel100, Pem, Carb0226101

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Dose Limiting Toxicity (DLT) Events in Chemotherapy in Combination With Selumetinib

Any toxicity not attributable to the disease or disease-related processess under investigation, considered related to the combination of chemotherapy plus selumetinib, which occurs within the timeframe and is dose limiting (NCT01809210)
Timeframe: The first dose on Cycle 1 Day 1 up to the time before dosing on Cycle 2 Day 1, assessed up to 3 weeks

,,,,,,
Interventionparticipants (Number)
Evaluable patientsEvaluable patients with a DLT Event
Cohort 1 sel50, Gem, Cis30
Cohort 2 sel50, Gem, Carb72
Cohort 3 sel75, Gem, Cis41
Cohort 4 sel150, Pem, Carb30
Cohort 5 sel75, Pem, Carb60
Cohort 6 sel75, Pem, Cis121
Cohort 7 sel100, Pem, Carb61

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Objective Response Rate (ORR)

The number of patients who had at least 1 confirmed visit response of Complete Response (CR) or Partial Response (PR) prior to any evidence of progression. Per Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm; Objective Response Rate (ORR) = CR + PR (NCT01809210)
Timeframe: Up until progression or last evaluable assessment in the absence of progression, up to 9 months

Interventionparticipants (Number)
Cohort 1 sel50, Gem, Cis1
Cohort 2 sel50, Gem, Carb2
Cohort 3 sel75, Gem, Cis2
Cohort 4 sel150, Pem, Carb1
Cohort 5 sel75, Pem, Carb1
Cohort 6 sel75, Pem, Cis2
Cohort 7 sel100, Pem, Carb2

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AUC (0-tau)

Area under the concentration time curve (AUC) over a dosing interval at steady state (0-tau) (NCT01809210)
Timeframe: Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose

Interventionh*ng/mL (Geometric Mean)
Cohort 1 sel50, Gem, CisNA
Cohort 2 sel50, Gem, Carb3571
Cohort 3 sel75, Gem, Cis3339
Cohort 4 sel150, Pem, Carb4813
Cohort 5 sel75, Pem, Carb4366
Cohort 6 sel75, Pem, Cis4116
Cohort 7 sel100, Pem, Carb5202

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Best Percentage Change From Baseline in Target Lesion Size

The best percentage change in tumour size a patient has had during their time in the study up until RECIST progression or last valuable assessment in the absence of RECIST progression. Percentage change was derived at each visit by the percentage change in the sum of the diameters of target lesions (NCT01809210)
Timeframe: Screening, week 6 and week 12

Intervention% change (Mean)
Cohort 1 sel50, Gem, Cis-11.9
Cohort 2 sel50, Gem, Carb-34.6
Cohort 3 sel75, Gem, Cis-41.3
Cohort 4 sel150, Pem, Carb-28.3
Cohort 5 sel75, Pem, Carb-34.7
Cohort 6 sel75, Pem, Cis-24.4
Cohort 7 sel100, Pem, Carb-25.4

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Duration of Response

Duration of response was the time from the first overall response contributing to an objective response to the first overall response of progressive disease (PD) occurring after the first overall response contributing to the objective response. Confidence intervals for median duration of response were calculated using the method of Brookmeyer and Crowley (1982). (NCT01822756)
Timeframe: Randomization to clinical cutoff 22Sept2015 (approx 244 days)

Interventiondays (Median)
Cohort A0132.0
Cohort B (-1)33.0
Cohort B0 (+GCSF)113.0
Cohort B0 (-GCSF)244.0
Cohort B1225.0

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Percentage of Participants With a Best Response by RECIST Criteria

"Best response was determined on the subject level using the highest overall response achieved post-baseline. In the case of stable disease (SD), measurements had to meet the SD criterion at least once after study entry at a minimum interval of 49 days. Subjects who failed to meet this criterion had best response of progressive disease (PD) if the next available RECIST evaluation after the initial scan indicated PD or not evaluable (NE) if no additional RECIST evaluations were available.~Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits." (NCT01822756)
Timeframe: every 2 cycles starting at Cycle 3 Day 1 up to approximately 4 to 6 months

,,,,
Interventionpercentage of participants (Number)
Overall responseComplete responsePartial responseStable diseaseProgressive diseaseNot evaluableMissing
Cohort A012.50.012.525.037.56.318.8
Cohort B (-1)25.00.025.075.00.00.00.0
Cohort B0 (-GCSF)25.025.00.050.00.00.025.0
Cohort B0 (+GCSF)50.00.050.020.010.00.020.0
Cohort B137.50.037.525.037.50.00.0

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Percentage of Participants With Adverse Events That Are Defined as Dose Limiting Toxicities (DLTs)

Toxicities occurring during the first treatment cycle (Cycle 1) defined tolerability. Within each cohort, subjects were considered evaluable if they had received at least 40 of 56 planned doses of RUX during the 28-day surveillance period and received 2 of the 3 planned doses of chemotherapy (gemcitabine and/or gemcitabine and nab-paclitaxel) at the assigned dose level, or they had experienced a DLT. (NCT01822756)
Timeframe: Approximately 28 days

Interventionpercentage of participants (Number)
Cohort A00.0
Cohort B (-1)0.0
Cohort B0 (+GCSF)20.0
Cohort B0 (-GCSF)50.0
Cohort B10.0

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Percentage of Responders

Duration of response was measured as the time from the first overall response contributing to an objective response to the first overall response of progressive disease (PD) occurring after the first overall response contributing to the objective response. (NCT01822756)
Timeframe: Randomization to clinical cutoff 22Sept2015 (approx 244 days)

InterventionPercentage of responders (Number)
Cohort A012.5
Cohort B (-1)25.0
Cohort B0 (+GCSF)50.0
Cohort B0 (-GCSF)25.0
Cohort B137.5

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Safety - Frequency of Toxicities Grade 3 and 4

Frequency of toxicities was reported by type and grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). (NCT01822886)
Timeframe: 24 months

Interventionevents (Number)
Romidepsin, Gemcitabine29

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Percentage of Participants With Progression-Free Survival

The time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS (progression-free survival) data will be censored on the day following the date of the last radiological assessment of measured lesions documenting absence of progressive disease for patients who do not have objective tumor progression and are still on study at the time of an analysis, are given antitumor treatment other than the study treatment or stem cell transplant, or are removed from study prior to documentation of objective tumor progression. Patients lacking an evaluation of tumor response after their first dose will have their event time censored at 1 day. Percentage of participants is an estimate based on Kaplan-Meier method. (NCT01822886)
Timeframe: 24 months

Interventionpercentage of partecipants (Number)
Romidepsin, Gemcitabine11.2

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Overall Survival is Measured From the Date of Study Entry to the Date of Patient's Death

OS (overall survival) is measured from the date of study entry to the date of patient's death. If the patient is alive or his vital status is unknown, the date of death will be censored at the date that the patient is last known to be alive. (NCT01822886)
Timeframe: 24 months

Interventionpercentage of partecipants (Number)
Romidepsin, Gemcitabine50

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Complete Remission (CR) Rate

"Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)" (NCT01822886)
Timeframe: 18 months

InterventionParticipants (Count of Participants)
Romidepsin, Gemcitabine3

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Overall Response Rate (ORR)

"ORR the proportion of patients who achieve CR (complete response), CRu (complete remission unconfirmed) or PR (partial response) relative to the per-protocol population. Disease response and progression will be evaluated according to the Revised Response Criteria for malignant lymphoma (Cheson et al. 2007)." (NCT01822886)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Romidepsin, Gemcitabine6

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MTD of MEK162 - Phase I

In the phase I portion, up to 18 patients will be enrolled in classic 3+3 cohort dose escalation design to identify the MTD of MEK162 when administered with gemcitabine and cisplatin given weeks 2 and 3 of a 3 week cycle . (NCT01828034)
Timeframe: 1 year

Interventionmg (Number)
Gemcitabine, Cisplatin and MEK16245

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Median PFS

progression free survival will be calculated from study entry to documented disease progression or death from any cause, whatever occurs first. (NCT01828034)
Timeframe: 1 year

Interventionmonths (Median)
Gemcitabine, Cisplatin and MEK1626

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Median Overall Survival

(survival) will be calculated from study entry to death or last follow up (NCT01828034)
Timeframe: 1 year

Interventionmonths (Mean)
Gemcitabine, Cisplatin and MEK16213.3

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Objective Response Rate (ORR)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01828034)
Timeframe: 1 year

Interventionpercentage of participants with ORR (Number)
Gemcitabine, Cisplatin and MEK16212

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Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Death

AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are events with start date on or after the date of first dose of study treatment and up to and including 30 days after the last dose of study treatment, or events with start date prior to the date of first dose of study treatment, and worsened in severity or become serious during treatment. TEAEs include both Serious TEAEs and non-serious TEAEs. (NCT01833546)
Timeframe: Baseline up to 33 months

,,,
InterventionParticipants (Count of Participants)
TEAEsSerious TEAEsTEAEs leading to death
Evofosfamide 240 mg300
Evofosfamide 340 mg300
Evofosfamide 340 mg + Gemcitabine610
Evofosfamide 480 mg810

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Number of Participants With Clinical Significant Laboratory Abnormalities and Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events

Clinical laboratory parameters that were assessed included: hematological parameters, blood chemistry parameters, coagulation and urinalysis and the vital signs that were assessed included: blood pressure, heart rate, respiratory rate, and body temperature. (NCT01833546)
Timeframe: Baseline up to 33 months

,,,
InterventionParticipants (Count of Participants)
Subjects with Lab AbnormalitiesSubjects with Vital signs Abnormalities
Evofosfamide 240 mg30
Evofosfamide 340 mg30
Evofosfamide 340 mg + Gemcitabine60
Evofosfamide 480 mg80

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Maximum Observed Plasma Concentration (Cmax) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])

Maximum observed Plasma concentration was assessed. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine. (NCT01833546)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15

Interventionng/mL (Geometric Mean)
Gemcitabine: Day 1Gemcitabine: Day 15dFdU: Day 1dFdU: Day 15
Evofosfamide 340 mg + Gemcitabine22596.221355.533923.933631.4

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Maximum Observed Plasma Concentration (Cmax) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])

Maximum observed plasma concentration was assessed. (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

,,,
InterventionNanogram per milliliter (ng/mL) (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15Br-IPM: Day 1Br-IPM: Day 15
Evofosfamide 240 mg6502.37159.963.3762.01
Evofosfamide 340 mg10009.810248.2103.74149.36
Evofosfamide 340 mg + Gemcitabine9303.48720.886.55124.92
Evofosfamide 480 mg14016.714661.2224.95207.88

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Cumulative Amount of Evofosfamide Excreted From Time Zero to Time After Dosing (Ae0-t)

Cumulative amount excreted in urine from time zero to the end of the last measurable concentration was reported. (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

,,,
Interventionmilligram per square meter (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15
Evofosfamide 240 mg22.91311.674
Evofosfamide 340 mg17.13522.605
Evofosfamide 340 mg + Gemcitabine22.69130.025
Evofosfamide 480 mg38.77140.049

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Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])

Area under the concentration-time curve from time zero extrapolated to infinity, calculated as AUC(0-last) + last observed concentration (Clast)/terminal rate constant (λz), using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Where AUC(0-last) is area under the concentration-time curve from time 0 to the last quantifiable concentration was assessed. λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine. (NCT01833546)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15

Interventionng*hour/mL (Geometric Mean)
Gemcitabine: Day 1Gemcitabine: Day 15dFdU: Day 1dFdU: Day 15
Evofosfamide 340 mg + Gemcitabine10719.59996.0159014.1133203.0

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Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])

Area under the concentration-time curve from time zero extrapolated to infinity, calculated as AUC(0-last) + last observed concentration (Clast)/terminal rate constant (λz), using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Where AUC(0-last) is area under the concentration-time curve from time 0 to the last quantifiable concentration was assessed. λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

,,
Interventionng*hour/mL (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15Br-IPM: Day 1Br-IPM: Day 15
Evofosfamide 240 mg5296.25261.39051
Evofosfamide 340 mg7904.78233.3105115.1
Evofosfamide 480 mg10459.610786.6174.6171.8

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Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])

Area under the concentration-time curve from time zero extrapolated to infinity, calculated as AUC(0-last) + last observed concentration (Clast)/terminal rate constant (λz), using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Where AUC(0-last) is area under the concentration-time curve from time 0 to the last quantifiable concentration was assessed. λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

Interventionng*hour/mL (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15
Evofosfamide 340 mg + Gemcitabine6049.55664.9

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Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Sampling Time With Concentration at or Above the Lower Limit of Quantitation (AUC[0-t]) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])

Area under the concentration-time curve from time 0 to the last quantifiable concentration was assessed. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine. (NCT01833546)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15

Interventionng*hour/mL (Geometric Mean)
Gemcitabine: Day 1Gemcitabine: Day 15dFdU: Day 1dFdU: Day 15
Evofosfamide 340 mg + Gemcitabine10001.29576.0139397.1116487.7

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Apparent Terminal Half-life (t1/2) of of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])

Terminal half-life was calculated as ln(2)/λz. Where λz is a Terminal rate constant, which was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine. (NCT01833546)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15

Interventionhours (Geometric Mean)
Gemcitabine: Day 1Gemcitabine: Day 15dFdU: Day 1dFdU: Day 15
Evofosfamide 340 mg + Gemcitabine0.21390.21867.7417.964

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Apparent Volume of Distribution During Terminal Phase (Vz) of Gemcitabine

Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following single dose. Area under the plasma concentration-time curve from time zero to infinity, calculated (AUC0-inf) as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured plasma concentration is at or above lower limit of quantification (LLQ) and λz is the elimination rate constant. And the elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine. (NCT01833546)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15

InterventionLiter per square meter (Geometric Mean)
Gemcitabine: Day 1Gemcitabine: Day 15
Evofosfamide 340 mg + Gemcitabine28.7830.14

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Apparent Volume of Distribution During Terminal Phase (Vz) of Evofosfamide

Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following single dose. Area under the plasma concentration-time curve from time zero to infinity, calculated (AUC0-inf) as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured plasma concentration is at or above lower limit of quantification (LLQ) and λz is the elimination rate constant. And the elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data. (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

,,,
InterventionLiter per square meter (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15
Evofosfamide 240 mg44.8545.41
Evofosfamide 340 mg39.1640.44
Evofosfamide 340 mg + Gemcitabine49.0751.34
Evofosfamide 480 mg42.1046.86

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Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Sampling Time With Concentration at or Above the Lower Limit of Quantitation (AUC[0-t]) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])

Area under the concentration-time curve from time 0 to the last quantifiable concentration was assessed. (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

,,,
Interventionng*hour per mL (ng*hour/mL) (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15Br-IPM: Day 1Br-IPM: Day 15
Evofosfamide 240 mg5266.95232.438.141.4
Evofosfamide 340 mg7864.28191.161.7101.2
Evofosfamide 340 mg + Gemcitabine5989.55616.447.777.0
Evofosfamide 480 mg10416.110742.8153.8149.4

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Time to Reach Maximum Plasma Concentration (Tmax) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])

Tmax was the time to peak concentration in plasma, obtained directly from the concentration versus time curve. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine. (NCT01833546)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15

Interventionhours (Median)
Gemcitabine: Day 1Gemcitabine: Day 15dFdU: Day 1dFdU: Day 15
Evofosfamide 340 mg + Gemcitabine0.5000.5000.5000.500

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Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as Treatment Emergent Adverse Events (TEAEs)

Twelve-lead ECGs were performed and assessed after at least 5 minutes rest in supine position locally. (NCT01833546)
Timeframe: Baseline up to 33 months

InterventionParticipants (Count of Participants)
Evofosfamide 240 mg0
Evofosfamide 340 mg0
Evofosfamide 480 mg3
Evofosfamide 340 mg + Gemcitabine1

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Time to Reach Maximum Plasma Concentration (Tmax) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])

(NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

,,,
Interventionhours (Median)
Evofosfamide: Day 1Evofosfamide: Day 15Br-IPM: Day 1Br-IPM: Day 15
Evofosfamide 240 mg0.5500.220.5500.600
Evofosfamide 340 mg0.2500.5330.6330.550
Evofosfamide 340 mg + Gemcitabine0.5500.5330.5670.533
Evofosfamide 480 mg0.3920.2670.5750.567

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Terminal Rate Constant Associated With the Terminal Elimination Phase (λz) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])

Terminal rate constant was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine. (NCT01833546)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15

InterventionPer hour (Geometric Mean)
Gemcitabine: Day 1Gemcitabine: Day 15dFdU: Day 1dFdU: Day 15
Evofosfamide 340 mg + Gemcitabine3.2413.1710.08950.0870

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Terminal Rate Constant Associated With the Terminal Elimination Phase (λz) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])

Terminal rate constant was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

,,
InterventionPer hour (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15Br-IPM: Day 1Br-IPM: Day 15
Evofosfamide 340 mg1.1001.0322.4362.701
Evofosfamide 240 mg1.0121.0071.4781.669
Evofosfamide 480 mg1.0940.9511.7581.581

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Number of Participants With Disease Control

Disease Control was defined as having achieved at least disease stabilization; that is participants with confirmed CR, PR, or SD lasting for at least 16 weeks. CR: Disappearance of all target lesions. PR: A decrease of at least 30% in the sum of the longest diameter of target lesions. PD: PD is defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. SD: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. (NCT01833546)
Timeframe: Time from first treatment to final assessment at 33 months

InterventionParticipants (Count of Participants)
Evofosfamide 240 mg0
Evofosfamide 340 mg0
Evofosfamide 480 mg2
Evofosfamide 340 mg + Gemcitabine2

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Terminal Rate Constant Associated With the Terminal Elimination Phase (λz) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])

Terminal rate constant was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

InterventionPer hour (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15
Evofosfamide 340 mg + Gemcitabine1.1461.177

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Renal Clearance (CL) for Evofosfamide

Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

,,,
InterventionLiter per hour per square meter (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15
Evofosfamide 240 mg4.352.23
Evofosfamide 340 mg2.182.76
Evofosfamide 340 mg + Gemcitabine3.795.35
Evofosfamide 480 mg3.723.73

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Apparent Volume of Distribution at Steady State (Vss) of Gemcitabine

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine. (NCT01833546)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15

InterventionLiter per square meter (Geometric Mean)
Gemcitabine: Day 1Gemcitabine: Day 15
Evofosfamide 340 mg + Gemcitabine34.4143.71

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Apparent Volume of Distribution at Steady State (Vss) of Evofosfamide

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state. (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

,,,
InterventionLiter per square meter (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15
Evofosfamide 240 mg21.7120.26
Evofosfamide 340 mg21.5418.83
Evofosfamide 340 mg + Gemcitabine39.0341.55
Evofosfamide 480 mg21.7921.35

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Apparent Total Body Clearance of (CL) of Gemcitabine

Apparent total clearance (CL/F) was calculated as dose divided by area under the plasma concentration-time profile from time zero extrapolated to infinity (AUC[inf]). This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine. (NCT01833546)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15

InterventionLiter per hour per square meter (Geometric Mean)
Gemcitabine: Day 1Gemcitabine: Day 15
Evofosfamide 340 mg + Gemcitabine93.29101.04

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Apparent Total Body Clearance of (CL) of Evofosfamide

Apparent total clearance (CL/F) was calculated as dose divided by area under the plasma concentration-time profile from time zero extrapolated to infinity (AUC[inf]). (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

,,,
InterventionLiter per hour per square meter (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15
Evofosfamide 240 mg45.8345.74
Evofosfamide 340 mg43.0541.74
Evofosfamide 340 mg + Gemcitabine56.2360.43
Evofosfamide 480 mg46.0744.59

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Best Overall Response (BOR)

BOR was determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). BOR was defined as the best response of any of the confirmed complete response (CR), confirmed partial response (PR), stable disease (SD) and progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Number of participants with CR, PR, SD and PD were reported. (NCT01833546)
Timeframe: Time from first treatment to final assessment at 33 months

,,,
InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable DiseaseProgressive Disease
Evofosfamide 240 mg0002
Evofosfamide 340 mg0003
Evofosfamide 340 mg + Gemcitabine0023
Evofosfamide 480 mg0024

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Apparent Terminal Half-life (t1/2) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])

Terminal half-life was calculated as ln(2)/λz. Where λz is a Terminal rate constant, which was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

Interventionhours (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15
Evofosfamide 340 mg + Gemcitabine0.60490.5889

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Number of Participants With Objective Response

OR was determined according to RECIST v1.1. Objective response is defined as a best overall response of confirmed complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Number of participants with OR were reported. (NCT01833546)
Timeframe: Time from first treatment to final assessment at 33 months

InterventionParticipants (Count of Participants)
Evofosfamide 240 mg0
Evofosfamide 340 mg0
Evofosfamide 480 mg0
Evofosfamide 340 mg + Gemcitabine0

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Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 2 or Higher Than 2

ECOG performance status measured to assess subject's performance status on a scale of 0 to 5, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (more than 50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=Death. Number of participants with ECOG performance status score of 2 or higher than 2 were reported. (NCT01833546)
Timeframe: Baseline up to 33 months

InterventionParticipants (Count of Participants)
Evofosfamide 240 mg0
Evofosfamide 340 mg0
Evofosfamide 480 mg1
Evofosfamide 340 mg + Gemcitabine0

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Number of Participants Who Experienced Any Dose-Limiting Toxicity (DLT) During First Cycle - Day 1 to 28

A DLT was defined as any of the following toxicities at any dose level that occurred during the first cycle, and were considered to be related to the study drug by the Investigator or the Sponsor: - Grade 3 or Grade 4 non-hematological toxicity, except for Grade 3 or Grade 4 nausea, vomiting and diarrhea, - Grade 3 or higher skin reactions or mucosal toxicities, - Febrile neutropenia, - Grade 3 alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevation lasting more than 7 days, - Grade 4 neutropenia lasting more than 5 days, - Grade 4 thrombocytopenia, - Grade 4 anemia, - Any non-preexisting Grade 2 or higher non-hematologic toxicity which, in the judgment of the Investigator and the Sponsor, was considered a DLT, - Any Grade 2 or higher non-hematologic toxicity that did not resolve to Grade 0 or Grade 1 toxicity by the start of the next cycle which, in the judgment of the Investigator and the Sponsor, was considered a DLT. (NCT01833546)
Timeframe: Day 1 up to Day 28 of Cycle 1

InterventionParticipants (Count of Participants)
Evofosfamide 240 mg0
Evofosfamide 340 mg0
Evofosfamide 480 mg1
Evofosfamide 340 mg + Gemcitabine0

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Apparent Terminal Half-life (t1/2) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])

Terminal half-life was calculated as ln(2)/λz. Where λz is a Terminal rate constant, which was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. (NCT01833546)
Timeframe: Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15

,,
Interventionhours (Geometric Mean)
Evofosfamide: Day 1Evofosfamide: Day 15Br-IPM: Day 1Br-IPM: Day 15
Evofosfamide 240 mg0.68500.68810.46910.4153
Evofosfamide 340 mg0.63040.67160.28460.2566
Evofosfamide 480 mg0.63340.72850.39420.4384

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Overall Survival

Overall survival was defined as the time from randomization until death from any cause. Participants who died or were lost to follow-up by the date of analysis data cutoff were censored at their last contact date. (NCT01839487)
Timeframe: From randomization until death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)

Interventionmonths (Median)
PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine9.59
AG: Nab-paclitaxel + Gemcitabine9.23

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Percentage of Participants in the PAG Arm Who Experienced Any Thromboembolic (TE) Event in Stage 2 of the Study

TE events were identified by applying the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Queries (SMQ) search strategy for 3 SMQs: TE arterial, TE venous, and TE vessel type unspecified and mixed arterial and venous. TE events were considered by the Sponsor to be adverse events (AEs) of special interest. All TE events, regardless of type of event, severity, or seriousness were reported. Participants with multiple events were counted only once. A summary of serious and all other non-serious adverse events regardless of causality is located in the 'Reported AE section'. (NCT01839487)
Timeframe: From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG)

Interventionpercentage of participants (Number)
PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine14.0

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Percentage of Participants With AEs

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. (NCT01839487)
Timeframe: From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG and 20.27 months for AG)

Interventionpercentage of participants (Number)
PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine99.4
AG: Nab-paclitaxel + Gemcitabine98.0

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Progression-Free Survival (PFS)

PFS: time from randomization until first occurrence of disease progression, either by central radiologic determination (Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or by clinical progression determined by Investigator, or death during treatment period from any cause. Radiological disease progression was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 millimeters (mm); Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using Kaplan-Meier (KM) method. (NCT01839487)
Timeframe: From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)

Interventionmonths (Median)
PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine6.05
AG: Nab-paclitaxel + Gemcitabine5.26

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Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of PEGPH20

Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 PK were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation [3.5 mg/mL], and Run-in Phase 2: New PEGPH20 formulation [0.3 mg/mL]). (NCT01839487)
Timeframe: Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1

,
Interventionhours*ng/mL (Mean)
Day 1Day 15
Run-in Phase 1-PAG: PEGPH20 (Original Formulation) + NAB + GEM1837.935752807.94210
Run-in Phase 2- PAG: PEGPH20 (New Formulation) + NAB + GEM2143.303192423.01690

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Maximum Observed Plasma Concentration (Cmax) of PEGPH20

Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 pharmacokinetic (PK) were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation [3.5 mg/mL], and Run-in Phase 2: New PEGPH20 formulation [0.3 mg/mL]). (NCT01839487)
Timeframe: Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1

,
Interventionnanograms/milliliter (ng/mL) (Mean)
Day 1Day 15
Run-in Phase 1-PAG: PEGPH20 (Original Formulation) + NAB + GEM72.182.9
Run-in Phase 2- PAG: PEGPH20 (New Formulation) + NAB + GEM67.884.1

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PFS in Relation to Tumor Hyaluronan (HA) Levels

PFS was defined as time from randomization until first occurrence of disease progression, either by central radiologic determination (RECIST version 1.1) or by clinical progression determined by Investigator, or death during treatment period from any cause. Disease progression was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 mm; Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using KM method. PFS was measured in HA-high and HA-low participants. (NCT01839487)
Timeframe: From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)

,
Interventionmonths (Median)
HA-HighHA-Low
AG: Nab-paclitaxel + Gemcitabine5.195.26
PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine9.235.59

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Time to Reach Cmax (Tmax) of PEGPH20

Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 PK were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation [3.5 mg/mL], and Run-in Phase 2: New PEGPH20 formulation [0.3 mg/mL]). (NCT01839487)
Timeframe: Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1

,
Interventionhours (Median)
Day 1Day 15
Run-in Phase 1-PAG: PEGPH20 (Original Formulation) + NAB + GEM0.4300.790
Run-in Phase 2- PAG: PEGPH20 (New Formulation) + NAB + GEM0.8650.810

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Objective Response Rate (ORR): Percentage of Participants With Objective Response

ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR) regardless of confirmation, as assessed by RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT01839487)
Timeframe: From the date of randomization until last date on study treatment (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)

Interventionpercentage of participants (Number)
PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine40.4
AG: Nab-paclitaxel + Gemcitabine32.7

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Number of Participants With Relapse-free Survival

In this small trial we will regard a median progression-free survival of 20 months as indicative of potential therapeutic benefit meriting additional study. (NCT01839799)
Timeframe: 20 months

InterventionParticipants (Count of Participants)
Arm 13
Arm 22

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Duration of Response

Duration of response: time from the date of first documented response per the investigator response assessment (CR or PR) to the date of PD or the date of last disease assessment if the participant discontinued the study before PD using RECIST 1.1 CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: >=30% decrease under baseline of sum of diameters of all target lesions; short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in sum of diameters of target lesions, taking as reference smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. (NCT01862328)
Timeframe: From the date of first documented response (CR or PR) to the date of first documented PD or the date of last disease assessment if the participants discontinued the study before PD (up to 5 years)

Interventionmonths (Mean)
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^22.880
Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC62.270
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC516.153
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC57.015

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Dose-escalation Phase: Plasma Concentrations-time Data of MLN4924

(NCT01862328)
Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 20 hours) post-dose (Cycle Length=21 days [Arm 1 and 2] and 28 days [Arm 3])

,,,,,
Interventionnanogram per milliliter (ng/ml) (Mean)
Cycle 1 Day 1: End-doseCycle 1 Day 1: 1.5 hours post doseCycle 1 Day 1: 3 hours post doseCycle 1 Day 1: 20 hours post dose
Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2163.882.048.07.5
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2197.1130.695.814.6
Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5275.7156.8152.423.4
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5257.3192.7138.034.6
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5372.7246.7186.924.4
Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2222.0160.5103.014.2

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MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924

The number of participants analyzed includes only those participants who had data available for this measure. (NCT01862328)
Timeframe: Cycle 1 Days 1 and 5 pre-dose and at multiple time points (up to 20 hours) post-dose (Cycle Length=21 days [Arm 1 and 2])

Interventionng/ml (Mean)
Cycle 1 Day 1: End-doseCycle 1 Day 1: 1.5 hours post doseCycle 1 Day 1: 3 hours post doseCycle 1 Day 1: 6 hours post doseCycle 1 Day 1: 20 hours post doseCycle 1 Day 5: End-doseCycle 1 Day 5: 1.5 hours post doseCycle 1 Day 5: 3 hours post doseCycle 1 Day 5: 6 hours post doseCycle 1 Day 5: 20 hours post dose
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5429.8253.6192.8136.330.2253.2171.0118.476.510.9

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MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924

The number of participants analyzed includes only those participants who had data available for this measure. (NCT01862328)
Timeframe: Cycle 1 Days 1 and 5 pre-dose and at multiple time points (up to 20 hours) post-dose (Cycle Length=21 days [Arm 1 and 2])

Interventionng/ml (Mean)
Cycle 1 Day 1: End-doseCycle 1 Day 1: 1.5 hours post doseCycle 1 Day 1: 3 hours post doseCycle 1 Day 1: 7 hours post doseCycle 1 Day 1: 20 hours post doseCycle 1 Day 5: End-doseCycle 1 Day 5: 1.5 hours post doseCycle 1 Day 5: 3 hours post doseCycle 1 Day 5: 7 hours post doseCycle 1 Day 5: 20 hours post dose
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2152.8137.386.463.414.2211.1115.396.738.39.8

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Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

(NCT01862328)
Timeframe: Baseline up to 30 days after the last dose of study drug (up to 5 years)

,,,,,,
InterventionParticipants (Count of Participants)
TEAESAE
Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^241
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2189
Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC572
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5123
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC571
Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC663
Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2107

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Percentage of Participants With Objective Response

Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]); no new lesions. PR: greater than or equal to (>=) 30 percent (%) decrease under baseline of sum of diameters of all target lesions; short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. (NCT01862328)
Timeframe: Screening, Cycle 2 Days 15 (Arm 1, 2a, and 2) and 22 (Arm 3) then every other Cycle thereafter up to 30 days after the last dose of study drug (up to 5 years) (Cycle Length = 21 days [Arm 1, 2a, and 2] and 28 days [Arm 3])

,,,,,,
Interventionpercentage of participants (Number)
CRPR
Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^200
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2019
Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC500
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC51836
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5040
Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6017
Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^200

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Progression-free Survival (PFS)

The median length of time from the beginning of study treatment that patients remain alive without progression of their disease (cancer). Per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. (NCT01879085)
Timeframe: Up to 7 years and 7 months

Interventionmonths (Median)
Phase 25.552361

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Six-month Overall Survival (OS)

Proportion of participants alive at six months from the start of treatment. (NCT01879085)
Timeframe: Up to 6 months (per patient)

Interventionproportion of participants (Number)
Phase 20.742

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Six-month Progression-free Survival (PFS)

Proportion of participants whose disease does not progress within 6 months of start of treatment (number of patients without progressive disease/total number of patients). Per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. (NCT01879085)
Timeframe: Up to 6 months (per patient)

Interventionproportion of participants (Number)
Phase 20.473

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Objective Response Rate (ORR)

Number of patients with Complete response [CR] + partial response [PR], per RECIST v1.1 criteria . Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10 mm. For non-target lesions: Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10mm short axis);PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters (NCT01879085)
Timeframe: Up to 7 years and 7 months

InterventionParticipants (Count of Participants)
Phase 27

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One-year Overall Survival (OS)

Proportion of participants alive at one year from the start of treatment. (NCT01879085)
Timeframe: Up to one year (per patient)

Interventionproportion of participants (Number)
Phase 20.477

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One-year Progression-free Survival (PFS)

Proportion of participants whose disease does not progress within one year of start of treatment (number of patients with progressive disease/total number of patients). Per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. (NCT01879085)
Timeframe: Up to one year (per patient)

Interventionproportion of participants (Number)
Phase 20.304

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Overall Survival (OS)

The median length of time from the start of treatment that diagnosed study participants remain alive. (NCT01879085)
Timeframe: Up to 7 years and 7 months

Interventionmonths (Median)
Phase 211.92608

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Kaplan-Meier Estimates of Overall Survival

Overall survival was defined as the time from the date of randomization to the date of death (from any cause). (NCT01881230)
Timeframe: From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C

Interventionmonths (Median)
Arm A: Nab-Paclitaxel + Gemcitabine12.1
Arm B: Nab-Paclitaxel + Carboplatin16.8
Arm C: Gemcitabine + Carboplatin12.6

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Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.

PFS was defined as the time from the date of randomization to the date of disease progression or death from any cause on or prior to the data cutoff date for the statistical analysis, whichever occurred earlier. Tumor responses were assessed every 6 weeks using, Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and defined as: Complete response (CR) is the disappearance of all target lesions; Partial response (PR) occurs when at least a 30% decrease in the sum of diameters of target lesions from baseline; Stable disease is neither sufficient shrinkage to qualify for a PR nor sufficient increase of lesions to qualify for Progressive disease (PD); Progressive Disease- is at least a 20% increase in the sum of diameters of target lesions from nadir. (NCT01881230)
Timeframe: From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C

Interventionmonths (Median)
Arm A: Nab-Paclitaxel + Gemcitabine5.5
Arm B: Nab-Paclitaxel + Carboplatin8.3
Arm C: Gemcitabine + Carboplatin6.0

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Percentage of Participants Who Discontinued From All Study Treatment Due to TEAEs

Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen with an onset date on or after the date of the first dose of IP through 28 days after the last dose. (NCT01881230)
Timeframe: From randomization through to 28 days after the last dose of IP; up to data-cut off of date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C

Interventionpercentage of participants (Number)
Arm A: Nab-Paclitaxel + Gemcitabine21.7
Arm B: Nab-Paclitaxel + Carboplatin26.6
Arm C: Gemcitabine + Carboplatin21.9

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Percentage of Participants Experiencing Dose Modifications (Reductions and Interruptions)

The number of participants with dose modifications occurring during the treatment period. Dose reductions and interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. (NCT01881230)
Timeframe: From randomization through to 28 days after the last dose of IP; up to data-cut off of date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C

,,
Interventionpercentage of participants (Number)
≥ one DR for both IPs≥ one DI for both IPs≥ one dose missed for both IPs
Arm A: Nab-Paclitaxel + Gemcitabine33.338.348.3
Arm B: Nab-Paclitaxel + Carboplatin46.970.345.3
Arm C: Gemcitabine + Carboplatin51.673.456.3

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Percentage of Participants Who Initiated Cycle 6 Receiving Doublet Combination Therapy

The percentage of participants who initiated Cycle 6 receiving doublet combination therapy regardless of the need for dose modifications. (NCT01881230)
Timeframe: Cycle 6

Interventionpercentage of participants (Number)
Arm A: Nab-Paclitaxel + Gemcitabine55.7
Arm B: Nab-Paclitaxel + Carboplatin64.1
Arm C: Gemcitabine + Carboplatin50.0

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Percentage of Participants With an Objective Complete or Partial Overall Response by Investigator Assessment.

Percentage of participants with an Objective Complete or Partial Overall Response according to RECIST 1.1 and defined as: Complete response-disappearance of all target lesions; partial response at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)• Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir. (NCT01881230)
Timeframe: Disease response was assessed every 6 weeks; from date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C

Interventionpercentage of participants (Number)
Arm A: Nab-Paclitaxel + Gemcitabine39.3
Arm B: Nab-Paclitaxel + Carboplatin73.4
Arm C: Gemcitabine + Carboplatin43.9

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Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Treatment-emergent adverse events (TEAEs) were defined as any AEs that began or worsened with the onset date on or after the date of the first dose of IP through 28 days after the last dose. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was graded based on the participant's symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity as follows: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death. (NCT01881230)
Timeframe: From randomization through to 28 days after the last dose of IP; up to data cut off date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C

,,
Interventionparticipants (Number)
Any TEAEAny Grade 3 or Higher TEAETreatment-related TEAETreatment-related, Grade 3 or Higher TEAESerious TEAETreatment-related Serious TEAETEAE Leading to Discontinuation (D/C) of IPTreatment Related (TR) TEAE Leading to D/C of IPTEAE Leading to Dose Reduction (DR) of IPTreatment related TEAE Leading to DR of IPTEAE Leading to Dose Interruption (DI) of IPTR TEAE Leading to DI of IPTEAE leading to D/C of nab-PaclitaxelTR TEAE leading to D/C of nab-PaclitaxelTEAE leading to DR of nab-PaclitaxelTR TEAE leading to DR of nab-PaclitaxelTEAE leading to DI of nab-PaclitaxelTR TEAE leading to DI of nab-PaclitaxelTEAE leading to D/C of GemcitabineTR TEAE leading to D/C of GemcitabineTEAE leading to DR of GemcitabineTR TEAE leading to DR of GemcitabineTEAE leading to DI of GemcitabineTR TEAE leading to DI of GemcitabineTEAE leading to D/C of CarboplatinTR TEAE leading to D/C of CarboplatinTEAE leading to DR of CarboplatinTR TEAE leading to DR of CarboplatinTEAE leading to DI of CarboplatinTR TEAE leading to DI of CarboplatinTEAE Leading to DeathTreatment Related TEAE leading to death
Arm A: Nab-Paclitaxel + Gemcitabine6046593522101612232331271611222131271371818312400000021
Arm B: Nab-Paclitaxel + Carboplatin6351624320929272020504417131919504400000028251717504410
Arm C: Gemcitabine + Carboplatin6454604625131512252350440000001392523494315122120504321

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Progression-Free Survival

Progression-free survival is defined as the time from study enrollment until the first documented tumor progression (using RECIST 1.1 criteria) or death from any cause. (NCT01893801)
Timeframe: Over the course of the subjects' treatment and participation in study, approx 18 mos

Interventionmonths (Median)
Nab-Pac+Cis+Gem10.1

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Percentage Change in CA 19-9

Percentage change in CA 19-9 from baseline values (NCT01893801)
Timeframe: Over the course of the subjects' treatment on study, approx 1 year

Interventionpercentage change CA 19-9 from baseline (Mean)
Nab-Pac+Cis+Gem-47.7

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Overall Survival

Overall survival is defined as the time from study enrollment until death from any cause. (NCT01893801)
Timeframe: Over the course of the subjects' treatment and participation in study, approx 18 mos

Interventionmonths (Median)
Nab-Pac+Cis+Gem16.4

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Toxicities Associated With Chemotherapy and Radiotherapy

The number of patients who experienced treatment related adverse events will be determined for all patients who received at least one cycle of FOLFIRINOX chemotherapy. These events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. (NCT01897454)
Timeframe: Up to 30 months

InterventionParticipants (Count of Participants)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)22

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Progression Free Survival (PFS)

Progression-free Survival defined as the duration of time from start of treatment to time of disease progression will be analyzed. Median progression free survival will be presented. (NCT01897454)
Timeframe: From start of treatment to time of progression, assessed up to 60 months

InterventionMonths (Median)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)34

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Percentage of Patients Able to Undergo Resection

The percentage of participants with resectable or borderline resectable disease to undergo resection will be determined. The ability for patients to complete preoperative therapy and undergo resection is correlated with more favorable overall survival outcomes. (NCT01897454)
Timeframe: Up to 30 months

InterventionParticipants (Count of Participants)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)15

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Percentage of Participants Achieving R0 Resection (R0 Resection Rate)

The percentage of participants achieving R0 resection, defined as the absence of gross and microscopic tumor involvement in the resection margins, will be determined for those participants who receive at least one cycle of FOLFIRINOX chemotherapy. A 90% confidence interval will be determined. (NCT01897454)
Timeframe: Up to 30 months

InterventionPercentage of Participants (Number)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)55.6

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Overall Survival (OS)

Median Overall Survival defined as the the duration of time from diagnosis to the time of death from any cause will be determined. (NCT01897454)
Timeframe: Up to 60 months

InterventionMonths (Median)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)35.1

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Overall Response Rate

Overall Response Rate, defined as the percentage of patients that achieved Partial Response (PR) or Complete Response (CR) as per the Response evaluation in solid tumors criteria, was assessed using RECIST Version 1.1 criteria. Complete Response (CR) is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is defined as having at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Higher percentages of PR and CR are associated with more favorable outcomes (NCT01897454)
Timeframe: Up to 30 months

InterventionParticipants (Count of Participants)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)4

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Vascular Reconstruction

The percentage of patients who underwent pancreaticoduodenectomy requiring vascular reconstruction will be evaluated. (NCT01897454)
Timeframe: Up to 30 months

InterventionParticipants (Count of Participants)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)5

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Pathologic Complete Response Rate (

The absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen. (NCT01916109)
Timeframe: 1 year

Interventionparticipants (Number)
Gemcitabine, Carboplatin, and Panitumumab (GCaP)3

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Overall Survival

Survival time is defined as time from randomization to date of death from any cause and was to be estimated by the Kaplan-Meier method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients last reported to be alive at time of study termination is reported. (NCT01921751)
Timeframe: From randomization until last follow-up. Analysis was to occur after a total of 140 deaths were reported within the pairing of each radiation arm with the chemotherapy alone arm. Maximum follow-up at time of study termination was 8.3 months.

InterventionParticipants (Count of Participants)
Chemotherapy + High Intensity Radiation4
Chemotherapy + Low Intensity Radiation4
Chemotherapy5

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Patterns of Failure (Local and Metastatic Failure)

Local progression is defined as least a 20% increase in the sum of diameters of the primary, taking as reference the baseline sum. Given the inherent inaccuracy in determining size of a primary pancreatic carcinoma, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and progression must be demonstrated on at least two sequential scans. Metastatic failure is defined as metastatic disease. Local and distant failure were to be estimated by the cumulative incidence method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients with failure is reported. (NCT01921751)
Timeframe: From randomization until last follow-up. Maximum follow-up at time of study termination was 8.3 months.

,
InterventionParticipants (Count of Participants)
Local FailureMetastatic Failure
Chemotherapy + High Intensity Radiation00
Chemotherapy + Low Intensity Radiation01

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Patients With Dose Limiting Toxicity

Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data (including change from baseline). (NCT01938573)
Timeframe: Up to 28 days

InterventionParticipants (Count of Participants)
Phase 1 - Sirolimus, Cisplatin, Gemcitabine0

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Percent of Patients With Pathologic Complete Response (Phase II)

The study will follow an optimal two-stage Simon design based on pathologic complete response rate. (NCT01938573)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Sirolimus, Cisplatin, Gemcitabine4

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The Number of Dose-limiting Toxicities

The number of dose-limiting toxicities in selumetinib in combination with cisplatin and gemcitabine (NCT01949870)
Timeframe: The first cycle with selumetinib until Day 1 of Cycle 2 of combination dosing

InterventionParticipants (Number)
YesNo
Selumetinib+ Cisplatin + Gemcitabine03

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Overall Response Rate

"Overall response rate (ORR) was defined as the percentage of patients with a response, either CR or PR, according to RECIST v.1.1.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters." (NCT01951157)
Timeframe: Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years

Interventionpercentage of participants (Number)
A - Docetaxel9.1
B - Lurbinectedin (PM01183)0
C - Gemcitabine + Lurbinectedin (PM01183)17.4

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Duration of Response

"Duration of response (DR) was defined as the time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters." (NCT01951157)
Timeframe: The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years

Interventionmonths (Median)
A - Docetaxel1.2
C - Gemcitabine + Lurbinectedin (PM01183)6.1

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Overall Survival (OS)

Overall survival (OS) will be defined as time from the date of first infusion to the date of death or last contact (NCT01951157)
Timeframe: From the date of first infusion to the date of death or last contact, up to 12 months after last patient inclusion

Interventionmonths (Median)
A - Docetaxel9.4
B - Lurbinectedin (PM01183)5.5
C - Gemcitabine + Lurbinectedin (PM01183)7.2

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Information on Quality of Life (QoL)

"The mean QoL scores self-reported by patients using the Lung Cancer Symptom Scale (LCSS) at baseline and after the start of the therapy in visits 3 or 6 (+/- 1 visit) and visit 9 for those patients in maintenance therapy.~Higher LCSS scores indicate more severe problems and the scale range is (0-100) Total score was calculated as the mean of the total scores of all nine patient ítems (Appetite, Fatigue, Cough, Dyspnea, Hemoptysis, Pain, Lung cancer symptoms, Normal activities, Global QoL)" (NCT01951157)
Timeframe: Baseline, Cycle 3 (~9 weeks), Cycle 6 (~18 weeks) and Cycle 9 (~27 weeks)

Interventionunits on a scale (Mean)
BaselineCycle 3Cycle 6Cycle 9
B - Lurbinectedin (PM01183)36.432.255.438.1

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Information on Quality of Life (QoL)

"The mean QoL scores self-reported by patients using the Lung Cancer Symptom Scale (LCSS) at baseline and after the start of the therapy in visits 3 or 6 (+/- 1 visit) and visit 9 for those patients in maintenance therapy.~Higher LCSS scores indicate more severe problems and the scale range is (0-100) Total score was calculated as the mean of the total scores of all nine patient ítems (Appetite, Fatigue, Cough, Dyspnea, Hemoptysis, Pain, Lung cancer symptoms, Normal activities, Global QoL)" (NCT01951157)
Timeframe: Baseline, Cycle 3 (~9 weeks), Cycle 6 (~18 weeks) and Cycle 9 (~27 weeks)

,
Interventionunits on a scale (Mean)
BaselineCycle 3Cycle 6
A - Docetaxel27.229.524.3
C - Gemcitabine + Lurbinectedin (PM01183)38.136.435.4

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Progression-free Survival Rate at Six Months (PFS6)

The rate estimate of the percentage of patients who are alive and progression-free at 24 weeks (~6 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. (NCT01951157)
Timeframe: At month six after patient inclusion

Interventionpercentage of participants (Number)
A - Docetaxel18.2
B - Lurbinectedin (PM01183)16.7
C - Gemcitabine + Lurbinectedin (PM01183)17.5

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Progression-free Survival Rate at Four Months (PFS4)

The rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (~4 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. (NCT01951157)
Timeframe: At month four after patient inclusion

Interventionpercentage of participants (Number)
A - Docetaxel27.3
B - Lurbinectedin (PM01183)15.8
C - Gemcitabine + Lurbinectedin (PM01183)26.1

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Progression-free Survival

PFS, progression-free survival Progression-free survival (PFS), defined as the time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. (NCT01951157)
Timeframe: Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years

Interventionmonths (Median)
A - Docetaxel3.1
B - Lurbinectedin (PM01183)1.9
C - Gemcitabine + Lurbinectedin (PM01183)3.3

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Distant Failure-free Survival

Analyzed using Kaplan-Meier plots, medians and ranges. (NCT01959672)
Timeframe: Date of administration study drug to the date of first appearance of tumor lesions by imaging, or death, assessed up to 5 years

Interventionmonths (Median)
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)11

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Surgical Complete Resection (Negative Margin) Rate

The percentage of patients who will undergo R0 resection (NCT01959672)
Timeframe: Up to week 18

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)4

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Overall Survival

Analyzed using Kaplan-Meier plots, medians and ranges. (NCT01959672)
Timeframe: Date of first of study drug to the date of death, assessed up to 5 years

Interventionmonths (Median)
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)14.4

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Number of Participants With Progressive Disease,

Rate of progressive disease defined as at least a 25% increase in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. An exact one-sided 90% confidence interval will be constructed round the progressive disease rate. (NCT01959672)
Timeframe: Up to 4 months

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)2

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Number of Participants With CA-125-Specific T-cell Signal.

The percentage of patients responding will be summarized using frequencies and percentages. (NCT01959672)
Timeframe: Baseline to up to week 12

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)2

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The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)

The number of participants with grade 3-4 laboratory abnormalities in selected clinically significant parameters. Grades for chemistry parameters were coded using National Cancer Institute Common Terminology Criteria for Adverse Events (Grade 3= severe, Grade 4= life-threatening). (NCT01964430)
Timeframe: From day 1 of study drug up to 28 days after the last dose of study drug, or the treatment discontinuation date, whichever was later (up to approximately 37 weeks).

,
InterventionParticipants (Count of Participants)
Alkaline phosphataseAlanine aminotransferaseAspartate aminotransferaseBilirubin
Gemcitabine3321
Nab-Paclitaxel and Gemcitabine7990

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Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee

Disease free survival was defined as the time from the date of randomization to the date of disease recurrence or death, whichever occurred earlier. Disease recurrence was determined by the independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants who did not have disease recurrence or did not die were censored at the last tumor assessment date with disease-free status or the randomization date if the last tumor assessment with disease-free status was missing. Disease-free status referred to a status that was neither being disease recurrent nor indeterminate or not evaluable. Participants who received new anti-cancer therapy or cancer-related surgery prior to disease recurrence or death were censored at the date of last tumor assessment with disease-free status prior to the start of new anti-cancer therapy or cancer-related surgery or the randomization date. (NCT01964430)
Timeframe: Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone

Interventionmonths (Median)
Nab-Paclitaxel and Gemcitabine19.4
Gemcitabine18.8

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Kaplan Meier Estimate of Overall Survival (OS)

Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cutoff date, whichever was earlier. (NCT01964430)
Timeframe: From randomization to date of death; median OS follow-up time for censored participants was 77.832 months for nab-Paclitaxel and gemcitabine and 77.799 months for gemcitabine alone

,
Interventionmonths (Median)
25th Quartile50th Quartile75th Quartile
Gemcitabine17.737.783.0
Nab-Paclitaxel and Gemcitabine20.741.890.2

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Number of Participants With Treatment Emergent Adverse Events (TEAE's)

"TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to one or both of the study drugs and reported as 'Suspected' on the case report form. AEs with a missing relationship were treated as 'treatment-related' in data summaries. IP (investigational product) refers to nab-Paclitaxel and/or Gemcitabine. Related TEAE refers to relation to study drug (IP)." (NCT01964430)
Timeframe: From day 1 of study drug up to 28 days after the last dose of study drug; up to the data cut off date of 31 December 2018 (up to approximately 37 weeks).

,
InterventionParticipants (Count of Participants)
≥1 TEAE≥1 Related TEAE≥1 TEAE of Severity Grade 3 or Higher≥ 1 Related TEAE of Severity Grade 3 or Higher≥1 Serious TEAE≥1 Serious Related TEAE≥1 TEAE Leading to Withdrawal of IP≥1 Related TEAE Leading to Withdrawal of IP≥1 TEAE Lead Dose Reduction: nab-Paclitaxel or Gem≥1 Related TEAE Dose Reduct: nab-Paclitaxel or GemTEAE Lead Dose Interruption nab-Paclitaxel or Gem≥1 Related TEAE Dose Interruption to IPTEAE Leading to Death>=1 Related TEAE Leading to Death
Gemcitabine4173992862399655433521020515812522
Nab-Paclitaxel and Gemcitabine4294233713321761021179827627026622122

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Evans Grade Histopathologic Response

The number of patients who exhibited an Evans grade Histologic response (I, IIA, IIB, or III) to pre-operative gemcitabine / nab-paclitaxel. Histological response validated scoring system by Evans is as follows: Grade I: 1-9% tumor destruction, Grade II: 10 - 90%, Grade III: >90% tumor destruction (Grade IIA = 10-50% of tumor cells destroyed; Grade IIB = 50-90% of tumor cells destroyed), Grade IV: Absence of viable tumor cells. (NCT01978184)
Timeframe: Up to 4 years

,
Interventionnumber of participants (Number)
Evans grade - IEvans grade - IIAEvans grade - IIBEvans grade - III
Gemcitabine + Abraxane101730
Gemcitabine + Abraxane and Hydroxychloroquine712139

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Type of Surgical Procedure (Operation)

The number of participants in having each type of surgical resection procedure: Celiac Axis Resection With Distal Pancreatectomy (DPCAR) (Modified Appleby), Distal Pancreatectomy, Total Pancreatectomy, or Whipple. (Operation variable used in the proportional odds logistic regression, secondary analysis of Evans Grade). (NCT01978184)
Timeframe: At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)

,
InterventionParticipants (Count of Participants)
DPCARDistal PancreatectomyTotal PancreatectomyWhipple
Gemcitabine + Abraxane23124
Gemcitabine + Abraxane and Hydroxychloroquine05036

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Carbohydrate Antigen 19-9 (CA19-9) Response

Levels of Carbohydrate antigen 19-9 (CA19-9) response to pre-operative gemcitabine/ nab-paclitaxel measured in the serum (original scale) (NCT01978184)
Timeframe: Prior to treatment (average 73.3 +/- 9.9 days prior to surgery)

Interventionunits per milliliter (U/mL) (Mean)
Gemcitabine + Abraxane351.820
Gemcitabine + Abraxane and Hydroxychloroquine1534.633

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Age at Diagnosis

The mean age of patients at the time of diagnosis of disease (as a variable in the proportional odds logistic regression, secondary analysis of Evans Grade). (NCT01978184)
Timeframe: Baseline - At the time of diagnosis, prior to treatment

Interventionyears (Mean)
Gemcitabine + Abraxane63.6
Gemcitabine + Abraxane and Hydroxychloroquine66.1

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Robotic Resection Surgery

The number of participants who had robotic resection surgery. (Robotic surgery variable used in the proportional odds logistic regression, secondary analysis of Evans Grade). (NCT01978184)
Timeframe: At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)

,
InterventionParticipants (Count of Participants)
Yes - robotic surgical resection procedureNo - not robotic surgical resection procedure
Gemcitabine + Abraxane822
Gemcitabine + Abraxane and Hydroxychloroquine1031

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Rate of R0 Resection

The proportion of participants having resection for cure or complete remission, in which the surgical margins are negative for tumor cells. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. (NCT01978184)
Timeframe: At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)

Interventionproportion of participants (Mean)
Gemcitabine + Abraxane0.7
Gemcitabine + Abraxane and Hydroxychloroquine0.829

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Cancer Diagnosis Stage

"The number of participants in cancer diagnosis stage groups. Stage 0: cancer hasn't spread to nearby tissues/located in the same of origin.Stage I: cancers hasn't grown deeply into nearby tissues or spread to lymph nodes or other parts of the body. Stage II and III: cancers have grown more deeply into nearby tissues (may have metastasized to lymph nodes but not other parts of the body). Stage IV: most advanced stage (metastatic cancer) ; cancer has spread to other parts of the body. Stages subdivided further into the categories A (less agressive disease) and B (more advanced cancer). Example: stage IIA is less aggressive than stage IIB, but stage IIIA is more aggressive than stage IIB. (Stage variable used in the proportional odds logistic regression, secondary analysis of Evans Grade)." (NCT01978184)
Timeframe: Baseline - At the time of diagnosis, prior to treatment

,
InterventionParticipants (Count of Participants)
IAIBIIAIIBNot Available
Gemcitabine + Abraxane056190
Gemcitabine + Abraxane and Hydroxychloroquine2111207

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Age-Adjusted Charlson Comorbidity Index

The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data, such as hospital abstracts data. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero. (NCT01978184)
Timeframe: Prior to treatment

,
InterventionParticipants (Count of Participants)
Age-Adjusted CCI=2Age-Adjusted CCI=3Age-Adjusted CCI=4Age-Adjusted CCI=5Age-Adjusted CCI=6Age-Adjusted CCI=7Age-Adjusted CCI=8
Gemcitabine + Abraxane3578520
Gemcitabine + Abraxane and Hydroxychloroquine121115822

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Positive Lymph Node Involvement

The proportion of participants with positive (disease) lymph nodes involvement. (NCT01978184)
Timeframe: At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)

Interventionproportion of participants (Number)
Gemcitabine + Abraxane0.8
Gemcitabine + Abraxane and Hydroxychloroquine0.561

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CT Tumor Size

Tumor size as measured via computerized tomography (CT) scan (as a variable in the proportional odds logistic regression, secondary analysis of Evans Grade). (NCT01978184)
Timeframe: Baseline - At the time of diagnosis, prior to treatment

Interventioncentimeters (Mean)
Gemcitabine + Abraxane2.562069
Gemcitabine + Abraxane and Hydroxychloroquine2.543056

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Carbohydrate Antigen 19-9 (CA19-9) Response

Levels of Carbohydrate antigen 19-9 (CA19-9) response to pre-operative gemcitabine/ nab-paclitaxel measured in the serum (original scale). (NCT01978184)
Timeframe: After treatment (50-67 days post treatment/surgery)

Interventionunits per milliliter (U/mL) (Mean)
Gemcitabine + Abraxane319.079
Gemcitabine + Abraxane and Hydroxychloroquine1696.710

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Frequency of DLT

Maximum tolerated dose (MTD) of azacitidine based on DLT was defined as any Grade 4 nonhematologic and noninfectious toxicity or any grade 3 mucositis or skin toxicity lasting > 3 days at peak severity. For dose finding, the continunal reassessment method was used with a target DLT probability per cohort of 25%. Azacitidine doses were chosen adaptively for sucessive cohorts with a minimum size of 2 patients. Toxicity scoring followed the National Cancer Institute Common Toxicity Criteria, version 3. (NCT01983969)
Timeframe: Enrollment up to day 30 post transplant for each dosing cohort

InterventionDose-limiting toxicities (Number)
Azacitidine Dose Level 116
Azacitidine Dose Level 228
Azacitidine Dose Level 340

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Participants With Event-free Survival (EFS)

EFS is defined as the time from transplantation to either relapse, second tumors, or death, whichever occurred first, or last contact. EFS was analzyed by the individual disease groups rather than the cohort dose levels. (NCT01983969)
Timeframe: Enrollment up to 100 days post transplant.

InterventionParticipants (Count of Participants)
DLBCL17
Hodgkin Lymphoma16
T-cell NHL7
Other B-cell Lymphoma5

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Duration of Response

Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death. (NCT01998919)
Timeframe: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases

Interventionweeks (Median)
Placebo Plus Chemotherapy24.1
Erlotinib Plus Chemotherapy38.4

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Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST

Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST. (NCT01998919)
Timeframe: Week 16

Interventionpercentage of participants (Number)
Placebo Plus Chemotherapy53.8
Erlotinib Plus Chemotherapy64.5

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Time to Progression

Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization. (NCT01998919)
Timeframe: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases

Interventionweeks (Median)
Placebo Plus Chemotherapy24.1
Erlotinib Plus Chemotherapy31.4

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Progression-Free Survival (PFS)

PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first. (NCT01998919)
Timeframe: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases

Interventionweeks (Median)
Placebo Plus Chemotherapy23.4
Erlotinib Plus Chemotherapy30.4

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Percentage of Participants With Confirmed CR or PR as Assessed by RECIST

CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. (NCT01998919)
Timeframe: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases

Interventionpercentage of participants (Number)
Placebo Plus Chemotherapy24.4
Erlotinib Plus Chemotherapy36.8

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Overall Survival

Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. (NCT01998919)
Timeframe: Date of randomization until date of death or date of last follow-up assessment

Interventionweeks (Median)
Placebo Plus Chemotherapy75.7
Erlotinib Plus Chemotherapy74.1

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Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started. (NCT01998919)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Placebo Plus Chemotherapy76.9
Erlotinib Plus Chemotherapy80.3

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Participants With Adverse Events

(NCT02000531)
Timeframe: start of second-line treatment to data cut-off in December 2014 (within 12 months)

,
Interventionparticipants (Number)
With any adverse events (AEs)With any serious AEs (SAEs)With any AEs Grade ≥ 3With any drug related (possible/probable) AEsWith any drug related (possible/probable) SAEsWith any AEs leading to study drug withdrawalWith any AEs leading to deathWith AEs of Special InterestWith pregnancy
Chemotherapy-Erlotinib1212900000
Erlotinib-Chemotherapy14051000000

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Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events

Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment. (NCT02000531)
Timeframe: within 3 years, 9 months (data cut-off December 2014)

InterventionMonths (Median)
Erlotinib-Chemotherapy26.3
Chemotherapy-Erlotinib23.4

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Kaplan-Meier Probability of Being Progression Free at 1 Year

(NCT02004093)
Timeframe: 1 year

Interventionpercent (Number)
Chemotherapy + Pertuzumab24
Chemotherapy19

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Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year

(NCT02004093)
Timeframe: 1 year

Interventionpercent (Number)
Chemotherapy + Pertuzumab18
Chemotherapy18

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Overall Survival

Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive. (NCT02004093)
Timeframe: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment

Interventionmonths (Median)
Chemotherapy + Pertuzumab28.2
ChemotherapyNA

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Duration of Response

For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death. Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement. (NCT02004093)
Timeframe: Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks

Interventionweeks (Median)
Chemotherapy + Pertuzumab28.7
Chemotherapy37.0

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Time to Progressive Disease

The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria. Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement. (NCT02004093)
Timeframe: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression

Interventionweeks (Median)
Chemotherapy + Pertuzumab34.3
Chemotherapy37.3

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Kaplan-Meier Probability of No Disease or Progression at 1 Year

The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk. (NCT02004093)
Timeframe: 1 year

Interventionpercent (Number)
Chemotherapy + Pertuzumab24
Chemotherapy21

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Kaplan-Meier Probability of Being Alive at 1 Year

(NCT02004093)
Timeframe: 1 year

Interventionpercent (Number)
Chemotherapy + Pertuzumab88
Chemotherapy85

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Percentage of Participants Who Died

(NCT02004093)
Timeframe: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment

Interventionpercentage of participants (Number)
Chemotherapy + Pertuzumab45.9
Chemotherapy41.3

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Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements

"Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were response, stable disease and progressive disease. Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of response or progressive disease." (NCT02004093)
Timeframe: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks

Interventionpercentage of participants (Number)
Chemotherapy + Pertuzumab74.3
Chemotherapy68.0

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Percentage of Participants With Disease Progression

Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment. (NCT02004093)
Timeframe: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression

Interventionpercentage of participants (Number)
Chemotherapy + Pertuzumab83.8
Chemotherapy76.0

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Percentage of Participants With Disease Progression or Death

Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment. (NCT02004093)
Timeframe: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks

Interventionpercentage of participants (Number)
Chemotherapy + Pertuzumab87.8
Chemotherapy80.0

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Progression-Free Survival

Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment. (NCT02004093)
Timeframe: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks

Interventionweeks (Median)
Chemotherapy + Pertuzumab34.1
Chemotherapy40.0

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Time To Response

Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease. If response was evaluable by both criteria, then the date of response was for the earlier of the two events. (NCT02004093)
Timeframe: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment

Interventionweeks (Median)
Chemotherapy + Pertuzumab6.0
Chemotherapy6.3

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Overall Survival - Time to Event

The median time, in months, from the start of study treatment to OS event. (NCT02006667)
Timeframe: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months

Interventionmonths (Median)
Trastuzumab/Gemcitabine/Cisplatin14.9

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Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)

Per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1): CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal [(short axis less than (<) 10 millimeters (mm)]. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, or Progressive Disease (PD). (NCT02006667)
Timeframe: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months

Interventionpercentage of participants (Number)
CRPRSDPDCR/PRCR/PR/SD
Trastuzumab/Gemcitabine/Cisplatin15.423.146.215.438.584.6

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Overall Survival (OS) - Percentage of Participants With an Event

OS was defined as the time from the start of study treatment to date of death due to any cause. (NCT02006667)
Timeframe: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months

Interventionpercentage of participants (Number)
Trastuzumab/Gemcitabine/Cisplatin84.6

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Progression-Free Survival - Time to Event

The median time, in months, from the first dose of study treatment to PFS event. (NCT02006667)
Timeframe: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months

Interventionmonths (Median)
Trastuzumab/Gemcitabine/Cisplatin11.0

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Progression-Free Survival (PFS) - Percentage of Participants With an Event

PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause. (NCT02006667)
Timeframe: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months

Interventionpercentage of participants (Number)
Trastuzumab/Gemcitabine/Cisplatin92.3

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Percentage of Participants Surviving at 12 and 24 Months

(NCT02006667)
Timeframe: Screening, and Months 12 and 24

Interventionpercentage of participants (Number)
12 Months24 Months
Trastuzumab/Gemcitabine/Cisplatin76.923.1

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Percentage of Participants Who Were Progression Free at 12 and 24 Months

(NCT02006667)
Timeframe: Screening, and Months 12 and 24

Interventionpercentage of participants (Number)
12 Months24 Months
Trastuzumab/Gemcitabine/Cisplatin38.515.4

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Phase 1: Dose Limiting Toxicities (DLT) Following Intravesical Administration of ABI-009

The primary endpoint of the Phase 1 study is DLT following intravesical administration of ABI-009 in patients with BCG refractory or recurrent nonmuscle-invasive transitional cell carcinoma (TCC) of the bladder to identify maximum deliverable dose (MDD). Systemic DLT will be defined as any grade systemic toxicity using the NCI CTCAE version 4.0. Local dose limiting toxicity was defined as grade 3 or 4 bladder toxicity (hematuria, dysuria, urinary retention, urinary frequency/urgency, or bladder spasms) using the NCI CTCAE version 4.0. (NCT02009332)
Timeframe: Duration of treatment (6 weeks) plus 30 days follow up (up to 2.5 months)

InterventionParticipants (Count of Participants)
Phase 1: ABI-009 100 mg/Week0
Phase 1: ABI-009 200 mg/Week0
Phase 1: ABI-009 100 mg 2×/Week0
Phase 1: ABI-009 300 mg/Week0
Phase 1: ABI-009 400 mg/Week0

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Phase 1: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009

Response rate will be measured and documented at the 6-week post-treatment assessment, including cystoscopy with biopsy. A complete response is defined as a cancer-negative biopsy at the 6-week post-treatment cystoscopy. No response will be defined as positive cystoscopic biopsy. (NCT02009332)
Timeframe: End of Study [EOS, 3 months]

InterventionParticipants (Count of Participants)
Phase 1: ABI-009 100 mg/Week0
Phase 1: ABI-009 200 mg/Week1
Phase 1: ABI-009 100 mg 2×/Week0
Phase 1: ABI-009 300 mg/Week0
Phase 1: ABI-009 400 mg/Week1

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Phase 2: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009 and Gemcitabine

The primary objective of the Phase 2 study is to evaluate the utility (potential for clinical efficacy) of ABI-009 in combination with gemcitabine in the treatment of BCG refractory or recurrent nonmuscle-invasive TCC of the bladder. Response rate will be measured and documented at the 6-week post-treatment assessment, including cystoscopy with biopsy. A complete response is defined as a cancer-negative biopsy at the 6-week post-treatment cystoscopy. No response will be defined as positive cystoscopic biopsy. (NCT02009332)
Timeframe: End of Study [EOS, 3 months]

InterventionParticipants (Count of Participants)
Phase 2: ABI-009 400 mg/Week + Gemcitabine 2000 mg/Week1

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Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)

TEAEs were defined as adverse events (AEs) that began or worsened in severity on or after the date of the first dose of study drug and within 30 days of the last dose of study drug. A Serious AE (SAE) = any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, is a congenital anomaly/birth defect; constitutes an important medical event. Treatment-related AEs (TRAEs) were any TEAEs considered to be related to the study drug. A TRAE is a TEAE with relationship as suspected to either ABI-007 or gemcitabine The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Other AEs not described in the CTCAE criteria, the intensity will be assessed by the investigator as mild grade (Gr 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5) (NCT02017015)
Timeframe: Study drug initiation through 30 days after the last dose of study drug or End Of Study, whichever is later; maximum treatment duration was 54.9 weeks

Interventionparticipants (Number)
At least 1 TEAEAt Least 1 Treatment-related TEAE≥ 1 TEAE with NCI CTCAE Gr 3 or higher≥ 1 TRAE NCI CTCAE ≥ Gr 3At Least 1 Serious TEAEAt Least 1 Treatment-related Serious TEAE≥ 1 TEAE causing discontinuing of either drug≥1 TRAE causing discontinuing of either drug≥ 1 TEAE causing reduction in ABI-007/Gemcitabine≥ 1 TRAE causing reduction in ABI-007/Gemcitabine≥1 TEAE causing interruption in either study drug≥1 TRAE causing interruption in either study drugAt Least 1 TEAE With Outcome of Death≥1 TRAE with Outcome of Death
Nab-paclitaxel and Gemcitabine838270622091053838434082

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Kaplan-Meier Estimate of Overall Survival (OS)

Overall survival was defined as the time from the date of first treatment to the date of death. Participants who did not die at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cut-off date, whichever was earlier. (NCT02017015)
Timeframe: From the first participant enrolled to data cut off of 01 June 2015; up to approximately 70 weeks

Interventionmonths (Median)
Nab-paclitaxel With Gemcitabine9.2

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Overall Response Rate (ORR) Based on Independent Radiological Review (IRR)

ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) based on independent radiological review per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Using RECIST Version 1.0, participants were to achieve either a complete response defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the independent radiological review of best overall response during study treatment. (NCT02017015)
Timeframe: Assessment every 8 weeks; Day 1 to data cut off of 01 June 2015; Up to approximately 70 weeks

Interventionpercentage of participants (Number)
Nab-paclitaxel and Gemcitabine35

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Duration of Response (DoR) Based on IRR According to RECIST Guidelines

DoR was defined as the time from the first tumor assessment when the confirmed CR/PR response criterion is met to the date of disease progression based on IRR following RECIST 1.0. Only for those participants with a confirmed CR/PR. If a participant had disease progression, then the date of disease progression was the event date. For a participant who did not develop disease progression or disease progression occurred after 2 or more missing tumor assessments, the participant was censored on the date of last tumor assessment where the participant was documented to be progression free. If a participant died prior to disease progression, the participant was censored on the date of death. If patient started new anti-cancer therapy, the patient was censored on the last tumor assessment date on or prior to the start date of new anti-cancer therapy (NCT02017015)
Timeframe: Assessment performed every 8 weeks; from the first participant enrolled to cut off date of 01 June 2015; up to approximately 70 weeks

Interventionmonths (Median)
Nab-paclitaxel With Gemcitabine8.9

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Number of Participants Experiencing Toxicities With Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Bladder Cancer

Toxicities assessed while patients are on treatments (NCT02030574)
Timeframe: Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)

Interventionparticipants (Number)
Gemcitabine and Fractionated Cisplatin (Combination Treatment)2

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Pathologic Complete Response Rate of Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Muscle Invasive Bladder Cancer Whom Are Not Candidates for High Dose Cisplatin.

Response will be evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 [Eur J Cancer. 2009;45:228-247.].Complete Response (CR): Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficie (NCT02030574)
Timeframe: at approximately 6 months

Interventionparticipants (Number)
Gemcitabine and Fractionated Cisplatin (Combination Treatment)2

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Overall Survival

Overall survival (OS) summarized by Kaplan-Meier curves and characterized by descriptive statistics such as median OS. The time frame for data collection for OS varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study. (NCT02037230)
Timeframe: Up to 48 months following treatment

Interventionmonths (Median)
AZD-1775 100 mg21.96
AZD-1775 125 mg21.73
AZD-1775 150 mg23.84
AZD-1775 175 mg22.45

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Time From Date of Registration to Date of Documented Disease Progression

Time from date of registration to date of documented disease progression summarized by Kaplan-Meier method. The time frame for data collection varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study. (NCT02037230)
Timeframe: Up to 48 months following treatment

Interventionmonths (Median)
AZD-1775 100 mg8.05
AZD-1775 125 mg9.44
AZD-1775 150 mg9.90
AZD-1775 175 mg6.08

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Number of Patients With Phosphorylation Inhibition of Greater Than 0

During the first cycle of treatment, patients underwent 2 biopsies: 3 h after treatment with gemcitabine (but before MK- 1775), and 2 hours after MK-1775. WEE1 signaling was assessed using immunohistochemistry (IHC) to measure phosphorylation of various markers including Cdk1 (Y15). Inhibition was quantified as the within subject change in the above markers between the two biopsy timepoints. Descriptive statistics of inhibition across subjects (for each marker) were calculated and reported by dose level. (NCT02037230)
Timeframe: First cycle of treatment

Interventionparticipants (Number)
AZD-1775 100 mg1
AZD-1775 125 mg7
AZD-1775 150 mg3
AZD-1775 175 mg5

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Maximum Tolerated Dose (MTD) of AZD1775 (MK-1775) When Used Concurrently With Gemcitabine and Radiation Therapy.

Probability of dose limiting toxicities was calculated for each dose (p[DLT/d]) using the Time to Event Continual Reassessment Method (TITE-CRM). The target DLT rate was 0.30. Dose level 1 (150 mg AZD1775) was determined to be the MTD and recommended phase 2 dose (RP2D). (NCT02037230)
Timeframe: The observation period for MTD is defined as the first 4 cycles of treatment (with a 3 week break between cycle 3 and cycle 4), for a total of 105 days in length.

Interventionmg (Number)
AZD1775 (MK-1775), Gemcitabine, Radiation Therapy150

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Progression-Free Survival in All Randomized Participants

Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy. (NCT02041533)
Timeframe: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)

InterventionMonths (Median)
Nivolumab4.21
Investigator Choice of Chemotherapy5.82

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Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%

ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir. (NCT02041533)
Timeframe: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)

InterventionPercentage of participants (Number)
Nivolumab26.1
Investigator Choice of Chemotherapy33.5

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Overall Survival in All Randomized Participants

Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up. (NCT02041533)
Timeframe: From date of randomization to date of death (up to approximately 89 months)

InterventionMonths (Median)
Nivolumab13.73
Investigator Choice of Chemotherapy13.80

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Overall Survival in Participants With PD-L1 Expression >= 5%

Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up. (NCT02041533)
Timeframe: From date of randomization to date of death (up to approximately 89 months)

InterventionMonths (Median)
Nivolumab14.36
Investigator Choice of Chemotherapy13.21

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Progression-Free Survival in Participants With PD-L1 Expression >= 5%

Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy. (NCT02041533)
Timeframe: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)

InterventionMonths (Median)
Nivolumab4.21
Investigator Choice of Chemotherapy5.88

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Number of Subjects Experiencing Dose Limiting Toxicity (DLT)

(NCT02047500)
Timeframe: Up to Day 28 of Cycle 1

InterventionParticipants (Count of Participants)
TH-302 Plus Nab-paclitaxel Plus Gemcitabine1

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Overall Survival

The secondary efficacy parameter was Overall Survival (OS) analysed in the Intent-to-treat (ITT) population. OS was defined as the time elapsed from the date of randomisation up to death or last follow-up. (NCT02054338)
Timeframe: OS was evaluated from the date of registration to the date of death due to any cause (median duration of follow-up: 14.1 months)

InterventionMonths (Median)
Vinflunine Plus Gemcitabine18.9
Paclitaxel Plus Gemcitabine19.1

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Overall Response Rate & Disease Control Rate

Disease control rate (DCR) is defined as the sum of Complete Response (CR) and Partial Response (PR) and Stable Disease (SD) ≥ 6 months rate. Objective response rate (ORR) is defined as the sum of Complete Response (CR) and Partial Response (PR) rate (using the best confirmed response recorded from the date of randomisation to the end of treatment). DCR and ORR, assessed by Independent Review Committee using RECIST 1.0, were calculated in the ITT population. (NCT02054338)
Timeframe: ORR and DCR were calculated from the date of randomisation of first patient until the database cut-off (30 June 2011), assessed up to 5 years

,
Interventionpercentage of patients (Median)
Overall Response RateDisease Control Rate
Paclitaxel Plus Gemcitabine14.644.9
Vinflunine Plus Gemcitabine11.339.8

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Progression Free Survival

The primary efficacy parameter was Progression-free survival (PFS) analysed in the Intent-to-treat (ITT) population. PFS was defined as the time elapsed from randomisation date until the date of progression or death due to any cause (whichever came first).Tumor response was evaluated using the RECIST version 1.0 every 6 weeks until progression was recorded. (NCT02054338)
Timeframe: PFS was calculated from the registration date until the date of progression or death due to any cause if no progression was recorded first (median duration of follow-up: 14.1 months)

InterventionMonths (Median)
Vinflunine Plus Gemcitabine8.0
Paclitaxel Plus Gemcitabine8.4

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PK: Area Under the Concentration Curve (AUC) of Abemaciclib in Part A, B, C, D and E

Area under the concentration time curve from zero to 8 hours AUC(0-8h) of abemaciclib in Part A, B, C, D and E was evaluated. (NCT02079636)
Timeframe: C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose

,
Interventionnanogram*hour/mL (ng*h/mL) (Geometric Mean)
Day 1
Part E: 100 mg Abemaciclib + 200 mg PembrolizumabNA
Part D: 200 mg Abemaciclib + 150 mg LY3023414967

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PK: Area Under the Concentration Curve (AUC) of Abemaciclib in Part A, B, C, D and E

Area under the concentration time curve from zero to 8 hours AUC(0-8h) of abemaciclib in Part A, B, C, D and E was evaluated. (NCT02079636)
Timeframe: C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose

,,,,,,,,
Interventionnanogram*hour/mL (ng*h/mL) (Geometric Mean)
Day 1Steady State
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed9793710
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine8862690
Part C: 150 mg Abemaciclib + 8 mg/kg or 10 mg/kg Ramucirumab7971720
Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day110301840
Part D: 100 mg Abemaciclib + 100 mg LY3023414394NA
Part D: 150 mg Abemaciclib + 100 or 150 or 200 mg LY30234147191550
Part A:150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed533NA
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine393NA
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab5181400

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PK: Area Under the Concentration Curve (AUC) of Active Gemcitabine Metabolite: 2',2'-Difluorodeoxyuridine (dFdU) on Day 1 and at Steady State (Cycle 2 Day 1) in Part B

Area under the plasma concentration time curve from time zero to 12 hours (AUC[0-12h]) of active gemcitabine metabolite (dFdU) in Part B was evaluated (NCT02079636)
Timeframe: C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose

,,
Interventionnanogram*hour/mL (ng*h/mL) (Geometric Mean)
Day 1Steady State
200 mg or MTD Abemaciclib + 1250 mg/m^2 Gemcitabine198000210000
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine175000NA
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine246000208000

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PK: Area Under the Concentration Curve (AUC) of LY3023414 in Part D

Area under the plasma concentration versus time curve from time zero to infinity (AUC) of LY3023414 in Part D was evaluated. For Day 1, AUC is defined as AUC from time zero to infinity (AUC[0-∞]), for steady state, AUC is defined as AUC from time zero to the end of the dosing interval, tau (AUC[0-tau ]) (NCT02079636)
Timeframe: C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose

,,
Interventionnanogram*hour/mL (ng*h/mL) (Geometric Mean)
Day 1Steady State
Part D: 100 or 150 mg Abemaciclib + 100 mg LY302341410051303
Part D: 150 mg Abemaciclib + 200 mg LY30234143809NA
Part D: 150 or 200 mg Abemaciclib + 150 mg LY302341417511293

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PK: Dose-normalized Maximum Concentration (Cmax) of Active Gemcitabine Metabolite: 2',2'-Difluorodeoxyuridine (dFdU) on Day 1 and at Steady State (Cycle 2 Day 1) in Part B

Cmax of active gemcitabine metabolite (dFdU) on day 1 and at steady state (Cycle 2 Day 1) dose-normalized to 1250 mg/m^2 in Part B was evaluated. (NCT02079636)
Timeframe: C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose

,,
Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
Day 1Steady State
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine35600NA
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine4960038700
Part B: 200 mg or MTD Abemaciclib + 1250 mg/m^2 Gemcitabine4190035800

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PK: Maximum Concentration (Cmax) of LY3023414 in Part D

Cmax of LY3023414 in Part D was evaluated. (NCT02079636)
Timeframe: C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose

,,
Interventionnanograms per milliliter (ng/mL) (Geometric Mean)
Day 1Steady State
Part D: 100 or 150 mg Abemaciclib + 100 mg LY3023414298438
Part D: 150 mg Abemaciclib + 200 mg LY3023414578NA
Part D: 150 or 200 mg Abemaciclib + 150 mg LY3023414454491

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PK: Maximum Concentration (Cmax) of Ramucirumab at 1 Hour Post-End-of-Infusion in Part C

Cmax of ramucirumab at 1 hour post-end-of-Infusion in Part C was evaluated. (NCT02079636)
Timeframe: C1D1 and C2D1: 1 hour post-end-of-infusion

,,,
Interventionmicrogram per milliliter (μg/mL) (Geometric Mean)
C1D1C2D1
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Day 1226NA
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8193NA
Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8174221
Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day1221226

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Pharmacokinetics: Maximum Concentration (Cmax) of Pemetrexed at Steady State in Part A

Cmax of pemetrexed at steady state in Part A was evaluated. (NCT02079636)
Timeframe: C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose

Interventionmicrogram per milliliter (μg/mL) (Geometric Mean)
Part A:150 mg Abemaciclib + 500 mg/m^2 Pemetrexed98.1
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed93.5

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Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) in Part A, B, C, D and E

ORR is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100. (NCT02079636)
Timeframe: Baseline through study completion (Up To 15 Months)

InterventionParticipants (Count of Participants)
Part A:150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed0
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed1
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine0
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine1
Part C:150 mg Abemaciclib+10mg/kg Ramucirumab Day11
Part C: 200 mg Abemaciclib + 10 mg/kg Ramucirumab Day 11
Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 80
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 80
Part D: 100 mg Abemaciclib + 100 mg LY30234140
Part D: 150 mg Abemaciclib + 100 mg LY30234140
Part D: 150 mg Abemaciclib + 150 mg LY30234141
Part D: 200 mg Abemaciclib + 150 mg LY30234140
Part D: 150 mg Abemaciclib + 200 mg LY30234140
Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab0
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab2

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Number of Participants With Dose-Limiting Toxicities (DLT) or DLT-equivalent in Part A, B, C, D and E

A DLT defined as adverse event(AE) occurring between Day 1 and Day 21 of Cycle 1 that was considered at least possibly related to either abemaciclib or the combination therapy and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 [NCI-CTCAE v 4.0] [NCI 2009]):Grade(Gr)≥3 nonhematological toxicity,Gr4 thrombocytopenia lasting at least 5 days and/or complicated with bleeding,Gr≥3 febrile neutropenia(ntr) and for Part D participants (pts): Gr3 hyperglycemia (fasting) of <5 days, Gr3 hypertriglyceridemia or hyperlipidemia without optimal treatment.A DLT-equivalent defined as AE that would have met the criteria for DLT if it had occurred during Cycle 1 for pts enrolled in dose-escalation phase,but that occurs between 1)Day 1 and Day 21 of Cycle 2 and beyond for a participant enrolled in dose-escalation phase 2) at any time for a participant in dose-expansion phase. (NCT02079636)
Timeframe: Baseline through study completion (Up To 15 Months)

InterventionParticipants (Count of Participants)
Part A:150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed1
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed4
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine0
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine5
Part C:150 mg Abemaciclib+10 mg/kg Ramucirumab Day 11
Part C: 200 mg Abemaciclib + 10 mg/kg Ramucirumab Day 14
Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 81
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 83
Part D: 100 mg Abemaciclib + 100 mg LY30234141
Part D: 150 mg Abemaciclib + 100 mg LY30234141
Part D: 150 mg Abemaciclib + 150 mg LY30234141
Part D: 200 mg Abemaciclib + 150 mg LY30234141
Part D: 150 mg Abemaciclib + 200 mg LY30234142
Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab0
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab0

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PK: Area Under the Concentration Curve (AUC) of Pemetrexed at Steady State in Part A

Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]) of Pemetrexed in Part A was evaluated. (NCT02079636)
Timeframe: C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose

Interventionmicrogram*hour per milliliter (μg*hr/mL) (Geometric Mean)
Part A:150 mg Abemaciclib + 500 mg/m^2 Pemetrexed201
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed198

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Progression Free Survival Time in Part A, B, C, D and E

Progression free survival (PFS) defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. PFS time was summarized using Kaplan-Meier estimates. (NCT02079636)
Timeframe: Date of first dose until first documented progression or death (Up To 15 Months)

InterventionMonths (Median)
Part A:Abemaciclib + 500 mg/m^2 Pemetrexed5.55
Part B: Abemaciclib + 1250 mg/m^2 Gemcitabine1.58
Part C:Abemaciclib+ 8/10mg/kg Ramucirumab Day1/84.83
Part D: Abemaciclib + 100 mg/150 mg/ 200 mg LY30234141.87
Part E: 100 mg/150 mg Abemaciclib + 200 mg Pembrolizumab4.11

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Change From Baseline in MD Anderson Symptom Inventory Scale-Lung Cancer (MDASI-LC) in Part A, B, C, D and E

"The MDASI-LC is a self-reported lung cancer instrument included 22 items covered by one of the following dimensions: Mean core symptom severity (Core items 1-13: pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sad, vomiting, numbness/tingling), Lung cancer symptoms (3 items: coughing, constipation, sore throat), Mean symptom severity (13 core items plus 3 lung items) and Interference with mood or functional status (6 items: general activity, mood, work, relations with other people, walking, enjoyment of life). The mean of all symptom subscale items was calculated where 0 equals not present and 10 equals as bad as you can imagine. A change from baseline with negative values indicate improvement, positive values indicate worsening." (NCT02079636)
Timeframe: Baseline, through study completion (Up To 15 Months)

,,,,,,,,,,,,,,
Interventionunits on a scale (Mean)
Mean core symptom severityMean symptom severityMean lung cancer symptomMean interference severity
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed0.890.830.710.49
Part A:150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed-0.16-0.051.222.32
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine-0.54-0.441.670.00
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine-0.08-0.030.190.95
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8-1.39-1.013.01-3.08
Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8-0.64-0.61-0.78-1.00
Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day10.610.721.130.15
Part C:150 mg Abemaciclib+10mg/kg Ramucirumab Day1-0.35-0.41-0.67-1.33
Part D: 100 mg Abemaciclib + 100 mg LY30234140.610.640.780.72
Part D: 150 mg Abemaciclib + 100 mg LY30234141.891.861.401.47
Part D: 150 mg Abemaciclib + 150 mg LY30234141.601.602.191.81
Part D: 150 mg Abemaciclib + 200 mg LY30234140.280.190.67-0.38
Part D: 200 mg Abemaciclib + 150 mg LY3023414-0.80-0.73-0.44-0.22
Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab0.910.991.671.44
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab0.880.750.231.00

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Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib on Day 1 and at Steady State (Cycle 2 Day 1) in Part A , B, C, D and E

Cmax of Abemaciclib on day 1 and at steady State (Cycle 2 Day 1) Part A , B, C, D and E was evaluated. (NCT02079636)
Timeframe: Cycle 1 Day 1 (C1D1) pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; Cycle 2 Day 1 (C2D1) pre-dose and 1, 2, 4, 6, 8, 10 h post-dose

Interventionnanograms per milliliter (ng/mL) (Geometric Mean)
Day 1
Part D: 200 mg Abemaciclib + 150 mg LY3023414225

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Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib on Day 1 and at Steady State (Cycle 2 Day 1) in Part A , B, C, D and E

Cmax of Abemaciclib on day 1 and at steady State (Cycle 2 Day 1) Part A , B, C, D and E was evaluated. (NCT02079636)
Timeframe: Cycle 1 Day 1 (C1D1) pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; Cycle 2 Day 1 (C2D1) pre-dose and 1, 2, 4, 6, 8, 10 h post-dose

,,,,,,,,,
Interventionnanograms per milliliter (ng/mL) (Geometric Mean)
Day 1Steady State
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed212509
Part A:150 mg Abemaciclib + 500 mg/m^2 Pemetrexed114NA
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine80.6NA
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine201417
Part C: 150 mg Abemaciclib + 8 mg/kg or 10 mg/kg Ramucirumab140322
Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day 1195228
Part D: 100 mg Abemaciclib + 100 mg LY302341486.2227
Part D: 150 mg Abemaciclib + 100 or 150 or 200 mg LY3023414159305
Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab125270
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab114240

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Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death. (NCT02082522)
Timeframe: Baseline, 13 weeks

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC0.0
Standard Medical Care (SMC)2.5

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Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death. (NCT02082522)
Timeframe: Baseline, 16 weeks

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC-6.7
Standard Medical Care (SMC)3.3

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Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death. (NCT02082522)
Timeframe: Baseline, up to 4 weeks

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC1.7
Standard Medical Care (SMC)0

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Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease. (NCT02082522)
Timeframe: Baseline, 29 weeks

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC0.0
Standard Medical Care (SMC)2.0

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Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease. (NCT02082522)
Timeframe: Baseline, 41 weeks

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC10.0
Standard Medical Care (SMC)0.0

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Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease. (NCT02082522)
Timeframe: Baseline, 54 weeks

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC0.0
Standard Medical Care (SMC)0.0

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Change From Baseline on Karnofsky Performance Scale (KPS)

The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease. (NCT02082522)
Timeframe: Baseline, 7 days

Interventionscore on a scale (Mean)
Photodynamic Therapy-Photofrin Plus SMC-0.7
Standard Medical Care (SMC)0

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Overall Survival Time

Time from the date of randomization until the date of death or the last date the subject was known to be alive (NCT02082522)
Timeframe: Up to 26 months

Interventiondays (Median)
Photodynamic Therapy-Photofrin Plus SMC444
Standard Medical Care (SMC)387

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Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors)

From the start of the treatment until disease progression or recurrence the RECIST 1.1 criteria are applied (Response Evaluation Criteria in Solid Tumors) (NCT02082522)
Timeframe: Up to 26 months

Interventionpercentage of participants (Number)
Photodynamic Therapy-Photofrin Plus SMC56
Standard Medical Care (SMC)75

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Number of Subjects With Dose Limiting Toxicities (DLTs)

DLT: any National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 Grade 4 hematologic or Grade 3/4 non-hematologic toxicities that occurred during DLT observation period and were considered by Investigator to be at least possibly related to trial treatment, and were confirmed by Safety Monitoring Committee (SMC), with exception of Grade 4 neutropenia for not >5 days; Grade 4 lymphocytopenia/ thrombocytopenia for not >5 days; fatigue/headache lasting < 7 days; nausea/vomiting/diarrhoea lasting not >3 days; asymptomatic Grade 3 increase in liver function tests that resolve to baseline within 7 days; Mucositis >= Grade 3 lasting < 7 days; Grade 3 hyperglycemia that resolves in < 7 days; any laboratory values >Grade 3 without any clinical correlate (resolve within 5 days); Grade 3 skin toxicities that resolve to Grade 2 within 7 days; Grade 3/4 hypomagnesemia that resolves within 5 days. Subjects with DLTs presented based on investigator and SMC decision. (NCT02083679)
Timeframe: Day 1 to Day 21 of Cycle 1

,,,
InterventionSubjects (Number)
InvestigatorSMC
Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel10
Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine22
Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed11
Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel00

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Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death

An adverse event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AEs were considered treatment emergent if they started on or after the day of first administration of the first trial treatment given (Sym004 or one of the individual Platinum-Doublet therapies) or if they worsened after receiving first dose of treatment. (NCT02083679)
Timeframe: Day 1 up to 28 days after last dose of study drug (up to 53 weeks)

,,,
Interventionsubjects (Number)
TEAEsSerious TEAEsTEAE leading to DiscontinuationTEAEs Leading to Death
Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel3300
Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine3310
Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed6530
Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel3320

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Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events

"Dose limiting toxicities were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting toxicities referred to toxicities experienced during the first 28 days (Cycle 1) of treatment that were judged to be clinically significant and related to study treatment.~No statistical analysis was planned or performed for this endpoint." (NCT02101021)
Timeframe: Up to 28 Days

Interventionpercentage of participants (Number)
MMB Dose Level 116.7
MMB Dose Level 20
MMB Dose Level 316.7
MMB Dose Level 40
MMB Dose Level 50

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Lead-In Phase: Overall Survival (OS)

Overall survival was defined as the time interval from first dose date of MMB to death from any cause (NCT02101021)
Timeframe: Baseline up to the Date of Death or Censoring, up to 3 years

InterventionMonths (Median)
MMB Dose Level 112.4
MMB Dose Level 25.1
MMB Dose Level 38.7
MMB Dose Level 45.6
MMB Dose Level 57.1

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Lead-In Phase: Overall Response Rate (ORR)

The ORR was defined as the proportion of participants who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR) as assessed by RECIST v1.1. (NCT02101021)
Timeframe: Baseline up to the Last Tumor Assessment Date, up to 3 years

,,,,
InterventionParticipants (Count of Participants)
Complete Response (CR)Partial Response (PR)
MMB Dose Level 122
MMB Dose Level 212
MMB Dose Level 334
MMB Dose Level 411
MMB Dose Level 504

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Lead-In Phase: Progression-Free Survival (PFS)

Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression is progression based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1. Data from survival, non-progressing participants will be censored at the earliest of the time of initiation of anti-tumor therapy other than the study treatment or the last time that lack of definitive disease progression was objectively documented while on study. (NCT02101021)
Timeframe: Baseline up to the Date of Event or Censoring, up to 3 years

InterventionMonths (Median)
MMB Dose Level 15.3
MMB Dose Level 23.2
MMB Dose Level 35.5
MMB Dose Level 45.3
MMB Dose Level 55.5

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TP53 Mutations

To evaluate TP53 mutations (presence of mutation and type of mutation) as potential predictive factors of benefit (defined as response or PFS prolongation) to AZD1775 and gemcitabine treatment. TP53 status was assessed using Sanger sequencing. (NCT02101775)
Timeframe: Baseline

InterventionParticipants (Count of Participants)
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)48
Arm II (Placebo, Gemcitabine Hydrochloride)22
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)8

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Progression Free Survival

To evaluate the progression free survival (PFS) of subjects with recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer receiving gemcitabine in combination with AZD1775 compared to subjects receiving gemcitabine in combination with placebo. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guideline, as at least a 20% increase in the sum of the diameters of target lesions or the appearance of one or more new lesions. (NCT02101775)
Timeframe: From start of treatment until date of progression or death, whichever occurs first, up to 1 year follow-up

Interventionmonths (Median)
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)4.6
Arm II (Placebo, Gemcitabine Hydrochloride)3.0
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine)5.3

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p53 Protein Expression

"To evaluate p53 protein expression by immunohistochemistry as potential predictive factors of benefit (defined as response or PFS prolongation) to AZD1775 and gemcitabine treatment.~Evaluating p53 expression in patients with high-grade serous ovarian cancer and in patients with high-grade serous ovarian cancer with TP53 mutations." (NCT02101775)
Timeframe: Baseline

InterventionParticipants (Count of Participants)
Abnormal p53 Expression in Patients With High-grade Serous Ovarian Cancer82
Abnormal p53 Expression in Patients With High-grade Serous Ovarian Cancer and With TP53 Mutations68

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Overall Survival

To evaluate the overall survival of patients receiving gemcitabine combined with AZD1775 compared to patients receiving gemcitabine in combination with placebo. (NCT02101775)
Timeframe: From start of study treatment, every 12 weeks, until death, up to 22 months follow-up

Interventionmonths (Median)
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)11.4
Arm II (Placebo, Gemcitabine Hydrochloride)7.2
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)13

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Patient Reported Outcomes

"Will be assessed using Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE).~Each symptomatic AE is assessed with respect to 1 to 3 of the following attributes: frequency (F), severity (S) and/or interference (I) with usual or daily activities, and a recall period of 'the past 7 days'. PRO-CTCAE responses are scored from 0 to 4 with scores of 3 and 4 corresponding to high frequency, severity and/or interference. Results show the number of patients in each arm reporting high scores (3-4) for symptomatic AEs occurring in >30% of patients" (NCT02101775)
Timeframe: First 3 months

,,
InterventionParticipants (Count of Participants)
Abdominal Pain FAbdominal Pain SAnxiety FBloating FBloating SFatigue SFatigue I
Arm I (WEE1 Inhibitor AZD-1775, Gemcitabine Hydrochloride)10971091617
Arm II (Placebo, Gemcitabine Hydrochloride)9565367
Arm III (Exploratory WEE1 Inhibitor AZD-1775, Gemcitabine)1021145

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Objective Response

To evaluate the objective response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) of patients receiving gemcitabine combined with AZD1775 compared to patients receiving gemcitabine in combination with placebo. RECIST v1.1 criteria used for evaluation of target lesions: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions; Progressive Disease (PD), at least a 20% increase in the sum of the diameters of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. The Best Overall Response is the best response recorded from the start of the treatment until disease progression/recurrence . (NCT02101775)
Timeframe: From start of treatment, every 6-8 weeks, until time of progression or death, whichever occurs first, up to 1 year follow-up

InterventionParticipants (Count of Participants)
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)14
Arm II (Placebo, Gemcitabine Hydrochloride)2
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)3

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Response According to CA125 Criteria

To evaluate the GCIG CA125 response rate of patients receiving gemcitabine combined with AZD1775 compared to patients receiving gemcitabine in combination with placebo. A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample. The response must be confirmed and maintained for at least 28 days. (NCT02101775)
Timeframe: From start of treatment, every 4 weeks, until time of progression or death, whichever occurs first, up to 1 year follow-up

InterventionParticipants (Count of Participants)
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)14
Arm II (Placebo, Gemcitabine Hydrochloride)3
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)4

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Duration of Response (in Responders)

Duration of response was calculated from the date of first documented response to the date of progression (including SD after PR) or date of start of new treatment in not progressed, when available. In 2 patients with CR, periods of PR are included. For those not documented as progressed before death, an unknown duration was kept and considered missing data. (NCT02106884)
Timeframe: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).

InterventionMonths (Median)
Arm A (Nab-Paclitaxel + Gemcitabine)6.3
Arm B (Gemcitabine)7.4

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Overall Survival

Overall survival was considered from start of treatment to death. All patients (ITT) (NCT02106884)
Timeframe: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).

InterventionMonths (Median)
Arm A (Nab-Paclitaxel + Gemcitabine)10.94
Arm B (Gemcitabine)11.73

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Progression Free Survival

Progression free survival time was considered from start of treatment until the first observation of disease progression or death from any cause, whichever occurred first. All patients (ITT). (NCT02106884)
Timeframe: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).

InterventionMonths (Median)
Arm A (Nab-Paclitaxel + Gemcitabine)7.01
Arm B (Gemcitabine)5.06

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QOL Global Health Status Deterioration-free Median Survival

The deterioration-free survival is defined as the Kaplan-Meier estimate of median survival time to definitive deterioration of the QOL score or death. See primary outcome 1 for scale description. The definitive deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) as compared to the baseline score, with no further improvement of more than 10 points as compared to the score qualifying the deterioration or with no data after the deterioration was observed. Death was also considered as an event if the patient did not experience deterioration before death. Patients without event were censored at the time of last follow-up. (NCT02106884)
Timeframe: From date of randomisation to end of follow up (max 3 years after database lock when applicable).

InterventionMonths (Median)
Arm A (Nab-Paclitaxel +Gemcitabine)10.04
Arm B (Gemcitabine)8.02

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Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos)

"The QOL global health status (GHS) is a functional parameter derived from the EORTC QLQ - C30 questionnaire, based on questions 29 How would you rate your overall health during the past week? and 30 How would you rate your overall quality of life during the past week?. Transformed scores range from 0 to 100% with higher scores representing better outcomes. The deterioration free survival rate at 3 mos is defined as the Kaplan-Meier estimate of the probability of being alive and free of deterioration of the QOL score at 3 mos. The definitive deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) as compared to baseline, with no further improvement of more than 10 points as compared to the score qualifying the deterioration or with no data after deterioration. Death was also considered as an event if the patient did not experience deterioration before death. Patients without event were censored at the time of last follow-up." (NCT02106884)
Timeframe: From date of randomisation to 3, 6 and 12 months respectively

,
Interventionpercentage of participants (Number)
Rate at 3 months (percentage)Rate at 6 months (percentage)Rate at 12 months (percentage)
Arm A (Nab-Paclitaxel + Gemcitabine)897440
Arm B (Gemcitabine)735935

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Laboratory Safety Assessment

Severe laboratory abnormalities (hematology and biochemistry grade 3 and higher). Worst grade per patient. All patients treated (Safety set). (NCT02106884)
Timeframe: Measured during treatment, from signature of informed consent to end of treatment, plus 30 days mandatory safety follow-up period. Duration of treatment was variable for each patient.

,
InterventionParticipants (Count of Participants)
Hemoglobin decreasedNeutrophils decreasedWhite blood cell count decreasedPlatelet count decreasedHyperglycemiaSerum creatinine increasedBilirubin increasedALT increasedAST increasedALP increasedAlbumin decreasedMagnesium decreasedSodium decreasedPotassium decreasedPotassium increasedCalcium decreased
Arm A (Nab-Paclitaxel + Gemcitabine)103122126031379448813
Arm B (Gemcitabine)8311111102888114913602

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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 1

(NCT02109445)
Timeframe: PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15.

Interventionhours (Median)
Tmax of PF-03084014 on Day 3 (n=3)Tmax of PF-03084014 on Day 15 (n=1)Tmax of nab-paclitaxel on Day 1 (n=3)Tmax of nab-paclitaxel on Day 15 (n=1)Tmax of gemcitabine on Day 1 (n=3)Tmax of gemcitabine on Day 15 (n=1)
PF-03084014 + Nab-Paclitaxel + Gemcitabine1.230.9000.5500.2170.5170.350

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Systemic Clearance (CL) of Nab-paclitaxel in Phase 1

(NCT02109445)
Timeframe: Cycle 1 Days 1-3, and 15-17

Interventionliter (L)/hour (hr) (Geometric Mean)
Day 1 (n=3)Day 15 (n=1)
PF-03084014 + Nab-Paclitaxel + Gemcitabine37.8838.60

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Systemic Clearance (CL) of Gemcitabine in Phase 1

(NCT02109445)
Timeframe: Cycle 1 Days 1 and 15

Interventionliter (L)/minute (min) (Geometric Mean)
Day 1 (n=3)Day 15 (n=1)
PF-03084014 + Nab-Paclitaxel + Gemcitabine5.4348.160

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Plasma Decay Half-life (t1/2) for Nab-P and GEM in Phase 1

(NCT02109445)
Timeframe: Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel)

Interventionhours (Mean)
t1/2 of nab-paclitaxel on Day 1 (n=3)t1/2 of nab-paclitaxel on Day 15 (n=1)t1/2 of gemcitabine on Day 1 (n=3)t1/2 of gemcitabine on Day 15 (n=1)
PF-03084014 + Nab-Paclitaxel + Gemcitabine2.5002.0300.28130.2230

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Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 1

(NCT02109445)
Timeframe: PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15.

Interventionnanogram/milliliter (ng/mL) (Geometric Mean)
Cmax for PF-03084014 on Day 3 (n=3)Cmax for PF-03084014 on Day 15 (n=1)Cmax for nab-paclitaxel on Day 1 (n=3)Cmax for nab-paclitaxel on Day 15 (n=1)Cmax for gemcitabine on Day 1 (n=3)Cmax for gemcitabine on Day 15 (n=1)
PF-03084014 + Nab-Paclitaxel + Gemcitabine527.3943.060235140107603620

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Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1

AUC included AUC from time 0 extrapolated to infinite time (AUCinf), AUC from time 0 to end of dosing interval (AUCtau, tau=12 hours), and AUC from time 0 to last measured concentration (AUClast). (NCT02109445)
Timeframe: PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15.

Interventionnanogram*hour/milliliter (ng*hr/mL) (Geometric Mean)
AUClast for PF-03084014 on Day 3 (n=3)AUClast for PF-03084014 on Day 15 (n=1)AUCinf for nab-paclitaxel on Day 1 (n=3)AUClast for nab-paclitaxel on Day 1 (n=3)AUCinf for nab-paclitaxel on Day 15 (n=1)AUClast for nab-paclitaxel on Day 15 (n=1)AUCinf for gemcitabine on Day 1 (n=3)AUClast for gemcitabine on Day 1 (n=3)AUCinf for gemcitabine on Day 15 (n=1)AUClast for gemcitabine on Day 15 (n=1)
PF-03084014 + Nab-Paclitaxel + Gemcitabine1122177057745185505046005316526225102500

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Number of Participants With Worsening QTc Results in Phase 1

Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) were corrected for heart rate (QTc) using Fridericia (QTcF) and Bazett (QTcB) formulas. Any change from baseline in QTc was considered as worsening in ECG and was classified accordingly to the Common Terminology Criteria (CTC) grade. Grading was as follows: prolonged QTc of 450 to 480 milliseconds (msec)=Grade 1, 481 to 500 msec=Grade 2, more than or equal to (>=) 501 msec on at least 2 seperate ECGs=Grade 3, >=501 or more than (>) 60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs of serious arrhythmia=Grade 4. (NCT02109445)
Timeframe: Screening, Cycle 1 Days 3 and 22, Cycles 2 and 3 Day 1, end of treatment

Interventionparticipants (Number)
PF-03084014 + Nab-Paclitaxel + GemcitabineNA

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Number of Participants With Objective Response (OR) in Phase 1

"Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST).~CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions. PR was defined as more than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions." (NCT02109445)
Timeframe: Screening till 28-35 days post last administration of study drug

Interventionparticipants (Number)
PF-03084014 + Nab-Paclitaxel + Gemcitabine0

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Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1

DLT was defined as any of the following events occurring during the first cycle of treatment and considered at least possibly-related to study medication: any Grade 3 or 4 clinically-relevant non-hematologic and/or hematologic toxicity, delay of more than 2 weeks in receiving the next scheduled cycle due to persisting treatment-related toxicities. (NCT02109445)
Timeframe: Cycle 1 (28 days)

Interventionparticipants (Number)
PF-03084014 + Nab-Paclitaxel + Gemcitabine2

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Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1

Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. Severity was graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1=mild, Grade 2=moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening. (NCT02109445)
Timeframe: Baseline up to 28-35 days post last administration of study drug

Interventionparticipants (Number)
All-causality TEAEsTreatment-related TEAEsGrade 3 or 4 TEAEs
PF-03084014 + Nab-Paclitaxel + Gemcitabine333

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Volume of Distribution at Steady State (Vss) for Nab-P and GEM in Phase 1

(NCT02109445)
Timeframe: Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel)

Interventionliters (Geometric Mean)
Vss of nab-paclitaxel on Day 1 (n=3)Vss of nab-paclitaxel on Day 15 (n=1)Vss of gemcitabine on Day 1 (n=3)Vss of gemcitabine on Day 15 (n=1)
PF-03084014 + Nab-Paclitaxel + Gemcitabine64.4660.8061.76201.0

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Number of Participants With Laboratory Abnormalities in Phase 1

Following parameters were analyzed for laboratory examination: hematology (hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (urea, creatinine, glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid); urinalysis (protein, blood, microscopy[if urine tested positive for blood or protein]). (NCT02109445)
Timeframe: Screening; Cycle 1 Days 1, 8, 15, 22; up to 28-35 days post last administration of study drug

Interventionparticipants (Number)
PF-03084014 + Nab-Paclitaxel + Gemcitabine3

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Survival at 6 Months

Evaluate the proportion of patients who are alive at 6 months following randomization (NCT02117024)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Viagenpumatucel-L Plus Metronomic Cyclophosphamide21
Chemotherapy Alone17

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Survival at 12 Months

Evaluate the proportion of patients who are alive at 12 months following randomization (NCT02117024)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Viagenpumatucel-L Plus Metronomic Cyclophosphamide8
Chemotherapy Alone11

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Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)

Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events (NCT02117024)
Timeframe: Up to 3 years

,
InterventionParticipants (Count of Participants)
At least one TEAEAt least one severe TEAEAt least one treatment-related TEAEAt least one SAEFatal TEAEAt least one TEAE Leading to Tx DiscontinuationAt least one TEAE Leading to a Dose Reduction
Chemotherapy Alone2011158022
Viagenpumatucel-L Plus Metronomic Cyclophosphamide41253217770

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Overall Survival (OS)

"Overall survival (OS) calculated as the duration of survival from the date of randomization to the date of death from any cause, or was censored on the date the patient was last known to be alive.~Survival time was calculated from the randomization date up to the date of death,or censored on the date that the patient was last known to be alive (last available visit date) utilizing Kaplan-Meier Estimate of Overall Survival Ending Events" (NCT02117024)
Timeframe: Up to 3 years

InterventionDays (Median)
Viagenpumatucel-L Plus Metronomic Cyclophosphamide176
Chemotherapy Alone372

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Time to Progression (TTP)

Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST (NCT02117024)
Timeframe: Up to 3 years

,
InterventionDays (Median)
immune-related TTP (irTTP)Time to Progression (TTP)
Chemotherapy Alone71.073.5
Viagenpumatucel-L Plus Metronomic Cyclophosphamide67.067.5

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Progression-Free Survival (PFS)

Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors) (NCT02117024)
Timeframe: Up to 3 years

,
InterventionDays (Median)
immune-related PFS (irPFS)Progression Free Survival (PFS)
Chemotherapy Alone190.0190.0
Viagenpumatucel-L Plus Metronomic Cyclophosphamide76.070.0

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Phase II: Objective Response Rate (ORR)

Objective Response Rate: Response according to Response Evaluation in Solid Tumors (RECIST) 1.1 for the combination of gemcitabine+trastuzumab+pertuzumab at the recommended phase II dose. Complete Response (CR): Disappearance of all evidence of tumor for at least two cycles of therapy. Tumor markers must be normal. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking a reference the baseline sum longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the beginning of treatment or the appearance of one or more new lesions. (NCT02139358)
Timeframe: Up to 36 Months

InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable Disease
Dose Escalation / Phase II Treatment118

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Phase II: Progression Free Survival (PFS)

Median progression free survival (in months) for all participants evaluable for response. The time-to-event data will be summarized using Kaplan-Meir curve method for all patients who are evaluable for the ORR endpoint. Progressive disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the beginning of treatment or the appearance of one or more new lesions. (NCT02139358)
Timeframe: Up to 12 months

Interventionmonths (Median)
Dose Escalation / Phase II Treatment6.4883

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Overall Survival (OS)

Median overall survival (in months) for all participants evaluable for response. The length of time from the start of treatment that participants are still alive. (NCT02139358)
Timeframe: Up to 36 months

Interventionmonths (Median)
Dose Escalation / Phase II Treatment11.3545

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Progression Free Survival (PFS) Rate at Month 6

PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The data cutoff was 09-May-2016. The PFS rate at Month 6 was calculated. (NCT02142738)
Timeframe: Month 6

InterventionPercentage of Participants (Number)
Pembrolizumab62.1
SOC Chemotherapy50.3

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Overall Survival (OS) Rate

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The data cutoff was 10-July-2017. The median OS rate at 12 months is presented. (NCT02142738)
Timeframe: 12 months

InterventionPercentage of Participants (Number)
Pembrolizumab70.3
SOC Chemotherapy54.8

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Objective Response Rate (ORR)

ORR was defined as the percentage of participants in the analysis population who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. ORR was assessed from enrollment/treatment initiation of a participant through data cutoff of 09-May-2016. The ORR is presented for each treatment group. (NCT02142738)
Timeframe: Up to ~1.6 years

InterventionPercentage of Participants (Number)
Pembrolizumab44.8
SOC Chemotherapy27.8

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Progression-free Survival (PFS)

Each biomarker evaluated using its expression level (continuous variable) and dichotomous form (based on a median cutoff). A univariable Cox regression model will be used to assess the relationship of expression levels of each biomarker to PFS. In addition, for the dichotomous variables, the sample will be divided into those above and below the median for each biomarker. PFS probabilities for each group will be estimated using the Kaplan-Meier method, with standard errors based on Greenwood's formula. Log rank tests will be used to determine the level of significance between survival curves. Since, the study was canceled due to slow accrual, no biomarkers were measured; therefore, no analysis with biomarkers. Only the PFS will be calculated. (NCT02145078)
Timeframe: From the date of protocol-specified treatment initiation to the date of progression, death, or last observation, assessed up to 12 months

Interventiondays (Median)
Treatment (Chemotherapy Regimen)42

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Overall Survival (OS)

Since, the study was canceled due to slow accrual, no biomarkers were measured; therefore, no analysis with biomarkers. Only the OS will be calculated. (NCT02145078)
Timeframe: From the date of protocol-specified treatment initiation to the date of death or last observation, assessed up to 12 months

Interventionmonths (Median)
Treatment (Chemotherapy Regimen)2.0

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Pathologic T0 Rate Evaluation: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)

Pathologic complete response rate at the time of cystectomy following GC or DDMVAC treatment (NCT02177695)
Timeframe: Up to 5 years post-registration

Interventionpercentage of participants (Number)
Gemcitabine & Cisplatin28
Dose Dense MVAC30

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Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate

"The proportion of participants achieving <=pT1 in both favorable and unfavorable treatment specific-COXEN score categories.~Unit of measure is the number of participants in each category that achieved <= pT1~____________________________________________________________________________________________________________________ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores~This will be done in two ways:~By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. .~By evaluating the correlation between the GC- and the DDMVAC-COXEN score." (NCT02177695)
Timeframe: up to 5 years post-registration

,
InterventionParticipants (Count of Participants)
Favorable treatment-COXEN scoreUnfavorable treatment-COXEN score
Dose Dense MVAC1631
Gemcitabine & Cisplatin1030

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Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC

"To assess in a hypothesis generating fashion, the ability of COXEN to select for an individual chemotherapy regimen (GC vs DDMVAC)~P-values are reported as a measure of whether COXEN can select between GC/DDMVAC and to determine the significance of interactions between treatment specific COXEN scores and treatment arms in models predicting either pT0 or <= pT1. Interactions with p-values > 0.05 are interpreted as not significant.~________ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores~This will be done in two ways:~By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. .~By evaluating the correlation between the GC- and the DDMVAC-COXEN score." (NCT02177695)
Timeframe: up to 5 years post-registration

Interventionp-value (Number)
P-value of interaction term (GCscore*treatment arm) in model predicting pT0P-value of interaction term (GCscore*treatment arm) in logistic regression model predicting <=pT1P-value of interaction term (MVACscore*treatment arm) in logistic regression model predicting pT0P-value of interaction term (MVACscore*treatment arm) in logistic regression model predicting <=pT1
All Participants0.880.430.660.85

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Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate

"The proportion of participants achieving pT0 in both favorable and unfavorable treatment specific-COXEN score categories.~Unit of measure is the number of participants in each category that achieved pT0~_____________________________________________________________________________________________________________________~The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores~This will be done in two ways:~By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. .~By evaluating the correlation between the GC- and the DDMVAC-COXEN score." (NCT02177695)
Timeframe: Up to 5 years post registration

,
InterventionParticipants (Count of Participants)
Favorable treatment-COXEN scoreUnfavorable treatment-COXEN score
Dose Dense MVAC1017
Gemcitabine & Cisplatin820

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Correlation Between GC-and ddMVAC-COXEN Score

"The Pearson and Spearman correlation coefficients for GC-and ddMVAC-COXEN score were calculated and are reported below.~___________________________________________________________________________________________________________________ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores~This will be done in two ways:~By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. .~By evaluating the correlation between the GC- and the DDMVAC-COXEN score." (NCT02177695)
Timeframe: up to 5 years post-registration

Interventioncorrelation coefficient (Number)
Pearson correlation coefficientSpearman correlation coefficient
All Participants0.3850.386

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Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)

In addition to stratification factors and dichotomous COXEN GEM score, an indicator for treatment arm and the interaction of treatment arm with COXEN GEM score was also included in a logistic regression model. A significant interaction would suggest that the respective COXEN GEM score was able to differentiate whether a patient was more likely to respond to one chemotherapy regimen over another. *note that this is the same objective at Primary Outcome #3 above - this was erroneously listed twice in the protocol. (NCT02177695)
Timeframe: Up to 5 years post registration

Interventionp-value (Number)
Pvalue of interaction term (GCscore*treatment arm) in model predicting pT0Pvalue of interaction term (GCscore*treatment arm) in model predicting <=pT1Pvalue of interaction term (MVACscore*treatment arm) in model predicting pT0Pvalue of interaction term (MVACscore*treatment arm) in model predicting <=pT1
All Participants0.880.430.660.85

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Observed Overall Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Observed Overall Response Rate = Number of patients who experienced a confirmed CR or PR divided by the number of eligible patients who began treatment. (NCT02178241)
Timeframe: Up to 36 months

Interventionpercentage of participants (Number)
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)50

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Overall Survival

Estimated using the product-limit method of Kaplan and Meier. (NCT02178241)
Timeframe: From start of treatment until death from any cause ,up to 36 months

Interventionmonths (Median)
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)11.9

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Progression-free Survival

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02178241)
Timeframe: From the start until progression, death, or the start of another treatment, assessed up to 12 months

Interventionmonths (Median)
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)5.3

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Incidence of Adverse Events.

"Toxicities that Occurred in 10% or More of Patients or At Least Once as a Grade 3+ Adverse Event (excluding those toxicities classified as unrelated or unlikely related to study drugs). Toxicities graded using CTCAEv4 criteria." (NCT02178241)
Timeframe: Up to 36 months

Interventionparticipants (Number)
Grade 1 or 2 : AnemiaGrade 1 or 2 : Febrile neutropeniaGrade 1 or 2 : Thrombotic microangiopathyGrade 1 or 2 : Chest pain - cardiacGrade 1 or 2 : Heart failureGrade 1 or 2 : ColitisGrade 1 or 2 : ConstipationGrade 1 or 2 : DiarrheaGrade 1 or 2 : Dry MouthGrade 1 or 2 : Mucositis oralGrade 1 or 2 : NauseaGrade 1 or 2 : VomitingGrade 1 or 2 : EdemaGrade 1 or 2 : FatigueGrade 1 or 2 : FeverGrade 1 or 2 : Appendicitis perforatedGrade 1 or 2 : Lung infectionGrade 1 or 2 : SepsisGrade 1 or 2 : Upper respiratory infectionGrade 1 or 2 : Urinary Tract InfectionGrade 1 or 2 : Electrocardiogram QTGrade 1 or 2 : Weight LossGrade 1 or 2 : Lymphocyte Count DecreasedGrade 1 or 2 : Neutrophil Count DecreasedGrade 1 or 2 : Platelet Count DecreasedGrade 1 or 2 : White Blood Cell DecreasedGrade 1 or 2 : INR increasedGrade 1 or 2 : Alanine Aminotransferase IncreasedGrade 1 or 2 : Aspartate Aminotransferase IncrGrade 1 or 2 : Creatinine IncreasedGrade 1 or 2 : AnorexiaGrade 1 or 2 : HyperglycemiaGrade 1 or 2 : DehydrationGrade 1 or 2 : HypoalbuminemiaGrade 1 or 2 : HypocalcemiaGrade 1 or 2 : HypokalemiaGrade 1 or 2 : HypomagnesemiaGrade 1 or 2 : HyponatremiaGrade 1 or 2 : HypophosphatemiaGrade 1 or 2 : Generalized Muscle WeaknessGrade 1 or 2 : Grip WeaknessGrade 1 or 2 : Pain in ExtremityGrade 1 or 2 : DizzinessGrade 1 or 2 : DysgeusiaGrade 1 or 2 : ParesthesiaGrade 1 or 2 : Peripheral Sensory NeuropathyGrade 1 or 2 : InsomniaGrade 1 or 2 : DyspneaGrade 1 or 2 : PneumonitisGrade 1 or 2 : Sore ThroatGrade 1 or 2 : AlopeciaGrade 1 or 2 : HypotensionGrade 1 or 2 : Thromboembolic eventGrade 3 or 4 : AnemiaGrade 3 or 4 : Febrile neutropeniaGrade 3 or 4 : Thrombotic microangiopathyGrade 3 or 4 : Chest pain - cardiacGrade 3 or 4 : Heart failureGrade 3 or 4 : ColitisGrade 3 or 4 : ConstipationGrade 3 or 4 : DiarrheaGrade 3 or 4 : Dry MouthGrade 3 or 4 : Mucositis oralGrade 3 or 4 : NauseaGrade 3 or 4 : VomitingGrade 3 or 4 : EdemaGrade 3 or 4 : FatigueGrade 3 or 4 : FeverGrade 3 or 4 : Appendicitis perforatedGrade 3 or 4 : Lung infectionGrade 3 or 4 : SepsisGrade 3 or 4 : Upper respiratory infectionGrade 3 or 4 : Urinary Tract InfectionGrade 3 or 4 : Electrocardiogram QTGrade 3 or 4 : Weight LossGrade 3 or 4 : Lymphocyte Count DecreasedGrade 3 or 4 : Neutrophil Count DecreasedGrade 3 or 4 : Platelet Count DecreasedGrade 3 or 4 : White Blood Cell DecreasedGrade 3 or 4 : INR increasedGrade 3 or 4 : Alanine Aminotransferase IncreasedGrade 3 or 4 : Aspartate Aminotransferase IncrGrade 3 or 4 : Creatinine IncreasedGrade 3 or 4 : AnorexiaGrade 3 or 4 : HyperglycemiaGrade 3 or 4 : DehydrationGrade 3 or 4 : HypoalbuminemiaGrade 3 or 4 : HypocalcemiaGrade 3 or 4 : HypokalemiaGrade 3 or 4 : HypomagnesemiaGrade 3 or 4 : HyponatremiaGrade 3 or 4 : HypophosphatemiaGrade 3 or 4 : Generalized Muscle WeaknessGrade 3 or 4 : Grip WeaknessGrade 3 or 4 : Pain in ExtremityGrade 3 or 4 : DizzinessGrade 3 or 4 : DysgeusiaGrade 3 or 4 : ParesthesiaGrade 3 or 4 : Peripheral Sensory NeuropathyGrade 3 or 4 : InsomniaGrade 3 or 4 : DyspneaGrade 3 or 4 : PneumonitisGrade 3 or 4 : Sore ThroatGrade 3 or 4 : AlopeciaGrade 3 or 4 : HypotensionGrade 3 or 4 : Thromboembolic event
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)7310001074272913400001244477191149038443745035445300312208001110202321701111210615313101001210002011100100110011

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Proportion of Patients With a Response

Point and 90% Wilson's confidence intervals will be estimated to describe response rate. If the best observed clinical response was complete response or partial response, we consider that the patient responded. (NCT02178436)
Timeframe: Up to 2 years

Interventionproportion of patients (Number)
Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor)0.40
GroupIII: Phase II Group II (Gemcitabine, Selinexor)0

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Progression Free Survival (Phase II)

Estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed at least one 4-week treatment cycle) using the Kaplan-Meier method. Both progression and death are considered events for this analysis. (NCT02178436)
Timeframe: Up to 2 years

Interventionmonths (Median)
Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor)4.60
GroupIII: Phase II Group II (Gemcitabine, Selinexor)1.74

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Maximum Tolerated Dose (MTD) of Selinexor, Gemcitabine Hydrochloride, and Paclitaxel Albumin-stabilized Nanoparticle Formulation Combination (Phase Ib)

MTD is defined as the lowest dose for which less than a third of patients experience a dose limiting toxicity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. (NCT02178436)
Timeframe: 28 days

Interventionmilligrams (Number)
Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor)80

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Overall Survival (Phase II)

Estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed at least one 4-week treatment cycle) using the Kaplan-Meier method. (NCT02178436)
Timeframe: Up to 7 months post treatment initiation

Interventionmonths (Median)
Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor)5.45
GroupIII: Phase II Group II (Gemcitabine, Selinexor)NA

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Proportion of Patients With a Toxic Event, Graded According to NCI CTCAE Version 4.03

The reported output is the proportion of patients that had a toxic event along with the associated 90% Wilson's confidence interval. (NCT02178436)
Timeframe: Up to 2 years

Interventionproportion of patients (Number)
Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor)1.00
GroupIII: Phase II Group II (Gemcitabine, Selinexor)0.75

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Time To Progression (TTP)

TTP was defined as the time from date of first dose of study therapy to date of removal from study for progression. Patients who have not experienced progression were censored at the date of last disease evaluation. Progression is evaluated using Solid Tumor Response Criteria (RECIST) Version 1.1. Progression is defined as at least a 20% increase in the sum of the diameters/axes of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm over the nadir. The appearance of new lesions or unequivocal progression of existing non-target lesions also constitutes disease progression. (NCT02181634)
Timeframe: Every 3-6 months for up to 3 years

Interventionmonths (Median)
Nab-Paclitaxel and Gemcitabine7.7

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Association Between OS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline

Patients were dichotomized into maximum CA 19-9 decline >=50% and maximum CA 19-9 decline <50%. Cox proportional hazards model was used to evaluate the association between OS and maximum change in CA 19-9. (NCT02181634)
Timeframe: CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment

Interventionmonths (Median)
CA 19-9 decline >=50%CA 19-9 decline <50%
Nab-Paclitaxel and Gemcitabine14.610.2

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Association Between PFS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline

Patients were dichotomized into maximum CA 19-9 decline >=50% and maximum CA 19-9 decline <50%. Cox proportional hazards model was used to evaluate the association between PFS and maximum change in CA 19-9. (NCT02181634)
Timeframe: CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment

Interventionmonths (Median)
CA 19-9 decline >=50%CA 19-9 decline <50%
Nab-Paclitaxel and Gemcitabine7.71.9

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Progression-Free Survival (PFS) Rate at 6 Months (Proportion of Participants Alive and Progression-Free at 6 Months)

"Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first. Progression-free survival rate at 6 months is defined as the proportion of patients who were disease progression-free and alive at 6 months.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameter/axes of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions." (NCT02181634)
Timeframe: Assessed at 6 months

Interventionproportion of participants (Number)
Nab-Paclitaxel and Gemcitabine0.605

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Overall Response Rate (ORR)

Overall response rate is defined as the proportion of patients with complete response or partial response per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. A confirmation assessment performed >=4 weeks after the criteria for response is met is required. (NCT02181634)
Timeframe: Every 3-6 months for up to 3 years

Interventionproportion of participants (Number)
Nab-Paclitaxel and Gemcitabine0.301

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Disease Control Rate (DCR)

Disease control rate is the proportion of patients achieved complete response, partial response or stable disease per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. Stable disease is defined as neither sufficient shrinkage to qualify for complete or partial response nor sufficient increase to qualify for progression. A confirmation assessment performed >=4 weeks after the criteria for response is met is required. (NCT02181634)
Timeframe: Every 3-6 months for up to 3 years

Interventionproportion of participants (Number)
Nab-Paclitaxel and Gemcitabine0.658

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Overall Survival (OS)

OS is defined as the time from enrollment until death or last patient contact. (NCT02181634)
Timeframe: Every 3-6 months for up to 3 years

Interventionmonths (Median)
Nab-Paclitaxel and Gemcitabine11.2

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Progression-free Survival (PFS)

Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first. (NCT02181634)
Timeframe: Every 3-6 months for up to 3 years

Interventionmonths (Median)
Nab-Paclitaxel and Gemcitabine7.7

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Number of Participants With Dose Limiting Toxicities (DLT)

A dose-limiting toxicity (DLT) was defined by the occurrence of any of the toxicities listed in section 5.1.5 of the protocol that are possibly, probably, or definitely related to study drug(s) within the first cycle (4 weeks = 28 days). (NCT02194829)
Timeframe: Assessed at 28 days

InterventionParticipants (Count of Participants)
Arm A (Phase I - Initial Dose Level)2
Arm B (Phase I - Dose Level -2)2

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as a new or worsening AE that occurred in the window of first infusion of any study drug (Day 1) and within 28 days of the last infusion of study drug or the day before surgery, whichever occurred first. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. (NCT02210559)
Timeframe: From first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196)

,
InterventionParticipants (Count of Participants)
TEAEsSAEs
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)249
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)126

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Median Progression-Free Survival

Progression-free survival was defined as the time from randomization until objective tumor progression or death. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. (NCT02210559)
Timeframe: From randomization until objective tumor progression or death, assessed up to 4 years

Interventionmonths (Median)
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)14.11
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)11.63

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Number of Participants in Whom R0 or R1 Resection Was Achieved

R0 or R1 resection was determined by pathological examination of the surgical specimen after resection. (NCT02210559)
Timeframe: After completion of 24 weeks of treatment with study drug

InterventionParticipants (Count of Participants)
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)8
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)1

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Median Overall Survival

Overall survival was defined as the time from randomization until death from any cause. (NCT02210559)
Timeframe: From randomization until death from any cause, assessed up to 4 years

Interventionmonths (Median)
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)19.38
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)23.47

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Number of Participants in Whom R0 Resection Was Achieved

R0 resection was determined by pathological examination of the surgical specimen after resection. (NCT02210559)
Timeframe: After completion of 24 weeks of treatment with study drug

InterventionParticipants (Count of Participants)
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)4
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)1

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Number of Participants Who Became Eligible for Surgery

(NCT02210559)
Timeframe: After completion of 24 weeks of treatment with study drug

InterventionParticipants (Count of Participants)
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)17
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)2

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Number of Participants Who Had Surgical Complications Post-Resection

Number of participants who had surgical complications (for example; surgical site infection, intra-abdominal abscess, or perioperative leak during surgery) has been reported (NCT02210559)
Timeframe: 30 days following discharge after surgery (up to Day 198)

InterventionParticipants (Count of Participants)
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)0
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)0

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Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduced in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT02210559)
Timeframe: From randomization up to Week 52

InterventionParticipants (Count of Participants)
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P)5
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP)3

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Determine the Maximum Tolerated Dose of Gemcitabine to be Delivered Locally to the Pancreas

"Maximum Tolerated Dose (MTD) of gemcitabine administered intra-arterially to the pancreatic tumor(s) using the RenovoCath™ RC120 catheter.~One week post treatment, toxicities will be assessed to determine if there is a pre-defined Dose Limiting Toxicity necessitating dose stopping or holding." (NCT02237157)
Timeframe: 1 week post treatment

Interventionmg/m^2 (Number)
Gemcitabine, Local Delivery1000

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Local Control Rate

The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response. (NCT02243007)
Timeframe: 2 Years

Intervention ()
Folfirinox-ARM A0
Gemcitabine/Nab-Paclitaxel- Arm B0

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Pathologic Complete Response Rate (pCR).

Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes. (NCT02243007)
Timeframe: 18 Months

Intervention ()
Folfirinox-ARM A0
Gemcitabine/Nab-Paclitaxel- Arm B0

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Correlation of Biomarkers With PFS

Analysis of the correlation between selected bio-markers and progression free survival. (NCT02243007)
Timeframe: 2 Years

Intervention ()
Folfirinox-ARM A0
Gemcitabine/Nab-Paclitaxel- Arm B0

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Rate of Pathologic Downstaging

The number of participants achieving a reduction in the pathological staging of the primary cancer. (NCT02243007)
Timeframe: 2 Years

Intervention ()
Folfirinox-ARM A0
Gemcitabine/Nab-Paclitaxel- Arm B0

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30-day Post-operative Mortality Rate

Number of patients who died following surgery. (NCT02243007)
Timeframe: 30 Days

Intervention ()
Folfirinox-ARM A0
Gemcitabine/Nab-Paclitaxel- Arm B0

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Survival Rate at 18 Month

Number of participants surviving after 18 months of study follow-up (NCT02243007)
Timeframe: 18 Month

InterventionParticipants (Count of Participants)
Folfirinox-ARM A2
Gemcitabine/Nab-Paclitaxel- Arm B3

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Surgical Morbidity Rate

Number of patients experiencing a specific surgery related morbidity (NCT02243007)
Timeframe: within 30 days of surgery

Intervention ()
Folfirinox-ARM A0
Gemcitabine/Nab-Paclitaxel- Arm B0

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Number of Participants With Serious and Non-Serious Adverse Events

Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days (NCT02243007)
Timeframe: Baseline, 28 Days

,
Interventionparticipants (Number)
Serious Adverse EventsOther Adverse Events
Folfirinox-ARM A04
Gemcitabine/Nab-Paclitaxel- Arm B23

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Number of Participants With Post-operative Complications After Partial Hepatectomy After Antecedent Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.

Measured post-operative complications include (but not limited to) bile leak, liver failure, ascites, infection, any organ failure or insufficiency, venous thromboembolism, and mortality. (NCT02254681)
Timeframe: up to 90 days after partial hepatectomy

InterventionParticipants (Count of Participants)
Treatment1

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Number of Participants With Intrahepatic Recurrence After Partial Hepatectomy With Antecedent Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.

To determine the number of participants with Intrahepatic recurrence assessed by RECIST criteria using MRI of the abdomen with intravenous gadolinium contrast. (NCT02254681)
Timeframe: From date of partial hepatectomy until date of first documented recurrence or date of death from any cause, assessed up to 24 months.

InterventionParticipants (Count of Participants)
Treatment1

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Number of Participants With Intrahepatic Disease Progression After Treatment With Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.

To determine the number of participants with Intrahepatic disease progression assessed by MRI of the abdomen with intravenous gadolinium contrast using RECIST criteria. (NCT02254681)
Timeframe: From date of first treatment until date of first documented progression or date of death from any cause, which ever comes first, assessed up to 24 months.

InterventionParticipants (Count of Participants)
Treatment6

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Number of Participants Post Operative/Radiation Therapy Complications

Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol. (NCT02256982)
Timeframe: 90 Days

Interventionparticipants (Number)
Resectable Disease0
Unresectable Disease0

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Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793

AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg. (NCT02265510)
Timeframe: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

InterventionnM*hr (Mean)
Phase 1a TGA - INCB052793 15 mg4750
Phase 1a TGA - INCB052793 25 mg9170
Phase 1a TGA - INCB052793 35 mg8430
Phase 1a TGA - INCB052793 50 mg14700
Phase 1a TGA - INCB052793 75 mg18300
Phase 1a TGA - INCB052793 100 mg27800
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg6390
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^29580
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^210200
Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^29380

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Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration of Itacitinib

Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15). (NCT02265510)
Timeframe: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

InterventionnM (Mean)
Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^21310

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Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment

Response rate is defined as the percentage of participants who achieved best overall response (BOR) as determined by IWG response criteria of investigator's assessment. A participant was considered an objective responder based on the following- Solid tumors: participant had a best overall response (BOR) of CR or PR, Lymphoma: participant had a BOR of complete radiologic response/complete metabolic response or partial remission/partial metabolic response, AML: participant had a BOR of CR, CRi, morphological leukemia-free state (MLFS), or PR, MDS: participant had a BOR of CR, PR, or marrow CR, MDS/myeloproliferative neoplasm (MPN): participant had a BOR of CR, PR, or marrow response, MM: participant had a BOR of stringent CR, CR, very good PR, PR, or MR. Subjects are combined by tumor type for this analysis. (NCT02265510)
Timeframe: Baseline through end of study (Up to approximately 4.5 years)

InterventionParticipants (Count of Participants)
Phase 1a TGA - INCB052793 in Solid Tumors0
Phase 1a TGB - INCB052793 in Lymphoma0
Phase 1a TGB - INCB052793 in MDS/MPN1
Phase 1a TGB - INCB052793 in MM0
Phase 1b Cohort B - INCB052793 + Dexamethasone in MM2
Phase 1b Cohort F-INCB052793 +Azacytidine in AML4
Phase 1b Cohort F-INCB052793 +Azacytidine in MDS3
Phase 1b Cohort F-INCB052793 +Azacytidine in MDS/MPN2

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Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793

Tmax is the time to maximum (peak) observed plasma drug concentration. Summary of Steady-State, Day 15, was evaluated by dosing regimen. For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg. (NCT02265510)
Timeframe: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

Interventionhours (hr) (Median)
Phase 1a TGA - INCB052793 15 mg1.1
Phase 1a TGA - INCB052793 25 mg0.76
Phase 1a TGA - INCB052793 35 mg2.0
Phase 1a TGA - INCB052793 50 mg1.1
Phase 1a TGA - INCB052793 75 mg2.2
Phase 1a TGA - INCB052793 100 mg2.0
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg1.0
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^21.1
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^21.1
Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^20.51

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Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for Itacitinib

Tmax is the time to maximum (peak) observed plasma drug concentration. (NCT02265510)
Timeframe: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

Interventionhr (Median)
Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^23.5

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Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793

Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg. (NCT02265510)
Timeframe: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

InterventionnM (Mean)
Phase 1a TGA - INCB052793 15 mg522
Phase 1a TGA - INCB052793 25 mg1110
Phase 1a TGA - INCB052793 35 mg1120
Phase 1a TGA - INCB052793 50 mg2050
Phase 1a TGA - INCB052793 75 mg1840
Phase 1a TGA - INCB052793 100 mg2890
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg928
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^21270
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^21480
Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^21610

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Phase 2: Objective Response Rate (ORR) in Hematological Malignancies

ORR is defined as the proportion of participants who achieved complete response (CR), CR with incomplete hematologic recovery (CRi), partial response (PR), or hematologic improvement (HI), using the IWG response criteria. (NCT02265510)
Timeframe: Baseline through end of study (Up to approximately 4.5 years)

InterventionParticipants (Count of Participants)
Phase 2 Cohort I-INCB052793 +Azacytidine (AML)0
Phase 2 Cohort I-INCB052793 +Azacytidine (MDS)1
Phase 2 Cohort J-Itacitinib +Azacitidine (AML)1
Phase 2 Cohort J-Itacitinib +Azacitidine (MDS)0

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Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug. (NCT02265510)
Timeframe: From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)

,,,,,,,,,,,
InterventionParticipants (Count of Participants)
TEAESAE
Phase 1a TGA - INCB052793 100 mg62
Phase 1a TGA - INCB052793 15 mg30
Phase 1a TGA - INCB052793 25 mg31
Phase 1a TGA - INCB052793 35 mg60
Phase 1a TGA - INCB052793 50 mg42
Phase 1a TGA - INCB052793 75 mg33
Phase 1a TGB - INCB052793 25 mg31
Phase 1a TGB - INCB052793 35 mg42
Phase 1a TGB - INCB052793 50 mg42
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg75
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^254
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^21614

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Phase 2: Number of Participants With at Least One TEAE and SAE

An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug. (NCT02265510)
Timeframe: From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years)

,
InterventionParticipants (Count of Participants)
TEAESAE
Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^297
Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2108

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Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib

AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). (NCT02265510)
Timeframe: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

InterventionnM*hr (Mean)
Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^29870

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Single Dose Adavosertib Cmax

Maximum plasma concentration of adavosertib after a single oral dose (Cycle 1 Day 1) in combination with IV infusion of commonly used chemotherapy agents, including gemcitabine, paclitaxel, and carboplatin. (NCT02272790)
Timeframe: Pre-dose, 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, and 8 hr

InterventionnM (Geometric Mean)
Arm A 800 mg/m² Gemcitabine477.4
Arm A 1000 mg/m² Gemcitabine571.1
Arm B533.8
Arm C556.6

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Progression Free Survival (Median, 80% CI)

"Progression-free survival (PFS) was defined as the elapsed time from date of first dose of AZD1775 until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment.~Progression-free survival was derived based on scan/assessment dates, not visit dates." (NCT02272790)
Timeframe: Throughout the Study, Approximately 4 years

InterventionMonths (Median)
Arm A1.7
Arm B5.5
Arm C4.2
Arm C212.0
Arm D-175 mg2.7
Arm D-225 mgNA

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Overall Survival (Median, 95% CI)

Overall survival (OS) was defined as the elapsed time from the date of first dose of AZD1775 until death due to any cause. Any patient not known to have died at the time of the analysis was censored based on the last recorded date on which the patient was known to be alive. (NCT02272790)
Timeframe: Throughout the Study, Approximately 4 years

InterventionMonths (Median)
Arm A16.0
Arm BNA
Arm C8.9
Arm C219.2
Arm D-175 mg6.2
Arm D-225 mgNA

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Overall Survival (Median, 80% CI)

Overall survival (OS) was defined as the elapsed time from the date of first dose of AZD1775 until death due to any cause. Any patient not known to have died at the time of the analysis was censored based on the last recorded date on which the patient was known to be alive. (NCT02272790)
Timeframe: Throughout the Study, Approximately 4 years

InterventionMonths (Median)
Arm A16.0
Arm BNA
Arm C8.9
Arm C219.2
Arm D-175 mg3.8
Arm D-225 mgNA

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Objective Response Rate (ORR)

Objective response rate is defined as the proportion of patients achieving a complete or partial tumour response according to RECIST v1.1 criteria. (NCT02272790)
Timeframe: Throughout the duration of the study (up to 19 months)

InterventionParticipants (Number)
Arm A1
Arm B11
Arm C7
Arm C28
Arm D-175 mg2
Arm D-225 mg1

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Multiple Dose Adavosertib Tmax

The time to reach maximum plasma concentration of adavosertib after multiple oral doses (Cycle 1 Day 3) in combination with IV infusion of 40 mg/m² pegylated liposomal doxorubicin. (NCT02272790)
Timeframe: Pre-dose, 1 hr, 2 hr, 4 hr, 6 hr, and 8 hr

Interventionhours (Median)
Arm D 175 mg3.92
Arm D 225 mg2.88

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Multiple Dose Adavosertib Cmax

Maximum plasma concentration of adavosertib after a multiple oral doses (Cycle 1 Day 3) in combination with IV infusion of 40 mg/m² pegylated liposomal doxorubicin. (NCT02272790)
Timeframe: Pre-dose, 1 hr, 2 hr, 4 hr, 6 hr, and 8 hr

InterventionnM (Geometric Mean)
Arm D 175 mg4135
Arm D 225 mg23530

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Gynecologic Cancer Intergroup (GCIG) CA-125 Response

The GCIG CA-125 response is defined as the proportion of patients achieving a 50% reduction in CA-125 levels from baseline, if baseline level is ≥2 x the upper limit of normal (ULN) within 2 weeks prior to starting treatment. Response must be confirmed and maintained for at least 28 days. (NCT02272790)
Timeframe: Throughout the study, approximately 4 years

InterventionPercent (Number)
Arm A25.0
Arm B53.6
Arm C26.7
Arm C263.6
Arm D-175 mg25.0
Arm D-225 mg25.0

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Duration of Response (DoR)

Duration of Response (DoR) is defined as the time from first documented tumour response until the date of documented progression or death from any cause. (NCT02272790)
Timeframe: Throughout the duration of the study, approximately 19 months.

InterventionMonths (Median)
Arm A4.4
Arm B12.0
Arm CNA
Arm C210.4
Arm D-175 mgNA
Arm D-225 mgNA

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Disease Control Rate (DCR)

The Disease Control Rate is defined as the proportion of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1 criteria. (NCT02272790)
Timeframe: Throughout the duration of the study (up to 19 months)

InterventionParticipants (Number)
Arm A3
Arm B27
Arm C19
Arm C212
Arm D-175 mg3
Arm D-225 mg5

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The Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) by Maximum CTCAE Grade.

"The number of patients experiencing at least one treatment-related adverse event (TEAE) by maximum CTCAE grade.~Severity Grade 1 = Mild; Severity Grade 2 = Moderate; Severity Grade 3 = Severe; Severity Grade 4 = Life Threatening; Severity Grade 5 = Fatal" (NCT02272790)
Timeframe: Throughout the duration of the study (up to 19 months)

,,,,,
InterventionParticipants (Number)
Number of patients with ≥1 TEAE of max Grade 1Number of patients with ≥1 TEAE of max Grade 2Number of patients with ≥1 TEAE of max Grade 3Number of patients with ≥1 TEAE of max Grade 4Number of patients with ≥1 TEAE of max Grade 5
Arm A01260
Arm B2119151
Arm C051080
Arm C200480
Arm D-175 mg03300
Arm D-225 mg04020

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Progression Free Survival (Median, 95% CI)

"Progression-free survival (PFS) was defined as the elapsed time from date of first dose of AZD1775 until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment.~Progression-free survival was derived based on scan/assessment dates, not visit dates." (NCT02272790)
Timeframe: Throughout the Study, Approximately 4 years

InterventionMonths (Median)
Arm A1.7
Arm B5.5
Arm C4.2
Arm C212.0
Arm D-175 mg2.7
Arm D-225 mgNA

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Serious Adverse Events

The number of patients experiencing at least one serious adverse event (SAE). (NCT02272790)
Timeframe: Throughout the duration of the study (up to 19 months)

,,,,,
InterventionParticipants (Number)
Pts. with ≥ one serious TEAE related to AZD1775.Pts. with ≥ one serious TEAE related to Chemo.
Arm A00
Arm B88
Arm C99
Arm C277
Arm D-175 mg11
Arm D-225 mg11

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Serious Adverse Events Leading to Death

The number of patients experiencing at least one serious adverse event (SAE) leading to death. (NCT02272790)
Timeframe: Throughout the duration of the study (up to 19 months)

,,,,,
InterventionParticipants (Number)
No. with STEAE related to AZD1775 leading to deathNo. with STEAE related to chemo leading to death
Arm A00
Arm B11
Arm C00
Arm C200
Arm D-175 mg00
Arm D-225 mg00

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Single Dose Adavosertib Tmax

The time to reach maximum plasma concentration of adavosertib after a single oral dose (Cycle 1 Day 1) in combination with IV infusion of commonly used chemotherapy agents, including gemcitabine, paclitaxel, and carboplatin. (NCT02272790)
Timeframe: Pre-dose, 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, and 8 hr

Interventionhours (Median)
Arm A 800 mg/m² Gemcitabine2.00
Arm A 1000 mg/m² Gemcitabine2.02
Arm B4.08
Arm C3.15

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Progression Free Survival (PFS)

Dose Expansion. PFS is defined as the time from randomization until objective tumor progression or death. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). (NCT02300610)
Timeframe: 14 months

Interventionmonths (Median)
Dose Escalation: Level 1 Dose3.81
Dose Escalation: Level 2 Dose14.63
Dose Expansion7.68

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Overall Response Rate (ORR): Complete Response (CR) + Partial Response (PR)

Dose Expansion. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (NCT02300610)
Timeframe: Up to 6 months

,,
InterventionParticipants (Count of Participants)
Partial ResponseProgressive DiseaseStable DiseaseComplete ResponseNot Evaluable
Dose Escalation: Level 1 Dose01101
Dose Escalation: Level 2 Dose30000
Dose Expansion10111

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Overall Survival (OS)

Dose Expansion. Overall survival is defined as the time from randomization until death from any cause, and is measured in the intent-to-treat population. (NCT02300610)
Timeframe: Up to 24 Months

Interventionmonths (Median)
Dose Escalation: Level 1 Dose4.14
Dose Escalation: Level 2 Dose14.63
Dose Expansion10.03

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Disease Control Rate (DCR): Percentage of Participants With Complete (CR) or Partial Response (PR), or Stable Disease (SD) for ≥ 16 Weeks According to RECIST Version 1.1

"DCR was defined as the percentage of participants with a CR or PR or SD from of date of first treatment to 16 weeks. Tumor assessments after start of non-protocol-defined anticancer therapy were excluded.~RECIST 1.1 Definition:~CR: disappearance of all target and non-target lesions; any pathological lymph nodes (target or non-target) must have reduction in short axis to < 10 mm and no new lesions diagnosed.~PR: a >= 30% decrease in the sum of diameters of target lesions from baseline; no evidence of progression in any of the non-target lesions diagnosed at baseline; and no new lesions diagnosed.~SD: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for PD.~The two-sided 90% binomial confidence intervals (CIs) were estimated by Wilson score method." (NCT02301143)
Timeframe: Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks

Interventionpercentage of participants (Number)
Nab-Paclitaxel Plus Gemcitabine77.6

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Kaplan-Meier Estimate of Progression-Free Survival (PFS)

"Progression-free Survival (PFS) was defined as the time from the date of the first dose to the date of disease progression or death (by any cause), whichever is earlier. The analysis day was calculated from enrollment date for one participant who was not treated. Participants who have no disease progression or have not died were censored to last tumor assessment date with progression-free.~The definition for progressive disease (PD) was at least a 20% increase in the sum of diameters of target lesions from nadir; the sum must also demonstrate an absolute increase of >= 5 mm; the progression of a non-target lesion or the appearance of any new lesions is also considered progression.~Median and its 90% confidence interval of PFS were estimated using the method of Brookmeyer and Crowley." (NCT02301143)
Timeframe: Day 1 of study treatment up to 28.75 months (maximum time for the last tumor assessment)

Interventionmonths (Median)
Nab-Paclitaxel Plus Gemcitabine10.9

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Kaplan-Meier Estimates for Overall Survival (OS)

Overall survival was defined as the time from the date of first dose of study therapy to the date of death (by any cause). Participants who were alive at the end of study or clinical data cut were censored on the last known time that the participant was alive or the clinical cutoff date, whichever was earlier. Median and its 90% confidence interval of OS were estimated using the method of Brookmeyer and Crowley (NCT02301143)
Timeframe: Day 1 of study treatment up to 31.34 months (maximum time for survival follow-up)

Interventionmonths (Median)
Nab-Paclitaxel Plus Gemcitabine18.8

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Kaplan-Meier Estimates for Time to Treatment Failure (TTF)

"TTF was defined as the time after the first dose of study therapy to discontinuation of study therapy due to disease progression, death by any cause, or the start of a new non-protocol-defined anticancer therapy/surgery. If a participant does not progress, die or start a new non-protocol-defined anticancer therapy, the participant was censored on the last tumor assessment date.~Tumor evaluations of CT or MRI scans were assessed by the investigative sites and response determined according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1.~The definition for progressive disease (PD) was >= 20% increase in the sum of diameters of target lesions from nadir, and the sum showed an absolute increase of >= 5 mm; the progression of a non-target lesion or the appearance of any new lesions is also considered progression.~Median and its 90% confidence interval (CI) of TTF were estimated using the method of Brookmeyer and Crowley." (NCT02301143)
Timeframe: Day 1 of study treatment up to 28.75 months; (maximum time for the last tumor assessment)

Interventionmonths (Median)
Nab-Paclitaxel Plus Gemcitabine9.0

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Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1

"ORR was defined as the percentage of participants that achieved a combined incidence of complete (CR) and partial response (PR) using RECIST 1.1 guidelines as assessed by the investigator. Assessments after new non-protocol-defined anticancer therapy are excluded. For participants who had resectable surgery in Investigator Choice period, assessments after surgical intervention are excluded.~RECIST 1.1 Definition:~CR: disappearance of all target and non-target lesions; any pathological lymph nodes (target or non-target) must have reduction in short axis to < 10 mm and no new lesions diagnosed.~PR: a >= 30% decrease in the sum of diameters of target lesions from baseline; no evidence of progression in any of the non-target lesions diagnosed at baseline; and no new lesions diagnosed.~The two-sided 90% binomial confidence intervals (CIs) were estimated by Wilson score method" (NCT02301143)
Timeframe: Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks

Interventionpercentage of participants (Number)
Nab-Paclitaxel Plus Gemcitabine39.3

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Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Global Health Status and 5 Functioning Scales

The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) is a validated health-related quality of life (HRQoL) measure. The EORTC QLQ-C30 is composed of both multi-item scales and single-item measures, including 5 functional scales, 3 symptom scales, 6 single symptom items, and 1 global health status / quality of life scale. No item occurs in more than one scale. All reported measures are transformed to a 0 - 100 scale. In the Global Health Status and 5 functional scales, 0 = worst possible quality of life/health status and 100 = best possible quality of life/health status. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: >=10 increase from baseline - Stable: neither increase nor decrease >10 - Worsened: >=10 decrease from baseline (NCT02301143)
Timeframe: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit

InterventionParticipants (Count of Participants)
Global Health Status: ImprovedGlobal Health Status: StableGlobal Health Status: WorsenedPhysical Functioning Scale: ImprovedPhysical Functioning Scale: StablePhysical Functioning Scale: WorsenedRole Functioning Scale: ImprovedRole Functioning Scale: StableRole Functioning Scale: WorsenedEmotional Functioning Scale: ImprovedEmotional Functioning Scale: StableEmotional Functioning Scale: WorsenedCognitive Functioning Scale: ImprovedCognitive Functioning Scale: StableCognitive Functioning Scale: WorsenedSocial Functioning Scale: ImprovedSocial Functioning Scale: StableSocial Functioning Scale: Worsened
Nab-Paclitaxel Plus Gemcitabine4334182066936461350405335111384314

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Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Symptom Scales and Single Symptom Items

The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) is a validated health-related quality of life (HRQoL) measure. The EORTC QLQ-C30 is composed of both multi-item scales and single-item measures, including 5 functional scales, 3 symptom scales, 6 single symptom items, and 1 global health status / quality of life scale. No item occurs in more than one scale. All reported measures are transformed to a 0 to 100 scale. In the symptom scales and single symptom items, 0 = optimal health state and 100 = worst possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: >=10 decrease from baseline - Stable: neither increase nor decrease >10 - Worsened: >=10 increase from baseline (NCT02301143)
Timeframe: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit

InterventionParticipants (Count of Participants)
Symptom Scale-Fatigue: ImprovedSymptom Scale-Fatigue: StableSymptom Scale-Fatigue: WorsenedScale-Nausea+Vomiting: ImprovedScale-Nausea+Vomiting: StableScale-Nausea+Vomiting: WorsenedSymptom Scale-Pain: ImprovedSymptom Scale-Pain: StableSymptom Scale-Pain: WorsenedSymptom - Dyspnoea: ImprovedSymptom - Dyspnoea: StableSymptom - Dyspnoea: WorsenedSymptom - Insomnia: ImprovedSymptom - Insomnia: StableSymptom - Insomnia: WorsenedSymptom - Appetite loss: ImprovedSymptom - Appetite loss: StableSymptom - Appetite loss: WorsenedSymptom - Constipation: ImprovedSymptom - Constipation: StableSymptom - Constipation: WorsenedSymptom - Diarrhoea: ImprovedSymptom - Diarrhoea: StableSymptom - Diarrhoea: WorsenedSymptom - Financial difficulties: ImprovedSymptom - Financial difficulties: stable:Symptom - Financial difficulties: Worsened
Nab-Paclitaxel Plus Gemcitabine4624252964262294127495335748398464541869817744

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Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): 10 Individual Item Scores

The EORTC pancreatic cancer module is a validated tool intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module includes 26 questions, organized into 7 scales and 10 individual item scores. The 10 individual item scores are reported. All reported measures are transformed to a 0 to 100 scale. Scores of 0 = best possible health state and 100 = worst possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: >=MID decrease from baseline - Stable: no increase or decrease >MID - Worsened: >=MID increase from baseline MID = half the baseline standard deviation (NCT02301143)
Timeframe: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit

InterventionParticipants (Count of Participants)
Abdominal Bloating: ImprovedAbdominal Bloating: StableAbdominal Bloating: WorsenedTaste Changes: ImprovedTaste Changes: StableTaste Changes: WorsenedIndigestion: ImprovedIndigestion: StableIndigestion: WorsenedFlatulence: ImprovedFlatulence: StableFlatulence: WorsenedWeight Loss: ImprovedWeight Loss: StableWeight Loss: WorsenedLimb Weakness: ImprovedLimb Weakness: StableLimb Weakness: WorsenedDry Mouth: ImprovedDry Mouth: StableDry Mouth: WorsenedTreatment Side-Effects: ImprovedTreatment Side-Effects: StableTreatment Side-Effects: WorsenedWorry About Future Health: ImprovedWorry About Future Health: StableWorry About Future Health: WorsenedLimits on Activity Planning: ImprovedLimits on Activity Planning: StableLimits on Activity Planning: Worsened
Nab-Paclitaxel Plus Gemcitabine5042320542141477473711365632255183745138483942458424211

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Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Satisfaction With Health Care Scale

The EORTC pancreatic cancer module is a validated tool intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module includes 26 questions, organized into 7 scales and 10 individual item scores. The summary scale for Satisfaction with Health Care is reported. All reported measures are transformed to a 0 to 100 scale. Scores of 0 = not satisfied, worst possible health state and 100 = extremely satisfied, best possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: >=MID increase from baseline - Stable: no increase or decrease >MID - Worsened: >=MID decrease from baseline MID = half the baseline standard deviation (NCT02301143)
Timeframe: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit

InterventionParticipants (Count of Participants)
Satisfaction with Health Care Scale: ImprovedSatisfaction with Health Care Scale: StableSatisfaction with Health Care Scale: Worsened
Nab-Paclitaxel Plus Gemcitabine424013

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Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Six Summary Scales

The EORTC pancreatic cancer module is a validated tool intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module includes 26 questions, organized into 7 scales and 10 individual item scores. All reported measures are transformed to a 0 to 100 scale. Six summary scales reported are: - Pancreatic Pain - Digestive Symptoms - Altered Bowel Habits - Hepatic Scale - Body Image - Sexuality Scores of 0 = optimal health state and 100 = worst possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline. Responder categories: - Improved: >=MID decrease from baseline - Stable: no increase or decrease >MID - Worsened: >=MID increase from baseline MID = half the baseline standard deviation (NCT02301143)
Timeframe: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit

InterventionParticipants (Count of Participants)
Pancreatic Pain Scale: ImprovedPancreatic Pain Scale: StablePancreatic Pain Scale: WorsenedDigestive Symptom Scale: ImprovedDigestive Symptom Scale: StableDigestive Symptom Scale: WorsenedAltered Bowel Habits Scale: ImprovedAltered Bowel Habits Scale: StableAltered Bowel Habits Scale: WorsenedHepatic Scale: ImprovedHepatic Scale: StableHepatic Scale: WorsenedBody Image Scale: ImprovedBody Image Scale: StableBody Image Scale: WorsenedSexuality Scale: ImprovedSexuality Scale: StableSexuality Scale: Worsened
Nab-Paclitaxel Plus Gemcitabine6233049361028531425664225023315113

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Participants With Treatment Emergent Adverse Events (TEAEs)

"TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to one or both of the study drugs and reported as 'Suspected' on the case report form. AEs with a missing relationship were treated as 'treatment-related' in data summaries. IP (investigational product) refers to nab-Paclitaxel and/or Gemcitabine. Related TEAE refers to relation to study drug (IP)." (NCT02301143)
Timeframe: Day 1 of study drug up to end of the study; up to 31.3 months

,
InterventionParticipants (Count of Participants)
>= 1 TEAE>=1 related TEAE>=1 TEAE of severity grade 3 or higher>=1 related TEAE of severity grade 3 or higher>=1 serious TEAE>= 1 related serious TEAE>=1 TEAE leading to discontinuation of IP>=1 related TEAE leading to discontinuation of IP>=1 TEAE leading to dose reduction of IP>=1 related TEAE leading to dose reduction of IP>=1 TEAE leading to interruption of IP>=1 related TEAE leading to interruption of IP>= TEAE leading to death>=1 related TEAE leading to death
Nab-Paclitaxel Plus Gemcitabine (Induction Period)1051028572381425156968664820
Nab-Paclitaxel Plus Gemcitabine (Overall)1051039075391428187271685020

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Progression Free Survival (PFS)

Progression free survival is defined as the time from treatment initiation to the earlier date of assessment of objective progression or death by any cause in the absence of progression. Progression Free Survival (PFS) is defined as the time from treatment initiation to the earlier date of assessment of objective progression or death by any cause in the absence of progression. Progression will be assessed by RECIST v. 1.1. (NCT02303262)
Timeframe: 27 months

Interventionmonths (Median)
Mocetinostat and Gemcitabine2.0

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Duration of Response

The duration of objective response will be measured from the time measurement criteria are first met until disease progression is objectively documented. (NCT02303262)
Timeframe: 27 months

Interventionmonths (Median)
Mocetinostat and Gemcitabine2

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Response Rate (Per RECIST 1.1)

Response rate (CR or PR) will be calculated by the number of patients achieving a response divided by the number of patients having been evaluated for response. Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameters of all target lesions. (NCT02303262)
Timeframe: 27 months

InterventionParticipants (Count of Participants)
Mocetinostat and Gemcitabine1

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Progression-free Survival

Measures the length of time from the first day of therapy until Progressive Disease, death from any cause, or last patient contact. Disease Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02303977)
Timeframe: Averaging about 16 weeks

InterventionMonths (Median)
Gemcitabine + Paciltaxel2.6

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Disease Control Rate

The percentage of patients with a Partial Response, a Complete Response, or Stable Disease during the study. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameter of target lesions; Overall Response (OR) = CR + PR. (NCT02303977)
Timeframe: The duration of study treatment, averaging about 16 weeks.

InterventionPercentage of participants (Number)
Gemcitabine + Paciltaxel59.5

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Overall Response Rate

The percentage of patients with a Partial Response or Complete Response recorded from the start of the treatment until disease progression/recurrence by RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameter of target lesions; Overall Response (OR) = CR + PR. (NCT02303977)
Timeframe: Averaging about 16 weeks.

Interventionpercentage of participants (Number)
Gemcitabine + Paciltaxel13.5

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Overall Survival

Length of time from the first day of therapy to death from any cause or last patient contact (NCT02303977)
Timeframe: Averaging about 47 weeks

InterventionMonths (Median)
Gemcitabine + Paciltaxel6.2

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Feasibility as Measured by Number of Participants Who Complete the Neoadjuvant Gemcitabine/Nab-paclitaxel and HIGRT Regimen

The neoadjuvant regimen will be considered feasible if (a) the trial can accrue 25 patients in no more than 3 years and (b) if at least 17 of the 25 patients adhere to the neoadjuvant regimen and c) the acute grade 3+ non-hematologic acute toxicity is less than 50% (exclusing fatigue and alopecia). (NCT02318095)
Timeframe: approximately 6 months

InterventionParticipants (Count of Participants)
Chemotherapy/Radiation/Surgery39

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Number of Participants Who Underwent Surgical Resection

Patients who undergo surgical resection will be documented (NCT02318095)
Timeframe: 14-30 days post surgery

InterventionParticipants (Count of Participants)
Chemotherapy/Radiation/Surgery24

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Number of Participants Who Received an R0 Resection

Pathologic review will determine if an R0 resection has been performed. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. (NCT02318095)
Timeframe: 14-30 days post surgery

InterventionParticipants (Count of Participants)
Chemotherapy/Radiation/Surgery18

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Number of Participants Experiencing Grade >/=2 Acute Toxicity

CTCAE version 4 will be used for all toxicity assessments. The acute toxicity rate, defined as any non-hematologic grade 2+ toxicity occurring during HIGRT treatment through 60 days post-treatment, will be estimated with its exact 80% confidence interval. Likewise, we will determine the rate of grade 2+ hematologic toxicity occurring during treatment through 60 days post treatment and the proportion of patients requiring treatment breaks longer than 5 days. (NCT02318095)
Timeframe: 60 days post surgery

InterventionParticipants (Count of Participants)
Chemotherapy/Radiation/Surgery10

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Plasma PK for Patients Treated With Rociletinib Based on Sparse Sampling

Blood samples were drawn for PK analysis at 21 ± 3 day intervals for the first 6 months (Day 1 of Cycles 2 to 7 inclusive). The sample could be taken predose or postdose. Plasma concentrations are presented for Rociletinib and 3 metabolites (M460, M502, M544). (NCT02322281)
Timeframe: Cycles 2 Day 1 to Cycle 7 Day 1, or approximately 6 months

,
InterventionPlasma concentration (ng/mL) (Median)
RociletinibM460M502M544
Rociletinib 500 mg BID80.420.0573.0765.0
Rociletinib 625 mg BID207.0555.03260.0525.0

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Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)

PFS was calculated as 1+ the number of days from the date of randomization to documented radiographic progression as determined by the investigator, or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression. (NCT02322281)
Timeframe: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months. This Time Frame includes the cross-over period, however, participants who crossed over to rociletinib were not analyzed for PFS.

InterventionDays (Median)
Rociletinib 500 mg BID125.0
Rociletinib 625 mg BID166.0
Chemotherapy77.0

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Percentage of Participants With Confirmed Response

Percentage of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Overall Response (OR),is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment was dependent on the achievement of both measurement and confirmation criteria. (NCT02322281)
Timeframe: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months. This Time Frame includes the cross-over period, however, participants who crossed over to rociletinib were not analyzed for best overall confirmed response.

Interventionpercentage of participants (Number)
Rociletinib 500 mg BID17.0
Rociletinib 625 mg BID18.2
Chemotherapy8.2

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Overall Survival (OS)

OS was calculated as 1+ the number of days from randomization to death due to any cause. Patients without a documented date of death were censored on the date the patient was last known to be alive. (NCT02322281)
Timeframe: Cycle 1 Day 1 to date of death, assessed up to 3 years

InterventionDays (Median)
Rociletinib 500 mg BID665
Rociletinib 625 mg BID541
Chemotherapy348

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Duration of Response (DOR) According to RECIST Version 1.1 as Determined by Investigator Assessment

DOR in patients with confirmed response per investigator. The DOR for complete response (CR) and partial response (PR) was measured from date that any of these best responses is first recorded until first date that progressive disease (PD) is objectively documented. For patients who continue treatment post-progression, the first date of progression was used for the analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. PR is at least a 30% decrease in sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Overall Response is the best response from start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). (NCT02322281)
Timeframe: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months

InterventionDays (Median)
Rociletinib 500 mg BID335.0
Rociletinib 625 mg BID275.0
Chemotherapy206.0

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Maximum Tolerated Dose (MTD) of Capecitabine

Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use. (NCT02324543)
Timeframe: 28 days

Interventionmg (Number)
Phase 1500

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Maximum Tolerated Dose (MTD) of Cisplatin

Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. (NCT02324543)
Timeframe: 28 days

Interventionmg/m^2 (Number)
Phase 120

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Overall Survival (OS)

OS will be measured (in months) from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (NCT02324543)
Timeframe: 5 years

InterventionMonths (Median)
Phase 211.02

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Maximum Tolerated Dose (MTD) of Gemcitabine

Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. (NCT02324543)
Timeframe: 28 days

Interventionmg/m^2 (Number)
Phase 1500

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Maximum Tolerated Dose (MTD) of Docetaxel

Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. (NCT02324543)
Timeframe: 28 days

Interventionmg/m^2 (Number)
Phase 120

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Maximum Tolerated Dose (MTD) of Irinotecan

Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. (NCT02324543)
Timeframe: 28 days

Interventionmg/m^2 (Number)
Phase 120

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Response Rate (RR) Using RECIST 1.1 Criteria

RR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. (NCT02324543)
Timeframe: 43 months

Interventionpercentage of participants (Number)
Phase 257

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Progression-free Survival (PFS) Using RECIST 1.1 Criteria

PFS is defined as the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve. (NCT02324543)
Timeframe: 5 years

InterventionMonths (Median)
Phase 28.34

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Overall Survival (OS) Rate at 9 Months

OS will be measured as the percentage of subjects alive at 9 months. (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (Phase 2 data only) (NCT02324543)
Timeframe: 9 months

Interventionpercentage of participants (Number)
Phase 257

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Disease Control Rate (DCR) Using RECIST 1.1 Criteria

DCR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. (NCT02324543)
Timeframe: 43 months

Interventionpercentage of participants (Number)
Phase 287

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OS, Contribution of the Components Analysis of Sub-study B

The OS was defined as the time from the date of randomization until death due to any cause. (NCT02352948)
Timeframe: From randomization (Day 1) until death due to any cause, approximately 36 months

Interventionmonths (Median)
Sub-study B: Durvalumab+Tremelimumab11.5
Sub-study B: Durvalumab10.0
Sub-study B: Tremelimumab6.9

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Objective Response Rate (ORR)

The ORR was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) among ITT participants who had measurable disease at baseline. CR was defined as disappearance of all target lesions (any pathological lymph nodes selected as target lesions must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum of diameters as long as criteria for PD are not met). The ORR was measured using Investigator assessments according to RECIST v1.1. (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Interventionpercentage of participants (Number)
Sub-study A: Durvalumab35.5
Sub-study A: SoC12.5
Sub-study B: Durvalumab+Tremelimumab14.9
Sub-study B: SoC6.8
Sub-study B: Durvalumab15.4
Sub-study B: Tremelimumab6.7

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Duration of Response (DoR)

The DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The DoR was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Interventionmonths (Median)
Sub-study A: Durvalumab9.5
Sub-study A: SoC4.8
Sub-study B: Durvalumab+Tremelimumab12.2
Sub-study B: SoC10.8
Sub-study B: Durvalumab10.0
Sub-study B: Tremelimumab4.7

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Overall Survival (OS)

The OS was defined as the time from the date of randomization until death due to any cause. (NCT02352948)
Timeframe: From randomization (Day 1) until death due to any cause, approximately 36 months

Interventionmonths (Median)
Sub-study A: Durvalumab11.7
Sub-study A: SoC6.8
Sub-study B: Durvalumab+Tremelimumab11.5
Sub-study B: SoC8.7

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Percentage of Participants Alive and Progression Free at 12 Months (APF12)

The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 12 months.

Interventionpercentage of participants (Number)
Sub-study A: Durvalumab19.4
Sub-study A: SoC9.9
Sub-study B: Durvalumab+Tremelimumab20.6
Sub-study B: SoC8.0
Sub-study B: Durvalumab15.0
Sub-study B: Tremelimumab7.3

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Percentage of Participants Alive and Progression Free at 6 Months (APF6)

The APF6 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 6 months after randomization per Kaplan-Meier estimate of PFS at 6 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 6 months

Interventionpercentage of participants (Number)
Sub-study A: Durvalumab35.5
Sub-study A: SoC24.1
Sub-study B: Durvalumab+Tremelimumab31.5
Sub-study B: SoC27.6
Sub-study B: Durvalumab27.2
Sub-study B: Tremelimumab14.5

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Percentage of Participants Alive at 12 Months (OS12)

The OS12 was defined as the percentage of participants who were alive at 12 months after randomisation per Kaplan-Meier estimate of OS at 12 months. (NCT02352948)
Timeframe: From randomization (Day 1) up to 12 months

Interventionpercentage of participants (Number)
Sub-study A: Durvalumab49.3
Sub-study A: SoC31.3
Sub-study B: Durvalumab+Tremelimumab49.5
Sub-study B: SoC38.8
Sub-study B: Durvalumab43.6
Sub-study B: Tremelimumab41.2

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PFS, Contribution of the Components Analysis of Sub-study B

The PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Interventionmonths (Median)
Sub-study B: Durvalumab+Tremelimumab3.5
Sub-study B: Durvalumab3.1
Sub-study B: Tremelimumab2.1

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Progression-Free Survival (PFS)

The PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to response evaluation criteria in solid tumours (RECIST) version 1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Interventionmonths (Median)
Sub-study A: Durvalumab3.8
Sub-study A: SoC2.2
Sub-study B: Durvalumab+Tremelimumab3.5
Sub-study B: SoC3.5

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Time From Randomisation to Second Progression (PFS2) of Sub-study B

The PFS2 was defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the PFS endpoint or death and determined by local standard clinical practice and have included any of the following: objective radiological, symptomatic progression, or death. PFS2 was reported for sub-study B only. (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until first progression. Disease then assessed per local practice until 2nd progression. Assessed up to a maximum of approximately 3 years.

Interventionmonths (Median)
Sub-study B: Durvalumab+Tremelimumab9.1
Sub-study B: SoC6.7
Sub-study B: Durvalumab8.0
Sub-study B: Tremelimumab5.7

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Median Progression Free Survival (PFS)

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT02392637)
Timeframe: up to 3 years

Interventionmonths (Median)
High Dosage11.4
Low Dosage14.9

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Median Overall Survival (OS)

The Kaplan-Meier method was used to estimate OS, with surviving patients censored at the time of surgery or at last known follow-up. (NCT02392637)
Timeframe: up to 3 years

Interventionmonths (Median)
High Dose19.5
Low Dose15.7

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Number of Participants With Treatment Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1.14) for target lesions and assessed by MRI: Complete Response (CR),Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT02392637)
Timeframe: Up to 2 years

,
InterventionParticipants (Count of Participants)
Disease Control Rate(DCR)Complete Response(CR)Partial Response (PR)Stable Disease(SD)Progressive Disease(PD)Unknown
High Dose250141134
Low Dose1809955

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Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1

AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose. (NCT02393248)
Timeframe: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1

Interventionhr*ng/mL (Mean)
Part 3: Pem/Intermittent Pemigatinib 9 mg1550
Part 3: Pem/Intermittent Pemigatinib 13.5 mg1910
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg2920
Part 3: Doc/Intermittent Pemigatinib 13.5 mg1890
Part 3: Tras/Intermittent Pemigatinib 13.5 mg1890

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Part 3: Accumulation Ratio of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)

The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose. (NCT02393248)
Timeframe: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

Interventionratio (Mean)
Part 3: Pem/Intermittent Pemigatinib 9 mg1.65
Part 3: Pem/Intermittent Pemigatinib 13.5 mg1.53
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg0.604
Part 3: Doc/Intermittent Pemigatinib 13.5 mg1.52
Part 3: Tras/Intermittent Pemigatinib 13.5 mg1.90

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Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)

Cmax was defined as the maximum observed plasma concentration. (NCT02393248)
Timeframe: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

Interventionng/mL (Mean)
Part 1: Intermittent Pemigatinib 1 mg QD26.2
Part 1: Intermittent Pemigatinib 2 mg QD22.9
Part 1: Intermittent Pemigatinib 4 mg QD103
Part 1: Intermittent Pemigatinib 6 mg QD86.1
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD196
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD271
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD449

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Part 3: t1/2 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)

t1/2 was defined as the apparent plasma terminal phase disposition half-life. (NCT02393248)
Timeframe: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

Interventionhr (Mean)
Part 3: Pem/Intermittent Pemigatinib 9 mg15.3
Part 3: Pem/Intermittent Pemigatinib 13.5 mg17.0
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg10.6
Part 3: Doc/Intermittent Pemigatinib 13.5 mg14.7
Part 3: Tras/Intermittent Pemigatinib 13.5 mg15.3

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Part 3: ORR

ORR was defined as the percentage of participants with a best overall response of CR or PR, per RECIST version 1.1, as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. (NCT02393248)
Timeframe: up to 203 days

Interventionpercentage of participants (Number)
Part 3: Gem/Cis/Intermittent Pemigatinib 9 mg0.0
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg42.9
Part 3: Tras/Intermittent Pemigatinib 13.5 mg0.0
Part 3: Doc/Intermittent Pemigatinib 13.5 mg14.3
Part 3: Pem/Intermittent Pemigatinib 9 mg0.0
Part 3: Pem/Intermittent Pemigatinib 13.5 mg28.6
Part 3: Pem/Continuous Pemigatinib 13.5 mg33.3
Part 3: Ref/Continuous Pemigatinib 9 mg0.0
Part 3: Ref/Continuous Pemigatinib 13.5 mg22.2
Part 3: Ref/Continuous Pemigatinib 20 mg0.0

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Parts 1 and 2: Tmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States

tmax was defined as the time to the maximum observed plasma concentration. (NCT02393248)
Timeframe: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

Interventionhr (Median)
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fasted1.58
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fed4.02

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Part 3: Number of Participants With Any TEAE

Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug. (NCT02393248)
Timeframe: up to 869 days

InterventionParticipants (Count of Participants)
Part 3: Gem/Cis/Intermittent Pemigatinib 9 mg1
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg7
Part 3: Tras/Intermittent Pemigatinib 13.5 mg6
Part 3: Doc/Intermittent Pemigatinib 13.5 mg7
Part 3: Pem/Intermittent Pemigatinib 9 mg3
Part 3: Pem/Intermittent Pemigatinib 13.5 mg14
Part 3: Pem/Continuous Pemigatinib 13.5 mg9
Part 3: Ref/Continuous Pemigatinib 9 mg7
Part 3: Ref/Continuous Pemigatinib 13.5 mg9
Part 3: Ref/Continuous Pemigatinib 20 mg2

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Part 2: Overall Response Rate (ORR)

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. (NCT02393248)
Timeframe: up to 126 days

Interventionpercentage of participants (Number)
Part 2: Intermittent Pemigatinib 9 mg QD25.0
Part 2: Intermittent Pemigatinib 13.5 mg QD4.5
Part 2: Continuous Pemigatinib 9 mg QD0.0
Part 2: Continuous Pemigatinib 13.5 mg QD30.0
Part 2: Continuous Pemigatinib 20 mg QD0.0

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EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2

EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate. (NCT02393248)
Timeframe: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

Interventionhours*nanomoles (Geometric Mean)
Parts 1 and 2: Intermittent or Continuous Pemigatinib1573

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Emax Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2

Emax was defined as the maximum degree of increasing of serum phosphate by pemigatinib. (NCT02393248)
Timeframe: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

Interventionmg/dL (Geometric Mean)
Parts 1 and 2: Intermittent or Continuous Pemigatinib5.76

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Parts 1 and 2: Cmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States

Cmax was defined as the maximum observed plasma concentration. (NCT02393248)
Timeframe: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

Interventionng/mL (Mean)
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fasted215
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fed179

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Parts 1 and 2: Cmin After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)

Cmin was defined as the minimum observed plasma concentration over the dose interval. (NCT02393248)
Timeframe: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

Interventionng/mL (Mean)
Part 1: Intermittent Pemigatinib 1 mg QD3.24
Part 1: Intermittent Pemigatinib 2 mg QD7.87
Part 1: Intermittent Pemigatinib 4 mg QD23.9
Part 1: Intermittent Pemigatinib 6 mg QD30.0
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD49.9
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD71.7
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD104

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Parts 1 and 2: Cmin Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States

Cmin was defined as the minimum observed plasma concentration over the dose interval. (NCT02393248)
Timeframe: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

Interventionng/mL (Mean)
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fasted61.1
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fed65.7

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Parts 1 and 2: t1/2 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)

t1/2 was defined as the apparent plasma terminal phase disposition half-life. (NCT02393248)
Timeframe: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

Interventionhr (Mean)
Part 1: Intermittent Pemigatinib 1 mg QD10.9
Part 1: Intermittent Pemigatinib 2 mg QD18.1
Part 1: Intermittent Pemigatinib 4 mg QD30.4
Part 1: Intermittent Pemigatinib 6 mg QD21.0
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD17.2
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD17.4
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD13.1

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Parts 1 and 2: t1/2 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States

t1/2 was defined as the apparent plasma terminal phase disposition half-life. (NCT02393248)
Timeframe: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

Interventionhr (Mean)
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fasted19.2
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fed23.8

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Part 3: Cmin of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)

Cmin was defined as the minimum observed plasma concentration over the dose interval. (NCT02393248)
Timeframe: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

Interventionng/mL (Mean)
Part 3: Pem/Intermittent Pemigatinib 9 mg58.0
Part 3: Pem/Intermittent Pemigatinib 13.5 mg56.6
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg48.5
Part 3: Doc/Intermittent Pemigatinib 13.5 mg63.1
Part 3: Tras/Intermittent Pemigatinib 13.5 mg64.2

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Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1

tmax was defined as the time to the maximum observed plasma concentration. (NCT02393248)
Timeframe: Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1

Interventionhours (hr) (Median)
Part 1: Intermittent Pemigatinib 1 mg QD1
Part 1: Intermittent Pemigatinib 2 mg QD5.92
Part 1: Intermittent Pemigatinib 4 mg QD2.02
Part 1: Intermittent Pemigatinib 6 mg QD1.14
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD1.17
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD1.20
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD1.98

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Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)

tmax was defined as the time to the maximum observed plasma concentration. (NCT02393248)
Timeframe: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

Interventionhr (Median)
Part 1: Intermittent Pemigatinib 1 mg QD1.07
Part 1: Intermittent Pemigatinib 2 mg QD3.98
Part 1: Intermittent Pemigatinib 4 mg QD2.02
Part 1: Intermittent Pemigatinib 6 mg QD1.58
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD1.00
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD1.13
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD1.12

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Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)

Cmax was defined as the maximum observed plasma concentration. (NCT02393248)
Timeframe: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

Interventionng/mL (Mean)
Part 3: Pem/Intermittent Pemigatinib 9 mg166
Part 3: Pem/Intermittent Pemigatinib 13.5 mg255
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg214
Part 3: Doc/Intermittent Pemigatinib 13.5 mg231
Part 3: Tras/Intermittent Pemigatinib 13.5 mg404

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Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1

Cmax was defined as the maximum observed plasma concentration. (NCT02393248)
Timeframe: Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1

Interventionnanograms per milliliter (ng/mL) (Mean)
Part 1: Intermittent Pemigatinib 1 mg QD25.3
Part 1: Intermittent Pemigatinib 2 mg QD13.6
Part 1: Intermittent Pemigatinib 4 mg QD109
Part 1: Intermittent Pemigatinib 6 mg QD64.6
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD139
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD196
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD300

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Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1

Cmax was defined as the maximum observed plasma concentration. (NCT02393248)
Timeframe: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1

Interventionng/mL (Mean)
Part 3: Pem/Intermittent Pemigatinib 9 mg137
Part 3: Pem/Intermittent Pemigatinib 13.5 mg199
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg234
Part 3: Doc/Intermittent Pemigatinib 13.5 mg214
Part 3: Tras/Intermittent Pemigatinib 13.5 mg259

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Parts 1 and 2: CL/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)

CL/F was defined as the apparent oral dose clearance. (NCT02393248)
Timeframe: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

InterventionLiters per hr (L/hr) (Mean)
Part 1: Intermittent Pemigatinib 1 mg QD9.86
Part 1: Intermittent Pemigatinib 2 mg QD12.8
Part 1: Intermittent Pemigatinib 4 mg QD5.93
Part 1: Intermittent Pemigatinib 6 mg QD12.0
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD15.7
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD11.9
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD10.3

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Parts 1 and 2: AUClast After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1

AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration. (NCT02393248)
Timeframe: Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1

Interventionhr*ng/mL (Mean)
Part 1: Intermittent Pemigatinib 1 mg QD190
Part 1: Intermittent Pemigatinib 2 mg QD68.8
Part 1: Intermittent Pemigatinib 4 mg QD1010
Part 1: Intermittent Pemigatinib 6 mg QD641
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD1140
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD1820
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD2510

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Parts 1 and 2: AUC0-24 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States

AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose. (NCT02393248)
Timeframe: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

Interventionhr*ng/mL (Mean)
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fasted2580
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fed2910

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Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)

AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose. (NCT02393248)
Timeframe: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

Interventionhr*ng/mL (Mean)
Part 1: Intermittent Pemigatinib 1 mg QD208
Part 1: Intermittent Pemigatinib 2 mg QD322
Part 1: Intermittent Pemigatinib 4 mg QD1380
Part 1: Intermittent Pemigatinib 6 mg QD1080
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD2180
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD3010
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD4350

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Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1

AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose. (NCT02393248)
Timeframe: Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1

Interventionhr*ng/mL (Mean)
Part 1: Intermittent Pemigatinib 1 mg QD191
Part 1: Intermittent Pemigatinib 2 mg QDNA
Part 1: Intermittent Pemigatinib 4 mg QD1010
Part 1: Intermittent Pemigatinib 6 mg QD644
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD1150
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD1840
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD2850

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Parts 1 and 2: Accumulation Ratio After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)

The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose. (NCT02393248)
Timeframe: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

Interventionratio (Mean)
Part 1: Intermittent Pemigatinib 1 mg QD1.09
Part 1: Intermittent Pemigatinib 2 mg QD1.64
Part 1: Intermittent Pemigatinib 4 mg QD1.36
Part 1: Intermittent Pemigatinib 6 mg QD1.67
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD1.71
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD1.69
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD1.76

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Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug. (NCT02393248)
Timeframe: up to 763 days

InterventionParticipants (Count of Participants)
Part 1: Intermittent Pemigatinib 1/2/4 mg QD3
Part 1: Intermittent Pemigatinib 6 mg QD3
Parts 1 and 2: Intermittent Pemigatinib 9 mg QD7
Parts 1 and 2: Intermittent Pemigatinib 13.5 mg QD50
Part 1: Intermittent Pemigatinib 20 mg QD6
Parts 1 and 2: Continuous Pemigatinib 9 mg QD14
Parts 1 and 2: Continuous Pemigatinib 13.5 mg QD30
Parts 1 and 2: Continuous Pemigatinib 20 mg QD15
Part 1: Continuous Pemigatinib 7.5 mg BID4
Part 1: Continuous Pemigatinib 10 mg BID3

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Parts 1 and 2: Vz/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)

Vz/F was defined as the apparent volume of distribution. (NCT02393248)
Timeframe: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

InterventionLiters (Mean)
Part 1: Intermittent Pemigatinib 1 mg QD156
Part 1: Intermittent Pemigatinib 2 mg QD334
Part 1: Intermittent Pemigatinib 4 mg QD260
Part 1: Intermittent Pemigatinib 6 mg QD301
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD246
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD274
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD180

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Parts 1 and 2: CL/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States

CL/F was defined as the apparent oral dose clearance. (NCT02393248)
Timeframe: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

InterventionL/hr (Mean)
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fasted12.4
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fed11.3

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Parts 1 and 2: Vz/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States

Vz/F was defined as the apparent volume of distribution. (NCT02393248)
Timeframe: Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

InterventionLiters (Mean)
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fasted307
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fed364

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Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1

tmax was defined as the time to the maximum observed plasma concentration. (NCT02393248)
Timeframe: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1

Interventionhr (Median)
Part 3: Pem/Intermittent Pemigatinib 9 mg1.98
Part 3: Pem/Intermittent Pemigatinib 13.5 mg1.05
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg2.00
Part 3: Doc/Intermittent Pemigatinib 13.5 mg1.00
Part 3: Tras/Intermittent Pemigatinib 13.5 mg0.783

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Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2

Serum phosphate concentration was assessed throughout Parts 1 and 2. (NCT02393248)
Timeframe: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

Interventionmg/dL (Number)
Minimum value in range of highest values for all participantsMaximum value in range of highest values for all participants
Parts 1 and 2: Intermittent or Continuous Pemigatinib3.511.2

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E0 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2

E0 was defined as the Baseline serum concentration of phosphate. (NCT02393248)
Timeframe: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

Interventionmilligrams per deciliter (mg/dL) (Geometric Mean)
Parts 1 and 2: Intermittent or Continuous Pemigatinib3.66

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Part 3: CL/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)

CL/F was defined as the apparent oral dose clearance. (NCT02393248)
Timeframe: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

InterventionL/hr (Mean)
Part 3: Pem/Intermittent Pemigatinib 9 mg8.03
Part 3: Pem/Intermittent Pemigatinib 13.5 mg13.4
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg24.5
Part 3: Doc/Intermittent Pemigatinib 13.5 mg12.7
Part 3: Tras/Intermittent Pemigatinib 13.5 mg8.26

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Part 3: AUClast of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1

AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration. (NCT02393248)
Timeframe: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1

Interventionhr*ng/mL (Mean)
Part 3: Pem/Intermittent Pemigatinib 9 mg1480
Part 3: Pem/Intermittent Pemigatinib 13.5 mg1880
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg2890
Part 3: Doc/Intermittent Pemigatinib 13.5 mg1890
Part 3: Tras/Intermittent Pemigatinib 13.5 mg2040

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Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)

AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose. (NCT02393248)
Timeframe: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

Interventionhr*ng/mL (Mean)
Part 3: Pem/Intermittent Pemigatinib 9 mg2400
Part 3: Pem/Intermittent Pemigatinib 13.5 mg2400
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg1650
Part 3: Doc/Intermittent Pemigatinib 13.5 mg2910
Part 3: Tras/Intermittent Pemigatinib 13.5 mg3440

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Part 3: Vz/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)

Vz/F was defined as the apparent volume of distribution. (NCT02393248)
Timeframe: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

InterventionLiters (Mean)
Part 3: Pem/Intermittent Pemigatinib 9 mg177
Part 3: Pem/Intermittent Pemigatinib 13.5 mg303
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg376
Part 3: Doc/Intermittent Pemigatinib 13.5 mg227
Part 3: Tras/Intermittent Pemigatinib 13.5 mg182

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Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)

tmax was defined as the time to the maximum observed plasma concentration. (NCT02393248)
Timeframe: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

Interventionhr (Median)
Part 3: Pem/Intermittent Pemigatinib 9 mg5.78
Part 3: Pem/Intermittent Pemigatinib 13.5 mg1.08
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg1.50
Part 3: Doc/Intermittent Pemigatinib 13.5 mg1.90
Part 3: Tras/Intermittent Pemigatinib 13.5 mg0.583

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Maximum Observed Serum Concentration (Cmax) of Atezolizumab

(NCT02409342)
Timeframe: 0 hour (predose) and 30 minutes after atezolizumab infusion on Day 1 (infusion duration = up to 1 hour)

Interventionmicrograms per milliliter (μg/ mL) (Mean)
Atezolizumab411

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Duration of Response (DOR) in the TC3 or IC3-WT Populations

DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. (NCT02409342)
Timeframe: From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

InterventionMonths (Number)
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)6.7
AtezolizumabNA

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Percentage of Participants With Anti-therapeutic Antibodies (ATAs)

(NCT02409342)
Timeframe: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

InterventionPercentage of participants (Number)
Baseline evaluable participantsPost-baseline evaluable participants
Atezolizumab1.424.3

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OS in Participants With PD-L1 Expression

OS is defined as the time from randomization to death from any cause. (NCT02409342)
Timeframe: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

,
InterventionMonths (Median)
SP263 >=50%-WT PopulationSP263 >=25%-WT PopulationSP263 =1%-WT Population
Atezolizumab19.518.217.8
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)16.112.614.0

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Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations

OS is defined as the time from randomization to death from any cause. (NCT02409342)
Timeframe: From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months)

,
InterventionMonths (Median)
TC2/3 or IC2/3-WT PopulationTC1/2/3 or IC1/2/3-WT Population
Atezolizumab19.918.9
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)16.114.7

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Percentage of Participants Who Are Alive at 1 Year in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations

(NCT02409342)
Timeframe: Baseline to 1 year or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months)

,
InterventionPercentage of participants (Number)
1-Year TC2/3 or IC2/3-WT Population1-Year TC1/2/3 or IC1/2/3-WT Population
Atezolizumab63.3959.95
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)58.6554.89

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Percentage of Participants Who Are Alive at 2 Years in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations

(NCT02409342)
Timeframe: Baseline to 2 years or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months)

,
InterventionPercentage of participants (Number)
2-Years TC2/3 or IC2/3-WT Population2-Years TC1/2/3 or IC1/2/3-WT Population
Atezolizumab44.1541.76
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)35.4230.82

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OS in Participants With Blood Tumor Mutational Burden (bTMB)

OS is defined as the time from randomization to death from any cause. (NCT02409342)
Timeframe: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

,
InterventionMonths (Median)
bTMB >=10-WT PopulationbTMB >=16-WT PopulationbTMB >=20-WT Population
Atezolizumab11.213.917.2
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)10.38.510.5

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Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations

Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1. (NCT02409342)
Timeframe: Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 4 Feb 2020 (up to approximately 54.5 months)

,
InterventionPercentage of participants (Number)
TC2/3 or IC2/3-WT PopulationTC1/2/3 or IC1/2/3-WT Population
Atezolizumab33.731.4
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)32.132.1

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Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations

PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested. (NCT02409342)
Timeframe: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months)

,
InterventionMonths (Number)
TC2/3 or IC2/3-WT PopulationTC1/2/3 or IC1/2/3-WT Population
Atezolizumab7.35.8
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)5.55.6

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Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations

TTD in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant. (NCT02409342)
Timeframe: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

,
InterventionMonths (Median)
CoughDyspneaChest pain
Atezolizumab3.51.31.7
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)3.41.01.1

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TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations

TTD in patient-reported lung cancer symptoms, defined as time from randomization to deterioration (10-point change) in any of the following symptom subscales (cough, dyspnea [multi-item scale], and chest pain), whichever occurs first, as measured by the EORTC QLQ-LC13. EORTC QLQ-LC13 module incorporates one multi-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. (NCT02409342)
Timeframe: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

,
InterventionMonths (Median)
CoughDyspneaChest pain
AtezolizumabNA11.1NA
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)NA11.8NA

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Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations

Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1. (NCT02409342)
Timeframe: Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 10 Sep 2018 (up to approximately 38 months)

InterventionPercentage of participants (Number)
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)28.6
Atezolizumab38.3

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Percentage of Participants With at Least One Adverse Event

Percentage of participants with at least one adverse event. (NCT02409342)
Timeframe: Baseline up to until data cut-off on 8 March 2022 (up to approximately 79.5 months)

InterventionPercentage of participants (Number)
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)95.1
Atezolizumab92.3

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Percentage of Participants Who Are Alive at 2 Years in the TC3 or IC3-WT Populations

(NCT02409342)
Timeframe: Baseline to 2 years or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

InterventionPercentage of participants (Number)
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)24.79
Atezolizumab45.49

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Percentage of Participants Who Are Alive at 1 Year in the TC3 or IC3-WT Populations

(NCT02409342)
Timeframe: Baseline to 1 year or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

InterventionPercentage of participants (Number)
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)50.64
Atezolizumab64.90

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Overall Survival (OS) in the TC3 or IC3-WT Populations

OS is defined as the time from randomization to death from any cause. (NCT02409342)
Timeframe: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

InterventionMonths (Median)
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)13.1
Atezolizumab20.2

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Progression-free Survival (PFS) in the TC3 or IC3-WT Populations

PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested. (NCT02409342)
Timeframe: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

InterventionMonths (Number)
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)5.0
Atezolizumab8.1

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Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations

Change from baseline in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant. (NCT02409342)
Timeframe: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

InterventionScore on a scale (Mean)
Chest Pain, Week 1Chest Pain, Week 2Chest Pain, Week 3Chest Pain, Week 4Chest Pain, Week 5Chest Pain, Week 6Chest Pain, Week 7Chest Pain, Week 8Chest Pain, Week 9Chest Pain, Week 10Chest Pain, Week 11Chest Pain, Week 12Chest Pain, Week 13Chest Pain, Week 14Chest Pain, Week 15Chest Pain, Week 16Chest Pain, Week 17Chest Pain, Week 18Chest Pain, Week 19Chest Pain, Week 20Chest Pain, Week 21Chest Pain, Week 22Chest Pain, Week 23Chest Pain, Week 24Chest Pain, Week 25Chest Pain, Week 26Chest Pain, Week 27Chest Pain, Week 28Chest Pain, Week 29Chest Pain, Week 30Chest Pain, Week 31Chest Pain, Week 32Chest Pain, Week 33Chest Pain, Week 34Chest Pain, Week 35Chest Pain, Week 36Chest Pain, Week 37Chest Pain, Week 38Chest Pain, Week 39Chest Pain, Week 40Chest Pain, Week 41Chest Pain, Week 42Chest Pain, Week 43Chest Pain, Week 44Chest Pain, Week 45Chest Pain, Week 46Chest Pain, Week 47Chest Pain, Week 48Chest Pain, Week 49Chest Pain, Week 50Chest Pain, Week 51Chest Pain, Week 52Chest Pain, Week 53Chest Pain, Week 54Chest Pain, Week 55Chest Pain, Week 56Chest Pain, Week 57Chest Pain, Week 58Chest Pain, Week 59Chest Pain, Week 60Chest Pain, Week 61Chest Pain, Week 62Chest Pain, Week 63Chest Pain, Week 64Chest Pain, Week 65Chest Pain, Week 66Chest Pain, Week 67Chest Pain, Week 68Chest Pain, Week 69Chest Pain, Week 70Chest Pain, Week 71Chest Pain, Week 72Chest Pain, Week 73Chest Pain, Week 74Chest Pain, Week 75Chest Pain, Week 76Chest Pain, Week 77Chest Pain, Week 78Chest Pain, Week 79Chest Pain, Week 80Chest Pain, Week 81Chest Pain, Week 82Chest Pain, Week 83Chest Pain, Week 84Chest Pain, Week 85Chest Pain, Week 86Chest Pain, Week 87Cough, Week 1Cough, Week 2Cough, Week 3Cough, Week 4Cough, Week 5Cough, Week 6Cough, Week 7Cough, Week 8Cough, Week 9Cough, Week 10Cough, Week 11Cough, Week 12Cough, Week 13Cough, Week 14Cough, Week 15Cough, Week 16Cough, Week 17Cough, Week 18Cough, Week 19Cough, Week 20Cough, Week 21Cough, Week 22Cough, Week 23Cough, Week 24Cough, Week 25Cough, Week 26Cough, Week 27Cough, Week 28Cough, Week 29Cough, Week 30Cough, Week 31Cough, Week 32Cough, Week 33Cough, Week 34Cough, Week 35Cough, Week 36Cough, Week 37Cough, Week 38Cough, Week 39Cough, Week 40Cough, Week 41Cough, Week 42Cough, Week 43Cough, Week 44Cough, Week 45Cough, Week 46Cough, Week 47Cough, Week 48Cough, Week 49Cough, Week 50Cough, Week 51Cough, Week 52Cough, Week 53Cough, Week 54Cough, Week 55Cough, Week 56Cough, Week 57Cough, Week 58Cough, Week 59Cough, Week 60Cough, Week 61Cough, Week 62Cough, Week 63Cough, Week 64Cough, Week 65Cough, Week 66Cough, Week 67Cough, Week 68Cough, Week 69Cough, Week 70Cough, Week 71Cough, Week 72Cough, Week 73Cough, Week 74Cough, Week 75Cough, Week 76Cough, Week 77Cough, Week 78Cough, Week 79Cough, Week 80Cough, Week 81Cough, Week 82Cough, Week 83Cough, Week 84Cough, Week 85Cough, Week 86Cough, Week 87Dyspnoea, Week 1Dyspnoea, Week 2Dyspnoea, Week 3Dyspnoea, Week 4Dyspnoea, Week 5Dyspnoea, Week 6Dyspnoea, Week 7Dyspnoea, Week 8Dyspnoea, Week 9Dyspnoea, Week 10Dyspnoea, Week 11Dyspnoea, Week 12Dyspnoea, Week 13Dyspnoea, Week 14Dyspnoea, Week 15Dyspnoea, Week 16Dyspnoea, Week 17Dyspnoea, Week 18Dyspnoea, Week 19Dyspnoea, Week 20Dyspnoea, Week 21Dyspnoea, Week 22Dyspnoea, Week 23Dyspnoea, Week 24Dyspnoea, Week 25Dyspnoea, Week 26Dyspnoea, Week 27Dyspnoea, Week 28Dyspnoea, Week 29Dyspnoea, Week 30Dyspnoea, Week 31Dyspnoea, Week 32Dyspnoea, Week 33Dyspnoea, Week 34Dyspnoea, Week 35Dyspnoea, Week 36Dyspnoea, Week 37Dyspnoea, Week 38Dyspnoea, Week 39Dyspnoea, Week 40Dyspnoea, Week 41Dyspnoea, Week 42Dyspnoea, Week 43Dyspnoea, Week 44Dyspnoea, Week 45Dyspnoea, Week 46Dyspnoea, Week 47Dyspnoea, Week 48Dyspnoea, Week 49Dyspnoea, Week 50Dyspnoea, Week 51Dyspnoea, Week 52Dyspnoea, Week 53Dyspnoea, Week 54Dyspnoea, Week 55Dyspnoea, Week 56Dyspnoea, Week 57Dyspnoea, Week 58Dyspnoea, Week 59Dyspnoea, Week 60Dyspnoea, Week 61Dyspnoea, Week 62Dyspnoea, Week 63Dyspnoea, Week 64Dyspnoea, Week 65Dyspnoea, Week 66Dyspnoea, Week 67Dyspnoea, Week 68Dyspnoea, Week 69Dyspnoea, Week 70Dyspnoea, Week 71Dyspnoea, Week 72Dyspnoea, Week 73Dyspnoea, Week 74Dyspnoea, Week 75Dyspnoea, Week 76Dyspnoea, Week 77Dyspnoea, Week 78Dyspnoea, Week 79Dyspnoea, Week 80Dyspnoea, Week 81Dyspnoea, Week 82Dyspnoea, Week 83Dyspnoea, Week 84Dyspnoea, Week 85Dyspnoea, Week 86Dyspnoea, Week 87
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)0.570.420.250.150.270.300.230.170.270.300.260.220.070.070.100.000.220.110.110.200.030.300.00-0.090.270.120.050.00-0.250.210.180.410.000.400.000.060.310.230.220.430.360.250.300.140.630.300.500.501.000.800.880.750.701.131.170.380.671.171.000.501.000.830.500.000.000.001.000.750.501.000.501.001.500.500.750.500.501.000.500.750.750.000.000.500.000.000.000.13-0.01-0.03-0.02-0.01-0.18-0.20-0.10-0.24-0.070.02-0.08-0.09-0.20-0.05-0.10-0.040.02-0.230.00-0.17-0.20-0.22-0.13-0.45-0.46-0.50-0.45-0.50-0.88-0.86-0.73-0.77-0.80-0.14-0.17-0.250.05-0.50-0.360.210.170.100.360.250.100.500.170.670.300.130.630.700.500.670.500.500.670.330.750.500.330.000.000.500.000.250.250.250.250.00-0.500.000.000.000.250.000.250.000.250.250.000.000.500.000.000.000.420.330.250.430.550.500.630.500.460.430.360.390.430.260.360.180.480.390.290.600.270.550.340.360.220.320.350.350.200.180.180.220.200.160.110.110.280.400.270.570.310.300.400.490.650.560.300.601.400.241.051.100.761.101.000.400.530.800.601.200.730.670.300.200.600.400.500.200.300.300.100.000.000.200.300.300.400.300.100.500.400.600.600.800.600.400.40

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Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations

Change from baseline in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant. (NCT02409342)
Timeframe: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

InterventionScore on a scale (Mean)
Chest Pain, Week 1Chest Pain, Week 2Chest Pain, Week 3Chest Pain, Week 4Chest Pain, Week 5Chest Pain, Week 6Chest Pain, Week 7Chest Pain, Week 8Chest Pain, Week 9Chest Pain, Week 10Chest Pain, Week 11Chest Pain, Week 12Chest Pain, Week 13Chest Pain, Week 14Chest Pain, Week 15Chest Pain, Week 16Chest Pain, Week 17Chest Pain, Week 18Chest Pain, Week 19Chest Pain, Week 20Chest Pain, Week 21Chest Pain, Week 22Chest Pain, Week 23Chest Pain, Week 24Chest Pain, Week 25Chest Pain, Week 26Chest Pain, Week 27Chest Pain, Week 28Chest Pain, Week 29Chest Pain, Week 30Chest Pain, Week 31Chest Pain, Week 32Chest Pain, Week 33Chest Pain, Week 34Chest Pain, Week 35Chest Pain, Week 36Chest Pain, Week 37Chest Pain, Week 38Chest Pain, Week 39Chest Pain, Week 40Chest Pain, Week 41Chest Pain, Week 42Chest Pain, Week 43Chest Pain, Week 44Chest Pain, Week 45Chest Pain, Week 46Chest Pain, Week 47Chest Pain, Week 48Chest Pain, Week 49Chest Pain, Week 50Chest Pain, Week 51Chest Pain, Week 52Chest Pain, Week 53Chest Pain, Week 54Chest Pain, Week 55Chest Pain, Week 56Chest Pain, Week 57Chest Pain, Week 58Chest Pain, Week 59Chest Pain, Week 60Chest Pain, Week 61Chest Pain, Week 62Chest Pain, Week 63Chest Pain, Week 64Chest Pain, Week 65Chest Pain, Week 66Chest Pain, Week 67Chest Pain, Week 68Chest Pain, Week 69Chest Pain, Week 70Chest Pain, Week 71Chest Pain, Week 72Chest Pain, Week 73Chest Pain, Week 74Chest Pain, Week 75Chest Pain, Week 76Chest Pain, Week 77Chest Pain, Week 78Chest Pain, Week 79Chest Pain, Week 80Chest Pain, Week 81Chest Pain, Week 82Chest Pain, Week 83Chest Pain, Week 84Chest Pain, Week 85Chest Pain, Week 86Chest Pain, Week 87Chest Pain, Week 88Chest Pain, Week 89Chest Pain, Week 90Chest Pain, Week 91Chest Pain, Week 92Chest Pain, Week 93Chest Pain, Week 94Chest Pain, Week 95Chest Pain, Week 96Chest Pain, Week 97Chest Pain, Week 98Chest Pain, Week 99Chest Pain, Week 100Chest Pain, Week 101Chest Pain, Week 102Chest Pain, Week 103Chest Pain, Week 104Chest Pain, Week 105Chest Pain, Week 106Chest Pain, Week 107Chest Pain, Week 108Chest Pain, Week 109Chest Pain, Week 110Chest Pain, Week 111Chest Pain, Week 112Chest Pain, Week 113Chest Pain, Week 114Chest Pain, Week 115Chest Pain, Week 116Chest Pain, Week 117Chest Pain, Week 118Chest Pain, Week 119Chest Pain, Week 120Chest Pain, Week 121Chest Pain, Week 122Chest Pain, Week 123Chest Pain, Week 124Chest Pain, Week 125Chest Pain, Week 126Chest Pain, Week 127Chest Pain, Week 128Chest Pain, Week 129Chest Pain, Week 130Chest Pain, Week 131Cough, Week 1Cough, Week 2Cough, Week 3Cough, Week 4Cough, Week 5Cough, Week 6Cough, Week 7Cough, Week 8Cough, Week 9Cough, Week 10Cough, Week 11Cough, Week 12Cough, Week 13Cough, Week 14Cough, Week 15Cough, Week 16Cough, Week 17Cough, Week 18Cough, Week 19Cough, Week 20Cough, Week 21Cough, Week 22Cough, Week 23Cough, Week 24Cough, Week 25Cough, Week 26Cough, Week 27Cough, Week 28Cough, Week 29Cough, Week 30Cough, Week 31Cough, Week 32Cough, Week 33Cough, Week 34Cough, Week 35Cough, Week 36Cough, Week 37Cough, Week 38Cough, Week 39Cough, Week 40Cough, Week 41Cough, Week 42Cough, Week 43Cough, Week 44Cough, Week 45Cough, Week 46Cough, Week 47Cough, Week 48Cough, Week 49Cough, Week 50Cough, Week 51Cough, Week 52Cough, Week 53Cough, Week 54Cough, Week 55Cough, Week 56Cough, Week 57Cough, Week 58Cough, Week 59Cough, Week 60Cough, Week 61Cough, Week 62Cough, Week 63Cough, Week 64Cough, Week 65Cough, Week 66Cough, Week 67Cough, Week 68Cough, Week 69Cough, Week 70Cough, Week 71Cough, Week 72Cough, Week 73Cough, Week 74Cough, Week 75Cough, Week 76Cough, Week 77Cough, Week 78Cough, Week 79Cough, Week 80Cough, Week 81Cough, Week 82Cough, Week 83Cough, Week 84Cough, Week 85Cough, Week 86Cough, Week 87Cough, Week 88Cough, Week 89Cough, Week 90Cough, Week 91Cough, Week 92Cough, Week 93Cough, Week 94Cough, Week 95Cough, Week 96Cough, Week 97Cough, Week 98Cough, Week 99Cough, Week 100Cough, Week 101Cough, Week 102Cough, Week 103Cough, Week 104Cough, Week 105Cough, Week 106Cough, Week 107Cough, Week 108Cough, Week 109Cough, Week 110Cough, Week 111Cough, Week 112Cough, Week 113Cough, Week 114Cough, Week 115Cough, Week 116Cough, Week 117Cough, Week 118Cough, Week 119Cough, Week 120Cough, Week 121Cough, Week 122Cough, Week 123Cough, Week 124Cough, Week 125Cough, Week 126Cough, Week 127Cough, Week 128Cough, Week 129Cough, Week 130Cough, Week 131Dyspnoea, Week 1Dyspnoea, Week 2Dyspnoea, Week 3Dyspnoea, Week 4Dyspnoea, Week 5Dyspnoea, Week 6Dyspnoea, Week 7Dyspnoea, Week 8Dyspnoea, Week 9Dyspnoea, Week 10Dyspnoea, Week 11Dyspnoea, Week 12Dyspnoea, Week 13Dyspnoea, Week 14Dyspnoea, Week 15Dyspnoea, Week 16Dyspnoea, Week 17Dyspnoea, Week 18Dyspnoea, Week 19Dyspnoea, Week 20Dyspnoea, Week 21Dyspnoea, Week 22Dyspnoea, Week 23Dyspnoea, Week 24Dyspnoea, Week 25Dyspnoea, Week 26Dyspnoea, Week 27Dyspnoea, Week 28Dyspnoea, Week 29Dyspnoea, Week 30Dyspnoea, Week 31Dyspnoea, Week 32Dyspnoea, Week 33Dyspnoea, Week 34Dyspnoea, Week 35Dyspnoea, Week 36Dyspnoea, Week 37Dyspnoea, Week 38Dyspnoea, Week 39Dyspnoea, Week 40Dyspnoea, Week 41Dyspnoea, Week 42Dyspnoea, Week 43Dyspnoea, Week 44Dyspnoea, Week 45Dyspnoea, Week 46Dyspnoea, Week 47Dyspnoea, Week 48Dyspnoea, Week 49Dyspnoea, Week 50Dyspnoea, Week 51Dyspnoea, Week 52Dyspnoea, Week 53Dyspnoea, Week 54Dyspnoea, Week 55Dyspnoea, Week 56Dyspnoea, Week 57Dyspnoea, Week 58Dyspnoea, Week 59Dyspnoea, Week 60Dyspnoea, Week 61Dyspnoea, Week 62Dyspnoea, Week 63Dyspnoea, Week 64Dyspnoea, Week 65Dyspnoea, Week 66Dyspnoea, Week 67Dyspnoea, Week 68Dyspnoea, Week 69Dyspnoea, Week 70Dyspnoea, Week 71Dyspnoea, Week 72Dyspnoea, Week 73Dyspnoea, Week 74Dyspnoea, Week 75Dyspnoea, Week 76Dyspnoea, Week 77Dyspnoea, Week 78Dyspnoea, Week 79Dyspnoea, Week 80Dyspnoea, Week 81Dyspnoea, Week 82Dyspnoea, Week 83Dyspnoea, Week 84Dyspnoea, Week 85Dyspnoea, Week 86Dyspnoea, Week 87Dyspnoea, Week 88Dyspnoea, Week 89Dyspnoea, Week 90Dyspnoea, Week 91Dyspnoea, Week 92Dyspnoea, Week 93Dyspnoea, Week 94Dyspnoea, Week 95Dyspnoea, Week 96Dyspnoea, Week 97Dyspnoea, Week 98Dyspnoea, Week 99Dyspnoea, Week 100Dyspnoea, Week 101Dyspnoea, Week 102Dyspnoea, Week 103Dyspnoea, Week 104Dyspnoea, Week 105Dyspnoea, Week 106Dyspnoea, Week 107Dyspnoea, Week 108Dyspnoea, Week 109Dyspnoea, Week 110Dyspnoea, Week 111Dyspnoea, Week 112Dyspnoea, Week 113Dyspnoea, Week 114Dyspnoea, Week 115Dyspnoea, Week 116Dyspnoea, Week 117Dyspnoea, Week 118Dyspnoea, Week 119Dyspnoea, Week 120Dyspnoea, Week 121Dyspnoea, Week 122Dyspnoea, Week 123Dyspnoea, Week 124Dyspnoea, Week 125Dyspnoea, Week 126Dyspnoea, Week 127Dyspnoea, Week 128Dyspnoea, Week 129Dyspnoea, Week 130Dyspnoea, Week 131
Atezolizumab0.310.330.430.430.280.250.300.200.330.250.210.330.300.270.450.190.220.260.230.230.110.190.330.180.290.110.200.230.180.320.330.350.040.310.280.080.390.310.140.300.300.330.180.420.310.370.310.170.470.200.310.540.290.250.150.290.080.190.000.380.360.430.290.400.350.45-0.090.390.500.180.450.420.270.500.330.000.190.210.310.720.080.080.500.430.380.210.290.43-0.200.07-0.070.330.500.200.330.330.500.330.880.500.830.500.631.001.000.501.001.501.752.001.501.501.502.001.752.002.002.001.752.502.003.002.503.003.003.002.003.003.002.002.000.100.19-0.01-0.030.00-0.18-0.06-0.13-0.06-0.10-0.07-0.09-0.20-0.07-0.19-0.19-0.21-0.26-0.27-0.33-0.19-0.170.05-0.120.14-0.03-0.050.080.050.120.05-0.04-0.29-0.02-0.09-0.36-0.04-0.07-0.20-0.390.05-0.200.03-0.11-0.260.08-0.030.230.260.000.060.270.380.070.120.140.150.080.06-0.040.000.14-0.040.350.120.45-0.090.610.500.230.550.420.640.560.670.310.560.360.630.330.580.250.670.290.380.570.640.640.500.430.500.670.790.300.670.580.570.670.250.600.500.500.250.000.33-0.500.000.000.500.500.500.000.500.500.500.500.500.500.502.002.002.002.002.002.002.002.002.002.002.002.000.120.290.250.280.210.210.320.250.340.490.240.350.230.260.390.260.160.210.330.230.400.220.380.420.500.280.370.450.380.540.410.580.360.280.27-0.020.420.500.250.440.530.520.410.310.530.370.390.390.470.530.590.720.400.630.720.610.450.600.180.570.540.660.770.660.940.670.330.820.740.750.840.800.670.890.710.530.650.400.550.690.530.530.870.890.830.660.661.200.560.740.510.871.200.480.871.131.260.800.700.881.130.960.551.071.070.401.131.501.301.501.601.501.501.601.401.301.501.301.502.202.402.202.202.202.202.202.202.202.202.202.20

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Duration of Response (DOR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations

DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. (NCT02409342)
Timeframe: From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months)

,
InterventionMonths (Number)
TC2/3 or IC2/3-WT PopulationTC1/2/3 or IC1/2/3-WT Population
Atezolizumab38.926.3
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)5.85.7

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Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1

PFS according to RECIST v1.1 in the bTMB subpopulations. (NCT02409342)
Timeframe: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

,
InterventionMonths (Median)
bTMB >=10-WT PopulationbTMB >=16-WT PopulationbTMB >=20-WT Population
Atezolizumab5.56.86.8
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)4.34.45.2

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Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1

Investigator-assessed PFS according to RECIST v1.1 in the PD-L1 (defined with SP263 IHC assay) (NCT02409342)
Timeframe: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

,
InterventionMonths (Median)
SP263 >=50%-WT PopulationSP263 >=25%-WT PopulationSP263 >=1%-WT Population
Atezolizumab7.06.96.8
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)4.94.95.4

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Minimum Observed Serum Concentration (Cmin) of Atezolizumab

(NCT02409342)
Timeframe: Prior to infusion (0 hour) on Day 1 of Cycles 2, 3, 4, 8, 16, and every eighth cycle thereafter, and at treatment discontinuation until data cut-off on 10 September 2018 (up to approximately 38 months) (cycle duration = 21 days)

Interventionmicrograms per milliliter (μg/ mL) (Mean)
Cycle 2 Day 1Cycle 3 Day 1Cycle 4 Day 1Cycle 8 Day 1Cycle 16 Day 1Cycle 24 Day 1Cycle 32 Day 1Cycle 40 Day 1Cycle 48 Day 1Treatment Discontinuation Visit
Atezolizumab76.7121154201213245276252555121

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Cumulative Incidence of Cancer-specific Death at 24 Months

Cancer-specific survival was defined as the time from registration to death due to cancer; deaths due to other causes are counted as competing events. Cancer-specific survival was analyzed using Gray's method and cumulative incidence of cancer-specific death at 24 months is reported. (NCT02412670)
Timeframe: Assessed every 3 months for 2 years

Interventionproportion of patients died of cancer (Number)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)0.09
Arm B (Gemcitabine, Carboplatin)0.20

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Complete Pathologic Response Rate

Complete pathologic response is defined as pT0pN0 (no evidence of disease) as assessed by pathologic evaluation of nephrectomy/ureterectomy and any identifiable regional lymph nodes. (NCT02412670)
Timeframe: Assessed at nephroureterectomy or regional lymph node dissection (21-60 days from completion of chemotherapy; chemotherapy was administered for a total of 4 cycles; cycle length is 14 days and 21 days for arms A and B, respectively)

Interventionproportion of participants (Number)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)0.103
Arm B (Gemcitabine, Carboplatin)0.167

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Event-free Survival

Event-free survival is defined as the time from registration to the earliest occurrence of recurrence of any type, disease progression, new invasive primary cancer, or death from any cause. Disease progression will be assessed using RECIST 1.1. Disease progression is defined as appearance of one or more new lesions, unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (NCT02412670)
Timeframe: Assessed every 3 months for 2 years, and every 6 months for 3-5 years

Interventionmonths (Median)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)NA
Arm B (Gemcitabine, Carboplatin)10.2

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Proportion of Patients With Renal Insufficiency at Completion of Chemotherapy

Renal insufficiency is defined as CrCl < 60 ml/min. (NCT02412670)
Timeframe: Assessed at completion of chemotherapy; at 8 weeks for Arm A and 12 weeks for Arm B

Interventionproportion of participants (Number)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)0.2
Arm B (Gemcitabine, Carboplatin)0.833

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Recurrence-free Survival

Recurrence-free survival is defined as the time from the date of surgery to disease recurrence or death from any cause. Patients alive without documented recurrence will be censored at the date of last disease assessment. (NCT02412670)
Timeframe: Assessed every 3 months for 2 years; and every 6 months for 3-5 years

Interventionmonths (Median)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)NA
Arm B (Gemcitabine, Carboplatin)8.5

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Bladder Cancer-free Survival

Bladder cancer-free survival was defined as the time from the date of surgery to the earlier of a return of bladder cancer or death from any cause. Patients alive without documented bladder cancer were censored at the date of last disease assessment. (NCT02412670)
Timeframe: Assessed every 3 months for 2 years, and every 6 months for 3-5 years

Interventionmonths (Median)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)NA
Arm B (Gemcitabine, Carboplatin)NA

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Proportion of Patients With Renal Insufficiency at Completion of Surgery

Renal insufficiency is defined as CrCl < 60 ml/min. (NCT02412670)
Timeframe: Assessed at completion of surgery (21-60 days from completion of chemotherapy; chemotherapy was administered for a total of 4 cycles; cycle length is 14 days and 21 days for arms A and B, respectively)

Interventionproportion of participants (Number)
Arm A (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)0.69
Arm B (Gemcitabine, Carboplatin)0.833

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Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0

Frequency and severity of adverse events will be tabulated based on the actual treatment and the number of courses the patient receives. In particular, grade 3 and 4 toxicity rates will be computed and summarized for all patients received at least one dose of the assigned treatment. (NCT02427841)
Timeframe: From the first dose of study drug(s) until 28 days after last study intervention, up to approximately 3 years, 10 months

InterventionAdverse Events (Number)
Blood and Lymphatic system disordersGastrointestinal disordersHepatobiliary disordersInfections and infestationsInvestigationsMetabolism and nutrition disordersMusculoskeletal and connective tissue disordersNervous system disordersPsychiatric disordersRespiratory, thoracic and mediastinal disordersSkin and subcutaneous tissue disordersVascular disorders
Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)4241313691527193

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Overall Survival Rate Defined as the Percentage of Subjects Alive at the 2 Year Time Point

The expected 2-year overall survival rate (%) will be reported with an associated 95% confidence interval for all enrolled participants (n = 19). Survival is assessed from the first dose of study drug(s) until the date of death due to any cause, up to two years. Participants known still alive at two-years will be censored at two years. Any participant lost to follow up during the two-year period will be censored on the last date known alive. (NCT02427841)
Timeframe: From first dose of study drug until 2 years or time of death by any cause, which ever comes first. Participants are assessed every 3 months after completing study interventions.

Interventionpercentage of participants (Number)
Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)41

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Overall Survival Rate Defined as the Percentage of Subjects Alive at the One Year Time Point

The expected 1-year overall survival rate (%) will be reported with an associated 95% confidence interval. Survival is assessed from the first dose of study drug(s) until the date of death due to any cause, up to one year. Participants known still alive at one-year will be censored at one year. Any participant lost to follow up during the one-year period will be censored on the last date known alive. (NCT02427841)
Timeframe: From first dose of study drug until 1 year or time of death by any cause, whichever comes first. Participants are assessed every 3 months after completing study interventions.

Interventionpercentage of participants (Number)
Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)79

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R0 Resection Rate Defined as Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins by Pathologic Assessment

The R0 resection rate, measured as the percent of participants achieving R0 resection among those who initiate study drug, will be computed with 95% confidence interval. A 2-sided binomial test will be used to determine whether the R0 resection rate is significantly greater than 0.37 at 10% significance level. (NCT02427841)
Timeframe: At the time of surgery

Interventionpercentage of participants (Number)
Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)42

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Relapse-free Survival Rate Defined as the Percentage of Subjects Who Are Without Recurrence or Death at One Year From Surgical Resection of the Primary Tumor

The expected 1-year relapse-free survival rate (%) will be reported with an associated 95% confidence interval for those who undergo resection (n = 11). Resection-free survival is assessed from the time of resection until time of progression or death by any cause, up to one year. Participants known still alive and without progression at one-year post-resection will be censored at one year. Any participant lost to follow up during the one-year post-resection period will be censored on the last disease assessment date. Response is measured per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 using tumor imaging with CT. Changes in the largest diameter of tumor lesions (target lesions) and shortest diameter of malignant lymph nodes are assessed. Progression is at least 20% increase in sum of diameters of target lesions (referencing nadir sum of diameters) and an absolute increase of at least 5 mm. Presence of any new lesion is also considered progression disease. (NCT02427841)
Timeframe: From time of resection until progression or death by any cause, within 1 year of resection. Participants are assessed by imaging every 3 months after completing study interventions.

Interventionpercentage of participants (Number)
Resection64

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Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Defined as the Percent of Subjects With Complete or Partial Disease Response as Confirmed Through Tumor Imaging With Computed Tomography (CT)

The objective response rate (percentage of participants having complete response (CR) or partial response (PR)) will be computed with associated 95% confidence interval using the binomial exact method. Response is measured per RECIST 1.1 using tumor imaging with CT. Changes in the largest diameter of tumor lesions (target lesions) and shortest diameter of malignant lymphnodes are assessed. CR is the disappearance of all target lesions; any pathologic lymph nodes must show a reduction in short axis to < 10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions using the baseline sum of diameters of target lesions as the reference level. (NCT02427841)
Timeframe: From first dose of study drug(s), with assessments at Staging 1 (approximately 2 months) and Staging 2 (approximately 5 months after first dose of study drug(s)).

Interventionpercentage of participants (Number)
Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)21

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Tumor Response Per RECIST v1.1 (by Local Investigator Assessment) Duration of Response

CR: complete response. PR: partial response. SD: stable disease: CBR: clinical benefit rate =CR + PR + SD lasting at least for 6 months. ORR = CR + PR. Efficacy Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design. (NCT02435680)
Timeframe: 4 years

Interventionmonths (Median)
MCS110+Carboplatin+Gemcitabine9.6
Carboplatin+Gemcitabine5

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Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)

PFS Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design. (NCT02435680)
Timeframe: 4 years

Interventionmonths (Median)
All MCS110+Carboplatin+Gemcitabine5.6
Carboplatin+Gemcitabine5.5

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Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)

CR: complete response. PR: partial response. SD: stable disease: CBR: clinical benefit rate =CR + PR + SD lasting at least for 6 months. ORR = CR + PR. Efficacy Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design. (NCT02435680)
Timeframe: 4 years

,
InterventionParticipants (Count of Participants)
PRNon-CR/ Non-progressive diseaseSDprogressive diseaseunknownclinical benefit rateORR
Carboplatin+Gemcitabine6071276
MCS110+Carboplatin+Gemcitabine811942108

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MCS110 Dose Intensity

"Relative dose intensity by categories.~Patients treated with MCS110 only. The dose intensity measures the dose actually taken versus the planned dose, and is expressed in percentage:~<50%: less than 50 % of the planned dose received; 50-<75 %: dose received is 50% or more, but less than 75 %; 75-<90 %: dose received is 75% or more, but less than 90%; 90-<110 %: dose received is 90% or more, but less than 110%" (NCT02435680)
Timeframe: 4 years

,
InterventionParticipants (Count of Participants)
<50%50-<75%75-<90%90-<110%
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine4353
MCS110+Carboplatin+Gemcitabine1873

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Free MCS110 : Derived Pharmacokinetics (PK) Parameters: Cmax

(NCT02435680)
Timeframe: day 21 (end cycle 1); day 84 (end cycle 4)

,
Interventionmicrogram / mL (Geometric Mean)
day 21day 84
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine281319
MCS110+Carboplatin+Gemcitabine186240

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Free MCS110 : Derived Pharmacokinetics (PK) Parameters: AUCtau

AUC tau derived from day 0 to 21 (cycle 1) from day 0 to 21 (cycle 4) Cycle duration is 21 days (NCT02435680)
Timeframe: day 21 (end cycle 1); day 84 (end cycle 4)

,
Interventionday * microgram / mL (Geometric Mean)
day 21day 84
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine29603240
MCS110+Carboplatin+Gemcitabine14301840

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Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)

day 21 (end cycle 1); day 84 (end cycle 4) (NCT02435680)
Timeframe: day 21, day 84

,,
Interventionnanogram /mL (Geometric Mean)
Cmax Carboplatin Day 21Cmax Carboplatin Day 84Cmax Gemcitabine Day 21Cmax Gemcitabine Day 84Cmax dFdU Day 21Cmax dFdU Day 84
Carboplatin+Gemcitabine1120011600237086303770032300
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine1250010000548034003390030300
MCS110+Carboplatin+Gemcitabine124009550275024703910036600

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Circulating Monocytes Cells in Blood

Cycle duration is 21 days results expressed in percentage of cells. Only 1 arm reported as results were available for 1 patient only. (NCT02435680)
Timeframe: day 15, 29, 43, 50

Interventionpercentage (Number)
day 15 CD14+CD16-day 15 CD14+CD16+day 29 (cycle 2 day 8) CD14+CD16-day 29 (cycle 2 day 8) CD14+CD16+day 43 (cycle 3 day 1) CD14+CD16-day 43 (cycle 3 day 1) CD14+CD16+day 50 (cycle 3 day 8) CD14+CD16-day 50 (cycle 3 day 8) CD14+CD16+
MCS110+Carboplatin+Gemcitabine43.554.886.612.29.189.78610

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Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels

results expressed as a the ratio change from baseline expressed in percentage. Cycle duration is 21 days. These Biomarker Analyses were performed for MCS110 treated patients only. (NCT02435680)
Timeframe: baseline, day 1, 4, 15, 22, 43, 64, 85, 106, 127, 148

,
Intervention% change from baseline (Mean)
Day 1Day 4Day 15Day 22 (cycle 2 day 1)Day 43 (cycle 3 day 1)Day 64 (cycle 4 day 1)Day 85 (cycle 5 day 1)Day 106 (cycle 6 day 1)Day 127 (cycle 7 day 1)Day 148 (cycle 8 day 1)
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine115435019500344007000078000107000103000109000111000
MCS110+Carboplatin+Gemcitabine1104930216003200057900736007930097500110000108000

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AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)

day 21 (end cycle 1); day 84 (end cycle 4) (NCT02435680)
Timeframe: day 21, day 84

,,
Interventionhours * nanogram /mL (Geometric Mean)
AUC Carboplatin Day 21AUC Carboplatin Day 84AUC Gemcitabine Day 21AUC Gemcitabine Day 84AUC dFdU Day 21AUC dFdU Day 84
Carboplatin+Gemcitabine218002050026206320231000211000
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine214001750042702770181000147000
MCS110+Carboplatin+Gemcitabine245001830023902410230000229000

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Serum C-terminal Telopeptide of Type I Collagen (CTX-I)

"results expressed as a the ratio change from baseline expressed in percentage. Cycle duration is 21 days.~Biomarker Analyses performed for MCS110 treated patients only." (NCT02435680)
Timeframe: baseline, day 2, 4, 15, 22, 43, 64, 85, 106, 127, 148

,
Intervention% change from baseline (Mean)
Day 2Day 4Day 15Day 22 (cycle 2 day 1)Day 43 (cycle 3 day 1)Day 64 (cycle 4 day 1)Day 85 (cycle 5 day 1)Day 106 (cycle 6 day 1)Day 127 (cycle 7 day 1)Day 148 (cycle 8 day 1)
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine85.080.269.452.939.329.540.650.268.775.3
MCS110+Carboplatin+Gemcitabine79.472.565.667.964.369.710241.238.740.5

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Tumor Associated Macrophage (TAM) and Tumor Infiltrating Lymphocyte (TIL) Content in Pre- and Post-dose Tumor Biopsies.

results expressed as a the ratio change from baseline expressed in percentage: Biopsies were taken at baseline and between Day 29 and Day 43. Patients treated with MCS110 only (NCT02435680)
Timeframe: Baseline, Day 29-43

,
Intervention% change from baseline (Geometric Mean)
CD163CD8
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine43.599.0
MCS110+Carboplatin+Gemcitabine42.1102

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Number of Patients With at Least One MCS110 Dose Reduction, and Number of Patients With at Least One MCS110 Dose Interruption

patients treated with MCS110 only (NCT02435680)
Timeframe: 4 years

,
InterventionParticipants (Count of Participants)
MCS110 dose reductionMCS110 dose interruption
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine59
MCS110+Carboplatin+Gemcitabine36

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Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.

This is a measure of percentage of subjects with Treatment Emergent Adverse Events Grade 3 or above collected Up to 30 days after the last participating subject discontinues study drug. (NCT02436668)
Timeframe: Results at an overall median follow-up of 24.87 months

,
Interventionpercentage of participants (Number)
Subjects with any TEAE >= Grade 3Subjects with ibrutinib/pbo-related TEAE >=Grade 3
Ibrutinib+Gemcitabine+Nab-paclitaxel85.654.3
Placebo+Gemcitabine+Nab-Paclitaxel86.855.7

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Clinical Benefit Response

"Subject achieved a ≥50% reduction in pain intensity (Memorial Pain Assessment Card [MPAC]) or analgesic consumption, or a 20-point or greater improvement in KPS for a period of at least 4 consecutive weeks, without showing any sustained worsening in other parameters.~OR Subject was stable on all of the aforementioned parameters, and showed a marked, sustained weight gain (≥7% increase maintained for ≥4 weeks) not due to fluid accumulation (Burris 1997)." (NCT02436668)
Timeframe: Results at an overall median follow-up of 24.87 months

,
Interventionpercentage of patients (Number)
Achieved a >=50% reduction in pain intensity>=20-pt improvement in KPS (>=4 consecutive weeks)Sustained weight gain (>=7% maintained >4 weeks
Ibrutinib+Gemcitabine+Nab-paclitaxel27.505.7
Placebo+Gemcitabine+Nab-Paclitaxel25.81.411.7

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Rate of Venous Thromboembolic Events (VTE)

The VTE rate is defined as percentage of subjects with Venous thromboembolic events (SMQ) per investigator assessment. (NCT02436668)
Timeframe: Results at an overall median follow-up of 24.87 months

InterventionPercentage of Participants (Number)
Placebo+Gemcitabine+Nab-Paclitaxel10.8
Ibrutinib+Gemcitabine+Nab-paclitaxel8.1

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Progression Free Survival (PFS)

PFS is defined as the time from the date of randomization until disease progression per RECIST 1.1 criteria assessed by investigator, or death from any cause, whichever occurs first. (NCT02436668)
Timeframe: Results at an overall median follow-up of 24.87 months

InterventionMonths (Median)
Ibrutinib+Gemcitabine+Nab-paclitaxel5.32
Placebo+Gemcitabine+Nab-Paclitaxel6.01

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Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).

"Unit is the month: TUDD1 - the time between random & 1st occurrence of a decrease in QLQ-C30 score ≥10 pts w/o improvement in QoL score of ≥10 points or any further QoL data due to deterioration. The proportion of subjects who met the responder criteria prior to subsequent anticancer therapy initiation. Response defined as achievement of a ≥50% reduction in MPAC visual analog scale which measures pain intensity or analgesic consumption, or a ≥20-point improvement from baseline in KPS sustained for a period of ≥ 4 consecutive weeks without showing any sustained worsening from baseline in any of the other parameters OR Subject stable on all parameters (pain and KPS), & showed a marked, sustained weight gain (≥7% increase from baseline maintained for ≥4 weeks) not due to fluid accumulation." (NCT02436668)
Timeframe: Results at an overall median follow-up of 24.87 months

Interventionmonths (Median)
Placebo+Gemcitabine+Nab-Paclitaxel6.14
Ibrutinib+Gemcitabine+Nab-paclitaxel4.21

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Overall Survival (OS)

OS, is defined as the time from date of randomization until date of death from any cause. (NCT02436668)
Timeframe: Results at an overall median follow-up of 24.87 months

InterventionMonths (Median)
Ibrutinib+Gemcitabine+Nab-paclitaxel9.69
Placebo+Gemcitabine+Nab-Paclitaxel10.78

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Overall Response Rate

ORR is defined as the percentage of subjects who achieve a complete response or partial response, based on investigator assessment according to RECIST 1.1. (NCT02436668)
Timeframe: Results at an overall median follow-up of 24.87 months

Interventionpercentage of Patients (Number)
Placebo+Gemcitabine+Nab-Paclitaxel42.3
Ibrutinib+Gemcitabine+Nab-paclitaxel29.5

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Carbohydrate Antigen 19-9 (CA19-9) Response

The CA19-9 response rate is defined as the percentage of subjects with a decline of 20%, 90%, and other thresholds considered clinically meaningful, from baseline. This is a percentage of patients with > or = 60% reduction from baseline. (NCT02436668)
Timeframe: Results at an overall median follow-up of 24.87 months

Interventionpercentage of patients (Number)
Placebo+Gemcitabine+Nab-Paclitaxel62.9
Ibrutinib+Gemcitabine+Nab-paclitaxel53.6

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Frequency and Severity of Adverse Effects

Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy, by Preferred term with incidence rate greater than 5%. (NCT02446600)
Timeframe: During treatment period and up to 100 days after stopping the study treatment, up to 39 months.

,,,
InterventionParticipants (Count of Participants)
AnemiaFatigueNeutrophil count decreasedPlatelet count decreasedUrinary tract infectionWhite blood cell decreased
Arm I (Platinum-based Chemotherapy)23351241022
Arm II (Olaparib)281232113
Arm III (Olaparib, Cediranib Maleate)113173152
Japanese Cohort101001

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Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria

Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Japanese cohort not included in progression free survival analysis, only included in toxicity assessments. (NCT02446600)
Timeframe: The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.

Interventionmonths (Median)
Arm I (Platinum-based Chemotherapy)10.3
Arm II (Olaparib)8.2
Arm III (Olaparib, Cediranib Maleate)10.4

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Overall Survival

Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Japanese cohort not included in overall survival analysis, the cohort was only included in toxicity assessments. (NCT02446600)
Timeframe: Approximately 30 months

Interventionmonths (Median)
Arm I (Platinum-based Chemotherapy)31.3
Arm II (Olaparib)29.2
Arm III (Olaparib, Cediranib Maleate)30.5

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Disease Control Rate

"The number of participants that achieved either Stable Disease (SD) or a Partial Response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) at 24 weeks.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study." (NCT02448537)
Timeframe: 24 Weeks

InterventionParticipants (Count of Participants)
PM01183 and Doxorubicin13
PM01183 and Gemcitabine2
Single Agent PM011833

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Overall Response Rate

"The overall response rate is the number of participants that achieved either Stable Disease (SD), a Partial Response (PR), or a Complete Response (CR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). The overall response rate is the best response recorded from the start of treatment until disease progression/recurrence.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study." (NCT02448537)
Timeframe: Every 6 weeks for the first 8 cycles (cycle is 21 days) and then every 9 weeks thereafter until disease progression

,,
InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable DiseaseUnknown
PM01183 and Doxorubicin0761
PM01183 and Gemcitabine0110
Single Agent PM011830031

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Number of Participants With ADA Response to Tremelimumab

Blood samples were measured for the presence of ADAs and ADA-nAb for tremelimumab using validated assays. Tiered analysis was performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples were employed. Immunogenicity results were analyzed by summarizing the number of participants who developed detectable ADAs against tremelimumab. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. (NCT02453282)
Timeframe: At Weeks 0 and 12; 3 and 6 months after last dose of study treatment.

InterventionParticipants (Count of Participants)
ADA positive at any timeTreatment-emergent ADA positiveADA positive at baseline and post-baselineADA positive at post-baseline onlyADA positive at baseline onlyTreatment-boosted ADAPersistent positiveTransient positivenAb positive at any visit
Durvalumab + Tremelimumab33281284025425

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Cmax_ss of Tremelimumab

Blood samples were collected to determine the Cmax_ss of tremelimumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods. (NCT02453282)
Timeframe: Within 1 hour after end of infusion on infusion day at Week 12.

Interventionmcg/mL (Mean)
Durvalumab + Tremelimumab24.8

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Trough Serum Concentration at Steady State (Ctrough_ss) of Durvalumab

Blood samples were collected to determine the Ctrough_ss of durvalumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods. (NCT02453282)
Timeframe: Pre-dose at Week 12.

Interventionmcg/mL (Mean)
Durvalumab Monotherapy139.5
Durvalumab + Tremelimumab140.8

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Time From Randomization to Second Progression (PFS2); PD-L1 (TC >=25%) Analysis Set Population

The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy12.7
Durvalumab + Tremelimumab10.9
SoC Chemotherapy10.4

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Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy

The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of at least 5 millimeter (mm), taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab + Tremelimumab3.9
SoC Chemotherapy5.4

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PFS2; FAS Population

The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy9.3
Durvalumab + Tremelimumab9.8
SoC Chemotherapy10.1

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PFS; PD-L1 (TC >=1%) Analysis Set Population

The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy3.6
Durvalumab + Tremelimumab2.8
SoC Chemotherapy5.5

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Ctrough_ss of Tremelimumab

Blood samples were collected to determine the Ctrough_ss of tremelimumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods. (NCT02453282)
Timeframe: Pre-dose at Week 12.

Interventionmcg/mL (Mean)
Durvalumab + Tremelimumab4.9

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Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population

The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of Complete Response (CR) or Partial Response (PR). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionpercentage of participants (Number)
Durvalumab Monotherapy35.6
Durvalumab + Tremelimumab34.4
SoC Chemotherapy37.7

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DoR; FAS Population

The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab MonotherapyNA
Durvalumab + TremelimumabNA
SoC Chemotherapy4.3

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PFS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs Durvalumab Monotherapy

The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy4.7
Durvalumab + Tremelimumab3.9
SoC Chemotherapy5.4

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PFS2; PD-L1 (TC >=1%) Analysis Set Population

The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy10.6
Durvalumab + Tremelimumab9.4
SoC Chemotherapy10.5

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Serum Concentrations of Tremelimumab

Blood samples were collected to determine the serum concentration of tremelimumab. (NCT02453282)
Timeframe: Pre-dose and within 1 hour after end of infusion at Week 0 and 12, and at follow-up Month 3.

Interventionmcg/mL (Mean)
At Week 0: Pre-infusionAt Week 0: End of infusionAt Week 12: Pre-infusionAt Week 12: End of infusionAt follow-up Month 3
Durvalumab + TremelimumabNA22.64.924.80.5

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Serum Concentrations of Durvalumab

Blood samples were collected to determine the serum concentration of durvalumab. (NCT02453282)
Timeframe: Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, and at follow-up Month 3.

,
Interventionmicrogram per milliliter (mcg/mL) (Mean)
At Week 0: Pre-infusionAt Week 0: End of infusionAt Week 12: Pre-infusionAt Week 12: End of infusionAt Week 24: Pre-infusionAt Week 24: End of infusionAt follow-up Month 3
Durvalumab + TremelimumabNA444.3140.8506.1197.0553.241.4
Durvalumab MonotherapyNA484.5139.5625.3163.0598.249.3

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Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab

Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. Tiered analysis was performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples were employed. Immunogenicity results were analyzed by summarizing the number of participants who developed detectable ADAs against durvalumab. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. (NCT02453282)
Timeframe: At Weeks 0, 12, and 24; 3 and 6 months after last dose of study treatment.

,
InterventionParticipants (Count of Participants)
ADA positive at any timeTreatment-emergent ADA positiveADA positive at baseline and post-baselineADA positive at post-baseline onlyADA positive at baseline onlyTreatment-boosted ADAPersistent positiveTransient positivenAb positive at any visit
Durvalumab + Tremelimumab1481850901
Durvalumab Monotherapy1783860832

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PFS; FAS Population

The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy2.8
Durvalumab + Tremelimumab2.9
SoC Chemotherapy5.4

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Percentage of Participants APF12; PD-L1 (TC >=1%) Analysis Set Population

The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 12 months.

Interventionpercentage of participants (Number)
Durvalumab Monotherapy27.0
Durvalumab + Tremelimumab20.4
SoC Chemotherapy14.9

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Percentage of Participants APF12; FAS Population

The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 12 months.

Interventionpercentage of participants (Number)
Durvalumab Monotherapy22.5
Durvalumab + Tremelimumab19.8
SoC Chemotherapy13.8

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Percentage of Participants Alive and Progression Free at 12 Months (APF12); PD-L1 (TC >=25%) Analysis Set Population

The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 12 months.

Interventionpercentage of participants (Number)
Durvalumab Monotherapy32.3
Durvalumab + Tremelimumab25.8
SoC Chemotherapy14.3

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Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy16.3
Durvalumab + Tremelimumab11.9
SoC Chemotherapy12.9

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OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy16.3
Durvalumab + Tremelimumab11.9
SoC Chemotherapy12.9

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OS; PD-L1 (TC >=1%) Analysis Set Population

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy14.6
Durvalumab + Tremelimumab10.9
SoC Chemotherapy12.3

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OS; FAS Population

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02453282)
Timeframe: From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab Monotherapy12.3
Durvalumab + Tremelimumab11.2
SoC Chemotherapy11.8

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ORR; PD-L1 (TC >=1%) Analysis Set Population

The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionpercentage of participants (Number)
Durvalumab Monotherapy26.5
Durvalumab + Tremelimumab25.3
SoC Chemotherapy33.6

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ORR; FAS Population

The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionpercentage of participants (Number)
Durvalumab Monotherapy22.2
Durvalumab + Tremelimumab24.7
SoC Chemotherapy30.1

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Maximum Serum Concentration at Steady State (Cmax_ss) of Durvalumab

Blood samples were collected to determine the Cmax_ss of durvalumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods. (NCT02453282)
Timeframe: Within 1 hour after end of infusion on infusion day at Week 12.

Interventionmcg/mL (Mean)
Durvalumab Monotherapy625.3
Durvalumab + Tremelimumab506.1

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Duration of Response (DoR); PD-L1 (TC >=25%) Analysis Set Population

The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab MonotherapyNA
Durvalumab + TremelimumabNA
SoC Chemotherapy4.4

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DoR; PD-L1 (TC >=1%) Analysis Set Population

The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). (NCT02453282)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).

Interventionmonths (Median)
Durvalumab MonotherapyNA
Durvalumab + TremelimumabNA
SoC Chemotherapy4.4

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Progression Free Survival

Progression Free Survival (PFS) is defined as the time from randomization to the event of disease recurrence/progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause. To determine the progression free survival of subjects dosed with Vigil immunotherapy in combination with irinotecan and temozolomide. (NCT02511132)
Timeframe: Estimated median 1.3 years

InterventionParticipants (Count of Participants)
Part 1: Vigil Alone5
Part 1: Gemicitabine and Docetaxel6
Part 2: Vigil in Combination With Temozolomide and Irinotecan9

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Overall Survival

OS is defined as time from randomization to death or to the date of last follow-up. The date of last follow-up confirming survival will be used as the censoring date for subjects who are alive and/or do not have a known date of death. (NCT02511132)
Timeframe: Estimated median 2 years

InterventionParticipants (Count of Participants)
Part 1: Vigil Alone3
Part 1: Gemcitabine and Docetaxel6
Part 2: Vigil in Combination With Temozolomide and Irinotecan5

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Number of Participants With Adverse Events Determined by Laboratory Assessments and Physical Examinations

"To determine safety profile of Vigil immunotherapy in combination with irinotecan and temozolomide with 30 days of last dose in patients with metastatic Ewing's sarcoma refractory or intolerant to at least 1 prior line of systemic chemotherapy.~• To determine safety profile of Vigil immunotherapy in combination with irinotecan and temozolimidetemozolomide in patients with metastatic Ewing's sarcoma refractory or intolerant to at least 1 prior line of systemic chemotherapy." (NCT02511132)
Timeframe: 30 days of last treatment dosing

InterventionParticipants (Count of Participants)
Part 1: Vigil Alone5
Part 1: Gemcitabine and Docetaxel6
Part 2: Vigil in Combination With Temozolomide and Irinotecan9

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Alive at 24 Months (OS24), PD-L1-Low/Negative Analysis Set

Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months. (NCT02516241)
Timeframe: From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).

Interventionpercentage of participants (Number)
Combination Therapy32.1
Monotherapy24.5
Standard of Care28.6

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PFS2, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy

"Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1).~Median PFS2 was calculated using the Kaplan-Meier technique." (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Combination Therapy10.7
Monotherapy9.4
Standard of Care11.6

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To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02516241)
Timeframe: From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Combination Therapy15.1
Standard of Care12.1

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Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

"Fatigue will be based on the question of I have a lack of energy and pain will be based on the question of I have pain, according to GP1 and GP4 in PWB, respectively.~Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL.~Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL." (NCT02516241)
Timeframe: At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

,,
InterventionParticipants (Count of Participants)
Patients with improvement in fatiguePatient with deterioration in pain
Combination Therapy1564
Monotherapy1359
Standard of Care1032

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PFS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy

"Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression.~Median PFS was calculated using the Kaplan-Meier technique." (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Combination Therapy2.0
Monotherapy2.0
Standard of Care7.2

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Alive and Progression-free at 12 Months (APF12), Full Analysis Set

Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months. (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).

Interventionpercentage of participants (Number)
Combination Therapy21.4
Monotherapy16.8
Standard of Care15.3

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Alive and Progression-free at 12 Months (APF12), PD-L1-High Analysis Set

Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months. (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).

Interventionpercentage of participants (Number)
Combination Therapy25.6
Monotherapy21.2
Standard of Care15.0

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Alive and Progression-free at 12 Months (APF12), PD-L1-Low/Negative Analysis Set

Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months. (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).

Interventionpercentage of participants (Number)
Combination Therapy15.2
Monotherapy9.7
Standard of Care15.6

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Alive at 24 Months (OS24), Full Analysis Set

Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months. (NCT02516241)
Timeframe: From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).

Interventionpercentage of participants (Number)
Combination Therapy39.0
Monotherapy31.5
Standard of Care29.0

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Alive at 24 Months (OS24), PD-L1-High Analysis Set

Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months. (NCT02516241)
Timeframe: From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).

Interventionpercentage of participants (Number)
Combination Therapy43.7
Monotherapy36.0
Standard of Care29.3

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Duration of Response (DoR), PD-L1-Low/Negative Analysis Set

Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Combination Therapy12.9
Monotherapy5.6
Standard of Care5.7

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Improvement in Fatigue and Deterioration in Pain Per FACT-BL, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

"Fatigue will be based on the question of I have a lack of energy and pain will be based on the question of I have pain, according to GP1 and GP4 in PWB, respectively.~Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL.~Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL." (NCT02516241)
Timeframe: At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

,,
InterventionParticipants (Count of Participants)
Patients with improvement in fatiguePatient with deterioration in pain
Combination Therapy38142
Monotherapy37130
Standard of Care2483

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Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

"the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score.~All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104).~NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items I feel weak all overall and I feel light-headed (dizzy). The range of each item is 0-4.~Higher score represent worse" (NCT02516241)
Timeframe: At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

,,
InterventionScores on a scale (Mean)
NFBLSI - 18 Score (Average overall visits)FACT-BL TOI (Average overall visits)FACT-BL Total score (Average overall visits)
Combination Therapy-3.4-4.9-5.7
Monotherapy-3.8-5.0-6.5
Standard of Care-2.0-3.0-3.2

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Disease Control Rate (DCR) at 12 Months, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC

Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment. (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).

Interventionpercentage of participants (Number)
Combination Therapy47.3
Monotherapy30.6
Standard of Care48.8

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Disease Control Rate (DCR) at 12 Months, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy

Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment. (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).

Interventionpercentage of participants (Number)
Combination Therapy24.1
Monotherapy24.1
Standard of Care53.3

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Disease Control Rate (DCR) at 6 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

Disease control rate (DCR) at 6 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 24 weeks (-7 days, i.e., 161 days), following the start of study treatment. (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 6 months or the data cut-off date (27JAN2020).

Interventionpercentage of participants (Number)
Combination Therapy41.5
Monotherapy31.8
Standard of Care55.5

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Disease Control Rate (DCR) at 6 Months, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC

Disease control rate (DCR) at 6 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 24 weeks (-7 days, i.e., 161 days), following the start of study treatment. (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 6 months or the data cut-off date (27JAN2020).

Interventionpercentage of participants (Number)
Combination Therapy49.8
Monotherapy34.4
Standard of Care53.1

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Disease Control Rate (DCR) at 6 Months, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy

Disease control rate (DCR) at 6 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 24 weeks (-7 days, i.e., 161 days), following the start of study treatment. (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 6 months or the data cut-off date (27JAN2020).

Interventionpercentage of participants (Number)
Combination Therapy29.2
Monotherapy27.7
Standard of Care59.1

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Disease Control Rate (DCR) at 12 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment. (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020)

Interventionpercentage of participants (Number)
Combination Therapy38.0
Monotherapy28.0
Standard of Care50.6

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Duration of Response (DoR), Full Analysis Set

Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Combination Therapy11.1
Monotherapy9.3
Standard of Care5.7

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Duration of Response (DoR), PD-L1-High Analysis Set

Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Combination Therapy10.0
Monotherapy18.5
Standard of Care5.8

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Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

"the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score.~All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104).~NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items I feel weak all overall and I feel light-headed (dizzy). The range of each item is 0-4.~Higher score represent worse" (NCT02516241)
Timeframe: At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

,,
InterventionScores on a scale (Mean)
NFBLSI - 18 Score (Average overall visits)FACT-BL TOI (Average overall visits)FACT-BL Total score (Average overall visits)
Combination Therapy-3.9-5.8-8.0
Monotherapy-2.0-2.6-2.7
Standard of Care-5.7-8.0-10.1

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Objective Response Rate (ORR) Based on BICR Assessment According to RECIST 1.1 - Responses Are Confirmed - Durvalumab Cisplatin Ineligible Population

"Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR.~unconfirmed responses are excluded." (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (01NOV2017, a maximum of 3 years).

Interventionpercentage of participants (Number)
Monotherapy - PD-L1 High23.0
Monotherapy - PD-L1 Low/Negative17.9
Monotherapy - Total21.0

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Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

Interventionpercentage of participants (Number)
Combination Therapy36.3
Monotherapy25.7
Standard of Care49.1

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Objective Response Rate (ORR), PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC

Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

Interventionpercentage of participants (Number)
Combination Therapy46.8
Monotherapy27.8
Standard of Care48.3

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Objective Response Rate (ORR), PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy

Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

Interventionpercentage of participants (Number)
Combination Therapy20.4
Monotherapy22.6
Standard of Care50.4

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OS, Full Analysis Set - Durvalumab Monotherapy vs SoC

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02516241)
Timeframe: From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Monotherapy13.2
Standard of Care12.1

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Serum Concentrations of Tremelimumab, Pharmacokinetic Analysis Set

Blood samples were collected to determine the serum concentration of tremelimumab. (NCT02516241)
Timeframe: Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, pre-dose at week 4, and at follow-up Month 3.

Interventionμg/mL (Mean)
Week 0 - PredoseWeek 0 - PostdoseWeek 4 - PredoseWeek 12 - PredoseWeek 12 - PostdoseFollow-up Month 3
Combination TherapyNA24.03.755.4328.10.943

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Serum Concentrations of Durvalumab, Pharmacokinetic Analysis Set

Blood samples were collected to determine the serum concentration of durvalumab. (NCT02516241)
Timeframe: Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, pre-dose at week 4, and at follow-up Month 3.

,
Interventionμg/mL (Mean)
Week 0 - PredoseWeek 0 - PostdoseWeek 4 - PredoseWeek 12 - PredoseWeek 12 - PostdoseWeek 24 - PredoseWeek 24 - PostdoseFollow-up Month 3
Combination TherapyNA51175.312559415060423.3
MonotherapyNA48478.914457616360019.9

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Number of Participants With Anti-Drug Antibody (ADA) Response to Tremelimumab, Safety Analysis Set - ADA Evaluable Patients

Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Tremelimumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline. (NCT02516241)
Timeframe: At week 0, 4, 12 and at follow-up Month 3.

InterventionParticipants (Count of Participants)
ADA evaluable patientsADA positive at any visit (ADA Prevalence)Treatment-emergent ADA positive (ADA Incidence)Treatment-boosted ADATreatment-induced ADA (Positive Post-baseline only)ADA Positive at Baseline onlyADA Positive Post-baseline and Positive at BaselinePersistently PositiveTransiently PositivenAb Positive at any visit
Combination Therapy292645415383312550

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Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab, Safety Analysis Set - ADA Evaluable Patients

Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Durvalumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline. (NCT02516241)
Timeframe: At week 0, 4, 12 and 24, and at follow-up Month 3.

,
InterventionParticipants (Count of Participants)
ADA evaluable patientsADA positive at any visit (ADA Prevalence)Treatment-emergent ADA positive (ADA Incidence)Treatment-boosted ADATreatment-induced ADA (Positive Post-baseline only)ADA Positive at Baseline onlyADA Positive Post-baseline and Positive at BaselinePersistently PositiveTransiently PositivenAb Positive at any visit
Combination Therapy29337280288115143
Monotherapy3023111110183852

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OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02516241)
Timeframe: From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Combination Therapy11.8
Monotherapy10.9
Standard of Care12.2

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PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

"Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression.~Median PFS was calculated using the Kaplan-Meier technique." (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Combination Therapy3.7
Monotherapy2.3
Standard of Care6.7

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PFS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC

"Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression.~Median PFS was calculated using the Kaplan-Meier technique." (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Combination Therapy4.1
Monotherapy2.4
Standard of Care5.8

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To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02516241)
Timeframe: From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Monotherapy14.4
Standard of Care12.1

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OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02516241)
Timeframe: From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Combination Therapy17.9
Standard of Care12.1

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PFS2, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

"Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1).~Median PFS2 was calculated using the Kaplan-Meier technique." (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Combination Therapy14.6
Monotherapy11.9
Standard of Care11.5

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PFS2, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC

"Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1).~Median PFS2 was calculated using the Kaplan-Meier technique." (NCT02516241)
Timeframe: Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

InterventionMonths (Median)
Combination Therapy17.2
Monotherapy13.4
Standard of Care11.3

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Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

"Fatigue will be based on the question of I have a lack of energy and pain will be based on the question of I have pain, according to GP1 and GP4 in PWB, respectively.~Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL.~Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL." (NCT02516241)
Timeframe: At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

,,
InterventionParticipants (Count of Participants)
Patients with improvement in fatiguePatient with deterioration in pain
Combination Therapy2378
Monotherapy2471
Standard of Care1451

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Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

"the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score.~All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104).~NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items I feel weak all overall and I feel light-headed (dizzy). The range of each item is 0-4.~Higher score represent worse outcome." (NCT02516241)
Timeframe: At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

,,
InterventionScores on a scale (Mean)
NFBLSI - 18 Score (Average overall visits)FACT-BL TOI (Average overall visits)FACT-BL Total score (Average overall visits)
Combination Therapy-3.7-5.5-7.2
Monotherapy-3.1-3.9-4.7
Standard of Care-5.2-7.2-8.8

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Overall Response Rate

defined as the percentage of patients with complete or partial responses based on RECIST 1.1, at any time prior to disease progression, out of all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT02525653)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Partial ResponseComplete ResponseNot Evaluated, withdrew from studyStable DiseaseNo Response
Albumin-Bound Paclitaxel and Gemcitabine1815124

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Number of Participants With Clinical Benefit

Clinical benefit defined as any response or stable disease ≥4 months. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (NCT02533674)
Timeframe: Every two cycles (every six weeks ± one week) until Cycle 4, and then every three cycles (every nine weeks ± one week) while on treatment, up to 2 years

InterventionParticipants (Count of Participants)
GEM/PM060184 Dose Level I1
GEM/PM060184 Dose Level II3
GEM/PM060184 Dose Level III2
GEM/PM060184 Dose Level IV1
GEM/PM060184 Dose Level V1
GEM/PM060184 Dose Level VI2
GEM/PM060184 Dose Level VII6
GEM/PM060184 Dose Level VIII2

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Number of Participants With Dose Limiting Toxicities

"Dose-limiting toxicities were defined as:~Grade 4 neutropenia lasting >3 days~Grade≥3 febrile neutropenia of any duration or neutropenic sepsis~Grade 4 thrombocytopenia or grade 3 with any major bleeding episode requiring a platelet transfusion~Grade 4 ALT/AST increase, or grade 3 lasting >7 days~Treatment-related grade≥2 ALT/AST increase concomitantly with ≥2 x ULN total bilirubin increase and normal AP~Any other grade≥3 non-hematological AE that was suspected to be related to study drugs, except nausea/vomiting, hypersensitivity reactions, extravasations, grade 3 asthenia lasting less than one week, anorexia, and non-clinically relevant isolated biochemical abnormalities~Delay in the administration of Cycle 2 of the combination exceeding seven (+1) days of the treatment due date due to any AEs related to study drugs.~The following circumstances were to be discussed between the Principal Investigator and the Sponsor, and the final consensus had to be documented" (NCT02533674)
Timeframe: From the start of treatment to the end of cycle one which are 3 weeks

InterventionParticipants (Count of Participants)
GEM/PM060184 Dose Level I0
GEM/PM060184 Dose Level II1
GEM/PM060184 Dose Level III0
GEM/PM060184 Dose Level IV0
GEM/PM060184 Dose Level V0
GEM/PM060184 Dose Level VI1
GEM/PM060184 Dose Level VII1
GEM/PM060184 Dose Level VIII1

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Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets

"The PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1] using Investigator assessments) was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1).~bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.~tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb and tTMB ≥8 mut/Mb analysis sets included the subset of participants in FAS whose tTMB status was ≥14 mut/Mb, ≥12 mut/Mb, ≥10 mut/Mb and ≥8 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).

,
Interventionmonths (Median)
bTMB ≥20 mut/Mb analysis setbTMB ≥16 mut/Mb analysis setbTMB ≥12 mut/Mb analysis settTMB ≥14 mut/Mb analysis settTMB ≥12 mut/Mb analysis settTMB ≥10 mut/Mb analysis settTMB ≥8 mut/Mb analysis set
Global: Durvalumab + Tremelimumab4.24.23.98.75.24.34.4
Global: SoC Chemotherapy5.15.55.15.85.85.15.0

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Serum Concentrations of Durvalumab

Blood samples were collected to determine the serum concentration of durvalumab. (NCT02542293)
Timeframe: Pre-dose and within 1 hour after end of infusion at Week 0 and 12; pre-dose on Week 24 and at follow-up Month 3

,
Interventionmicrogram per milliliter (µg/mL) (Geometric Mean)
Week 0: Pre-infusionWeek 0: End of infusionWeek 12: Pre-infusionWeek 12: End of infusionWeek 24: Pre-infusionFollow-up Month 3
China: Durvalumab + TremelimumabNA392.772.4448.985.65.4
Global: Durvalumab + TremelimumabNA418.677.5434.3108.88.8

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Serum Concentrations of Tremelimumab

Blood samples were collected to determine the serum concentration of tremelimumab. (NCT02542293)
Timeframe: Pre-dose and within 1 hour after end of infusion at Week 0 and 12, and at follow-up Month 3

,
Interventionµg/mL (Geometric Mean)
Week 0: Pre-infusionWeek 0: End of infusionWeek 12: Pre-infusionWeek 12: End of infusionFollow-up Month 3
China: Durvalumab + TremelimumabNA18.43.323.2NA
Global: Durvalumab + TremelimumabNA20.33.420.8NA

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DoR; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets

"DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1).~PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~Global Cohort: The FAS included all randomized participants prior to the end of global recruitment.~China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.

,,,
Interventionmonths (Median)
PD-L1-negative NSCLC analysis setFAS
China: Durvalumab + Tremelimumab10.512.9
China: SoC Chemotherapy6.16.1
Global: Durvalumab + Tremelimumab10.211.1
Global: SoC Chemotherapy4.94.9

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APF12; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets

"The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months).~PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~Global Cohort: The FAS included all randomized participants prior to the end of global recruitment.~China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses." (NCT02542293)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 12 months.

,,,
Interventionpercentage of participants (Number)
PD-L1-negative NSCLC analysis setFAS
China: Durvalumab + Tremelimumab15.623.9
China: SoC Chemotherapy11.316.6
Global: Durvalumab + Tremelimumab18.220.2
Global: SoC Chemotherapy12.114.9

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OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02542293)
Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the China cohort DCO date (a maximum of approximately 44 months).

Interventionmonths (Median)
China: Durvalumab + Tremelimumab15.0
China: SoC Chemotherapy11.7

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Time From Randomization to Second Progression or Death (PFS2); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets

"The PFS2 was defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the primary variable PFS, or death (ie, date of PFS2 event or censoring - date of randomization + 1).~bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).

,
Interventionmonths (Median)
bTMB ≥20 mut/Mb analysis setbTMB ≥16 mut/Mb analysis setbTMB ≥12 mut/Mb analysis set
Global: Durvalumab + Tremelimumab10.610.99.9
Global: SoC Chemotherapy8.610.59.0

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Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT02542293)
Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).

Interventionmonths (Median)
Global: Durvalumab + Tremelimumab11.7
Global: SoC Chemotherapy9.1

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Alive and Progression-Free at 12 Months (APF12); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets

"The APF12 was defined as the percentage of participants who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months).~bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline then every 6 weeks up to 12 months.

,
Interventionpercentage of participants (Number)
bTMB ≥20 mut/Mb analysis setbTMB ≥16 mut/Mb analysis setbTMB ≥12 mut/Mb analysis set
Global: Durvalumab + Tremelimumab25.622.021.6
Global: SoC Chemotherapy7.012.313.8

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Duration of Response (DoR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets

"DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1).~bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).

,
Interventionmonths (Median)
bTMB ≥20 mut/Mb analysis setbTMB ≥16 mut/Mb analysis setbTMB ≥12 mut/Mb analysis set
Global: Durvalumab + Tremelimumab11.610.611.5
Global: SoC Chemotherapy4.24.34.3

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Number of Participants With ADA Response to Tremelimumab

Blood samples were measured for the presence of ADAs and ADA-nAb for tremelimumab using validated assays. ADA prevalence is defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as the sum of treatment-induced ADA and treatment-boosted ADA. ADA incidence is the percentage of participants who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted to >=4 fold during the study period. Persistently positive is defined as having at least 2 post baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least 1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive. (NCT02542293)
Timeframe: At Weeks 0 and 12; 3 and 6 months after last dose of study treatment.

,
InterventionParticipants (Count of Participants)
ADA positive at any visit (ADA prevalence)Treatment-emergent ADA positive (ADA incidence)Treatment-boosted ADATreatment-induced ADA (positive post-baseline only)ADA positive post-baseline and positive at baselinePersistent positiveTransient positivenAb positive at any visitADA positive at baseline and not detected post-baseline
China: Durvalumab + Tremelimumab210110200
Global: Durvalumab + Tremelimumab493713642911339

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Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab

Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. ADA prevalence is defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as the sum of treatment-induced ADA and treatment-boosted ADA. ADA incidence is the percentage of participants who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted to >=4 fold during the study period. Persistently positive is defined as having at least 2 post baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least 1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive. (NCT02542293)
Timeframe: At Weeks 0, 12, and 24; 3 and 6 months after last dose of study treatment.

,
InterventionParticipants (Count of Participants)
ADA positive at any visit (ADA prevalence)Treatment-emergent ADA positive (ADA incidence)Treatment-boosted ADATreatment-induced ADA (positive post-baseline only)ADA positive post-baseline and positive at baselinePersistent positiveTransient positivenAb positive at any visitADA positive at baseline and not detected post-baseline
China: Durvalumab + Tremelimumab110101000
Global: Durvalumab + Tremelimumab26120121112313

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Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets

"The ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) prior to PD.~bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.~tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb and tTMB ≥8 mut/Mb analysis sets included the subset of participants in FAS whose tTMB status was ≥14 mut/Mb, ≥12 mut/Mb, ≥10 mut/Mb and ≥8 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).

,
Interventionpercentage of participants (Number)
bTMB ≥20 mut/Mb analysis setbTMB ≥16 mut/Mb analysis setbTMB ≥12 mut/Mb analysis settTMB ≥14 mut/Mb analysis settTMB ≥12 mut/Mb analysis settTMB ≥10 mut/Mb analysis settTMB ≥8 mut/Mb analysis set
Global: Durvalumab + Tremelimumab27.531.228.761.342.637.736.7
Global: SoC Chemotherapy43.346.142.044.741.842.541.2

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ORR; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets

"The ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD.~PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~Global Cohort: The FAS included all randomized participants prior to the end of global recruitment.~China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.~PD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included the subset of participants in the FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.

,,,
Interventionpercentage of participants (Number)
PD-L1-negative NSCLC analysis setFASPD-L1 TC ≥25% analysis setPD-L1 TC ≥50% analysis set
China: Durvalumab + Tremelimumab23.135.954.860.0
China: SoC Chemotherapy41.439.040.646.4
Global: Durvalumab + Tremelimumab23.125.935.237.4
Global: SoC Chemotherapy38.841.743.944.0

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OS at Months 12, 18 and 24; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets

"The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1).~PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~Global Cohort: The FAS included all randomized participants prior to the end of global recruitment.~China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses." (NCT02542293)
Timeframe: Months 12, 18 and 24

,,,
Interventionpercentage of participants (Number)
Month 12: PD-L1-negative NSCLC analysis setMonth 12: FASMonth 18: PD-L1-negative NSCLC analysis setMonth 18: FASMonth 24: PD-L1-negative NSCLC analysis setMonth 24: FAS
China: Durvalumab + Tremelimumab68.072.844.054.636.044.2
China: SoC Chemotherapy46.453.139.341.817.930.4
Global: Durvalumab + Tremelimumab47.847.734.134.822.125.7
Global: SoC Chemotherapy52.850.034.534.622.323.4

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OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets

"The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1).~bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay." (NCT02542293)
Timeframe: Months 12, 18 and 24

,
Interventionpercentage of participants (Number)
Month 12: bTMB ≥20 mut/Mb analysis setMonth 12: bTMB ≥16 mut/Mb analysis setMonth 12: bTMB ≥12 mut/Mb analysis setMonth 18: bTMB ≥20 mut/Mb analysis setMonth 18: bTMB ≥16 mut/Mb analysis setMonth 18: bTMB ≥12 mut/Mb analysis setMonth 24: bTMB ≥20 mut/Mb analysis setMonth 24: bTMB ≥16 mut/Mb analysis setMonth 24: bTMB ≥12 mut/Mb analysis set
Global: Durvalumab + Tremelimumab49.350.546.936.235.529.426.124.021.3
Global: SoC Chemotherapy40.848.944.620.428.527.813.618.219.0

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OS; Global and China Cohorts: FAS, PD-L1 Tumor Cell (TC) ≥25%, and PD-L1 TC ≥50% Analysis Sets

"The OS was defined as time from date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on last recorded date on which participant was known to be alive.~Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. Any participants recruited in China, after global recruitment had ended, were not included in the FAS.~China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.~PD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included the subset of participants in the FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay." (NCT02542293)
Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global or China cohort DCO dates, as applicable (a maximum of approximately 44 months) for each cohort.

,,,
Interventionmonths (Median)
FASPD-L1 TC ≥25% analysis setPD-L1 TC ≥50% analysis set
China: Durvalumab + Tremelimumab20.036.636.6
China: SoC Chemotherapy14.115.815.8
Global: Durvalumab + Tremelimumab10.912.214.1
Global: SoC Chemotherapy12.110.410.5

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OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets

"OS was defined as time from date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at time of analysis was censored based on last recorded date on which participant was known to be alive.~bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb and bTMB <20 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥16 mut/Mb, ≥12 mut/Mb and <20 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.~PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~bTMB non-evaluable analysis set included the subset of participants in FAS whose bTMB status at baseline could not be determined by the GuardantOMNI CDx assay or whose sample was not available.~tTMB analysis sets are defined same as the bTMB analysis sets (NCT02542293)
Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).

,
Interventionmonths (Median)
bTMB ≥16 mut/Mb analysis setbTMB ≥12 mut/Mb analysis setPD-L1 negative analysis setbTMB <20 mut/Mb analysis setbTMB non-evaluable analysis settTMB ≥14 mut/Mb analysis settTMB ≥12 mut/Mb analysis settTMB ≥10 mut/Mb analysis settTMB ≥8 mut/Mb analysis set
Global: Durvalumab + Tremelimumab12.110.911.19.99.317.511.111.111.0
Global: SoC Chemotherapy11.910.312.511.510.410.613.910.610.2

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PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets

"PFS (per RECIST 1.1 using Investigator assessments) was defined as time from date of randomization until date of objective PD or death regardless of whether participant withdrew from randomized therapy or received another anticancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1).~PD-L1-negative analysis set included subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~Global Cohort: FAS included all randomized participants prior to end of global recruitment.~China Cohort: China FAS included all randomized participants in China cohort and were used for all China only efficacy analyses.~PD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included subset of participants in FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.

,,,
Interventionmonths (Median)
PD-L1-negative NSCLC analysis setFASPD-L1 TC ≥25% analysis setPD-L1 TC ≥50% analysis set
China: Durvalumab + Tremelimumab5.14.26.86.8
China: SoC Chemotherapy6.06.05.75.7
Global: Durvalumab + Tremelimumab4.14.04.24.6
Global: SoC Chemotherapy5.65.65.45.4

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PFS2; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets

"The PFS2 was defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the primary variable PFS, or death (ie, date of PFS2 event or censoring - date of randomization + 1).~PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, <1% PD-L1-membrane expression in tumoral tissue).~Global Cohort: The FAS included all randomized participants prior to the end of global recruitment.~China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses." (NCT02542293)
Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.

,,,
Interventionmonths (Median)
PD-L1-negative NSCLC analysis setFAS
China: Durvalumab + Tremelimumab13.815.5
China: SoC Chemotherapy10.312.9
Global: Durvalumab + Tremelimumab9.19.4
Global: SoC Chemotherapy12.410.4

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Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10

Overall Response Rate (ORR), based on a Blinded Independent Central Review (BICR) assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionPercentage of participants (Number)
Pembrolizumab17.7
Chemotherapy9.2

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Overall Survival in All Participants

Overall survival (OS) was defined as the time from randomization to death due to any cause. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab9.9
Chemotherapy10.8

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Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 Who Had a Confirmed Response

For participants with PD-L1 CPS ≥1 who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR. (NCT02555657)
Timeframe: Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab12.2
ChemotherapyNA

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Overall Survival in Participants With PD-L1 CPS ≥1

Overall survival (OS) was defined as the time from randomization to death due to any cause. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab10.7
Chemotherapy10.2

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Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥1

Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab2.1
Chemotherapy3.1

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Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥10

Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab2.1
Chemotherapy3.4

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Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 Who Had a Confirmed Response

For participants with PD-L1 CPS ≥10 who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR. (NCT02555657)
Timeframe: Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
PembrolizumabNA
Chemotherapy7.1

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Duration of Response Per RECIST 1.1 in All Participants Who Had a Confirmed Response

For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR. (NCT02555657)
Timeframe: Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab12.2
ChemotherapyNA

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Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1

Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.]) (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionPercentage of participants (Number)
Pembrolizumab14.3
Chemotherapy15.8

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Disease Control Rate Per RECIST 1.1 in All Participants

Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.]) (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionPercentage of participants (Number)
Pembrolizumab12.2
Chemotherapy18.7

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Overall Response Rate Per RECIST 1.1 in All Participants

Overall Response Rate (ORR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionPercentage of participants (Number)
Pembrolizumab9.6
Chemotherapy10.6

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Overall Response Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1

Overall Response Rate (ORR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionPercentage of participants (Number)
Pembrolizumab12.3
Chemotherapy9.4

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Number of Participants Who Experienced One or More Adverse Events

An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. (NCT02555657)
Timeframe: Up to approximately 60 months

InterventionParticipants (Count of Participants)
Pembrolizumab285
Chemotherapy281

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Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥10

Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.]) (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionPercentage of participants (Number)
Pembrolizumab19.8
Chemotherapy17.3

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Number of Participants Who Discontinued Study Treatment Due to an Adverse Event

An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. (NCT02555657)
Timeframe: Up to approximately 60 months

InterventionParticipants (Count of Participants)
Pembrolizumab14
Chemotherapy16

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Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10

Overall survival (OS) was defined as the time from randomization to death due to any cause. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab12.7
Chemotherapy11.6

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Progression-Free Survival Per RECIST 1.1 in All Participants

Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab2.1
Chemotherapy3.3

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Safety of Drug Regimen as Measured by Number of Adverse Events

Toxicity assessment will be observational. Numbers and types of events will be quantified and graded according to CTCAE. (NCT02560038)
Timeframe: From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months

Interventionadverse event (Number)
Combination Chemotherapy124

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Efficacy as Measured by Number Who Progressed

"Progression is defined using RECIST 1.1 criteria: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)." (NCT02560038)
Timeframe: From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months

InterventionParticipants (Count of Participants)
Combination Chemotherapy1

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Efficacy as Measured by the Objective Response Rate (ORR).

Objective Response Rate (ORR) is defined as the proportion of patients achieving either a complete response or a partial response based on imaging at any time during the study. Complete response or partial response is based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT02560038)
Timeframe: From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months

InterventionParticipants (Count of Participants)
Combination Chemotherapy3

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Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT02562716)
Timeframe: Up to 6 months post registration (and within 2 to 4 weeks after the last dose of Cycle 3 preoperative chemotherapy.).

InterventionParticipants (Count of Participants)
mFOLFIRINOX ->Surg ->mFOLFIRINOX5
Gem/Nab-P ->Surg ->Gem/Nab-P10

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Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy.

(NCT02562716)
Timeframe: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).

InterventionParticipants (Count of Participants)
mFOLFIRINOX ->Surg ->mFOLFIRINOX40
Gem/Nab-P ->Surg ->Gem/Nab-P33

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Number of Patients Achieving R0 Resection After Preoperative Chemotherapy.

R0 resection classification is defined as macroscopically complete tumor removal with negative microscopic surgical margins (bile duct, pancreatic parenchyma, and superior mesenteric artery margins). (NCT02562716)
Timeframe: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).

InterventionParticipants (Count of Participants)
mFOLFIRINOX ->Surg ->mFOLFIRINOX34
Gem/Nab-P ->Surg ->Gem/Nab-P28

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Disease-free Survival From the Time of R0 or R1 Resection.

Disease-free survival (DFS) is calculated for patients who undergo surgical resection (R0/R1). DFS will be measured from the date of surgical resection to date of first documentation of recurrence (loco-regional or distant) or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last contact. (NCT02562716)
Timeframe: Up to 4 years

InterventionMonths (Median)
mFOLFIRINOX ->Surg ->mFOLFIRINOX10.9
Gem/Nab-P ->Surg ->Gem/Nab-P14.2

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Overall Survival (OS)

OS is the length of time between protocol registration and patient death (NCT02562716)
Timeframe: Up to 4 years for the estimates of median overall survival. Up to 2 years for Statistical Analysis 1 and 2, comparing the observed 2-year overall survival (OS) to the null hypothesis of 40%, in each arm.

InterventionMonths (Median)
mFOLFIRINOX ->Surg ->mFOLFIRINOX23.2
Gem/Nab-P ->Surg ->Gem/Nab-P23.6

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CA19-9 Clinical Response Rate

The CA19-9 Response Rate is calculated using CA 19-9 treated patients who had a baseline CA19-9 > 75 units who have confirmed CA19-9 reduction of 75% from baseline value. Patients who have missing CA19-9 measurements will be treated as non-responders, i.e., they will be included in the denominator when calculating the percentage. The CA19-9 Response Rate, along with exact 95% confidence intervals, will be reported for the study. (NCT02562898)
Timeframe: 12 months

Interventionproportion of responders (Number)
Dose Escalation for Safety and Toxicity0.333
Immune Response Cohort0.143

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Maximum Tolerated Dose (MTD)

The dose level at which fewer than 2 of 6 patients experience a dose-limiting toxicity (DLT) will be designated as the Maximum Tolerated Dose (MTD) (NCT02562898)
Timeframe: Up to 2 years

Interventionmg/day (Number)
Dose Escalation for Safety and Toxicity820
Immune Response Cohort560

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Median Overall Survival (OS)

Median OS for all enrolled patients will be calculated from date of first dose of protocol therapy until date of death, using chart review and/or follow up phone calls to determine date of death in patients after removal from study. The survival of patients still alive after 2 years of follow up post study discontinuation will be censored. Alive patients are censored at the date last known alive. Kaplan-Meier methods will be used to summarize median OS with 95% confidence intervals. (NCT02562898)
Timeframe: Up to 2 years

Interventiondays (Median)
Dose Escalation for Safety and Toxicity246
Immune Response Cohort170

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Median Progression-free Survival (PFS)

PFS is defined as the duration of time from date of first dose of protocol therapy to time of documented radiographic and/or clinical disease progression or death from any cause. Eligible patients are evaluable for PFS who are response-evaluable and who are removed from study for radiographic or clinical progression and/or who experience death from any cause during study follow up. Patients who have not progressed or died are censored at the date last known to be progression-free. Kaplan-Meier methods will be used to summarize median PFS with 95% confidence intervals. The proportion of patients with PFS equal to or exceeding 6 months will also be calculated and reported along with 95% confidence intervals. (NCT02562898)
Timeframe: 10 months

Interventiondays (Median)
Dose Escalation for Safety and Toxicity128
Immune Response Cohort99

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Median Time-to-progression (TTP)

Time to Progression is defined as the time from date of first dose of protocol therapy to time of documented radiographic and/or clinical disease progression or death from any cause. Kaplan-Meier methods will be used to summarize median TTP with 95% confidence intervals. (NCT02562898)
Timeframe: 10 months

Interventiondays (Median)
Dose Escalation for Safety and Toxicity128
Immune Response Cohort126

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Number of Patients Who Experienced a Dose-Limiting Toxicity (DLT)

DLTs will be based on the first course of treatment and defined as any unexpected grade 3 non-hematologic toxicity not reversible to grade 2 or less within 96 hours, or any grade 4 toxicity. Grade 4 hematological toxicities will not be considered dose limiting in this trial since a significant fraction of patients who are treated with gemcitabine and nab-paclitaxel are expected to experience these toxicities. Grade 3 peripheral neuropathy, a common and expected toxicity of treatment with nabpaclitaxel, will not be considered a DLT. (NCT02562898)
Timeframe: Up to 2 years

Interventionparticipants (Number)
Dose Escalation for Safety and Toxicity9
Immune Response Cohort8

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Treatment Limiting Adverse Events

Adverse events that were fatal or led to treatment discontinuation. (NCT02567409)
Timeframe: Assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months.

,
InterventionParticipants (Count of Participants)
HypotensionMulti-organ failureCardiac arrestNeutropeniaRespiratory failurePulmonary embolismThrombocytopeniaCreatinine IncreasedLeukocytosisAcute kidney injuryVomitingUrinary tract infection
Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin)001211211101
Arm B (Gemcitabine Hydrochloride, Cisplatin)110001220010

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Confirmed Objective Response Rate

Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Confirmed Objective Response = CR + PR. (NCT02567409)
Timeframe: Up to 36 months

Interventionpercentage of participants (Number)
Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin)54
Arm B (Gemcitabine Hydrochloride, Cisplatin)63

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Progression-free Survival (PFS)

Estimated using the product-limit method of Kaplan and Meier. Event defined as progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02567409)
Timeframe: Day of randomization, until progression, or death, assessed up to 12 months

InterventionMonths (Median)
Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin)8.0
Arm B (Gemcitabine Hydrochloride, Cisplatin)8.0

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Overall Survival (OS)

Estimated using the product-limit method of Kaplan and Meier. Event defined as death from any cause. (NCT02567409)
Timeframe: Up to 36 months

InterventionMonths (Median)
Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin)14.4
Arm B (Gemcitabine Hydrochloride, Cisplatin)19.8

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Overall Response Rate (ORR)

The overall response rate (ORR) of ACP-196 plus nab-paclitaxel/gemcitabine compared with nab-paclitaxel/gemcitabine in patients with previously untreated metastatic pancreatic cancer (NCT02570711)
Timeframe: At screening, Cycle 3, and Day 1 of every other cycle afterwards (e.g., Cycle 5 Day 1). Every cycle is 28 days.

InterventionParticipants (Count of Participants)
Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine0
Arm 2 - Nab-Paclitaxel and Gemcitabine0

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Progression-Free Survival (PFS), Group E Only

Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first. (NCT02574078)
Timeframe: up to approximately 48 months

Interventionmonths (Median)
Group E9.63

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Duration of Response (DOR), Groups A-D Only

"Duration of response (DOR) is defined as the time from first confirmed response (complete response (CR) or partial response (PR)) to the date of the initial objectively documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first.~Median computed using Kaplan-Meier method." (NCT02574078)
Timeframe: up to approximately 48 months

Interventionmonths (Median)
Group A, Cohort A, Nivo12.780
Group A, Cohort A, Beva + NivoNA
Group A, Cohort A, Beva17.084
Group A, Cohort B, Nivo12.912
Group A, Cohort B, Peme + Nivo8.542
Group A, Cohort B, Peme14.982
Group B, NivoNA
Group B, BSCNA
Group C, Nivo3.877
Group C, ICC2.940
Group D, Nivo + Erlo8.805
Group D, Erlo10.152

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Progression-Free Survival (PFS), Groups A-D Only

Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first. (NCT02574078)
Timeframe: up to approximately 48 months

InterventionMonths (Median)
Group A, Cohort A, Nivo15.0
Group A, Cohort A, Beva + Nivo6.7
Group A, Cohort A, Beva6.0
Group A, Cohort B, Nivo5.9
Group A, Cohort B, Peme + Nivo8.1
Group A, Cohort B, Peme5.0
Group B, Nivo9.6
Group B, BSC2.3
Group C, Nivo2.7
Group C, ICC6.7
Group D, Nivo + Erlo11.0
Group D, Erlo11.0

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Overall Survival (OS), Groups A-C Only

Overall survival (OS) is defined as the time from randomization to the date of death. (NCT02574078)
Timeframe: up to approximately 60 months

InterventionMonths (Median)
Group A, Cohort A, Nivo20.0
Group A, Cohort A, Beva + Nivo30.8
Group A, Cohort A, Beva18.1
Group A, Cohort B, Nivo28.9
Group A, Cohort B, Peme + Nivo17.4
Group A, Cohort B, Peme18.4
Group B, NivoNA
Group B, BSC13.6
Group C, Nivo3.9
Group C, ICC15.8

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Overall Survival (OS), Group D Only

Overall survival (OS) is defined as the time from randomization to the date of death. (NCT02574078)
Timeframe: up to approximately 60 months

Interventionmonths (Median)
Group D, Nivo + ErloNA
Group D, Erlo34.8

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Objective Response Rate (ORR), Groups A-E

"Objective response rate (ORR) is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.~Confidence interval based on the Clopper and Pearson method." (NCT02574078)
Timeframe: up to approximately 48 months

InterventionPercentage of participants (Number)
Group A, Cohort A, Nivo23.1
Group A, Cohort A, Beva + Nivo16.7
Group A, Cohort A, Beva12.5
Group A, Cohort B, Nivo29.4
Group A, Cohort B, Peme + Nivo21.2
Group A, Cohort B, Peme3.1
Group B, Nivo18.8
Group B, BSC5.9
Group C, Nivo20.8
Group C, ICC15.4
Group D, Nivo + Erlo64.7
Group D, Erlo62.5
Group E23.1

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Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population

CBR was defined as the percentage of participants with best response as either CR, PR, or stable disease (SD) with a duration of ≥6 months. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; and Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD: ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT02574455)
Timeframe: From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

,
Interventionpercentage of participants (Number)
IRC AssessmentInvestigator Assessment
Sacituzumab Govitecan44.745.5
Treatment of Physician's Choice (TPC)8.610.3

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Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population

DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. (NCT02574455)
Timeframe: From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

,
Interventionmonths (Median)
IRC AssessmentInvestigator Assessment
Sacituzumab Govitecan6.36.9
Treatment of Physician's Choice (TPC)3.63.0

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Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug

"Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:~Fatal~Life-threatening~Disabling/incapacitating~Results in hospitalization or prolongs a hospital stay~A congenital abnormality~Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above" (NCT02574455)
Timeframe: First dose date up to last follow-up (maximum up to 30.8 months)

,
Interventionpercentage of participants (Number)
Any TEAEsSAEsTEAEs Leading to Discontinuation of Study Drug
Sacituzumab Govitecan99.626.74.7
Treatment of Physician's Choice (TPC)97.828.65.4

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Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population

ORR was defined as the percentage of participants who had the overall best response as either a confirmed complete response (CR) or partial response (PR) relative to the size of population under evaluation. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and no new lesions. (NCT02574455)
Timeframe: From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

,
Interventionpercentage of participants (Number)
ORR by IRC AssessmentORR by Investigator Assessment
Sacituzumab Govitecan34.933.2
Treatment of Physician's Choice (TPC)4.76.4

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Overall Survival (OS) in BM-ve Population

Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. (NCT02574455)
Timeframe: From the randomization to death from any cause (maximum follow-up duration: 30.8 months)

Interventionmonths (Median)
Sacituzumab Govitecan12.1
Treatment of Physician's Choice (TPC)6.7

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Progression-Free Survival (PFS) by IRC Assessment in the ITT Population

PFS was defined as the time from randomization until objective tumor progression by RECIST v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. (NCT02574455)
Timeframe: From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Interventionmonths (Median)
Sacituzumab Govitecan4.8
Treatment of Physician's Choice (TPC)1.7

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Time to Objective Response by the IRC Assessment in BM-ve Population

Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. (NCT02574455)
Timeframe: From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Interventionmonths (Mean)
Sacituzumab Govitecan2.67
Treatment of Physician's Choice (TPC)1.86

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Time to Progression (TTP) by Investigator Assessment in BM-ve Population

Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. (NCT02574455)
Timeframe: From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Interventionmonths (Median)
Sacituzumab Govitecan5.7
Treatment of Physician's Choice (TPC)1.8

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Time to Progression (TTP) by IRC Assessment in BM-ve Population

Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. (NCT02574455)
Timeframe: From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Interventionmonths (Median)
Sacituzumab Govitecan5.8
Treatment of Physician's Choice (TPC)2.1

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Overall Survival (OS) in ITT Population

Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. (NCT02574455)
Timeframe: From the randomization to death from any cause (maximum follow-up duration: 30.8 months)

Interventionmonths (Median)
Sacituzumab Govitecan11.8
Treatment of Physician's Choice (TPC)6.9

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Time to Objective Response by the Investigator Assessment in BM-ve Population

Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. (NCT02574455)
Timeframe: From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Interventionmonths (Mean)
Sacituzumab Govitecan2.14
Treatment of Physician's Choice (TPC)2.72

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Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population

PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to [≥] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. (NCT02574455)
Timeframe: From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Interventionmonths (Median)
Sacituzumab Govitecan5.6
Treatment of Physician's Choice (TPC)1.7

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Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline

Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported. (NCT02574455)
Timeframe: First dose date up to last follow-up (maximum up to 30.8 months)

,
Interventionpercentage of participants (Number)
AnemiaLymphocyte Count DecreasedNeutrophil Count DecreasedPlatelet Count DecreasedWhite Blood Cell DecreasedAlanine Aminotransferase IncreasedAlkaline Phosphatase IncreasedAspartate Aminotransferase IncreasedBlood Bilirubin IncreasedCreatinine IncreasedHypercalcemiaHyperglycemiaHyperkalemiaHypermagnesemiaHypernatremiaHypoalbumenemiaHypocalcemiaHypoglycemiaHypokalemiaHypomagnesemiaHyponatremiaHypophosphatemia
Sacituzumab Govitecan8.933.348.81.241.11.23.13.51.90.403.10.80.400.81.60.44.30.83.98.1
Treatment of Physician's Choice (TPC)5.425.035.32.725.42.23.62.22.700.43.100.401.31.300.903.63.6

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score

The EORTC QLQ-C30 is a questionnaire to assess quality of life (QoL), it is composed of 30 questions (items) resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom and single-item scales indicate a better quality of life; a negative change from baseline indicates improvement. (NCT02574455)
Timeframe: Baseline; End of Treatment (EOT) (up to 29.6 months)

,
Interventionscore on a scale (Mean)
Global Health Status/QoL: BaselineGlobal Health Status/QoL: Change From Baseline at EOTPhysical Functioning: BaselinePhysical Functioning: Change From Baseline at EOTRole Functioning: BaselineRole Functioning: Change From Baseline at EOTEmotional Functioning: BaselineEmotional Functioning: Change From Baseline at EOTCognitive Functioning: BaselineCognitive Functioning: Change From Baseline at EOTSocial Functioning: BaselineSocial Functioning: Change From Baseline at EOTFatigue: BaselineFatigue: Change From Baseline at EOTNausea and Vomiting: BaselineNausea and Vomiting: Change From Baseline at EOTPain: BaselinePain: Change From Baseline at EOTDyspnoea: BaselineDyspnoea: Change From Baseline at EOTInsomnia: BaselineInsomnia: Change From Baseline at EOTAppetite Loss: BaselineAppetite Loss: Change From Baseline at EOTConstipation: BaselineConstipation: Change From Baseline at EOTDiarrhoea: BaselineDiarrhoea: Change From Baseline at EOTFinancial Difficulties: BaselineFinancial Difficulties: Change From Baseline at EOT
Sacituzumab Govitecan61.9-5.873.2-4.668.1-8.471.9-3.881.7-7.569.1-5.939.45.18.35.237.92.825.40.733.24.420.83.117.73.37.211.427.60.4
Treatment of Physician's Choice (TPC)56.4-9.471.2-13.565.1-18.868.9-3.579.5-6.169.6-10.342.114.010.37.342.56.825.05.935.6-4.325.810.019.07.06.53.622.41.1

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Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionmonths (Median)
Avelumab Weekly5.6
Chemotherapy5.6

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Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Modified Full Analysis Set

Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionpercentage of participants (Median)
Avelumab Weekly34.6
Chemotherapy30.2

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Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Full Analysis Set

Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionpercentage of participants (Number)
Avelumab Biweekly33.5
Chemotherapy30.3

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Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Modified Full Analysis Set

Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionpercentage of participants (Number)
Avelumab Weekly30.6
Chemotherapy30.6

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Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set

EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items). (NCT02576574)
Timeframe: Baseline, End of treatment (up to Week 283.9)

,
Interventionscore on a scale (Mean)
DyspneaCoughingHemoptysisSore mouthDysphagiaPeripheral neuropathyAlopeciaPain in chestPain in arm or shoulderPain in other parts
Avelumab Biweekly7.32.4-1.83.03.03.60.0-4.20.61.8
Chemotherapy5.2-4.31.51.9-0.610.814.2-1.51.91.5

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Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set

EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items). (NCT02576574)
Timeframe: Baseline, End of treatment (up to Week 283.9)

,
Interventionscore on a scale (Mean)
DyspneaCoughingHemoptysisSore mouthDysphagiaPeripheral neuropathyAlopeciaPain in chestPain in arm or shoulderPain in other parts
Avelumab Weekly6.1-0.6-0.60.63.80.6-2.52.54.410.1
Chemotherapy4.9-5.20.01.9-0.59.915.0-0.51.41.4

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Number of Participants With At Least One Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab

Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

,
InterventionParticipants (Count of Participants)
ADAs to AvelumabNAbs to Avelumab
Avelumab Biweekly6643
Avelumab Weekly3818

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Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score

ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. ECOG performance status was reported in terms of number of participants with baseline value vs worst post-baseline value (that is [i.e.] highest score). (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

,,
InterventionParticipants (Count of Participants)
Baseline score 0, worst post-baseline score 0Baseline score 0, worst post-baseline score 1Baseline score 0, worst post-baseline score 2Baseline score 0, worst post-baseline score 3Baseline score 0, worst post-baseline score 4Baseline score 0, worst post-baseline score 5Baseline score 0, worst post-baseline score MissingBaseline score 1, worst post-baseline score 0Baseline score 1, worst post-baseline score 1Baseline score 1, worst post-baseline score 2Baseline score 1, worst post-baseline score 3Baseline score 1, worst post-baseline score 4Baseline score 1, worst post-baseline score 5Baseline score 1, worst post-baseline score MissingBaseline score >=2, worst post-baseline score 0Baseline score >=2, worst post-baseline score 1Baseline score >=2, worst post-baseline score 2Baseline score >=2, worst post-baseline score 3Baseline score >=2, worst post-baseline score 4Baseline score >=2, worst post-baseline score 5Baseline score >=2, worst post-baseline score missingBaseline score missing, worst post-baseline score 0Baseline score missing, worst post-baseline score 1Baseline score missing, worst post-baseline score 2Baseline score missing, worst post-baseline score 3Baseline score missing, worst post-baseline score 4Baseline score missing, worst post-baseline score 5Baseline score missing, worst post-baseline score missing
Avelumab Biweekly50568110611683516351000010000000000
Avelumab Weekly3549970042153321811600000100000000
Chemotherapy84831140144233466431600000000100000

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Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase

The number of participants with changes from baseline in increased Body Temperature (degree Celsius [°C]) were reported by using criteria: Baseline temperature (temp.) less than (<) 37°C, on treatment change <1°C, 1 - <2°C, 2 - <3°C, greater than or equal to (>=)3°C and missing; Baseline temp. 37 - <38°C, on treatment change <1°C, 1 - <2°C, 2 - <3°C, >=3°C and missing; Baseline temp. 38 - <39°C, on treatment change <1°C, 1 - <2°C, 2 - <3°C, >=3°C and missing; Baseline temp. 39-<40°C, on treatment change <1°C, 1 - <2°C, 2 - <3°C, >=3°C and missing; Baseline temp. >=40°C, on treatment change <1°C, 1 - <2°C, 2 - <3°C, >=3°C and missing; Baseline temp. missing, on treatment change missing. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

,,
InterventionParticipants (Count of Participants)
Baseline temp. <37°C, on treatment change <1°CBaseline temp.<37°C, on treatment change 1 - <2°CBaseline temp. <37°C, on treatment change 2 - <3°CBaseline temp. <37°C, on treatment change >=3°CBaseline temp. <37°C, on treatment change missingBaseline temp. 37 - <38°C, on treatment change <1°CBaseline temp. 37 - <38°C, on treatment change 1 - <2°CBaseline temp. 37 - <38°C, on treatment change 2 - <3°CBaseline temp. 37 - <38°C, on treatment change >=3°CBaseline temp. 37 - <38°C, on treatment change missingBaseline temp. 38 - <39°C, on treatment change <1°CBaseline temp. 38 - <39°C, on treatment change 1 - <2°CBaseline temp. 38 - <39°C, on treatment change 2 - <3°CBaseline temp. 38 - <39°C, on treatment change >=3°CBaseline temp. 38 - <39°C, on treatment change missingBaseline temp. 39 - <40°C, on treatment change <1°CBaseline temp. 39 - <40°C, on treatment change 1 - <2°CBaseline temp. 39 - <40°C, on treatment change 2 - <3°CBaseline temp. 39 - <40°C, on treatment change >=3°CBaseline temp. 39 - <40°C, on treatment change missingBaseline temp. >=40°C, on treatment change <1°CBaseline temp. >=40°C, on treatment change 1 - <2°CBaseline temp. >=40°C, on treatment change 2 - <3°CBaseline temp. >=40°C, on treatment change >=3°CBaseline temp. >=40°C, on treatment change missingBaseline temp. missing, on treatment change missing
Avelumab Biweekly2714530162310010000010000000000
Avelumab Weekly256322161920000000000000000000
Chemotherapy4033300213710030000000000000002

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Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease

The number of participants with maximal on-treatment (TR) changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) heart rate (HR) (beats per minute [bpm]) were reported by using criteria: Ic./Dc. BS HR <100/>=100 bpm, on treatment change =<20 bpm, >20 - =<40 bpm, >40 bpm and missing; Ic./Dc. BS HR missing, on treatment change missing. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

,,
InterventionParticipants (Count of Participants)
Ic. BS HR <100 bpm, on TR change =<20 bpmIc. BS HR <100 bpm, on TR change >20 - =<40 bpmIc. BS HR <100 bpm, on TR change >40 bpmIc. BS HR <100 bpm, on TR change missingIc. BS HR >= 100 bpm, on TR change =<20 bpmIc. BS HR >= 100 bpm, on TR change >20 - =<40 bpmIc. BS HR >= 100 bpm, on TR change >40 bpmIc. BS HR >= 100 bpm, on TR change missingIc. BS HR missing, on TR change missingDc. BS HR <100 bpm, on TR change =<20 bpmDc. BS HR <100 bpm, on TR change >20 - =<40 bpmDc. BS HR <100 bpm, on TR change >40 bpmDc. BS HR <100 bpm, on TR change missingDc. BS HR >= 100 bpm, on TR change =<20 bpmDc. BS HR >= 100 bpm, on TR change >20 - =<40 bpmDc. BS HR >= 100 bpm, on TR change >40 bpmDc. BS HR >= 100 bpm, on TR change missingDc. BS HR missing, on TR change missing
Avelumab Biweekly206862114310030267442141461130
Avelumab Weekly2026612530201022752151312710
Chemotherapy33285916463072385401162026372

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Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)

PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionmonths (Median)
Avelumab Biweekly8.4
Chemotherapy5.6

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Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS)

PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionmonths (Median)
Avelumab Weekly7.5
Chemotherapy5.6

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Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)

PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionmonths (Median)
Avelumab Biweekly6.9
Chemotherapy5.6

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Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Full Analysis Set

Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionpercentage of participants (Number)
Avelumab Biweekly37.7
Chemotherapy30.1

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Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters

ECG parameters included heart rate, PR interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). PCSA criteria for abnormal value of ECG parameters: any heart rate <= 50 bpm and decrease from baseline >=20 bpm , any hear rate >= 120 bpm and increase from baseline >= 20 bpm; PR interval: >= 220 milliseconds (ms) and increase from baseline >= 20 ms; QRS interval >= 120 ms; QTcF > 450 ms, > 480 ms, > 500 ms, QTcF increase from baseline > 30 ms and QTcF increase from baseline > 60 ms; QTcB > 450 ms, > 480 ms, > 500 ms, QTcB increase from baseline > 30 ms and QTcB increase from baseline > 60 ms. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

,,
InterventionParticipants (Count of Participants)
Heart Rate <= 50 bpm and decrease from baseline >= 20 bpmHeart Rate >= 120 bpm and decrease from baseline >= 20 bpmPR interval >= 220 ms and increase from baseline >= 20 msQRS interval >= 120 msQTcF > 450 msQTcF > 480 msQTcF > 500 msQTcF increase from baseline > 30 msQTcF increase from baseline > 60 msQTcB > 450 msQTcB > 480 msQTcB > 500 msQTcB increase from baseline > 30 msQTcB increase from baseline > 60 ms
Avelumab Biweekly1100181953206491363211
Avelumab Weekly16510134112131115257
Chemotherapy073152411539137024164919

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Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Weight Increase/Decrease

The number of participants with maximal on-treatment changes from baseline in Increase (Ic.)/Decrease (Dc.) in maximal weight were reported by using criteria: Ic./Dc. From baseline, on treatment (TR) change <10 percentage (%), >=10% and missing. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

,,
InterventionParticipants (Count of Participants)
Ic. from baseline, on TR change <10%Ic. from baseline, on TR change >=10%Ic. from baseline, on TR change missingDc. from baseline, on TR change <10%Dc. from baseline, on TR change >=10%Dc. from baseline, on TR change missing
Avelumab Biweekly30238212964421
Avelumab Weekly28028102585010
Chemotherapy43639254235225

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Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease

The number of participants with maximal on-treatment changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) Systolic Blood Pressure (SBP) and diastolic blood pressure (DBP) (millimeter of mercury [mmHg]) were reported by using criteria: Ic./Dc. BS SBP <140 mmHg and >=140 mmHg, on maximal treatment (TR) change =<20 mmHg, >20 - =<40 mmHg, >40 mmHg and missing; Ic./Dc. BS SBP missing, on maximal treatment (TR) change missing; Ic./Dc. BS DBP <90 mmHg and >= 90 mmHg, on maximal TR change =<20 mmHg, >20 - =<40 mmHg, >40 mmHg and missing; Ic./Dc. BS DBP missing on maximal TR change missing. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

,,
InterventionParticipants (Count of Participants)
Ic. BS SBP <140 mmHg, on TR change =<20 mmHgIc. BS SBP <140 mmHg, on TR change >20 - =<40 mmHgIc. BS SBP <140 mmHg, on TR change >40 mmHgIc. BS SBP <140 mmHg, on TR change missingIc. BS SBP >=140 mmHg, on TR change =<20 mmHgIc. BS SBP >=140 mmHg, on TR change >20 - =<40 mmHgIc. BS SBP >=140 mmHg, on TR change >40 mmHgIc. BS SBP > = 140 mmHg, on TR change missingIc. BS SBP missing, on TR change missingDc. BS SBP <140 mmHg, on TR change =<20 mmHgDc. BS SBP <140 mmHg, on TR change >20 - =<40 mmHgDc. BS SBP <140 mmHg, on TR change >40 mmHgDc. BS SBP <140 mmHg, on TR change missingDc. BS SBP >=140 mmHg, on TR change =<20 mmHgDc. BS SBP >=140 mmHg, on TR change >20 - =<40 mmHgDc. BS SBP >=140 mmHg, on TR change >40 mmHgDc. BS SBP > = 140 mmHg, on TR change missingDc. BS SBP missing, on TR change missingIc. BS DBP <90 mmHg, on TR change =<20 mmHgIc. BS DBP <90 mmHg, on TR change >20 - =<40 mmHgIc. BS DBP <90 mmHg, on TR change >40 mmHgIc. BS DBP <90 mmHg, on TR change missingIc. BS DBP missing, on TR change missingIc. BS DBP >=90 mmHg, on TR change =<20 mmHgIc. BS DBP >=90 mmHg, on TR change >20 - =<40 mmHgIc. BS DBP >=90 mmHg, on TR change >40 mmHgIc. BS DBP >=90 mmHg, on TR change missingDc. BS DBP <90 mmHg, on TR change =<20 mmHgDc. BS DBP <90 mmHg, on TR change >20 - =<40 mmHgDc. BS DBP <90 mmHg, on TR change >40 mmHgDc. BS DBP <90 mmHg, on TR change missingDc. BS DBP >=90 mmHg, on TR change =<20 mmHgDc. BS DBP >=90 mmHg,on TR change >20 - =<40 mmHgDc. BS DBP >=90 mmHg, on TR change >40 mmHgDc. BS DBP >=90 mmHg, on TR change missingDc. BS DBP missing, on TR change missing
Avelumab Biweekly219611614417030220706141125123027248017024000279383171112100
Avelumab Weekly20956164265020204707461510202603715012111264331559010
Chemotherapy2781041021785121322691213234182140245123128000415321231810001

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Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease

The number of participants with maximal on-treatment (TR) changes from baseline (BS) in Increase (Ic.)/Decrease (Dc.) maximal Respiration Rate (RR) were reported by using criteria: Ic./Dc. BS RR <20 breaths per minute (breaths/min), on TR change =<5 breaths/min, >5 - =<10 breaths/min, >10 breaths/min and missing. Ic./Dc. BS RR missing, on TR change missing. Ic./Dc. BS RR >=20 breaths/min, on TR change =<5 breaths/min, >5 - =<10 breaths/min, >10 breaths/min and missing. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to 71.5 months)

,,
InterventionParticipants (Count of Participants)
Ic. BS RR <20 breaths/min, on TR change =<5 breaths/minIc.BS RR<20 breaths/min, on TR change >5 - = <10 breaths/minIc. BS RR <20 breaths/min, on TR change >10 breaths/minIc. BS RR <20 breaths/min, on TR change missingIc. BS RR >=20 breaths/min, on TR change =<5 breaths/minIc.BS RR >=20 breaths/min, on TR change >5 - =<10 breaths/minIc. BS RR >=20 breaths/min, on TR change >10 breaths/minIc. BS RR >=20 breaths/min, on TR change missingIc. BS RR missing, on TR change missingDc. BS RR <20 breaths/min, on TR change =<5 breaths/minDc. BS RR <20 breaths/min, on TR change >5 - =<10 breaths/minDc. BS RR <20 breaths/min, on TR change >10 breaths/minDc. BS RR <20 breaths/min, on TR change missingDc. BS RR >=20 breaths/min, on TR ch =<5 breaths/minDc.BS RR >=20 breaths/min, on TR change >5 - =<10 breaths/minDc. BS RR >=20 breaths/min, on TR change >10 breaths/minDc. BS RR >=20 breaths/min, on TR change missingDc. BS RR missing, on TR change missing
Avelumab Biweekly2211811189537623280117914476
Avelumab Weekly22413146841212362045813221
Chemotherapy3062621412420151132581141012231511

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Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set

EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL. (NCT02576574)
Timeframe: Baseline, End of treatment (up to Week 283.9)

Interventionscore on a scale (Mean)
Avelumab Biweekly-0.3
Chemotherapy-6.1

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Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set

EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL. (NCT02576574)
Timeframe: Baseline, End of treatment (Week 283.9)

Interventionscore on a scale (Mean)
Avelumab Weekly-12.9
Chemotherapy-4.5

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Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03

Number of participants with shifts from Baseline values (Grade 0/1/2/3) to abnormal post-baseline values (shift to >= Grade 4) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death. Shifts in laboratory parameter (anemia, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, white blood cell count decreased, alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased and Hyperglycemia) were reported. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

,,
InterventionParticipants (Count of Participants)
Anemia: Grade 0 to Grade 3Anemia: Grade 1 to Grade 3Anemia: Grade 2 to Grade 3Lymphocyte count decreased: Grade 0 to Grade 3Lymphocyte count decreased: Grade 0 to Grade 4Lymphocyte count decreased: Grade 1 to Grade 3Lymphocyte count decreased: Grade 2 to Grade 3Lymphocyte count decreased: Grade 2 to Grade 4Lymphocyte count decreased: Grade 3 to Grade 4Neutrophil count decreased: Grade 0 to Grade 3Neutrophil count decreased: Grade 0 to Grade 4Neutrophil count decreased: Grade 1 to Grade 3Platelet count decreased: Grade 0 to Grade 3Platelet count decreased: Grade 0 to Grade 4Platelet count decreased: Grade 1 to Grade 3White blood cell count decreased: Grade 0 to Grade 3White blood cell count decreased: Grade 0 to Grade 4Alanine aminotransferase increased: Grade 0 to Grade 3Alanine aminotransferase increased: Grade 0 to Grade 4Alanine aminotransferase increased: Grade 1 to Grade 3Alkaline phosphatase increased: Grade 0 to Grade 3Alkaline phosphatase increased: Grade 1 to Grade 3Alkaline phosphatase increased: Grade 1 to Grade 4Alkaline phosphatase increased: Grade 2 to Grade 3Aspartate aminotransferase increased: Grade 0 to Grade 3Aspartate aminotransferase increased: Grade 0 to Grade 4Aspartate aminotransferase increased: Grade 1 to Grade 3Blood bilirubin increased: Grade 0 to Grade 3Blood bilirubin increased: Grade 0 to Grade 4Creatine phosphokinase increased: Grade 0 to Grade 3Creatine phosphokinase increased: Grade 0 to Grade 4Creatine phosphokinase increased: Grade 1 to Grade 4Creatine phosphokinase increased: Grade 2 to Grade 3Creatinine increased: Grade 0 to Grade 3Creatinine increased: Grade 1 to Grade 3Hyperglycemia: Grade 0 to Grade 3Hyperglycemia: Grade 0 to Grade 4
Avelumab Biweekly4441612700401000001211010071000650060210
Avelumab Weekly2561521060043013131810330142041501140200
Chemotherapy5830631312121165251182002411532111032130100041353

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Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionmonths (Median)
Avelumab Biweekly35.9
Chemotherapy8.4

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Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set

EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. (NCT02576574)
Timeframe: Baseline, End of treatment (Week 283.9)

Interventionmillimeter (Mean)
Avelumab Weekly-10.3
Chemotherapy-3.9

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Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionmonths (Median)
Avelumab Weekly19.4
Chemotherapy8.4

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Overall Survival (OS) in Full Analysis Set (FAS)

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionmonths (Median)
Avelumab Biweekly15.0
Chemotherapy14.3

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Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionmonths (Median)
Avelumab Biweekly20.1
Chemotherapy14.9

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Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionmonths (Median)
Avelumab Weekly19.3
Chemotherapy15.3

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and AEs of Special Interest (AESIs)

Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAEs were those events with onset dates occurring during the on-treatment period or if the worsening of an event is during the on-treatment period TEAEs included both serious TEAEs and non-serious TEAEs. Any AE that was suspicious to be a potential Immune-related adverse event (irAE) including infusion related reactions were considered AESIs. Number of participants with TEAEs and AESIs were reported. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

,,
InterventionParticipants (Count of Participants)
TEAEsAESIs
Avelumab Biweekly346158
Avelumab Weekly308160
Chemotherapy484173

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Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionmonths (Median)
Avelumab Biweekly18.7
Chemotherapy13.3

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Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionmonths (Median)
Avelumab Weekly16.8
Chemotherapy13.0

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Overall Survival (OS) in Modified Full Analysis Set (mFAS)

OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. (NCT02576574)
Timeframe: Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Interventionmonths (Median)
Avelumab Weekly15.4
Chemotherapy14.8

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Progression-free Survival (PFS) of Subjects With Advanced Nasopharyngeal Carcinoma.

Progression-free survival was defined as the duration from randomization to the first occurrence of documented disease progression [based on imaging results] or death from any cause, whichever occurred first. (NCT02578641)
Timeframe: From randomization until first occurrence of disease progression or death of any cause, whichever occurred first, assessed up to 7 years. Subjects who received subsequent anti-cancer therapy were censored at the date of last tumor assessment.

InterventionMonths (Median)
Chemo + EBV-CTL7.9
Chemo Only8.5

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Overall Survival (OS) of Subjects With Advanced Nasopharyngeal Carcinoma.

Efficacy of EBV-CTL following first line chemotherapy was compared to chemotherapy alone in terms of OS of subjects with advanced nasopharyngeal carcinoma. Overall survival was defined as the duration in months from the day of randomization until death from any cause for a subject known to be deceased, or censored at the last contact date that a subject was known to be alive or lost to follow-up. (NCT02578641)
Timeframe: From randomization until death, assessed up to 7 years. Survivors and lost to follow-up subjects were censored at the date of last contact. Survival follow-up was done every 12 weeks from end of treatment.

InterventionMonths (Median)
Chemo + EBV-CTL25
Chemo Only24.9

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Objective Response Rate (ORR) in Cohort 2

ORR is defined as the percentage of participants with a confirmed overall response of complete response (CR) or partial response (PR). A confirmed response of CR/PR means that a response of CR/PR is recorded at 1 visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit and not less than 4 weeks after the visit when the response was first observed with no evidence of progression between the initial and CR/PR confirmation visit. CR is defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of TLs, taking as reference the baseline sum of diameters as long as criteria for PD were not met. ORR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). (NCT02583477)
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.

Interventionpercentage of participants (Number)
Cohort 2 (MEDI4736 + AZD5069)5.6

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Mean Plasma Concentrations of MEDI4736 in Cohort 2

Mean peak and trough plasma concentrations of MEDI4736 are presented. (NCT02583477)
Timeframe: Predose (within 60 minutes prior to treatment with any IP) on Day 1 of Cycles 1, 2, 3, 4, and 7; and post infusion (within 10 minutes after end of MEDI4736 infusion) on Day 1 of Cycles 1 and 7

Interventionnanograms per milliliter (Mean)
Cycle 1 Day 1: PredoseCycle 1 Day 1: Post infusionCycle 2 Day 1: PredoseCycle 3 Day 1: PredoseCycle 4 Day 1: PredoseCycle 7 Day 1: PredoseCycle 7 Day 1: Post infusion
Cohort 2 (MEDI4736 + AZD5069)1444.730339342.22956773.55563655.84069325.23379687.820435297.610

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Number of Participants With Dose-Limiting Toxicities (DLT)

"DLT period was defined as first treatment cycle for Cohort 1, and first dose of AZD5069 and MEDI4736 to end of Cycle 1 or until a participant experienced a DLT, whichever occurs first for Cohort 2.~A DLT was defined as any of below listed laboratory abnormalities or adverse events (AE) related to MEDI4736 collected during DLT period.~Liver transaminase elevation >= 5× but <= 8× upper limit of normal (ULN) that doesn't resolve to Grade 2 within 5 days~Transaminase elevation > 8× ULN or total bilirubin > 5× ULN~Any Grade 4 immune-related AE (irAE) not attributed to local tumor response, Grade >=3 colitis, Grade >=2 pneumonitis that doesn't resolve to <= Grade 1 within 7 days, Grade 3 irAE, that doesn't resolve to Grade <=1 or baseline status within 14 days~Any Grade >=3 non-irAE toxicity that doesn't resolve to Grade <=1 or baseline status within 14 days A DLT was defined as any Grade 3 or worse AE related to AZD5069 that occurs from first dose of AZD5069 up to end of DLT period." (NCT02583477)
Timeframe: Cohort 1: From time of first dose of MEDI4736 on Day 1 up to Day 28 of Cycle 1 and Cohort 2: From time of first dose of AZD5069 and MEDI4736 on Day 1 up to Day 28 of Cycle 1 or until a participant experiences a DLT, whichever occurs first.

InterventionParticipants (Count of Participants)
Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine)0
Cohort 2 (MEDI4736 + AZD5069)4

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Median Progression-Free Survival (PFS) in Cohort 2

PFS is defined as the time from the date of first dose until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraws from allocated therapy or receives another anticancer therapy prior to progression. PFS was determined using Investigator assessments according to RECIST v1.1 and calculated using the Kaplan-Meier technique. (NCT02583477)
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.

Interventionmonths (Median)
Cohort 2 (MEDI4736 + AZD5069)1.6

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Median Overall Survival (OS) in Cohort 2

OS is defined as the time from the date of first dose until death due to any cause (i.e. date of death or censoring - date of first dose + 1). OS was calculated using the Kaplan-Meier technique. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive (censored at end of study). (NCT02583477)
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.

Interventionmonths (Median)
Cohort 2 (MEDI4736 + AZD5069)2.8

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Number of Participants With AEs

An AE is the development of an undesirable medical condition or deterioration of a pre-existing medical condition following or during exposure to study treatment, whether or not considered causally related to study treatment. An undesirable medical condition can be symptoms, signs or abnormal results of an investigation. A serious AE (SAE) is an AE that fulfills one or more following criteria: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions, congenital abnormality or birth defect, and an important medical event that may jeopardize participant or may require medical intervention to prevent one of outcomes listed above. AEs leading to discontinuation of study treatment were those with action taken was 'Drug Permanently Discontinued' for any study treatment. Only treatment emergent AEs were presented. (NCT02583477)
Timeframe: From first dose of study treatment administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months.

,
InterventionParticipants (Count of Participants)
Any AEAny AE causally related to treatment (CRT)Any AE of CTCAE Grade 3 or higherAny AE of CTCAE Grade 3 or higher CRTAny AE leading discontinuation of study treatmentAny AE with outcome of deathAny AE with outcome of death CRTAny SAEAny SAE CRT
Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine)333321111
Cohort 2 (MEDI4736 + AZD5069)20141810340168

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Number of Participants With Anti-Drug Antibody (ADAs) for MEDI4736 in Cohort 2

Samples were measured for the presence of ADAs and ADA-neutralizing antibodies for MEDI4736 using validated assays. Persistently positive is defined as positive at >=2 post-baseline assessments or positive at the last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. NAB = neutralizing antibody. (NCT02583477)
Timeframe: On Day 1 of Cycles 1, 2, 3, 4, and 7; At months 3 and 6 after last dose

InterventionParticipants (Count of Participants)
Positive at any visitBoth baseline and post-baseline positiveOnly post-baseline positiveOnly baseline positiveADA persistently positiveADA transiently positiveADA positive participants who are NAB positive
Cohort 2 (MEDI4736 + AZD5069)3012010

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Duration of Response (DoR) in Cohort 2

DoR was defined as the time from the first documentation of CR/PR (which is subsequently confirmed) until the date of progression/death, or the last evaluable RECIST assessment for participants that did not progress or did progress after 2 missed visits of the last evaluable assessment (or first dose). PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. DoR was determined using Investigator assessments according to RECIST v1.1 and was calculated using the Kaplan-Meier technique. (NCT02583477)
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.

Interventionweeks (Median)
Cohort 2 (MEDI4736 + AZD5069)18.29

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Progression-Free Survival Rate at 3 Months (PFS3) in Cohort 2

The PFS rate was defined as percentage of participants alive and progression-free after 3 months. The PFS3 was calculated using Kaplan-Meier estimates. Tumor progression was determined based on Investigator assessment and RECIST v1.1. (NCT02583477)
Timeframe: RECIST assessments were performed at baseline (within 28 days before start of study treatment) and every 6 weeks +/- 7 days up to 3 months

Interventionpercentage of participants (Number)
Cohort 2 (MEDI4736 + AZD5069)11.1

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Overall Survival at 6 Months (OS6) in Cohort 2

OS6 is defined as percentage of participants alive at 6 months from first dose of study treatment. OS6 was calculated using the Kaplan-Meier estimate of OS at 6 months. (NCT02583477)
Timeframe: From first dose of study treatment (Day 1) up to 6 months

Interventionpercentage of participants (Number)
Cohort 2 (MEDI4736 + AZD5069)22.2

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Overall Survival at 12 Months (OS12) in Cohort 2

OS12 is defined as percentage of participants alive at 12 months from first dose of study treatment. OS12 was calculated using the Kaplan-Meier estimate of OS at 12 months. (NCT02583477)
Timeframe: From first dose of study treatment (Day 1) up to 12 months

Interventionpercentage of participants (Number)
Cohort 2 (MEDI4736 + AZD5069)14.8

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Disease Control Rate (DCR) in Cohort 2

DCR at 6 months is defined as the percentage of participants who had a best objective response (BoR) of CR or PR in the first 6 months (i.e. 24+1=25 weeks to allow for a late assessment within the assessment window) or who had demonstrated stable disease (SD) for a minimum interval of 24 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. DCR at 12 months is defined as the percentage of participants who had a BoR of CR or PR in the first 12 months (i.e. 48+1=49 weeks to allow for a late assessment within the assessment window) or who had demonstrated SD for a minimum interval of 48 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 329 days) following the start of treatment. DCR was determined using Investigator assessments according to RECIST v1.1. (NCT02583477)
Timeframe: RECIST assessments were performed at baseline (within 28 days before start of study treatment) and every 6 weeks +/- 7 days for first 48 weeks up to 6 months and 12 months

Interventionpercentage of participants (Number)
At 6 monthsAt 12 months
Cohort 2 (MEDI4736 + AZD5069)11.15.6

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Mean Plasma Concentrations of AZD5069 in Cohort 2

Mean peak and trough plasma concentration of AZD5069 are presented. Concentration of AZD5069 was calculated by plasma concentration-time profile. (NCT02583477)
Timeframe: Predose (within 60 minutes prior to treatment with any IP) on Day 1 of Cycles 1, 2, 3, 4, and 7; and postdose (within 10 minutes after end of MEDI4736 infusion) on Day 1 of Cycles 1, 2, and 7

Interventionnanomoles per liter (Mean)
Cycle 1 Day 1: PredoseCycle 1 Day 1: PostdoseCycle 2 Day 1: PredoseCycle 2 Day 1: PostdoseCycle 3 Day 1: PredoseCycle 4 Day 1: PredoseCycle 7 Day 1: PredoseCycle 7 Day 1: Postdose
Cohort 2 (MEDI4736 + AZD5069)10.602236.291829.3624.40502.481345.001200.007540.00

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Progression-Free Survival Rate at 6 Months (PFS6) in Cohort 2

The PFS6 was defined as percentage of participants alive and progression-free after 6 months. The PFS6 was calculated using Kaplan-Meier estimates. Tumor progression was determined based on Investigator assessment and RECIST v1.1. (NCT02583477)
Timeframe: RECIST assessments were performed at baseline (within 28 days before start of study treatment) and every 6 weeks +/- 7 days up to 6 months

Interventionpercentage of participants (Number)
Cohort 2 (MEDI4736 + AZD5069)11.1

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Duration of Response

Duration of response was evaluated at the first instance of CR or PR through the earliest assessment of progressive disease, death, or the last follow-up where the subject had not yet progressed from her prior response. Informational summaries without formal statistical comparisons were produced. (NCT02595892)
Timeframe: Assessed for up to 3 years.

InterventionWeeks (Number)
Patient 5
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)7

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Progression Free Survival at 6 Months (PFS-6)

Assessed and compared PFS-6 between gemcitabine/VX-970 and gemcitabine alone arms (NCT02595892)
Timeframe: Number of days from the day the subject received the first dose of protocol therapy to the date of documented progressive disease by RECIST version 1.1 or death (regardless of cause), assessed at 6 months

InterventionParticipants (Count of Participants)
Arm I (Gemcitabine Hydrochloride)13
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)17

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Progression Free Survival (PFS)

PFS was summarized using Kaplan-Meier analyses and compared between the two arms using the logrank test. Additionally, PFS was analyzed using a Cox Proportional Hazards Model, including the stratification factor, and will be used to estimate the hazard ratio of the gemcitabine hydrochloride (gemcitabine)/ataxia telangiectasia mutated and Rad3-related (ATR) kinase inhibitor M6620 (formerly VX-970) arm relative to the gemcitabine alone arm and the associated 90% confidence interval. Disease progression, per protocol, is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (NCT02595892)
Timeframe: Number of days from the day the subject received the first dose of protocol therapy to the date of documented progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death (regardless of cause), assessed up to 3 years

InterventionWeeks (Median)
Arm I (Gemcitabine Hydrochloride)14.7
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)22.9

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Percentage of Patients With a Reduction in CA-125

Determined and compared CA125 reduction by > 50% between gemcitabine/VX-970 and gemcitabine alone arms. (NCT02595892)
Timeframe: CA-125 serum samples were collected from participants in both Arms I and II at baseline, on Day 1 of each cycle, and at the end-of-study treatment visit, assessed up to 2 years.

InterventionParticipants (Count of Participants)
Arm I (Gemcitabine Hydrochloride)9
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)9

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Overall Survival (OS)

Assessed and compared OS between gemcitabine/VX-970 and gemcitabine alone arms. (NCT02595892)
Timeframe: Number of weeks from the date of registration until date of death (regardless of cause), assessed up to 3 years.

InterventionWeeks (Median)
Arm I (Gemcitabine Hydrochloride)43.0
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)59.4

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Objective Response Rate (ORR)

Defined as the percentage of subjects achieving a response rating of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) in the whole population. Per RECIST v1.1 definitions for target lesions and assessed by conventional CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR. ORR was summarized by counts (percentages) in each Arm. (NCT02595892)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Arm I (Gemcitabine Hydrochloride)4
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)1

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Number of Participants With Serious Adverse Events (SAEs)

Determined and compared the safety profile of gemcitabine/VX-970 and gemcitabine alone regimens. (NCT02595892)
Timeframe: AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.

InterventionParticipants (Count of Participants)
Arm I (Gemcitabine Hydrochloride)10
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)9

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Clinical Benefit Rate (CBR)

CBR is defined as the percentage of subjects achieving a response rating of stable disease >= 4 months, partial response (PR), or complete response (CR). Subject demographic and baseline characteristics will be summarized by mean, standard deviation, median, minimum, and maximum for continuous variables; and by counts and percentages for categorical variables. Summaries will be provided separately for each treatment group. Treatment group comparisons in CBR will be evaluated using logistic regression and expressed as odds ratios with associated 90% confidence intervals. In the event that rates are low, comparisons will be based on Fisher's exact test. (NCT02595892)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Arm I (Gemcitabine Hydrochloride)9
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)12

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Duration of Response

Duration of response was evaluated at the first instance of CR or PR through the earliest assessment of progressive disease, death, or the last follow-up where the subject had not yet progressed from her prior response. Informational summaries without formal statistical comparisons were produced. (NCT02595892)
Timeframe: Assessed for up to 3 years.

InterventionWeeks (Number)
Patient 1Patient 2Patient 3Patient 4
Arm I (Gemcitabine Hydrochloride)1061827

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Objective Response Rate by Platinum Free Status

Objective response rate by platinum-free status includes only informational summaries (counts of participants who met the categories outlined below) without formal statistical comparisons. (NCT02595892)
Timeframe: Up to 3 years

,
InterventionParticipants (Count of Participants)
Patients who experienced an ORR with a platinum-free interval ≤3 monthsPatients who experienced an ORR with a platinum-free interval 3-6 months
Arm I (Gemcitabine Hydrochloride)13
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)10

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Overall Survival (OS)

-OS is defined as the days from the date of treatment start and death from any cause. Participants alive or lost to follow-up are censored. (NCT02608229)
Timeframe: Up to 2 years

Interventionmonths (Median)
600 mg BVD-523/Nab-paclitaxel/Gemcitabine13.8
450 mg BVD-523/Nab-paclitaxel/Gemcitabine5.7

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Progression-free Survival (PFS)

"Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).~PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Patients alive without progression or lost to follow-up are censored." (NCT02608229)
Timeframe: Up to 2 years

Interventiondays (Median)
Dose De-escalation: BVD-523/Nab-paclitaxel/Gemcitabine85
Dose Expansion: BVD-523/Nab-paclitaxel/Gemcitabine39.5

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Time to Tumor Progression (TTP)

"Time to tumor progression is defined as the days from start of treatment until progressive disease.~Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions)." (NCT02608229)
Timeframe: Up to 2 years

Interventiondays (Median)
Dose De-escalation: BVD-523/Nab-paclitaxel/Gemcitabine85
Dose Expansion: BVD-523/Nab-paclitaxel/Gemcitabine39.5

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Safety and Toxicity Profile of Treatment Regimen as Measured by Grade and Frequency of Adverse Events

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. (NCT02608229)
Timeframe: 30 days after completion of treatment (median time was 67.5 days)

,
InterventionParticipants (Count of Participants)
Grade 1/2 Hearing ImpairedGrade 1/2 blurred visionGrade 3 abdominal infectionGrade 1/2 constipationGrade 1/2 diarrheaGrade 3 diarrheaGrade 1/2 dry mouthGrade 1/2 dyspepsiaGrade 1/2 flatulenceGrade 1/2 gastrointestinal painGrade 1/2 mucositis oralGrade 1/2 nauseaGrade 3 nauseaGrade 1/2 taste changeGrade 1/2 vomitingGrade 3 vomitingGrade 1/2 acute kidney injuryGrade 3 lower GI hemorrhageGrade 1/2 chillsGrade 1/2 edema limbsGrade 1/2 edema trunkGrade 1/2 fatigueGrade 1/2 feverGrade 1/2 thrushGrade 5 death due to disease progressionGrade 1/2 alanine aminotransferase increasedGrade 1/2 alkaline phosphtaseGrade 4 blood bilirubin increasedGrade 3/4 neutrophil count decreasedGrade 3 platelet count decreasedGrade 1/2 lymphocyte countGrade 1/2 white blood cell count decreasedGrade 1/2 hypercalcemiaGrade 1/2 hyperglycemiaGrade 1/2 hyperkalemiaGrade 1/2 hypoalbuminemiaGrade 1/2 hypocalcemiaGrade 1/2 dehydrationGrade 1/2 arthralgiaGrade 1/2 back painGrade 1/2 dizzinessGrade 1/2 headacheGrade 1/2 peripheral sensory neuropathyGrade 1/2 numbnessGrade 1/2 insomniaGrade 1/2 anxietyGrade 1/2 coughGrade 1/2 dyspneaGrade 1/2 epistaxisGrade 5 adult respiratory distress syndromeGrade 1/2 alopeciaGrade 1/2 rash acneiformGrade 3 rash acneiformGrade 1/2 rash maculo-papularGrade 1/2 sweatingGrade 1 scalp sun burnedGrade 1/2 hypertensionGrade 3 hypertensionGrade 1/2 hyperhydrosisGrade 1/2 pruritusGrade 1/2 myalgiaGrade 1/2 blood in stoolGrade 1/2 anorexiaGrade 3 anorexiaGrade 1/2 abdominal painGrade 3 abdominal painGrade 3 portal vein thrombosisGrade 3 lung infectionGrade 1/2 anemiaGrade 3 anemia
450 mg BVD-523/Nab-paclitaxel/Gemcitabine0002400100211011001102211000110000000110100011100034000000111111211111
600 mg BVD-523/Nab-paclitaxel/Gemcitabine1315522111251102113313511221311221211142435121121153241131000030200030

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Response Rate

"Response rate is the percentage of participants with best response of complete response or partial response per RECIST 1.1~Complete response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level.~Partial response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters." (NCT02608229)
Timeframe: Through completion of treatment (median time was 37.5 days)

InterventionParticipants (Count of Participants)
Dose De-escalation: BVD-523/Nab-paclitaxel/Gemcitabine2
Dose Expansion: BVD-523/Nab-paclitaxel/Gemcitabine0

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Biochemical Response of Treatment Regimen

-The biochemical response (BR) is defined as more than 50% of decrease from baseline CA 19-9 (NCT02608229)
Timeframe: Through completion of treatment (median time was 37.5 days)

InterventionParticipants (Count of Participants)
Dose De-escalation: BVD-523/Nab-paclitaxel/Gemcitabine3
Dose Expansion: BVD-523/Nab-paclitaxel/Gemcitabine1

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Maximum Tolerated Dose (MTD) of BVD-523

-The maximum tolerated dose (MTD) is defined as the Dose Level 1 if 0 or 1 dose-limiting toxicities (DLTs) are seen in patients at that dose level or Dose Level -1 if 2+ DLTs are seen in Dose Level 1 but only 0 or 1 DLTs are seen in patients at Dose Level -1. (NCT02608229)
Timeframe: Completion of cycle 1 for all dose de-escalation patients (1.8 years), the first cycle is 28 days for each individual patient

Interventionmg (Number)
Dose De-escalation: BVD-523/Nab-paclitaxel/Gemcitabine450

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Time to Progression

Calculated in months from the start of treatment to disease progression as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Progressive Disease (PD), At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest sum on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression. (NCT02608684)
Timeframe: Up to 2 years

Interventionmonths (Median)
Cisplatin+Gemcitabine+Pembrolizumab6.25

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Overall Survival (OS)

Calculated in months from the start of treatment to the date of death from any cause (NCT02608684)
Timeframe: Up to 2 years

Interventionmonths (Median)
Cisplatin+Gemcitabine+Pembrolizumab17.75

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Duration of Response

Calculated in months as time from documentation of tumor response to disease progression (NCT02608684)
Timeframe: Up to 2 years

Interventionmonths (Median)
Cisplatin+Gemcitabine+Pembrolizumab3.75

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Progression-free Survival (PFS) at 6 Months and at 12 Months

Percentage of patients who have not progressed at 6 and 12 months with progression-free survival calculated from the start of treatment to the date of progression or death from any cause. Progression is measured by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Progressive Disease (PD), At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest sum on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression. (NCT02608684)
Timeframe: 6 months and 12 months

Interventionpercentage of participants (Number)
PFS rate at 6 monthsPFS rate at 12 months
Cisplatin+Gemcitabine+Pembrolizumab50.005.56

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Overall Response Rate by iRECIST

Per Immune Response Evaluation Criteria In Solid Tumors Criteria (iRECIST) for target lesions and assessed by CT or MRI, where the threshold is reset if RECIST 1.1 progression is followed at the next assessment by tumor shrinkage: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT02608684)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseNot applicable
Cisplatin+Gemcitabine+Pembrolizumab000126

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Overall Response Rate (ORR)

Defined as complete or partial response per RECIST 1.1 criteria with assessment every 6 weeks during first 6 cycles of therapy and every 9 weeks thereafter. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT02608684)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable DiseaseProgressive Disease
Cisplatin+Gemcitabine+Pembrolizumab11052

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Disease Control Rate (DCR)

Disease control rate of transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine in patients with unresectable malignant pleural mesothelioma using modified Response Evaluation Criteria in Solid Tumors (RECIST) for mesothelioma. DCR provided as percentage of participants with partial response + percentage of participants with stable disease. (NCT02611037)
Timeframe: Up to 3 years

Interventionpercentage of participants (Number)
Chemoperfusion + Questionnaire75

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Progression Free Survival (PFS)

Progression free survival defined as the time from the first day of transarterial chemoperfusion treatment to disease progression based on imaging findings using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for mesothelioma. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). (NCT02611037)
Timeframe: Up to 3 years

Interventionmonths (Median)
Chemoperfusion + Questionnaire4.7

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Overall Survival (OS)

Overall survival defined as the time from the first day of transarterial chemoperfusion treatment to death. (NCT02611037)
Timeframe: Up to 3 years

Interventionmonths (Median)
Chemoperfusion + Questionnaire8.9

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Overall Survival (OS)

Overall Survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. OS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)

InterventionMonths (Median)
Pembrolizumab17.2
Standard Treatment15.3

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Percentage of Participants Who Experience One or More Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm. (NCT02611960)
Timeframe: Up to approximately 73 months

InterventionPercentage of Participants (Number)
Pembrolizumab97.4
Standard Treatment97.3

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Percentage of Participants Who Discontinue Study Treatment Due to an AE

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm. (NCT02611960)
Timeframe: Up to approximately 72 months

InterventionPercentage of Participants (Number)
Pembrolizumab8.6
Standard Treatment15.2

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Percentage of Participants Surviving (OS Rate) at 24 Months

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 24 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: 24 months

InterventionPercentage of Participants (Number)
Pembrolizumab40.2
Standard Treatment32.2

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Percentage of Participants Surviving (OS Rate) at 12 Months

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: 12 months

InterventionPercentage of Participants (Number)
Pembrolizumab58.1
Standard Treatment57.4

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Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded independent central review (BICR), or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. PFS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)

InterventionMonths (Median)
Pembrolizumab4.1
Standard Treatment5.5

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Objective Response Rate (ORR) Per RECIST 1.1

ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. ORR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)

InterventionPercentage of Participants (Number)
Pembrolizumab21.4
Standard Treatment23.3

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Duration of Response (DOR) Per RECIST 1.1

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)

InterventionMonths (Median)
Pembrolizumab12.0
Standard Treatment13.1

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Percentage of Participants With PFS (PFS Rate) at 12 Months

PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: 12 months

InterventionPercentage of Participants (Number)
Pembrolizumab18.7
Standard Treatment30.8

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Percentage of Participants With PFS (PFS Rate) at 6 Months

PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 6 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: 6 months

InterventionPercentage of Participants (Number)
Pembrolizumab36.3
Standard Treatment43.9

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Incidence of Toxicity (CTCAE Version 4.0)

Toxicity rates will be estimated using all treated patients. (NCT02620865)
Timeframe: Up to 18 months

InterventionParticipants (Count of Participants)
AnorexiaAnxietyChillsDepressionDiarrheaDizzinessDry MouthFatigueFeverGastroesophageal reflux diseaseHeadacheMyalgiaNauseaRash maculo-papularVomiting
Treatment (Anti-CD3 x Anti-EGFR BATs)112121122121221

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Progression Free Survival (PFS)

Descriptive statistics (point and exact 90% confidence interval estimates from the resultant Kaplan-Meier curve) will be generated for PFS. The median PFS will be estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed all BAT infusions) using the Kaplan-Meier method. (NCT02620865)
Timeframe: Up to 18 months

InterventionYears (Median)
Treatment (Anti-CD3 x Anti-EGFR BATs)0.934

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Median Overall Survival (OS)

Descriptive statistics (point and exact 90% confidence interval estimates from the resultant Kaplan-Meier curve) will be generated for OS. The median OS will be estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed all BAT infusions) using the Kaplan-Meier method. (NCT02620865)
Timeframe: Up to 18 months

Interventionyears (Median)
Treatment (Anti-CD3 x Anti-EGFR BATs)0.934

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Overall Survival (OS)

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. (NCT02631590)
Timeframe: Up to 24 months

Interventionmonths (Median)
Combination Therapy13.7

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Response Rate

Complete Response + Partial Response according to RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (NCT02631590)
Timeframe: Up to 24 months

Interventionpercentage of participants (Number)
Partial ResponseStable Disease
Combination Therapy31.657.9

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Progression Free Survival (PFS)

PFS at six months. Response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1). PFS will be calculated from study entry to documented disease progression, death from any cause, or date of last follow-up, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.) (NCT02631590)
Timeframe: 6 months

Interventionmonths (Median)
Combination Therapy6.2

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Phase 1b: PK: Elimination Half-Life (T1/2) of Olaratumab

T1/2 of Olaratumab. (NCT02659020)
Timeframe: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8

,
Interventiondays (Geometric Mean)
Cycle 1 (Day 1)Cycle 1 (Day 8)Cycle 3 (Day 1)Cycle 3 (Day 8)
Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel4.606.255.175.82
Phase 1b: Cohort 2 Overall - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel4.296.626.366.39

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Phase 1b/2: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Docetaxel

AUC [0-∞] of Docetaxel. (NCT02659020)
Timeframe: 5 min, 1, 3, 24, 48 h post-dose on Cycle 1 Day 8

Interventionnanograms*hours per milliliter (Geometric Mean)
Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel4440
Phase 1b: Cohort 2 Overall - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel2990

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Phase 1b: PK: Minimum Serum Concentration (Cmin) of Olaratumab

Cmin of Olaratumab. (NCT02659020)
Timeframe: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1

,
Interventionμg/mL (Geometric Mean)
Cycle 1 (Day 1)Cycle 1 (Day 8)Cycle 3 (Day 1)
Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel95.964.3137
Phase 1b: Cohort 2 Overall - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel14293.3252

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Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab

Cmax of Olaratumab. (NCT02659020)
Timeframe: Pre-dose, 5 minutes (min), 1, 4, 4.5, 24, 96, 168, 336 hours (h) post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8

,
Interventionmicrograms per milliliter (μg/mL) (Geometric Mean)
Cycle 1 (Day 1)Cycle 1 (Day 8)Cycle 3 (Day 1)Cycle 3 (Day 8)
Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel432460523513
Phase 1b: Cohort 2 Overall - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel572697644689

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Phase 2: Progression Free Survival (PFS)

PFS was defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 [RECIST v.1.1]) or death due to any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. (NCT02659020)
Timeframe: Baseline to Objective Disease Progression or Death from Any Cause (Up To 38 Months)

InterventionMonths (Median)
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)7.62
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)4.37
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)5.45
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)4.17

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Phase 2: Percentage of Participants With a Complete or Partial Response (Objective Response Rate [ORR])

ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. (NCT02659020)
Timeframe: Baseline to Objective Disease Progression or Start of New Anti-Cancer Therapy (Up To 38 Months)

InterventionPercentage of participants (Number)
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)32.1
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)23.3
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)30.4
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)14

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Phase 2: Overall Survival (OS) (Olaratumab-Naive)

OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact. (NCT02659020)
Timeframe: Baseline to Date of Death Due to Any Cause (Up To 38 Months)

InterventionMonths (Median)
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)16.76
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)18.04

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Phase 2: Overall Survival (Olaratumab Pre-Treated)

OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact. (NCT02659020)
Timeframe: Baseline to Date of Death Due to Any Cause (Up To 38 Months)

InterventionMonths (Median)
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)19.84
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)17.31

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Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)

The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status. (NCT02659020)
Timeframe: Cycle 1 (Day 1), Follow-up (Up to 38 Months)

,,,
Interventionscore on a scale (Mean)
EQ-5D-5L - Index Value [Cycle 1 (Day 1)]EQ-5D-5L - VAS Score [Cycle 1 (Day 1)]EQ-5D-5L - Index Value [Follow-up (Up to 38 Months)]EQ-5D-5L - VAS Score [Follow-up (Up to 38 Months)]
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)0.8376.20.8074.8
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)0.8073.50.7468.7
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)0.8370.30.7670.8
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)0.8172.70.7163.0

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Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies

Number of Participants with Treatment Emergent Anti-Olaratumab Antibodies (NCT02659020)
Timeframe: Baseline through Follow-Up (Up to 38 Months)

InterventionParticipants (Count of Participants)
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)0
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)0

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Phase 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD)

DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. (NCT02659020)
Timeframe: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up To 38 Months)

InterventionPercentage of participants (Number)
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)74.1
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)72.1
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)67.4
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)62.8

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Phase 1b/2: Population PK: Volume of Distribution at Steady State (Vss) of Olaratumab

The Vss is the sum of central volume of distribution (V1) + peripheral volume of distribution (V2). (NCT02659020)
Timeframe: Cycle 1-19: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on days 1, 8

InterventionLiter (Mean)
Olaratumab + Gemcitabine + Docetaxel5.14

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Phase 1b/2: PK: Cmax of Gemcitabine

Cmax of Gemcitabine. (NCT02659020)
Timeframe: Day 8 of Cycle 1 (end of infusion, 1, 2, 4, 24 hours post-infusion)

Interventionμg/mL (Geometric Mean)
Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel2.79
Phase 1b: Cohort 2 Overall - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel3.49
Phase 2: Olaratumab + Gemcitabine + Docetaxel3.01
Phase 2: Placebo + Gemcitabine + Docetaxel2.35

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Phase 1b/2: PK: Cmax of Docetaxel

Cmax of Docetaxel. (NCT02659020)
Timeframe: 5 min, 1, 3, 24, 48 h post-dose on Cycle 1 Day 8

InterventionNanograms per milliliter (Geometric Mean)
Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel903
Phase 1b: Cohort 2 Overall - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel1110
Phase 2: Olaratumab + Gemcitabine + Docetaxel1030
Phase 2: Placebo + Gemcitabine + Docetaxel827

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Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)

"A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE Version 4.0:~Febrile neutropenia with documented Grade ≥3 infection or sepsis~Grade 4 neutropenia lasting 7 days or longer.~Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage.~Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, or diarrhoea that can be controlled with optimal medical management within 48 hours." (NCT02659020)
Timeframe: Cycle 1 (Up To 21 Days)

InterventionParticipants (Count of Participants)
Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel1
Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel4
Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel3

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"Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) Worst Pain Score"

"The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf worst pain score (TWP) was defined as the time from the date of randomization to the first date of either a worst pain score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the patient has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered." (NCT02659020)
Timeframe: Baseline to Follow-up (Up To 24 Months)

InterventionMonths (Median)
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)3.61
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)2.27
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)3.15
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)2.20

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Phase 1b/2: Population PK: Clearance of Olaratumab

Population PK: Clearance of Olaratumab (NCT02659020)
Timeframe: Cycle 1-19: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on days 1, 8

InterventionLiter Per Hour (Mean)
Olaratumab + Gemcitabine + Docetaxel0.0186

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Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.

The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems. (NCT02659020)
Timeframe: Baseline to Follow-up (Up to 33 months)

,,,
InterventionMonths (Median)
FatigueNausea and vomitingPainDyspnoeaInsomniaAppetite lossConstipationDiarrhoeaFinancial difficulties
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)0.853.982.432.331.911.414.633.557.29
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)0.953.784.672.145.321.123.251.41NA
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)0.7613.173.062.795.091.973.813.52NA
Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)0.952.460.992.144.242.562.861.817.66

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Percentage of Subjects That Reach Complete Pathologic Response (pT0) at the Time of Cystectomy

"Pathologic (p) anatomic response for bladder cancer uses the American Joint Committee on Cancer (AJCC) TNM staging system, which is based on:~Size of primary tumor (T) and whether it has grown into nearby areas. Spread to regional lymph nodes (N). Spread (metastasis) (M) to other organs of the body. Once the T, N, and M categories have been determined, this information is combined into a prognostic group. Higher numbers mean the cancer is more advanced.~Pathologic staging is based on the operative and pathology report from cystectomy at the local site.~Complete pathologic response (pT0) is defined as pT0 N0 M0." (NCT02690558)
Timeframe: 14 weeks of treatment plus cystectomy within 70 days of treatment

Interventionpercentage of patients with response (Number)
Pembrolizumab, Gemcitabine and Cisplatin36

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Percentage of Subjects That Reach Pathological Downstaging (Response) at the Time of Cystectomy

"Pathologic (p) anatomic stage for bladder cancer uses the American Joint Committee on Cancer (AJCC) Tumor/Nodes/Metastasis (TNM) system, which is based on:~Size of primary tumor (T) and whether it has grown into nearby areas. Spread to regional lymph nodes (N). Spread (metastasis; M) to other organs of the body. Once the T, N, and M categories have been determined, this information is combined into a prognostic group. Higher numbers mean the cancer is more advanced.~Pathologic staging is based on the operative and pathology report from cystectomy at the local site. A pathologic response or downstaging is defined as a reduction in stage to below pathological tumor stage 2 (NCT02690558)
Timeframe: 14 weeks of treatment plus cystectomy within 70 days after treatment

Interventionpercentage of patients with response (Number)
Pembrolizumab, Gemcitabine and Cisplatin56

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Overall Survival (OS)

OS was defined as the time from start of treatment to time of death from any cause. Participants who had not died at the time of final analysis were censored at the date of last contact. OS was estimated by Kaplan-Meier methodology and expressed in months. (NCT02694536)
Timeframe: Up to approximately 40 months (assessed continuously through end of study)

Interventionmonths (Median)
Erlotinib + Gemcitabine7.49

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Percentage of Participants Who Died

The percentage of participants who died from any cause was reported to the nearest integer. (NCT02694536)
Timeframe: Up to approximately 40 months (assessed continuously through end of study)

Interventionpercentage of participants (Number)
Erlotinib + Gemcitabine73

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Percentage of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported. (NCT02694536)
Timeframe: Up to approximately 40 months (assessed continuously during treatment)

Interventionpercentage of participants (Number)
Erlotinib + Gemcitabine78.8

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Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)

Tumor assessments were performed using RECIST. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of longest diameters (LD) of target lesions in reference to smallest sum of LD on study. The percentage of participants who died or demonstrated disease progression was reported to the nearest integer. (NCT02694536)
Timeframe: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)

Interventionpercentage of participants (Number)
Erlotinib + Gemcitabine88

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European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores

"The QLQ-C30 is a 30-item questionnaire that assesses physical (Questions 1-5), role (Questions 6-7), emotional (Questions 21-24), cognitive (Questions 20 and 25), and social (Questions 26-27) functional domains as well as global health status (Questions 29-30) and several symptoms including fatigue (Questions 10, 12, and 18), pain (Questions 9 and 19), nausea/vomiting (Questions 14-15), dyspnea (Question 8), appetite loss (Question 13), insomnia (Question 11), constipation/diarrhea (Questions 16-17), and financial difficulties (Question 28). Questions 1 to 28 were assessed on a 4-point scale from 1 (no/not at all) to 4 (very much) where higher scores represented worse symptoms. Questions 29 and 30 were assessed on a 7-point scale from 1 (very poor) to 7 (excellent) where higher scores represented better functioning. Item scores over the study period were averaged among all participants across all visits for which data were available." (NCT02694536)
Timeframe: Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)

Interventionunits on a scale (Mean)
Q1: Trouble in strenuous activities (n=256)Q2: Trouble with long walk (n=259)Q3: Trouble with short walk (n=258)Q4: Need to say in bed or chair (n=255)Q5: Need help in daily activities (n=259)Q6: Limited in doing work/daily activities (n=257)Q7: Limited in pursuing hobbies (n=255)Q8: Short of breath (n=258)Q9: Pain (n=257)Q10: Need to rest (n=255)Q11: Trouble sleeping (n=257)Q12: Felt weak (n=255)Q13: Lacked appetite (n=257)Q14: Felt nauseated (n=257)Q15: Vomited (n=259)Q16: Constipated (n=259)Q17: Diarrhea (n=259)Q18: Tired (n=255)Q19: Pain interference with daily activity (n=256)Q20: Difficulty concentrating (n=257)Q21: Felt tense (n=256)Q22: Worried (n=253)Q23: Felt irritable (n=258)Q24: Felt depressed (n=258)Q25: Difficulty remembering things (n=257)Q26: Interference with family life (n=257)Q27: Interference with social activities (n=257)Q28: Financial difficulties (n=258)Q29: Overall health (n=255)Q30: Overall quality of life (n=255)
Erlotinib + Gemcitabine1.962.031.501.871.211.821.731.381.882.051.742.051.701.481.101.511.272.071.691.491.972.101.751.671.441.591.621.324.444.38

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Progression-Free Survival (PFS) According to RECIST

Tumor assessments were performed using RECIST. PFS was defined as the time from treatment start to the time of death or disease progression. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum of LD on study. PFS was estimated by Kaplan-Meier methodology and expressed in months. (NCT02694536)
Timeframe: Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)

Interventionmonths (Median)
Erlotinib + Gemcitabine4.864

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Freedom From Bladder Stones/Dystrophic Calcification

The secondary endpoint for this study will be the number of subjects who did not experience dystrophic calcification or bladder calculi measured by the number of patients with Grade 3 through Grade 5 Adverse Events that are related to study arm, graded according to NCI CTCAE Version 4.03.Version 4.03 (NCT02695771)
Timeframe: Two years

InterventionParticipants (Count of Participants)
Mitomycin C24
Gemcitabine23
No Intervention25

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Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03

The NCI CTCAE Version 4.03 grades adverse events as follows: grade 3 include severe but non-life-threatening consequences that result in hospitalization and/or interventions, including elective radiologic or operative interventions; grade 4 events include life-threatening consequences, such as those requiring urgent reoperation; and grade 5 events result in treatment-related death. (NCT02695771)
Timeframe: Two years

InterventionParticipants (Count of Participants)
Mitomycin C15
Gemcitabine14
No Intervention20

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One- and Two-year Progression Survival Rate Will be Determined. Will be Determined.

The proportion of patients without disease progressions at 1 year and 2 years. (NCT02704156)
Timeframe: 2 years

,
InterventionParticipants (Count of Participants)
1-year PFS rate2-year PFS rate
SBRT Plus Gemcitabine70
SBRT Plus Pembrolizumab and Trametinib180

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The Quality of Life Will be Analyzed.

The analysis of quality of life is based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30). All scales and subscales range from 0 to 100. Regarding physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning and global health, higher scores may indicate better outcomes. In the case of fatigue, nausea and vomitting, pain, dyspnea, insomina, appetite loss, constipation, diarrhea and financial difficulties, lower scores may indicate better outcomes. Scales of all items are independent and not combined to compute a total score. (NCT02704156)
Timeframe: 3 years

,
Interventionunits on a scale (Mean)
Physical functioningRole functioningEmotional functioningCognitive functioningSocial functioningGlobal healthFatigueNausea and vomittingPainDyspneaInsominaAppetite lossConstipationDiarrheaFinancial difficulties
SBRT Plus Gemcitabine86.281.873.984.785.583.629.629.423.916.114.931.014.515.716.8
SBRT Plus Pembrolizumab and Trametinib83.784.572.183.384.183.226.628.826.513.717.633.316.515.717.2

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The Median Progression Free Survival Time Will be Determined.

The time from the start of treatment until documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02704156)
Timeframe: 3 years

Interventionmonths (Median)
SBRT Plus Gemcitabine5.4
SBRT Plus Pembrolizumab and Trametinib8.2

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The Median Survival Time Will be Determined.

The time from the start of treatment to death (NCT02704156)
Timeframe: 3 years

Interventionmonths (Median)
SBRT Plus Gemcitabine12.8
SBRT Plus Pembrolizumab and Trametinib14.9

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One- and Two-year Overall Survival Rate Will be Determined.

The number of patients alive at 1 year and 2 years. (NCT02704156)
Timeframe: 2 year

,
InterventionParticipants (Count of Participants)
1-year OS rate2-year OS rate
SBRT Plus Gemcitabine480
SBRT Plus Pembrolizumab and Trametinib532

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AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy

Area under the steady-state plasma concentration-time curve over 1 dosing interval from Hour 0 to 24 for QD administration of INCB057643 administered as monotherapy in fed state. (NCT02711137)
Timeframe: C2D1

Interventionh*nM (Mean)
12mg QD INCB0576432980

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AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy

Area under the steady-state plasma concentration-time curve over 1 dosing interval from Hour 0 to 24 for QD administration of INCB057643 administered as monotherapy in fasted state (NCT02711137)
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D8

Interventionh*nM (Mean)
8mg QD INCB0576431940
12mg QD INCB0576432740
16mg QD INCB0576433610

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Objective Response Rate (ORR) With INCB057643 in Solid Tumors

Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)]. (NCT02711137)
Timeframe: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months

,,
InterventionParticipants (Number)
Solid TumorsLymphoma
Part1/Treatment Group A : 12mg QD INCB05764300
Part1/Treatment Group A : 16mg QD INCB05764301
Part1/Treatment Group A : 8mg QD INCB05764301

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Number of Participants With Treatment Emergent Adverse Events (TEAE's).

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. (NCT02711137)
Timeframe: From screening through at least 30 days after end of treatment, up to approximately 24 months

InterventionParticipants (Number)
Part1/Treatment Group A : 8mg QD INCB0576434
Part1/Treatment Group A : 12mg QD INCB0576435
Part1/Treatment Group A : 16mg QD INCB0576438
Part1/Treatment Group B : 8mg QD INCB0576437
Part1/Treatment Group B : 12mg QD INCB0576435
Part1/Treatment Group C : 8mg QD INCB0576431
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort86
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort5
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg1
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg2
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg4
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni3
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg1
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg2

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Percent Inhibition of Total Cellular Myc Protein Concentrations Before and After Administration of INCB057643 When Administered as Monotherapy in an Ex-vivo Assay

An ex vivo assay (utilized in monotherapy only), Measuring Total c-Myc protein expressed from an exogenously added cell line (KMS12BM) to patient plasma, before and after administration of INCB057643. (NCT02711137)
Timeframe: PD in plasma at pre-dose and 0.5, 1, 2, 4, 6 and 8 hours postdose, for C1D1 and C1D8, and 24hrs post dose for C1D1

,,
Intervention%Inhibition of Total c-Myc (Mean)
C1D1C1D8
12mg QD INCB0576432843.4
16mg QD INCB0576435465
8mg QD INCB0576432430

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Part 2 - Cmax: Maximum Observed Plasma Concentration of INCB057643.

Maximum Observed Plasma Concentration INCB057643 administered as monotherapy in fed state. (NCT02711137)
Timeframe: C2D1

InterventionnM (Mean)
12mg QD INCB057643220

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Tmax: Time to Maximum Plasma Concentration of INCB057643

Time to maximum plasma concentration of INCB057643 administered as monotherapy in fasted state (NCT02711137)
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8

,,
Interventionhours (Median)
C1D1C1D8
12mg QD INCB05764322
16mg QD INCB0576432.002.00
8mg QD INCB0576432.001.00

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Part 2-Tmax: Time to Maximum Plasma Concentration of INCB057643

Time to maximum plasma concentration of INCB057643 administered as monotherapy in fed state (NCT02711137)
Timeframe: C2D1

Interventionhours (Median)
12mg QD INCB0576436.00

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Objective Response Rate (ORR) With INCB057643 in Solid Tumors

Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)]. (NCT02711137)
Timeframe: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months

InterventionParticipants (Number)
Solid TumorsLymphomaGlioblastoma
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort020

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Cmax: Maximum Observed Plasma Concentration of INCB057643.

Maximum Observed Plasma Concentration INCB057643 administered as monotherapy in fasted state. (NCT02711137)
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8

,,
InterventionnM (Mean)
C1D1C1D8
12mg QD INCB057643266293
16mg QD INCB057643343340
8mg QD INCB057643201210

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Objective Response Rate (ORR) With INCB057643 in Solid Tumors

Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)]. (NCT02711137)
Timeframe: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months

InterventionParticipants (Number)
AML
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg0

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AUC0-t: Area Under the Single-dose Plasma Concentration-time Curve of INCB057643

Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration of INCB057643 administered as monotherapy in fasted state (NCT02711137)
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1

Interventionh*nM (Mean)
8mg QD INCB0576432090
12mg QD INCB0576432550
16mg QD INCB0576433210

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Objective Response Rate (ORR) With INCB057643 in Solid Tumors

Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)]. (NCT02711137)
Timeframe: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months

InterventionParticipants (Number)
AMLMyelodysplastic Syndrome
Part1/Treatment Group B : 12mg QD INCB05764300

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Objective Response Rate (ORR) With INCB057643 in Solid Tumors

Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)]. (NCT02711137)
Timeframe: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months

InterventionParticipants (Number)
Multiple Myeloma
Part1/Treatment Group C : 8mg QD INCB0576430

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Objective Response Rate (ORR) With INCB057643 in Solid Tumors

Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)]. (NCT02711137)
Timeframe: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months

InterventionParticipants (Number)
Myelofibrosis
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg0

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Objective Response Rate (ORR) With INCB057643 in Solid Tumors

Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)]. (NCT02711137)
Timeframe: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months

,,,
InterventionParticipants (Number)
Solid Tumors
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg0
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg1
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg0
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni0

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Objective Response Rate (ORR) With INCB057643 in Solid Tumors

Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)]. (NCT02711137)
Timeframe: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months

,
InterventionParticipants (Number)
AMLMyelodysplastic SyndromeMyelofibrosis
Part1/Treatment Group B : 8mg QD INCB057643000
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort100

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Progression Free Survival (PFS)

PFS time was measured from the date of randomization until the first radiographic documentation of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. (NCT02711553)
Timeframe: Randomization to Progressive Disease or Death from Any Cause (Up To 20 Months)

InterventionMonths (Median)
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine6.47
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine6.97
Pooled Placebo6.64

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Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

PK was determined by the minimum observed plasma concentration (Cmin). 1 Cycle (C) = 21 days (D). (NCT02711553)
Timeframe: C1 D8, C2 D1, C3 D1, C4 D1,C5 D1,C7 D1, C9 D1 and C13 D1: Within 3 days Prior to Infusion(PTI)

InterventionMicrogram per milliliter (µg/mL) (Geometric Mean)
Cycle 1 Day 8 (Week 1)Cycle 2 Day 1 (Week 3)Cycle 3 Day 1 (Week 6)Cycle 4 Day 1 (Week 9)Cycle 5 Day 1 (Week 12)Cycle 7 Day 1 (Week 18)Cycle 9 Day 1 (Week 24)Cycle 13 Day 1 (Week 36)
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine46.238.154.177.382.985.682.797.7

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Change From Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep)

"FACT-Hep consists of 45 items in five subscales (1) physical well-being (PWB) score rage 0 -28; (2) social well-being (SWB) score range 0-28; (3) emotional well-being (EWB) score range 0-24; (4) functional well-being (FWB) score range 0-28; and (5) the hepatobiliary cancer subscale (HCS) Score range 0-72. The Trial Outcomes Index (TOI) is the sum of the PWB, FWB and Hep subscales with a scores range of 0 to 128. The Total FACT-Hep score was the sum of all questions with a scores range of 0 to 180.Total FACT-G score was the sum of the 27 questions in the PWB, SFWB, EWB and FWB with a scores range of 0 to 108. The FACT-Hep Symptoms Index with 8 key questions and scores range of 0 to 32 from the Hep Subscale. Higher score in sub-score or total score indicates better QOL and better health state. Participants were classified as Improved if they had positive change from baseline, Worsened if they had negative change from baseline, and Stable otherwise." (NCT02711553)
Timeframe: Baseline, Follow Up (Up To 48 Months)

,,
InterventionUnits on a Scale (Least Squares Mean)
PWBSWBEWBFWBHCSFACT-HepTOI
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine-2.75-0.260.23-2.40-3.62-1.11-8.68
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine-2.880.220.64-1.34-2.32-0.74-6.43
Pooled Placebo-1.650.560.93-0.75-0.68-0.09-3.01

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Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)

ORR was the number of participants who achieve a best overall response of CR or PR divided by the total number of participants randomized to the corresponding treatment arm as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. (NCT02711553)
Timeframe: Randomization to Disease Progression (Up To 30 Months)

InterventionPercentage of participants (Number)
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine31.1
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine19.6
Pooled Placebo32.7

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Overall Survival (OS)

OS defined as the time from from randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. (NCT02711553)
Timeframe: Randomization to Date of Death from Any Cause (Up To 48 Months)

InterventionMonths (Median)
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine10.45
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine14.03
Pooled Placebo13.04

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Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)

Disease Control Rate (DCR) was the number of participants who achieve a best overall response of CR, PR, or SD divided by the total number of participants randomized to the corresponding treatment arm as per RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. (NCT02711553)
Timeframe: Randomization to Disease Progression (Up To 30 Months)

InterventionPercentage of participants (Number)
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine81.1
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine83.3
Pooled Placebo78.2

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Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies

Number of participants with positive treatment emergent anti-ramucirumab antibodies (ADA) was summarized by treatment group. (NCT02711553)
Timeframe: Predose Cycle 1 Day 1 through Follow Up (Up To 48 Months)

InterventionParticipants (Count of Participants)
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine3
Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine0

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Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the US algorithm (-0.109 to 1). A higher score indicates better health state. (NCT02711553)
Timeframe: Baseline, Follow Up (Up To 48 Months)

InterventionUnits on a Scale (Mean)
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine0.61
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine0.63
Pooled Placebo0.66

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Change From Baseline in Participant-Reported EQ-5D-5L Visual Analog Scale (VAS) Score

EQ-5D-5L is a 2-part questionnaire that assesses general health status 'today'. The second part is assessed using a VAS on which the patient rates their perceived health state, ranging from 0 millimeter (the worst health you can imagine) to 100 millimeter (the best health you can imagine). (NCT02711553)
Timeframe: Baseline, Follow Up (Up To 48 Months)

Interventionmillimeter (mm) (Mean)
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine66.44
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine66.57
Pooled Placebo69.08

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Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)

ECGs including clinical significance was evaluated by the Investigator. Criteria for clinical significance were as per investigator's discretion. (NCT02715804)
Timeframe: From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)

InterventionParticipants (Count of Participants)
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine8
AG: Placebo + Nab-Paclitaxel + Gemcitabine4

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Number of Participants With Treatment-Emergent Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as AEs that begin or worsen in severity during or after the participant's first dose of study treatment and no later than 30 days after the date of the last dose of study treatment and/or any treatment-related AE regardless of the onset date. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. (NCT02715804)
Timeframe: From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)

InterventionParticipants (Count of Participants)
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine325
AG: Placebo + Nab-Paclitaxel + Gemcitabine156

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Duration of Response (DOR)

DOR was defined as the time from the first objective response of CR or PR until disease progression (as determined by the blinded CIV based on RECIST version 1.1) or death within 14 days of last dose of study treatment or randomization. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study thus far, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. DOR was analyzed using Kaplan-Meier methods. (NCT02715804)
Timeframe: From date of first objective response (CR or PR) until date of first disease progression (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)

Interventionmonths (Median)
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine6.1
AG: Placebo + Nab-Paclitaxel + Gemcitabine7.4

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Number of Participants With Worst Post-Baseline Hematology and Chemistry (Clinical Laboratory Parameters) Severity Grade During the Study

Severity grade associated with a laboratory parameter value was determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening. Grade 0 indicates evaluable lab records but not fall into any CTCAE grade for certain CTCAE term. A worst post-baseline grade shift was defined as the worst change that occurred at any measured timepoint during study. Hematology abnormalities: anemia(hemoglobin decreased), lymphocyte count decreased, lymphocyte count increased, neutropenia(neutrophil count decreased), thrombocytopenia(platelet count decreased), and leukopenia(white blood cell decreased). Chemistry abnormalities: hypoalbuminemia, alkaline phosphatase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hyperbilirubinemia, hypo- and hypercalcemia, creatinine increased, hypo- and hyperglycaemia, hypo- and hyperkalemia, hypo- and hypermagnesemia, hypo- and hypernatremia. (NCT02715804)
Timeframe: From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)

InterventionParticipants (Count of Participants)
Anemia: Post-baseline72032340Anemia: Post-baseline72032341Lymphocyte count decreased: Post-baseline72032340Lymphocyte count decreased: Post-baseline72032341Lymphocyte count increased: Post-baseline72032340Lymphocyte count increased: Post-baseline72032341Neutropenia: Post-baseline72032340Neutropenia: Post-baseline72032341Thrombocytopenia: Post-baseline72032341Thrombocytopenia: Post-baseline72032340Leukopenia: Post-baseline72032340Leukopenia: Post-baseline72032341Hypoalbuminemia (Albumin): Post-baseline72032340Hypoalbuminemia (Albumin): Post-baseline72032341Alkaline phosphatase increased: Post-baseline72032340Alkaline phosphatase increased: Post-baseline72032341Alanine aminotransferase increased: Post-baseline72032340Alanine aminotransferase increased: Post-baseline72032341Aspartate aminotransferase increased:Post-baseline72032340Aspartate aminotransferase increased:Post-baseline72032341Hyperbilirubinemia: Post-baseline72032340Hyperbilirubinemia: Post-baseline72032341Hypocalcemia (calcium): Post-baseline72032340Hypocalcemia (calcium): Post-baseline72032341Hypercalcemia (calcium): Post-baseline72032340Hypercalcemia (calcium): Post-baseline72032341Creatinine increased: Post-baseline72032340Creatinine increased: Post-baseline72032341Hypoglycemia (glucose): Post-baseline72032340Hypoglycemia (glucose): Post-baseline72032341Hyperglycemia (glucose): Post-baseline72032340Hyperglycemia (glucose): Post-baseline72032341Hypokalemia (potassium): Post-baseline72032341Hypokalemia (potassium): Post-baseline72032340Hyperkalemia (potassium): Post-baseline72032341Hyperkalemia (potassium): Post-baseline72032340Hypomagnesemia (magnesium): Post-baseline72032340Hypomagnesemia (magnesium): Post-baseline72032341Hypermagnesemia (magnesium): Post-baseline72032341Hypermagnesemia (magnesium): Post-baseline72032340Hyponatremia (sodium): Post-baseline72032341Hyponatremia (sodium): Post-baseline72032340Hypernatremia (sodium): Post-baseline72032340Hypernatremia (sodium): Post-baseline72032341
Grade 0Grade 1Grade 2Grade 3Grade 4
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine84
AG: Placebo + Nab-Paclitaxel + Gemcitabine41
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine164
AG: Placebo + Nab-Paclitaxel + Gemcitabine74
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine67
AG: Placebo + Nab-Paclitaxel + Gemcitabine37
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine33
AG: Placebo + Nab-Paclitaxel + Gemcitabine17
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine83
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine102
AG: Placebo + Nab-Paclitaxel + Gemcitabine46
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine90
AG: Placebo + Nab-Paclitaxel + Gemcitabine40
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine13
AG: Placebo + Nab-Paclitaxel + Gemcitabine6
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine302
AG: Placebo + Nab-Paclitaxel + Gemcitabine150
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine0
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine19
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine85
AG: Placebo + Nab-Paclitaxel + Gemcitabine31
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine27
AG: Placebo + Nab-Paclitaxel + Gemcitabine11
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine57
AG: Placebo + Nab-Paclitaxel + Gemcitabine30
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine98
AG: Placebo + Nab-Paclitaxel + Gemcitabine48
AG: Placebo + Nab-Paclitaxel + Gemcitabine35
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine52
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine134
AG: Placebo + Nab-Paclitaxel + Gemcitabine63
AG: Placebo + Nab-Paclitaxel + Gemcitabine20
AG: Placebo + Nab-Paclitaxel + Gemcitabine4
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine74
AG: Placebo + Nab-Paclitaxel + Gemcitabine32
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine30
AG: Placebo + Nab-Paclitaxel + Gemcitabine15
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine100
AG: Placebo + Nab-Paclitaxel + Gemcitabine43
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine87
AG: Placebo + Nab-Paclitaxel + Gemcitabine51
AG: Placebo + Nab-Paclitaxel + Gemcitabine14
AG: Placebo + Nab-Paclitaxel + Gemcitabine62
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine185
AG: Placebo + Nab-Paclitaxel + Gemcitabine44
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine12
AG: Placebo + Nab-Paclitaxel + Gemcitabine3
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine135
AG: Placebo + Nab-Paclitaxel + Gemcitabine57
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine114
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine50
AG: Placebo + Nab-Paclitaxel + Gemcitabine26
AG: Placebo + Nab-Paclitaxel + Gemcitabine10
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine69
AG: Placebo + Nab-Paclitaxel + Gemcitabine33
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine155
AG: Placebo + Nab-Paclitaxel + Gemcitabine72
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine43
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine51
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine77
AG: Placebo + Nab-Paclitaxel + Gemcitabine28
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine168
AG: Placebo + Nab-Paclitaxel + Gemcitabine96
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine49
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine25
AG: Placebo + Nab-Paclitaxel + Gemcitabine13
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine237
AG: Placebo + Nab-Paclitaxel + Gemcitabine125
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine36
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine224
AG: Placebo + Nab-Paclitaxel + Gemcitabine119
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine68
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine22
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine278
AG: Placebo + Nab-Paclitaxel + Gemcitabine148
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine34
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine267
AG: Placebo + Nab-Paclitaxel + Gemcitabine135
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine45
AG: Placebo + Nab-Paclitaxel + Gemcitabine16
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine6
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine292
AG: Placebo + Nab-Paclitaxel + Gemcitabine140
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine17
AG: Placebo + Nab-Paclitaxel + Gemcitabine9
AG: Placebo + Nab-Paclitaxel + Gemcitabine1
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine3
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine31
AG: Placebo + Nab-Paclitaxel + Gemcitabine24
AG: Placebo + Nab-Paclitaxel + Gemcitabine45
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine119
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine76
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine4
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine202
AG: Placebo + Nab-Paclitaxel + Gemcitabine104
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine89
AG: Placebo + Nab-Paclitaxel + Gemcitabine38
AG: Placebo + Nab-Paclitaxel + Gemcitabine0
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine24
AG: Placebo + Nab-Paclitaxel + Gemcitabine2
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine245
AG: Placebo + Nab-Paclitaxel + Gemcitabine122
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine44
AG: Placebo + Nab-Paclitaxel + Gemcitabine19
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine21
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine7
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine2
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine209
AG: Placebo + Nab-Paclitaxel + Gemcitabine113
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine95
AG: Placebo + Nab-Paclitaxel + Gemcitabine36
AG: Placebo + Nab-Paclitaxel + Gemcitabine5
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine306
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine8
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine96
AG: Placebo + Nab-Paclitaxel + Gemcitabine49
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine167
AG: Placebo + Nab-Paclitaxel + Gemcitabine85
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine54
AG: Placebo + Nab-Paclitaxel + Gemcitabine21
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine1
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine308
AG: Placebo + Nab-Paclitaxel + Gemcitabine153
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine9

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Number of Participants With Clinically Significant Abnormalities in Vital Signs

Vital signs included measurement of blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), heart rate, and body weight. Criteria for clinical significance abnormalities were: Heart rate: <50 beats per minute (bpm), >120 bpm, >=30 bpm increase from baseline, >=30 bpm decrease from baseline. SBP: >140 millimeters of mercury (mmHg) and increase from baseline >20 mmHg, >180 mmHg, <90 mmHg and decrease from baseline >10 mmHg. DBP: >90 mmHg and increase from baseline >20 mmHg, >105 mmHg, <60 mmHg and decrease from baseline >10 mmHg. Change in weight: >=5% increase from baseline, >=5% decrease from baseline. (NCT02715804)
Timeframe: From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)

,
InterventionParticipants (Count of Participants)
Heart rate: <50 bpmHeart rate: >120 bpmHeart rate: >=30 bpm increase from baselineHeart rate: >=30 bpm decrease from baselineSBP: >140 mmHg and increase from baseline >20 mmHgSBP: >180 mmHgSBP: <90 mmHg and decrease from baseline >10 mmHgDBP: >90 mmHg and increase from baseline >20 mmHgDBP: >105 mmHgDBP: <60 mmHg and decrease from baseline >10 mmHgChange in weight: >=5% increase from baselineChange in weight: >=5% decrease from baseline
AG: Placebo + Nab-Paclitaxel + Gemcitabine413261937417106565257
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine747102387566021814285151

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Progression-Free Survival (PFS)

PFS was defined as the time from randomization until the first occurrence of radiological disease progression, as determined by the blinded Central Imaging Vendor (CIV) based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, or death from any cause during the treatment period. Disease progression was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 millimeters (mm); Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using Kaplan-Meier method. (NCT02715804)
Timeframe: From the date of randomization until disease progression or death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)

Interventionmonths (Median)
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine7.1
AG: Placebo + Nab-Paclitaxel + Gemcitabine7.1

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Overall Survival

Overall survival was defined as the time from randomization until death from any cause. Overall survival was analyzed using Kaplan-Meier methods. (NCT02715804)
Timeframe: From randomization until death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)

Interventionmonths (Median)
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine11.2
AG: Placebo + Nab-Paclitaxel + Gemcitabine11.5

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Objective Response Rate (ORR): Percentage of Participants With Objective Response

ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR) as determined by the blinded CIV based on RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT02715804)
Timeframe: From the date of randomization until CR or PR (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)

Interventionpercentage of participants (Number)
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine47.1
AG: Placebo + Nab-Paclitaxel + Gemcitabine36.4

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PF-04136309 Minimum Observed Plasma Concentration (Cmin) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]

Cmin of PF-04136309 was observed directly from data. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. (NCT02732938)
Timeframe: Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)

Interventionng/mL (Geometric Mean)
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine72.34

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PF-04136309 Maximum Observed Plasma Concentration (Cmax) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]

Cmax of PF-04136309 was observed directly from data. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. Arithmetic coefficient of variation (CV) was the intended method of dispersion for reporting but system only has geometric CV option, hence geometric CV data were reported for this parameter. (NCT02732938)
Timeframe: Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)

Interventionng/mL (Geometric Mean)
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine1276

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PF-04136309 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]

The dosing interval was 12 hours for PF-04136309 BID dosing. AUCtau was determined by linear/log trapezoidal method. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. (NCT02732938)
Timeframe: Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)

Interventionnanogram*hour/milliliter (ng*hr/mL) (Number)
Individual value for Participant 1Individual value for Participant 2
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine1570010600

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PF-04136309 Maximum Observed Plasma Concentration (Cmax) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]

Cmax of PF-04136309 was observed directly from data. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. (NCT02732938)
Timeframe: Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)

Interventionnanograms per milliliter (ng/mL) (Number)
Individual value for Participant 1Individual value for Participant 2
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine33902950

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Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b]

Following parameters were analyzed for chemistry laboratory test: blood urea nitrogen (BUN), creatinine, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, AST, ALT, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, Magnesium, phosphorous or phosphate. For potential Hy's Law cases, in addition to repeating AST and ALT, laboratory tests should have included albumin, creatine kinase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase (GGT), prothrombin time / international normalized ratio (PT/INR), alkaline phosphatase, total bile acids, and acetaminophen drug and/or protein adduct levels. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here. (NCT02732938)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
ALT, Grade 1ALT, Grade 2ALT, Grade 3ALT, Grade 4Alkaline phosphatase, Grade 1Alkaline phosphatase, Grade 2Alkaline phosphatase, Grade 3AST, Grade 1AST, Grade 2AST, Grade 3Bilirubin (total), Grade 1Bilirubin (total), Grade 2Bilirubin (total), Grade 3Creatinine, Grade 1Creatinine, Grade 2GGT, Grade 1Hyperglycemia, Grade 1Hyperglycemia, Grade 2Hyperglycemia, Grade 3Hyperkalemia, Grade 1Hypermagnesemia, Grade 1Hypoalbuminemia, Grade 1Hypoalbuminemia, Grade 2Hypocalcemia, Grade 1Hypocalcemia, Grade 2Hypoglycemia, Grade 2Hypokalemia, Grade 1Hypokalemia, Grade 3Hypomagnesemia, Grade 1Hyponatremia, Grade 1Hyponatremia, Grade 3Hypophosphatemia, Grade 2Hypophosphatemia, Grade 3
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine834175281513292166521866213157331

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PF-04136309 Time to Reach Maximum Observed Plasma Concentration (Tmax) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]

Tmax of PF-04136309 was observed directly from data as time of first occurrence. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. (NCT02732938)
Timeframe: Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)

Interventionhours (hr) (Number)
Individual value for Participant 1Individual value for Participant 2
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine1.003.02

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PF-04136309 Minimum Observed Plasma Concentration (Cmin) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]

Cmin of PF-04136309 was observed directly from data. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. (NCT02732938)
Timeframe: Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)

Interventionng/mL (Number)
Individual value for Participant 1Individual value for Participant 2
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine4360

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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Phase 1b]

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. (NCT02732938)
Timeframe: 1 year

,
InterventionParticipants (Count of Participants)
Treatment-emergent AE (all causality)Treatment-emergent AE (PF-04136309 related)Treatment-emergent SAE (all causality)Treatment-emergent SAE (PF-04136309 related)
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine1716114
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine4332

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PF-04136309 Apparent Oral Clearance (CL/F) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]

CL/F was determined by Dose/AUCtau. AUCtau is the area under the curve from time 0 to end of dosing interval. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data. (NCT02732938)
Timeframe: Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)

InterventionLiters per hour (L/hr) (Number)
Individual value for Participant 1Individual value for Participant 2
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine47.870.5

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Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity [Phase 1b]

Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE. (NCT02732938)
Timeframe: 1 year

,
InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4Grade 5
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine011231
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine00400

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Number of Participants With Urinalysis Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b]

Following parameters were analyzed for urinalysis laboratory test: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase), urine dipstick for urine protein (if positive collected 24 hour and microscopic [reflex testing]), urine dipstick for urine blood (if positive collected a microscopic [reflex testing]). Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here. (NCT02732938)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine1
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine0

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Objective Response Rate (ORR) [Phase 1b]

ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1, relative to all randomized participants who had baseline measurable disease. Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. (NCT02732938)
Timeframe: 1 year

InterventionPercentage of Participants (Number)
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine0
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine29.4

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PF-04136309 Apparent Oral Clearance (CL/F) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]

CL/F was determined by Dose/AUCtau. AUCtau is the area under the curve from time 0 to end of dosing interval. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. Arithmetic CV was the intended method of dispersion for reporting but system only has geometric CV option, hence geometric CV data were reported for this parameter. (NCT02732938)
Timeframe: Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)

InterventionLiters per hour (L/hr) (Geometric Mean)
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine85.09

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PF-04136309 Apparent Volume of Distribution (Vz/F) for Cycle 1 Day 15 [Phase 1b]

Vz/F was determined by Dose/(AUCtau×kel). AUCtau is the area under the curve from time 0 to end of dosing interval and kel is the terminal phase rate constant. (NCT02732938)
Timeframe: Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)

InterventionLiters (L) (Geometric Mean)
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine120
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine398.3

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PF-04136309 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]

The dosing interval was 12 hours for PF-04136309 BID dosing. AUCtau was determined by linear/log trapezoidal method. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. Arithmetic CV was the intended method of dispersion for reporting but system only has geometric CV option, hence geometric CV data were reported for this parameter. (NCT02732938)
Timeframe: Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)

Interventionng*hr/mL (Geometric Mean)
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine5873

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Number of Participants With Dose-Limiting Toxicities (DLTs) [Phase 1b]

DLT: Any of the following events occurred in the first treatment cycle and was attributed to the combination of PF-04136309 with nab-paclitaxel and gemcitabine where relationship with the combination could not be ruled out. Hematologic: Grade (Gr) 4 neutropenia lasting more than (>)5 days; febrile neutropenia; Gr≥3 neutropenic infection; Gr≥3 thrombocytopenia with Gr≥2 bleeding; Gr4 thrombocytopenia. Non-Hematologic: Gr3 toxicities (except: nausea and vomiting responding to prophylaxis and/or treatment and lasting less than (<)7 days from each chemotherapy infusion period; diarrhea responding to treatment and lasting <7 days; Gr3 QTc prolongation [QTc >500 milliseconds] [a DLT only if persisting after correction of any reversible causes]; Gr3 aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) increase lasting less than or equal to (≤)7 days); all Gr4 toxicities; delay of >2 weeks in receiving the next scheduled cycle due to persisting treatment-related toxicities. (NCT02732938)
Timeframe: Day 1 to Day 28

InterventionParticipants (Count of Participants)
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine1
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine3

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Number of Participants With Hematology Laboratory Abnormalities by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Phase 1b]

Following parameters were analyzed for hematology laboratory test: hemoglobin, hematocrit, red blood cell (RBC) count, mean corpuscular volume (MCV); mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell (WBC) count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here. (NCT02732938)
Timeframe: 1 year

,
InterventionParticipants (Count of Participants)
Anemia, Grade 1Anemia, Grade 2Anemia, Grade 3Lymphocyte count increased, Grade 2Lymphopenia, Grade 1Lymphopenia, Grade 2Lymphopenia, Grade 3Neutrophils (absolute), Grade 1Neutrophils (absolute), Grade 2Neutrophils (absolute), Grade 3Neutrophils (absolute), Grade 4Platelets, Grade 1Platelets, Grade 2WBC, Grade 1WBC, Grade 2WBC, Grade 3WBC, Grade 4
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine584133815211022521
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine13001210030310030

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PF-04136309 Time to Reach Maximum Observed Plasma Concentration (Tmax) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]

Tmax of PF-04136309 was observed directly from data as time of first occurrence. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. (NCT02732938)
Timeframe: Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)

Interventionhours (hr) (Median)
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine1.42

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PF-04136309 Plasma Decay Half-Life (t1/2) for Cycle 1 Day 15 [Phase 1b]

t1/2 was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. (NCT02732938)
Timeframe: Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)

Interventionhours (hr) (Mean)
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine1.18
Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine3.41

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Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b]

Following parameters were analyzed for chemistry laboratory test: blood urea nitrogen (BUN), creatinine, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, AST, ALT, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, Magnesium, phosphorous or phosphate. For potential Hy's Law cases, in addition to repeating AST and ALT, laboratory tests should have included albumin, creatine kinase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase (GGT), prothrombin time / international normalized ratio (PT/INR), alkaline phosphatase, total bile acids, and acetaminophen drug and/or protein adduct levels. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here. (NCT02732938)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
ALT, Grade 1ALT, Grade 2ALT, Grade 3ALT, Grade 4Alkaline phosphatase, Grade 1Alkaline phosphatase, Grade 2Alkaline phosphatase, Grade 3AST, Grade 1AST, Grade 2AST, Grade 3Bilirubin (total), Grade 1Bilirubin (total), Grade 2Bilirubin (total), Grade 3Creatinine, Grade 1Creatinine, Grade 2Hyperglycemia, Grade 1Hyperglycemia, Grade 2Hyperglycemia, Grade 3Hyperkalemia, Grade 1Hypermagnesemia, Grade 1Hypoalbuminemia, Grade 1Hypoalbuminemia, Grade 2Hypocalcemia, Grade 1Hypocalcemia, Grade 2Hypoglycemia, Grade 2Hypokalemia, Grade 1Hypokalemia, Grade 3Hypomagnesemia, Grade 1Hyponatremia, Grade 1Hyponatremia, Grade 3Hypophosphatemia, Grade 2Hypophosphatemia, Grade 3
Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine12102102110004022000012001010000

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Time to Progression

Time to progression is defined as the time from treatment initiation to the date of first documentation of disease progression per RECIST v1.1. Otherwise, patients are censored at last radiographic assessment for progression. (NCT02769832)
Timeframe: Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)

Interventionmonths (Median)
Nab-Paclitaxel With Gemcitabine2.9

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Progression-Free Survival

Progression-free survival is defined as the time from treatment initiation to the date of first documentation of disease progression or death due to any cause. Otherwise, patients are censored at the date of last radiographic assessment for progression. (NCT02769832)
Timeframe: Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)

Interventionmonths (Median)
Nab-Paclitaxel With Gemcitabine2.9

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Overall Survival

Overall survival is defined as the time from treatment initiation to death due to any cause. Patients still alive are censored at last date known to be alive. (NCT02769832)
Timeframe: Patients will be evaluated every 3 months until death or study completion (up to 3 years)

Interventionmonths (Median)
Nab-Paclitaxel With Gemcitabine9.3

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Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments >= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline. (NCT02807636)
Timeframe: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)

InterventionPercentage of Participants (Number)
Placebo+Gemcitabine+Carboplatin/Cisplatin44.4
Atezolizumab Monotherapy24.2

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Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments >= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline. (NCT02807636)
Timeframe: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)

InterventionPercentage of Participants (Number)
Placebo+Gemcitabine+Carboplatin/Cisplatin44.8
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin48.1

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Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm

Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm. (NCT02807636)
Timeframe: Up to approximately 73 months

InterventionMonths (Median)
Placebo+Gemcitabine+Carboplatin/Cisplatin15.74
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin16.39

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Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm

Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab Monotherapy Arm. (NCT02807636)
Timeframe: Up to approximately 73 months

InterventionMonths (Median)
Placebo+Gemcitabine+Carboplatin/Cisplatin16.10
Atezolizumab Monotherapy9.23

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Investigator-Assessed Progression-Free Survival (INV-PFS) in Participants Treated With Atezolizumab Monotherapy Arm Compared With Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever occurs first. (NCT02807636)
Timeframe: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 35 months)

InterventionMonths (Median)
Placebo+Gemcitabine+Carboplatin/Cisplatin6.31
Atezolizumab Monotherapy2.69

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OS Event Free Rate in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

Overall Survival (OS) Event Free Rate at 1 Year. (NCT02807636)
Timeframe: Year 1

InterventionPercentage (Number)
Placebo+Gemcitabine+Carboplatin/Cisplatin54.56
Atezolizumab Monotherapy57.91

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Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm

PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever occurs first. (NCT02807636)
Timeframe: Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months)

InterventionMonths (Median)
Placebo+Gemcitabine+Carboplatin/Cisplatin6.34
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin8.18

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Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first. (NCT02807636)
Timeframe: From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)

InterventionMonths (Number)
Placebo+Gemcitabine+Carboplatin/Cisplatin8.15
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin9.13

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Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first. (NCT02807636)
Timeframe: From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)

InterventionMonths (Number)
Placebo+Gemcitabine+Carboplatin/Cisplatin8.11
Atezolizumab Monotherapy29.63

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Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

OS is defined as the time from randomization to death due to any cause. (NCT02807636)
Timeframe: Baseline until death due to any cause (up to approximately 73 months)

InterventionMonths (Median)
Placebo+Gemcitabine+Carboplatin/Cisplatin13.44
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin16.13

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Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

OS is defined as the time from randomization to death due to any cause. (NCT02807636)
Timeframe: Baseline until death due to any cause (up to approximately 73 months)

InterventionMonths (Median)
Placebo+Gemcitabine+Carboplatin/Cisplatin13.34
Atezolizumab Monotherapy15.21

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Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs)

Percentage of participants with Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs). (NCT02807636)
Timeframe: Up to approximately 35 months

,
InterventionPercentage of participants (Number)
Baseline evaluable participantsPost-baseline evaluable participants
Atezolizumab Monotherapy0.926.3
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin1.219.7

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Minimum Atezolizumab Serum Concentration

Minimum atezolizumab serum concentration. (NCT02807636)
Timeframe: Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, Cycle 16 Day 1, Cycle 24 Day 1, Cycle 32 Day 1, Day 120 post dose of last blinded atezolizumab treatment, and study drug early discontinuation

,
Interventionμg/ mL (Mean)
Cycle 2 Day 1Cycle 3 Day 1Cycle 4 Day 1Cycle 8 Day 1Cycle 16 Day 1Cycle 24 Day 1Cycle 32 Day 1Day 120 Post Dose of Last Blinded Atezo TrtStudy Drug Early Discontinuation
Atezolizumab Monotherapy80.21291571932202332589.53124
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin79.812215321623524425918.8154

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PFS Event Free Rate

Progression Free Survival (PFS) Event Free Rate at Year 1 (NCT02807636)
Timeframe: Year 1

InterventionPercentage (Number)
Placebo+Gemcitabine+Carboplatin/Cisplatin22.17
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin30.47

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Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm

Time to deterioration in global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm. (NCT02807636)
Timeframe: Up to approximately 73 months

InterventionMonths (Median)
Placebo+Gemcitabine+Carboplatin/Cisplatin12.06
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin32.07

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Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm

Time to deterioration in global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 in the Placebo+Chemo Arm versus Atezolizumab Monotherapy Arm. (NCT02807636)
Timeframe: Up to approximately 73 months

InterventionMonths (Median)
Placebo+Gemcitabine+Carboplatin/Cisplatin12.02
Atezolizumab Monotherapy23.20

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IRF-PFS

Independent review facility PFS (IRF-PFS) is defined as the time from randomization to the first documented disease progression as determined by blinded independent central review with use of RECIST v1.1, or death due to any cause, whichever occurs first. (NCT02807636)
Timeframe: Randomization to first documented disease progression or death from any cause (up to 35 months)

InterventionMonths (Number)
Placebo+Gemcitabine+Carboplatin/Cisplatin6.34
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin7.10

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Maximum Atezolizumab Serum Concentration

Maximum atezolizumab serum concentration. (NCT02807636)
Timeframe: Cycle 1 Day 1

Interventionμg/ mL (Mean)
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin379
Atezolizumab Monotherapy390

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OS Event Free Rate Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

Overall Survival (OS) Event Free Rate at 1 Year. (NCT02807636)
Timeframe: Year 1

InterventionPercentage (Number)
Placebo+Gemcitabine+Carboplatin/Cisplatin55.00
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin60.00

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Part 2: DOR - Participants With PD-L1 CPS ≥10 Tumors

For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionMonths (Median)
Part 2: Pembrolizumab + ChemotherapyNA
Part 2: Placebo + Chemotherapy7.3

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Part 2: Duration of Response (DOR) - All Participants

For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionMonths (Median)
Part 2: Pembrolizumab + ChemotherapyNA
Part 2: Placebo + Chemotherapy6.5

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Part 2: Objective Response Rate (ORR) - All Participants

Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionPercentage of Participants (Number)
Part 2: Pembrolizumab + Chemotherapy40.8
Part 2: Placebo + Chemotherapy37.0

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Part 2: ORR - Participants With PD-L1 CPS ≥1 Tumors

Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionPercentage of Participants (Number)
Part 2: Pembrolizumab + Chemotherapy44.9
Part 2: Placebo + Chemotherapy38.9

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Part 2: ORR - Participants With PD-L1 CPS ≥10 Tumors

Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionPercentage of Participants (Number)
Part 2: Pembrolizumab + Chemotherapy52.7
Part 2: Placebo + Chemotherapy40.8

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Part 2: OS - Participants With PD-L1 CPS ≥1 Tumors

Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionMonths (Median)
Part 2: Pembrolizumab + Chemotherapy17.6
Part 2: Placebo + Chemotherapy16.0

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Part 2: OS - Participants With PD-L1 CPS ≥10 Tumors

Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionMonths (Median)
Part 2: Pembrolizumab + Chemotherapy23.0
Part 2: Placebo + Chemotherapy16.1

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Part 2: Overall Survival (OS) - All Participants

Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionMonths (Median)
Part 2: Pembrolizumab + Chemotherapy17.2
Part 2: Placebo + Chemotherapy15.5

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Part 2: Percentage of Participants Who Discontinued Study Drug Due to an AE- All Participants

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. (NCT02819518)
Timeframe: Up to approximately 52 months

InterventionPercentage of Participants (Number)
Part 2: Pembrolizumab + Chemotherapy20.5
Part 2: Placebo + Chemotherapy13.5

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Part 2: Percentage of Participants Who Experienced an AE- All Participants

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionPercentage of Participants (Number)
Part 2: Pembrolizumab + Chemotherapy98.6
Part 2: Placebo + Chemotherapy98.2

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Part 2: PFS - Participants With PD-L1 CPS ≥10 Tumors

Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionMonths (Median)
Part 2: Pembrolizumab + Chemotherapy9.7
Part 2: Placebo + Chemotherapy5.6

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Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors

Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionMonths (Median)
Part 2: Pembrolizumab + Chemotherapy7.6
Part 2: Placebo + Chemotherapy5.6

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Part 2: Progression-Free Survival (PFS) - All Participants

Progression-free survival was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionMonths (Median)
Part 2: Pembrolizumab + Chemotherapy7.5
Part 2: Placebo + Chemotherapy5.6

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Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. (NCT02819518)
Timeframe: Up to approximately 39 months

InterventionPercentage of Participants (Number)
Part 1: Pembrolizumab + Nab-paclitaxel38.5
Part 1: Pembrolizumab + Paclitaxel50.0
Part 1: Pembrolizumab + Gemcitabine/Carboplatin27.3

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Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. (NCT02819518)
Timeframe: Up to approximately 39 months

InterventionPercentage of Participants (Number)
Part 1: Pembrolizumab + Nab-paclitaxel100.0
Part 1: Pembrolizumab + Paclitaxel100.0
Part 1: Pembrolizumab + Gemcitabine/Carboplatin100.0

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Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score - Participants With PD-L1 CPS ≥1 Tumors

"The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions How would you rate your overall health during the past week? (Item 29) and How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented." (NCT02819518)
Timeframe: Baseline and Week 15

InterventionScores on a scale (Least Squares Mean)
Part 2: Pembrolizumab + Chemotherapy-3.92
Part 2: Placebo + Chemotherapy-3.15

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Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score-Participants With PD-L1 CPS ≥10 Tumors

"The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions How would you rate your overall health during the past week? (Item 29) and How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented." (NCT02819518)
Timeframe: Baseline and Week 15

InterventionScores on a scale (Least Squares Mean)
Part 2: Pembrolizumab + Chemotherapy-2.69
Part 2: Placebo + Chemotherapy-0.88

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Part 2: Change From Baseline to Week 15 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score- All Participants

"The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions How would you rate your overall health during the past week? (Item 29) and How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented." (NCT02819518)
Timeframe: Baseline and Week 15

InterventionScores on a scale (Least Squares Mean)
Part 2: Pembrolizumab + Chemotherapy-3.52
Part 2: Placebo + Chemotherapy-2.15

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Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)-All Participants

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented. (NCT02819518)
Timeframe: Baseline and Week 15

InterventionScores on a scale (Least Squares Mean)
Part 2: Pembrolizumab + Chemotherapy12.50
Part 2: Placebo + Chemotherapy12.36

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Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 - Participants With PD-L1 CPS ≥1 Tumors

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented. (NCT02819518)
Timeframe: Baseline and Week 15

InterventionScores on a scale (Least Squares Mean)
Part 2: Pembrolizumab + Chemotherapy13.00
Part 2: Placebo + Chemotherapy11.86

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Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23- Participants With PD-L1 CPS ≥10 Tumors

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented. (NCT02819518)
Timeframe: Baseline and Week 15

InterventionScores on a scale (Least Squares Mean)
Part 2: Pembrolizumab + Chemotherapy13.56
Part 2: Placebo + Chemotherapy13.26

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Part 2: DCR - Participants With PD-L1 CPS ≥1 Tumors

Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionPercentage of Participants (Number)
Part 2: Pembrolizumab + Chemotherapy58.6
Part 2: Placebo + Chemotherapy53.6

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Part 2: Disease Control Rate (DCR) - All Participants

Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionPercentage of Participants (Number)
Part 2: Pembrolizumab + Chemotherapy56.0
Part 2: Placebo + Chemotherapy51.2

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Part 2: DCR - Participants With PD-L1 CPS ≥10 Tumors

Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionPercentage of Participants (Number)
Part 2: Pembrolizumab + Chemotherapy65.0
Part 2: Placebo + Chemotherapy54.4

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Part 2: DOR - Participants With PD-L1 CPS ≥1 Tumors

For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. (NCT02819518)
Timeframe: Up to approximately 53 months

InterventionMonths (Median)
Part 2: Pembrolizumab + ChemotherapyNA
Part 2: Placebo + Chemotherapy6.8

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Pembro Combo vs Chemo: Duration of Response (DOR) Using RECIST 1.1 as Assessed by BICR

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro combo arm and chemo arm who had CR or PR. Per protocol, DOR was assessed separately in responders of the pembro arm and chemo arm and is presented later in the record. (NCT02853305)
Timeframe: Up to approximately 42 months

InterventionMonths (Median)
Pembrolizumab + ST Chemotherapy (Pembro Combo)8.5
ST Chemotherapy (Chemo)6.2

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Pembro vs Chemo: PFS Using RECIST 1.1 as Assessed by BICR

"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study.~Per protocol, PFS in the pembro arm was compared to the chemo arm as a pre-specified analysis of the ITT population (all randomized participants). PFS is reported here for all participants in the pembro arm and chemo arm. Per protocol, PFS was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record." (NCT02853305)
Timeframe: Up to approximately 42 months

InterventionMonths (Median)
Pembrolizumab (Pembro)3.9
ST Chemotherapy (Chemo)7.1

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Pembro vs Chemo: TTD in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score

"EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question How would you rate your overall health during the past week? (Item 29) and the QoL question How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL was defined as the time from first dose date to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score without confirmation. Per protocol, TTD in GHS/QoL combined score was compared between the pembro arm and chemo arm. TTD in GHS/QoL combined score was compared separately between the pembro combo arm and chemo arm and is presented earlier in the record." (NCT02853305)
Timeframe: Baseline up to approximately 25 months

InterventionMonths (Median)
Pembrolizumab (Pembro)3.6
ST Chemotherapy (Chemo)4.5

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PFS Using RECIST 1.1 as Assessed by BICR at 12 Months

PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS was compared between arms as a pre-specified secondary analysis of the ITT population (all randomized participants). PFS is reported here for all participants at 12 months based on the product-limit (Kaplan-Meier) method for censored data. (NCT02853305)
Timeframe: 12 months

InterventionPercentage of Participants (Number)
Pembrolizumab + ST Chemotherapy (Pembro Combo)33.7
Pembrolizumab (Pembro)26.6
ST Chemotherapy (Chemo)20.9

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Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10%

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the CPS ≥10% subset of the pembro arm was compared to OS in the CPS ≥10% subset of the chemo arm for this endpoint as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro arm and chemo arm who were PD-L1 CPS ≥10%. Per protocol, OS in the CPS ≥10% subset of the pembro combo arm was not a pre-specified analysis of the ITT population and is not presented. (NCT02853305)
Timeframe: Up to approximately 42 months

InterventionMonths (Median)
Pembrolizumab (Pembro)16.1
ST Chemotherapy (Chemo)15.2

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Pembro Combo vs Chemo: Objective Response Rate (ORR) Using RECIST 1.1 as Assessed by BICR

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, ORR in the pembro combo arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and chemo arm. Per protocol, ORR was compared separately between participants of the pembro arm and chemo arm and is presented later in the record. (NCT02853305)
Timeframe: Up to approximately 42 months

InterventionPercentage of Participants (Number)
Pembrolizumab + ST Chemotherapy (Pembro Combo)54.7
ST Chemotherapy (Chemo)44.9

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Number of Participants Who Discontinue Study Drug Due to an AE

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that discontinued any study drug due to an AE was reported for each treatment arm. (NCT02853305)
Timeframe: Up to approximately 52 months

InterventionParticipants (Count of Participants)
Pembrolizumab + ST Chemotherapy (Pembro Combo)108
Pembrolizumab (Pembro)48
ST Chemotherapy (Chemo)62

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Number of Participants Who Experience an Adverse Event (AE)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm. (NCT02853305)
Timeframe: Up to approximately 55 months

InterventionParticipants (Count of Participants)
Pembrolizumab + ST Chemotherapy (Pembro Combo)348
Pembrolizumab (Pembro)289
ST Chemotherapy (Chemo)341

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PFS Using RECIST 1.1 as Assessed by BICR at 18 Months

PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS was compared between arms as a pre-specified secondary analysis of the ITT population (all randomized participants). PFS is reported here for all participants at 18 months based on the product-limit (Kaplan-Meier) method for censored data. (NCT02853305)
Timeframe: 18 months

InterventionPercentage of Participants (Number)
Pembrolizumab + ST Chemotherapy (Pembro Combo)23.0
Pembrolizumab (Pembro)19.1
ST Chemotherapy (Chemo)13.5

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Pembro Combo vs Chemo: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score

"The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question How would you rate your overall health during the past week? (Item 29) and the Quality of Life (QoL) question How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record." (NCT02853305)
Timeframe: Baseline, Week 18

InterventionScore on a Scale (Least Squares Mean)
Pembrolizumab + ST Chemotherapy (Pembro Combo)2.54
ST Chemotherapy (Chemo)-0.14

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Pembro Combo vs Chemo: Disease Control Rate (DCR) Using RECIST 1.1 as Assessed by BICR

DCR was defined as the percentage of participants who had a confirmed CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD]). Per protocol, DCR in the pembro combo arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by BICR was reported as the DCR for all participants in the pembro combo arm and chemo arm. Per protocol, DCR was compared separately between participants of the pembro arm and chemo arm and is presented later in the record. (NCT02853305)
Timeframe: Up to approximately 42 months

InterventionPercentage of Participants (Number)
Pembrolizumab + ST Chemotherapy (Pembro Combo)80.3
ST Chemotherapy (Chemo)75.9

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Pembro Combo vs Chemo: Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the chemo arm as a pre-specified primary analysis of the ITT population (all randomized participants). OS is reported here for all participants in the pembro combo arm and chemo arm. Per protocol, OS was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record. (NCT02853305)
Timeframe: Up to approximately 42 months

InterventionMonths (Median)
Pembrolizumab + ST Chemotherapy (Pembro Combo)17.0
ST Chemotherapy (Chemo)14.3

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Pembro Combo vs Chemo: Progression-free Survival (PFS) Using Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

"PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study.~Per protocol, PFS in the pembro combo arm was compared to the chemo arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population (all randomized participants). PFS is reported here for all participants in the pembro combo arm and chemo arm. Per protocol, PFS was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record." (NCT02853305)
Timeframe: Up to approximately 42 months

InterventionMonths (Median)
Pembrolizumab + ST Chemotherapy (Pembro Combo)8.3
ST Chemotherapy (Chemo)7.1

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Pembro Combo vs Chemo: Time to Deterioration (TTD) in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score

"EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question How would you rate your overall health during the past week? (Item 29) and the QoL question How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL was defined as the time from first dose date to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score without confirmation. Per protocol, TTD in GHS/QoL combined score was compared between the pembro combo arm and chemo arm. TTD in GHS/QoL combined score was compared separately between the pembro arm and chemo arm and is presented later in the record." (NCT02853305)
Timeframe: Baseline up to approximately 25 months

InterventionMonths (Median)
Pembrolizumab + ST Chemotherapy (Pembro Combo)8.0
ST Chemotherapy (Chemo)4.5

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Pembro vs Chemo: Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score

"The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question How would you rate your overall health during the past week? (Item 29) and the Quality of Life (QoL) question How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record." (NCT02853305)
Timeframe: Baseline, Week 18

InterventionScore on a Scale (Least Squares Mean)
Pembrolizumab (Pembro)-1.89
ST Chemotherapy (Chemo)-0.95

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Pembro vs Chemo: DCR Using RECIST 1.1 as Assessed by BICR

DCR was defined as the percentage of participants who had a CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD]). Per protocol, DCR in the pembro arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by BICR was reported as the DCR for all participants in the pembro arm and chemo arm. Per protocol, DCR was compared separately between participants of the pembro combo arm and chemo arm and is presented earlier in the record. (NCT02853305)
Timeframe: Up to approximately 42 months

InterventionPercentage of Participants (Number)
Pembrolizumab (Pembro)47.2
ST Chemotherapy (Chemo)75.9

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Pembro vs Chemo: DOR Using RECIST 1.1 as Assessed by BICR

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro arm and chemo arm who had CR or PR. Per protocol, DOR was assessed separately in responders of the pembro combo arm and chemo arm and is presented earlier in the record. (NCT02853305)
Timeframe: Up to approximately 42 months

InterventionMonths (Median)
Pembrolizumab (Pembro)28.2
ST Chemotherapy (Chemo)6.2

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Pembro vs Chemo: ORR Using RECIST 1.1 as Assessed by BICR

ORR was defined as the percentage of participants in the analysis population who had a CR (disappearance of all target lesions) or a PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, ORR in the pembro arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro arm and chemo arm. Per protocol, ORR was compared separately between participants of the pembro combo arm and chemo arm and is presented earlier in the record. (NCT02853305)
Timeframe: Up to approximately 42 months

InterventionPercentage of Participants (Number)
Pembrolizumab (Pembro)30.3
ST Chemotherapy (Chemo)44.9

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Pembro vs Chemo: OS

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro arm was compared to the chemo arm as a pre-specified primary analysis of the ITT population (all randomized participants). OS is reported here for all participants in the pembro arm and chemo arm. Per protocol, OS was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record. (NCT02853305)
Timeframe: Up to approximately 42 months

InterventionMonths (Median)
Pembrolizumab (Pembro)15.6
ST Chemotherapy (Chemo)14.3

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PFS Using RECIST 1.1 as Assessed by BICR at 6 Months

PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS was compared between arms as a pre-specified secondary analysis of the ITT population (all randomized participants). PFS is reported here for all participants at 6 months based on the product-limit (Kaplan-Meier) method for censored data. (NCT02853305)
Timeframe: 6 months

InterventionPercentage of Participants (Number)
Pembrolizumab + ST Chemotherapy (Pembro Combo)73.7
Pembrolizumab (Pembro)43.6
ST Chemotherapy (Chemo)70.3

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Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population)

The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02855944)
Timeframe: Assessments every 8 weeks from Cycle 1 Day 1 (C1D1) until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

InterventionMonths (Median)
Rucaparib7.4
Chemotherapy5.7

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Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (Efficacy Population)

EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean changes from baseline global score over the first 6 cycles in the Treatment Part of the study were analyzed. (NCT02855944)
Timeframe: Baseline to the end of Cycle 6, or up to approximately 6 months

Interventionscore on a scale (Least Squares Mean)
Rucaparib0.5
Chemotherapy0.3

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Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (ITT Population)

EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean changes from baseline global score over the first 6 cycles in the Treatment Part of the study were analyzed. (NCT02855944)
Timeframe: Baseline to the end of Cycle 6, or up to approximately 6 months

Interventionscore on a scale (Least Squares Mean)
Rucaparib0.6
Chemotherapy0.4

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Overall Survival (Efficacy Population)

Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive. (NCT02855944)
Timeframe: All patients were followed for survival up to approximately 3.5 years.

InterventionMonths (Median)
Rucaparib21.1
Chemotherapy26.2

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Overall Survival (ITT Population)

Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive. (NCT02855944)
Timeframe: All patients were followed for survival up to approximately 3.5 years.

InterventionMonths (Median)
Rucaparib19.4
Chemotherapy25.4

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Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (Efficacy Population)

A secondary endpoint is ORR for the Treatment Part of the study defined as the percentage of patients with best response of CR or PR using RECIST v1.1 or response per Gynecologic Cancer InterGroup Cancer Antigen 125 (GCIG CA-125) criteria. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Response to CA-125 has occurred if there is at least a 50% decrease from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Interventionpercentage of patients (Number)
Rucaparib50.7
Chemotherapy43.6

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Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (ITT Population)

A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Interventionpercentage of participants (Number)
Rucaparib37.9
Chemotherapy30.2

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Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (Efficacy Population)

A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Interventionpercentage of participants (Number)
Rucaparib40.3
Chemotherapy32.3

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Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (ITT Population)

A secondary endpoint is the DOR for the Treatment Part of the study. The DOR as assessed by investigator is analyzed in the subgroup of patients who had a confirmed response by RECIST v1.1. DOR for any confirmed RECIST CR or PR will be measured from the date of the first response until the first date that progressive disease (PD) is documented. DOR is calculated in months as the time from the first date of the scan showing a response to the first scan with disease progression +1 day. Any patients with an ongoing response are censored at the date of the last post-baseline scan. Only tumor scans up to and within 6 weeks of start of any subsequent anti-cancer treatment are included. Progressive disease (PD) is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Interventionmonths (Median)
Rucaparib9.4
Chemotherapy7.2

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Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (ITT Population)

The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

InterventionMonths (Median)
Rucaparib7.4
Chemotherapy5.7

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Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (Efficacy Population)

A secondary endpoint is the DOR for the Treatment Part of the study. The DOR as assessed by investigator is analyzed in the subgroup of patients who had a confirmed response by RECIST v1.1. DOR for any confirmed RECIST CR or PR will be measured from the date of the first response until the first date that progressive disease (PD) is documented. DOR is calculated in months as the time from the first date of the scan showing a response to the first scan with disease progression +1 day. Any patients with an ongoing response are censored at the date of the last post-baseline scan. Only tumor scans up to and within 6 weeks of start of any subsequent anti-cancer treatment are included. Progressive disease (PD) is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Interventionmonths (Median)
Rucaparib9.4
Chemotherapy7.2

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Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 and/or CA-125 Response (ITT Population)

A secondary endpoint is ORR for the Treatment Part of the study defined as the percentage of patients with best response of CR or PR using RECIST v1.1 or response per Gynecologic Cancer InterGroup Cancer Antigen 125 (GCIG CA-125) criteria. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Response to CA-125 has occurred if there is at least a 50% decrease from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response. (NCT02855944)
Timeframe: Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.

Interventionpercentage of patients (Number)
Rucaparib47.8
Chemotherapy40.5

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The Maximum Tolerated Dose (MTD) of Stereotactic Body Radiotherapy (SBRT) in Locally Advanced Pancreatic Cancer (LAPC) Patients Who Have Not Developed Distant Progression After Induction Chemotherapies.

This will be accomplished by the standard 3+3 dose escalation design. Dose limiting toxicities (DLT) are defined by ≥ Grade 3 treatment-related GI toxicity within 3 months of SBRT. These include: (1) Bowel (includes bowel perforation, obstruction, or hemorrhage) and (2) Stomach (bleeding ulcer, perforation) as determined by imaging or endoscopic evaluation. (NCT02873598)
Timeframe: Up to 3 months

Interventiongrey (Number)
FOLFIRINOX or Gemcitabine/Abraxane Followed by SBRT33

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Progression Free Survival

Defined as the time from randomization to the first objective documentation of disease progression, defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death due to any cause with patients who had not progressed or died at the time of final analysis censored on the date of the last tumour assessment. (NCT02879318)
Timeframe: 35 months

Interventionmonths (Median)
Gemcitabine Plus Nab-Paclitaxel5.4
Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab5.5

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Overall Survival

Time from randomization to death from any cause with patients who were alive at the time of the final analysis or who became lost to follow-up censored at their last date known to be alive. (NCT02879318)
Timeframe: 35 months

Interventionmonths (Median)
Gemcitabine Plus Nab-Paclitaxel8.8
Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab9.8

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The Number of Participants With Grade 3/4/5 Adverse Events (AEs) as a Measure of Safety.

The reported incidence of AEs with an onset on or after the initiation of therapy will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. (NCT02887248)
Timeframe: through study completion, an average of 1 year

InterventionParticipants (Count of Participants)
Nab-paclitaxel+Gemcitabine2

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Overall Survival (OS) of Patients

To compare Overall Survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician's Choice (TPC). Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for OS analysis. (NCT02915744)
Timeframe: Within 3 years from study start

Interventionmonths (Median)
NKTR-1027.8
Treatment of Physician's Choice (TPC)7.5

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Duration of Response (DoR)

Duration of response (DoR) outside the CNS will be defined as the time from first documented CR or PR until the earliest evidence of disease progression per RECIST v1.1 or death from any cause. CR is defined as disappearance of all target lesions for at least 4 weeks with no new lesions, not use of corticosteroids, and patient was stable or improved clinically. PR is defined as at least a 30% decrease in the sum of longest diameters sustained for at least 4 weeks, no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (NCT02915744)
Timeframe: Through study completion, an expected average of 1 year

Interventionmonths (Median)
NKTR-1027.4
Treatment of Physician's Choice (TPC)3.5

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Magnitude of Clinical Benefit Assessed by ESMO-MCBS Derived From Overall Survival

The magnitude of clinical benefit of NKTR-102 is assessed by the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) (v1.0). The scale is graded 5, 4, 3, 2, 1, where grades 5 and 4 represent a high level of proven clinical benefit, and grade 1 represents no clinical benefit. To determine the magnitude of clinical benefit when the median OS with the standard of treatment is ≤ 1 year, the score is derived from the Hazard Ratio (HR) of Overall Survival, overall survival gain, and QoL improvement between two treatment arms. Values reported in the data table are Overall Survival values. (NCT02915744)
Timeframe: Through study completion, within 3 years from study start

Interventionmonths (Median)
NKTR-1027.8
Treatment of Physician's Choice (TPC)7.5

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Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3

The number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3 (NCT02915744)
Timeframe: Through study completion, an expected average of 1 year

InterventionParticipants (Count of Participants)
NKTR-10290
Treatment of Physician's Choice (TPC)76

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Progression-Free Survival (Outside the Central Nervous System)

Progression-Free Survival (PFS) is defined as the time from the date of randomization to the earliest evidence of documented Progressive Disease (PD) or of death from any cause. The date of global deterioration or symptomatic deterioration will not be used as the date of PD. The assessment of PFS outside the CNS will utilize RECIST criteria v1.1. (NCT02915744)
Timeframe: Through study completion, an expected average of 1 year

Interventionmonths (Median)
NKTR-1022.8
Treatment of Physician's Choice (TPC)1.9

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Progression-Free Survival (Overall)

Progression-free survival (CNS and peripheral) is defined as the time from the date of randomization to the earliest evidence of documented PD in either the CNS or peripheral (using RANO-BM) or death from any cause. The PD will be determined by both the investigator's and the central imaging facility assessments. The same statistical methods that were used for PFS and PFS-BM will be used for PFS (Overall). Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameters of CNS target lesions, taking as reference the smallest sum on study. This included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, at least 1 lesion had to increase by an absolute value of 5 mm or more to be considered progression. (NCT02915744)
Timeframe: Through study completion, an expected average of 1 year

Interventionmonths (Median)
NKTR-1022.1
Treatment of Physician's Choice (TPC)1.9

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Progression-Free Survival in Brain Metastasis (PFS-BM)

Progression-Free Survival in Brain Metastasis (PFS-BM) is defined as the time from the date of randomization to the earliest evidence of documented Progressive Disease (PD) per Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) in brain metastases or death from any cause. The PD will also be determined by the investigator's assessments. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameters of CNS target lesions, taking as reference the smallest sum on study. This included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, at least 1 lesion had to increase by an absolute value of 5 mm or more to be considered progression. (NCT02915744)
Timeframe: Through study completion, an expected average of 1 year

Interventionmonths (Median)
NKTR-1023.9
Treatment of Physician's Choice (TPC)3.3

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Clinical Benefit Rate (CBR)

Clinical Benefit Rate will be defined as the proportion of patients having a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for at least 4 months (≥ 120 days). CR is defined as disappearance of all target lesions for at least 4 weeks with no new lesions, not use of corticosteroids, and patient was stable or improved clinically. PR is defined as at least a 30% decrease in the sum of longest diameters sustained for at least 4 weeks, no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (NCT02915744)
Timeframe: For at least 4 months, with an expected average of 1 year

,
Interventionparticipants (Number)
# of Patients who achieved Complete Response# of Patients who achieved Partial Response# of Patients who have Stable Disease >= 120 days# of Patients who achieved Clinical Benefit Rate (CBR)
NKTR-102061723
Treatment of Physician's Choice (TPC)06511

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Volume of Distribution of IBI308 in Plasma After Single Dose Administration

(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

InterventionL (Geometric Mean)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)5.02
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)5.14
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)5.95
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)7.2

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Clearance of IBI308 in Plasma After Single Dose Administration

(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Interventionml/h (Geometric Mean)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)8.53
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)11.7
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)13.7
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)12.9

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Number of All Study Participants Who Demonstrate a Tumor Response

(NCT02937116)
Timeframe: Through out the study (up to 2 years)

InterventionParticipants (Number)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)0
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)1
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)0
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)1
MEL: Sintilimab 200mg Q3W (Cohort A)1
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)13
NSCLC: Sintilimab 200mg Q3W (Cohort C)5
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)13
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)11
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)17
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)3
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)1

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DOR According to RECIST 1.1 as Assessed by Investigator

(NCT02937116)
Timeframe: Through out the study (up to 2 years)

InterventionDays (Median)
MEL: Sintilimab 200mg Q3W (Cohort A)NA
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)NA
NSCLC: Sintilimab 200mg Q3W (Cohort C)368.0
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)NA
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)170.5
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)181.0
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)NA
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)NA

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Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator

ORR was defined as the percentage of participants in the analysis population who had achieved BOR of CR or PR according to RECIST 1.1. (NCT02937116)
Timeframe: Through out the study (up to 2 years)

Interventionpercentage of participants (Number)
MEL: Sintilimab 200mg Q3W (Cohort A)4.5
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)14.9
NSCLC: Sintilimab 200mg Q3W (Cohort C)13.5
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)61.9
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)55.0
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)85.0
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)42.9
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)14.3

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Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

(NCT02937116)
Timeframe: Up to 28 days in Cycle 1

InterventionParticipants (Number)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)0
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)0
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)0
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)0

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PFS According to RECIST 1.1 as Assessed by Investigator

(NCT02937116)
Timeframe: Through out the study (up to 2 years)

InterventionDays (Median)
MEL: Sintilimab 200mg Q3W (Cohort A)62.0
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)66.0
NSCLC: Sintilimab 200mg Q3W (Cohort C)84.0
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)377.0
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)194.0
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)230.0
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)NA
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)NA

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Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants

(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Interventionug/ml (Geometric Mean)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)21.9
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)69.7
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)220
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)54.6

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TTR According to RECIST 1.1 as Assessed by Investigator

(NCT02937116)
Timeframe: Through out the study (up to 2 years)

InterventionDays (Median)
MEL: Sintilimab 200mg Q3W (Cohort A)63.0
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)64.0
NSCLC: Sintilimab 200mg Q3W (Cohort C)63.0
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)63.0
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)62.0
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)63.0
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)62.0
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)62.0

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Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants

(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Interventionhours (Median)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)1.05
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)2.07
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)2.27
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)1.93

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The Half-life (t1/2) of IBI308 in Plasma After Single Dose Administration

(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

InterventionDays (Geometric Mean)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)17
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)12.7
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)12.5
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)16.1

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Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t)

(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, and 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Interventionh*ug/ml (Geometric Mean)
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)4800
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)12300
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)39800
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)10800

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OS for Participants

(NCT02937116)
Timeframe: Through out the study

InterventionDays (Median)
MEL: Sintilimab 200mg Q3W (Cohort A)518.0
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)342.0
NSCLC: Sintilimab 200mg Q3W (Cohort C)431.0
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)566.0
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)461.0
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)NA
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)NA
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)NA

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Progression-Free Survival (PFS) as Assessed by the Investigator Per Lugano Response Classification Criteria

Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. PFS data was censored on the date of the last adequate tumor assessment for participants who had no an event (PD or death), for participants who start a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing or inadequate post-baseline tumor assessment. Participants without an adequate baseline or post-baseline tumor assessment were censored on the date of randomization unless death occurred on or before the time of the second planned tumor assessment in which case the death was considered as an event. (NCT02951156)
Timeframe: From the date of randomization to progression of disease, study discontinuation, censoring date or death due to any cause, whichever occurred first (up to 36 months)

InterventionMonths (Median)
Avelumab+Rituximab+Utomilumab1.8
Avelumab+Azacitidine+Utomilumab1.5
Avelumab+Bendamustine+Rituximab2.7

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Overall Survival

Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. (NCT02951156)
Timeframe: From the date of randomization to discontinuation from the study or death, whichever occurred first (maximum up to 36 months)

InterventionMonths (Median)
Avelumab+Rituximab+Utomilumab14.8
Avelumab+Azacitidine+Utomilumab4.0
Avelumab+Bendamustine+Rituximab5.2

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Objective Response Rate (ORR) as Assessed by Investigator Per Lugano Response Classification Criteria

ORR was defined as percentage of participants with complete response (CR) or partial response (PR), as assessed by investigator per lugano response classification criteria. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [<=] mediastinum), or 3 (uptake less than [<] mediastinum but <=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. PR was defined as >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in sum of products of diameters (SPD) of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. (NCT02951156)
Timeframe: Randomization until date of PD, start of new anticancer therapy, discontinuation from study or death due to any cause, whichever occurred first (maximum up to 36 months)

InterventionPercentage of participants (Number)
Avelumab+Rituximab+Utomilumab11.1
Avelumab+Azacitidine+Utomilumab0
Avelumab+Bendamustine+Rituximab27.3

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Number of Participants With Dose Limiting Toxicities (DLT)

AEs occurring in first 4 weeks of treatment,attributable to 1 of study drugs. Hematology:1)Grade 4 neutropenia,2)Grade >=3 febrile neutropenia with single temperature of >38.3 degrees Celsius (C)/sustained temperature of >=38.0 degrees C for more than 1 hour with/without associated sepsis,3)Grade >=3 neutropenic infection,4)Grade 4 thrombocytopenia/Grade 3 thrombocytopenia with clinically significant bleeding,5)Grade 4 anemia 6)Any grade >=3 non-hematology toxicity except:transient Grade 3 flu like symptoms/fever controlled with standard medical management;transient Grade 3 fatigue,localized skin reactions/headache that resolves to Grade <=1;Grade 3 nausea,vomiting/diarrhea resolved to Grade <=1 in ˂72 hours after initiation of adequate medical management;Grade 3 skin toxicity resolved to Grade <=1 in ˂7 days;tumor flare;Single laboratory values that are out of normal range,that have no clinical correlate and resolve to Grade <=1 within 7 days with adequate medical management. (NCT02951156)
Timeframe: Day 1 Cycle 1 up to 4 Weeks

InterventionParticipants (Count of Participants)
Avelumab+Rituximab+Utomilumab1
Avelumab+Azacitidine+Utomilumab0
Avelumab+Bendamustine+Rituximab0

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Duration of Response (DOR) as Assessed by Investigator Per Lugano Response Classification Criteria

Investigator assessed DOR: was defined for participants with OR as time from first documentation of OR to time of first documentation of disease progression/death due to any cause, whichever occurred first. CR: score of 1(no uptake above background),2(uptake <=mediastinum),or 3(uptake =50% decrease in SPD of up to 6 of largest dominant lymph nodes,no increase in size of other nodes,liver,spleen volume,>=50% decrease in SPD of hepatic splenic nodules,absence of other organ involvement,no new sites of disease. PD: appearance of new lesion more than 1.5 cm in any axis,at least a 50% increase from nadir in SPD/longest diameter of previous lesion/node. Data was censored on date of last adequate tumor assessment in participants with no event,started new anti-cancer therapy/had 2 or more missing assessments. (NCT02951156)
Timeframe: First response (CR or PR) to date of PD, start of new anti-cancer therapy, discontinuation from the study, censoring date or death due to any cause, whichever occurred first (maximum up to 36 months)

InterventionMonths (Median)
Avelumab+Rituximab+Utomilumab1.81
Avelumab+Bendamustine+RituximabNA

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Disease Control Rate as Assessed by the Investigator Per Lugano Response Classification Criteria

Disease control rate was defined as percentage of participants with disease control. Disease Control (DC) was defined as the best overall response of CR, PR, or stable disease (SD). CR: score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake less than =50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. SD: <50% decrease in SDP of up to 6 dominant, measurable nodes and extranodal sites; no criteria for progressive disease met. To qualify as a best overall response of SD, at least one SD assessment must be observed >=6 weeks after start date and before disease progression. (NCT02951156)
Timeframe: From the date of randomization to the first documentation of PD, study discontinuation, start of new anti-cancer therapy or death due to any cause, whichever occurred first (maximum up to 36 months)

InterventionPercentage of participants (Number)
Avelumab+Rituximab+Utomilumab22.2
Avelumab+Azacitidine+Utomilumab0
Avelumab+Bendamustine+Rituximab36.4

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Number of Participants With Laboratory Abnormalities As Per National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.03

Laboratory parameters included hematological and biochemistry: Hematological parameters included: anemia, haemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cells decreased. Biochemistry parameters included alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholesterol high, creatine kinase(cpk) increased, creatinine increased, gamma glutamyl transferase(ggt) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, lipase increased,serum amylase increased.Test abnormalities were graded by NCI CTCAE version 4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. Number of participants with abnormalities of any grade were reported. (NCT02951156)
Timeframe: From first dose of study treatment up to at least 30 days after the last dose of study treatment or initiation of new anti-cancer therapy (up to 36 months)

,,
InterventionParticipants (Count of Participants)
AnemiaHemoglobin increasedLymphocyte count decreasedLymphocyte count increasedNeutrophil count decreasedPlatelet count decreasedWhite blood cell decreasedAlanine aminotransferase increasedAlkaline phosphatase increasedAspartate aminotransferase increasedBlood bilirubin increasedCholesterol highCpk increasedCreatinine increasedGGT increasedHypercalcemiaHyperglycemiaHyperkalemiaHypermagnesemiaHypernatremiaHypertriglyceridemiaHypoalbuminemiaHypocalcemiaHypoglycemiaHypokalemiaHypomagnesemiaHyponatremiaHypophosphatemiaLipase increasedSerum amylase increased
Avelumab+Azacitidine+Utomilumab807023454633164310103400101021
Avelumab+Bendamustine+Rituximab10090988263332106222117621443533
Avelumab+Rituximab+Utomilumab604024123302263030103310100112

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Greater Than or Equal to (>=) Grade 3, As Per National Cancer Institute Common Terminology Criteria For Adverse Events (NCI-CTCAE), Version 4.03

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03,severity was graded as Grade 1:asymptomatic/mild symptoms,clinical/diagnostic observations only, intervention not indicated; Grade 2:moderate, minimal, local/noninvasive intervention indicated,limiting age-appropriate instrumental activities of daily life (ADL); Grade 3:severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4:life-threatening consequence, urgent intervention indicated; Grade 5:death related to AE. TEAE was defined as events which occurred during on-treatment period beginning with first dose of study treatment through minimum (30 days + last dose of study treatment or start of new anti-cancer drug therapy). In this outcome measure participant with any TEAE of Grade 3 or above are reported. (NCT02951156)
Timeframe: From first dose of study treatment up to at least 30 days after the last dose of study treatment or initiation of new anti-cancer therapy (up to 36 months)

InterventionParticipants (Count of Participants)
Avelumab+Rituximab+Utomilumab4
Avelumab+Azacitidine+Utomilumab7
Avelumab+Bendamustine+Rituximab10

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Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor and Immune Cells as Assessed by Immunohistochemistry (IHC) at Baseline

Percentage of Tumor and Immune Cells as Assessed by Immunohistochemistry at Baseline. (NCT02951156)
Timeframe: Screening (prior to first dose of study treatment)

,,
InterventionPercentage of cells staining positive (Median)
Tumor Cells (membrane)Immune Cells
Avelumab+Azacitidine+Utomilumab0.57.5
Avelumab+Bendamustine+Rituximab017.5
Avelumab+Rituximab+Utomilumab07.5

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Number of Participants With Neutralizing Antibodies (nAb) Against Utomilumab by Never and Ever Positive Status

nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point. (NCT02951156)
Timeframe: From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months)

,
InterventionParticipants (Count of Participants)
nAb ever-positivenAb never-positive
Avelumab+Azacitidine+Utomilumab02
Avelumab+Rituximab+Utomilumab01

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Number of Participants With Minimal Residual Disease Burden (MRD) Positive, Negative and Not Evaluable (NE) Status

Number of participants with MRD positive, negative and not evaluable status were reported in this outcome measure. (NCT02951156)
Timeframe: Baseline, Day 1 of Cycle 3, 6, 9, 12 and 18

,,
InterventionParticipants (Count of Participants)
Baseline: PositiveBaseline: NegativeBaseline: NECycle 3 Day 1: PositiveCycle 3 Day 1: NegativeCycle 3 Day 1: NECycle 6 Day 1: PositiveCycle 6 Day 1: NegativeCycle 6 Day 1: NECycle 9 Day 1: PositiveCycle 9 Day 1: NegativeCycle 9 Day 1: NECycle 12 Day 1: PositiveCycle 12 Day 1: NegativeCycle 12 Day 1: NECycle 18 Day 1: PositiveCycle 18 Day 1: NegativeCycle 18 Day 1: NE
Avelumab+Azacitidine+Utomilumab108101100000000000
Avelumab+Bendamustine+Rituximab326131022012012001
Avelumab+Rituximab+Utomilumab305302000000000000

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Number of Participants With Electrocardiogram (ECG) Abnormalities

ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value >450 ms, >480 ms and >500 ms; 2) heart rate (HR): absolute value <=50 beats per minute (bpm) and decrease from baseline >=20 bpm; absolute value >=120 bpm and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >=120 ms. (NCT02951156)
Timeframe: From first dose of study treatment up to at least 30 days after the last dose of study treatment or initiation of new anti-cancer therapy (up to 36 months)

,,
InterventionParticipants (Count of Participants)
QT: Increase from baseline >30 msQT: Increase from baseline >60 msQT: >450 msQT: >480 msQT: >500 msQTcB: Increase from baseline >30 msQTcB: Increase from baseline >60 msQTcB: >450 msQTcB: >480 msQTcB: >500 msQTcF: Increase from baseline >30 msQTcF: Increase from baseline >60 msQTcF: >450 msQTcF: >480 msQTcF: >500 msHeart rate: <=50 bpm and decrease from baseline >=20 bpmHeart rate: >=120 bpm and increase from baseline >=20 bpmPR: >=220 ms and increase from baseline >=20 msQRS: >=120 ms
Avelumab+Azacitidine+Utomilumab4321031532323221001
Avelumab+Bendamustine+Rituximab4221040941306000102
Avelumab+Rituximab+Utomilumab4120011421104000001

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Number of Participants With Anti-Drug Antibodies (ADA) Against Utomilumab by Never and Ever Positive Status

ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. (NCT02951156)
Timeframe: From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months)

,
InterventionParticipants (Count of Participants)
ADA ever-positiveADA never-positive
Avelumab+Azacitidine+Utomilumab27
Avelumab+Rituximab+Utomilumab17

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Number of Participants With Anti-Drug Antibodies (ADA) Against Rituximab by Never and Ever Positive Status

ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. (NCT02951156)
Timeframe: From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months)

,
InterventionParticipants (Count of Participants)
ADA ever-positiveADA never-positive
Avelumab+Bendamustine+Rituximab011
Avelumab+Rituximab+Utomilumab08

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Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status

ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. (NCT02951156)
Timeframe: Baseline: 2 hours pre-dose of first dose of avelumab, Post baseline: post first dose up to up to 30 Days after the end of treatment (maximum up to 36 months)

,,
InterventionParticipants (Count of Participants)
Baseline: ADA ever-positiveBaseline: ADA never-positivePost Baseline: ADA ever-positivePost Baseline: ADA never-positive
Avelumab+Azacitidine+Utomilumab0909
Avelumab+Bendamustine+Rituximab110011
Avelumab+Rituximab+Utomilumab0808

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Concentration Verses Time Summary of Avelumab

(NCT02951156)
Timeframe: 1 hour Post dose Day 2 Cycle 1, 144 hour Post dose Day 8 of Cycle 1, 0 hour Post dose Day 16 of Cycle 1, Day 1 of Cycle 4 and Cycle 6

,
Interventionmicrogram per milliliter (mcg/mL) (Mean)
Cycle 1 Day 2Cycle 1 Day 8Cycle 1 Day 16Cycle 4 Day 1Cycle 6 Day 1
Avelumab+Azacitidine+Utomilumab198.4368.4426.5362.007.57
Avelumab+Bendamustine+Rituximab193.3065.3319.36120.8839.43

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Concentration Verses Time Summary of Avelumab

(NCT02951156)
Timeframe: 1 hour Post dose Day 2 Cycle 1, 144 hour Post dose Day 8 of Cycle 1, 0 hour Post dose Day 16 of Cycle 1, Day 1 of Cycle 4 and Cycle 6

Interventionmicrogram per milliliter (mcg/mL) (Mean)
Cycle 1 Day 2Cycle 1 Day 8Cycle 1 Day 16Cycle 4 Day 1
Avelumab+Rituximab+Utomilumab183.2975.1425.3325.00

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Time to Tumor Response (TTR) as Assessed by Investigator Per Lugano Response Classification Criteria

TTR was defined for participants who achieved objective response as time from randomization to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as a score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake =50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. (NCT02951156)
Timeframe: From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to 36 months)

InterventionMonths (Median)
Avelumab+Rituximab+Utomilumab1.8
Avelumab+Bendamustine+Rituximab1.9

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Dose Escalation Phase: Maximum Tolerated Dose (MTD) of TAK-659

MTD was defined as the maximum dose that is determined to be safe and tolerable in different cohorts. Each cohort (A, B, C, D and E) received different escalating doses of TAK-659 in combination with other drugs. For each cohort the maximum tolerated dose of TAK-659 in combination with the other drug/s from the selected dose range is reported. (NCT02954406)
Timeframe: Cycle 1 (Cohorts A, B and C - each cycle was of 21 days and Cohorts D and E - each cycle was of 28 days)

Interventionmg (Number)
Dose Escalation Phase Cohort A: TAK-659 60-100 mg + Bendamustine 90 mg/m^2NA
Dose Escalation Phase Cohort B: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2NA
Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2NA
Dose Escalation Phase Cohort D: TAK-659 40-60 mg + Lenalidomide 25 mgNA
Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mgNA

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AUCtau: Area Under the Plasma Concentration-time Curve During Dosing Interval

(NCT02954406)
Timeframe: Days 1 and 15: Pre-dose and at multiple time points (up to 24 hours) post-dose in Cycle 1 (Cohorts A, B and C - each cycle was of 21 days and Cohorts D and E - each cycle was of 28 days)

,,,,,,,,,
Interventionh×ng/mL (Geometric Mean)
Cycle 1 Day 1Cycle 1 Day 15
Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^21532.343050.97
Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^21094.511845.21
Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^21011.491675.91
Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^21444.892662.16
Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2852.361896.76
Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^21455.922788.61
Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2387.543251.29
Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg1456.032536.48
Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg758.762578.30
Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg968.824218.90

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Duration of Response (DOR)

DOR was defined as the time from the date of first documented response to the date of first documented PD. PD was defined as any new lesion or increase by > 50% of previously involved sites from nadir. (NCT02954406)
Timeframe: Up to 123 weeks

Interventionmonths (Median)
Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^22.3
Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^22.8
Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^2NA
Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2NA
Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^23.9
Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg1.8
Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mgNA
Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mgNA

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Tmax: Time to Reach the Maximum Plasma Concentration for TAK-659

(NCT02954406)
Timeframe: Days 1 and 15: Pre-dose and at multiple time points (up to 24 hours) post-dose in Cycle 1 (Cohorts A, B and C - each cycle was of 21 days and Cohorts D and E - each cycle was of 28 days)

,,,,,,,,,
Interventionhours (h) (Median)
Cycle 1 Day 1Cycle 1 Day 15
Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^24.003.83
Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^24.004.00
Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^22.031.09
Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^22.002.47
Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^21.101.17
Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^22.001.93
Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^24.132.76
Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg0.61.9
Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg2.122.08
Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg1.001.01

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Cmax: Maximum Observed Plasma Concentration for TAK-659

(NCT02954406)
Timeframe: Days 1 and 15: Pre-dose and at multiple time points (up to 24 hours) post-dose in Cycle 1 (Cohorts A, B and C - each cycle was of 21 days and Cohorts D and E - each cycle was of 28 days)

,,,,,,,,,
Interventionnanograms(ng)/mL (Geometric Mean)
Cycle 1 Day 1Cycle 1 Day 15
Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^2118.10187.73
Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^283.61126.49
Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^289.74145.03
Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2180.10223.53
Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2128.58158.28
Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2142.84222.96
Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2141.27303.34
Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg139.00188.00
Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg65.03202.90
Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg120.23306.59

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Time to Progression (TTP)

TTP was defined as the time from the date of first drug administration to the date of first documented PD. PD was defined as any new lesion or increase by >50% of previously involved sites from nadir. (NCT02954406)
Timeframe: Up to 123 weeks

Interventionmonths (Median)
Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^24.2
Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^22.7
Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^29.6
Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^22.6
Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^24.2
Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^21.3
Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^21.4
Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg3.4
Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mgNA
Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg2.7

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Overall Response Rate (ORR)

ORR was defined as the percentage of participants in the response-evaluable population who achieved either complete response (CR), or partial response (PR). CR was defined as the disappearance of all evidence of disease, and PR was defined as regression of measurable disease and no new sites. (NCT02954406)
Timeframe: Up to 123 weeks

Interventionpercentage of participants (Number)
Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^233.3
Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^275.0
Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^250.0
Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^240.0
Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^280.0
Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^20.0
Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^20.0
Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg100.0
Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg33.3
Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg50.0

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Terminal Elimination Half-Life (t1/2) of Trilaciclib

t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve, the actual body exposure to drug after administration of a dose of the drug ( in mg*h/L). (NCT02978716)
Timeframe: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)

Interventionhours (Median)
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)5.27
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)5.31

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Duration of Severe (Grade 4) Neutropenia (DSN) During Cycle 1

DSN was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of less than (<) 0.5 × 10^9 cells/liter (L) observed between Day 1 Cycle 1 and the end of Cycle 1 to the date of the first ANC value greater than or equal to (>=) 0.5 × 10^9/L that met the following: (1) occurred after the ANC value of < 0.5 × 10^9 cells/L and (2) no other ANC values < 0.5 × 10^9 cells/L occurred between this day and the end of Cycle 1. Severe neutropenia (SN) was set to zero for participants who did not experience severe (Grade 4) neutropenia in Cycle 1, including those who were randomized but never treated. (NCT02978716)
Timeframe: From randomization to the end of Cycle 1 (Each cycle= 21 days)

Interventiondays (Mean)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)1
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)2
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)1

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Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

BOR was defined as the best response across all time points (RECIST v1.1). The best overall response was determined once all the data for the participant is known. Each participant has been assigned one of the following categories (RECIST 1.1): complete response (CR): disappearance of all target lesions; partial response (PR): >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; progression disease (PD): >= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study); stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD); NE: not evaluable and missing. (NCT02978716)
Timeframe: From date of randomization until the occurrence of progressive disease or a censoring event, assessed up to a maximum of 875 days

,,
InterventionParticipants (Count of Participants)
Complete response (CR)Partial response (PR)Stable disease (SD)Progressive disease (PD)Not evaluable (NE)Missing
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)0711600
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)0159501
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)01115311

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Relative Dose Intensity of Gemcitabine and Carboplatin

Relative dose intensity was defined as 100% times the actual dose intensity divided by the planned dose intensity. The planned dose intensity was defined as the cumulative planned dose through the study divided by (number of cycles × 3 weeks). Relative dose intensity (%) was calculated as: for gemcitabine (100 * [Dose intensity (mg/m2/week) / (2000/3 (mg/m2/week)]); for carboplatin (100 * [Dose intensity (AUC/week)/ (4/3) (AUC/week)]) and for trilaciclib (100 * [Dose intensity (mg/m2/week)/ (480 /3 (mg/m2/week)] for Group 2 and 100 * [Dose intensity (mg/m2/week) / (960 /3 (mg/m2/week)] for Group 3). (NCT02978716)
Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days

,,
Interventionpercentage of dose (Mean)
CarboplatinGemcitabine
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)77.579.1
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)79.180.8
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)81.781.0

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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

An Adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with this treatment. Any AE that started on or after the first dose of study drugs was included as a TEAE. A Serious AE was defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) and regardless of causality that met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. TEAEs included serious and non-serious TEAEs. (NCT02978716)
Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 1116 days

,,
InterventionParticipants (Count of Participants)
Participants with any TEAEsParticipants with any Serious TEAEs
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)3010
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)3311
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)344

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Number of Participants With Grade 3 and 4 Hematologic Toxicities

Hematologic toxicities events were defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for >= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 hematologic toxicities was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 hematologic toxicities during the treatment period, the participant was assigned as Yes to the occurrence of Grade 3 and 4 hematologic toxicities; otherwise, it was No. If a participant did not have an event, the value of 0 was assigned to that participant. (NCT02978716)
Timeframe: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days

,,
InterventionParticipants (Count of Participants)
Participants with Grade 3 and 4 hematologic toxicities: YesParticipants with Grade 3 and 4 hematologic toxicities: No
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)259
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)303
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)278

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Dose Modifications: Number of Participants With Any Dose Interruptions

Dose interruptions was defined as interruption of infusion, regardless of whether the study drug was continued after the interruption. (NCT02978716)
Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days

,,
InterventionParticipants (Count of Participants)
TrilaciclibCarboplatinGemcitabine
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)NA12
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)314
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)500

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Dose Modifications - Number of Participants With Dose Reductions

Dose (mg/m2) reductions were not permitted for trilaciclib. Dose reductions for carboplatin and gemcitabine were determined by comparing the planned dose on the respective drug administration pages between the current cycle and the previous cycle. (NCT02978716)
Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days

,,
InterventionParticipants (Count of Participants)
CarboplatinGemcitabine
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)1013
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)1320
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)1517

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Volume of Distribution at Steady State (Vss) of Free Carboplatin

Vss was the volume of distribution at steady state of free carboplatin was reported. (NCT02978716)
Timeframe: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)

InterventionLiter (Mean)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)44.4
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)35.0
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)34.0

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Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Gemcitabine

AUC0-t was calculated with the linear/log-trapezoidal method. (NCT02978716)
Timeframe: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)

Interventionhour*microgram per milliliter (h*mcg/mL) (Mean)
Group 1: Gemcitabine/Carboplatin (Day 1 and 8)NA
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)20.4
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)15.4

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Terminal Elimination Half-Life (t1/2) of Free Carboplatin

t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve. (NCT02978716)
Timeframe: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)

Interventionhours (Median)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)5.23
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)2.49
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)1.79

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Progression Free Survival (PFS) as Per RECIST v1.1 as Determined by Investigator

PFS was defined as the time (months) from date of randomization until date of documented PD or death due to any cause, whichever comes first. PD: >= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study). The PFS was calculated using Kaplan-Meier method. (NCT02978716)
Timeframe: From date of randomization until the occurrence of disease progression, death due to any cause or a censoring event, assessed up to a maximum of 875 days

Interventionmonths (Median)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)5.7
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)9.4
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)7.3

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Overall Survival (OS)

Overall survival was defined as the time (months) from date of randomization to the date of death due to any cause. Participants who do not die during the study were censored at the date last known to be alive. The OS was calculated using Kaplan-Meier method. (NCT02978716)
Timeframe: From date of randomization to date of death due to any cause, assessed up to a maximum of 1120 days

Interventionmonths (Median)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)12.6
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)NA
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)17.8

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Number of Participants With Febrile Neutropenia (FN)

"The criterion for identifying FN was if the PT was FEBRILE NEUTROPENIA the occurrence during the treatment period was defined as a binary variable (Yes or No); Yes if total number of events >=1 was observed, No for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant." (NCT02978716)
Timeframe: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days

InterventionParticipants (Count of Participants)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)1
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)1
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)0

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Number of Cycles Participants Received Treatment in Each Treatment Arm

Participants were considered to have started a cycle if they have received at least 1 dose of any study drug. (NCT02978716)
Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days

Interventionnumber of cycles (Mean)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)6
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)9
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)8

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Maximum Observed Plasma Concentration (Cmax) of Trilaciclib

The observed peak plasma concentration was determined from the plasma concentration-versus time data. (NCT02978716)
Timeframe: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)

Interventionng/mL (Mean)
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)2280
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)1630

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Major Adverse Hematologic Event (MAHE) Rate

MAHE was a composite endpoint incorporating the measurement of several clinically meaningful aspects of myelosuppression into a single endpoint by summing of the total number of events across a set of pre-specified components.The individual components for MAHE were all-cause hospitalizations, all-cause dose reductions, febrile neutropenia, prolonged severe neutropenia (duration > 5 days), RBC transfusion and platelet transfusion. Event rate for MAHE was calculated as the number of events/durations of treatment period divided by 7 days/1 week. (NCT02978716)
Timeframe: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days

Interventionevent rate per week (Number)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)0.153
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)0.108
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)0.080

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Duration of Objective Response (DOR) as Per RECIST v1.1 as Determined by Investigator

DOR is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Participants who do not experience PD or death was censored at the last tumor assessment date. 95% Confidence Interval (CI) was calculated using the Kaplan-Meier method. (NCT02978716)
Timeframe: From date of randomization until the occurrence of progressive disease or a censoring event, assessed up to a maximum of 875 days

Interventionmonths (Median)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)7.8
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)11.5
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)9.6

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Number of Participants With Grade 3 or 4 Thrombocytopenia

"Hematologic toxicities events are defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for >= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 thrombocytopenia was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 thrombocytopenia during the treatment period, the participant was assigned as Yes to the occurrence of Grade 3 and 4 thrombocytopenia; otherwise, it was No. If a participant did not have an event, the value of 0 was assigned to that participant." (NCT02978716)
Timeframe: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days

InterventionParticipants (Count of Participants)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)21
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)12
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)19

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Dose Modifications: Number of Participants With Cycle Delays

Dose modifications was summarized for each study drug based on number of cycles received during the treatment period. If the participant was unable to start a new cycle at that next visit, then the cycle is delayed, the reason entered, and the question was asked again at the next visit until the participant either starts a new cycle or discontinues treatment. (NCT02978716)
Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days

InterventionParticipants (Count of Participants)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)17
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)19
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)22

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Dose Modifications - Number of Participants With Skipped Doses

Dose modifications was summarized for each study drug based on skipped doses not received during the treatment period. Primary reasons for skipped doses included toxicity, investigator decision and administrative reasons (e.g., holidays). (NCT02978716)
Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days

InterventionParticipants (Count of Participants)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)15
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)20
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)13

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Duration of Exposure

Duration of exposure (days) = First dose date of study drug from the last cycle - first dose date of study drug + 21. (NCT02978716)
Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days

Interventiondays (Median)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)101
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)161
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)168

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Maximum Observed Plasma Concentration (Cmax) of Gemcitabine

The observed peak plasma concentration was determined from the plasma concentration-versus time data. (NCT02978716)
Timeframe: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)

Interventionmicrogram per milliliter (mcg/mL) (Mean)
Group 1: Gemcitabine/Carboplatin (Day 1 and 8)NA
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)18.0
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)23.8

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Cumulative Dose of Gemcitabine

Cumulative dose: Sum of the total doses by cycle administered to a participant in the duration of exposure, i.e. total number of cycles received (milligram per meter square [mg/m^2]). (NCT02978716)
Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days

Interventionmg/m^2 (Mean)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)10694.3
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)14680.9
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)13277.2

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Cumulative Dose of Carboplatin

Cumulative dose: Sum of the total doses by cycle (AUC) administered to a participant in the duration of exposure, i.e. total number of cycles received (in total prescribed AUC). (NCT02978716)
Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days

InterventionAUC (mg/mL/min) (Mean)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)20.3
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)27.8
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)26.0

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Clearance (CL) of of Free Carboplatin

Clearance after intravenous infusion administration was calculated as: CL=Dose/AUC0-inf. AUC0-inf was calculated as: AUC0-inf=AUClast+Clast/lambdaz where Clast is the last quantifiable concentration in the terminal elimination phase. (NCT02978716)
Timeframe: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)

InterventionLiter/hour (L/h) (Mean)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)6.65
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)14.0
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)13.7

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Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Trilaciclib

AUC0-t was calculated with the linear/log-trapezoidal method, which uses linear interpolation between data points to calculate the AUC. The linear/log-trapezoidal method will be employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method will be used for those arising from decreasing concentrations. (NCT02978716)
Timeframe: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)

Interventionhour* nanogram per milliliter (h*ng/mL) (Mean)
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)3610
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)3800

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All-cause Dose Reductions, Event Rate (Per Cycle)

Dose reductions were not permitted for trilaciclib. Dose reductions for gemcitabine or carboplatin were collected on the dosing page. No more than 3 dose modifications for toxicity in total were allowed for any participant. All dose reductions were counted as a separate event. Discontinuations of an individual component of the chemotherapy regimen were counted as a dose reduction If the participant continued the other chemotherapy drug as a monotherapy. Event rate was calculated as the total number of cycles with an event divided by the total number of cycles. (NCT02978716)
Timeframe: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days

Interventionevent rate per cycle (Number)
Group 1: Gemcitabine/Carboplatin (Days 1 and 8)0.141
Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)0.118
Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)0.133

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Stage 2: Overall Survival (OS)

"OS duration is measured from the date of randomization to the date of death from any cause. for participants who is not known to have died as of the data-inclusion cutoff date, OS was censored at the last known alive date.~No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1." (NCT02981342)
Timeframe: Baseline to Death from Any Cause (Up to 10 Months)

InterventionMonths (Median)
200mg Abemaciclib2.71
150mg Abemaciclib + 150mg LY30234143.29
Gemcitabine or CapecitabineNA

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Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months

"Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD ≥6 months. CR is defined as the disappearance of all target and non-target lesions & no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.~No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1." (NCT02981342)
Timeframe: Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 6 Months)

Interventionpercentage of participants (Number)
200mg Abemaciclib3
150mg Abemaciclib + 150mg LY30234140
Gemcitabine or Capecitabine3

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Stage 2: Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

"The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:~Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).~Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)~Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).~Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden.~No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1." (NCT02981342)
Timeframe: Baseline, 6 Months

,,
Interventionunits on a scale (Least Squares Mean)
Global Health StatusFunctional Scales: Physical FunctioningFunctional Scales: Role FunctioningFunctional Scales: Emotional FunctioningFunctional Scales: Cognitive FunctioningFunctional Scale: Social FunctioningSymptom Scales: FatigueSymptom Scales: Nausea and VomitingSymptom Scales: PainSymptom Scale: DysopneaSymptom Scale: InsomniaSymptom Scale: Appetite LossSymptom Scale: ConstipationSymptom Scale: DiarrhoeaSymptom Scale: Financial difficulties
150mg Abemaciclib + 150mg LY3023414-4.82-11.65-18.05-0.63-8.39-17.0914.909.422.6811.191.8315.32-6.5126.282.45
200mg Abemaciclib-6.21-14.44-17.09-4.89-10.43-21.1214.137.989.790.35-5.1912.542.9615.713.96
Gemcitabine or Capecitabine-2.40-5.42-17.102.06-5.18-2.005.6411.885.43-4.51-6.719.5112.9320.51-3.30

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Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)

"mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, and enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours, and typical completion time for this instrument is less than 5 minutes.~No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1." (NCT02981342)
Timeframe: Baseline, 6 Months

,,
Interventionscore on a scale (Least Squares Mean)
Pain at its Worst in Last 24 hoursPain at its Least in Last 24 hoursPain on the AveragePain Right NowPain Interfered General ActivityPain Interfered with MoodPain Interfered Walking AbilityPain Interfered with Normal WorkPain Interfered with RelationsPain Interfered with SleepPain Interfered Enjoyment of LifeBPI Mean Pain Interference Score
150mg Abemaciclib + 150mg LY3023414-0.330.18-0.030.340.070.280.830.660.670.340.390.50
200mg Abemaciclib0.630.860.620.380.640.540.051.070.390.190.690.55
Gemcitabine or Capecitabine-0.020.39-0.07-0.380.220.600.190.190.26-0.56-0.130.05

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Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level

No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1. (NCT02981342)
Timeframe: Baseline, 6 Months

InterventionU/mL (Mean)
200mg Abemaciclib4281.53
150mg Abemaciclib + 150mg LY30234143225.29
Gemcitabine or Capecitabine-501.17

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Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414

Mean steady state exposure was reported by trough pre-dose plasma concentrations. (NCT02981342)
Timeframe: C2D1: 0h, C3D1: 0h, C4D1: 0h

Interventionng/mL (Geometric Mean)
150mg Abemaciclib + 150mg LY302341427.3

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Stage 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. (NCT02981342)
Timeframe: Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)

Interventionpercentage of Participants (Number)
200mg Abemaciclib15.2
150mg Abemaciclib + 150mg LY302341412.1
Gemcitabine or Capecitabine36.4

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Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose

Mean single dose exposure was reported by plasma concentrations collected approximately 2 hours post-dose. (NCT02981342)
Timeframe: C1D1: 2h Post dose

Interventionng/mL (Geometric Mean)
150mg Abemaciclib + 150mg LY3023414518

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Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR

Objective response rate (ORR) is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. (NCT02981342)
Timeframe: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months)

Interventionpercentage of Participants (Number)
200mg Abemaciclib3
150mg Abemaciclib + 150mg LY30234140
Gemcitabine or Capecitabine3

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Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))

Mean steady state exposure was reported as measured by maximum observed plasma concentration (Cmax). (NCT02981342)
Timeframe: Cycle(C)1 Day(D)14: 0 hour(h),0.5h,1h,2h,4h,6h,8h post dose

InterventionNanogram per Millilitre (ng/mL) (Geometric Mean)
AbemaciclibLSN2839567 (M2)LSN3106726 (M20)
150mg Abemaciclib + 150mg Galunisertib35685.1153

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Stage 2: Progression Free Survival (PFS)

PFS was defined as the time from the date of randomization until first observation of objective progressive disease as defined by RECIST v1.1 or death from any cause, whichever comes first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a patient does not have a complete baseline disease assessment, then the PFS time will be censored at the randomization date, regardless of whether or not objectively determined disease progression or death has been observed for the patient; otherwise, if a patient is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date. (NCT02981342)
Timeframe: Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 6 Months)

InterventionMonths (Median)
200mg Abemaciclib1.68
150mg Abemaciclib + 150mg LY30234141.81
Gemcitabine or Capecitabine3.25

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Percentage of Patients Experienced AEs/SAEs

The safety and tolerability of pembrolizumab treatment will be assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period. Adverse events are collected from study treatment initiation to 30 days after treatment is ceased for any reason. Serious adverse events and events of clinical interest are collected within 90 days after last dose of trial treatment. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

,
InterventionParticipants (Count of Participants)
Experienced any adverse eventExperienced treatment related adverse eventExperienced treatment related adverse event of grade 3-5Experienced treatment related adverse event leading to deathExperienced treatment related adverse event leading to treatment discontinuation
Pembrolizumab Arm70501415
Standard Chemotherapy Arm65521815

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Progression Free Survival (PFS) Assessed by Investigator

Investigator assessed PFS, from the date of randomisation until documented progression or death, if progression is not documented. Censoring occurs at the last tumor assessment. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

Interventionmonths (Median)
Pembrolizumab Arm3.5
Standard Chemotherapy Arm3.7

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Progression Free Survival (PFS) as Assessed by Independent Radiological Review

To investigate whether treatment with pembrolizumab improves PFS, compared to standard, institutional choice chemotherapy, assessed according to RECIST 1.1 criteria based on independent radiological review; using Kaplan-Meier method and compared between the two treatment arms by a stratified log rank test. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

Interventionmonths (Median)
Pembrolizumab Arm2.5
Standard Chemotherapy Arm3.4

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Overall Survival.

Defined as time from the date of randomisation until death from any cause. Censoring will occur at the last follow-up date. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).

Interventionmonths (Median)
Pembrolizumab Arm10.7
Standard Chemotherapy Arm12.4

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Time to Treatment Failure.

Time from from randomisation to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, refusal and death, by Kaplan Meier method. Censoring will occur at the last follow-up date. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

Interventionmonths (Median)
Pembrolizumab Arm2.8
Standard Chemotherapy Arm2.3

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Objective Response Rate by Independent Radiological Review

Defined as the best overall response (complete or partial response) across all assessment time-points from randomisation to end of trial treatment, determined by RECIST 1.1 criteria. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

Interventionpercentage of participants (Number)
Pembrolizumab Arm21.9
Standard Chemotherapy Arm5.6

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Overall Response Rate in Biomarker Positive Patients

To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. ORR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue. (NCT02993731)
Timeframe: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months

InterventionPercentage (Number)
Napabucasin Plus Nab-paclitaxel With Gemcitabine (pSTAT3 Positive; Response Analysis Set)42
Nab-paclitaxel With Gemcitabine (pSTAT3 Positive; Response Analysis Set)47

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Overall Survival

To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma. (NCT02993731)
Timeframe: From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.

InterventionMonths (Median)
Napabucasin Plus Nab-paclitaxel With Gemcitabine11.43
Nab-paclitaxel With Gemcitabine11.73

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Overall Response Rate

To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma. ORR is evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). (NCT02993731)
Timeframe: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months

InterventionPercentage (Number)
Napabucasin Plus Nab-paclitaxel With Gemcitabine (Response Analysis Set)43
Nab-paclitaxel With Gemcitabine (Response Analysis Set)43

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Number of Patients With Adverse Events

All patients who have received at least one dose of napabucasin will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity. (NCT02993731)
Timeframe: Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months.

InterventionParticipants (Count of Participants)
Napabucasin Plus Nab-paclitaxel With Gemcitabine (Safety Population)560
Nab-paclitaxel With Gemcitabine (Safety Population)543

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Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks.

QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) in patients with metastatic pancreatic ductal adenocarcinoma with napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine. EORTQ QLC-C30 is a questionnaire used to assess the overall quality of life in cancer patients - 28 questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher overall score = better quality of life. (NCT02993731)
Timeframe: 8 weeks

InterventionScore on a scale (Mean)
Napabucasin Plus Nab-paclitaxel With Gemcitabine-1.63
Nab-paclitaxel With Gemcitabine-0.57

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Disease Control Rate in Biomarker Positive Patients

To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. DCR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue. (NCT02993731)
Timeframe: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months

InterventionPercentage (Number)
Napabucasin Plus Nab-paclitaxel With Gemcitabine (pSTAT3 Positive; Response Analysis Set)75
Nab-paclitaxel With Gemcitabine (pSTAT3 Positive; Response Analysis Set)79

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Disease Control Rate

To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma. DCR is defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1. (NCT02993731)
Timeframe: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months

InterventionPercentage of participants (Number)
Napabucasin Plus Nab-paclitaxel With Gemcitabine (Response Analysis Set)74
Nab-paclitaxel With Gemcitabine (Response Analysis Set)76

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Progression Free Survival in Biomarker Positive Patients

To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue. (NCT02993731)
Timeframe: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months

InterventionMonths (Median)
Napabucasin Plus Nab-paclitaxel With Gemcitabine (pSTAT3 Positive)5.68
Nab-paclitaxel With Gemcitabine (pSTAT3 Positive)5.82

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Progression Free Survival

To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause. (NCT02993731)
Timeframe: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months

InterventionMonths (Median)
Napabucasin Plus Nab-paclitaxel With Gemcitabine6.70
Nab-paclitaxel With Gemcitabine6.08

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Overall Survival in Biomarker Positive Patients

To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue. (NCT02993731)
Timeframe: From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.

InterventionMonths (Number)
Napabucasin Plus Nab-paclitaxel With Gemcitabine (pSTAT3 Positive)11.40
Nab-paclitaxel With Gemcitabine (pSTAT3 Positive)10.78

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Event-Free Survival (EFS)

Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). (NCT02998528)
Timeframe: From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)

InterventionMonths (Median)
Arm B: Platinum Doublet Chemo20.80
Arm C: Nivo 360 mg + Platinum Doublet Chemo31.57

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Time to Death or Distant Metastases (TTDM)

TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment. (NCT02998528)
Timeframe: From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to a median of 30 months)

InterventionMonths (Median)
Arm B: Platinum Doublet Chemo26.71
Arm C: Nivo 360 mg + Platinum Doublet ChemoNA

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Pathologic Complete Response (pCR) Rate

Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). (NCT02998528)
Timeframe: From randomization up to a median of 30 months after randomization.

InterventionParticipants (Count of Participants)
Arm B: Platinum Doublet Chemo4
Arm C: Nivo 360 mg + Platinum Doublet Chemo43

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Major Pathologic Response (MPR) Rate

Major pathologic response (MPR) rate is defined as number of randomized participants with NCT02998528)
Timeframe: From randomization up to a median of 30 months after randomization.

InterventionParticipants (Count of Participants)
Arm B: Platinum Doublet Chemo16
Arm C: Nivo 360 mg + Platinum Doublet Chemo66

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OS at 24 Months

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months. (NCT03003962)
Timeframe: From date of randomization till 24 months

Interventionpercentage of participants (Number)
Durvalumab34.6
Platinum-based SoC27.2

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OS in PD-L1 TC >= 50% Analysis Set

OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. (NCT03003962)
Timeframe: From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)

Interventionmonths (Median)
Durvalumab14.6
Platinum-based SoC11.8

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Time to Deterioration of EORTC QLQ-C30 in PD-L1 TC >= 25% LREM Analysis Set

Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful deterioration a decrease in the function scales or the global health status/ HRQoL from baseline of ≥10) that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. (NCT03003962)
Timeframe: From randomization until date of first symptom deterioration that is confirmed, assessed up to a maximum of approximately 69 months (DCO 27 October 2022)

,
Interventionmonths (Median)
Global health statusPhysical functioningAppetite lossFatigue
Durvalumab7.47.49.35.5
Platinum-based SoC5.54.73.71.8

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Time to Deterioration of EORTC QLQ-LC13

Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful symptom deterioration a decrease in the function scales or the global health status/ HRQoL from baseline of ≥10) that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. (NCT03003962)
Timeframe: From randomization until date of first symptom deterioration that is confirmed, assessed up to maximum of approximately 69 months (DCO 27 October 2022)

,
Interventionmonths (Median)
CoughDyspneaChest pain
Durvalumab7.52.89.0
Platinum-based SoC6.63.66.4

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Time to Deterioration of EORTC QLQ-LC13 in PD-L1 TC >= 25% LREM Analysis Set

Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful symptom deterioration a decrease in the function scales or the global health status/ HRQoL from baseline of ≥10) that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. (NCT03003962)
Timeframe: From randomization until date of first symptom deterioration that is confirmed, assessed up to maximum of approximately 69 months (DCO 27 October 2022)

,
Interventionmonths (Median)
CoughDyspneaChest pain
Durvalumab9.23.69.8
Platinum-based SoC8.23.66.6

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Percentage of Participants With Antidrug Antibody (ADA) Response to Durvalumab

Treatment-emergent ADA positive was defined as either treatment-induced or treatment-boosted ADA. Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following study drug administration. Persistently positive was defined as positive at least 2 post-baseline assessments with at least 16 weeks between the first and last positive assessment or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. (NCT03003962)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Treatment-emergent ADA positiveTreatment-boosted ADAPersistently positiveTransiently positive
Durvalumab0.80.400.8

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OS at 18 Months in PD-L1 TC > = 25% LREM Analysis Set

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months. (NCT03003962)
Timeframe: From date of randomization till 18 months

Interventionpercentage of participants (Number)
Durvalumab43.0
Platinum-based SoC41.4

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PFS2 in PD-L1 TC >= 25% LREM Analysis Set

PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab11.8
Platinum-based SoC10.9

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Overall Survival (OS)

OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. (NCT03003962)
Timeframe: From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months [data cut-off (DCO) 27 October 2022]

Interventionmonths (Median)
Durvalumab14.6
Platinum-based SoC12.8

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PFS Based on Investigator Assessment According to RECIST 1.1 in LREM Analysis Set

The PFS (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab5.5
Platinum-based SoC5.6

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Percentage of Participants With ADA Response to Durvalumab in LREM Analysis Set

Treatment-emergent ADA positive was defined as either treatment-induced or treatment-boosted ADA. Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following study drug administration. Persistently positive was defined as positive at least 2 post-baseline assessments with at least 16 weeks between the first and last positive assessment or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. (NCT03003962)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Treatment-emergent ADA positiveTreatment-boosted ADAPersistently positiveTransiently positive
Durvalumab1.00.501.0

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Time to Deterioration of EORTC QLQ-C30

Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful deterioration (a decrease in the function scales or the global health status/ health-related quality of life [HRQoL] from baseline of ≥10) that was confirmed at a subsequent visit or death in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. (NCT03003962)
Timeframe: From randomization until date of first symptom deterioration that is confirmed, assessed up to a maximum of approximately 69 months (DCO 27 October 2022)

,
Interventionmonths (Median)
Global health statusPhysical functioningAppetite lossFatigue
Durvalumab7.37.49.24.9
Platinum-based SoC3.83.83.61.8

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OS in PD-L1 TC >= 50% LREM Analysis Set

OS is defined as the time from the date of randomization until death due to ay cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. (NCT03003962)
Timeframe: From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)

Interventionmonths (Median)
Durvalumab14.9
Platinum-based SoC14.9

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OS at 18 Months in PD-L1 TC >= 50% LREM Analysis Set

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months. (NCT03003962)
Timeframe: From date of randomization till 18 months

Interventionpercentage of participants (Number)
Durvalumab44.3
Platinum-based SoC42.2

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OS at 18 Months in PD-L1 TC >= 50% Analysis Set

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months. (NCT03003962)
Timeframe: From date of randomization till 18 months

Interventionpercentage of participants (Number)
Durvalumab43.2
Platinum-based SoC34.9

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PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% LREM Analysis Set

The PFS (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab5.7
Platinum-based SoC5.5

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OS at 18 Months

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months. (NCT03003962)
Timeframe: From date of randomization till 18 months.

Interventionpercentage of participants (Number)
Durvalumab42.5
Platinum-based SoC34.2

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ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 50% LREM Analysis Set

ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with an unconfirmed response of CR or PR. CR was defined as disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionpercentage of participants (Number)
Durvalumab44.0
Platinum-based SoC43.7

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ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 50% Analysis Set

ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with an unconfirmed response of CR or PR. CR was defined as disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionpercentage of participants (Number)
Durvalumab42.1
Platinum-based SoC40.7

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ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 25% LREM Analysis Set

ORR (per RECIST 1.1 using Investigator assessments)was defined as the percentage of participants with an unconfirmed response of CR or PR. CR was defined as disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionpercentage of participants (Number)
Durvalumab38.5
Platinum-based SoC40.2

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Objective Response Rate (ORR) as Per RECIST 1.1 Using Investigator Assessment

ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with an unconfirmed response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target lesions (TLs). Any pathological lymph nodes selected as TLs had a reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionpercentage of participants (Number)
Durvalumab37.6
Platinum-based SoC37.4

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Duration of Response (DoR) as Per RECIST 1.1 Using Investigator Assessment

DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab11.9
Platinum-based SoC4.2

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DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=50% LREM Analysis Set

DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab12.2
Platinum-based SoC4.2

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DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=50% Analysis Set

DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab12.2
Platinum-based SoC4.2

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OS at 24 Months in PD-L1 TC > = 25% LREM Analysis Set

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months. (NCT03003962)
Timeframe: From date of randomization till 24 months

Interventionpercentage of participants (Number)
Durvalumab34.7
Platinum-based SoC32.8

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OS at 24 Months in PD-L1 TC >= 50% Analysis Set

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months. (NCT03003962)
Timeframe: From date of randomization till 24 months

Interventionpercentage of participants (Number)
Durvalumab37.0
Platinum-based SoC27.0

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OS at 24 Months in PD-L1 TC >= 50% LREM Analysis Set

OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months. (NCT03003962)
Timeframe: From date of randomization till 24 months

Interventionpercentage of participants (Number)
Durvalumab36.9
Platinum-based SoC32.6

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OS in Participants With LREM

OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. (NCT03003962)
Timeframe: From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)

Interventionmonths (Median)
Durvalumab14.6
Platinum-based SoC15.0

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PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% Analysis Set

The PFS (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab5.6
Platinum-based SoC4.5

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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) 30-Item Core Quality of Life Questionnaire Version 3 (QLQ-C30)

The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. An outcome variable consisted of a score from 0 to 100. Higher scores on the global health status and functioning scales indicate better health status/function, but higher scores on symptom scales/items represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The mixed model repeated measures (MMRM) analysis of EORTC QLQ-C30 considered all data from baseline to PD or 12 months. (NCT03003962)
Timeframe: Baseline and 12 months

,
Interventionscores on a scale (Mean)
Global health statusPhysical functioningFatigueAppetite loss
Durvalumab-0.7-3.31.4-1.1
Platinum-based SoC-7.4-6.17.29.1

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PFS2 in PD-L1 TC >= 50% Analysis Set

PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab11.3
Platinum-based SoC8.8

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PFS2 in PD-L1 TC >= 50% LREM Analysis Set

PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab12.0
Platinum-based SoC10.9

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Progression Free Survival (PFS) Based on Investigator Assessment According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

The PFS (per RECIST 1.1) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). Progression of disease per RECIST 1.1, when either 1 of the criteria met: Target lesion (TL): at least a 20% increase in the sum of diameters of TLs, for reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Non-target lesion (NTL): Unequivocal progression of existing NTLs. It may be due to an important progression in 1 lesion only or in several lesions. In all cases the progression must be clinically significant for the physician to consider changing (or stopping) therapy. New lesions: the presence of 1 or more new lesions was assessed as progression. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months DCO 27 October 2022)

Interventionmonths (Median)
Durvalumab5.4
Platinum-based SoC4.8

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Time From Randomization to Second Progression (PFS2)

PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab11.3
Platinum-based SoC9.3

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DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=25% LREM Analysis Set

DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique. (NCT03003962)
Timeframe: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)

Interventionmonths (Median)
Durvalumab11.6
Platinum-based SoC4.2

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APF12 in PD-L1 TC >= 50% LREM Analysis Set

The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis. (NCT03003962)
Timeframe: From date of randomization until 12 months

Interventionpercentage of participants (Number)
Durvalumab26.5
Platinum-based SoC14.5

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Change From Baseline in EORTC 13-Item Lung Cancer Quality of Life Questionnaire (QLQ-LC13)

The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. An outcome variable consisted of a score from 0 to 100. Higher scores on symptom scales represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The MMRM analysis of EORTC QLQ-LC13 considered all data from baseline to PD or 12 months. (NCT03003962)
Timeframe: Baseline and 12 months

,
Interventionscores on a scale (Mean)
CoughDyspneaChest pain
Durvalumab-6.42.4-1.0
Platinum-based SoC-7.94.1-0.2

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APF12 in PD-L1 TC >= 50% Analysis Set

The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis. (NCT03003962)
Timeframe: From date of randomization until 12 months

Interventionpercentage of participants (Number)
Durvalumab26.1
Platinum-based SoC11.7

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APF12 in PD-L1 TC >= 25% LREM Analysis Set

The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis. (NCT03003962)
Timeframe: From date of randomization until 12 months

Interventionpercentage of participants (Number)
Durvalumab24.1
Platinum-based SoC16.4

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Alive and Progression-Free at 12 Months (APF12)

The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis. (NCT03003962)
Timeframe: From date of randomization until 12 months

Interventionpercentage of participants (Number)
Durvalumab25.5
Platinum-based SoC13.3

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Change From Baseline in EORTC QLQ-C30 in PD-L1 TC >= 25% LREM Analysis Set

The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. An outcome variable consisted of a score from 0 to 100. Higher scores on the global health status and functioning scales indicate better health status/function, but higher scores on symptom scales/items represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The MMRM analysis of EORTC QLQ-C30 considered all data from baseline to PD or 12 months. (NCT03003962)
Timeframe: Baseline and 12 months

,
Interventionscores on a scale (Mean)
Global health statusPhysical functioningFatigueAppetite loss
Durvalumab-1.4-3.92.2-0.2
Platinum-based SoC-7.3-6.07.79.8

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Change From Baseline in EORTC QLQ-LC13 in PD-L1 TC >= 25% LREM Analysis Set

The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. An outcome variable consisted of a score from 0 to 100. Higher scores on symptom scales represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The MMRM analysis of EORTC QLQ-LC13 considered all data from baseline to PD or 12 months. (NCT03003962)
Timeframe: Baseline and 12 months

,
Interventionscores on a scale (Mean)
CoughDyspneaChest pain
Durvalumab-6.62.9-0.7
Platinum-based SoC-8.63.9-1.0

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Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status

ECOG performance status was assessed at the times specified based on the following and scored as 0: fully active: able to carry out all usual activities without restrictions. 1: Restricted in strenuous activity, but ambulatory and able to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of only limited self-care; confined to bed or chair more than 50% of waking hours. 4: Completely disabled; unable to carry out any self-care and totally confined to bed or chair and 5: death. Data for only participants with restricted activity has been reported. (NCT03003962)
Timeframe: From Baseline and until follow-up period of 57 months

,
Interventionnumber of participants (Number)
Restricted activity, BaselineRestricted activity, Follow-up Month 57
Durvalumab2670
Platinum-based SoC2552

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Number of Participants With ECOG Performance Status in PD-L1 TC >=25% LREM Analysis Set

ECOG performance status was assessed at the times specified based on the following and scored as 0: fully active: able to carry out all usual activities without restrictions. 1: Restricted in strenuous activity, but ambulatory and able to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of only limited self-care; confined to bed or chair more than 50% of waking hours. 4: Completely disabled; unable to carry out any self-care and totally confined to bed or chair and 5: death. Data for only participants with restricted activity has been reported. (NCT03003962)
Timeframe: From Baseline and until follow-up period of 57 months

,
Interventionnumber of participants (Number)
Restricted activity, BaselineRestricted activity, Follow-up Month 57
Durvalumab2210
Platinum-based SoC2032

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Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle

DLT was defined as the occurrence of any of the following adverse events (AE) or abnormal laboratory value (graded according to the NCI Common Terminology Criteria for AE (CTCAE) version 4.0), assessed as possibly, probably or definitively related to study drug/medication, occurring within the first cycle of study treatment: any Grade 4 thrombocytopenia or neutropenia lasting > 7 days; episcleritis, uveitis, or iritis of Grade 2 or higher, any Grade 4 toxicity, any Grade 3 toxicity EXCLUDING: nausea, vomiting, or diarrhea controlled by medical intervention within 72 hours, grade 3 rash in the absence of desquamation, no mucosal involvement, does not require steroids, and resolves to Grade 1 by the next scheduled dose of pembrolizumab, transient Grade 3 Aspartate Transaminase (AST) or Alanine Transaminase (ALT) elevation, defined as no more than 3 days with or without steroid use, discontinuation or delay of more than 2 weeks of any study drug/medication due to treatment-related AE. (NCT03025880)
Timeframe: Up to cycle 1

InterventionParticipants (Count of Participants)
Run-in Phase Dose Level 01

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Objective Response Rate (ORR)

Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1). ORR is defined as the percentage of patients with a Complete Response (CR) or Partial Response (PR) out of the patients from the efficacy population. Per RECIST, CR is defined as the disappearance of all target lesions; PR is defined as an >=30% decrease in the sum of the longest diameter of target lesions. (NCT03025880)
Timeframe: Through study treatment, and average of 3 months

InterventionParticipants (Count of Participants)
Run-in Phase Dose Level 00
Phase II5
Run-in Phase Plus Phase II5

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Overall Survival (OS)

OS is defined as the time from the date of enrollment to the date of death from any cause. (NCT03025880)
Timeframe: Up to 2 years

InterventionMonths (Median)
Run-in Phase Dose Level 06.1
Phase II10.1
Run-in Phase Plus Phase II8.7

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Clinical Benefit Rate (CBR)

Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. CBR was defined as the percentage of patients with a Complete Response (CR) or Partial Response (PR) plus stable disease (SD) out of the efficacy population. Per RECIST, CR is defined as the disappearance of all target lesions; PR is defined as an >=30% decrease in the sum of the longest diameter of target lesions; SD is defined as a failure to meet criteria for CR or PR in the absence of progressive disease. Overall Response (OR) = CR + PR. (NCT03025880)
Timeframe: Through study treatment, and average of 3 months

InterventionParticipants (Count of Participants)
Run-in Phase Dose Level 07
Phase II10
Run-in Phase Plus Phase II17

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Clinical Benefit Rate (CBR) at Least 24 Weeks

Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. CBR was defined as the percentage of patients with a Complete Response (CR) or Partial Response (PR) plus stable disease (SD) lasting at least 24 months out of the efficacy population. Per RECIST, CR is defined as the disappearance of all target lesions; PR is defined as an >=30% decrease in the sum of the longest diameter of target lesions; SD is defined as a failure to meet criteria for CR or PR in the absence of progressive disease lasting at least 24 months. Overall Response (OR) = CR + PR. (NCT03025880)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Run-in Phase Dose Level 01
Phase II5
Run-in Phase Plus Phase II6

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Progression-Free Survival (PFS)

Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1). PFS is defined as the time from enrollment to the first documented progression disease (PD), or death from any cause, whichever occurs first. PD is defined using RECIST, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT03025880)
Timeframe: Through study treatment, and average of 3 months

InterventionMonths (Median)
Run-in Phase Dose Level 03.1
Phase II2.6
Run-in Phase Plus Phase II3.1

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Response Duration (RD)

Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. RD was defined as the time from the first documentation of objective tumor response (complete response (CR) or partial response (PR)) to the first documented progressive disease (PD), or to death due to any cause, whichever occurs first. Per RECIST, CR is defined as the disappearance of all target lesions; PR is defined as an >=30% decrease in the sum of the longest diameter of target lesions; PD is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT03025880)
Timeframe: Through study treatment, and average of 3 months

InterventionMonths (Median)
Phase II4.3
Run-in Phase Plus Phase II4.3

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Number of Participants With Grade 3 or Grade 4 Adverse Events

Assess toxicity of Nivolumab plus single agent chemotherapy compared with single agent chemotherapy alone. Number of grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4. (NCT03041181)
Timeframe: 6 months

,
Interventionparticipants (Number)
GR4 Thromboembolic EventGR3 Adverse Events
Arm A00
Arm B10

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Phases 1 and 2: Objective Response Rate (ORR)

ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. (NCT03085914)
Timeframe: Up to Week 18

,,,,,,
InterventionParticipants (Count of Participants)
Complete ResponsePartial Response
Group A: Epa + Pembrolizumab + mFOLFOX605
Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine12
Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin03
Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent02
Group E: Epa + Pembrolizumab + Cyclophosphamide03
Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent01
Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent05

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Phases 1 & 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of epacadostat, pembrolizumab, or chemotherapy. Serious adverse event is defined as an event that meets 1 of the following criteria: is fatal or life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, incapacity, or a substantial disruption of a person's ability to conduct normal life functions, constitutes a congenital anomaly or birth defect,is a medically important event that may jeopardize the participant or may require medical or surgical intervention to prevent 1 of the outcomes listed above. (NCT03085914)
Timeframe: Up to 21 months

,,,,,,
InterventionParticipants (Count of Participants)
TEAESerious TEAE
Group A: Epa + Pembrolizumab + mFOLFOX695
Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine95
Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin113
Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent96
Group E: Epa + Pembrolizumab + Cyclophosphamide134
Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent86
Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent115

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Phases 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)

A DLT was defined as the occurrence of any of the protocol-specified toxicities occurring up to and including Day 28 for the cohorts where mFOLFOX6 and nab-paclitaxel/gemcitabine are administered and Day 21 for all other chemotherapy regimens in Phase 1, except those with a clear alternative explanation (eg, disease progression) or transient (≤ 72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. (NCT03085914)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Group A: Epa + Pembrolizumab + mFOLFOX62
Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine0
Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin0
Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent0
Group E: Epa + Pembrolizumab + Cyclophosphamide0
Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent3
Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent0

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"Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) Worst Pain Score"

"The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf worst pain score (TWP) was defined as the time from the date of randomization to the first date of either a worst pain score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the participant has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered." (NCT03086369)
Timeframe: Baseline through Follow-up (Up To 21 Months)

InterventionMonths (Median)
Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine14.13
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine6.11

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Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)

"A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE version 4.03:~Any febrile neutropenia~Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage~Grade 4 neutropenia lasting 7 days or longer~Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc.~Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1)." (NCT03086369)
Timeframe: Cycle 1 (Up to 28 days)

InterventionParticipants (Count of Participants)
Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine0
Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine0
Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine0

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Phase 1b/2: Duration of Response (DoR)

DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. (NCT03086369)
Timeframe: From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)

InterventionMonths (Median)
Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + GemcitabineNA
Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + GemcitabineNA
Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine5.55
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine5.55

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Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.

The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems. (NCT03086369)
Timeframe: Baseline through Follow-up (Up To 21 Months)

,
InterventionMonths (Median)
Appetite lossConstipationDiarrhoeaDyspnoeaFatigueFinancial difficultiesInsomniaNausea and vomitingPain
Phase 2: Olaratumab + Nab-paclitaxel + GemcitabineNANA2.792.791.87NA3.193.19NA
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine2.86NA1.973.121.87NANA2.863.25

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Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)

The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status. (NCT03086369)
Timeframe: Cycle 1 Day 1, Cycle 7 Day 1

,
Interventionscore on a scale (Mean)
Index Value [Cycle 1 (Day1)]Index Value [Cycle 7 (Day1)]VAS Score [Cycle 1 (Day1)]VAS Score [Cycle 7 (Day1)]
Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine0.80.870.171.7
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine0.80.869.773.2

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Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab

PK: Cmin of olaratumab (NCT03086369)
Timeframe: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15

,,,
Interventionmicrograms per milliliter (μg/mL) (Geometric Mean)
Cycle 1 (Day 1)Cycle 1 (Day 15)Cycle 3 (Day 1)Cycle 3 (Day 15)
Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine11294.7147106
Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine87.8101173101
Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine12878.7204159
Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine86.3172NANA

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Phase 2: Progression-Free Survival (PFS)

PFS is defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 [RECIST v.1.1]) or death due to any cause in the absence of progressive disease (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who did not progress or are lost to follow-up were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. If death or PD occurs after 2 or more consecutive missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the missed visits. (NCT03086369)
Timeframe: Baseline to Disease Progression or Death (Up To 26 Months)

InterventionMonths (Median)
Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine5.55
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine6.41

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Phase 2: Overall Survival (OS)

OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study. (NCT03086369)
Timeframe: Baseline to Date of Death from Any Cause (Up To 29 Months)

InterventionMonths (Median)
Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine9.10
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine10.81

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Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies

Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies (NCT03086369)
Timeframe: Baseline through Follow-up (Up To 29 Months)

InterventionParticipants (Count of Participants)
Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine0

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Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. (NCT03086369)
Timeframe: Baseline through Disease Progression or Death (Up To 26 Months)

InterventionPercentage of participants (Number)
Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine33.3
Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine14.3
Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine0
Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine30.5
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine33.8

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The Percentage of Patients Alive and Without Progression at 6 Months Following the Initiation of Treatment

The primary endpoint is PFS (Progression Free Survival) at 6 months following the initiation of treatment. Progression will be defined clinically or on imaging as per immune related response evaluation criteria in solid tumors (irRECIST) definition. (NCT03101566)
Timeframe: 6 Months

Interventionpercentage of participants (Number)
Gemcitabine + Cisplatin + Nivolumab59.4
Nivolumab + Ipilimumab21.2

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Overall Response Rate (ORR)

Overall Response Rate will be determined as per the combined RECIST v1.1 and irRECIST criteria (NCT03101566)
Timeframe: Up to two years

Interventionpercentage of patients (Number)
Gemcitabine + Cisplatin + Nivolumab22.9
Nivolumab + Ipilimumab3.0

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Median Progression Free Survival Time

The median time patients are alive without progression following the initiation of treatment wherein progression will be defined clinically or on imaging as per irRECIST criteria. (NCT03101566)
Timeframe: Patients will be followed until death, withdrawal from study, or until 2 years, whichever is earliest

Interventionmonths (Median)
Gemcitabine + Cisplatin + Nivolumab6.6
Nivolumab + Ipilimumab3.9

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Median Overall Survival Time

The median overall survival time following the initiation of treatment. (NCT03101566)
Timeframe: Patients will be followed until death, withdrawal from study, or until 2 years, whichever is earliest

Interventionmonths (Median)
Gemcitabine + Cisplatin + Nivolumab10.6
Nivolumab + Ipilimumab8.2

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowled habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues. (NCT03126435)
Timeframe: Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))

,
Interventionscore on a scale (Mean)
Pancreatic painDigestiveAltered bowel habitHepaticBody imageHealth care satisfactionSexuality
EndoTAG-1 and Gemcitabine1.00.60.50.00.60.8-0.1
Gemcitabine Monotherapy1.70.9-0.10.00.70.40.8

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Percentage of Subjects With Objective Response

Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1. (NCT03126435)
Timeframe: Up to approximately 33.5 months (assessed continuously during treatment)

InterventionParticipants (Count of Participants)
EndoTAG-1 and Gemcitabine11
Gemcitabine Monotherapy6

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Percentage of Subjects With Disease Control According to RECIST v.1.1

Percentage of subjects with disease control is based on assessment of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST v.1.1 (NCT03126435)
Timeframe: Up to approximately 33.5 months (assessed continuously during treatment)

InterventionParticipants (Count of Participants)
EndoTAG-1 and Gemcitabine57
Gemcitabine Monotherapy43

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Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate

Responders are defined as subjects with a reduction in CA 19-9 levels by least 50% from baseline to the end of cycle 1 (or end of full treatment course). If a subject died while on study, he/she was classified as a failure, regardless of previous assessments. (NCT03126435)
Timeframe: Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course)

InterventionParticipants (Count of Participants)
EndoTAG-1 and Gemcitabine2
Gemcitabine Monotherapy2

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Overall Survival

The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning subject death, compared to number of subjects censored at the time of analysis. (NCT03126435)
Timeframe: From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment)

Interventiondays (Median)
EndoTAG-1 and Gemcitabine226
Gemcitabine Monotherapy209

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Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score

Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30): included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/ vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score = better level of functioning or greater degree of symptoms. Change from baseline = Cycle/day score minus baseline score. (NCT03126435)
Timeframe: Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))

,
Interventionscore on a scale (Mean)
Global health QoLFunctional scalesSymptom scalesSide effect scalesPhysicalRoleCognitiveEmotionalSocialFatiguePainNausea/vomitingDyspnoeaAppetite lossInsomniaConstipation/diarrhea
EndoTAG-1 and Gemcitabine-1.65.42.61.32.01.10.51.20.61.50.70.40.50.50.00.4
Gemcitabine Monotherapy-2.06.92.61.42.41.40.61.60.91.40.90.20.60.30.20.4

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Duration of Response

Duration of Response = (date of tumor progression or death - date of first objective response (CR or PR) +1) / 30. (NCT03126435)
Timeframe: From the first documentation of objective tumor response (date of the first CR or PR) to objective tumor progression or death due to any cause.

InterventionMonths (Mean)
EndoTAG-1 and Gemcitabine5.8
Gemcitabine Monotherapy9.1

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Progression Free Survival (PFS)

The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning first observation of progressive disease, compared to number of subjects censored at the time of analysis. (NCT03126435)
Timeframe: From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment)

Interventiondays (Median)
EndoTAG-1 and Gemcitabine113
Gemcitabine Monotherapy110

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Duration of Response (DoR)

DoR (per RECIST 1.1 using BICR assessments) was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression. The end of response coincided with the date of progression or death from any cause used for the RECIST 1.1 PFS endpoint. The time of the initial response was defined as the latest of the dates contributing towards the first visit of PR or CR. Results are presented for the pre-specified DoR analysis using unconfirmed responses based on BICR. (NCT03164616)
Timeframe: Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).

Interventionmonths (Median)
T + D + SoC7.4
D + SoC6.0
SoC Alone4.2

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Objective Response Rate (ORR)

ORR (per RECIST 1.1 using BICR assessments) was defined as the percentage of patients with at least one visit response of complete response (CR) or partial response (PR). Results are presented for the pre-specified ORR analysis using unconfirmed responses based on BICR. (NCT03164616)
Timeframe: Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).

Interventionpercentage of patients (Number)
T + D + SoC46.3
D + SoC48.5
SoC Alone33.4

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PK of Tremelimumab; Peak and Trough Serum Concentrations

To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively. (NCT03164616)
Timeframe: Samples were collected post-dose on Day 1 (Week 0), pre-dose on Weeks 3 and 12 and at follow-up (3 months after the last valid dose). Assessed at the global cohort DCO of 12 March 2021.

Interventionμg/mL (Geometric Mean)
Week 0Week 3Week 12Follow-up (3 months)
T + D + SoC23.174.167.820.86

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OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC

OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. (NCT03164616)
Timeframe: From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).

Interventionmonths (Median)
T + D + SoC14.0
D + SoC13.3
SoC Alone11.7

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Overall Survival (OS); D + SoC Compared With SoC Alone

OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The final analysis of OS in the global cohort was pre-specified after approximately 532 OS events occurred across the D + SoC and SoC alone treatment arms (80% maturity). (NCT03164616)
Timeframe: From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).

Interventionmonths (Median)
D + SoC13.3
SoC Alone11.7

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PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC

PFS (per RECIST 1.1 using BICR assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. (NCT03164616)
Timeframe: Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months.

Interventionmonths (Median)
T + D + SoC6.2
D + SoC5.5
SoC Alone4.8

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Progression-Free Survival (PFS); D + SoC Compared With SoC Alone

PFS (per RECIST version 1.1 [RECIST 1.1] using Blinded Independent Central Review [BICR] assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. The final analysis of PFS in the global cohort was pre-specified after approximately 497 BICR PFS events occurred across the D + SoC and SoC alone treatment arms (75% maturity). (NCT03164616)
Timeframe: Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).

Interventionmonths (Median)
D + SoC5.5
SoC Alone4.8

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Time From Randomization to Second Progression (PFS2)

PFS2 was defined as the time from the date of randomization to the earliest of the progression event (subsequent to that used for the primary variable PFS) or death. The date of second progression was recorded by the Investigator and defined according to local standard clinical practice and could involve any of: objective radiological imaging, symptomatic progression or death. (NCT03164616)
Timeframe: Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).

Interventionmonths (Median)
T + D + SoC10.4
D + SoC10.2
SoC Alone9.4

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Number of Patients With ADA Response to Tremelimumab

Blood samples were collected at pre-specified timepoints and number of patients who developed detectable ADAs against tremelimumab was determined. ADA prevalence is defined as percentage of patients with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as either treatment-induced ADA or treatment-boosted ADA. ADA incidence is percentage of patients who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted by ≥4-fold during the study period. Persistently positive is defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks (112 days) between the first and last positive, or an ADA positive result at the last available assessment. Transiently positive is defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of nAb was tested for all ADA positive samples. (NCT03164616)
Timeframe: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of study treatment (ie, tremelimumab).

InterventionParticipants (Count of Participants)
ADA positive at any visit (ADA prevalence)Treatment-emergent ADA positive (ADA incidence)Treatment-boosted ADATreatment-induced ADA (ADA positive post-baseline only)ADA positive at baseline onlyADA positive post-baseline and positive at baselinePersistently positiveTransiently positivenAb positive at any visit
T + D + SoC443833545221831

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Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab

Blood samples were collected at pre-specified timepoints and number of patients who developed detectable ADAs against durvalumab was determined. ADA prevalence is defined as percentage of patients with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as either treatment-induced ADA or treatment-boosted ADA. ADA incidence is percentage of patients who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted by ≥4-fold during the study period. Persistently positive is defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks (112 days) between the first and last positive, or an ADA positive result at the last available assessment. Transiently positive is defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of neutralizing antibody (nAb) was tested for all ADA positive samples. (NCT03164616)
Timeframe: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of study treatment (ie, durvalumab).

,
InterventionParticipants (Count of Participants)
ADA positive at any visit (ADA prevalence)Treatment-emergent ADA positive (ADA incidence)Treatment-boosted ADATreatment-induced ADA (ADA positive post-baseline only)ADA positive at baseline onlyADA positive post-baseline and positive at baselinePersistently positiveTransiently positivenAb positive at any visit
D + SoC33191181327133
T + D + SoC4229227878263

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Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations

To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively. (NCT03164616)
Timeframe: Samples were collected post-dose on Day 1 (Week 0), pre-dose on Weeks 3 and 12 and at follow-up (3 months after the last valid dose). Assessed at the global cohort DCO of 12 March 2021.

,
Interventionmicrograms/milliliter (μg/mL) (Geometric Mean)
Week 0Week 3Week 12Follow-up (3 months)
D + SoC505.0191.53212.1116.06
T + D + SoC418.8082.08195.6213.42

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Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13)

The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and treatment-related symptoms from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration was defined as time from randomization until the date of first clinically meaningful deterioration that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration. (NCT03164616)
Timeframe: At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever came first). Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).

,,
Interventionmonths (Median)
QLQ-LC13 CoughQLQ-LC13 HemoptysisQLQ-LC13 DyspneaQLQ-LC13 Pain in ChestQLQ-LC13 Pain in Arm or ShoulderQLQ-LC13 Pain in Other Parts
D + SoC11.014.05.09.58.98.9
SoC Alone8.811.43.68.68.85.8
T + D + SoC9.717.85.410.08.99.7

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Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score

EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by participants as clinically significant (Osoba et al. 1998). (NCT03191786)
Timeframe: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)

Interventionunits of a scale (Mean)
GHS/HRQoL Scale Score, BaselineGHS/HRQoL Scale Score, Week 6GHS/HRQoL Scale Score, Week 12GHS/HRQoL Scale Score, Week 18GHS/HRQoL Scale Score, Week 24GHS/HRQoL Scale Score, Week 30GHS/HRQoL Scale Score, Week 36GHS/HRQoL Scale Score, Week 42GHS/HRQoL Scale Score, Week 48GHS/HRQoL Scale Score, Week 57GHS/HRQoL Scale Score, Week 66GHS/HRQoL Scale Score, Week 75GHS/HRQoL Scale Score, Week 84GHS/HRQoL Scale Score, Week 93GHS/HRQoL Scale Score, Week 102GHS/HRQoL Scale Score, Safety Follow-Up VisitPhysical Functioning, BaselinePhysical Functioning, Week 6Physical Functioning, Week 12Physical Functioning, Week 18Physical Functioning, Week 24Physical Functioning, Week 30Physical Functioning, Week 36Physical Functioning, Week 42Physical Functioning, Week 48Physical Functioning, Week 57Physical Functioning, Week 66Physical Functioning, Week 75Physical Functioning, Week 84Physical Functioning, Week 93Physical Functioning, Week 102Physical Functioning, Safety Follow-Up VisitRole Functioning, BaselineRole Functioning, Week 6Role Functioning, Week 12Role Functioning, Week 18Role Functioning, Week 24Role Functioning, Week 30Role Functioning, Week 36Role Functioning, Week 42Role Functioning, Week 48Role Functioning, Week 57Role Functioning, Week 66Role Functioning, Week 75Role Functioning, Week 84Role Functioning, Week 93Role Functioning, Week 102Role Functioning, Safety Follow-Up VisitEmotional Functioning, BaselineEmotional Functioning, Week 6Emotional Functioning, Week 12Emotional Functioning, Week 18Emotional Functioning, Week 24Emotional Functioning, Week 30Emotional Functioning, Week 36Emotional Functioning, Week 42Emotional Functioning, Week 48Emotional Functioning, Week 57Emotional Functioning, Week 66Emotional Functioning, Week 75Emotional Functioning, Week 84Emotional Functioning, Week 93Emotional Functioning, Week 102Emotional Functioning, Safety Follow-Up VisitCognitive Functioning, BaselineCognitive Functioning, Week 6Cognitive Functioning, Week 12Cognitive Functioning, Week 18Cognitive Functioning, Week 24Cognitive Functioning, Week 30Cognitive Functioning, Week 36Cognitive Functioning, Week 42Cognitive Functioning, Week 48Cognitive Functioning, Week 57Cognitive Functioning, Week 66Cognitive Functioning, Week 75Cognitive Functioning, Week 84Cognitive Functioning, Week 93Cognitive Functioning, Week 102Cognitive Functioning, Safety Follow-Up VisitSocial Functioning, BaselineSocial Functioning, Week 6Social Functioning, Week 12Social Functioning, Week 18Social Functioning, Week 24Social Functioning, Week 30Social Functioning, Week 36Social Functioning, Week 42Social Functioning, Week 48Social Functioning, Week 57Social Functioning, Week 66Social Functioning, Week 75Social Functioning, Week 84Social Functioning, Week 93Social Functioning, Week 102Social Functioning, Safety Follow-Up VisitFatigue, BaselineFatigue, Week 6Fatigue, Week 12Fatigue, Week 18Fatigue, Week 24Fatigue, Week 30Fatigue, Week 36Fatigue, Week 42Fatigue, Week 48Fatigue, Week 57Fatigue, Week 66Fatigue, Week 75Fatigue, Week 84Fatigue, Week 93Fatigue, Week 102Fatigue, Safety Follow-Up VisitNausea and Vomiting, BaselineNausea and Vomiting, Week 6Nausea and Vomiting, Week 12Nausea and Vomiting, Week 18Nausea and Vomiting, Week 24Nausea and Vomiting, Week 30Nausea and Vomiting, Week 36Nausea and Vomiting, Week 42Nausea and Vomiting, Week 48Nausea and Vomiting, Week 57Nausea and Vomiting, Week 66Nausea and Vomiting, Week 75Nausea and Vomiting, Week 84Nausea and Vomiting, Week 93Nausea and Vomiting, Week 102Nausea and Vomiting, Safety Follow-Up VisitPain, BaselinePain, Week 6Pain, Week 12Pain, Week 18Pain, Week 24Pain, Week 30Pain, Week 36Pain, Week 42Pain, Week 48Pain, Week 57Pain, Week 66Pain, Week 75Pain, Week 84Pain, Week 93Pain, Week 102Pain, Safety Follow-Up VisitDyspnoea, BaselineDyspnoea, Week 6Dyspnoea, Week 12Dyspnoea, Week 18Dyspnoea, Week 24Dyspnoea, Week 30Dyspnoea, Week 36Dyspnoea, Week 42Dyspnoea, Week 48Dyspnoea, Week 57Dyspnoea, Week 66Dyspnoea, Week 75Dyspnoea, Week 84Dyspnoea, Week 93Dyspnoea, Week 102Dyspnoea, Safety Follow-Up VisitInsomnia, BaselineInsomnia, Week 6Insomnia, Week 12Insomnia, Week 18Insomnia, Week 24Insomnia, Week 30Insomnia, Week 36Insomnia, Week 42Insomnia, Week 48Insomnia, Week 57Insomnia, Week 66Insomnia, Week 75Insomnia, Week 84Insomnia, Week 93Insomnia, Week 102Insomnia, Safety Follow-Up VisitAppetite Loss, BaselineAppetite Loss, Week 6Appetite Loss, Week 12Appetite Loss, Week 18Appetite Loss, Week 24Appetite Loss, Week 30Appetite Loss, Week 36Appetite Loss, Week 42Appetite Loss, Week 48Appetite Loss, Week 57Appetite Loss, Week 66Appetite Loss, Week 75Appetite Loss, Week 84Appetite Loss, Week 93Appetite Loss, Week 102Appetite Loss, Safety Follow-Up VisitConstipation, BaselineConstipation, Week 6Constipation, Week 12Constipation, Week 18Constipation, Week 24Constipation, Week 30Constipation, Week 36Constipation, Week 42Constipation, Week 48Constipation, Week 57Constipation, Week 66Constipation, Week 75Constipation, Week 84Constipation, Week 93Constipation, Week 102Constipation, Safety Follow-Up VisitDiarrhoea, BaselineDiarrhoea, Week 6Diarrhoea, Week 12Diarrhoea, Week 18Diarrhoea, Week 24Diarrhoea, Week 30Diarrhoea, Week 36Diarrhoea, Week 42Diarrhoea, Week 48Diarrhoea, Week 57Diarrhoea, Week 66Diarrhoea, Week 75Diarrhoea, Week 84Diarrhoea, Week 93Diarrhoea, Week 102Diarrhoea, Safety Follow-Up VisitFinancial Difficulties, BaselineFinancial Difficulties, Week 6Financial Difficulties, Week 12Financial Difficulties, Week 18Financial Difficulties, Week 24Financial Difficulties, Week 30Financial Difficulties, Week 36Financial Difficulties, Week 42Financial Difficulties, Week 48Financial Difficulties, Week 57Financial Difficulties, Week 66Financial Difficulties, Week 75Financial Difficulties, Week 84Financial Difficulties, Week 93Financial Difficulties, Week 102Financial Difficulties, Safety Follow-Up Visit
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)55.250.291.85-0.42-1.722.65-0.521.194.868.335.002.08-2.78-12.50-25.003.8561.97-1.071.46-1.58-5.50-1.23-4.900.952.22-3.332.67-1.67-8.89-26.67-40.00-6.6761.72-3.51-1.591.71-5.00-7.25-14.58-4.76-2.78-4.17-6.678.33-11.11-25.00-33.33-1.2873.380.464.210.284.072.17-5.38-7.14-3.473.136.6712.500.00-4.17-16.67-5.7782.65-5.94-2.60-7.92-10.00-8.70-11.46-7.14-11.11-2.08-3.33-4.175.560.000.005.1374.43-4.49-4.17-14.17-11.11-5.80-14.58-7.14-5.562.083.334.1722.228.3316.67-12.8242.622.08-1.562.222.96-3.384.863.171.851.39-6.67-8.3322.2222.2233.331.717.991.013.653.333.333.623.133.570.002.08-3.33-4.170.00-8.330.000.0032.99-1.01-5.733.753.89-9.423.13-4.76-11.11-6.25-20.000.00-11.11-16.67-33.33-7.6939.31-0.58-4.69-3.33-4.44-8.700.00-7.69-3.03-12.50-20.00-16.670.00-16.670.00-2.7831.05-1.16-3.65-2.50-5.56-15.94-18.75-9.522.784.17-6.67-16.67-22.220.000.00-5.1331.050.007.2913.3310.007.256.252.385.568.3313.330.0022.2250.0066.67-7.6921.921.45-0.520.831.115.806.250.00-6.06-8.330.0016.6711.1133.3333.337.695.713.481.065.835.564.352.082.388.334.176.670.000.000.000.000.0020.320.001.564.172.22-1.454.442.38-5.56-4.17-6.678.33-22.22-16.67-33.330.00

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Duration of Response (DOR), as Determined by the Investigator Using RECIST v1.1

DOR is defined as the time from the first tumor assessment that supports the participants' objective response (CR or PR, whichever is first reported) to documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first, among patients who have a best overall response as CR or PR. (NCT03191786)
Timeframe: Time from the first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)

InterventionMonths (Median)
Atezolizumab14.0
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)7.8

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Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1 in Participants With PD-L1 Positive Status

Investigator-assessed PFS according to RECIST v1.1 assessed in participants whose tumors express PD-L1 protein as measured by PD-L1 SP263 IHC assay. (NCT03191786)
Timeframe: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)

InterventionMonths (Median)
Atezolizumab4.2
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)3.0

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Overall Survival (OS)

Overall survival is defined as the time between the date of randomization and the date of death due to any cause. (NCT03191786)
Timeframe: From randomization up to death from any cause (up to approximately 55 months)

InterventionMonths (Median)
Atezolizumab10.3
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)9.2

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Overall Survival in Participants With PD-L1 Positive Status

Overall survival will be assessed in participants whose tumors express PD-L1 protein as measured by PD-L1 SP263 IHC assay. (NCT03191786)
Timeframe: From randomization up to death from any cause (up to approximately 55 months)

InterventionMonths (Median)
Atezolizumab9.4
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)10.3

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Percentage of Participants With At Lease One Adverse Event

Percentage of participants with at least one adverse event. (NCT03191786)
Timeframe: From randomization up to approximately 55 months

InterventionPercentage of participants (Number)
Atezolizumab91.7
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)97.3

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Percentage of Participants With Objective Response Rate, as Determined by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (v1.1)

Objective response rate (ORR) is defined as a Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR), as determined by the investigator with use of RECIST v1.1. A minimum interval of 6 weeks (42 days) will be considered for Stable Disease (SD) to be assigned as best overall response, i.e. in the case the single response is SD, PR or CR, this single response must have been assessed no less than 6 weeks (at least 42 days) after start date of study treatment. (NCT03191786)
Timeframe: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)

InterventionPercentage of participants (Number)
Atezolizumab16.9
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)7.9

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Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score

The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score is perceived by participants as clinically significant (Osoba et al. 1998). (NCT03191786)
Timeframe: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)

Interventionunits of a scale (Mean)
Dyspnoea, BaselineDyspnoea, Week 6Dyspnoea, Week 12Dyspnoea, Week 18Dyspnoea, Week 24Dyspnoea, Week 30Dyspnoea, Week 36Dyspnoea, Week 42Dyspnoea, Week 48Dyspnoea, Week 57Dyspnoea, Week 66Dyspnoea, Week 75Dyspnoea, Week 84Dyspnoea, Week 93Dyspnoea, Week 102Dyspnoea, Week 111Dyspnoea, Week 120Dyspnoea, Week 129Dyspnoea, Week 138Dyspnoea, Week 147Dyspnoea, Week 156Dyspnoea, Week 165Dyspnoea, Week 174Dyspnoea, Week 183Dyspnoea, Week 192Dyspnoea, Week 201Dyspnoea, Week 210Dyspnoea, Safety Follow-Up VisitCoughing, BaselineCoughing, Week 6Coughing, Week 12Coughing, Week 18Coughing, Week 24Coughing, Week 30Coughing, Week 36Coughing, Week 42Coughing, Week 48Coughing, Week 57Coughing, Week 66Coughing, Week 75Coughing, Week 84Coughing, Week 93Coughing, Week 102Coughing, Week 111Coughing, Week 120Coughing, Week 129Coughing, Week 138Coughing, Week 147Coughing, Week 156Coughing, Week 165Coughing, Week 174Coughing, Week 183Coughing, Week 192Coughing, Week 201Coughing, Week 210Coughing, Safety Follow-Up VisitHaemoptysis, BaselineHaemoptysis, Week 6Haemoptysis, Week 12Haemoptysis, Week 18Haemoptysis, Week 24Haemoptysis, Week 30Haemoptysis, Week 36Haemoptysis, Week 42Haemoptysis, Week 48Haemoptysis, Week 57Haemoptysis, Week 66Haemoptysis, Week 75Haemoptysis, Week 84Haemoptysis, Week 93Haemoptysis, Week 102Haemoptysis, Week 111Haemoptysis, Week 120Haemoptysis, Week 129Haemoptysis, Week 138Haemoptysis, Week 147Haemoptysis, Week 156Haemoptysis, Week 165Haemoptysis, Week 174Haemoptysis, Week 183Haemoptysis, Week 192Haemoptysis, Week 201Haemoptysis, Week 210Haemoptysis, Safety Follow-Up VisitSore Mouth, BaselineSore Mouth, Week 6Sore Mouth, Week 12Sore Mouth, Week 18Sore Mouth, Week 24Sore Mouth, Week 30Sore Mouth, Week 36Sore Mouth, Week 42Sore Mouth, Week 48Sore Mouth, Week 57Sore Mouth, Week 66Sore Mouth, Week 75Sore Mouth, Week 84Sore Mouth, Week 93Sore Mouth, Week 102Sore Mouth, Week 111Sore Mouth, Week 120Sore Mouth, Week 129Sore Mouth, Week 138Sore Mouth, Week 147Sore Mouth, Week 156Sore Mouth, Week 165Sore Mouth, Week 174Sore Mouth, Week 183Sore Mouth, Week 192Sore Mouth, Week 201Sore Mouth, Week 210Sore Mouth, Safety Follow-Up VisitDysphagia, BaselineDysphagia, Week 6Dysphagia, Week 12Dysphagia, Week 18Dysphagia, Week 24Dysphagia, Week 30Dysphagia, Week 36Dysphagia, Week 42Dysphagia, Week 48Dysphagia, Week 57Dysphagia, Week 66Dysphagia, Week 75Dysphagia, Week 84Dysphagia, Week 93Dysphagia, Week 102Dysphagia, Week 111Dysphagia, Week 120Dysphagia, Week 129Dysphagia, Week 138Dysphagia, Week 147Dysphagia, Week 156Dysphagia, Week 165Dysphagia, Week 174Dysphagia, Week 183Dysphagia, Week 192Dysphagia, Week 201Dysphagia, Week 210Dysphagia, Safety Follow-Up VisitPeripheral Neuropathy, BaselinePeripheral Neuropathy, Week 6Peripheral Neuropathy, Week 12Peripheral Neuropathy, Week 18Peripheral Neuropathy, Week 24Peripheral Neuropathy, Week 30Peripheral Neuropathy, Week 36Peripheral Neuropathy, Week 42Peripheral Neuropathy, Week 48Peripheral Neuropathy, Week 57Peripheral Neuropathy, Week 66Peripheral Neuropathy, Week 75Peripheral Neuropathy, Week 84Peripheral Neuropathy, Week 93Peripheral Neuropathy, Week 102Peripheral Neuropathy, Week 111Peripheral Neuropathy, Week 120Peripheral Neuropathy, Week 129Peripheral Neuropathy, Week 138Peripheral Neuropathy, Week 147Peripheral Neuropathy, Week 156Peripheral Neuropathy, Week 165Peripheral Neuropathy, Week 174Peripheral Neuropathy, Week 183Peripheral Neuropathy, Week 192Peripheral Neuropathy, Week 201Peripheral Neuropathy, Week 210Peripheral Neuropathy, Safety Follow-Up VisitAlopecia, BaselineAlopecia, Week 6Alopecia, Week 12Alopecia, Week 18Alopecia, Week 24Alopecia, Week 30Alopecia, Week 36Alopecia, Week 42Alopecia, Week 48Alopecia, Week 57Alopecia, Week 66Alopecia, Week 75Alopecia, Week 84Alopecia, Week 93Alopecia, Week 102Alopecia, Week 111Alopecia, Week 120Alopecia, Week 129Alopecia, Week 138Alopecia, Week 147Alopecia, Week 156Alopecia, Week 165Alopecia, Week 174Alopecia, Week 183Alopecia, Week 192Alopecia, Week 201Alopecia, Week 210Alopecia, Safety Follow-Up VisitPain in Chest, BaselinePain in Chest, Week 6Pain in Chest, Week 12Pain in Chest, Week 18Pain in Chest, Week 24Pain in Chest, Week 30Pain in Chest, Week 36Pain in Chest, Week 42Pain in Chest, Week 48Pain in Chest, Week 57Pain in Chest, Week 66Pain in Chest, Week 75Pain in Chest, Week 84Pain in Chest, Week 93Pain in Chest, Week 102Pain in Chest, Week 111Pain in Chest, Week 120Pain in Chest, Week 129Pain in Chest, Week 138Pain in Chest, Week 147Pain in Chest, Week 156Pain in Chest, Week 165Pain in Chest, Week 174Pain in Chest, Week 183Pain in Chest, Week 192Pain in Chest, Week 201Pain in Chest, Week 210Pain in Chest, Safety Follow-Up VisitPain in Arm or Shoulder, BaselinePain in Arm or Shoulder, Week 6Pain in Arm or Shoulder, Week 12Pain in Arm or Shoulder, Week 18Pain in Arm or Shoulder, Week 24Pain in Arm or Shoulder, Week 30Pain in Arm or Shoulder, Week 36Pain in Arm or Shoulder, Week 42Pain in Arm or Shoulder, Week 48Pain in Arm or Shoulder, Week 57Pain in Arm or Shoulder, Week 66Pain in Arm or Shoulder, Week 75Pain in Arm or Shoulder, Week 84Pain in Arm or Shoulder, Week 93Pain in Arm or Shoulder, Week 102Pain in Arm or Shoulder, Week 111Pain in Arm or Shoulder, Week 120Pain in Arm or Shoulder, Week 129Pain in Arm or Shoulder, Week 138Pain in Arm or Shoulder, Week 147Pain in Arm or Shoulder, Week 156Pain in Arm or Shoulder, Week 165Pain in Arm or Shoulder, Week 174Pain in Arm or Shoulder, Week 183Pain in Arm or Shoulder, Week 192Pain in Arm or Shoulder, Week 201Pain in Arm or Shoulder, Week 210Pain in Arm or Shoulder, Safety Follow-Up VisitPain in other parts, BaselinePain in other parts, Week 6Pain in other parts, Week 12Pain in other parts, Week 18Pain in other parts, Week 24Pain in other parts, Week 30Pain in other parts, Week 36Pain in other parts, Week 42Pain in other parts, Week 48Pain in other parts, Week 57Pain in other parts, Week 66Pain in other parts, Week 75Pain in other parts, Week 84Pain in other parts, Week 93Pain in other parts, Week 102Pain in other parts, Week 111Pain in other parts, Week 120Pain in other parts, Week 129Pain in other parts, Week 138Pain in other parts, Week 147Pain in other parts, Week 156Pain in other parts, Week 165Pain in other parts, Week 174Pain in other parts, Week 183Pain in other parts, Week 192Pain in other parts, Week 201Pain in other parts, Week 210Pain in other parts, Safety Follow-Up Visit
Atezolizumab34.301.13-0.23-4.78-5.05-5.34-3.90-11.11-4.84-7.89-6.58-4.55-8.50-2.34-2.96-2.56-4.273.700.00-0.851.59-1.851.595.565.560.000.0012.1241.36-1.80-7.61-9.64-11.01-9.24-7.10-10.06-15.91-14.29-11.46-9.33-19.30-21.67-14.58-11.90-11.90-14.29-16.67-21.43-23.81-16.67-19.050.00-16.670.000.003.035.860.75-1.80-1.64-2.52-3.97-1.67-1.26-3.79-2.78-2.15-1.33-3.51-1.67-2.08-2.38-2.38-2.38-2.38-2.380.000.000.000.000.000.000.003.034.171.64-0.22-0.82-1.90-3.57-2.730.00-5.30-5.56-4.17-5.33-1.75-1.672.080.002.38-4.762.380.000.004.170.000.000.000.000.0027.2711.15-1.20-0.44-2.19-4.72-3.57-6.11-7.55-5.30-3.70-6.45-4.00-8.770.000.00-4.762.38-2.384.76-4.760.00-8.330.000.000.0016.670.0012.1211.263.291.991.103.774.827.788.186.827.416.255.338.776.676.252.382.382.380.002.38-4.760.00-4.76-8.3316.670.000.0021.217.91-1.06-2.01-1.93-1.27-1.205.563.853.107.626.675.561.755.004.172.384.762.387.142.380.000.000.000.008.3316.670.000.0020.29-2.45-4.03-9.37-7.62-7.23-11.67-11.54-17.83-18.10-15.05-13.89-22.81-23.33-20.83-26.19-26.19-21.43-26.19-19.05-23.81-25.00-23.81-16.67-16.67-33.33-66.670.0019.16-0.450.67-1.65-3.21-0.40-4.44-1.89-1.527.411.08-1.393.516.678.332.384.762.382.382.389.524.170.0025.000.000.000.0012.1225.32-1.85-0.91-1.74-3.53-2.88-5.08-2.67-4.65-1.963.458.33-1.75-3.33-4.17-5.130.00-7.14-7.140.00-14.29-16.67-9.528.33-8.33-33.33-66.679.09

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Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score

The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score is perceived by participants as clinically significant (Osoba et al. 1998). (NCT03191786)
Timeframe: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)

Interventionunits of a scale (Mean)
Dyspnoea, BaselineDyspnoea, Week 6Dyspnoea, Week 12Dyspnoea, Week 18Dyspnoea, Week 24Dyspnoea, Week 30Dyspnoea, Week 36Dyspnoea, Week 42Dyspnoea, Week 48Dyspnoea, Week 57Dyspnoea, Week 66Dyspnoea, Week 75Dyspnoea, Week 84Dyspnoea, Week 93Dyspnoea, Week 102Dyspnoea, Safety Follow-Up VisitCoughing, BaselineCoughing, Week 6Coughing, Week 12Coughing, Week 18Coughing, Week 24Coughing, Week 30Coughing, Week 36Coughing, Week 42Coughing, Week 48Coughing, Week 57Coughing, Week 66Coughing, Week 75Coughing, Week 84Coughing, Week 93Coughing, Week 102Coughing, Safety Follow-Up VisitHaemoptysis, BaselineHaemoptysis, Week 6Haemoptysis, Week 12Haemoptysis, Week 18Haemoptysis, Week 24Haemoptysis, Week 30Haemoptysis, Week 36Haemoptysis, Week 42Haemoptysis, Week 48Haemoptysis, Week 57Haemoptysis, Week 66Haemoptysis, Week 75Haemoptysis, Week 84Haemoptysis, Week 93Haemoptysis, Week 102Haemoptysis, Safety Follow-Up VisitSore Mouth, BaselineSore Mouth, Week 6Sore Mouth, Week 12Sore Mouth, Week 18Sore Mouth, Week 24Sore Mouth, Week 30Sore Mouth, Week 36Sore Mouth, Week 42Sore Mouth, Week 48Sore Mouth, Week 57Sore Mouth, Week 66Sore Mouth, Week 75Sore Mouth, Week 84Sore Mouth, Week 93Sore Mouth, Week 102Sore Mouth, Safety Follow-Up VisitDysphagia, BaselineDysphagia, Week 6Dysphagia, Week 12Dysphagia, Week 18Dysphagia, Week 24Dysphagia, Week 30Dysphagia, Week 36Dysphagia, Week 42Dysphagia, Week 48Dysphagia, Week 57Dysphagia, Week 66Dysphagia, Week 75Dysphagia, Week 84Dysphagia, Week 93Dysphagia, Week 102Dysphagia, Safety Follow-Up VisitPeripheral Neuropathy, BaselinePeripheral Neuropathy, Week 6Peripheral Neuropathy, Week 12Peripheral Neuropathy, Week 18Peripheral Neuropathy, Week 24Peripheral Neuropathy, Week 30Peripheral Neuropathy, Week 36Peripheral Neuropathy, Week 42Peripheral Neuropathy, Week 48Peripheral Neuropathy, Week 57Peripheral Neuropathy, Week 66Peripheral Neuropathy, Week 75Peripheral Neuropathy, Week 84Peripheral Neuropathy, Week 93Peripheral Neuropathy, Week 102Peripheral Neuropathy, Safety Follow-Up VisitAlopecia, BaselineAlopecia, Week 6Alopecia, Week 12Alopecia, Week 18Alopecia, Week 24Alopecia, Week 30Alopecia, Week 36Alopecia, Week 42Alopecia, Week 48Alopecia, Week 57Alopecia, Week 66Alopecia, Week 75Alopecia, Week 84Alopecia, Week 93Alopecia, Week 102Alopecia, Safety Follow-Up VisitPain in Chest, BaselinePain in Chest, Week 6Pain in Chest, Week 12Pain in Chest, Week 18Pain in Chest, Week 24Pain in Chest, Week 30Pain in Chest, Week 36Pain in Chest, Week 42Pain in Chest, Week 48Pain in Chest, Week 57Pain in Chest, Week 66Pain in Chest, Week 75Pain in Chest, Week 84Pain in Chest, Week 93Pain in Chest, Safety Follow-Up VisitPain in Arm or Shoulder, BaselinePain in Arm or Shoulder, Week 6Pain in Arm or Shoulder, Week 12Pain in Arm or Shoulder, Week 18Pain in Arm or Shoulder, Week 24Pain in Arm or Shoulder, Week 30Pain in Arm or Shoulder, Week 36Pain in Arm or Shoulder, Week 42Pain in Arm or Shoulder, Week 48Pain in Arm or Shoulder, Week 57Pain in Arm or Shoulder, Week 66Pain in Arm or Shoulder, Week 75Pain in Arm or Shoulder, Week 84Pain in Arm or Shoulder, Week 93Pain in Arm or Shoulder, Safety Follow-Up VisitPain in other parts, BaselinePain in other parts, Week 6Pain in other parts, Week 12Pain in other parts, Week 18Pain in other parts, Week 24Pain in other parts, Week 30Pain in other parts, Week 36Pain in other parts, Week 42Pain in other parts, Week 48Pain in other parts, Week 57Pain in other parts, Week 66Pain in other parts, Week 75Pain in other parts, Week 84Pain in other parts, Week 93Pain in other parts, Safety Follow-Up Visit
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)36.670.92-2.870.902.681.525.56-6.841.854.170.00-2.783.705.560.006.4846.26-5.46-9.38-3.423.330.000.00-2.380.004.17-13.33-8.3311.1116.670.00-17.957.76-4.64-3.17-1.71-1.11-2.90-6.25-2.38-5.56-8.330.000.000.000.000.00-2.565.020.000.002.562.300.00-2.084.76-2.780.006.6716.6711.110.000.000.008.682.90-1.04-0.851.112.906.254.760.004.170.0016.670.000.000.000.0014.841.452.085.137.78-1.4512.509.528.3320.8313.338.330.000.000.00-2.784.836.097.9412.8214.2910.1410.427.1413.8929.176.678.3311.1116.6733.3312.8219.91-4.09-5.29-5.26-2.30-9.092.38-2.563.03-4.76-16.67-22.22-16.670.0012.8219.08-0.58-4.23-2.630.004.55-2.22-5.13-6.06-9.52-33.33-33.33-16.670.007.6927.551.18-0.5411.11-4.76-7.582.22-12.82-15.15-9.52-16.670.000.000.000.00

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Time to Deterioration in Patient-Reported Lung Cancer Symptoms As Assessed by EORTC QLQ-LC13 Score

TTD with use of the EORTC is defined as the time from randomization to the first confirmed clinically meaningful deterioration in EORTC symptom scores. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a = 10-point increase above baseline in a symptom score that must be held for at least two consecutive assessments or an initial = 10-point increase above baseline followed by either (a) death within 6 weeks from the last assessment through Week 48 or (b) death within 9 weeks from the last assessment from Week 48 thereafter. A = 10-point change in the EORTC scale score is perceived by participants as clinically significant. (NCT03191786)
Timeframe: From baseline up to approximately 55 months

,
InterventionMonths (Median)
CoughChest PainDyspnoeaArm and/or Shoulder PainComposite of Cough, Dyspnea and Chest Pain
AtezolizumabNANA17.321.38.3
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)21.4NA8.313.94.2

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Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC QLQ-C30 Score

TTD with use of the EORTC is defined as the time from randomization to the first confirmed clinically meaningful deterioration in EORTC symptom scores. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a = 10-point increase above baseline in a symptom score that must be held for at least two consecutive assessments or an initial = 10-point increase above baseline followed by either (a) death within 6 weeks from the last assessment through Week 48 or (b) death within 9 weeks from the last assessment from Week 48 thereafter. A = 10-point change in the EORTC scale score is perceived by participants as clinically significant (Osoba et al. 1998). (NCT03191786)
Timeframe: From baseline up to approximately 55 months

,
InterventionMonths (Median)
DyspnoeaFatigue
AtezolizumabNA13.5
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)NA8.4

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Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1

PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1 or death from any cause, whichever occurs first. (NCT03191786)
Timeframe: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)

InterventionMonths (Median)
Atezolizumab4.2
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)4.0

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OS Rates at the 6, 12, 18, 24-Months Timepoints

OS rate at 6, 12, 18 and 24 months were estimated for each treatment arm. (NCT03191786)
Timeframe: 6, 12, 18 and 24 months

,
InterventionPercentage (Number)
6 Months12 Months18 Months24 Months
Atezolizumab64.043.731.424.3
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)57.538.624.012.4

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Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score

EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by participants as clinically significant (Osoba et al. 1998). (NCT03191786)
Timeframe: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)

Interventionunits of a scale (Mean)
GHS/HRQoL Scale Score, BaselineGHS/HRQoL Scale Score, Week 6GHS/HRQoL Scale Score, Week 12GHS/HRQoL Scale Score, Week 18GHS/HRQoL Scale Score, Week 24GHS/HRQoL Scale Score, Week 30GHS/HRQoL Scale Score, Week 36GHS/HRQoL Scale Score, Week 42GHS/HRQoL Scale Score, Week 48GHS/HRQoL Scale Score, Week 57GHS/HRQoL Scale Score, Week 66GHS/HRQoL Scale Score, Week 75GHS/HRQoL Scale Score, Week 84GHS/HRQoL Scale Score, Week 93GHS/HRQoL Scale Score, Week 102GHS/HRQoL Scale Score, Week 111GHS/HRQoL Scale Score, Week 120GHS/HRQoL Scale Score, Week 129GHS/HRQoL Scale Score, Week 138GHS/HRQoL Scale Score, Week 147GHS/HRQoL Scale Score, Week 156GHS/HRQoL Scale Score, Week 165GHS/HRQoL Scale Score, Week 174GHS/HRQoL Scale Score, Week 183GHS/HRQoL Scale Score, Week 192GHS/HRQoL Scale Score, Week 201GHS/HRQoL Scale Score, Week 210GHS/HRQoL Scale Score, Safety Follow-Up VisitPhysical Functioning, BaselinePhysical Functioning, Week 6Physical Functioning, Week 12Physical Functioning, Week 18Physical Functioning, Week 24Physical Functioning, Week 30Physical Functioning, Week 36Physical Functioning, Week 42Physical Functioning, Week 48Physical Functioning, Week 57Physical Functioning, Week 66Physical Functioning, Week 75Physical Functioning, Week 84Physical Functioning, Week 93Physical Functioning, Week 102Physical Functioning, Week 111Physical Functioning, Week 120Physical Functioning, Week 129Physical Functioning, Week 138Physical Functioning, Week 147Physical Functioning, Week 156Physical Functioning, Week 165Physical Functioning, Week 174Physical Functioning, Week 183Physical Functioning, Week 192Physical Functioning, Week 201Physical Functioning, Week 210Physical Functioning, Safety Follow-Up VisitRole Functioning, BaselineRole Functioning, Week 6Role Functioning, Week 12Role Functioning, Week 18Role Functioning, Week 24Role Functioning, Week 30Role Functioning, Week 36Role Functioning, Week 42Role Functioning, Week 48Role Functioning, Week 57Role Functioning, Week 66Role Functioning, Week 75Role Functioning, Week 84Role Functioning, Week 93Role Functioning, Week 102Role Functioning, Week 111Role Functioning, Week 120Role Functioning, Week 129Role Functioning, Week 138Role Functioning, Week 147Role Functioning, Week 156Role Functioning, Week 165Role Functioning, Week 174Role Functioning, Week 183Role Functioning, Week 192Role Functioning, Week 201Role Functioning, Week 210Role Functioning, Safety Follow-Up VisitEmotional Functioning, BaselineEmotional Functioning, Week 6Emotional Functioning, Week 12Emotional Functioning, Week 18Emotional Functioning, Week 24Emotional Functioning, Week 30Emotional Functioning, Week 36Emotional Functioning, Week 42Emotional Functioning, Week 48Emotional Functioning, Week 57Emotional Functioning, Week 66Emotional Functioning, Week 75Emotional Functioning, Week 84Emotional Functioning, Week 93Emotional Functioning, Week 102Emotional Functioning, Week 111Emotional Functioning, Week 120Emotional Functioning, Week 129Emotional Functioning, Week 138Emotional Functioning, Week 147Emotional Functioning, Week 156Emotional Functioning, Week 165Emotional Functioning, Week 174Emotional Functioning, Week 183Emotional Functioning, Week 192Emotional Functioning, Week 201Emotional Functioning, Week 210Emotional Functioning, Safety Follow-Up VisitCognitive Functioning, BaselineCognitive Functioning, Week 6Cognitive Functioning, Week 12Cognitive Functioning, Week 18Cognitive Functioning, Week 24Cognitive Functioning, Week 30Cognitive Functioning, Week 36Cognitive Functioning, Week 42Cognitive Functioning, Week 48Cognitive Functioning, Week 57Cognitive Functioning, Week 66Cognitive Functioning, Week 75Cognitive Functioning, Week 84Cognitive Functioning, Week 93Cognitive Functioning, Week 102Cognitive Functioning, Week 111Cognitive Functioning, Week 120Cognitive Functioning, Week 129Cognitive Functioning, Week 138Cognitive Functioning, Week 147Cognitive Functioning, Week 156Cognitive Functioning, Week 165Cognitive Functioning, Week 174Cognitive Functioning, Week 183Cognitive Functioning, Week 192Cognitive Functioning, Week 201Cognitive Functioning, Week 210Cognitive Functioning, Safety Follow-Up VisitSocial Functioning, BaselineSocial Functioning, Week 6Social Functioning, Week 12Social Functioning, Week 18Social Functioning, Week 24Social Functioning, Week 30Social Functioning, Week 36Social Functioning, Week 42Social Functioning, Week 48Social Functioning, Week 57Social Functioning, Week 66Social Functioning, Week 75Social Functioning, Week 84Social Functioning, Week 93Social Functioning, Week 102Social Functioning, Week 111Social Functioning, Week 120Social Functioning, Week 129Social Functioning, Week 138Social Functioning, Week 147Social Functioning, Week 156Social Functioning, Week 165Social Functioning, Week 174Social Functioning, Week 183Social Functioning, Week 192Social Functioning, Week 201Social Functioning, Week 210Social Functioning, Safety Follow-Up VisitFatigue, BaselineFatigue, Week 6Fatigue, Week 12Fatigue, Week 18Fatigue, Week 24Fatigue, Week 30Fatigue, Week 36Fatigue, Week 42Fatigue, Week 48Fatigue, Week 57Fatigue, Week 66Fatigue, Week 75Fatigue, Week 84Fatigue, Week 93Fatigue, Week 102Fatigue, Week 111Fatigue, Week 120Fatigue, Week 129Fatigue, Week 138Fatigue, Week 147Fatigue, Week 156Fatigue, Week 165Fatigue, Week 174Fatigue, Week 183Fatigue, Week 192Fatigue, Week 201Fatigue, Week 210Fatigue, Safety Follow-Up VisitNausea and Vomiting, BaselineNausea and Vomiting, Week 6Nausea and Vomiting, Week 12Nausea and Vomiting, Week 18Nausea and Vomiting, Week 24Nausea and Vomiting, Week 30Nausea and Vomiting, Week 36Nausea and Vomiting, Week 42Nausea and Vomiting, Week 48Nausea and Vomiting, Week 57Nausea and Vomiting, Week 66Nausea and Vomiting, Week 75Nausea and Vomiting, Week 84Nausea and Vomiting, Week 93Nausea and Vomiting, Week 102Nausea and Vomiting, Week 111Nausea and Vomiting, Week 120Nausea and Vomiting, Week 129Nausea and Vomiting, Week 138Nausea and Vomiting, Week 147Nausea and Vomiting, Week 156Nausea and Vomiting, Week 165Nausea and Vomiting, Week 174Nausea and Vomiting, Week 183Nausea and Vomiting, Week 192Nausea and Vomiting, Week 201Nausea and Vomiting, Week 210Nausea and Vomiting, Safety Follow-Up VisitPain, BaselinePain, Week 6Pain, Week 12Pain, Week 18Pain, Week 24Pain, Week 30Pain, Week 36Pain, Week 42Pain, Week 48Pain, Week 57Pain, Week 66Pain, Week 75Pain, Week 84Pain, Week 93Pain, Week 102Pain, Week 111Pain, Week 120Pain, Week 129Pain, Week 138Pain, Week 147Pain, Week 156Pain, Week 165Pain, Week 174Pain, Week 183Pain, Week 192Pain, Week 201Pain, Week 210Pain, Safety Follow-Up VisitDyspnoea, BaselineDyspnoea, Week 6Dyspnoea, Week 12Dyspnoea, Week 18Dyspnoea, Week 24Dyspnoea, Week 30Dyspnoea, Week 36Dyspnoea, Week 42Dyspnoea, Week 48Dyspnoea, Week 57Dyspnoea, Week 66Dyspnoea, Week 75Dyspnoea, Week 84Dyspnoea, Week 93Dyspnoea, Week 102Dyspnoea, Week 111Dyspnoea, Week 120Dyspnoea, Week 129Dyspnoea, Week 138Dyspnoea, Week 147Dyspnoea, Week 156Dyspnoea, Week 165Dyspnoea, Week 174Dyspnoea, Week 183Dyspnoea, Week 192Dyspnoea, Week 201Dyspnoea, Week 210Dyspnoea, Safety Follow-Up VisitInsomnia, BaselineInsomnia, Week 6Insomnia, Week 12Insomnia, Week 18Insomnia, Week 24Insomnia, Week 30Insomnia, Week 36Insomnia, Week 42Insomnia, Week 48Insomnia, Week 57Insomnia, Week 66Insomnia, Week 75Insomnia, Week 84Insomnia, Week 93Insomnia, Week 102Insomnia, Week 111Insomnia, Week 120Insomnia, Week 129Insomnia, Week 138Insomnia, Week 147Insomnia, Week 156Insomnia, Week 165Insomnia, Week 174Insomnia, Week 183Insomnia, Week 192Insomnia, Week 201Insomnia, Week 210Insomnia, Safety Follow-Up VisitAppetite Loss, BaselineAppetite Loss, Week 6Appetite Loss, Week 12Appetite Loss, Week 18Appetite Loss, Week 24Appetite Loss, Week 30Appetite Loss, Week 36Appetite Loss, Week 42Appetite Loss, Week 48Appetite Loss, Week 57Appetite Loss, Week 66Appetite Loss, Week 75Appetite Loss, Week 84Appetite Loss, Week 93Appetite Loss, Week 102Appetite Loss, Week 111Appetite Loss, Week 120Appetite Loss, Week 129Appetite Loss, Week 138Appetite Loss, Week 147Appetite Loss, Week 156Appetite Loss, Week 165Appetite Loss, Week 174Appetite Loss, Week 183Appetite Loss, Week 192Appetite Loss, Week 201Appetite Loss, Week 210Appetite Loss, Safety Follow-Up VisitConstipation, BaselineConstipation, Week 6Constipation, Week 12Constipation, Week 18Constipation, Week 24Constipation, Week 30Constipation, Week 36Constipation, Week 42Constipation, Week 48Constipation, Week 57Constipation, Week 66Constipation, Week 75Constipation, Week 84Constipation, Week 93Constipation, Week 102Constipation, Week 111Constipation, Week 120Constipation, Week 129Constipation, Week 138Constipation, Week 147Constipation, Week 156Constipation, Week 165Constipation, Week 174Constipation, Week 183Constipation, Week 192Constipation, Week 201Constipation, Week 210Constipation, Safety Follow-Up VisitDiarrhoea, BaselineDiarrhoea, Week 6Diarrhoea, Week 12Diarrhoea, Week 18Diarrhoea, Week 24Diarrhoea, Week 30Diarrhoea, Week 36Diarrhoea, Week 42Diarrhoea, Week 48Diarrhoea, Week 57Diarrhoea, Week 66Diarrhoea, Week 75Diarrhoea, Week 84Diarrhoea, Week 93Diarrhoea, Week 102Diarrhoea, Week 111Diarrhoea, Week 120Diarrhoea, Week 129Diarrhoea, Week 138Diarrhoea, Week 147Diarrhoea, Week 156Diarrhoea, Week 165Diarrhoea, Week 174Diarrhoea, Week 183Diarrhoea, Week 192Diarrhoea, Week 201Diarrhoea, Week 210Diarrhoea, Safety Follow-Up VisitFinancial Difficulties, BaselineFinancial Difficulties, Week 6Financial Difficulties, Week 12Financial Difficulties, Week 18Financial Difficulties, Week 24Financial Difficulties, Week 30Financial Difficulties, Week 36Financial Difficulties, Week 42Financial Difficulties, Week 48Financial Difficulties, Week 57Financial Difficulties, Week 66Financial Difficulties, Week 75Financial Difficulties, Week 84Financial Difficulties, Week 93Financial Difficulties, Week 102Financial Difficulties, Week 111Financial Difficulties, Week 120Financial Difficulties, Week 129Financial Difficulties, Week 138Financial Difficulties, Week 147Financial Difficulties, Week 156Financial Difficulties, Week 165Financial Difficulties, Week 174Financial Difficulties, Week 183Financial Difficulties, Week 192Financial Difficulties, Week 201Financial Difficulties, Week 210Financial Difficulties, Safety Follow-Up Visit
Atezolizumab54.702.092.764.204.924.328.206.176.448.566.823.8511.402.084.691.792.38-2.981.194.17-2.38-3.13-2.38-6.67-4.170.00-16.67-9.8561.34-2.930.173.023.494.256.983.587.447.594.654.873.701.672.402.383.33-1.03-0.48-0.48-4.76-3.61-1.902.67-3.33-3.33-20.00-9.7062.53-2.63-1.78-0.961.25-0.202.151.544.923.150.51-0.643.70-1.672.08-3.57-1.19-1.19-2.38-3.57-2.38-10.42-7.14-10.00-16.670.000.00-22.7374.202.121.243.824.133.152.022.015.045.784.290.326.582.924.693.571.792.984.175.362.38-1.042.38-1.67-2.08-4.17-16.676.8281.39-1.67-1.792.620.48-2.01-0.54-4.94-1.89-3.15-4.04-5.13-3.513.334.174.760.000.00-2.381.194.766.250.003.330.000.000.00-16.6771.321.301.585.605.084.823.01-0.311.893.605.565.772.638.339.382.387.14-2.382.387.144.76-6.257.146.67-4.17-25.00-50.001.5241.623.370.53-1.79-3.14-2.88-4.06-2.67-6.72-3.30-2.53-4.70-6.79-5.56-5.56-0.79-2.38-2.78-1.59-3.17-1.591.39-4.764.445.56-5.56-11.110.008.280.901.12-0.41-1.87-2.382.121.54-1.552.25-1.012.560.88-1.67-2.084.76-1.190.00-2.38-2.38-2.38-2.08-2.38-3.330.000.000.0013.6431.52-0.98-3.58-5.51-6.70-5.36-7.41-5.25-9.85-7.21-13.13-5.77-15.79-7.50-17.71-14.29-15.48-10.71-15.48-13.10-14.29-10.42-11.90-13.33-12.50-25.00-16.679.0936.17-1.360.45-1.91-5.03-4.37-6.99-8.64-7.58-9.01-3.03-5.13-9.260.004.17-7.690.002.38-2.38-4.760.00-4.174.766.670.000.000.0024.2430.50-1.95-1.78-4.37-6.23-3.17-3.17-3.09-6.20-9.91-8.08-8.97-7.41-8.33-10.42-9.52-11.90-9.52-16.67-14.29-4.760.00-9.52-13.33-8.33-33.33-33.3312.1231.631.06-4.22-7.38-9.43-12.30-11.11-7.41-10.85-6.31-9.09-10.26-17.54-10.00-10.42-7.14-9.52-7.14-9.52-16.670.000.00-9.52-13.338.3316.670.00-9.0921.20-0.45-2.46-6.01-5.61-6.75-7.94-4.94-10.61-15.32-13.13-5.13-3.51-8.33-10.42-7.14-4.76-7.14-9.52-11.90-14.29-8.33-14.29-13.330.0016.670.003.035.63-0.611.80-0.830.002.010.00-3.09-0.760.00-4.04-5.131.751.670.007.144.762.38-4.76-4.76-4.760.00-9.52-13.330.000.000.006.0622.22-3.20-4.95-4.41-4.76-3.21-2.69-1.85-0.76-4.500.001.283.510.002.082.38-2.38-2.382.38-2.38-9.524.17-9.520.000.0016.670.00-3.03

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Disease Control Rate (DCR)

Phase 2 Secondary Efficacy Outcome. Disease Control Rate is defined as the proportion of participants who had a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as defined by RECIST v1.1. (NCT03214250)
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy with a maximum exposure of 24.2 months.

Interventionpercentage of participants (Number)
Gem/NP/Nivolumab73.5
Gem/NP/APX005M (0.3 mg/kg)77.8
Gem/NP/Nivolumab/APX005M (0.3 mg/kg)68.6

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Phase 1b Primary Safety Outcome

Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) (NCT03214250)
Timeframe: Initiation of study drug (or informed consent for SAEs) through 100 days after the last dose of study drug or initiation of a new systemic anti-cancer therapy with a maximum exposure of 34.3 months.

,,,
InterventionParticipants (Count of Participants)
Adverse Events (AEs)Serious Adverse Events (SAEs)Dose-Limiting Toxicities (DLTs)
Phase 1b: Gem/NP/APX005M (0.1 mg/kg)640
Phase 1b: Gem/NP/APX005M (0.3 mg/kg)641
Phase 1b: Gem/NP/Nivolumab/APX005M (0.1 mg/kg)661
Phase 1b: Gem/NP/Nivolumab/APX005M (0.3 mg/kg)610

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Progression-free Survival (PFS)

PFS is defined as the time from treatment initiation until radiographic disease progression or death (whichever occurred first). PFS and the CIs were estimated using the Kaplan-Meier method. (NCT03214250)
Timeframe: Initiation of study drug through radiographic progression or death with a maximum exposure of 24.2 months.

Interventionmonths (Median)
Gem/NP/Nivolumab6.37
Gem/NP/APX005M (0.3 mg/kg)7.26
Gem/NP/Nivolumab/APX005M (0.3 mg/kg)6.74

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Objective Response Rate (ORR): Efficacy Population

Phase 2 Secondary Efficacy Outcome. Overall Response Rate is defined as the proportion of participants who had a best overall response of Complete Response (CR) or Partial Response (PR) as defined by RECIST v1.1. Overall Response (OR) = CR + PR. (NCT03214250)
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy with a maximum exposure of 24.2 months.

Interventionpercentage of participants (Number)
Gem/NP/Nivolumab50
Gem/NP/APX005M (0.3 mg/kg)33.3
Gem/NP/Nivolumab/APX005M (0.3 mg/kg)31.4

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Objective Response Rate (ORR): DLT-Evaluable Population

Phase 1b DLT-Evaluable Population. Overall Response Rate is defined as the proportion of participants who had a best overall response of Complete Response (CR) or Partial Response (PR) as defined by RECIST v1.1. Overall Response (OR) = CR + PR. (NCT03214250)
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy with a maximum exposure of 34.3 months.

Interventionpercentage of participants (Number)
Gem/NP/APX005M (0.1 mg/kg)66.7
Gem/NP/APX005M (0.3 mg/kg)33.3
Gem/NP/Nivolumab/APX005M (0.1 mg/kg)66.7
Gem/NP/Nivolumab/APX005M (0.3 mg/kg)66.7

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Duration of Response (DOR): Efficacy Population

DOR was the time from the first tumor assessment demonstrating response until the date of radiographic disease progression. DOR and the CIs were estimated using the Kaplan-Meier method. (NCT03214250)
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy with a maximum exposure of 24.2 months.

Interventionmonths (Median)
Gem/NP/Nivolumab7.36
Gem/NP/APX005M (0.3 mg/kg)5.55
Gem/NP/Nivolumab/APX005M (0.3 mg/kg)7.88

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Duration of Response (DOR): DLT-Evaluable Population

DOR was the time from the first tumor assessment demonstrating response until the date of radiographic disease progression. DOR and the CIs were estimated using the Kaplan-Meier method. (NCT03214250)
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy with a maximum exposure of 34.3 months.

Interventionmonths (Median)
Gem/NP/APX005M (0.1 mg/kg)15.51
Gem/NP/APX005M (0.3 mg/kg)7.03
Gem/NP/Nivolumab/APX005M (0.1 mg/kg)9.07
Gem/NP/Nivolumab/APX005M (0.3 mg/kg)10.35

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1-year Overall Survival Rate

The primary endpoint was the 1-year OS rate of each treatment arm, compared to the historical rate of 35% for gemcitabine and nab-Paclitaxel. OS was defined as the time from treatment initiation until death from any cause. Patients who were not reported as having died at the time of analysis were censored at the most recent contact date. OS and the 1-year OS rate were estimated by the Kaplan-Meier method for each treatment arm. The 1-year OS rate and corresponding one-sided, 95% CI were calculated to determine whether the lower bound of the CI excluded the assumed historical value of 35%. P values were calculated using a one-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%. This study was not powered for statistical comparison between arms. (NCT03214250)
Timeframe: 1 year from initiation of study therapy

Interventionprobability (Number)
Gem/NP/Nivolumab0.577
Gem/NP/APX005M (0.3 mg/kg)0.481
Gem/NP/Nivolumab/APX005M (0.3 mg/kg)0.413

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Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)

Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin (NCT03294304)
Timeframe: Treatment day 8 of cycle 4

InterventionParticipants (Count of Participants)
Nivolumab, Cisplatin, & Gemcitabine11

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Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)

Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin (NCT03294304)
Timeframe: Treatment day 1 of cycle 4

InterventionParticipants (Count of Participants)
Nivolumab, Cisplatin, & Gemcitabine8

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Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)

Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin (NCT03294304)
Timeframe: Treatment Day 8 of cycle 1

InterventionParticipants (Count of Participants)
Nivolumab, Cisplatin, & Gemcitabine27

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Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)

Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin (NCT03294304)
Timeframe: Treament day 8 of cycle 2

InterventionParticipants (Count of Participants)
Nivolumab, Cisplatin, & Gemcitabine15

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Safety of Nivolumab With Gemcitabine/Cisplatin

Incidence of Adverse Events (NCT03294304)
Timeframe: 30 Days +/- 7 Days after last chemotherapy

InterventionParticipants (Count of Participants)
Nivolumab, Cisplatin, & Gemcitabine5

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Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)

Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin (NCT03294304)
Timeframe: Treatment Day 1 of cycle 2

InterventionParticipants (Count of Participants)
Nivolumab, Cisplatin, & Gemcitabine18

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Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)

Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin (NCT03294304)
Timeframe: Treatment day 1 of cycle 3

InterventionParticipants (Count of Participants)
Nivolumab, Cisplatin, & Gemcitabine16

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Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)

Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin (NCT03294304)
Timeframe: Treatment Day 1 of cycle 1

InterventionParticipants (Count of Participants)
Nivolumab, Cisplatin, & Gemcitabine7

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Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)

Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin (NCT03294304)
Timeframe: Treatment day 8 of cycle 3

InterventionParticipants (Count of Participants)
Nivolumab, Cisplatin, & Gemcitabine13

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Safety of Nivolumab With Gemcitabine/Cisplatin

Incidence of Adverse Events (NCT03294304)
Timeframe: 4 weeks post radical cystectomy

InterventionParticipants (Count of Participants)
Nivolumab, Cisplatin, & Gemcitabine24

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Pathologic Response Rate (PaR) at Time of Radical Cystectomy. PaR is Defined as Absence of Residual MIBC at Cystectomy in the Surgical Specimen (Pathologic Down-staging to ≤pT1pN0 Which Includes pT0, pT1, pTa and pTis)

"Incidence of Measurable Disease pT in the TNM staging system refers to the size and extend of the primary tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. pTa refers to noninvasive papillary carcinoma. pTis refers to carcinoma in situ (CIS) or a flat tumor stage. pN refers to lymph nodes. N0 mans cancer has not spread to nearby lymph nodes." (NCT03294304)
Timeframe: Surgery Day 1

InterventionParticipants (Count of Participants)
Nivolumab, Cisplatin, & Gemcitabine27

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Count of Participants Experiencing Progression Free Survival (PFS)

Count of participants experiencing Progression Free Survival (PFS) (NCT03294304)
Timeframe: Every 3 Months for 2 Years

InterventionParticipants (Count of Participants)
Nivolumab, Cisplatin, & Gemcitabine36

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Phases 1 and 2: Duration of Response

DOR was defined as the time from initial objective response (CR or PR) (as determined by investigator assessment of radiographic disease assessment per RECIST v1.1) until the earliest date of disease progression or death due to any cause, if it occurred sooner than disease progression. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. (NCT03314935)
Timeframe: up to 368 days

Interventionmonths (Median)
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)5.8

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Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. (NCT03314935)
Timeframe: up to 1385 days

InterventionParticipants (Count of Participants)
Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX68
Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX66
Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX613
Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin7
Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin4
Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin46
Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel7
Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel5
Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel51

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AUC0-t of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration

AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward. (NCT03314935)
Timeframe: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection

,,,,,
Interventionhours x ng/mL (Geometric Mean)
Cycle 1 Day 1Cycle 2 Day 1
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)724010600
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)1060012200
Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)691011000
Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)929014400
Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)468010000
Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)884012800

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Phase 2: Objective Response Rate (ORR)

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Analysis was conducted by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates. (NCT03314935)
Timeframe: up to 1385 days

Interventionpercentage of participants (Number)
Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)0.0
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)24.2
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)22.2
Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)9.1
Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)30.0
Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)16.7

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Cmin of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy on Cycle 2 Day 1 Following Repeated Dose Administration

Cmin was defined as the minimum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward. (NCT03314935)
Timeframe: Day 1 of Cycle 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycle 2: predose; 1 and 4 hours post-dose for sparse sample collection

Interventionnanograms per milliliter (ng/mL) (Geometric Mean)
Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)747
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)407
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)268
Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)542
Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)1020
Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)633

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Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)

A DLT was defined as the occurrence of any protocol-defined toxicity occurring up to and including Day 28, except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. All DLTs were assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria. (NCT03314935)
Timeframe: up to Day 28

InterventionParticipants (Count of Participants)
Phase 1: INCB001158 50 mg + mFOLFOX60
Phase 1: INCB001158 75 mg + mFOLFOX60
Phase 1: INCB001158 100 mg + mFOLFOX60
Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin1
Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin0
Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin0
Phase 1: INCB001158 50 mg + Paclitaxel0
Phase 1: INCB001158 75 mg + Paclitaxel0
Phase 1: INCB001158 100 mg + Paclitaxel0

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Tmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration

tmax was defined as the time to the maximum concentration. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward. (NCT03314935)
Timeframe: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection

,,,,,
Interventionhours (Median)
Cycle 1 Day 1Cycle 2 Day 1
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)4.074.00
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)4.084.06
Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)4.134.00
Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)4.093.85
Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)5.054.13
Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)3.973.95

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Tlast of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration

tlast was defined as the time of the last sample collected from which a concentration was measured. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward. (NCT03314935)
Timeframe: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection

,,,,,
Interventionhours (Median)
Cycle 1 Day 1Cycle 2 Day 1
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)7.737.58
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)7.537.60
Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)7.537.50
Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)7.537.55
Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)7.507.57
Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)7.657.58

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Cmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration

Cmax was defined as the maximum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward. (NCT03314935)
Timeframe: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection

,,,,,
Interventionng/mL (Geometric Mean)
Cycle 1 Day 1Cycle 2 Day 1
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)13501860
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)21602250
Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)12901960
Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)17602390
Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)11001600
Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)16402100

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Phase 1: ORR

ORR was defined as the percentage of participants with a confirmed best overall response of CR or PR, as determined by investigator assessment of radiographic disease as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the Baseline sum diameters, no new lesions, and no progression of non-target lesions. (NCT03314935)
Timeframe: up to 580 days

Interventionpercentage of participants (Number)
Phase 1: INCB001158 50 mg + mFOLFOX612.5
Phase 1: INCB001158 75 mg + mFOLFOX60.0
Phase 1: INCB001158 100 mg + mFOLFOX60.0
Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin0.0
Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin25.0
Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin0.0
Phase 1: INCB001158 50 mg + Paclitaxel14.3
Phase 1: INCB001158 75 mg + Paclitaxel0.0
Phase 1: INCB001158 100 mg + Paclitaxel28.6

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Phases 1 and 2: Progression-free Survival

According to RECIST 1.1, PFS was defined as the length of time from the date of the first dose study of drug until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death due to any cause, if it occurred sooner than progression. (NCT03314935)
Timeframe: up to 1385 days

Interventionmonths (Median)
Phase 1: INCB001158 50 mg + mFOLFOX63.7
Phase 1: INCB001158 75 mg + mFOLFOX66.6
Phase 1: INCB001158 100 mg + mFOLFOX61.7
Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin3.9
Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin5.3
Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin6.4
Phase 1: INCB001158 50 mg + Paclitaxel3.9
Phase 1: INCB001158 75 mg + Paclitaxel3.7
Phase 1: INCB001158 100 mg + Paclitaxel11.8
Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)3.7
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)8.5
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)7.8
Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)3.5
Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)7.1
Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)3.7

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Phases 1 and 2: Disease Control Rate

DCR was defined as the percentage of participants with an overall response of CR, PR, or stable disease (SD), as determined by investigator assessment of radiographic disease as per RECIST v1.1, for at least 8 weeks. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. (NCT03314935)
Timeframe: up to 1385 days

Interventionpercentage of participants (Number)
Phase 1: INCB001158 50 mg + mFOLFOX662.5
Phase 1: INCB001158 75 mg + mFOLFOX683.3
Phase 1: INCB001158 100 mg + mFOLFOX616.7
Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin57.1
Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin75.0
Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin100.0
Phase 1: INCB001158 50 mg + Paclitaxel42.9
Phase 1: INCB001158 75 mg + Paclitaxel60.0
Phase 1: INCB001158 100 mg + Paclitaxel85.7
Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)100.0
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)66.7
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)88.9
Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)54.5
Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)80.0
Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)66.7

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Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment

OR: complete response(CR) or partial response(PR)determined by investigator according to RECIST v1.1 from date of first dose of study treatment until date of first documentation of progressive disease(PD),confirmed by repeat assessments performed no less than 4 weeks after first response. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (<)10 millimeter(mm). PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. (NCT03317496)
Timeframe: From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 3.5 years approximately)

InterventionPercentage of Participants (Number)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin50.0
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin53.8
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin33.3
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin39.0

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Overall Survival (OS)

OS was defined as the time from the first dose of study treatment to the date of death due to any cause. Participants last known to be alive were censored at the date of last contact. The median duration of OS was not derived for less than (<) 10 participants. (NCT03317496)
Timeframe: From first dose of study treatment until death due to any cause (maximum up to 5 years approximately)

InterventionMonths (Median)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/CarboplatinNA
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin18.1
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/CarboplatinNA
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin15.1

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Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v 4.03

AE was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. TEAEs were graded by the investigator using NCI CTCAE v 4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with grade 3 or higher TEAEs were reported. (NCT03317496)
Timeframe: From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5 years approximately)

InterventionParticipants (Count of Participants)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin5
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin12
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin6
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin37

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Serum Concentration of Avelumab

The lower limit of quantification (LLOQ) for avelumab was 0.2 micrograms per milliliter. Pharmacokinetic concentration analysis set was subset of safety analysis set and included participants who had at least one concentration measurement for avelumab or other study drugs which they were assigned to receive. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan. (NCT03317496)
Timeframe: Pre-dose, 1 hour post-dose on Day 1 of Cycle 1, 2, 3, 6, 10, 14; 336 hours post-dose on Day 15 of Cycle 1, 2, 3 (each cycle of 21 days)

,,,
InterventionMicrograms per milliliter (Geometric Mean)
Cycle 1/Day 1- 1 hourCycle 1/Day 15- 336 hoursCycle 2/Day 1- pre-doseCycle 2/Day 1- 1 hourCycle 2/Day 15- 336 hoursCycle 3/Day 1- pre-doseCycle 3/Day 1- 1 hourCycle 3/Day 15- 336 hoursCycle 6/Day 1- pre-doseCycle 6/Day 1- 1 hourCycle 10/Day 1- pre-doseCycle 10/Day 1- 1 hourCycle 14/Day 1- pre-doseCycle 14/Day 1- 1 hour
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin284.116.514.328104.516.824.87893.8126.1710.86245.46.6206.04012.2429.05
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin172.29.5703.754197.013.555.651204.017.159.518208.38.695222.013.37216.6
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin173.312.324.780164.216.878.122147.019.4011.3892.539.523179.014.97215.3
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin300.214.715.013311.918.666.771296.822.5510.39344.018.55242.916.49402.2

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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

Adverse event (AE) was any untoward medical occurrence in a participants who received any study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. (NCT03317496)
Timeframe: From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5 years approximately)

,,,
InterventionParticipants (Count of Participants)
TEAEsSerious TEAEs
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin65
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin139
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin63
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin4020

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Absolute Value of Tumor Mutational Burden (TMB) in Tumor Tissue

Mutational load within tumor tissue was defined as number per megabase of the genome, coding, base substitution, and indel mutations present in the sample. Mutational load was determined in whole blood samples using next generation deoxyribonucleic acid (DNA) sequencing followed by computational analysis. (NCT03317496)
Timeframe: Pre-dose on Day 1 of Cycle 1

InterventionMutations per megabase (Mean)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin4.3
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin2.8
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin4.4
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin2.5

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Duration of Response (DOR) as Per RECIST v 1.1 by Investigator Assessment

DOR was defined as time from first documentation of objective response (confirmed CR or PR) to the date of first PD documentation or death due to any cause, whichever occurs first. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (<)10 millimeter(mm). PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. Median DOR was not derived for < 5 participants. (NCT03317496)
Timeframe: From date of first documented response to date of first documented PD or death due to any cause, whichever occurred first (maximum up to 5 years approximately)

InterventionMonths (Median)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/CarboplatinNA
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin9.6
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/CarboplatinNA
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/CisplatinNA

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Number of Participants With Programmed Death-Ligand 1 (PD-L1) Expression

PD-L1 expression was determined using the Ventana PD-L1 SP263 IHC assay. PD-L1-positive status in UC cohorts was defined using an algorithm that combines assessments of PD-L1 staining on tumor and immune cells scored by pathologists and in NSCLC cohorts was defined as PD-L1 expression on >=1% of tumor cells. PD-L1 expression at baseline and on-treatment were reported in this outcome measure. (NCT03317496)
Timeframe: Baseline and Cycle 2 Day 8 (each cycle of 21 days)

,,,
InterventionParticipants (Count of Participants)
Baseline- Positive PD-L1Baseline- Negative PD-L1Baseline- Unknown PD-L1On-treatment (Cycle 2 Day 8)- Positive PD-L1On-treatment (Cycle 2 Day 8)- Negative PD-L1On-treatment (Cycle 2 Day 8)- Unknown PD-L1
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin141105
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin6702110
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin042024
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin281303632

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Number of Participants With Grade 3 or Higher Laboratory Abnormalities by CTCAE Grade

Participants with laboratory abnormalities of any Grade as per NCI CTCAE toxicity grading v4.03 were summarized:hematology(anemia,hemoglobin increased,lymphocyte count decreased,lymphocyte count increased, neutrophil count decreased,platelet count decreased and white blood cell decreased)and clinical chemistry(alanine aminotransferase increased,alkaline phosphatase,increased,aspartate,aminotransferase increased,blood bilirubin increased,cholesterol high,creatinine phosphokinase[cpk] increased,creatinine increased,gamma-glutamyl transferase[ggt] increased,hypercalcemia,hyperglycemia,hyperkalemia, hypermagnesemia,hypernatremia,hypertriglyceridemia,hypoalbuminemia,hypocalcemia,hypoglycemia,hypokalemia,hypomagnesemia,hyponatremia, hypophosphatemia,serum amylase increased and lipase increased).As per NCI CTCAE toxicity grading v4.03, Grade1=mild;Grade2=moderate;Grade3=severe;Grade4=life-threatening;Grade 5=death.Parameters with at least 1 participant with abnormal value are reported. (NCT03317496)
Timeframe: From screening up to 90 days after last dose of study drug (maximum up to 5 years approximately)

,,,
InterventionParticipants (Count of Participants)
ALANINE AMINOTRANSFERASE INCREASEDALKALINE PHOSPHATASE INCREASEDASPARTATE AMINOTRANSFERASE INCREASEDBLOOD BILIRUBIN INCREASEDCPK INCREASEDCREATININE INCREASEDGGT INCREASEDHYPERGLYCEMIAHYPERKALEMIAHYPOKALEMIAHYPONATREMIALIPASE INCREASEDSERUM AMYLASE INCREASEDHYPOPHOSPHATEMIAHYPOMAGNESEMIAHYPOCALCEMIAHYPERTRIGLYCERIDEMIAHYPERNATREMIAHYPERMAGNESEMIAHYPERCALCEMIAANEMIALYMPHOCYTE COUNT DECREASEDLYMPHOCYTE COUNT INCREASEDNEUTROPHIL COUNT DECREASEDPLATELET COUNT DECREASEDWHITE BLOOD CELL DECREASED
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin00000010001101000000010303
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin10110122102220003000550827
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin10100102010102020000230332
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin31201044254443212111671211116

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Time-to-Tumor Response (TTR) as Per RECIST v 1.1 by Investigator Assessment

TTR was defined as the time from the date of first dose of study treatment to the first documentation of objective response (CR or PR) as assessed by investigator according to RECIST v 1.1. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (<)10 millimeter(mm). PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. (NCT03317496)
Timeframe: From first dose of study treatment until first documentation of CR or PR (maximum up to 5 years approximately)

InterventionMonths (Median)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin2.8
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin1.4
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin1.3
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin1.5

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Progression Free Survival (PFS) as Per RECIST v 1.1 by Investigator Assessment

PFS was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurred first. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. The median duration of PFS was not derived for less than (<) 10 participants. (NCT03317496)
Timeframe: From start of treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 5 years approximately)

InterventionMonths (Median)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/CarboplatinNA
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin9.8
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/CarboplatinNA
Phase 1b Lead-in+Phase 2:Avelumab 1200mg+Gemcitabine/Cisplatin5.4

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Phase 1b Lead-in: Number of Participants With Dose-Limiting Toxicities (DLT)

DLTs=occurrence of any AEs attributable to study treatment in first 2 treatment cycles:Hematologic: grade(G)4 neutropenia lasting >7days;febrile neutropenia with body temperature >=38 degree Celsius for >1hour; G>=3 neutropenic infection(absolute neutrophil count <1.0*10^9/L),G>=3 thrombocytopenia (platelet count<50.0-25.0*10^9/L)with bleeding;G4 thrombocytopenia(PC<25.0*10^9/L),G4 anemia(life-threatening).Non-hematologic: any G4 toxicities;G3 toxicities persisting for >3days despite medical treatment(nausea,vomiting,diarrhea)except endocrinopathies controlled with hormonal therapy;ALT/AST >3*upper limit of normal(ULN)if normal at baseline or 2*Baseline(>ULN at baseline)with total bilirubin >2*ULN and alkaline phosphatase <2*ULN;G3 QTcF prolongation after correction of any reversible cause(electrolyte abnormalities/hypoxia).Delay of >=3weeks in scheduled administration/failure to deliver 75% of doses due to toxicities attributable to any study treatment. DLT-evaluable analysis set. (NCT03317496)
Timeframe: Day 1 up to Week 6 (first 2 treatment cycles; 1 cycle = 21 days)

InterventionParticipants (Count of Participants)
Phase 1b Lead-in: Avelumab 800 mg + Pemetrexed/Carboplatin0
Phase 1b Lead-in: Avelumab 800 mg + Gemcitabine/Cisplatin1
Phase 1b Lead-in: Avelumab 1200 mg + Pemetrexed/Carboplatin0
Phase 1b Lead-in: Avelumab 1200mg+Gemcitabine/Cisplatin1

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Change in CA19-9 Levels

Levels of CA19-9 (tumor marker) in preoperative and postoperative tissues will be determined. Higher levels of CA19-9 are associated with progressive disease. (NCT03344172)
Timeframe: Up to 3 years

Interventionunits per milliliter (U/mL) (Mean)
PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab-0.37
PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine-0.88

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Proportion of Grade IIb or Higher Histolopathologic Responses

Number of grade IIb+lll+lllm+IV+lVm responses / total number of all grade histolopathologic responses. Histoligic appearance will be assess per the Grading System for Pathological Response: Grade I - Characteristic cytologic changes of malignancy present, but little (< 10%) or no tumor cell destruction is evident; Grade II - Characteristic cytologic changes of malignancy; 10% to 90% of tumor cells are destroyed; Grade IIa - Destruction of 10% to 50% of tumor cells; Grade IIb - Destruction of 51% to 90% of tumor cells; Grade III - Few (< 10%) viable-appearing tumor cells are present; Grade IIIm - Sizable pools of mucin present; Grade IV - No viable tumor cells present; Grade IVm - Acellular pools of mucin present. (NCT03344172)
Timeframe: up to 3 years

Interventionpercentage of participants (Number)
PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab33.3
PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine50.0

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Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1

DCR was defined as the percentage of participants with observed tumor response of CR, PR or stable disease (SD) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir). The percentages of participants are rounded off to the nearest single decimal point. (NCT03386721)
Timeframe: Baseline up to disease progression or study treatment discontinuation (up to 38 months)

Interventionpercentage of participants (Number)
NSCLC: Part I Cohort A (QW/Q2W)53.8
NSCLC: Part I Cohort B (QW/Q2W)62.5
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)0
NSCLC: Part I Cohort D, Arm 2 (Q3W)20.0
NSCLC: Part I Cohort F (Q3W)57.1
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)66.7
NSCLC: Part II Cohort E, Arm 2 (Q3W)50.0
SCCHN: Part III Cohort G (Q3W)50.0
SCCHN: Part III Cohort H (Q3W)14.3
ESCC: Part III Cohort I (Q3W)43.8
CSCC: Part III Cohort J (Q3W)68.2
SCCHN: Part III Cohort K (QW/Q2W)36.0
ESCC: Part III Cohort M (QW/Q2W)50.0
CSCC: Part III Cohort N (QW/Q2W)0

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Progression-Free Survival (PFS) According to RECIST Version 1.1

PFS was defined as the time from study treatment initiation (Cycle 1 Day 1 [1 cycle=14 days for QW/Q2W cohorts; 1 cycle=21 days for Q3W cohorts]) to the first occurrence of documented disease progression (based on Investigator's assessment) or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment. (NCT03386721)
Timeframe: Study treatment initiation up to disease progression or study treatment discontinuation (up to 38 months)

Interventionmonths (Median)
NSCLC: Part I Cohort A (QW/Q2W)3.5
NSCLC: Part I Cohort B (QW/Q2W)3.7
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)2.0
NSCLC: Part I Cohort D, Arm 2 (Q3W)2.0
NSCLC: Part I Cohort F (Q3W)3.5
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)NA
NSCLC: Part II Cohort E, Arm 2 (Q3W)10.5
SCCHN: Part III Cohort G (Q3W)2.5
SCCHN: Part III Cohort H (Q3W)1.9
ESCC: Part III Cohort I (Q3W)1.9
CSCC: Part III Cohort J (Q3W)3.7
SCCHN: Part III Cohort K (QW/Q2W)1.9
ESCC: Part III Cohort M (QW/Q2W)2.6
CSCC: Part III Cohort N (QW/Q2W)1.9

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Overall Survival (OS)

OS was defined as the time from the first dose of study treatment to the time of death from any cause on study. Participants who were still alive at the time of analysis were censored at the last date known alive. (NCT03386721)
Timeframe: From first dose of study treatment up to death due to any cause (up to approximately 47 months)

Interventionmonths (Median)
NSCLC: Part I Cohort A (QW/Q2W)NA
NSCLC: Part I Cohort B (QW/Q2W)NA
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)NA
NSCLC: Part I Cohort D, Arm 2 (Q3W)NA
NSCLC: Part I Cohort F (Q3W)NA
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)NA
NSCLC: Part II Cohort E, Arm 2 (Q3W)NA
SCCHN: Part III Cohort G (Q3W)NA
SCCHN: Part III Cohort H (Q3W)NA
ESCC: Part III Cohort I (Q3W)NA
CSCC: Part III Cohort J (Q3W)NA
SCCHN: Part III Cohort K (QW/Q2W)NA
ESCC: Part III Cohort M (QW/Q2W)NA
CSCC: Part III Cohort N (QW/Q2W)NA

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Percentage of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT03386721)
Timeframe: Baseline up to end of the study (up to approximately 47 months)

Interventionpercentage of participants (Number)
NSCLC: Part I Cohort A (QW/Q2W)100
NSCLC: Part I Cohort B (QW/Q2W)100
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)100
NSCLC: Part I Cohort D, Arm 2 (Q3W)100
NSCLC: Part I Cohort D, Arm 3 (Q3W)100
NSCLC: Part I Cohort F (Q3W)100
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)100
NSCLC: Part II Cohort E, Arm 2 (Q3W)100
SCCHN: Part III Cohort G (Q3W)100
SCCHN: Part III Cohort H (Q3W)100
ESCC: Part III Cohort I (Q3W)100
CSCC: Part III Cohort J (Q3W)100
SCCHN: Part III Cohort K (QW/Q2W)100
ESCC: Part III Cohort M (QW/Q2W)100
CSCC: Part III Cohort N (QW/Q2W)100

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Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point. (NCT03386721)
Timeframe: Baseline up to disease progression or study treatment discontinuation (up to 38 months)

Interventionpercentage of participants (Number)
NSCLC: Part I Cohort A (QW/Q2W)19.2
NSCLC: Part I Cohort B (QW/Q2W)6.3
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)0
NSCLC: Part I Cohort D, Arm 2 (Q3W)0
NSCLC: Part I Cohort F (Q3W)4.8
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)66.7
NSCLC: Part II Cohort E, Arm 2 (Q3W)50.0
SCCHN: Part III Cohort G (Q3W)18.2
SCCHN: Part III Cohort H (Q3W)3.6
ESCC: Part III Cohort I (Q3W)21.9
CSCC: Part III Cohort J (Q3W)27.3
SCCHN: Part III Cohort K (QW/Q2W)4.0
ESCC: Part III Cohort M (QW/Q2W)0
CSCC: Part III Cohort N (QW/Q2W)0

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Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting. (NCT03449901)
Timeframe: From start of treatment through 30 days after completion of treatment (median treatment of 9 months + 1 month follow-up)

,,,
InterventionParticipants (Count of Participants)
Grade 1-2 anemiaGrade 3-5 anemiaGrade 3-5 febrile neutropeniaGrade 1-2 eosiniphiliaGrade 3-5 mitral valve diseaseGrade 1-2 atrial fibrillationGrade 3-5 atrial fibrillationGrade 1-2 palpitationsGrade 3-5 pericardial effusionGrade 1-2 sinus bradycardiaGrade 1-2 sinus tachycardiaGrade 3-5 sinus tachycardiaGrade 1-2 chest pain - cardiacGrade 1-2 ear painGrade 1-2 vertigoGrade 3-5 tinnitusGrade 1-2 hyperthyroidismGrade 1-2 cataractGrade 1-2 blurred visionGrade 1-2 watering eyesGrade 1-2 retinal tearGrade 1-2 dry eyeGrade 1-2 abdominal distensionGrade 1-2 abdominal painGrade 3-5 abdominal painGrade 1-2 anal hemorrhageGrade 1-2 anal mucositisGrade 1-2 ascitesGrade 3-5 ascitesGrade 1-2 bloatingGrade 1-2 colitisGrade 1-2 colonic hemorrhageGrade 3-5 colonic perforationGrade 1-2 constipationGrade 1-2 dental cariesGrade 3-5 dental cariesGrade 1-2 diarrheaGrade 3-5 diarrheaGrade 1-2 dry mouthGrade 1-2 dyspepsiaGrade 1-2 dysphagiaGrade 1-2 fecal incontinenceGrade 1-2 flatulenceGrade 1-2 gastroesophageal reflux diseaseGrade 1-2 hematocheziaGrade 3-5 generalized GI bleedGrade 1-2 tooth extractionGrade 1-2 hemorrhoidsGrade 3-5 lower gastrointestinal hemorrhageGrade 1-2 lip painGrade 1-2 mucositis oralGrade 1-2 nauseaGrade 1-2 oral painGrade 1-2 rectal hemorrhageGrade 3-5 small intestinal obstructionGrade 3-5 typhlitisGrade 3-5 upper gastrointestinal hemorrhageGrade 1-2 vomitingGrade 3-5 vomitingGrade 1-2 chillsGrade 5 death NOSGrade 1-2 edema faceGrade 1-2 edema limbsGrade 3-5 edema limbsGrade 1-2 edema trunkGrade 3-5 edema trunkGrade 1-2 facial painGrade 1-2 fatigueGrade 3-5 fatigueGrade 1-2 feverGrade 1-2 flu-like symptomsGrade 1-2 generalized edemaGrade 1-2 infusion related reactionGrade 1-2 injection site reactionGrade 1-2 localized edemaGrade 1-2 malaiseGrade 1-2 non-cardiac chest painGrade 3-5 non-cardiac chest painGrade 1-2 pain at injection siteGrade 1-2 painGrade 3-5 hepatic hemorrhageGrade 1-2 allergic reactionGrade 3-5 allergic reactionGrade 3-5 Celiac diseaseGrade 1-2 bladder infectionGrade 1-2 bronchial infectionGrade 1-2 enterocolitis infectiousGrade 3-5 enterocolitis infectiousGrade 1-2 eye infectionGrade 1-2 folliculitisGrade 1-2 gum infectionGrade 3-5 influenza A infectionGrade 1-2 lung infectionGrade 3-5 lung infectionGrade 1-2 papulopustular rashGrade 1-2 paronychiaGrade 3-5 pleural infectionGrade 3-5 sepsisGrade 1-2 sinusitisGrade 1-2 skin infectionGrade 3-5 skin infectionGrade 1-2 thrushGrade 1-2 tooth infectionGrade 1-2 upper respiratory infectionGrade 3-5 upper respiratory infectionGrade 1-2 urinary tract infectionGrade 3-5 urinary tract infectionGrade 3-5 wound infectionGrade 1-2 ankle fractureGrade 1-2 bruisingGrade 1-2 fallGrade 3-5 fallGrade 1-2 fractureGrade 1-2 twisted kneeGrade 3-5 ileal bleed due to tumor invasionGrade 3-5 postoperative hemorrhageGrade 1-2 spinal fractureGrade 3-5 wound complicationGrade 1-2 activated partial thromboplastin time prolongedGrade 3-5 activated partial thromboplastin time prolongedGrade 1-2 alanine aminotransferase increasedGrade 3-5 alanine aminotransferase increasedGrade 1-2 alkaline phosphatase increasedGrade 3-5 alkaline phosphatase increasedGrade 1-2 aspartate aminotransferase increasedGrade 3-5 aspartate aminotransferase increasedGrade 1-2 blood bilirubin increasedGrade 3-5 blood bilirubin increasedGrade 1-2 lactate dehydrogenase increasedGrade 1-2 cardiac troponin I increasedGrade 3-5 cardiac troponin I increasedGrade 1-2 cardiac troponin T increasedGrade 1-2 creatinine increasedGrade 3-5 creatinine increasedGrade 1-2 electrocardiogram QT corrected interval prolongedGrade 3-5 electrocardiogram QT corrected interval prolongedGrade 1-2 INR increasedGrade 3-5 GGT increasedGrade 3-5 INR increasedGrade 3-5 ammonia increasedGrade 1-2 lipase increasedGrade 3-5 lipase increasedGrade 1-2 lymphocyte count decreasedGrade 3-5 lymphocyte count decreasedGrade 1-2 neutrophil count decreasedGrade 3-5 neutrophil count decreasedGrade 1-2 platelet count decreasedGrade 3-5 platelet count decreasedGrade 1-2 weight lossGrade 1-2 white blood cell count decreasedGrade 3-5 white blood cell count decreasedGrade 3-5 acidosisGrade 1-2 anorexiaGrade 3-5 anorexiaGrade 1-2 dehydrationGrade 3-5 dehydrationGrade 1-2 hypercalcemiaGrade 1-2 hyperglycemiaGrade 3-5 hyperglycemiaGrade 1-2 hyperkalemiaGrade 3-5 hyperkalemiaGrade 1-2 hyperlipidemiaGrade 1-2 hypermagnesemiaGrade 3-5 hypermagnesemiaGrade 1-2 hypernatremiaGrade 1-2 hyperuricemiaGrade 3-5 hyperuricemiaGrade 1-2 hypoalbuminemiaGrade 3-5 hypoalbuminemiaGrade 1-2 hypocalcemiaGrade 3-5 hypocalcemiaGrade 1-2 hypoglycemiaGrade 3-5 hypoglycemiaGrade 1-2 hypokalemiaGrade 3-5 hypokalemiaGrade 1-2 hyponatremiaGrade 3-5 hyponatremiaGrade 1-2 hypophosphatemiaGrade 3-5 hypophosphatemiaGrade 1-2 arthralgiaGrade 1-2 back painGrade 3-5 back painGrade 1-2 bone painGrade 1-2 flank painGrade 1-2 generalized muscle weaknessGrade 1-2 joint effusionGrade 1-2 muscle crampGrade 1-2 muscle weakness lower limbGrade 1-2 myalgiaGrade 1-2 neck painGrade 1-2 pain in extremityGrade 1-2 palpable lump RUEGrade 1-2 skin pailloma, R halluxGrade 3-5 disease progressionGrade 1-2 tumor painGrade 3-5 tumor painGrade 1-2 concentration impairmentGrade 1-2 dizzinessGrade 1-2 dysgeusiaGrade 1-2 extrapyramidal disorderGrade 1-2 headacheGrade 1-2 plantar sensitivityGrade 3-5 cerebral hemorrhageGrade 1-2 neuralgiaGrade 1-2 paresthesiaGrade 1-2 paresthesia (face)Grade 1-2 peripheral sensory neuropathyGrade 1-2 phantom painGrade 1-2 presyncopeGrade 3-5 spinal cord compressionGrade 3-5 syncopeGrade 1-2 tremorGrade 3-5 agitationGrade 1-2 anxietyGrade 1-2 confusionGrade 3-5 confusionGrade 1-2 depressionGrade 3-5 depressionGrade 1-2 insomniaGrade 1-2 irritabilityGrade 1-2 acute kidney injuryGrade 3-5 acute kidney injuryGrade 1-2 dysuriaGrade 1-2 hematuriaGrade 1-2 proteinuriaGrade 1-2 renal calculiGrade 1-2 urinary frequencyGrade 1-2 urinary incontinenceGrade 1-2 urinary retentionGrade 3-5 urinary tract obstructionGrade 1-2 genital edemaGrade 1-2 pelvic painGrade 1-2 groin painGrade 1-2 vaginal hemorrhageGrade 1-2 allergic rhinitisGrade 3-5 bronchial obstructionGrade 1-2 coughGrade 1-2 dyspneaGrade 3-5 dyspneaGrade 1-2 epistaxisGrade 1-2 hoarsenessGrade 1-2 hypoxiaGrade 3-5 hypoxiaGrade 1-2 laryngeal hemorrhageGrade 1-2 laryngeal inflammationGrade 1-2 nasal congestionGrade 1-2 pleural effusionGrade 3-5 pleural effusionGrade 3-5 pneumonitisGrade 1-2 pneumothoraxGrade 3-5 pneumothoraxGrade 1-2 postnasal dripGrade 1-2 productive coughGrade 3-5 pulmonary edemaGrade 3-5 respiratory failureGrade 1-2 chest pressure with exertionGrade 1-2 rhinorrheaGrade 1-2 sore throatGrade 1-2 wheezingGrade 1-2 alopeciaGrade 1-2 bullous dermatitisGrade 1-2 dry skinGrade 1-2 hyperhidrosisGrade 1-2 nail changesGrade 1-2 nail discolorationGrade 1-2 nail lossGrade 1-2 palmar-plantar erythrodysesthesia syndromeGrade 1-2 pruritusGrade 3-5 pruritusGrade 1-2 rash acneiformGrade 1-2 rash maculo-papularGrade 3-5 rash maculo-papularGrade 1-2 skin atrophyGrade 1-2 rash NOSGrade 3-5 petechial rashGrade 1-2 skin ulcerationGrade 1-2 urticariaGrade 1-2 minor gum transplantGrade 1-2 hot flashesGrade 1-2 hypertensionGrade 3-5 hypertensionGrade 1-2 hypotensionGrade 3-5 hypotensionGrade 1-2 lymphedemaGrade 1-2 thromboembolic eventGrade 3-5 thromboembolic eventGrade 1-2 peripheral edema"Grade 1-2 muscle tightness"Grade 1-2 left hand painGrade 1-2 right axillary painGrade 1-2 right neck stiffness"Grade 1-2 frozen thumb"Grade 1-2 hip painGrade 1-2 ankle sprainGrade 1-2 port site bleedGrade 1-2 vaginal cystGrade 1-2 rash NOS on neckGrade 1-2 rash NOS on bilateral UEGrade 1-2 nail bed painGrade 1-2 feet peelingGrade 3-5 leukemia secondary to oncology chemotherapy
Cohort 1, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel1119201002101101100101000300000000083110014100110100161300200610009100116751513000100031001111111211001301312110001202111001112212110202100611040000061861962306190501016010000162141123105214060340314060503112901181500120902020132141200219700011001010512361101113210002101211210001101012011011213110101011000010000100
Cohort 1, 750 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel911300110012000011112101100000110050071121000100210581120140101511001579100300102000010001000011000321010500301011000000201311117160011050013010007111185183517051412411000015062611061701333121302171200030155051112050011002201030102371111000012164161011101000002110231201110011101100000002131021100111001111011
Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel121210001000001020000201021111101118007203001001010031400010300001010101085100111110010001110000002010401210404110110000011328313082611011900090301142061191205151511115201111164132111227311142241304100201002000280300200101200100000020010870000111000056131010002100211000011110140111021000000000230011000000100000000
Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel9411000000100000000000010000000002001102110100000022000004001020000501001100100100000001000001001100100000000000000000004051201100000100010100283747229020001202000112012220021513000020100010100011000110000100000000101011000000000000000023030000002101000000010100000000004000110000000000000000100000000

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Progression-free Survival (PFS) (Cohort 1 Only)

"PFS: defined as time on study to time patients progressed on the drug combination or death or latest follow-up if progression/death is not observed yet~Progressive disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions)." (NCT03449901)
Timeframe: Through completion of follow-up (median follow-up 494 days, full range of 5-1500 days).

Interventionmonths (Median)
Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel5.0597

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Clinical Benefit Rate (CBR) (Cohort 1 Only)

"CBR = proportion of patients who have experienced complete response (CR)+ partial response (PR) + stable disease (SD) lasting 24 weeks or longer~CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).~PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study." (NCT03449901)
Timeframe: Through completion of treatment (median treatment of 9 months)

InterventionParticipants (Count of Participants)
Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel27

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Overall Survival (OS) (Cohort 1 Only)

-OS: defined as time on study to time of death due to any reasons or latest follow-up (whichever is earlier) (NCT03449901)
Timeframe: Through completion of follow-up (median follow-up 494 days, full range of 5-1500 days).

Interventionmonths (Median)
Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel18.1359

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Overall Progression Free Survival

PFS is the median amount of time subject survives without disease progression after treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of new lesions. (NCT03451773)
Timeframe: up to 6 months

InterventionMonths (Median)
All Participants1.4

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Percentage of Participants Who Have Not Progressed at 3 Months

Percentage of participants who have not progressed at 3 months. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of new lesions. (NCT03451773)
Timeframe: 3 months

Interventionpercentage of participants (Number)
Dose Level -1: Gemcitabine + De-escalating Dose of M7824 (MSB0011359C)NA
Dose Level 0: Gemcitabine + Recommended Phase 2 Dose (RP2D) of M7824 (MSB0011359C)16.7

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Percentage of Evaluable Participants Alive at 6 Months and 9 Months

Participants who are alive at 6 months and 9 months after therapy. (NCT03451773)
Timeframe: At 6 and 9 months

,
Interventionpercentage of participants (Number)
6 Months9 Months
Dose Level -1: Gemcitabine + De-escalating Dose of M7824 (MSB0011359C)NANA
Dose Level 0: Gemcitabine + Recommended Phase 2 Dose (RP2D) of M7824 (MSB0011359C)33.316.7

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Phase II: Number of Participants With a Best Overall Response (BOR)

Changes in tumor size and occurrence of metastases was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 to determine the best overall response: Complete Response (CR), Partial Response (PR), and Stable Disease (SD), whichever is recorded first. Complete Response is disappearance of all lesions, Partial Response is at least a 30% decrease in the sum of diameters of target lesions, and Stable Disease is when the sum of all target lesions does not qualify for CR, PR, or Progressive Disease (PD), defined as the appearance of new lesions. (NCT03451773)
Timeframe: Every 8 weeks, up to 2 years

,
InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable DiseaseProgressive Disease
Dose Level -1: Gemcitabine + De-escalating Dose of M7824 (MSB0011359C)0010
Dose Level 0: Gemcitabine + Recommended Phase 2 Dose (RP2D) of M7824 (MSB0011359C)0030

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Overall Median Survival

OS is the median amount of time subject survives after therapy. (NCT03451773)
Timeframe: up to 1 year

InterventionMonths (Median)
All Participants3.5

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Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT03451773)
Timeframe: Date treatment consent signed to date off study, approximately 7 months and 20 days for Dose Level -1, and 15 months and 20 days for Dose Level 0.

InterventionParticipants (Count of Participants)
Dose Level -1: Gemcitabine + De-escalating Dose of M7824 (MSB0011359C)1
Dose Level 0: Gemcitabine + Recommended Phase 2 Dose (RP2D) of M7824 (MSB0011359C)6

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Overall Survival

Time from start of therapy (day 1, cycle 1) to death. (NCT03468075)
Timeframe: Every 2 months for first 6 months, then every 3 months up to 2 years post treatment

InterventionParticipants (Count of Participants)
AliveDead
Gemcitabine + High-Dose Ascorbate55

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Progression Free Survival

Time from start of therapy (day 1, cycle 1) to documented disease progression or death due to any cause. Progression will be defined using the RECIST 1.1 guidelines. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST. (NCT03468075)
Timeframe: Every 2 months for first 6 months, then every 3 months up to 2 years post treatment

InterventionParticipants (Count of Participants)
2 months3 months6 months9 months
Gemcitabine + High-Dose Ascorbate7111

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Tumor Response

From first day of treatment to documented disease progression as described by RECIST 1.1 criteria. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST. (NCT03468075)
Timeframe: Every 2 months for first 6 months, then every 3 months up to 2 years post treatment

InterventionParticipants (Count of Participants)
PDSDPR
Gemcitabine + High-Dose Ascorbate811

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Incidence of Adverse Events (AE) Per CTCAE 4.03

Categorize and quantify adverse events from start of therapy (day 1, cycle 1) to end of study per (CTCAE) version 4.03. (NCT03468075)
Timeframe: Up to 30 days after completion of study treatment

Interventionadverse events (Number)
Blood and lymphatic system disordersGastrointestinal disordersInfections and infestationsInvestigationsMetabolism and nutrition disordersMusculoskeletal and connective tissue disordersPsychiatric disordersRenal and urinary disordersRespiratory, thoracic and mediastinal disordersSkin and subcutaneous tissue disordersVascular disordersGeneral disorders and administration site conditions
Gemcitabine + High-Dose Ascorbate47143211111327

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Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An AE is as any untoward medical occurrence in a participant or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental intervention(s). A SAE is any AE that is fatal or life-threatening, permanently disabling (incapacitating or interfering with the ability to resume usual life patterns), results in unplanned in-subject hospitalization or prolongation of an existing hospitalization, results in a congenital abnormality or birth defect, or any other situation that require medical or scientific judgement. Number of participants with common >=0 percent (%) TEAEs and SAEs are presented. (NCT03488251)
Timeframe: Up to 168 Days

InterventionParticipants (Count of Participants)
TEAEsSAEs
Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX84

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Part 1 and 2: Number of Participants With Anti-drug Antibody Titer

Blood samples were planned to be collected at indicated time points for analysis of anti-drug antibody titer. (NCT03488251)
Timeframe: Up to 168 Days

InterventionParticipants (Count of Participants)
Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OXNA

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Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)

A DLT is any treatment-emergent adverse event (TEAE) that occurred after the start of infusion in cycle 1 of Part 1 and the TEAE is at least possibly related to the study drug, as determined by the sponsor after consultation with the investigator(s). (NCT03488251)
Timeframe: Up to 168 Days

InterventionParticipants (Count of Participants)
Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX2

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Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range

Blood samples were planned to be collected at indicated time points for analysis of immunophenotyping parameters which included cluster of differentiation (CD)3 (Percentage [%] and absolute), CD4 (% and absolute), CD8 (% and absolute), CD4:CD8 ratio, CD19 (% and absolute), Natural Killer (NK) cells (% and absolute), naïve B cells (% and absolute), non-switched memory B cells (% and absolute), class-switched memory B cells, Immunoglobulin (Ig)M only memory B cells (% and absolute), and total memory B cells (% and absolute). (NCT03488251)
Timeframe: Up to 168 Days

InterventionParticipants (Count of Participants)
Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OXNA

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Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724

Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724. (NCT03488251)
Timeframe: Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)

InterventionHours*micrograms per milliliter (Geometric Mean)
Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OXNA

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Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724

Blood samples were planned to be collected at indicated time points for pharmacokinetic (PK) analysis of MT-3724. PK Population consisted of all participants who received at least one dose of MT-3724 and have at least one post-Baseline PK value. (NCT03488251)
Timeframe: Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)

InterventionMicrograms per milliliter (Geometric Mean)
Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OXNA

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Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies

Blood samples were planned to be collected at indicated time points for analysis of positive neutralizing antibodies. (NCT03488251)
Timeframe: Up to 168 Days

InterventionParticipants (Count of Participants)
Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OXNA

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Part 1 and 2: Objective Response Rate

Objective response rate is defined as the participants with a reduction in tumor size (Partial Response [PR] or Complete Response [CR]) using the Lugano Classification for Lymphoma, adjusted according to Lymphoma response to immunomodulatory therapy criteria (LYRIC). (NCT03488251)
Timeframe: Up to 168 Days

InterventionParticipants (Count of Participants)
Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX3

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Part 1 and 2: Disease Control Rate

Disease Control rate is defined as participants with objective response of CR, PR or stable disease (SD) defined as SD for 3 months or longer from the Baseline scan. (NCT03488251)
Timeframe: Up to 168 Days

InterventionParticipants (Count of Participants)
Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OXNA

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Part 1 and 2: Duration of Response

Duration of Response is defined as the time from first documented stable disease to the actual date of disease progression or death, for participants who met the criteria of having stable disease for at least 3 months from Baseline. Data was not collected due to early termination of the trial. (NCT03488251)
Timeframe: Up to 168 Days

InterventionMonths (Median)
Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OXNA

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Part 1 and 2: Progression-free Survival

Progression-Free Survival is defined as the time from the start of treatment with MT-3724 on Cycle 1 Day 1 to the date of disease progression or death from any cause. Data was not collected due to early termination of the trial. (NCT03488251)
Timeframe: Up to 168 Days

InterventionMonths (Median)
Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OXNA

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Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724

Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724. (NCT03488251)
Timeframe: Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)

InterventionHours (Median)
Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OXNA

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(Part B and Part A Experimental Dose Level 0 Only): Objective Response Rate

"Objective response rate (ORR) is defined as number of participants with complete response or partial response.~Complete Response (CR): Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Normalization of tumor marker level.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters." (NCT03496662)
Timeframe: Through completion of treatment (approximately 4 months)

InterventionParticipants (Count of Participants)
Part A - Experimental Dose Level 01
Part B - Dose Expansion6

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(Part B and Part A Experimental Dose Level 0 Only): Percentage of Patients Whose Disease Becomes Resectable After Treatment

(NCT03496662)
Timeframe: Completion of treatment (approximately 4 months)

InterventionParticipants (Count of Participants)
Part A - Experimental Dose Level 01
Part B - Dose Expansion8

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(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting. (NCT03496662)
Timeframe: Through 100 days after completion of treatment (approximately 7.5 months)

InterventionParticipants (Count of Participants)
Grade 1-2 anemiaGrade 3 anemiaGrade 1-2 leukocytosisGrade 1-2 abdominal painGrade 1-2 constipationGrade 1-2 diarrheaGrade 3 diarrheaGrade 1-2 hemorrhoidsGrade 1-2 mucositis oralGrade 1-2 nauseaGrade 4 upper gastrointestinal hemorrhageGrade 1-2 vomitingGrade 1-2 chillsGrade 1-2 edema limbsGrade 1-2 fatigueGrade 3 fatigueGrade 1-2 feverGrade 1-2 foot painGrade 1-2 sweatingGrade 1-2 activated partial thromboplastin time prolongedGrade 1-2 alanine aminotransferase increasedGrade 3 alanine aminotransferase increasedGrade 1-2 alkaline phosphatase increasedGrade 3 alkaline phosphatase increasedGrade 1-2 aspartate aminotransferase increasedGrade 3 aspartate aminotransferase increasedGrade 1-2 creatinine increasedGrade 1-2 lymphocyte count decreasedGrade 3 lymphocyte count decreasedGrade 1-2 neutrophil count decreasedGrade 3 neutrophil count decreasedGrade 4 neutrophil count decreasedGrade 1-2 platelet count decreasedGrade 1-2 white blood cell decreasedGrade 3 white blood cell decreasedGrade 1-2 anorexiaGrade 1-2 dehydrationGrade 1-2 hyperglycemiaGrade 3 hyperglycemiaGrade 1-2 hypoalbuminemiaGrade 1-2 hypocalcemiaGrade 1-2 hypoglycemiaGrade 1-2 hypokalemiaGrade 3 hypokalemiaGrade 1-2 hyponatremiaGrade 3 hyponatremiaGrade 1-2 arthralgiaGrade 1-2 back painGrade 1-2 myalgiaGrade 1-2 pain in extremityGrade 1-2 vertigoGrade 1-2 dizzinessGrade 1-2 dysgeusiaGrade 1-2 headacheGrade 1-2 paresthesiaGrade 1-2 peripheral sensory neuropathyGrade 1-2 tremorGrade 1-2 depressionGrade 1-2 insomniaGrade 1-2 coughGrade 1-2 dyspneaGrade 3 dyspneaGrade 1-2 epistaxisGrade 1-2 hoarsenessGrade 1-2 nasal congestionGrade 1-2 pneumonitisGrade 1-2 alopeciaGrade 1-2 dermatitisGrade 1-2 discolorationGrade 1-2 nail ridgingGrade 1-2 pruritisGrade 1-2 rash maculopapularGrade 1-2 skin hyperpigmentationGrade 1-2 acute kidney injuryGrade 1-2 dysuriaGrade 1-2 hematuriaGrade 1-2 proteinuriaGrade 3 cholangitisGrade 1-2 cholecystitisGrade 3 gallbladder obstructionGrade 1-2 hypertensionGrade 3 hypertensionGrade 1-2 hypotensionGrade 1-2 thromboembolic eventGrade 1-2 chest swellingGrade 1-2 sinus bradycardiaGrade 1-2 vaginal bleedingGrade 1-2 bruisingGrade 1-2 infusion related reactionGrade 1-2 wound dehiscenceGrade 3 sepsisGrade 1-2 gallbladder infectionGrade 1-2 upper respiratory infection
Part A - Experimental Dose Level 0611232112613353341214241422331317335131521311121321412152115114111712113111111111221121111121

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Surgically Resectable

Patients able to proceed to surgery after administering necitumumab in the neoadjuvant setting with gemcitabine and cisplatin in surgically resectable patients with stage IB with tumor size >4cm, II and potentially resectable IIIA squamous cell lung cancer. (NCT03574818)
Timeframe: up to 63 days

InterventionParticipants (Count of Participants)
Arm 11

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Serum Concentrations of Durvalumab

Serum concentrations of durvalumab are reported. (NCT03611556)
Timeframe: Ten mins (± 5 mins) post EOI, approximately 1 hour (+ 15 mins) after start of infusion on C1D1 and C5D1; and pre-dose on C2D1 and C5D1

,,,
Interventionμg/mL (Geometric Mean)
C1D1 (EOI)C2D1 (pre-dose)C5D1 (pre-dose)C5D1 (EOI)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel292.535.97NANA
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel374.514.3974.52522.1
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX380.759.97175.9664.5
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel345.886.20137.9597.9

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Serum Concentrations of Durvalumab

Serum concentrations of durvalumab are reported. (NCT03611556)
Timeframe: Ten mins (± 5 mins) post EOI, approximately 1 hour (+ 15 mins) after start of infusion on C1D1 and C5D1; and pre-dose on C2D1 and C5D1

Interventionμg/mL (Geometric Mean)
C1D1 (EOI)C2D1 (pre-dose)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX309.050.52

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Plasma Concentrations of Nab-paclitaxel

Plasma concentrations of nab-paclitaxel are reported. (NCT03611556)
Timeframe: Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1

,,,,
Interventionng/mL (Geometric Mean)
C1D1 (EOI)C4D1 (pre-dose)C4D1 (EOI)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel1711NANA
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel2685NA1474
Dose-expansion, Gemcitabine + Nab-paclitaxel2381NA1825
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel2611NA1747
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel2711NA1445

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Plasma Concentrations of Gemcitabine and Metabolite 2',2'-Difluorodeoxyuridine (dFdU)

Plasma concentrations of gemcitabine and metabolite dFdU are reported. (NCT03611556)
Timeframe: Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1

,,,,
Interventionng/mL (Geometric Mean)
Gemcitabine C1D1 (EOI)Gemcitabine C4D1 (pre-dose)Gemcitabine C4D1 (EOI)dFdU C1D1 (EOI)dFdU C4D1 (pre-dose)dFdU C4D1 (EOI)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel3194NANA33700NANA
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel4659NA353032160434.634550
Dose-expansion, Gemcitabine + Nab-paclitaxel3301NA174829510245.123900
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel4086NA299826300177.527260
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel3315NA143132350149.921970

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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. (NCT03611556)
Timeframe: Day 1 through 65.7 weeks (maximum observed duration)

,,,
InterventionParticipants (Count of Participants)
Any TEAEsAny TESAEs
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel74
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX30
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel76
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX84

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Number of Participants With Positive ADA to Durvalumab

Number of participants with positive ADA to durvalumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with <16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration. (NCT03611556)
Timeframe: Day 1 through 128 weeks (Pre-dose on C1D1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of durvalumab)

,,,,
InterventionParticipants (Count of Participants)
ADA positive at baselineADA positive post-baselinePersistent PositiveTransient PositiveTreatment-boosted ADA
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel01100
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX00000
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel00000
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX02200
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel20000

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Number of Participants With TEAEs and TESAEs in Dose Expansion Phase

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. (NCT03611556)
Timeframe: Day 1 through 172.1 weeks (maximum observed duration)

,,
InterventionParticipants (Count of Participants)
Any TEAEsAny TESAEs
Dose-expansion, Gemcitabine + Nab-paclitaxel6234
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel7037
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel3724

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Number of Participants With Positive Anti-drug Antibodies (ADA) to Oleclumab

Number of participants with positive ADA to oleclumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with <16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration. (NCT03611556)
Timeframe: Day 1 through 172.1 weeks (Pre-dose on Cycle [C] 1 Day [D] 1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of oleclumab)

,,,,,
InterventionParticipants (Count of Participants)
ADA positive at baselineADA positive post-baselinePersistent PositiveTransient PositiveTreatment-boosted ADA
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel01100
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX00000
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel00000
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX01100
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel00000
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel01010

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Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Expansion Phase

Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported. (NCT03611556)
Timeframe: Day 1 through 172.1 weeks (maximum observed duration)

,,
InterventionParticipants (Count of Participants)
HypothermiaPyrexiaDyspnoeaDyspnoea exertionalHypertensionHypotensionOrthostatic hypotension
Dose-expansion, Gemcitabine + Nab-paclitaxel01571231
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel121821140
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel01261340

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Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase

Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported. (NCT03611556)
Timeframe: Day 1 through 65.7 weeks (maximum observed duration)

,,,
InterventionParticipants (Count of Participants)
PyrexiaDyspnoeaDyspnoea exertionalHypotensionTemperature intoleranceHypertension
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel310200
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX000010
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel301100
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX100101

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Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase

Number of participants with abnormal ECG parameters reported as TEAEs are reported. (NCT03611556)
Timeframe: Day 1 through 65.7 weeks (maximum observed duration)

,,,
InterventionParticipants (Count of Participants)
Atrial fibrillationTachycardiaAtrioventricular block
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel000
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX000
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel110
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX001

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Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase

Number of participants with abnormal ECG parameters reported as TEAEs are reported. (NCT03611556)
Timeframe: Day 1 through 172.1 weeks (maximum observed duration)

,,
InterventionParticipants (Count of Participants)
Supraventricular tachycardiaTachycardia
Dose-expansion, Gemcitabine + Nab-paclitaxel02
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel03
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel13

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Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase

Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. (NCT03611556)
Timeframe: Day 1 through 172.1 weeks (maximum observed duration)

,,
InterventionParticipants (Count of Participants)
AnaemiaFebrile neutropeniaLeukocytosisLeukopeniaLymphopeniaNeutropeniaThrombocytopeniaThrombocytosisHyperthyroidismHypothyroidismHypertransaminasaemiaAlanine aminotransferase decreasedAlanine aminotransferase increasedAmylase increasedAspartate aminotransferase increasedBlood albumin decreasedBlood alkaline phosphatase increasedBlood bilirubin increasedBlood creatinine increasedBlood glucose increasedBlood lactate dehydrogenase increasedBlood magnesium decreasedBlood oestrogen decreasedGamma-glutamyltransferase increasedHaemoglobin decreasedInternational normalised ratio increasedLipase increasedLiver function test increasedLymphocyte count decreasedNeutrophil countNeutrophil count decreasedPlatelet count decreasedTroponin I increasedWhite blood cell count decreasedWhite blood cell count increasedHyperglycaemiaHyperkalaemiaHypoalbuminaemiaHypocalcaemiaHypoglycaemiaHypokalaemiaHypomagnesaemiaHyponatraemiaHypophosphataemiaHypovolaemiaIron deficiencyType 2 diabetes mellitusProteinuria
Dose-expansion, Gemcitabine + Nab-paclitaxel17011222620001811113320100600014019131604132044811000
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel28313216131370016115082803008112061242001006163286300101
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel14102015700010908023020111001020890612122023000011

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Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase

Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. (NCT03611556)
Timeframe: Day 1 through 65.7 weeks (maximum observed duration)

,,,
InterventionParticipants (Count of Participants)
AnaemiaNeutropeniaThrombocytopeniaHypothyroidismAlanine aminotransferase increasedAspartate aminotransferase increasedBlood alkaline phosphatase increasedBlood bilirubin increasedBlood creatinine increasedBlood glucose decreasedInternational normalised ratio increasedLymphocyte count decreasedNeutrophil count decreasedPlatelet count decreasedWhite blood cell count decreasedHypoalbuminaemiaHypocalcaemiaHypokalaemiaHypomagnesaemiaHyponatraemiaHypophosphataemiaProteinuriaHyperthyroidismAmylase increasedGamma-glutamyltransferase increasedLipase increased
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel32203321011001000010010000
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX12200000000011000000000100
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel32214310300123221322100000
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX01112311000232211212001111

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Progression-free Survival According to RECIST v1.1 in Dose Expansion Phase

The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionMonths (Median)
Dose-expansion, Gemcitabine + Nab-paclitaxel6.7
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel5.6
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel7.5

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Progression-free Survival According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase

The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant receives subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in >=50% of tumor cells. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionMonths (Median)
Gemcitabine + Nab-paclitaxel: CD73 Level = High5.6
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High5.2
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High5.5
Gemcitabine + Nab-paclitaxel: CD73 Level = Low10.5
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low7.6
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low10.9

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Percentage of Participants With OR According to RECIST v1.1 in Dose Escalation Phase

The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)

InterventionPercentage of Participants (Number)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel0
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel14.3
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX0
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX12.5

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Percentage of Participants With OR According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase

The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The OR is assessed by cluster of differentiation 73 (CD73) expression level either low or high at baseline. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionPercentage of Participants (Number)
Gemcitabine + Nab-paclitaxel: CD73 Level = High23.9
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High22.2
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High31.4
Gemcitabine + Nab-paclitaxel: CD73 Level = Low43.8
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low18.2
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low36.8

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Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose Expansion Phase

The OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions (TLs) and non-target lesions (NTLs), any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionPercentage of Participants (Number)
Dose-expansion, Gemcitabine + Nab-paclitaxel29.0
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel21.1
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel32.9

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Percentage of Participants With Disease Control (DC) According to RECIST v1.1 in Dose Escalation Phase

The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for >=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for progressive disease (PD), taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)

InterventionPercentage of Participants (Number)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel42.9
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel71.4
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX66.7
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX62.5

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Percentage of Participants With DC According to RECIST v1.1 in Dose Expansion Phase

The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for >=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for PD, taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionPercentage of Participants (Number)
Dose-expansion, Gemcitabine + Nab-paclitaxel66.1
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel73.7
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel75.7

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Overall Survival in Dose Expansion Phase

The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)

InterventionMonths (Median)
Dose-expansion, Gemcitabine + Nab-paclitaxel10.8
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel8.9
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel12.9

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Overall Survival by CD73 Expression at Baseline in Dose Expansion Phase

The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)

InterventionMonths (Median)
Gemcitabine + Nab-paclitaxel: CD73 Level = High9.9
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High7.9
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High12.1
Gemcitabine + Nab-paclitaxel: CD73 Level = Low22.2
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low16.0
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low16.1

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Number of Participants With Progression-free Survival Events According to RECIST v1.1 in Dose Expansion Phase

Progression-free survival (PFS) is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method. The number of participants with PFS events is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionParticipants with event (Number)
Dose-expansion, Gemcitabine + Nab-paclitaxel43
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel32
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel51

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Number of Participants With Progression-free Survival Events According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase

PFS: Time from randomization until first documentation of PD/death due to any cause, whichever occurred first, regardless of whether participant received subsequent anticancer treatment prior to progression. PD:>=20% increase in SoD of TLs and an absolute increase of >= 5 mm of SoD/unequivocal progression of existing NTLs/appearance of new lesion. Participants who had no documented progression and were still alive at the time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in >=50% of tumor cells. Number of participants with PFS events is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionParticipants with event (Number)
Gemcitabine + Nab-paclitaxel: CD73 Level = High35
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High23
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High39
Gemcitabine + Nab-paclitaxel: CD73 Level = Low8
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low9
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low12

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Number of Participants With Overall Survival Events in Dose Expansion Phase

The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method. The number of participants with overall survival events (deaths) is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)

InterventionParticipants with event (Number)
Dose-expansion, Gemcitabine + Nab-paclitaxel47
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel32
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel53

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Serum Concentrations of Oleclumab

Serum concentrations of oleclumab are reported. (NCT03611556)
Timeframe: Ten minutes (mins) (± 5 mins) post end of infusion (EOI), approximately 1 hour (+ 15 mins) after start of infusion on C1D1, C3D1, and C5D1; and pre-dose on C3D1 and C5D1

,,,,
Interventionμg/mL (Geometric Mean)
C1D1 (EOI)C3D1 (pre-dose)C3D1 (EOI)C5D1 (pre-dose)C5D1 (EOI)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel297.6128.6NANANA
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel710.2211.5870.373.19948.3
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX734.6368.91181235.71057
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel725.9226.8894.4116.4753.2
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel704.4164.8893.085.99852.8

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Serum Concentrations of Oleclumab

Serum concentrations of oleclumab are reported. (NCT03611556)
Timeframe: Ten minutes (mins) (± 5 mins) post end of infusion (EOI), approximately 1 hour (+ 15 mins) after start of infusion on C1D1, C3D1, and C5D1; and pre-dose on C3D1 and C5D1

Interventionμg/mL (Geometric Mean)
C1D1 (EOI)C3D1 (pre-dose)C3D1 (EOI)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX412.7134.3571.1

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Number of Participants With Overall Survival Events by CD73 Expression at Baseline in Dose Expansion Phase

The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells. The number of participants with overall survival events (deaths) is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)

InterventionParticipants with event (Number)
Gemcitabine + Nab-paclitaxel: CD73 Level = High37
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High22
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High39
Gemcitabine + Nab-paclitaxel: CD73 Level = Low10
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low10
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low14

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Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase

DLT: Any study drug related Grade (G)3 or higher toxicity including: any G4 immune-mediated AEs, >=G3 colitis/pneumonitis/interstitial lung disease (ILD), >=G3 nausea/vomiting/diarrhea that does not resolve to G2 or less within 3 days of maximal supportive care (MSC), G2 pneumonitis/ILD that does not resolve within 7 days of initiation of MSC, G4 anemia, G3 anemia with clinical sequelae/requires >2 units of red blood cells transfusion, G4 thrombocytopenia/neutropenia >=7 days, G3/4 thrombocytopenia with >=G3 hemorrhage, G4 febrile neutropenia (FN), G3 FN lasting >=5 days while receiving MSC, isolated G3 liver transaminase elevation (LTE)/ isolated G3 total bilirubin (TBL) that does not downgrade to G1 or less within 14 days of onset, isolated G4 LTE or TBL, elevated aspartate aminotransferase/alanine aminotransferase >3×upper limit of normal (ULN) and concurrent TBL >2×ULN without cholestasis or alternative explanations, any other toxicity judged as a DLT by Dose Escalation Committee. (NCT03611556)
Timeframe: From Day 1 to 28 days after the first dose of study drugs

InterventionParticipants (Count of Participants)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel0
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel0
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX0
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX1

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Duration of Response (DoR) According to RECIST v1.1 in Dose Expansion Phase

The DoR is defined as the time from the first documentation of an OR until the first documentation of a PD or death due to any cause, whichever occurs first. The OR is defined as best overall response of confirmed CR or PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. The DoR is assessed using the Kaplan-Meier method. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionMonths (Median)
Dose-expansion, Gemcitabine + Nab-paclitaxel7.2
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel12.9
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel9.5

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DOR (Duration of Response)

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BIRRC assessment. The DOR according to RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported for each arm. (NCT03629925)
Timeframe: Through Database Cutoff Date of 25 March 2020 (up to approximately 18 months)

InterventionMonths (Median)
Sintilimab+ Gemcitabine Plus Platinum6.05
Placebo+Gemcitabine Plus Platinum5.06

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DCR (Disease Control Rate)

DCR was defined as the percentage of participants who had a CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD]). The percentage of participants who experienced a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by BIRRC was reported as the DCR for each arm. (NCT03629925)
Timeframe: Through Database Cutoff Date of 25 March 2020 (up to approximately 18 months)

InterventionPercentage of Participants (Number)
Sintilimab+ Gemcitabine Plus Platinum86.0
Placebo+Gemcitabine Plus Platinum80.3

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PFS(Progression Free Survival)

PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS according to RECIST 1.1 as assessed by BIRRC was reported for each arm. (NCT03629925)
Timeframe: Through Database Cutoff Date of 25 March 2020 (up to approximately 18 months)

Interventionmonths (Median)
Sintilimab+ Gemcitabine Plus Platinum5.5
Placebo+Gemcitabine Plus Platinum4.9

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TTR (Time to Response)

TTR was defined as the time of participants from the first treatment administration to the first incidence of a confirmed CR (disappearance of all lesions) or PR (at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1. The time from first treatment administration to the first incidence of treatment response was reported as the TTR for each arm. (NCT03629925)
Timeframe: Through Database Cutoff Date of 25 March 2020 (up to approximately 18 months)

InterventionMonths (Median)
Sintilimab+ Gemcitabine Plus Platinum1.41
Placebo+Gemcitabine Plus Platinum1.41

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OS (Overall Survival)

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. OS was reported for each arm. (NCT03629925)
Timeframe: Through Database Cutoff Date of 15 October 2019 (up to approximately 13 months)

InterventionMonths (Median)
Sintilimab+ Gemcitabine Plus PlatinumNA
Placebo+Gemcitabine Plus PlatinumNA

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ORR(Objective Response Rate)

ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1. The percentage of participants who experienced a confirmed CR or PR according to RECIST 1.1 as assessed by BIRRC was reported as the ORR for each arm. (NCT03629925)
Timeframe: Through Database Cutoff Date of 25 March 2020 (up to approximately 18 months)

InterventionPercentage of Participants (Number)
Sintilimab+ Gemcitabine Plus Platinum44.7
Placebo+Gemcitabine Plus Platinum35.4

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Number of Participants With an Adverse Event of Grade 3 or Higher

Assess safety and tolerability of bemcentinib plus chemotherapy in patients with metastatic pancreatic adenocarcinoma and will be graded according to the NCI CTCAE, Version 5 (NCT03649321)
Timeframe: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.

InterventionParticipants (Count of Participants)
Phase 1b5
Phase 20

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Overall Response Rate (ORR)

Determine the clinical activity as defined by overall response rate (ORR) of bemcentinib plus chemotherapy (nab-paclitaxel/gemcitabine) in patients with metastatic pancreatic adenocarcinoma. The analyses of ORR was performed on the Response Evaluable Population. ORR is defined as the proportion of patients with CR+partial response as their best clinical response. (NCT03649321)
Timeframe: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.

InterventionParticipants (Count of Participants)
Phase 1b2
Phase 20

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Clinical Benefit Rate

Determine clinical benefit rate as defined by complete response (CR), Partial Response (PR), and Stable Disease (SD) response rates. Clinical benefit response - percent of CR, PR, and SD. (NCT03649321)
Timeframe: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.

InterventionParticipants (Count of Participants)
Phase 1b6
Phase 20

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Complete Response Rate (CR)

Determine clinical activity of bemcentinib plus chemotherapy as defined by complete response rate (CRR), partial response, stable disease, duration of response - overall response/stable disease, median progression free survival (PFS) and overall survival (OS) rate. (NCT03649321)
Timeframe: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.

InterventionParticipants (Count of Participants)
Phase 1b0
Phase 20

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Number of Participants With Positive Responses to Therapy Per Response Evaluation Criteria in Solid Tumors (RECIST)

"Objective RR (complete response [CR] + partial response [PR]) will be compared between this study sample and a historical benchmark value of 10%. For this comparison we will use a one-sample test of proportion.~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): Decrease by ≥ 30% in sum of longest diameter of target lesions.~Stable Disease (SD): Not meeting criteria for CR, PR, or PD.~Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions.~The response in non-target lesions is defined as follows:~Complete Response (CR): Complete disappearance of all non-target lesions.~Stable Disease (SD): Persistence of one or more non-target lesion(s).~Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions." (NCT03662074)
Timeframe: Up to 8 weeks

InterventionParticipants (Count of Participants)
Partial responseProgressive diseaseLost to follow up
Treatment (Gemcitabine, Nivolumab)1112

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Progression-free Survival (PFS) - Months

A median value (months) of progressive-free survival will be estimated using standard Kaplan Meier survival analysis methods. Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions (NCT03662074)
Timeframe: Duration of time from the start of treatment to the time of investigator assessed progression or death, assessed up to 2 years

Interventionmonths (Median)
Treatment (Gemcitabine, Nivolumab)1.8

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Overall Survival (OS) - Months

A median value (months) of overall survival will be estimated using standard Kaplan Meier survival analysis methods. (NCT03662074)
Timeframe: Duration of time from the start of treatment to date of death, assessed up to 2 years

Interventionmonths (Median)
Treatment (Gemcitabine, Nivolumab)3.2

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Number of Adverse Events

Toxicity rates will be estimated by responder status and presented overall and by body site per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (NCT03662074)
Timeframe: Up to 2 years

InterventionNumber of adverse events reported (Number)
Treatment (Gemcitabine, Nivolumab)12

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Progression-free Survival (PFS) - Number of Participants

Progression-free survival will be estimated using standard Kaplan Meier survival analysis methods. Progression-Free Survival (PFS) is defined as the duration of time from the start of treatment to the time of investigator assessed progression or death. Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions (NCT03662074)
Timeframe: Duration of time from the start of treatment to the time of investigator assessed progression or death, assessed up to 2 years

InterventionParticipants (Count of Participants)
Participants that had disease progressionParticipants that did not have disease progression
Treatment (Gemcitabine, Nivolumab)113

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Overall Survival (OS) - Number of Participants

OS will be estimated using standard Kaplan Meier survival analysis methods. (NCT03662074)
Timeframe: Duration of time from the start of treatment to date of death, assessed up to 2 years

InterventionParticipants (Count of Participants)
Deaths - any reasonSurvivors
Treatment (Gemcitabine, Nivolumab)86

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Disease Control Rate (DCR)

To compare the between the 2 treatment arms (NCT03665441)
Timeframe: ~24 weeks

InterventionParticipants (Count of Participants)
Eryaspase Plus Chemotherapy147
Chemotherapy Alone126

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Time to Quality of Life Questionnaire EORTC QLQ-C30 First Worsening in Global Health Status Analysis

The time to first Worsening was defined as the date of randomization to the date of first Worsening occurred in patient score on their global health status. Patients who did not have any worsening were censored at date of last measurement or at baseline if no measurement is available post-baseline. (NCT03665441)
Timeframe: ~1 year

Interventionmonths (Median)
Eryaspase Plus Chemotherapy4.0
Chemotherapy Alone3.6

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Duration of Response (DoR)

To compare the DoR between the 2 treatment arms (NCT03665441)
Timeframe: ~24 weeks

Interventionmonths (Median)
Eryaspase Plus Chemotherapy5.7
Chemotherapy Alone6.8

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Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0

To evaluate the safety and tolerability of eryaspase in combination with chemotherapy versus chemotherapy alone by assessing the number of patients with with treatment emergent adverse events per CTCAE v5.0 (NCT03665441)
Timeframe: ~9 months

,
Interventionparticipants (Number)
Number of patients with treatment emergent adverse events (TEAE)number of patients with TEAE >= Grade 3Number of patients with TE SAENumber of patients with TEAEs leading to study drug discontinuationNumber of patients with TE SAE with outcome of death
Chemotherapy Alone246176105419
Eryaspase Plus Chemotherapy2481951224614

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Objective Response Rate (ORR)

To compare the ORR between the 2 treatment arms. ORR is defined as the proportion of patients who achieve objective tumor response (CR or PR) per modified RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. (NCT03665441)
Timeframe: ~24 weeks

InterventionParticipants (Count of Participants)
Eryaspase Plus Chemotherapy41
Chemotherapy Alone32

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Overall Survival (OS)

To determine whether the addition of eryaspase to chemotherapy improves OS when compared to chemotherapy alone (NCT03665441)
Timeframe: ~12 months

Interventionmonths (Median)
Eryaspase Plus Chemotherapy7.5
Chemotherapy Alone6.7

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Progression Free Survival (PFS)

To compare PFS between the 2 treatment arm. Progression is determined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT03665441)
Timeframe: ~24 weeks

Interventionmonths (Median)
Eryaspase Plus Chemotherapy3.7
Chemotherapy Alone3.4

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Overall Response Rate (ORR)

ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) as per RANO (2010) criteria for patients with high grade glioma (Cohorts 1a and 1b). For patients with low grade glioma, ORR is defined as CR+PR+minor response (MR) as per LGG RANO criteria (2011). For Cohorts 2-5, ORR is defined as CR+PR as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. (NCT03684811)
Timeframe: While on treatment

InterventionParticipants (Count of Participants)
Cohort 1A2
Cohort 1B0
Cohort 2A1
Cohort 3A0
Cohort 4A0
Cohort 5A0

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Overall Survival (OS)

Overall survival (OS), defined as the time in weeks from the first dose to death due to any cause or date last known alive at end of follow-up (NCT03684811)
Timeframe: From date of first dose until the date of death from any cause, assessed up to 101 weeks

Interventionweeks (Median)
Cohort 1A75.00
Cohort 1BNA
Cohort 2ANA
Cohort 3ANA
Cohort 4A36.43
Cohort 5ANA

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Progression-Free Survival (PFS)

Progression-Free Survival from time of entry on study. Progression-free survival (PFS) is defined as the time from the first dose to disease progression as determined by applicable disease criteria or death due to any cause, whichever was sooner. Disease progression as measured by the appropriate response criteria, unless deemed by the Investigator to be receiving clinical benefit (NCT03684811)
Timeframe: From time of entry on study through progression, up to 24 weeks, on average

Interventionweeks (Median)
Cohort 1A8.21
Cohort 1B8.29
Cohort 2ANA
Cohort 3A8.57
Cohort 4A8.29
Cohort 5A8.07

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Rate of Drug Distribution Within the Blood Stream (Vd/F)

Rate of drug distribution within the blood stream (Vd/F) (NCT03684811)
Timeframe: Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).

Interventionunits (Number)
Cohort 1ANA
Cohort 1BNA
Cohort 2ANA
Cohort 3ANA
Cohort 4ANA
Cohort 5ANA

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Time for Half of the Drug to be Absent in Blood Stream Following Dose (T 1/2)

Time for half of the drug to be absent in blood stream following dose (T 1/2) (NCT03684811)
Timeframe: Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).

Interventionng / mL (Mean)
Cohort 1ANA
Cohort 1BNA
Cohort 2ANA
Cohort 3ANA
Cohort 4ANA
Cohort 5ANA

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Time to Progression (TTP)

Time to progression is defined as the time (in weeks) from start of treatment until disease specified progression. (NCT03684811)
Timeframe: From first dose of study drug through time of disease progression

Interventionweeks (Median)
Cohort 1A8.21
Cohort 1B8.29
Cohort 2ANA
Cohort 3A15.00
Cohort 4A13.86
Cohort 5A8.14

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Time to Response (TTR)

Time to response (TTR) in weeks. TTR is defined as the time from first dose to first response. First response is defined as first observation of overall response of CR+PR+MR (glioma) or CR+PR (Cohort 2-5). (NCT03684811)
Timeframe: Response may be observed from time of first dose through time of treatment discontinuation, up to 2 years.

Interventionweeks (Median)
Cohort 1A38.07
Cohort 2A31.43

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Area Under the Plasma Concentration Versus Time Curve (AUC)

Area under the plasma concentration versus time curve (AUC) summarized for Cycle 1 and Cycle 2 (NCT03684811)
Timeframe: Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).

,,,,,
Interventionh*ng/mL (Mean)
Cycle 1Cycle 2
Cohort 1A684020390
Cohort 1B619021210
Cohort 2A1314027580
Cohort 3A1200028170
Cohort 4A1078024400
Cohort 5A1103039540

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Peak Plasma Concentration (Cmax)

Peak Plasma Concentration (Cmax) was summarized for Cycle 1 and Cycle 2. (NCT03684811)
Timeframe: Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).

,,,,,
Interventionng / mL (Mean)
Cycle 1Cycle 2
Cohort 1A388.12965
Cohort 1B369.52870
Cohort 2A879.44045
Cohort 3A863.44104
Cohort 4A744.13650
Cohort 5A815.45663

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Time of Peak Plasma Concentration (Tmax)

Time of peak plasma concentration (Tmax) was summarized for Cycle 1 and Cycle 2. (NCT03684811)
Timeframe: Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).

,,,,,
Interventionhours (Median)
Cycle 1Cycle 2
Cohort 1A4.181.97
Cohort 1B3.954.00
Cohort 2A15.271.05
Cohort 3A16.371.98
Cohort 4A7.501.04
Cohort 5A4.171.52

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Number of Participants With a Dose Limiting Toxicity (DLT)

DLTs are AEs unrelated to the underlying disease and considered related to FT-2102. For non-hematologic AEs: Grade 3 or higher per CTCAE v 4.03 criteria except Grade 3 nausea, vomiting, diarrhea, or rash: lasting <72 hours (with optimal medical management) or clinically relevant Grade 3 or higher non-hematologic laboratory finding. For hematologic AEs: Grade 3 or higher thrombocytopenia or febrile neutropenia or Grade 4 or higher neutropenia lasting for >7 days. (NCT03684811)
Timeframe: Day 1-28

InterventionParticipants (Count of Participants)
Cohort 1A0
Cohort 1B2
Cohort 3A0
Cohort 5A1

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Apparent Clearance (CL/F)

Rate at which drug is removed from the blood stream (CL/F). (NCT03684811)
Timeframe: Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).

Interventionunits (Geometric Mean)
Cohort 1ANA
Cohort 1BNA
Cohort 2ANA
Cohort 3ANA
Cohort 4ANA
Cohort 5ANA

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Duration of Response (DOR)

Duration of response (DOR), defined as the time from the first response to documented disease progression as determined by applicable disease criteria. First response is defined as first observation of overall response of CR+PR+MR (glioma) or CR+PR (Cohort 2-5). Disease progression as measured by the appropriate response criteria, unless deemed by the Investigator to be receiving clinical benefit (NCT03684811)
Timeframe: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 44 weeks

Interventionweeks (Median)
Cohort 1A43.71
Cohort 2ANA

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Olutasidenib Concentration Within Cerebro-spinal Fluid (CSF)

Olutasidenib concentration within CSF (Glioma Cohorts 1-A and 1-B only). Due to sparse data, analysis was not conducted by timepoint. (NCT03684811)
Timeframe: CSF sample for drug concentration was collected at Day 1 of Cycles 1 and 3 (each cycle is 28 days) and through study completion, up to 24 weeks, on average.

Interventionng/mL (Mean)
Cohort 1A27.15

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Number of Participants With Positive Anti-Drug Antibody (ADA) of Cetuximab

The detection of antibodies to cetuximab was performed using a validated immunoassay method with tiered testing of screening, confirmatory and titration. Number of participants with positive anti-drug antibody (ADA) of cetuximab were reported. (NCT03717155)
Timeframe: Pre-dose up to 149 days

InterventionParticipants (Count of Participants)
Avelumab and Cetuximab1

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Progression-Free Survival (PFS) Time Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Progression free survival (PFS) is defined as the time (in months) from first treatment day to the date of the first documentation of objective progression of disease (PD) according to RECIST version 1.1 assessed by Investigator, or death due to any cause, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. (NCT03717155)
Timeframe: Time from the first dose of study drug until occurrence of PD, death due to any cause (assessed up to 737 days)

InterventionMonths (Median)
Avelumab and Cetuximab6.1

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Percentage of Participants With Confirmed Best Objective Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 Assessed by Investigator

Confirmed BOR was defined as the percentage of participants who achieved confirmed complete responses (CR) or partial response (PR), according to RECIST version 1.1 assessed by the Investigator.CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)= Neither sufficient increase to qualify for progression of disease (PD) nor sufficient shrinkage to qualify for PR. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Confirmed CR=as at least two determinations of CR at least 4 weeks apart with no PD. Confirmed PR=as at least 2 determinations of PR or better (PR followed by PR or PR followed by CR), at least 4 weeks apart (not qualifying for a CR) with no PD in between. Percentage of Participants with confirmed BOR were reported. (NCT03717155)
Timeframe: Time from the first dose of study drug until occurrence of PD, death due to any cause (assessed up to 612 days)

Interventionpercentage of participants (Number)
Avelumab and Cetuximab34.9

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Overall Survival (OS)

OS is defined as the time from the first treatment day to the date of death due to any cause. Overall survival was assessed using Kaplan-Meier analysis. (NCT03717155)
Timeframe: Time from the first dose of study drug until occurrence of death due to any cause (assessed up to 941 days)

InterventionMonths (Median)
Avelumab and Cetuximab10.1

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Duration of Response (DOR)

DOR is defined for participants with confirmed complete response (CR) or partial response (PR), as the time from first documentation of confirmed response to the date of first documentation of progression of disease (PD) according to RECIST version 1.1 (assessed by Investigator) or death due to any cause or tumor assessment. Duration of objective response was assessed using Kaplan-Meier analysis. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. (NCT03717155)
Timeframe: Time from the first dose of study drug until occurrence of PD, death due to any cause or last tumor assessment (assessed up to 612 days)

InterventionMonths (Median)
Avelumab and Cetuximab7.1

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Number of Participants With Positive Anti-Drug Antibody (ADA) of Avelumab

The detection of antibodies to avelumab was performed using a validated immunoassay method with tiered testing of screening, confirmatory and titration. Number of participants with positive anti-drug antibody (ADA) of avelumab were reported. (NCT03717155)
Timeframe: Pre-dose up to 149 days

InterventionParticipants (Count of Participants)
Avelumab and Cetuximab7

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Serum Trough Concentration Levels (Ctrough) of Cetuximab

Ctrough is the serum concentration observed immediately before next dosing. (NCT03717155)
Timeframe: Pre-dose: Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 99, Day 113, Day 127, Day 169, Day 253 and Day 337

Interventionmcg/mL (Geometric Mean)
Day 8Day 22Day 29Day 43Day 50Day 64Day 71Day 85Day 99Day 113Day 127Day 169Day 253Day 337
Avelumab and Cetuximab12.112.822.825.623.917.235.426.522.635.038.040.431.928.9

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Serum Trough Concentration Levels (Ctrough) of Avelumab

Ctrough is the serum concentration observed immediately before next dosing. (NCT03717155)
Timeframe: Pre-dose: Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 99, Day 113, Day 127, Day 169, Day 253 and Day 337

Interventionmcg/mL (Geometric Mean)
Day 8Day 22Day 29Day 43Day 50Day 64Day 71Day 85Day 99Day 113Day 127Day 169Day 253Day 337
Avelumab and Cetuximab28.813.642.415.656.419.758.221.521.219.418.119.317.020.8

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Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Cetuximab

Ceoi is the serum concentration observed immediately at the end of infusion. This was taken directly from the observed cetuximab concentration-time data. (NCT03717155)
Timeframe: Pre-dose, 2 hours after end of infusion on Day 1, 8, 22 and 29; Pre-dose, 30 minutes after the end of infusion on Day 43, 50, 64, 71; Pre-dose, 3 hours after end of infusion on Day 85, 99, 113, 127, 169, 253, and 337

Interventionmcg/mL (Geometric Mean)
Day 1Day 8Day 22Day 29Day 43Day 50Day 64Day 71Day 85Day 99Day 113Day 127Day 169Day 253Day 337
Avelumab and Cetuximab109198124260154238159262239252250245297269304

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Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Avelumab

Ceoi is the serum concentration observed immediately at the end of infusion. This was taken directly from the observed Avelumab concentration-time data. (NCT03717155)
Timeframe: Pre-dose, 2 hours after end of infusion on Day 1, 8, 22 and 29; Pre-dose, 30 minutes after the end of infusion on Day 43, 50, 64, 71; Pre-dose, 3 hours after end of infusion on Day 85, 99, 113, 127, 169, 253, and 337

Interventionmicrogram per milliliter (mcg/mL) (Geometric Mean)
Day 1Day 8Day 22Day 29Day 43Day 50Day 64Day 71Day 85Day 99Day 113Day 127Day 169Day 253Day 337
Avelumab and Cetuximab206243234282237259214244223202234222245249246

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Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status

Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. (NCT03734029)
Timeframe: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years

Interventionmonths (Median)
Trastuzumab Deruxtecan (T-DXd)9.9
Physician's Choice5.1

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Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer

Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive. (NCT03734029)
Timeframe: From the date of randomization up to the date of death due to any cause, up to approximately 3 years

Interventionmonths (Median)
Trastuzumab Deruxtecan (T-DXd)23.9
Physician's Choice17.5

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Overall Survival (OS) in All Patients

Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive. (NCT03734029)
Timeframe: From the date of randomization up to the date of death due to any cause, up to approximately 3 years

Interventionmonths (Median)
Trastuzumab Deruxtecan (T-DXd)23.4
Physician's Choice16.8

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Number of Overall Survival Events (Deaths)

(NCT03734029)
Timeframe: From the date of randomization up to the date of death due to any cause, up to approximately 3 years

Interventionevents (deaths) (Number)
Trastuzumab Deruxtecan (T-DXd)149
Physician's Choice90

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Duration of Response in Participants With HER2-low Breast Cancer (All Patients)

Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method. (NCT03734029)
Timeframe: From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years

,
Interventionmonths (Median)
BICR: DoRInvestigator: DoR
Physician's Choice6.85.6
Trastuzumab Deruxtecan (T-DXd)10.78.3

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Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer

Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. (NCT03734029)
Timeframe: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years

Interventionmonths (Median)
Trastuzumab Deruxtecan (T-DXd)9.6
Physician's Choice4.2

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Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients)

Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. (NCT03734029)
Timeframe: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years

Interventionmonths (Median)
Trastuzumab Deruxtecan (T-DXd)8.8
Physician's Choice4.2

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Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer

Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment. (NCT03734029)
Timeframe: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years

,
InterventionParticipants (Count of Participants)
BICR: Complete responseBICR: Partial responseBICR: Stable diseaseBICR: Progressive diseaseBICR: Not evaluableInvestigator: Complete responseInvestigator: Partial responseInvestigator: Stable diseaseInvestigator: Progressive diseaseInvestigator: Not evaluableBICR: Confirmed Objective response rateInvestigator: Confirmed Objective response rate
Physician's Choice1268134210308034192730
Trastuzumab Deruxtecan (T-DXd)12164115261451631242811175168

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Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer

Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method. (NCT03734029)
Timeframe: From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years

,
Interventionmonths (Median)
BICR: DoRInvestigator: DoR
Physician's Choice6.85.6
Trastuzumab Deruxtecan (T-DXd)10.78.3

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All-Cause Mortality

All-cause mortality is defined as all anticipated and unanticipated deaths due to any cause, with the number and frequency of such events by arm or comparison group of the clinical study. (NCT03734029)
Timeframe: From the date of randomization up to the date of death due to any cause, up to approximately 3 years

InterventionParticipants (Count of Participants)
Trastuzumab Deruxtecan (T-DXd)148
Physician's Choice88

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Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer

Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. (NCT03734029)
Timeframe: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years

Interventionmonths (Median)
Trastuzumab Deruxtecan (T-DXd)10.1
Physician's Choice5.4

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Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients)

Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment. (NCT03734029)
Timeframe: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years

,
InterventionParticipants (Count of Participants)
BICR: Complete responseBICR: Partial responseBICR: Stable diseaseBICR: Progressive diseaseBICR: Not evaluableInvestigator: Complete responseInvestigator: Partial responseInvestigator: Stable diseaseInvestigator: Progressive diseaseInvestigator: Not evaluableBICR: Confirmed Objective response rateInvestigator: Confirmed Objective response rate
Physician's Choice2289141220319340203031
Trastuzumab Deruxtecan (T-DXd)13183129311761871353213195193

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Clinical Benefit Rate (CBR) With irRECIST

"Clinical benefit rate (CBR) of treatment (defined by proportion of all subjects with stable disease for at least 3 months, partial response, or complete response) using irRECIST from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment).~Per irRECIST for target lesions: Complete Response (irCR), Disappearance of all target lesions; Partial Response (irPR), >=30% decrease in the sum of the longest diameter of target lesions, neither sufficient shrinkage to qualify for irPR nor sufficient increase to qualify for irPD, taking as reference the smallest sum longest diameter since the treatment started; Clinical Benefit Rate (CBR) = irCR +irPR +irSD (for atleast 3 months)." (NCT03737123)
Timeframe: From C1D1 until death or up to a maximum of 28 months.

Interventionpercentage of participants (Number)
Phase IIA : Atezolizumab + Carboplatin + Gemcitabine100

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Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Carboplatin + Gemcitabine or Docetaxel

Assess the safety and tolerability of the combination of atezolizumab plus chemotherapy (carboplatin + gemcitabine or docetaxel) using CTCAE v4.03. Number of subjects who had any adverse events or events greater than grade 3 were reported in this outcome measure. (NCT03737123)
Timeframe: From C1D1 until death or up to a maximum of 8 months

InterventionParticipants (Count of Participants)
Number of patients had at least one adverse event of any gradeNumber of patients had at least one grade 3 or greater adverse eventNumber of patients had at least one grade 3 or greater treatment related adverse eventNumber of patients having serious adverse event
Phase IIA : Atezolizumab + Carboplatin + Gemcitabine6663

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Clinical Benefit Rate (CBR) With RECIST 1.1

Clinical benefit rate (CBR) of treatment (defined by proportion of all subjects with stable disease for at least 3 months, partial response, or complete response) using RECIST 1.1 from the start of treatment until disease/recurrence(taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started; Clinical Benefit Rate (CBR) = CR +PR +SD (for atleast 3 months). (NCT03737123)
Timeframe: From C1D1 until death or up to a maximum of 28 months.

Interventionpercentage of participants (Number)
Phase IIA : Atezolizumab + Carboplatin + Gemcitabine100

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Progression Free Survival (PFS) for Atezolizumab + Carboplatin and Gemcitabine

Evaluate PFS for atezolizumab + carboplatin and gemcitabine. PFS defined as duration from date of treatment start until progression according to RECIST 1.1 criteria, or death from any cause.Per RECIST 1.1 criteria, Progressive disease can be defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. (NCT03737123)
Timeframe: From C1D1 until death or progression or up to a maximum of 26 months

Interventionmonths (Median)
Phase IIA : Atezolizumab + Carboplatin + Gemcitabine11.3

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Progression Free Survival (PFS) Compared to Historical Controls

"To compare Progression Free Survival(PFS) with the historical control, Null hypothesis - Patients receiving atezolizumab plus chemotherapy (carboplatin +gemcitabine or docetaxel) will have a median PFS of 4 months.~Alternative hypothesis - Patients receiving atezolizumab plus chemotherapy (carboplatin + gemcitabine or docetaxel) will have a median PFS of 7.2 months.~Progression Free Survival defined as duration from date of treatment start until progression according to RECIST 1.1 criteria, or death from any cause.Per RECIST 1.1 criteria, Progressive disease can be defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions." (NCT03737123)
Timeframe: From C1D1 until progression or death or up to a maximum of 26 months

Interventionmonths (Median)
Phase IIA : Atezolizumab + Carboplatin + Gemcitabine11.3

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Overall Survival (OS)

OS defined by the date of treatment start to date of death from any cause. (NCT03737123)
Timeframe: From C1D1 until death or up to a maximum of 28 months

Interventionmonths (Median)
Phase IIA : Atezolizumab + Carboplatin + GemcitabineNA

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PFS by irRECIST

PFS defined as duration from date of treatment start until progression according to irRECIST criteria or death from any cause. Per irRECIST criteria, Progressive disease can be defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. (NCT03737123)
Timeframe: From C1D1 until progression or death or up to a maximum of 26 months

Interventionmonths (Median)
Phase IIA : Atezolizumab + Carboplatin + Gemcitabine11.3

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Progression Free Survival (PFS)

"Evaluate PFS among patients to be treated with atezolizumab in combination with carboplatin + gemcitabine or docetaxel, who have cisplatin-ineligible metastatic urothelial carcinoma and who have progressed on prior PD-1 or PD-L1 inhibitor. PFS defined as duration from date of treatment start until progression according to RECIST 1.1 criteria, or death from any cause.~Per RECIST 1.1 criteria, Progressive disease can be defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions." (NCT03737123)
Timeframe: From C1D1 until progression or death or up to a maximum of 26 months

Interventionmonths (Median)
Phase IIA : Atezolizumab + Carboplatin + Gemcitabine11.3

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Objective Response Rate (ORR) With RECIST 1.1

"Objective response rate (ORR) using RECIST 1.1 defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR" (NCT03737123)
Timeframe: From C1D1 until death or up to a maximum of 28 months.

Interventionpercentage of participants (Number)
Phase IIA : Atezolizumab + Carboplatin + Gemcitabine40

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Objective Response Rate (ORR) With irRECIST

"ORR defined as the proportion of all subjects with confirmed PR or CR using immunerelated response criteria (irRECIST), from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment).~Per irRECIST for target lesions Complete Response (irCR), Disappearance of all target lesions; Partial Response (irPR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = irCR + irPR." (NCT03737123)
Timeframe: From C1D1 until death or up to a maximum of 28 months.

Interventionpercentage of participants (Number)
Phase IIA : Atezolizumab + Carboplatin + Gemcitabine40

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Presence of Anti-drug Antibodies (ADAs) for Durvalumab

Presence of anti-drug antibodies (ADAs) for durvalumab, as assessed at 3, 6, 12, 16 and 20 weeks after start of treatment and every 12 weeks thereafter until 3 and 6 months after last dose of durvalumab (NCT03775486)
Timeframe: Assessed from start of initial therapy up to 2 years.

,
InterventionParticipants (Count of Participants)
ADA prevalence (any ADA positive, baseline or post-baseline)ADA incidence (treatment-induced or treatment-boosted)ADA positive post-baseline and positive at baselineADA positive post-baseline and not detected at baseline (treatment-induced)ADA not detected at post-baseline and positive at baselineTreatment-boosted ADAPersistent positiveTransient positiveNeutralizing anti-drug antibody positive at any visit
Durvalumab/Olaparib Combination Therapy1150560051
Durvalumab/Placebo Therapy941440321

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Progression-free Survival

"Progression-free survival (PFS) based on investigator assessments according to Response Evaluation Criteria in Solid Tumours version 1.1.~PFS is defined as time from date of randomization until the date of objective radiological disease progression using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression)." (NCT03775486)
Timeframe: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

,
InterventionParticipants (Count of Participants)
RECIST progression: Target LesionsRECIST progression: Non Target LesionsRECIST progression: New LesionsDeath in the absence of progressionCensored subjects: Censored RECIST progressionCensored subjects: Censored deathCensored subjects: Progression-free at time of analysisCensored subjects: Progression-free prior to lost to follow-upCensored subjects: Progression-free prior to withdrawal of consentCensored subjects: Progression-free prior to discontinuation due to other reasonCensored subjects: No post-baseline evaluable tumor assessment
Durvalumab/Olaparib Combination Therapy402844801440302
Durvalumab/Placebo Therapy633039900340202

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Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30

"Disease-related symptoms and health-related quality of life (HRQoL) assessed by time to deterioration (for maintenance phase) in EORTC QLQ-C30.~NA is not applicable. The upper confidence limit was not calculable because of an insufficient number of participants with events." (NCT03775486)
Timeframe: From randomization until date of first symptom deterioration that is confirmed, up to 18 months.

,
Interventiontime to deterioration (months) (Median)
EORTC QLQ-C30: FatigueEORTC QLQ-C30: Nausea And VomitingEORTC QLQ-C30: PainEORTC QLQ-C30: DyspnoeaEORTC QLQ-C30: InsomniaEORTC QLQ-C30: Appetite LossEORTC QLQ-C30: ConstipationEORTC QLQ-C30: DiarrhoeaPhysical FunctioningRole FunctioningEmotional FunctioningCognitive FunctioningSocial FunctioningGlobal Health Status/Quality of Life
Durvalumab/Olaparib Combination Therapy8.812.210.212.213.811.712.213.812.010.012.210.29.310.2
Durvalumab/Placebo Therapy1012.69.711.010.611.512.011.512.010.611.010.610.09.7

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Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13

"Disease-related symptoms assessed by time to deterioration (for maintenance phase) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13.~Symptom deterioration is defined as an increase in the score from baseline of less than or equal to 10) that is confirmed at a subsequent assessment, or death (by any cause) in the absence of a clinically meaningful symptom deterioration.~NA is not applicable. The upper confidence limit was not calculable because of an insufficient number of participants with events." (NCT03775486)
Timeframe: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

,
Interventionmonths (Median)
EORTC QLQ-LC13: DyspnoeaEORTC QLQ-LC13: CoughingEORTC QLQ-LC13: HaemoptysisEORTC QLQ-LC13: Pain In ChestEORTC QLQ-LC13: Pain In Arm Or ShoulderEORTC QLQ-LC13: Pain In Other Parts
Durvalumab/Olaparib Combination Therapy10.011.715.013.815.010.3
Durvalumab/Placebo Therapy9.710.612.611.59.710.6

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Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30

"Disease-related symptoms and health-related quality of life (HRQoL) assessed by change from baseline (for maintenance phase) in EORTC QLQ-C30. Average adjusted mean over first 11 cycles is presented.~The EORTC QLQ-C30 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales, each of the function scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and function scales indicate better health status/function.~A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems." (NCT03775486)
Timeframe: Includes all assessments occurring within the first 12 months of randomization or until disease progression, up to 18 months.

,
Interventionchange from baseline score (Mean)
EORTC QLQ-C30: FatigueEORTC QLQ-C30: Appetite loss
Durvalumab/Olaparib Combination Therapy0.15-0.13
Durvalumab/Placebo Therapy-1.49-3.35

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Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13

"Disease-related symptoms assessed by change from baseline (for maintenance phase) in EORTC QLQ-LC13. Average adjusted mean over first 11 cycles is presented.~The EORTC QLQ-LC13 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales in the EORTC QLQ-LC13. Higher scores on symptom scales represent greater symptom severity." (NCT03775486)
Timeframe: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

,
Interventionchange from baseline score (Mean)
EORTC QLQ-LC13: DyspnoeaEORTC QLQ-LC13: CoughingEORTC QLQ-LC13: Pain in chest
Durvalumab/Olaparib Combination Therapy-1.27-2.141.31
Durvalumab/Placebo Therapy-0.76-3.093.57

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Concentration of Durvalumab

Concentration (pharmacokinetics) of durvalumab (NCT03775486)
Timeframe: Assessed from start of initial therapy up to 2 years.

,
Interventionμg/mL (Geometric Mean)
Cycle 01 Day 01 (Initial Therapy Phase) Post doseCycle 02 Day 01 (Initial Therapy Phase) Pre doseCycle 04 Day 01 (Initial Therapy Phase) Pre doseCycle 01 (Maintenance Phase) Post doseCycle 02 (Maintenance Phase) Pre doseCycle 05 (Maintenance Phase) Pre doseCycle 08 (Maintenance Phase) Pre doseCycle 11 (Maintenance Phase) Pre doseCycle 14 (Maintenance Phase) Pre doseCycle 17 (Maintenance Phase) Pre doseCycle 20 (Maintenance Phase) Pre doseMonth 03 (Maintenance Phase) Pre dose
Durvalumab/Olaparib Combination Therapy417.15276.812155.461535.078159.157166.644198.932210.794276.612264.096528.04612.289
Durvalumab/Placebo Therapy453.72476.959154.947524.306160.315147.848154.057186.092182.042217.137112.27612.769

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Overall Survival

"Overall survival (OS) across the maintenance phase.~OS is defined as time from date of randomization until the date of death by any cause" (NCT03775486)
Timeframe: From randomization until the date of death due to any cause, up to 18 months.

,
InterventionParticipants (Count of Participants)
DeathCensored participants (still in survival at follow up or terminated study prior to death)
Durvalumab/Olaparib Combination Therapy4490
Durvalumab/Placebo Therapy4590

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Duration of Response

"Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression.~Percentage of participants remaining in response at 3, 6, 9 and 12 months estimated using the Kaplan-Meier method." (NCT03775486)
Timeframe: From date of first documented response until objective radiological disease progression or death, up to 18 months.

,
Interventionpercent (Number)
Percentage of participants remaining in response at 3 monthsPercentage of participants remaining in response at 6 monthsPercentage of participants remaining in response at 9 monthsPercentage of participants remaining in response at 12 months
Durvalumab/Olaparib Combination Therapy90.579.169.269.2
Durvalumab/Placebo Therapy85.165.765.765.7

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Change From Baseline in Serum Albumin

Mean change from Baseline to Month 12 serum albumin levels (NCT03790111)
Timeframe: Month 12

Interventiong/L (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-2.2

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Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)

Mean change from Baseline to End of Study in plasma 5-hydroxyindoleacetic acid (5-HIAA) (NCT03790111)
Timeframe: End of Study as defined up to 24 months

Interventionmicrograms/Liter (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg4.154

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Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)

Mean change from Baseline to Month 12 in plasma level 5-hydroxyindoleacetic Acid (5-HIAA) (NCT03790111)
Timeframe: Month 12

Interventionmicrograms/Liter (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-5.608

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Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)

Mean change from Baseline to Month 6 plasma level 5-hydroxyindoleacetic acid (5-HIAA) (NCT03790111)
Timeframe: Month 6

Interventionmicrograms/Liter (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-1.735

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Median Progression Free Survival

Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12. (NCT03790111)
Timeframe: Month 12

InterventionMonths (Median)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg6.233

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Weight Change From Baseline

Mean change in weight from baseline to End of Study (NCT03790111)
Timeframe: End of Study as defined up to 24 months

Interventionkg (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-3.28

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Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment

"Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.~(CR) + partial response (PR) at Months 6" (NCT03790111)
Timeframe: Month 6

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg7

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Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment

Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12. (NCT03790111)
Timeframe: Month 12

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg7

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Overall (Objective) Response Rate (ORR), Local Reader's Assessment

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. (NCT03790111)
Timeframe: End of Study as defined up to 24 months

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg8

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Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment

"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate." (NCT03790111)
Timeframe: Month 6

InterventionParticipants (Count of Participants)
Safety Population71994742Per Protocol Population71994742By Treatment Cycle Population71994742
Responders, Central ReviewerNon-Responders, Central Reviewer
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg41
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg12
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg30
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg21

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Overall (Objective) Response Rate, Central Radiologist's Assessment

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. (NCT03790111)
Timeframe: End of Study as defined up to 24 months

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg7

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Weight Change From Baseline

Mean change in weight at Month 6 from baseline measurement (NCT03790111)
Timeframe: Month 6

Interventionkg (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-0.69

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Weight Change From Baseline

Mean change in weight at Month 12 from baseline measurement (NCT03790111)
Timeframe: Month 12

Interventionkg (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg1.69

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Summary of Duration of Progression Free Survival, Local Radiologist's Assessment

Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months. (NCT03790111)
Timeframe: up to 7 months

InterventionMonths (Median)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg7.000

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Project Overall Survival Rate at Month 6

Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6. (NCT03790111)
Timeframe: 6 Months

InterventionProportion of participants (Number)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg0.87

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Overall (Objective) Response Rate, Local Read

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6. (NCT03790111)
Timeframe: 6 Months

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg6

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Project Overall Survival Rate at Month 12

Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12. (NCT03790111)
Timeframe: 12 Months

InterventionProportion of participants (Number)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg0.60

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Progression Free Survival, Local Radiologist's Assessment

Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12. (NCT03790111)
Timeframe: Month 12

InterventionMonths (Median)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg7.467

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Change From Baseline in Serum Albumin

Mean change from Baseline to Month 6 serum albumin levels (NCT03790111)
Timeframe: Month 6

Interventiong/L (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-0.2

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Progression Free Survival, Local Radiologist's Assessment

Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study (NCT03790111)
Timeframe: End of Study as defined up to 24 months

InterventionMonths (Median)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg7.467

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Overall Survival (OS)

Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause. (NCT03790111)
Timeframe: First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months

InterventionMonths (Median)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg17.667

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Overall (Objective) Response Rate, Local Reader's Assessment

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12. (NCT03790111)
Timeframe: 12 Months

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg8

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Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)

Mean change from Baseline to Month 12 in plasma carbohydrate antigen 19-9 (CA 19-9) (NCT03790111)
Timeframe: Month 12

InterventionU/mL (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-18.04

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Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)

Mean change from Baseline to month 6 in plasma carbohydrate antigen 19-9 (CA 19-9) (NCT03790111)
Timeframe: Month 6

InterventionU/mL (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-229.82

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Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)

Mean change from Baseline to End of Study in plasma carbohydrate antigen 19-9 (CA 19-9) (NCT03790111)
Timeframe: End of Study as defined up to 24 months

InterventionUnits per milliliter (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-153.98

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Change From Baseline in Serum Albumin

Mean change from Baseline to End of Study serum albumin levels (NCT03790111)
Timeframe: End of Study as defined up to 24 months

Interventiong/L (Mean)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg-1.2

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Disease Control Rate (DCR), Central Radiologist's Assessment

"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.." (NCT03790111)
Timeframe: Month 6

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg33

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Disease Control Rate (DCR), Central Radiologist's Assessment

Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. (NCT03790111)
Timeframe: End of Study up to 24 months

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg35

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Disease Control Rate (DCR), Central Radiologist's Assessment

Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. (NCT03790111)
Timeframe: Month 12

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg33

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Disease Control Rate (DCR), Local Reviewer

Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. (NCT03790111)
Timeframe: Month 12 as defined by 1 year

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg40

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Disease Control Rate (DCR), Local Reviewer

Disease control rate (DCR), Local Reviewer, 6 Months (NCT03790111)
Timeframe: Month 6

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg40

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Disease Control Rate End of Study, Local Reviewer

Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. (NCT03790111)
Timeframe: End of Study as defined up to 24 months

InterventionParticipants (Count of Participants)
Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg40

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Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator

PFS was defined as the time from first administration of study intervention until date of the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Kaplan-Meier estimates was used to calculate PFS. (NCT03840915)
Timeframe: Time from first administration of study drug until the first documentation of PD or death, assessed up to approximately 26 months

Interventionmonths (Median)
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed5.0
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel4.1
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine5.4
Cohort D: Bintrafusp Alfa + Docetaxel2.6

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Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator (IRC)

Percentage of participants with confirmed objective response that is at least one overall assessment of complete response (CR) or partial response (PR) reported here. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by Investigator. (NCT03840915)
Timeframe: Time from first treatment assessed up to approximately 26 months

InterventionPercentage of Participants (Number)
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed45.0
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel66.7
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine44.4
Cohort D: Bintrafusp Alfa + Docetaxel16.7

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Overall Survival (OS)

OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method. (NCT03840915)
Timeframe: Time from first treatment assessed up to approximately 26 months

Interventionmonths (Median)
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed11.4
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel11.8
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + GemcitabineNA
Cohort D: Bintrafusp Alfa + Docetaxel16.5

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Number of Participants With Positive Antidrug Antibodies (ADA)

Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported. (NCT03840915)
Timeframe: Time from first treatment assessed up to approximately 26 months

InterventionParticipants (Count of Participants)
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed9
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel3
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine2
Cohort D: Bintrafusp Alfa + Docetaxel3

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Number of Participants With Dose-Limiting Toxicities (DLTs)

DLT was defined as Adverse Events(AEs) with any of following toxicities: Grade 4 nonhematologic toxicity or hematologic toxicity lasting more than equal to(>=) 7 days despite medical intervention; Grade 3 nausea, vomiting, and diarrhea lasting >= 3 days despite supportive care; Any Grade 3 or Grade 4 nonhematologic lab value leading to hospitalization or persisting for >= 7 days; Grade 3 or Grade 4: grade 3 is defined as absolute neutrophil count (ANC) less than (<) 1,000/Cubic Millimeter(mm3) with a temperature of > 38.3 degree Celsius (°C); grade 4 is defined as ANC < 1,000/mm3 with a temperature of > 38.3°C, with life-threatening consequences; Thrombocytopenia < 25,000/mm3 associated with bleeding not resulting in hemodynamic instability or a life-threatening bleeding resulting in urgent intervention; Bleeding events >= Grade 3 occurring within 5 days of bintrafusp alfa treatment; Prolonged delay(> 3 weeks) in initiating Cycle 2 due to treatment-related toxicity; Grade 5 toxicity. (NCT03840915)
Timeframe: Day 1 Week 1 up to Week 3

InterventionParticipants (Count of Participants)
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed1
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel1
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine0
Cohort D: Bintrafusp Alfa + Docetaxel3

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Duration of Response (DOR)

DOR was defined for participants with confirmed response, as the time from first documentation of confirmed objective response (Complete Response [CR] or Partial Response [PR]) according to RECIST 1.1 to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Results were calculated based on Kaplan-Meier estimates. (NCT03840915)
Timeframe: Time from first documentation of a confirmed objective response to PD or death due to any cause (assessed up to approximately 26 months)

Interventionmonths (Median)
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed9.6
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxelNA
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine10.5
Cohort D: Bintrafusp Alfa + Docetaxel3.4

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. (NCT03840915)
Timeframe: Time from first treatment assessed up to approximately 26 months

,,,
InterventionParticipants (Count of Participants)
TEAEsSerious TEAEs
Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed4031
Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel95
Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine96
Cohort D: Bintrafusp Alfa + Docetaxel129

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Incidence of Grade 3-5 Adverse Events

Graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The safety and tolerability of durvalumab in combination with chemotherapy in subjects with variant histology bladder cancer who initiate study treatment will be assessed as the number, by treatment cohort, of grade 3, 4, or 5 adverse events, considered probably or definitely related by the investigator. (NCT03912818)
Timeframe: At 120 days

,
Interventionevents (Number)
Grade 3Grade 4Grade 5
Cohort I (Durvalumab, DD MVAC)100
Cohort III (Durvalumab, Carbo-gem)200

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Proportion of Subjects Who Initiate Study Treatment and Achieve Tumor Stage of pT2 N0 M0 or Better (e.g., pT0, pT1 N0) at Cystectomy

"Achievement of tumor staging will be determined by pathologist at cystectomy and reported by treatment cohort. Assessed per National Comprehensive Cancer Network bladder cancer guidelines.~T0 N0 M0 = No evidence of primary tumor~T1 N0 M0 = Tumor staging by pathological assessment detected in lamina propria (T0), with no tumor positive nodes (N0).~T2 N0 M0 = Tumor staging by pathological assessment detected in muscularis propria (pT2), with no tumor positive nodes (N0) or tumor metastases (M0) observed." (NCT03912818)
Timeframe: At 20 weeks

InterventionParticipants (Count of Participants)
Cohort I (Durvalumab, DD MVAC)1
Cohort III (Durvalumab, Carbo-gem)1

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Incidence of SSI Requiring Intervention

Number of participants with SSI requiring reoperation or other procedural intervention at 30 days. (NCT03945357)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Saline Irrigation8
Antibiotic Irrigation8

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Surgical Site Infection

Number of participants with Surgical Site Infections (NCT03945357)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Saline Irrigation11
Antibiotic Irrigation10

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Overall Survival (OS), Subgroup Analysis by Stratification Factors

Number of participants who died due to any cause. Participants last known to be alive are censored at date of last contact. (NCT03971474)
Timeframe: From date of registration to a maximum of 3 years or death

,
InterventionParticipants (Number)
PD-L1: < 1%PD-L1: >= 1%Histology: SquamousHistology: Non-squamous
Ramucirumab + Pembrolizumab21191827
Standard of Care (Inv. Choice)21272427

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Disease Control Rate (DCR)

"Percentage of participants with complete response (CR), partial response (PR), or stable disease as best response.~CR: Complete disappearance of all target and non-target lesions. No new lesions. No disease related symptoms. Any lymph nodes must have reduction in short axis to <1.0cm. All disease must be assessed using the same technique as baseline.~PR: Applies only to participants with at least one measurable lesion. At least 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.~Stable disease: Does not qualify for CR, PR, Progression or Symptomatic Deterioration. All target measurable lesions must be assessed using the same techniques as baseline." (NCT03971474)
Timeframe: From date of registration to a maximum of 3 years or death

InterventionPercentage of participants (Number)
Standard of Care (Inv. Choice)73
Ramucirumab + Pembrolizumab75

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Investigator-Assessed Progression-Free Survival (IA-PFS), Subgroup Analysis by Stratification Factors

"Number of participants with progression assessed by local review or symptomatic deterioration, or death due to any cause. Participants last known to be alive without report of progression are censored at date of last disease assessment. For participants with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan is used as the date of progression.~Symptomatic deterioration: Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Efforts should be made to obtain objective evidence of progression after discontinuation." (NCT03971474)
Timeframe: From date of registration to a maximum of 3 years or death

,
InterventionParticipants (Number)
Histology: Non-squamousHistology: SquamousPD-L1: < 1%PD-L1: >= 1%
Ramucirumab + Pembrolizumab34232724
Standard of Care (Inv. Choice)34282534

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Response Rate (RR)

"Percentage of participants with a complete or partial, confirmed or unconfirmed response.~Complete Response (CR): Complete disappearance of all target and non-target lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to < 1.0 cm. All disease must be assessed using the same technique as baseline.~Partial Response (PR): Applies only to participants with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline." (NCT03971474)
Timeframe: From date of registration to a maximum of 3 years or death

InterventionPercentage of participants (Number)
Standard of Care (Inv. Choice)28
Ramucirumab + Pembrolizumab22

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Investigator Assessed-progression-free Survival (IA-PFS)

"Time from date of registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause. Participants last known to be alive without report of progression are censored at date of last disease assessment. For participants with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan is used as the date of progression.~Symptomatic deterioration: Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Efforts should be made to obtain objective evidence of progression after discontinuation." (NCT03971474)
Timeframe: From date of registration to a maximum of 3 years or death

Interventionmonths (Median)
Standard of Care (Inv. Choice)5.2
Ramucirumab + Pembrolizumab4.5

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Duration of Response (DOR)

Time from date of first documentation of response (complete or partial) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among participants who achieve a response. Participants last known to be alive without report of progression are censored at date of last disease assessment. For participants with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan (as defined by the disease assessment schedule) is used as the date of progression. (NCT03971474)
Timeframe: From date of registration to a maximum of 3 years or death

Interventionmonths (Median)
Standard of Care (Inv. Choice)5.6
Ramucirumab + Pembrolizumab12.9

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Overall Survival (OS)

Time from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact. (NCT03971474)
Timeframe: From date of registration to a maximum of 2 years and 11 months or death

Interventionmonths (Median)
Standard of Care (Inv. Choice)11.6
Ramucirumab + Pembrolizumab14.5

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Number of Participants With the Indicated EQ-5D-5L Dimension Scores

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 [worst overall health] to 100 [best overall health]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health. (NCT04003610)
Timeframe: up to 160 days

InterventionParticipants (Count of Participants)Participants (Count of Participants)
Anxiety/Depression, Baseline72490111Anxiety/Depression, Baseline72490112Anxiety/Depression, Cycle 4 Day 172490112Anxiety/Depression, Cycle 7 Day 172490112Anxiety/Depression, Follow Up72490112Mobility, Baseline72490111Mobility, Baseline72490112Mobility, Cycle 4 Day 172490112Mobility, Cycle 7 Day 172490112Mobility, Follow Up72490112Pain/Discomfort, Baseline72490111Pain/Discomfort, Baseline72490112Pain/Discomfort, Cycle 4 Day 172490112Pain/Discomfort, Cycle 7 Day 172490112Pain/Discomfort, Follow Up72490112Self-care, Baseline72490111Self-care, Baseline72490112Self-care, Cycle 4 Day 172490112Self-care, Cycle 7 Day 172490112Self-care, Follow Up72490112Usual Activities, Baseline72490111Usual Activities, Baseline72490112Usual Activities, Cycle 4 Day 172490112Usual Activities, Cycle 7 Day 172490112Usual Activities, Follow Up72490112
12345
Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg3
Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg1
Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg2
Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg0
Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg1
Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg0

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EORTC QLQ-C30 Score

The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items and measures 5 functional dimensions (i.e., physical, role, emotional, cognitive, and social), 3 symptom items (i.e., fatigue, nausea/vomiting, and pain), 6 single items (i.e., dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and quality of life scale. For each scale and single item, a linear transformation was applied to standardize the scores between 0 (worst) and 100 (best) as described in the EORTC QLQ-C30 Scoring Manual. (NCT04003610)
Timeframe: up to 160 days

Interventionscores on a scale (Mean)
Appetite Loss, BaselineCognitive Functioning, BaselineConstipation, BaselineDiarrhea, BaselineDyspnea, BaselineEmotional Functioning, BaselineFatigue, BaselineFinancial Difficulties, BaselineGlobal Health Status/Quality of Life (QoL), BaselineInsomnia, BaselineNausea and Vomiting, BaselinePain, BaselinePhysical Functioning, BaselineRole Functioning, BaselineSocial Functioning, Baseline
Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg33.366.70.00.00.050.044.433.316.733.30.050.073.366.766.7

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Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 [worst overall health] to 100 [best overall health]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health. (NCT04003610)
Timeframe: Baseline; up to 160 days

Interventionscores on a scale (Mean)
BaselineCycle 4 Day 1Cycle 7 Day 1Follow Up
Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg525530

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Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 [worst overall health] to 100 [best overall health]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health. (NCT04003610)
Timeframe: Baseline; up to 160 days

Interventionscores on a scale (Mean)
Baseline
Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg40

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Change From Baseline in the EORTC QLQ-C30 Score

The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items and measures 5 functional dimensions (i.e., physical, role, emotional, cognitive, and social), 3 symptom items (i.e., fatigue, nausea/vomiting, and pain), 6 single items (i.e., dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and quality of life scale. For each scale and single item, a linear transformation was applied to standardize the scores between 0 (worst) and 100 (best) as described in the EORTC QLQ-C30 Scoring Manual. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT04003610)
Timeframe: Baseline; up to 160 days

Interventionscores on a scale (Mean)
Appetite Loss, Cycle 3 Day 1Appetite Loss, Cycle 6 Day 1Appetite Loss, Follow UpCognitive Functioning, Cycle 3 Day 1Cognitive Functioning, Cycle 6 Day 1Cognitive Functioning, Follow UpConstipation, Cycle 3 Day 1Constipation, Cycle 6 Day 1Constipation, Follow UpDiarrhea, Cycle 3 Day 1Diarrhea, Cycle 6 Day 1Diarrhea, Follow UpDyspnea, Cycle 3 Day 1Dyspnea, Cycle 6 Day 1Dyspnea, Follow UpEmotional Functioning, Cycle 3 Day 1Emotional Functioning, Cycle 6 Day 1Emotional Functioning, Follow UpFatigue, Cycle 3 Day 1Fatigue, Cycle 6 Day 1Fatigue, Follow UpFinancial Difficulties, Cycle 3 Day 1Financial Difficulties, Cycle 6 Day 1Financial Difficulties, Follow UpGlobal Health Status/QoL, Cycle 3 Day 1Global Health Status/QoL, Cycle 6 Day 1Global Health Status/QoL, Follow UpInsomnia, Cycle 3 Day 1Insomnia, Cycle 6 Day 1Insomnia, Follow UpNausea and Vomiting, Cycle 3 Day 1Nausea and Vomiting, Cycle 6 Day 1Nausea and Vomiting, Follow UpPain, Cycle 3 Day 1Pain, Cycle 6 Day 1Pain, Follow UpPhysical Functioning, Cycle 3 Day 1Physical Functioning, Cycle 6 Day 1Physical Functioning, Follow UpRole Functioning, Cycle 3 Day 1Role Functioning, Cycle 6 Day 1Role Functioning, Follow UpSocial Functioning, Cycle 3 Day 1Social Functioning, Cycle 6 Day 1Social Functioning, Follow Up
Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg-16.70.00.033.30.033.3-33.3-33.3-33.3-50.00.0-66.70.033.333.312.50.041.7-11.111.1-44.40.00.0-33.333.316.733.3-16.70.0-33.30.00.00.0-8.30.0-83.3-26.70.0-13.30.00.033.341.733.366.7

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Progression-free Survival (PFS)

PFS was defined as the time from the randomization date until the date of disease progression (as measured by a blinded independent central review [BICR] per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) or death due to any cause, whichever occurred first. (NCT04003610)
Timeframe: up to 130 days

Interventionmonths (Median)
Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg1.81
Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg2.12

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Overall Survival (OS)

OS was defined as the time from the date of randomization until death due to any cause. (NCT04003610)
Timeframe: up to 225 days

Interventionmonths (Median)
Pemigatinib 13.5 mg Plus Pembrolizumab 200 mgNA
Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mgNA

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Objective Response Rate (ORR)

ORR was defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 (as measured by BICR). (NCT04003610)
Timeframe: up to 148 days

Interventionpercentage of participants (Number)
Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg0
Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg0

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Number of Participants With Treatment-emergent Adverse Events

A treatment-emergent adverse event was defined as an adverse event that was either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug. (NCT04003610)
Timeframe: up to 178 days

InterventionParticipants (Count of Participants)
Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg1
Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg6

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EORTC QLQ-C30 Score

The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items and measures 5 functional dimensions (i.e., physical, role, emotional, cognitive, and social), 3 symptom items (i.e., fatigue, nausea/vomiting, and pain), 6 single items (i.e., dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and quality of life scale. For each scale and single item, a linear transformation was applied to standardize the scores between 0 (worst) and 100 (best) as described in the EORTC QLQ-C30 Scoring Manual. (NCT04003610)
Timeframe: up to 160 days

Interventionscores on a scale (Mean)
Appetite Loss, BaselineAppetite Loss, Cycle 3 Day 1Appetite Loss, Cycle 6 Day 1Appetite Loss, Follow UpCognitive Functioning, BaselineCognitive Functioning, Cycle 3 Day 1Cognitive Functioning, Cycle 6 Day 1Cognitive Functioning, Follow UpConstipation, BaselineConstipation, Cycle 3 Day 1Constipation, Cycle 6 Day 1Constipation, Follow UpDiarrhea, BaselineDiarrhea, Cycle 3 Day 1Diarrhea, Cycle 6 Day 1Diarrhea, Follow UpDyspnea, BaselineDyspnea, Cycle 3 Day 1Dyspnea, Cycle 6 Day 1Dyspnea, Follow UpEmotional Functioning, BaselineEmotional Functioning, Cycle 3 Day 1Emotional Functioning, Cycle 6 Day 1Emotional Functioning, Follow UpFatigue, BaselineFatigue, Cycle 3 Day 1Fatigue, Cycle 6 Day 1Fatigue, Follow UpFinancial Difficulties, BaselineFinancial Difficulties, Cycle 3 Day 1Financial Difficulties, Cycle 6 Day 1Financial Difficulties, Follow UpGlobal Health Status/Quality of Life (QoL), BaselineGlobal Health Status/QoL, Cycle 3 Day 1Global Health Status/QoL, Cycle 6 Day 1Global Health Status/QoL, Follow UpInsomnia, BaselineInsomnia, Cycle 3 Day 1Insomnia, Cycle 6 Day 1Insomnia, Follow UpNausea and Vomiting, BaselineNausea and Vomiting, Cycle 3 Day 1Nausea and Vomiting, Cycle 6 Day 1Nausea and Vomiting, Follow UpPain, BaselinePain, Cycle 3 Day 1Pain, Cycle 6 Day 1Pain, Follow UpPhysical Functioning, BaselinePhysical Functioning, Cycle 3 Day 1Physical Functioning, Cycle 6 Day 1Physical Functioning, Follow UpRole Functioning, BaselineRole Functioning, Cycle 3 Day 1Role Functioning, Cycle 6 Day 1Role Functioning, Follow UpSocial Functioning, BaselineSocial Functioning, Cycle 3 Day 1Social Functioning, Cycle 6 Day 1Social Functioning, Follow Up
Gemcitabine 1000 mg/m^2 Plus carboplatinGemcitabine 1000 mg/m^2 Plus Carboplatin26.716.70.066.766.791.766.783.340.016.70.033.320.00.00.033.326.716.733.366.773.387.591.7100.046.750.033.355.620.016.70.00.051.766.766.750.046.733.30.066.76.78.30.016.740.041.70.016.765.333.366.740.056.733.366.733.353.366.766.783.3

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Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)

An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT04003636)
Timeframe: Up to approximately 38 months

InterventionParticipants (Count of Participants)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)138
Arm B (Placebo+Gemcitabine+Cisplatin)122

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Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)

PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR, or death due to any cause, whichever occurred first. (NCT04003636)
Timeframe: Up to approximately 26 months

InterventionMonths (Median)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)6.5
Arm B (Placebo+Gemcitabine+Cisplatin)5.6

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Overall Survival (OS)

Overall survival was defined as the time from randomization to death due to any cause. (NCT04003636)
Timeframe: Up to approximately 38 months

InterventionMonths (Median)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)12.7
Arm B (Placebo+Gemcitabine+Cisplatin)10.9

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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters [SOD] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ. (NCT04003636)
Timeframe: Up to approximately 26 months

InterventionPercentage of Participants (Number)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)28.7
Arm B (Placebo+Gemcitabine+Cisplatin)28.5

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Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

For participants who demonstrate a confirmed CR or PR, DOR was the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. (NCT04003636)
Timeframe: Up to approximately 38 months

InterventionMonths (Median)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)9.7
Arm B (Placebo+Gemcitabine+Cisplatin)6.9

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Number of Participants Who Experience One or More Adverse Events (AE)

An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. (NCT04003636)
Timeframe: Up to approximately 38 months

InterventionParticipants (Count of Participants)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)524
Arm B (Placebo+Gemcitabine+Cisplatin)532

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Number of Participants With Treatment-emergent Adverse Events to Evaluate Tolerability of Oxaliplatin With Gemcitabine

To evaluate the tolerability of administering Oxaliplatin in combination with gemcitabine in patients with recurrent or advanced TCC bladder. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. (NCT04039867)
Timeframe: From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year.

InterventionParticipants (Count of Participants)
Oxaliplatin With Gemcitabine17

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Overall Survival of Patients Who Received Gemcitabine and Oxaliplatin

To evaluate overall survival in patients with advanced TCC bladder treated with this combination of gemcitabine and Oxaliplatin. (NCT04039867)
Timeframe: From date of registration for 5 years or until death from any cause, whichever came first.

Interventiondays (Median)
Oxaliplatin With Gemcitabine314

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Overall Response Rate as Assessed by RECIST Criteria of Patients Who Received Gemcitabine and Oxaliplatin

To assess the overall response rate to the combination of gemcitabine and Oxaliplatin in patients with recurrent or advanced TCC bladder. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI. Complete Response (CR) is defined as disappearance of all target lestions. Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is defined as confirmed complete response (CR) and partial response (PR). ORR = CR + PR (NCT04039867)
Timeframe: From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.

Interventionparticipants (Number)
Oxaliplatin With Gemcitabine5

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Safety Run-in Part: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)

A DLT is a toxicity related to the study intervention that meets the following criteria as evaluated in the open-label, safety run-in: Grade 3 or 4 Immune-related adverse event (irAE) that needs permanent discontinuation of M7824 treatment; a malignant skin lesion induced by M7824 that is local and can be resected with a negative resection margin is not a DLT; Grade 3 or 4 nonhematologic toxicity other than irAE, A life threatening hematological toxicity (unless clearly attributable to chemotherapy alone), which is hardly medically manageable, including a bleeding event resulting in urgent intervention and admission to an intensive care unit and Grade 5 toxicity. (NCT04066491)
Timeframe: Day 1 up to Day 21 of Cycle 1 (each Cycle is of 21 days)

InterventionParticipants (Count of Participants)
Safety Run-In Part: M7824 + Gemcitabine + Cisplatin0

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Safety Run-in Part: Number of Participants With Grade Greater Than or Equal (>=) 3 Laboratory Abnormalities

Laboratory investigation included hematology and biochemistry. The number of participants with Grade >=3 laboratory abnormalities were reported. Severity of grade 3 or higher TEAEs were graded using NCI-CTCAE v5.0 toxicity grades, as follows: Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. (NCT04066491)
Timeframe: Time from first treatment up to data cutoff (assessed up to 609 days)

InterventionParticipants (Count of Participants)
Hemoglobin lowLeukocytes lowNeutrophils lowPlatelets lowAlanine Aminotransferase highBilirubin highCreatinine highLipase highPotassium lowLymphocytes lowCorrected Calcium high
Safety Run-In Part: M7824 + Gemcitabine + Cisplatin64632111121

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Double-blind Part: Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

Percentage of participants with confirmed objective response that is at least one overall assessment of complete response (CR) or partial response (PR) reported here. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC. (NCT04066491)
Timeframe: Time from randomization of study drug up to data cut off (assessed up to 609 days)

InterventionPercentage of participants (Number)
Double-blinded Part: Placebo + Gemcitabine + Cisplatin19.5
Double-blinded Part: M7824 + Gemcitabine + Cisplatin31.5

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Double-blind Part: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)

Progression free survival was defined as the time from randomization of study intervention until the first documentation of disease progression (PD) or death due to any cause in the absence of documented PD, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. (NCT04066491)
Timeframe: Time from randomization of study drug until the first documentation of PD or death, assessed up to 609 days

InterventionMonths (Median)
Double-blinded Part: Placebo + Gemcitabine + Cisplatin5.6
Double-blinded Part: M7824 + Gemcitabine + Cisplatin5.5

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Double-blind Part: Overall Survival

Overall Survival was defined as the time from study day 1 to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method. (NCT04066491)
Timeframe: Time from study day 1 up to data cutoff (assessed up to 609 days)

InterventionMonths (Median)
Double-blinded Part: Placebo + Gemcitabine + Cisplatin11.5
Double-blinded Part: M7824 + Gemcitabine + Cisplatin11.5

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Double-blind Part: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

DOR was defined for participants with objective response, as the time from first documentation of objective response (confirmed Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates. (NCT04066491)
Timeframe: From first documented objective response to PD or death due to any cause, assessed up to 609 days

InterventionMonths (Median)
Double-blinded Part: Placebo + Gemcitabine + Cisplatin12.5
Double-blinded Part: M7824 + Gemcitabine + Cisplatin7.0

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Maximum Observed Concentration (Cmax) Was Performed for Patients in Arm A.

A non-compartmental analysis (NCA) was applied on the data. (NCT04099888)
Timeframe: Timepoints for pharmacokinetic (PK) sampling: Day -4 (before, 30m and 4hrs after Amphinex), C1-D1, C1-D8, C2-D8, C3-D8, C4-D8, C4-D18 (before, 30m and 4hrs after Amphinex), C5-D1, and C5-D8

Interventionng/ml (Number)
101-01 1st dose101-01 2nd dose101-02101-03 1st dose101-03 2nd dose106-01 1st dose (No samples taken before 90 hrs, Cmax value likely underestimated)106-01 2nd dose111-02 1st dose111-02 2nd dose181-06 1st dose (No sample at 30 minutes, Cmax is likely underestimated)181-06 2nd dose183-03 1st dose183-03 2nd dose183-03 3rd dose187-02 1st dose187-02 2nd dose192-01303-01 1st dose303-01 2nd dose303-02 1st dose303-02 2nd dose401-01501-01
PCI Treatment in Conjunction With Standard of Care (SoC)2462237726312495317280029232221325514272321262421872571275019372017260618482868312429122300

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Overall Disease Control Rate (DCR)

Proportion of patients with BOR of CR, PR or stable disease (SD) (according to RECIST 1.1) at or after the first follow-up scan, partial response or complete response (NCT04099888)
Timeframe: 6 months and 12 months

,
InterventionParticipants (Count of Participants)
Overall Disease Control RateDisease Control Rate at 6 Months
PCI Treatment in Conjunction With Standard of Care (SoC)1511
Standard of Care (SoC)1410

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Time to Cmax (Tmax) Was Performed for Patients in Arm A.

A non-compartmental analysis (NCA) was applied on the data as described by Gabrielsson & Weiner (Methods in molecular biology, 929:161-180, 2012). (NCT04099888)
Timeframe: Timepoints for PK sampling: Day -4 (before, 30 min and 4 hours after Amphinex), C1-D1, C1-D8, C2-D8, C3-D8, C4-D8, C4-D18 (before, 30 min and 4 hours after Amphinex) , C5-D1, and C5-D8

Interventionhours (Number)
101-01 1st dose101-01 2nd dose101-02101-03 1st dose101-03 2nd dose106-01 1st dose (No samples taken before 90 hrs, erroneous data)106-01 2nd dose111-02 1st dose111-02 2nd dose181-06 1st dose (No sample at 30 minutes)181-06 2nd dose183-03 1st dose183-03 2nd dose183-03 3rd dose187-02 1st dose187-02 2nd dose192-01303-01 1st dose303-01 2nd dose303-02 1st dose303-02 2nd dose401-01501-01
PCI Treatment in Conjunction With Standard of Care (SoC)0.500.500.500.500.50900.500.500.5040.500.500.500.500.500.500.500.500.500.500.500.500.50

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Duration of Response (DoR)

From first documented tumour response until first documented disease progression, or death in the absence of disease progression (in months) (NCT04099888)
Timeframe: Up to 24 months

,
InterventionDays (Number)
Patient APatient BPatient CPatient DPatient EPatient F
PCI Treatment in Conjunction With Standard of Care (SoC)169260264NANANA
Standard of Care (SoC)NANANA8511

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Area Under the Plasma Concentration Curve (AUC) Was Performed for Patients in Arm A.

A non-compartmental analysis (NCA) was applied on the data. AUC from time zero to the last measured concentration (AUC 0-t) was initially estimated by the linear trapezoidal method. (NCT04099888)
Timeframe: Time Frame AUC calculated from time zero to C5-D8 (3 months from the first PCI treatment)

Intervention(ng/ml)*hrs (Number)
101-01 1st dose101-01 2nd dose101-02101-03 1st dose101-03 2nd dose106-01 1st dose (No samples taken before 90 hrs, therefore AUC values is likely underestimated)106-01 2nd dose111-02 1st dose111-02 2nd dose181-06 1st dose181-06 2nd dose183-03 1st dose183-03 2nd dose183-03 3rd dose187-02 1st dose187-02 2nd dose192-01303-01 1st dose303-01 2nd dose303-02 1st dose303-02 2nd dose401-01501-01
PCI Treatment in Conjunction With Standard of Care (SoC)10176721399905385730576835600546677373874614492274NA566460NA751771475001646845709053383882805049434347NA681663730864521326549955

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Progression-free Survival (PFS)

From date of randomisation to date of objective disease progression or death, whichever comes first (in months) (NCT04099888)
Timeframe: Up to 18 months

InterventionMonths (Median)
PCI Treatment in Conjunction With Standard of Care (SoC)7.29
Standard of Care (SoC)8.08

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Adverse Events (AEs)/Serious Adverse Events (SAEs)

Number and proportion of patients with AEs/SAEs (NCT04099888)
Timeframe: Up to 12 months

InterventionParticipants (Count of Participants)
PCI Treatment in Conjunction With Standard of Care (SoC)12
Standard of Care (SoC)8

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Change in Tumor Size

Best overall percentage change in tumour size from baseline (NCT04099888)
Timeframe: Up to 18 months

InterventionPercentage Change in Tumor Size (Mean)
PCI Treatment in Conjunction With Standard of Care (SoC)-12.06
Standard of Care (SoC)-14.73

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Objective Response Rate (ORR)

Proportion of patients with measurable disease at baseline who have at least one visit response with a complete response (CR) or partial response (PR) noted (according to RECIST 1.1) (NCT04099888)
Timeframe: Up to 18 months

InterventionParticipants (Count of Participants)
PCI Treatment in Conjunction With Standard of Care (SoC)3
Standard of Care (SoC)3

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Overall Survival (OS)

From date of randomisation to date of death from any cause (in months) (NCT04099888)
Timeframe: Up to 24 months

InterventionParticipants (Count of Participants)
PCI Treatment in Conjunction With Standard of Care (SoC)12
Standard of Care (SoC)13

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Complete Response (CR): Percentage of Participants Who Achieve CR

CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. (NCT04145700)
Timeframe: Baseline Up to 6.94 months

InterventionPercentage of participants (Number)
Ramucirumab + Gemcitabine + Docetaxel0
Gemcitabine + Docetaxel0

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Duration of Response (DoR)

DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. (NCT04145700)
Timeframe: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 4.13 Months)

InterventionMonths (Number)
Ramucirumab + Gemcitabine + DocetaxelNA

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PK: Minimum Serum Concentration of Ramucirumab (Cmin)

Cmin was the concentration of study drug in the blood immediately before the next dose was administered. It was measured pre-dose at all visits and was summarized using descriptive statistics. (NCT04145700)
Timeframe: Prior to ramucirumab infusion on Day 8 of Cycle 1, Day 1 of Cycle 2 and Day 1 of Cycle 5

Interventionmicrogram per milliliter (µg/mL) (Geometric Mean)
Day 8 of Cycle 1Day 1 of Cycle 2Day 1 of Cycle 5
Ramucirumab + Gemcitabine + Docetaxel73.355.4NA

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Progression Free Survival (PFS)

PFS is defined as the time from randomization until the first investigator-determined objective progression as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause in the absence of progressive disease. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment or date of randomization, whichever is later. (NCT04145700)
Timeframe: Baseline to Objective Progression or Death Due to Any Cause (Up To 6.4 Months)

InterventionMonths (Median)
Ramucirumab + Gemcitabine + Docetaxel2.10
Gemcitabine + Docetaxel2.03

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Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax)

Cmax was the concentration of study drug in the blood after the dose is administered. It was measured post-dose and was summarized using descriptive statistics. (NCT04145700)
Timeframe: 0.5 hours after the end of ramucirumab infusion on Day 1 of Cycle 1

Interventionmicrogram per milliliter (µg/mL) (Geometric Mean)
Ramucirumab + Gemcitabine + Docetaxel231

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Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. (NCT04145700)
Timeframe: Baseline through Measured Progressive Disease (Up To 6.4 Months)

InterventionPercentage of participants (Number)
Ramucirumab + Gemcitabine + Docetaxel6.3
Gemcitabine + Docetaxel0

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Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA)

A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement (treatment-boosted). If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer >= 20 (treatment-induced). (NCT04145700)
Timeframe: Baseline Up to 6.94 months

InterventionParticipants (Count of Participants)
Ramucirumab + Gemcitabine + Docetaxel0
Gemcitabine + Docetaxel0

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Objective Response Rate (ORR)

"Percentage of patients achieving a confirmed complete response (CR) or partial response (PR) to treatment as assessed by blinded independent review according to RECIST v1.1 criteria. ORR = patients with CR + patients with PR, where CR = disappearance of all target lesions PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters This outcome was assessed in the population of patients with measurable disease at baseline who were also randomized ≥28 weeks before the data cut-off (ITTMD28). Patients were to receive a confirmatory scan 28-42 days after response is first observed." (NCT04163900)
Timeframe: Evaluated at Screening (baseline) then every 9 weeks from treatment start (C1D1), or every 12 weeks if treatment is stopped with no evidence of progression, until disease progression or death from any cause up to the end of study, an average of 6 months.

InterventionParticipants (Count of Participants)
A - NUC-1031 and Cisplatin53
B - Gemcitabine and Cisplatin34

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Overall Survival (OS)

The median time, in months, from the date of randomization to the date of death from any cause. For patients who were alive at the time of a data cut-off or were permanently lost to follow up, duration of OS was censored at the date at which they were last known to be alive. (NCT04163900)
Timeframe: From the date of randomization until the date of death from any cause, assessed up to 12 months on average

InterventionMonths (Median)
A - NUC-1031 and Cisplatin9.2
B - Gemcitabine and Cisplatin12.6

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3-Month Complete Response Rate

Number of patients with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage as assessed by cystoscopy with biopsy and urine cytology. (NCT04386746)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Intravesical Gemcitabine/Docetaxel25

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Time to Death

Defined as the time (days) from date of Radical Nephroureterectomy to date of death (NCT04398368)
Timeframe: Up to 2 years

InterventionDays (Mean)
Prevention (Gemcitabine Hydrochloride)543

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Time to Development of Muscle-invasive Bladder Cancer

Defined as the time (days) from date of Radical Nephroureterectomy to date of histologic proof of Urothelial Carcinoma (NCT04398368)
Timeframe: Up to 2 years

InterventionDays (Mean)
Prevention (Gemcitabine Hydrochloride)178.75

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Incidence of Adverse Events

Adverse events will be categorized by grade and further distinguished as serious adverse events. Furthermore, they will be designated by each site as not related, unlikely, possible, probably, and definitely related to treatment adverse events. they will also be summarized and organized by organ system, with the number and percent of patients experiencing the adverse event at least once and the number of patients exposed. Adverse events will be described and analyzed qualitatively. Adverse events will be grouped into categories and numerically described. (NCT04398368)
Timeframe: Up to 2 years

InterventionAdverse Events (Number)
Prevention (Gemcitabine Hydrochloride)213

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Incidence of Muscle-invasive Bladder Cancer

Number of subject to experience muscle-invasive bladder cancer. Assessed by Urothelial Carcinoma on final pathology of Transurethral Resection of Bladder Tumor specimen or Urothelial Carcinoma on final pathology of radical cystectomy specimen. (NCT04398368)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Prevention (Gemcitabine Hydrochloride)4

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Urothelial Carcinoma Relapse-free Survival

Number of participants without recurrence of Urothelial Carcinoma. Relapse-free survival will be assessed by cystoscopy and urine cytology. (NCT04398368)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Prevention (Gemcitabine Hydrochloride)14

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Time to Recurrence

Number of days from Radical Nephroureterectomy to date of histologic proof of recurrence/relapse of Urothelial Carcinoma (NCT04398368)
Timeframe: Up to 1 year

InterventionDays (Mean)
Prevention (Gemcitabine Hydrochloride)178.75

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Time to Confirmed Deterioration (TTCD)

TTCD in patient-reported physical functioning, role functioning, and quality of life, as measured by the respective scales of the EORTC QLQ-C30 and/or EORTC IL77, and defined as the time from randomization to the first clinically meaningful deterioration that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks. (NCT04677504)
Timeframe: Randomization to the first clinically meaningful deterioration (up to approximately 14 months)

,
InterventionMonths (Median)
Quality of LifePhysical Function ScaleRole Function Scale
Arm A: Atezo+Bev+CisGem, Followed by Atezo+Bev2.796.214.24
Arm B: Atezo+PBO+CisGem, Followed by Atezo+PBO6.283.293.52

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Confirmed Objective Response Rate (ORR)

Confirmed ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1. (NCT04677504)
Timeframe: Randomization up to approximately 14 months

InterventionPercentage of participants (Number)
Arm B: Atezo+PBO+CisGem, Followed by Atezo+PBO25.3
Arm A: Atezo+Bev+CisGem, Followed by Atezo+Bev24.1

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Duration of Response (DOR)

DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). (NCT04677504)
Timeframe: First occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months)

InterventionMonths (Median)
Arm B: Atezo+PBO+CisGem, Followed by Atezo+PBO5.78
Arm A: Atezo+Bev+CisGem, Followed by Atezo+BevNA

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Progression Free Survival (PFS)

PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (NCT04677504)
Timeframe: Randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months)

InterventionMonths (Median)
Arm B: Atezo+PBO+CisGem, Followed by Atezo+PBO7.92
Arm A: Atezo+Bev+CisGem, Followed by Atezo+Bev8.35

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Serum Concentration of Atezolizumab

Serum concentration of atezolizumab at specified timepoints. (NCT04677504)
Timeframe: Pre-Dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, and 16, and Post Dose Day 1 of Cycle 1 (cycle length=21 days)

,
Interventionμg/ mL (Mean)
Cycle 1 Day 1 Pre-DoseCycle 1 Day 1 Post DoseCycle 2 Day 1 Pre-DoseCycle 3 Day 1 Pre-DoseCycle 4 Day 1 Pre-DoseCycle 8 Day 1 Pre-DoseCycle 12 Day 1 Pre-DoseCycle 16 Day 1 Pre-Dose
Arm A: Atezo+Bev+CisGem, Followed by Atezo+BevNA41179.4118155200210174
Arm B: Atezo+PBO+CisGem, Followed by Atezo+PBONA41685.0129153224223230

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Disease Control Rate (DCR)

DCR is defined as the proportion of participants with a CR or a PR on two consecutive occasions >= 4 weeks apart or SD with a minimum duration of 9weeks, as determined by the investigator according to RECIST v1.1 (NCT04677504)
Timeframe: Randomization up to approximately 14 months

InterventionPercentage of participants (Number)
Arm B: Atezo+PBO+CisGem, Followed by Atezo+PBO75.9
Arm A: Atezo+Bev+CisGem, Followed by Atezo+Bev78.5

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Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)

An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. (NCT04924062)
Timeframe: Up to approximately 29 months

InterventionParticipants (Count of Participants)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)18
Arm B (Placebo+Gemcitabine+Cisplatin)14

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Overall Survival (OS)

Overall survival was defined as the time from randomization to death due to any cause. Per protocol the final reported outcome for OS did not include any sensitivity or supportive analysis. (NCT04924062)
Timeframe: Up to approximately 29 months

InterventionMonths (Median)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)14.1
Arm B (Placebo+Gemcitabine+Cisplatin)9.9

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Number of Participants Who Experience One or More Adverse Events (AE)

An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. (NCT04924062)
Timeframe: Up to approximately 29 months

InterventionParticipants (Count of Participants)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)73
Arm B (Placebo+Gemcitabine+Cisplatin)82

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Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by BICR

Progression-free survival was defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurred first. (NCT04924062)
Timeframe: Up to approximately 29 months

InterventionMonths (Median)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)5.6
Arm B (Placebo+Gemcitabine+Cisplatin)5.7

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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters [SOD] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ. (NCT04924062)
Timeframe: Up to approximately 29 months

InterventionPercentage (Number)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)36.0
Arm B (Placebo+Gemcitabine+Cisplatin)28.9

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Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

For participants who demonstrated a confirmed CR or PR, DOR was the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. (NCT04924062)
Timeframe: Up to approximately 29 months

InterventionMonths (Median)
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)10.2
Arm B (Placebo+Gemcitabine+Cisplatin)5.7

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