ifosfamide has been researched along with Carcinoma, Epidermoid in 173 studies
| Excerpt | Relevance | Reference |
|---|---|---|
| " A 49-year-old white male diagnosed with T3 N3 M0 Stage IIIB anal cancer was treated initially with surgical excision and adjuvant fluorouracil/cisplatin due unavailability of mitomycin." | 7.81 | Recurrent metastatic anal cancer treated with modified paclitaxel, ifosfamide, and cisplatin and third-line mitomycin/cetuximab. ( Baxley, A; Khawandanah, M; Pant, S, 2015) |
| "Generalized and partial seizures with secondary generalization were observed during ifosfamide-mesna (IFO) treatment in a patient with lung epidermoid carcinoma." | 7.69 | [Epileptic seizures and treatment with ifosfamide-mesna]. ( Farisse, P; Somma-Mauvais, H; Viallat, JR, 1994) |
| "Fifty-three patients with inoperable non-small cell bronchial carcinoma were treated at four-weekly intervals with two cytostatic drugs, doxorubicin (50 mg/m2 on day 1) and ifosfamide (2000 mg/m2 on days 1-3)." | 7.66 | [Combined cytostatic chemotherapy of advanced non-small-cell bronchial carcinoma with doxorubicin and ifosfamide]. ( Göbel, D; Matthiessen, W; Stempinski, E; Thalmann, U, 1983) |
| "We have reported the results of a previous Phase II trial of two courses of neoadjuvant mitomycin (6 mg/m2), ifosfamide (3 g/m2) and cisplatin (50 mg/m2) (MIC) in squamous or anaplastic carcinoma of the oesophagus." | 5.08 | A phase II trial of four courses of preoperative chemotherapy in squamous or anaplastic carcinoma of the oesophagus. ( Cullen, MH; Darnton, SJ; Matthews, HR; McAleer, JA; McManus, KG; Steyn, RS, 1998) |
| " A 49-year-old white male diagnosed with T3 N3 M0 Stage IIIB anal cancer was treated initially with surgical excision and adjuvant fluorouracil/cisplatin due unavailability of mitomycin." | 3.81 | Recurrent metastatic anal cancer treated with modified paclitaxel, ifosfamide, and cisplatin and third-line mitomycin/cetuximab. ( Baxley, A; Khawandanah, M; Pant, S, 2015) |
| "The stage-by-stage prognosis for cervical cancer patients has not improved in the past decades." | 3.77 | Neoadjuvant therapy for cervical cancer. ( Achterrath, W; Eiermann, W; Kuehnle, H; Meerpohl, HG, 1992) |
| " Three courses with cisplatin 75 mg/m(2), paclitaxel 175 mg/m(2) and ifosfamide 5 g/m(2) (epirubicin 80 mg/m(2) in adenocarcinoma) were followed by cold-knife conization and pelvic lymphadenectomy." | 3.74 | Neoadjuvant chemotherapy and conservative surgery for stage IB1 cervical cancer. ( Bonazzi, C; Chiari, S; Maneo, A; Mangioni, C, 2008) |
| "The multidrug resistance gene product P-glycoprotein (P-GP) was assessed immunohistochemically (by antibody JSB-1) in biopsy specimens from 27 oesophageal squamous carcinomas and 10 adenocarcinomas before treatment with mitomycin, ifosfamide and cisplatin (MIC)." | 3.69 | Lack of correlation of P-glycoprotein expression with response to MIC chemotherapy in oesophageal cancer. ( Darnton, SJ; Ferry, DR; Jenner, K; Matthews, HR; Steyn, RS, 1995) |
| "Generalized and partial seizures with secondary generalization were observed during ifosfamide-mesna (IFO) treatment in a patient with lung epidermoid carcinoma." | 3.69 | [Epileptic seizures and treatment with ifosfamide-mesna]. ( Farisse, P; Somma-Mauvais, H; Viallat, JR, 1994) |
| "Of 13 patients with adenocarcinoma treated with 5-fluorouracil, adriamycin, and mitomycin (FAM), nine showed minor histological changes compared with 14 control cases." | 3.68 | Histopathological findings in oesophageal carcinoma with and without preoperative chemotherapy. ( Allen, SM; Darnton, SJ; Edwards, CW; Matthews, HR, 1993) |
| "Fifty-three patients with inoperable non-small cell bronchial carcinoma were treated at four-weekly intervals with two cytostatic drugs, doxorubicin (50 mg/m2 on day 1) and ifosfamide (2000 mg/m2 on days 1-3)." | 3.66 | [Combined cytostatic chemotherapy of advanced non-small-cell bronchial carcinoma with doxorubicin and ifosfamide]. ( Göbel, D; Matthiessen, W; Stempinski, E; Thalmann, U, 1983) |
| "Men with penile squamous cell carcinoma and regional lymph node involvement have a low probability of survival with lymphadenectomy alone." | 2.75 | Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study. ( Daliani, D; Kincaid, M; Osai, W; Pagliaro, LC; Pettaway, CA; Thall, PF; Wen, S; Williams, DL; Williams, MB, 2010) |
| "Grade 3/4 neutropenia was observed in 21 % of patients and grade 3/4 febrile neutropenia was seen in only one patient." | 2.73 | Salvage chemotherapy with mitomycin C, ifosfamide, and cisplatin (MIC) for previously treated metastatic or recurrent esophageal squamous cell carcinoma. ( Ahn, JS; Ahn, MJ; Hwang, IG; Im, YH; Kang, WK; Lee, SC; Lim, HY; Park, BB; Park, K, 2008) |
| "Ifosfamide is an active alkylating agent used in the first-line treatment of NSCLC." | 2.71 | Phase II study of docetaxel and ifosfamide combination chemotherapy in non-small-cell lung cancer patients failing previous chemotherapy with or without paclitaxel. ( Chen, MC; Chen, YM; Lee, CS; Lin, WC; Perng, RP; Shih, JF; Tsai, CM, 2003) |
| " Haematological toxicity and dosage reductions were higher with SuperMIP, which was nevertheless associated with a significantly increased absolute dose intensity." | 2.71 | A phase III randomised study comparing two different dose-intensity regimens as induction chemotherapy followed by thoracic irradiation in patients with advanced locoregional non-small-cell lung cancer. ( Berghmans, T; Corhay, JL; Efremidis, A; Giner, V; Koumakis, G; Lafitte, JJ; Lecomte, J; Lothaire, P; Mommen, P; Ninane, V; Paesmans, M; Richez, M; Sculier, JP; Thiriaux, J; Van Houtte, P; Wackenier, P, 2004) |
| "Twelve patients in stage IIIB cervical cancer were submitted to NAC and 12 (control group)--received standart pelvic radiation to whole pelvis--52 Gy." | 2.71 | [Effect of neoadjuvant chemotherapy in the treatment of patients with stage IIIB cervical cancer]. ( Gorchev, G; Kornovski, Ia, 2003) |
| "All of the patients had biopsy-proven squamous cell carcinoma of the uterine cervix." | 2.71 | Retrospective analysis of concurrent chemoradiation with the combination of bleomycin, ifosfamide and cisplatin (BIP) for uterine cervical cancer. ( Abe, Y; Aida, T; Akahira, J; Aoki, M; Ito, K; Katahira, A; Kitamura, T; Niikura, H; Okamura, C; Okamura, K; Otsuki, K; Saito, S; Sato, N; Takano, T; Utsunomiya, H; Yaegashi, N, 2004) |
| "Megestrol acetate 250 mg PO was administered throughout the duration of chemotherapy." | 2.69 | A brief intensive cisplatin-based outpatient chemotherapy regimen with filgrastim and megestrol acetate support for advanced non-small cell lung cancer: results of a phase II trial. ( Craffey, M; Dowlati, A; Levitan, N; MacKay, W; McKenney, J; Remick, SC; Tahsildar, H, 1998) |
| "Ifosfamide was given initially to 12 patients in combination with standard fixed doses of cisplatin and 5-fluorouracil, at 1,000 mg/m2 daily on days 2, 3, and 4." | 2.69 | Phase II clinical trial of cisplatin, 5-fluorouracil, and ifosfamide as treatment for advanced locoregional head and neck carcinoma. ( Abad, T; Alvárez, I; Churruca, C; Egana, L; Guimón, E; Lacasta, A; López de Argumedo, G; Paredes, A; Piera, JM; Sánchez Parra, M, 1999) |
| "A preliminary co-operative study by 7 institutes was conducted to determine the optimal dosage of the combination regimen with nedaplatin, bleomycin and ifosfamide, which is used in a phase III clinical study, to investigate its efficacy as neoadjuvant chemotherapy against advanced cervical cancer of the uterus." | 2.68 | [Combination chemotherapy with nedaplatin, bleomycin and ifosfamide for advanced cervical cancer of the uterus--a preliminary study for phase III clinical study]. ( Hatae, M; Hirabayashi, K; Kanazawa, K; Noda, K; Ozaki, M; Terashima, Y; Yakushiji, M, 1997) |
| "All patients were required to have squamous cell carcinoma of the head and neck that had recurred following surgery or radiotherapy or both." | 2.68 | A phase II study of ifosfamide in recurrent squamous cell carcinoma of the head and neck. ( Benner, SE; Dimery, IW; Dunnington, JS; Hong, WK; Huber, MH; Lippman, SM; Shirinian, M, 1996) |
| "Granulocytopenia was the dose-limiting toxicity." | 2.68 | Phase I study of paclitaxel, cisplatin, and ifosfamide in patients with recurrent or metastatic squamous cell cancer of the head and neck. ( Benner, SE; Hong, WK; Huber, MH; Lippman, SM, 1995) |
| "The early stages of bronchial carcinoma are still a domain of operative treatment." | 2.68 | [Neoadjuvant radiochemotherapy in locally advanced non-small cell bronchial carcinoma. Initial results of a prospective multicenter study]. ( Klinke, F; Micke, O; Rübe, C; von Eiff, M; Wagner, W; Willich, N, 1995) |
| "Thirty patients with advanced squamous cell carcinoma of the cervix were included in a phase II study with cisplatin (DDP) and ifosfamide (IF)/mesna." | 2.68 | Cisplatin and ifosfamide in patients with advanced squamous cell carcinoma of the uterine cervix. A phase II trial. ( Araujo, CE; Cervellino, JC; Miles, H; Nishihama, A; Sánchez, O, 1995) |
| "A total of 37 men with epidermoid head and neck cancer whose disease had recurred following primary treatment (surgery and/or radiotherapy) received first-line chemotherapy with ifosfamide at i." | 2.67 | Ifosfamide in advanced epidermoid head and neck cancer. ( Almenarez, J; Casado, A; Diaz-Rubio, E; Dominguez, S; González Larriba, JL; López-Vega, JM; Martín, M; Sastre, J, 1993) |
| "Neo-adjuvant therapy with MIC in squamous carcinoma of the oesophagus has shown encouraging early results, with acceptable toxicity." | 2.67 | A phase II study of mitomycin, ifosfamide and cisplatin in operable and inoperable squamous cell carcinoma of the oesophagus. ( Allen, SM; Cullen, MH; Darnton, SJ; Duffy, JP; Matthews, HR; Walker, SJ, 1994) |
| "Ifosfamide/mesna has activity in a wide range of gynecologic malignancies." | 2.67 | Gynecologic Oncology Group experience with ifosfamide. ( Berman, ML; Blessing, JA; Homesley, HD; Photopulos, G; Sutton, GP, 1990) |
| " The major dose-limiting toxic effect of CIA was leukopenia." | 2.64 | Protection against chemotherapy toxicity by IV hyperalimentation. ( Bodey, GP; Copeland, EW; Dudrick, SJ; Freireich, EJ; Issell, BF; Valdivieso, M; Zaren, HA, 1978) |
| "Ifosfamide (IFO) has demonstrated activity in recurrent/metastatic squamous cell head and neck carcinoma with an overall response rate of 24-26%." | 2.42 | Ifosfamide in the treatment of head and neck cancer. ( Airoldi, M; Bumma, C; Cortesina, G; Giordano, C; Pedani, F, 2003) |
| "Patients with advanced squamous cell head and neck cancer have a dismal long-term survival rate not only because of metastatic disease, but also primarily because of failure in local disease control." | 2.41 | Treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck: current status and future directions. ( Glisson, BS; Hong, WK; Khuri, FR; Lippman, SM; Shin, DM, 2000) |
| "Paclitaxel has been tested with interesting results in cervical cancer." | 2.41 | Chemotherapy with paclitaxel, ifosfamide, and cisplatin for the treatment of squamous cell cervical cancer: the experience of Monza. ( Fei, F; Mangioni, C; Zanetta, G, 2000) |
| " The Eastern Cooperative Oncology Group is currently evaluating high-dose (200 mg/m2) and low-dose (135 mg/m2) paclitaxel in combination with cisplatin to assess dose-response effects, toxicity, and efficacy." | 2.39 | Single-agent paclitaxel and paclitaxel plus ifosfamide in the treatment of head and neck cancer. ( Forastiere, AA; Urba, SG, 1995) |
| "We report a case of metastatic penile cancer refractory to TIP chemotherapy, with a dramatic treatment response to ipilimumab and nivolumab." | 1.62 | Metastatic penile squamous cell carcinoma with dramatic response to combined checkpoint blockade with ipilimumab and nivolumab. ( Baweja, A; Mar, N, 2021) |
| " In this study, we adjusted the dosage of the triplet regimen and introduced carboplatin in cisplatin-intolerable patients." | 1.48 | Response to Combination Chemotherapy With Paclitaxel/Ifosfamide/Platinum Versus Paclitaxel/Platinum for Patients With Metastatic, Recurrent, or Persistent Carcinoma of the Uterine Cervix: A Retrospective Analysis. ( Bae, DS; Choi, CH; Choi, HJ; Kim, BG; Kim, TJ; Lee, JW; Lee, YY; Paik, ES, 2018) |
| "Locally advanced cervical cancer (LACC) is one of the leading health problems of the developing countries." | 1.42 | Long follow-up of patients with locally advanced cervical cancer treated with concomitant chemobrachyradiotherapy with cisplatin and ifosfamide followed by consolidation chemotherapy. ( Boraska Jelavić, T; Hamm, W; Hrepić, D; Petrić Miše, B; Prskalo, T; Strikic, A; Tomić, K; Tomić, S; Vrdoljak, E, 2015) |
| "Standard treatment of cervical cancer FIGO stage IB1 is a radical hysterectomy with pelvic lymphadenectomy." | 1.42 | Neoadjuvant chemotherapy followed by large cone resection as fertility-sparing therapy in stage IB cervical cancer. ( Leunen, K; Moerman, P; Neven, P; Salihi, R; Van Limbergen, E; Vergote, I, 2015) |
| "Standard chemotherapy for advanced penile cancer has not been established because of its rarity." | 1.42 | [Dramatic response of penile cancer with inguinal lymph node metastases to neoadjuvant chemotherapy with paclitaxel, ifosfamide and cisplatin : a case report]. ( Arakawa, H; Deguchi, T; Horie, K; Kato, H; Kubota, Y; Matsuoka, K; Nagai, S; Nakano, M, 2015) |
| "Downstaging by NAC in IB1 and IB2 cervical cancer before fertility-sparing surgery is still an experimental procedure, but shows some promise." | 1.40 | Oncological and pregnancy outcomes after high-dose density neoadjuvant chemotherapy and fertility-sparing surgery in cervical cancer. ( Halaska, MJ; Lisy, J; Matecha, J; Pluta, M; Rob, L; Robova, H; Skapa, P, 2014) |
| "The management of advanced cervical cancer is challenging." | 1.40 | Robotic radical hysterectomy following neoadjuvant chemotherapy in FIGO stage IIIB cervical cancer: a case report. ( Siesto, G; Vitobello, D, 2014) |
| " Our patient was subsequently enrolled on a phase 1 clinical trial of a novel, orally bioavailable bromodomain and extra terminal inhibitor, GSK525762 (NCT01587703)." | 1.39 | NUT midline carcinoma: an aggressive intrathoracic neoplasm. ( Costello, BA; Dronca, RS; French, CA; Hilton, J; Marks, RS; Molina, JR; Nerby, CL; Parikh, SA; Peddareddigari, VG; Roden, AC; Shapiro, GI, 2013) |
| "The role of chemotherapy (CHX) in squamous cell carcinoma of the head and neck (SCCHN) has been expanding." | 1.38 | The anti-tumour effect of cisplatin and ifosfamide on xenografted squamous cell carcinoma of the head and neck is schedule-dependent. ( Ekblad, L; Kjellén, E; Mineta, H; Sasaki, Y; Wahlberg, P; Wennerberg, J, 2012) |
| "Pure primary squamous cell carcinoma (SCC) of the breast is rare and difficult to treat." | 1.35 | Primary squamous cell carcinoma of the breast: achieving long-term control with cisplatin-based chemotherapy. ( Bhatt, L; Fernando, I, 2009) |
| "In 20." | 1.35 | A retrospective study of patients with locally advanced cancer of the cervix treated with neoadjuvant chemotherapy followed by radical surgery. ( Doval, DC; Kumar, JV; Rao, R; Rawal, S, 2009) |
| "For patients with stage II to IV laryngeal cancer, radiation therapy (RT) either alone or with concurrent chemotherapy provides the highest rate of organ preservation but can be associated with functional impairment." | 1.35 | Durable long-term remission with chemotherapy alone for stage II to IV laryngeal cancer. ( Ark, N; Diaz, EM; El-Naggar, AK; Garden, AS; Gillenwater, AM; Ginsberg, LE; Glisson, BS; Holsinger, FC; Khuri, FR; Ki Hong, W; Kies, MS; Lee, JJ; Lewin, JS; Lin, HY; Shin, DM, 2009) |
| "The prognosis of recurrent metastatic cervical cancer is extremely poor." | 1.34 | Unexpected long-term survival without evidence of disease after salvage chemotherapy for recurrent metastatic cervical cancer: a case series. ( Abu-Rustum, NR; Aghajanian, C; Bowes, RJ; Jhamb, N; Khoury-Collado, F, 2007) |
| "Human-derived head-and-neck squamous cell carcinoma xenografts (implanted in nude mice/nine groups of 10 mice) were treated with various treatment modalities and combinations of them (radiation with 5 x 2 or 10 x 2 Gy, hyperthermia at 41 degrees C or 41." | 1.31 | Tumor oxygenation after radiotherapy, chemotherapy, and/or hyperthermia predicts tumor free survival. ( Feyerabend, T; Ressel, A; Weiss, C, 2001) |
| "43 patients with Stage IV squamous cell carcinoma of the head and neck have been treated neoadjuvantly with two cycles chemotherapy (ifosfamide 1." | 1.31 | [The value of qualitative regression grading as a prognostic factor for survival after preoperative radiochemotherapy in patients with advanced head and neck cancer]. ( Christoph, B; Esser, E; Hartlapp, J; Hermann, RM; Krech, R; Müller, MK; Wagner, W, 2001) |
| "The response rate was higher in squamous cell carcinomas (85%) than adenocarcinomas or adenosquamous carcinomas (67%)." | 1.30 | [Neoadjuvant chemotherapy for advanced cervical cancer]. ( Hongo, A; Ikuhashi, H; Kobashi, Y; Kodama, J; Kudo, T; Miyagi, Y; Mizutani, Y; Okuda, H; Yoshinouchi, M, 1999) |
| "Seven oesophageal squamous carcinomas, treated with pre-operative chemotherapy (mitomycin-C, ifosfamide and cisplatin-MIC), with a course finishing 21 days prior to resection, were examined by electronmicroscopy." | 1.29 | Effects of chemotherapy on ultrastructure of oesophageal squamous cell carcinoma. ( Antonakopoulos, GN; Darnton, SJ; Duffy, JP; Matthews, HR; Newman, J, 1994) |
| "Ifosfamide (IFX) has activity in a number of gynaecological malignancies and was selected for evaluation in this disease." | 1.28 | A phase II study of ifosfamide in endometrial cancer. ( Barton, C; Blackledge, G; Buxton, EJ; Meanwell, CA; Mould, JJ, 1990) |
| "Ifosfamide has shown promising single-agent activity in non-small cell lung cancer (NSCLC)." | 1.28 | Phase II study of cisplatin, ifosfamide with mesna, and etoposide (PIE) chemotherapy for advanced non-small cell lung cancer. ( Dhingra, HH; Greenberg, J; Hong, WK; Lee, JS; Shirinian, M, 1992) |
| "The authors report a case of pulmonary squamous cell carcinoma which occurred after chemotherapy of non-Hodgkin's lymphoma (NHL)." | 1.28 | [Elderly non-Hodgkin's lymphoma presenting with pulmonary squamous cell carcinoma as a complication of chemotherapy for malignant lymphoma]. ( Annoh, S; Arai, N; Kaneko, H; Shirai, T; Tsukahara, T; Umeda, M, 1992) |
| "Thirty-one patients with inoperable squamous cell carcinoma of the lung were treated with a combination of cis-platin (CDDP, 100 mg/m2 day 1), ifosfamide (IFX, 2 g/m2 day 1, 2, 3; with mesna) and vindesine (VDS, 3 mg/m2 day 1)." | 1.28 | [Cisplatin, ifosfamide and vindesine in the chemotherapy of squamous cell carcinoma of the lung]. ( Asakawa, M; Fujita, A; Honda, R; Inoue, Y; Nakajima, S; Sasaki, H; Sekine, K; Suzuki, A, 1991) |
| "Survival in patients with advanced cervical cancer (stage III B) treated by radical radiotherapy is low." | 1.28 | Cisplatin-ifosfamide as neoadjuvant chemotherapy in stage IIIB cervical uterine squamous-cell carcinoma. ( Garcia-Puche, JL; Lara, PC; Pedraza, V, 1990) |
| "The tumors included 5 squamous cell carcinomas (non keratinizing: 2, keratinizing: 3), two adenosquamous (including one glassy cell carcinoma), one adenocarcinoma (endometrioid type) and one argyrophil cell carcinoma." | 1.28 | Ifosfamide, adriamycin and cisplatin (IAP) plus bleomycin (B) combination chemotherapy in patients with recurrent cancer of the uterine cervix. ( Arimatsu, T; Izumi, S; Matsumura, T; Nagano, H; Nagasue, N; Nishida, T; Okura, N; Yakushiji, M, 1989) |
| "Thirty patients with advanced squamous carcinoma of the uterine cervix recurrent after radiotherapy or surgery and refractory to first-line chemotherapeutic agents were treated with ifosfamide in a dose of 1." | 1.28 | Phase II study of ifosfamide and mesna in patients with previously-treated carcinoma of the cervix. A Gynecologic Oncology Group study. ( Adcock, L; Blessing, JA; DeEulis, T; Sutton, GP; Webster, KD, 1989) |
| "Ifosfamide/mesna has activity in a wide range of gynecologic malignancies." | 1.28 | Phase II experience with ifosfamide/mesna in gynecologic malignancies: preliminary report of Gynecologic Oncology Group studies. ( Berman, ML; Blessing, JA; Homesley, HD; Photopulos, G; Sutton, GP, 1989) |
| "The course of 72 patients (36 with squamous carcinoma, 25 with adenocarcinoma, two with alveolar-cell carcinoma and nine with large-cell carcinoma) could be evaluated." | 1.27 | [Chemotherapy of the non-small cell carcinoma of the lung with ifosfamide and cisplatin]. ( Abel, U; Dirks, HP; Drings, P; Grimm, V; Heinrich, S; Kleckow, M; Manke, HG; Queisser, W; Stiefel, P, 1984) |
| " Bone marrow suppression was the dose-limiting toxicity and led to dosage modification in 24 patients." | 1.27 | A phase II study of ifosfamide in advanced and relapsed carcinoma of the cervix. ( Coleman, RE; Gallagher, C; Harper, PG; Osborne, R; Rankin, EM; Silverstone, AC; Slevin, ML; Souhami, RL; Tobias, JS; Trask, CW, 1986) |
| "The most frequent histology was squamous cell carcinoma found in 20 patients." | 1.27 | [Chemotherapy with mitomycin C, vindesine and ifosfamide in the treatment of inoperable non-small cell bronchial carcinoma]. ( Gatzemeier, U; Hossfeld, DK; Radenbach, D; Zschaber, R, 1985) |
| "The etoposide combination was tolerated better." | 1.27 | Experience with ifosfamide combinations (etoposide or DDP) in non-small cell lung cancer. ( Abel, U; Bülzebruck, H; Drings, P; Kleckow, M; Manke, HG; Stiefel, P, 1986) |
| "Ifosfamide has minimal activity in esophageal cancer and causes severe myelosuppression." | 1.27 | Phase II trial of ifosfamide in epidermoid carcinoma of the esophagus: unexpectant severe toxicity. ( Eisenberger, M; Kelsen, DP; Lipperman, R; Nanus, DM, 1988) |
| "Ifosfamide was administered to 21 patients with recurrent or disseminated lung cancer at a dose of 4." | 1.26 | Ifosfamide in the treatment of recurrent or disseminated lung cancer: a phase II study of two dose schedules. ( Costanzi, JJ; Gagliano, R; Hokanson, JA; Loukas, D; Panettiere, FJ, 1978) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 36 (20.81) | 18.7374 |
| 1990's | 58 (33.53) | 18.2507 |
| 2000's | 47 (27.17) | 29.6817 |
| 2010's | 31 (17.92) | 24.3611 |
| 2020's | 1 (0.58) | 2.80 |
| Authors | Studies |
|---|---|
| Baweja, A | 1 |
| Mar, N | 1 |
| Karageorgopoulou, S | 1 |
| Kostakis, ID | 1 |
| Gazouli, M | 1 |
| Markaki, S | 1 |
| Papadimitriou, M | 1 |
| Bournakis, E | 1 |
| Dimopoulos, MA | 2 |
| Papadimitriou, CA | 1 |
| Choi, HJ | 1 |
| Paik, ES | 1 |
| Choi, CH | 1 |
| Kim, TJ | 1 |
| Lee, YY | 1 |
| Lee, JW | 1 |
| Bae, DS | 1 |
| Kim, BG | 1 |
| Xu, J | 1 |
| Li, G | 1 |
| Zhu, SM | 1 |
| Cai, QL | 1 |
| Wang, Z | 1 |
| Yang, X | 2 |
| Zhang, HT | 1 |
| Niu, YJ | 1 |
| Pinkavova, I | 1 |
| Fischerova, D | 1 |
| Zikan, M | 1 |
| Burgetova, A | 1 |
| Slama, J | 1 |
| Svarovsky, J | 1 |
| Dundr, P | 1 |
| Dusek, L | 1 |
| Cibula, D | 1 |
| Siesto, G | 2 |
| Vitobello, D | 2 |
| Ozdemir, O | 1 |
| Ozdemir, P | 1 |
| Veral, A | 1 |
| Uluer, H | 1 |
| Ozhan, MH | 1 |
| Ma, K | 1 |
| Yang, YH | 1 |
| Feng, ZY | 1 |
| Liu, TY | 1 |
| Wen, HW | 1 |
| Liao, QP | 1 |
| Parikh, SA | 1 |
| French, CA | 1 |
| Costello, BA | 1 |
| Marks, RS | 1 |
| Dronca, RS | 1 |
| Nerby, CL | 1 |
| Roden, AC | 1 |
| Peddareddigari, VG | 1 |
| Hilton, J | 1 |
| Shapiro, GI | 1 |
| Molina, JR | 1 |
| Vizza, E | 1 |
| Corrado, G | 1 |
| Zanagnolo, V | 2 |
| Tomaselli, T | 1 |
| Cutillo, G | 1 |
| Mancini, E | 1 |
| Maggioni, A | 2 |
| Khawandanah, M | 1 |
| Baxley, A | 1 |
| Pant, S | 1 |
| Robova, H | 1 |
| Halaska, MJ | 1 |
| Pluta, M | 1 |
| Skapa, P | 1 |
| Matecha, J | 1 |
| Lisy, J | 1 |
| Rob, L | 1 |
| Petrić Miše, B | 1 |
| Boraska Jelavić, T | 1 |
| Strikic, A | 1 |
| Hrepić, D | 1 |
| Tomić, K | 1 |
| Hamm, W | 3 |
| Tomić, S | 1 |
| Prskalo, T | 3 |
| Vrdoljak, E | 3 |
| Kubota, Y | 1 |
| Nakano, M | 1 |
| Nagai, S | 1 |
| Matsuoka, K | 1 |
| Arakawa, H | 1 |
| Horie, K | 1 |
| Deguchi, T | 1 |
| Kato, H | 1 |
| Scandurra, G | 1 |
| Scibilia, G | 1 |
| Banna, GL | 1 |
| D'Agate, G | 1 |
| Lipari, H | 1 |
| Gieri, S | 1 |
| Scollo, P | 2 |
| Gakis, G | 1 |
| Morgan, TM | 1 |
| Daneshmand, S | 1 |
| Keegan, KA | 1 |
| Todenhöfer, T | 1 |
| Mischinger, J | 1 |
| Schubert, T | 1 |
| Zaid, HB | 1 |
| Hrbacek, J | 1 |
| Ali-El-Dein, B | 1 |
| Clayman, RH | 1 |
| Galland, S | 1 |
| Olugbade, K | 1 |
| Rink, M | 1 |
| Fritsche, HM | 1 |
| Burger, M | 1 |
| Chang, SS | 1 |
| Babjuk, M | 1 |
| Thalmann, GN | 1 |
| Stenzl, A | 1 |
| Efstathiou, JA | 1 |
| Salihi, R | 1 |
| Leunen, K | 1 |
| Van Limbergen, E | 1 |
| Moerman, P | 1 |
| Neven, P | 1 |
| Vergote, I | 1 |
| Zwenger, AO | 1 |
| Grosman, G | 1 |
| Iturbe, J | 1 |
| Leone, J | 1 |
| Vallejo, CT | 2 |
| Leone, JP | 1 |
| Verdera, PP | 1 |
| Pérez, JE | 2 |
| Leone, BA | 2 |
| Minig, L | 1 |
| Cárdenas-Rebollo, JM | 1 |
| Colombo, N | 5 |
| Hancock, SB | 1 |
| Krempl, GA | 1 |
| Canfield, V | 1 |
| Bogardus, C | 1 |
| Kojouri, K | 1 |
| Kaneaster, SK | 1 |
| Medina, JE | 1 |
| Rivera, F | 1 |
| Eugenia Vega-Villegas, M | 1 |
| López, C | 1 |
| Francisca López-Brea, M | 1 |
| Rubio, A | 1 |
| Del Valle, A | 1 |
| García-Reija, F | 1 |
| García-Montesinos, B | 1 |
| Rodríguez-Iglesias, J | 1 |
| Hinojo, C | 1 |
| Márquez, R | 1 |
| Angel Alonso-Bermejo, M | 1 |
| Salcedo, M | 1 |
| Blanco, Y | 1 |
| Vega, N | 1 |
| López-Tarruella, S | 1 |
| Sanz-Ortiz, J | 1 |
| Maneo, A | 1 |
| Chiari, S | 2 |
| Bonazzi, C | 1 |
| Mangioni, C | 4 |
| Lissoni, AA | 1 |
| Pellegrino, A | 2 |
| Parma, G | 2 |
| Zola, P | 2 |
| Katsaros, D | 2 |
| Buda, A | 2 |
| Landoni, F | 2 |
| Peiretti, M | 1 |
| Dell'anna, T | 1 |
| Fruscio, R | 1 |
| Signorelli, M | 1 |
| Grassi, R | 1 |
| Floriani, I | 2 |
| Fossati, R | 2 |
| Torri, V | 2 |
| Rulli, E | 1 |
| Holsinger, FC | 1 |
| Kies, MS | 2 |
| Diaz, EM | 1 |
| Gillenwater, AM | 2 |
| Lewin, JS | 1 |
| Ginsberg, LE | 1 |
| Glisson, BS | 7 |
| Garden, AS | 1 |
| Ark, N | 1 |
| Lin, HY | 1 |
| Lee, JJ | 3 |
| El-Naggar, AK | 2 |
| Ki Hong, W | 1 |
| Shin, DM | 9 |
| Khuri, FR | 8 |
| Kumar, JV | 1 |
| Doval, DC | 1 |
| Rao, R | 1 |
| Rawal, S | 1 |
| Bhatt, L | 1 |
| Fernando, I | 1 |
| Saba, NF | 1 |
| Choi, M | 1 |
| Muller, S | 1 |
| Shin, HJ | 1 |
| Tighiouart, M | 1 |
| Papadimitrakopoulou, VA | 1 |
| Chen, ZG | 1 |
| Specenier, PM | 1 |
| Van Den Brande, J | 1 |
| Schrijvers, D | 1 |
| Huizing, MT | 1 |
| Altintas, S | 1 |
| Dyck, J | 1 |
| Van Den Weyngaert, D | 1 |
| Van Laer, C | 1 |
| Vermorken, JB | 1 |
| Pagliaro, LC | 1 |
| Williams, DL | 1 |
| Daliani, D | 1 |
| Williams, MB | 1 |
| Osai, W | 1 |
| Kincaid, M | 1 |
| Wen, S | 1 |
| Thall, PF | 1 |
| Pettaway, CA | 1 |
| Downs, LS | 1 |
| Chura, JC | 1 |
| Argenta, PA | 1 |
| Judson, PL | 1 |
| Ghebre, R | 1 |
| Geller, MA | 1 |
| Carson, LF | 1 |
| Huang, YC | 1 |
| Chang, PM | 1 |
| Chen, MH | 1 |
| Chu, PY | 1 |
| Tzeng, CH | 1 |
| Chang, SY | 1 |
| Yang, MH | 1 |
| Zheng, M | 1 |
| Huang, L | 1 |
| Liu, JH | 1 |
| Xiong, Y | 1 |
| Li, JD | 1 |
| Huang, X | 1 |
| He, L | 1 |
| Ren, YF | 1 |
| Wang, HY | 1 |
| Wang, Y | 1 |
| Wang, G | 1 |
| Wei, LH | 1 |
| Huang, LH | 1 |
| Wang, JL | 1 |
| Wang, SJ | 1 |
| Li, XP | 1 |
| Shen, DH | 1 |
| Bao, DM | 1 |
| Gao, J | 1 |
| Sasaki, Y | 1 |
| Kjellén, E | 1 |
| Ekblad, L | 1 |
| Wahlberg, P | 1 |
| Mineta, H | 1 |
| Wennerberg, J | 1 |
| Gong, L | 1 |
| Lou, JY | 1 |
| Wang, P | 1 |
| Zhang, JW | 1 |
| Liu, H | 1 |
| Peng, ZL | 1 |
| Wang, PL | 1 |
| Cheng, YB | 1 |
| Kuerban, G | 1 |
| Hasegawa, K | 1 |
| Okamoto, H | 1 |
| Kawamura, K | 1 |
| Kato, R | 1 |
| Kobayashi, Y | 1 |
| Sekiya, T | 1 |
| Udagawa, Y | 1 |
| Vercellino, GF | 1 |
| Piek, JM | 1 |
| Schneider, A | 1 |
| Köhler, C | 1 |
| Mangler, M | 1 |
| Speiser, D | 1 |
| Chiantera, V | 1 |
| Mouillet, G | 1 |
| Monnet, E | 1 |
| Milleron, B | 1 |
| Puyraveau, M | 1 |
| Quoix, E | 1 |
| David, P | 1 |
| Ducoloné, A | 1 |
| Molinier, O | 1 |
| Zalcman, G | 1 |
| Depierre, A | 1 |
| Westeel, V | 1 |
| Dede, DS | 1 |
| Aksoy, S | 1 |
| Cengiz, M | 1 |
| Gullu, I | 1 |
| Altundag, K | 1 |
| Pirovano, C | 1 |
| Ieda, N | 1 |
| Lippman, SM | 8 |
| Ginsberg, L | 4 |
| Diaz, E | 1 |
| Papadimitrakopoulou, V | 2 |
| Feng, L | 1 |
| Francisco, M | 1 |
| Garden, A | 1 |
| Myers, J | 1 |
| Clayman, G | 2 |
| Hong, WK | 9 |
| Gebbia, V | 1 |
| Galetta, D | 1 |
| Caruso, M | 1 |
| Verderame, F | 1 |
| Pezzella, G | 1 |
| Valdesi, M | 1 |
| Borsellino, N | 1 |
| Pandolfo, G | 1 |
| Durini, E | 1 |
| Rinaldi, M | 1 |
| Loizzi, M | 1 |
| Gebbia, N | 1 |
| Valenza, R | 1 |
| Tirrito, ML | 1 |
| Varvara, F | 1 |
| Colucci, G | 1 |
| Chen, YM | 1 |
| Shih, JF | 1 |
| Lee, CS | 1 |
| Chen, MC | 1 |
| Lin, WC | 2 |
| Tsai, CM | 2 |
| Perng, RP | 2 |
| Haddad, R | 1 |
| Posner, M | 1 |
| Fujita, A | 3 |
| Ohkubo, T | 1 |
| Hoshino, H | 1 |
| Takabatake, H | 1 |
| Tagaki, S | 1 |
| Sekine, K | 2 |
| Abe, S | 1 |
| Darnton, SJ | 6 |
| Archer, VR | 1 |
| Stocken, DD | 1 |
| Mulholland, PJ | 1 |
| Casson, AG | 1 |
| Ferry, DR | 2 |
| Airoldi, M | 1 |
| Cortesina, G | 1 |
| Giordano, C | 1 |
| Pedani, F | 1 |
| Bumma, C | 1 |
| Cavaletti, G | 1 |
| Bogliun, G | 1 |
| Marzorati, L | 1 |
| Zincone, A | 1 |
| Piatti, M | 1 |
| Lissoni, A | 3 |
| Fei, F | 3 |
| Cundari, S | 1 |
| Zanna, C | 1 |
| Sculier, JP | 1 |
| Lafitte, JJ | 1 |
| Berghmans, T | 1 |
| Van Houtte, P | 1 |
| Lecomte, J | 1 |
| Thiriaux, J | 1 |
| Efremidis, A | 1 |
| Koumakis, G | 1 |
| Giner, V | 1 |
| Richez, M | 1 |
| Corhay, JL | 1 |
| Wackenier, P | 1 |
| Lothaire, P | 1 |
| Paesmans, M | 1 |
| Mommen, P | 1 |
| Ninane, V | 1 |
| Omrcen, T | 2 |
| Gorchev, G | 1 |
| Kornovski, Ia | 1 |
| Aoki, M | 1 |
| Akahira, J | 1 |
| Niikura, H | 1 |
| Saito, S | 1 |
| Abe, Y | 1 |
| Aida, T | 1 |
| Sato, N | 1 |
| Kitamura, T | 1 |
| Otsuki, K | 1 |
| Katahira, A | 1 |
| Utsunomiya, H | 1 |
| Okamura, C | 1 |
| Takano, T | 1 |
| Ito, K | 1 |
| Okamura, K | 1 |
| Yaegashi, N | 1 |
| Watanabe, A | 1 |
| Taniguchi, M | 1 |
| Rapidis, AD | 1 |
| Gakiopoulou, H | 1 |
| Stavrianos, SD | 1 |
| Vilos, GA | 1 |
| Faratzis, G | 1 |
| Douzinas, EE | 1 |
| Givalos, N | 1 |
| Patsouris, E | 1 |
| Situm, K | 1 |
| Boraska, T | 1 |
| Frleta Ilić, N | 1 |
| Janković, S | 1 |
| Kato, D | 1 |
| Achiwa, H | 1 |
| Sato, S | 1 |
| Bessho, Y | 1 |
| Shimizu, S | 1 |
| Hattori, N | 1 |
| Maeda, H | 1 |
| Niimi, T | 1 |
| Oguri, T | 1 |
| Ueda, R | 1 |
| Gueli Alletti, D | 1 |
| Malzoni, C | 1 |
| Sartori, E | 1 |
| Duck, L | 1 |
| Devogelaer, JP | 1 |
| Persu, A | 1 |
| Berlière, M | 1 |
| Caussin, E | 1 |
| Baurain, JF | 1 |
| Machiels, JP | 1 |
| Mizuno, K | 1 |
| Kidokoro, K | 1 |
| Miyazaki, K | 1 |
| Yoshida, K | 1 |
| Nakagawa, A | 1 |
| Mizuno, M | 1 |
| Suzuki, S | 1 |
| Kuno, N | 1 |
| Furuhashi, M | 1 |
| Ishizuka, T | 1 |
| Ishikawa, K | 1 |
| Boutemy, M | 1 |
| Mispelaere, D | 1 |
| Krzisch, C | 1 |
| Jounieaux, V | 1 |
| Galsky, MD | 1 |
| Iasonos, A | 1 |
| Mironov, S | 1 |
| Scattergood, J | 1 |
| Donat, SM | 1 |
| Bochner, BH | 1 |
| Herr, HW | 1 |
| Russo, P | 1 |
| Boyle, MG | 1 |
| Bajorin, DF | 1 |
| Khoury-Collado, F | 1 |
| Bowes, RJ | 1 |
| Jhamb, N | 1 |
| Aghajanian, C | 1 |
| Abu-Rustum, NR | 1 |
| Ferrandina, G | 1 |
| Fanfani, F | 1 |
| Ludovisi, M | 1 |
| Fagotti, A | 1 |
| Carbone, A | 1 |
| Zannoni, G | 1 |
| Guerriero, M | 1 |
| Petrillo, M | 1 |
| Scambia, G | 1 |
| Han, JQ | 1 |
| Han, CY | 1 |
| Bi, YH | 1 |
| Park, BB | 1 |
| Im, YH | 1 |
| Hwang, IG | 1 |
| Lee, SC | 1 |
| Ahn, JS | 1 |
| Ahn, MJ | 1 |
| Lim, HY | 1 |
| Kang, WK | 1 |
| Park, K | 1 |
| Recchia, F | 2 |
| Candeloro, G | 1 |
| Di Staso, M | 1 |
| Necozione, S | 1 |
| Bisegna, R | 1 |
| Bratta, M | 1 |
| Tombolini, V | 1 |
| Rea, S | 2 |
| Drings, P | 4 |
| Stiefel, P | 3 |
| Dirks, HP | 1 |
| Grimm, V | 1 |
| Kleckow, M | 2 |
| Manke, HG | 3 |
| Queisser, W | 2 |
| Abel, U | 2 |
| Heinrich, S | 1 |
| Saiers, JH | 2 |
| Slavik, M | 2 |
| Harrison, EF | 1 |
| Hawke, JE | 1 |
| Hunter, HL | 1 |
| Costanzi, JJ | 3 |
| Morgan, LR | 2 |
| Plotkin, D | 1 |
| Tucker, WG | 1 |
| Worrall, PM | 1 |
| Hokanson, J | 1 |
| Holoye, PY | 2 |
| Anderson, T | 2 |
| Duelge, J | 2 |
| Hansen, RM | 2 |
| Ritch, PS | 2 |
| Bakowski, MT | 1 |
| Crouch, JC | 1 |
| Joss, RA | 1 |
| Cavalli, F | 1 |
| Goldhirsch, A | 1 |
| Mermillod, B | 1 |
| Brunner, KW | 1 |
| Araujo, CE | 4 |
| Tessler, J | 1 |
| Focan, C | 1 |
| Salamon, E | 1 |
| Le Hung, S | 1 |
| Frère, MH | 1 |
| Mbuyamba, P | 1 |
| Claessens, JJ | 1 |
| Gad-el-Mawla, N | 1 |
| Ziegler, JL | 1 |
| Hamza, R | 1 |
| Elserafi, M | 1 |
| Khaled, H | 1 |
| Matthiessen, W | 1 |
| Stempinski, E | 1 |
| Göbel, D | 1 |
| Thalmann, U | 1 |
| Kohno, I | 1 |
| Kazuta, M | 1 |
| Miyao, J | 1 |
| Kunimi, N | 1 |
| Kawamoto, M | 1 |
| Tanimura, T | 1 |
| Fujiwara, K | 1 |
| Sekiba, K | 1 |
| Issell, BF | 3 |
| MacFadyen, BV | 1 |
| Gum, ET | 1 |
| Valdivieso, M | 3 |
| Dudrick, SJ | 2 |
| Bodey, GP | 3 |
| Benner, SE | 2 |
| Huber, MH | 2 |
| Murad, AM | 1 |
| Triginelli, SA | 1 |
| Ribalta, JC | 1 |
| Singhal, RM | 1 |
| Jindel, R | 1 |
| Gupta, AK | 1 |
| Kumar, L | 2 |
| Kaushal, R | 1 |
| Nandy, M | 1 |
| Biswal, BM | 1 |
| Kumar, S | 1 |
| Kriplani, A | 1 |
| Singh, R | 1 |
| Rath, GK | 1 |
| Kochupillai, V | 1 |
| Forastiere, AA | 1 |
| Urba, SG | 1 |
| Wagner, W | 2 |
| von Eiff, M | 1 |
| Klinke, F | 1 |
| Micke, O | 1 |
| Rübe, C | 1 |
| Willich, N | 1 |
| Zulian, GB | 1 |
| Tullen, E | 1 |
| Maton, B | 1 |
| Cervellino, JC | 3 |
| Sánchez, O | 2 |
| Miles, H | 1 |
| Nishihama, A | 1 |
| Somma-Mauvais, H | 1 |
| Farisse, P | 1 |
| Viallat, JR | 1 |
| Antonakopoulos, GN | 1 |
| Newman, J | 1 |
| Duffy, JP | 2 |
| Matthews, HR | 5 |
| Fanning, J | 1 |
| Ladd, C | 1 |
| Hilgers, RD | 1 |
| Allen, SM | 2 |
| Walker, SJ | 1 |
| Cullen, MH | 3 |
| Filtenborg, TA | 1 |
| Hansen, HH | 1 |
| Aage Engelholm, S | 1 |
| Rørth, M | 1 |
| Martín, M | 1 |
| Diaz-Rubio, E | 1 |
| González Larriba, JL | 1 |
| Casado, A | 1 |
| Sastre, J | 1 |
| López-Vega, JM | 1 |
| Almenarez, J | 1 |
| Dominguez, S | 1 |
| Edwards, CW | 1 |
| Sutton, GP | 4 |
| Blessing, JA | 6 |
| McGuire, WP | 1 |
| Patton, T | 1 |
| Look, KY | 1 |
| Jenner, K | 1 |
| Steyn, RS | 2 |
| Souquet, PJ | 1 |
| Fournel, P | 1 |
| Bohas, CH | 1 |
| Fortune, IC | 1 |
| Chatte, G | 1 |
| Niehues, T | 1 |
| Harms, D | 1 |
| Jürgens, H | 1 |
| Göbel, U | 1 |
| Shirinian, M | 2 |
| Dimery, IW | 1 |
| Dunnington, JS | 1 |
| Vansteenkiste, J | 1 |
| Vandebroek, J | 1 |
| Mariën, S | 1 |
| Roex, L | 1 |
| Bertrand, P | 1 |
| Bockaert, J | 1 |
| De Beukelaar, T | 1 |
| Deman, R | 1 |
| De Muynck, P | 1 |
| Ulrichts, H | 1 |
| Lokich, J | 1 |
| Anderson, N | 1 |
| Moore, C | 1 |
| Bern, M | 1 |
| Coco, F | 1 |
| Dow, E | 1 |
| Scagliotti, GV | 1 |
| Ricardi, U | 1 |
| Crinó, L | 1 |
| Maranzano, E | 1 |
| De Marinis, F | 1 |
| Morandi, MG | 1 |
| Meacci, L | 1 |
| Marangolo, M | 1 |
| Emiliani, E | 1 |
| Rosti, G | 1 |
| Figoli, F | 1 |
| Bolzicco, G | 1 |
| Masiero, P | 1 |
| Gentile, A | 1 |
| Tonato, M | 1 |
| Omura, GA | 1 |
| Vaccarello, L | 1 |
| Berman, ML | 3 |
| Clarke-Pearson, DL | 1 |
| Mutch, DG | 1 |
| Anderson, B | 1 |
| Kyriakakis, Z | 1 |
| Kostakopoulos, A | 1 |
| Karayiannis, A | 1 |
| Sofras, F | 1 |
| Zervas, A | 1 |
| Giannopoulos, A | 1 |
| Dimopoulos, C | 1 |
| Noda, K | 1 |
| Hirabayashi, K | 2 |
| Terashima, Y | 1 |
| Ozaki, M | 1 |
| Yakushiji, M | 2 |
| Hatae, M | 1 |
| Kanazawa, K | 1 |
| Sur, M | 1 |
| Taylor, L | 1 |
| Cooper, K | 1 |
| Sur, RK | 1 |
| Lawhorn, K | 2 |
| Sandler, A | 1 |
| Saxman, S | 1 |
| Bandealy, M | 1 |
| Heilman, D | 1 |
| Monaco, F | 1 |
| McClean, J | 1 |
| Arquette, M | 1 |
| Ang, KK | 2 |
| Clayman, GL | 1 |
| Callender, DL | 1 |
| Latz, D | 1 |
| Schulze, T | 1 |
| Manegold, C | 1 |
| Schraube, P | 1 |
| Flentje, M | 1 |
| Weber, KJ | 1 |
| McManus, KG | 1 |
| McAleer, JA | 1 |
| Zanetta, G | 2 |
| Sessa, C | 1 |
| Gueli-Alletti, D | 1 |
| Kodama, J | 1 |
| Ikuhashi, H | 1 |
| Hongo, A | 1 |
| Mizutani, Y | 1 |
| Miyagi, Y | 1 |
| Yoshinouchi, M | 1 |
| Kobashi, Y | 1 |
| Okuda, H | 1 |
| Kudo, T | 1 |
| Sánchez Parra, M | 1 |
| Churruca, C | 1 |
| Paredes, A | 1 |
| Lacasta, A | 1 |
| López de Argumedo, G | 1 |
| Alvárez, I | 1 |
| Abad, T | 1 |
| Egana, L | 1 |
| Guimón, E | 1 |
| Piera, JM | 1 |
| Levitan, N | 1 |
| Dowlati, A | 1 |
| Craffey, M | 1 |
| Tahsildar, H | 1 |
| MacKay, W | 1 |
| McKenney, J | 1 |
| Remick, SC | 1 |
| Brücker, C | 1 |
| Sieg, P | 2 |
| Chen, Y | 1 |
| Yang, KY | 1 |
| Wu, HW | 1 |
| Whang-Peng, J | 1 |
| Domínguez, ME | 1 |
| Machiavelli, MR | 1 |
| Lacava, JA | 1 |
| Romero, AO | 1 |
| Ortiz, EH | 1 |
| Grasso, S | 1 |
| Amato, S | 1 |
| Rodríguez, R | 1 |
| Barbieri, M | 1 |
| Romero Acuña, J | 1 |
| Focaccia, G | 1 |
| Suttora, G | 1 |
| Scenna, M | 1 |
| Boughen, JM | 1 |
| Romero Acuña, LA | 1 |
| Langhi, MJ | 1 |
| Ressel, A | 1 |
| Weiss, C | 1 |
| Feyerabend, T | 2 |
| Papadimitrakopoulou, VM | 1 |
| Thurnher, D | 1 |
| Kornfehl, J | 1 |
| Burian, M | 1 |
| Gedlicka, C | 1 |
| Selzer, E | 1 |
| Quint, C | 1 |
| Neuchrist, C | 1 |
| Kornek, GV | 1 |
| Sommer, K | 1 |
| Peters, SO | 1 |
| Robins, IH | 1 |
| Raap, M | 1 |
| Wiedemann, GJ | 1 |
| Remmert, S | 1 |
| Bittner, C | 1 |
| Hermann, RM | 1 |
| Krech, R | 1 |
| Hartlapp, J | 1 |
| Esser, E | 1 |
| Christoph, B | 1 |
| Müller, MK | 1 |
| Lalli, A | 1 |
| Lombardo, M | 1 |
| De Filippis, S | 1 |
| Saggio, G | 1 |
| Fabbri, F | 1 |
| Rosselli, M | 1 |
| Capomolla, E | 1 |
| Bloss, JD | 1 |
| Behrens, BC | 1 |
| Mannel, RS | 1 |
| Rader, JS | 1 |
| Sood, AK | 1 |
| Markman, M | 1 |
| Benda, J | 1 |
| Zaren, HA | 1 |
| Freireich, EJ | 1 |
| Copeland, EW | 1 |
| Gagliano, R | 1 |
| Loukas, D | 1 |
| Panettiere, FJ | 1 |
| Hokanson, JA | 1 |
| Hersh, EM | 1 |
| Richman, S | 1 |
| Gutterman, JU | 1 |
| Tay, SK | 1 |
| Lai, FM | 1 |
| Soh, LT | 1 |
| Ho, TH | 1 |
| Ang, PT | 1 |
| Au, E | 1 |
| Lee, JS | 1 |
| Dhingra, HH | 1 |
| Greenberg, J | 1 |
| Okada, E | 1 |
| Nakazuma, Y | 1 |
| Akamatsu, Y | 1 |
| Sezaki, H | 1 |
| Ohta, M | 1 |
| Nakanishi, Y | 1 |
| Buxton, EJ | 4 |
| Kuehnle, H | 1 |
| Meerpohl, HG | 1 |
| Eiermann, W | 2 |
| Achterrath, W | 1 |
| Arai, N | 1 |
| Annoh, S | 1 |
| Kaneko, H | 1 |
| Umeda, M | 1 |
| Tsukahara, T | 1 |
| Shirai, T | 1 |
| Saunders, N | 1 |
| Blackledge, GR | 1 |
| Kelly, K | 1 |
| Redman, CW | 1 |
| Monaghan, J | 2 |
| Paterson, ME | 1 |
| Luesley, DM | 1 |
| Bhargava, VL | 1 |
| Hannigan, EV | 1 |
| Dinh, TV | 1 |
| Doherty, MG | 1 |
| Pirisi, C | 2 |
| Francia, A | 1 |
| Cerruti, R | 1 |
| Inoue, Y | 2 |
| Sasaki, H | 1 |
| Nakajima, S | 1 |
| Honda, R | 2 |
| Asakawa, M | 2 |
| Suzuki, A | 2 |
| Brosto, M | 1 |
| Rossi, R | 1 |
| Photopulos, G | 2 |
| Homesley, HD | 2 |
| Fujii, M | 1 |
| Segawa, Y | 1 |
| Matsutomo, S | 1 |
| Genba, K | 1 |
| Paccagnella, A | 1 |
| Favaretto, A | 1 |
| Brandes, A | 1 |
| Ghiotto, C | 1 |
| Fornasiero, A | 1 |
| Volpi, A | 1 |
| Pappagallo, G | 1 |
| Festi, G | 1 |
| Cipriani, A | 1 |
| Vinante, O | 1 |
| Coleman, RE | 2 |
| Clarke, JM | 1 |
| Slevin, ML | 2 |
| Sweetenham, J | 1 |
| Williams, CJ | 1 |
| Blake, P | 1 |
| Calman, F | 1 |
| Wiltshaw, E | 1 |
| Harper, PG | 2 |
| Lara, PC | 1 |
| Garcia-Puche, JL | 1 |
| Pedraza, V | 1 |
| Barton, C | 1 |
| Blackledge, G | 3 |
| Mould, JJ | 3 |
| Meanwell, CA | 3 |
| Paterson, M | 1 |
| Tobias, J | 1 |
| Alcock, C | 1 |
| Spooner, D | 2 |
| Nishida, T | 1 |
| Nagasue, N | 1 |
| Arimatsu, T | 1 |
| Nagano, H | 1 |
| Izumi, S | 1 |
| Okura, N | 1 |
| Matsumura, T | 1 |
| Ansell, SM | 1 |
| Alberts, AS | 1 |
| Falkson, G | 1 |
| Adcock, L | 1 |
| Webster, KD | 1 |
| DeEulis, T | 1 |
| Meier, W | 1 |
| Stieber, P | 1 |
| Fateh-Moghadam, A | 1 |
| Hepp, H | 1 |
| Ardizzoni, A | 1 |
| Fusco, V | 1 |
| Gulisano, M | 1 |
| Pronzato, P | 1 |
| Baracco, F | 1 |
| Capaccio, A | 1 |
| Pastorino, G | 1 |
| Nosenzo, M | 1 |
| Felletti, R | 1 |
| Fabiano, F | 1 |
| Ohnoshi, T | 1 |
| Hiraki, S | 1 |
| Ueoka, H | 1 |
| Tamura, T | 1 |
| Kawahara, S | 1 |
| Yonei, T | 1 |
| Yamashita, H | 1 |
| Ishii, J | 1 |
| Tamai, M | 1 |
| Egawa, T | 1 |
| Becker, H | 1 |
| Bülzebruck, H | 2 |
| Djawid, N | 1 |
| Ruchalla, E | 1 |
| Tessen, HW | 1 |
| Paschke, R | 1 |
| Worst, P | 1 |
| Brust, J | 1 |
| Banks, J | 1 |
| Anderson, EG | 1 |
| Smith, AP | 1 |
| Gatzemeier, U | 1 |
| Hossfeld, DK | 1 |
| Radenbach, D | 1 |
| Zschaber, R | 1 |
| Lawton, FG | 1 |
| Stuart, NS | 1 |
| Kavanagh, J | 1 |
| Latief, TN | 1 |
| Chetiyawardana, AD | 1 |
| Nanus, DM | 1 |
| Kelsen, DP | 1 |
| Lipperman, R | 1 |
| Eisenberger, M | 1 |
| Verweij, J | 1 |
| Alexieva-Figusch, J | 1 |
| de Boer, MF | 1 |
| Reichgelt, B | 1 |
| Stoter, G | 1 |
| Gallagher, C | 1 |
| Osborne, R | 1 |
| Rankin, EM | 1 |
| Silverstone, AC | 1 |
| Souhami, RL | 1 |
| Tobias, JS | 1 |
| Trask, CW | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers[NCT01587703] | Phase 1 | 196 participants (Actual) | Interventional | 2012-03-28 | Completed | ||
| Prospective Study for the Validation of the Genetic Signature 354849 to Predict the Response to Standard Treatment in Patients With Locally Advanced Cervical Cancer[NCT04067882] | 189 participants (Anticipated) | Observational | 2019-09-30 | Recruiting | |||
| Multicenter Prospective Randomized Study on NeoAdjuvant Chemotherapy Followed by Radical Hysterectomy (OP) Versus Primary Chemo-RADiation in Patients With Cervical Cancer FIGO Stage IB2 and IIB[NCT02422563] | Phase 3 | 534 participants (Anticipated) | Interventional | 2015-10-31 | Not yet recruiting | ||
| A Randomized Phase II Study to Evaluate the Efficacy and Safety of Cetuximab in Metastatic Penile Carcinoma[NCT02014831] | Phase 2 | 0 participants (Actual) | Interventional | 2016-02-29 | Withdrawn (stopped due to Industry decline to supply study drug) | ||
| A Phase II Study of (Neoadjuvant Chemotherapy Trial Prior to Extirpative Surgery) for Clinical Stage TanyN2-3M0 Squamous Cell Carcinoma of the Penis[NCT00512096] | Phase 2 | 30 participants (Actual) | Interventional | 1999-08-31 | Completed | ||
| Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC): an Open-label, Single-center, Phase 2, Single-arm Trial (CaboPen)[NCT03943602] | Phase 2 | 37 participants (Anticipated) | Interventional | 2019-08-01 | Recruiting | ||
| Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC[NCT00198354] | Phase 3 | 530 participants (Actual) | Interventional | 2001-05-31 | Completed | ||
| "Phase III Clinical Trial: Evaluation of the Combination of TRANSKRIP ® Plus Carboplatin and Paclitaxel as First Line Chemotherapy on Survival of Patients With Recurrent - Persistent Cervical Cancer"[NCT02446652] | Phase 3 | 230 participants (Anticipated) | Interventional | 2015-07-31 | Not yet recruiting | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points. (NCT01587703)
Timeframe: Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)
| Intervention | Per hour (Geometric Mean) |
|---|---|
| GSK525762 80 mg Amorphous+6 mg Stable Isotope | 5.628 |
| GSK525762 80 mg Besylate+6 mg Stable Isotope | 5.176 |
| GSK525762 30 mg Besylate+6 mg Stable Isotope | 5.088 |
| GSK525762 80 mg Besylate Fed | 5.954 |
Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points. (NCT01587703)
Timeframe: Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)
| Intervention | Nanograms per milliliter (Geometric Mean) |
|---|---|
| GSK525762 80 mg Amorphous+6 mg Stable Isotope | 1431.41 |
| GSK525762 80 mg Besylate+6 mg Stable Isotope | 1483.21 |
| GSK525762 30 mg Besylate+6 mg Stable Isotope | 655.33 |
| GSK525762 80 mg Besylate Fed | 1305.59 |
The number of participants who had any dose reductions or delays is presented. (NCT01587703)
Timeframe: Median of 1.87 months of drug exposure
| Intervention | Participants (Count of Participants) |
|---|---|
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 3 |
| 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 1 |
The number of participants who had any dose reductions or delays is presented. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) |
|---|---|
| Part 1: GSK525762 20 mg BID | 0 |
| Part 1: GSK525762 30 mg BID | 3 |
| Part 1: GSK525762 40 mg BID | 1 |
The number of participants who had any dose reductions or delays is presented. (NCT01587703)
Timeframe: Median of 1.38 months of drug exposure
| Intervention | Participants (Count of Participants) |
|---|---|
| Part 1: GSK525762 2 mg QD | 0 |
| Part 1: GSK525762 4 mg QD | 0 |
| Part 1: GSK525762 8 mg QD | 0 |
| Part 1: GSK525762 16 mg QD | 0 |
| Part 1: GSK525762 30 mg QD | 0 |
| Part 1: GSK525762 60 mg QD | 2 |
| Part 1: GSK525762 80 mg QD | 8 |
| Part 1: GSK525762 100 mg QD | 7 |
The number of participants who had any dose reductions or delays is presented. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) |
|---|---|
| Participants With NMC | 7 |
| Participants With SCLC | 4 |
| Participants With CRPC | 11 |
| Participants With TNBC | 6 |
| Participants With ER+BC | 6 |
| Participants With GIST | 4 |
PSA 50 response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals. (NCT01587703)
Timeframe: Median of 1.38 months of drug exposure
| Intervention | Participants (Number) |
|---|---|
| Part 1: GSK525762 2 mg QD | 0 |
| Part 1: GSK525762 4 mg QD | 0 |
| Part 1: GSK525762 8 mg QD | 0 |
| Part 1: GSK525762 16 mg QD | 0 |
| Part 1: GSK525762 30 mg QD | 0 |
| Part 1: GSK525762 60 mg QD | 0 |
| Part 1: GSK525762 80 mg QD | 2 |
| Part 1: GSK525762 100 mg QD | 1 |
PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Participants (Number) |
|---|---|
| Part 1: GSK525762 20 mg BID | 0 |
| Part 1: GSK525762 30 mg BID | 0 |
| Part 1: GSK525762 40 mg BID | 0 |
PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals. (NCT01587703)
Timeframe: Median of 1.87 months of drug exposure
| Intervention | Participants (Number) |
|---|---|
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 0 |
| 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 0 |
PSA 50 response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Participants (Number) |
|---|---|
| Participants With NMC | 0 |
| Participants With SCLC | 0 |
| Participants With CRPC | 0 |
| Participants With TNBC | 0 |
| Participants With ER+BC | 0 |
| Participants With GIST | 0 |
Number of participants withdrawn due to toxicities is presented. (NCT01587703)
Timeframe: Median of 1.87 months of drug exposure
| Intervention | Participants (Count of Participants) |
|---|---|
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 0 |
| 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 0 |
Number of participants withdrawn due to toxicities is presented. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) |
|---|---|
| Part 1: GSK525762 20 mg BID | 0 |
| Part 1: GSK525762 30 mg BID | 2 |
| Part 1: GSK525762 40 mg BID | 2 |
Number of participants withdrawn due to toxicities is presented. (NCT01587703)
Timeframe: Median of 1.38 months of drug exposure
| Intervention | Participants (Count of Participants) |
|---|---|
| Part 1: GSK525762 2 mg QD | 0 |
| Part 1: GSK525762 4 mg QD | 1 |
| Part 1: GSK525762 8 mg QD | 0 |
| Part 1: GSK525762 16 mg QD | 0 |
| Part 1: GSK525762 30 mg QD | 0 |
| Part 1: GSK525762 60 mg QD | 2 |
| Part 1: GSK525762 80 mg QD | 7 |
| Part 1: GSK525762 100 mg QD | 2 |
Number of participants withdrawn due to toxicities is presented. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) |
|---|---|
| Participants With NMC | 1 |
| Participants With SCLC | 3 |
| Participants With CRPC | 6 |
| Participants With TNBC | 4 |
| Participants With ER+BC | 6 |
| Participants With GIST | 2 |
Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. (NCT01587703)
Timeframe: Median of 1.87 months of drug exposure
| Intervention | Percentage of participants (Number) |
|---|---|
| All Participants in Besylate Substudy | 0 |
Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Percentage of participants (Number) |
|---|---|
| Part 1: GSK525762 20 mg BID | 0 |
| Part 1: GSK525762 30 mg BID | 0 |
| Part 1: GSK525762 40 mg BID | 0 |
Overall response rate is defined as the percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST version (v) 1.1). CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. (NCT01587703)
Timeframe: Median of 1.38 months of drug exposure
| Intervention | Percentage of participants (Number) |
|---|---|
| Part 1: GSK525762 2 mg QD | 0 |
| Part 1: GSK525762 4 mg QD | 25 |
| Part 1: GSK525762 8 mg QD | 0 |
| Part 1: GSK525762 16 mg QD | 0 |
| Part 1: GSK525762 30 mg QD | 0 |
| Part 1: GSK525762 60 mg QD | 0 |
| Part 1: GSK525762 80 mg QD | 3 |
| Part 1: GSK525762 100 mg QD | 11 |
Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Percentage of participants (Number) |
|---|---|
| Participants With NMC | 8 |
| Participants With SCLC | 0 |
| Participants With CRPC | 4 |
| Participants With TNBC | 0 |
| Participants With ER+BC | 0 |
| Participants With GIST | 0 |
Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method. (NCT01587703)
Timeframe: Median of 1.87 months of drug exposure
| Intervention | Months (Median) |
|---|---|
| All Participants in Besylate Substudy | 6.3 |
Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Months (Median) |
|---|---|
| Part 1: GSK525762 20 mg BID | NA |
| Part 1: GSK525762 30 mg BID | 6.0 |
| Part 1: GSK525762 40 mg BID | 13.3 |
Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method. (NCT01587703)
Timeframe: Median of 1.38 months of drug exposure
| Intervention | Months (Median) |
|---|---|
| Part 1: GSK525762 2 mg QD | 0.6 |
| Part 1: GSK525762 4 mg QD | 4.1 |
| Part 1: GSK525762 8 mg QD | 2.2 |
| Part 1: GSK525762 16 mg QD | 9.1 |
| Part 1: GSK525762 30 mg QD | 3.8 |
| Part 1: GSK525762 60 mg QD | 8.9 |
| Part 1: GSK525762 80 mg QD | 7.1 |
| Part 1: GSK525762 100 mg QD | 9.8 |
Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Months (Median) |
|---|---|
| Participants With NMC | 5.0 |
| Participants With SCLC | 2.6 |
| Participants With CRPC | 9.1 |
| Participants With TNBC | 5.0 |
| Participants With ER+BC | 8.8 |
| Participants With GIST | 7.3 |
Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and the date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method. (NCT01587703)
Timeframe: Median of 1.87 months of drug exposure
| Intervention | Months (Median) |
|---|---|
| All Participants in Besylate Substudy | 3.5 |
Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Months (Median) |
|---|---|
| Part 1: GSK525762 20 mg BID | 7.7 |
| Part 1: GSK525762 30 mg BID | 5.6 |
| Part 1: GSK525762 40 mg BID | 8.0 |
Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method. (NCT01587703)
Timeframe: Median of 1.38 months of drug exposure
| Intervention | Months (Median) |
|---|---|
| Part 1: GSK525762 2 mg QD | 0.3 |
| Part 1: GSK525762 4 mg QD | 4.1 |
| Part 1: GSK525762 8 mg QD | 2.2 |
| Part 1: GSK525762 16 mg QD | 9.1 |
| Part 1: GSK525762 30 mg QD | 3.8 |
| Part 1: GSK525762 60 mg QD | 3.6 |
| Part 1: GSK525762 80 mg QD | 6.5 |
| Part 1: GSK525762 100 mg QD | 7.5 |
Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and the date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Months (Median) |
|---|---|
| Participants With NMC | 4.8 |
| Participants With SCLC | 2.2 |
| Participants With CRPC | 8.0 |
| Participants With TNBC | 2.4 |
| Participants With ER+BC | 4.7 |
| Participants With GIST | 3.4 |
Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points. (NCT01587703)
Timeframe: Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)
| Intervention | Hours (Median) |
|---|---|
| GSK525762 80 mg Amorphous+6 mg Stable Isotope | 0.5833 |
| GSK525762 80 mg Besylate+6 mg Stable Isotope | 0.8083 |
| GSK525762 30 mg Besylate+6 mg Stable Isotope | 0.8333 |
| GSK525762 80 mg Besylate Fed | 2.0000 |
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762. (NCT01587703)
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4
| Intervention | Liter per hour (Geometric Mean) | |||
|---|---|---|---|---|
| Week1 AM dose;n=3,10,5 | Week1 PM dose;n=4,7,5 | Week3 AM dose;n=3,7,3 | Week3 PM dose;n=3,5,3 | |
| Part 1: GSK525762 20 mg BID | 23.246 | 21.745 | 16.731 | 18.867 |
| Part 1: GSK525762 30 mg BID | 9.621 | 11.057 | 11.949 | 20.133 |
| Part 1: GSK525762 40 mg BID | 14.155 | 16.382 | 34.623 | 37.097 |
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762. (NCT01587703)
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4
| Intervention | Liter per hour (Geometric Mean) | |
|---|---|---|
| Week1;n=3,4,1,3,4,9,32,9 | Week3;n=1,2,1,3,4,6,16,6 | |
| Part 1: GSK525762 100 mg QD | 13.707 | 26.188 |
| Part 1: GSK525762 16 mg QD | 18.036 | 23.823 |
| Part 1: GSK525762 2 mg QD | 11.467 | 13.082 |
| Part 1: GSK525762 30 mg QD | 6.720 | 9.535 |
| Part 1: GSK525762 4 mg QD | 11.085 | 11.955 |
| Part 1: GSK525762 60 mg QD | 13.769 | 23.296 |
| Part 1: GSK525762 8 mg QD | 18.470 | 24.277 |
| Part 1: GSK525762 80 mg QD | 13.589 | 27.029 |
Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points. Besylate sub-study pharmacokinetic (PK) Parameter Population consisted of all participants in the PK Parameter Population who participated in the besylate substudy. (NCT01587703)
Timeframe: Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)
| Intervention | Hours*nanograms per milliliter (Geometric Mean) | ||
|---|---|---|---|
| AUC(0 to 24) | AUC(0 to inf) | AUC(0 to t) | |
| GSK525762 30 mg Besylate+6 mg Stable Isotope | 2977.3 | 3096.9 | 3053.9 |
| GSK525762 80 mg Amorphous+6 mg Stable Isotope | 6954.3 | 7292.0 | 7227.1 |
| GSK525762 80 mg Besylate Fed | 9123.8 | 9727.7 | 9597.1 |
| GSK525762 80 mg Besylate+6 mg Stable Isotope | 7377.9 | 7703.4 | 7657.6 |
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762. (NCT01587703)
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4
| Intervention | Hours*nanogram per milliter (Geometric Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| AUC (0 to 24); Week1 AM dose;n=3,10,5 | AUC (0 to 24); Week1 PM dose;n=4,7,5 | AUC (0 to 24); Week3 AM dose;n=3,7,3 | AUC (0 to 24); Week3 PM dose;n=3,5,3 | AUC (0 to inf); Week1 AM dose;n=3,10,5 | AUC (0 to t); Week1 AM dose;n=4,10,5 | AUC (0 to t); Week1 PM dose;n=4,9,5 | AUC (0 to t); Week3 AM dose;n=3,7,3 | AUC (0 to t); Week3 PM dose;n=3,6,3 | |
| Part 1: GSK525762 20 mg BID | 856.1 | 981.4 | 1279.0 | 1155.8 | 860.4 | 932.2 | 927.5 | 1194.6 | 1053.6 |
| Part 1: GSK525762 30 mg BID | 3067.0 | 3261.1 | 2725.3 | 1662.1 | 3118.3 | 2727.2 | 2840.4 | 2472.4 | 1490.8 |
| Part 1: GSK525762 40 mg BID | 2794.4 | 2607.6 | 1184.6 | 1131.6 | 2825.8 | 2579.0 | 2446.7 | 1140.9 | 1073.6 |
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762. PK parameter population comprised of all participants in the PK Concentration Population (all participants in the All Treated Population for whom a blood sample for pharmacokinetics is obtained and analyzed) for whom a PK parameter has been obtained. (NCT01587703)
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4
| Intervention | Hours*nanogram per milliliter (Geometric Mean) | ||||
|---|---|---|---|---|---|
| AUC (0 to 24); Week1;n=3,4,1,3,4,9,32,9 | AUC (0 to 24); Week3;n=1,2,1,3,4,6,16,6 | AUC (0 to inf); Week1;n=3,4,1,3,4,9,32,9 | AUC (0 to t); Week1;n=3,4,1,3,4,9,32,9 | AUC (0 to t); Week3;n=1,2,1,3,4,6,16,6 | |
| Part 1: GSK525762 100 mg QD | 6958.3 | 3818.5 | 7295.6 | 7218.4 | 3819.9 |
| Part 1: GSK525762 16 mg QD | 867.9 | 671.6 | 887.1 | 877.7 | 672.3 |
| Part 1: GSK525762 2 mg QD | 169.2 | 152.9 | 174.4 | 168.6 | 152.8 |
| Part 1: GSK525762 30 mg QD | 3943.2 | 3146.2 | 4464.5 | 4147.8 | 3164.3 |
| Part 1: GSK525762 4 mg QD | 354.3 | 334.6 | 360.8 | 357.5 | 334.3 |
| Part 1: GSK525762 60 mg QD | 4225.0 | 2575.6 | 4357.5 | 4304.1 | 2576.9 |
| Part 1: GSK525762 8 mg QD | 431.5 | 329.5 | 433.1 | 431.1 | 330.6 |
| Part 1: GSK525762 80 mg QD | 5692.4 | 2959.8 | 5887.2 | 5667.3 | 2953.8 |
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762. (NCT01587703)
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4
| Intervention | Per hour (Geometric Mean) | |||
|---|---|---|---|---|
| Week1 AM dose;n=3,10,5 | Week1 PM dose;n=3,7,3 | Week3 AM dose;n=3,7,3 | Week3 PM dose;n=3,5,3 | |
| Part 1: GSK525762 20 mg BID | 0.23463 | 0.21171 | 0.23565 | 0.20507 |
| Part 1: GSK525762 30 mg BID | 0.19989 | 0.14307 | 0.21751 | 0.19263 |
| Part 1: GSK525762 40 mg BID | 0.23721 | 0.18789 | 0.30868 | 0.29133 |
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762. (NCT01587703)
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4
| Intervention | Per hour (Geometric Mean) | |
|---|---|---|
| Week1;n=3,4,1,3,4,9,32,9 | Week3;n=1,2,1,3,4,6,16,6 | |
| Part 1: GSK525762 100 mg QD | 0.10992 | 0.17560 |
| Part 1: GSK525762 16 mg QD | 0.09903 | 0.15599 |
| Part 1: GSK525762 2 mg QD | 0.21411 | 0.15579 |
| Part 1: GSK525762 30 mg QD | 0.07863 | 0.12513 |
| Part 1: GSK525762 4 mg QD | 0.13554 | 0.15472 |
| Part 1: GSK525762 60 mg QD | 0.12468 | 0.17629 |
| Part 1: GSK525762 8 mg QD | 0.23126 | 0.14087 |
| Part 1: GSK525762 80 mg QD | 0.15613 | 0.16667 |
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762. (NCT01587703)
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4
| Intervention | Nanogram per milliliter (Geometric Mean) | |
|---|---|---|
| Week1;n=3,4,1,3,4,9,32,9 | Week3;n=1,2,1,3,4,6,16,6 | |
| Part 1: GSK525762 100 mg QD | 1080.49 | 918.56 |
| Part 1: GSK525762 16 mg QD | 179.45 | 137.57 |
| Part 1: GSK525762 2 mg QD | 50.95 | 52.04 |
| Part 1: GSK525762 30 mg QD | 603.92 | 602.70 |
| Part 1: GSK525762 4 mg QD | 70.46 | 53.37 |
| Part 1: GSK525762 60 mg QD | 889.52 | 633.71 |
| Part 1: GSK525762 8 mg QD | 120.35 | 103.18 |
| Part 1: GSK525762 80 mg QD | 1099.81 | 815.40 |
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762. (NCT01587703)
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4
| Intervention | Nanogram per milliter (Geometric Mean) | |||
|---|---|---|---|---|
| Week1 AM dose;n=4,10,5 | Week1 PM dose;n=4,9,5 | Week3 AM dose;n=3,7,3 | Week3 PM dose;n=3,6,3 | |
| Part 1: GSK525762 20 mg BID | 231.68 | 166.62 | 284.71 | 256.08 |
| Part 1: GSK525762 30 mg BID | 628.01 | 445.17 | 604.38 | 263.72 |
| Part 1: GSK525762 40 mg BID | 703.31 | 425.76 | 419.15 | 229.91 |
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is 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; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment. All Treated Population comprised of all participants who received at least one dose of study treatment. (NCT01587703)
Timeframe: Median of 1.38 months of drug exposure
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Any AE | Any SAE | |
| Part 1: GSK525762 100 mg QD | 9 | 3 |
| Part 1: GSK525762 16 mg QD | 3 | 0 |
| Part 1: GSK525762 2 mg QD | 3 | 0 |
| Part 1: GSK525762 30 mg QD | 3 | 1 |
| Part 1: GSK525762 4 mg QD | 4 | 2 |
| Part 1: GSK525762 60 mg QD | 9 | 2 |
| Part 1: GSK525762 8 mg QD | 1 | 0 |
| Part 1: GSK525762 80 mg QD | 31 | 21 |
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is 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; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Any AE | Any SAE | |
| Part 1: GSK525762 20 mg BID | 4 | 0 |
| Part 1: GSK525762 30 mg BID | 10 | 4 |
| Part 1: GSK525762 40 mg BID | 5 | 2 |
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is 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; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Any AE | Any SAE | |
| Participants With CRPC | 23 | 16 |
| Participants With ER+BC | 21 | 15 |
| Participants With GIST | 13 | 8 |
| Participants With NMC | 11 | 6 |
| Participants With SCLC | 14 | 9 |
| Participants With TNBC | 19 | 11 |
SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| DBP; Increase to Grade 1;n=11,14,22,19,19,12 | DBP; Increase to Grade 2;n=11,14,22,19,19,12 | DBP; Increase to Grade 3/4;n=11,14,22,19,19,12 | SBP; Increase to Grade 1;n=11,14,21,19,19,12 | SBP; Increase to Grade 2;n=11,14,21,19,19,12 | SBP; Increase to Grade 3/4;n=11,14,21,19,19,12 | |
| Participants With CRPC | 8 | 4 | 1 | 2 | 11 | 3 |
| Participants With ER+BC | 4 | 6 | 1 | 7 | 4 | 1 |
| Participants With GIST | 3 | 1 | 2 | 1 | 7 | 0 |
| Participants With NMC | 2 | 4 | 0 | 4 | 2 | 0 |
| Participants With SCLC | 3 | 1 | 0 | 4 | 4 | 1 |
| Participants With TNBC | 5 | 3 | 2 | 9 | 3 | 1 |
Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is <60 beats per minute and >100 beats per minute. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Pulse rate; decrease to <60 | Pulse rate; Change to normal/no change | Pulse rate; increase to >100 | |
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 0 | 3 | 2 |
| 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 0 | 1 | 4 |
Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Pulse rate; decrease to <60 | Pulse rate; Change to normal/no change | Pulse rate; increase to >100 | |
| Part 1: GSK525762 20 mg BID | 0 | 3 | 1 |
| Part 1: GSK525762 30 mg BID | 0 | 4 | 6 |
| Part 1: GSK525762 40 mg BID | 0 | 2 | 3 |
"Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is <60 beats per minute and >100 beats per minute. Participants were counted twice if the participant Decreased to <60 and Increased to >100 post-baseline. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented" (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Pulse rate; decrease to <60 | Pulse rate; Change to normal/no change | Pulse rate; increase to >100 | |
| Part 1: GSK525762 100 mg QD | 1 | 4 | 5 |
| Part 1: GSK525762 16 mg QD | 1 | 1 | 1 |
| Part 1: GSK525762 2 mg QD | 0 | 2 | 1 |
| Part 1: GSK525762 30 mg QD | 0 | 1 | 3 |
| Part 1: GSK525762 4 mg QD | 1 | 1 | 2 |
| Part 1: GSK525762 60 mg QD | 1 | 5 | 2 |
| Part 1: GSK525762 8 mg QD | 0 | 0 | 1 |
| Part 1: GSK525762 80 mg QD | 1 | 12 | 18 |
"Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is <60 beats per minute and >100 beats per minute. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. Participants were counted twice if the participant Decreased to <60 and Increased to >100 post-baseline." (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Pulse rate; decrease to <60 | Pulse rate; Change to normal/no change | Pulse rate; increase to >100 | |
| Participants With CRPC | 0 | 13 | 9 |
| Participants With ER+BC | 1 | 9 | 10 |
| Participants With GIST | 1 | 8 | 3 |
| Participants With NMC | 0 | 7 | 5 |
| Participants With SCLC | 1 | 10 | 4 |
| Participants With TNBC | 0 | 11 | 9 |
Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Decrease to <=35 | Change to normal/No change | Increase to >=38 | |
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 0 | 4 | 1 |
| 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 0 | 5 | 0 |
Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Decrease to <=35 | Change to normal/No change | Increase to >=38 | |
| Part 1: GSK525762 20 mg BID | 0 | 4 | 0 |
| Part 1: GSK525762 30 mg BID | 0 | 9 | 1 |
| Part 1: GSK525762 40 mg BID | 0 | 5 | 0 |
Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Decrease to <=35 | Change to normal/No change | Increase to >=38 | |
| Part 1: GSK525762 100 mg QD | 1 | 8 | 0 |
| Part 1: GSK525762 16 mg QD | 0 | 3 | 0 |
| Part 1: GSK525762 2 mg QD | 0 | 3 | 0 |
| Part 1: GSK525762 30 mg QD | 0 | 3 | 1 |
| Part 1: GSK525762 4 mg QD | 0 | 3 | 1 |
| Part 1: GSK525762 60 mg QD | 0 | 9 | 0 |
| Part 1: GSK525762 8 mg QD | 0 | 1 | 0 |
| Part 1: GSK525762 80 mg QD | 2 | 27 | 3 |
Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Decrease to <=35 | Change to normal/No change | Increase to >=38 | |
| Participants With CRPC | 0 | 20 | 2 |
| Participants With ER+BC | 1 | 18 | 1 |
| Participants With GIST | 0 | 12 | 0 |
| Participants With NMC | 1 | 10 | 0 |
| Participants With SCLC | 0 | 11 | 3 |
| Participants With TNBC | 0 | 18 | 1 |
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glucose; Any grade increase; n=5,5 | Glucose; Increase to Grade 3; n=5,5 | Glucose; Increase to Grade 4; n=5,5 | Albumin; Any grade increase; n=5,5 | Albumin; Increase to Grade 3; n=5,5 | Albumin; Increase to Grade 4; n=5,5 | ALP; Any grade increase; n=5,5 | ALP; Increase to Grade 3; n=5,5 | ALP; Increase to Grade 4; n=5,5 | ALT; Any grade increase; n=5,5 | ALT; Increase to Grade 3; n=5,5 | ALT; Increase to Grade 4; n=5,5 | Amylase; Any grade increase; n=5,5 | Amylase; Increase to Grade 3; n=5,5 | Amylase; Increase to Grade 4; n=5,5 | AST; Any grade increase; n=5,5 | AST; Increase to Grade 3; n=5,5 | AST; Increase to Grade 4; n=5,5 | Dir bil; Any grade increase; n=5,5 | Dir bil; Increase to Grade 3; n=5,5 | Dir bil; Increase to Grade 4; n=5,5 | Bilirubin; Any grade increase; n=5,5 | Bilirubin; Increase to Grade 3; n=5,5 | Bilirubin; Increase to Grade 4; n=5,5 | NT-BNP; Any grade increase; n=5,5 | NT-BNP; Increase to Grade 3; n=5,5 | NT-BNP; Increase to Grade 4; n=5,5 | Calcium; Any grade increase; n=5,5 | Calcium; Increase to Grade 3; n=5,5 | Calcium; Increase to Grade 4; n=5,5 | Cholesterol; Any grade increase; n=5,3 | Cholesterol; Increase to Grade 3; n=5,3 | Cholesterol; Increase to Grade 4; n=5,3 | CK; Any grade increase; n=5,5 | CK; Increase to Grade 3; n=5,5 | CK; Increase to Grade 4; n=5,5 | Chloride; Any grade increase; n=5,5 | Chloride; Increase to Grade 3; n=5,5 | Chloride; Increase to Grade 4; n=5,5 | CO2; Any grade increase; n=5,5 | CO2; Increase to Grade 3; n=5,5 | CO2; Increase to Grade 4; n=5,5 | Creatinine; Any grade increase; n=5,5 | Creatinine; Increase to Grade 3; n=5,5 | Creatinine; Increase to Grade 4; n=5,5 | GGT; Any grade increase; n=5,5 | GGT; Increase to Grade 3; n=5,5 | GGT; Increase to Grade 4; n=5,5 | HDL; Any grade increase; n=5,3 | HDL; Increase to Grade 3; n=5,3 | HDL; Increase to Grade 4; n=5,3 | Insulin; Any grade increase; n=5,5 | Insulin; Increase to Grade 3; n=5,5 | Insulin; Increase to Grade 4; n=5,5 | Potassium; Any grade increase; n=5,5 | Potassium; Increase to Grade 3; n=5,5 | Potassium; Increase to Grade 4; n=5,5 | LDL; Any grade increase; n=5,3 | LDL; Increase to Grade 3; n=5,3 | LDL; Increase to Grade 4; n=5,3 | Lipase; Any grade increase; n=5,4 | Lipase; Increase to Grade 3; n=5,4 | Lipase; Increase to Grade 4;n=5,4 | Magnesium; Any grade increase; n=5,5 | Magnesium; Increase to Grade 3; n=5,5 | Magnesium; Increase to Grade 4; n=5,5 | Protein; Any grade increase; n=5,5 | Protein; Increase to Grade 3; n=5,5 | Protein; Increase to Grade 4; n=5,5 | Sodium; Any grade increase; n=5,5 | Sodium; Increase to Grade 3; n=5,5 | Sodium; Increase to Grade 4; n=5,5 | Thyroxine; Any grade increase; n=5,3 | Thyroxine; Increase to Grade 3; n=5,3 | Thyroxine; Increase to Grade 4; n=5,3 | Testosterone; Any grade increase; n=2,1 | Testosterone; Increase to Grade 3; n=2,1 | Testosterone; Increase to Grade 4; n=2,1 | Triglycerides; Any grade increase; n=5,3 | Triglycerides; Increase to Grade 3; n=5,3 | Triglycerides; Increase to Grade 4; n=5,3 | Troponin T; Any grade increase; n=5,5 | Troponin T; Increase to Grade 3; n=5,5 | Troponin T; Increase to Grade 4; n=5,5 | Urate; Any grade increase; n=5,5 | Urate; Increase to Grade 3; n=5,5 | Urate; Increase to Grade 4; n=5,5 | Urea; Any grade increase; n=5,5 | Urea; Increase to Grade 3; n=5,5 | Urea; Increase to Grade 4; n=5,5 | |
| 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 5 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 4 | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glucose; Any grade increase; n=5,5 | Glucose; Increase to Grade 3; n=5,5 | Glucose; Increase to Grade 4; n=5,5 | Albumin; Any grade increase; n=5,5 | Albumin; Increase to Grade 3; n=5,5 | Albumin; Increase to Grade 4; n=5,5 | ALP; Any grade increase; n=5,5 | ALP; Increase to Grade 3; n=5,5 | ALP; Increase to Grade 4; n=5,5 | ALT; Any grade increase; n=5,5 | ALT; Increase to Grade 3; n=5,5 | ALT; Increase to Grade 4; n=5,5 | Amylase; Any grade increase; n=5,5 | Amylase; Increase to Grade 3; n=5,5 | Amylase; Increase to Grade 4; n=5,5 | AST; Any grade increase; n=5,5 | AST; Increase to Grade 3; n=5,5 | AST; Increase to Grade 4; n=5,5 | Dir bil; Any grade increase; n=5,5 | Dir bil; Increase to Grade 3; n=5,5 | Dir bil; Increase to Grade 4; n=5,5 | Bilirubin; Any grade increase; n=5,5 | Bilirubin; Increase to Grade 3; n=5,5 | Bilirubin; Increase to Grade 4; n=5,5 | NT-BNP; Any grade increase; n=5,5 | NT-BNP; Increase to Grade 3; n=5,5 | NT-BNP; Increase to Grade 4; n=5,5 | Calcium; Any grade increase; n=5,5 | Calcium; Increase to Grade 3; n=5,5 | Calcium; Increase to Grade 4; n=5,5 | Cholesterol; Any grade increase; n=5,3 | Cholesterol; Increase to Grade 3; n=5,3 | Cholesterol; Increase to Grade 4; n=5,3 | CK; Any grade increase; n=5,5 | CK; Increase to Grade 3; n=5,5 | CK; Increase to Grade 4; n=5,5 | Chloride; Any grade increase; n=5,5 | Chloride; Increase to Grade 3; n=5,5 | Chloride; Increase to Grade 4; n=5,5 | CO2; Any grade increase; n=5,5 | CO2; Increase to Grade 3; n=5,5 | CO2; Increase to Grade 4; n=5,5 | Creatinine; Any grade increase; n=5,5 | Creatinine; Increase to Grade 3; n=5,5 | Creatinine; Increase to Grade 4; n=5,5 | GGT; Any grade increase; n=5,5 | GGT; Increase to Grade 3; n=5,5 | GGT; Increase to Grade 4; n=5,5 | HDL; Any grade increase; n=5,3 | HDL; Increase to Grade 3; n=5,3 | HDL; Increase to Grade 4; n=5,3 | Insulin; Any grade increase; n=5,5 | Insulin; Increase to Grade 3; n=5,5 | Insulin; Increase to Grade 4; n=5,5 | Potassium; Any grade increase; n=5,5 | Potassium; Increase to Grade 3; n=5,5 | Potassium; Increase to Grade 4; n=5,5 | LDL; Any grade increase; n=5,3 | LDL; Increase to Grade 3; n=5,3 | LDL; Increase to Grade 4; n=5,3 | Lipase; Any grade increase; n=5,4 | Lipase; Increase to Grade 3; n=5,4 | Lipase; Increase to Grade 4;n=5,4 | Magnesium; Any grade increase; n=5,5 | Magnesium; Increase to Grade 3; n=5,5 | Magnesium; Increase to Grade 4; n=5,5 | Protein; Any grade increase; n=5,5 | Protein; Increase to Grade 3; n=5,5 | Protein; Increase to Grade 4; n=5,5 | Sodium; Any grade increase; n=5,5 | Sodium; Increase to Grade 3; n=5,5 | Sodium; Increase to Grade 4; n=5,5 | Thyroxine; Any grade increase; n=5,3 | Thyroxine; Increase to Grade 3; n=5,3 | Thyroxine; Increase to Grade 4; n=5,3 | Testosterone; Any grade increase; n=2,1 | Testosterone; Increase to Grade 3; n=2,1 | Testosterone; Increase to Grade 4; n=2,1 | Triglycerides; Any grade increase; n=5,3 | Triglycerides; Increase to Grade 3; n=5,3 | Triglycerides; Increase to Grade 4; n=5,3 | Troponin I; Any grade increase; n=1,0 | Troponin I; Increase to Grade 3; n=1,0 | Troponin I; Increase to Grade 4; n=1,0 | Troponin T; Any grade increase; n=5,5 | Troponin T; Increase to Grade 3; n=5,5 | Troponin T; Increase to Grade 4; n=5,5 | Urate; Any grade increase; n=5,5 | Urate; Increase to Grade 3; n=5,5 | Urate; Increase to Grade 4; n=5,5 | Urea; Any grade increase; n=5,5 | Urea; Increase to Grade 3; n=5,5 | Urea; Increase to Grade 4; n=5,5 | |
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 4 | 0 | 0 | 3 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glucose; Any grade increase; n=4, 10, 5 | Glucose; Increase to Grade 3; n=4, 10, 5 | Glucose; Increase to Grade 4; n=4, 10, 5 | Albumin; Any grade increase; n=4, 10, 5 | Albumin; Increase to Grade 3; n=4, 10, 5 | Albumin; Increase to Grade 4; n=4, 10, 5 | ALP; Any grade increase; n=4, 10, 5 | ALP; Increase to Grade 3; n=4, 10, 5 | ALP; Increase to Grade 4; n=4, 10, 5 | ALT; Any grade increase; n=4, 10, 5 | ALT; Increase to Grade 3; n=4, 10, 5 | ALT; Increase to Grade 4; n=4, 10, 5 | Amylase; Any grade increase; n=4, 10, 5 | Amylase; Increase to Grade 3; n=4, 10, 5 | Amylase; Increase to Grade 4; n=4, 10, 5 | AST; Any grade increase; n=4, 10, 5 | AST; Increase to Grade 3; n=4, 10, 5 | AST; Increase to Grade 4; n=4, 10, 5 | Dir bil; Any grade increase; n=4, 9, 4 | Dir bil; Increase to Grade 3; n=4, 9, 4 | Dir bil; Increase to Grade 4; n=4, 9, 4 | Bilirubin; Any grade increase; n=4, 10, 5 | Bilirubin; Increase to Grade 3; n=4, 10, 5 | Bilirubin; Increase to Grade 4; n=4, 10, 5 | NT-BNP; Any grade increase; n=4, 10, 5 | NT-BNP; Increase to Grade 3; n=4, 10, 5 | NT-BNP; Increase to Grade 4; n=4, 10, 5 | Calcium; Any grade increase; n=4, 10, 5 | Calcium; Increase to Grade 3; n=4, 10, 5 | Calcium; Increase to Grade 4; n=4, 10, 5 | Cholesterol; Any grade increase; n=2, 9, 5 | Cholesterol; Increase to Grade 3; n=2, 9, 5 | Cholesterol; Increase to Grade 4; n=2, 9, 5 | CK; Any grade increase; n=4, 10, 5 | CK; Increase to Grade 3; n=n=4, 10, 5 | CK; Increase to Grade 4; n=n=4, 10, 5 | Chloride; Any grade increase; n=4, 10, 5 | Chloride; Increase to Grade 3; n=4, 10, 5 | Chloride; Increase to Grade 4; n=4, 10, 5 | CO2; Any grade increase; n=4, 10, 5 | CO2; Increase to Grade 3; n=4, 10, 5 | CO2; Increase to Grade 4; n=4, 10, 5 | Creatinine; Any grade increase; n=4, 10, 5 | Creatinine; Increase to Grade 3; n=4, 10, 5 | Creatinine; Increase to Grade 4; n=4, 10, 5 | GGT; Any grade increase; n=4, 10, 5 | GGT; Increase to Grade 3; n=4, 10, 5 | GGT; Increase to Grade 4; n=4, 10, 5 | HDL; Any grade increase; n=2, 9, 5 | HDL; Increase to Grade 3; n=2, 9, 5 | HDL; Increase to Grade 4; n=2, 9, 5 | Insulin; Any grade increase; n=4, 10, 5 | Insulin; Increase to Grade 3; n=4, 10, 5 | Insulin; Increase to Grade 4; n=4, 10, 5 | Potassium; Any grade increase; n=4, 10, 5 | Potassium; Increase to Grade 3; n=4, 10, 5 | Potassium; Increase to Grade 4; n=4, 10, 5 | LDL; Any grade increase; n=2, 9, 5 | LDL; Increase to Grade 3; n=2, 9, 5 | LDL; Increase to Grade 4; n=2, 9, 5 | Lipase; Any grade increase; n=4, 10, 5 | Lipase; Increase to Grade 3; n=4, 10, 5 | Lipase; Increase to Grade 4; n=4, 10, 5 | Magnesium; Any grade increase; n=4, 10, 5 | Magnesium; Increase to Grade 3; n=4, 10, 5 | Magnesium; Increase to Grade 4; n=4, 10, 5 | Protein; Any grade increase; n=4, 10, 5 | Protein; Increase to Grade 3; n=4, 10, 5 | Protein; Increase to Grade 4; n=4, 10, 5 | Sodium; Any grade increase; n=4, 10, 5 | Sodium; Increase to Grade 3; n=4, 10, 5 | Sodium; Increase to Grade 4; n=4, 10, 5 | Thyroxine; Any grade increase; n=3, 9, 5 | Thyroxine; Increase to Grade 3; n=3, 9, 5 | Thyroxine; Increase to Grade 4; n=3, 9, 5 | Testosterone; Any grade increase; n=1, 4, 4 | Testosterone; Increase to Grade 3; n=1, 4, 4 | Testosterone; Increase to Grade 4; n=1, 4, 4 | Triglycerides; Any grade increase; n=2, 9, 5 | Triglycerides; Increase to Grade 3; n=2, 9, 5 | Triglycerides; Increase to Grade 4; n=2, 9, 5 | Troponin I; Any grade increase; n=3, 10, 5 | Troponin I; Increase to Grade 3; n=3, 10, 5 | Troponin I; Increase to Grade 4; n=3, 10, 5 | Troponin T; Any grade increase; n=4, 10, 5 | Troponin T; Increase to Grade 3; n=4, 10, 5 | Troponin T; Increase to Grade 4; n=4, 10, 5 | Urate; Any grade increase; n=4, 10, 5 | Urate; Increase to Grade 3; n=4, 10, 5 | Urate; Increase to Grade 4; n=4, 10, 5 | Urea; Any grade increase; n=4, 10, 5 | Urea; Increase to Grade 3; n=4, 10, 5 | Urea; Increase to Grade 4; n=4, 10, 5 | |
| Part 1: GSK525762 20 mg BID | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: GSK525762 30 mg BID | 9 | 3 | 0 | 4 | 0 | 0 | 4 | 2 | 0 | 5 | 1 | 0 | 2 | 0 | 0 | 6 | 2 | 0 | 0 | 0 | 0 | 7 | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 4 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 7 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: GSK525762 40 mg BID | 5 | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Blood samples were collected for the analysis of: glucose, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), amylase, aspartate aminotransferase (AST), direct bilirubin (Dir bil), bilirubin, N-Terminal proB-type natriuretic peptide (NT-BNP), calcium, cholesterol, creatine kinase (CK), chloride, carbon dioxide (CO2), creatinine, gamma glutamyl transferase (GGT), high and low density lipoprotein (HDL and LDL), insulin, potassium, lactate dehydrogenase (LDH), lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Grading was done according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glucose; Any grade increase; n=2,4,1,3,4,9,32,9 | Glucose; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Glucose; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Albumin; Any grade increase; n=2,4,1,3,4,9,32,9 | Albumin; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Albumin; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | ALP; Any grade increase; n=2,4,1,3,4,9,31,9 | ALP; Increase to Grade 3; n=2,4,1,3,4,9,31,9 | ALP; Increase to Grade 4; n=2,4,1,3,4,9,31,9 | ALT; Any grade increase; n=2,4,1,3,4,9,32,9 | ALT; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | ALT; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Amylase; Any grade increase; n=2,4,1,3,4,9,32,9 | Amylase; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Amylase; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | AST; Any grade increase; n=2,4,1,3,4,9,32,9 | AST; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | AST; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Dir bil; Any grade increase; n=2,4,1,3,4,9,30,9 | Dir bil; Increase to Grade 3; n=2,4,1,3,4,9,30,9 | Dir bil; Increase to Grade 4; n=2,4,1,3,4,9,30,9 | Bilirubin; Any grade increase; n=2,4,1,3,4,9,32,9 | Bilirubin; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Bilirubin; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | NT-BNP; Any grade increase; n=2,4,1,3,4,9,30,9 | NT-BNP; Increase to Grade 3; n=2,4,1,3,4,9,30,9 | NT-BNP; Increase to Grade 4; n=2,4,1,3,4,9,30,9 | Calcium; Any grade increase; n=2,4,1,3,4,9,32,9 | Calcium; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Calcium; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Cholesterol;Any grade increase;n=2,4,1,3,4,7,29,9 | Cholesterol;Increase to Grade 3;n=2,4,1,3,4,7,29,9 | Cholesterol;Increase to Grade 4;n=2,4,1,3,4,7,29,9 | CK;Any grade increase;n=3,4,1,3,4,9,31,9 | CK; Increase to Grade 3; n=3, 4, 1, 3, 4, 9, 31, 9 | CK; Increase to Grade 4; n=3, 4, 1, 3, 4, 9, 31, 9 | Chloride; Any grade increase; n=2,4,1,3,4,9,32,9 | Chloride; Increase to Grade 3;n=2,4,1,3,4,9,32,9 | Chloride;Increase to Grade 4;n=2,4,1,3,4,9,32,9 | CO2; Any grade increase; n=2, 4, 1, 3, 4, 9, 32, 9 | CO2; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | CO2; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Creatinine;Any grade increase;n=2,4,1,3,4,9,32,9 | Creatinine;Increase to Grade 3;n=2,4,1,3,4,9,32,9 | Creatinine;Increase to Grade 4;n=2,4,1,3,4,9,32,9 | GGT; Any grade increase; n=2, 4, 1, 3, 4, 9, 31, 7 | GGT;Increase to Grade 3; n=2,4,1,3,4,9,31,7 | GGT; Increase to Grade 4; n=2,4,1,3,4,9,31,7 | HDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 9 | HDL; Increase to Grade 3; n=2,4,1,3,4,7,28,9 | HDL; Increase to Grade 4; n=2,4,1,3,4,7,28,9 | Insulin; Any grade increase; n=2,4,1,3,4,9,31,9 | Insulin; Increase to Grade 3; n=2,4,1,3,4,9,31,9 | Insulin; Increase to Grade 4; n=2,4,1,3,4,9,31,9 | Potassium;Any grade increase;n=3,4,1,3,4,9,32,9 | Potassium;Increase to Grade 3;n=3,4,1,3,4,9,32,9 | Potassium;Increase to Grade 4;n=3,4,1,3,4,9,32,9 | LDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 8 | LDL;Increase to Grade 3; n=2,4,1,3,4,7,28,8 | LDL;Increase to Grade 4; n=2,4,1,3,4,7,28,8 | Lipase;Any grade increase; n=2,4,1,3,4,9,31,9 | Lipase;Increase to Grade 3; n=2,4,1,3,4,9,31,9 | Lipase;Increase to Grade 4; n=2,4,1,3,4,9,31,9 | Magnesium;Any grade increase;n=3,4,1,3,4,9,32,9 | Magnesium;Increase to Grade 3;n=3,4,1,3,4,9,32,9 | Magnesium;Increase to Grade 4;n=3,4,1,3,4,9,32,9 | Protein;Any grade increase; n=2,4,1,3,4,9,32,9 | Protein;Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Protein;Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Sodium;Any grade increase; n=3,4,1,3,4,9,32,9 | Sodium;Increase to Grade 3; n=3,4,1,3,4,9,32,9 | Sodium;Increase to Grade 4; n=3,4,1,3,4,9,32,9 | Thyroxine;Any grade increase;n=2,4,1,3,4,7,29,9 | Thyroxine;Increase to Grade 3; n=2,4,1,3,4,7,29,9 | Thyroxine;Increase to Grade 4; n=2,4,1,3,4,7,29,9 | Triglyc;Any grade increase;n=2,4,1,3,4,7,29,9 | Triglyc;Increase to Grade 3;n=2,4,1,3,4,7,29,9 | Triglyc;Increase to Grade 4;n=2,4,1,3,4,7,29,9 | Troponin T;Any grade increase;n=3,4,1,3,4,9,31,9 | Troponin T;Increase to Grade 3; n=3,4,1,3,4,9,31,9 | Troponin T;Increase to Grade 4; n=3,4,1,3,4,9,31,9 | Urate;Any grade increase; n=2,4,1,3,4,9,32,9 | Urate; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Urate; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Urea; Any grade increase; n=2,4,1,3,4,9,31,9 | Urea; Increase to Grade 3; n=2,4,1,3,4,9,31,9 | Urea; Increase to Grade 4; n=2,4,1,3,4,9,31,9 | |
| Part 1: GSK525762 16 mg QD | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: GSK525762 4 mg QD | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: GSK525762 8 mg QD | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Blood samples were collected for the analysis of: glucose, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), amylase, aspartate aminotransferase (AST), direct bilirubin (Dir bil), bilirubin, N-Terminal proB-type natriuretic peptide (NT-BNP), calcium, cholesterol, creatine kinase (CK), chloride, carbon dioxide (CO2), creatinine, gamma glutamyl transferase (GGT), high and low density lipoprotein (HDL and LDL), insulin, potassium, lactate dehydrogenase (LDH), lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Grading was done according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glucose; Any grade increase; n=2,4,1,3,4,9,32,9 | Glucose; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Glucose; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Albumin; Any grade increase; n=2,4,1,3,4,9,32,9 | Albumin; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Albumin; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | ALP; Any grade increase; n=2,4,1,3,4,9,31,9 | ALP; Increase to Grade 3; n=2,4,1,3,4,9,31,9 | ALP; Increase to Grade 4; n=2,4,1,3,4,9,31,9 | ALT; Any grade increase; n=2,4,1,3,4,9,32,9 | ALT; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | ALT; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Amylase; Any grade increase; n=2,4,1,3,4,9,32,9 | Amylase; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Amylase; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | AST; Any grade increase; n=2,4,1,3,4,9,32,9 | AST; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | AST; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Dir bil; Any grade increase; n=2,4,1,3,4,9,30,9 | Dir bil; Increase to Grade 3; n=2,4,1,3,4,9,30,9 | Dir bil; Increase to Grade 4; n=2,4,1,3,4,9,30,9 | Bilirubin; Any grade increase; n=2,4,1,3,4,9,32,9 | Bilirubin; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Bilirubin; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | NT-BNP; Any grade increase; n=2,4,1,3,4,9,30,9 | NT-BNP; Increase to Grade 3; n=2,4,1,3,4,9,30,9 | NT-BNP; Increase to Grade 4; n=2,4,1,3,4,9,30,9 | Calcium; Any grade increase; n=2,4,1,3,4,9,32,9 | Calcium; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Calcium; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Cholesterol;Any grade increase;n=2,4,1,3,4,7,29,9 | Cholesterol;Increase to Grade 3;n=2,4,1,3,4,7,29,9 | Cholesterol;Increase to Grade 4;n=2,4,1,3,4,7,29,9 | CK;Any grade increase;n=3,4,1,3,4,9,31,9 | CK; Increase to Grade 3; n=3, 4, 1, 3, 4, 9, 31, 9 | CK; Increase to Grade 4; n=3, 4, 1, 3, 4, 9, 31, 9 | Chloride; Any grade increase; n=2,4,1,3,4,9,32,9 | Chloride; Increase to Grade 3;n=2,4,1,3,4,9,32,9 | Chloride;Increase to Grade 4;n=2,4,1,3,4,9,32,9 | CO2; Any grade increase; n=2, 4, 1, 3, 4, 9, 32, 9 | CO2; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | CO2; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Creatinine;Any grade increase;n=2,4,1,3,4,9,32,9 | Creatinine;Increase to Grade 3;n=2,4,1,3,4,9,32,9 | Creatinine;Increase to Grade 4;n=2,4,1,3,4,9,32,9 | GGT; Any grade increase; n=2, 4, 1, 3, 4, 9, 31, 7 | GGT;Increase to Grade 3; n=2,4,1,3,4,9,31,7 | GGT; Increase to Grade 4; n=2,4,1,3,4,9,31,7 | HDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 9 | HDL; Increase to Grade 3; n=2,4,1,3,4,7,28,9 | HDL; Increase to Grade 4; n=2,4,1,3,4,7,28,9 | Insulin; Any grade increase; n=2,4,1,3,4,9,31,9 | Insulin; Increase to Grade 3; n=2,4,1,3,4,9,31,9 | Insulin; Increase to Grade 4; n=2,4,1,3,4,9,31,9 | Potassium;Any grade increase;n=3,4,1,3,4,9,32,9 | Potassium;Increase to Grade 3;n=3,4,1,3,4,9,32,9 | Potassium;Increase to Grade 4;n=3,4,1,3,4,9,32,9 | LDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 8 | LDL;Increase to Grade 3; n=2,4,1,3,4,7,28,8 | LDL;Increase to Grade 4; n=2,4,1,3,4,7,28,8 | Lipase;Any grade increase; n=2,4,1,3,4,9,31,9 | Lipase;Increase to Grade 3; n=2,4,1,3,4,9,31,9 | Lipase;Increase to Grade 4; n=2,4,1,3,4,9,31,9 | Magnesium;Any grade increase;n=3,4,1,3,4,9,32,9 | Magnesium;Increase to Grade 3;n=3,4,1,3,4,9,32,9 | Magnesium;Increase to Grade 4;n=3,4,1,3,4,9,32,9 | Protein;Any grade increase; n=2,4,1,3,4,9,32,9 | Protein;Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Protein;Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Sodium;Any grade increase; n=3,4,1,3,4,9,32,9 | Sodium;Increase to Grade 3; n=3,4,1,3,4,9,32,9 | Sodium;Increase to Grade 4; n=3,4,1,3,4,9,32,9 | Thyroxine;Any grade increase;n=2,4,1,3,4,7,29,9 | Thyroxine;Increase to Grade 3; n=2,4,1,3,4,7,29,9 | Thyroxine;Increase to Grade 4; n=2,4,1,3,4,7,29,9 | Testosterone;Any grade increase;n=1,0,0,0,3,3,14,7 | Testosterone;Increase to Grade3;n=1,0,0,0,3,3,14,7 | Testosterone;Increase to Grade4;n=1,0,0,0,3,3,14,7 | Triglyc;Any grade increase;n=2,4,1,3,4,7,29,9 | Triglyc;Increase to Grade 3;n=2,4,1,3,4,7,29,9 | Triglyc;Increase to Grade 4;n=2,4,1,3,4,7,29,9 | Troponin T;Any grade increase;n=3,4,1,3,4,9,31,9 | Troponin T;Increase to Grade 3; n=3,4,1,3,4,9,31,9 | Troponin T;Increase to Grade 4; n=3,4,1,3,4,9,31,9 | Urate;Any grade increase; n=2,4,1,3,4,9,32,9 | Urate; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Urate; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Urea; Any grade increase; n=2,4,1,3,4,9,31,9 | Urea; Increase to Grade 3; n=2,4,1,3,4,9,31,9 | Urea; Increase to Grade 4; n=2,4,1,3,4,9,31,9 | |
| Part 1: GSK525762 2 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
Blood samples were collected for the analysis of: glucose, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), amylase, aspartate aminotransferase (AST), direct bilirubin (Dir bil), bilirubin, N-Terminal proB-type natriuretic peptide (NT-BNP), calcium, cholesterol, creatine kinase (CK), chloride, carbon dioxide (CO2), creatinine, gamma glutamyl transferase (GGT), high and low density lipoprotein (HDL and LDL), insulin, potassium, lactate dehydrogenase (LDH), lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Grading was done according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glucose; Any grade increase; n=2,4,1,3,4,9,32,9 | Glucose; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Glucose; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Albumin; Any grade increase; n=2,4,1,3,4,9,32,9 | Albumin; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Albumin; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | ALP; Any grade increase; n=2,4,1,3,4,9,31,9 | ALP; Increase to Grade 3; n=2,4,1,3,4,9,31,9 | ALP; Increase to Grade 4; n=2,4,1,3,4,9,31,9 | ALT; Any grade increase; n=2,4,1,3,4,9,32,9 | ALT; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | ALT; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Amylase; Any grade increase; n=2,4,1,3,4,9,32,9 | Amylase; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Amylase; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | AST; Any grade increase; n=2,4,1,3,4,9,32,9 | AST; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | AST; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Dir bil; Any grade increase; n=2,4,1,3,4,9,30,9 | Dir bil; Increase to Grade 3; n=2,4,1,3,4,9,30,9 | Dir bil; Increase to Grade 4; n=2,4,1,3,4,9,30,9 | Bilirubin; Any grade increase; n=2,4,1,3,4,9,32,9 | Bilirubin; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Bilirubin; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | NT-BNP; Any grade increase; n=2,4,1,3,4,9,30,9 | NT-BNP; Increase to Grade 3; n=2,4,1,3,4,9,30,9 | NT-BNP; Increase to Grade 4; n=2,4,1,3,4,9,30,9 | Calcium; Any grade increase; n=2,4,1,3,4,9,32,9 | Calcium; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Calcium; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Cholesterol;Any grade increase;n=2,4,1,3,4,7,29,9 | Cholesterol;Increase to Grade 3;n=2,4,1,3,4,7,29,9 | Cholesterol;Increase to Grade 4;n=2,4,1,3,4,7,29,9 | CK;Any grade increase;n=3,4,1,3,4,9,31,9 | CK; Increase to Grade 3; n=3, 4, 1, 3, 4, 9, 31, 9 | CK; Increase to Grade 4; n=3, 4, 1, 3, 4, 9, 31, 9 | Chloride; Any grade increase; n=2,4,1,3,4,9,32,9 | Chloride; Increase to Grade 3;n=2,4,1,3,4,9,32,9 | Chloride;Increase to Grade 4;n=2,4,1,3,4,9,32,9 | CO2; Any grade increase; n=2, 4, 1, 3, 4, 9, 32, 9 | CO2; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | CO2; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Creatinine;Any grade increase;n=2,4,1,3,4,9,32,9 | Creatinine;Increase to Grade 3;n=2,4,1,3,4,9,32,9 | Creatinine;Increase to Grade 4;n=2,4,1,3,4,9,32,9 | GGT; Any grade increase; n=2, 4, 1, 3, 4, 9, 31, 7 | GGT;Increase to Grade 3; n=2,4,1,3,4,9,31,7 | GGT; Increase to Grade 4; n=2,4,1,3,4,9,31,7 | HDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 9 | HDL; Increase to Grade 3; n=2,4,1,3,4,7,28,9 | HDL; Increase to Grade 4; n=2,4,1,3,4,7,28,9 | Insulin; Any grade increase; n=2,4,1,3,4,9,31,9 | Insulin; Increase to Grade 3; n=2,4,1,3,4,9,31,9 | Insulin; Increase to Grade 4; n=2,4,1,3,4,9,31,9 | Potassium;Any grade increase;n=3,4,1,3,4,9,32,9 | Potassium;Increase to Grade 3;n=3,4,1,3,4,9,32,9 | Potassium;Increase to Grade 4;n=3,4,1,3,4,9,32,9 | LDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 8 | LDL;Increase to Grade 3; n=2,4,1,3,4,7,28,8 | LDL;Increase to Grade 4; n=2,4,1,3,4,7,28,8 | Lipase;Any grade increase; n=2,4,1,3,4,9,31,9 | Lipase;Increase to Grade 3; n=2,4,1,3,4,9,31,9 | Lipase;Increase to Grade 4; n=2,4,1,3,4,9,31,9 | Magnesium;Any grade increase;n=3,4,1,3,4,9,32,9 | Magnesium;Increase to Grade 3;n=3,4,1,3,4,9,32,9 | Magnesium;Increase to Grade 4;n=3,4,1,3,4,9,32,9 | Protein;Any grade increase; n=2,4,1,3,4,9,32,9 | Protein;Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Protein;Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Sodium;Any grade increase; n=3,4,1,3,4,9,32,9 | Sodium;Increase to Grade 3; n=3,4,1,3,4,9,32,9 | Sodium;Increase to Grade 4; n=3,4,1,3,4,9,32,9 | Thyroxine;Any grade increase;n=2,4,1,3,4,7,29,9 | Thyroxine;Increase to Grade 3; n=2,4,1,3,4,7,29,9 | Thyroxine;Increase to Grade 4; n=2,4,1,3,4,7,29,9 | Testosterone;Any grade increase;n=1,0,0,0,3,3,14,7 | Testosterone;Increase to Grade3;n=1,0,0,0,3,3,14,7 | Testosterone;Increase to Grade4;n=1,0,0,0,3,3,14,7 | Triglyc;Any grade increase;n=2,4,1,3,4,7,29,9 | Triglyc;Increase to Grade 3;n=2,4,1,3,4,7,29,9 | Triglyc;Increase to Grade 4;n=2,4,1,3,4,7,29,9 | Troponin I;Any grade increase;n=0,0,0,0, 2,5,24,5 | Troponin I;Increase to Grade 3;n=0,0,0,0,2,5,24,5 | Troponin I;Increase to Grade 4; n=0,0,0,0,2,5,24,5 | Troponin T;Any grade increase;n=3,4,1,3,4,9,31,9 | Troponin T;Increase to Grade 3; n=3,4,1,3,4,9,31,9 | Troponin T;Increase to Grade 4; n=3,4,1,3,4,9,31,9 | Urate;Any grade increase; n=2,4,1,3,4,9,32,9 | Urate; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Urate; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Urea; Any grade increase; n=2,4,1,3,4,9,31,9 | Urea; Increase to Grade 3; n=2,4,1,3,4,9,31,9 | Urea; Increase to Grade 4; n=2,4,1,3,4,9,31,9 | |
| Part 1: GSK525762 100 mg QD | 8 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 8 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: GSK525762 30 mg QD | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Part 1: GSK525762 80 mg QD | 24 | 2 | 0 | 12 | 0 | 0 | 7 | 1 | 0 | 9 | 0 | 0 | 10 | 1 | 1 | 14 | 0 | 0 | 0 | 0 | 0 | 15 | 5 | 0 | 0 | 0 | 0 | 17 | 0 | 0 | 11 | 0 | 0 | 11 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 1 | 0 | 11 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 1 | 1 | 0 | 0 | 0 | 8 | 3 | 0 | 9 | 0 | 0 | 0 | 0 | 0 | 16 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
Blood samples were collected for the analysis of: glucose, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), amylase, aspartate aminotransferase (AST), direct bilirubin (Dir bil), bilirubin, N-Terminal proB-type natriuretic peptide (NT-BNP), calcium, cholesterol, creatine kinase (CK), chloride, carbon dioxide (CO2), creatinine, gamma glutamyl transferase (GGT), high and low density lipoprotein (HDL and LDL), insulin, potassium, lactate dehydrogenase (LDH), lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Grading was done according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glucose; Any grade increase; n=2,4,1,3,4,9,32,9 | Glucose; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Glucose; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Albumin; Any grade increase; n=2,4,1,3,4,9,32,9 | Albumin; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Albumin; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | ALP; Any grade increase; n=2,4,1,3,4,9,31,9 | ALP; Increase to Grade 3; n=2,4,1,3,4,9,31,9 | ALP; Increase to Grade 4; n=2,4,1,3,4,9,31,9 | ALT; Any grade increase; n=2,4,1,3,4,9,32,9 | ALT; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | ALT; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Amylase; Any grade increase; n=2,4,1,3,4,9,32,9 | Amylase; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Amylase; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | AST; Any grade increase; n=2,4,1,3,4,9,32,9 | AST; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | AST; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Dir bil; Any grade increase; n=2,4,1,3,4,9,30,9 | Dir bil; Increase to Grade 3; n=2,4,1,3,4,9,30,9 | Dir bil; Increase to Grade 4; n=2,4,1,3,4,9,30,9 | Bilirubin; Any grade increase; n=2,4,1,3,4,9,32,9 | Bilirubin; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Bilirubin; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | NT-BNP; Any grade increase; n=2,4,1,3,4,9,30,9 | NT-BNP; Increase to Grade 3; n=2,4,1,3,4,9,30,9 | NT-BNP; Increase to Grade 4; n=2,4,1,3,4,9,30,9 | Calcium; Any grade increase; n=2,4,1,3,4,9,32,9 | Calcium; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Calcium; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Cholesterol;Any grade increase;n=2,4,1,3,4,7,29,9 | Cholesterol;Increase to Grade 3;n=2,4,1,3,4,7,29,9 | Cholesterol;Increase to Grade 4;n=2,4,1,3,4,7,29,9 | CK;Any grade increase;n=3,4,1,3,4,9,31,9 | CK; Increase to Grade 3; n=3, 4, 1, 3, 4, 9, 31, 9 | CK; Increase to Grade 4; n=3, 4, 1, 3, 4, 9, 31, 9 | Chloride; Any grade increase; n=2,4,1,3,4,9,32,9 | Chloride; Increase to Grade 3;n=2,4,1,3,4,9,32,9 | Chloride;Increase to Grade 4;n=2,4,1,3,4,9,32,9 | CO2; Any grade increase; n=2, 4, 1, 3, 4, 9, 32, 9 | CO2; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | CO2; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Creatinine;Any grade increase;n=2,4,1,3,4,9,32,9 | Creatinine;Increase to Grade 3;n=2,4,1,3,4,9,32,9 | Creatinine;Increase to Grade 4;n=2,4,1,3,4,9,32,9 | GGT; Any grade increase; n=2, 4, 1, 3, 4, 9, 31, 7 | GGT;Increase to Grade 3; n=2,4,1,3,4,9,31,7 | GGT; Increase to Grade 4; n=2,4,1,3,4,9,31,7 | HDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 9 | HDL; Increase to Grade 3; n=2,4,1,3,4,7,28,9 | HDL; Increase to Grade 4; n=2,4,1,3,4,7,28,9 | Insulin; Any grade increase; n=2,4,1,3,4,9,31,9 | Insulin; Increase to Grade 3; n=2,4,1,3,4,9,31,9 | Insulin; Increase to Grade 4; n=2,4,1,3,4,9,31,9 | Potassium;Any grade increase;n=3,4,1,3,4,9,32,9 | Potassium;Increase to Grade 3;n=3,4,1,3,4,9,32,9 | Potassium;Increase to Grade 4;n=3,4,1,3,4,9,32,9 | LDH; Any grade increase; n=0, 0, 0, 0, 0, 1, 0, 0 | LDH; Increase to Grade 3; n=0, 0, 0, 0, 0, 1, 0, 0 | LDH; Increase to Grade 4; n=0, 0, 0, 0, 0, 1, 0, 0 | LDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 8 | LDL;Increase to Grade 3; n=2,4,1,3,4,7,28,8 | LDL;Increase to Grade 4; n=2,4,1,3,4,7,28,8 | Lipase;Any grade increase; n=2,4,1,3,4,9,31,9 | Lipase;Increase to Grade 3; n=2,4,1,3,4,9,31,9 | Lipase;Increase to Grade 4; n=2,4,1,3,4,9,31,9 | Magnesium;Any grade increase;n=3,4,1,3,4,9,32,9 | Magnesium;Increase to Grade 3;n=3,4,1,3,4,9,32,9 | Magnesium;Increase to Grade 4;n=3,4,1,3,4,9,32,9 | Protein;Any grade increase; n=2,4,1,3,4,9,32,9 | Protein;Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Protein;Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Sodium;Any grade increase; n=3,4,1,3,4,9,32,9 | Sodium;Increase to Grade 3; n=3,4,1,3,4,9,32,9 | Sodium;Increase to Grade 4; n=3,4,1,3,4,9,32,9 | Thyroxine;Any grade increase;n=2,4,1,3,4,7,29,9 | Thyroxine;Increase to Grade 3; n=2,4,1,3,4,7,29,9 | Thyroxine;Increase to Grade 4; n=2,4,1,3,4,7,29,9 | Testosterone;Any grade increase;n=1,0,0,0,3,3,14,7 | Testosterone;Increase to Grade3;n=1,0,0,0,3,3,14,7 | Testosterone;Increase to Grade4;n=1,0,0,0,3,3,14,7 | Triglyc;Any grade increase;n=2,4,1,3,4,7,29,9 | Triglyc;Increase to Grade 3;n=2,4,1,3,4,7,29,9 | Triglyc;Increase to Grade 4;n=2,4,1,3,4,7,29,9 | Troponin I;Any grade increase;n=0,0,0,0, 2,5,24,5 | Troponin I;Increase to Grade 3;n=0,0,0,0,2,5,24,5 | Troponin I;Increase to Grade 4; n=0,0,0,0,2,5,24,5 | Troponin T;Any grade increase;n=3,4,1,3,4,9,31,9 | Troponin T;Increase to Grade 3; n=3,4,1,3,4,9,31,9 | Troponin T;Increase to Grade 4; n=3,4,1,3,4,9,31,9 | Urate;Any grade increase; n=2,4,1,3,4,9,32,9 | Urate; Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Urate; Increase to Grade 4; n=2,4,1,3,4,9,32,9 | Urea; Any grade increase; n=2,4,1,3,4,9,31,9 | Urea; Increase to Grade 3; n=2,4,1,3,4,9,31,9 | Urea; Increase to Grade 4; n=2,4,1,3,4,9,31,9 | |
| Part 1: GSK525762 60 mg QD | 7 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides (triglyc), troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glucose; Any grade increase; n=11,13,23,19,21,12 | Glucose; Increase to Grade 3; n=11,13,23,19,21,12 | Glucose; Increase to Grade 4; n=11,13,23,19,21,12 | Albumin; Any grade increase; n=11,13,23,19,21,12 | Albumin; Increase to Grade 3; n=11,13,23,19,21,12 | Albumin; Increase to Grade 4; n=11,13,23,19,21,12 | ALP; Any grade increase; n=11,13,23,19,21,12 | ALP; Increase to Grade 3; n=11,13,23,19,21,12 | ALP; Increase to Grade 4; n=11,13,23,19,21,12 | ALT; Any grade increase; n=11,14,23,19,21,12 | ALT; Increase to Grade 3; n=11,14,23,19,21,12 | ALT; Increase to Grade 4; n=11,14,23,19,21,12 | Amylase; Any grade increase; n=11,12,22,19,20,12 | Amylase; Increase to Grade 3; n=11,12,22,19,20,12 | Amylase; Increase to Grade 4; n=11,12,22,19,20,12 | AST; Any grade increase; n=11,13,23,19,21,12 | AST; Increase to Grade 3; n=11,13,23,19,21,12 | AST; Increase to Grade 4; n=11,13,23,19,21,12 | Dir bil; Any grade increase; n=11,13,23,19,20,12 | Dir bil; Increase to Grade 3; n=11,13,23,19,20,12 | Dir bil; Increase to Grade 4; n=11,13,23,19,20,12 | Bilirubin;Any grade increase;n=11,14,23,19,21,12 | Bilirubin;Increase to Grade 3; n=11,14,23,19,21,12 | Bilirubin;Increase to Grade 4; n=11,14,23,19,21,12 | NT-BNP; Any grade increase; n=11,12,22,17,15,12 | NT-BNP; Increase to Grade 3; n=11,12,22,17,15,12 | NT-BNP; Increase to Grade 4; n=11,12,22,17,15,12 | Calcium; Any grade increase; n=11,13,23,19,21,12 | Calcium; Increase to Grade 3; n=11,13,23,19,21,12 | Calcium; Increase to Grade 4; n=11,13,23,19,21,12 | Cholesterol;Any grade increase;n=10,12,22,19,20,12 | Cholesterol;Increase to Grade3;n=10,12,22,19,20,12 | Cholesterol;Increase to Grade4;n=10,12,22,19,20,12 | CK; Any grade increase; n=9,9,21,17,18,11 | CK; Increase to Grade 3; n=9,9,21,17,18,11 | CK; Increase to Grade 4; n=9,9,21,17,18,11 | Chloride; Any grade increase; n=11,13,23,19,21,12 | Chloride; Increase to Grade 3; n=11,13,23,19,21,12 | Chloride; Increase to Grade 4; n=11,13,23,19,21,12 | CO2; Any grade increase; n=11,12,23,19,21,12 | CO2; Increase to Grade 3; n=11,12,23,19,21,12 | CO2; Increase to Grade 4; n=11,12,23,19,21,12 | Creatinine;Any grade increase;n=11,14,23,19,21,12 | Creatinine;Increase to Grade3;n=11,14,23,19,21,12 | Creatinine;Increase to Grade4;n=11,14,23,19,21,12 | GGT; Any grade increase; n=11,13,22,19,20,12 | GGT; Increase to Grade 3; n=11,13,22,19,20,12 | GGT; Increase to Grade 4; n=11,13,22,19,20,12 | HDL; Any grade increase; n=10,10,22,19,19,12 | HDL; Increase to Grade 3; n=10,10,22,19,19,12 | HDL; Increase to Grade 4;n=10,10,22,19,19,12 | Insulin; Any grade increase; n=11,12,22,19,20,12 | Insulin; Increase to Grade 3; n=11,12,22,19,20,12 | Insulin; Increase to Grade 4; n=11,12,22,19,20,12 | Potassium; Any grade increase; n=11,14,23,19,21,12 | Potassium;Increase to Grade3;n=11,14,23,19,21,12 | Potassium;Increase to Grade4;n=11,14,23,19,21,12 | LDL; Any grade increase; n=10,10,22,19,19,12 | LDL; Increase to Grade 3; n=10,10,22,19,19,12 | LDL; Increase to Grade 4;n=10,10,22,19,19,12 | Lipase; Any grade increase; n=11,12,22,19,20,12 | Lipase; Increase to Grade 3;n=11,12,22,19,20,12 | Lipase; Increase to Grade 4;n=11,12,22,19,20,12 | Magnesium; Any grade increase; n=11,12,22,19,21,12 | Magnesium; Increase to Grade 3;n=11,12,22,19,21,12 | Magnesium; Increase to Grade4;n=11,12,22,19,21,12 | Protein; Any grade increase; n=11,13,23,19,21,12 | Protein; Increase to Grade 3;n=11,13,23,19,21,12 | Protein; Increase to Grade 4;n=11,13,23,19,21,12 | Sodium; Any grade increase; n=11, 14,23,19,21,12 | Sodium; Increase to Grade 3; n=11, 14,23,19,21,12 | Sodium; Increase to Grade 4; n=11, 14,23,19,21,12 | Thyroxine; Any grade increase;n=7,7,20,15,18,8 | Thyroxine; Increase to Grade3;n=7,7,20,15,18,8 | Thyroxine; Increase to Grade4;n=7,7,20,15,18,8 | Testosterone; Any grade increase; n=4,3,18,0,1,5 | Testosterone; Increase to Grade3; n=4,3,18,0,1,5 | Testosterone; Increase to Grade4; n=4,3,18,0,1,5 | Triglyc;Any grade increase;n=10,12,22,19,20,12 | Triglyc;Increase to Grade3;n=10,12,22,19,20,12 | Triglyc;Increase to Grade4;n=10,12,22,19,20,12 | Troponin I; Any grade increase; n=7,6,15,15,14,7 | Troponin I; Increase to Grade 3; n=7,6,15,15,14,7 | Troponin I; Increase to Grade 4; n=7,6,15,15,14,7 | Troponin T;Any grade increase;n=11,12,22,19,20,12 | Troponin T;Increase to Grade3;n=11,12,22,19,20,12 | Troponin T;Increase to Grade4;n=11,12,22,19,20,12 | Urate; Any grade increase; n=11,12,22,19,20,12 | Urate; Increase to Grade 3; n=11,12,22,19,20,12 | Urate; Increase to Grade 4; n=11,12,22,19,20,12 | Urea; Any grade increase; n=11,14,23,17,17,11 | Urea; Increase to Grade 3; n=11,14,23,17,17,11 | Urea; Increase to Grade 4;n=11,14,23,17,17,11 | |
| Part 2: Participants With CRPC | 20 | 0 | 0 | 9 | 0 | 0 | 6 | 2 | 0 | 6 | 0 | 0 | 9 | 2 | 0 | 10 | 1 | 0 | 0 | 0 | 0 | 13 | 2 | 0 | 0 | 0 | 0 | 8 | 2 | 0 | 2 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 2 | 1 | 7 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 1 | 0 | 0 | 0 | 0 | 7 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 8 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 0 |
| Part 2: Participants With ER+BC | 18 | 1 | 0 | 7 | 1 | 0 | 4 | 0 | 0 | 12 | 0 | 0 | 6 | 2 | 0 | 14 | 3 | 0 | 0 | 0 | 0 | 13 | 3 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 9 | 0 | 0 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 6 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 11 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 2: Participants With GIST | 9 | 2 | 0 | 5 | 0 | 0 | 4 | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 5 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 0 |
| Part 2: Participants With NMC | 10 | 0 | 0 | 5 | 0 | 0 | 3 | 0 | 0 | 3 | 0 | 0 | 5 | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 8 | 1 | 0 | 0 | 0 | 0 | 6 | 1 | 0 | 5 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 2: Participants With SCLC | 10 | 0 | 0 | 6 | 0 | 0 | 1 | 0 | 0 | 6 | 1 | 0 | 5 | 2 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 10 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 5 | 3 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 5 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 2: Participants With TNBC | 16 | 0 | 0 | 8 | 0 | 0 | 3 | 0 | 0 | 5 | 0 | 0 | 5 | 2 | 0 | 8 | 1 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 5 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Basophils; Any grade increase | Basophils; Increase to Grade 3 | Basophils; Increase to Grade 4 | Eosinophils; Any grade increase | Eosinophils; Increase to Grade 3 | Eosinophils; Increase to Grade 4 | Hemoglobin; Any grade increase | Hemoglobin; Increase to Grade 3 | Hemoglobin; Increase to Grade 4 | INR; Any grade increase | INR; Increase to Grade 3 | INR; Increase to Grade 4 | Lymphocytes; Any grade increase | Lymphocytes; Increase to Grade 3 | Lymphocytes; Increase to Grade 4 | Monocytes; Any grade increase | Monocytes; Increase to Grade 3 | Monocytes; Increase to Grade 4 | Neutrophils; Any grade increase | Neutrophils; Increase to Grade 3 | Neutrophils; Increase to Grade 4 | Platelets; Any grade increase | Platelets; Increase to Grade 3 | Platelets; Increase to Grade 4 | PT; Any grade increase | PT; Increase to Grade 3 | PT; Increase to Grade 4 | RBC; Any grade increase | RBC; Increase to Grade 3 | RBC; Increase to Grade 4 | WBC; Any grade increase | WBC; Increase to Grade 3 | WBC; Increase to Grade 4 | Fib; Any grade increase | Fib; Increase to Grade 3 | Fib; Increase to Grade 4 | aPTT; Any grade increase | aPTT; Increase to Grade 3 | aPTT; Increase to Grade 4 | |
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 2 | 0 | 1 | 0 | 0 | 3 | 1 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 5 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 |
| 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 0 | 1 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 5 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Basophils; Any grade increase; n=4,10,5 | Basophils; Increase to Grade 3; n=4,10,5 | Basophils; Increase to Grade 4; n=4,10,5 | Eosinophils; Any grade increase; n=4,10,5 | Eosinophils; Increase to Grade3; n=4,10,5 | Eosinophils; Increase to Grade4; n=4,10,5 | Hemoglobin; Any grade increase; n=4,10,5 | Hemoglobin; Increase to Grade 3; n=4,10,5 | Hemoglobin; Increase to Grade 4; n=4,10,5 | INR; Any grade increase; n=4,10,5 | INR; Increase to Grade 3; n=4,10,5 | INR; Increase to Grade 4; n=4,10,5 | Lymphocytes; Any grade increase; n=4,10,5 | Lymphocytes; Increase to Grade3; n=4,10,5 | Lymphocytes; Increase to Grade4; n=4,10,5 | Monocytes; Any grade increase; n=4,10,5 | Monocytes;Increase to Grade3; n=4,10,5 | Monocytes; Increase to Grade 4; n=4,10,5 | Neutrophils; Any grade increase; n=4,10,5 | Neutrophils; Increase to Grade 3; n=4,10,5 | Neutrophils; Increase to Grade 4; n=4,10,5 | Platelets; Any grade increase; n=4,10,5 | Platelets; Increase to Grade 3; n=4,10,5 | Platelets; Increase to Grade 4; n=4,10,5 | PT; Any grade increase;n=4,10,5 | PT; Increase to Grade 3; n=4,10,5 | PT; Increase to Grade 4; n=4,10,5 | RBC; Any grade increase; n=4,10,5 | RBC; Increase to Grade 3; n=4,10,5 | RBC; Increase to Grade 4; n=4,10,5 | WBC; Any grade increase; n=4,10,5 | WBC; Increase to Grade 3; n=4,10,5 | WBC; Increase to Grade 4; n=4,10,5 | Fib; Any grade increase; n=4,10,5 | Fib; Increase to Grade 3; n=4,10,5 | Fib; Increase to Grade 4; n=4,10,5 | aPTT; Any grade increase; n=4,10,5 | aPTT; Increase to Grade 3; n=4,10,5 | aPTT; Increase to Grade 4; n=4,10,5 | |
| Part 1: GSK525762 20 mg BID | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: GSK525762 30 mg BID | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 3 | 0 | 6 | 0 | 0 | 8 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 |
| Part 1: GSK525762 40 mg BID | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 2 | 0 | 3 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 5 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
Blood samples were collected for the analysis of hematology parameters: activated partial thromboplastin time (aPTT), platelet count, red blood cell count (RBC), white blood cell count (WBC), prothrombin international normalized ratio (INR), prothrombin time (PT), fibrinogen (Fib), hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Basophils;Any grade increase | Basophils;Increase to Grade 3 | Basophils;Increase to Grade 4 | Eosinophils;Any grade increase | Eosinophils;Increase to Grade3 | Eosinophils;Increase to Grade 4 | Hemoglobin;Any grade increase | Hemoglobin;Increase to Grade 3; n=2,4,1,3,4,9,32,9 | Hemoglobin;Increase to Grade 4 | INR; Any grade increase | INR;Increase to Grade 3 | INR; Increase to Grade 4 | Lymphocytes;Any grade increase | Lymphocytes;Increase to Grade3 | Lymphocytes;Increase to Grade4 | Monocytes;Any grade increase | Monocytes;Increase to Grade3 | Monocytes;Increase to Grade 4 | Neutrophils;Any grade increase | Neutrophils;Increase to Grade 3 | Neutrophils;Increase to Grade 4 | Platelets;Any grade increase | Platelets;Increase to Grade 3 | Platelets;Increase to Grade 4 | PT; Any grade increase | PT; Increase to Grade 3 | PT; Increase to Grade 4 | RBC; Any grade increase | RBC;Increase to Grade 3 | RBC;Increase to Grade 4 | WBC; Any grade increase | WBC; Increase to Grade 3 | WBC; Increase to Grade 4 | Fib; Any grade increase | Fib;Increase to Grade 3 | Fib;Increase to Grade 4 | aPTT; Any grade increase | aPTT; Increase to Grade 3 | aPTT; Increase to Grade 4 | |
| Part 1: GSK525762 100 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 1 | 0 | 2 | 0 | 0 | 4 | 1 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 8 | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Part 1: GSK525762 16 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: GSK525762 2 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: GSK525762 30 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: GSK525762 4 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: GSK525762 60 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 1 | 0 | 0 | 5 | 2 | 0 | 0 | 00 | 0 | 0 | 0 | 0 | 5 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: GSK525762 8 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: GSK525762 80 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 21 | 9 | 0 | 21 | 0 | 0 | 19 | 8 | 1 | 0 | 0 | 0 | 7 | 0 | 1 | 26 | 11 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 11 | 0 | 1 | 4 | 0 | 0 | 14 | 1 | 0 |
Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Basophils; Any grade increase; n=11,13,23,19,21,13 | Basophils; Increase to Grade3; n=11,13,23,19,21,13 | Basophils; Increase to Grade4; n=11,13,23,19,21,13 | Eosinophils;Any grade increase;n=11,13,23,19,21,13 | Eosinophils;Increase to Grade3;n=11,13,23,19,21,13 | Eosinophils;Increase to Grade4;n=11,13,23,19,21,13 | Hemoglobin;Any grade increase;n=11,14,23,19,21,13 | Hemoglobin;Increase to Grade3;n=11,14,23,19,21,13 | Hemoglobin;Increase to Grade4;n=11,14, 23,19,21,13 | INR; Any grade increase; n=11,12,21,17,18,12 | INR; Increase to Grade3; n=11,12,21,17,18,12 | INR; Increase to Grade4; n=11,12,21,17,18,12 | Lymphocytes;Any grade increase;n=11,13,23,19,21,13 | Lymphocytes;Increase to Grade3;n=11,13,23,19,21,13 | Lymphocytes;Increase to Grade4;n=11,13,23,19,21,13 | Monocytes; Any grade increase; n=11,13,23,19,21,13 | Monocytes;Increase to Grade3; n=11,13,23,19,21,13 | Monocytes; Increase to Grade4; n=11,13,23,19,21,13 | Neutrophils;Any grade increase;n=11,14,23,19,21,13 | Neutrophils;Increase to Grade3;n=11,14,23,19,21,13 | Neutrophils;Increase to Grade4;n=11,14,23,19,21,13 | Platelets; Any grade increase; n=11,14,23,19,21,13 | Platelets; Increase to Grade3; n=11,14,23,19,21,13 | Platelets; Increase to Grade4; n=11,14,23,19,21,13 | PT; Any grade increase;n=10,10, 18, 17, 18, 12 | PT; Increase to Grade 3; n=10,10, 18, 17, 18, 12 | PT; Increase to Grade 4; n=10,10, 18, 17, 18, 12 | RBC; Any grade increase; n=11, 13, 23, 19, 21, 13 | RBC; Increase to Grade 3; n=11, 13, 23, 19, 21, 13 | RBC; Increase to Grade 4; n=11, 13, 23, 19, 21, 13 | WBC; Any grade increase; n=11, 14, 23, 19, 21, 13 | WBC; Increase to Grade 3; n=11, 14, 23, 19, 21, 13 | WBC; Increase to Grade 4; n=11, 14, 23, 19, 21, 13 | Fib; Any grade increase; n=11, 11, 21, 17, 18, 12 | Fib; Increase to Grade 3; n=11, 11, 21, 17, 18, 12 | Fib; Increase to Grade 4; n=11, 11, 21, 17, 18, 12 | aPTT; Any grade increase; n=11,12,21,17,18,12 | aPTT; Increase to Grade3; n=11,12,21, 17, 18, 12 | aPTT; Increase to Grade4; n=11,12,21,17,18,12 | |
| Participants With CRPC | 0 | 0 | 0 | 0 | 0 | 0 | 18 | 9 | 0 | 13 | 0 | 0 | 14 | 6 | 0 | 0 | 00 | 0 | 8 | 0 | 0 | 20 | 5 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Participants With ER+BC | 0 | 0 | 0 | 0 | 0 | 0 | 18 | 5 | 0 | 11 | 0 | 0 | 13 | 1 | 0 | 0 | 0 | 0 | 6 | 1 | 0 | 18 | 6 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 |
| Participants With GIST | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 3 | 0 | 7 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 0 | 4 | 0 | 0 |
| Participants With NMC | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 3 | 0 | 8 | 0 | 0 | 8 | 2 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 7 | 4 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 1 | 0 | 2 | 1 | 0 | 4 | 0 | 0 |
| Participants With SCLC | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 2 | 0 | 6 | 0 | 0 | 7 | 2 | 1 | 0 | 0 | 0 | 4 | 1 | 0 | 12 | 4 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 |
| Participants With TNBC | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 4 | 0 | 8 | 0 | 0 | 9 | 2 | 0 | 0 | 0 | 0 | 3 | 2 | 0 | 17 | 6 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 1 | 0 | 0 | 0 | 0 | 3 | 1 | 0 |
SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| DBP; Increase to Grade 1 | DBP; Increase to Grade 2 | DBP; Increase to Grade 3/4 | SBP; Increase to Grade 1 | SBP; Increase to Grade 2 | SBP; Increase to Grade 3/4 | |
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 1 | 2 | 0 | 1 | 0 | 0 |
| 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 1 | 1 | 0 | 1 | 1 | 0 |
SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| DBP; Increase to Grade 1;n=4,10,4 | DBP; Increase to Grade 2;n=4,10,4 | DBP; Increase to Grade 3/4;n=4,10,4 | SBP; Increase to Grade 1;n=4,9,5 | SBP; Increase to Grade 2;n=4,9,5 | SBP; Increase to Grade 3/4;n=4,9,5 | |
| Part 1: GSK525762 20 mg BID | 2 | 0 | 0 | 1 | 1 | 0 |
| Part 1: GSK525762 30 mg BID | 4 | 4 | 0 | 2 | 6 | 0 |
| Part 1: GSK525762 40 mg BID | 1 | 1 | 1 | 2 | 1 | 1 |
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| DBP; Increase to Grade 1 | DBP; Increase to Grade 2 | DBP; Increase to Grade 3/4 | SBP; Increase to Grade 1 | SBP; Increase to Grade 2 | SBP; Increase to Grade 3/4 | |
| Part 1: GSK525762 100 mg QD | 0 | 1 | 2 | 1 | 3 | 2 |
| Part 1: GSK525762 16 mg QD | 0 | 1 | 0 | 1 | 1 | 0 |
| Part 1: GSK525762 2 mg QD | 2 | 0 | 0 | 1 | 1 | 0 |
| Part 1: GSK525762 30 mg QD | 0 | 1 | 0 | 1 | 3 | 0 |
| Part 1: GSK525762 4 mg QD | 1 | 0 | 0 | 1 | 0 | 1 |
| Part 1: GSK525762 60 mg QD | 3 | 0 | 1 | 2 | 1 | 2 |
| Part 1: GSK525762 8 mg QD | 0 | 1 | 0 | 1 | 0 | 0 |
| Part 1: GSK525762 80 mg QD | 9 | 10 | 2 | 11 | 9 | 5 |
Electrocardiogram (ECG) measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported. (NCT01587703)
Timeframe: Median of 1.38 months of drug exposure
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Any Grade increase | Increase to Grade 2 | Increase to Grade 3 | |
| Part 1: GSK525762 100 mg QD | 4 | 1 | 0 |
| Part 1: GSK525762 16 mg QD | 1 | 0 | 0 |
| Part 1: GSK525762 2 mg QD | 1 | 0 | 1 |
| Part 1: GSK525762 30 mg QD | 4 | 0 | 0 |
| Part 1: GSK525762 4 mg QD | 0 | 0 | 0 |
| Part 1: GSK525762 60 mg QD | 4 | 1 | 0 |
| Part 1: GSK525762 8 mg QD | 0 | 0 | 0 |
| Part 1: GSK525762 80 mg QD | 13 | 0 | 0 |
ECG measurements were done using 12-lead ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QTcF intervals. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported. (NCT01587703)
Timeframe: Median of 1.87 months of drug exposure
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Any Grade increase | Increase to Grade 2 | Increase to Grade 3 | |
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 2 | 0 | 0 |
| 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 0 | 0 | 0 |
ECG measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Any Grade increase | Increase to Grade 2 | Increase to Grade 3 | |
| Part 1: GSK525762 20 mg BID | 3 | 3 | 0 |
| Part 1: GSK525762 30 mg BID | 4 | 0 | 0 |
| Part 1: GSK525762 40 mg BID | 2 | 0 | 0 |
ECG measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported. (NCT01587703)
Timeframe: Median of 1.41 months of drug exposure
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Any Grade increase | Increase to Grade 2 | Increase to Grade 3 | |
| Participants With CRPC | 6 | 0 | 0 |
| Participants With ER+BC | 2 | 2 | 0 |
| Participants With GIST | 0 | 0 | 0 |
| Participants With NMC | 1 | 0 | 1 |
| Participants With SCLC | 2 | 0 | 0 |
| Participants With TNBC | 1 | 0 | 0 |
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5,9,17 and discharge/progression
| Intervention | Participants (Count of Participants) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glucose; Week 5;n=2,7,3 | Glucose; Week 9;n=0,4,2 | Glucose; disc/prog;n=0,6,1 | Ketones; Week 5;n=2,7,3 | Occult blood; Week 5;n=2,7,3 | Occult blood; Week 9;n=0,4,2 | Occult blood; disc/prog;n=0,6,1 | pH; Week 5;n=2,7,3 | pH; Week 9;n=0,4,2 | pH; disc/prog;n=0,7,1 | Protein; Week 5;n=2,7,3 | Protein; Week 9;n=0,4,2 | Protein; disc/prog;n=0,7,1 | Erythrocytes; Week 5;n=1,5,1 | Erythrocytes; Week 9;n=0,1,1 | Specific gravity; Week 5;n=2,7,3 | Specific gravity; Week 9;n=0,4,2 | Specific gravity; disc/prog;n=0,7,1 | Leukocytes; Week 5;n=1,5,1 | Leukocytes; Week 9;n=0,1,1 | |
| Part 1: GSK525762 40 mg BID | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 2 | 1 | 0 | 1 | 1 |
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5,9,17 and discharge/progression
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glucose; Week 5;n=2,7,3 | Glucose; Week 9;n=0,4,2 | Glucose; Week 17;n=0,2,0 | Glucose; disc/prog;n=0,6,1 | Ketones; Week 5;n=2,7,3 | Ketones; Week 17;n=0,2,0 | Occult blood; Week 5;n=2,7,3 | Occult blood; Week 9;n=0,4,2 | Occult blood; disc/prog;n=0,6,1 | pH; Week 5;n=2,7,3 | pH; Week 9;n=0,4,2 | pH; Week 17;n=0,2,0 | pH; disc/prog;n=0,7,1 | Protein; Week 5;n=2,7,3 | Protein; Week 9;n=0,4,2 | Protein; Week 17;n=0,2,0 | Protein; disc/prog;n=0,7,1 | Erythrocytes; Week 5;n=1,5,1 | Erythrocytes; Week 9;n=0,1,1 | Erythrocytes; Week 17;n=0,1,0 | Specific gravity; Week 5;n=2,7,3 | Specific gravity; Week 9;n=0,4,2 | Specific gravity; Week 17;n=0,2,0 | Specific gravity; disc/prog;n=0,7,1 | Leukocytes; Week 5;n=1,5,1 | Leukocytes; Week 9;n=0,1,1 | Leukocytes; Week 17;n=0,1,0 | |
| Part 1: GSK525762 30 mg BID | 0 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 2 | 4 | 4 | 1 | 4 | 3 | 2 | 2 | 1 | 4 | 0 | 1 | 1 | 1 | 1 | 2 | 4 | 0 | 1 |
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5,9,17 and discharge/progression
| Intervention | Participants (Count of Participants) | |||||||
|---|---|---|---|---|---|---|---|---|
| Glucose; Week 5;n=2,7,3 | Ketones; Week 5;n=2,7,3 | Occult blood; Week 5;n=2,7,3 | pH; Week 5;n=2,7,3 | Protein; Week 5;n=2,7,3 | Erythrocytes; Week 5;n=1,5,1 | Specific gravity; Week 5;n=2,7,3 | Leukocytes; Week 5;n=1,5,1 | |
| Part 1: GSK525762 20 mg BID | 0 | 0 | 0 | 2 | 0 | 1 | 2 | 0 |
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1), Weeks 5,9,17,25 and disc/prog
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hyaline casts; Week5;n=1,1 | Hyaline casts; Week9;n=2,1 | Glucose; Week5;n=3,2 | Glucose; Week9;n=4,1 | Ketones; Week9;n=4,1 | pH;Week5;n=3,2 | pH;Week9;n=4,1 | pH;disc/prog;n=2,2 | Protein; Week5; n=3,2 | Protein; Week9; n=4,1 | Erythrocytes; Week9; n=4,1 | Specific gravity; Week5; n=3,2 | Specific gravity; Week9; n=4,1 | Specific gravity; disc/prog; n=2,2 | Leukocytes; Week5; n=3,1 | Leukocytes; Week9; n=4,1 | |
| 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 |
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1), Weeks 5,9,17,25 and disc/prog
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hyaline casts; Week5;n=1,1 | Hyaline casts; Week9;n=2,1 | Hyaline casts; Week17;n=1,0 | Hyaline casts; Week25;n=1,0 | Glucose; Week5;n=3,2 | Glucose; Week9;n=4,1 | Glucose; Week17;n=2,0 | Ketones; Week9;n=4,1 | pH;Week5;n=3,2 | pH;Week9;n=4,1 | pH;Week17;n=2,0 | pH;Week25;n=1,0 | pH;disc/prog;n=2,2 | Protein; Week5; n=3,2 | Protein; Week9; n=4,1 | Protein; Week17; n=2,0 | Protein; Week25; n=1,0 | Erythrocytes; Week9; n=4,1 | Erythrocytes; Week17; n=2,0 | Erythrocytes; Week25; n=1,0 | Erythrocytes; disc/prog; n=1,0 | Specific gravity; Week5; n=3,2 | Specific gravity; Week9; n=4,1 | Specific gravity; Week17; n=2,0 | Specific gravity; Week25; n=1,0 | Specific gravity; disc/prog; n=2,2 | Leukocytes; Week5; n=3,1 | Leukocytes; Week9; n=4,1 | Leukocytes; Week17; n=2,0 | Leukocytes; Week25; n=1,0 | Leukocytes; disc/prog; n=1,0 | |
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 3 | 3 | 2 | 1 | 2 | 3 | 3 | 2 | 1 | 2 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 0 | 3 | 4 | 1 | 1 | 1 |
Urine samples were collected for the analysis of following urine parameters: potential of hydrogen (pH), glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)
| Intervention | Participants (Count of Participants) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Glucose;Week 5; n=1,2,1,3,2,7,20,7 | Glucose;Disc/Prog; n=0, 1, 0,1,0,3,17,2 | Ketones;Week 5; n=1,2,1,3,2,7,20,7 | Occult blood;Week 5; n=1,2,1,3,2,7,17,7 | pH;Week 5; n=1, 2, 1, 3,2,7,20,7 | pH;Week 9; n=1,1,0,1,1,3,12,5 | pH;Week 25; n=0,1,0,0,0,0,3,1 | Protein;Week 5; n=1, 2,1,3,2,7,20,7 | Specific gravity;Week 5; n=1,2,1,3,2,7,20,7 | Leukocytes;Week 5; n=1,2,1,2,2,6,11,6 | |
| Part 1: GSK525762 8 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Urine samples were collected for the analysis of following urine parameters: potential of hydrogen (pH), glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)
| Intervention | Participants (Count of Participants) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hyaline casts;Week 5; n=0,1,0,0,1,2,5,3 | Glucose;Week 5; n=1,2,1,3,2,7,20,7 | Glucose;Week 9; n=1, 1, 0, 1,1,3,12,5 | Ketones;Week 5; n=1,2,1,3,2,7,20,7 | Ketones;Week 9; n=1,1,0,1,1,3,12,5 | Occult blood;Week 5; n=1,2,1,3,2,7,17,7 | Occult blood;Week 9; n=1,1,0,1,1,3,11,5 | pH;Week 5; n=1, 2, 1, 3,2,7,20,7 | pH;Week 9; n=1,1,0,1,1,3,12,5 | Protein;Week 5; n=1, 2,1,3,2,7,20,7 | Protein;Week 9; n=1,1,0,1,1,3,12,5 | Specific gravity;Week 5; n=1,2,1,3,2,7,20,7 | Specific gravity;Week 9; n=1,1,0,1,1,3,12,5 | Leukocytes;Week 5; n=1,2,1,2,2,6,11,6 | Leukocytes;Week 9; n=1,1,0,1,1,1,6,4 | |
| Part 1: GSK525762 30 mg QD | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 1 |
Urine samples were collected for the analysis of following urine parameters: potential of hydrogen (pH), glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glucose;Week 5; n=1,2,1,3,2,7,20,7 | Glucose;Week 9; n=1, 1, 0, 1,1,3,12,5 | Glucose;Disc/Prog; n=0, 1, 0,1,0,3,17,2 | Ketones;Week 5; n=1,2,1,3,2,7,20,7 | Ketones;Week 9; n=1,1,0,1,1,3,12,5 | Occult blood;Week 5; n=1,2,1,3,2,7,17,7 | Occult blood;Week 9; n=1,1,0,1,1,3,11,5 | pH;Week 5; n=1, 2, 1, 3,2,7,20,7 | pH;Week 9; n=1,1,0,1,1,3,12,5 | pH;Week 25; n=0,1,0,0,0,0,3,1 | Protein;Week 5; n=1, 2,1,3,2,7,20,7 | Protein;Week 9; n=1,1,0,1,1,3,12,5 | Specific gravity;Week 5; n=1,2,1,3,2,7,20,7 | Specific gravity;Week 9; n=1,1,0,1,1,3,12,5 | Leukocytes;Week 5; n=1,2,1,2,2,6,11,6 | Leukocytes;Week 9; n=1,1,0,1,1,1,6,4 | |
| Part 1: GSK525762 2 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
Urine samples were collected for the analysis of following urine parameters: potential of hydrogen (pH), glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glucose;Week 5; n=1,2,1,3,2,7,20,7 | Glucose;Week 9; n=1, 1, 0, 1,1,3,12,5 | Glucose;Disc/Prog; n=0, 1, 0,1,0,3,17,2 | Ketones;Week 5; n=1,2,1,3,2,7,20,7 | Ketones;Week 9; n=1,1,0,1,1,3,12,5 | Occult blood;Week 5; n=1,2,1,3,2,7,17,7 | Occult blood;Week 9; n=1,1,0,1,1,3,11,5 | Occult blood;Disc/Prog; n=0,1,0,1,0,3,17,2 | pH;Week 5; n=1, 2, 1, 3,2,7,20,7 | pH;Week 9; n=1,1,0,1,1,3,12,5 | pH;Week 25; n=0,1,0,0,0,0,3,1 | pH;Disc/Prog; n=0,1,0,1,0,3,17,2 | Protein;Week 5; n=1, 2,1,3,2,7,20,7 | Protein;Week 9; n=1,1,0,1,1,3,12,5 | Protein;Disc/Prog; n=0,1,0,1,0,3,17,2 | Specific gravity;Week 5; n=1,2,1,3,2,7,20,7 | Specific gravity;Week 9; n=1,1,0,1,1,3,12,5 | Specific gravity;Disc/Prog; n=0,1,0,1,0,3,16,2 | Leukocytes;Week 5; n=1,2,1,2,2,6,11,6 | Leukocytes;Week 9; n=1,1,0,1,1,1,6,4 | Leukocytes;Disc/Prog; n=0,1,0,1,0,2,6,1 | |
| Part 1: GSK525762 16 mg QD | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 |
Urine samples were collected for the analysis of following urine parameters: potential of hydrogen (pH), glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cellular casts; Week 9; n=0,0, 0, 0, 0,1,4,1 | Cellular casts; Disc/Prog; n=0,0,0,0,0,1,5,1 | Hyaline casts;Week 5; n=0,1,0,0,1,2,5,3 | Hyaline casts;Week 9; n=0,1,0, 0,0,1,5,3 | Glucose;Week 5; n=1,2,1,3,2,7,20,7 | Glucose;Week 9; n=1, 1, 0, 1,1,3,12,5 | Glucose;Disc/Prog; n=0, 1, 0,1,0,3,17,2 | Ketones;Week 5; n=1,2,1,3,2,7,20,7 | Ketones;Week 9; n=1,1,0,1,1,3,12,5 | Occult blood;Week 5; n=1,2,1,3,2,7,17,7 | Occult blood;Week 9; n=1,1,0,1,1,3,11,5 | Occult blood;Disc/Prog; n=0,1,0,1,0,3,17,2 | pH;Week 5; n=1, 2, 1, 3,2,7,20,7 | pH;Week 9; n=1,1,0,1,1,3,12,5 | pH;Disc/Prog; n=0,1,0,1,0,3,17,2 | Protein;Week 5; n=1, 2,1,3,2,7,20,7 | Protein;Week 9; n=1,1,0,1,1,3,12,5 | Protein;Disc/Prog; n=0,1,0,1,0,3,17,2 | Specific gravity;Week 5; n=1,2,1,3,2,7,20,7 | Specific gravity;Week 9; n=1,1,0,1,1,3,12,5 | Specific gravity;Disc/Prog; n=0,1,0,1,0,3,16,2 | Leukocytes;Week 5; n=1,2,1,2,2,6,11,6 | Leukocytes;Week 9; n=1,1,0,1,1,1,6,4 | Leukocytes;Disc/Prog; n=0,1,0,1,0,2,6,1 | |
| Part 1: GSK525762 60 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 2 | 1 | 3 | 1 | 0 | 5 | 2 | 1 | 2 | 0 | 0 |
Urine samples were collected for the analysis of following urine parameters: potential of hydrogen (pH), glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cellular casts; Week 9; n=0,0, 0, 0, 0,1,4,1 | Cellular casts; Disc/Prog; n=0,0,0,0,0,1,5,1 | Hyaline casts;Week 5; n=0,1,0,0,1,2,5,3 | Hyaline casts;Week 9; n=0,1,0, 0,0,1,5,3 | Glucose;Week 5; n=1,2,1,3,2,7,20,7 | Glucose;Week 9; n=1, 1, 0, 1,1,3,12,5 | Glucose;Week 25; n=0,1,0,0,0,0,3,1 | Glucose;Disc/Prog; n=0, 1, 0,1,0,3,17,2 | Ketones;Week 5; n=1,2,1,3,2,7,20,7 | Ketones;Week 9; n=1,1,0,1,1,3,12,5 | Occult blood;Week 5; n=1,2,1,3,2,7,17,7 | Occult blood;Week 9; n=1,1,0,1,1,3,11,5 | Occult blood;Week 17; n=0, 1,0,0,0,0,5,3 | Occult blood;Week 25; n=0,1,0,0,0,0,3,1 | Occult blood;Disc/Prog; n=0,1,0,1,0,3,17,2 | pH;Week 5; n=1, 2, 1, 3,2,7,20,7 | pH;Week 9; n=1,1,0,1,1,3,12,5 | pH;Week 25; n=0,1,0,0,0,0,3,1 | pH;Disc/Prog; n=0,1,0,1,0,3,17,2 | Protein;Week 5; n=1, 2,1,3,2,7,20,7 | Protein;Week 9; n=1,1,0,1,1,3,12,5 | Protein;Week 17; n=0,1,0,0,0,0,5,3 | Protein;Week 25; n=0,1,0,0,0,0,3,1 | Protein;Disc/Prog; n=0,1,0,1,0,3,17,2 | Specific gravity;Week 5; n=1,2,1,3,2,7,20,7 | Specific gravity;Week 9; n=1,1,0,1,1,3,12,5 | Specific gravity;Week 17; n=0,1,0,0,0,0,5,3 | Specific gravity;Week 25; n=0,1,0,0,0,0,3,1 | Specific gravity;Disc/Prog; n=0,1,0,1,0,3,16,2 | Leukocytes;Week 5; n=1,2,1,2,2,6,11,6 | Leukocytes;Week 9; n=1,1,0,1,1,1,6,4 | Leukocytes;Week 17; n=0,1,0,0,0,0,1,2 | Leukocytes;Disc/Prog; n=0,1,0,1,0,2,6,1 | |
| Part 1: GSK525762 100 mg QD | 1 | 0 | 1 | 1 | 2 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 1 | 1 | 4 | 3 | 0 | 0 | 1 | 5 | 4 | 2 | 0 | 1 | 2 | 1 | 0 | 1 |
Urine samples were collected for the analysis of following urine parameters: potential of hydrogen (pH), glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hyaline casts;Week 5; n=0,1,0,0,1,2,5,3 | Hyaline casts;Week 9; n=0,1,0, 0,0,1,5,3 | Glucose;Week 5; n=1,2,1,3,2,7,20,7 | Glucose;Week 9; n=1, 1, 0, 1,1,3,12,5 | Glucose;Week 25; n=0,1,0,0,0,0,3,1 | Glucose;Disc/Prog; n=0, 1, 0,1,0,3,17,2 | Ketones;Week 5; n=1,2,1,3,2,7,20,7 | Ketones;Week 9; n=1,1,0,1,1,3,12,5 | Occult blood;Week 5; n=1,2,1,3,2,7,17,7 | Occult blood;Week 9; n=1,1,0,1,1,3,11,5 | Occult blood;Week 17; n=0, 1,0,0,0,0,5,3 | Occult blood;Week 25; n=0,1,0,0,0,0,3,1 | Occult blood;Week 33; n=0,1,0,0,0,0,2,0 | Occult blood;Disc/Prog; n=0,1,0,1,0,3,17,2 | pH;Week 5; n=1, 2, 1, 3,2,7,20,7 | pH;Week 9; n=1,1,0,1,1,3,12,5 | pH;Week 25; n=0,1,0,0,0,0,3,1 | pH;Week 33; n=0,1,0,0,0,0,2,0 | pH;Disc/Prog; n=0,1,0,1,0,3,17,2 | Protein;Week 5; n=1, 2,1,3,2,7,20,7 | Protein;Week 9; n=1,1,0,1,1,3,12,5 | Protein;Week 17; n=0,1,0,0,0,0,5,3 | Protein;Week 25; n=0,1,0,0,0,0,3,1 | Protein;Disc/Prog; n=0,1,0,1,0,3,17,2 | Specific gravity;Week 5; n=1,2,1,3,2,7,20,7 | Specific gravity;Week 9; n=1,1,0,1,1,3,12,5 | Specific gravity;Week 17; n=0,1,0,0,0,0,5,3 | Specific gravity;Week 25; n=0,1,0,0,0,0,3,1 | Specific gravity;Week 33; n=0,1,0,0,0,0,2,0 | Specific gravity;Disc/Prog; n=0,1,0,1,0,3,16,2 | Leukocytes;Week 5; n=1,2,1,2,2,6,11,6 | Leukocytes;Week 9; n=1,1,0,1,1,1,6,4 | Leukocytes;Week 17; n=0,1,0,0,0,0,1,2 | Leukocytes;Disc/Prog; n=0,1,0,1,0,2,6,1 | |
| Part 1: GSK525762 4 mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
Urine samples were collected for the analysis of following urine parameters: potential of hydrogen (pH), glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cellular casts; Week 9; n=0,0, 0, 0, 0,1,4,1 | Cellular casts; Week 17; n=0,0, 0, 0, 0,0,1,0 | Cellular casts; Disc/Prog; n=0,0,0,0,0,1,5,1 | Hyaline casts;Week 5; n=0,1,0,0,1,2,5,3 | Hyaline casts;Week 9; n=0,1,0, 0,0,1,5,3 | Glucose;Week 5; n=1,2,1,3,2,7,20,7 | Glucose;Week 9; n=1, 1, 0, 1,1,3,12,5 | Glucose;Week 25; n=0,1,0,0,0,0,3,1 | Glucose;Disc/Prog; n=0, 1, 0,1,0,3,17,2 | Ketones;Week 5; n=1,2,1,3,2,7,20,7 | Ketones;Week 9; n=1,1,0,1,1,3,12,5 | Occult blood;Week 5; n=1,2,1,3,2,7,17,7 | Occult blood;Week 9; n=1,1,0,1,1,3,11,5 | Occult blood;Week 17; n=0, 1,0,0,0,0,5,3 | Occult blood;Week 25; n=0,1,0,0,0,0,3,1 | Occult blood;Week 33; n=0,1,0,0,0,0,2,0 | Occult blood;Disc/Prog; n=0,1,0,1,0,3,17,2 | pH;Week 5; n=1, 2, 1, 3,2,7,20,7 | pH;Week 9; n=1,1,0,1,1,3,12,5 | pH;Week 25; n=0,1,0,0,0,0,3,1 | pH;Week 33; n=0,1,0,0,0,0,2,0 | pH;Disc/Prog; n=0,1,0,1,0,3,17,2 | Protein;Week 5; n=1, 2,1,3,2,7,20,7 | Protein;Week 9; n=1,1,0,1,1,3,12,5 | Protein;Week 17; n=0,1,0,0,0,0,5,3 | Protein;Week 25; n=0,1,0,0,0,0,3,1 | Protein;Disc/Prog; n=0,1,0,1,0,3,17,2 | Specific gravity;Week 5; n=1,2,1,3,2,7,20,7 | Specific gravity;Week 9; n=1,1,0,1,1,3,12,5 | Specific gravity;Week 17; n=0,1,0,0,0,0,5,3 | Specific gravity;Week 25; n=0,1,0,0,0,0,3,1 | Specific gravity;Week 33; n=0,1,0,0,0,0,2,0 | Specific gravity;Disc/Prog; n=0,1,0,1,0,3,16,2 | Specific gravity;Week 41; n=0,0,0,0,0,0,1,0 | Specific gravity;Week 49; n=0,0,0,0,0,0,1,0 | Leukocytes;Week 5; n=1,2,1,2,2,6,11,6 | Leukocytes;Week 9; n=1,1,0,1,1,1,6,4 | Leukocytes;Week 17; n=0,1,0,0,0,0,1,2 | Leukocytes;Disc/Prog; n=0,1,0,1,0,2,6,1 | |
| Part 1: GSK525762 80 mg QD | 1 | 1 | 1 | 2 | 0 | 4 | 1 | 0 | 1 | 2 | 2 | 2 | 3 | 1 | 1 | 1 | 2 | 6 | 8 | 1 | 0 | 9 | 9 | 7 | 1 | 1 | 5 | 7 | 6 | 4 | 1 | 1 | 6 | 1 | 1 | 4 | 3 | 1 | 4 |
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1), Weeks 5,9,13,25,37, 49, 73, 85 and discharge/progression
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Granular cast;disc/prog;n=1,2,6,3,4,0 | Hyaline cast;Week9;n=0,0,1,2,1,1 | Glucose;Week 5;n=8,7,18,12,14,8 | Glucose;Week9;n=8,3,12,3,6,5 | Glucose;Week13;n=7,2,6,1,2,2 | Glucose;disc/prog;n=3,6,16,12,12,5 | Ketones;Week5;n=8,7,18,12,14,8 | Ketones;Week9;n=8,3,12,3,6,5 | Ketones;disc/prog;n=3,6,16,12,12,5 | Occult blood;Week5;n=8,7,18,12,14,8 | Occult blood;Week9;n=8,3,12,3,6,5 | Occult blood;Week13;n=7,2,6,1,2,2 | Occult blood;disc/prog;n=3,6,16,12,12,5 | pH;Week5;n=8,7,18,12,14,8 | pH;Week9;n=8,3,12,3,6,5 | pH;Week13;n=7,2,6,1,2,2 | pH;disc/prog;n=3,6,16,12,12,5 | Protein;Week5;n=8,7,18,12,14,8 | Protein;Week9;n=8,3,12,3,6,5 | Protein;Week13;n=7,2,6,1,2,2 | Protein;disc/prog;n=3,6,16,12,12,5 | Erythrocytes;Week5;n=3,3,8,4,4,4 | Erythrocytes;Week9;n=4,0,2,2,1,2 | Erythrocytes;Week13;n=3,1,0,0,0,1 | Erythrocytes;disc/prog;n=1,2,6,3,4,2 | Specific gravity;Week5;n=8,7,18,12,14,8 | Specific gravity;Week9;n=8,3,12,3,6,5 | Specific gravity;Week13;n=7,2,6,1,2,2 | Specific gravity;disc/prog;n=3,6,16,12,12,5 | Leukocytes;Week5;n=3,3,8,4,4,4 | Leukocytes;Week9;n=4,0,2,2,1,3 | Leukocytes;Week13;n=3,1,0,0,0,1 | Leukocytes;disc/prog;n=1,2,7,3,4,1 | |
| Part 2: Participants With GIST | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 1 | 2 | 6 | 3 | 0 | 2 | 2 | 1 | 0 | 0 | 2 | 3 | 1 | 1 | 4 | 3 | 0 | 1 |
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1), Weeks 5,9,13,25,37, 49, 73, 85 and discharge/progression
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Granular cast;Week5;n=0,2,2,1,3,0 | Granular cast;disc/prog;n=1,2,6,3,4,0 | Hyaline cast;Week5;n=1,2,2,2,4,0 | Hyaline cast;Week13;n=1,1,0,0,0,0 | Hyaline cast;disc/prog;n=1,2,6,3,4,0 | Glucose;Week 5;n=8,7,18,12,14,8 | Glucose;Week9;n=8,3,12,3,6,5 | Glucose;Week13;n=7,2,6,1,2,2 | Glucose;disc/prog;n=3,6,16,12,12,5 | Ketones;Week5;n=8,7,18,12,14,8 | Ketones;Week9;n=8,3,12,3,6,5 | Ketones;disc/prog;n=3,6,16,12,12,5 | Occult blood;Week5;n=8,7,18,12,14,8 | Occult blood;Week9;n=8,3,12,3,6,5 | Occult blood;Week13;n=7,2,6,1,2,2 | Occult blood;disc/prog;n=3,6,16,12,12,5 | pH;Week5;n=8,7,18,12,14,8 | pH;Week9;n=8,3,12,3,6,5 | pH;Week13;n=7,2,6,1,2,2 | pH;disc/prog;n=3,6,16,12,12,5 | Protein;Week5;n=8,7,18,12,14,8 | Protein;Week9;n=8,3,12,3,6,5 | Protein;Week13;n=7,2,6,1,2,2 | Protein;disc/prog;n=3,6,16,12,12,5 | Erythrocytes;Week5;n=3,3,8,4,4,4 | Erythrocytes;Week13;n=3,1,0,0,0,1 | Erythrocytes;disc/prog;n=1,2,6,3,4,2 | Specific gravity;Week5;n=8,7,18,12,14,8 | Specific gravity;Week9;n=8,3,12,3,6,5 | Specific gravity;Week13;n=7,2,6,1,2,2 | Specific gravity;disc/prog;n=3,6,16,12,12,5 | Leukocytes;Week5;n=3,3,8,4,4,4 | Leukocytes;Week13;n=3,1,0,0,0,1 | Leukocytes;disc/prog;n=1,2,7,3,4,1 | |
| Part 2: Participants With SCLC | 0 | 0 | 0 | 1 | 0 | 2 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 3 | 1 | 1 | 2 | 1 | 2 | 1 | 1 | 0 | 1 | 0 | 4 | 1 | 1 | 2 | 1 | 0 | 1 |
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1), Weeks 5,9,13,25,37, 49, 73, 85 and discharge/progression
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Granular cast;Week5;n=0,2,2,1,3,0 | Granular cast;disc/prog;n=1,2,6,3,4,0 | Hyaline cast;Week5;n=1,2,2,2,4,0 | Hyaline cast;Week9;n=0,0,1,2,1,1 | Hyaline cast;disc/prog;n=1,2,6,3,4,0 | Glucose;Week 5;n=8,7,18,12,14,8 | Glucose;Week9;n=8,3,12,3,6,5 | Glucose;Week13;n=7,2,6,1,2,2 | Glucose;disc/prog;n=3,6,16,12,12,5 | Ketones;Week5;n=8,7,18,12,14,8 | Ketones;Week9;n=8,3,12,3,6,5 | Ketones;disc/prog;n=3,6,16,12,12,5 | Occult blood;Week5;n=8,7,18,12,14,8 | Occult blood;Week9;n=8,3,12,3,6,5 | Occult blood;Week13;n=7,2,6,1,2,2 | Occult blood;disc/prog;n=3,6,16,12,12,5 | pH;Week5;n=8,7,18,12,14,8 | pH;Week9;n=8,3,12,3,6,5 | pH;Week13;n=7,2,6,1,2,2 | pH;disc/prog;n=3,6,16,12,12,5 | Protein;Week5;n=8,7,18,12,14,8 | Protein;Week9;n=8,3,12,3,6,5 | Protein;Week13;n=7,2,6,1,2,2 | Protein;disc/prog;n=3,6,16,12,12,5 | Erythrocytes;Week5;n=3,3,8,4,4,4 | Erythrocytes;Week9;n=4,0,2,2,1,2 | Erythrocytes;disc/prog;n=1,2,6,3,4,2 | Specific gravity;Week5;n=8,7,18,12,14,8 | Specific gravity;Week9;n=8,3,12,3,6,5 | Specific gravity;Week13;n=7,2,6,1,2,2 | Specific gravity;disc/prog;n=3,6,16,12,12,5 | Leukocytes;Week5;n=3,3,8,4,4,4 | Leukocytes;Week9;n=4,0,2,2,1,3 | Leukocytes;disc/prog;n=1,2,7,3,4,1 | |
| Part 2: Participants With ER+BC | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 6 | 4 | 0 | 5 | 5 | 0 | 0 | 3 | 3 | 1 | 2 | 7 | 5 | 0 | 5 | 4 | 0 | 3 |
| Part 2: Participants With TNBC | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 1 | 6 | 3 | 0 | 0 | 2 | 2 | 1 | 1 | 5 | 2 | 0 | 3 | 3 | 1 | 3 |
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1), Weeks 5,9,13,25,37, 49, 73, 85 and discharge/progression
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Granular cast;Week5;n=0,2,2,1,3,0 | Granular cast;disc/prog;n=1,2,6,3,4,0 | Hyaline cast;Week5;n=1,2,2,2,4,0 | Hyaline cast;Week9;n=0,0,1,2,1,1 | Hyaline cast;disc/prog;n=1,2,6,3,4,0 | Glucose;Week 5;n=8,7,18,12,14,8 | Glucose;Week9;n=8,3,12,3,6,5 | Glucose;Week13;n=7,2,6,1,2,2 | Glucose;Week37;n=3,0,1,0,0,0 | Glucose;Week49;n=1,0,1,0,0,0 | Glucose;disc/prog;n=3,6,16,12,12,5 | Ketones;Week5;n=8,7,18,12,14,8 | Ketones;Week9;n=8,3,12,3,6,5 | Ketones;disc/prog;n=3,6,16,12,12,5 | Occult blood;Week5;n=8,7,18,12,14,8 | Occult blood;Week9;n=8,3,12,3,6,5 | Occult blood;Week13;n=7,2,6,1,2,2 | Occult blood;Week25;n=2,0,3,0,0,0 | Occult blood;Week37;n=3,0,1,0,0,0 | Occult blood;disc/prog;n=3,6,16,12,12,5 | pH;Week5;n=8,7,18,12,14,8 | pH;Week9;n=8,3,12,3,6,5 | pH;Week13;n=7,2,6,1,2,2 | pH;Week25;n=2,0,3,0,0,0 | pH;Week37;n=3,0,1,0,0,0 | pH;Week49;n=1,0,1,0,0,0 | pH;disc/prog;n=3,6,16,12,12,5 | Protein;Week5;n=8,7,18,12,14,8 | Protein;Week9;n=8,3,12,3,6,5 | Protein;Week13;n=7,2,6,1,2,2 | Protein;Week37;n=1,0,1,0,0,0 | Protein;disc/prog;n=3,6,16,12,12,5 | Erythrocytes;Week5;n=3,3,8,4,4,4 | Erythrocytes;Week9;n=4,0,2,2,1,2 | Erythrocytes;disc/prog;n=1,2,6,3,4,2 | Specific gravity;Week5;n=8,7,18,12,14,8 | Specific gravity;Week9;n=8,3,12,3,6,5 | Specific gravity;Week13;n=7,2,6,1,2,2 | Specific gravity;disc/prog;n=3,6,16,12,12,5 | Leukocytes;Week5;n=3,3,8,4,4,4 | Leukocytes;Week9;n=4,0,2,2,1,3 | Leukocytes;Week25;n=2,0,1,0,0,0 | Leukocytes;disc/prog;n=1,2,7,3,4,1 | |
| Part 2: Participants With CRPC | 0 | 2 | 0 | 0 | 2 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 5 | 5 | 0 | 1 | 0 | 8 | 8 | 7 | 3 | 1 | 0 | 0 | 6 | 9 | 4 | 2 | 0 | 6 | 5 | 1 | 5 | 2 | 2 | 1 | 3 | 5 | 2 | 1 | 2 |
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented. (NCT01587703)
Timeframe: Baseline (pre-dose Week1 Day1), Weeks 5,9,13,25,37, 49, 73, 85 and discharge/progression
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Granular cast;disc/prog;n=1,2,6,3,4,0 | Hyaline cast;Week5;n=1,2,2,2,4,0 | Hyaline cast;Week13;n=1,1,0,0,0,0 | Hyaline cast;disc/prog;n=1,2,6,3,4,0 | Glucose;Week 5;n=8,7,18,12,14,8 | Glucose;Week9;n=8,3,12,3,6,5 | Glucose;Week13;n=7,2,6,1,2,2 | Glucose;Week37;n=3,0,1,0,0,0 | Glucose;Week49;n=1,0,1,0,0,0 | Glucose;Week73;n=1,0,0,0,0,0 | Glucose;Week85;n=1,0,0,0,0,0 | Glucose;disc/prog;n=3,6,16,12,12,5 | Ketones;Week5;n=8,7,18,12,14,8 | Ketones;Week9;n=8,3,12,3,6,5 | Ketones;disc/prog;n=3,6,16,12,12,5 | Occult blood;Week5;n=8,7,18,12,14,8 | Occult blood;Week9;n=8,3,12,3,6,5 | Occult blood;Week13;n=7,2,6,1,2,2 | Occult blood;Week25;n=2,0,3,0,0,0 | Occult blood;Week37;n=3,0,1,0,0,0 | Occult blood;disc/prog;n=3,6,16,12,12,5 | pH;Week5;n=8,7,18,12,14,8 | pH;Week9;n=8,3,12,3,6,5 | pH;Week13;n=7,2,6,1,2,2 | pH;Week25;n=2,0,3,0,0,0 | pH;Week37;n=3,0,1,0,0,0 | pH;Week49;n=1,0,1,0,0,0 | pH;Week73;n=1,0,0,0,0,0 | pH;Week85;n=1,0,0,0,0,0 | pH;disc/prog;n=3,6,16,12,12,5 | Protein;Week5;n=8,7,18,12,14,8 | Protein;Week9;n=8,3,12,3,6,5 | Protein;Week13;n=7,2,6,1,2,2 | Protein;Week37;n=1,0,1,0,0,0 | Protein;disc/prog;n=3,6,16,12,12,5 | Erythrocytes;Week5;n=3,3,8,4,4,4 | Erythrocytes;Week9;n=4,0,2,2,1,2 | Erythrocytes;Week13;n=3,1,0,0,0,1 | Erythrocytes;disc/prog;n=1,2,6,3,4,2 | Specific gravity;Week5;n=8,7,18,12,14,8 | Specific gravity;Week9;n=8,3,12,3,6,5 | Specific gravity;Week13;n=7,2,6,1,2,2 | Specific gravity;disc/prog;n=3,6,16,12,12,5 | Leukocytes;Week5;n=3,3,8,4,4,4 | Leukocytes;Week9;n=4,0,2,2,1,3 | Leukocytes;Week13;n=3,1,0,0,0,1 | Leukocytes;Week25;n=2,0,1,0,0,0 | Leukocytes;disc/prog;n=1,2,7,3,4,1 | |
| Part 2: Participants With NMC | 0 | 1 | 0 | 0 | 1 | 2 | 2 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 6 | 5 | 2 | 1 | 3 | 1 | 1 | 1 | 1 | 1 | 3 | 3 | 1 | 1 | 2 | 2 | 3 | 0 | 4 | 2 | 2 | 0 | 1 | 0 | 1 | 0 | 0 |
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is 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; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment (NCT01587703)
Timeframe: Median of 1.87 months of drug exposure
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Any non-serious AE | Any SAE | |
| 80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 5 | 3 |
| 80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes | 5 | 3 |
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762. (NCT01587703)
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4
| Intervention | Hour (Median) | |||
|---|---|---|---|---|
| Week1 AM dose;n=4,10,5 | Week1 PM dose;n=4,9,5 | Week3 AM dose;n=3,7,3 | Week3 PM dose;n=3,6,3 | |
| Part 1: GSK525762 20 mg BID | 1.5500 | 1.9583 | 1.1833 | 1.0000 |
| Part 1: GSK525762 30 mg BID | 0.9667 | 1.9667 | 1.0667 | 1.4500 |
| Part 1: GSK525762 40 mg BID | 0.5500 | 1.9833 | 0.5833 | 2.0667 |
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762. (NCT01587703)
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4
| Intervention | Hours (Median) | |
|---|---|---|
| Week1;n=3,4,1,3,4,9,32,9 | Week3;n=1,2,1,3,4,6,16,6 | |
| Part 1: GSK525762 100 mg QD | 1.0000 | 1.5000 |
| Part 1: GSK525762 16 mg QD | 2.0167 | 1.0500 |
| Part 1: GSK525762 2 mg QD | 0.5833 | 1.0000 |
| Part 1: GSK525762 30 mg QD | 2.0083 | 0.9000 |
| Part 1: GSK525762 4 mg QD | 1.2250 | 2.5083 |
| Part 1: GSK525762 60 mg QD | 1.0000 | 1.0583 |
| Part 1: GSK525762 8 mg QD | 1.1000 | 0.5000 |
| Part 1: GSK525762 80 mg QD | 1.0000 | 0.5667 |
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762. (NCT01587703)
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4
| Intervention | Liters (Geometric Mean) | |||
|---|---|---|---|---|
| Week1 AM dose;n=3,10,5 | Week1 PM dose;n=3,7,3 | Week3 AM dose;n=3,7,3 | Week3 PM dose;n=3,5,3 | |
| Part 1: GSK525762 20 mg BID | 99.07 | 116.52 | 71.00 | 92.00 |
| Part 1: GSK525762 30 mg BID | 48.13 | 77.28 | 54.94 | 104.52 |
| Part 1: GSK525762 40 mg BID | 59.67 | 81.11 | 112.17 | 127.34 |
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762. (NCT01587703)
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4
| Intervention | Liters (Geometric Mean) | |
|---|---|---|
| Week1;n=3,4,1,3,4,9,32,9 | Week3;n=1,2,1,3,4,6,16,6 | |
| Part 1: GSK525762 100 mg QD | 124.70 | 149.14 |
| Part 1: GSK525762 16 mg QD | 182.13 | 152.72 |
| Part 1: GSK525762 2 mg QD | 53.56 | 83.97 |
| Part 1: GSK525762 30 mg QD | 85.46 | 76.20 |
| Part 1: GSK525762 4 mg QD | 81.79 | 77.27 |
| Part 1: GSK525762 60 mg QD | 110.44 | 132.14 |
| Part 1: GSK525762 8 mg QD | 79.87 | 172.33 |
| Part 1: GSK525762 80 mg QD | 87.03 | 162.17 |
Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions. (NCT00512096)
Timeframe: restaging with second and fourth 21-day cycles followed by surgery
| Intervention | participants (Number) |
|---|---|
| Cisplatin + Ifosfamide + Paclitaxel | 3 |
11 reviews available for ifosfamide and Carcinoma, Epidermoid
| Article | Year |
|---|---|
Ifosfamide in the treatment of head and neck cancer.
Topics: Antineoplastic Agents, Alkylating; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamo | 2003 |
[Clinical features of patients with metastasis in phalanges as first symptom of primary lung cancer].
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Carcino | 2007 |
Chemotherapy of non-small cell lung cancer: a reappraisal and a look to the future.
Topics: Adenocarcinoma; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Sm | 1983 |
New agents in non-small cell lung cancer.
Topics: Adenocarcinoma; Adult; Alkylating Agents; Animals; Anthraquinones; Antibiotics, Antineoplastic; Anti | 1984 |
Chemotherapy followed by radiotherapy versus radiotherapy alone in locally advanced cervical cancer: a randomized study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Brachytherapy; Carcinoma, Sq | 1994 |
Single-agent paclitaxel and paclitaxel plus ifosfamide in the treatment of head and neck cancer.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Clinical Trials | 1995 |
Treatment of pediatric malignant thymoma: long-term remission in a 14-year-old boy with EBV-associated thymic carcinoma by aggressive, combined modality treatment.
Topics: Adolescent; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Antineoplastic Agents, Phytoge | 1996 |
Chemotherapy with paclitaxel, ifosfamide, and cisplatin for the treatment of squamous cell cervical cancer: the experience of Monza.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, | 2000 |
Paclitaxel (Taxol)/ifosfamide-based chemotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Squamous Cell; Cisplatin; Cl | 2000 |
Treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck: current status and future directions.
Topics: Antineoplastic Agents; Carcinoma, Squamous Cell; Deoxycytidine; Docetaxel; Gemcitabine; Head and Nec | 2000 |
Neoadjuvant therapy for cervical cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Squamous Cell; | 1992 |
68 trials available for ifosfamide and Carcinoma, Epidermoid
| Article | Year |
|---|---|
Prognostic and predictive factors in patients with metastatic or recurrent cervical cancer treated with platinum-based chemotherapy.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Carc | 2017 |
Treatment of base of tongue cancer with paclitaxel, ifosfamide, and cisplatinum induction chemotherapy followed by chemoradiotherapy.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Di | 2008 |
A phase II, randomized trial of neo-adjuvant chemotherapy comparing a three-drug combination of paclitaxel, ifosfamide, and cisplatin (TIP) versus paclitaxel and cisplatin (TP) followed by radical surgery in patients with locally advanced squamous cell ce
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, Adjuv | 2009 |
Docetaxel, ifosfamide and cisplatin (DIP) in squamous cell carcinoma of the head and neck.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Case-Control | 2009 |
Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, | 2010 |
Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, | 2010 |
Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, | 2010 |
Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, | 2010 |
Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, | 2010 |
Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, | 2010 |
Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, | 2010 |
Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, | 2010 |
Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, | 2010 |
Ifosfamide, paclitaxel, and carboplatin, a novel triplet regimen for advanced, recurrent, or persistent carcinoma of the cervix: a phase II trial.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Squamous Cell; | 2011 |
A study using ifosfamide and etoposide in patients with cisplatin-refractory recurrent or metastatic head and neck squamous cell carcinoma.
Topics: Adult; Aged; Analysis of Variance; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamo | 2011 |
Pathologic complete response to preoperative chemotherapy predicts cure in early-stage non-small-cell lung cancer: combined analysis of two IFCT randomized trials.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Carcino | 2012 |
Phase II study of induction chemotherapy with paclitaxel, ifosfamide, and carboplatin (TIC) for patients with locally advanced squamous cell carcinoma of the head and neck.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcino | 2002 |
Gemcitabine and cisplatin versus vinorelbine and cisplatin versus ifosfamide+gemcitabine followed by vinorelbine and cisplatin versus vinorelbine and cisplatin followed by ifosfamide and gemcitabine in stage IIIB-IV non small cell lung carcinoma: a prospe
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Large Cell; | 2003 |
Phase II study of docetaxel and ifosfamide combination chemotherapy in non-small-cell lung cancer patients failing previous chemotherapy with or without paclitaxel.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Agents, Phytogenic; Antineoplastic Combined Chemotherapy | 2003 |
Phase II study of cisplatin, ifosfamide, and irinotecan with rhG-CSF support in patients with stage IIIb and IV non-small-cell lung cancer.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Carcinoma | 2003 |
Preoperative mitomycin, ifosfamide, and cisplatin followed by esophagectomy in squamous cell carcinoma of the esophagus: pathologic complete response induced by chemotherapy leads to long-term survival.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Co | 2003 |
A phase III randomised study comparing two different dose-intensity regimens as induction chemotherapy followed by thoracic irradiation in patients with advanced locoregional non-small-cell lung cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Carcino | 2004 |
[Effect of neoadjuvant chemotherapy in the treatment of patients with stage IIIB cervical cancer].
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carcinoma, Squamous Cell; Chemothe | 2003 |
Retrospective analysis of concurrent chemoradiation with the combination of bleomycin, ifosfamide and cisplatin (BIP) for uterine cervical cancer.
Topics: Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carci | 2004 |
Concomitant chemobrachyradiotherapy with ifosfamide and cisplatin followed by consolidation chemotherapy in locally advanced squamous cell carcinoma of the uterine cervix: results of a phase II study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Brachytherapy; Carcinoma, Squamous Cell | 2005 |
Randomized trial of neoadjuvant chemotherapy comparing paclitaxel, ifosfamide, and cisplatin with ifosfamide and cisplatin followed by radical surgery in patients with locally advanced squamous cell cervical carcinoma: the SNAP01 (Studio Neo-Adjuvante Por
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chi-Square Di | 2005 |
[Neoadjuvant chemotherapy with intra-arterial infusion in the treatment of advanced cervical cancer].
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carcinoma, Squamous Cell; Ch | 2005 |
Prospective trial of ifosfamide, paclitaxel, and cisplatin in patients with advanced non-transitional cell carcinoma of the urothelial tract.
Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Biop | 2007 |
Salvage chemotherapy with mitomycin C, ifosfamide, and cisplatin (MIC) for previously treated metastatic or recurrent esophageal squamous cell carcinoma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Di | 2008 |
Maintenance immunotherapy in recurrent or metastatic squamous cell carcinoma of the head and neck.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; CD4-CD8 Ratio | 2008 |
Single-dose ifosfamide: efficacy studies in non-small cell lung cancer.
Topics: Actuarial Analysis; Adenocarcinoma; Adult; Aged; Carcinoma, Small Cell; Carcinoma, Squamous Cell; Cl | 1982 |
Use and safety of high-dose ifosfamide.
Topics: Adenocarcinoma; Aged; Carcinoma, Small Cell; Carcinoma, Squamous Cell; Clinical Trials as Topic; Cyc | 1982 |
Chemotherapy of non-small cell lung cancer: a reappraisal and a look to the future.
Topics: Adenocarcinoma; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Sm | 1983 |
New agents in non-small cell lung cancer.
Topics: Adenocarcinoma; Adult; Alkylating Agents; Animals; Anthraquinones; Antibiotics, Antineoplastic; Anti | 1984 |
Treatment of ifosfamide-induced urothelial toxicity by oral administration of sodium 2-mercaptoethane sulphonate (MESNA) to patients with inoperable lung cancer.
Topics: Administration, Oral; Adult; Aged; Carcinoma, Squamous Cell; Cyclophosphamide; Drug Therapy, Combina | 1983 |
Phase I study of paclitaxel, cisplatin, and ifosfamide in patients with recurrent or metastatic squamous cell cancer of the head and neck.
Topics: Adenocarcinoma; Adult; Aged; Agranulocytosis; Antineoplastic Combined Chemotherapy Protocols; Carcin | 1995 |
Phase II trial of bleomycin, ifosfamide, and carboplatin in metastatic cervical cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carboplatin; Carcinoma, Squa | 1994 |
Chemotherapy followed by radiotherapy versus radiotherapy alone in locally advanced cervical cancer: a randomized study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Brachytherapy; Carcinoma, Sq | 1994 |
[Neoadjuvant radiochemotherapy in locally advanced non-small cell bronchial carcinoma. Initial results of a prospective multicenter study].
Topics: Adenocarcinoma; Antineoplastic Combined Chemotherapy Protocols; Brain; Carboplatin; Carcinoma, Bronc | 1995 |
Cisplatin and ifosfamide in patients with advanced squamous cell carcinoma of the uterine cervix. A phase II trial.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Fe | 1995 |
Cisplatin, 5-fluorouracil, and ifosfamide in the treatment of recurrent or advanced cervical cancer.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cel | 1995 |
A phase II study of mitomycin, ifosfamide and cisplatin in operable and inoperable squamous cell carcinoma of the oesophagus.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Esophagea | 1994 |
A phase II study of ifosfamide, carboplatin and cisplatin in advanced and recurrent squamous cell carcinoma of the uterine cervix.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Squamous Cell; | 1993 |
Mitomycin, ifosfamide, and cisplatin in non-small cell lung cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Body Weight; Carcinoma, Non-Small-Cell | 1993 |
Ifosfamide in advanced epidermoid head and neck cancer.
Topics: Adult; Aged; Alopecia; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Hea | 1993 |
Phase II trial of ifosfamide and mesna in patients with advanced or recurrent squamous carcinoma of the cervix who had never received chemotherapy: a Gynecologic Oncology Group study.
Topics: Adult; Aged; Aged, 80 and over; Carcinoma, Squamous Cell; Female; Humans; Ifosfamide; Mesna; Middle | 1993 |
Cisplatin and ifosfamide with various doses of vinorelbine (navelbine) in advanced non-small lung cancer.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Antineoplasti | 1996 |
A phase II study of ifosfamide in recurrent squamous cell carcinoma of the head and neck.
Topics: Adult; Aged; Agranulocytosis; Antineoplastic Agents, Alkylating; Carcinoma, Squamous Cell; Female; H | 1996 |
Combination chemotherapy with vindesine-ifosfamide-cisplatin (VIP) in locally advanced unresectable stage III and in stage IV non-small cell lung cancer: a phase II trial.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Large Cell; | 1995 |
Pilot study of ambulatory infusional delivery of a multidrug regimen: ifosfamide, carboplatin and etoposide (ICE).
Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Ambulatory Care; Anemia; Antineoplastic Combined Che | 1996 |
Phase II study of intensive chemotherapy with carboplatin, ifosfamide and etoposide plus recombinant human granulocyte colony-stimulating factor and sequential radiotherapy in locally advanced, unresectable non-small-cell lung cancer.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, | 1996 |
Randomized trial of cisplatin versus cisplatin plus mitolactol versus cisplatin plus ifosfamide in advanced squamous carcinoma of the cervix: a Gynecologic Oncology Group study.
Topics: Adult; Age Distribution; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Ca | 1997 |
Cisplatin, ifosfamide, methotrexate and vinblastine combination chemotherapy for metastatic urothelial cancer.
Topics: Adenocarcinoma; Antimetabolites, Antineoplastic; Antineoplastic Agents, Alkylating; Antineoplastic A | 1997 |
[Combination chemotherapy with nedaplatin, bleomycin and ifosfamide for advanced cervical cancer of the uterus--a preliminary study for phase III clinical study].
Topics: Adult; Aged; Anorexia; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Bone Marrow; Carci | 1997 |
Recent advances in paclitaxel-containing chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Dr | 1997 |
Ifosfamide in the treatment of advanced or recurrent squamous cell carcinoma of the head and neck: a phase II Hoosier Oncology Group trial.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Alkylating; Carcinoma, Squamous Cell; Female; | 1998 |
Phase II trial of paclitaxel, ifosfamide, and cisplatin in patients with recurrent head and neck squamous cell carcinoma.
Topics: Adult; Aged; Antineoplastic Agents, Phytogenic; Antineoplastic Combined Chemotherapy Protocols; Carc | 1998 |
Role of paclitaxel, ifosfamide, and cisplatin in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Di | 1998 |
A phase II trial of four courses of preoperative chemotherapy in squamous or anaplastic carcinoma of the oesophagus.
Topics: Adult; Aged; Alopecia; Antibiotics, Antineoplastic; Antineoplastic Agents; Antineoplastic Agents, Al | 1998 |
Neoadjuvant chemotherapy with cisplatin, ifosfamide and paclitaxel for locally advanced squamous-cell cervical cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, | 1998 |
Phase II clinical trial of cisplatin, 5-fluorouracil, and ifosfamide as treatment for advanced locoregional head and neck carcinoma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Fl | 1999 |
A brief intensive cisplatin-based outpatient chemotherapy regimen with filgrastim and megestrol acetate support for advanced non-small cell lung cancer: results of a phase II trial.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Appetite Stimulants; Ca | 1998 |
Phase II study of tamoxifen, ifosfamide, epirubicin and cisplatin combination chemotherapy in patients with non-small cell lung cancer failing previous chemotherapy.
Topics: Adenocarcinoma; Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Pro | 2000 |
Neoadjuvant chemotherapy with ifosfamide, cisplatin, and vinorelbine in advanced squamous cell carcinoma of the cervix.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Fe | 2000 |
Phase II study of paclitaxel, ifosfamide, and carboplatin in patients with recurrent or metastatic head and neck squamous cell carcinoma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Squamous Cell; | 2001 |
Ifosfamide and mitoxantrone in the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck.
Topics: Adult; Aged; Anemia; Antigens, Neoplasm; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, | 2001 |
Ifosfamide, cisplatin, and 13-Cis retinoic acid for patients with advanced or recurrent squamous cell carcinoma of the head and neck: a phase I-II study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Fe | 2001 |
Randomized trial of cisplatin and ifosfamide with or without bleomycin in squamous carcinoma of the cervix: a gynecologic oncology group study.
Topics: Adult; Aged; Aged, 80 and over; Antibiotics, Antineoplastic; Antimetabolites, Antineoplastic; Antine | 2002 |
Protection against chemotherapy toxicity by IV hyperalimentation.
Topics: Bacterial Vaccines; Carcinoma, Squamous Cell; Doxorubicin; Evaluation Studies as Topic; Humans; Ifos | 1978 |
Combination chemoimmunotherapy for extensive non-oat cell lung cancer.
Topics: Adenocarcinoma; Adult; Aged; Bacterial Vaccines; Body Weight; Carcinoma, Squamous Cell; Clinical Tri | 1978 |
Experience with bleomycin, ifosfamide, and cisplatin in primary and recurrent cervical cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carcinoma; Carcinoma, Squamo | 1992 |
Neoadjuvant therapy for cervical cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Squamous Cell; | 1992 |
Ifosfamide and mesna for the treatment of advanced squamous cell head and neck cancer. A GETLAC study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Female; Head | 1991 |
Gynecologic Oncology Group experience with ifosfamide.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Combined Modality Therapy; | 1990 |
Cisplatin, etoposide, and ifosfamide in non-small cell lung carcinoma. A phase II randomized study with cisplatin and etoposide as the control arm.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Ce | 1990 |
The role of ifosfamide in cervical cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carcinoma, Squamous Cell; Ci | 1989 |
98 other studies available for ifosfamide and Carcinoma, Epidermoid
| Article | Year |
|---|---|
Metastatic penile squamous cell carcinoma with dramatic response to combined checkpoint blockade with ipilimumab and nivolumab.
Topics: Antineoplastic Combined Chemotherapy Protocols; B7-H1 Antigen; Carcinoma, Squamous Cell; Cisplatin; | 2021 |
Response to Combination Chemotherapy With Paclitaxel/Ifosfamide/Platinum Versus Paclitaxel/Platinum for Patients With Metastatic, Recurrent, or Persistent Carcinoma of the Uterine Cervix: A Retrospective Analysis.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Squamous Cell; | 2018 |
Neoadjuvant docetaxel, cisplatin and ifosfamide (ITP) combination chemotherapy for treating penile squamous cell carcinoma patients with terminal lymph node metastasis.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Di | 2019 |
Transrectal ultrasound and magnetic resonance imaging in the evaluation of tumor size following neoadjuvant chemotherapy for locally advanced cervical cancer.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cel | 2013 |
Robotic radical hysterectomy following neoadjuvant chemotherapy in FIGO stage IIIB cervical cancer: a case report.
Topics: Adult; Carcinoma, Squamous Cell; Chemotherapy, Adjuvant; Cisplatin; Female; Humans; Hysterectomy; If | 2014 |
ERCC1 expression does not predict survival and treatment response in advanced stage non-small cell lung cancer cases treated with platinum based chemotherapy.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Carb | 2013 |
[Efficacy of postoperative simple chemotherapy and concurrent chemoradiotherapy in FIGO stage IB2-IIB cervical cancer].
Topics: Adenocarcinoma; Adult; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carcinoma, Squamou | 2013 |
NUT midline carcinoma: an aggressive intrathoracic neoplasm.
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Etoposid | 2013 |
Neoadjuvant chemotherapy followed by robotic radical hysterectomy in locally advanced cervical cancer: a multi-institution study.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cel | 2014 |
Recurrent metastatic anal cancer treated with modified paclitaxel, ifosfamide, and cisplatin and third-line mitomycin/cetuximab.
Topics: Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Carcinoma, Squamous Cell; Cetuximab; | 2015 |
Oncological and pregnancy outcomes after high-dose density neoadjuvant chemotherapy and fertility-sparing surgery in cervical cancer.
Topics: Abortion, Spontaneous; Adenocarcinoma; Adolescent; Adult; Antineoplastic Combined Chemotherapy Proto | 2014 |
Long follow-up of patients with locally advanced cervical cancer treated with concomitant chemobrachyradiotherapy with cisplatin and ifosfamide followed by consolidation chemotherapy.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Brachytherapy; Carcinoma, Squamous Cell | 2015 |
[Dramatic response of penile cancer with inguinal lymph node metastases to neoadjuvant chemotherapy with paclitaxel, ifosfamide and cisplatin : a case report].
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, Adjuvant; Ci | 2015 |
Efficacy and tolerability of paclitaxel, ifosfamide, and cisplatin as a neoadjuvant chemotherapy in locally advanced cervical carcinoma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Di | 2015 |
Impact of perioperative chemotherapy on survival in patients with advanced primary urethral cancer: results of the international collaboration on primary urethral carcinoma.
Topics: Adenocarcinoma; Aged; Albumin-Bound Paclitaxel; Antineoplastic Combined Chemotherapy Protocols; Carb | 2015 |
Neoadjuvant chemotherapy followed by large cone resection as fertility-sparing therapy in stage IB cervical cancer.
Topics: Abortion, Missed; Adenocarcinoma; Adult; Antineoplastic Combined Chemotherapy Protocols; Carboplatin | 2015 |
Expression of ERCC1 and TUBB3 in locally advanced cervical squamous cell cancer and its correlation with different therapeutic regimens.
Topics: Adult; Aged; Antineoplastic Agents, Alkylating; Antineoplastic Combined Chemotherapy Protocols; Brac | 2015 |
Feasibility of robotic radical hysterectomy after neoadjuvant chemotherapy in women with locally advanced cervical cancer.
Topics: Adenocarcinoma; Adult; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cis | 2016 |
Retrospective analysis of surgical resection after induction chemotherapy for patients with T4b squamous cell head and neck cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Squamous Cell; | 2008 |
Neoadjuvant chemotherapy and conservative surgery for stage IB1 cervical cancer.
Topics: Adenocarcinoma; Adult; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Che | 2008 |
Durable long-term remission with chemotherapy alone for stage II to IV laryngeal cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, | 2009 |
A retrospective study of patients with locally advanced cancer of the cervix treated with neoadjuvant chemotherapy followed by radical surgery.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Adenosquamou | 2009 |
Primary squamous cell carcinoma of the breast: achieving long-term control with cisplatin-based chemotherapy.
Topics: Aged; Antineoplastic Agents; Breast Neoplasms; Carcinoma, Squamous Cell; Cisplatin; Combined Modalit | 2009 |
Role of cyclooxygenase-2 in tumor progression and survival of head and neck squamous cell carcinoma.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Squamous Cell; Case-Control | 2009 |
Type II radical hysterectomy and adjuvant therapy for pelvic lymph node metastasis with stage IB-IIB cervical carcinoma: a retrospective study of 288 patients.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Brachytherapy; Carcinoma, Sq | 2011 |
Neoadjuvant chemotherapy for locally advanced cervical cancer reduces surgical risks and lymph-vascular space involvement.
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carcinoma, Squamous Cell; Cisplati | 2011 |
The anti-tumour effect of cisplatin and ifosfamide on xenografted squamous cell carcinoma of the head and neck is schedule-dependent.
Topics: Animals; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Carcinoma, Squamous Cell; Cisplat | 2012 |
Clinical evaluation of neoadjuvant chemotherapy followed by radical surgery in the management of stage IB2-IIB cervical cancer.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carcinoma, S | 2012 |
The clinical characteristic differences between thrombosis-related edema and lymphedema following radiotherapy or chemoradiotherapy for patients with cervical cancer.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Agents, Alkylating; Antineoplastic Combined Chemotherapy | 2012 |
The effect of chemotherapy or radiotherapy on thymidine phosphorylase and dihydropyrimidine dehydrogenase expression in cancer of the uterine cervix.
Topics: Adult; Aged; Antimetabolites, Antineoplastic; Capecitabine; Carcinoma, Squamous Cell; Chemoradiother | 2012 |
Laparoscopic lymph node dissection should be performed before fertility preserving treatment of patients with cervical cancer.
Topics: Adenocarcinoma; Adult; Antineoplastic Combined Chemotherapy Protocols; Brachytherapy; Carcinoma, Squ | 2012 |
Ifosfamide and doxorubicin combination chemotherapy for recurrent nasopharyngeal carcinoma patients.
Topics: Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Carcinoma, Squamo | 2012 |
Surgical outcomes of robotic radical hysterectomy after neoadjuvant chemotherapy for locally advanced cervical cancer: comparison with early stage disease.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Brachytherapy; Carcinom | 2013 |
Phase II study of induction chemotherapy with paclitaxel, ifosfamide, and carboplatin (TIC) for patients with locally advanced squamous cell carcinoma of the head and neck.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Squamous Cell; Clinical Tria | 2003 |
Grading of chemotherapy-induced peripheral neurotoxicity using the Total Neuropathy Scale.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Drug-Related Si | 2003 |
Long-lasting complete remission of a patient with cervical cancer FIGO IVB treated by concomitant chemobrachyradiotherapy with ifosfamide and cisplatin and consolidation chemotherapy--a case report.
Topics: Antineoplastic Combined Chemotherapy Protocols; Brachytherapy; Carcinoma, Squamous Cell; Cisplatin; | 2004 |
[A case of oropharyngeal cancer with multiple bone metastases from prostate cancer that responded to docetaxel, ifosfamide and cisplatin combination therapy].
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Carcinoma, Squamous Cell; Cisp | 2005 |
Sarcomas of the head and neck. Results from the treatment of 25 patients.
Topics: Adolescent; Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Carc | 2005 |
[A case of thymic carcinoma responding to combination chemotherapy with nedaplatin, etoposide, and ifosfamide].
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Drug Administration | 2005 |
Osteomalacia due to chemotherapy-induced Fanconi syndrome in an adult patient.
Topics: Carcinoma, Squamous Cell; Fanconi Syndrome; Female; Humans; Ifosfamide; Middle Aged; Osteomalacia; U | 2005 |
[Evaluation of combined chemotherapy with vinorelbine, ifosfamide and cisplatin in the treatment of metastatic non-small cell bronchial carcinoma].
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Brain Neoplasms; Carcin | 2005 |
Unexpected long-term survival without evidence of disease after salvage chemotherapy for recurrent metastatic cervical cancer: a case series.
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Disease- | 2007 |
Is frozen section analysis of pelvic lymph nodes accurate in locally advanced cervical cancer patients administered preoperative chemoradiation?
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous | 2008 |
[Chemotherapy of the non-small cell carcinoma of the lung with ifosfamide and cisplatin].
Topics: Adenocarcinoma; Adult; Aged; Alopecia; Carcinoma, Small Cell; Carcinoma, Squamous Cell; Cisplatin; C | 1984 |
Pilot study of intravenous ifosfamide plus oral acetylcysteine in the treatment of non-small cell lung cancer.
Topics: Acetylcysteine; Adenocarcinoma; Administration, Oral; Carcinoma; Carcinoma, Small Cell; Carcinoma, S | 1981 |
Ifosfamide in the treatment of extensive non-oat cell carcinoma of the lung.
Topics: Adenocarcinoma; Carcinoma, Small Cell; Carcinoma, Squamous Cell; Cyclophosphamide; Drug Administrati | 1982 |
[Efficacy of sequential chemotherapy including vincristine, cisplatin and ifosfamide in the treatment of stage IV head and neck carcinomas and melanomas with visceral involvement. Preliminary results].
Topics: Abdominal Neoplasms; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamou | 1984 |
Phase II chemotherapy trials of 5-FU, cyclophosphamide, ifosfamide, and vincristine in carcinoma of the bilharzial bladder.
Topics: Carcinoma, Squamous Cell; Cyclophosphamide; Drug Administration Schedule; Drug Evaluation; Fluoroura | 1984 |
Phase I clinical study of acetylcysteine's preventing ifosfamide-induced hematuria.
Topics: Acetylcysteine; Acrolein; Adenocarcinoma; Carcinoma, Squamous Cell; Cyclophosphamide; Cystitis; Dose | 1983 |
Prophylaxis of ifosfamide toxicity with oral acetylcysteine.
Topics: Acetylcysteine; Adenocarcinoma; Aged; Carcinoma, Squamous Cell; Cyclophosphamide; Dose-Response Rela | 1983 |
[Combined cytostatic chemotherapy of advanced non-small-cell bronchial carcinoma with doxorubicin and ifosfamide].
Topics: Adenocarcinoma; Adult; Aged; Carcinoma; Carcinoma, Bronchogenic; Carcinoma, Squamous Cell; Cyclophos | 1983 |
[Clinical studies of ifosfamide for gynecological malignancies].
Topics: Adenocarcinoma; Aged; Carcinoma, Squamous Cell; Cyclophosphamide; Drug Evaluation; Female; Humans; I | 1983 |
Serum zinc levels in lung cancer patients.
Topics: Adult; Aged; Bacterial Vaccines; Carcinoma, Squamous Cell; Copper; Doxorubicin; Humans; Ifosfamide; | 1981 |
Bleomycin, cisplatinum and ifosfamide infusion chemotherapy in advanced/recurrent cancer of cervix.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carcinoma, Squamous Cell; Ci | 1993 |
Methylene blue for ifosfamide-associated encephalopathy.
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Brain Diseases; Carcinoma, Squamous Cell; Cisp | 1995 |
[Epileptic seizures and treatment with ifosfamide-mesna].
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Epilepsy; Fatal Outcome; H | 1994 |
Effects of chemotherapy on ultrastructure of oesophageal squamous cell carcinoma.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous | 1994 |
Histopathological findings in oesophageal carcinoma with and without preoperative chemotherapy.
Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Carc | 1993 |
Lack of correlation of P-glycoprotein expression with response to MIC chemotherapy in oesophageal cancer.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; ATP Binding Cassette Tr | 1995 |
Lack of correlation of P-glycoprotein expression with response to MIC chemotherapy in oesophageal cancer.
Topics: Antineoplastic Combined Chemotherapy Protocols; ATP Binding Cassette Transporter, Subfamily B, Membe | 1997 |
Combined effects of ionizing radiation and 4-hydroperoxyfosfamide in vitro.
Topics: Animals; Carcinoma, Squamous Cell; Cell Cycle; Cell Survival; Colonic Neoplasms; Combined Modality T | 1998 |
[Neoadjuvant chemotherapy for advanced cervical cancer].
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Adenosquamou | 1999 |
[Effect of combined carboplatin and ifosfamide with local hyperthermia on human mouth carcinoma in the animal model].
Topics: Animals; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Squamous Cell; Comb | 1999 |
Tumor oxygenation after radiotherapy, chemotherapy, and/or hyperthermia predicts tumor free survival.
Topics: Animals; Antineoplastic Agents; Carcinoma, Squamous Cell; Cisplatin; Combined Modality Therapy; Dise | 2001 |
A preclinical model for experimental chemotherapy of human head and neck cancer.
Topics: Animals; Antineoplastic Combined Chemotherapy Protocols; Blood Platelets; Body Weight; Carboplatin; | 2001 |
[The value of qualitative regression grading as a prognostic factor for survival after preoperative radiochemotherapy in patients with advanced head and neck cancer].
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Chemotherapy, Adjuv | 2001 |
Ifosfamide in the treatment of recurrent or disseminated lung cancer: a phase II study of two dose schedules.
Topics: Adenocarcinoma; Adult; Aged; Bone Marrow; Carcinoma, Small Cell; Carcinoma, Squamous Cell; Cyclophos | 1978 |
Combined chemotherapy using cisplatin, ifosfamide and bleomycin (PIB) in the treatment of advanced and recurrent cervical carcinoma.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carcinoma, S | 1992 |
Phase II study of cisplatin, ifosfamide with mesna, and etoposide (PIE) chemotherapy for advanced non-small cell lung cancer.
Topics: Adenocarcinoma; Adult; Aged; Agranulocytosis; Antineoplastic Combined Chemotherapy Protocols; Carcin | 1992 |
[Combination chemotherapy with 254-S, ifosfamide and peplomycin for advanced or recurrent cervical cancer].
Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Antibiotics, Antineoplastic; Antineoplastic Agents; | 1992 |
[Elderly non-Hodgkin's lymphoma presenting with pulmonary squamous cell carcinoma as a complication of chemotherapy for malignant lymphoma].
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cyclophosphamide; Hu | 1992 |
The potential for adjuvant therapy in early-stage cervical cancer.
Topics: Adenocarcinoma; Adult; Aged; Analysis of Variance; Antineoplastic Combined Chemotherapy Protocols; B | 1990 |
Chemotherapy in recurrent and advanced cervical cancer.
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carcinoma, Squamous Cell; Cisplati | 1991 |
Ifosfamide with mesna in squamous carcinoma of the cervix: phase II results in patients with advanced or recurrent disease.
Topics: Adult; Aged; Carcinoma, Squamous Cell; Drug Evaluation; Drug Therapy, Combination; Female; Hematolog | 1991 |
[Cisplatin, ifosfamide and vindesine in the chemotherapy of squamous cell carcinoma of the lung].
Topics: Antineoplastic Combined Chemotherapy Protocols; Bone Marrow; Carcinoma, Squamous Cell; Cisplatin; Dr | 1991 |
Ifosfamide and mesna at high doses for the treatment of cancer of the cervix: a GETLAC study.
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Female; Humans; Ifo | 1990 |
[Phase II study of ifosfamide and vindesine combination of non-small cell lung cancer in elderly patients and patients with reduced renal function].
Topics: Adenocarcinoma; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung | 1990 |
Cisplatin, ifosfamide and vindesine in the chemotherapy of non-small-cell lung cancer: a combination phase II study.
Topics: Acute Kidney Injury; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Sma | 1990 |
A phase II study of ifosfamide and cisplatin chemotherapy for metastatic or relapsed carcinoma of the cervix.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Dr | 1990 |
Cisplatin-ifosfamide as neoadjuvant chemotherapy in stage IIIB cervical uterine squamous-cell carcinoma.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Cisplatin; Fe | 1990 |
A phase II study of ifosfamide in endometrial cancer.
Topics: Adenocarcinoma; Adult; Aged; Carcinoma, Squamous Cell; Drug Evaluation; Female; Humans; Ifosfamide; | 1990 |
Ifosfamide, adriamycin and cisplatin (IAP) plus bleomycin (B) combination chemotherapy in patients with recurrent cancer of the uterine cervix.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Carcinoma, S | 1989 |
Ifosfamide in advanced carcinoma of the esophagus: a phase II trial with severe toxicity.
Topics: Carcinoma, Squamous Cell; Drug Administration Schedule; Drug Evaluation; Esophageal Neoplasms; Femal | 1989 |
Phase II study of ifosfamide and mesna in patients with previously-treated carcinoma of the cervix. A Gynecologic Oncology Group study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Drug Evaluati | 1989 |
Phase II experience with ifosfamide/mesna in gynecologic malignancies: preliminary report of Gynecologic Oncology Group studies.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma; Carcinoma, Squamous Cell; Ci | 1989 |
[The course of squamous cell carcinoma antigen and CEA as prognostic criteria for response to chemotherapy in cervix cancer].
Topics: Adenocarcinoma; Antigens, Neoplasm; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumo | 1989 |
Etoposide, ifosfamide, and cisplatin in the treatment of advanced non-small cell lung cancer.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Ce | 1987 |
[Phase II study of a three-drug combination of ifosfamide, cisplatin and vindesine in non-small-cell lung cancer].
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Ce | 1988 |
[Chemotherapy of non-small cell bronchial cancer with ifosfamide in combination with cisplatin, etoposide or vindesine].
Topics: Adenocarcinoma; Adult; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lun | 1988 |
[Hepatotoxicity with etoposide-ifosfamide combination therapy].
Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Small Cell; Carcinoma, Squamous Cel | 1988 |
Failure of response to ifosfamide in squamous cell bronchogenic carcinoma.
Topics: Carcinoma, Bronchogenic; Carcinoma, Squamous Cell; Drug Resistance; Humans; Ifosfamide; Lung Neoplas | 1989 |
[Treatment of non-small-cell bronchial carcinoma with cisplatin, ifosfamide, vindesine and VP 16].
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Bronchogenic | 1985 |
[Chemotherapy with mitomycin C, vindesine and ifosfamide in the treatment of inoperable non-small cell bronchial carcinoma].
Topics: Adenocarcinoma; Aged; Carcinoma, Bronchogenic; Carcinoma, Small Cell; Carcinoma, Squamous Cell; Drug | 1985 |
Experience with ifosfamide combinations (etoposide or DDP) in non-small cell lung cancer.
Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Small Cell; | 1986 |
Phase II study of ifosfamide in cervical cancer.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Central Nervo | 1986 |
Phase II trial of ifosfamide in epidermoid carcinoma of the esophagus: unexpectant severe toxicity.
Topics: Adult; Aged; Carcinoma, Squamous Cell; Drug Evaluation; Esophageal Neoplasms; Female; Hematologic Te | 1988 |
Ifosfamide in advanced head and neck cancer. A phase II study of the Rotterdam Cooperative Head and Neck Cancer Study Group.
Topics: Adult; Aged; Carcinoma, Squamous Cell; Drug Evaluation; Head and Neck Neoplasms; Humans; Ifosfamide; | 1988 |
A phase II study of ifosfamide in advanced and relapsed carcinoma of the cervix.
Topics: Adenocarcinoma; Adult; Aged; Carcinoma, Squamous Cell; Drug Evaluation; Female; Humans; Ifosfamide; | 1986 |