Trial | Phase | Enrollment | Study Type | Start Date | Status |
Study of Sintilimab vs Standard Therapy in Participants With Mismatch Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Stage III Colorectal Cancer [NCT05236972] | Phase 3 | 323 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting |
Phase Ⅱ Study of Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer [NCT03775928] | Phase 2 | 80 participants (Anticipated) | Interventional | 2018-12-18 | Recruiting |
Effect of Intravenous Pump of Recombinant Human Endostatin Combined With XELOX Chemotherapy, and a Potential Prognostic Biomarkers in Patient With Advanced Colorectal Cancer [NCT03577392] | Phase 2/Phase 3 | 120 participants (Anticipated) | Interventional | 2018-07-01 | Recruiting |
Randomized Phase II Study of S-1 (SOX) or Capecitabine (XELOX) in Combination With Oxaliplatin in Patients With Recurrent or Metastatic Gastric Cancer [NCT00985556] | Phase 2 | 130 participants (Anticipated) | Interventional | 2009-01-31 | Recruiting |
A Randomized Open-Label, Phase II Study of Lapatinib-capecitabine or Lapatinib-vinorelbine or Lapatinib/Gemcitabine in Subjects With Her2/Neu Amplified Metastatic Breast Cancer Patients Progression After Taxanes Treatment [NCT01050322] | Phase 2 | 142 participants (Actual) | Interventional | 2009-11-30 | Completed |
A Phase I Clinical Trial of Hepatic Arterial Infusion of Oxaliplatin, Oral Capecitabine, With or Without Systemic Bevacizumab for Patients With Advanced Cancer Metastatic to the Liver [NCT01213238] | Phase 1 | 116 participants (Anticipated) | Interventional | 2010-09-30 | Completed |
Randomized Trial of Preoperative Radiotherapy With an Integrated Simultaneous Boost Compared to Chemoradiotherapy for T3-4 Rectal Cancer [NCT01224392] | Phase 3 | 156 participants (Anticipated) | Interventional | 2010-01-31 | Completed |
A Multicentre, Open-label Phase II Study of Irinotecan, Capecitabine(Xeloda), and Oxaliplatin (IXO) as First Line Treatment in Patients With Metastatic Gastric or Gastroesophageal (GEJ) Adenocarcinoma. [NCT01129310] | Phase 2 | 47 participants (Actual) | Interventional | 2010-07-31 | Completed |
Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry [NCT03923036] | | 2,000 participants (Anticipated) | Observational | 2019-04-30 | Not yet recruiting |
A Comparative, Multicenter, Open-Label, Randomized, Phase 2 Study of the Safety and Antitumor Activity of Oral Eniluracil + 5 Fluorouracil + Leucovorin Versus Capecitabine Monotherapy in Subjects With Metastatic Breast Cancer [NCT01231802] | Phase 2 | 140 participants (Anticipated) | Interventional | 2011-04-30 | Recruiting |
A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes [NCT00337103] | Phase 3 | 1,276 participants (Actual) | Interventional | 2006-09-20 | Completed |
Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer [NCT01152710] | Phase 2 | 57 participants (Actual) | Interventional | 2004-06-30 | Completed |
Phase II Study of Fixed Dose Rate Gemcitabine Plus Capecitabine in Locally Advanced Pancreatic Cancer [NCT01268384] | Phase 2 | 43 participants (Actual) | Interventional | 2006-04-30 | Completed |
Phase II Clinical Study of Bevacizumab in Combination With Capecitabine as First-line Treatment in Elderly Patients With Metastatic Breast Cancer [NCT01195298] | Phase 2 | 88 participants (Anticipated) | Interventional | 2010-05-31 | Recruiting |
An Open Label, Randomized, Multi-center, Phase II/III Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy With Intensity-modified Radiation Therapy (IMRT) in Local Advanced Rectal Cancer [NCT01064999] | Phase 2/Phase 3 | 240 participants (Anticipated) | Interventional | 2010-03-31 | Recruiting |
A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma [NCT00033540] | Phase 2 | 57 participants (Actual) | Interventional | 2003-09-30 | Completed |
"A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients CapTere" [NCT00290693] | Phase 2 | 45 participants (Actual) | Interventional | 2004-07-31 | Completed |
A Phase III Clinical Trial Comparing Oxaliplatin, Capecitabine and Hepatic Arterial Infusion of Floxuridine to Oxaliplatin and Capecitabine in Patients With Resected or Ablated Liver Metastases From Colorectal Cancer [NCT00268463] | Phase 3 | 22 participants (Actual) | Interventional | 2006-01-31 | Terminated(stopped due to The study was terminated due to low accrual.) |
A Phase Ib, Open Label, Dose Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors [NCT01332604] | Phase 1 | 41 participants (Actual) | Interventional | 2011-07-31 | Completed |
Phase II Trial of Circulating Tumor DNA Monitoring During Adjuvant Capecitabine in Patients With Triple-negative Breast Cancer and Residual Disease Following Standard Neoadjuvant Chemotherapy [NCT04768426] | Phase 2 | 25 participants (Anticipated) | Interventional | 2021-02-03 | Recruiting |
Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection (CAPOGA): A Large Multicenter Phase III Randomized Controlled Trial [NCT03817268] | Phase 3 | 768 participants (Anticipated) | Interventional | 2019-01-16 | Recruiting |
A Phase II Trial Using a Combination of Oxaliplatin, Capecitabine, and Celecoxib With Concurrent Radiation for Patients With Newly Diagnosed Resectable Rectal Cancer [NCT00250835] | Phase 2 | 38 participants (Actual) | Interventional | 2005-04-30 | Terminated(stopped due to Low accrual) |
A Multicenter Trial Investigating the Duration of Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX Regimen for Patients With High Risk Stage II or Stage III Colon Cancer [NCT01308086] | Phase 3 | 2,000 participants (Actual) | Interventional | 2010-10-31 | Active, not recruiting |
A Randomized, Phase III Study Comparing TAC (Docetaxel, Doxorubicin, Cyclophosphamide) With TCX ( Docetaxel, Cyclophosphamide, Capecitabine) as Adjuvant Treatment for Node-Positive Her2-Negative Breast Cancer [NCT01354522] | Phase 3 | 400 participants (Anticipated) | Interventional | 2011-05-31 | Recruiting |
A Phase II Study of Oral Xeloda (Capecitabine) in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/or Metastatic Colorectal Cancer [NCT00022698] | Phase 2 | 67 participants (Actual) | Interventional | 2001-05-31 | Completed |
A Phase II Clinical Study of PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy in First-line Treatment of HER2-negative Advanced G/GEJ Cancer [NCT06158919] | | 58 participants (Anticipated) | Interventional | 2023-11-20 | Recruiting |
A Randomized Phase II Study of Perioperative Atezolizumab +/- Chemotherapy in Resectable MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer [NCT05836584] | Phase 2 | 240 participants (Anticipated) | Interventional | 2024-06-08 | Recruiting |
An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal [NCT05702229] | Phase 2 | 240 participants (Anticipated) | Interventional | 2023-01-16 | Recruiting |
A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma [NCT01013649] | Phase 2/Phase 3 | 545 participants (Anticipated) | Interventional | 2009-11-17 | Active, not recruiting |
Phase II Study of the Combination of Cetuximab, Capecitabine, and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer [NCT00321100] | Phase 2 | 23 participants (Actual) | Interventional | 2006-04-12 | Terminated(stopped due to Enrollment closed 10/15/2008 based on data about KRAS.) |
Efficacy and Safety of Alternating Systemic and Hepatic Artery Infusion Therapy Versus Systemic Chemotherapy Alone As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer: A Randomized, Parallel-Group, Open-Labelled, Active-Contro [NCT02529774] | Phase 2/Phase 3 | 432 participants (Anticipated) | Interventional | 2015-09-30 | Not yet recruiting |
Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer [NCT01112826] | Phase 3 | 443 participants (Actual) | Interventional | 2010-04-23 | Completed |
Phase II Clinical Trial of Neoadjuvant Weekly Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer [NCT01227408] | Phase 2 | 0 participants (Actual) | Interventional | 2009-02-28 | Withdrawn(stopped due to Sponsor withdrew due to funding issues) |
Pyrotinib Combined With Capecitabine Metronomic Therapy in HER2-postitive Advanced Breast Cancer: Single Arm, Single Center, Phase II Clinical Trial. [NCT03923166] | Phase 2 | 35 participants (Anticipated) | Interventional | 2019-04-19 | Recruiting |
Phase II Trial to Evaluate the Addition of Nivolumab to Neoadjuvant Chemoradiation With FOLFOX for Locally Advanced Rectal Cancer [NCT03921684] | Phase 2 | 29 participants (Anticipated) | Interventional | 2019-04-30 | Recruiting |
A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Clinical Benefit of a Post-operative Treatment Associating Radiotherapy + Nivolumab + Ipilimumab Versus Radiotherapy + Capecitabine for Triple Negative Breast Cancer Patients With Residu [NCT03818685] | Phase 2 | 95 participants (Actual) | Interventional | 2019-07-02 | Active, not recruiting |
A Phase II Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Capecitabine (Xeloda) in Frail Patients With Untreated Metastatic Colorectal Cancer [NCT00203411] | Phase 2 | 45 participants (Actual) | Interventional | 2006-03-31 | Completed |
Randomized, Open, Multicenter Phase III Study With Capecitabine Plus Bevacizumab Versus Capecitabine Plus Irinotecan Plus Bevacizumab as First-line Therapy in Patients With Metastatic Colorectal Cancer [NCT01249638] | Phase 3 | 516 participants (Anticipated) | Interventional | 2010-12-31 | Recruiting |
Neoadjuvant Immunotherapy in Rectal Cancer: A Pilot Study Examining the Safety and Feasibility of PD-1 Blockade in the Treatment of dMMR or MSI-H Rectal Cancer [NCT04357587] | Phase 1 | 10 participants (Anticipated) | Interventional | 2020-08-06 | Recruiting |
A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer [NCT03889626] | Phase 3 | 242 participants (Anticipated) | Interventional | 2019-03-22 | Not yet recruiting |
Oxaliplatin Pharmacokinetics With and Without Ca2+/MG2+ Infusion in Colorectal Cancer Patients [NCT01157052] | Phase 1 | 15 participants (Anticipated) | Interventional | 2015-01-31 | Not yet recruiting |
Randomised Phase II Study of the Combination of Oral Vinorelbine With Capecitabine Versus Gemcitabine in Combination With Paclitaxel Versus Gemcitabine in Combination With Docetaxel as First Line Chemotherapy in Patients With Metastatic Breast Cancer [NCT03887130] | Phase 2 | 152 participants (Actual) | Interventional | 2006-03-31 | Completed |
A Phase I Study of Nab-paclitaxel (Abraxane), Gemcitabine, and Capecitabine (Xeloda) (AGX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma [NCT01161186] | Phase 1 | 15 participants (Actual) | Interventional | 2010-07-31 | Completed |
A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer [NCT01167738] | Phase 2 | 60 participants (Actual) | Interventional | 2010-07-31 | Terminated(stopped due to concern of detrimental effect) |
Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane [NCT03858972] | Phase 2 | 152 participants (Actual) | Interventional | 2019-02-05 | Terminated(stopped due to The Sponsor has discontinued the development of tesetaxel) |
A Single-arm Phase II Downsizing Study of Irinotecan, Capecitabine and Oxaliplatin (IXO) and Bevacizumab as First-line Treatment to Assess Conversion to Resectability of Liver-only Metastases in Colorectal Cancer Patients With Initially Unresectable Metas [NCT01293942] | Phase 2 | 0 participants (Actual) | Interventional | 2011-03-31 | Withdrawn |
Phase II Study of the Combination of Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Inoperable Well-Differentiated Neuroendocrine Tumors [NCT01203306] | Phase 2 | 42 participants (Anticipated) | Interventional | 2006-01-31 | Recruiting |
A Phase II Study of Capecitabine and Pseudomonas Aeruginosa Combination in the Salvage Treatment of Metastatic Breast Cancer [NCT01380808] | Phase 2 | 100 participants (Actual) | Interventional | 2011-05-31 | Completed |
A Phase 1 and Pharmacologic Study of MM-111 in Combination With Multiple Treatment Regimens in Patients With Advanced HER2 Positive Solid Tumors [NCT01304784] | Phase 1 | 100 participants (Anticipated) | Interventional | 2011-01-31 | Completed |
An Open-label, Phase 1/2, Dose-escalation and Expansion Study of SBT6050 Combined With Other HER2-directed Therapies in Subjects With Pretreated Unresectable Locally Advanced and/or Metastatic HER2-expressing or HER2-amplified Cancers [NCT05091528] | Phase 1/Phase 2 | 2 participants (Actual) | Interventional | 2022-02-08 | Terminated(stopped due to Sponsor decision based on strategic re-alignment) |
A Single-arm, Open-label, Multicenter Phase 2 Study to Evaluate XELOX + Tislelizumab in Combination With Doxorubicin Hydrochloride Liposome Injection (XELOX+PD-1+PLD)as Neoadjuvant Therapy for Resectable Gastric Cancer [NCT05536102] | Phase 2 | 38 participants (Anticipated) | Interventional | 2022-09-05 | Recruiting |
Adjuvant Capecitabine Metronomic Chemotherapy Plus Endocrine Therapy for HR-positive, HER2-negative, Primary Breast Cancer: a Multicenter, Randomized, Double-blind Phase III Clinical Trial [NCT05063136] | Phase 3 | 1,979 participants (Anticipated) | Interventional | 2021-09-28 | Recruiting |
A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination With Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer [NCT01311050] | | 46 participants (Anticipated) | Observational | 2009-01-31 | Recruiting |
The Influence of Micrometastases on Prognosis and Survival in Stage I-II Colon Cancer Patients: The EnRoute+ Study [NCT01097265] | Phase 2/Phase 3 | 1,500 participants (Anticipated) | Interventional | 2010-07-31 | Recruiting |
A Phase II Study Examining the Feasibility of Long Term and Low Dose Oral Capecitabine (Xeloda®) in Newly Diagnosed Head and Neck Squamous Cell Carcinoma (HNSCC) After Surgery, Radiation and/or Chemotherapy [NCT00258310] | Phase 2 | 35 participants (Actual) | Interventional | 2003-12-31 | Completed |
A Phase I/II Trial of RAD001/Capecitabine in Refractory Gastric Cancer [NCT01099527] | Phase 1/Phase 2 | 59 participants (Actual) | Interventional | 2009-10-31 | Completed |
OXEL: A Pilot Study of Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease Following Neoadjuvant Chemotherapy [NCT03487666] | Phase 2 | 45 participants (Actual) | Interventional | 2018-05-21 | Active, not recruiting |
Single-arm, Open-label, Single-center Phase II Clinical Study of Cadonilimab Combined With CapeOX Regimen in Perioperative Treatment of Resectable Locally Advanced Gastric Cancer [NCT05974059] | Phase 2 | 20 participants (Anticipated) | Interventional | 2023-08-01 | Not yet recruiting |
A Phase III, Randomized, Open-label Study to Evaluate Capecitabine Plus Pembrolizumab vs Pembrolizumab Alone as Post-operative Therapy for Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Chemo-immunotherapy [NCT05973864] | Phase 3 | 418 participants (Anticipated) | Interventional | 2024-01-31 | Not yet recruiting |
A Phase II, Randomized, Open Label, Parallel-group Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer [NCT05009069] | Phase 2 | 58 participants (Actual) | Interventional | 2022-03-18 | Active, not recruiting |
Prospective Safety Study of Sintilimab Combined With XELOX Plus Bevacizumab for Preoperative Neoadjuvant Therapy of CRLM Patients With pMMR/MSS Status [NCT04940546] | Phase 1/Phase 2 | 36 participants (Actual) | Interventional | 2021-06-16 | Active, not recruiting |
A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer [NCT01310985] | | 15 participants (Actual) | Observational | 2008-03-31 | Completed |
Phase II Clinical Study of PD1 Antibody (SHR-1210) Combined With Trastuzumab, Oxaliplatin and Capecitabine for Neoadjuvant Therapy of Gastric Adenocarcinoma/Gastroesophageal Junction Adenocarcinoma [NCT03950271] | Phase 2 | 25 participants (Anticipated) | Interventional | 2020-01-21 | Recruiting |
Neoadjuvant Chemotherapy and Biological Treatment for Patients With Locally Advanced Colon Cancer [NCT01108107] | Phase 2 | 76 participants (Actual) | Interventional | 2010-04-30 | Completed |
Effectiveness of First Line Treatment With Lapatinib and ECF/X in Histologically Proven Adenocarcinoma of the Stomach or the Esophagogastric Junction, Metastatic or Not Amenable to Curative Surgery According to HER2 and EGFR Status: a Randomized Phase II [NCT01123473] | Phase 2 | 29 participants (Actual) | Interventional | 2010-12-31 | Terminated(stopped due to company withdrew interest) |
Safety and Tolerability of Bevacizumab Plus Paclitaxel vs. Bevacizumab Plus Metronomic Cyclophosphamide and Capecitabine as First-Line Therapy in Patients With HER2-Negative Metastatic or Locally Recurrent Breast Cancer - A Multicenter, Randomized Phase I [NCT01131195] | Phase 3 | 139 participants (Actual) | Interventional | 2010-07-19 | Completed |
Sensitivity Detection and Drug Resistance Mechanism of Breast Cancer Therapeutic Drugs Based on Organ-like Culture [NCT03925233] | | 300 participants (Anticipated) | Observational | 2019-01-02 | Enrolling by invitation |
A Phase II Study of Pazopanib in Combination With Capecitabine and Oxaliplatin (CAPEOX) in Patients With Advanced Gastric Cancer [NCT01130805] | Phase 2 | 66 participants (Actual) | Interventional | 2010-12-31 | Completed |
A Phase 3, Open-Label, Randomized Study to Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer Patients at Stage IIIB and IV (M0) (Based on AJCC Ed. 6) Who Received Radical Resecti [NCT01935778] | Phase 3 | 286 participants (Anticipated) | Interventional | 2013-10-02 | Recruiting |
Bevacizumab Plus Capecitabin vs S-1 as Maintenance Treatment Following First-line Chemotherapy in the Patients With Advanced Colorectal Adenocarcinoma. A Phase 3 Randomised Controlled Trial [NCT03708536] | Phase 3 | 0 participants (Actual) | Interventional | 2018-11-30 | Withdrawn(stopped due to There are no fund to support) |
PHASE II STUDY Evaluating the Toxicity and Activity of the Combination Lapatinib + Capecitabine in Elderly Patients Aged 70 and Over With Metastatic Breast Cancer Over Expressing HER2 [NCT01262469] | Phase 2 | 4 participants (Actual) | Interventional | 2009-12-31 | Completed |
Multi Gene Detection Tool Based Recurrence Score-guiding Chemotherapy in Non-pathologic Complete Response HR Positive and HER2 Negative Breast Cancer After Neoadjuvant Treatment [NCT03638648] | Phase 2 | 80 participants (Anticipated) | Interventional | 2019-11-01 | Not yet recruiting |
Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy w/ Adenoviral & Yeast-based Vaccines to Induce T-cell Responses in Subjects w/ Advanced, Unresectable & Untransplantable HCC [NCT03563170] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2018-05-25 | Withdrawn(stopped due to Enrollment not initiated) |
An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer [NCT01355302] | Phase 1/Phase 2 | 7 participants (Actual) | Interventional | 2011-11-30 | Terminated(stopped due to Sites not recruiting) |
REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation [NCT05902533] | Phase 2/Phase 3 | 33 participants (Anticipated) | Interventional | 2023-08-14 | Recruiting |
An Investigational Randomized Study on Epirubicin Plus Cyclophospamide (EC) or Cyclophosphamide Plus Methotrexat Plus 5-fluorouracil (CMF) Versus Nab-paclitaxel Plus Capecitabine as Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Ri [NCT01204437] | Phase 2/Phase 3 | 400 participants (Actual) | Interventional | 2009-03-31 | Completed |
A Two Stage Multicenter Phase II Trial of Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma [NCT01351038] | Phase 2 | 43 participants (Anticipated) | Interventional | | Terminated(stopped due to REAL trial showed a significant difference in OS for reduced EOX and standard EOX) |
Irinotecan Gastro-resistant Tablet. An Open Label Phase I, Dose Escalating Study Evaluating Safety, Tolerability and Pharmacokinetics of Oral Administration of Irinotecan in Adult Patients With Solid Tumors [NCT03295084] | Phase 1 | 39 participants (Actual) | Interventional | 2015-07-15 | Completed |
Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy Compared With Standard of Care Therapy as First-line Intervention in Participants With Advanced/Metastatic Gastroeso [NCT04662710] | Phase 3 | 890 participants (Anticipated) | Interventional | 2020-12-30 | Active, not recruiting |
Phase II Study of Docetaxel and Capecitabine in Advanced Squamous Cell Carcinoma of the Head and Neck [NCT02524275] | Phase 2 | 14 participants (Actual) | Interventional | 2015-03-30 | Terminated(stopped due to low enrollment) |
A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors [NCT01315431] | Phase 1 | 9 participants (Anticipated) | Interventional | 2011-03-31 | Active, not recruiting |
An Open Label Study to Assess the Resection Rate of Liver Metastases Following Neoadjuvant Therapy With Avastin in Combination With Oxaliplatin and Capecitabine (XELOX) in Patients With Metastatic Colorectal Cancer With Unresectable Liver Metastasis [NCT00700570] | Phase 2 | 45 participants (Actual) | Interventional | 2008-08-31 | Completed |
An Open-label Randomized Phase II Study of Panitumumab Plus Oral Capecitabine and Infusional Oxaliplatin (XELOX) or XELOX Alone for Second-line Treatment of Patients With Metastatic Colorectal Cancer (VOXEL-Study) [NCT00950820] | Phase 2 | 9 participants (Actual) | Interventional | 2009-09-30 | Terminated(stopped due to Recruitment rate to low; changed environment made protocol in its current state obsolete) |
NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy [NCT03197584] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
NANT Triple Negative Breast Cancer (TNBC) Vaccine: Combination Immunotherapy in Subjects With TNBC Who Have Progressed on or After Anthracycline-based Chemotherapy [NCT03175666] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
NANT Non-small Cell Lung Cancer (NSCLC) Vaccine: Combination Immunotherapy in Subjects With NSCLC Who Have Progressed After Treatment With Programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Inhibitors [NCT03169738] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2018-02-28 | Withdrawn(stopped due to Trial not initiated) |
Image-Guided Radiation Therapy (IGRT) Associated With Concurrent Capecitabine and Oxaliplatin in the Treatment of Locally Advanced or Inoperable Hepatocellular Carcinoma (HCC): A Phase I Study [NCT02403544] | Phase 1 | 30 participants (Anticipated) | Interventional | 2013-09-30 | Recruiting |
NANT Merkel Cell Carcinoma (MCC) Vaccine: Combination Immunotherapy in Subjects With MCC Who Have Progressed on or After Anti-programmed Death-ligand 1 (PD-L1) Therapy [NCT03167164] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Varlitinib Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer as Second Line Systemic Therapy [NCT03093870] | Phase 2/Phase 3 | 151 participants (Actual) | Interventional | 2017-07-04 | Completed |
A Phase II Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer [NCT02694718] | Phase 2 | 60 participants (Actual) | Interventional | 2005-03-31 | Completed |
A Phase II Study of Perioperative Disitamab Vedotin Plus Toripalimab and XELOX Versus Disitamab Vedotin Plus Toripalimab Versus XELOX in Subjects With HER2-expressing Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. [NCT06155383] | Phase 2 | 90 participants (Anticipated) | Interventional | 2023-11-27 | Recruiting |
A Phase III Randomized Controlled Trial to Compare BL-B01D1 With Physician's Choice of Chemotherapy (Last Line) in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Previously Treated With PD-1/PD-L1 Monoclonal Antibody and at Least Two [NCT06118333] | Phase 3 | 368 participants (Anticipated) | Interventional | 2023-12-04 | Recruiting |
A Phase 3, Randomized, Multi-center, Open-Label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-Low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients Whose Disease Has Progress [NCT06018337] | Phase 3 | 532 participants (Anticipated) | Interventional | 2024-01-31 | Not yet recruiting |
A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, [NCT05568095] | Phase 3 | 970 participants (Anticipated) | Interventional | 2022-11-21 | Recruiting |
An Open-label, Single Arm Study to Evaluate the Efficacy and Safety of Trastuzumab in Combination With Capecitabine and Oxaliplatin (XELOX) as a First-line Chemotherapy for Inoperable, Locally Advanced or Recurrent and/or Metastatic Gastric Cancer [NCT01364493] | Phase 2 | 51 participants (Actual) | Interventional | 2011-05-31 | Completed |
A Phase I Study of Pyrotinib In Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer [NCT02361112] | Phase 1 | 38 participants (Anticipated) | Interventional | 2014-08-31 | Completed |
An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination With Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenoca [NCT02981342] | Phase 2 | 106 participants (Actual) | Interventional | 2017-01-12 | Completed |
mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or Stage IIIC Colorectal Cancer: A Randomized Controlled Clinical Research [NCT05200299] | Phase 2 | 100 participants (Anticipated) | Interventional | 2022-02-01 | Recruiting |
Phase II Study of Pembrolizumab and Capecitabine for Advanced Triple Negative and Hormone-Refractory Breast Cancer [NCT03044730] | Phase 2 | 30 participants (Actual) | Interventional | 2017-05-25 | Active, not recruiting |
Capecitabine Combined With Lenvatinib and Tislelizumab as Adjuvant Treatment After Resection in Patients With Biliary Tract Cancer: A Single-arm, Phase II Study [NCT05254847] | Phase 2 | 75 participants (Anticipated) | Interventional | 2021-12-30 | Recruiting |
Phase Ib/II Study of Intra-Arterial Liver Isolation Chemotherapy in Patients With Hepatic Metastases From Colorectal Cancer [NCT04701281] | Phase 1/Phase 2 | 95 participants (Anticipated) | Interventional | 2019-06-20 | Recruiting |
InterAACT - An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin Plus 5-Fluorouracil Versus Carboplatin Plus Weekly Paclitaxel in Patients With Inoperable Locally Recurrent or Metastatic Disease [NCT02560298] | Phase 2 | 91 participants (Actual) | Interventional | 2016-08-23 | Active, not recruiting |
A Phase II Clinical Study of Trastuzumab in Combination With Capecitabine and Cisplatin (XP) in Patients With Tissue HER2-negative But Serum HER2-positive Advanced Gastric Cancer: XP+Samfenet [NCT04309578] | Phase 2 | 28 participants (Anticipated) | Interventional | 2020-03-12 | Recruiting |
A Multicenter, Phase I/II Study of Every Other Week Capecitabine Dosing With Bevacizumab for the Treatment of Metastatic Breast Cancer Based Upon the Norton-Simon Mathematical Model [NCT00468585] | Phase 1/Phase 2 | 62 participants (Actual) | Interventional | 2005-06-30 | Completed |
A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination With Standard Chemotherapy Regimens (CT) in Patients With Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer or Other Tumor Types Suitable for T [NCT00107250] | Phase 1 | 50 participants (Actual) | Interventional | 2005-01-21 | Completed |
Perioperative Chemotherapy Prior To and After Reoperation for Incidental Gallbladder Cancer - An International, Randomized Phase III Trial [NCT03579758] | Phase 3 | 0 participants (Actual) | Interventional | 2019-04-03 | Withdrawn(stopped due to This trial will open as an NCTN trial.) |
SHR-1210,a Novel Anti-pd-1 Antibody, in Combination With BP102,a Biosimilar of Bevacizumab, and XELOX, (Oxaliplatin Plus Capecitabine) in Patient With Metastatic Colorectal Cancer: a Single-arm, Open Label, Multi-center, Phase II Study [NCT03645876] | Phase 2 | 12 participants (Actual) | Interventional | 2018-11-08 | Terminated(stopped due to The study was terminated early due to company decision) |
A Phase IIb Randomized Study to Evaluate the Efficacy of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer [NCT01303029] | Phase 2 | 120 participants (Actual) | Interventional | 2011-02-28 | Completed |
A Randomized Phase 2 Study in Patients With Triple-negative Androgen Receptor Positive Locally Recurrent (Unresectable) or Metastatic Breast Cancer Treated With Darolutamide or Capecitabine [NCT03383679] | Phase 2 | 94 participants (Actual) | Interventional | 2018-03-14 | Completed |
A Phase II Study of Ziv-aflibercept in Combination With Capecitabine/Oxaliplatin (XELOX) Chemotherapy in the Front-Line Treatment of Patients With Metastatic Colorectal Cancer [NCT02079220] | Phase 2 | 0 participants (Actual) | Interventional | 2014-03-31 | Withdrawn(stopped due to Funding for the study was withdrawn, no participants were ever recruited.) |
Fruquintinib Plus Camrelizumab and Capecitabine as Salvage Therapy After Progression on FOLFOXIRI-based First-line Treatment in Patients With Unresectable/Metastatic Colorectal Cancer: a Prospective Phase II Study [NCT06148402] | Phase 2 | 30 participants (Anticipated) | Interventional | 2024-01-31 | Recruiting |
Anlotinib Plus Chemotherapy as First-line Therapy for Gastrointestinal Tumor Patients With Unresectable Liver Metastasis: A Multi-cohort, Multi-center Clinical Trial (ALTER-G-001) [NCT05262335] | Phase 2 | 116 participants (Anticipated) | Interventional | 2021-12-01 | Recruiting |
Metabolic and Molecular Response Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction [NCT02287129] | Phase 2 | 75 participants (Actual) | Interventional | 2014-12-05 | Completed |
A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer [NCT01348009] | Phase 1/Phase 2 | 63 participants (Anticipated) | Interventional | 2011-05-31 | Recruiting |
QUILT-3.088 NANT Pancreatic Cancer Vaccine: Phase II Randomized Trial of the NANT Pancreatic Cancer Vaccine vs. Standard-of-Care as First- Line Treatment for Patients With Metastatic Pancreatic Cancer [NCT03563144] | Phase 2 | 0 participants (Actual) | Interventional | 2018-08-31 | Withdrawn(stopped due to Trial not initiated) |
A Randomized, Multicenter, Open-label Phase III Study to Evaluate the Efficacy and Safety of Adding Metronomic Chemotherapy of Capecitabine to Standard Adjuvant Therapy for Patients With High Risk HER2-positive Primary Breast Cancer [NCT03561740] | Phase 3 | 794 participants (Anticipated) | Interventional | 2018-07-25 | Recruiting |
Anrotinib in Combination With Capecitabine in the Single-arm, Open Phase II Treatment of Relapsed or Metastatic Triple-negative Breast Cancer Clinical Research [NCT05089643] | Phase 2 | 35 participants (Anticipated) | Interventional | 2019-04-11 | Recruiting |
Phase II Study of Docetaxel, Oxaliplatin, Capecitabine With Bevacizumab and Trastuzumab in Case of Human Epidermal Growth Factor Receptor 2 (HER2)-Positivity in Patients With Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oe [NCT01359397] | Phase 2 | 0 participants | Interventional | 2011-03-31 | Active, not recruiting |
A Phase Ib/II Study of PEP503 (Radioenhancer) With Radiotherapy, in Combination With Concurrent Chemotherapy for Patients With Locally Advanced or Unresectable Rectal Cancer [NCT02465593] | Phase 1/Phase 2 | 32 participants (Actual) | Interventional | 2015-06-30 | Terminated |
Phase II Neoadjuvant Trial of Capecitabine, Cyclophosphamide and Epirubicin for Patients With Axillary Lymph Node Positive Stage II-III Operable Breast Cancer [NCT02115152] | Phase 2 | 100 participants (Anticipated) | Interventional | 2014-06-30 | Not yet recruiting |
Phase III Study of Adjuvant Capecitabine vs Observation Alone in Curatively Resected Stage IB (by AJCC 6th Edition) Gastric Cancer(KCSG ST14-05) [NCT01917552] | Phase 3 | 870 participants (Anticipated) | Interventional | 2013-08-19 | Recruiting |
A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil Versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects Wit [NCT02494583] | Phase 3 | 763 participants (Actual) | Interventional | 2015-07-31 | Completed |
The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma: A Multi-center Randomized Controlled Prospective Study [NCT05494190] | | 111 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting |
A Combination of Sorafenib, Capecitabine and Oxaliplatin (SECOX) as Neoadjuvant Therapy in Patients With Locally Advanced Hepatocellular Carcinoma: A Phase II Study [NCT03578874] | Phase 2 | 15 participants (Actual) | Interventional | 2016-06-20 | Completed |
Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in Colorectal Patients After Surgery [NCT03564912] | Phase 1/Phase 2 | 160 participants (Actual) | Interventional | 2018-08-12 | Completed |
Non-OpeRative MANagement of Rectal Cancer Patients Who Had Clinical Complete Response After Pre-operative Chemo-raDiotherapY [NCT04696757] | Early Phase 1 | 15 participants (Anticipated) | Interventional | 2018-02-01 | Recruiting |
Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomised, Phase 3 Study. [NCT02460419] | Phase 3 | 104 participants (Actual) | Interventional | 2015-04-30 | Completed |
A Randomized, Multi-center Phase III Trial of Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine Alone in Curatively Resected Biliary Tract Cancer [NCT04401709] | Phase 3 | 490 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
A Multicenter Prospective Phase III Clinical Trial of Neoadjuvant CapOx in Patients With Intermediate Risk CRM-negative Middle Rectal Cancer [NCT04134897] | Phase 3 | 316 participants (Anticipated) | Interventional | 2019-10-14 | Enrolling by invitation |
Pilot Trial of KD018 With Neo-Adjuvant Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Rectal Cancer [NCT02178644] | Phase 1 | 29 participants (Actual) | Interventional | 2014-07-31 | Completed |
Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma - Carboplatin, Docetaxel and Capecitabine (CTX) or Epirubicin, Oxaliplatin and Capecitabine: a Randomised Phase 2 Trial. [NCT02177552] | Phase 2 | 98 participants (Anticipated) | Interventional | 2014-06-30 | Active, not recruiting |
Randomized Phase II-III Trial of Peri- or Post-Operative Chemotherapy in Resectable Pancreatic Adenocarcinoma [NCT01150630] | Phase 2 | 98 participants (Actual) | Interventional | 2010-05-31 | Completed |
A Phase 1 Study of RO4929097 (NSC749225) in Combination With Capecitabine in Refractory Solid Tumors [NCT01158274] | Phase 1 | 30 participants (Actual) | Interventional | 2010-06-30 | Completed |
A Randomized, Open, Multi-center Phase IIb/III Clinical Study to Assess the Efficacy and Safety of Surufatinib Compared to Capecitabine in Advanced or Metastatic Biliary Tract Carcinoma (BTC) Patients [NCT03873532] | Phase 2/Phase 3 | 298 participants (Anticipated) | Interventional | 2018-07-10 | Recruiting |
A Single Arm, Open-label Trial Assessing the Effect of Capecitabine (Xeloda® ) on Progression-free Survival Rate at Four Months in Breast Cancer Patients With CNS Progression After Whole Brain Radiotherapy [NCT01077726] | Phase 2 | 3 participants (Actual) | Interventional | 2010-01-31 | Completed |
Preoperative Chemoradiotherapy With Capecitabine With or Without Temozolomide in Patients With Locally Advanced Rectal Cancer; A Prospective Randomised Phase 2 Study Stratified by MGMT (O6-methylguanine DNA Methyltransferase) Status [NCT03156036] | Phase 2 | 64 participants (Actual) | Interventional | 2017-11-30 | Completed |
A Phase II Trial Evaluating Weekly Docetaxel and Capecitabine in Patients With Metastatic or Advanced, Locally, Recurrent Head and Neck Cancer [NCT00148122] | Phase 2 | 40 participants (Actual) | Interventional | 2002-11-30 | Completed |
Phase II Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma Patients [NCT01182142] | Phase 2 | 51 participants (Anticipated) | Interventional | 2007-09-30 | Completed |
A Randomized Phase II Study of Capecitabine and Cisplatin (XP) +/- Sorafenib (Nexavar®) in Patients With Advanced Gastric Cancer [NCT01187212] | Phase 2 | 195 participants (Actual) | Interventional | 2010-08-31 | Completed |
Dose Determination of Taxotere®, Eloxatin® and Xeloda® (TEX)in Combination With Herceptin® as First-line Treatment for Patients With HER2 Positive Non-resectable Oesophagus, Cardia or Gastric Cancer (ECV) [NCT01295086] | | 27 participants (Actual) | Interventional | 2011-03-31 | Completed |
Clinical Trial on Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III Among Chinese Population [NCT01196260] | Phase 2/Phase 3 | 8,000 participants (Anticipated) | Interventional | 2004-01-31 | Recruiting |
A Randomized, Multicenter, Open-Label, Phase 3 Study Comparing the Efficacy and Safety of SHR-1210 Plus Capecitabine and Oxaliplatin Sequenced by Apatinib With or Without SHR-1210 Versus Capecitabine and Oxaliplatin in Subjects With Previously Untreated A [NCT03813784] | Phase 3 | 887 participants (Actual) | Interventional | 2019-03-07 | Active, not recruiting |
A Randomized, Controlled, Open-label, Multicenter, Phase III Trial of Anus-preservation in Low Rectal Adenocarcinoma Based on MMR/MSI Status(APRAM) [NCT05669092] | Phase 3 | 174 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting |
A Phase 1b, Open-Label, Dose-Escalating Trial of Tivozanib (AV-951) in Combination With Capecitabine (Xeloda®) in Subjects With Advanced Solid Tumors [NCT01306630] | Phase 1 | 24 participants (Anticipated) | Interventional | 2010-11-30 | Completed |
A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes [NCT01589159] | Phase 2 | 54 participants (Actual) | Interventional | 2013-01-31 | Completed |
Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients [NCT01322152] | Phase 2 | 52 participants (Actual) | Interventional | 2011-03-31 | Completed |
Anti-Angiogenesis Treatment After Preoperative Chemotherapy: A Pilot Study in Women With Operable Breast Cancer [NCT00121134] | | 164 participants (Actual) | Interventional | 2005-06-30 | Completed |
A Phase I/ II, Non-randomized, Feasibility/ Safety and Efficacy Study of the Combination of Everolimus, Cetuximab and Capecitabine in Patients With Metastatic Pancreatic Cancer [NCT01077986] | Phase 1/Phase 2 | 35 participants (Actual) | Interventional | 2009-08-31 | Completed |
"An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) (XELOX) Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) (FOLFOX4) as [NCT00069108] | Phase 3 | 627 participants (Actual) | Interventional | 2003-07-31 | Completed |
A Phase I/II, Non-randomized, Multi-center, Dose-escalating, Two-stage Efficacy and Feasibility Study of the Combination of Everolimus and Capecitabine in Patients With Advanced Malignancies [NCT01079702] | Phase 1/Phase 2 | 35 participants (Anticipated) | Interventional | 2008-04-30 | Recruiting |
A Phase 2 Study of GTI-2040 (NSC 722929) in Combination With Capecitabine in Metastatic Breast Cancer [NCT00068588] | Phase 2 | 24 participants (Actual) | Interventional | 2003-10-31 | Completed |
A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant [NCT00080301] | Phase 3 | 752 participants (Actual) | Interventional | 2003-09-30 | Completed |
The Efficacy and Safety of Maintenance Therapy With Treprilimumab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma:Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study [NCT05869227] | Phase 3 | 166 participants (Anticipated) | Interventional | 2023-04-28 | Recruiting |
A Phase Ib/II Study of Regorafenib and Nivolumab Plus Chemotherapy in Patients With Unresectable Advanced/Recurrent Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma [NCT05394740] | Phase 1/Phase 2 | 30 participants (Actual) | Interventional | 2022-06-06 | Active, not recruiting |
Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced,High-Risk,MSS Rectal Cancer [NCT05877573] | | 53 participants (Anticipated) | Interventional | 2023-07-01 | Recruiting |
A Phase II Trial of Escalated Dose Proton Radiotherapy With Elective Nodal Irradiation and Concomitant Chemotherapy for Patients With Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma [NCT02598349] | Phase 2 | 60 participants (Anticipated) | Interventional | 2016-04-30 | Recruiting |
A Phase I, Dose Escalation Trial of Endoluminal High Dose Rate Brachytherapy With Concurrent Chemotherapy for Rectal or Anal Cancer in Patients With Recurrent Disease or Undergoing Non-Operative Management [NCT02199236] | Phase 1 | 15 participants (Actual) | Interventional | 2014-07-31 | Active, not recruiting |
Adjuvant Chemotherapy In Elderly With Colon Cancer Stage III - Geriatric Assessment and Prognostic Gene Signatures [NCT02978612] | Phase 2 | 170 participants (Anticipated) | Interventional | 2016-06-30 | Active, not recruiting |
MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy (SCPRT) Followed by Consolidation Chemotherapy Versus Long Course Chemoradiation for Unresectable Rectal Cancer [NCT03714490] | Phase 2 | 200 participants (Anticipated) | Interventional | 2018-10-23 | Recruiting |
A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) When Added to 5 Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) With the Efficacy and Safety of Plac [NCT00399035] | Phase 3 | 1,254 participants (Actual) | Interventional | 2006-11-30 | Completed |
A Phase 2 Study of Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in Subjects With Advanced Biliary Tract Carcinoma (BTC) [NCT03111732] | Phase 2 | 11 participants (Actual) | Interventional | 2017-06-14 | Completed |
Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer [NCT00100815] | Phase 2 | 50 participants (Actual) | Interventional | 2004-08-31 | Completed |
A Prospective, Multicenter and Registry-based Cohort Study of Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer [NCT06035016] | | 300 participants (Anticipated) | Observational | 2023-06-01 | Recruiting |
Phase II Study of Chemo-Radiation-Induced Abscopal Effect in Metastatic Breast Cancer and in Other Metastatic Sites of Solid Tumors [NCT02474186] | Phase 2 | 41 participants (Actual) | Interventional | 2003-04-30 | Completed |
Metformin in Association to Chemoradiotherapy for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Randomized, Placebo-controlled Phase II Study [NCT02473094] | Phase 2 | 3 participants (Actual) | Interventional | 2015-07-31 | Terminated(stopped due to Slow Accrual) |
A Randomized, Controlled Phase Ⅲ Study of Paclitaxel Polymeric Micelles for Injection Versus Physician's Choice(TPC) in Human Epidermal Growth Factor Receptor 2-negative (HER2-) Metastatic Breast Cancer (MBC) Subjects Who Have Failed at Least Two Previous [NCT06143553] | Phase 3 | 168 participants (Anticipated) | Interventional | 2023-10-30 | Recruiting |
Chemotherapy Combined With High-dose Radiotherapy for Low Rectal Cancer Using Magnetic Resonance Guided Radiotherapy Linear Accelerator:A Prospective Phase 2 Trial [NCT05338866] | | 58 participants (Anticipated) | Observational | 2022-01-01 | Enrolling by invitation |
Risk-Adapted Therapy for HIV-Associated Anal Cancer [NCT04929028] | Phase 2 | 53 participants (Anticipated) | Interventional | 2022-08-09 | Recruiting |
No Operation After Short Course Equivalent Dose (Ht) Radiation Therapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer: The Prospective, Single Arm NOAHS-ARC Trial [NCT04864067] | Phase 2 | 73 participants (Anticipated) | Interventional | 2021-06-09 | Recruiting |
A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer [NCT00717951] | Phase 2 | 120 participants (Actual) | Interventional | 2008-05-31 | Active, not recruiting |
"A Randomized Phase III Trial of Trastuzumab + ALpelisib +/- Fulvestrant Versus Trastuzumab + Chemotherapy in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer. ALPHABET Study." [NCT05063786] | Phase 3 | 300 participants (Anticipated) | Interventional | 2021-09-14 | Recruiting |
A Pilot and Phase II Study to Assess the Safety, Tolerability and Efficacy of Pembrolizumab Plus Chemotherapy in Metastatic Triple Negative Breast Cancer Patients [NCT02734290] | Phase 1/Phase 2 | 29 participants (Actual) | Interventional | 2016-02-23 | Active, not recruiting |
Phase 1/2 Study of Valproic Acid and Short-course Radiotherapy Plus Capecitabine as preoperatIve Treatment in Low-moderate Risk Rectal Cancer [NCT01898104] | Phase 1/Phase 2 | 152 participants (Anticipated) | Interventional | 2012-05-31 | Recruiting |
A Phase II, Single-center, Open-label, Single-arm Study of Induction Chemotherapy Combined With Immunotherapy for Locally Advanced Hypopharyngeal Carcinoma [NCT04156698] | Phase 2 | 51 participants (Anticipated) | Interventional | 2020-05-21 | Active, not recruiting |
Single-arm Phase II Clinical Study of Short-course Radiotherapy Combined With Neoadjuvant Chemotherapy and PD-1 Inhibitor in the Treatment of Locally Advanced Gastric Adenocarcinoma [NCT05563012] | Phase 2 | 29 participants (Anticipated) | Interventional | 2022-09-26 | Recruiting |
A Randomized Phase II Trial of Standard of Care Alone or in Combination With Ad-CEA Vaccine and Avelumab in Patients With Previously Untreated Metastatic or Unresectable Colorectal Cancer [NCT03050814] | Phase 2 | 30 participants (Actual) | Interventional | 2017-04-05 | Terminated(stopped due to Terminated after an unplanned interim efficacy analysis.) |
Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University. [NCT05207735] | Phase 2 | 73 participants (Anticipated) | Interventional | 2022-01-31 | Not yet recruiting |
A Randomized Single Center Controlled Study of Perioperative Chemotherapy of Oxaliplatin Combined With Capecitabine (XELOX) Versus XELOX as Post-operative Chemotherapy in Advanced Gastric Adenocarcinoma With D2 Dissection [NCT01665274] | Phase 2 | 15 participants (Actual) | Interventional | 2013-09-30 | Terminated(stopped due to we are working on a larger similar multicenter cinical trials as a participant.so in order to avoid conflicts of interest, we have to suspended this project.) |
An Open-label, Randomised, Non-comparative Phase 2 Study Evaluating S 95005 (TAS-102) Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Metastatic COlorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1 [NCT02743221] | Phase 2 | 154 participants (Actual) | Interventional | 2016-04-29 | Completed |
A Phase 2A, Single Arm, Multicentre, Study of Varlitinib Plus Capecitabine in Chinese Patients With Advanced or Metastatic Biliary Tract Cancer Who Progressed on at Least 1 Line of Systemic Therapy [NCT03231176] | Phase 2 | 62 participants (Actual) | Interventional | 2017-12-19 | Completed |
Phase II Study of Capecitabine, Oxaliplatin and Cetuximab Given Throughout Multi-Modal Therapy for Locally Advanced Rectal Adenocarcinoma [NCT00353457] | Phase 2 | 6 participants (Actual) | Interventional | 2006-02-28 | Terminated(stopped due to new studies were finding that Erbitux was not beneficial) |
Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After 2nd-line or Over 2nd-line Therapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer [NCT03204734] | Phase 2 | 132 participants (Anticipated) | Interventional | 2016-01-01 | Recruiting |
A Phase Ib/II Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus) [NCT02423954] | Phase 1/Phase 2 | 33 participants (Actual) | Interventional | 2015-04-30 | Terminated(stopped due to Investigator no longer at site to enroll patients or write up data) |
A Phase 3 Randomized Controlled Study of Metronomic Capecitabine Combined With Aromatase Inhibitor Versus Aromatase Inhibitor Alone for First Line Treatment in Hormone Receptor-positive, Her2-negative Metastatic Breast Cancer [NCT02767661] | Phase 3 | 240 participants (Anticipated) | Interventional | 2017-07-19 | Active, not recruiting |
PAXG Out in the Country [NCT04480268] | Phase 4 | 175 participants (Anticipated) | Interventional | 2020-07-08 | Recruiting |
NANT Non-Hodgkin Lymphoma (NHL) Vaccine: Combination Immunotherapy in Subjects With Relapsed CD20-positive NHL [NCT03169790] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer [NCT03507465] | Phase 2/Phase 3 | 290 participants (Anticipated) | Interventional | 2017-11-29 | Recruiting |
Randomised, Multicenter Phase II Study in Patients With High Risk Breast Cancer With Capecitabine Versus Vinorelbine With Pathologic Residual Tumors After Preoperative Chemotherapy Secondary ID [NCT03703427] | Phase 2 | 200 participants (Anticipated) | Interventional | 2018-11-30 | Not yet recruiting |
A Phase IB Study FOLFIRINOX and NIS793 in Patients With Pancreatic Cancer [NCT05417386] | Phase 1 | 50 participants (Anticipated) | Interventional | 2022-08-09 | Recruiting |
Randomised, Multicenter Phase II Study in Patients With HER-2 Positive Breast Cancer With Capecitabine Versus Observation With Pathologic Residual Tumors After Preoperative Chemotherapy [NCT03684863] | Phase 2 | 200 participants (Anticipated) | Interventional | 2018-10-31 | Not yet recruiting |
A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer [NCT05382442] | Phase 2 | 114 participants (Anticipated) | Interventional | 2022-07-27 | Recruiting |
Totally Neoadjuvant FOLFOXIRI Chemotherapy Followed by Short-course Radiation and XELOX Chemotherapy in Patients With Locally Advanced Rectal Cancer:an Open-label, Single-arm, Multicenter Phase II Study. [NCT03484221] | Phase 2 | 30 participants (Anticipated) | Interventional | 2018-04-01 | Recruiting |
A Phase I Dose-Escalation Trial of Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab Following Cytoreduction in Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer [NCT01061515] | Phase 1 | 21 participants (Actual) | Interventional | 2011-05-10 | Active, not recruiting |
Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial. [NCT05797077] | Phase 3 | 346 participants (Anticipated) | Interventional | 2023-02-20 | Recruiting |
Rectal Preserving Treatment for Early Rectal Cancer. A Multi-centred Randomised Trial of Radical Surgery Versus Adjuvant Chemoradiotherapy After Local Excision for Early Rectal Cancers [NCT02371304] | Phase 3 | 302 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
Sun Yat-sen University Cancer Center [NCT02362958] | Phase 2 | 159 participants (Actual) | Interventional | 2015-01-09 | Completed |
A Phase 2, Multi-Cohort Study to Investigate the Safety, Pharmacokinetics and Preliminary Antitumor Activity of the Anti-PD-1 Monoclonal Antibody BGB A317 in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced [NCT03469557] | Phase 2 | 30 participants (Actual) | Interventional | 2017-07-18 | Completed |
Estudo Randomizado de Fase II Com Capecitabina Versus 5-Fluorouracil/Leucovorin em Bolus Associados à Radioterapia no Tratamento Neoadjuvante de câncer de Reto Localmente avançado: INCAGI004. [NCT03428529] | Phase 2/Phase 3 | 63 participants (Actual) | Interventional | 2011-01-12 | Completed |
A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer [NCT01060007] | Phase 2 | 80 participants (Actual) | Interventional | 2009-11-30 | Completed |
The Efficacy of Induction Chemotherapy With Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma [NCT03427359] | Phase 2 | 65 participants (Actual) | Interventional | 2015-01-22 | Completed |
Prospective Randomized Controlled Study of the Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy [NCT03423849] | Phase 2/Phase 3 | 200 participants (Anticipated) | Interventional | 2018-02-08 | Not yet recruiting |
An Open Label Continuation Study of TRC105 Therapy for Patients Who Have Completed a Prior TRC105 Trial and Are Judged by the Investigator to Have the Potential to Benefit From Continued TRC105 Therapy [NCT02354612] | | 0 participants | Expanded Access | | No longer available |
QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After P [NCT03387111] | Phase 1/Phase 2 | 65 participants (Anticipated) | Interventional | 2018-01-13 | Active, not recruiting |
A Phase IB/II Clinical Study to Assess the Efficacy and Safety of QLS31905 in Combination With Chemotherapy as First-line Treatment in Patients With Claudin 18.2 (CLDN18.2) Positive Advanced Malignant Solid Tumors [NCT06041035] | Phase 1/Phase 2 | 115 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer [NCT05555888] | Phase 2 | 34 participants (Anticipated) | Interventional | 2022-12-12 | Recruiting |
Multicenter, Single-arm, Open-label Phase II Clinical Study of Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer [NCT05841134] | Phase 2 | 25 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer [NCT05288777] | Phase 2/Phase 3 | 45 participants (Anticipated) | Interventional | 2022-07-11 | Recruiting |
A Multi-Center, Open Label Phase 1/2 Study of CYT-0851 in Patients With Relapsed/Refractory B-Cell Malignancies and Advanced Solid Tumors [NCT03997968] | Phase 1/Phase 2 | 170 participants (Anticipated) | Interventional | 2019-10-09 | Active, not recruiting |
An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments [NCT02574455] | Phase 3 | 529 participants (Actual) | Interventional | 2017-11-07 | Completed |
A Randomized Phase III Study Of Low-Docetaxel Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin And Capecitabine (Eox) In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer [NCT02076594] | Phase 3 | 171 participants (Actual) | Interventional | 2013-01-31 | Terminated(stopped due to The interim analysis performed on 09 November 2018, showed the failure to achieve the primary objective of effectiveness of the experimental treatment.) |
A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer [NCT02213744] | Phase 2/Phase 3 | 113 participants (Actual) | Interventional | 2014-07-31 | Terminated(stopped due to Felt not to show benefit over control per DMC and confirmed via futility analysis) |
Randomized Prospective Multicentric Study: Radio-chemotherapy and Liver Transplantation Versus Liver Resection to Treat Respectable Hilar Cholangiocarcinoma [NCT02232932] | | 60 participants (Anticipated) | Interventional | 2014-03-31 | Active, not recruiting |
MRI Guided Adaptive Radiation for Locally Advanced Rectal Adenocarcinoma to Enhance Complete Response [NCT05108428] | Early Phase 1 | 20 participants (Actual) | Interventional | 2021-12-23 | Active, not recruiting |
A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not [NCT04456699] | Phase 3 | 335 participants (Actual) | Interventional | 2020-08-19 | Completed |
Phase II Study Of Preoperative Chemoradiotherapy Plus Avelumab In Patients With Locally Advanced Rectal Cancer [NCT03854799] | Phase 2 | 101 participants (Actual) | Interventional | 2019-04-01 | Completed |
A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer [NCT03262935] | Phase 3 | 437 participants (Actual) | Interventional | 2017-12-15 | Completed |
Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Multicenter, Open, Randomized, Controlled Clinical Study [NCT02555358] | Phase 2 | 300 participants (Actual) | Interventional | 2014-11-30 | Completed |
A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer [NCT01097018] | Phase 3 | 468 participants (Actual) | Interventional | 2010-04-30 | Completed |
PERIOPERATIVE TREATMENT WITH COI-B (CAPECITABINE, OXALIPLATIN, IRINOTECAN AND BEVACIZUMAB) OF HIGH RISK OR BORDERLINE RESECTABLE COLORECTAL CANCER LIVER METASTASES [NCT02086656] | Phase 2 | 46 participants (Actual) | Interventional | 2013-06-30 | Completed |
A Prospective Phase II Trial of Short-course Radiotherapy Based Total Neoadjuvant Therapy Combined With PD-1 Inhibitor for Locally Advanced Rectal Cancer (TORCH) [NCT04518280] | Phase 2 | 130 participants (Anticipated) | Interventional | 2021-05-01 | Recruiting |
A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy [NCT00372944] | Phase 2 | 70 participants (Actual) | Interventional | 2006-08-31 | Completed |
Prospective Randomized Clinical Trial for no Inferiority With Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery (TEM) Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer [NCT01308190] | Phase 3 | 173 participants (Actual) | Interventional | 2010-08-31 | Completed |
An Investigator Sponsored Phase I Trial of Selinexor Combined With Standard Capecitabine Based Chemoradiation as a Neoadjuvant Treatment in Locally Advanced Rectal Cancer [NCT02137356] | Phase 1 | 28 participants (Anticipated) | Interventional | 2014-12-31 | Recruiting |
Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Treatment of Patients With Local Recurrence of Esophageal Cancer [NCT04390945] | Phase 2 | 62 participants (Anticipated) | Interventional | 2021-12-01 | Recruiting |
An Open, Randomized Phase III Study of Famitinib With Camrelizumab Plus Treatment of Physician's Choice (TPC) Versus Camrelizumab Plus TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic Triple-negative Breast Cancer [NCT05760378] | Phase 3 | 223 participants (Anticipated) | Interventional | 2023-03-17 | Recruiting |
LUME-Colon 2: An Open-label Randomized Phase II Study to Assess the Efficacy and Safety of Nintedanib Alone or in Combination With Capecitabine for Patients With Refractory Metastatic Colorectal Cancer [NCT02780700] | Phase 2 | 1 participants (Actual) | Interventional | 2016-07-05 | Terminated(stopped due to Substance discontinued) |
To Observe the Pathological Remission Rate and Safety of FOLFOXIRI for Neoadjuvant Treatment of High-risk Locally Advanced Colorectal Cancer With a Single-arm, Open, Prospective Phase II Exploratory Clinical Study [NCT05018182] | Phase 2 | 69 participants (Anticipated) | Interventional | 2021-08-02 | Recruiting |
Apatinib Combined Capecitabine Versus Capecitabine Alone for Adjuvant Therapy in Patients After Biliary Carcinoma Surgery: a Prospective Randomized Controlled Study [NCT03609489] | Phase 2 | 40 participants (Anticipated) | Interventional | 2018-09-10 | Not yet recruiting |
Dose-escalation, Phase I Multicentric Trial, Evaluating the Combination of Ribociclib and Capecitabine in Locally Advanced or Metastatic Breast Cancer HER2 Negative in Patients Previously Treated With Anthracyclines and Taxanes [NCT02754011] | Phase 1 | 18 participants (Actual) | Interventional | 2017-02-02 | Completed |
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer - A Pilot Study [NCT02528175] | | 6 participants (Actual) | Interventional | 2015-04-30 | Completed |
A Phase II Trial of Capecitabine and Irinotecan With or Without Amifostine in Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer [NCT03702985] | Phase 2 | 160 participants (Anticipated) | Interventional | 2018-05-28 | Recruiting |
A Prospective Randomized Controlled Clinical Trial of Capecitabine Treatment in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck After Radiotherapy: Phase II Study [NCT03678649] | Phase 2 | 180 participants (Anticipated) | Interventional | 2018-09-10 | Recruiting |
Phase 1/2 Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer [NCT02324543] | Phase 1/Phase 2 | 47 participants (Actual) | Interventional | 2015-02-28 | Completed |
An Open-label, Phase II Study Evaluating the Efficacy and Safety of Trastuzumab Combined With Oral Chemotherapy in Patients With HER-2 Positive Stage I Breast Cancer [NCT04922008] | Phase 2 | 356 participants (Anticipated) | Interventional | 2021-07-01 | Not yet recruiting |
Fluoropyrimidine Tailored-dose Based on Uracil Concentration in Patients Treated for Digestive Carcinomas: Evaluation of Clinical Practice [NCT04918264] | | 334 participants (Actual) | Observational | 2020-11-02 | Completed |
Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+ Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study [NCT06016387] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-10-05 | Not yet recruiting |
Efficacy and Safety of Inetetamab Plus Pyrotiniband and Capecitabine in HER2-positive Metastatic Breast Cancer Patients With or Without Brain Metastasis [NCT06015100] | | 40 participants (Anticipated) | Interventional | 2021-02-20 | Active, not recruiting |
A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroe [NCT04859582] | Phase 3 | 0 participants (Actual) | Interventional | 2018-11-08 | Withdrawn(stopped due to Withdrawn due to protocol amendment) |
A Single Arm, Multicenter Phase II Clinical Study of TQB2450 (PD-L1 Inhibitor) Plus Anlotinib Combined With Oxaliplatin, Capecitabine in the First-line Treatment of Advanced Gastric Cancer (GC) or Adenocarcinoma of Esophagogastric Junction (AEG) [NCT04891900] | | 25 participants (Anticipated) | Interventional | 2021-05-31 | Not yet recruiting |
Randomized Open-label Trial of Dose Dense, Fixed Dose Capecitabine Compared to Standard Dose Capecitabine in Metastatic Breast Cancer and Advanced/Metastatic Gastrointestinal Cancers. [NCT02595320] | Phase 2 | 200 participants (Actual) | Interventional | 2015-10-05 | Active, not recruiting |
An Open-Label, Randomized Phase II Study of Herceptin (Trastuzumab), Taxotere (Docetaxel), and Xeloda (Capecitabine) in Combination, Versus Herceptin (Trastuzumab) Plus Taxotere (Docetaxel), in Patients With Advanced and/or Metastatic Breast Cancers That [NCT02748213] | Phase 2 | 225 participants (Actual) | Interventional | 2002-02-28 | Completed |
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma (MORPHEUS C-Gastric and Gastroesophageal Junction Carci [NCT05251948] | Phase 1/Phase 2 | 255 participants (Anticipated) | Interventional | 2022-03-01 | Active, not recruiting |
A Study of RC48-ADC Combine With Toripalimab and Chemotherapy or RC48-ADC Combine With Toripalimab and Herceptin as First-line Treatment in Local Advanced or Metastatic Gastric Cancer With the HER2 Expression [NCT05980481] | Phase 2/Phase 3 | 60 participants (Anticipated) | Interventional | 2023-08-04 | Recruiting |
A Prospective, Multicenter, Open, Randomized Controlled Phase II Clinical Study Evaluating Recombinant Oncolytic HSV2(OH2)Therapeutic Injecta(Vero Cell) for Human Use(rHSV2hGM-CSF) in Combination With Capecitabine for First-line Maintenance Therapy in Adv [NCT05648006] | Phase 2 | 60 participants (Anticipated) | Interventional | 2023-10-17 | Recruiting |
Short-course Radiotherapy Versus Chemoradiotherapy, Followed by Consolidation Chemotherapy, and Selective Organ Preservation for MRI-defined Intermediate and High-risk Rectal Cancer Patients [NCT04246684] | Phase 3 | 702 participants (Anticipated) | Interventional | 2020-10-15 | Active, not recruiting |
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: PRIME [NCT03878524] | Phase 1 | 2 participants (Actual) | Interventional | 2020-04-01 | Active, not recruiting |
A Multi-Center, Double-Blind, Randomized, Phase III Study of CS1001 in Combination With CAPOX Chemotherapy Compared to Placebo in Combination With CAPOX Chemotherapy in Subjects With Unresectable Locally Advanced or Metastatic GC or GEJ Adenocarcinoma [NCT03802591] | Phase 3 | 479 participants (Actual) | Interventional | 2019-03-28 | Completed |
First-line Combination of Capecitabine and Oxaliplatin + Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer [NCT03451370] | | 121 participants (Anticipated) | Observational [Patient Registry] | 2017-11-01 | Active, not recruiting |
MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-metastatic Pancreatic Cancer [NCT01972919] | Phase 2 | 23 participants (Actual) | Interventional | 2015-12-10 | Active, not recruiting |
Preoperative Radiochemotherapy With IMRT - Simultaneous Integrated Boost in Locally Advanced Rectal Cancer - BISER [NCT02268006] | Phase 2 | 50 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma (ALIX) [NCT03974854] | Phase 2 | 90 participants (Anticipated) | Interventional | 2019-07-08 | Recruiting |
A Randomized Phase 2/3 Multi-Center Study of SM-88 in Subjects With Pancreatic Cancer Whose Disease Has Progressed or Recurred [NCT03512756] | Phase 2/Phase 3 | 132 participants (Actual) | Interventional | 2018-03-27 | Completed |
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects With Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, an [NCT00719550] | Phase 1/Phase 2 | 130 participants (Actual) | Interventional | 2009-02-28 | Completed |
A Phase 2, Single Arm Study of Varlitinib Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer as First-line Systemic Therapy [NCT03129074] | Phase 2 | 0 participants (Actual) | Interventional | 2018-05-31 | Withdrawn(stopped due to sponsor decision) |
Phase II Study of Recombinant Anti-tumor and Anti-Virus Protein for Injection Plus Capatabine in Treating Patients With Metastatic Colorectal Cancer After Failure of Standard Treatment [NCT02068131] | Phase 2 | 30 participants (Anticipated) | Interventional | 2014-02-28 | Recruiting |
A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Chemotherapy as Second-line Treatment in Subjects With Advanced Biliary Cancer [NCT04809142] | Phase 3 | 392 participants (Anticipated) | Interventional | 2021-02-04 | Recruiting |
A Randomized, Double Blind, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination With AMG 386 or Placebo in Subjects With Metastatic Gastric, Gastroesophageal Junctio [NCT00583674] | Phase 2 | 171 participants (Actual) | Interventional | 2007-12-31 | Completed |
A Phase Ib, Multicenter, Open-label, Dose-escalation and Dose-expansion Study of the Safety, Tolerability and Pharmacokinetics of HB002.1T in Combination With Chemotherapy in Patients With Advanced Solid Tumors. [NCT04802980] | Phase 1 | 72 participants (Anticipated) | Interventional | 2020-04-28 | Recruiting |
Phase Ib/II Study of Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer [NCT03377387] | Phase 1/Phase 2 | 34 participants (Actual) | Interventional | 2017-12-13 | Active, not recruiting |
A Phase II Study of Capecitabine (Xeloda)/Oxaliplatin (Eloxatin) With Concomitant Radiotherapy (XRT), XELOX/RT in Squamous Cell Carcinoma of the Anal Canal [NCT00093379] | Phase 2 | 20 participants (Actual) | Interventional | 2004-04-30 | Completed |
XELOX for 4 Months Versus 6 Months as Adjuvant Chemotherapy in Gastric Cancer After D2 Resection (LOMAC) [NCT03399110] | Phase 3 | 1,032 participants (Anticipated) | Interventional | 2017-12-01 | Recruiting |
The Effect of Monosialotetrahexosylganglioside (GM1) in Prevention of Oxaliplatin Induced Neurotoxicity in Colorectal Cancer Patients Who Received Oxaliplatin-based Adjuvant Chemotherapy: A Multi-center, Randomized, Placebo-controlled Trial [NCT02251977] | Phase 3 | 196 participants (Actual) | Interventional | 2014-09-30 | Completed |
A Randomized Controlled Trial of CAPEOX vs Observation in Early-stage Colorectal Cancer Patients With Positive MRD After Curative Surgery [NCT05699746] | Phase 3 | 38 participants (Anticipated) | Interventional | 2023-03-31 | Not yet recruiting |
Phase III Clinical Trials of UTD1 Injection Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced and Metastatic Breast Cancer [NCT02253459] | Phase 3 | 405 participants (Actual) | Interventional | 2014-08-31 | Completed |
Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer - a Two Step Study With a Retrospective Analyses Followed by a Translational Phase II Study [NCT04350021] | | 40 participants (Anticipated) | Observational | 2019-03-01 | Recruiting |
A Non-Interventional Trial of Xeloda in Metastatic Colorectal Cancer, Adjuvant Colon Cancer, Advanced Gastric Cancer and Breast Cancer [NCT01664494] | | 563 participants (Actual) | Observational | 2010-04-30 | Completed |
Utidelone Plus Capecitabine Versus Taxane Plus Capecitabine in HER2-negative Locally Advanced or Metastatic Breast Cancer : A Phase III, Open-label, Randomized Controlled Trial [NCT05172518] | Phase 3 | 512 participants (Anticipated) | Interventional | 2022-03-01 | Not yet recruiting |
NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With Pancreatic Cancer Who Have [NCT03387098] | Phase 1/Phase 2 | 173 participants (Anticipated) | Interventional | 2018-01-02 | Active, not recruiting |
Phase II Study of TGFβ Type I Receptor Inhibitor LY2157299 With Neoadjuvant Chemoradiation in Patients With Locally Advanced Rectal Adenocarcinoma [NCT02688712] | Phase 2 | 50 participants (Anticipated) | Interventional | 2016-03-24 | Active, not recruiting |
An International, Multicenter, Phase II, Randomized, Parallel-arm Trial Investigating the Role of Two Different Metronomic Chemotherapy Regimens in Locally Advanced or Metastatic Triple Negative Breast Cancer Patients (TNBC) as Maintenance Therapy After F [NCT03358004] | Phase 2 | 4 participants (Actual) | Interventional | 2017-06-14 | Terminated(stopped due to Low accrual rate) |
Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in Induction Chemotherapy Plus Concurrent Chemoradiotherapy for Locoregionally Advanced NPC: a Phase 3, Multicentre, Non-inferiority, Randomised Factorial Trial [NCT03503136] | Phase 3 | 632 participants (Anticipated) | Interventional | 2018-06-30 | Not yet recruiting |
GRECCAR 8 : Impact on Survival of the Primary Tumor Resection in Rectal Cancer With Unresectable Synchronous Metastasis a Randomized Multicenter Study [NCT02314182] | Phase 3 | 5 participants (Actual) | Interventional | 2014-11-20 | Completed |
A Randomized Phase III Study to Investigate the Efficacy and Safety of Docetaxel + Capecitabine vs. Vinorelbine + Capecitabine Followed by Capecitabine Alone as 1st Therapy on Locally Advanced and Metastatic Breast Cancer Patients. [NCT01126138] | Phase 3 | 200 participants (Anticipated) | Interventional | 2010-07-31 | Recruiting |
An Open Label Randomized Controlled Phase II Trial of Panitumumab in Combination With Epirubicin, Cisplatin and Capecitabine (ECX) Versus ECX Alone in Subjects With Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction. [NCT01234324] | Phase 2 | 171 participants (Actual) | Interventional | 2010-10-31 | Completed |
A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer [NCT00114231] | Phase 2 | 90 participants (Actual) | Interventional | 2006-05-31 | Completed |
Lapatinib Versus Lapatinib With Capecitabine as Second-line Treatment in Her2-Overexpressing Metastatic Gastro-Esophageal Cancer: A Randomized Phase II Trial [NCT01145404] | Phase 2 | 76 participants (Anticipated) | Interventional | 2010-06-30 | Terminated(stopped due to Changes of SoC for third line therapy resulting in poor recruitment) |
Toxicity OF Fluoropyrimidines: A Comparative Study of the Cardiotoxicity of capEcitabine and tEysuno [NCT01845337] | Phase 2 | 59 participants (Actual) | Interventional | 2014-02-05 | Completed |
A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane [NCT00082433] | Phase 3 | 1,221 participants (Actual) | Interventional | 2003-11-30 | Completed |
"A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) (XELOX) With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin Wit [NCT00069095] | Phase 3 | 2,035 participants (Actual) | Interventional | 2003-07-31 | Completed |
Capecitabine and Bevacizumab With Radiotherapy After 3-6 Months Chemotherapy for Patients With Oligometastatic Colorectal Cancer (OLGA Trial) [NCT01759238] | Phase 2 | 1 participants (Actual) | Interventional | 2013-05-31 | Terminated(stopped due to unexpectedly slow recruitment) |
Metronomic Poly-chemotherapy for Metastatic Colorectal Cancer at Progression Following Established Treatments: Clinical and Laboratory Research [NCT02280694] | Phase 2 | 45 participants (Actual) | Interventional | 2015-01-31 | Completed |
Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer: a Prospective Single-center Multi-arm Open-label Randomized Phase II Study [NCT05914389] | Phase 2 | 100 participants (Anticipated) | Interventional | 2023-08-31 | Recruiting |
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating Combination of TST001, Nivolumab and Chemotherapy as First-Line Treatment in Subjects With Claudin18.2 Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G [NCT06093425] | Phase 3 | 950 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
RIBBON-LA-01: Single-arm, Open-label, Phase 2 Trial of Tislelizumab and Metronomic Capecitabine as Maintenance Therapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma [NCT06093061] | Phase 2 | 69 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
BRE-08: A Phase II Study of an All-Oral Adjuvant Chemotherapy Regimen of Cyclophosphamide, Methotrexate, and Capecitabine (CMC) for Early-Stage Breast Cancer [NCT06085742] | Phase 2 | 25 participants (Anticipated) | Interventional | 2023-10-31 | Recruiting |
A Randomized, Controlled, Open-label, Multi-center Phase III Clinical Trial of SKB264 for Injection Versus Investigator Selected Regimens in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer Who Have Failed [NCT05347134] | Phase 3 | 254 participants (Anticipated) | Interventional | 2022-06-10 | Active, not recruiting |
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT) [NCT05238831] | Early Phase 1 | 25 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
A Phase II Trial of HKI-272 (Neratinib), Neratinib and Capecitabine, and Ado-Trastuzumab Emtansine for Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer and Brain Metastases [NCT01494662] | Phase 2 | 140 participants (Actual) | Interventional | 2012-02-29 | Active, not recruiting |
Phase II Study of Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin and Capecitabine for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma [NCT04390958] | Phase 2 | 70 participants (Anticipated) | Interventional | 2020-05-15 | Recruiting |
Neoadjuvant Tislelizumab With Oxaliplatin and Capecitabine in Microsatellite Stable, Locally Advanced Colon Cancer: A Prospective, Single-arm, Single-center, Exploratory Phase II Clinical Study [NCT06124378] | Phase 2 | 60 participants (Anticipated) | Interventional | 2023-11-13 | Recruiting |
A Phase II Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer (PERSEVERE) [NCT04849364] | Phase 2 | 197 participants (Anticipated) | Interventional | 2021-08-24 | Recruiting |
A Phase II, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) and Trastuzumab in Combination With Capecitabine and Oxaliplatin (Xelox) in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Jun [NCT04661150] | Phase 2 | 41 participants (Actual) | Interventional | 2021-03-12 | Active, not recruiting |
Personalised, Rational, Efficacy-driven Cancer Drug Dosing Via an Artificial Intelligence SystEm - CURATE.AI (PRECISE CURATE.AI Trial) [NCT04522284] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2020-08-20 | Recruiting |
A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithe [NCT01081262] | Phase 3 | 50 participants (Actual) | Interventional | 2010-10-12 | Active, not recruiting |
A Phase II Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, Panitumumab and External Beam Radiation, in Patients With Localized, Non-Metastatic Pancreatic Adenocarcinoma [NCT01130701] | Phase 2 | 0 participants (Actual) | Interventional | 2010-05-31 | Withdrawn(stopped due to Study never went beyond FDA application for an IND #. FDAA required institutional DSMC which this institution then lacked.) |
Pattern and Clinical Implication of Lymph Node Metastasis From Gastric Cancer Which Was Resected by Radical Surgery With Extended Lymphadenectomy [NCT02298010] | | 899 participants (Actual) | Observational | 2016-01-31 | Completed |
A Phase I Study of ABT-888 in Combination With Oxaliplatin and Capecitabine in Advanced Solid Tumors [NCT01233505] | Phase 1 | 16 participants (Actual) | Interventional | 2010-10-31 | Terminated |
Combinational Therapy of Capecitabine, Lapatinib and Vinorelbine for the Treatment of Patients With her2/Neu Positive, Relapsed or Metastatic Breast Carcinoma Following Treatment Failure With Trastuzumab [NCT01238029] | Phase 1 | 12 participants (Actual) | Interventional | 2010-10-31 | Terminated(stopped due to new methods of treatment, no more patients appilicable for study) |
Safety, Feasibility and Cost-effectiveness of Genotype-directed Individualized Dosing of Fluoropyrimidines [NCT02324452] | | 1,103 participants (Actual) | Interventional | 2015-03-31 | Completed |
An Open-Label Study of AMG 386 in Combination With Either Paclitaxel and Trastuzumab or Capecitabine and Lapatinib in Subjects With HER2-positive Locally Recurrent or Metastatic Breast Cancer [NCT00807859] | Phase 1 | 65 participants (Actual) | Interventional | 2009-03-09 | Completed |
Phase-1 Study of Escalated-dose Pelvic Radiation Therapy Using Intensity-Modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB), in Combination With Xeloda, for Initially Metastatic, Low and Middle Rectal Cancer [NCT03634202] | | 9 participants (Actual) | Interventional | 2015-05-05 | Terminated(stopped due to the study was stopped for lack of inclusion) |
Window of Opportunity Study With Neoadjuvant Pembrolizumab in Colorectal Cancer [NCT03984578] | Phase 2 | 50 participants (Anticipated) | Interventional | 2019-06-12 | Recruiting |
Neoadjuvant Chemotherapy With Xeloda in Combination With Paclitaxel in Gastric Cancer With Liver Metastasis [NCT01167049] | Phase 2 | 60 participants (Anticipated) | Interventional | 2009-08-31 | Recruiting |
An Open-Label Randomized Phase III Study Comparing Xeloda (Capecitabine) With IV Bolus 5-Fluorouracil in Combination With Low-Dose Leucovorin as Adjuvant Chemotherapy in Patients Who Underwent Surgery for Dukes C Colon Cancer [NCT00009737] | Phase 3 | 1,987 participants (Actual) | Interventional | 1998-11-30 | Completed |
A Phase 3 Asian Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (MBC) Who Have Fail [NCT04639986] | Phase 3 | 331 participants (Actual) | Interventional | 2020-11-23 | Active, not recruiting |
Phase II Clinical Study of Capecitabine in Combination With Mitomycin C as First-Line Treatment in Patients With Metastatic Breast Cancer [NCT01196455] | Phase 2 | 39 participants (Anticipated) | Interventional | 2006-03-31 | Recruiting |
Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations [NCT01206049] | Phase 2 | 88 participants (Actual) | Interventional | 2010-09-30 | Completed |
A Phase I Study of Induction AMG 479 and Gemcitabine, Followed by AMG 479, Capecitabine, and 3D-Conformal Radiation Therapy (3D-CRT) With Subsequent Maintenance Therapy for Locally Advanced Pancreatic Cancer [NCT01298401] | Phase 1 | 8 participants (Actual) | Interventional | 2012-02-29 | Completed |
A Phase II Randomized Trial of Telatinib in Combination With Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin as First-Line Therapy in Patients With HER2-negative Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction [NCT03817411] | Phase 2 | 90 participants (Anticipated) | Interventional | 2019-01-25 | Recruiting |
MoTriColor: Phase I/II Study With Galunisertib (LY2157299) Combined With Capecitabine in Patients With Advanced Chemotherapy Resistant Colorectal Cancer and an Activated TGF-beta Signature [NCT03470350] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2018-08-24 | Withdrawn(stopped due to No study drug available. Same concept with new study drug will be explored in M19TGA study) |
Perioperative Versus Preoperative Chemotherapy With Surgery in Patients With Locoregional Squamous Carcinoma of Esophagus [NCT01225523] | Phase 1 | 350 participants (Actual) | Interventional | 1997-01-31 | Completed |
A Pilot and Phase II Study of Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma [NCT01302613] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2011-03-31 | Withdrawn(stopped due to Drug shortage) |
[NCT01229813] | Phase 3 | 233 participants (Actual) | Interventional | 2010-10-31 | Completed |
A Prospective Evaluation of Capecitabine and Metabolite Pharmacokinetics in Elderly Breast and Colorectal Cancer Patients and Their Association With Toxicity and Molecular Markers of Enzyme Activity and Aging [NCT03465202] | Phase 4 | 100 participants (Anticipated) | Interventional | 2016-05-31 | Not yet recruiting |
Organ Preservation for Patients With Locally Advanced Rectal Adenocarcinoma: Evaluating the Efficacy of Short Course Radiation Therapy Followed by FOLFOX or CapeOX [NCT04703101] | Phase 1 | 25 participants (Anticipated) | Interventional | 2021-02-11 | Recruiting |
Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine for Biliary Tract Cancer After Curative Resection [NCT03779035] | Phase 3 | 460 participants (Anticipated) | Interventional | 2018-12-15 | Recruiting |
Perioperative CapeOX Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Resectable Colon Cancer: An Open Label Randomized Controlled Phase III Trial [NCT03125980] | Phase 3 | 1,370 participants (Anticipated) | Interventional | 2017-05-31 | Recruiting |
Randomised Phase III Trial of Chemoradiotherapy With or Without Paclitaxel in Patients With Squamous-cell Anal Cancer [NCT02526953] | Phase 3 | 314 participants (Anticipated) | Interventional | 2016-01-31 | Enrolling by invitation |
[NCT00710736] | Phase 1 | 29 participants (Actual) | Interventional | 2008-06-30 | Completed |
A Randomized Phase II Trial of Capecitabine and Temozolomide (CAPTEM) or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas and Exploratory Analysis of Predictive Role of Positron Emission Tomography (PET) Imaging and Biological Markers [NCT03387592] | Phase 2 | 112 participants (Anticipated) | Interventional | 2017-03-06 | Recruiting |
Pilot / Phase III Randomized Trial Comparing Standard Systemic Therapy to Cytoreduction + Hyperthermic Intraperitoneal Mitomycin C + Standard Systemic Therapy in Patients With Limited Peritoneal Dissemination of Colon Adenocarcinoma [NCT01167725] | Phase 3 | 340 participants (Anticipated) | Interventional | 2010-08-31 | Active, not recruiting |
Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer [NCT03381352] | Phase 2 | 27 participants (Anticipated) | Interventional | 2015-12-02 | Recruiting |
Phase 1 Trail to Observe Safety and Efficacy of Metronomic Capecitabine Plus PD-L1 Antibody Camrelizumab as Third-line Regimen to Treat HER2 Negative Advanced Gastric Cancer Patients [NCT04508686] | Phase 1 | 20 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
A Phase II Prospective Trial of mXELOXIRI Reintroduction for the Unresectable Metastatic Colorectal Cancer [NCT04508452] | Phase 2 | 91 participants (Anticipated) | Interventional | 2020-05-18 | Recruiting |
A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy [NCT03473639] | Phase 1 | 13 participants (Actual) | Interventional | 2019-01-29 | Completed |
Phase Ⅱ Clinical Study of RALOX or CAPOX Combined With Bevacizumab in the First-line Treatment of Advanced Colorectal Cancer [NCT03813641] | Phase 2 | 100 participants (Anticipated) | Interventional | 2019-01-28 | Recruiting |
Randomized Phase 2 Trial Of Two Chemotherapy Regimens Plus Or Minus Bevacizumab In Patients With Well Differentiated Pancreatic Neuroendocrine Tumors [NCT03351296] | Phase 2 | 140 participants (Anticipated) | Interventional | 2018-06-26 | Recruiting |
Targeting Myeloid Derived Suppressor Cells in Recurrent Glioblastoma: Phase 0/1 Trial of Low Dose Capecitabine + Bevacizumab in Patients With Recurrent Glioblastoma [NCT02669173] | Phase 1 | 12 participants (Actual) | Interventional | 2016-10-11 | Active, not recruiting |
A Pilot Study in Gastric Cancer of Assignment to Postoperative Chemoradiation or Chemotherapy Based Upon Surgical Lymph Node Assessment After Preoperative Chemotherapy, With Gene Assay as Correlate of Biologic Response [NCT03515941] | Early Phase 1 | 6 participants (Actual) | Interventional | 2018-06-22 | Terminated(stopped due to The PI has decided to close the study due to the outdated study design.) |
NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adaptive T-cell Therapy (Adenovirus, Yeast, Fusion Protein Vaccine) in Subjects With Pancreatic Cancer Who [NCT03329248] | Phase 1/Phase 2 | 80 participants (Anticipated) | Interventional | 2017-11-06 | Active, not recruiting |
An Open-label, Randomized, Phase II Clinical Trial Comparing the Efficacy and Safety of Intraperitoneal and System Chemotherapy Versus XELOX as First-line Chemotherapy for Metastatic Colorectal Cancer [NCT03792269] | Phase 2 | 100 participants (Anticipated) | Interventional | 2016-01-01 | Recruiting |
A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane [NCT03326674] | Phase 3 | 685 participants (Actual) | Interventional | 2017-12-21 | Terminated(stopped due to The Sponsor has discontinued the development of tesetaxel) |
A Phase II Study of Sequential Capecitabine Plus Oxaliplatin (XELOX) Followed by Docetaxel Plus Capecitabine (TX) in Patients With Unresectable Gastric [NCT01331928] | Phase 2 | 51 participants (Anticipated) | Interventional | 2011-01-31 | Recruiting |
Phase II Trial of Accelerated Fraction Radiotherapy With Concomitant Capecitabine as Neoadjuvant Therapy of Resectable and Borderline Resectable Pancreas Cancer [NCT01333332] | Phase 2 | 35 participants (Anticipated) | Interventional | 2010-08-31 | Recruiting |
Precise Targeted Therapy for Refractory HER2 Positive Advanced Breast Cancer Based on Genome Signature and Drug Sensitivity of PDO Model [NCT05429684] | Phase 3 | 120 participants (Anticipated) | Interventional | 2021-01-01 | Recruiting |
Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy [NCT06065371] | Phase 1 | 20 participants (Anticipated) | Interventional | 2024-02-29 | Not yet recruiting |
A Single-arm, Open-label,Phase Ib Clinical Study of ZKAB001 Combined With Capecitabine in Adjuvant Therapy for Patients With Biliary Tract Cancer After Radical Resection [NCT04608786] | Phase 1 | 10 participants (Anticipated) | Interventional | 2021-02-01 | Enrolling by invitation |
Phase I/II Trial of Motesanib in Combination With Ixabepilone and Capecitabine in Women With Locally Recurrent or Metastatic Breast Cancer [NCT01349088] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2013-12-31 | Withdrawn |
A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma [NCT00609336] | Phase 2 | 35 participants (Actual) | Interventional | 2008-01-31 | Completed |
Adjuvant Chemotherapy Versus Observation in Stage II Colon Cancer Patients With High-Risk Factors and High-Immunoscore® [NCT04303429] | Phase 3 | 962 participants (Anticipated) | Interventional | 2020-08-31 | Not yet recruiting |
A Phase I Study, With Expanded Cohort, of Biweekly Fixed-dose Rate Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic and Biliary Carcinomas [NCT00626158] | Phase 1 | 45 participants (Actual) | Interventional | 2008-02-29 | Completed |
PD1 Antibody Toripalimab and Chemoradiotherapy for dMMR/MSI-H Locally Advanced Colorectal Cancer [NCT04301557] | Phase 2 | 25 participants (Anticipated) | Interventional | 2020-07-31 | Recruiting |
Effect of PD-1 Antibody (SHR-1210) Combined With Capecitabine Treatment After Resection of Intrahepatic Cholangiocarcinoma With High Risk of Recurrence : a Phase 2 Study. [NCT04295317] | Phase 2 | 65 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
Liposomal iRInotecan, Carboplatin or oXaliplatin in the First Line Treatment of Esophagogastric Cancer: a Randomized Phase 2 Study [NCT03764553] | Phase 2 | 310 participants (Anticipated) | Interventional | 2019-05-01 | Recruiting |
A Multicenter Phase II Clinical Study of Bevacizumab Combined With Biweekly XELOX/XELIRI Alternative First-line Treatment for Unresectable Advanced Colorectal Cancer [NCT04324476] | Phase 2 | 50 participants (Anticipated) | Interventional | 2019-09-01 | Recruiting |
A Multicenter Randomized Phase III Study to Compare the Combination Trastuzumab and Capecitabine, With or Without Pertuzumab, in Patients With HER2-Positive Metastatic Breast Cancer That Have Progressed After One Line of Trastuzumab-Based Therapy in the M [NCT01026142] | Phase 3 | 452 participants (Actual) | Interventional | 2010-01-26 | Completed |
A Prospective, Multi-cohort, Single-center Phase II Clinical Study of Chemoradiotherapy Sequential Fluzoparib in Pan-solid Tumors [NCT06055166] | Phase 2 | 120 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting |
A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases [NCT03161522] | Phase 2 | 100 participants (Anticipated) | Interventional | 2018-02-19 | Recruiting |
A Phase II, Randomised, Multi-Centre Study Evaluating Lapatinib in Combination With Vinorelbine or Capecitabine in Women With ErbB2 Overexpressing Metastatic Breast Cancer [NCT01013740] | Phase 2 | 112 participants (Actual) | Interventional | 2009-11-25 | Completed |
JCOG1801: A Phase III Randomized Controlled Trial Comparing Surgery Plus Adjuvant Chemotherapy With Preoperative Chemoradiotherapy Followed by Surgery Plus Adjuvant Chemotherapy for Locally Recurrent Rectal Cancer (RC-SURVIVE Study) [NCT04288999] | Phase 3 | 110 participants (Anticipated) | Interventional | 2019-10-01 | Recruiting |
Phase II Study of Bevacizumab Combined With Capecitabine and Oxaliplatin (CAPOX) in Patients With Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater [NCT01208103] | Phase 2 | 30 participants (Actual) | Interventional | 2011-05-06 | Completed |
Phase I/II Study of Azacitidine and CAPOX (Capecitabine + Oxaliplatin) in Metastatic Colorectal Cancer Patients Enriched for Hypermethylation of CpG Promoter Islands [NCT01193517] | Phase 1/Phase 2 | 26 participants (Actual) | Interventional | 2010-08-31 | Completed |
A Multicenter Phase II Study of Gemcitabine, Capecitabine and Bevacizumab for Locally Advanced or Metastatic Adenocarcinoma of the Gall Bladder or Biliary Ducts. [NCT01007552] | Phase 2 | 50 participants (Actual) | Interventional | 2009-12-31 | Completed |
Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy With Selective Radiotherapy Use in Patients With Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging [NCT00909987] | Phase 2 | 46 participants (Actual) | Interventional | 2009-03-31 | Completed |
Phase I Dose Escalation Trial of External Beam Radiation and Cyberknife Radiosurgery Boost With Concurrent Capecitabine for Hilar Cholangiocarcinoma (Klatskin Tumor) [NCT00630890] | Phase 1 | 11 participants (Actual) | Interventional | 2007-10-31 | Terminated(stopped due to investigator left UCSF and study was closed prematurely in 2008. No results to report.) |
Phase II Study of a Novel Capecitabine Dosing Schedule in Combination With Lapatinib, Based on the Norton-Simon Mathematical Method in Patients With HER2 Overexpressed/Amplified, Trastuzumab (Herceptin) -Refractory, Metastatic Breast Cancer [NCT00721630] | Phase 2 | 24 participants (Actual) | Interventional | 2008-07-31 | Completed |
Effect of Second-line Irinotecan and Capecitabine Versus Irinotecan Alone in Advanced Biliary Tract Cancer Patients Progressed After First-line Gemcitabine and Cisplatin: A Randomized Controlled Study [NCT02558959] | Phase 2 | 64 participants (Actual) | Interventional | 2015-09-01 | Completed |
A Phase II Trial of Neoadjuvant Chemoradiation (CRT) and Pembrolizumab in Patients With Rectal Cancer: Hoosier Cancer Research Network GI15-213 [NCT02586610] | Phase 2 | 0 participants (Actual) | Interventional | 2016-10-31 | Withdrawn(stopped due to Dr. Rahma decided to run the study through a different group) |
Phase III Study of Neoadjuvant Chemotherapy With Capecitabine and Oxaliplatin Versus Chemoradiation for Locally Advanced Rectal Cancer Patients [NCT02288195] | Phase 3 | 663 participants (Actual) | Interventional | 2014-08-13 | Active, not recruiting |
A Randomized, Open-Label, Multiple-center, Phase II Study to Evaluate the Efficacy and Safety of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ Metastatic Breast Cancer Who Have Received Pri [NCT04262804] | Phase 2 | 123 participants (Actual) | Interventional | 2020-01-13 | Active, not recruiting |
A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane [NCT00437294] | Phase 2 | 86 participants (Actual) | Interventional | 2007-03-31 | Terminated(stopped due to Lack of efficacy) |
A Randomized, Phase II Study of Concurrent Radiotherapy and Oxaliplatin, Capecitabine With or Without Cetuximab in Rectal Cancer Tumor Stratified by KRAS Mutation Status. [NCT00795301] | Phase 2 | 74 participants | Interventional | 2008-07-31 | Active, not recruiting |
A Randomized Study of the Effect of Maintenance Therapy With Bevacizumab + Capecitabine Versus Bevacizumab Alone on Progression-free Survival in Patients With HER2-negative Metastatic Breast Cancer That Has Not Progressed During First-line Docetaxel Plus [NCT00929240] | Phase 3 | 287 participants (Actual) | Interventional | 2009-07-31 | Completed |
Maintenance and Reinduction Chemotherapy With Avastin in Metastatic Colon Cancer: The MARTHA (SICOG 0803) Trial [NCT00797485] | Phase 3 | 672 participants (Anticipated) | Interventional | 2008-07-31 | Recruiting |
Second Line ERIbulin Followed by CApecitabine or the Reverse Sequence in HER2-negative Metastatic Breast Cancer (MBC) Patients: a Randomized Phase II Study - ERICA Trial [NCT05833919] | Phase 2 | 122 participants (Actual) | Interventional | 2018-07-30 | Active, not recruiting |
Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer [NCT01918527] | Phase 3 | 250 participants (Actual) | Interventional | 2013-09-30 | Active, not recruiting |
Phase II Study of Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer [NCT04001621] | Phase 2 | 100 participants (Anticipated) | Interventional | 2019-06-26 | Active, not recruiting |
Total Neoadjuvant Induction and Consolidation CapeOX Plus Neoadjuvant Intensity Modulated Radiotherapy With Concurrent Capecitabine for MRI Defined High-risk Rectal Cancer [NCT02864849] | Phase 2 | 81 participants (Actual) | Interventional | 2016-08-31 | Completed |
Camrelizumab Combined With Apatinib 、XELOX 、RFA in the Treatment of Liver Metastases of Colorectal Cancer: One-arm Exploratory Clinical Study [NCT04202978] | Phase 1/Phase 2 | 23 participants (Anticipated) | Interventional | 2020-03-01 | Recruiting |
Phase Ib Study To Evaluate The Safety Of Combining IGF-1R Antagonist R1507 With Multiple Standard Chemotherapy Drug Treatments In Patients With Advanced Malignancies [NCT00811993] | Phase 1 | 104 participants (Actual) | Interventional | 2009-02-28 | Terminated |
Randomized Trial of Concurrent Cisplatin Chemoradiotherapy Plus Capecitabine Adjuvant Chemotherapy vs Concurrent Cisplatin Chemoradiotherapy Alone for Patients With Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis [NCT02973386] | Phase 3 | 278 participants (Anticipated) | Interventional | 2017-01-31 | Recruiting |
Phase II Study of Pembrolizumab Plus Capecitabine and Bevacizumab in Microsatellite Stable Metastatic Colorectal Cancer [NCT03396926] | Phase 2 | 44 participants (Actual) | Interventional | 2018-04-18 | Active, not recruiting |
A Phase II Study of Capecitabine, Oxaliplatin and Selenomethionine and Radiation Therapy in Patients With Stage II and III Rectal Adenocarcinoma [NCT00625183] | Phase 2 | 5 participants (Actual) | Interventional | 2008-03-31 | Terminated(stopped due to Withdrawn due to poor/low accrual) |
Multicenter, Open-label, Randomized Phase III to Evaluate Efficacy of Maintenance Treatment With Capecitabine Following Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer Patients [NCT00130533] | Phase 3 | 876 participants (Actual) | Interventional | 2006-01-31 | Completed |
REAL 3 : A Randomised Open-labelled Multicentre Trial of the Efficacy of Epirubicin, Oxaliplatin and Capecitabine (EOX) With or Without Panitumumab in Previously Untreated Advanced Oesophago-gastric Cancer [NCT00824785] | Phase 3 | 574 participants (Actual) | Interventional | 2008-05-31 | Terminated(stopped due to Lack of efficacy) |
Envafolimab Combined With XELOX in Neoadjuvant Therapy for Locally Advanced Colon Cancer,A Prospective, Single Arm, Single Center ǁ Phase Clinical Trial [NCT05335460] | Phase 2 | 36 participants (Anticipated) | Interventional | 2022-05-31 | Not yet recruiting |
Randomized Phase II Study Assessing the Efficacy and Safety of 2 Therapeutic Strategies Combining Bevacizumab With Chemotherapy: De-escalation Versus Escalation in Patients With Non-pretreated Unresectable Metastatic Colorectal Cancer [NCT02842580] | Phase 2 | 20 participants (Actual) | Interventional | 2016-09-30 | Terminated(stopped due to Inclusion rythm too slow.) |
Oxaliplatin Plus Gemcitabine Versus Capecitabine Alone as Adjuvant Treatment in the Prevention of Recurrence of Intrahepatic Cholangiocarcinoma [NCT02548195] | Phase 3 | 286 participants (Anticipated) | Interventional | 2015-07-31 | Recruiting |
A Phase II Study of Endostar (Recombinant Human Endostatin ®) With Cisplatin and Capecitabine (Xeloda) as 1st Line Treatment in the Advanced Gastric Cancer [NCT00842491] | Phase 2 | 45 participants (Actual) | Interventional | 2008-11-30 | Completed |
A Single-Center, Phase II Trial of Sunitinib and Capecitabine in First Line Treatment of Patients With Metastatic Colorectal Cancer [NCT00961571] | Phase 2 | 50 participants (Actual) | Interventional | 2009-08-31 | Terminated(stopped due to Unanticipated side effects and futility) |
A Pharmacokinetic Study of Capecitabine in Patients Undergoing Peri-operative Chemotherapy and a Total Gastrectomy for Adenocarcinoma of the Stomach [NCT00871273] | Phase 4 | 13 participants (Actual) | Interventional | 2009-11-30 | Terminated(stopped due to 1. Slow recruitment; 2. Change to clinical environment reducing the pool of potentially eligible patients; 3. Availability of data from another similar study) |
Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease [NCT05360277] | Phase 2 | 52 participants (Anticipated) | Interventional | 2023-08-22 | Recruiting |
A Phase 1b/2 Dose Escalation and Expansion Study of Tucatinib in Combination With Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers [NCT04430738] | Phase 1/Phase 2 | 120 participants (Anticipated) | Interventional | 2020-09-15 | Recruiting |
A Phase II Study of Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis [NCT04034251] | Phase 2 | 12 participants (Actual) | Interventional | 2020-06-09 | Active, not recruiting |
A Phase III Study of Gemcitabine Plus Capecitabine (GEMCAP) Versus Gemcitabine Alone in Advanced Biliary Cancer [NCT00658593] | Phase 3 | 19 participants (Actual) | Interventional | 2008-10-10 | Terminated(stopped due to due to poor accrual) |
An Open-Label, Multicenter Study of IBI308 in Subjects With Selected Advanced Solid Tumors [NCT02937116] | Phase 1 | 233 participants (Actual) | Interventional | 2016-10-19 | Completed |
A Phase I and Pharmacokinetics Study of Docetaxel in Combination With Capecitabine and Cisplatin in Solid Tumors [NCT00084734] | Phase 1 | 61 participants (Actual) | Interventional | 2002-05-31 | Completed |
A Study to Characterize and Evaluate Biomarkers of Chemotherapy in Patients With Metastatic Colorectal Cancer In The First-line Setting [NCT03532711] | | 264 participants (Actual) | Observational | 2012-01-01 | Completed |
SRT Versus WBRT Combined With Pyrrotinib and Capecitabine in the Treatment of HER2-positive Advanced Breast Cancer Patients With Brain Metastases: A Randomized Controlled, Prospective Clinical Study [NCT05042791] | Phase 2 | 362 participants (Anticipated) | Interventional | 2022-03-01 | Recruiting |
X-TRAP: Phase I/II Study of Capecitabine Plus Aflibercept in Metastatic Colorectal Cancer [NCT01661972] | Phase 1/Phase 2 | 63 participants (Actual) | Interventional | 2012-08-31 | Completed |
A Randomized Phase II Study of S-1 Versus Capecitabine as First-Line Chemotherapy in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer [NCT00580359] | Phase 2 | 96 participants (Anticipated) | Interventional | 2007-05-31 | Recruiting |
Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Herceptin in Patients With Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis [NCT02380131] | Phase 4 | 60 participants (Anticipated) | Interventional | 2013-02-28 | Recruiting |
Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM): An Open Label, Prospective, Single Arm Clinical Trial [NCT05216653] | Phase 2 | 32 participants (Actual) | Interventional | 2022-04-07 | Active, not recruiting |
NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy [NCT03136406] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2017-08-14 | Active, not recruiting |
Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Chemoradiotherapy: A Multi-centre, Adaptive-design, Phase II Prospective Cohort Study [NCT04443543] | Phase 2 | 222 participants (Anticipated) | Interventional | 2020-06-22 | Not yet recruiting |
A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Advanced Breast Cancer [NCT02514681] | Phase 3 | 370 participants (Anticipated) | Interventional | 2015-08-01 | Active, not recruiting |
The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer: An Open-label, Multi-center, Prospective and Randomised Study [NCT02395640] | Phase 3 | 438 participants (Anticipated) | Interventional | 2015-03-31 | Completed |
Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma [NCT05111444] | Phase 2 | 65 participants (Anticipated) | Interventional | 2021-12-31 | Not yet recruiting |
Evaluation of Pathological Response in Patient With Resectable Gastric Cancer and Perioperative Chemotherapy FLOT Versus XELOX; Phase 2 [NCT04937738] | Phase 2 | 284 participants (Anticipated) | Interventional | 2021-07-21 | Active, not recruiting |
A Phase 2, International, Multicenter, Open-labeled, Randomized Trial of PAlbociclib and Fulvestrant vs. Standard Oral Capecitabine In Patients With Hormone Receptor (HR)+ / HER2- Advanced Breast Cancer and Documented Endocrine Resistance [NCT03322215] | Phase 2 | 42 participants (Actual) | Interventional | 2017-10-24 | Active, not recruiting |
Phase II Clinical Study of the Maintenance Therapy of Capecitabine Afer the XELOX in Treatment of Advanced Gastric Cancer [NCT02038621] | Phase 2 | 224 participants (Anticipated) | Interventional | 2014-01-31 | Not yet recruiting |
Phase III Study of Palbociclib in Combination With Exemestane or Fulvestrant vs. Chemotherapy (Capecitabine) in Hormonal Receptor Positive/HER2 Negative Metastatic Breast Cancer Patients With Resistance to Aromatase Inhibitors [NCT02028507] | Phase 3 | 693 participants (Actual) | Interventional | 2014-03-13 | Completed |
Randomized Phase III Trial of 5-FU Based Maintenance Therapy With or Without Panitumumab in Patients With RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX + Panitumumab [NCT03300609] | Phase 3 | 4 participants (Actual) | Interventional | 2018-02-27 | Terminated(stopped due to Insufficient Accrual) |
Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma: A Single-center, Single-arm, Phase Ⅱ Study [NCT05507658] | Phase 2 | 30 participants (Anticipated) | Interventional | 2022-07-18 | Recruiting |
A Multicenter Open-label Randomized Controlled Prospective Phase II Study Evaluating the Efficacy of Selective Internal Radiation Therapy (Yttrium-90 Glass Microspheres) Combined With Capecitabine in the Neoadjuvant Setting of Operable Intrahepatic CHOlan [NCT05265208] | Phase 2 | 62 participants (Anticipated) | Interventional | 2022-02-04 | Suspended(stopped due to 1st level of sequential inclusion reached) |
Randomized Phase 2 Study of Valproic Acid in Combination With Bevacizumab and Oxaliplatin/Fluoropyrimidine Regimens in Patients With Ras-mutated Metastatic Colorectal Cancer [NCT04310176] | Phase 2 | 200 participants (Anticipated) | Interventional | 2019-05-24 | Recruiting |
A Phase Ib/II Clinical Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer [NCT02483247] | Phase 1 | 165 participants (Actual) | Interventional | 2015-09-30 | Completed |
Comparison of Efficacy and Tolerance Between Combination Therapy and Monotherapy as a First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer; Multicenter Randomized Phase 3 Study [NCT02114359] | Phase 3 | 111 participants (Actual) | Interventional | 2014-02-28 | Completed |
NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer: a Randomized Phase II Trial [NCT03280407] | Phase 2 | 124 participants (Anticipated) | Interventional | 2017-03-01 | Recruiting |
Randomized Controlled Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer [NCT02128243] | Phase 2 | 242 participants (Actual) | Interventional | 2014-09-30 | Completed |
A Prospective, Open-lable, Multicenter, Randomized, Controlled Phase II Clinical Trial to Evaluate the Efficacy of Irinotecan Versus Oxaliplatin in the First-line Treatment of Refractory Metastatic Colorectal Cancer [NCT03567629] | Phase 2 | 130 participants (Anticipated) | Interventional | 2018-05-29 | Active, not recruiting |
A Phase III Trial of XELOX (Xeloda/Oxaliplatin) Followed by Xeloda Maintenance Versus Best Supportive Care (BSC) in Metastatic Colorectal Cancer [NCT02060669] | Phase 3 | 10 participants (Actual) | Interventional | 2010-06-20 | Terminated(stopped due to others) |
[NCT02071043] | Phase 2 | 48 participants (Actual) | Interventional | 2008-11-30 | Completed |
TISLELIZUMAB in Combination With Anlotinib and Chemotherapy(XELOX) as First-Line Treatment in Adults With Inoperable, Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma [NCT04963088] | Phase 1/Phase 2 | 66 participants (Anticipated) | Interventional | 2021-03-06 | Recruiting |
A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols [NCT01369433] | | 225 participants (Actual) | Interventional | 2010-06-30 | Terminated(stopped due to Lack of new studies contributing subjects to this study) |
Phase II Study of First-line Capecitabine Plus Oxaliplatin Plus Aflibercept for 6 Cycles Followed by Capecitabine Plus Aflibercept as Maintenance Therapy in Patients With Metastatic Colorectal Cancer: DROP and GO Trial [NCT02085005] | Phase 2 | 0 participants (Actual) | Interventional | 2014-03-31 | Withdrawn |
Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1) [NCT03199989] | Phase 3 | 1,254 participants (Anticipated) | Interventional | 2017-06-01 | Recruiting |
QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy [NCT03197571] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
Trastuzumab Plus XELOX for HER2-positive Stage III Gastric Cancer After D2 Gastrectomy:Prospective Observational Study. [NCT02250209] | Phase 2 | 40 participants (Anticipated) | Interventional | 2014-07-31 | Recruiting |
A Phase II Trial of AK104 Combined With Neoadjuvant Chemoradiotherapy in Proficient Mismatch Repair/Microsatellite Stable Locally Advanced Rectal Cancer [NCT05980689] | Phase 2 | 33 participants (Anticipated) | Interventional | 2023-10-24 | Recruiting |
Total Neoadjuvant trEatment to Increase the Clinical Complete reSponse Rate for diStal Locally Advanced Rectal Cancer (TESS) [NCT03840239] | Phase 2 | 98 participants (Anticipated) | Interventional | 2018-12-25 | Active, not recruiting |
Optimisation of Response for Organ Preservation in Rectal Cancer : Neoadjuvant Chemotherapy and Radiochemotherapy vs. Radiochemotherapy [NCT02514278] | Phase 3 | 218 participants (Actual) | Interventional | 2016-01-28 | Active, not recruiting |
A Phase I Clinical Trial of Capecitabine and SIR-Spheres® Y-90-Radioembolization in Patients With Advanced Intrahepatic Cholangiocarcinoma [NCT03117855] | Phase 1 | 0 participants (Actual) | Interventional | 2016-12-31 | Withdrawn(stopped due to Company no longer interested in supporting this trial) |
A Randomized, Multicenter, Controlled Study of XELOX (Oxaliplatin With Capecitabine) Combined With Apatinib Versus XELOX as Post-operative Chemotherapy in Locally Advanced Gastric Signet Ring Carcinoma With D2 Dissection. [NCT03355612] | Phase 3 | 456 participants (Anticipated) | Interventional | 2017-12-20 | Not yet recruiting |
Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (OLAparib) Followed by Adjuvant Combination of DuRvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With BreAst Cancer [NCT04711824] | Phase 1/Phase 2 | 41 participants (Anticipated) | Interventional | 2022-03-09 | Recruiting |
Concurrent Xeloda and Radiotherapy for Bone Metastases [NCT00192777] | Phase 2 | 20 participants (Anticipated) | Interventional | 2004-11-30 | Recruiting |
Phase I/II Study With Galunisertib Combined With Capecitabine in Patients With Advanced Chemotherapy Resistant Colorectal Cancer With Peritoneal Metastases [NCT05700656] | Phase 1/Phase 2 | 31 participants (Anticipated) | Interventional | 2023-04-30 | Not yet recruiting |
Precision Treatment of Luminal Advanced Breast Cancer Based on Molecular Subtyping [NCT04355858] | Phase 2 | 319 participants (Anticipated) | Interventional | 2020-05-01 | Recruiting |
A Single-center Prospective Single-arm Study of the Efficacy of Carrelizumab (PD-1) Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer and Its Effect on Tumor Immune Microenvironment [NCT05545436] | Phase 2 | 34 participants (Anticipated) | Interventional | 2022-09-20 | Recruiting |
CAPEcitabine eXtension of Adjuvant Therapy for Pancreatic Adenocarcinoma: (CAPE-X) [NCT06110598] | Phase 2 | 86 participants (Anticipated) | Interventional | 2024-01-31 | Not yet recruiting |
A Phase lb/ll, Open Label, Single Arm Study to Assess Efficacy and Safety of Alpelisib and Capecitabine in Patients With PIK3CA Mutant Metastatic Colorectal Cancer Who Failed Two Prior Standard Chemotherapies [NCT04753203] | Phase 1/Phase 2 | 65 participants (Anticipated) | Interventional | 2021-02-28 | Active, not recruiting |
A Phase lb/ll, Multicenter, Open Label, Single Arm Study to Assess the Safety and Efficacy of the Anti-VEGFR2 Monoclonal Antibody Olinvacimab and the Capecitabine in Patients With mCRC Who Failed Two Prior Chemotherapies [NCT04751955] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2022-01-01 | Withdrawn(stopped due to This clinical trial was not finally approved by the Korea FDA.) |
a Phase II, Open-label, Single Arm Study of Sintilimab (an Anti-PD-1 Inhibitor) Combined With Apatinib and Capecitabine in Advanced Hepatocellular Carcinoma [NCT04411706] | Phase 2 | 46 participants (Anticipated) | Interventional | 2020-06-21 | Recruiting |
Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer [NCT04304209] | Phase 2 | 195 participants (Anticipated) | Interventional | 2019-10-28 | Active, not recruiting |
A Multicenter Randomized Phase Ⅲ Clinical Trial of Gemcitabine in Combination With Capecitabine Versus Gemcitabine Plus Carboplatin as First-line Treatment in Triple-negative Recurrent or Metastatic Breast Cancer [NCT02207335] | Phase 3 | 120 participants (Anticipated) | Interventional | 2013-12-31 | Recruiting |
A Phase II/III, Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Bevacizumab and/or Chemotherapy Versus Sintilimab in Combination With Bevacizumab as First-line Treatment in Patients With Advance [NCT05976568] | Phase 2/Phase 3 | 668 participants (Anticipated) | Interventional | 2023-09-01 | Not yet recruiting |
An Open-label Study of Xeloda Plus Taxotere on Treatment Response in Patients With HER2-neu-negative, and the Addition of Herceptin for HER2-neu-positive Breast Cancer [NCT00127933] | Phase 4 | 157 participants (Actual) | Interventional | 2005-08-31 | Completed |
Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT) [NCT05693766] | Phase 2 | 64 participants (Anticipated) | Interventional | 2023-09-11 | Recruiting |
A Phase I Trial of Capecitabine in Combination With Cemiplimab in Patients With Hormone Receptor Positive Metastatic Breast Cancer [NCT05064085] | Phase 1 | 13 participants (Actual) | Interventional | 2021-10-12 | Active, not recruiting |
A Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of AK104 Plus Oxaliplatin and Capecitabine (XELOX) Versus Placebo Plus XELOX as First-line Treatment for Locally Advanced Unresectable or G/GEJ Adenocarcinoma [NCT05008783] | Phase 3 | 588 participants (Anticipated) | Interventional | 2021-09-17 | Recruiting |
A Double-Blind, Randomized Phase 2b Study of Sorafenib Compared to Placebo When Administered in Combination With Chemotherapy for Patients With Locally Advanced or MBC That Has Progressed During or After Bevacizumab Therapy [NCT00493636] | Phase 2 | 160 participants (Actual) | Interventional | 2007-06-30 | Completed |
An Open-Label Phase II Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling [NCT04965064] | Phase 2 | 22 participants (Anticipated) | Interventional | 2022-09-23 | Recruiting |
A Phase II Trial of Postoperative Chemotherapy and Chemo-radiotherapy for Resected Adenocarcinoma of the Stomach and Gastro-esophageal Junction [NCT00718913] | Phase 2 | 40 participants (Actual) | Interventional | 2008-04-30 | Completed |
Efficacy and Safety of Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin in pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: An Open, Multi-center, Prospective, Single-arm Phase II Clinical Study [NCT06056804] | Phase 2 | 20 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
Systemic Therapy Combined With Thoracic Concurrent Chemoradiotherapy Versus Systemic Therapy Alone in Stage IVB Esophageal Squamous Cell Carcinoma: A Prospective Randomized Phase II Study [NCT05512520] | Phase 2 | 126 participants (Anticipated) | Interventional | 2022-09-20 | Recruiting |
A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA) [NCT05152147] | Phase 3 | 714 participants (Anticipated) | Interventional | 2021-12-02 | Recruiting |
A Phase III Study of Consolidative Radiotherapy in Patients With Oligometastatic HER2 Negative Esophageal and Gastric Adenocarcinoma (EGA) [NCT04248452] | Phase 3 | 314 participants (Anticipated) | Interventional | 2020-05-26 | Recruiting |
A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors [NCT01824875] | Phase 2 | 144 participants (Actual) | Interventional | 2013-08-08 | Active, not recruiting |
An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer, Dukes Stage C. [NCT00502671] | Phase 4 | 228 participants (Actual) | Interventional | 2007-07-31 | Completed |
Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer [NCT01080547] | Phase 3 | 374 participants (Actual) | Interventional | 2010-03-31 | Completed |
A Pilot Safety And Feasibility Study Of Concurrent Capecitabine (Xeloda) And External Beam Irradiation In The Adjuvant Treatment Of High Risk Early Stage Breast Cancer. [NCT00562718] | Phase 2 | 50 participants (Actual) | Interventional | 2004-09-30 | Completed |
An Open-label, Phase II Study of Capecitabine Plus Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer [NCT02565641] | Phase 2 | 63 participants (Actual) | Interventional | 2003-03-31 | Completed |
A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer [NCT01024504] | Phase 2 | 46 participants (Anticipated) | Interventional | 2006-03-31 | Completed |
Phase I/II of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer [NCT00438256] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2007-12-31 | Completed |
Open Label, Phase II Study of Capecitabine (Xeloda®) as Fluoropyrimidine of Choice in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer Suitable for Treatment With a Fluoropyrimidine-Based Regimen [NCT00454636] | Phase 2 | 158 participants (Actual) | Interventional | 2007-03-31 | Completed |
A Phase 1 Study Of Sunitinib Malate In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer [NCT00555620] | Phase 1 | 76 participants (Actual) | Interventional | 2008-05-31 | Completed |
A Single Arm, Open-label Study to Evaluate the Efficacy on Tumor Response and the Safety of Bevacizumab and Trastuzumab Combination and Sequential Capecitabine in Patients With HER2 +Ive Locally Recurrent or Metastatic Breast Cancer After Early Relapse to [NCT00964704] | Phase 2 | 0 participants (Actual) | Interventional | 2011-03-31 | Withdrawn(stopped due to No patients have been recruited therefore study has been cancelled) |
Randomized Phase II-III Trial of Post-operative Treatment of Pancreatic Adenocarcinoma: Gemcitabine Versus PEFG Followed by Radiochemotherapy With Concomitant Continuous Infusion of 5-fluorouracil [NCT00960284] | Phase 2/Phase 3 | 102 participants (Actual) | Interventional | 2003-06-30 | Completed |
A Phase II Study of Lapatinib and Capecitabine in the Treatment of Metastatic Pancreatic Cancer. [NCT00962312] | Phase 2 | 9 participants (Actual) | Interventional | 2009-01-31 | Completed |
Phase I Trial of Chemoradiation With Capecitabine and Vorinostat in Pancreatic Cancer. [NCT00983268] | Phase 1 | 21 participants (Actual) | Interventional | 2009-10-31 | Completed |
A Phase II Randomized Study of the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Physician Choice Chemotherapy in Premenopausal or Perimenopausal Patients With Hormone Receptor-positive/ HER2-negative Inoperable Locally Adv [NCT03839823] | Phase 2 | 223 participants (Actual) | Interventional | 2019-02-25 | Completed |
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer S [NCT03523585] | Phase 3 | 608 participants (Actual) | Interventional | 2018-08-01 | Active, not recruiting |
A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas [NCT00685763] | | 13 participants (Actual) | Interventional | 2008-03-31 | Completed |
A Phase IIa Trial of Sorafenib With Capecitabine and Oxaliplatin in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma [NCT00752063] | Phase 2 | 52 participants (Anticipated) | Interventional | 2007-09-30 | Recruiting |
Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma [NCT00483405] | Phase 2 | 33 participants (Actual) | Interventional | 2006-10-31 | Completed |
Phase II Safety and Efficacy Study of Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Metastatic or Unresectable Sarcomatoid Renal Cell Carcinoma [NCT00496587] | Phase 2 | 34 participants (Actual) | Interventional | 2007-07-31 | Completed |
A Phase II Study for Short Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine in Patients With Resectable Rectal Carcinoma [NCT00973778] | Phase 2 | 62 participants (Anticipated) | Interventional | 2009-07-31 | Recruiting |
An Open-Label Phase 1b Study of the Safety and Tolerability of Veliparib in Combination With Capecitabine and Radiation in Subjects With Locally Advanced Rectal Cancer (LARC) [NCT01589419] | Phase 1 | 32 participants (Actual) | Interventional | 2012-06-30 | Completed |
A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda® in Combination With Taxotere® on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer [NCT00077857] | Phase 2 | 470 participants (Actual) | Interventional | 2003-07-31 | Completed |
Phase 2 Study of Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer [NCT00976976] | Phase 2 | 46 participants (Actual) | Interventional | 2007-05-31 | Completed |
"An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) (XELOX) Versus Fluorouracil/Leucovorin as Adjuvant Therapy for Patients Who Have Undergone Surgery for Colon Carcinoma, AJCC/UICC [NCT00069121] | Phase 3 | 1,886 participants (Actual) | Interventional | 2003-04-18 | Completed |
A Phase II Study of Capecitabine, Oxaliplatin and Bevacizumab for Metastatic or Unresectable Neuroendocrine Tumors [NCT00398320] | Phase 2 | 40 participants (Actual) | Interventional | 2006-11-30 | Completed |
Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer [NCT00050167] | Phase 1 | 603 participants (Actual) | Interventional | 2002-11-30 | Completed |
A Phase I Dose Finding Study of RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer [NCT01049620] | Phase 1 | 40 participants (Actual) | Interventional | 2010-02-28 | Completed |
Phase II Clinical Trial of Capecitabine and Oxaliplatin Plus Bevacizumab as Neoadjuvant Treatment for Patients With Previously Untreated Unresectable Liver-only Metastases From Colorectal Cancer [NCT01022541] | Phase 2 | 47 participants (Actual) | Interventional | 2006-06-30 | Completed |
A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease [NCT00382720] | Phase 2 | 275 participants (Actual) | Interventional | 2006-09-30 | Completed |
Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Advanced Breast Cancer [NCT00452673] | Phase 1 | 52 participants (Actual) | Interventional | 2007-06-30 | Completed |
Neoadjuvant Radiotherapy and Capecitabine With or Without Panitumumab in Patients With Advanced, K-ras Unmutated Rectal Cancer. A Randomized Multicenter Phase II Trial [NCT00814619] | Phase 2 | 68 participants (Actual) | Interventional | 2008-11-30 | Completed |
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy or HLX0 [NCT05246982] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-03-23 | Recruiting |
Study EGF107671 - a Phase II Study of Lapatinib Plus Topotecan or Lapatinib Plus Capecitabine in the Treatment of Recurrent Brain Metastases From ErbB2-Positive Breast Cancer Following Cranial Radiotherapy [NCT00437073] | Phase 2 | 22 participants (Actual) | Interventional | 2007-05-31 | Terminated(stopped due to Lapatinib-topotecan arm enrollment closed early per protocol amendment 2. Then enrollment into remaining arm terminated due to operational issues.) |
A Multi-Center Randomized Phase II Study of Induction Chemotherapy Followed by Gemcitabine or Capecitabine Based Chemoradiotherapy for Locally Advanced Non-Metastatic Pancreatic Cancer [NCT01032057] | Phase 2 | 114 participants (Actual) | Interventional | 2009-07-31 | Completed |
A Phase II Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas [NCT01118377] | Phase 2 | 45 participants (Actual) | Interventional | 2007-05-31 | Completed |
A Phase 1 Dose-Finding Study Of The Anti-Angiogenesis Agent, AG-013736, In Combinations Of Paclitaxel/Carboplatin, Weekly Paclitaxel, Docetaxel, Capecitabine, Gemcitabine/Cisplatin and Pemetrexed/Cisplatin In Patients With Advanced Solid Tumors [NCT00454649] | Phase 1 | 102 participants (Actual) | Interventional | 2005-12-31 | Completed |
A Pilot Trial of Sequential Primary (Neoadjuvant) Combination Chemotherapy With Docetaxel/Capecitabine (TX) and Doxorubicin/Cyclophosphamide (AC) in Primary Breast Cancer With Evaluation of Chemotherapy Effects on Gene Expression [NCT00005908] | Phase 2 | 30 participants (Actual) | Interventional | 2000-06-30 | Completed |
A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 - Claudin18.2 Monoclonal Antibody in the Treatment of Locally Advanced or Metastatic Solid Tumors [NCT04495296] | Phase 1/Phase 2 | 320 participants (Anticipated) | Interventional | 2020-08-13 | Recruiting |
An Efficacy and Safety Study of mXELIRI Versus. FOLFIRI + Bevacizumab Therapy as First-line Chemotherapy in Metastatic Colorectal Cancer [NCT04247984] | Phase 2 | 264 participants (Actual) | Interventional | 2018-05-01 | Completed |
A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Gemcitabine (GEM) and Capecitabine (CAP) With or Without T-ChOS as Adjuvant Therapy in Patients With Surgically Resected Pancreatic Cancer. [NCT02767752] | Phase 2 | 21 participants (Actual) | Interventional | 2016-11-30 | Terminated(stopped due to Poor accrual and change of SOC (FOLFIRINOX in adjuvant setting)) |
A Phase 2,Randomized, Evaluate Efficacy and Safety of Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer [NCT04246502] | Phase 2 | 200 participants (Anticipated) | Interventional | 2020-01-31 | Not yet recruiting |
A Double-Blind, Randomized, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-Line Therapy in Patients With Advanced Gastric Cancer. [NCT00887822] | Phase 3 | 202 participants (Actual) | Interventional | 2009-03-31 | Completed |
Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer [NCT00604409] | Phase 1 | 34 participants (Actual) | Interventional | 2006-04-30 | Completed |
A Multicenter Prospective Phase III Clinical Trial of Neoadjuvant CapOx Chemotherapy in Patients With Intermediate Risk Middle and Upper Rectal Cancer [NCT04103697] | Phase 3 | 560 participants (Anticipated) | Interventional | 2019-08-01 | Enrolling by invitation |
SCOPE2 - A Randomised Phase II/III Trial to Study Radiotherapy Dose Escalation in Patients With Oesophageal Cancer Treated With Definitive Chemo-radiation With an Embedded Phase II Trial for Patients With a Poor Early Response Using Positron Emission Tomo [NCT02741856] | Phase 2/Phase 3 | 584 participants (Anticipated) | Interventional | 2016-11-04 | Recruiting |
An Exploratory Study of Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction [NCT04263870] | Phase 2 | 36 participants (Anticipated) | Interventional | 2020-03-31 | Not yet recruiting |
Feasibility of Switching Fluoropyrimidine Due to Cardiotoxicity in Patients With Solid Tumors: A Retrospective, International and Non-interventional Study [NCT04260269] | | 200 participants (Anticipated) | Observational | 2018-06-01 | Enrolling by invitation |
An Open Label Study to Evaluate the Safety and Effect on Disease Progression of Triple Combination Treatment With Erlotinib (Tarceva), Bevacizumab (Avastin), and Capecitabine (Xeloda) in Patients With Locally Advanced and/or Metastatic Pancreatic Cancer ( [NCT00925769] | Phase 1 | 32 participants (Actual) | Interventional | 2009-01-31 | Completed |
[NCT02798510] | Phase 3 | 140 participants (Anticipated) | Interventional | 2016-04-30 | Recruiting |
Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy [NCT04258163] | | 760 participants (Actual) | Observational | 2019-01-01 | Completed |
Adjuvant Gemcitabine and Capecitabine Chemotherapy in Resected Pancreatic Cancer Following Neoadjuvant Chemotherapy [NCT05415917] | Phase 2 | 75 participants (Anticipated) | Interventional | 2022-07-29 | Recruiting |
BALLAD BELGIUM: A Trial to Evaluate the Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma [NCT04257461] | Phase 3 | 30 participants (Anticipated) | Interventional | 2020-02-20 | Recruiting |
Single Arm, Open, Multicenter Phase II Clinical Study of Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC [NCT04220528] | Phase 2 | 129 participants (Anticipated) | Interventional | 2019-12-01 | Recruiting |
A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - [NCT03355157] | Phase 4 | 150 participants (Anticipated) | Interventional | 2018-03-01 | Recruiting |
Randomised Phase II Trial of Sorafenib, Capecitabine and Oxaliplatin (SECOX) Versus Single Agent Sorafenib in Patients With Advanced Hepatocellular Carcinoma [NCT02716766] | Phase 2 | 46 participants (Actual) | Interventional | 2016-03-31 | Completed |
A Randomized, Double-blind, Multi-center Phase Ⅲ Clinical Study to Evaluate the Recombinant Anti-HER2 Humanized Monoclonal Antibody or Placebo in Combination With Capecitabine for the Treatment of HER-2-positive Advanced Breast Cancer [NCT04164615] | Phase 3 | 336 participants (Anticipated) | Interventional | 2016-11-24 | Recruiting |
Metronomic Capecitabine With or Without Tislelizuamb (PD-1 Antibody) as Adjuvant Therapy in High-risk Non-metastatic Nasopharyngeal Carcinoma: a Multicentre, Open-label, Randomised Phase 3 Trial [NCT05342792] | Phase 3 | 556 participants (Anticipated) | Interventional | 2022-04-17 | Recruiting |
A Multicenter, Open-label, Phase I Dose-escalation and Dose-expansion Study of Mitoxantrone Hydrochloride Liposome Injection Combination Therapy in Chinese Patients With Advanced Solid Tumors [NCT05344742] | Phase 1 | 116 participants (Anticipated) | Interventional | 2022-04-30 | Not yet recruiting |
A Multicenter, Open-label, Phase Ib/II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Advanced Solid Tumors or AK104 in Combination With Oxaliplatin and Capecitabine As First-line Therapy in Subjects With Advanced Unresectable or Meta [NCT03852251] | Phase 1/Phase 2 | 338 participants (Actual) | Interventional | 2019-01-18 | Active, not recruiting |
A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma. [NCT00639522] | Phase 1 | 18 participants (Anticipated) | Interventional | 2008-05-31 | Recruiting |
Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced [NCT04188158] | Phase 2 | 238 participants (Anticipated) | Interventional | 2017-03-10 | Recruiting |
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Colorectal Cancer During Radical Colorectal Resection [NCT02830139] | Phase 2 | 100 participants (Actual) | Interventional | 2016-07-31 | Completed |
Phase I Study of Intermittent High-Dose Lapatinib in Tandem With Capecitabine for HER2 Overexpressed/Amplified Metastatic Breast Cancer With Central Nervous System (CNS) Metastases [NCT02650752] | Phase 1 | 11 participants (Actual) | Interventional | 2016-01-06 | Completed |
A Single-arm, Open-label, Multicenter Phase II Clinical Study of Fruquintinib Combined With Sintilimab and XELOX in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma [NCT06094868] | Phase 2 | 45 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
Atorvastatin in Triple-Negative Breast Cancer (TNBC) Patients Who Did Not Achieve a Pathologic Complete Response (pCR) After Receiving Neoadjuvant Chemotherapy, a Multicenter Pilot Study [NCT03872388] | Phase 2 | 6 participants (Actual) | Interventional | 2019-01-14 | Completed |
GUided Treatment Based on Mini-PDX in metastaTIc refractOry Triple Negative Breast Cancer(GUMPTION):a Prospective Randomized Controlled Single Center Clinical Trial [NCT04745975] | Phase 2 | 100 participants (Anticipated) | Interventional | 2021-02-01 | Recruiting |
A Phase I, Open-label, Non-randomized Study, to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With Cisplatin Plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese Patients With Previously Untreated Locally Advanced or Metast [NCT00960349] | Phase 1 | 14 participants (Actual) | Interventional | 2009-08-31 | Completed |
Accelerated Growth of Synchronous Colorectal Liver Metastases: Effects of Neo-adjuvant Therapy [NCT00659022] | Phase 2 | 60 participants (Anticipated) | Interventional | 2008-07-31 | Recruiting |
Phase I Study Of Oxaliplatin, Gemcitabine And Capecitabine In Advanced Gastrointestinal Malignancies And Other Solid Tumors [NCT00660426] | Phase 1 | 30 participants (Actual) | Interventional | 2005-03-31 | Completed |
Randomized Three Arm Phase III Trial on Induction Treatment With a Fluoropyrimidine-, Oxaliplatin- and Bevacizumab-based Chemotherapy for 24 Weeks Followed by Maintenance Treatment With a Fluoropyrimidine and Bevacizumab vs. Bevacizumab Alone vs. no Maint [NCT00973609] | Phase 3 | 853 participants (Actual) | Interventional | 2009-08-31 | Completed |
Phase Ib/II Study of Regorafenib and XELOX Combination as 2nd Line Treatment in Metastatic Colorectal Cancer Patients [NCT04008511] | Phase 1/Phase 2 | 54 participants (Anticipated) | Interventional | 2019-07-31 | Not yet recruiting |
A Neo-Adjuvant Study of Sequential Epirubicin and Docetaxel in Combination With Capecitabine in Patients With Locally Advanced Breast Cancer [NCT00645866] | Phase 2 | 47 participants (Anticipated) | Interventional | 2003-04-30 | Completed |
Single-arm, Prospective, Open-label, Exploratory Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer Patients After at Least Second-line Standard Treatment [NCT04227041] | Phase 1/Phase 2 | 34 participants (Anticipated) | Interventional | 2020-01-10 | Not yet recruiting |
Study on Skin Microbiota of Hand Foot Syndrome [NCT04132713] | | 50 participants (Anticipated) | Observational | 2019-09-10 | Recruiting |
CA225103: A Phase II Study of a Combination of Cetuximab and Capecitabine in Patients With Metastatic Colorectal Cancer After Progression on Previous Fluoropyrimidine Containing Therapy [NCT00538291] | Phase 2 | 13 participants (Actual) | Interventional | 2005-08-31 | Terminated(stopped due to Study was terminated early due to lack of efficacy.) |
Randomized Phase II/III Study of Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic Estrogen Receptor Positive Breast Cancer [NCT00684216] | Phase 2/Phase 3 | 10 participants (Actual) | Interventional | 2008-04-30 | Terminated(stopped due to acrual too slow) |
Randomized, Phase III-b, Multi-centre, Open-label, Parallel Study of Enoxaparin (Low Molecular Weight Heparin) Given Concomitantly With Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Gastric and Gastro-oesophageal Cancer [NCT00718354] | Phase 3 | 740 participants (Actual) | Interventional | 2008-07-31 | Completed |
A Phase I/II Study of Lapatinib in Combination With Oxaliplatin and Capecitabine in Subjects With Advanced or Metastatic Colorectal Cancer [NCT00536809] | Phase 1 | 12 participants (Actual) | Interventional | 2007-09-26 | Completed |
A Pharmacokinetic Study of Adjuvant Capecitabine in Patients Who Have Undergone Proximal Pancreatico-duodenectomy for Resection of Pancreatic Adenocarcinoma [NCT00854477] | Phase 4 | 13 participants (Actual) | Interventional | 2009-11-30 | Completed |
An Open Non-randomized Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Tarceva in Combination With Capecitabine in Patients With Advanced Pancreatic Cancer [NCT00873353] | Phase 2 | 32 participants (Actual) | Interventional | 2008-03-31 | Completed |
Phase II Study of Irinotecan, Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients [NCT00875771] | Phase 2 | 80 participants (Actual) | Interventional | 2009-04-30 | Completed |
A Phase II Study of Capecitabine Plus Concomitant Radiotion Therapy Followed by Durvalumab (MEDI4736) as Preoperative Treatment in Rectal Cancer. [NCT04083365] | Phase 2 | 100 participants (Anticipated) | Interventional | 2020-01-01 | Recruiting |
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy [NCT05633654] | Phase 3 | 1,514 participants (Anticipated) | Interventional | 2022-12-12 | Recruiting |
A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors [NCT05007106] | Phase 2 | 610 participants (Anticipated) | Interventional | 2021-09-16 | Recruiting |
A Phase II, Single-Arm Study to Explore the Efficacy and Safety of Atezolizumab Plus Tiragolumab and Chemotherapy in 1st Line HER2 Negative Unresectable, Recurrent or Metastatic Gastric Cancer or Adenocarcinoma of Gastroesophageal Junction (GEJ) [NCT04933227] | Phase 2 | 29 participants (Actual) | Interventional | 2021-08-06 | Active, not recruiting |
A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adeno [NCT04882241] | Phase 3 | 120 participants (Anticipated) | Interventional | 2020-07-29 | Active, not recruiting |
Regorafenib in Combination With Metronomic Cyclophosphamide, Capecitabine, and Low-dose Aspirin in Metastatic Colorectal Cancer Carcinoma An Open-label Phase II [NCT04534218] | Phase 2 | 49 participants (Actual) | Interventional | 2020-10-16 | Completed |
A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With R [NCT04428151] | Phase 2 | 400 participants (Anticipated) | Interventional | 2020-08-06 | Recruiting |
An Umbrella Trial Based on Molecular Pathway for Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer (FUTURE SUPER) [NCT04395989] | Phase 2 | 139 participants (Actual) | Interventional | 2020-07-28 | Active, not recruiting |
A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresect [NCT03653507] | Phase 3 | 507 participants (Actual) | Interventional | 2018-11-28 | Active, not recruiting |
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Treatment Combinations In Patients With Metastatic Breast Cancer (Morpheus-panBC) [NCT03424005] | Phase 1/Phase 2 | 242 participants (Anticipated) | Interventional | 2018-04-02 | Recruiting |
Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels [NCT03117972] | Phase 2 | 177 participants (Anticipated) | Interventional | 2017-08-04 | Active, not recruiting |
A Phase II, Two-arm, Non-comparative, Multicentre Study of Tucatinib (ONT-380), Pembrolizumab and Trastuzumab in Patients With Pre-treated Advanced HER2-positive Breast Cancer [NCT04789096] | Phase 2 | 50 participants (Anticipated) | Interventional | 2023-03-07 | Recruiting |
A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy [NCT06081959] | Phase 3 | 376 participants (Anticipated) | Interventional | 2023-11-30 | Not yet recruiting |
A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participa [NCT04379596] | Phase 2 | 357 participants (Anticipated) | Interventional | 2020-06-03 | Recruiting |
A Phase Ib, Dose Escalation Study of Lithium When Added to Standard Chemotherapy of Oxaliplatin and Capecitabine in Patients With Advanced Oesophago-Gastric or Colorectal Cancer [NCT03153280] | Phase 1 | 2 participants (Actual) | Interventional | 2022-01-13 | Active, not recruiting |
A Phase III Study Evaluating Two Neoadjuvant Treatments Radiochemotherapy (5 Weeks - 50Gy+Capecitabine) and Radiotherapy (1week - 25Gy) in Patient Over 75 With Locally Advanced Rectal Carcinoma [NCT02551237] | Phase 3 | 103 participants (Actual) | Interventional | 2016-01-07 | Completed |
A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adeno [NCT03221426] | Phase 3 | 1,007 participants (Actual) | Interventional | 2017-10-09 | Active, not recruiting |
A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma [NCT00523640] | Phase 2 | 30 participants (Actual) | Interventional | 2005-03-31 | Terminated(stopped due to Too slow accrual) |
NANT Colorectal Cancer (CRC) Vaccine: A Phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects With Metastatic CRC Who Have Been Previously Treated With Standard-of-Care Therapy [NCT03563157] | Phase 1/Phase 2 | 332 participants (Anticipated) | Interventional | 2018-05-25 | Active, not recruiting |
A Phase I/II Study of Induction Conatumumab and Gemcitabine, Followed by Conatumumab, Capecitabine and 3-D Conformal Radiation Therapy (3D-CRT) With Subsequent Maintenance Therapy for Locally Advanced Pancreatic Cancer [NCT01017822] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to This study was withdrawn due to study agent availability.) |
An Open-Label Multicenter Study Administering Lapatinib and Capecitabine (Xeloda) in Women With Advanced or Metastatic Breast Cancer [NCT00508274] | Phase 3 | 52 participants (Actual) | Interventional | 2007-07-18 | Terminated(stopped due to Primary analysis was completed in 2015 and data collection post 1-Jul-2019 was not reportable due to local regulations in China.) |
Multicentric Pilot Study of Dihydropyrimidine Dehydrogenase (DPD) Deficiency for Predicting Capecitabine Toxicity in Breast Cancer Patients [NCT00953537] | | 303 participants (Actual) | Interventional | 2009-01-31 | Completed |
Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline [NCT00373113] | Phase 3 | 482 participants (Actual) | Interventional | 2006-11-30 | Terminated(stopped due to See termination reason in detailed description.) |
A Phase II Study to Evaluate the Efficacy and Safety of Neoadjuvant Radiation in Combination With Capecitabine & Paniumumab With and Without Irinotecan in Patients With Localized Rectal Cancer [NCT00967655] | Phase 2 | 54 participants (Anticipated) | Interventional | 2009-07-31 | Recruiting |
A Multicenter Phase II Clinical Trial Assessing the Efficacy of the Combination of Lapatinib and Capecitabine in Patients With Non Pretreated Brain Metastasis From HER2 Positive Breast Cancer [NCT00967031] | Phase 2 | 45 participants (Actual) | Interventional | 2009-04-30 | Completed |
EXCITE: Erbitux, Xeloda, Campto, Irradiation Then Excision for Locally Advanced Rectal Cancer (North West Clinical Oncology Group-04 on Behalf of the NCRI Rectal Cancer Subgroup) [NCT00972881] | Phase 1/Phase 2 | 82 participants (Actual) | Interventional | 2009-04-30 | Completed |
A Randomized Phase 2 Study of ARQ 197 Versus Investigator's Choice of Second-Line Chemotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer Who Have Progressive Neoplastic Disease Following Treatment With One Prior Chemotherapy Regimen [NCT01070290] | Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn |
A Phase II Study of Cetuximab Plus Biweekly Capecitabine and Oxaliplatin (C-CO2) in the Treatment of Patients With KRAS Wild Type Metastatic Colorectal Cancer [NCT00444678] | Phase 2 | 36 participants (Actual) | Interventional | 2004-06-01 | Completed |
Prospective, Randomized, Controlled, Multicenter, Phase III Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ,III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction [NCT03986385] | Phase 3 | 180 participants (Anticipated) | Interventional | 2019-06-01 | Recruiting |
A Randomized, Multi-Center Phase III Trial Of Irinotecan In Combination With Three Different Methods Of Administration Of Fluoropyrimidine: Infusional 5-FU (FOLFIRI), Modified-Bolus 5-FU (Day 1 & 8), And Oral Capecitabine (Day 1-14); With Celecoxib Versus [NCT00101686] | Phase 3 | 547 participants (Actual) | Interventional | 2003-02-28 | Completed |
UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2 Neuroendocrine Tumors [NCT04339036] | Phase 2 | 50 participants (Anticipated) | Interventional | 2021-10-07 | Recruiting |
Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma (ACTICCA-1 Trial) [NCT02170090] | Phase 3 | 789 participants (Actual) | Interventional | 2014-04-30 | Active, not recruiting |
A Phase I/II Clinical Trial of Combination of Irinotecan, Xeloda and Oxaliplatin (IXO) Regimen With Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer [NCT00819754] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2003-11-30 | Terminated |
A Prospective, Open, Comparative Multicentre Phase II Study for the Evaluation of Irinotecan and Capecitabine Versus Cisplatin and Capecitabine in Advanced Gastric Adenocarcinoma or Gastric-Oesophagal Junction [NCT00675194] | Phase 2 | 120 participants (Anticipated) | Interventional | 2003-10-31 | Completed |
Phase II Study for Inoperable Non-Metastatic Pancreatic Cancer (Stage IVA) With Neoadjuvant Gemzar, Taxotere and Xeloda (GTX), and Radiation With Gemzar [NCT00869258] | Phase 2 | 32 participants (Actual) | Interventional | 2005-06-30 | Completed |
An Open-Label Randomized International Multi-Center Phase III Study of Capecitabine (Xeloda) in Combination With Cisplatin Versus FU/Cisplatin in Patients With Advanced and/or Metastatic Gastric Cancer [NCT02563054] | Phase 3 | 316 participants (Actual) | Interventional | 2003-04-30 | Completed |
A Phase I Study of Capecitabine In Patients With Solid Tumors [NCT00697502] | Phase 1 | 23 participants (Actual) | Interventional | 2007-05-31 | Completed |
A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer [NCT02688023] | Phase 2 | 50 participants (Anticipated) | Interventional | 2014-03-31 | Recruiting |
A Randomised, Open-label Phase III Study to Assess Efficacy and Safety of Bevacizumab in Combination With Capecitabine as First-line Treatment for Elderly Patients With Metastatic Colorectal Cancer [NCT00484939] | Phase 3 | 280 participants (Actual) | Interventional | 2007-07-31 | Completed |
A Phase II Study of Adjuvant Gemcitabine/Capecitabine and Bevacizumab for Patients Treated Neoadjuvantly Chemotherapy for Early Stage Breast Cancer With High Risk for Relapse [NCT00462865] | Phase 2 | 18 participants (Actual) | Interventional | 2007-11-30 | Terminated(stopped due to DSMB determined toxicity of regimen more than originally thought. Slow accrual.) |
A Perspective Study of the Predictive Value of microRNA in Patients With HER2 Positive Advanced Stage Breast Cancer Who Were Treated With Herceptin [NCT02656589] | | 300 participants (Anticipated) | Observational | 2015-06-30 | Recruiting |
A Phase Ⅱ Trial Program Exploring The Integration Of Novel HER2-targeted Tyrosine Kinase Inhibitor Pyrotinib and CDK4/6 Inhibitor SHR6390 Into Current Chemotherapy/Endocrine Therapy Regimes For Prior Trastuzumab-treated Advanced HER2-positive Breast Cance [NCT04095390] | Phase 2 | 60 participants (Anticipated) | Interventional | 2019-09-30 | Recruiting |
Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study [NCT00744640] | Phase 1/Phase 2 | 46 participants (Actual) | Interventional | 2005-10-31 | Completed |
A Prospective Study to Evaluate Alterations in Molecular Biomarkers in HER2 Neu Positive Metastatic Breast Cancer Together With Assessment of Trastuzumab Use Beyond Progression After Initial Response to Trastuzumab-taxane Based Treatment [NCT00885755] | Phase 2 | 33 participants (Actual) | Interventional | 2009-08-13 | Completed |
Preoperative Combined RadioChemo-MolecularTargetTherapy of the Locally Advanced Rectum Carcinoma (cT3NxM0) - a Phase II Pilot Study With Preoperative Application of Capecitabine, Bevacizumab and Radiotherapy (RTx) [NCT00671645] | Phase 2 | 8 participants (Actual) | Interventional | 2008-07-31 | Terminated(stopped due to reaching of step 1 (recruitment of 8 patients) per protocol -> risk assessment -> termination because of occurance of toxicity Grade 3 and 4) |
A Phase 1 Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer [NCT00842244] | Phase 1 | 22 participants (Actual) | Interventional | 2009-04-30 | Completed |
An Open Label Study of the Effect of Xeloda and Radiotherapy on Pathological Response Rate in Patients With Locally Advanced Rectal Cancer [NCT00796718] | Phase 2 | 62 participants (Actual) | Interventional | 2008-10-31 | Completed |
A Multicenter, Randomized Clinical Trail Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After the 1st-line Chemotherapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negat [NCT02597868] | | 132 participants (Anticipated) | Interventional | 2013-01-31 | Recruiting |
A Phase 2 Open-label, Single Arm Study of MK-7119 in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic HER2+ Breast Carcinoma [NCT04721977] | Phase 2 | 66 participants (Actual) | Interventional | 2021-04-08 | Active, not recruiting |
A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma [NCT02608073] | Phase 2 | 45 participants (Actual) | Interventional | 2004-11-30 | Completed |
Phase II Study of Lapatinib and Capecitabine in 2nd Line Treatment of Locally Advanced/Metastatic Pancreatic Cancer [NCT00881621] | Phase 2 | 17 participants (Actual) | Interventional | 2009-08-31 | Terminated(stopped due to slow enrollment) |
A Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of Patients With HER2/Neu+ Breast Cancer Who Have Failed Trastuzumab and Chemotherapy Including a Taxane [NCT00657137] | Phase 2 | 12 participants (Actual) | Interventional | 2008-04-30 | Terminated(stopped due to Slow accrual) |
Effects of S-1 and Capecitabine in Combination With Oxaliplatin on the Coronary Artery Blood Flow in Patients Metastatic Gastrointestinal Tract Adenocarcinoma: a Randomized Phase II Study [NCT02216149] | Phase 2 | 20 participants (Actual) | Interventional | 2015-01-31 | Terminated(stopped due to Slow accrual) |
A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer [NCT00828672] | Phase 2 | 84 participants (Actual) | Interventional | 2009-06-30 | Completed |
A Randomized Phase III Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1 in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer [NCT02605265] | Phase 3 | 360 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
Adjuvant Nab-paclitaxel Plus S-1 Versus Capecitabine Plus Oxaliplatin for Patients With Stage III Gastric Cancer After D2 Gastrectomy : a Randomised,Open-label, Phase III Study [NCT04135781] | Phase 3 | 616 participants (Anticipated) | Interventional | 2020-03-01 | Recruiting |
Induction and Consolidation Chemotherapy in Locally Advanced Rectal Cancer Patients With Circumferential Resection Margin Involvement: a Multicenter Prospective Randomized Phase III Clinical Trial [NCT04135313] | Phase 3 | 540 participants (Anticipated) | Interventional | 2019-10-20 | Enrolling by invitation |
Quadruplet 1st Line Treatment of CAPOXIRI Plus Bevacizumab Versus FOLFOXIRI Plus Bevacizumab for mCRC, Multicenter Randomised Phase II Study (QUATTRO-II) [NCT04097444] | Phase 2 | 112 participants (Anticipated) | Interventional | 2019-10-11 | Recruiting |
Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma [NCT00585078] | Phase 2 | 40 participants (Actual) | Interventional | 2004-05-31 | Completed |
Two Cycles Versus Four Cycles of Capecitabine Combined Oxaliplatin Concurrent Radiotherapy as First-line Therapy for Chinese Locally Advanced Esophageal Squamous Cell Carcinomas, an Open Randomised Phase III Cilinical Trial [NCT02604615] | Phase 3 | 60 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
A Phase 1/2, Open-Label Study Of Neratinib (HKI-272) In Combination With Capecitabine In Subjects With Solid Tumors And ErbB-2 Positive Metastatic Or Locally Advanced Breast Cancer [NCT00741260] | Phase 1/Phase 2 | 105 participants (Actual) | Interventional | 2008-12-09 | Completed |
[NCT02603159] | Phase 3 | 200 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
The CapSul Trial: A Phase II Study of Sunitinib and Capecitabine for the Treatment of Unresectable or Metastatic Hepatocellular Carcinoma (HCC) [NCT00787787] | Phase 2 | 41 participants (Actual) | Interventional | 2008-09-30 | Terminated |
A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer [NCT00435409] | Phase 3 | 442 participants (Actual) | Interventional | 2007-02-28 | Completed |
Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors [NCT00726687] | Phase 1/Phase 2 | 7 participants (Actual) | Interventional | 2008-06-30 | Active, not recruiting |
Effects of a Pneumatic Compression Device in Post-Chemoradiation Head and Neck Cancer Population [NCT05512767] | | 0 participants (Actual) | Interventional | 2022-12-01 | Withdrawn(stopped due to PI retired and study not moving forward) |
An Open-label Study of the Safety, Tolerability, and Response Rate of Xeloda in Treatment-naïve Patients With Metastatic Colorectal Cancer [NCT02567331] | Phase 4 | 28 participants (Actual) | Interventional | 2004-10-31 | Completed |
A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Ther [NCT00829166] | Phase 3 | 991 participants (Actual) | Interventional | 2009-02-28 | Completed |
A Phase II Study of Pre-operative Chemotherapy Plus Bevacizumab With Early Salvage Therapy Based on PET Assessment of Response in Patients With Locally Advanced But Resectable Gastric and GEJ Adenocarcinoma [NCT00737438] | Phase 2 | 22 participants (Actual) | Interventional | 2008-08-31 | Completed |
A Phase II Randomized Study of Palbociclib in Combination With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer [NCT02592746] | Phase 2 | 182 participants (Anticipated) | Interventional | 2016-06-30 | Active, not recruiting |
A Randomized Phase II Trial of Capecitabine Plus Cisplatin (XP) Versus Capecitabine Plus Paclitaxel (XT) as a First-line Treatment for Advanced or Recurrent Esophageal Squamous Cell Carcinoma [NCT00816634] | Phase 2 | 94 participants (Anticipated) | Interventional | 2008-10-31 | Recruiting |
A Phase II Study of Erlotinib in Combination With Capecitabine as First-line Treatment in Elderly Patients With Stage IIIB/IV Adenocarcinoma Non-small Cell Lung Cancer (NSCLC) [NCT00816868] | Phase 2 | 62 participants (Actual) | Interventional | 2009-01-31 | Completed |
A Phase 2 Study of the Efficacy and Safety of Irinotecan (Campto®) in Combination With Capecitabine (Xeloda®) as First-Line Chemotherapy in Asian Subjects With Inoperable Hepatocellular Carcinoma [NCT00635323] | Phase 2 | 73 participants (Anticipated) | Interventional | 2002-11-30 | Completed |
Maintenance Treatment With Capecitabine Plus Cetuximab After First-line 5-Fluorouracil-based Chemotherapy Plus Cetuximab for Patients With RAS Wild-type Metastatic Colorectal Cancer: a Single Arm, Open-label, Multi-center Clinical Trial [NCT02717923] | Phase 2 | 50 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
Preoperative Chemoradiotherapy and Postoperative Chemotherapy With Capecitabine and Oxaplatin vs.Capecitabine Alone in Locally Advanced Rectal Cancer (PETACC-6) [NCT00766155] | Phase 3 | 1,094 participants (Actual) | Interventional | 2008-08-31 | Completed |
Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX) [NCT00996333] | Phase 2 | 46 participants (Actual) | Interventional | 2003-06-30 | Completed |
Multi-omics Model Predicts Efficacy of Preoperative Neoadjuvant Chemoradiotherapy Combined PD-1 Antibody Therapy for Locally Advanced Rectal Cancer [NCT05368051] | | 30 participants (Anticipated) | Observational | 2021-10-01 | Recruiting |
A Two-arm Phase II Randomised Trial of Intermittent Chemotherapy Plus Continuous Cetuximab and of Intermittent Chemotherapy Plus Intermittent Cetuximab in First Line Treatment of Patients With K-ras-normal (Wild-type) Metastatic Colorectal Cancer [NCT00640081] | Phase 2 | 169 participants (Actual) | Interventional | 2007-07-31 | Completed |
XERAD: Open-Label, Phase II, Randomized, Comparative, Multicentre Trial of Concurrent Whole Brain Radiation Therapy (WBRT) and Capecitabine (Xeloda®) Followed by Maintenance Capecitabine Compared With Standard WBRT in Breast Cancer Patients With Newly Dia [NCT00977379] | Phase 2 | 24 participants (Actual) | Interventional | 2009-08-31 | Terminated(stopped due to Due to an insufficient number of participants enrolled.) |
A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer [NCT00662025] | Phase 2 | 63 participants (Actual) | Interventional | 2008-04-30 | Completed |
A Phase I/IB Study of Ipatasertib in Combination With Carboplatin, Carboplatin/Paclitaxel, or Capecitabine/Atezolizumab in Patients With Metastatic Triple Negative Breast Cancer [NCT03853707] | Phase 1/Phase 2 | 28 participants (Actual) | Interventional | 2019-03-04 | Active, not recruiting |
A Randomized, Open-label Study Comparing the Effect of 3 Chemotherapy Regimens Containing Avastin on Time to Disease Progression in Patients With Metastatic Colorectal Cancer [NCT01131078] | Phase 2 | 306 participants (Actual) | Interventional | 2005-06-30 | Completed |
A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis [NCT00630045] | Phase 3 | 392 participants (Anticipated) | Interventional | 2008-01-31 | Recruiting |
Phase 1b/II Trial of Checkpoint Inhibitor (Pembrolizumab an Anti PD-1 Antibody) Plus Standard IMRT in HPV Induced Stage III/IV Carcinoma of Anus [NCT04046133] | Phase 1 | 50 participants (Anticipated) | Interventional | 2020-10-19 | Recruiting |
Phase I Study to Evaluate the Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine [NCT02648425] | Phase 1 | 31 participants (Actual) | Interventional | 2014-08-05 | Completed |
A Phase I/Ib, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Monotherapy and in Combination With Capecitabine, Given Orally on a Daily Schedule in Patients With Advanced Solid Tumors or Lymphoma [NCT03775525] | Phase 1 | 127 participants (Anticipated) | Interventional | 2019-03-01 | Active, not recruiting |
Preoperative Radiotherapy With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer: CRAB Phase II Study [NCT00842686] | Phase 2 | 60 participants (Anticipated) | Interventional | 2009-01-31 | Active, not recruiting |
Pilot Feasibility Trial of Preoperative Capecitabine, Oxaliplatin, Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma [NCT00430027] | | 8 participants (Actual) | Interventional | 2006-11-30 | Terminated(stopped due to This study was terminated due slow accrual.) |
An Open-Label Phase II Study of Capecitabine in Combination With Pegylated Interferon Alfa-2a in Patients With Advanced Hepatocellular Carcinoma [NCT02576964] | Phase 2 | 16 participants (Actual) | Interventional | 2005-01-31 | Completed |
Selective Treatment With Magnetic Resonance Image Guided Pelvic Adaptive Radiation Therapy Combined With Total Neoadjuvant ChemoTherapy for the Conservative Management of Locally Advanced Rectal Cancer [NCT05412082] | Phase 1 | 25 participants (Anticipated) | Interventional | 2022-10-05 | Recruiting |
Randomized Phase 3 Study on the Optimization of Bevacizumab With mFOLFOX/mOXXEL in the Treatment of Patients With Metastatic Colorectal Cancer [NCT01718873] | Phase 3 | 230 participants (Actual) | Interventional | 2012-05-31 | Completed |
A Phase I/II Study Evaluating the Combination of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Patients With Advanced Gastric Cancer [NCT00845884] | Phase 1/Phase 2 | 49 participants (Anticipated) | Interventional | 2009-02-28 | Not yet recruiting |
A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and RAD001 (XELOX-A-Ev) for Subjects With Advanced Solid Tumors [NCT00849550] | Phase 1 | 32 participants (Actual) | Interventional | 2009-07-31 | Completed |
Alternating Treatment With Fruquintinib and Bevacizumab Plus Capecitabine Versus Bevacizumab Plus Capecitabine as Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer: A Multi-center, Parallel-group, Phase II Study. [NCT05659290] | Phase 2 | 40 participants (Anticipated) | Interventional | 2023-01-31 | Recruiting |
A Phase II Study of Irinotecan, Capecitabine and Avastin in Patients With Metastatic Colorectal Cancer, Who Have Progressed After 1ST Line Therapy With Folfox/Avastin. [NCT00717990] | Phase 2 | 15 participants (Actual) | Interventional | 2008-04-30 | Terminated(stopped due to Poor Accrual) |
Phase II Study of Adjusted-dose Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status. [NCT00733616] | Phase 2 | 44 participants (Actual) | Interventional | 2008-11-30 | Completed |
Concurrent Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer: A Prospective Feasibility Trial [NCT03958721] | Phase 1 | 20 participants (Actual) | Interventional | 2019-07-18 | Completed |
A Randomized, Controlled, Multi-center Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Breast [NCT03500380] | Phase 2/Phase 3 | 301 participants (Anticipated) | Interventional | 2018-04-24 | Active, not recruiting |
A Randomized Phase 2 Study of SCH 727965 in Subjects With Advanced Breast and Non Small Cell Lung (NSCLC) Cancers [NCT00732810] | Phase 2 | 97 participants (Actual) | Interventional | 2008-07-31 | Completed |
An Open-Label, Multicenter, Randomized, Phase II Study to Evaluate the Efficacy and Safety of Two Combination Dose Regimens: Capecitabine + Epirubicin + Cyclophosphamide (CEX) Versus 5-FU + Epirubicin + Cyclophosphamide (FEC 100) as Neoadjuvant Therapy in [NCT02846428] | Phase 2 | 182 participants (Actual) | Interventional | 2004-03-31 | Completed |
A Prospective, Multicenter, Single-armed, Phase II Study Evaluating Efficacy and Safety of Neoadjuvant Sintilimab in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcin [NCT04065282] | Phase 2 | 36 participants (Anticipated) | Interventional | 2019-08-06 | Recruiting |
A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and Dasatinib for Patients With Advanced Solid Tumors With Expanded Cohort of Patients With Previously Untreated Metastatic Colorectal Cancer. [NCT00920868] | Phase 1 | 22 participants (Actual) | Interventional | 2009-05-31 | Completed |
A Randomized Phase III Study of SOX vs. COX in Patients With Advanced Colorectal Cancer [NCT00677443] | Phase 3 | 344 participants (Actual) | Interventional | 2008-06-30 | Completed |
A Phase II, Single-center, Dynamic Observational Study With PET of 68Ga-HER2-affibody in Anti-HER2 Treatment [NCT04769050] | | 50 participants (Anticipated) | Observational | 2021-02-18 | Recruiting |
Phase 2 Study of Comparison Between XELOX (Capecitabine and Oxaliplatin) and Docetaxel, Oxaliplatin and S1 Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer [NCT02623153] | Phase 2 | 200 participants (Anticipated) | Interventional | 2016-01-31 | Not yet recruiting |
Phase II Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer [NCT02897050] | Phase 2 | 170 participants (Anticipated) | Interventional | 2016-09-30 | Suspended |
A Randomized, Multicenter, Parallel,Phase III Open-label Study of the Efficacy and Safety of Hemay022 + AI in Patients With ER+/HER2+ Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy [NCT05122494] | Phase 3 | 339 participants (Anticipated) | Interventional | 2022-01-19 | Recruiting |
A Prospective, Observational, Multicenter Study on Biomarkers for Predicting the Efficacy and Toxicities of Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer Based on Tissue and Plasma Exosome RNA [NCT04227886] | | 250 participants (Anticipated) | Observational | 2019-12-01 | Recruiting |
177Lutethium - Peptide Receptor Radionuclide Therapy (Lu-PRRT) Plus Capecitabine Versus Lu-PRRT in FDG Positive, Gastro-entero-pancreatic Neuroendocrine Tumors: a Randomized Phase II Study. [NCT02736448] | Phase 2 | 35 participants (Actual) | Interventional | 2016-05-31 | Active, not recruiting |
A Randomized, Multicenter Phase III Trial to Assess the Efficacy and Safety of Bevacizumab and Capecitabine as Maintenance Treatment, After Initial Combination Treatment With Capecitabine, Oxaliplatin and Bevacizumab in Patients With Metastatic Colorectal [NCT00623805] | Phase 3 | 123 participants (Actual) | Interventional | 2008-03-31 | Completed |
A Phase 1 Study of TKI 258 in Combination With Xeloda and Oxaliplatin in Upfront Treatment of Advanced Colorectal and Gastric Cancer With a Dose Expansion Cohort in Advanced Gastric Cancer [NCT02720926] | Phase 1 | 3 participants (Actual) | Interventional | 2011-09-30 | Terminated(stopped due to Unafavourable toxicity profile) |
A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer [NCT00743964] | Phase 2 | 91 participants (Actual) | Interventional | 2008-04-30 | Completed |
Capecitabine in Combination With Aromatase Inhibitor Versus Aromatase Inhibitors, in Hormonal Receptor Positive Recurrent or Metastatic Breast Cancer Patients, Randomized Controlled Study (CONCEPT Trial) [NCT04012918] | Phase 2 | 124 participants (Anticipated) | Interventional | 2018-08-30 | Recruiting |
FOxTROT - Fluoropyrimidine, Oxaliplatin and Targeted Receptor Pre-Operative Therapy: a Controlled Trial in High-Risk Operable Colon Cancer [NCT00647530] | Phase 2/Phase 3 | 1,053 participants (Actual) | Interventional | 2008-05-15 | Active, not recruiting |
A Phase I Study Of Vinorelbine Oral Plus Capecitabine Combination In Patients With Metastatic Breast Cancer [NCT00706069] | Phase 1 | 40 participants (Anticipated) | Interventional | 2008-06-30 | Completed |
A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin Versus Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4N0) and IIIb (T3N2) Gastric Adenocarcinoma [NCT02560974] | Phase 3 | 1,035 participants (Actual) | Interventional | 2006-06-30 | Completed |
A Phase II Study of Gemzar, Taxotere, and Xeloda (GTX) for Adjuvant Pancreatic Cancer [NCT00882310] | Phase 2 | 37 participants (Actual) | Interventional | 2006-09-30 | Completed |
A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer [NCT00686166] | Phase 2 | 83 participants (Actual) | Interventional | 2009-02-28 | Completed |
A Single Arm Open-label, Phase II Study of Bevacizumab in Combination With Trastuzumab and Capecitabine as First-line Treatment of Patients With HER2-positive Locally Recurrent or Metastatic Breast Cancer [NCT00811135] | Phase 2 | 88 participants (Actual) | Interventional | 2008-12-31 | Completed |
Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver [NCT00858429] | Phase 1 | 18 participants (Actual) | Interventional | 2009-04-01 | Completed |
A Phase I Study of a Combination of High Selenium Brassica Juncea With Irinotecan and Capecitabine [NCT00547547] | Phase 1 | 22 participants (Actual) | Interventional | 2006-04-30 | Completed |
A Phase I Study of Gemcitabine, Capecitabine and ZD6474 (ZACTIMA) in Patients With Advanced Solid Tumors With an Expanded Cohort of Patients With Biliary or Pancreatic Malignancies. [NCT00551096] | Phase 1 | 23 participants (Actual) | Interventional | 2007-10-31 | Completed |
Capecitabine as Adjuvant Chemotherapy to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection: a Randomized Controlled Trial [NCT00561522] | Phase 2/Phase 3 | 290 participants (Anticipated) | Interventional | 2007-11-30 | Active, not recruiting |
Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure [NCT04679597] | | 161 participants (Actual) | Observational | 2016-01-01 | Completed |
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma [NCT02137343] | Phase 3 | 34 participants (Actual) | Interventional | 2014-07-31 | Terminated(stopped due to All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.) |
Capecitabine-based Chemoradiotherapy in Combination With the IL-1 Receptor Antagonist Anakinra for Rectal Cancer Patients. A Phase I Trial of the German Rectal Cancer Study Group [NCT04942626] | Phase 1 | 12 participants (Actual) | Interventional | 2021-08-20 | Active, not recruiting |
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG102) With Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma [NCT01697072] | Phase 3 | 609 participants (Actual) | Interventional | 2012-10-31 | Terminated(stopped due to All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.) |
Phase I Study of Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy in Patients With Resectable Esophageal Cancer [NCT01386346] | Phase 1 | 12 participants (Actual) | Interventional | 2011-06-30 | Completed |
A Phase I Study of the mTOR Inhibitor Temsirolimus Plus Capecitabine in Patients With Advanced Malignancies [NCT01050985] | Phase 1 | 47 participants (Actual) | Interventional | 2010-07-31 | Completed |
A Double-blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-line Therapy in Patients With Advanced Gastric Cancer [NCT00548548] | Phase 3 | 774 participants (Actual) | Interventional | 2007-09-30 | Completed |
Phase Ⅱ Trial of Fixed Dose Rate Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Capecitabine in Patients With Locally Advanced Pancreatic Cancer [NCT01396668] | Phase 2 | 35 participants (Anticipated) | Interventional | 2004-12-31 | Completed |
IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer [NCT00546364] | Phase 2 | 62 participants (Actual) | Interventional | 2008-02-29 | Terminated(stopped due to Slow Accrual) |
A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer [NCT05814354] | Phase 3 | 530 participants (Anticipated) | Interventional | 2023-06-30 | Recruiting |
A Phase II Study of Immunotherapy With Durvalumab and Tremelimumab in Combination With Capecitabine or Without Capecitabine in Adjuvant Situation for Biliary Tract Cancer [NCT05239169] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-05-23 | Recruiting |
Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Using a Limited Pharmacokinetic Sampling Plan [NCT00960544] | Phase 2 | 0 participants (Actual) | Interventional | 2019-01-31 | Withdrawn(stopped due to Principal Investigator departed from institution) |
PEXG (Cisplatin, Epirubicin, Capecitabine, Gemcitabine) Versus PDXG (Cisplatin, Docetaxel, Capecitabine, Gemcitabine) in Locally Advanced or Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial [NCT00966706] | Phase 2 | 105 participants (Actual) | Interventional | 2005-06-30 | Completed |
A Single Arm,Multicenter,Open-label Study of Dalpiciclib Plus Letrozole and Capecitabine of First-line Treatment With High-risk HR- Positive /HER-2 Negative Advanced Breast Cancer [NCT05469750] | Phase 2 | 48 participants (Anticipated) | Interventional | 2022-08-10 | Not yet recruiting |
Multicenter, Open Lable Phase II Study to Evaluate the Safety and Efficacy of a Perioperative Chemotherapy With Docetaxel, Cisplatin and Capecitabine in Patients With Gastric Adenocarcinoma, Adenocarcinoma of the Gastro-esophageal Junction or the Distal E [NCT00865982] | Phase 2 | 50 participants (Anticipated) | Interventional | 2008-09-30 | Active, not recruiting |
A Randomized Phase 2 Study to Evaluate Safety and Efficacy of the Combination of SHR-1210 With Capecitabine + Oxaliplatin or Apatinib as First-line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma [NCT03472365] | Phase 2 | 67 participants (Actual) | Interventional | 2018-04-02 | Completed |
Short-course Radiotherapy Combined With CAPOX and Pd-1 Inhibitor for Locally Advanced Colon Cancer: a Randomized, Prospective, Multicentre, Phase II Trial (TORCH-C) [NCT05732493] | Phase 2 | 120 participants (Anticipated) | Interventional | 2023-03-01 | Not yet recruiting |
Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients [NCT00868634] | Phase 3 | 600 participants (Actual) | Interventional | 2009-02-28 | Completed |
A Phase I/II Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Combination in Metastatic Pancreatic Cancer [NCT03535727] | Phase 1/Phase 2 | 86 participants (Anticipated) | Interventional | 2018-06-21 | Recruiting |
Neoadjuvant Radiotherapy Combined With Capecitabine and Sorafenib in Patients With Advanced, K-ras Mutated Rectal Cancer. A Multicenter Phase I/IIa Trial. [NCT00869570] | Phase 1/Phase 2 | 54 participants (Actual) | Interventional | 2009-03-31 | Completed |
Phase II Trial of Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in Patients With HER2/Neu-Overexpressing Advanced or Metastatic Breast Cancer [NCT00496366] | Phase 2 | 11 participants (Actual) | Interventional | 2007-07-23 | Terminated |
A Randomized Two-armed Open Study on the Adjuvant Therapy in Patients With R0/R1 Resected Pancreatic Carcinoma With Gemcitabine Plus Capecitabine (Arm GC) vs. Gemcitabine Plus Cisplatin With Regional Hyperthermia (Arm GPH) [NCT01077427] | Phase 3 | 336 participants (Anticipated) | Interventional | 2012-03-31 | Recruiting |
Neoadjuvant Chemoradiation Therapy With Oxaliplatin and Capecitabine for Patients With Surgically Resectable Gastric Cancer: A Pilot Phase II Trial With Molecular Correlates [NCT00335959] | Phase 2 | 7 participants (Actual) | Interventional | 2006-05-31 | Terminated(stopped due to Closed due to slow accrual) |
Phase I Clinical Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma [NCT00881816] | Phase 1 | 15 participants (Anticipated) | Interventional | 2009-04-30 | Active, not recruiting |
A Phase I Study of the Hsp90 Inhibitor AUY922 Plus Capecitabine for the Treatment of Patients With Advanced Solid Tumors [NCT01226732] | Phase 1 | 23 participants (Actual) | Interventional | 2010-11-30 | Completed |
An Open Labelled, Multicenter-phase II Study of Chiauranib Combine With Capecitabine in Advanced Triple-negative Breast Cancer Failed to Prior Anthracyclines and Taxanes Therapy [NCT05336721] | Phase 2 | 38 participants (Anticipated) | Interventional | 2021-11-05 | Recruiting |
Phase 1/2 Evaluation of Adenoviral p53 (Ad-p53) in Combination With Capecitabine (Xeloda) or Anti-PD-1 in Patients With Unresectable Liver Metastases of Colorectal Carcinoma(CRC) and Other Solid Tumors, Recurrent Head and Neck Squamous Cell Carcinoma (HNS [NCT02842125] | Phase 1/Phase 2 | 4 participants (Actual) | Interventional | 2018-11-20 | Terminated(stopped due to Arm C rolled into parallel study; Arms A and B halted for greater efficacy in Arm C) |
Phase II Study of Capecitabine and Temozolomide for Progressive, Differentiated, Metastatic Neuroendocrine Cancers [NCT00869050] | Phase 2 | 41 participants (Actual) | Interventional | 2005-08-31 | Completed |
A Phase II Study of XELOX and Toripalimab in the Neoadjuvant Treatment of Stage II/III Gastric or GE Junction Adenocarcinoma [NCT04119622] | Phase 2 | 30 participants (Anticipated) | Interventional | 2019-10-08 | Recruiting |
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma [NCT00779454] | Phase 2 | 72 participants (Actual) | Interventional | 2008-09-30 | Completed |
A Phase I/II Study of Capecitabine/Oxaliplatin (XELOX) in Combination With Bevacizumab and Imatinib as First-line Treatment of Patients With Stage IV Colorectal Cancer [NCT00784446] | Phase 1/Phase 2 | 51 participants (Actual) | Interventional | 2008-04-30 | Completed |
A Phase II Study of Preoperative Capecitabine and Concomitant Radiation in Women With Advanced Inflammatory or Non-Inflammatory Breast Cancer [NCT00916578] | Phase 2 | 33 participants (Actual) | Interventional | 2009-06-05 | Completed |
A Prospective Phase I Study of Radiation Therapy and Concurrent Capecitabine and Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma [NCT00707278] | Phase 1 | 13 participants (Actual) | Interventional | 2005-09-30 | Completed |
Short Course Oncology Therapy - A Study of Adjuvant Chemotherapy in Colorectal Cancer [NCT00749450] | Phase 3 | 6,088 participants (Actual) | Interventional | 2008-03-31 | Completed |
Clinical Study to Assess Entry of Chemotherapeutic Agents Into Brain Metastases in Women With Breast Cancer [NCT00795678] | | 10 participants (Actual) | Observational | 2008-09-30 | Completed |
A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Anthracycline- or Taxane-Exposed ErbB2-Positive Metastatic Breast Cancer [NCT00820222] | Phase 3 | 540 participants (Actual) | Interventional | 2009-04-14 | Completed |
A Parallel Phase II Study With Irinotecan/Cetuximab (Until PD) Followed by XELOX/Cetuximab (Until PD) vs the Reverse Sequence in Metastatic CRC With Previous Benefit on Irinotecan/Bevacizumab Based Therapy [NCT00755534] | Phase 2 | 68 participants (Actual) | Interventional | 2008-11-30 | Terminated(stopped due to Due to poor accrual) |
A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum [NCT00354601] | Phase 2 | 2 participants (Actual) | Interventional | 2006-01-31 | Terminated(stopped due to funding withdrawn) |
A Phase I, Multi-arm, Dose Escalation Study of Brivanib Alaninate Combined With Several Chemotherapy Regimens in Subjects With Solid Tumors [NCT00798252] | Phase 1 | 111 participants (Actual) | Interventional | 2009-03-31 | Completed |
A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2+ Gastric /Gastroesophageal Junction Adenocarcinoma [NCT05671822] | Phase 2 | 156 participants (Anticipated) | Interventional | 2023-03-14 | Recruiting |
A Phase 2 Study to Evaluate the Efficacy and Safety of an Adjuvant Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Low Breast Cancer (Cornerstone-001) [NCT05163223] | Phase 2 | 146 participants (Anticipated) | Interventional | 2022-02-28 | Recruiting |
Randomized Multicenter Phase III Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas: Gemcitabine With or Without Chemoradiotherapy and With or Without Erlotinib. Intergroup Study [NCT00634725] | Phase 3 | 820 participants (Anticipated) | Interventional | 2008-02-29 | Completed |
Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation (CIRCULATE) AIO-KRK-0217 [NCT04089631] | Phase 3 | 4,812 participants (Anticipated) | Interventional | 2020-06-26 | Recruiting |
Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer: a Phase II Study. [NCT02745639] | Phase 2 | 18 participants (Actual) | Interventional | 2010-02-28 | Completed |
Professor, Ege University Faculty of Dentistry [NCT02744703] | | 10 participants (Actual) | Interventional | 2013-04-30 | Completed |
Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2 [NCT04400695] | Phase 3 | 366 participants (Anticipated) | Interventional | 2020-09-29 | Recruiting |
A Phase 2 Trial of Capecitabine Concomitantly With Whole Brain Radiotherapy(WBRT) Followed by Capecitabine and Sunitinib for Central Nervous System, (CNS) Metastases in Breast Cancer [NCT00570908] | Phase 2 | 12 participants (Actual) | Interventional | 2009-02-28 | Terminated(stopped due to Due to poor accrual this study is being closed to accrual) |
Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors [NCT04047862] | Phase 1 | 542 participants (Anticipated) | Interventional | 2019-08-26 | Recruiting |
Phase II Study of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX) and Bevacizumab in Patients With Locally Advanced Rectal Cancer [NCT00321685] | Phase 2 | 57 participants (Actual) | Interventional | 2006-07-25 | Completed |
A Phase I Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas and High Grade Gliomas [NCT00532948] | Phase 1 | 24 participants (Actual) | Interventional | 2007-05-31 | Completed |
A Phase II Trial of Combination Irinotecan and Capecitabine as Second-Line Treatment for Patients With Locally Advanced/Metastatic Biliary Tract Cancers Who Progressed or Intolerant to Front-Line Gemcitabine and Platinum Combination [NCT02720601] | Phase 2 | 0 participants (Actual) | Interventional | 2015-11-30 | Withdrawn(stopped due to Study was never submitted to the IRB & never opened. PI is leaving institution.) |
An Open-Label, Multicenter Phase Ib Study of The Safety and Efficacy of Atezolizumab (Anti-PD-L1 Antibody) Administered in Combination With Bevacizumab and/or Other Treatments in Patients With Solid Tumors [NCT02715531] | Phase 1 | 243 participants (Actual) | Interventional | 2016-04-06 | Completed |
Evaluation on the Tolerance and Preliminary Efficacy of Sintilimab (IBI308) Combined With Bevacizumab, Oxaliplatin and Capecitabine Regimen for Ras Gene Mutant and Microsatellite Stable Unresectable Metastatic Colorectal Cancer [NCT04194359] | Phase 2 | 25 participants (Anticipated) | Interventional | 2021-02-04 | Active, not recruiting |
A Non Randomized Phase II Trial to Assess Efficacy and Safety of Bevacizumab, Capecitabine and Oxaliplatin as First Line Treatment for Elderly Patients With Metastatic Colorectal Adenocarcinoma, Suitable for Polychemotherapy Treatment [NCT01067053] | Phase 2 | 69 participants (Anticipated) | Interventional | 2009-11-30 | Active, not recruiting |
Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer [NCT01067989] | Phase 2 | 22 participants (Actual) | Interventional | 2010-03-31 | Terminated(stopped due to No satisfactory acrual) |
A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC) [NCT00789958] | Phase 2 | 105 participants (Actual) | Interventional | 2008-12-31 | Completed |
A Randomised Phase II/III Trial of Peri-Operative Chemotherapy With or Without Bevacizumab in Operable Oesophagogastric Adenocarcinoma and A Feasibility Study Evaluating Lapatinib in HER-2 Positive Oesophagogastric Adenocarcinomas and (in Selected Centres [NCT00450203] | Phase 2/Phase 3 | 1,103 participants (Anticipated) | Interventional | 2007-10-31 | Recruiting |
BACCI: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Capecitabine Bevacizumab Plus Atezolizumab Versus Capecitabine Bevacizumab Plus Placebo in Patients With Refractory Metastatic Colorectal Cancer [NCT02873195] | Phase 2 | 133 participants (Actual) | Interventional | 2017-07-07 | Active, not recruiting |
A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer [NCT00777101] | Phase 2 | 233 participants (Actual) | Interventional | 2009-02-04 | Completed |
Randomized Trial of Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy to Patients With Early Low and Mid Rectal Cancer: The Watchful Waiting 3 Trial (WW3) [NCT04095299] | Phase 2 | 111 participants (Anticipated) | Interventional | 2020-01-20 | Recruiting |
A Phase 2 Open-Label Study Evaluating the Efficacy and Safety of Telatinib in Combination With Chemotherapy as First-Line Therapy in Subjects With Advanced Gastric Cancer [NCT00952497] | Phase 2 | 48 participants (Actual) | Interventional | 2009-06-30 | Completed |
A Randomized Phase III Study of Metronomic vs. Intermittent Capecitabine Maintenance Therapy Following First-line Capecitabine and Docetaxel Therapy in HER2-negative Metastatic Breast Cancer [NCT01917279] | Phase 3 | 280 participants (Anticipated) | Interventional | 2013-10-31 | Recruiting |
Hypofractionated Radiotherapy Combined With Chemotherapy and Toripalimab for Locally Recurrent Rectal Cancer: a Single-arm, Two-cohort, Phase II Trial (TORCH-R) [NCT05628038] | Phase 2 | 93 participants (Anticipated) | Interventional | 2022-08-18 | Recruiting |
A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients Wi [NCT04556773] | Phase 1 | 139 participants (Actual) | Interventional | 2020-12-17 | Active, not recruiting |
A Phase III Open-label, Multicenter Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esop [NCT02625610] | Phase 3 | 499 participants (Actual) | Interventional | 2015-12-24 | Completed |
A Phase 1 Dose Escalation Safety Study Combining the ATR Inhibitor M6620 With Chemoradiotherapy in Oesophageal Cancer & Other Solid Cancers Using Time to Event Continual Reassessment Method [NCT03641547] | Phase 1 | 36 participants (Actual) | Interventional | 2018-12-04 | Completed |
Maintenance Chemotherapy for Metastatic Colorectal Carcinoma [NCT02043821] | | 80 participants (Anticipated) | Interventional | | Not yet recruiting |
A Phase III Trial of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant. [NCT01095003] | Phase 3 | 770 participants (Actual) | Interventional | 2009-05-31 | Completed |
A Phase II Trial of Xeloda, Every Three Week Taxol and Herceptin in Metastatic Breast Cancer [NCT00006108] | Phase 1/Phase 2 | 0 participants | Interventional | 1999-08-31 | Completed |
A Phase I Study Of Cyclophoshamide And Epirubicin In Combination With Capecitabine (XELODA) (CEX) As Primary Treatment Of Locally Advanced/Inflammatory Or Large Operable Breast Cancer [NCT00008034] | Phase 1 | 15 participants (Actual) | Interventional | 2000-02-29 | Completed |
A Phase II Trial of Preoperative Capecitabine Plus Irinotecan Followed by Combined Modality Capecitabine and Radiation for Locally Advanced Rectal Cancer: Hoosier Oncology Group GI03-53 [NCT00216086] | Phase 2 | 22 participants (Actual) | Interventional | 2005-05-31 | Terminated(stopped due to Funding withdrawn) |
A Phase 1, Multicenter, Dose-Escalation Study to Investigate the Safety and Tolerability of ADH-1 in Combination With 1) Carboplatin or 2) Docetaxel or 3) Capecitabine in Subjects With N-Cadherin Positive, Advanced Solid Tumors (Adherex Protocol Number AH [NCT00390676] | Phase 1 | 0 participants | Interventional | 2006-11-30 | Completed |
A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer [NCT02942563] | Phase 2 | 100 participants (Anticipated) | Interventional | 2016-11-01 | Recruiting |
A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer [NCT00146588] | | 55 participants (Actual) | Interventional | 2002-04-30 | Completed |
A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer [NCT00613080] | Phase 2 | 79 participants (Actual) | Interventional | 2008-04-30 | Completed |
"A Translational Randomized Phase III Study Exploring the Effect of the Addition of Capecitabine to Carboplatine Based Chemotherapy in Early Triple Negative Breast Cancer" [NCT04335669] | Phase 3 | 920 participants (Anticipated) | Interventional | 2019-12-20 | Recruiting |
Phase II Study of Irinotecan Plus Capecitabine in Patients With Antracycline and Taxane Pretreated Metastatic Breast Cancer [NCT00532714] | Phase 2 | 36 participants (Actual) | Interventional | 2006-08-31 | Completed |
A Phase I Trial of Vandetanib Combined With Capecitabine, Oxaliplatin and Bevacizumab for the First-Line Treatment of Metastatic Colorectal Cancer [NCT00532909] | Phase 1 | 13 participants (Actual) | Interventional | 2006-07-31 | Completed |
Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥75 Years) [NCT00812864] | Phase 4 | 20 participants (Actual) | Interventional | 2009-01-31 | Completed |
Docetaxel and Carboplatin Followed by a Dose-Ranging Study of Oral Capecitabine, Weekly Docetaxel, and Concomitant External Beam Radiotherapy for the Treatment of Patients With Stage II-III Carcinoma of the Esophagus and Gastro-Esophageal Junction [NCT00153881] | Phase 1 | 44 participants (Actual) | Interventional | 2000-02-29 | Completed |
Phase 1b Multiple Ascending Dose Study of BMS-833923 (XL139) Administered in Combination With Cisplatin and Capecitabine as First-Line Therapy in Patients With Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas [NCT00909402] | Phase 1 | 39 participants (Actual) | Interventional | 2009-11-30 | Completed |
A Three-Arm Randomised Controlled Trial Comparing Either Continuous Chemotherapy Plus Cetuximab or Intermittent Chemotherapy With Standard Continuous Palliative Combination Chemotherapy With Oxaliplatin and a Fluoropyrimidine in First Line Treatment of Me [NCT00182715] | Phase 3 | 2,421 participants (Anticipated) | Interventional | 2005-03-31 | Active, not recruiting |
A Phase I/II Study on the Treatment With Taxotere in Combination With Xeloda in Patients With Metastatic Oesophageal Cancer or Cancer in the Cardia Region [NCT00821912] | Phase 1/Phase 2 | 93 participants (Actual) | Interventional | 2006-03-31 | Active, not recruiting |
Pilot Study to Determine Therapeutic Response of Oral Capecitabine (Xeloda) in Recurrent High Grade Gliomas (HGGs) by Establishing the Radiographic Response Rate Using Modified Macdonald Criteria [NCT00717197] | Phase 2 | 30 participants (Actual) | Interventional | 2008-07-31 | Completed |
A Single Arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of Capecitabine Plus Oxaliplatin (XELOX) in the Peri-operative Treatment of Patients With Potentially Resectable Liver Metastasis From Colorectal Cancer [NCT00997685] | Phase 2 | 110 participants (Anticipated) | Interventional | 2009-11-30 | Not yet recruiting |
A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma [NCT00411762] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2006-12-31 | Completed |
The Third Phase of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence Was Compared With the Clinical Comparison [NCT04404491] | Phase 3 | 240 participants (Anticipated) | Interventional | 2020-06-01 | Not yet recruiting |
A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Wit [NCT00408408] | Phase 3 | 1,206 participants (Actual) | Interventional | 2006-11-30 | Active, not recruiting |
Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant, Dose-Dense Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer [NCT00209092] | Phase 2 | 51 participants (Actual) | Interventional | 2006-08-31 | Completed |
An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination With Gemcitabine and in Combination With Chemoradiation (Capecitabine and Radiation) in Patients With Completely-Resected Pancreatic Carcinoma [NCT00305877] | Phase 2 | 137 participants (Actual) | Interventional | 2006-02-28 | Completed |
Phase II Randomized Study to Compare Capecitabine + Bevacizumab Concomitantly With Radiotherapy Versus Capecitabine Concomitantly With Radiotherapy, as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer [NCT01043484] | Phase 2 | 90 participants (Actual) | Interventional | 2009-12-31 | Completed |
A Randomised Fase I/II Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer [NCT01042028] | Phase 1/Phase 2 | 39 participants (Actual) | Interventional | 2010-01-31 | Terminated(stopped due to Emergence of FOLFIRINOX and slow recruitment) |
A Multicenter Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A) [NCT00127036] | Phase 2 | 65 participants (Actual) | Interventional | 2003-10-31 | Terminated(stopped due to drug now on market) |
An Open-label Study to Assess the Pharmacokinetic Interaction Between Xeloda and Oxaliplatin in Patients With Metastatic Colorectal Cancer. [NCT00353262] | Phase 1 | 36 participants (Actual) | Interventional | 2005-07-31 | Completed |
A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer [NCT01048580] | Phase 1 | 10 participants (Actual) | Interventional | 2009-10-31 | Completed |
A Real-world Observational Study of Fruquintinib in Combination With Irinotecan and Capecitabine for the Second-line Treatment of Patients With Advanced Colorectal Cancer [NCT06169202] | | 50 participants (Anticipated) | Observational | 2023-06-01 | Recruiting |
A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab W [NCT06112379] | Phase 3 | 1,728 participants (Anticipated) | Interventional | 2023-11-14 | Recruiting |
Dose-finding Phase 1 Trial: Evaluating Safety and Biomarkers Using DK210 (EGFR) for Inoperable Locally Advanced and/or Metastatic EGFR+ Tumors With Progressive Disease Failing Systemic Therapy [NCT05704985] | Phase 1 | 60 participants (Anticipated) | Interventional | 2023-04-03 | Recruiting |
Phase I Trial of ZW25 in Patients With Locally Advanced (Unresectable) and/or Metastatic HER2-expressing Cancers [NCT02892123] | Phase 1 | 279 participants (Actual) | Interventional | 2016-09-30 | Active, not recruiting |
A Phase I/II Study of Vorinostat (Zolinza®) in Combination With Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer [NCT01045538] | Phase 1/Phase 2 | 45 participants (Actual) | Interventional | 2010-02-28 | Completed |
A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgical Resection for Locally-Advanced Rectal Cancer [NCT00226941] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2004-06-30 | Terminated(stopped due to The response rate observed in the phase 1 portion of the study did not merit further evaluation in phase 2 portion of the study.) |
Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer [NCT01016639] | Phase 1/Phase 2 | 106 participants (Actual) | Interventional | 2003-06-30 | Completed |
A Phase II Study to Evaluate the Efficacy, Safety, and Genomic Markers of Response of Capecitabine as NeoAdjuvant Therapy in Women With Newly Diagnosed Locally Advanced Breast Cancer [NCT00347438] | Phase 2 | 18 participants (Actual) | Interventional | 2006-09-30 | Terminated(stopped due to a result of slow accrual) |
Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma [NCT01065870] | Phase 2/Phase 3 | 64 participants (Anticipated) | Interventional | 2009-12-31 | Recruiting |
Phase I Trial of Oral Capecitabine Combined With 131I-huA33 in Patients With Metastatic Colorectal Cancer [NCT00291486] | Phase 1 | 19 participants (Actual) | Interventional | 2003-10-31 | Completed |
A Feasibility Study for Individualized Treatment of Patients With Advanced Pancreatic Cancer [NCT00276744] | Phase 2 | 249 participants (Actual) | Interventional | 2005-10-31 | Terminated(stopped due to Because there was no longer an active laboratory component to this study.) |
Phase II Study of Capecitabine in Combination With Vinorelbine and Trastuzumab for the First- or Second-LineTreatment of HER2+ Metastatic Breast Cancer [NCT00093808] | Phase 2 | 47 participants (Actual) | Interventional | 2004-08-31 | Completed |
A Multi Phase II Clinical Trials Evaluating the Association of Bevacizumab With Weekly Paclitaxel and Capecitabine in First Line Treatment for Patients With Triple Negative Metastatic or Locally Advanced Cancer [NCT01069796] | Phase 2 | 64 participants (Actual) | Interventional | 2010-04-30 | Terminated(stopped due to The number of inclusion was reached normally) |
Phase II Clinical Trial: Capecitabine Maintenance Therapy in Colorectal Cancer Patients With Stage IIIC and R0-R1 Resected Stage IV [NCT01880658] | Phase 2 | 100 participants (Anticipated) | Interventional | 2013-06-30 | Recruiting |
A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer [NCT00125021] | Phase 2 | 32 participants (Actual) | Interventional | 2003-10-31 | Completed |
Safety and Efficacy Evaluation of Capecitabine, Cisplatin, and Herzuma Combination Chemotherapy for the First Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients. [NCT03588533] | Phase 2 | 50 participants (Anticipated) | Interventional | 2018-06-10 | Recruiting |
Pre-operative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer (PROCTFUL) [NCT00263029] | Phase 2 | 18 participants (Actual) | Interventional | 2002-06-30 | Completed |
S1 Versus Capecitabine in the First Line Treatment of Metastatic Colorectal Cancer Patients, the SALTO Randomised Phase III Study of the Dutch Colorectal Cancer Group. A Safety Evaluation of Oral Fluoropyrimidines [NCT01918852] | Phase 3 | 161 participants (Actual) | Interventional | 2013-12-31 | Completed |
8 Continuous vs 8 Intermittent Cycles in First and Second Line Treatment of Patients With HER2/Neu Negative, Incurable, Metastatic or Unresectable Locally Advanced Breast Cancer. [NCT01935492] | Phase 3 | 420 participants (Actual) | Interventional | 2010-11-30 | Completed |
First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Patients With Advanced Gastrointestinal Neuroendocrine Carcinoma: A Prospective Single-arm Phase II Study [NCT06070740] | Phase 2 | 22 participants (Anticipated) | Interventional | 2023-11-01 | Recruiting |
A Multicenter Phase II Study to Determine the Efficacy of Capecitabine as First Line Monochemotherapy in Patients With HER2 Negative, Medium-risk, Metastatic Breast Cancer [NCT00196820] | Phase 2 | 200 participants (Anticipated) | Interventional | 2005-07-31 | Completed |
Ibandronate With or Without Capecitabine in Elderly Patients With Early Breast Cancer [NCT00196859] | Phase 3 | 1,500 participants (Anticipated) | Interventional | 2004-06-30 | Completed |
A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma [NCT00226980] | Phase 2 | 30 participants (Anticipated) | Interventional | 2002-10-31 | Completed |
A Randomized, Controlled, Open-Label, Multicenter, Phase 2 Study of Nimotuzumab Plus Docetaxel and Capecitabine Versus Docetaxel and Capecitabine as First-Line Treatment in Patients With Recurrent/Metastatic Triple Negative Breast Cancer [NCT01939054] | Phase 2 | 90 participants (Anticipated) | Interventional | 2013-09-30 | Recruiting |
A Phase II Study of Oxaliplatin, 5-fluorouracil, and Leucovorin in Combination With Oral Capecitabine in Patients With Metastatic Colorectal Cancer [NCT00205322] | Phase 2 | 45 participants (Actual) | Interventional | 2004-04-30 | Completed |
Randomized Phase II Trial of Capecitabine Plus Oral Vinorelbine Day 1 and 8 vs Metronomic Capecitabine Plus Oral Vinorelbine as Treatment of Metastatic Breast Cancer. [NCT01941771] | Phase 2 | 110 participants (Actual) | Interventional | 2012-06-30 | Completed |
A Phase II Study of Substitution of 5-FU (Fluorouracil) by Capecitabine in Scheme of Chemo-radiotherapy in Patients With Squamous Cell Carcinoma of the Anal Canal. [NCT01941966] | Phase 2 | 51 participants (Anticipated) | Interventional | 2010-11-30 | Completed |
A Phase III, Randomized Study of Adjuvant Chemotherapy for Patients With Rectal Adenocarcinoma Who Achieved Suboptimal Response After Neoadjuvant Chemo-radiotherapy. [NCT01941979] | Phase 3 | 309 participants (Anticipated) | Interventional | 2011-09-30 | Recruiting |
Phase I Study to Assess the Optimal Dose for Pazopanib in Combination With Capecitabine in Patients With HER2-negative, Metastatic Breast Cancer (PazoX) [NCT01498458] | Phase 1 | 9 participants (Actual) | Interventional | 2010-10-31 | Completed |
A Phase I Trial of Capecitabine or Continuous Infusion 5-Fluorouracil in Combination With Weekly Irinotecan and Cisplatin in Patients With Advanced Solid Tumor Malignancies [NCT00215501] | Phase 1 | 54 participants (Actual) | Interventional | 2001-11-30 | Completed |
A Multicentre, Randomized Study of Trastuzumab Combined With Chemotherapy or Endocrine Therapy as the First Line Treatment for Patients With Metastatic Luminal B2 Breast Cancer Subtype [NCT01950182] | Phase 3 | 392 participants (Actual) | Interventional | 2013-09-16 | Completed |
A Phase I Dose Escalation Study to Assess the Maximum Tolerated Dose and Feasibility of Combining Oral Capecitabine (Xeloda) and Conformal Radiotherapy (CRT) for Patients With Unresectable Hepatocellular Carcinoma, Multiple Hepatic Metastases or Cholangio [NCT00216437] | Phase 1 | 30 participants (Anticipated) | Interventional | 2004-12-31 | Terminated(stopped due to lack of accrual) |
An Open-label, Multicenter Phase II Study of QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC [NCT05799820] | Phase 2 | 60 participants (Anticipated) | Interventional | 2022-09-29 | Recruiting |
A Randomized Phase II Trial of Preoperative Chemoradiation (Preop CRT) Followed by CapOx (Capecitabine Plus Oxaliplatin) Versus Preop CRT Alone for Locally Advanced Rectal Cancer (LARC) [NCT01952951] | Phase 2 | 110 participants (Actual) | Interventional | 2014-06-30 | Active, not recruiting |
A Phase 3, Multi-Center, Double-Blind, Randomized, Efficacy and Safety Study of M108 Monoclonal Antibody Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectab [NCT06177041] | Phase 3 | 486 participants (Anticipated) | Interventional | 2023-12-18 | Not yet recruiting |
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01) [NCT06109779] | Phase 3 | 750 participants (Anticipated) | Interventional | 2023-12-04 | Recruiting |
Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Bevacizumab in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis [NCT01962376] | Phase 4 | 60 participants (Anticipated) | Interventional | 2013-02-28 | Recruiting |
Phase II Trial of Exploring the Predictive Factors of Docetaxol Plus Capecitabine(TX) Regimen and Oxaliplatin Plus Capecitabine (XELOX) Regimen in the First Line Treatment of Patients With Metastatic Gastric Cancer (MGC) [NCT01963702] | Phase 2 | 120 participants (Anticipated) | Interventional | 2012-08-31 | Recruiting |
A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/o [NCT05629585] | Phase 3 | 1,075 participants (Anticipated) | Interventional | 2022-11-28 | Recruiting |
A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors [NCT05625412] | Phase 1 | 220 participants (Anticipated) | Interventional | 2022-12-09 | Recruiting |
A Prospective, Multi-Center, Randomized Control Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer [NCT01967875] | Phase 2 | 27 participants (Actual) | Interventional | 2013-07-31 | Terminated(stopped due to slow enrollment) |
Phase 2 Study of Two Consequent Chemotherapy Regimens as Induction Preoperative Therapy for Patients With Locally Advanced Triple Negative Breast Cancer [NCT01969032] | Phase 2 | 41 participants (Actual) | Interventional | 2011-08-31 | Completed |
A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer [NCT01975454] | Phase 1/Phase 2 | 62 participants (Actual) | Interventional | 2012-04-30 | Completed |
Andrographolides With or Without Capecitabine for Elderly Patients With Locally Advanced or Recurrent or Metastasis Inoperable Colorectal Cancer: a Randomized, Open-label Trial. [NCT01993472] | Phase 2 | 308 participants (Anticipated) | Interventional | 2013-11-30 | Terminated(stopped due to low accrual rate) |
A Multinational, Randomized, Phase III Study of XELIRI With/Without Bevacizumab Versus FOLFIRI With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer [NCT01996306] | Phase 3 | 650 participants (Actual) | Interventional | 2013-12-02 | Completed |
Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy [NCT00250029] | | 30 participants (Actual) | Interventional | 2004-04-30 | Completed |
Modified Folinic Acid-Fluorouracil-Oxaliplatin (FOLFOX) Followed by Capecitabine as First-line Chemotherapy for Elderly or Frail Patients With Metastatic or Recurrent Gastric Cancer [NCT02002195] | | 47 participants (Anticipated) | Observational | 2013-11-30 | Recruiting |
Phase II Study of Trastuzumab in Combination With Chemotherapy (Docetaxel Plus Capecitabine) For First Line Treatment of Her2-Positive Advanced Gastric or Gastro-Esophageal Junction Cancer [NCT02004769] | Phase 2 | 67 participants (Actual) | Interventional | 2013-11-30 | Completed |
Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma [NCT00225056] | Phase 2 | 43 participants | Interventional | 2003-10-31 | Terminated(stopped due to Terminated due to lack of accrual) |
XELOX and Bevacizumab in Combination With Tislelizumab for First-Line Treatment of Patients With MSS/pMMR RAS-mutated Metastatic Colorectal Cancer (mCRC): A Single-arm, Phase II Study. [NCT05970302] | Phase 2 | 52 participants (Anticipated) | Interventional | 2023-07-07 | Recruiting |
Total Neoadjuvant Therapy With Split-course Hypofraction Radiotherapy Combined With CAPOX and Envafolimab Followed by Local Excision for Locally Advanced Very Low Rectal Cancer: an Open-label, Single-arm, Multi-center, Phase II Trial [NCT05969847] | Phase 2 | 72 participants (Anticipated) | Interventional | 2023-08-15 | Not yet recruiting |
An Open-Label, Multi-center Phase Ⅰb/Ⅱ Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression. [NCT05845138] | Phase 1/Phase 2 | 116 participants (Anticipated) | Interventional | 2023-07-25 | Recruiting |
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid Tumors [NCT04487236] | Phase 1 | 84 participants (Anticipated) | Interventional | 2020-10-15 | Recruiting |
Perioperative Chemotherapy Plus PD-1 Antibody Compared With Perioperative Chemotherapy in the Locally Advanced Gastric Cancer: a Open-label, Phase 2 Randomised Controlled Trial [NCT04250948] | Phase 2 | 108 participants (Actual) | Interventional | 2019-10-12 | Active, not recruiting |
Phase III Clinical Study of PD-1 Monoclonal Antibody-activated Autologous Peripheral Blood T-lymphocyte (PD1-T) Combined With XELOX and Bevacizumab in the First-line Treatment of Recurrent and Metastatic Colorectal Cancer [NCT03950154] | Phase 3 | 198 participants (Anticipated) | Interventional | 2019-06-01 | Recruiting |
MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer Patients Previously Treated With Fluoropyrimidine and Platinum Agents MiCADO Study [NCT02007148] | Phase 2 | 51 participants (Anticipated) | Interventional | 2013-11-30 | Recruiting |
A Randomized Phase III Post-operative Trial of Platinum Based Chemotherapy vs. Capecitabine in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy [NCT02445391] | Phase 3 | 415 participants (Actual) | Interventional | 2015-10-20 | Active, not recruiting |
Efficacy and Safety of Neoadjuvant Chemo-chemoradio-chemo Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer: a Phase II Trial [NCT02022852] | Phase 2 | 80 participants (Anticipated) | Interventional | 2013-07-31 | Recruiting |
A Multi-centre Randomised Study of Induction Chemotherapy Followed by Capecitabine (+/-Nelfinavir) With High or Standard Dose Radiotherapy for Locally Advanced Non-metastatic Pancreatic Cancer [NCT02024009] | Phase 1/Phase 2 | 289 participants (Anticipated) | Interventional | 2016-03-31 | Recruiting |
A Phase 1b, Open-label Study to Assess the Safety and Tolerability of Tucatinib (ONT-380) Combined With Capecitabine and Trastuzumab, Alone and in Combination in HER2+ Metastatic Breast Cancer [NCT02025192] | Phase 1 | 60 participants (Actual) | Interventional | 2013-12-31 | Completed |
A Phase III, Multicenter, Open-label, Randomized Study to Assess the Efficacy and Safety of Cetuximab Plus Capecitabine Versus Cetuximab as Maintenance Treatment Following First-line Induction Treatment With FOLFOX and Cetuximab in Chinese Patients With R [NCT04262635] | Phase 3 | 80 participants (Actual) | Interventional | 2021-09-24 | Active, not recruiting |
A Phase 1, Open-Label, Non-randomized, Dose-Escalating Safety, Tolerability, and Pharmacokinetic Study of TAS-114 in Combination With Capecitabine in Patients With Advanced Solid Tumors [NCT02025803] | Phase 1 | 60 participants (Anticipated) | Interventional | 2012-11-30 | Completed |
Maintenance Treatment With Capecitabine Versus Observation After First Line Chemotherapy in Patients With Metastatic Colorectal Cancer: a Randomized Phase II Study [NCT02027363] | Phase 2 | 245 participants (Anticipated) | Interventional | 2010-01-31 | Active, not recruiting |
Evaluation of Response to Two Schedules of Capecitabine in Patients With Metastatic Breast Cancer [NCT02028494] | | 350 participants (Anticipated) | Interventional | 2013-08-31 | Recruiting |
A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinoma [NCT05940441] | | 74 participants (Anticipated) | Observational [Patient Registry] | 2023-07-01 | Recruiting |
A Phase I Study of Oxaliplatin in Combination With Capecitabine in Metastatic/Recurrent Solid Tumors [NCT00005839] | Phase 1 | 0 participants | Interventional | 2000-08-31 | Completed |
Randomised Phase III Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over Intergroup Trial: Ffcd, Gercor, Gerico, Unicancer-gi [NCT02355379] | Phase 3 | 774 participants (Anticipated) | Interventional | 2015-01-31 | Recruiting |
Phase I Study of Oxaliplatin (NSC# 266046), Irinotecan, and Capecitabine in Patients With Solid Tumors [NCT00006465] | Phase 1 | 22 participants (Actual) | Interventional | 2000-12-31 | Completed |
Organoid-Guided Functional Precision Therapy Versus Treatment of Physician's Choice in Previously Treated HER2-negative Advanced Breast Cancer: A Phase II, Multicenter, Open-label, Randomized Controlled Trial [NCT06102824] | Phase 2 | 252 participants (Anticipated) | Interventional | 2024-01-20 | Recruiting |
A Phase I/II Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC) [NCT05849480] | Phase 1/Phase 2 | 60 participants (Anticipated) | Interventional | 2024-01-03 | Not yet recruiting |
Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment of Stage III and High-risk Stage II Resected Colon Cancer Patients With Adjuvant FOLFOXIRI and/or Post-adjuvant Trifluridine/Tipiracil [NCT05062889] | Phase 2 | 477 participants (Anticipated) | Interventional | 2023-05-17 | Recruiting |
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+ [NCT04895358] | Phase 3 | 800 participants (Anticipated) | Interventional | 2021-06-18 | Recruiting |
Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study [NCT00689702] | Phase 2 | 43 participants (Actual) | Interventional | 2007-02-28 | Active, not recruiting |
Phase II Study of the Combination of Bevacizumab (rhuMab VEGF) and Oxaliplatin Plus Capecitabine (XELOX) in Patients With Advanced Colorectal Cancer [NCT01159171] | Phase 2 | 50 participants (Actual) | Interventional | 2006-01-31 | Completed |
Priming the Tumour MicroEnvironment for Effective Treatment With Immunotherapy in Locally Advanced Rectal Cancer A Phase II Trial of Durvalumab (MEDI 4736) in Combination With Extended Neoadjuvant Regimens in Rectal Cancer [NCT04621370] | Phase 2 | 48 participants (Anticipated) | Interventional | 2020-12-07 | Not yet recruiting |
Phase I Study of Combination of Capecitabine and Erlotinib Concurrent With Radiotherapy in Patients With Non-Operable Locally Advanced Pancreatic Cancer [NCT00565487] | Phase 1 | 15 participants (Actual) | Interventional | 2007-12-31 | Completed |
Phase II Study on Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer [NCT00568529] | Phase 2 | 30 participants (Anticipated) | Interventional | 2007-10-31 | Suspended(stopped due to There are not enough patients enrolled.) |
An Open-label Study of the Effect of First-line Treatment With Avastin+Xelox, Followed by Avastin+Tarceva, on Progression-free Survival in Patients With Metastatic Colorectal Cancer [NCT01135498] | Phase 2 | 90 participants (Actual) | Interventional | 2006-11-30 | Completed |
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Unresectable Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) [NCT02210364] | Phase 1 | 81 participants (Actual) | Interventional | 2013-04-30 | Completed |
Phase II Study of Capecitabine in Combination With Oxaliplatin and Radiotherapy for Esophageal and Gastroesophageal Junction Cancer [NCT00470184] | Phase 2 | 41 participants (Actual) | Interventional | 2006-11-30 | Completed |
Phase II Study of an All-Oral Combination of Capecitabine (X) and Cyclophosphamide (C) in Patients With Anthracycline- and Taxane-Pretreated Metastatic Breast Cancer [NCT00589901] | Phase 2 | 60 participants (Anticipated) | Interventional | 2006-08-31 | Recruiting |
Phase II Study of Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens [NCT00591188] | Phase 2 | 49 participants (Anticipated) | Interventional | 2006-12-31 | Completed |
Neoadjuvant Complete Hormonal Blockade Followed by Neoadjuvant Chemotherapy for Resectable Hormone Receptor Positive, HER-2/Neu Negative Breast Cancer, A Phase II Study [NCT00194792] | Phase 2 | 28 participants (Actual) | Interventional | 2005-08-31 | Terminated |
Clinical Evaluation of Lapatinib Administered With Capecitabine in Japanese Patients With ErbB2 Overexpressing Advanced or Metastatic Breast Cancer [NCT00477464] | Phase 2 | 51 participants (Actual) | Interventional | 2007-06-30 | Completed |
An Open-label, Multi-centre Study of Lapatinib in Combinationwith Chemotherapy in Patients With ErbB2 Overexpressing Breastcancer After Trastuzumab Failure in the Neoadjuvant or Adjuvantsetting. [NCT00479856] | Phase 2 | 9 participants (Actual) | Interventional | 2007-11-30 | Terminated(stopped due to Study was terminated due to difficulty in identifying eligible subjects) |
A Randomized Controlled Clinical Trial to Investigate the Effect of Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer [NCT02882269] | Phase 2/Phase 3 | 400 participants (Anticipated) | Interventional | 2016-12-31 | Not yet recruiting |
A Phase 2 Study of Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma [NCT02218164] | Phase 2 | 8 participants (Actual) | Interventional | 2014-08-12 | Completed |
Randomized Phase II Trial of Preoperative Chemoradiation With or Without Induction Chemotherapy In Patients With Locally Advanced Or Borderlinely Resectable Rectal Cancer With Resectable Synchronous Liver Metastases [NCT01643070] | Phase 2 | 38 participants (Anticipated) | Interventional | 2010-01-31 | Active, not recruiting |
Study Evaluating Vinorelbine Plus Capecitabine in the Treatment of Luminal B Breast Cancer Patients After Neoadjuvant Chemotherapy [NCT04307147] | Phase 3 | 316 participants (Anticipated) | Interventional | 2018-07-03 | Recruiting |
A Phase 1, Open-Label Study Of Neratinib (HKI-272) In Combination With Capecitabine In Japanese Subject With Solid Tumors [NCT01128842] | Phase 1 | 7 participants (Actual) | Interventional | 2010-04-30 | Completed |
Pharmacogenetics and Therapeutic Drug Monitoring for the Optimization of Fluoropyrimidine Treatment in Patients With Advanced Colorectal Cancer [NCT01641458] | Phase 4 | 37 participants (Actual) | Interventional | 2012-10-31 | Completed |
Preoperative ChemoRadiation And FOLFOXIRI To Escalate Complete Response for Rectal Cancer (CRAFTER) [NCT05358704] | Phase 2 | 38 participants (Anticipated) | Interventional | 2022-05-13 | Recruiting |
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects [NCT06079983] | Phase 3 | 400 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
Neoadjuvant Chemoradiotherapy Versus Neoadjuvant Chemotherapy For Unresectable Locally Advanced Colon Cancer: An Open, Multi-centered, Randomize Controlled Phase 3 Trial. [NCT03970694] | Phase 3 | 49 participants (Actual) | Interventional | 2019-05-11 | Terminated(stopped due to Significant differences in conversion rate as well as R0 resection rate between the two groups.) |
A Phase I/II Study Exploring the Safety and Activity of Trifluridine/Tipiracil in Combination With Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients [NCT04564898] | Phase 1/Phase 2 | 48 participants (Anticipated) | Interventional | 2022-01-25 | Recruiting |
A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroe [NCT03675737] | Phase 3 | 1,579 participants (Actual) | Interventional | 2018-11-08 | Active, not recruiting |
A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer [NCT02921256] | Phase 2 | 363 participants (Actual) | Interventional | 2017-01-11 | Completed |
A Phase III Study for ErbB2 Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma Treated With Capecitabine Plus Oxaliplatin With or Without Lapatinib [NCT00680901] | Phase 3 | 545 participants (Actual) | Interventional | 2008-06-04 | Active, not recruiting |
AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST-LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC [NCT04607421] | Phase 3 | 815 participants (Anticipated) | Interventional | 2020-12-21 | Recruiting |
A Randomized, Phase II Study of Tesetaxel Once Every 3 Weeks Versus Tesetaxel Once Weekly for 3 Weeks Versus Capecitabine Twice Daily for 14 Days as First-line Therapy for Subjects With Locally Advanced or Metastatic Breast Cancer [NCT01609127] | Phase 2 | 213 participants (Anticipated) | Interventional | 2012-05-31 | Recruiting |
Phase II Randomized Study of Maintenance Treatment With Bevacizumab or Bevacizumab Plus Metronomic Chemotherapy After First-line Induction FOLFOXIRI Plus Bevacizumab for Metastatic Colorectal Cancer Patients [NCT02271464] | Phase 2 | 232 participants (Actual) | Interventional | 2012-03-31 | Completed |
A Phase II Study of Capecitabine and Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer [NCT00107315] | Phase 2 | 16 participants (Actual) | Interventional | 2004-07-31 | Terminated(stopped due to Terminated due to low accrual) |
Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer [NCT00107276] | Phase 2 | 112 participants (Actual) | Interventional | 2005-08-31 | Completed |
A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin With or Without Cisplatin Chemotherapy as Treatment for Unresectable or Metastatic Neuroendocrine Tumors [NCT00602082] | Phase 2 | 84 participants (Anticipated) | Interventional | 2005-08-31 | Completed |
A Phase 1b/2, Multicenter, Open-Label, Dose-Escalation and Confirmation Study of Eribulin in Combination With Capecitabine [NCT01323530] | Phase 1/Phase 2 | 76 participants (Actual) | Interventional | 2010-01-26 | Completed |
A Single-arm Open-label Phase II Study: Treatment Beyond Progression by Adding Bevacizumab to XELOX or FOLFOX Chemotherapy in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI + Bevacizumab Combination [NCT01077739] | Phase 2 | 75 participants (Actual) | Interventional | 2009-07-31 | Completed |
Randomized Phase II Study of NaliCap (Irinotecan Liposome/Capecitabine) Compared to NAPOLI (Irinotecan Liposome/5-fluorouracil/Leucovorin) in Gemcitabine-pretreated Advanced Pancreatic Cancer [NCT04371224] | Phase 2 | 200 participants (Anticipated) | Interventional | 2020-06-23 | Recruiting |
A Randomized Phase II Study of the Efficacy and Safety of Hypofractionated Stereotactic Radiotherapy and 5FU or Capecitabine With and Without Zometa in Patients With Locally Advanced Pancreatic Adenocarcinoma [NCT03073785] | Phase 2 | 44 participants (Anticipated) | Interventional | 2016-09-16 | Recruiting |
TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma, a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial [NCT02940925] | Phase 3 | 241 participants (Actual) | Interventional | 2016-10-20 | Completed |
Phase III, Multicenter, Ramdomised, Open-label, Study to Evaluate the Safety and Efficacy of Combination Therapy With XELOX vs. Oxaliplatin and 5-FU CI as First Line Treatment in Advanced or Metastatic Colorectal Cancer [NCT00202774] | Phase 3 | 348 participants (Actual) | Interventional | 2002-04-30 | Completed |
Phase II Study of Oxaliplatin, Capecitabine and Endostar as First Line Treatment for Patients With Advanced Colorectal Cancer [NCT00853684] | Phase 2 | 44 participants (Anticipated) | Interventional | 2009-02-28 | Recruiting |
Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies [NCT02419495] | Phase 1 | 221 participants (Actual) | Interventional | 2015-06-26 | Active, not recruiting |
Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers [NCT00885066] | Phase 1 | 30 participants (Actual) | Interventional | 2008-05-31 | Completed |
Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines [NCT00838370] | Phase 1 | 22 participants (Actual) | Interventional | 2007-05-31 | Completed |
NGR005: Pilot Study of NGR-hTNF Administered at Low and High Doses in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer [NCT00675012] | Phase 2 | 24 participants (Actual) | Interventional | 2007-12-31 | Completed |
Phase I/IB Multi-center Study of Irreversible EGFR/HER2 Tyrosine Kinase Inhibitor Afatinib (BIBW 2992) in Combination With Capecitabine for Advanced Solid Tumors and Pancretico-Biliary Cancers [NCT02451553] | Phase 1 | 41 participants (Actual) | Interventional | 2015-11-05 | Completed |
Phase II Study of the Gemzar, Taxotere and Xeloda Regimen (GTX) for Inoperable or Metastatic Adenocarcinoma of the Biliary System [NCT00868998] | Phase 2 | 4 participants (Actual) | Interventional | 2005-08-31 | Terminated(stopped due to Poor patient accrual) |
A Phase I Pharmacokinetic and Safety Study of Sorafenib + Capecitabine in Advanced Solid Tumors [NCT00613145] | Phase 1 | 32 participants (Actual) | Interventional | 2008-02-29 | Completed |
Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer [NCT04159142] | Phase 2 | 414 participants (Anticipated) | Interventional | 2019-11-20 | Recruiting |
A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma [NCT00711412] | Phase 2 | 44 participants (Actual) | Interventional | 2006-05-31 | Completed |
An Exploratory, Phase II Trial to Determine the Association of Lapatinib Induced Fluoropyrimidine Gene Changes With Efficacy Parameters of Lapatinib and Capecitabine in First Line Gastric Cancer [NCT00526669] | Phase 2 | 68 participants (Actual) | Interventional | 2008-03-31 | Completed |
A Phase II Study of Capecitabine in Combination With Irinotecan and Oxaliplatin (Eloxatin) in Adult Patients With Advanced Colorectal Cancer [NCT00215982] | Phase 2 | 24 participants (Actual) | Interventional | 2004-12-31 | Completed |
A Randomized Multicenter Phase III Study Comparing Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment or Cisplatin Plus Capecitabine in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction [NCT01015339] | Phase 3 | 320 participants (Anticipated) | Interventional | 2009-11-30 | Recruiting |
A Randomized Phase II Study of Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Advanced or Recurrent Colorectal Cancer [NCT00677144] | Phase 2 | 88 participants (Actual) | Interventional | 2008-04-30 | Completed |
Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer [NCT06156761] | | 24 participants (Anticipated) | Interventional | 2023-11-28 | Not yet recruiting |
Novel Targeting of the Microenvironment to Decrease Metastatic Recurrence of High-Risk TNBC: A Randomized Phase II Study of Tetrathiomolybdate (TM) Plus Capecitabine in Patients With Breast Cancer at High Risk of Recurrence [NCT06134375] | Phase 1/Phase 2 | 204 participants (Anticipated) | Interventional | 2024-03-31 | Not yet recruiting |
A Phase Ib, Open-Label, Multicenter Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Patients With Locally Advanced or Metas [NCT05867121] | Phase 1 | 120 participants (Anticipated) | Interventional | 2023-10-02 | Recruiting |
A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine as Maintenance Therapy in Patients With Unresectab [NCT05609370] | Phase 1/Phase 2 | 226 participants (Anticipated) | Interventional | 2023-01-29 | Recruiting |
Metastatic Triple-Negative Taxane-Resistant Breast Cancer: Investigating the Role of Bexarotene in Inducing Susceptibility to Chemotherapy by Differentiating Cancer Cells From a Mesenchymal-Like to an Epithelial-Like Phenotype [NCT04664829] | Phase 1 | 12 participants (Anticipated) | Interventional | 2020-10-01 | Recruiting |
Single Arm, Open, Multicenter Phase II Clinical Study of Sufficient Chemotherapy Combine With Maintenance Chemotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma [NCT04319471] | Phase 2 | 70 participants (Anticipated) | Interventional | 2020-06-01 | Not yet recruiting |
Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia [NCT00938470] | Phase 2 | 73 participants (Actual) | Interventional | 2010-01-31 | Completed |
Phase II Trial Assessing the Impact on the Activity of Daily Living of an Oral Chemotherapy by Capecitabine Associated With an Intravenous Chemotherapy by Oxaliplatin as First Line Treatment of Metastatic Colorectal Adenocarcinoma of Patients Aged Over 70 [NCT00104689] | Phase 2 | 60 participants (Anticipated) | Interventional | 2003-06-30 | Completed |
Phase 1/2 Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Oesophageal Cancer [NCT02735239] | Phase 1/Phase 2 | 73 participants (Actual) | Interventional | 2016-06-24 | Completed |
Single-agent Capecitabine as Metronomic Chemotherapy in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (CMHN):A Phase III, Multicentre, Randomised Controlled Trial [NCT05044117] | Phase 3 | 220 participants (Anticipated) | Interventional | 2021-10-18 | Recruiting |
Phase I Trial of Preoperative Radiotherapy With Concurrent Bevacizumab, Erlotinib and Capecitabine for Locally Advanced Pancreatic Cancer [NCT00614653] | Phase 1 | 17 participants (Actual) | Interventional | 2008-01-31 | Completed |
A Clinical Study Evaluating the Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer - A Multicenter, Randomized, Open-label, Positive-controlled, Superiority Phase III Clinical Trial in China [NCT04185649] | Phase 3 | 410 participants (Anticipated) | Interventional | 2018-07-01 | Active, not recruiting |
Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer--Randomized, Open, Multicenter Clinical Study [NCT05479240] | Phase 2 | 94 participants (Anticipated) | Interventional | 2023-09-01 | Not yet recruiting |
A Phase II Open-label Randomized Study of a Fixed-dose Combination of Capecitabine and Cyclophosphamide Administered at Different Doses/Regimens With Metronomic Schedule in Patients With Metastatic Breast Cancer [NCT02664103] | Phase 2 | 2 participants (Actual) | Interventional | 2016-01-23 | Completed |
A Randomized, Phase II Study Comparing Single X (Xeloda/Capetabine) With Placebo as Postoperative Adjuvant Treatment for Elder Breast Cancer [NCT02838238] | Phase 2 | 300 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
The Effect of Preoperative Docetaxel, Cisplatin and Capecitabine on Serum RUNX3 Hypermethylation Status in Patients With Gastric and Lower Oesophagus Adenocarcinoma. [NCT00674167] | Phase 2 | 21 participants (Actual) | Interventional | 2007-05-31 | Active, not recruiting |
A Phase 1 Safety And Pharmacokinetic Study Of SU011248 And Capecitabine In Patients With Advanced Solid Tumors [NCT00618124] | Phase 1 | 77 participants (Actual) | Interventional | 2005-05-31 | Completed |
A Phase II Study to Assess the Effectiveness and Safety of Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID) [NCT04296162] | Phase 2 | 178 participants (Anticipated) | Interventional | 2019-03-01 | Recruiting |
Safety and Efficacy of Induction and Individualized Neoadjuvant Chemotherapy Based on Oxaliplatin Combined With Fluorouracil for MRF-negative, Moderate-risk and Initially Resectable Middle and Low Rectal Cancer [NCT04296240] | Phase 2 | 119 participants (Anticipated) | Interventional | 2019-03-01 | Recruiting |
Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer [NCT00629148] | Phase 2 | 60 participants (Actual) | Interventional | 2007-08-31 | Completed |
Phase Ⅲ Randomized Trial of Cisplatin Plus Docetaxel Versus Cetuximab, Cisplatin, and Docetaxel Induction Chemotherapy Followed by Concurrent Chemoradiation in Previously Untreated Patients Metastatic Nasopharyngeal Carcinoma [NCT02633176] | Phase 3 | 120 participants (Anticipated) | Interventional | 2015-01-31 | Recruiting |
A Phase Ib/II, Open Label, Multi-center Study Evaluating the Safety and Efficacy of BKM120 in Combination With Trastuzumab in Patients With Relapsing HER2 Overexpressing Breast Cancer Who Have Previously Failed Trastuzumab [NCT01132664] | Phase 1/Phase 2 | 72 participants (Actual) | Interventional | 2010-05-31 | Terminated(stopped due to Due to the rare patient population and challenges to enroll patients.) |
mXELOXIRI Combined With Molecular Targeted Drug as First-line Therapy in Patients With Initially Unresectable Metastatic Colorectal Cancer: A Phase II, Single-arm, Prospective Clinical Study [NCT04160416] | Phase 2 | 48 participants (Anticipated) | Interventional | 2019-07-01 | Recruiting |
A Phase II Study of Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma [NCT00658840] | Phase 2 | 55 participants (Anticipated) | Interventional | 2006-06-30 | Recruiting |
Effect of Concurrent Capecitabine-based Long-term Radiotherapy Followed by 4 Cycles XELOX Pre- a Delayed TME Compared With 6 Cycles XELOX post-a Regular Timing TME in Patients With High Risk Rectal Cancer: a Multi-centers, Randomized, Open-Label Trial [NCT03038256] | Phase 2 | 244 participants (Anticipated) | Interventional | 2018-01-31 | Recruiting |
A Multicenter, Open-label, Treatment Protocol of Tucatinib in Combination With Capecitabine and Trastuzumab in Patients With Previously Treated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma [NCT04220203] | | 0 participants | Expanded Access | | Approved for marketing |
A Phase III Randomized, Double Blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer [NCT01234337] | Phase 3 | 537 participants (Actual) | Interventional | 2011-02-21 | Completed |
A Phase 1/2, Open-Label Study Of Bosutinib Administered In Combination With Capecitabine In Subjects With Solid Tumor And ErbB2 Negative Locally Advanced Or Metastatic Breast Cancer [NCT00959946] | Phase 1/Phase 2 | 32 participants (Actual) | Interventional | 2009-09-30 | Terminated |
A Phase 2, Single Arm, Multi-center, Open-Label Trial to Evaluate the Safety and Efficacy of Treatment With Tumor Treating Fields (TTFields) and Chemotherapy as First-Line Treatment for Subjects With Unresectable Gastroesophageal Junction (GEJ) Adenocarci [NCT04281576] | | 28 participants (Anticipated) | Interventional | 2019-12-19 | Recruiting |
A Randomized, Open Label Study Comparing the Efficacy of Topical Corticosteroids or Bepantol in the Prophylaxis of Hand-foot Syndrome in Patients Receiving Oral Xeloda for Treatment of Metastatic Breast Cancer or Colorectal Cancer. [NCT00661102] | Phase 3 | 598 participants (Actual) | Interventional | 2008-12-31 | Completed |
Biweekly Docetaxel (Taxotere®)in Combination With Capecitabine (Xeloda®)as First-Line Treatment in Patients With Advanced Gastric Cancer [NCT00669370] | Phase 2 | 50 participants (Anticipated) | Interventional | 2006-06-30 | Recruiting |
A Phase II Trial of Capecitabine, Oxaliplatin and Trastuzumab (CAPOX-T) in Patients With HER-2 Positive Metastatic Breast Cancer: Hoosier Oncology Group BRE03-61 [NCT00216073] | Phase 2 | 11 participants (Actual) | Interventional | 2004-03-31 | Terminated(stopped due to Lack of patient accrual) |
An Open-label Study to Assess the Effect of Combination Treatment With Avastin and Xeloda, Plus Pre-operative Standard Radiotherapy, on Response Rate in Patients With Locally Advanced Rectal Cancer. [NCT01227707] | Phase 2 | 43 participants (Actual) | Interventional | 2005-11-30 | Completed |
MoTriColor: Phase I/II Study With LY3200882 Combined With Capecitabine in Patients With Advanced Chemotherapy Resistant Colorectal Cancer and an Activated TGF-beta Signature [NCT04031872] | Phase 1/Phase 2 | 31 participants (Anticipated) | Interventional | 2020-02-29 | Not yet recruiting |
Tailored Operative or Non-operative Management for MRI Defined Low-risk Rectal Cancer Following Neoadjuvant Intensity Modulated Radiotherapy With Concurrent Capecitabine Plus Consolidation CapeOX. [NCT02860234] | | 68 participants (Actual) | Observational | 2016-08-31 | Completed |
A Phase 1 Study of Veliparib (ABT-888) in Combination With Capecitabine and Temozolomide in Advanced Well-Differentiated Neuroendocrine Tumors [NCT02831179] | Phase 1 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Loss of funding support) |
A Prospective, Randomized, Open-label, Multicenter, Parallel Design, Phase III Study to Assess the Efficacy and Safety of GV1001 Concurrent With Gemcitabine/Capecitabine Versus Gemcitabine/Capecitabine Alone in Treating Locally Advanced and Metastatic Pan [NCT02854072] | Phase 3 | 148 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting |
A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab as the Adjuvant Treatment of HER2 Positive Patients Following Neoadjuvant Chemotherapy [NCT04302441] | Phase 2 | 550 participants (Anticipated) | Interventional | 2016-11-10 | Recruiting |
Phase III Multicenter Study of the Effects on Quality of Life of Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer [NCT00540800] | Phase 3 | 139 participants (Actual) | Interventional | 2004-02-29 | Completed |
Phase II Multicenter Study of the Impact of the Therapeutic Sequence of Radiochemotherapy (50 Gy + Capecitabine + Oxaliplatin + Cetuximab) Followed by Total Mesorectal Excision Surgery Then Post-surgery Chemotherapy (FOLFOX 4 + Cetuximab) in Synchronous L [NCT00541112] | Phase 2 | 19 participants (Actual) | Interventional | 2007-10-29 | Terminated(stopped due to Toxicity and lack of efficacy) |
Phase I/II Trial of Preoperative Radiotherapy With Concurrent Bevacizumab, Erlotinib and Capecitabine for Locally Advanced Rectal Cancer [NCT00543842] | Phase 1 | 19 participants (Actual) | Interventional | 2007-12-31 | Completed |
Phase Ib Study of MEK162 in Combination With Capecitabine in Gemcitabine-pretreated Advanced Biliary Tract Cancer [NCT02773459] | Phase 1/Phase 2 | 31 participants (Actual) | Interventional | 2016-04-30 | Completed |
A Phase II Study of Neoadjuvant FOLFOXIRI Followed by Concurrent Capecitabine and Radiotherapy for High Risk Rectal Cancer [NCT01941641] | Phase 2 | 40 participants (Anticipated) | Interventional | 2013-10-09 | Active, not recruiting |
Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Capecitabine in Patient With Non-resectable Liver Metastases From Breast Cancer. A Phase II Trial [NCT01387373] | Phase 2 | 14 participants (Actual) | Interventional | 2010-04-30 | Completed |
A Phase II Study of Trastuzumab in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer [NCT01396707] | Phase 2 | 55 participants (Actual) | Interventional | 2011-06-30 | Completed |
Precise Treatment for BLIS Subtype of Triple-negative Breast Cancer in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer [NCT05806060] | Phase 3 | 192 participants (Anticipated) | Interventional | 2023-04-25 | Recruiting |
Induction Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma A Prospective Evaluation in Patients With Locally Advanced Pancreas Cancer [NCT01360593] | Phase 2 | 35 participants (Actual) | Interventional | 2011-07-25 | Completed |
Phase II Study to Evaluate Efficacy and Safety of Capecitabine/Cisplatin Combination Therapy in Gastric Cancer Patients Who Relapsed After S-1 Adjuvant Chemotherapy (XParTS) [NCT01412294] | Phase 2 | 40 participants (Anticipated) | Interventional | 2011-07-31 | Active, not recruiting |
A Randomized, Open-Label, Phase III Study of RPR109881 IV Every 3 Weeks Versus Capecitabine (Xeloda) Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients With Metastatic Breast Cancer Progressing After Taxanes and Anthracycline Therapy [NCT00081796] | Phase 3 | 438 participants (Actual) | Interventional | 2004-04-30 | Completed |
AX (Doxorubicin, Capecitabine) Versus AC (Doxorubicin, Cyclophosphamide) as Adjuvant Treatment for Node-Negative Breast Cancer [NCT01415336] | Phase 2/Phase 3 | 300 participants (Anticipated) | Interventional | 2010-03-31 | Recruiting |
INST: Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer [NCT00277069] | Phase 1/Phase 2 | 33 participants (Actual) | Interventional | 2000-05-31 | Completed |
An Open Label Study of First Line Chemotherapy With Xeloda in Combination With Cisplatin on Treatment Response in Patients With Metastatic Nasopharyngeal Cancer [NCT00439426] | Phase 2 | 25 participants (Actual) | Interventional | 2007-04-30 | Completed |
A Phase I Study of GTI-2040 in Combination With Oxaliplatin and Capecitabine in Patients With Advanced Metastatic Solid Tumors [NCT00084643] | Phase 1 | 20 participants (Actual) | Interventional | 2004-05-31 | Completed |
Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer: A Phase II Trial With Molecular Correlates [NCT00194727] | Phase 2 | 40 participants (Actual) | Interventional | 2002-05-31 | Completed |
A Phase I/II Study of Capecitabine (XELODA®, Roche) Plus Oxaliplatin (Eloxatin®, Sanofi) Plus ZD 1893 (IRESSA®) in the Treatment of Metastatic Colorectal Cancer [NCT00087334] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2004-01-31 | Terminated(stopped due to Withdrawn due to poor/low accrual) |
S0225: Phase II Study of Adjuvant Low-Dose Capecitabine After Salvage Surgery in Patients With Locally Recurrent or Persistent Squamous Cell Carcinoma of the Head and Neck [NCT00095641] | Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to no longer studying this disease site) |
Genomic and Proteomic Analysis of Docetaxel and Capecitabine as Primary Chemotherapy for Stage II-III Breast Cancer [NCT00198237] | Phase 2 | 40 participants | Interventional | 2003-03-31 | Completed |
A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer [NCT01041404] | Phase 3 | 584 participants (Actual) | Interventional | 2005-09-30 | Completed |
Phase IV Clinical Study of Safety and Tolerability of Oral Xeloda (Capecitabine) in Adjuvant Treatment of Resected Cancer of the Colon [NCT02581423] | Phase 4 | 63 participants (Actual) | Interventional | 2005-08-31 | Completed |
Pilot Trial of Capecitabine and Radiation Therapy With Pre and Post Combination Chemotherapy in Advanced Pancreatic Cancer [NCT00176735] | | 0 participants | Interventional | 2001-12-31 | Terminated |
Effect and Safety of Adjuvant Huaier Granule Versus Standard Chemotherapy Regimens in Resectable Stage II-III Gastric Cancer Patients: a Prospective, Multi-center, and Observational Study [NCT05498766] | | 828 participants (Anticipated) | Observational | 2023-10-12 | Recruiting |
A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN [NCT04550260] | Phase 3 | 640 participants (Actual) | Interventional | 2020-10-19 | Active, not recruiting |
Randomized Trial to Evaluate the Therapeutic Gain by Changing the Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and the Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma [NCT00577057] | | 798 participants (Anticipated) | Interventional | 2006-09-30 | Not yet recruiting |
INtegratioN of Trastuzumab, With or Without Pertuzumab, Into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL [NCT02205047] | Phase 2 | 171 participants (Anticipated) | Interventional | 2015-07-15 | Active, not recruiting |
A Phase II Multicenter Randomized Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Managem [NCT02008656] | Phase 2 | 358 participants (Actual) | Interventional | 2013-11-30 | Active, not recruiting |
A Phase I Pilot Study of the Oral mTOR Inhibitor RAD001 in Combination With Capecitabine for Metastatic Breast Cancer [NCT00473005] | Phase 1 | 18 participants (Actual) | Interventional | 2007-08-31 | Terminated(stopped due to Principal Investigator (Dr. Guardino) left Stanford) |
Phase I/II Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors [NCT00183833] | Phase 1 | 40 participants (Actual) | Interventional | 2002-12-31 | Completed |
Evaluation of Primary Chemotherapy With Docetaxel Plus Capecitabine in Selected Patients With Newly Diagnosed Localized or Locally Advanced Prostate Cancer [NCT00151047] | Phase 2 | 15 participants (Actual) | Interventional | 2003-03-31 | Completed |
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer [NCT05861271] | Phase 2 | 1,008 participants (Anticipated) | Interventional | 2023-07-01 | Not yet recruiting |
A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer [NCT00212589] | Phase 3 | 60 participants | Interventional | 2002-12-31 | Completed |
A Phase II Trial Assessing the Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer. [NCT00220116] | Phase 2 | 172 participants (Actual) | Interventional | 2002-08-31 | Completed |
[NCT00189683] | Phase 3 | 0 participants | Interventional | | Recruiting |
Nivolumab and CapeOX in Patients With FGFR2/PD-L1-positive Metastatic Gastric Adenocarcinoma: a Single-arm, Phase 2 Study [NCT05859477] | Phase 2 | 23 participants (Anticipated) | Interventional | 2022-06-05 | Recruiting |
Implementation of a Therapeutic Educational Program Applicated to Adherence of Patients Treated by Capecitabine Alone or in Combination With Lapatinib [NCT01847599] | | 65 participants (Actual) | Interventional | 2011-09-06 | Terminated(stopped due to interim analysis : discontinuation for efficacy of the intervention) |
Phase III Study of Docetaxel in Combination With Gemcitabine Versus Docetaxel in Combination With Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer [NCT00191438] | Phase 3 | 300 participants | Interventional | 2002-10-31 | Completed |
A Phase II Study of OSI-774 (Tarceva) in Combination With Oxaliplatin and Capecitabine in Previously Treated Patients With Stage IV Colorectal Cancer [NCT00123851] | Phase 2 | 32 participants | Interventional | 2003-03-31 | Completed |
Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer [NCT01871363] | Phase 2 | 35 participants (Anticipated) | Interventional | 2012-10-31 | Recruiting |
A Phase 1b/2, Dose-escalation, Randomized, Multicenter Study of Maintenance Ivaltinostat Plus Capecitabine or Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on FOLFIRINOX [NCT05249101] | Phase 1/Phase 2 | 70 participants (Anticipated) | Interventional | 2022-08-15 | Recruiting |
Multi-agent Low Dose Chemotherapy (Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, Irinotecan) Followed by Maintenance Olaparib and Pembrolizumab in Untreated Metastatic Pancreatic Ductal Adenocarcinoma. [NCT04753879] | Phase 2 | 38 participants (Anticipated) | Interventional | 2021-09-29 | Recruiting |
Study of Trastuzumab Combined With Capecitabine on HER2-positive Metastatic Breast Cancer Patients Pretreated With Trastuzumab and Taxanes or HER2- Positive Breast Cancer Patients Relapsed From (Neo)Adjuvant Therapy of Trastuzumab and Taxanes [NCT01290718] | Phase 2 | 4 participants (Actual) | Interventional | 2011-12-31 | Terminated(stopped due to Slow recruitment) |
The Combination of Neoadjuvant Short-course Radiotherapy and Immunotherapy in Locally Advanced Rectal Cancer:A Open-label Single-arm Phase II Trial. [NCT04663763] | Phase 2 | 40 participants (Anticipated) | Interventional | 2020-12-01 | Not yet recruiting |
Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma [NCT00544011] | Phase 2 | 47 participants (Anticipated) | Interventional | 2007-04-30 | Recruiting |
A Phase II Trial of Lapatinib and Capectiabine for Patients With Refractory Advanced Colorectal Adenocarcinoma (LAP109859) [NCT00574171] | Phase 2 | 29 participants (Actual) | Interventional | 2007-09-30 | Completed |
A Drug-drug Interaction Study of Capecitabine and Celecoxib in Patients With Advanced Solid Malignancies [NCT01705106] | Phase 1 | 21 participants (Actual) | Interventional | 2012-08-29 | Terminated(stopped due to The study was terminated early due to slow accrual.) |
A Muti-center, Open-label, Randomized, Phase III Study of Camrelizumab Plus Treatment of Physician Choice Versus Treatment of Physician Choice for Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Systemic Chemotherapy Regimens for [NCT05134194] | Phase 3 | 104 participants (Anticipated) | Interventional | 2021-11-30 | Not yet recruiting |
A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer [NCT00089479] | Phase 3 | 2,611 participants (Actual) | Interventional | 2002-08-31 | Completed |
Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer [NCT03745170] | Phase 3 | 650 participants (Actual) | Interventional | 2018-12-19 | Completed |
A Phase II Study of Combination Chemotherapy With Bevacizumab, Capecitabine and Oxaliplatin in Patients With Previously Untreated Metastatic or Recurrent Colorectal Cancer [NCT00378066] | Phase 2 | 49 participants (Actual) | Interventional | 2006-08-31 | Completed |
A Randomized, Phase III, Multicenter Clinical Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer [NCT01470742] | Phase 3 | 0 participants (Actual) | Interventional | 2010-09-30 | Withdrawn(stopped due to We stop because of problems such as insurance.) |
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer [NCT01472770] | Phase 2 | 49 participants (Actual) | Interventional | 2011-10-31 | Completed |
Phase I/IIB Study of Induction Chemotherapy With XELOX, Followed by Radiation Therapy and Dose Escalation of RAD001 in Patients With Esophageal Cancer [NCT01490749] | Phase 1 | 17 participants (Actual) | Interventional | 2012-02-29 | Completed |
A Phase I/IIa Study Combining Curcumin (Curcumin C3-Complex, Sabinsa) With Standard Care FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer. [NCT01490996] | Phase 1/Phase 2 | 41 participants (Actual) | Interventional | 2012-02-29 | Completed |
Phase II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton or Photon RT Plus Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer [NCT01494155] | Phase 2 | 50 participants (Actual) | Interventional | 2011-12-31 | Active, not recruiting |
Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer [NCT00345059] | Phase 3 | 84 participants (Actual) | Interventional | 2005-05-31 | Terminated(stopped due to slow accrual) |
A Randomized Phase III Study of Irinotecan Plus 5-fluorouracil Plus Leucovorin and Bevacizumab (FOLFIRI+Avastin) Versus Irinotecan Plus Capecitabine and Bevacizumab (XELIRI+Avastin) as 1st Line Treatment of Locally Advanced or Metastatic Colorectal Cancer [NCT00469443] | Phase 3 | 330 participants (Anticipated) | Interventional | 2006-12-31 | Completed |
A Open Label Study of the Effect of First-line Therapy With Xeloda in Combination With Oxaliplatin on Overall Response Rate in Patients With Locally Advanced and/or Metastatic Gastric Cancer [NCT00436241] | Phase 2 | 45 participants (Actual) | Interventional | 2007-03-31 | Completed |
Maintenance Treatment With Capecitabine and Bevacizumab Versus Observation After Induction Treatment With Chemotherapy and Bevacizumab as First-line Treatment in Patients With Advanced Colorectal Carcinoma [NCT00442637] | Phase 3 | 635 participants (Anticipated) | Interventional | 2007-01-31 | Active, not recruiting |
A Multicenter Randomized Phase III Study of Gemcitabine Plus Herceptin Combination Versus the Capecitabine Plus Herceptin Combination in Pretreated Patients With HER-2 Positive Metastatic Breast Cancer [NCT00440622] | Phase 3 | 90 participants (Actual) | Interventional | 2003-04-30 | Terminated(stopped due to Due to poor accrual) |
A Phase I/II Study to Determine the Safety and Efficacy of Second-Line Treatment With XELOX Plus Gemcitabine in Irinotecan Pre-Treated Advanced Colorectal Cancer Patients [NCT00496704] | Phase 1/Phase 2 | 56 participants (Anticipated) | Interventional | 2007-01-31 | Recruiting |
Capecitabine Metronomic Chemotherapy Versus Conventional Chemotherapy as Maintenance Treatment in Metastatic Colorectal Cancer [NCT02893540] | Phase 2/Phase 3 | 250 participants (Anticipated) | Interventional | 2016-09-30 | Recruiting |
An Open-label Study of the Effect of Intermittent Xeloda in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer [NCT00048139] | Phase 2 | 52 participants (Actual) | Interventional | 2001-10-31 | Completed |
A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer [NCT00049660] | Phase 2/Phase 3 | 47 participants (Actual) | Interventional | 2002-09-30 | Terminated(stopped due to low accrual) |
A Phase I Study of Capecitabine, Cisplatin and Imatinib in Patients With Unresectable or Metastatic Gastric Cancer. [NCT00601510] | Phase 1 | 38 participants (Actual) | Interventional | 2007-11-30 | Completed |
Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Gemcitabine and Capecitabine in Combination With Cetuximab in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma. A Phase II Trial. [NCT01247337] | Phase 2 | 56 participants (Actual) | Interventional | 2011-02-02 | Completed |
A Phase I Trial of GemCap-T, Capecitabine in Combination With Gemcitabine and Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma [NCT00480584] | Phase 1 | 20 participants (Actual) | Interventional | 2007-04-30 | Completed |
Phase II Study of Comparing Toripalimab Combined With GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic Nasopharyngeal Carcinoma [NCT04517214] | Phase 2 | 126 participants (Anticipated) | Interventional | 2020-11-01 | Recruiting |
A Phase Ⅱ Trials of Sintilimab as Consolidation Therapy After Radical Concurrent Chemoradiotherapy in Locally Advanced Unresectable ESCC [NCT04514835] | Phase 2 | 44 participants (Anticipated) | Interventional | 2021-12-01 | Not yet recruiting |
A Phase I Trial of Epirubicin, Carboplatin and Capecitabine in Adult Cancer Patients [NCT00486356] | Phase 1 | 46 participants (Actual) | Interventional | 2004-10-31 | Completed |
Phase 1 Trail to Observe Safety and Efficacy of Metronomic Capecitabine Plus Camrelizumab as Second-line Regimen to Treat Head and Neck Cancer or Esophageal Squamous Cancer Patients [NCT04510818] | Phase 1 | 20 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer [NCT00506844] | Phase 2 | 40 participants (Actual) | Interventional | 2006-05-31 | Active, not recruiting |
Phase II Clinical Trial, Non-Randomized, Multicentre, on the Combination of Gemcitabine, Capecitabine and Sorafenib (Bay 43-9006) in Treatment of Patients With Unresectable and/or Metastatic Renal Cell Carcinoma (RCC) [NCT00496301] | Phase 2 | 40 participants (Anticipated) | Interventional | 2006-11-30 | Completed |
A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-n [NCT05374512] | Phase 3 | 600 participants (Anticipated) | Interventional | 2022-05-16 | Recruiting |
An Open Label, Multicentre, Long-Term Extension Study of Tislelizumab- Containing Treatment and/or Pamiparib-Containing Treatment in Patients With Advanced Malignancies [NCT04164199] | Phase 3 | 300 participants (Anticipated) | Interventional | 2019-12-19 | Enrolling by invitation |
Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients With Stage IIA Colon Cancer (COBRA) [NCT04068103] | Phase 2/Phase 3 | 1,408 participants (Anticipated) | Interventional | 2019-12-16 | Recruiting |
Safety and Efficacy of Pembrolizumab Combined With CAPOX Plus Bevacizumab as Neoadjuvant Treatment of pMMR/MSS Locally Advanced Colorectal Cancer Patients:a Single-arm, Phase II, Prospective Study [NCT05585814] | Phase 2 | 12 participants (Anticipated) | Interventional | 2022-10-31 | Not yet recruiting |
A Phase II, Open, Randomized Study to Assess the Efficacy and Safety of AZD6244 vs Capecitabine (Xeloda) in Patients With Colorectal Cancer Who Have Failed One or Two Prior Chemotherapeutic Regimens. [NCT00514761] | Phase 2 | 64 participants (Anticipated) | Interventional | 2006-09-30 | Completed |
Phase II Trial of Bexarotene (Targretin) Capsules With Tretinoin and Chemotherapy in Patients With Advanced Non-small-cell Lung Cancer [NCT00514293] | Phase 2 | 39 participants (Anticipated) | Interventional | 2007-01-31 | Recruiting |
A Randomised Phase II/III Multi-Centre Clinical Trial of Definitive Chemotherapy, With or Without Cetuximab, in Carcinoma of the Oesophagus [NCT00509561] | Phase 2/Phase 3 | 259 participants (Actual) | Interventional | 2008-02-29 | Active, not recruiting |
A Phase 1b/2 Multicenter Study to Investigate the Safety, Efficacy and Proof of Concept (POC) of Nivolumab Monotherapy as a Sequential Therapy Following Preoperative Chemoradiotherapy Patients With Locally Advanced Resectable Rectal Cancer [NCT02948348] | Phase 1/Phase 2 | 90 participants (Anticipated) | Interventional | 2016-10-31 | Recruiting |
A Pilot Study of Bevacizumab Based Peri-Operative Therapy for Operable Pancreatic Adenocarcinoma [NCT00524069] | | 0 participants (Actual) | Interventional | 2007-01-31 | Withdrawn(stopped due to Withdrawn due to no accrual) |
S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer: a Phase 2, Prospective,Multicenter, Randomised Study [NCT02947061] | Phase 2 | 300 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
"A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as Chemotherapy) Versus Chemotherapy in [NCT05144854] | Phase 3 | 626 participants (Actual) | Interventional | 2021-11-05 | Active, not recruiting |
Phase II Trial of CAPOX, Bevacizumab and Trastuzumab for Patients With HER2-Positive Metastatic Esophagogastric Cancer [NCT01191697] | Phase 2 | 37 participants (Actual) | Interventional | 2011-02-28 | Active, not recruiting |
A Phase I Trial of Lenvatinib (Multi-kinase Inhibitor) and Capecitabine (Anti-metabolite) in Patients With Advanced Malignancies [NCT02915172] | Phase 1 | 0 participants (Actual) | Interventional | 2016-12-31 | Withdrawn |
A Single -Centers, Randomized, Open-label, Controlled Phase Ⅱ Clinical Trial of Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer [NCT05086627] | Phase 2 | 100 participants (Anticipated) | Interventional | 2022-10-15 | Recruiting |
Phase II Study of Neo-adjuvant Chemoradiotherapy Using Infusional Gemcitabine Followed by Surgery for Locally Advanced (T3 and T4 or Node Positive) Rectal Adenocarcinoma [NCT02919878] | Phase 2 | 25 participants (Anticipated) | Interventional | 2014-12-31 | Recruiting |
Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer: A Multicenter, Phase II Study [NCT05997524] | Phase 2 | 60 participants (Actual) | Interventional | 2021-03-01 | Completed |
Phase I Study of Dovitinib (TKI258) in Combination With Gemcitabine and Capecitabine in Advanced Solid Tumors, Pancreatic Cancer and Biliary Cancers [NCT01497392] | Phase 1 | 26 participants (Actual) | Interventional | 2012-03-29 | Completed |
A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy [NCT03006705] | Phase 3 | 800 participants (Actual) | Interventional | 2017-01-31 | Completed |
A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-100 Via Intravenous Infusion in Patients With Advanced Solid Tumors [NCT03781362] | Phase 1 | 36 participants (Actual) | Interventional | 2018-12-21 | Completed |
An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Ramucirumab (IMC-1121B) Drug Product or Icrucumab (IMC-18F1) in Combination With Capecitabine or Capecitabine Monotherapy, in Unresectable, Locally Advanced or Meta [NCT01234402] | Phase 2 | 153 participants (Actual) | Interventional | 2011-03-31 | Completed |
A Phase I/II Trial of the PD-L1 Inhibitor, Durvalumab Plus CV301 in Combination With Maintenance Chemotherapy for Patients With Metastatic Colorectal or Pancreatic Adenocarcinoma [NCT03376659] | Phase 1/Phase 2 | 8 participants (Actual) | Interventional | 2018-08-08 | Terminated(stopped due to Study closed due to lack of enrollment.) |
Chemoradiation OR Brachytherapy for RECTal Cancer [NCT02017704] | Phase 2 | 9 participants (Actual) | Interventional | 2014-06-12 | Completed |
Fulvestrant or Capecitabine Combined With Pyrotinib in HR-positive and HER2-Positive Metastatic Breast Cancer: A Multicenter, Randomized, Phase III Study [NCT04646759] | Phase 3 | 516 participants (Anticipated) | Interventional | 2020-10-14 | Recruiting |
A Phase II Single-arm Clinical Trial of Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer [NCT04681911] | Phase 2 | 71 participants (Anticipated) | Interventional | 2020-09-09 | Recruiting |
Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer [NCT00559676] | Phase 4 | 200 participants (Anticipated) | Interventional | 2005-03-31 | Completed |
Phase II Trial of Vinfluinine and Capecitabine in Previously Treated Metastatic Breast Cancer [NCT00450515] | Phase 2 | 0 participants (Actual) | Interventional | 2007-03-31 | Withdrawn(stopped due to Study was dropped prior to opening.) |
Randomized Trial to Evaluate Therapeutic Gain by Changing Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma [NCT00379262] | Phase 3 | 803 participants (Actual) | Interventional | 2006-09-30 | Completed |
Randomized Phase II Trial Of Neoadjuvant Combined Modality Therapy For Locally Advanced Rectal Cancer [NCT00081289] | Phase 2 | 146 participants (Actual) | Interventional | 2004-03-31 | Completed |
A Phase II Trial of Oxaliplatin and Capecitabine in the Treatment of Patients With Relapsed/Refractory Carcinoma of Unknown Primary Site [NCT00193609] | Phase 2 | 48 participants (Actual) | Interventional | 2004-09-30 | Completed |
A Phase 1b Study Evaluating Momelotinib Combined With Capecitabine and Oxaliplatin in Subjects With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma [NCT02244489] | Phase 1 | 16 participants (Actual) | Interventional | 2014-11-05 | Terminated |
Safety and Efficacy of Sintilimab in Combination With Albumin-Paclitaxel/Oxaliplatin/Capecitabine and Radiotherapy Followed by D2 Surgical Resection in Patients With Advanced Gastric Cancer With Retroperitoneal Lymph Node Metastasis: A Multiple Center Sin [NCT05002686] | Phase 2/Phase 3 | 60 participants (Anticipated) | Interventional | 2021-08-07 | Recruiting |
A Phase 1b/2 Open-Label Study With Randomization in Phase 2 of IMU-131 HER2/Neu Peptide Vaccine Plus Standard of Care Chemotherapy in Patients With HER2/Neu Overexpressing Metastatic or Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction [NCT02795988] | Phase 1/Phase 2 | 36 participants (Actual) | Interventional | 2017-08-30 | Active, not recruiting |
Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study [NCT00297128] | Phase 2 | 31 participants (Actual) | Interventional | 2005-10-31 | Completed |
Phase II Randomized Trial of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer [NCT00421824] | Phase 2 | 108 participants (Actual) | Interventional | 2006-05-31 | Completed |
A Phase III Study of Chemotherapy With or Without Algenpantucel-L (HyperAcute®-Pancreas) Immunotherapy in Subjects With Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer [NCT01836432] | Phase 3 | 302 participants (Actual) | Interventional | 2013-05-31 | Terminated(stopped due to Company decision) |
A Phase II Study of Neoadjuvant Chemotherapy With Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer [NCT01471470] | Phase 2 | 31 participants (Actual) | Interventional | 2010-07-31 | Completed |
A Phase Ib/Randomized Phase II Study of BEZ235 and Trastuzumab Versus Lapatinib and Capecitabine in Patients With HER2-positive Locally Advanced or Metastatic Breast Cancer Who Failed Prior to Trastuzumab [NCT01471847] | Phase 1 | 5 participants (Actual) | Interventional | 2012-02-29 | Completed |
Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer [NCT01474187] | Phase 1 | 60 participants (Anticipated) | Interventional | 2011-11-30 | Recruiting |
A Randomized Phase II Trial of Capecitabine Plus Cisplatin (XP) Versus Capecitabine Plus Genexol (XG) as a First-line Treatment for Advanced or Recurrent Esophageal Squamous Cell Carcinoma [NCT01474642] | Phase 2 | 64 participants (Actual) | Interventional | 2008-09-30 | Completed |
Irinotecan Combined With Infusional 5-FU/Folinic Acid or Capecitabine and the Role of Celecoxib in Patients With Metastatic Colorectal Cancer [NCT00064181] | Phase 3 | 86 participants (Actual) | Interventional | 2003-05-31 | Completed |
Phase I Trial With Weekly Docetaxel, Capecitabine and Carboplatin as Induction Chemotherapy Followed by Concomitant Capecitabine and Radiotherapy in Patients With Locally Advanced Esophageal Cancer [NCT00238147] | Phase 1 | 18 participants (Anticipated) | Interventional | 2004-09-30 | Completed |
A Phase I/II, Multicentre Clinical Study Of ZD1839 (Iressa™) In Combination With Capecitabine (Xeloda™) In Subjects With Advanced Colorectal Carcinoma After Failure Of First-Line Chemotherapy [NCT00242788] | Phase 1/Phase 2 | 40 participants | Interventional | 2004-02-29 | Completed |
A Randomized Phase II-study to Evaluate the Safety and Efficacy of Capecitabine Plus Irinotecan Plus Cetuximab Compared to Capecitabine Plus Oxaliplatin Plus Cetuximab in First-line Treatment of Patients With Metastatic Colorectal Cancer. [NCT00254137] | Phase 2 | 92 participants | Interventional | 2004-09-30 | Completed |
Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer [NCT00415285] | Phase 2 | 100 participants | Interventional | 2006-12-31 | Recruiting |
A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver [NCT00070265] | Phase 2 | 80 participants (Actual) | Interventional | 2003-08-31 | Terminated(stopped due to Administratively complete.) |
A Phase II Study of Celecoxib/Oxaliplatin/Capecitabine Combination Chemotherapy for Unresectable,Recurrent, or Metastatic Gastric/Gastroesophageal Junction Carcinoma [NCT00256321] | Phase 2 | 4 participants (Actual) | Interventional | 2004-10-31 | Terminated(stopped due to Closed due to poor accrual) |
Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer [NCT00258232] | Phase 2 | 0 participants | Interventional | 2002-01-31 | Completed |
A Prospective, Randomized, Open, Multi-center Phase III Clinical Study Comparing Efficacy and Safety of Sequential T-FEC and TX-XEC as Post-operative Adjuvant Chemotherapy Options for the Treatment of Triple-negative Breast Cancer [NCT01642771] | Phase 3 | 636 participants (Anticipated) | Interventional | 2012-06-30 | Active, not recruiting |
A Phase I And Pharmacogenetic Study Of CPT-11, Oxaliplatin, And Capecitabine In Patients With Solid Tumors [NCT00074321] | Phase 1 | 84 participants (Actual) | Interventional | 2003-11-30 | Completed |
A Phase I Study of Oral Capecitabine in Combination With Weekly IV Carboplatin/Paclitaxel and Radiation Therapy for Patients [NCT00281788] | Phase 1 | 13 participants (Actual) | Interventional | 2003-09-30 | Completed |
A Phase II Trial of Capecitabine in Combination With the Farnesyltransferase Inhibitor, R115777 (Tipifarnib, Zarnestra) in Patients With Metastatic Breast Cancer [NCT00077363] | Phase 2 | 70 participants (Actual) | Interventional | 2004-05-31 | Completed |
A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) Versus Capecitabine in Women With Refractory Advanced or Metastatic Breast Cancer [NCT00078572] | Phase 3 | 408 participants (Actual) | Interventional | 2004-03-31 | Completed |
A Phase I/II Study of Weekly Intravenous Oxaliplatin in Combination With Oral Daily Capecitabine and Radiation Therapy in the Neoadjuvant Treatment of Rectal Cancer [NCT00086931] | Phase 1/Phase 2 | 37 participants (Actual) | Interventional | 2003-09-30 | Completed |
A Phase II Trial Of Celecoxib (Celebrex) And Capecitabine (Xeloda) Combined With Pelvic Irradiation As Neoadjuvant Treatment Of Stage II or III Adenocarcinoma Of The Rectum [NCT00081224] | Phase 2 | 3 participants (Actual) | Interventional | 2004-12-31 | Terminated |
A Phase I/II Study of Aroplatin and Capecitabine in Subjects With Unresectable Local Recurrence or Distant Metastases of Colorectal Cancer Refractory to 5-FU/Leucovorin and Irinotecan [NCT00081536] | Phase 1/Phase 2 | 105 participants | Interventional | | Active, not recruiting |
Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer [NCT00303745] | Phase 2 | 78 participants (Anticipated) | Interventional | 2006-06-30 | Active, not recruiting |
[NCT00083525] | Phase 1 | 33 participants (Anticipated) | Interventional | 2004-05-31 | Completed |
A Randomized Phase III Study Comparing Epirubicin, Docetaxel and Capecitabine + G-CSF to Epirubicin and Docetaxel + G-CSF as Neoadjuvant Treatment for Early HER-2 Negative Breast Cancer and Comparing Epirubicin, Docetaxel and Capecitabine + G-CSF ± Trastu [NCT00309556] | Phase 3 | 536 participants (Actual) | Interventional | 2005-02-28 | Completed |
Phase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer [NCT00088998] | Phase 2 | 46 participants (Actual) | Interventional | 2004-12-31 | Completed |
Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-center phaseIII-Trial [NCT00311467] | Phase 3 | 172 participants (Actual) | Interventional | 2004-03-31 | Terminated(stopped due to no patient recruitment) |
Dose-Dense and Dose-Intense Alternating Irinotecan/Capecitabine and Oxaliplatin/Capecitabine: Phase I in Solid Tumors and Phase II With Bevacizumab a First-Line Therapy of Advanced Colorectal Cancer [NCT00296062] | Phase 1 | 12 participants (Actual) | Interventional | 2006-03-31 | Terminated(stopped due to Trial did not move to Phase II portion due to poor tolerance of treatment) |
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study [NCT05826964] | Phase 2 | 500 participants (Anticipated) | Interventional | 2023-06-12 | Recruiting |
Pembrolizumab in Combination With Xelox Bevacizumab in Patients With Microsatellite Stable Mestatic Colorectal Cancer and a High Immune Infiltrate : a Proof of Concept Study [NCT04262687] | Phase 2 | 55 participants (Anticipated) | Interventional | 2021-04-06 | Recruiting |
A Phase II Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors [NCT04165772] | Phase 2 | 200 participants (Anticipated) | Interventional | 2019-12-11 | Recruiting |
Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma [NCT00316420] | Phase 1 | 20 participants (Actual) | Interventional | 2003-12-31 | Completed |
Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies [NCT00329329] | Phase 1 | 24 participants (Actual) | Interventional | 2006-05-31 | Terminated(stopped due to Sponsor decided to discontinue study drug development) |
Phase III Randomized Controlled Trial of Adjuvant Capecitabine/Cisplatin Chemotherapy and Chemoradiation Therapy for Gastric Adenocarcinoma [NCT00323830] | Phase 3 | 458 participants (Actual) | Interventional | 2004-10-31 | Completed |
Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer [NCT00324610] | Phase 1/Phase 2 | 46 participants | Interventional | 2006-03-31 | Recruiting |
Phase 2 Clinical Trial of Bi-weekly Dosing of Irofulven Plus Capecitabine in Patients With Anaplastic or Locally Advanced/Metastatic Differentiated Thyroid Cancer [NCT00124527] | Phase 2 | 35 participants | Interventional | 2005-03-31 | Completed |
Three-Arm Randomized Phase II Clinical Study of Irofulven/Prednisone, Irofulven/Capecitabine/Prednisone or Mitoxantrone/Prednisone in Docetaxel-Pretreated Hormone-Refractory Prostate Cancer Patients [NCT00124566] | Phase 2 | 135 participants (Actual) | Interventional | 2004-06-30 | Completed |
[NCT00087620] | Phase 4 | 0 participants | Interventional | 2004-09-30 | Terminated |
An Open-Label, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma [NCT05126719] | Phase 2 | 238 participants (Anticipated) | Interventional | 2021-08-04 | Recruiting |
A Phase I, Dose-Escalating, Safety Study of an Intravenously Administered Pegylated Liposomal Mitomycin-C Lipid-based Prodrug (PL-MLP, PROMITIL) in Cancer Patients With Solid Tumors. [NCT01705002] | Phase 1 | 88 participants (Actual) | Interventional | 2012-10-31 | Completed |
Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 3, Multicentre, Randomised Controlled Trial (CAN) [NCT02958111] | Phase 3 | 406 participants (Actual) | Interventional | 2017-01-31 | Active, not recruiting |
A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer [NCT00833859] | Phase 2 | 2 participants (Actual) | Interventional | 2009-03-31 | Terminated(stopped due to Abandoned - Lack of funding after only 2 patients enrolled) |
A Phase II Study to Determine the Efficacy and Safety of Panitumumab in Combination With Chemoradiotherapy for Unresectable or Locally Recurrent Adenocarcinoma of the Rectum With or Without Metastatic Disease [NCT00346099] | Phase 2 | 0 participants (Actual) | Interventional | 2006-06-30 | Withdrawn(stopped due to Protocol closed based on new (and as yet unpublished) information from a phase II clinical trial.) |
A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer [NCT00429871] | Phase 3 | 272 participants (Actual) | Interventional | 2002-05-31 | Completed |
Neo-AEGIS (NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study): Randomised Clinical Trial of Neoadjuvant and Adjuvant Chemotherapy (Modified MAGIC or FLOT Regimen) vs. Neoadjuvant Chemoradiation (CROSS [NCT01726452] | Phase 3 | 377 participants (Actual) | Interventional | 2013-01-24 | Completed |
Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers [NCT00101075] | Phase 2 | 9 participants (Actual) | Interventional | 2004-10-31 | Terminated(stopped due to Slow Accrual) |
Multicenter Phase IV.II Trial, for the Administration of Capecitabine Simultaneous to Radiotherapy for Local Relapse Breast Cancer Patients With Negative Her2 Tumours [NCT00434941] | Phase 2 | 1 participants (Actual) | Interventional | 2007-09-30 | Terminated(stopped due to Due to the slow rate of recruitment the study was stopped.) |
A Randomized, Controlled Phase II Study to Compare Capecitabine Combined With Dacarbazine(CAPDTIC) Versus Capecitabine Combined Temozolomide(CAPTEM) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Tumor [NCT03279601] | Phase 2 | 148 participants (Anticipated) | Interventional | 2017-09-01 | Recruiting |
Phase II Study of Trastuzumab (Herceptin) and Capecitabine (Xeloda) in Women With Taxanes and Anthracyclines Refractory Metastatic Breast Cancer and HER2 Over-Expression [NCT00107393] | Phase 2 | 75 participants (Anticipated) | Interventional | 2003-06-30 | Completed |
Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer [NCT00440167] | Phase 3 | 280 participants (Anticipated) | Interventional | 2006-06-30 | Active, not recruiting |
Phase I Trial of Induction Paraplatin® and Xeloda® Followed by Concurrent Paraplatin and Xeloda With Intensity Modulated Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck [NCT00114153] | Phase 1 | 48 participants (Anticipated) | Interventional | 2003-06-30 | Completed |
A Phase III Randomized Study of Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer [NCT00352378] | Phase 3 | 209 participants (Actual) | Interventional | 2002-06-30 | Completed |
A Randomized Phase III Study Comparing Docetaxel Followed by Cyclophosphamide, Epirubicin and 5-FU to Docetaxel With Capecitabine Followed by Cyclophosphamide, Epirubicin and Capecitabine as Adjuvant Treatment for Early Breast Cancer [NCT00114816] | Phase 3 | 1,500 participants (Anticipated) | Interventional | 2004-01-31 | Completed |
A Phase I/II Study to Evaluate the Efficacy and Toxicity of Imatinib Mesylate in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma [NCT00354523] | Phase 1/Phase 2 | 21 participants (Actual) | Interventional | 2004-12-31 | Terminated(stopped due to Study closed following Phase I portion, insufficient activity to continue to Phase II.) |
A Phase II Study of Bevacizumab With Concurrent Capecitabine and Radiation Followed by Maintenance Gemcitabine and Bevacizumab For Locally Advanced Pancreatic Cancer [NCT00114179] | Phase 2 | 82 participants (Actual) | Interventional | 2005-01-31 | Completed |
Treatment of Relapsed or Metastatic Head and Neck Carcinomas With Oxaliplatin and Capecitabine [NCT00448552] | Phase 2 | 30 participants (Anticipated) | Interventional | 2004-02-29 | Completed |
Parallel Phase I Study of Ixabepilone Plus Lapatinib and Ixabepilone Plus Lapatinib Plus Capecitabine in Subjects With HER2 Positive Locally Advanced or Metastatic Breast Cancer [NCT00634088] | Phase 1 | 13 participants (Actual) | Interventional | 2008-06-30 | Terminated(stopped due to Slow Accrual) |
Phase II Trial of OSI-774 (Erlotinib, Tarceva™,) and Capecitabine for Patients With Previously Untreated Metastatic Colorectal Cancer [NCT00459901] | Phase 2 | 13 participants (Actual) | Interventional | 2004-06-30 | Terminated(stopped due to Study halted by drug manufacturer) |
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Capecitabine on an Every 21-Day Schedule in Subjects With Advanced Solid Tumors [NCT00119171] | Phase 1 | 30 participants | Interventional | 2004-11-30 | Completed |
A Phase I Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Capecitabine in Patients With Solid Tumors [NCT00121277] | Phase 1 | 28 participants (Actual) | Interventional | 2005-09-30 | Completed |
A Prospective Single-arm Phase Ⅱ Study of Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma [NCT04844385] | Phase 2 | 83 participants (Anticipated) | Interventional | 2021-02-20 | Recruiting |
A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer [NCT00122291] | Phase 2 | 66 participants (Anticipated) | Interventional | 2002-01-31 | Active, not recruiting |
An Open Label Study of the Effect of First Line Treatment With Bevacizumab in Combination With Capecitabine and Oxaliplatin on Progression-free Survival in Patients With Metastatic Cancer of the Colon and Rectum [NCT01399190] | | 68 participants (Actual) | Observational | 2011-07-31 | Completed |
A Phase I/II Trial of Proton Therapy With Concurrent Capecitabine for Locally Advanced and Recurrent Rectal Cancer [NCT00503932] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2007-07-31 | Withdrawn(stopped due to No participant enrollment.) |
Phase II Study of Docetaxel and Capecitabine as 1st Line Therapy for Patients With Locally Advanced or Metastatic Gastric Cancer [NCT00142038] | Phase 2 | 80 participants | Interventional | 2004-03-31 | Completed |
A Pilot Trial of Germline Polymorphisms as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer. [NCT00159471] | | 1 participants (Actual) | Interventional | 2005-02-28 | Terminated(stopped due to Insufficient Accrual) |
Docetaxel by 1 Hour Infusion Followed by 24 Hour Infusion of Cisplatin Plus Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer [NCT00155259] | Phase 2 | 47 participants (Actual) | Interventional | 2004-10-31 | Completed |
A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer. [NCT00506623] | Phase 2 | 48 participants (Actual) | Interventional | 2004-07-31 | Active, not recruiting |
Evaluation of Thymidine Phosphorylase and Other Predictive/Prognostic Factors in Primary Breast Cancer Treated With Docetaxel and Capecitabine (DC) [NCT00156312] | | 25 participants (Anticipated) | Interventional | 2003-07-31 | Completed |
Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study [NCT00156975] | Phase 3 | 384 participants | Interventional | 2004-11-30 | Active, not recruiting |
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-] [NCT05840211] | Phase 3 | 654 participants (Anticipated) | Interventional | 2023-05-08 | Recruiting |
Phase I Trial of ZEN003694 (ZEN-3694) in Combination With Capecitabine in Patients With Solid Tumors [NCT05803382] | Phase 1 | 30 participants (Anticipated) | Interventional | 2023-11-08 | Recruiting |
A Phase Ib Trial of Preoperative Short-Course Chemoradiotherapy Followed by Chemotherapy for Resectable Gastric Adenocarcinoma [NCT04523818] | Phase 1 | 25 participants (Actual) | Interventional | 2020-08-11 | Active, not recruiting |
Phase II Study of Neoadjuvant Gemcitabine/Oxaliplatin and Cetuximab Followed by Surgery or Concurrent External Beam Radiation With Capecitabine for Patients With Locally Advanced Unresectable Nonmetastatic Pancreatic Cancer [NCT00408564] | Phase 2 | 39 participants (Actual) | Interventional | 2006-01-31 | Completed |
Combination of 6-Thioguanine, Capecitabine, Celecoxib and Temozolomide or CCNU for Recurrent Anaplastic Glioma and Glioblastoma Multiforme [NCT00504660] | Phase 2 | 75 participants (Actual) | Interventional | 2003-09-30 | Completed |
A Phase ll Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Metastatic Esophagogastric Adenocarcinomas [NCT00447330] | Phase 2 | 60 participants (Actual) | Interventional | 2007-02-28 | Completed |
Phase II Randomized Trial of Adjuvant XELOX Chemotherapy and XELOX With Concurrent Capecitabine and Radiotherapy for Gastric Adenocarcinoma With D2 Dissection [NCT01711242] | Phase 2 | 208 participants (Actual) | Interventional | 2012-01-31 | Completed |
A Phase II Study to Explore the Neoadjuvant Treatment of Serplulimab Combined With CAPEOX + Celecoxib in the Treatment of Locally Advanced Rectal Cancer [NCT05731726] | Phase 2 | 50 participants (Anticipated) | Interventional | 2023-02-22 | Recruiting |
A Randomized, Open, Multicenter Phase III Clinical Trial of Combination of Sintilimab Injection (IBI308) and XELOX+Bevacizumab Compared With XELOX+Bevacizumab as 1st Line Therapy of RAS-Mutant Metastatic Colorectal Cancer [NCT05171660] | Phase 3 | 436 participants (Anticipated) | Interventional | 2022-02-08 | Recruiting |
A Phase 3, Randomized, Multicenter, Open-Label Study to Compare the Efficacy and Safety of Anti-HER2 Therapy Plus Fulvestrant or Capecitabine in First-line Treatment of Women With HR+, HER2+, Non-visceral Metastases, Stage IV Breast Cancer [NCT04337658] | Phase 3 | 493 participants (Anticipated) | Interventional | 2020-07-01 | Not yet recruiting |
Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients Who Received Capecitabine and Concurrent Intensity Modulated Radiotherapy (IMRT) [NCT03015168] | | 117 participants (Actual) | Observational | 2012-01-31 | Completed |
Multicentric Single Arm Phase II Study Evaluating the Efficacy of Association of Tucatinib, Capecitabine and Intra-CSF Trastuzumab in HER2 Amplified Breast Cancer Patients With Leptomeningeal Metastases [NCT05800275] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-11-30 | Not yet recruiting |
Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma - Phase II Trials - Protocol 5: Capecitabine [NCT00006023] | Phase 2 | 0 participants | Interventional | 2000-03-31 | Completed |
The First-line Therapy With the Combination of Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma: a Single-arm, Open-label, Phase II Trial [NCT05807880] | Phase 2 | 110 participants (Anticipated) | Interventional | 2023-10-01 | Not yet recruiting |
A Multicenter Randomized Phase III Trial of Neo-adjuvant Chemotherapy Followed by Surgery and Chemotherapy or by Surgery and Chemoradiotherapy in Resectable Gastric Cancer (CRITICS Study) [NCT00407186] | Phase 3 | 788 participants (Actual) | Interventional | 2007-01-11 | Active, not recruiting |
Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046) [NCT00176787] | Phase 2 | 30 participants | Interventional | 2000-10-31 | Terminated(stopped due to recruitment goals met) |
A Phase Ib/II Study of First Line Pembrolizumab in Combination With Trastuzumab, Capecitabine, and Cisplatin in HER2 Positive Gastric Cancer [NCT02901301] | Phase 1/Phase 2 | 41 participants (Actual) | Interventional | 2017-02-06 | Active, not recruiting |
A Phase III Study to Evaluate the 3-year Disease-free Survival in Patients With Locally Advanced Colon Cancer Receiving Either Perioperative or Postoperative Chemotherapy With FOLFOX or CAPOX Regimens [NCT02572141] | Phase 3 | 738 participants (Anticipated) | Interventional | 2015-01-01 | Active, not recruiting |
Weekly Taxol® Plus Xeloda® Versus Taxotere® Every Three Weeks Plus Xeloda® in the Treatment of Metastatic Breast Cancer A Phase II/III Study [NCT00201435] | Phase 2/Phase 3 | 224 participants (Anticipated) | Interventional | 2005-03-31 | Completed |
A Single-arm, Single-center, Prospective Phase I/II Study of Fuquinitinib Combined With Capecitabine First-line Maintenance in the Treatment of Metastatic Colorectal Cancer [NCT06115733] | | 56 participants (Anticipated) | Interventional | 2023-12-28 | Not yet recruiting |
Letrozole With or Without Metronomic Capecitabine in First Line Treatment of Patients With ER-positive HER2 Negative Advanced Breast Cancer: A Randomized Phase II Study. [NCT04571437] | Phase 2 | 204 participants (Anticipated) | Interventional | 2020-03-01 | Recruiting |
A Phase II Trial of Capecitabine and Oxaliplatin (CAPOX) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE03-60 [NCT00216021] | Phase 2 | 25 participants (Actual) | Interventional | 2004-03-31 | Completed |
A Single Arm Phase II Trial of Docetaxel and Capecitabine for the First Line Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN): Hoosier Oncology Group HN02-40 [NCT00216138] | Phase 2 | 19 participants (Actual) | Interventional | 2004-03-31 | Terminated(stopped due to Interim analysis results did not meet criteria for second stage of trial) |
Effect of Capecitabine on the Pharmacokinetics of BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies [NCT00207129] | Phase 1 | 25 participants | Interventional | 2004-10-31 | Completed |
A Phase II Trial of Capecitabine and Oxaliplatin in Metastatic Breast Cancer [NCT00204776] | Phase 2 | 37 participants (Anticipated) | Interventional | 2005-03-31 | Completed |
A Phase 1b Study of Venetoclax and Capecitabine In Subjects With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Experienced Disease Progression During or After CDK4/6 Inhibitor Therapy [NCT04274933] | Phase 1 | 4 participants (Actual) | Interventional | 2020-05-21 | Terminated(stopped due to Company Decision) |
XELOX III. Capecitabine (Xeloda) in Combination With Oxaliplatin (Eloxatin) as First-line Treatment of Patients With Advanced or Metastatic Colorectal Cancer. A Randomized Phase II Study [NCT00212615] | Phase 2/Phase 3 | 116 participants (Actual) | Interventional | 2004-02-29 | Completed |
Pre-operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma [NCT00220103] | Phase 2 | 80 participants (Anticipated) | Interventional | 2002-11-30 | Completed |
An Open-label, Multi-center Study to Evaluate the Disease Free Survival Rate of a Perioperative Combination of Capecitabine (Xeloda), Trastuzumab (Herceptin) and Oxaliplatin (XELOX- Trastuzumab) in Patients With Resectable Gastric or Gastro-esophageal Jun [NCT01130337] | Phase 2 | 36 participants (Actual) | Interventional | 2010-07-31 | Completed |
Rationale and Design of a Prospective, Multicenter Phase Ⅱ Clinical Trial of Safety and Efficacy Evaluation of Long Course Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by TME for LARC. [NCT04911517] | Phase 2 | 50 participants (Anticipated) | Interventional | 2021-06-01 | Recruiting |
A Multicenter Randomized Phase III Study of Combination Treatment With Vinorelbine and Gemcitabine Versus Capecitabine Monotherapy in Metastatic Breast Cancer Patients Following Treatment Failure With the Combination of a Taxane and an Anthracycline [NCT00431106] | Phase 3 | 144 participants (Anticipated) | Interventional | 2002-04-30 | Completed |
Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer [NCT00345761] | Phase 1/Phase 2 | 64 participants (Actual) | Interventional | 2006-02-28 | Completed |
Phase II Trial of Capecitabine for the Treatment of Unresectable/ Metastatic or Advanced Hepatocellular Carcinoma(HCC) [NCT00464295] | Phase 2 | 15 participants (Actual) | Interventional | 2006-08-31 | Completed |
[NCT00477711] | Phase 2 | 41 participants (Actual) | Interventional | 2007-03-31 | Completed |
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine [NCT00480597] | Phase 2 | 141 participants (Actual) | Interventional | 2002-10-31 | Completed |
A Randomized Phase III Study of Oxaliplatin (Eloxatin) and Capecitabine on Top of Sorafenib Versus Sorafenib Alone as First-line Palliative Treatment in Advanced Hepatocellular Carcinoma Patients [NCT01245582] | Phase 3 | 0 participants (Actual) | Interventional | 2011-07-31 | Withdrawn |
An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination With Capecitabine for Progressive or Recurrent Metastatic Breast Cancer [NCT01326481] | Phase 1/Phase 2 | 19 participants (Actual) | Interventional | 2011-06-30 | Completed |
A Prospective Randomised Open Label Trial of Oxaliplatin/Fluoropyrimidine Versus Oxaliplatin/Fluoropyrimidine Plus Cetuximab Pre and Post Operatively in Patients With Resectable Colorectal Liver Metastasis Requiring Chemotherapy [NCT00482222] | Phase 3 | 340 participants (Anticipated) | Interventional | 2007-02-28 | Recruiting |
A Phase II Study of Bevacizumab, Irinotecan and Capecitabine in Patients With Previously Untreated Metastatic Colorectal Cancer [NCT00483834] | Phase 2 | 50 participants (Actual) | Interventional | 2006-12-31 | Completed |
A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gast [NCT02872116] | Phase 3 | 2,031 participants (Actual) | Interventional | 2016-10-12 | Active, not recruiting |
A Four Part, Phase I Dose-Escalation Study of the Combinations of Concurrent BKM120 and Capecitabine, or Concurrent BYL719 and Capecitabine, or Concurrent BKM120 and Capecitabine and Trastuzumab, or Concurrent BKM120 and Capecitabine and Lapatinib in Pati [NCT01300962] | Phase 1 | 47 participants (Actual) | Interventional | 2011-08-31 | Completed |
Phase II Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer [NCT00511446] | Phase 2 | 56 participants (Actual) | Interventional | 2007-08-31 | Completed |
Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer [NCT00506168] | Phase 2 | 37 participants (Actual) | Interventional | 2001-11-30 | Terminated(stopped due to The study drugs are not covered anymore by insurance.) |
A Single-arm, Multicenter, Open-labeled Clinical Study of UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases [NCT05535413] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2022-08-01 | Recruiting |
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer [NCT01517009] | Phase 2 | 50 participants (Anticipated) | Interventional | 2008-06-30 | Completed |
Perioperative Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin in Patients With Localized Advanced Gastric Cancer [NCT01516944] | Phase 2/Phase 3 | 749 participants (Actual) | Interventional | 2012-02-29 | Completed |
Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer [NCT04894643] | | 10 participants (Anticipated) | Interventional | 2020-09-14 | Recruiting |
Radiotherapy Combined With Recombinant Human Endostatin and Capecitabine for Patients With Nasopharyngeal Carcinoma Resistant to Induction Chemotherapy [NCT05514275] | Phase 2 | 41 participants (Anticipated) | Interventional | 2022-08-01 | Recruiting |
Total Neoadjuvant NALIRIFOX Plus Ablative Dose Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma [NCT05851924] | Phase 2 | 60 participants (Anticipated) | Interventional | 2023-05-12 | Recruiting |
A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Patients With Locally Advanced or Metastatic Tumors [NCT02794571] | Phase 1 | 518 participants (Actual) | Interventional | 2016-05-23 | Active, not recruiting |
Combined Chemotherapy and Tislelizumab With Preoperative Split-course Hypofraction Radiotherapy for Locally Advanced Rectal Cancer:Study Protocol of a Prospective, Single-arm Phase II Trial [NCT05176964] | | 50 participants (Anticipated) | Observational | 2021-12-31 | Recruiting |
Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Single-arm, Open-label, Ahead Study [NCT03691051] | Phase 2 | 78 participants (Actual) | Interventional | 2018-11-20 | Active, not recruiting |
A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding [NCT01525771] | Phase 1/Phase 2 | 37 participants (Actual) | Interventional | 2011-02-28 | Completed |
A Randomized Phase II Trial of Second Line Therapy in Advanced Biliary Tract Cancer: Capecitabine or Capecitabine Plus Mitomycin C [NCT01530503] | Phase 2 | 52 participants (Actual) | Interventional | 2011-11-30 | Completed |
A Randomized, Multicenter, Controlled Phase III Study to Compare Perioperative Chemotherapy of Oxaliplatin Combined With S-1(SOX) Versus SOX or Oxaliplatin With Capecitabine (XELOX) as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma [NCT01534546] | Phase 3 | 1,094 participants (Actual) | Interventional | 2012-03-31 | Active, not recruiting |
Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante [NCT01549795] | | 33 participants (Anticipated) | Interventional | 2012-01-31 | Recruiting |
A Phase II Trial Evaluating a Modified Regimen of Oxaliplatin and Capecitabine in First-Line Treatment of Metastatic Colorectal Adenocarcinoma [NCT01552967] | Phase 2 | 30 participants (Anticipated) | Interventional | 2012-03-31 | Recruiting |
Phase I Trial of Ganetespib, Capecitabine, and Radiation in Rectal Cancer [NCT01554969] | Phase 1 | 16 participants (Actual) | Interventional | 2012-05-31 | Completed |
Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal Cancer [NCT00006812] | Phase 2 | 0 participants | Interventional | 2001-03-31 | Terminated |
Capecitabine (Xeloda) in Malignant Mesothelioma: A Phase II Study [NCT00004183] | Phase 2 | 27 participants (Actual) | Interventional | 2000-11-30 | Completed |
Phase 2 Study of Temozolomide Plus Capecitabine in Patients With Grade 3 and Low Ki-67 Gastroenteropancreatic Neuroendocrine Tumors [NCT03079440] | Phase 2 | 31 participants (Actual) | Interventional | 2017-05-15 | Completed |
A Phase II Trial of Neoadjuvant Capecitabine, Oxaliplatin, and Bevacizumab for Resectable Colorectal Metastases in the Liver [NCT00118105] | Phase 2 | 0 participants (Actual) | Interventional | 2006-11-30 | Withdrawn(stopped due to Budget Constraints) |
Phase I Study of Capecitabine (Xeloda) and Radiation Therapy in Patients With Locally Advanced Cervical and Pelvic Malignancies [NCT00118300] | Phase 1 | 0 participants (Actual) | Interventional | 2005-04-30 | Withdrawn(stopped due to Competing studies) |
Carcinoma Unknown Primary: Treatment With Gemcitabine, Docetaxel and Capecitabine (GTX) an Evaluation and Treatment Study of The Cancer Institute of New Jersey Oncology Group [NCT00119314] | Phase 2 | 0 participants (Actual) | Interventional | 2004-07-31 | Withdrawn(stopped due to slow accrual) |
A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer [NCT00120172] | Phase 2 | 40 participants (Anticipated) | Interventional | 2005-05-31 | Terminated(stopped due to positive results from a larger study with same regimen was released.) |
A Phase I Study of Oral Fluoropyrimidine Capecitabine (Xeloda Roche) Combined With Intravenous Cisplatin in Patients With Advanced Cancer of the Digestive System [NCT00010023] | Phase 1 | 0 participants | Interventional | 2000-08-31 | Completed |
Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer [NCT00031876] | Phase 1/Phase 2 | 34 participants (Actual) | Interventional | 2000-05-31 | Completed |
Tailored Treatment of Metastatic Colorectal Cancer Based on Genetic Markers [NCT00396487] | Phase 3 | 1 participants (Actual) | Interventional | 2006-11-30 | Terminated(stopped due to Only one patient included as per Feb. 4, 2008.) |
Phase I-II Study to Evaluate Safety, Efficacy and Pharmacokinetic Interactions Between Capecitabine (XELODA) and Exisulind (APTOSYN) in Patients With Metastatic Breast Cancer [NCT00037609] | Phase 1/Phase 2 | 35 participants (Actual) | Interventional | 2001-01-31 | Completed |
A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix [NCT00016926] | Phase 2 | 0 participants | Interventional | 2001-04-30 | Completed |
A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix [NCT00039442] | Phase 2 | 21 participants (Actual) | Interventional | 2002-04-29 | Completed |
Phase 1b Study of Ramucirumab in Combination With Fluoropyrimidines and Platinum-Based Agents in Japanese Patients With Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma [NCT02359058] | Phase 1 | 18 participants (Actual) | Interventional | 2015-02-28 | Completed |
A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer [NCT00047710] | Phase 1 | 48 participants (Actual) | Interventional | 2002-09-30 | Completed |
A Phase I Dose Escalation Study With Oral LY317615 in Combination With Capecitabine in Advanced Cancer Patients [NCT00052273] | Phase 1 | 16 participants (Actual) | Interventional | 2002-12-31 | Completed |
A Phase II Study Of Docetaxel And Capecitabine In Patients With Measurable Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction [NCT00054457] | Phase 2 | 46 participants (Actual) | Interventional | 2003-09-30 | Completed |
A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer [NCT00058318] | Phase 2 | 43 participants (Actual) | Interventional | 2004-12-31 | Completed |
A Clinical Trial Comparing Preoperative Radiation Therapy And Capecitabine With or Without Oxaliplatin With Preoperative Radiation Therapy And Continuous Intravenous Infusion Of 5-Fluorouracil With or Without Oxaliplatin In The Treatment Of Patients With [NCT00058474] | Phase 3 | 1,608 participants (Actual) | Interventional | 2004-07-31 | Active, not recruiting |
A Single Center, Open-labeled, Single Arm Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy [NCT04866108] | Phase 2 | 49 participants (Anticipated) | Interventional | 2021-12-08 | Recruiting |
Drug Treatment for Bowel Cancer: Making the Best Choices When a Milder Treatment is Needed [NCT00070213] | Phase 3 | 460 participants (Actual) | Interventional | 2003-09-30 | Completed |
Phase Ib/II Neoadjuvant Trial of the Farnesyltransferase Inhibitor, R115777 With Docetaxel and Capecitabine for Patients With Stage IIIA or IIIB Breast Cancer [NCT00070252] | Phase 1/Phase 2 | 53 participants (Actual) | Interventional | 2003-09-30 | Completed |
Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer [NCT00075556] | Phase 2 | 0 participants | Interventional | 2002-01-31 | Active, not recruiting |
Adjuvant PD-1 Antibody(Tislelizumab) in Combination With Capecitabine for Patients With Cholangiocarcinoma at High-Risk of Postoperative Recurrence [NCT04782804] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2021-01-01 | Recruiting |
A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma [NCT00076609] | Phase 1/Phase 2 | 31 participants | Interventional | 2003-10-31 | Completed |
A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors [NCT00077077] | Phase 1 | 0 participants | Interventional | 2004-02-29 | Completed |
Phase II Study of Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Biliary Tract and Gallbladder Cancer [NCT00142480] | Phase 2 | 8 participants (Actual) | Interventional | 2004-12-31 | Completed |
Randomized Phase 2 Study of Capecitabine vs Gemcistabine Plus Cisplatin in Patients With Resected Extrahepatic Cholangiocarcinoma With Regional Lymph Node Metastasis [NCT03079427] | Phase 2 | 101 participants (Actual) | Interventional | 2017-05-15 | Completed |
Single Arm and Phase II Clinical Trial of a Sandwich Regimen as XELOX Regimen and Capecitabine Alternate Administration Combined With Preoperative Intensity Modulated Radiation Therapy for pMMR Locally Advanced Rectal Cancer [NCT05228431] | Phase 2 | 121 participants (Anticipated) | Interventional | 2022-12-01 | Not yet recruiting |
ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE [NCT00847119] | Phase 2 | 43 participants (Actual) | Interventional | 2007-09-30 | Completed |
A Phase II Trial of Evaluating Circulating Endothelial Cell as A Surrogate Marker for Monitoring Treatment Efficacy of Docetaxel Plus Capecitabine With Bevacizumab as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer [NCT00845910] | Phase 2 | 22 participants (Actual) | Interventional | 2009-05-31 | Terminated(stopped due to To be confirmed) |
Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients [NCT00019773] | Phase 1 | 0 participants | Interventional | 1999-07-31 | Completed |
Efficacy and Safety of Short-course Radiotherapy Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of Microsatellite Stable Locally Advanced Rectal Cancer: a Single-centre, Single-arm, Phase 2 Study [NCT05576480] | Phase 2 | 55 participants (Anticipated) | Interventional | 2022-10-31 | Not yet recruiting |
Randomized Phase III Study Post Radical Resection of Liver Metastasis of Colorectal Cancer: Bevacizumab in Combination With XELOX as Adjuvant Chemotherapy vs XELOX Alone [NCT00394992] | Phase 3 | 79 participants (Actual) | Interventional | 2006-12-31 | Terminated(stopped due to Data from the C08 study and Avant study) |
A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer [NCT00026442] | Phase 2 | 0 participants | Interventional | 2001-11-30 | Active, not recruiting |
A Multi-center, II Phase,Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Gemcitabine Plus Capecitabine Standard Adjuvant Therapy for Stage II/III Pancreatic Cancer [NCT03959150] | Phase 2/Phase 3 | 231 participants (Anticipated) | Interventional | 2020-01-05 | Recruiting |
Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial [NCT00030732] | Phase 3 | 319 participants (Actual) | Interventional | 2001-06-30 | Completed |
A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer [NCT00032175] | Phase 3 | 508 participants (Anticipated) | Interventional | 2002-04-30 | Completed |
iMmunoscore Associated Decision GuIdance for adjuvaNt Chemotherapy and Physical Exercise in Stage III Colon Cancer (iMAGINE): a Prospective, Randomized, Open-label, Multicenter, Phase III Clinical Trial [NCT04488159] | Phase 3 | 1,638 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
Phase II Trial PD-L1/PD-1 Blockade Avelumab (MSB0010718C) With Chemoradiotherapy for Locally Advanced Resectable Rectal Cancer [NCT03299660] | Phase 2 | 37 participants (Actual) | Interventional | 2018-04-30 | Completed |
Phase II Trial of Pembrolizumab in Combination With Trastuzumab, Fluoropyrimidine, and Platinum Chemotherapy in First Line Stage IV HER2-positive Metastatic Esophagogastric (EG) Cancer [NCT02954536] | Phase 2 | 37 participants (Actual) | Interventional | 2016-11-03 | Completed |
A Phase I Trial of ZD1839 With Capecitabine in Patients With Advanced Solid Tumors (Formerly a Phase I Trial of ZD1839 With Capecitabine and Celecoxib) [NCT00039390] | Phase 1 | 41 participants (Actual) | Interventional | 2002-04-30 | Completed |
A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients [NCT00021047] | Phase 1/Phase 2 | 0 participants | Interventional | 2001-07-31 | Completed |
Protocol For Assessment Of Capecitabine For Advanced Colorectal Cancer In Patients Aged 70 Years And Older (And In A Cohort Of Patients Younger Than 60 Years) [NCT00049335] | Phase 2 | 29 participants (Actual) | Interventional | 2003-02-28 | Completed |
Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer [NCT00397761] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | 2006-07-31 | Withdrawn |
A Phase II Trial Evaluating Multiple Metastasectomy Combined With Hepatic Artery Infusion Of Floxuridine (FUDR) And Dexamethasone (DXM), Alternating With Systemic Oxaliplatin (OXAL) And Capecitabine (CAPCIT) For Colorectal Carcinoma Metastatic To The Live [NCT00026234] | Phase 2 | 75 participants (Actual) | Interventional | 2002-02-28 | Completed |
Phase II Randomized Study of First-Line Therapy Comprising Bevacizumab and Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil (FOLFIRI) Versus Bevacizumab and Irinotecan Hydrochloride and Capecitabine (XELIRI) in Patients With Unresectable Met [NCT00423696] | Phase 2 | 145 participants (Actual) | Interventional | 2006-03-23 | Completed |
A Phase III Trial of Modified FOLFOX6 Versus CAPOX, With Bevacizumab (NSC-704865) or Placebo, as First-Line Therapy in Patients With Previously Untreated Advanced Colorectal Cancer [NCT00070122] | Phase 3 | 2,200 participants (Actual) | Interventional | 2004-04-30 | Terminated(stopped due to Administratively complete.) |
A Phase II Feasibility Translational Research Trial of Induction Chemotherapy Followed by Concomitant Chemoradiation in Patients With Clinical T4 Rectal Cancer [NCT00070434] | Phase 2 | 0 participants (Actual) | Interventional | 2004-08-31 | Withdrawn(stopped due to poor accrual) |
A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin vs Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4NO), and IIIb (T3N2) Gastric Adenocarcinoma [NCT00411229] | Phase 3 | 1,035 participants (Actual) | Interventional | 2006-06-30 | Completed |
Cetuximab Added to Capecitabine, Oxaliplatin and Bevacizumab in Patients With Previously Untreated Advanced Colorectal Carcinoma, a Randomised Phase III Study [NCT00208546] | Phase 3 | 750 participants (Actual) | Interventional | 2005-06-30 | Completed |
A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia [NCT00040859] | Phase 2 | 48 participants (Actual) | Interventional | 2002-09-30 | Completed |
A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer [NCT00214864] | Phase 2 | 18 participants (Actual) | Interventional | 2002-12-31 | Completed |
An Open Label, Phase II Study of Capecitabine (Xeloda) Plus Conformal Radiotherapy for Patients With Locally Advanced, Non-Metastatic Rectosigmoid Carcinoma [NCT00216424] | Phase 4 | 40 participants (Anticipated) | Interventional | 2005-02-28 | Terminated(stopped due to lack of accrual) |
Oxaliplatin, Irinotecan, and Capecitabine as a Combination Regimen for First-Line Treatment of Advanced or Metastatic Colorectal Cancer [NCT00217711] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2005-05-31 | Completed |
A Phase II Study of Oxaliplatin (Eloxatin) Capecitabine (Xeloda) and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer. [NCT00220051] | Phase 2 | 109 participants (Actual) | Interventional | 2001-11-30 | Completed |
Neoadjuvant Epirubicin, Cisplatin and Capecitabine (Xeloda) [ECX] Followed by Definitive Chemoradiation With or Without Surgery for Patients With Newly Diagnosed Localized Squamous Cell Carcinoma of the Oesophagus [NCT00220129] | Phase 2 | 16 participants (Actual) | Interventional | 2002-11-30 | Completed |
A Phase II Trial Evaluating Irinotecan and Capecitabine in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours [NCT00220168] | Phase 4 | 33 participants (Actual) | Interventional | 2003-01-31 | Completed |
A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma [NCT00042965] | Phase 2 | 60 participants (Actual) | Interventional | 2002-10-31 | Completed |
Capecitabine And Gemcitabine In Patients With Advanced Or Metastatic Biliary Tract Cancer, A Multicenter Phase II Trial [NCT00073905] | Phase 2 | 44 participants (Actual) | Interventional | 2003-04-30 | Completed |
A Phase I Study of Oxaliplatin, 5-Fluorouracil, and Leucovorin in Combination With Oral Capecitabine in Patients With Advanced Malignancy [NCT00043121] | Phase 1 | 50 participants (Actual) | Interventional | 2002-06-30 | Completed |
Randomized Controlled Trial Comparing Dendritic Cells Co-cultured With Cytokine-induced Killer Cells Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer [NCT02491697] | Phase 2 | 400 participants (Anticipated) | Interventional | 2016-02-29 | Active, not recruiting |
A Randomized, Multi-center, Open-label, Phase III Trial of Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast [NCT04263298] | Phase 3 | 210 participants (Anticipated) | Interventional | 2018-05-01 | Recruiting |
Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer. [NCT00403429] | Phase 2 | 36 participants (Actual) | Interventional | 2006-03-31 | Completed |
Randomized Trial to Assess the Benefit of Adding Trastuzumab to Capecitabine and Vinorelbine as Second Line for HER2positive Breast Cancer Patients With Locally Advanced or Metastatic Disease, Previously Treated With Trastuzumab and Taxanes [NCT00130507] | Phase 2 | 14 participants (Actual) | Interventional | 2005-11-04 | Terminated(stopped due to A new alternative treatment caused the decrease in the rhythm of recruitment.) |
Combined Phase I/II Study of Epirubicin (Pharmorubicin®), Carboplatin (Paraplatin®) and Capecitabine (Xeloda®) (ECC) in the Treatment of Unresectable Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer With Pharmacogenetic Correlates [NCT00130936] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2005-10-31 | Terminated |
A Phase II Trial Evaluating the Combination of Carboplatin, Gemcitabine, and Capecitabine in Patients With Carcinoma of Unknown Primary Site [NCT00148135] | Phase 2 | 0 participants | Interventional | 2001-05-31 | Terminated(stopped due to recruitment goals met) |
A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer [NCT00148720] | Phase 2 | 80 participants (Anticipated) | Interventional | 2004-09-30 | Terminated(stopped due to Slow accrual) |
A Multicenter Randomized Phase III Study to Compare Capecitabine Alone or in Combination With Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer and Progression After Previous Treatment With Trastuzumab [NCT00148876] | Phase 3 | 482 participants (Anticipated) | Interventional | 2003-09-30 | Completed |
A Randomized, Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer in Women 60 Years and Older [NCT00082095] | Phase 3 | 62 participants (Actual) | Interventional | 2004-04-30 | Terminated(stopped due to The study was terminated due to poor recruitment (after enrolling 62 of planned 300 patients in 20 months) |
A Phase I Study of BMS-247550 in Combination With Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With a Taxane and an Anthracycline [NCT00049244] | Phase 1 | 0 participants | Interventional | 2002-09-30 | Active, not recruiting |
Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma [NCT00083148] | Phase 1 | 12 participants (Actual) | Interventional | 2002-11-30 | Completed |
A Phase I Study of Oral Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer [NCT00153907] | Phase 1 | 40 participants (Actual) | Interventional | 2002-03-31 | Completed |
Impact of Early FDG-PET Directed Intervention on Preoperative Therapy for Locally Advanced Gastric Cancer: A Random Assignment Phase II Study [NCT02485834] | Phase 2 | 5 participants (Actual) | Interventional | 2015-08-31 | Terminated(stopped due to Poor accrual) |
Phase II Study of Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer [NCT00159445] | Phase 2 | 53 participants (Anticipated) | Interventional | 2004-03-31 | Completed |
A Phase II Trial of Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma [NCT00165217] | Phase 2 | 37 participants | Interventional | 2001-11-30 | Completed |
Phase I Study of a Novel Schedule of Capecitabine and Docetaxel in Patients With Advanced Solid Tumors [NCT00169000] | Phase 1 | 12 participants (Actual) | Interventional | 2003-01-31 | Completed |
Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer [NCT00174616] | Phase 2 | 87 participants (Actual) | Interventional | 2003-07-31 | Completed |
Multicenter, Randomized Controlled Trial Designed to Evaluate the Efficacy and Safety of Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Raltitrexed or Oxaliplatin Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study) [NCT02965248] | Phase 3 | 147 participants (Anticipated) | Interventional | 2016-11-30 | Recruiting |
Phase II Study of Oxaliplatin and Xeloda and Cetuximab as First Line Treatment for Metastatic or Unresectable Gastric or Gastroesophageal Junction Cancer [NCT00183898] | Phase 2 | 75 participants (Actual) | Interventional | 2004-12-28 | Active, not recruiting |
Efficacy of Neoadjuvant XELOX/AVASTIN Therapy for Nonresectable Colorectal Liver Metastases With Secondary Hepatic Resection/Radiofrequency [NCT00408772] | Phase 2 | 0 participants (Actual) | Interventional | 2007-06-30 | Withdrawn(stopped due to Lack of accrual) |
Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer [NCT00193102] | Phase 2 | 40 participants (Anticipated) | Interventional | 2001-04-30 | Terminated |
An Open-label Study of the Effect of Continuous Xeloda Therapy in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer [NCT00048126] | Phase 2 | 57 participants (Actual) | Interventional | 2001-07-31 | Completed |
MAVERICC (Marker Evaluation for Avastin Research in CRC): A Randomized Phase II Study of Bevacizumab+mFOLFOX6 Vs. Bevacizumab+FOLFIRI With Biomarker Stratification in Patients With Previously Untreated Metastatic Colorectal Cancer [NCT01374425] | Phase 2 | 376 participants (Actual) | Interventional | 2011-08-31 | Completed |
Phase I Study of Preoperative Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer [NCT00084591] | Phase 1 | 0 participants | Interventional | 2003-12-31 | Completed |
A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma [NCT00084942] | Phase 2 | 0 participants | Interventional | 2002-10-31 | Completed |
A Randomized, Prospective Study Comparing Three Regimens Of Eloxatin ™ Plus Fluoropyrimidine For Evaluation Of Safety And Tolerability In First Line Treatment Of Patients With Advanced Colorectal Cancer (Tree Study) [NCT00062426] | Phase 3 | 0 participants | Interventional | 2003-05-31 | Completed |
Interleukin-2, Interferon Alpha,Capecitabine and Vinblastin for Treatment of Metastatic Renal Cell Carcinoma: A Multicenter Study [NCT00226798] | Phase 2 | 45 participants | Interventional | 2003-12-31 | Recruiting |
A Phase II Study Of Capecitabine In Previously Treated, Recurrent And/Or Metastatic Nasopharyngeal Carcinoma [NCT00095901] | Phase 2 | 3 participants (Actual) | Interventional | 2004-06-30 | Completed |
Phase II Trial of Capecitabine (Xeloda®) and Pegylated Interferon Alfa-2A(Pegasys®) for Recurrent or Progressive Brain Metastasis From Breast Carcinoma [NCT00227656] | Phase 2 | 2 participants (Actual) | Interventional | 2005-09-30 | Terminated(stopped due to Study slow to accrue.) |
Capecitabine and Oxaliplatin Alone or in Combination With Cetuximab as First-Line Treatment for Metastatic EGFR-Positive Colorectal Cancer, A Randomized Multicenter Phase II Trial [NCT00227734] | Phase 2 | 74 participants (Actual) | Interventional | 2004-06-30 | Completed |
A Dose Escalating (Phase I) Study Looking at the Biomodulation of Capecitabine by Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer [NCT00320749] | Phase 1 | 21 participants (Actual) | Interventional | 2005-12-31 | Completed |
A Phase 1, Open-Label Dose Escalation First-in-Human Study to Evaluate the Tolerability, Safety, Maximum Tolerated Dose, Preliminary Clinical Activity and Pharmacokinetics of AM0010 in Patients With Advanced Solid Tumors [NCT02009449] | Phase 1 | 350 participants (Actual) | Interventional | 2013-11-15 | Active, not recruiting |
Induction Cetuximab (IM-C225), Gemcitabine and Oxaliplatin, Followed by Radiotherapy With Concurrent Capecitabine, and Cetuximab, Followed by Maintenance Cetuximab and Gemcitabine for Patients With Locally Advanced Pancreatic Cancer [NCT00338039] | Phase 2 | 69 participants (Actual) | Interventional | 2005-09-30 | Completed |
A Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Adenocarcinoma of the Small Bowel and Ampulla of Vater [NCT00354887] | Phase 2 | 31 participants (Actual) | Interventional | 2004-11-30 | Completed |
A Phase II Study of Neo-adjuvant Chemotherapy in Locally Advanced Gastric Cancer [NCT00414271] | Phase 2 | 18 participants (Actual) | Interventional | 2006-01-31 | Completed |
A Phase II Clinical Trial of Bevacizumab Beginning Concurrently With a Sequential Regimen of Doxorubicin and Cyclophosphamide Followed by Docetaxel and Capecitabine as Neoadjuvant Therapy Followed by Postoperative Bevacizumab Alone for Women With Locally [NCT00365417] | Phase 2 | 45 participants (Actual) | Interventional | 2006-08-31 | Completed |
A Randomized Phase 2 Study of Ruxolitinib Efficacy and Safety in Combination With Capecitabine for Subjects With Recurrent or Treatment Refractory Metastatic Pancreatic Cancer (The RECAP Trial) [NCT01423604] | Phase 2 | 136 participants (Actual) | Interventional | 2011-07-31 | Completed |
Carrilizumab Combined With Bevacizumab Plus Capecitabine in a Second-line Prospective, One-arm Exploratory Study of Relapsed Metastatic Squamous Cell Carcinoma of Head and Neck [NCT05965154] | Phase 2 | 22 participants (Anticipated) | Interventional | 2023-08-01 | Not yet recruiting |
A Phase I/II Clinical Trial to Evaluate the Safety Tolerance and Initial Efficacy of Q-1802 Combined With Standard Treatment in Patients With Gastrointestinal Tumors [NCT05964543] | Phase 1/Phase 2 | 72 participants (Anticipated) | Interventional | 2023-06-21 | Recruiting |
A Multicenter, Open-label, Phase II Pan-Tumor Study in Patients Who Have Participated in Trials to Investigate Efficacy and Safety of ONO-4538 as Monotherapy or in Combination With Other Therapies and Are Continuing ONO-4538 Treatment (ONO-4538-98) [NCT04566380] | Phase 2 | 59 participants (Anticipated) | Interventional | 2020-09-10 | Recruiting |
Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor (McCrest) Trial: Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi) (Cohort 3) [NCT04932187] | Phase 1 | 20 participants (Anticipated) | Interventional | 2021-08-01 | Recruiting |
The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer. A Pan-European Prospective Multicenter Double Single Arm Cohort Study. [NCT06068023] | | 400 participants (Anticipated) | Observational | 2023-07-01 | Recruiting |
SHR-1701 in Combination With Radiotherapy and Chemotherapy as Perioperative Treatment for Resectable Locally Advanced Rectal Cancer, an Open Label, Single-arm, Multicenter Phase II Trial [NCT05300269] | Phase 2 | 73 participants (Anticipated) | Interventional | 2022-07-05 | Recruiting |
A Phase 1 Study of IPdR in Combination With Capecitabine and Radiotherapy in Rectal Cancer [NCT04406857] | Phase 1 | 1 participants (Actual) | Interventional | 2021-03-17 | Terminated(stopped due to Inadequate accrual rate) |
Phase II Trial of Metronomic Capecitabine and Cyclophosphamide With Lapatinib and Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen [NCT01873833] | Phase 2 | 10 participants (Actual) | Interventional | 2013-07-29 | Terminated(stopped due to Insufficient accrual) |
A Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin Chemotherapy With External Beam Radiation Therapy for the Treatment of Resectable, Locally Advanced/Unresectable or Metastatic Esophageal Cancer [NCT00578071] | Phase 1/Phase 2 | 29 participants (Actual) | Interventional | 2007-12-31 | Completed |
Phase II Study of Capecitabine and Cisplatin in Anthracycline and Taxanes-pretreated Metastatic Triple Negative Breast Cancer Patients [NCT01928680] | Phase 2 | 33 participants (Actual) | Interventional | 2012-11-30 | Active, not recruiting |
A Phase 1b-2 Study of Mitomycin-c/ Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study [NCT03844256] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2019-01-07 | Recruiting |
Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Aden [NCT00678535] | Phase 3 | 904 participants (Actual) | Interventional | 2008-06-30 | Completed |
A Randomized Phase II Study De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE) [NCT04166318] | Phase 2 | 252 participants (Anticipated) | Interventional | 2020-01-02 | Recruiting |
Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy in Hepatic Metastases of Metastatic Colorectal Cancer: a Phase II Multicentric Study With Patients in Progression After First Line Systemic Chemotherapy [NCT01677884] | Phase 2 | 10 participants (Actual) | Interventional | 2012-11-30 | Completed |
Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer [NCT00087152] | Phase 2 | 27 participants (Actual) | Interventional | 2004-06-30 | Completed |
Phase II Study of Panitumumab, Chemotherapy, and External Beam Radiation in Patients With Locally Advanced Pancreatic Cancer [NCT00601627] | Phase 2 | 52 participants (Actual) | Interventional | 2009-06-30 | Completed |
A Phase III, Randomized, Multicenter Study of PD-1 Antibody Combined With mXELIRI Versus mXELIRI in the Second-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma [NCT05737563] | Phase 3 | 380 participants (Anticipated) | Interventional | 2023-02-17 | Recruiting |
A Phase I Study of LBH589 in Combination With Capecitabine ± Lapatinib [NCT00632489] | Phase 1 | 20 participants (Actual) | Interventional | 2008-05-31 | Completed |
Randomized Phase III Trial of mFOLFOX7 or XELOX Plus Bevacizumab Versus 5-Fluorouracil/Leucovorin or Capecitabine Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer [NCT01279681] | Phase 3 | 32 participants (Actual) | Interventional | 2011-01-31 | Terminated(stopped due to Slow accrual) |
CHEMORADIOTHERAPY FOR RECTAL CANCER IN THE DISTAL RECTUM FOLLOWED BY ORGANSPARING TRANSANAL ENDOSCOPIC MICROSURGERY: CARTS Study CApecitabine, Radiotherapy and Tem Surgery. A PHASE II, FEASIBILITY TRIAL [NCT01273051] | Phase 2 | 55 participants (Actual) | Interventional | 2010-11-30 | Completed |
Phase I/II Study Combining Tosedostat With Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma [NCT02352831] | Phase 1/Phase 2 | 16 participants (Actual) | Interventional | 2015-08-31 | Terminated(stopped due to Insufficient funding and drug supply from manufacturer) |
An Open-label,Phase II Study Evaluating the Efficacy and Safety of Trastuzumab Combined With Oral Chemotherapy or Endocrine Therapy in Patients With HER-2 Positive Stage I Breast Cancer [NCT04383275] | Phase 2 | 356 participants (Anticipated) | Interventional | 2020-05-15 | Not yet recruiting |
A Randomized Phase-II Study of Patients With Locally Advanced Gastric of Gastro-Esophageal Adenocarcinoma Treated With Induction Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Adjuvant Intraperitoneal Floxuridine, Followed by Prolonged [NCT00848783] | Phase 2 | 8 participants (Actual) | Interventional | 2008-05-31 | Terminated(stopped due to Due to slow accrual) |
A Phase I/II Study of Irinotecan, Oxaliplatin, Capecitabine (XELOXIRI) and Bevacizumab as a First-line Therapy for Patients With Metastatic Colorectal Cancer [NCT04380103] | Phase 1/Phase 2 | 106 participants (Anticipated) | Interventional | 2020-04-26 | Recruiting |
Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection [NCT05720559] | Phase 2 | 100 participants (Anticipated) | Interventional | 2023-03-01 | Not yet recruiting |
A Phase II Study of Capecitabine and Lapatinib in Squamous Cell Carcinoma of the Head and Neck [NCT01044433] | Phase 2 | 44 participants (Actual) | Interventional | 2009-10-31 | Completed |
Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer (mRCAT): An Open-label, Single-arm, Prospective Multicenter Clinical Trial [NCT05972655] | Phase 2 | 32 participants (Anticipated) | Interventional | 2023-08-02 | Recruiting |
Pilot Study Evaluating Pharmacokinetic Parameters of Capecitabine Dosing in Patients With Advanced Cancer and Elevated Body Mass Index [NCT01828554] | | 8 participants (Actual) | Interventional | 2013-06-30 | Completed |
Multi-target Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine Maintenance Therapy Treating Oligometastatic Nasopharyngeal Carcinoma: a Single-arm, Multicenter, Prospective, Open-label Phase II Clinical Trial [NCT05290194] | Phase 2 | 28 participants (Anticipated) | Interventional | 2022-03-28 | Recruiting |
Phase II, Multi-Center, Open-Label, Prospective Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type KRAS Colorectal Cancer Who Are Considered Nonoptimal Candidates or Are Intolerant to a First-Line Oxaliplatin/I [NCT00954876] | Phase 2 | 0 participants (Actual) | Interventional | 2009-08-31 | Withdrawn(stopped due to Study halted prematurely, prior to enrollment of first participant) |
Surufatinib and Sintilimab in Combination With Capecitabine in Patients With Previously Treated Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma : a Single-arm, a Single-center , Phase 2 Trial [NCT05472948] | Phase 2 | 36 participants (Anticipated) | Interventional | 2023-02-01 | Recruiting |
Evaluating Trifluridine/Tipiracil Based Chemoradiation in Locally Advanced Rectal Cancer - The Phase I/II TARC Trial [NCT04177602] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2019-11-04 | Terminated(stopped due to Due to the amended therapy strategies for rectal cancer recently, it was decided not to transfer the study to the phase II part, as superiority over standard chemoradiation and transfer to a new therapy standard are increasingly unlikely.) |
Maximal Ablative Irradiation Because of Encasement (MAIBE) for Patients With Potentially Resectable Locally Advanced Pancreatic Cancer [NCT03523312] | Phase 2 | 47 participants (Actual) | Interventional | 2018-04-30 | Active, not recruiting |
Antiangiogenic Therapy or Chemotherapy Combined With PD-1 Inhibitor Versus Standard Chemotherapy for PD-1 Inhibitor Refractory R/M NPC [NCT05549466] | Phase 2 | 84 participants (Anticipated) | Interventional | 2022-10-08 | Recruiting |
Capecitabine Metronomic Chemotherapy Combined With Aromatase Inhibitors in Postmenopausal Hormone-receptor-positive Breast Cancer [NCT01924078] | Phase 2 | 100 participants (Anticipated) | Interventional | 2010-10-31 | Recruiting |
Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer [NCT02025036] | Phase 3 | 249 participants (Actual) | Interventional | 2014-10-31 | Active, not recruiting |
Phase II Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Concurrent Radiotherapy in Patients With Potentially Resectable Adenocarcinoma of Gastroesophageal Cancer [NCT01962246] | Phase 2/Phase 3 | 169 participants (Actual) | Interventional | 2012-02-29 | Completed |
Randomized Phase III Trial Comparing in a Preoperative Schedule the Result of Two Concurrent Chemoradiation Schemes (45 Gy + Capecitabine vs 50 Gy + Capecitabine - Oxaliplatin) on the Rate of Sterilization of the Operative Specimen in Resectable Rectal Ca [NCT00227747] | Phase 3 | 598 participants (Anticipated) | Interventional | 2005-11-08 | Completed |
Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd [NCT00191152] | Phase 3 | 475 participants (Actual) | Interventional | 2002-02-28 | Completed |
Phase II Study of the A-ICOX Regimen Consisting of Bevacizumab (Avastinâ), Intermittent Dose Capecitabine (Xelodaâ) and Oxaliplatin (Eloxatinâ) in Patients With Untreated Advanced Colorectal Cancer [NCT00177307] | Phase 2 | 40 participants (Actual) | Interventional | 2005-01-31 | Completed |
A Phase I-II Dose Finding and Early Efficacy Study of Combination Therapy With Erlotinib (Tarceva), Gemcitabine, Bevacizumab (Avastin), and Capecitabine in Advanced Pancreatic Cancer [NCT00260364] | Phase 1/Phase 2 | 44 participants (Actual) | Interventional | 2005-11-30 | Completed |
Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01 [NCT00235235] | | 80 participants (Actual) | Observational | 2005-09-30 | Terminated(stopped due to Funding terminated) |
Randomized Phase II Trial of Capecitabine and Lapatinib With or Without IMC-A12 in Patients With HER2 Positive Breast Cancer Previously Treated With Trastuzumab and an Anthracycline and/or a Taxane [NCT00684983] | Phase 2 | 64 participants (Actual) | Interventional | 2008-07-30 | Completed |
An Open-Label Phase 2 Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib [NCT04366713] | Phase 2 | 6 participants (Actual) | Interventional | 2020-06-30 | Completed |
Camrelizumab Combined With Apatinib and Capecitabine for Patients With Advanced Unresectable Biliary Tract Cancer: a Phase 2, Single-arm, Prospective Study. [NCT04720131] | Phase 2 | 39 participants (Anticipated) | Interventional | 2021-02-01 | Not yet recruiting |
Phase I Study Of Capecitabine in Combination With Cisplatin and Irinotecan in Patients With Advanced Malignancies. [NCT00249977] | Phase 1 | 21 participants (Actual) | Interventional | 2003-04-30 | Completed |
Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors [NCT01640665] | Phase 1 | 24 participants (Actual) | Interventional | 2012-07-31 | Completed |
Phase II Study of First-Line Capecitabine and Cetuximab for Treatment of Metastatic Colorectal Cancer in Elderly Patients and/or Those With Multiple Comorbidities Unable to Receive Chemotherapy Doublets [NCT00251186] | Phase 2 | 18 participants | Interventional | 2006-04-30 | Terminated(stopped due to Funding unavailable) |
"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer" [NCT01641406] | Phase 2 | 60 participants (Anticipated) | Interventional | 2011-03-31 | Recruiting |
A Phase I Study of AZD6244 in Combination With Capecitabine and Radiotherapy in Locally Advanced Adenocarcinoma of the Rectum [NCT01134601] | Phase 1 | 1 participants (Actual) | Interventional | 2010-05-24 | Terminated(stopped due to As per Cancer Therapy Evaluation Program (CTEP), this protocol has only enrolled one participant and it is unlikely that the study will be able to be completed successfully. CTEP slated the protocol to be administratively closed.) |
A Phase I Dose Escalation Study of Imatinib Mesylate (Gleevec/STI571) Plus Capecitabine (Xeloda) in Advanced Solid Tumor Malignancies [NCT00253565] | Phase 1 | 25 participants (Actual) | Interventional | 2003-08-31 | Completed |
A Phase II Trial of Capecitabine and Docetaxel in the Treatment of Advanced and Recurrent Cervical Cancer [NCT00257348] | Phase 2 | 5 participants (Actual) | Interventional | 2004-03-31 | Completed |
Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma [NCT00258284] | Phase 2 | 30 participants (Actual) | Interventional | 2003-08-31 | Completed |
Adjuvant Capecitabine in Elderly Patients With Breast Cancer: a Phase II Study [NCT00263705] | Phase 2 | 43 participants (Actual) | Interventional | 2003-01-31 | Completed |
Phase II Trial of CT-2103 (Xyotax™) With Capecitabine as First-Line Chemotherapy for Patients With Metastatic Breast Cancer [NCT00265733] | Phase 2 | 48 participants (Actual) | Interventional | 2006-02-28 | Completed |
Phase I Study of Oxaliplatin (Eloxatin) and Capecitabine (Xeloda) and Concurrent Radiation Therapy (XELOX-RT) in Non-Small Cell Lung Cancer [NCT00268151] | Phase 1 | 24 participants | Interventional | 2005-02-28 | Terminated(stopped due to Study was terminated due to lack of funding.) |
Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum [NCT00297141] | Phase 2 | 60 participants (Actual) | Interventional | 2004-10-31 | Completed |
A Multicenter Randomized Phase II Study Evaluating Tolerance and Efficacy of Capecitabine 5/7 Days With Weekly Paclitaxel Versus the Recommended Treatment Plan of Weekly Paclitaxel-capecitabine, in Patients With Metastatic Breast Cancer. [NCT00270491] | Phase 2 | 130 participants (Anticipated) | Interventional | 2005-12-31 | Completed |
A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC Study) [NCT01997333] | Phase 2 | 327 participants (Actual) | Interventional | 2013-11-30 | Completed |
A Randomised Study of Sequential Versus Combination Chemotherapy in Patients With Previously Untreated Advanced Colorectal Carcinoma [NCT00312000] | Phase 3 | 820 participants (Actual) | Interventional | 2003-01-31 | Completed |
A Randomized Phase III Study Exploring the Efficacy of Capecitabine Given Concomitantly or in Sequence to EC-Doc With or Without Trastuzumab as Neoadjuvant Treatment of Primary Breast Cancer [NCT00288002] | Phase 3 | 1,500 participants (Anticipated) | Interventional | 2005-01-31 | Completed |
A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JS015 Combination Therapy in Patients With Advanced Solid Tumors [NCT06139211] | Phase 1/Phase 2 | 186 participants (Anticipated) | Interventional | 2023-11-30 | Not yet recruiting |
A Phase Ib Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours [NCT03082053] | Phase 1 | 24 participants (Actual) | Interventional | 2017-01-31 | Completed |
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer and Low Risk for Local Failure: A Randomized Phase III Trial of the German Rectal Cancer Study Group [NCT04495088] | Phase 3 | 818 participants (Anticipated) | Interventional | 2020-09-30 | Recruiting |
A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER IN LATIN AMERICA [NCT04158258] | | 2,907 participants (Actual) | Observational | 2020-02-21 | Active, not recruiting |
Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Lea [NCT03901339] | Phase 3 | 543 participants (Actual) | Interventional | 2019-05-08 | Completed |
An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in firST-line Treatment of Patients With metastatIC Colorectal Cancer Who Are Not candida [NCT03869892] | Phase 3 | 856 participants (Actual) | Interventional | 2019-03-21 | Active, not recruiting |
Thymidylate Synthase (TS) Genotype-Directed Phase II Trial of Oral Capecitabine for 2-Line Treatment of Advanced Pancreatic Cancer [NCT00303927] | Phase 2 | 65 participants (Anticipated) | Interventional | 2005-12-31 | Completed |
The MAX Study: A Randomised Phase II/III Study to Evaluate the Role of Mitomycin C, Avastin and Xeloda in Patients With Untreated Metastatic Colorectal Cancer [NCT00294359] | Phase 2/Phase 3 | 333 participants (Anticipated) | Interventional | 2005-06-30 | Completed |
Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2) [NCT00301925] | Phase 3 | 4,400 participants (Anticipated) | Interventional | 2005-12-16 | Active, not recruiting |
A Phase II Study of Weekly Paclitaxel and Capecitabine in Patients With Metastatic or Recurrent Esophageal Cancer [NCT00453323] | Phase 2 | 33 participants (Actual) | Interventional | 2006-06-30 | Active, not recruiting |
C-2424: Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer [NCT00230399] | Phase 2 | 15 participants | Interventional | 2003-06-30 | Completed |
An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects With ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer [NCT00338247] | | 0 participants | Expanded Access | 2006-07-31 | Approved for marketing |
A Randomized, Open-label, Single Dose, Two-way Cross-Over Study to Investigate the Relative Bioavailability of Capecitabine in Rapid Disintegrating Tablets (RDT) Versus the Commercial Xeloda® Tablets Following Oral Administrations in Adult Patients With S [NCT01493336] | Phase 1 | 37 participants (Actual) | Interventional | 2012-05-31 | Completed |
Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer [NCT06105684] | Phase 2 | 40 participants (Anticipated) | Interventional | 2024-04-30 | Not yet recruiting |
A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours [NCT05489211] | Phase 2 | 670 participants (Anticipated) | Interventional | 2022-09-06 | Recruiting |
5-Fluorouracil Versus Capecitabine as Perioperative Treatment for Locally Advanced Rectal Cancer. a Randomized Phase III Trial [NCT01500993] | Phase 3 | 401 participants (Actual) | Interventional | 2002-03-31 | Completed |
Phase III Multicenter Randomized Open-label Study of Irinotecan Plus Capecitabine Versus Capecitabine in Patients Previously Treated With Anthracycline and Taxane for HER2 Negative Metastatic Breast Cancer[PROCEED] [NCT01501669] | Phase 3 | 222 participants (Anticipated) | Interventional | 2011-06-30 | Recruiting |
Phase II Study to Assess the Efficacy and Safety of Trastuzumab in Combination With Xelox as First-line Treatment of Patients With Advanced or Metastatic Gastric Cancer or Gastro-esophageal Junction, (HER2)-Positive. [NCT01503983] | Phase 2 | 45 participants (Actual) | Interventional | 2011-08-31 | Completed |
An Observational Study of Avastin® (Bevacizumab) in Combination With Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma [NCT01506167] | | 719 participants (Actual) | Observational | 2012-07-06 | Completed |
A Phase II Randomized Controlled Trial of Adjuvant Chemotherapy for High Risk Gastric Cancer Patients (IIIb-IIIc) [NCT01618474] | Phase 2 | 100 participants (Anticipated) | Interventional | 2012-05-31 | Enrolling by invitation |
A Multicenter, Open Label, Randomized, Balanced, Two Treatment, Three Period, Three Sequence, Reference Replicate Crossover, Single Dose, Bioequivalence Fed Study of Capecitabine Tablets in Comparison With XELODA in Adult Cancer Patients [NCT03435666] | Phase 1 | 45 participants (Anticipated) | Interventional | 2018-05-31 | Not yet recruiting |
A Randomized Phase II Multicenter, Open-Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination With the EOX (Epirubicin, Oxaliplatin, Capecitabine) Regimen as First-Line Treatment of Patients With CLDN18.2-Positive Advanced Adenocarcinom [NCT01630083] | Phase 2 | 252 participants (Actual) | Interventional | 2012-07-19 | Completed |
Prospective Observational Study of Patients With Locally Advanced Gastric Cancer Treated With Perioperative Chemotherapy and Surgery [NCT01633203] | | 61 participants (Actual) | Observational | 2010-08-31 | Completed |
A Phase I Study of the Phosphatidylserine-Targeting Antibody Bavituximab in Combination With Capecitabine and Radiation Therapy for the Treatment of Stage II and III Rectal Adenocarcinoma [NCT01634685] | Phase 1 | 15 participants (Actual) | Interventional | 2012-08-08 | Completed |
Metronomic Capecitabine With Digoxin for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment [NCT01887288] | Phase 2 | 16 participants (Actual) | Interventional | 2013-04-30 | Terminated(stopped due to PI Leaving Site) |
A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer. [NCT01655992] | Phase 3 | 386 participants (Anticipated) | Interventional | 2012-01-31 | Terminated(stopped due to The sponsor decided to stop the study.) |
Quinacrine-Capecitabine Combinatorial Therapy for Advanced Stage Colorectal Adenocarcinoma:A Phase I/II Investigator-Initiated Clinical Trial [NCT01844076] | Phase 1/Phase 2 | 19 participants (Actual) | Interventional | 2016-01-14 | Terminated(stopped due to The single Quinacrine manufacture facility in the US was shut down by the FDA) |
Randomized Phase II Open-Label Controlled Study of EMD 72000 (Matuzumab), in Combination With the Chemotherapy Regimen ECX or the Chemotherapy Regimen ECX Alone as First-line Treatment in Subjects With Metastatic Esophago-Gastric Adenocarcinoma [NCT00215644] | Phase 2 | 72 participants (Actual) | Interventional | 2005-08-31 | Completed |
Randomized Controlled Trials of Efficacy and Safety With Xeloda as Sequential Adjuvant Therapy After Chemotherapy of Anthracycline and/or Taxane in Breast Cancer of Triple Negative or HER-2 Positive or Axillary Lymph Node Metastasis ≥4 [NCT01662128] | Phase 2/Phase 3 | 600 participants (Anticipated) | Interventional | 2012-06-30 | Recruiting |
Metronomic Chemotherapy With Anti-angiogenic Effect as Maintenance Treatment for Metastatic Colorectal Carcinoma Following Response to FOLFIRI+Bevacizumab: Clinical and Laboratory Studies [NCT01668680] | Phase 2 | 80 participants (Anticipated) | Interventional | 2012-09-30 | Terminated(stopped due to No satisfactory acrual) |
Randomized Phase II Trial of Continuous Versus Standard Capecitabine in Advanced Breast Cancer. [NCT00418028] | Phase 2/Phase 3 | 195 participants (Actual) | Interventional | 2005-09-30 | Completed |
A Multicentre Randomised Phase II Trial of Neo-adjuvant Chemotherapy Followed by Surgery vs. Neo-adjuvant Chemotherapy and Subsequent Chemoradiotherapy Followed by Surgery vs. Neo-adjuvant Chemoradiotherapy Followed by Surgery in Resectable Gastric Cancer [NCT02931890] | Phase 2 | 207 participants (Anticipated) | Interventional | 2017-12-21 | Recruiting |
A Single-arm, Open-label Clinical Study of Combined Therapy of Tisleizumab , Lenvatinib and XELOX Regimen (Oxaliplatin Combined With Capecitabine) in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors [NCT05291052] | Phase 2 | 20 participants (Anticipated) | Interventional | 2022-02-14 | Recruiting |
A Randomized, Open-label, Multicenter Study Comparing Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer [NCT05292742] | Phase 2 | 206 participants (Anticipated) | Interventional | 2021-07-02 | Recruiting |
Total Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction (GEJ) and Gastric Cancers: A Pilot Trial [NCT05296005] | Phase 1 | 20 participants (Anticipated) | Interventional | 2022-05-31 | Not yet recruiting |
A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Preoperative Short-course Radiotherapy Followed by Sequential Chemotherapy and AK104 for Locally Advanced Rectal Cancer [NCT05794750] | Phase 2 | 50 participants (Anticipated) | Interventional | 2023-04-24 | Not yet recruiting |
Defining the Molecular Profile of Breast Cancer in Uganda and Its Clinical Implications [NCT03518242] | Phase 1 | 100 participants (Actual) | Interventional | 2018-06-06 | Completed |
Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples. [NCT01703910] | Phase 2 | 29 participants (Actual) | Interventional | 2012-11-30 | Completed |
A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer [NCT01710592] | Phase 2 | 35 participants (Actual) | Interventional | 2007-05-31 | Completed |
Multi-institutional Phase I/II Study: Neoadjuvant Chemoradiation With 5-FU (or Capecitabine) and Oxaliplatin Combined With Deep Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer [NCT01716949] | Phase 1/Phase 2 | 59 participants (Anticipated) | Interventional | 2012-09-30 | Recruiting |
Cetuximab Monotherapy and Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With KRAS- and BRAF Wild-type Metastatic Colorectal Cancer. A Multicenter Phase II Trial [NCT01718808] | Phase 2 | 24 participants (Actual) | Interventional | 2012-11-30 | Terminated(stopped due to FU for 3 years from randomization as initially planned is stopped as we do not expect any changes to the endpoints in the future after one year of FU.) |
A Phase I-II Study of PAXG in Stage III-IV Pancreatic Adenocarcinoma [NCT01730222] | Phase 1/Phase 2 | 137 participants (Actual) | Interventional | 2012-11-30 | Completed |
Safety and Tolerability of Oxaliplatin-Capecitabine-Trastuzumab Combination and Chemoradiotherapy in Operated Patients With HER-2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma: Phase II Study, TOXAG [ML25574] [NCT01748773] | Phase 2 | 34 participants (Actual) | Interventional | 2013-01-29 | Completed |
Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial [NCT06176534] | Phase 2 | 240 participants (Anticipated) | Interventional | 2023-12-20 | Not yet recruiting |
A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction A [NCT03615326] | Phase 3 | 732 participants (Anticipated) | Interventional | 2018-10-05 | Active, not recruiting |
Neoadjuvant CAPOXIRI Chemotherapy in the Treatment of Resectable, Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma Protocol [NCT01760252] | Phase 2 | 17 participants (Actual) | Interventional | 2011-12-31 | Terminated |
Treatment Options in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Patients [NCT01782651] | | 1 participants (Actual) | Observational | 2014-08-31 | Completed |
Phase 1b/2 Single-arm Trial Evaluating the Combination of Lapatinib, Everolimus and Capecitabine for the Treatment of Patients With HER2-positive Metastatic Breast Cancer With CNS Progression After Trastuzumab [NCT01783756] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2013-06-26 | Completed |
Pilot Safety and Blood Immune Cell Transcriptional Profiling Study of Anakinra Plus the Physician's Chemotherapy Choice in Metastatic Breast Cancer Patients [NCT01802970] | Phase 1 | 10 participants (Actual) | Interventional | 2012-12-31 | Completed |
Phase I/II Study of CB-839 and Capecitabine in Patients With Advanced Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer [NCT02861300] | Phase 1/Phase 2 | 53 participants (Anticipated) | Interventional | 2016-09-12 | Active, not recruiting |
A Dose-escalating, Multicenter, Single Arm, Open-Label Study of XRP9881 in Combination With Capecitabine (Xeloda), in Metastatic Breast Cancer Patients With Disease Progressing After Anthracycline and Taxane Therapy [NCT00327743] | Phase 1/Phase 2 | 34 participants (Actual) | Interventional | 2006-08-31 | Completed |
[NCT01818973] | Phase 2 | 45 participants (Anticipated) | Interventional | 2013-03-31 | Recruiting |
Neoadjuvant FOLFIRINOX and Chemoradiation Followed by Definitive Surgery and Postoperative Gemcitabine for Patients With Borderline Resectable Pancreatic Adenocarcinoma: An Intergroup Single-Arm Pilot Study [NCT01821612] | Early Phase 1 | 23 participants (Actual) | Interventional | 2013-05-31 | Completed |
Phase II Study of Concomitant Intensity-modulated Radiotherapy Combined to Capecitabine, Mitomycin and Panitumumab in Patients With Stage II-IIIB Squamous-cell Carcinoma of the Anal Canal [NCT01843452] | Phase 2 | 8 participants (Actual) | Interventional | 2012-12-31 | Terminated(stopped due to Poor recruitment) |
Modulation of Metabolic Index in Tailoring Treatment of Incurable Metastatic ColoRectal Cancer (CRC) Program 1. [NCT01843725] | Phase 1 | 37 participants (Actual) | Interventional | 2013-09-30 | Completed |
A Randomised Phase II Study of Two Pre-operative Chemoradiotherapy Regimens (Oxaliplatin and Capecitabine Followed by Radiotherapy With Either Oxaliplatin and Capecitabine or Paclitaxel and Carboplatin) for Resectable Oesophageal Cancer [NCT01843829] | Phase 2 | 85 participants (Anticipated) | Interventional | 2013-10-31 | Recruiting |
A Bioequivalence Study of Capecitabine Tablets in Patients of Locally Advanced or Metastatic Breast Cancer or Metastatic Colorectal Cancer [NCT01846650] | Phase 1 | 36 participants (Actual) | Interventional | 2012-12-31 | Completed |
European Phase III Study Comparing a Radiation Dose Escalation Using 2 Different Approaches : External Beam Radiation Therapy Versus Endocavitary Radiation Therapy With Contact X-ray Brachytherapy 50 kiloVolts (kV) for Patients With Rectal Adenocarcinoma [NCT02505750] | Phase 3 | 236 participants (Anticipated) | Interventional | 2015-06-24 | Active, not recruiting |
A Prospective Randomized Controlled Trail to Evaluate Efficacy and Safety of Sequential Neo-adjuvant Chemotherapy Plus Surgery Followed by Capecitabine Versus Conventional Postoperative Adjuvant Chemotherapy [NCT03011060] | Phase 3 | 1,588 participants (Anticipated) | Interventional | 2016-12-31 | Recruiting |
Planning Treatment for Oesophago-gastric Cancer: a Randomised Maintenance Therapy Trial [NCT02678182] | Phase 2 | 924 participants (Anticipated) | Interventional | 2015-02-28 | Recruiting |
A Phase II Trial of Margetuximab in Combination With Tucatinib and Capecitabine in Patients With HER2-Positive Metastatic Breast Cancer [NCT05227131] | Phase 2 | 0 participants (Actual) | Interventional | 2022-05-15 | Withdrawn(stopped due to Funder decided to not continue the study) |
An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type Patients With Metastatic Colorectal Carcinoma as 1st Therapy [NCT04080843] | Phase 2 | 30 participants (Actual) | Interventional | 2019-11-15 | Completed |
Using PERS(PErsonalized Regimen Selection) Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer Multicentric, Prospective, Randomized Controlled Phase III Clinical Study [NCT03006614] | Phase 3 | 320 participants (Anticipated) | Interventional | 2016-04-30 | Recruiting |
A Fixed-Sequence, Open-Label Study to Determine the Activity of SCH 717454 as Assessed by Positron Emission Tomography in Subjects With Relapsed or Recurrent Colorectal Cancer [NCT00551213] | Phase 2 | 67 participants (Actual) | Interventional | 2007-11-21 | Completed |
A Phase II Randomized Trial Evaluating the Addition of High or Standard Intensity Radiation to Gemcitabine and Nab-paclitaxel for Locally Advanced Pancreatic Cancer [NCT01921751] | Phase 2 | 20 participants (Actual) | Interventional | 2013-08-31 | Terminated(stopped due to Trial would not be completed in a reasonable timeframe per CTEP guidelines) |
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC (Artemis) [NCT04803539] | Phase 2/Phase 3 | 260 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
A Randomized, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Sintilimab Plus Capecitabine Versus Capecitabine Alone as Adjuvant Therapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma [NCT05201859] | Phase 2 | 150 participants (Anticipated) | Interventional | 2022-03-29 | Recruiting |
A Phase II Trial of Gemcitabine and Erlotinib (GE) Plus Proton-chemotherapy (PCT) and Capox for Locally Advanced Pancreatic Cancer (LAPC) [NCT01683422] | | 9 participants (Actual) | Interventional | 2013-01-02 | Terminated(stopped due to Updated chemotherapy regimens currently evaluated in clinical trials due to lack of progress in treating this condition; analysis continues in the realm of patterns of failure and increasing quality of life) |
A Prospective, Phase II Trial Using Circulating Tumor DNA to Initiate Post-operation Boost Therapy After Neoadjuvant Chemotherapy in Triple-negative Breast Cancer [NCT04501523] | Phase 2 | 460 participants (Anticipated) | Interventional | 2020-08-03 | Recruiting |
Phase II Study of Levocetirizine in Combination With Capecitabine + Bevacizumab to Overcome Resistance to Anti-angiogenic Therapy in Patients With Refractory Colorectal Cancer [NCT01722162] | Phase 2 | 47 participants (Actual) | Interventional | 2013-04-30 | Completed |
An Exploratory Study of Chemotherapy for Metastatic Colorectal Cancer Based Upon Thymidine Phosphorylase Expression, KRAS and BRAF Mutation Status, and ERCC1 Expression [NCT01280643] | | 3 participants (Actual) | Interventional | 2010-03-31 | Terminated(stopped due to Slow accrual) |
Phase II Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin in Subjects With Metastatic Pancreatic Cancer [NCT01459614] | Phase 2 | 44 participants (Actual) | Interventional | 2011-11-30 | Completed |
A Randomized, Open Label Study of the Effect of First Line Treatment With Xeloda in Combination With Avastin and Either Short Course Irinotecan or Short Course Oxaliplatin on Progression-free Survival in Patients With Metastatic Colorectal Cancer [NCT00642603] | Phase 2 | 41 participants (Actual) | Interventional | 2008-05-31 | Terminated |
A Multicenter Phase III Placebo-Controlled Trial of Celecoxib for Prevention of Capecitabine-Induced Palmar/Plantar (Hand/Foot) Syndrome in Patients With Metastatic Breast and Colorectal Cancer [NCT00305643] | Phase 3 | 11 participants (Actual) | Interventional | 2006-02-28 | Terminated(stopped due to Terminated due to low accrual. No data analyzed.) |
The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer: A Randomized Controlled Trial [NCT03607656] | Phase 2/Phase 3 | 270 participants (Actual) | Interventional | 2018-06-08 | Completed |
An Open-Label Multicenter Phase 1b Study of E7046 in Combination With Radiotherapy/Chemoradiotherapy (RT/CRT) in Preoperative Treatment of Subjects With Rectum Cancer [NCT03152370] | Phase 1 | 29 participants (Actual) | Interventional | 2017-05-17 | Completed |
Phase 1b/2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-HER2 Bispecific Antibody ZW25 in Combination With Chemotherapy With/Without Tislelizumab in Patients With Advanced HER2-positive Breast Cancer [NCT04276493] | Phase 1/Phase 2 | 71 participants (Actual) | Interventional | 2020-03-26 | Active, not recruiting |
Cytoreductive Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy and Systemic Chemotherapy in Gastric Cancer With Regional Peritoneal Metastasis, a Multicenter and Single-arm Phase III Study [NCT03023436] | Phase 3 | 220 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
Aromatase Inhibitors Plus Metronomic Capecitabine in Treatment of Patients With Recurrent or Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer [NCT04942899] | Phase 2 | 70 participants (Anticipated) | Interventional | 2023-08-30 | Not yet recruiting |
A Randomized, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Sintilimab Combined With Ramucirumab as Compared to Chemotherapy for the First-line Treatment of Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Juncti [NCT04675983] | Phase 3 | 36 participants (Actual) | Interventional | 2021-03-10 | Terminated(stopped due to Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators) |
Phase III Postneoadjuvant Study Evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in Primary HER2-negative Breast Cancer Patients With High Relapse Risk After Standard Neoadjuvant Treatment - SASCIA [NCT04595565] | Phase 3 | 1,332 participants (Anticipated) | Interventional | 2020-10-28 | Recruiting |
Treatment With the Combination of Epirubicin and Paclitaxel Alone or Together With Capecitabine as First Line Treatment in Metastatic Breast Cancer. A Multicenter, Randomized Phase III Study [NCT01433614] | Phase 3 | 304 participants (Actual) | Interventional | 2002-12-31 | Completed |
Preoperative Induction Chemotherapy in Combination With Bevacizumab Followed by Combined Chemoradiotherapy in Locally Advanced Rectal Cancer With High Risk of Recurrence- Phase II Pilot Study With Preoperative Administration of Capecitabine (Xeloda), Oxal [NCT01434147] | Phase 2 | 25 participants (Actual) | Interventional | 2011-10-31 | Completed |
A Phase I Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas and High Grade Gliomas [NCT00357253] | Phase 1 | 24 participants (Actual) | Interventional | 2006-01-31 | Completed |
MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer [NCT04808323] | Phase 1 | 22 participants (Anticipated) | Interventional | 2021-06-17 | Recruiting |
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients Wi [NCT03777657] | Phase 3 | 997 participants (Actual) | Interventional | 2018-12-13 | Active, not recruiting |
A Randomised Clinical Trial Evaluating Adjuvant Chemotherapy With Capecitabine Compared to Expectant Treatment Alone (Observation) Following Surgery for Biliary Tract Cancer [NCT00363584] | Phase 3 | 360 participants (Anticipated) | Interventional | 2006-03-31 | Completed |
A Randomized Multicenter Phase III Study:Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone vs.Taxanes or Platinum Combined With Capecitabine in Advanced Adenocarcinoma of the Stomach or Esophagogastric Junction. [NCT01468389] | Phase 3 | 300 participants (Anticipated) | Interventional | 2011-11-30 | Recruiting |
Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With Simultaneous Integrated Boost Intensity-modulated Radiotherapy in the Treatment of Locally Advanced Rectal Cancer [NCT06017583] | Phase 3 | 48 participants (Anticipated) | Interventional | 2023-09-01 | Recruiting |
A Phase I Dose Escalation Study of Capecitabine, Carboplatin and Weekly Paclitaxel and a Phase II Trial of the Same Combination in Patients With Adenocarcinoma of Unknown Primary [NCT00201734] | Phase 1/Phase 2 | 57 participants (Actual) | Interventional | 2005-06-30 | Terminated(stopped due to Due to lack of funding provided for Phase II portion of trial) |
Rectal Artery Infusion Chemotherapy of Oxaliplatin Plus Capecitabine Combined With Anti-PD1 Antibody After Induction Chemotherapy for Microsatellite Stable Locally Advanced Rectal Cancer:a Prospective Single-arm Phase II Study [NCT05307198] | Phase 2 | 38 participants (Anticipated) | Interventional | 2022-05-11 | Recruiting |
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Che [NCT05104866] | Phase 3 | 733 participants (Actual) | Interventional | 2021-10-18 | Active, not recruiting |
Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases [NCT05062317] | Phase 2 | 120 participants (Anticipated) | Interventional | 2022-04-26 | Recruiting |
MINDACT (Microarray In Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy): A Prospective, Randomized Study Comparing the 70-Gene Signature With the Common Clinical-Pathological Criteria in Selecting Patients for Adjuvant Chemothe [NCT00433589] | Phase 3 | 6,600 participants (Anticipated) | Interventional | 2007-02-28 | Completed |
The Therapeutic and Prognostic Implications of Tumor Immune Microenvironment in The Neoadjuvant Immunotherapy Combined With Chemoradiotherapy for Rectal Cancer [NCT05507112] | Phase 2 | 100 participants (Anticipated) | Interventional | 2022-09-20 | Not yet recruiting |
A Phase II Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer [NCT03026803] | Phase 2 | 4 participants (Actual) | Interventional | 2006-11-30 | Terminated(stopped due to Due to Sorafenib became first line treatment for HCC, the designed treatment became less competitive. The company Sanofi decided not to continue to support) |
A Randomised Phase II/III Trial of Preoperative Chemoradiotherapy Versus Preoperative Chemotherapy for Resectable Gastric Cancer [NCT01924819] | Phase 2/Phase 3 | 574 participants (Actual) | Interventional | 2009-09-30 | Active, not recruiting |
Randomized Phase 2A/2B Study to Compare the Efficacy and Safety of ASLAN001 + Capecitabine to Lapatinib + Capecitabine in Patients With HER 2-Positive MBC That Has Failed on Prior Trastuzumab Therapy [NCT02338245] | Phase 2 | 200 participants (Anticipated) | Interventional | 2014-12-29 | Completed |
A Phase I/II Study of Nintedanib and Capecitabine in Refractory Metastatic Colorectal Cancer [NCT02393755] | Phase 1/Phase 2 | 42 participants (Actual) | Interventional | 2015-05-08 | Completed |
A Phase II Trial of Immunotherapy Combined With Neoadjuvant Chemoradiotherapy in Microsatellite Instability-High Locally Advanced Rectal Cancer [NCT04411524] | Phase 2 | 50 participants (Anticipated) | Interventional | 2020-07-01 | Not yet recruiting |
Ensayo Fase II de selección Individualizada Del Tratamiento de Quimioterapia en Pacientes Con Carcinoma de páncreas Avanzado en función de la determinación de Dianas terapéuticas en el Tejido Tumoral [NCT01454180] | Phase 2 | 31 participants (Actual) | Interventional | 2011-10-31 | Completed |
Phase 1 Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer [NCT03132025] | Phase 2 | 40 participants (Anticipated) | Interventional | 2017-04-30 | Not yet recruiting |
Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics [NCT02297230] | Phase 1/Phase 2 | 44 participants (Actual) | Interventional | 2002-06-30 | Terminated(stopped due to PI Left Institution prior to reaching accrual goal and analyzing data.) |
DETECT V / CHEVENDO A Multicenter, Randomized Phase III Study to Compare Chemo- Versus Endocrine Therapy in Combination With Dual HER2-targeted Therapy of Herceptin® (Trastuzumab) and Perjeta® (Pertuzumab) Plus Kisqali® (Ribociclib) in Patients With HER2 [NCT02344472] | Phase 3 | 270 participants (Anticipated) | Interventional | 2015-09-30 | Recruiting |
Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial [NCT02143388] | Phase 3 | 180 participants (Actual) | Interventional | 2014-03-31 | Completed |
Phase II Study of Stereotactic Body Radiotherapy (SBRT) and Chemotherapy for Unresectable Cholangiocarcinoma Followed by Liver Transplantation [NCT01151761] | Phase 2 | 2 participants (Actual) | Interventional | 2011-01-31 | Terminated(stopped due to Poor accrual) |
Randomized Phase III Study Comparing Preoperative Chemoradiotherapy Alone Versus Neoadjuvant Chemotherapy With Folfirinox Regimen Followed by Preoperative Chemoradiotherapy for Patients With Resectable Locally Advanced Rectal Cancer [NCT01804790] | Phase 3 | 461 participants (Actual) | Interventional | 2012-01-31 | Active, not recruiting |
A Feasibility Study to Discern the Tolerability of 5-FU/Gemcitabine Based Chemotherapy Concurrent With Upper Abdominal Radiation and the Utility of Aprepitant/5HT-3 Antagonist (EMEND) for the Prevention of ChemoRadiation-Induced Nausea and Vomiting (CRINV [NCT01534637] | Phase 2 | 22 participants (Actual) | Interventional | 2006-08-31 | Completed |
A Phase II Trial of Oral Capecitabine in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma [NCT00004012] | Phase 2 | 0 participants | Interventional | 1998-12-31 | Completed |
Efficacy and Safety of Triweekly Cetuximab in Combination With Capecitabine as First-line Maintenance Treatment for KRAS/BRAF Wild-type Metastatic Colorectal Cancer [NCT05775900] | Phase 1/Phase 2 | 24 participants (Anticipated) | Interventional | 2023-02-01 | Recruiting |
Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer [NCT02031939] | Phase 3 | 556 participants (Anticipated) | Interventional | 2014-01-31 | Active, not recruiting |
Pyrotinib Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer:a Randomised, Double-blind, Multicentre, Phase 3 Trial [NCT02973737] | Phase 3 | 279 participants (Actual) | Interventional | 2016-07-20 | Active, not recruiting |
The Efficacy and Safety of Postoperative Chemotherapy With Docetaxel Plus Oxaliplatin and Capecitabine Versus Oxaliplatin Plus Capecitabine for Postoperative Pathological Stage IIIB/IIIC Gastric Adenocarcinoma: a Randomised, Phase 3 Trial [NCT04351867] | Phase 3 | 196 participants (Anticipated) | Interventional | 2020-09-30 | Not yet recruiting |
An Open Labelled Phase III Adjuvant Trial of Disease-free Survival in Patients With Resected Pancreatic Ductal Adenocarcinoma Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic T [NCT05314998] | Phase 3 | 394 participants (Anticipated) | Interventional | 2023-07-01 | Not yet recruiting |
A Randomized Phase II Trial of Sunitinib Plus Capecitabine Versus Capecitabine Alone (With the Potential for Crossover) for Elderly and/or Poor Performance Status Patients With Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction [NCT00891878] | Phase 2 | 12 participants (Actual) | Interventional | 2009-08-31 | Completed |
Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma [NCT00084617] | Phase 2 | 39 participants (Actual) | Interventional | 2004-03-31 | Completed |
"A Phase I/II STudy of Oxaliplatin, Oral Capecitabine and Sorafenib in Patients With Advanced Pancreatic and Biliary Carcinoma" [NCT00634751] | Phase 1/Phase 2 | 48 participants (Actual) | Interventional | 2008-02-29 | Completed |
Phase 1 Study of Postoperative Capecitabine With Concurrent Radiation in Elderly With Stage II/III Rectal Cancer [NCT01268943] | Phase 1 | 18 participants (Actual) | Interventional | 2010-11-30 | Completed |
A Phase II, Single-center, Randomized Study of Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer [NCT04780347] | Phase 2 | 92 participants (Anticipated) | Interventional | 2020-12-15 | Recruiting |
Phase III Trial to Compare Epirubicin and Cyclophosphamide (EC) Followed by Docetaxel (T) to Epirubicin and Docetaxel (ET) Followed by Capecitabine (X) as Adjuvant Treatment, Node Positive Breast Cancer Patients [NCT00129935] | Phase 3 | 1,384 participants (Actual) | Interventional | 2004-02-29 | Completed |
A Randomized Open-Label Phase 2b Study of Hepatic Infusions of Anti-CEA CAR-T Cells Alternating With Systemic Chemotherapy Versus Chemotherapy Alone In Patients With Liver Metastases Due To CEA-Expressing Pancreatic Adenocarcinoma [NCT04037241] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | 2021-11-01 | Withdrawn(stopped due to Sponsor terminated) |
Phase II Open-Label Trial of Neoadjuvant Atezolizumab in Combination With CAPEOX for Resectable Non-Metastatic Proficient Mismatch Repair (PMMR) Colon Cancer [NCT05870800] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-09-01 | Not yet recruiting |
Randomized Phase 2 Study of Valproic Acid combinEd With Simvastatin and Gemcitabine/Nab-paclitaxel-based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients (The VESPA Trial). [NCT05821556] | Phase 2 | 240 participants (Anticipated) | Interventional | 2023-06-12 | Recruiting |
A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects [NCT03734029] | Phase 3 | 557 participants (Actual) | Interventional | 2018-12-27 | Active, not recruiting |
Combining Abraxane With Capecitabine and Radiation Therapy for Consolidation of Treatment Following Induction Chemotherapy for Locally Advanced Pancreatic Cancer [NCT02394535] | Phase 1 | 25 participants (Actual) | Interventional | 2015-11-12 | Completed |
A Multicenter, Prospective, Randomized Clinical Trial to Investigate the Combined Modality Therapy for Locally Advanced Mid/Low Rectal Cancer. [NCT03042000] | | 1,200 participants (Anticipated) | Interventional | 2017-02-28 | Not yet recruiting |
A Randomized Phase II Study Evaluating Maintenance Therapy After First Line Induction Chemotherapy in Metastatic Cancer Pancreas [NCT05566743] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-09-11 | Recruiting |
A Randomized, Double-blinded,Multicenter,Phase II Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Placebo in Combination With Trastuzumab and Chemother [NCT04908813] | Phase 2 | 150 participants (Anticipated) | Interventional | 2021-09-29 | Recruiting |
A Study of Weekly Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel as Neoadjuvant Therapy for Resectable, Hormone Receptor Negative or Hormone Receptor Positive, HER-2/Neu Positive Breast Cancer Followed by a Novel Regi [NCT00194779] | Phase 2 | 50 participants (Actual) | Interventional | 2003-10-31 | Completed |
Clinico-pharmacological Study of Metronomic Capecitabine and Oxaliplatin Versus Classic XELOX in Egyptian Metastatic Colorectal Cancer [NCT04425564] | Phase 2 | 70 participants (Actual) | Interventional | 2016-01-01 | Completed |
A Phase II Trial of Maintenance ADAPT Therapy With Capecitabine and Celecoxib in Patients With Metastatic Colorectal Cancer [NCT01729923] | Phase 2 | 27 participants (Actual) | Interventional | 2013-03-31 | Terminated(stopped due to Funding ended) |
Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer [NCT02243007] | Phase 2 | 7 participants (Actual) | Interventional | 2014-09-30 | Terminated(stopped due to Slow Accrual) |
Randomized Multicenter Phase II Trial of Capecitabine Versus S-1 as First-line Treatment in Elderly Patients With Advanced or Recurrent Unresectable Gastric Cancer [NCT00278863] | Phase 2 | 96 participants (Actual) | Interventional | 2004-11-30 | Completed |
Neoadjuvant Treatment With Regorafenib and Capecitabine Combined With Radiotherapy in Locally Advanced Rectal Cancer. A Multicenter Phase Ib Trial (RECAP) [NCT02910843] | Phase 1 | 25 participants (Actual) | Interventional | 2017-02-22 | Terminated(stopped due to due to structural financial deficit of SAKK) |
Phase II Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies [NCT00266279] | Phase 2 | 17 participants (Actual) | Interventional | 2005-04-30 | Completed |
Preoperative Chemoradiation With Capecitabine Plus Temozolomide in Patients With Locally Advanced Resectable Rectal Cancer: Phase I Study [NCT01781403] | Phase 1 | 22 participants (Actual) | Interventional | 2013-05-10 | Completed |
Possible Protective Effect of Celecoxib Against Capecitabine Induced Hand and Foot Syndrome in Patients With Colorectal Cancer [NCT05327751] | Phase 3 | 44 participants (Anticipated) | Interventional | 2022-04-01 | Recruiting |
NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy [NCT03169764] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
Phase II Study of Oxaliplatin, Capecitabine, Cetuximab, and Bevacizumab in the Treatment of Metastatic Colorectal Cancer [NCT00290615] | Phase 2 | 30 participants (Actual) | Interventional | 2006-01-31 | Completed |
A Randomized, Open-label Study of the Effect of 2 Different Treatment Schedules of Xeloda With Eloxatin and Avastin on Progression-free Survival in Treatment-naïve Patients With Locally Advanced or Metastatic Colorectal Cancer [NCT00118755] | Phase 2 | 435 participants (Actual) | Interventional | 2005-07-31 | Completed |
Phase I,II Study of First Line Intraperitoneal Paclitaxel With Systemic Capecitabine and Oxaliplatin Combination Therapy in Patients With Advanced Gastric Cancer With Peritoneal Metastasis [NCT04943653] | Phase 1/Phase 2 | 61 participants (Anticipated) | Interventional | 2021-06-08 | Recruiting |
Safety and Efficacy of Metronomic Vinorelbine in Combination With Toripalimab for Patients With HER2- Metastatic Breast Cancer [NCT04389073] | Phase 2 | 138 participants (Anticipated) | Interventional | 2020-04-01 | Recruiting |
An Open-Label, Multicenter, Rollover Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib [NCT02955940] | Phase 2 | 10 participants (Actual) | Interventional | 2016-11-30 | Active, not recruiting |
A Phase II Trial of Immunotherapy Combined With Neoadjuvant Chemoradiotherapy in Microsatellite Stable Locally Advanced Rectal Cancer [NCT04411537] | Phase 2 | 50 participants (Anticipated) | Interventional | 2020-07-01 | Not yet recruiting |
Phase I/II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer [NCT00889187] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2009-12-31 | Terminated(stopped due to Excess toxicity was identified intraoperatively) |
A Prospective Phase I Clinical Trial of Carbon Ion Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer [NCT03403049] | Phase 1 | 14 participants (Actual) | Interventional | 2016-04-01 | Completed |
A Randomized, Multicenter, Phase III Open-Label Study of the Efficacy and Safety of Trastuzumab Emtansine Versus Lapatinib Plus Capecitabine in Chinese Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastu [NCT03084939] | Phase 3 | 351 participants (Actual) | Interventional | 2017-04-24 | Completed |
Using Genetic Polymorphisms of Drug Metabolism and Immunohistochemical Stain to Predict the Efficacy and Toxicity in Patients With Gastric Adenocarcinoma - A Phase II Study [NCT01558011] | Phase 2 | 51 participants (Actual) | Interventional | 2012-03-31 | Terminated(stopped due to The budget issues.) |
An Open-label, Single-centre, Single-arm Phase II Study of Capecitabine Combined With Oxaliplatin and Irinotecan (Xeloxiri) as First-line Treatment in Patients With Advanced Unresectable Pancreatic Adenocarcinoma [NCT01558869] | Phase 2 | 37 participants (Actual) | Interventional | 2012-04-30 | Completed |
Phase II Study of Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil in Patients With Unresectable Biliary Tract Carcinomas [NCT01572324] | Phase 2 | 37 participants (Actual) | Interventional | 2012-03-31 | Completed |
A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer [NCT01573468] | Phase 2 | 580 participants (Anticipated) | Interventional | 2012-04-30 | Recruiting |
A Randomized, Open-label, Multicenter, Two-arm, Phase III Study to Evaluate Efficacy and Quality of Life in Patients With Metastatic Hormone Receptor-positive HER2-negative Breast Cancer Receiving Ribociclib in Combination With Endocrine Therapy or Chemot [NCT03462251] | Phase 3 | 41 participants (Actual) | Interventional | 2018-05-24 | Completed |
Integration of Cetuximab, in Combination With Local Radiotherapy, in Perioperative Chemotherapy of Resectable and Locally Advanced Gastric Cancer. A Pilot Phase Ib-trial [NCT01611506] | Phase 1/Phase 2 | 1 participants (Actual) | Interventional | 2012-02-29 | Terminated(stopped due to Outcome of EXPAND study (no benefit from adding cetuximab to the first-line chemotherapy in advanced gastric cancer in the overall patient population)) |
A Phase Ib/II Pilot Study of Pyrotinib Plus Capecitabine Combined With Brain Radiotherapy in HER2 Positive Breast Cancer Patients With Brain Metastases [NCT04582968] | Phase 1/Phase 2 | 39 participants (Anticipated) | Interventional | 2020-01-02 | Active, not recruiting |
A Phase II Randomized Study of the Protection Effect of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer [NCT04394598] | Phase 2 | 210 participants (Anticipated) | Interventional | 2020-03-01 | Recruiting |
A Randomized, Double-blind, Placebo-controlled Study of Capecitabine in the Treatment of Early-stage Breast Cancer With Low-hormone Receptor Expression and Residual Invasive Carcinoma After Neoadjuvant Chemotherapy [NCT03821454] | | 50 participants (Anticipated) | Interventional | 2019-02-01 | Not yet recruiting |
A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil - (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Bre [NCT00024102] | Phase 3 | 633 participants (Actual) | Interventional | 2001-09-30 | Completed |
A Phase I/II Trial of Preoperative Oxaliplatin, Docetaxel, and Capecitabine With Concurrent Radiation Therapy in Localized Carcinoma of the Esophagus or Gastroesophageal Junction [NCT00193128] | Phase 1/Phase 2 | 59 participants (Actual) | Interventional | 2004-04-30 | Completed |
An Open-label Study of Xeloda Plus Avastin at Time of Disease Progression in Treatment-naïve Women With HER2-negative Metastatic Breast Cancer [NCT00121836] | Phase 4 | 109 participants (Actual) | Interventional | 2005-06-30 | Completed |
Neoadjuvant FOLFOXIRI Chemotherapy Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer: An Open Label Randomized Controlled Phase III Trial [NCT05201430] | Phase 3 | 300 participants (Anticipated) | Interventional | 2021-08-27 | Recruiting |
A Phase II Study of Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma, Including Carcinoma of the Gallbladder and Biliary Tract [NCT00338988] | Phase 2 | 44 participants (Actual) | Interventional | 2003-08-31 | Completed |
A Clinical Study of the Efficacy and Safety of Chidamide in Combination With Camrelizumab and Carboplatin or Capecitabine in the Second and Third Line Treatment of Relapsed/Metastatic Triple-negative Breast Cancer [NCT05438706] | Phase 2 | 70 participants (Anticipated) | Interventional | 2022-07-10 | Not yet recruiting |
Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Capecitabine in Patient With Non-resectable Liver Metastases From Breast Cancer A Phase II Trial in Patients With Limited Extrahepatic Disease [NCT01387295] | Phase 2 | 38 participants (Actual) | Interventional | 2010-04-30 | Completed |
Phase II Study of First Line Capecitabine Administered on Continuous Way Combined With Oxaliplatin and Bevacizumab Every Two Weeks in Metastatic Colorectal Cancer Patients. [NCT00345696] | Phase 2 | 32 participants (Actual) | Interventional | 2006-06-30 | Completed |
Phase I-II Study of bi-Weekly Fixed Dose Rate Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma [NCT00350961] | Phase 1/Phase 2 | 39 participants (Anticipated) | Interventional | 2004-06-30 | Completed |
A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC [NCT00351195] | Phase 2 | 39 participants (Anticipated) | Interventional | 2006-02-28 | Terminated(stopped due to Did not meet the criteria for continuation to second stage) |
Chemotherapy or No Chemotherapy in Clear Margins After Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer. A Randomised Phase III Trial of Control Vs Capecitabine Plus Oxaliplatin [CHRONICLE] [NCT00427713] | Phase 3 | 800 participants (Anticipated) | Interventional | 2004-11-30 | Completed |
A Phase Ia-Ib Dose-escalation Study Evaluating Safety and Efficacy of Neoadjuvant Stereotactic Body Radiotherapy (SBRT) With Concomitant Capecitabine Chemotherapy for Resectable Carcinoma of Exocrine Pancreas. [NCT01918644] | Phase 1 | 21 participants (Actual) | Interventional | 2014-04-08 | Completed |
A Phase II Study of Vorinostat and Capecitabine in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) and Nasopharyngeal Carcinoma (NPC) [NCT01267240] | Phase 2 | 25 participants (Actual) | Interventional | 2010-12-31 | Terminated(stopped due to Study treatment did not show clinical activity.) |
A Novel Phase I/IIa Open Label Study of IMM 101 in Combination With Selected Standard of Care (SOC) Regimens in Patients With Metastatic Cancer or Unresectable Cancer at Study Entry [NCT03009058] | Phase 1/Phase 2 | 2 participants (Actual) | Interventional | 2017-05-24 | Terminated(stopped due to Commercial reasons) |
A Phase III, Multicenter, Randomized, Open-Label, Parallel Controlled Study of SHR-A1811 Versus Pyrotinib in Combination With Capecitabine for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Tax [NCT05424835] | Phase 3 | 269 participants (Anticipated) | Interventional | 2022-07-29 | Recruiting |
A Multi-Centre Randomised Clinical Trial of Biomarker-Driven Maintenance Treatment for First-Line Metastatic Colorectal Cancer (MODUL) [NCT02291289] | Phase 2 | 609 participants (Actual) | Interventional | 2015-04-17 | Completed |
Multicenter Phase II Study of Preoperative Chemoradiotherapy With CApecitabine Plus Temozolomide in Patients With MGMT Silenced and Microsatellite Stable Locally Advanced RecTal Cancer: the CATARTIC Trial [NCT05136326] | Phase 2 | 21 participants (Anticipated) | Interventional | 2021-12-01 | Recruiting |
Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer [NCT00314353] | Phase 2 | 7 participants (Actual) | Interventional | 2006-03-31 | Terminated(stopped due to The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.) |
Phase I Study of Oral Capecitabine (Xeloda) as a Radiation Enhancer in Locally Unresectable, Residual, or Recurrent Colorectal Cancer Localized in the Pelvis [NCT00003704] | Phase 1 | 51 participants (Actual) | Interventional | 1999-04-30 | Completed |
Phase I/II of Capecitabine and Vinorelbine in Elderly Patients (At Least 65 Years) With Metastatic Breast Cancer With or Without Bone Involvement [NCT00003902] | Phase 1/Phase 2 | 110 participants (Anticipated) | Interventional | 1999-03-31 | Completed |
A Multicentre Randomised Phase II Clinical Trial Comparing Oxaliplatin (Eloxatin), Capecitabine (Xeloda) and Pre-Operative Radiotherapy With or Without Cetuximab Followed by Total Mesorectal Excision for the Treatment of Patients With Magnetic Resonance I [NCT00383695] | Phase 2 | 164 participants (Anticipated) | Interventional | 2005-09-30 | Active, not recruiting |
A Phase II Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil in Subjects With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE-059) [NCT02335411] | Phase 2 | 318 participants (Actual) | Interventional | 2015-02-03 | Completed |
A Phase Ⅰb/Ⅱ Study of Fruquintinib Combined With Capecitabine in the First-line Maintenance Treatment of RAS/BRAF Wild-type Metastatic Colorectal Cancer [NCT05016869] | Phase 1/Phase 2 | 48 participants (Anticipated) | Interventional | 2022-04-12 | Recruiting |
A Phase II Study to Assess Efficacy and Safety of Capecitabine and Irinotecan Plus Bevacizumab Followed by Capecitabine and Oxaliplatin Plus Bevacizumab or the Reverse Sequence in Patients With Metastatic Colorectal Cancer [NCT02119026] | Phase 2 | 120 participants (Actual) | Interventional | 2011-02-28 | Completed |
Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses Versus Investigator's Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclon [NCT02083653] | Phase 2 | 254 participants (Actual) | Interventional | 2014-03-06 | Completed |
Phase Ib/II Study of Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Locally Advanced Rectal Cancer [NCT02010567] | Phase 1/Phase 2 | 32 participants (Actual) | Interventional | 2013-12-31 | Terminated(stopped due to The study was halted prematurely at the funding partner's request.) |
Pyrotinib Combined With Capecitabine and Bevacizumab for Patients With HER2 Positive Breast Cancer and Brain Metastases:a Single-arm,Prospective,Phase II Study [NCT06152822] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-11-30 | Recruiting |
A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer [NCT04854668] | Phase 3 | 748 participants (Actual) | Interventional | 2020-07-30 | Active, not recruiting |
A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction and Gastric C [NCT01774786] | Phase 3 | 780 participants (Actual) | Interventional | 2013-06-10 | Completed |
Validation of a Radiation Response Signature in Borderline Resectable Pancreatic Cancer Patients Treated With Induction Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT) [NCT01754623] | Phase 2 | 9 participants (Actual) | Interventional | 2013-02-28 | Terminated(stopped due to Lack of pre-treatment tissue to make the study plan feasible.) |
Program for Assessment of Capecitabine (Xeloda) Plus Docetaxel First-line Therapies in HER2-negative Metastatic Breast Cancer (XEBRA Study) [NCT01777945] | | 46 participants (Actual) | Observational | 2012-12-31 | Completed |
Phase I Study of the Combination of Trastuzumab Emtansine (T-DM1) and Capecitabine in HER2-Positive Metastatic Breast Cancer and HER2-Positive Locally Advanced/Metastatic Gastric Cancer Patients, Followed by a Randomized, Open-Label Phase II Study of Tras [NCT01702558] | Phase 2 | 182 participants (Actual) | Interventional | 2012-12-03 | Terminated(stopped due to The sponsor decided to terminate study after 70% of participants had experienced a progression-free survival event.) |
BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Phase I Study [NCT02550743] | Phase 1 | 7 participants (Actual) | Interventional | 2016-06-03 | Terminated(stopped due to lack of accural) |
A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ,III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction [NCT03349866] | Phase 2 | 48 participants (Anticipated) | Interventional | 2017-11-30 | Recruiting |
Safety and Efficacy of Nivolumab Combined With CAPOX Plus Bevacizumab as Neoadjuvant Treatment of pMMR/MSS Colorectal Cancer Liver Metastases Patients:a Single-arm, Phase II, Prospective Study [NCT05588297] | Phase 2 | 12 participants (Anticipated) | Interventional | 2022-10-31 | Not yet recruiting |
Efficacy and Safety of Fruquintinib Plus Capecitabine Versus Capecitabine as Maintenance Treatment for Metastatic Colorectal Cancer After First-line Chemotherapy: A Phase II, Randomized, Controlled Study [NCT05451719] | Phase 2 | 116 participants (Anticipated) | Interventional | 2022-07-31 | Not yet recruiting |
A Single-Arm, Open Label Study of Aflibercept as Maintenance Therapy Following Induction With Aflibercept in Combination With XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient [NCT01955629] | Phase 1/Phase 2 | 4 participants (Actual) | Interventional | 2013-12-31 | Terminated(stopped due to The study enrollment was prematurely halted due to safety reasons.) |
A Phase II Study of Bevacizumab With Docetaxel and Capecitabine in the Neoadjuvant Setting for Breast Cancer Patients [NCT02005549] | Phase 2 | 18 participants (Actual) | Interventional | 2006-02-28 | Completed |
Phase 2 Study of ZW25 Plus First-line Combination Chemotherapy in HER2-Expressing Gastrointestinal (GI) Cancers, Including Gastroesophageal Adenocarcinoma (GEA), Biliary Tract Cancer (BTC), and Colorectal Cancer (CRC) [NCT03929666] | Phase 2 | 362 participants (Anticipated) | Interventional | 2019-08-29 | Recruiting |
A Prospective Phase II Trial of Molecular Profiling to Guide Neoadjuvant Therapy for Resectable and Borderline Resectable Adenocarcinoma of the Pancreas [NCT01726582] | Phase 2 | 229 participants (Actual) | Interventional | 2011-11-30 | Completed |
A Single Arm, Phase II Study of Pembrolizumab, Oxaliplatin, and Capecitabine in the First Line Treatment of Patients With Gastro-esophageal Cancer. [NCT03342937] | Phase 2 | 41 participants (Actual) | Interventional | 2018-01-11 | Completed |
A Phase II Non-randomized Study to Assess the Safety and Efficacy of the Combination of Tucatinib and Trastuzumab and Capecitabine for Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer [NCT03501979] | Phase 2 | 17 participants (Actual) | Interventional | 2019-02-20 | Active, not recruiting |
Comparison of the Clinical Response of Total nEoadjuvant Treatment of Two Methods of Long-term or Short-term cHemoRadiotherapy Followed by Consolidation Chemotherapy in Patients With Locally Advanced rectAl Cancer (TEHRAN) , a Randomized Controlled Clinic [NCT05920928] | | 114 participants (Anticipated) | Interventional | 2023-09-23 | Not yet recruiting |
A Phase II Study of Metronomic Oral Chemotherapy With Cyclophosphamide Plus Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients [NCT04304352] | Phase 2 | 162 participants (Anticipated) | Interventional | 2011-07-29 | Recruiting |
A Phase 1 Trial of the Safety, Tolerability and Biological Effects of Intravenous Enadenotucirev, a Novel Oncolytic Virus, in Combination With Chemoradiotherapy in Locally Advanced Rectal Cancer [NCT03916510] | Phase 1 | 13 participants (Actual) | Interventional | 2019-07-01 | Completed |
Phase III Study to Evaluate the Quality of Life in Elderly Patients With Metastatic Colorectal Cancer Receiving First-line Therapy Based on Simplified Geriatric Parameters. [NCT03828227] | Phase 3 | 188 participants (Anticipated) | Interventional | 2019-06-07 | Recruiting |
Sorafenib in Combination With Capecitabine for Patients With Measurable Hepatocellular Carcinoma [NCT01032850] | Phase 2 | 15 participants (Actual) | Interventional | 2009-09-30 | Terminated(stopped due to Low accrual rate) |
Proactive Management of Endoperitoneal Spread in Colonic Cancer [NCT02974556] | Phase 3 | 140 participants (Anticipated) | Interventional | 2024-03-01 | Not yet recruiting |
A Multicenter, Open-Label, Randomized-Controlled Study of Abemaciclib, a CDK4 and 6 Inhibitor, in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer With Visceral Metastases [NCT04031885] | Phase 4 | 4 participants (Actual) | Interventional | 2019-08-14 | Terminated(stopped due to Business decision based on the inability to enroll subjects into the trial) |
A Multicenter Phase II Trial of Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer [NCT01899118] | Phase 2 | 50 participants (Anticipated) | Interventional | 2013-04-30 | Recruiting |
Phase I Clinical Study of Every Three Week Irinotecan With Oral Capecitabine Given Twice Daily for Two Weeks Out of Three in Patients With Gastrointestinal and Other Solid Malignancies [NCT00003867] | Phase 1 | 30 participants (Actual) | Interventional | 1999-03-31 | Completed |
An Open-Label Combination Study of Capecitabine and Standard Paclitaxel Therapy as First or Second Line Therapy in Women With Metastatic Breast Carcinoma [NCT00005649] | Phase 2 | 0 participants | Interventional | 1998-07-31 | Completed |
A Randomized Phase 3 Clinical Trial Investigating Optimal Duration of Oxaliplatin Administration in Postoperative XELOX (Oxaliplatin + Capecitabine) Adjuvant Chemotherapy for the Patients With Stage II/III Gastric Cancer [NCT04787354] | Phase 3 | 976 participants (Anticipated) | Interventional | 2021-11-01 | Recruiting |
Open-label, Randomized, Multicenter, Phase III Study, Comparing Standard Chemotherapy to Standard Combination of Endocrine Therapy With Abemaciclib as Initial Metastatic Treatment Among Patients With Visceral Metastasis of ER+ HER2-breast Cancer, High Bur [NCT04158362] | Phase 3 | 378 participants (Anticipated) | Interventional | 2020-06-11 | Recruiting |
A Phase II Study of Total Neoadjuvant Chmoradiation Treatment Plus SHR1210 for High-risk Locally Advanced Rectal Cancer and Biomarker Screening Base on Neoantigen [NCT04340401] | Phase 2 | 25 participants (Anticipated) | Interventional | 2020-05-25 | Recruiting |
Phase I Study of Dose Escalation Using Image-guided Radiotherapy to Deliver a Stereotactic Radiosurgical Boost After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Esophageal Cancer [NCT00368329] | Phase 1 | 4 participants (Actual) | Interventional | 2006-06-30 | Terminated(stopped due to low accrual) |
Capecitabine ON Temozolomide Radionuclide Therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study [NCT02358356] | Phase 2 | 75 participants (Actual) | Interventional | 2015-11-30 | Completed |
A Multicenter Study With an Open-label Phase Ib Part Followed by a Randomized, Placebo-controlled, Double-blind, Phase II Part to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of the DNA-PK Inhibitor Peposertib (M3814) in Combination With [NCT03770689] | Phase 1/Phase 2 | 19 participants (Actual) | Interventional | 2019-03-20 | Completed |
A Prospective, Phase III, Controlled, Multicentre, Randomised Clinical Trial Comparing Combination Gemcitabine and Capecitabine Therapy With Concurrent and Sequential Chemoimmunotherapy Using a Telomerase Vaccine in Locally Advanced and Metastatic Pancrea [NCT00425360] | Phase 3 | 1,110 participants (Anticipated) | Interventional | 2006-09-30 | Completed |
Efficacy and Safety of Supplement Adjuvant Capecitabine in Postoperative Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative High-risk Breast Cancer Patients: a Multicenter, Single-arm Clinical Trial [NCT05212454] | Phase 3 | 400 participants (Anticipated) | Interventional | 2023-03-15 | Recruiting |
Anti-PD-1, Capecitabine, and Oxaliplatin for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus-dMMR): a Proof-of-principle Study [NCT05177133] | Phase 2 | 25 participants (Anticipated) | Interventional | 2021-11-05 | Recruiting |
P-RAD: A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer [NCT04443348] | Phase 2 | 120 participants (Anticipated) | Interventional | 2020-12-16 | Recruiting |
A Randomized, Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (PELICAN Trial) [NCT00266799] | Phase 3 | 210 participants (Actual) | Interventional | 2006-01-13 | Completed |
Phase I Trial of OXIRI [Oxaliplatin (O), Xeloda (X) and Irinotecan (I)] Treatment in Patients With Advanced and/or Metastatic Pancreatic Adenocarcinoma [NCT02368860] | Phase 1 | 33 participants (Actual) | Interventional | 2013-09-17 | Completed |
Phase II Study of Second Line Capecitabine Plus Oxaliplatin (XELOX) in Patients With Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy [NCT02350686] | Phase 2 | 67 participants (Anticipated) | Interventional | 2015-05-14 | Recruiting |
Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Responders After Induction Therapy in Metastatic Colorectal Cancer [NCT03158610] | Phase 2/Phase 3 | 20 participants (Actual) | Interventional | 2018-01-29 | Terminated(stopped due to Difficult to enrollment patient) |
A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of Fixed-dose PCS6422 With Escalating Doses of Capecitabine Administered Orally to Patients With Advanced, Refractory Gastrointestinal Tract Tumors [NCT04861987] | Phase 1 | 42 participants (Anticipated) | Interventional | 2021-06-18 | Recruiting |
Epstein-Barr Virus DNA to Systemic Therapy for Treatment Adaptation in High Risk Nasopharyngeal Carcinoma (EP-STAR Trial) A Phase II, Multi-center, Biomarker-guided, Umbrella Trial [NCT04072107] | Phase 2 | 110 participants (Anticipated) | Interventional | 2020-06-01 | Active, not recruiting |
Phase II Trial of Capecitabine in Combination With Fulvestrant for Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer [NCT00534417] | Phase 2 | 41 participants (Actual) | Interventional | 2007-10-31 | Completed |
Phase II Study of Ramucirumab With Trastuzumab, Fluoropyrimidine, and Platinum in Patients With Metastatic HER2-Positive Gastroesophageal Junction and Gastric Cancer [NCT02726399] | Phase 2 | 7 participants (Actual) | Interventional | 2016-03-18 | Terminated(stopped due to Low accrual rate) |
Investigation of the Value of ctDNA Analysis in the Diagnosis, Treatment, and Surveillance of Patients With Surgically Resectable Colorectal Cancer [NCT03038217] | Phase 3 | 300 participants (Anticipated) | Interventional | 2017-02-28 | Not yet recruiting |
Phase I Study to Evaluate the Safety and Tolerability of ASLAN001 in Combination With Oxaliplatin and Capecitabine or Oxaliplatin and 5-FU With Leucovorin [NCT02435927] | Phase 1 | 60 participants (Anticipated) | Interventional | 2014-08-31 | Active, not recruiting |
A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab [NCT02422199] | Phase 1/Phase 2 | 128 participants (Anticipated) | Interventional | 2015-05-31 | Active, not recruiting |
Open-label, Randomized, Multicenter, Phase II Trial to Compare Efficacy of CAPTEM Versus FOLFIRI as Second Line in Patients Progressed on or After First-line Oxaliplatin Chemo for Advanced, MGMT Methylated, RAS Mutated Colorectal Cancer [NCT02414009] | Phase 2 | 82 participants (Actual) | Interventional | 2014-09-30 | Completed |
Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Gemcitabine/Cisplatin Plus Toripalimab Treatment: a Single Arm, Open Label, Multicenter, Phase II Clinical Study [NCT05484375] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-09-30 | Not yet recruiting |
NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death Ligand 1 (PD-L1) Therapy [NCT03167177] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Locally Advanced or Metastatic Nasopharyngeal Carcinoma: a Prospective, Phase 2 Study [NCT02360501] | Phase 2 | 50 participants (Actual) | Interventional | 2008-01-31 | Completed |
Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors. An Open-label, Multicenter, Randomized Phase III Trial Comparing Safety and Efficacy of Personalized Versus Non-personalized Radionuclide Therapy With 177Lu (Lutetium)-DOTATOC. [NCT05387603] | Phase 3 | 300 participants (Anticipated) | Interventional | 2022-06-30 | Not yet recruiting |
Phase II Study to Evaluate Postoperative Chemotherapy in High-Grade Appendiceal Adenocarcinoma With Peritoneal Carcinomatosis [NCT02420509] | | 2 participants (Actual) | Observational | 2015-08-27 | Terminated(stopped due to unable to accrue) |
[NCT02415829] | Phase 2 | 55 participants (Anticipated) | Interventional | 2014-11-30 | Recruiting |
XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma, a Randomized, Controlled, Multicenter Clinical Trial [NCT05494060] | Phase 2 | 80 participants (Anticipated) | Interventional | 2022-03-16 | Recruiting |
NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC [NCT03169777] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2018-08-31 | Withdrawn(stopped due to Trial not initiated) |
Apatinib Combined With Capecitabine Compared With Apatinib in the Treatment of Advanced Non-resectable Hepatocellular Carcinoma [NCT03114085] | Phase 2 | 170 participants (Anticipated) | Interventional | 2017-05-20 | Not yet recruiting |
Open, Multicenter, Phase Ic Clinical Study on the Pharmacokinetics and Drug Interactions of Utidelone Plus Capecitabine in Patients With Recurrent and Metastatic Breast Cancer [NCT05052437] | Phase 1 | 16 participants (Actual) | Interventional | 2020-10-15 | Completed |
An Open-label, Single-centre, Single-arm Phase II Study of Triplet Combination of Capecitabine, Oxaliplatin and Irinotecan (Xeloxiri) as Salvage Therapy in Patients With Refractory Metastatic Colorectal Cancer [NCT03146377] | Phase 2 | 32 participants (Actual) | Interventional | 2014-04-30 | Completed |
Combination of Nelmastobart and Capecitabine Therapy in Metastatic Colorectal Cancer With Resistance or Intolerance to Oxaliplatin and Irinotecan-based Chemotherapy - A Single Arm, Phase 1b/2, Multicenter Study [NCT05990543] | Phase 1/Phase 2 | 59 participants (Anticipated) | Interventional | 2023-08-30 | Not yet recruiting |
Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors [NCT05040360] | Phase 2 | 141 participants (Anticipated) | Interventional | 2022-05-05 | Recruiting |
Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma [NCT02614794] | Phase 2 | 612 participants (Actual) | Interventional | 2016-01-28 | Completed |
An Open-Label Multicenter Phase 1b Study of Tolinapant (ASTX660) in Combination With Radiotherapy/Chemoradiotherapy (RT/CRT) in Preoperative Treatment of Patients With Rectum Cancer (PRAAR 1: Preoperative Radiotherapy And ASTX660 in Rectum Cancer) [NCT05912075] | Phase 1 | 78 participants (Anticipated) | Interventional | 2023-07-01 | Not yet recruiting |
Randomized Phase II Study of Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced G3 Non-small Cell Gastroenteropancreatic Neuroendocrine Carcinomas [NCT02595424] | Phase 2 | 126 participants (Anticipated) | Interventional | 2016-04-06 | Recruiting |
A Phase II, Multicenter, Single-Arm, Feasibility Study of Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer [NCT01439282] | Phase 2 | 77 participants (Actual) | Interventional | 2011-08-31 | Completed |
A Multicenter, Randomized, Controlled Phase III Study of Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy as Adjuvant Regimen for D2/R0 Resected pN3 Gastric (G) or Gastroesophageal Junction (GEJ) Adenocarcinoma [NCT04997837] | Phase 3 | 433 participants (Anticipated) | Interventional | 2021-07-21 | Recruiting |
A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach [NCT01798251] | Phase 2 | 40 participants (Anticipated) | Interventional | 2012-12-31 | Recruiting |
An Open Label Study of the Effect of Adjuvant Treatment With Capecitabine in Combination With Oxaliplatin on Disease-Free Survival in Patients With Stage III Colon Cancer [NCT01442155] | | 74 participants (Actual) | Observational | 2011-10-31 | Completed |
MASTERPLAN: A Randomised Phase II Study of MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease [NCT04089150] | Phase 2 | 120 participants (Anticipated) | Interventional | 2019-10-01 | Recruiting |
Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer [NCT00159432] | Phase 2 | 63 participants (Actual) | Interventional | 2005-02-28 | Completed |
A Phase 2 Study of Capecitabine, Temozolomide, and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors [NCT01525082] | Phase 2 | 20 participants (Actual) | Interventional | 2012-12-31 | Completed |
A Phase II Study of XELOX in Locally Advanced or Metastatic Gastric Cancer [NCT00354224] | Phase 2 | 10 participants (Actual) | Interventional | 2005-01-31 | Terminated(stopped due to due to low accrual) |
A Phase Ib, Open-Label, Multicenter Study of the Safety and Pharmacokinetics of the Combination of RhuMab 2C4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors [NCT02494596] | Phase 1 | 19 participants (Actual) | Interventional | 2004-01-31 | Completed |
Phase II Study of Preoperative FOLFIRINOX Followed by Accelerated Short Course Radiation Therapy for Borderline-Resectable Pancreatic Cancer [NCT01591733] | Phase 2 | 48 participants (Actual) | Interventional | 2012-05-31 | Active, not recruiting |
An Open Label, randomIzed Controlled Prospective Multicenter Two Arm Phase IV Trial to Determine Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab for Advanced (Inoperable or Metastatic) HER2- [NCT02248571] | Phase 4 | 85 participants (Actual) | Interventional | 2014-08-31 | Completed |
Maintenance Treatment With Capecitabine Plus Apatinib vs. Apatinib and Observation After First-line XELOX/SOX Chemotherapy for Patients With Advanced Gastric Cancer: a Multicenter, Randomized, Controlled Trial [NCT03598348] | Phase 3 | 288 participants (Anticipated) | Interventional | 2018-01-16 | Recruiting |
Program for Assessment of Capecitabine (Xeloda) Based First-line Therapies in Metastatic Colorectal Cancer (AXEL Study) [NCT01696695] | | 882 participants (Actual) | Observational | 2011-07-31 | Completed |
Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer Under Fed Conditions: a Multicenter, Randomized, Open-label, Three-period, and Reference-replicated Crossover Study [NCT04420871] | Phase 1 | 48 participants (Actual) | Interventional | 2018-12-10 | Completed |
Metro-PD1: a Phase I/II Trial Evaluating Anti-PD1 (Nivolumab) in Combination With Metronomic Chemotherapy in Children and Teenagers With Refractory / Relapsing Solid Tumors [NCT03585465] | Phase 1/Phase 2 | 102 participants (Anticipated) | Interventional | 2019-03-26 | Recruiting |
A Phase I Study of Talimogene Laherparepvec (Talimogene Laherparepvec) With Neoadjuvant Chemotherapy and Radiation in Adenocarcinoma of the Rectum [NCT03300544] | Phase 1 | 3 participants (Actual) | Interventional | 2017-09-20 | Active, not recruiting |
Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast Cancer After CDK4/6 Inhibitor:a Prospective, Single-arm, Phase II Clinical Trial. [NCT05411380] | Phase 2 | 73 participants (Anticipated) | Interventional | 2022-10-03 | Recruiting |
Tucidinostat and Metronomic Capecitabine for Metastatic Triple-negative Breast Cancer:a Multicenter,Open-label, Randomized Controlled, Phase II Clinical Trial [NCT05390476] | Phase 2 | 126 participants (Anticipated) | Interventional | 2022-08-01 | Recruiting |
Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer [NCT01471353] | Phase 2 | 43 participants (Actual) | Interventional | 2011-11-30 | Completed |
A Randomized, Three Arm Multinational Phase III Study to Investigate Bevacizumab (q3w or q2w) in Combination With Either Intermittent Capecitabine Plus Oxaliplatin (XELOX) (q3w) or Fluorouracil/Leucovorin With Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 Regime [NCT00112918] | Phase 3 | 3,451 participants (Actual) | Interventional | 2004-12-31 | Completed |
Phase II Trial Of Neoadjuvant Concurrent Capecitabine, RHUMAB VEGF (Avastin) And Radiotherapy In Patients Presenting With Locally Advanced Rectal Cancer [NCT00113230] | Phase 2 | 25 participants (Actual) | Interventional | 2005-02-28 | Completed |
XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for MRF-negative Locally Advanced, pMMR Rectal Cancer: a Randomised, Phase 2 Trial [NCT05815303] | Phase 2 | 92 participants (Anticipated) | Interventional | 2023-03-29 | Recruiting |
A Phase II/III Randomized Clinical Trial of CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence: PURITY Study [NCT06037980] | Phase 2/Phase 3 | 300 participants (Anticipated) | Interventional | 2023-11-07 | Recruiting |
NeoOPTIMIZE: An Open-Label, Phase II Trial to Assess the Efficacy of Adaptive Switching of FOLFIRINOX or Gemcitabine/Nab-Paclitaxel as a Neoadjuvant Strategy for Patients With Resectable and Borderline Resectable/Locally Advanced Unresectable Pancreatic C [NCT04539808] | Phase 2 | 60 participants (Anticipated) | Interventional | 2021-05-27 | Recruiting |
A Multicenter, Open-Label, Non-Comparative, Three-Arm, Phase IIa Trial of Ipatasertib (GDC-0068) in Combination With Non-Taxane Chemotherapy Agents for Taxane-Pretreated Unresectable Locally Advanced or Metastatic TNBC Patients [NCT04464174] | Phase 2 | 54 participants (Actual) | Interventional | 2020-10-08 | Completed |
A Randomised Study to Assess the Efficacy of Cetuximab Rechallenge in Patients With Metastatic Colorectal Cancer (RAS Wild-type) Responding to First-line Treatment With FOLFIRI Plus Cetuximab [NCT02934529] | Phase 3 | 673 participants (Actual) | Interventional | 2015-03-31 | Active, not recruiting |
ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer [NCT02746796] | Phase 2/Phase 3 | 680 participants (Anticipated) | Interventional | 2016-03-31 | Completed |
A Phase Ib/II Clinical Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer [NCT02024607] | Phase 1/Phase 2 | 495 participants (Actual) | Interventional | 2014-01-31 | Completed |
A Phase II Clinical Study of BBI608 in Adult Patients With Advanced Colorectal Cancer [NCT01776307] | Phase 2 | 200 participants (Actual) | Interventional | 2012-03-31 | Completed |
Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer [NCT00274768] | Phase 2 | 26 participants (Actual) | Interventional | 2004-04-30 | Completed |
An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer [NCT01461057] | Phase 2 | 30 participants (Actual) | Interventional | 2011-12-06 | Completed |
A Prospective Phase II Study of Cetuximab (Erbitux®) in Combination With XELOX [XELoda® (Capecitabine) and OXaliplatin] in Patients With Advanced Gastric Cancer [NCT00398398] | Phase 2 | 44 participants (Actual) | Interventional | 2006-11-30 | Completed |
Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab in the Treatment of Metastatic Colorectal Cancer [NCT00416494] | Phase 2 | 50 participants (Actual) | Interventional | 2003-09-30 | Completed |
Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients [NCT00438100] | Phase 2 | 142 participants (Actual) | Interventional | 2008-04-30 | Completed |
A Prospective, Randomized, Open-label, Phase II Study of QYHJ Granules Versus Xeloda in the Second-line Treatment of Patients With Metastatic Pancreatic Cancer [NCT01796782] | Phase 2 | 60 participants (Anticipated) | Interventional | 2013-01-31 | Active, not recruiting |
A Phase I Study of Docetaxel, Capecitabine and Oxaliplatin (DXO) in Patients With Advanced Stomach Cancer [NCT00446290] | Phase 1 | 22 participants (Actual) | Interventional | 2006-03-31 | Completed |
Study on Xeloda® to Document Its Use in Routine Practice in Patients With Metastatic or Advanced Breast Cancer [NCT01725386] | | 274 participants (Actual) | Observational | 2011-03-31 | Completed |
Improving the Safety of Fluoropyrimidine-based Chemotherapy by Combined DPYD Genotype-guided and DPD Phenotype-guided Dose Individualization: The ALPE2U Study [NCT04194957] | | 1,440 participants (Anticipated) | Interventional | 2020-01-15 | Recruiting |
Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas [NCT03930771] | Phase 2 | 1 participants (Actual) | Interventional | 2019-05-21 | Terminated(stopped due to the study had a low accrual rate) |
Phase 1 Trial of Tucatinib, Trastuzumab, and Capecitabine With Stereotactic Radiosurgery (SRS) in Patients With Brain Metastases From HER-2 Positive Breast Cancer [NCT05553522] | Phase 1 | 40 participants (Anticipated) | Interventional | 2023-09-18 | Recruiting |
A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients With Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma ( [NCT04363801] | Phase 2 | 232 participants (Anticipated) | Interventional | 2020-07-29 | Recruiting |
Post-surgical Liquid Biopsy-guided Treatment of Stage III and High-risk Stage II Colon Cancer Patients: the PEGASUS Trial [NCT04259944] | Phase 2 | 140 participants (Anticipated) | Interventional | 2020-06-16 | Active, not recruiting |
NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With TNBC Wh [NCT03387085] | Phase 1/Phase 2 | 79 participants (Anticipated) | Interventional | 2018-03-16 | Active, not recruiting |
A Phase III Randomized Trial Investigating the Duration of Adjuvant Therapy(3 Versus 6 Months) With the Modified FOLFOX 6 or XELOX Regimens for Patients With Stage III Colon Cancer [NCT00958737] | Phase 3 | 2,000 participants (Anticipated) | Interventional | 2009-05-12 | Active, not recruiting |
A Randomized Double Blinded Study of Curcumin With Pre-operative Capecitabine and Radiation Therapy Followed by Surgery for Rectal Cancer [NCT00745134] | Phase 2 | 22 participants (Actual) | Interventional | 2008-08-11 | Terminated(stopped due to The trial was stopped early because there was only one patient with pCR among the first 15 patients randomized to the curcumin arm.) |
Phase Ib/II Study of GQ1001 and Pyrotinib in HER2 Positive Metastatic Breast Cancer Patients Who Had Failed Previous Anti-HER2 Treatment(GRACE) [NCT05575804] | Phase 1/Phase 2 | 75 participants (Anticipated) | Interventional | 2022-10-01 | Active, not recruiting |
A Randomized Phase III 2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab for the First-line Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Locally Recurrent or Metastatic Breast Cancer [NCT00600340] | Phase 3 | 564 participants (Actual) | Interventional | 2008-04-30 | Completed |
QUILT-3.080: Phase 1B/2 Trial Of The NANT Pancreatic Cancer Vaccine As Treatment For Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-Of-Care Therapy [NCT03586869] | Phase 1/Phase 2 | 173 participants (Anticipated) | Interventional | 2018-07-28 | Active, not recruiting |
Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer [NCT01671891] | | 100 participants (Anticipated) | Observational | 2012-02-29 | Recruiting |
A Randomised, Open-label, Parallel Controlled, Multicentre, Phase 3 Clinical Trial of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer: [NCT03080805] | Phase 3 | 240 participants (Anticipated) | Interventional | 2017-05-03 | Active, not recruiting |
A Phase 1 Study of NBTXR3 Activated by Radiotherapy With Concurrent Chemotherapy for Adenocarcinoma of the Esophagus [NCT04615013] | Phase 1 | 24 participants (Anticipated) | Interventional | 2020-11-23 | Recruiting |
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metast [NCT04494425] | Phase 3 | 866 participants (Actual) | Interventional | 2020-07-24 | Active, not recruiting |
A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual [NCT04333706] | Phase 1/Phase 2 | 65 participants (Anticipated) | Interventional | 2023-11-03 | Recruiting |
Study of the Impact of DPD Activity on the Efficacy of Capecitabine [NCT04198727] | | 155 participants (Anticipated) | Interventional | 2020-07-20 | Recruiting |
Randomized, Phase II Trial to Evaluate the Efficacy and Safety of Atezolizumab Plus Capecitabine Adjuvant Therapy Compared to Capecitabine Monotherapy for TNBC With Residual Invasive Cancer After Neoadjuvant Chemotherapy. [NCT03756298] | Phase 2 | 284 participants (Actual) | Interventional | 2019-01-15 | Active, not recruiting |
A Single-arm, Open-label Study of Avastin Plus Xeloda on Objective Treatment Response in Patients With Advanced or Metastatic Liver Cancer Who Have Had no Previous Cytotoxic Chemotherapy [NCT02013830] | Phase 2 | 45 participants (Actual) | Interventional | 2005-05-31 | Completed |
Randomized Phase II Trial of Chemotherapy of Physician's Choice Plus Trastuzumab Versus Chemotherapy of Physician's Choice Plus Trastuzumab Plus Pertuzumab In Women With Pretreated, HER2-Overexpressing Metastatic Breast Cancer (MBC) [NCT02229149] | Phase 2 | 33 participants (Actual) | Interventional | 2014-12-31 | Terminated(stopped due to per Sponsor request) |
A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well- [NCT04919226] | Phase 3 | 202 participants (Anticipated) | Interventional | 2021-12-21 | Recruiting |
A Phase II, Randomized, Controlled Study to Assess the Efficacy and Safety of Fruquintinib Plus Capecitabine Versus Bevacizumab Plus Capecitabine as Maintenance Treatment Following First-line Chemotherapy for Metastatic Colorectal Cancer [NCT04733963] | Phase 2 | 112 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting |
A Phase I-II Study of Capecitabine and Oxaliplatin in Chemotherapy-Naive and Thymidylate Synthase Inhibitor Pretreated Advanced or Metastatic Colorectal Cancer [NCT00004187] | Phase 1/Phase 2 | 0 participants | Interventional | 1999-06-30 | Completed |
Open-Label, Multicenter, Phase II/III Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer After Gemcitabine and Cisplatin-Based Treatment Failure [NCT05065957] | Phase 2/Phase 3 | 180 participants (Anticipated) | Interventional | 2022-03-29 | Recruiting |
Differential Gene Regulation During Neoadjuvant Therapy Trial of Epirubicin/Cyclophosphamide (EC) vs Docetaxel/Capecitabine (DX) Regimens in Patients With Large ER-positive and ER-negative Breast Cancers: A Randomized Phase II Trial. [NCT01869192] | Phase 2 | 72 participants (Actual) | Interventional | 2003-03-05 | Completed |
A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303cversus Trastuzumab Combined With Vinorelbine/Capecitabine in of HER2-positive Advanced Breast Cancer [NCT05901935] | Phase 3 | 420 participants (Anticipated) | Interventional | 2023-07-31 | Not yet recruiting |
A Phase II Trial of Pharmacogenetic-Based Dosing of Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy for Advanced Small Bowel Adenocarcinoma [NCT00433550] | Phase 2 | 33 participants (Actual) | Interventional | 2007-05-31 | Completed |
A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer [NCT00565370] | Phase 1/Phase 2 | 22 participants (Actual) | Interventional | 2007-11-30 | Completed |
A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane [NCT00568022] | Phase 1 | 9 participants (Actual) | Interventional | 2008-02-29 | Completed |
A Phase II Study of Capecitabine, Carboplatin, and Bevacizumab for Metastatic or Unresectable Gastroesophageal Junction and Gastric Adenocarcinoma [NCT00780494] | Phase 2 | 35 participants (Actual) | Interventional | 2009-02-28 | Completed |
Phase II Multicenter Single-arm Study of BKM120 Plus Capecitabine for Breast Cancer Patients With Brain Metastases [NCT02000882] | Phase 2 | 10 participants (Actual) | Interventional | 2014-05-29 | Completed |
Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients [NCT01584544] | Phase 1 | 24 participants (Actual) | Interventional | 2011-01-31 | Completed |
Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Colon Cancer at High Risk of Peritoneal Carcinomatosis [NCT02231086] | Phase 3 | 204 participants (Actual) | Interventional | 2015-03-31 | Completed |
A Phase I, Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of DZD1516 in Combination With Trastuzumab and Capecitabine, or DZD1516 in Combination With T-DM1, in Patients With Metastatic HER2 [NCT04509596] | Phase 1 | 23 participants (Actual) | Interventional | 2020-09-21 | Active, not recruiting |
Neoadjuvant Therapy and Biomarker Analysis of Stage II and III Breast Cancer With Docetaxel/Capecitabine and Celecoxib Followed by Doxorubicin/Cyclophosphamide and Celecoxib [NCT00665457] | Phase 2 | 3 participants (Actual) | Interventional | 2004-04-15 | Terminated(stopped due to study drug was removed from the market and low enrollment.) |
Phase I Study of Imatinib, Gemcitabine and Capecitabine in Patients With Solid Tumors [NCT00483366] | Phase 1 | 13 participants (Actual) | Interventional | 2006-08-15 | Completed |
A STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA) [NCT01808573] | Phase 3 | 621 participants (Actual) | Interventional | 2013-03-29 | Completed |
A Doublelet Metronomic Chemotherapeutic Regimen With Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer Patients: A Monocentric Retrospective Study in China [NCT05747326] | Phase 2 | 30 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting |
Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes [NCT05608785] | Phase 1/Phase 2 | 45 participants (Anticipated) | Interventional | 2023-01-01 | Not yet recruiting |
A Randomized Phase II Trial of Metronomic Oral Vinorelbine Plus Cyclophosphamide and Capecitabine (VEX) Versus Weekly Paclitaxel as First-line or Second-line Treatment in Patients With ER-positive/HER2-negative Advanced or Metastatic Breast Cancer [NCT02954055] | Phase 2 | 140 participants (Actual) | Interventional | 2017-09-13 | Active, not recruiting |
A Randomized Open-Label, Multi-Center Pivotal Study of ANG1005 Compared With Physician's Best Choice in HER2-Negative Breast Cancer Patients With Newly Diagnosed Leptomeningeal Carcinomatosis and Previously Treated Brain Metastases (ANGLeD) [NCT03613181] | Phase 3 | 150 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
Capecitabine in Combination With Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer, a Phase II Trial [NCT01891227] | Phase 2 | 40 participants (Actual) | Interventional | 2013-08-09 | Completed |
A Biologic Study of Global Gene Expression, NF-Kappa B and p53 in Adenocarcinoma of the Rectum. [NCT00280761] | | 47 participants (Actual) | Observational | 2003-12-31 | Completed |
The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer [NCT05610163] | Phase 2 | 312 participants (Anticipated) | Interventional | 2022-12-08 | Recruiting |
Phase II Randomized, Prospective Trial of Lutetium Lu 177 Dotatate PRRT Versus Capecitabine and Temozolomide in Well-Differentiated Pancreatic Neuroendocrine Tumors [NCT05247905] | Phase 2 | 198 participants (Anticipated) | Interventional | 2022-03-16 | Recruiting |
A Single Arm Study of Brain Metastasis in Patients With HER2-positive Breast Cancer Treated With Pyrrolidine Maleate and Capecitabine Combined With Brain Radiotherapy [NCT04767828] | Phase 4 | 43 participants (Anticipated) | Interventional | 2020-05-01 | Recruiting |
A Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Cancer [NCT01463982] | Phase 1 | 21 participants (Actual) | Interventional | 2010-12-31 | Completed |
Total Neoadjuvant Therapy Followed by 'Watch and Wait' Approach or Organ Preservation for MRI Stratified Low-risk Rectal Cancer: a Multi-center, Prospective, Single-arm Phase II Trial. [NCT04405206] | | 54 participants (Anticipated) | Observational | 2020-05-25 | Recruiting |
Randomized Phase 3 Study of Xelox(Capecitabine Plus Oxaliplatin) Followed by Maintenance Capecitabine or Observation in Patients With Advanced Gastric Adenocarcinoma [NCT02289547] | Phase 3 | 184 participants (Anticipated) | Interventional | 2015-05-31 | Recruiting |
A Single Arm,Multicenter,Real-world Observational Study of Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer [NCT05255523] | Phase 2 | 60 participants (Anticipated) | Interventional | 2022-02-20 | Not yet recruiting |
Low-dose Versus Standard-dose Capecitabine Adjuvant Chemotherapy for Chinese Elderly Patients With Stage II/III Colorectal Cancer: A Randomized, Phase 3 Non-inferiority Study [NCT02316535] | Phase 3 | 710 participants (Anticipated) | Interventional | 2014-11-30 | Recruiting |
A Phase Ib/II Study of AK104#PD-1 / CTLA-4 Bispecific Antibody# and AK117#Anti-CD47 Antibody# in Combination With or Without Chemotherapy in Advanced Malignant Tumors [NCT05235542] | Phase 1/Phase 2 | 130 participants (Anticipated) | Interventional | 2022-07-12 | Recruiting |
Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma [NCT05838391] | | 20 participants (Anticipated) | Interventional | 2023-05-18 | Recruiting |
A Phase II Study of Preoperative Pembrolizumab for Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer Followed by Chemotherapy and Chemoradiation With Pembrolizumab [NCT03257163] | Phase 2 | 40 participants (Anticipated) | Interventional | 2017-09-29 | Recruiting |
A Two-arm, Open-label, Randomized Phase III Study of Pembrolizumab (MK-3475) Monotherapy Versus Standard Chemotherapy in Platinum Pre-treated, Recurrent or Metastatic Nasopharyngeal Cancer (NPC) (Keynote-122) [NCT02611960] | Phase 3 | 233 participants (Actual) | Interventional | 2016-04-18 | Completed |
A Randomized, Open Label Multi-Center Study Of Single Agent Larotaxel (XRP9881) Compared To Continuous Administration of 5-FU For The Treatment Of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen [NCT00417209] | Phase 3 | 408 participants (Actual) | Interventional | 2006-12-31 | Completed |
A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients [NCT00398879] | Phase 2 | 381 participants (Actual) | Interventional | 2005-08-31 | Completed |
An Open-label, Single Center, Phase I/II Clinical Trial to Assess the Maximum Tolerated Dose, Safety and Efficacy of BEY1107 in Combination With Capecitabine in Patients With Metastatic Colorectal Cancer Refractory or Intolerant to Standard of Care [NCT05093907] | Phase 1/Phase 2 | 27 participants (Anticipated) | Interventional | 2021-08-31 | Recruiting |
A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119) [NCT02555657] | Phase 3 | 622 participants (Actual) | Interventional | 2015-10-13 | Completed |
A Prospective Randomized Controlled Trial to Compare Oxaliplatin Combined With S-1 (SOX) Versus Oxaliplatin With Capecitabine (XELOX) as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients [NCT03448549] | Phase 3 | 1,191 participants (Anticipated) | Interventional | 2018-01-01 | Recruiting |
Adjuvant CAPECITABINE in High Risk PSEUDOMYXOMA PERITONEI Patients Treated With CYTOREDUCTIVE SURGERY (CRS) and HYPERTERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC) [NCT05321329] | Phase 2 | 28 participants (Anticipated) | Interventional | 2018-12-03 | Recruiting |
Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Non-metastatic, Resectable Gastric and GE-junction Cancer: The PANDA Trial [NCT03448835] | Phase 2 | 20 participants (Anticipated) | Interventional | 2018-03-07 | Recruiting |
Biomarkers and Clinical Outcomes in Localized Rectal Adenocarcinoma Treated With Neoadjuvant Therapy [NCT04418895] | Phase 2 | 0 participants (Actual) | Interventional | 2021-08-13 | Withdrawn(stopped due to lack of resources) |
Phase I Study of Pre-operative Capecitabine and Lenvatinib With External Radiation Therapy in Locally Advanced Rectal Adenocarcinoma [NCT02935309] | Phase 1 | 20 participants (Actual) | Interventional | 2016-10-14 | Completed |
Efficacy of Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy: A Pathology-oriented, Prospective, Multicenter, Randomized, Open-label, Parallel Group Clinical Trial [NCT03415763] | Phase 3 | 764 participants (Anticipated) | Interventional | 2018-11-05 | Recruiting |
A Prospective Study of Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab for Siewert II ,III of HER-2 Positive Adenocarcinoma at Gastroesophageal Junction [NCT03368131] | Phase 2 | 48 participants (Actual) | Interventional | 2017-12-01 | Active, not recruiting |
Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial [NCT05131893] | | 300 participants (Anticipated) | Observational [Patient Registry] | 2022-03-31 | Not yet recruiting |
DURVA+ : Evaluation of the Safety and Pharmacodynamics of Anti-PD-L1 Antibody Durvalumab in Combination With Chemotherapy in Patients With Advanced Solid Tumors [NCT03907475] | Phase 2 | 115 participants (Anticipated) | Interventional | 2019-07-16 | Recruiting |
A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Es [NCT03783442] | Phase 3 | 649 participants (Actual) | Interventional | 2018-12-11 | Active, not recruiting |
Phase I/II Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM) [NCT03213002] | Phase 1/Phase 2 | 67 participants (Anticipated) | Interventional | 2017-06-13 | Recruiting |
A Phase I/II Trial of BAY 43-9006 Plus Gemcitabine and Capecitabine in the Treatment of Patients With Advanced Renal Cell Carcinoma [NCT00121251] | Phase 1/Phase 2 | 17 participants (Actual) | Interventional | 2005-06-03 | Completed |
Precision Treatment of Refractory Triple Negative Breast Cancer Based on Molecular Subtyping --FUSCC-TNBC- Umbrella Trial [NCT03805399] | Phase 1/Phase 2 | 140 participants (Anticipated) | Interventional | 2018-10-18 | Recruiting |
A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor, Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy [NCT02117479] | Phase 3 | 321 participants (Actual) | Interventional | 2014-03-31 | Terminated(stopped due to The study was terminated early based on the results of the planned interim analysis.) |
A Randomized, Open Label, Multicenter Phase IIIb Study Comparing Two Trastuzumab Dosing Regimens, Each in Combination With Cisplatin/Capecitabine Chemotherapy, as First-Line Therapy in Patients With HER2-Positive Metastatic Gastric or Gastro-Esophageal Ju [NCT01450696] | Phase 3 | 296 participants (Actual) | Interventional | 2011-12-31 | Terminated(stopped due to futility following planned interim analysis) |
Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib (GSK1120212) Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer [NCT02042443] | Phase 2 | 53 participants (Actual) | Interventional | 2014-02-28 | Completed |
A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer [NCT02120417] | Phase 2 | 149 participants (Actual) | Interventional | 2014-05-31 | Terminated(stopped due to The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation.) |
A Phase 2 Study of Capecitabine in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin [NCT01823679] | Phase 2 | 2 participants (Actual) | Interventional | 2013-03-31 | Terminated(stopped due to Low accrual) |
Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer. A Randomized Phase II Marker Trial [NCT04245865] | Phase 2 | 74 participants (Anticipated) | Interventional | 2020-06-26 | Recruiting |
Phase II of Short Course Radiation Therapy Followed by Pre-operative Chemotherapy and Surgery in Primary High-risk Rectal Cancer [NCT03729687] | Phase 2 | 280 participants (Actual) | Interventional | 2016-07-04 | Active, not recruiting |
A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer [NCT03371017] | Phase 3 | 572 participants (Anticipated) | Interventional | 2018-01-11 | Active, not recruiting |
PERSONALIZED MEDICINE GROUP / UCBG UC-0105/1304: SAFIR02_Breast - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer [NCT02299999] | Phase 2 | 1,460 participants (Actual) | Interventional | 2014-04-07 | Active, not recruiting |
A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma [NCT02358863] | | 13 participants (Actual) | Interventional | 2015-02-28 | Terminated(stopped due to Issues with recruitment.) |
Randomized Trial of Primary Surgery Followed Selective Radiochemotherapy Versus Conventional Preoperative Radiochemotherapy for Locally Advanced Rectal Cancer With MRI Negative Circumferential Margin [NCT02121405] | Phase 3 | 350 participants (Anticipated) | Interventional | 2015-10-31 | Suspended(stopped due to DSMB stopped this trial due to the difference of 3-year DFS's rate between two groups more than 5% at the interim analysis in July 2021.) |
A Phase II Study of Weekly Docetaxel (Taxotere®) in Combination With Capecitabine (Xeloda) in Advanced Gastric and Gastro-Esophageal Adenocarcinomas. [NCT00177255] | Phase 2 | 40 participants (Actual) | Interventional | 2005-04-30 | Terminated(stopped due to Roche has withdrawn support) |
A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients [NCT00201825] | Phase 2 | 29 participants (Actual) | Interventional | 2004-12-31 | Completed |
A Randomized, Open-label, Positive-controlled, Multicenter Phase Ш Study Comparing Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine Versus Capecitabine Monotherapy in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma Who [NCT05717764] | Phase 3 | 500 participants (Anticipated) | Interventional | 2023-02-28 | Not yet recruiting |
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL) [NCT02314117] | Phase 3 | 645 participants (Actual) | Interventional | 2015-01-20 | Completed |
A Phase II, Open-Label Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection [NCT04856761] | | 160 participants (Anticipated) | Observational | 2020-11-01 | Recruiting |
A Three-arm, Randomized, Open Label, Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in the Treatment of Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastat [NCT01783444] | Phase 2 | 309 participants (Actual) | Interventional | 2013-02-26 | Completed |
Steam (Sequencing Triplet With Avastin and Maintenance): FOLFOXIRI/Bevacizumab Regimens (Concurrent and Sequential) vs. FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer [NCT01765582] | Phase 2 | 280 participants (Actual) | Interventional | 2013-01-23 | Terminated |
Nab-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT). [NCT02301143] | Phase 2 | 107 participants (Actual) | Interventional | 2015-04-21 | Completed |
A Randomised, Multicentre, Open Label, Phase II Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer [NCT02294786] | Phase 2 | 62 participants (Actual) | Interventional | 2014-12-17 | Terminated |
A Multicenter, Randomised, Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously [NCT01953003] | Phase 3 | 112 participants (Actual) | Interventional | 2013-09-30 | Completed |
An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab (Avastin™) [NCT01588990] | Phase 4 | 128 participants (Actual) | Interventional | 2012-06-26 | Completed |
A Randomized, Double-Blind, Phase 3 Study of the JAK 1/2 Inhibitor Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy [NCT02119663] | Phase 3 | 86 participants (Actual) | Interventional | 2014-06-30 | Terminated(stopped due to The safety committee found no safety issues but recommended halting the study based on a lack of efficacy in a similar trial. The sponsor terminated the trial.) |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
NCT00005908 (4) [back to overview] | Overall Clinical Response Rate |
NCT00005908 (4) [back to overview] | Complementary Deoxyribonucleic Acid (cDNA) Expression |
NCT00005908 (4) [back to overview] | Number of Participants With Adverse Events |
NCT00005908 (4) [back to overview] | Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models |
NCT00009737 (6) [back to overview] | Disease-free Survival |
NCT00009737 (6) [back to overview] | Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters |
NCT00009737 (6) [back to overview] | Mean Change From Baseline in Global Health Status at Week 25 |
NCT00009737 (6) [back to overview] | Overall Survival |
NCT00009737 (6) [back to overview] | Relapse-Free Survival |
NCT00009737 (6) [back to overview] | Number of Participants With Any Adverse Events and Serious Adverse Events |
NCT00022698 (9) [back to overview] | Duration of Overall Complete Response |
NCT00022698 (9) [back to overview] | Duration of Overall Response |
NCT00022698 (9) [back to overview] | Overall Survival |
NCT00022698 (9) [back to overview] | Percentage of Participants With One-year Survival |
NCT00022698 (9) [back to overview] | Time to Disease Progression |
NCT00022698 (9) [back to overview] | Time To Objective Response |
NCT00022698 (9) [back to overview] | Time to Treatment Failure |
NCT00022698 (9) [back to overview] | Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths |
NCT00022698 (9) [back to overview] | Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0) |
NCT00024102 (3) [back to overview] | Relapse-free Survival Rates at 2.4 Years |
NCT00024102 (3) [back to overview] | Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment. |
NCT00024102 (3) [back to overview] | Overall Survival Rate at 2.4 Years |
NCT00033540 (5) [back to overview] | Overall Survival |
NCT00033540 (5) [back to overview] | Accrual of Patients With This Disease Site |
NCT00033540 (5) [back to overview] | Median Survival Time for Participants With Relevant Biologic Markers |
NCT00033540 (5) [back to overview] | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug |
NCT00033540 (5) [back to overview] | Response |
NCT00050167 (1) [back to overview] | Percentage of Participants With Reoccurrence |
NCT00068588 (2) [back to overview] | Maximum Tolerated Dose Determined by Dose-limiting Toxicities |
NCT00068588 (2) [back to overview] | Response Rate of a Combination of GTI-2040 and Capecitabine |
NCT00069095 (22) [back to overview] | PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone |
NCT00069095 (22) [back to overview] | Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4 |
NCT00069095 (22) [back to overview] | Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4 |
NCT00069095 (22) [back to overview] | Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone |
NCT00069095 (22) [back to overview] | Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4 |
NCT00069095 (22) [back to overview] | Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone |
NCT00069095 (22) [back to overview] | Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4 |
NCT00069095 (22) [back to overview] | Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone |
NCT00069095 (22) [back to overview] | PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4 |
NCT00069095 (22) [back to overview] | PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone |
NCT00069095 (22) [back to overview] | PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4 |
NCT00069095 (22) [back to overview] | PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone |
NCT00069095 (22) [back to overview] | PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone |
NCT00069095 (22) [back to overview] | Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4 |
NCT00069095 (22) [back to overview] | Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone |
NCT00069095 (22) [back to overview] | Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4 |
NCT00069095 (22) [back to overview] | BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4 |
NCT00069095 (22) [back to overview] | BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone |
NCT00069095 (22) [back to overview] | Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4 |
NCT00069095 (22) [back to overview] | Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone |
NCT00069095 (22) [back to overview] | PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4 |
NCT00069095 (22) [back to overview] | Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone |
NCT00069108 (11) [back to overview] | Best Overall Response, Investigators' Assessments |
NCT00069108 (11) [back to overview] | Best Overall Response, Independent Review Committee Assessment |
NCT00069108 (11) [back to overview] | Time To Treatment Failure |
NCT00069108 (11) [back to overview] | Progression Free Survival Based on Treatment Analysis- Per Population |
NCT00069108 (11) [back to overview] | Progression Free Survival Based on Treatment Analysis- Intent To Treat Population |
NCT00069108 (11) [back to overview] | Overall Survival |
NCT00069108 (11) [back to overview] | Duration Of Response |
NCT00069108 (11) [back to overview] | Progression Free Survival |
NCT00069108 (11) [back to overview] | Time To Response |
NCT00069108 (11) [back to overview] | Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment |
NCT00069108 (11) [back to overview] | Progression Free Survival Based on Independent Review Committee Assessment |
NCT00069121 (7) [back to overview] | Relapse-Free Survival (RFS) [Number of Events] |
NCT00069121 (7) [back to overview] | Overall Survival [Number of Events] |
NCT00069121 (7) [back to overview] | Number of Participants With at Least One Adverse Event by Most Severe Intensity |
NCT00069121 (7) [back to overview] | Disease-Free Survival (DFS) [Time to Event] |
NCT00069121 (7) [back to overview] | Disease-Free Survival (DFS) [Number of Events] |
NCT00069121 (7) [back to overview] | Relapse-Free Survival (RFS) [Time to Event] |
NCT00069121 (7) [back to overview] | Overall Survival [Time to Event] |
NCT00077857 (7) [back to overview] | Duration of Overall Response |
NCT00077857 (7) [back to overview] | Overall Survival |
NCT00077857 (7) [back to overview] | Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR) |
NCT00077857 (7) [back to overview] | Time to Progression of Disease or Death |
NCT00077857 (7) [back to overview] | Time to Treatment Failure |
NCT00077857 (7) [back to overview] | Number of Participants With Adverse Events and Serious Adverse Events |
NCT00077857 (7) [back to overview] | Time to Overall Response |
NCT00080301 (7) [back to overview] | Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) |
NCT00080301 (7) [back to overview] | Time to Response Per IRRC |
NCT00080301 (7) [back to overview] | Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC) |
NCT00080301 (7) [back to overview] | Overall Survival (OS) |
NCT00080301 (7) [back to overview] | Overall Response Rate (ORR) Per IRRC |
NCT00080301 (7) [back to overview] | Duration of Response Per IRRC |
NCT00080301 (7) [back to overview] | Treatment-related Safety Summary |
NCT00081289 (18) [back to overview] | Pathologic Complete Response Rate |
NCT00081289 (18) [back to overview] | Second Primary Rate at 4 Years |
NCT00081289 (18) [back to overview] | Survival Rate at 4 Years |
NCT00081289 (18) [back to overview] | Change From Baseline in QLQ-C30 Global Health Status Score at Two Years |
NCT00081289 (18) [back to overview] | Disease-free Survival Rate at 4 Years |
NCT00081289 (18) [back to overview] | Distant Failure Rate at 4 Years |
NCT00081289 (18) [back to overview] | Local-regional Failure Rate at 4 Years |
NCT00081289 (18) [back to overview] | Number of Participants With Grade 3+ Treatment-related Adverse Events |
NCT00081289 (18) [back to overview] | Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Two Years |
NCT00081289 (18) [back to overview] | Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Chemoradiation |
NCT00081289 (18) [back to overview] | Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Two Years |
NCT00081289 (18) [back to overview] | Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Post-operative Chemotherapy |
NCT00081289 (18) [back to overview] | Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Completion of Chemoradiation |
NCT00081289 (18) [back to overview] | Number of Participants With Grade 3+ Treatment-related Adverse Events Postoperatively |
NCT00081289 (18) [back to overview] | Number of Participants With Grade 3+ Treatment-related Adverse Events Preoperatively |
NCT00081289 (18) [back to overview] | Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Post-operative Chemotherapy |
NCT00081289 (18) [back to overview] | Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Chemoradiation |
NCT00081289 (18) [back to overview] | Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Post-operative Chemotherapy |
NCT00082433 (7) [back to overview] | Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) |
NCT00082433 (7) [back to overview] | Treatment-Related Safety Summary |
NCT00082433 (7) [back to overview] | Time to Response |
NCT00082433 (7) [back to overview] | Response Rate (RR) |
NCT00082433 (7) [back to overview] | Progression-Free Survival (PFS) |
NCT00082433 (7) [back to overview] | Overall Survival (OS) |
NCT00082433 (7) [back to overview] | Duration of Response |
NCT00084617 (3) [back to overview] | Response Rates (RR) in Metastatic Gastric/GE Junction Tumors |
NCT00084617 (3) [back to overview] | Overall Survival |
NCT00084617 (3) [back to overview] | Complete Response (CR) and Partial Response (PR) Duration |
NCT00087152 (3) [back to overview] | Progression-free Survival at 6 Months |
NCT00087152 (3) [back to overview] | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug |
NCT00087152 (3) [back to overview] | Confirmed Response Rate (Complete and Partial) |
NCT00089479 (10) [back to overview] | Overall Survival [Number of Events] |
NCT00089479 (10) [back to overview] | Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events] |
NCT00089479 (10) [back to overview] | Disease Free Survival Including Any New Cancer as Event [Number of Events] |
NCT00089479 (10) [back to overview] | Breast Cancer Free Survival [Time to Event] |
NCT00089479 (10) [back to overview] | Breast Cancer Free Survival [Number of Events] |
NCT00089479 (10) [back to overview] | Disease Free Survival [Number of Events] |
NCT00089479 (10) [back to overview] | Overall Survival [Time to Event] |
NCT00089479 (10) [back to overview] | Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event |
NCT00089479 (10) [back to overview] | Disease Free Survival [Time to Event] |
NCT00089479 (10) [back to overview] | Disease Free Survival Including Any New Cancer as Event [Time to Event] |
NCT00093379 (3) [back to overview] | Number of Participants With Complete Response at 2 Years |
NCT00093379 (3) [back to overview] | Number of Participants With 2-year Colostomy-Free Survival |
NCT00093379 (3) [back to overview] | 2 Year Failure Free Survival |
NCT00093808 (4) [back to overview] | Overall Survival as Assessed by Time |
NCT00093808 (4) [back to overview] | Time to Progression (TTP) |
NCT00093808 (4) [back to overview] | Duration of Response as Measured by RECIST Criteria |
NCT00093808 (4) [back to overview] | Confirmed Response Rate |
NCT00100815 (5) [back to overview] | Percentage of Participants With Improved Quality of Life |
NCT00100815 (5) [back to overview] | Clinical Response |
NCT00100815 (5) [back to overview] | Overall Survival |
NCT00100815 (5) [back to overview] | Percentage of Participants With Grades 3-5 Treatment Related Toxicities |
NCT00100815 (5) [back to overview] | Progression-free Survival |
NCT00101686 (14) [back to overview] | Survival Time: Celecoxib and Placebo |
NCT00101686 (14) [back to overview] | 1 Year Survival: FOLFIRI, mIFL and CapeIRI |
NCT00101686 (14) [back to overview] | Time to Progression: Bevacizumab With FOLFIRI, mIFL |
NCT00101686 (14) [back to overview] | Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL |
NCT00101686 (14) [back to overview] | Overall Response: FOLFIRI, mIFL and CapeIRI |
NCT00101686 (14) [back to overview] | Overall Response: Celecoxib and Placebo |
NCT00101686 (14) [back to overview] | Overall Response: Bevacizumab With FOLFIRI, mIFL |
NCT00101686 (14) [back to overview] | Dose Reduction Due to Treatment Emergent Adverse Events |
NCT00101686 (14) [back to overview] | Time to Progression: FOLFIRI, mIFL and CapeIRI |
NCT00101686 (14) [back to overview] | Overall Relative Dose Intensity of Irinotecan |
NCT00101686 (14) [back to overview] | 1 Year Survival: Bevacizumab With FOLFIRI, mIFL |
NCT00101686 (14) [back to overview] | Survival Time: FOLFIRI, mIFL and CapeIRI |
NCT00101686 (14) [back to overview] | Time to Progression : Celecoxib and Placebo |
NCT00101686 (14) [back to overview] | Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL |
NCT00107276 (3) [back to overview] | Progression-free Survival and Overall Survival |
NCT00107276 (3) [back to overview] | Response Rate (Complete and Partial, Confirmed and Unconfirmed) |
NCT00107276 (3) [back to overview] | Toxicity |
NCT00112918 (6) [back to overview] | Overall Survival in Stage III Cancer Patients - Time to Event |
NCT00112918 (6) [back to overview] | Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis |
NCT00112918 (6) [back to overview] | Overall Survival in Stage III Cancer Patients - Number of Events |
NCT00112918 (6) [back to overview] | Disease-free Survival in Stage III Cancer Patients - Number of Events |
NCT00112918 (6) [back to overview] | Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis |
NCT00112918 (6) [back to overview] | Disease-free Survival in Stage III Cancer Patients - Time to Event |
NCT00113230 (1) [back to overview] | Pathologic Local Tumor Response |
NCT00114231 (5) [back to overview] | Morbidity and Mortality Rate |
NCT00114231 (5) [back to overview] | Rate of Pathologic Complete Response of the Primary Tumor |
NCT00114231 (5) [back to overview] | R0 Resection Rate (Negative Margin Rate) |
NCT00114231 (5) [back to overview] | 3-Year Disease-free Survival |
NCT00114231 (5) [back to overview] | Local Recurrence Rate |
NCT00118755 (4) [back to overview] | Duration of Overall Clinical Response (CR or PR) |
NCT00118755 (4) [back to overview] | Overall Survival |
NCT00118755 (4) [back to overview] | Progression-free Survival (PFS) |
NCT00118755 (4) [back to overview] | Best Overall Clinical Response |
NCT00121134 (1) [back to overview] | The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts |
NCT00121251 (3) [back to overview] | Number of Participants Who Survived (Overall Survival) |
NCT00121251 (3) [back to overview] | Median Number of Months of Progression Free Survival (PFS) |
NCT00121251 (3) [back to overview] | Objective Response for BAY 43-9006 in Combination With Gemcitabine and Capecitabine Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) |
NCT00121836 (4) [back to overview] | Number of Subjects With Adverse Events |
NCT00121836 (4) [back to overview] | Number of Participants With Marked Laboratory Abnormalities |
NCT00121836 (4) [back to overview] | Overall Survival |
NCT00121836 (4) [back to overview] | Premature Withdrawal From Study Due to Adverse Events |
NCT00127036 (1) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) |
NCT00127933 (6) [back to overview] | Participants With Disease-Free Survival |
NCT00127933 (6) [back to overview] | Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery |
NCT00127933 (6) [back to overview] | Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery |
NCT00127933 (6) [back to overview] | Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR)) |
NCT00127933 (6) [back to overview] | Percentage of Participants With Local Recurrence |
NCT00127933 (6) [back to overview] | Participants With Overall Survival |
NCT00129935 (4) [back to overview] | Quality of Life Questionnaire: Time to Taking Off the Wig |
NCT00129935 (4) [back to overview] | Number of Participants With Overall Survival (OS) Event |
NCT00129935 (4) [back to overview] | The Number of Participants Who Experienced Adverse Events (AE) |
NCT00129935 (4) [back to overview] | Number of Participants With Disease-free Survival (DFS) Event |
NCT00130533 (3) [back to overview] | Disease Free Survival (DFS) Events |
NCT00130533 (3) [back to overview] | The Number of Participants Who Experienced Adverse Events (AE) |
NCT00130533 (3) [back to overview] | Overall Survival (OS) Event |
NCT00148122 (3) [back to overview] | Frequency of Grade III/IV Toxicities Experienced by Participants |
NCT00148122 (3) [back to overview] | Probability of Progression Free Survival |
NCT00148122 (3) [back to overview] | Overall Response Rate at 4 Months |
NCT00159432 (2) [back to overview] | Median Time for Progression Free Survival |
NCT00159432 (2) [back to overview] | Number of Participants With Grade 3 or Higher Toxicity |
NCT00177255 (2) [back to overview] | Overall Survival |
NCT00177255 (2) [back to overview] | Overall Response Rate |
NCT00177307 (4) [back to overview] | 1-, 2-, and 3-year Overall Survival |
NCT00177307 (4) [back to overview] | Response Rate (RR) |
NCT00177307 (4) [back to overview] | Progression Free Survival (PFS) |
NCT00177307 (4) [back to overview] | Overall Survival |
NCT00191152 (13) [back to overview] | Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment) |
NCT00191152 (13) [back to overview] | Best Overall Response (Crossover Treatment) |
NCT00191152 (13) [back to overview] | Time to Disease Progression (Crossover Treatment) |
NCT00191152 (13) [back to overview] | Progression-Free Survival (Initial Treatment) |
NCT00191152 (13) [back to overview] | Time to Disease Progression (Initial Treatment) |
NCT00191152 (13) [back to overview] | Progression-Free Survival (Crossover Treatment) |
NCT00191152 (13) [back to overview] | Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment) |
NCT00191152 (13) [back to overview] | Overall Survival |
NCT00191152 (13) [back to overview] | Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment) |
NCT00191152 (13) [back to overview] | Duration of Response (Crossover Treatment) |
NCT00191152 (13) [back to overview] | Duration of Response (Initial Treatment) |
NCT00191152 (13) [back to overview] | Best Overall Response (Initial Treatment) |
NCT00191152 (13) [back to overview] | Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment) |
NCT00193128 (3) [back to overview] | Overall Survival (OS) |
NCT00193128 (3) [back to overview] | Disease-Free Survival (DFS) |
NCT00193128 (3) [back to overview] | Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery |
NCT00193609 (2) [back to overview] | Overall Survival |
NCT00193609 (2) [back to overview] | Progression Free Survival |
NCT00194779 (6) [back to overview] | Time to Progression |
NCT00194779 (6) [back to overview] | Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR) |
NCT00194779 (6) [back to overview] | Relapse Rate in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed by Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy |
NCT00194779 (6) [back to overview] | Disease-free Survival |
NCT00194779 (6) [back to overview] | OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN |
NCT00194779 (6) [back to overview] | Number and Percent of Patients Reporting Grade 2, 3, 4, or Fatal Toxicities of These Regimens, Need for Dose Reduction, or Treatment Interruption or Discontinuation |
NCT00194792 (6) [back to overview] | Overall Survival |
NCT00194792 (6) [back to overview] | Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities |
NCT00194792 (6) [back to overview] | Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response |
NCT00194792 (6) [back to overview] | Number of Participants With Clinical Response |
NCT00194792 (6) [back to overview] | Disease-free Survival |
NCT00194792 (6) [back to overview] | Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation |
NCT00201734 (6) [back to overview] | Objective Response Rate (ORR) for the Phase II Portion of the Study. CR+PR Per RECIST v1.0 Criteria Using a Single Arm , Two Stage Minimax Design. |
NCT00201734 (6) [back to overview] | One Year Survival for Patients |
NCT00201734 (6) [back to overview] | Progression-Free Survival at 6 Months for Patients |
NCT00201734 (6) [back to overview] | Phase I: To Determine Side Effects |
NCT00201734 (6) [back to overview] | Maximum Tolerated Dose in Phase I Portion of Study |
NCT00201734 (6) [back to overview] | Time to Tumor Progression for Patients |
NCT00201825 (3) [back to overview] | Time to Tumor Progression |
NCT00201825 (3) [back to overview] | Determine Objective Response Rate |
NCT00201825 (3) [back to overview] | One Year Survival |
NCT00203411 (4) [back to overview] | Quality of Life of Patients |
NCT00203411 (4) [back to overview] | Response Rates |
NCT00203411 (4) [back to overview] | Time to Disease Progression |
NCT00203411 (4) [back to overview] | Number of Subjects Requiring Dose Modifications |
NCT00209092 (2) [back to overview] | Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. |
NCT00209092 (2) [back to overview] | Long Term Follow up Data on Recurrence and Survival |
NCT00215644 (5) [back to overview] | Overall Survival (OS) |
NCT00215644 (5) [back to overview] | Duration of Objective Response Assessed by Independent Review Committee |
NCT00215644 (5) [back to overview] | Percentage of Participants With Objective Response Assessed by Independent Review Committee |
NCT00215644 (5) [back to overview] | Progression-Free Survival |
NCT00215644 (5) [back to overview] | Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score |
NCT00216086 (3) [back to overview] | Pathological Complete Response (pCR) Rate |
NCT00216086 (3) [back to overview] | Local and Distant Disease Recurrence Rates |
NCT00216086 (3) [back to overview] | Disease-Free Survival |
NCT00226941 (7) [back to overview] | Survival at 5 Years |
NCT00226941 (7) [back to overview] | Overall Survival (OS) |
NCT00226941 (7) [back to overview] | Dose-limiting Toxicity (DLT) - Number of Participants Affected |
NCT00226941 (7) [back to overview] | Dose-limiting Toxicity (DLT) - Number of DLTs by Treatment Group |
NCT00226941 (7) [back to overview] | Pathologic Response Rate |
NCT00226941 (7) [back to overview] | Tumor Downstaging at Surgical Resection |
NCT00226941 (7) [back to overview] | Time-to-Progression (TTP) |
NCT00250835 (6) [back to overview] | Incidence of Sphincter-sparing Surgery |
NCT00250835 (6) [back to overview] | Pelvic Local Control Rate |
NCT00250835 (6) [back to overview] | Progression-free Survival (PFS) |
NCT00250835 (6) [back to overview] | Toxicity |
NCT00250835 (6) [back to overview] | Surgical Downstaging Rate |
NCT00250835 (6) [back to overview] | Pathologic Complete Response (PCR) |
NCT00258310 (4) [back to overview] | Recurrence-free Survival |
NCT00258310 (4) [back to overview] | Overall Survival |
NCT00258310 (4) [back to overview] | Compliance With Treatment . |
NCT00258310 (4) [back to overview] | Incidence of Second Primary Tumors |
NCT00266279 (2) [back to overview] | Qualitative and Quantitative Toxicity |
NCT00266279 (2) [back to overview] | Overall Response Rate |
NCT00266799 (5) [back to overview] | Overall Survival Time in the PLD and Capecitabine Treatment Groups |
NCT00266799 (5) [back to overview] | Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups |
NCT00266799 (5) [back to overview] | Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) |
NCT00266799 (5) [back to overview] | Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST) |
NCT00266799 (5) [back to overview] | Time to Treatment Failure in the PLD and the Capecitabine Treatment Groups |
NCT00274768 (6) [back to overview] | Adherence and Compliance to Oral Medication Using Electronic Monitoring |
NCT00274768 (6) [back to overview] | Clinical Benefit as Assessed by Lack of Progression for at Least 24 Weeks |
NCT00274768 (6) [back to overview] | Response Rate |
NCT00274768 (6) [back to overview] | Time to Treatment Failure |
NCT00274768 (6) [back to overview] | Pharmacokinetics of Capecitabine and Metabolites as Assessed by Maximum Plasma Concentration |
NCT00274768 (6) [back to overview] | Pharmacokinetics of Capecitabine and Metabolites as Assessed by Area Under the Curve (AUC) |
NCT00276744 (1) [back to overview] | 6-month Overall Survival |
NCT00278863 (2) [back to overview] | Number of Patients With Adverse Events |
NCT00278863 (2) [back to overview] | Response Rate |
NCT00290615 (4) [back to overview] | Response Rate (Percentage of Participants With Partial or Complete Response) |
NCT00290615 (4) [back to overview] | Progression-free Survival |
NCT00290615 (4) [back to overview] | Overall Survival |
NCT00290615 (4) [back to overview] | Safety and Tolerability |
NCT00290693 (5) [back to overview] | Number of Study Participants Experiencing Toxicity After Receiving Protocol Therapy |
NCT00290693 (5) [back to overview] | Overall Surival (OS) |
NCT00290693 (5) [back to overview] | Progression-free Survival (PFS) |
NCT00290693 (5) [back to overview] | Rate of Participants Achieving a 50% or More Reduction in CA 19-9 Levels |
NCT00290693 (5) [back to overview] | Rate of Participants Achieving Complete Response or Partial Response to Therapy. |
NCT00291486 (11) [back to overview] | Impact of Capecitabine on 131I-huA33 Clearance (CL) as Measured by Initial and Therapy Dose Clearance (CL) |
NCT00291486 (11) [back to overview] | Mean Specific Absorbed Dose of 131I-huA33 for Normal Organs Calculated From the Initial Infusion |
NCT00291486 (11) [back to overview] | Pharmacokinetics (PK) of 131I-huA33 as Measured by Area Under the Serum Concentration Curve Extrapolated to Infinite Time (AUC) |
NCT00291486 (11) [back to overview] | Pharmacokinetics (PK) of 131I-huA33 as Measured by Clearance (CL) |
NCT00291486 (11) [back to overview] | Number of Patients With Dose-Limiting Toxicities (DLT) |
NCT00291486 (11) [back to overview] | Pharmacokinetics (PK) of 131I-huA33 as Measured by Maximum Serum Concentration (Cmax) |
NCT00291486 (11) [back to overview] | Pharmacokinetics (PK) of 131I-huA33 as Measured by T½α and T½β (Half Lives of the Initial and Terminal Phases of Disposition, Respectively) |
NCT00291486 (11) [back to overview] | Pharmacokinetics (PK) of 131I-huA33 as Measured by the Volume of the Central Compartment (V1) |
NCT00291486 (11) [back to overview] | Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33 |
NCT00291486 (11) [back to overview] | Biodistribution of 131I-huA33 Measured by Whole Body Clearance and Normal Organ Clearance Reported as Mean Biological Half-life (T1/2 Biological) After Initial 131I-huA33 Infusion |
NCT00291486 (11) [back to overview] | Mean Total Tumor Dose of 131I-huA33 |
NCT00305877 (3) [back to overview] | Two-year Overall Survival Rate |
NCT00305877 (3) [back to overview] | Two-year Disease-free Survival (DFS) |
NCT00305877 (3) [back to overview] | Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy |
NCT00320749 (3) [back to overview] | Common Toxicities |
NCT00320749 (3) [back to overview] | Maximum Tolerated Dose (MTD) |
NCT00320749 (3) [back to overview] | Therapeutic Response |
NCT00321100 (3) [back to overview] | Overall Survival |
NCT00321100 (3) [back to overview] | Objective Response Rate (ORR) |
NCT00321100 (3) [back to overview] | Time to Progression (TTP) |
NCT00321685 (5) [back to overview] | Resection Rate for T4 Rectal Cancers |
NCT00321685 (5) [back to overview] | Resection Rate for T3 Rectal Cancers |
NCT00321685 (5) [back to overview] | Pathologic Complete Response Rate |
NCT00321685 (5) [back to overview] | 5-year Overall Survival Rate |
NCT00321685 (5) [back to overview] | 5-year Recurrence-free Survival Rate |
NCT00335959 (2) [back to overview] | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug |
NCT00335959 (2) [back to overview] | Pathologic Complete Response |
NCT00337103 (14) [back to overview] | Progression Free Survival (PFS) |
NCT00337103 (14) [back to overview] | Overall Survival (OS) |
NCT00337103 (14) [back to overview] | Objective Response Rate (ORR): Independent Review |
NCT00337103 (14) [back to overview] | Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Parameter Values |
NCT00337103 (14) [back to overview] | Number of Participants With Consumption of Analgesics During the Study |
NCT00337103 (14) [back to overview] | Number of Participants Who Took at Least One Concomitant Medication |
NCT00337103 (14) [back to overview] | Duration of Response (DOR): Independent Review |
NCT00337103 (14) [back to overview] | Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for the Treatment of Cancer Quality of Life Core Questionnaire Scores Based on Core 30 Items (EORTC-QLQ-C30) at Week 6 |
NCT00337103 (14) [back to overview] | Change From Baseline in Pain Intensity by Visual Analog Scale (VAS) Until 30 Days After the Last Dose of Study Drug |
NCT00337103 (14) [back to overview] | Change From Baseline in European Organization for the Treatment of Cancer Quality of Life Core Questionnaire Scores Based on Breast Cancer Specific 23 Items (EORTC-QLQ- BR 23) at Week 6 |
NCT00337103 (14) [back to overview] | Plasma Concentrations of Eribulin Mesylate |
NCT00337103 (14) [back to overview] | Overall Survival Rate |
NCT00337103 (14) [back to overview] | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
NCT00337103 (14) [back to overview] | Duration of Eribulin Mesylate Exposure |
NCT00338039 (2) [back to overview] | Median Overall Survival |
NCT00338039 (2) [back to overview] | Overall Survival Rate |
NCT00338988 (1) [back to overview] | Number of Participants With Objective Response |
NCT00347438 (4) [back to overview] | Complete Clinical Response Rate (CCR) |
NCT00347438 (4) [back to overview] | Complete Pathologic Response Rate (cPR) |
NCT00347438 (4) [back to overview] | Partial Clinical Response Rate (PR) |
NCT00347438 (4) [back to overview] | Overall Clinical Response Rate (OCR) |
NCT00353262 (14) [back to overview] | Maximum Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL) |
NCT00353262 (14) [back to overview] | Clearance of Total And Free Platinum |
NCT00353262 (14) [back to overview] | Marked Laboratory Abnormalities |
NCT00353262 (14) [back to overview] | Elimination Half-life Period (t1/2 Beta) of Capecitabine and Its Metabolites (5'-DFUR , 5'-DFCR, 5 FU, and FBAL) |
NCT00353262 (14) [back to overview] | Cmax of Total And Free Platinum |
NCT00353262 (14) [back to overview] | AUC (0-infinity) of Capecitabine and Its Metabolites (5'-DFCR, 5-FU, and FBAL) |
NCT00353262 (14) [back to overview] | AUC0-inf for Free Platinum |
NCT00353262 (14) [back to overview] | AUC0-infinity for Total Platinum |
NCT00353262 (14) [back to overview] | AUC0-last of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL) |
NCT00353262 (14) [back to overview] | AUC0-last of Total And Free Platinum |
NCT00353262 (14) [back to overview] | Volume of Distribution at Steady State (VSS) of Total And Free Platinum |
NCT00353262 (14) [back to overview] | Number Of Participants With Adverse Events (AEs) |
NCT00353262 (14) [back to overview] | Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0-Inf) of 5'-Deoxy-5-fluorouridine 5'-(DFUR) |
NCT00353262 (14) [back to overview] | T1/2 Beta of Total And Free Platinum |
NCT00354224 (1) [back to overview] | Number of Adverse Events |
NCT00354601 (1) [back to overview] | Number of Participants With Grade 3 or Higher Toxicity |
NCT00354887 (1) [back to overview] | Number of Participants With Overall Response |
NCT00365417 (8) [back to overview] | Number of Patients With at Least One Surgical Complications (Wound Dehiscence, Infection, Seroma, or Hematoma). |
NCT00365417 (8) [back to overview] | Clinical Response Rate (cRR) of the Sequential Regimen |
NCT00365417 (8) [back to overview] | Cardiac Events |
NCT00365417 (8) [back to overview] | pCR in the Breast and Nodes |
NCT00365417 (8) [back to overview] | Progression-free Survival |
NCT00365417 (8) [back to overview] | Overall Survival |
NCT00365417 (8) [back to overview] | Pathologic Complete Response (pCR) in the Breast |
NCT00365417 (8) [back to overview] | Reported Adverse Events |
NCT00373113 (5) [back to overview] | Time to Tumor Progression (TTP) |
NCT00373113 (5) [back to overview] | Number of Participants With Overall Response (OR) |
NCT00373113 (5) [back to overview] | Overall Survival (OS) |
NCT00373113 (5) [back to overview] | Progression-Free Survival (PFS) |
NCT00373113 (5) [back to overview] | Duration of Response (DR) |
NCT00382720 (3) [back to overview] | Overall Survival (OS) |
NCT00382720 (3) [back to overview] | Time to Progression |
NCT00382720 (3) [back to overview] | Best Overall Response Rate (ORR) |
NCT00398320 (5) [back to overview] | 12-month Progression Free Survival (PFS) |
NCT00398320 (5) [back to overview] | Overall Survival (OS) |
NCT00398320 (5) [back to overview] | Number of Patients Who Experienced Treatment-related Grade 3 or Higher Adverse Events by CTCAE Version 3.0 |
NCT00398320 (5) [back to overview] | Biochemical Markers |
NCT00398320 (5) [back to overview] | Response Rates |
NCT00398398 (4) [back to overview] | Progression-free Survival |
NCT00398398 (4) [back to overview] | Toxicity Profile |
NCT00398398 (4) [back to overview] | Overall Survival |
NCT00398398 (4) [back to overview] | Overall Response Rate |
NCT00399035 (7) [back to overview] | Rate of Resection of Liver Metastases |
NCT00399035 (7) [back to overview] | Time to Wound Healing Complications |
NCT00399035 (7) [back to overview] | Overall Survival |
NCT00399035 (7) [back to overview] | Overall Response Rate |
NCT00399035 (7) [back to overview] | Progression-free Survival |
NCT00399035 (7) [back to overview] | Duration of Response |
NCT00399035 (7) [back to overview] | Best Percentage Change in Tumour Size |
NCT00408408 (9) [back to overview] | Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone |
NCT00408408 (9) [back to overview] | Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens |
NCT00408408 (9) [back to overview] | Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy |
NCT00408408 (9) [back to overview] | Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens |
NCT00408408 (9) [back to overview] | Pathologic Complete Response (pCR) of the Primary Tumor in the Breast |
NCT00408408 (9) [back to overview] | pCR in the Breast and Nodes |
NCT00408408 (9) [back to overview] | Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy |
NCT00408408 (9) [back to overview] | Disease-free Survival (DFS) |
NCT00408408 (9) [back to overview] | Surgical Complication |
NCT00408564 (4) [back to overview] | Number of Participants With Grade 3-4 Adverse Events Reported |
NCT00408564 (4) [back to overview] | Response Rate |
NCT00408564 (4) [back to overview] | Progression-free Survival at 6 Months |
NCT00408564 (4) [back to overview] | Overall Survival |
NCT00411762 (2) [back to overview] | Median Overall Survival |
NCT00411762 (2) [back to overview] | Median Progression Free Survival |
NCT00414271 (4) [back to overview] | Feasibility and Safety of Pre-operative Chemotherapy in Locally Advanced Gastric Cancer as Assessed by Number of Participants Who Experienced Adverse Events Grade 3 or Higher as Defined by CTCAE. |
NCT00414271 (4) [back to overview] | Overall Survival |
NCT00414271 (4) [back to overview] | Progression-free Survival as Measured by Number of Participants Without Disease Progression. |
NCT00414271 (4) [back to overview] | Number of Participants With Pathological Response |
NCT00416494 (5) [back to overview] | Time to Progression |
NCT00416494 (5) [back to overview] | Safety and Tolerability |
NCT00416494 (5) [back to overview] | Overall Survival |
NCT00416494 (5) [back to overview] | Disease Free Survival |
NCT00416494 (5) [back to overview] | Response Rate (Percentage of Participants With Partial or Complete Response) |
NCT00418028 (7) [back to overview] | Response Rate |
NCT00418028 (7) [back to overview] | Response Duration |
NCT00418028 (7) [back to overview] | Progression Free Survival |
NCT00418028 (7) [back to overview] | Overall Survival |
NCT00418028 (7) [back to overview] | Time to Progression |
NCT00418028 (7) [back to overview] | Time to Treatment Failure |
NCT00418028 (7) [back to overview] | Clinical Benefit |
NCT00433550 (5) [back to overview] | Duration of Response |
NCT00433550 (5) [back to overview] | Confirmed Tumor Response Rate (Proportion of Participants With Complete Response) |
NCT00433550 (5) [back to overview] | Time to Treatment Failure |
NCT00433550 (5) [back to overview] | Progression Free Survival |
NCT00433550 (5) [back to overview] | Overall Survival |
NCT00435409 (5) [back to overview] | Overall Survival (OS) |
NCT00435409 (5) [back to overview] | Duration of Response (DR) |
NCT00435409 (5) [back to overview] | Percent Chance of Participant Survival |
NCT00435409 (5) [back to overview] | Percentage of Participants With Objective Response (OR) |
NCT00435409 (5) [back to overview] | Progression Free Survival (PFS) |
NCT00437073 (2) [back to overview] | Number of Participants With the Indicated Central Nervous System (CNS) Objective Response (OR) |
NCT00437073 (2) [back to overview] | Number of Participants With the Indicated CNS Responses |
NCT00437294 (8) [back to overview] | Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State |
NCT00437294 (8) [back to overview] | Pharmacology Toxicity and Adverse Events (AEs) |
NCT00437294 (8) [back to overview] | Duration of Response (DOR) |
NCT00437294 (8) [back to overview] | Pharmacokinetics: Maximum Observed Concentration (Cmax) of Capecitabine |
NCT00437294 (8) [back to overview] | Overall Survival (OS) |
NCT00437294 (8) [back to overview] | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate) |
NCT00437294 (8) [back to overview] | Progression Free Survival (PFS) |
NCT00437294 (8) [back to overview] | Pharmacokinetics: Area Under the Concentration Curve Versus Time From Time 0 to Last Quantifiable Value (AUC0-tlast) of Capecitabine |
NCT00438100 (1) [back to overview] | Progression Free Survival |
NCT00438256 (7) [back to overview] | Median Progression Free Survival |
NCT00438256 (7) [back to overview] | 30-Day Post Operative Mortality |
NCT00438256 (7) [back to overview] | Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm |
NCT00438256 (7) [back to overview] | Number of Participants With a Pathological Complete Response |
NCT00438256 (7) [back to overview] | Number of Participants With Grade 3 or Greater Toxicity in Phase II |
NCT00438256 (7) [back to overview] | Number of Participants With Surgical Morbidity |
NCT00438256 (7) [back to overview] | Number of Participants With Treatment Related Serious Adverse Events |
NCT00444678 (4) [back to overview] | Toxicity Rates |
NCT00444678 (4) [back to overview] | Time to Progression |
NCT00444678 (4) [back to overview] | Survival |
NCT00444678 (4) [back to overview] | Response Rate for the Combination Treatment |
NCT00446290 (1) [back to overview] | Number of Participants With DLTs |
NCT00447330 (4) [back to overview] | Median Progression-Free Survival (PFS) |
NCT00447330 (4) [back to overview] | Response Rate |
NCT00447330 (4) [back to overview] | To Assess the Safety and Tolerability of the Combination of Bevacizumab, Oxaliplatin and Capecitabine in Patients With Previously Untreated Metastatic Esophagogastric Adenocarcinoma |
NCT00447330 (4) [back to overview] | Median Survival |
NCT00452673 (6) [back to overview] | Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population |
NCT00452673 (6) [back to overview] | Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population |
NCT00452673 (6) [back to overview] | Number of Participants On-study With Grade 3 - 4 Chemistry Laboratory Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population |
NCT00452673 (6) [back to overview] | Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population |
NCT00452673 (6) [back to overview] | Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population |
NCT00452673 (6) [back to overview] | Number of Participants On-Study With Grade 3 - 4 Hematology Laboratory Test Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population |
NCT00454636 (6) [back to overview] | Time to Response |
NCT00454636 (6) [back to overview] | Progression-Free Survival (PFS) |
NCT00454636 (6) [back to overview] | Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) |
NCT00454636 (6) [back to overview] | Overall Survival (OS) |
NCT00454636 (6) [back to overview] | Duration of Response |
NCT00454636 (6) [back to overview] | Overall Response Rate (ORR) |
NCT00454649 (34) [back to overview] | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin |
NCT00454649 (34) [back to overview] | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel |
NCT00454649 (34) [back to overview] | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine |
NCT00454649 (34) [back to overview] | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel |
NCT00454649 (34) [back to overview] | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed |
NCT00454649 (34) [back to overview] | Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736) |
NCT00454649 (34) [back to overview] | Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine |
NCT00454649 (34) [back to overview] | Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin |
NCT00454649 (34) [back to overview] | Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736) |
NCT00454649 (34) [back to overview] | Maximum Observed Plasma Concentration (Cmax) for Capecitabine |
NCT00454649 (34) [back to overview] | Maximum Observed Plasma Concentration (Cmax) for Carboplatin |
NCT00454649 (34) [back to overview] | Maximum Observed Plasma Concentration (Cmax) for Cisplatin |
NCT00454649 (34) [back to overview] | Maximum Observed Plasma Concentration (Cmax) for Docetaxel |
NCT00454649 (34) [back to overview] | Maximum Observed Plasma Concentration (Cmax) for Gemcitabine |
NCT00454649 (34) [back to overview] | Maximum Observed Plasma Concentration (Cmax) for Paclitaxel |
NCT00454649 (34) [back to overview] | Maximum Observed Plasma Concentration (Cmax) for Pemetrexed |
NCT00454649 (34) [back to overview] | Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy |
NCT00454649 (34) [back to overview] | Percentage of Participants With Objective Response |
NCT00454649 (34) [back to overview] | Plasma Clearance (CL) for Carboplatin |
NCT00454649 (34) [back to overview] | Plasma Clearance (CL) for Cisplatin |
NCT00454649 (34) [back to overview] | Plasma Clearance (CL) for Docetaxel |
NCT00454649 (34) [back to overview] | Plasma Clearance (CL) for Gemcitabine |
NCT00454649 (34) [back to overview] | Plasma Decay Half Life (t1/2) for Paclitaxel |
NCT00454649 (34) [back to overview] | Plasma Decay Half Life (t1/2) for Pemetrexed |
NCT00454649 (34) [back to overview] | Plasma Clearance (CL) for Pemetrexed |
NCT00454649 (34) [back to overview] | Plasma Decay Half Life (t1/2) for Axitinib (AG-013736) |
NCT00454649 (34) [back to overview] | Plasma Decay Half Life (t1/2) for Capecitabine |
NCT00454649 (34) [back to overview] | Plasma Decay Half Life (t1/2) for Carboplatin |
NCT00454649 (34) [back to overview] | Plasma Decay Half Life (t1/2) for Cisplatin |
NCT00454649 (34) [back to overview] | Plasma Decay Half Life (t1/2) for Docetaxel |
NCT00454649 (34) [back to overview] | Plasma Decay Half Life (t1/2) for Gemcitabine |
NCT00454649 (34) [back to overview] | Apparent Oral Clearance (CL/F) for Axitinib (AG-013736) |
NCT00454649 (34) [back to overview] | Apparent Oral Clearance (CL/F) for Capecitabine |
NCT00454649 (34) [back to overview] | Plasma Clearance (CL) for Paclitaxel |
NCT00462865 (2) [back to overview] | Number of Participants With Recurrent Disease |
NCT00462865 (2) [back to overview] | Toxicity Related to Treatment |
NCT00468585 (1) [back to overview] | Overall Objective Response |
NCT00470184 (4) [back to overview] | Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1 |
NCT00470184 (4) [back to overview] | Quality of Life Improved Rate |
NCT00470184 (4) [back to overview] | Complete Response |
NCT00470184 (4) [back to overview] | Median Time to Progression |
NCT00477464 (20) [back to overview] | Trough Concentration of Lapatinib |
NCT00477464 (20) [back to overview] | 6-Month Progression-free Survival (Independent Reviewer-assessed) |
NCT00477464 (20) [back to overview] | Area Under the Plasma Concentration-time Curve From Zero to 24 Hours AUC0-24 of Lapatinib |
NCT00477464 (20) [back to overview] | Area Under the Plasma Concentration-time Curve Within the Dosing Interval AUC0-tau of Lapatinib |
NCT00477464 (20) [back to overview] | Clinical Benefit Response (Independent Reviewer-assessed) |
NCT00477464 (20) [back to overview] | Duration of Response (Independent Reviewer-assessed) |
NCT00477464 (20) [back to overview] | Maximum Plasma Concentration (Cmax) of Lapatinib |
NCT00477464 (20) [back to overview] | Objective Response (Independent Reviewer-assessed) |
NCT00477464 (20) [back to overview] | Overall Survival (Independent Reviewer-assessed) |
NCT00477464 (20) [back to overview] | Progression-free Survival (PFS) (Independent Reviewer-assessed) |
NCT00477464 (20) [back to overview] | Terminal Elimination Half-life (t1/2) of Lapatinib |
NCT00477464 (20) [back to overview] | Time to Maximum Plasma Concentration (Tmax) of Lapatinib |
NCT00477464 (20) [back to overview] | Time to Progression (Independent Reviewer-assessed) |
NCT00477464 (20) [back to overview] | Time to Response (Independent Reviewer-assessed) |
NCT00477464 (20) [back to overview] | Area Under the Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12) of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL) |
NCT00477464 (20) [back to overview] | AUC0-tau of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL) |
NCT00477464 (20) [back to overview] | Cmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL) |
NCT00477464 (20) [back to overview] | t1/2 of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL) |
NCT00477464 (20) [back to overview] | Tmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL) |
NCT00477464 (20) [back to overview] | Trough Concentration of Capecitabine, 5-FU, and FBAL |
NCT00479856 (1) [back to overview] | Overall Tumor Response |
NCT00483405 (4) [back to overview] | Time to Progression |
NCT00483405 (4) [back to overview] | Disease Response Rate |
NCT00483405 (4) [back to overview] | Number of Subjects Experiencing Adverse Events |
NCT00483405 (4) [back to overview] | Overall Survival |
NCT00484939 (8) [back to overview] | Duration of Follow-up |
NCT00484939 (8) [back to overview] | Duration of Response |
NCT00484939 (8) [back to overview] | Time to Response |
NCT00484939 (8) [back to overview] | Progression-free Survival |
NCT00484939 (8) [back to overview] | Percentage of Participants Requiring Additional Treatment for Malignancy |
NCT00484939 (8) [back to overview] | Overall Survival |
NCT00484939 (8) [back to overview] | Best Overall Response (BOR) |
NCT00484939 (8) [back to overview] | Eastern Cooperative Oncology Group (ECOG) Performance Status |
NCT00493636 (5) [back to overview] | Progression Free Survival |
NCT00493636 (5) [back to overview] | Overall Survival |
NCT00493636 (5) [back to overview] | Overall Response Rate |
NCT00493636 (5) [back to overview] | Duration of Overall Response |
NCT00493636 (5) [back to overview] | Time to Progression |
NCT00496366 (2) [back to overview] | -Determine the Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease for at Least 6 Months) of Capecitabine and Lapatinib. -Determine Time to Disease Progression After Treatment With Capecitabine and Lapatinib. -Evaluate Overall |
NCT00496366 (2) [back to overview] | Determine the Response Rate (as Determined by RECIST Criteria) of Capecitabine and Lapatinib as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer That Overexpress HER2. |
NCT00496587 (3) [back to overview] | Time to Treatment Failure (TTF) |
NCT00496587 (3) [back to overview] | Objective Response Rate (ORR) |
NCT00496587 (3) [back to overview] | Progression Free Survival (PFS) |
NCT00502671 (2) [back to overview] | Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE |
NCT00502671 (2) [back to overview] | Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE |
NCT00504660 (2) [back to overview] | 6 Month Progression-free Survival for Participants With Glioblastoma |
NCT00504660 (2) [back to overview] | 12 Month-progression-free Survival for Participants With Anaplastic Tumors |
NCT00508274 (7) [back to overview] | Number of Participants With Central Nervous System (CNS) as First Site of Relapse |
NCT00508274 (7) [back to overview] | All Collected Deaths |
NCT00508274 (7) [back to overview] | Time to Response (TTR) |
NCT00508274 (7) [back to overview] | Six Months Progression-Free Survival |
NCT00508274 (7) [back to overview] | Progression-Free Survival (PFS) |
NCT00508274 (7) [back to overview] | Duration of Response (DOR) |
NCT00508274 (7) [back to overview] | Clinical Benefit Rate (CBR) |
NCT00523640 (3) [back to overview] | Progression-free Survival |
NCT00523640 (3) [back to overview] | Overall Survival |
NCT00523640 (3) [back to overview] | Objective Response Rate |
NCT00526669 (26) [back to overview] | PFS |
NCT00526669 (26) [back to overview] | Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response]) |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Duration of Response |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Time to Progression (All Deaths Are Treated as Competing Risk) |
NCT00526669 (26) [back to overview] | Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk) |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Overall Survival (OS) |
NCT00526669 (26) [back to overview] | Time to Response |
NCT00526669 (26) [back to overview] | Change From Start of Run-in Period in Biomarker Expression Levels at Day 0 |
NCT00526669 (26) [back to overview] | Number of Participants in the Indicated Categories for Best Overall Response (BOR) |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points |
NCT00526669 (26) [back to overview] | Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS) |
NCT00532948 (8) [back to overview] | Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters |
NCT00532948 (8) [back to overview] | Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters |
NCT00532948 (8) [back to overview] | The Area Under the Plasma Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL) |
NCT00532948 (8) [back to overview] | Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL) |
NCT00532948 (8) [back to overview] | Dose Limiting Toxicities (DLTs) |
NCT00532948 (8) [back to overview] | Maximum Tolerated Dose (MTD) of Capecitabine. |
NCT00532948 (8) [back to overview] | Number of Participants With Adverse Events (AE) |
NCT00532948 (8) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR], 5'-Deoxy-5-Fluorouridine [5'-DFUR], 5-Fluorouracil [5-FU] and Alpha-fluoro-beta-alanine [FBAL]) |
NCT00534417 (9) [back to overview] | Patients Experiencing Severe Symptom Burden (Physical Symptoms) |
NCT00534417 (9) [back to overview] | Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms) |
NCT00534417 (9) [back to overview] | Patients Experiencing Severe Symptom Burden (Physical Functioning) |
NCT00534417 (9) [back to overview] | Best Overall Response |
NCT00534417 (9) [back to overview] | Time to Progression (TTP) |
NCT00534417 (9) [back to overview] | Clinical Benefit Rate |
NCT00534417 (9) [back to overview] | Progression-free Survival (PFS) |
NCT00534417 (9) [back to overview] | Overall Survival (OS) |
NCT00534417 (9) [back to overview] | Overall Response Rate |
NCT00536809 (1) [back to overview] | Overall Response in Phase II |
NCT00538291 (1) [back to overview] | Response Rate |
NCT00546364 (8) [back to overview] | Median Number of Treatment Cycles |
NCT00546364 (8) [back to overview] | Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort |
NCT00546364 (8) [back to overview] | Percentage of Participants With Best Response to Treatment of Complete or Partial |
NCT00546364 (8) [back to overview] | Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial |
NCT00546364 (8) [back to overview] | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade |
NCT00546364 (8) [back to overview] | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) |
NCT00546364 (8) [back to overview] | Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy |
NCT00546364 (8) [back to overview] | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results |
NCT00548548 (8) [back to overview] | Overall Survival |
NCT00548548 (8) [back to overview] | Participants With Adverse Events |
NCT00548548 (8) [back to overview] | Progression-free Survival |
NCT00548548 (8) [back to overview] | Progression-free Survival During First-line Therapy |
NCT00548548 (8) [back to overview] | Participants With Disease Control |
NCT00548548 (8) [back to overview] | Duration of Response |
NCT00548548 (8) [back to overview] | Time to Disease Progression |
NCT00548548 (8) [back to overview] | Participants With a Best Overall Response of Complete or Partial Response |
NCT00551213 (6) [back to overview] | Number of Participants Who Experienced One or More Adverse Events (AEs) |
NCT00551213 (6) [back to overview] | Number of Participants Who Discontinued Study Drug Due to an AE |
NCT00551213 (6) [back to overview] | Best Overall Tumor Response Per Central Review |
NCT00551213 (6) [back to overview] | Change From Baseline in Tumor Growth Rate |
NCT00551213 (6) [back to overview] | Best Overall Tumor Response Per Investigator Review |
NCT00551213 (6) [back to overview] | Number of Participants With a >20% Decrease in Positron Emission Tomography (PET)-Assessed Tumor Glucose Metabolism: Fluorodeoxyglucose (FDG) Standardized Uptake Value (SUV) in the Target Lesion |
NCT00555620 (30) [back to overview] | Progression-Free Survival (PFS) |
NCT00555620 (30) [back to overview] | Percentage of Participants With Objective Response |
NCT00555620 (30) [back to overview] | Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) |
NCT00555620 (30) [back to overview] | Duration of Response (DR) |
NCT00555620 (30) [back to overview] | Tmax for CAP |
NCT00555620 (30) [back to overview] | Tmax for 5'DFUR |
NCT00555620 (30) [back to overview] | Tmax for 5'DFCR |
NCT00555620 (30) [back to overview] | Tmax for 5-FU |
NCT00555620 (30) [back to overview] | Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662) |
NCT00555620 (30) [back to overview] | Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662) |
NCT00555620 (30) [back to overview] | t1/2 for CAP |
NCT00555620 (30) [back to overview] | t1/2 for 5'DFUR |
NCT00555620 (30) [back to overview] | Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR) |
NCT00555620 (30) [back to overview] | Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR) |
NCT00555620 (30) [back to overview] | Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU) |
NCT00555620 (30) [back to overview] | AUClast for 5'DFUR |
NCT00555620 (30) [back to overview] | Cmin of 5-FU |
NCT00555620 (30) [back to overview] | Cmin of 5'DFCR |
NCT00555620 (30) [back to overview] | Cmin of 5'DFUR |
NCT00555620 (30) [back to overview] | Cmin of CAP |
NCT00555620 (30) [back to overview] | t1/2 for 5-FU |
NCT00555620 (30) [back to overview] | t1/2 for 5'DFCR |
NCT00555620 (30) [back to overview] | Cmax of CAP |
NCT00555620 (30) [back to overview] | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP |
NCT00555620 (30) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662) |
NCT00555620 (30) [back to overview] | AUClast for 5'DFCR |
NCT00555620 (30) [back to overview] | AUClast for 5-FU |
NCT00555620 (30) [back to overview] | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU |
NCT00555620 (30) [back to overview] | Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU |
NCT00555620 (30) [back to overview] | Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662) |
NCT00562718 (3) [back to overview] | Recurrence |
NCT00562718 (3) [back to overview] | Cosmesis |
NCT00562718 (3) [back to overview] | Overall Safety |
NCT00565370 (5) [back to overview] | Overall Survival |
NCT00565370 (5) [back to overview] | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) |
NCT00565370 (5) [back to overview] | Progression-free Survival |
NCT00565370 (5) [back to overview] | Response Rate |
NCT00565370 (5) [back to overview] | Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0) |
NCT00568022 (9) [back to overview] | Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval |
NCT00568022 (9) [back to overview] | Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval |
NCT00568022 (9) [back to overview] | Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval |
NCT00568022 (9) [back to overview] | Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval |
NCT00568022 (9) [back to overview] | Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval |
NCT00568022 (9) [back to overview] | Participants Experiencing Dose Limiting Toxicity (DLT) |
NCT00568022 (9) [back to overview] | Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT00568022 (9) [back to overview] | Participant Tumor Response at Study Endpoint |
NCT00568022 (9) [back to overview] | Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) |
NCT00570908 (1) [back to overview] | Progression Free Survival |
NCT00574171 (1) [back to overview] | Response Rate of Lapatinib/Capecitabine. |
NCT00578071 (4) [back to overview] | Number of Participants With Dose-limiting Toxicities (DLTs) |
NCT00578071 (4) [back to overview] | Overall Survival Rates for the Patients Studied on This Protocol. |
NCT00578071 (4) [back to overview] | Panitumumab Maximum Tolerated Dose in Milligrams (mg) |
NCT00578071 (4) [back to overview] | Pathological Complete Response Rates Associated With This Regimen. |
NCT00585078 (4) [back to overview] | Response Rate |
NCT00585078 (4) [back to overview] | Overall Survival |
NCT00585078 (4) [back to overview] | Progression-Free Survival |
NCT00585078 (4) [back to overview] | Best Response |
NCT00600340 (15) [back to overview] | Unconfirmed Objective Response Rate and Disease Control Rate (ITT Population) |
NCT00600340 (15) [back to overview] | Observation Time (ITT Population) |
NCT00600340 (15) [back to overview] | Duration of Response (PP Population) |
NCT00600340 (15) [back to overview] | Duration of Response (ITT Population) |
NCT00600340 (15) [back to overview] | Overall Survival (PP Population) |
NCT00600340 (15) [back to overview] | Progression Free Survival (ITT Population) |
NCT00600340 (15) [back to overview] | Progression Free Survival (PP Population) |
NCT00600340 (15) [back to overview] | Time to Treatment Failure (ITT Population) |
NCT00600340 (15) [back to overview] | Overall Survival (ITT Population) |
NCT00600340 (15) [back to overview] | Time to Treatment Failure (PP Population) |
NCT00600340 (15) [back to overview] | Objective Response Rate and Disease Control Rate (ITT Population) |
NCT00600340 (15) [back to overview] | Time to Response (ITT Population) |
NCT00600340 (15) [back to overview] | Unconfirmed Objective Response Rate and Disease Control Rate (PP Population) |
NCT00600340 (15) [back to overview] | Time to Response (PP Population) |
NCT00600340 (15) [back to overview] | Objective Response Rate and Disease Control Rate (PP Population) |
NCT00601627 (5) [back to overview] | One Year Survival Rate |
NCT00601627 (5) [back to overview] | Time to Treatment Failure |
NCT00601627 (5) [back to overview] | Confirmed Response Rate |
NCT00601627 (5) [back to overview] | Overall Survival |
NCT00601627 (5) [back to overview] | Progression Free Survival (PFS) |
NCT00609336 (7) [back to overview] | Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy |
NCT00609336 (7) [back to overview] | Percent of Patients Surviving at 5 Years |
NCT00609336 (7) [back to overview] | Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 |
NCT00609336 (7) [back to overview] | Percent of Patients Surviving at Annual Intervals |
NCT00609336 (7) [back to overview] | Surgical Completion Rate and Complication Rate |
NCT00609336 (7) [back to overview] | Median Overall Survival of Patients With Adenocarcinoma of the Pancreas |
NCT00609336 (7) [back to overview] | Median Recurrence Free Survival Following Pancreaticoduodenectomy |
NCT00613080 (9) [back to overview] | Disease-free Survival: 4-year Rate |
NCT00613080 (9) [back to overview] | The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively |
NCT00613080 (9) [back to overview] | Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning |
NCT00613080 (9) [back to overview] | Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 |
NCT00613080 (9) [back to overview] | Overall Survival: 4-year Rate |
NCT00613080 (9) [back to overview] | Number of Patients With Pathologic Complete Response |
NCT00613080 (9) [back to overview] | Number of Patients Who Underwent Abdominoperineal Resection |
NCT00613080 (9) [back to overview] | Local-regional Failure: 4-year Rate |
NCT00613080 (9) [back to overview] | Distant Failure: 4-year Rate |
NCT00623805 (5) [back to overview] | Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery |
NCT00623805 (5) [back to overview] | Time Until a Complete Response or a Partial Response |
NCT00623805 (5) [back to overview] | Progression-free Survival |
NCT00623805 (5) [back to overview] | Percentage of Participants With a Complete Response or a Partial Response |
NCT00623805 (5) [back to overview] | Overall Survival |
NCT00625183 (1) [back to overview] | Safety and Tolerability as Assessed by NCI CTCAE Version 3.0 |
NCT00632489 (2) [back to overview] | To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil |
NCT00632489 (2) [back to overview] | To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil |
NCT00634088 (10) [back to overview] | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst CTC Grade |
NCT00634088 (10) [back to overview] | Area Under the Concentration-time Curve From 0 to Infinity (AUC[INF]) and AUC From 0 to Last Quantifiable Concentration (AUC[O-T] of Ixabepilone |
NCT00634088 (10) [back to overview] | Volume of Distribution at Steady State of Ixabepilone |
NCT00634088 (10) [back to overview] | Time to Peak Concentration of Ixabepilone |
NCT00634088 (10) [back to overview] | Number of Participants With DLT |
NCT00634088 (10) [back to overview] | Terminal Half-life of Ixabepilone |
NCT00634088 (10) [back to overview] | Maximum Concentration of Ixabepilone |
NCT00634088 (10) [back to overview] | Overall Tumor Response By Number of Participants |
NCT00634088 (10) [back to overview] | Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Treatment-related AEs, Treatment-related AEs (Grade 3 or 4), Peripheral Neuropathy (PN), PN (Grade 3 or 4) |
NCT00634088 (10) [back to overview] | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results by Worst CTC Grade |
NCT00634751 (3) [back to overview] | Overall Survival |
NCT00634751 (3) [back to overview] | Progression-free Survival (PFS) |
NCT00634751 (3) [back to overview] | Overall Response Rate |
NCT00662025 (17) [back to overview] | Time to Objective Tumor Response (TTR) |
NCT00662025 (17) [back to overview] | AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) |
NCT00662025 (17) [back to overview] | Time to Tumor Progression (TTP) |
NCT00662025 (17) [back to overview] | Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) |
NCT00662025 (17) [back to overview] | Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) |
NCT00662025 (17) [back to overview] | Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) |
NCT00662025 (17) [back to overview] | Overall Survival (OS) |
NCT00662025 (17) [back to overview] | AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) |
NCT00662025 (17) [back to overview] | Progression-Free Survival (PFS) |
NCT00662025 (17) [back to overview] | Duration of Objective Tumor Response (DR) |
NCT00662025 (17) [back to overview] | t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) |
NCT00662025 (17) [back to overview] | Number of Subjects With CBR Based on Investigator's Assessment |
NCT00662025 (17) [back to overview] | Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) |
NCT00662025 (17) [back to overview] | Number of Participants With Objective Response Based on Investigator's Assessment |
NCT00662025 (17) [back to overview] | Number of Participants With Objective Response Based on Data Review Committee's Assessment |
NCT00662025 (17) [back to overview] | Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment |
NCT00662025 (17) [back to overview] | Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) |
NCT00665457 (1) [back to overview] | Number of Participants With Grade 4 Adverse Events |
NCT00678535 (6) [back to overview] | Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) |
NCT00678535 (6) [back to overview] | Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire |
NCT00678535 (6) [back to overview] | Safety - Number of Participants With Adverse Events (AEs) |
NCT00678535 (6) [back to overview] | Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments |
NCT00678535 (6) [back to overview] | Overall Survival (OS) |
NCT00678535 (6) [back to overview] | Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments |
NCT00680901 (15) [back to overview] | Number of Participants With Any Non-serious Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) or Any Serious Adverse Event (SAE) |
NCT00680901 (15) [back to overview] | Number of Participants With Adverse Events of the Indicated Severity, Per the National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE) |
NCT00680901 (15) [back to overview] | Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Hematology Parameters |
NCT00680901 (15) [back to overview] | Overall Survival |
NCT00680901 (15) [back to overview] | Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Clinical Chemistry Parameters |
NCT00680901 (15) [back to overview] | Mean Change in Scores on the Questionnaire EuroQoL-5 Dimensions (EQ-5D) From Baseline to Week 36 |
NCT00680901 (15) [back to overview] | Mean Change in Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) From Baseline to Week 36 |
NCT00680901 (15) [back to overview] | Mean Change in Scores on the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) From Baseline to Week 36 |
NCT00680901 (15) [back to overview] | Mean Change in Scores on the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) From Baseline to Week 36 |
NCT00680901 (15) [back to overview] | Time to Response (TTR) |
NCT00680901 (15) [back to overview] | Progression Free Survival (PFS) |
NCT00680901 (15) [back to overview] | Overall Survival in All Randomized Participants |
NCT00680901 (15) [back to overview] | Duration of Response (DOR) |
NCT00680901 (15) [back to overview] | Number of Participants With a Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) |
NCT00680901 (15) [back to overview] | Number of Participants With Clinical Benefit (CB) |
NCT00684983 (6) [back to overview] | Overall Survival |
NCT00684983 (6) [back to overview] | Adverse Event Profile of Capecitabine and Lapatinib With and Without IMC-A12 (Using NCI CTCAE v3.0) |
NCT00684983 (6) [back to overview] | Confirmed Tumor Response, Defined as Either a Complete Response (CR) or Partial Response (PR) Noted as the Objective Status on 2 Consecutive Evaluations at Least 6 Weeks Apart, Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) |
NCT00684983 (6) [back to overview] | Duration of Response |
NCT00684983 (6) [back to overview] | Progression-free Survival (PFS) |
NCT00684983 (6) [back to overview] | Time to Treatment Failure |
NCT00685763 (1) [back to overview] | Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start) |
NCT00686166 (3) [back to overview] | 3-year Disease-free Survival |
NCT00686166 (3) [back to overview] | Pathologic Complete Response Rate |
NCT00686166 (3) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. |
NCT00700570 (5) [back to overview] | Percentage of Participants With Disease Progression |
NCT00700570 (5) [back to overview] | Time to Disease Progression |
NCT00700570 (5) [back to overview] | Percentage of Participants by Best Overall Tumor Response According to RECIST Version 1.1 |
NCT00700570 (5) [back to overview] | Percentage of Participants With a Best Overall Tumor Response of Complete Response (CR) or PR According to RECIST Version 1.1 |
NCT00700570 (5) [back to overview] | Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases |
NCT00711412 (7) [back to overview] | Toxicity Profile |
NCT00711412 (7) [back to overview] | Time to Progression |
NCT00711412 (7) [back to overview] | Recurrence Rate |
NCT00711412 (7) [back to overview] | Determine Pathologic Complete Response |
NCT00711412 (7) [back to overview] | Clinical Response Rate |
NCT00711412 (7) [back to overview] | Overall Survival |
NCT00711412 (7) [back to overview] | Determine Progressive Free Survival |
NCT00717197 (1) [back to overview] | Percentage of Participants With Progression-free Survival. |
NCT00721630 (1) [back to overview] | Number of Participants With Toxicities Associated With Capecitabine and Lapatinib |
NCT00737438 (1) [back to overview] | Overall Response Will be Characterized by the Patient's FDG-PET Scan |
NCT00741260 (6) [back to overview] | Maximum Tolerated Dose (MTD) of Neratinib |
NCT00741260 (6) [back to overview] | Maximum Tolerated Dose (MTD) of Capecitabine |
NCT00741260 (6) [back to overview] | Duration of Response |
NCT00741260 (6) [back to overview] | Overall Response Rate |
NCT00741260 (6) [back to overview] | Clinical Benefit Rate |
NCT00741260 (6) [back to overview] | Number of Participants With Dose Limiting Toxicities |
NCT00745134 (7) [back to overview] | Tumor Regression Grade |
NCT00745134 (7) [back to overview] | Progression Free Survival (PFS) |
NCT00745134 (7) [back to overview] | Overall Survival (OS) |
NCT00745134 (7) [back to overview] | Number of Participants With Tumor Downstaging |
NCT00745134 (7) [back to overview] | Number of Participants With Pathologic Complete Response (pCR) Rate |
NCT00745134 (7) [back to overview] | Change in Curcumin Level in Tumor Tissue |
NCT00745134 (7) [back to overview] | Change in Curcumin Level in Serum |
NCT00777101 (7) [back to overview] | Frequency of CNS Metastases (Frequency) |
NCT00777101 (7) [back to overview] | Time to CNS Metastases |
NCT00777101 (7) [back to overview] | Clinical Benefit Rate |
NCT00777101 (7) [back to overview] | Duration of Response |
NCT00777101 (7) [back to overview] | Progression Free Survival |
NCT00777101 (7) [back to overview] | Overall Survival (OS) |
NCT00777101 (7) [back to overview] | Objective Response Rate (ORR). |
NCT00780494 (4) [back to overview] | Adverse Events ≥ Grade 3 and Related to Bevacizumab |
NCT00780494 (4) [back to overview] | Progression-Free Survival (PFS) |
NCT00780494 (4) [back to overview] | Objective (Overall) Therapeutic Response |
NCT00780494 (4) [back to overview] | Overall Survival (OS) |
NCT00787787 (2) [back to overview] | Median Overall Survival |
NCT00787787 (2) [back to overview] | Median Progression-free Survival |
NCT00789958 (7) [back to overview] | 2-year Stratum-specific Disease-free Survival |
NCT00789958 (7) [back to overview] | 2-year Stratum-specific Local Relapse Rate |
NCT00789958 (7) [back to overview] | Stratum-specific (R0 and R1) 2-year Overall Survival |
NCT00789958 (7) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
NCT00789958 (7) [back to overview] | 2-year Disease-free Survival in All Patients |
NCT00789958 (7) [back to overview] | 2-year Overall Local Relapse Rate |
NCT00789958 (7) [back to overview] | 2-year Overall Survival for All Patients |
NCT00796718 (4) [back to overview] | Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment) |
NCT00796718 (4) [back to overview] | Percentage of Participants With Adverse Events |
NCT00796718 (4) [back to overview] | Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment) |
NCT00796718 (4) [back to overview] | Percentage of Participants With Pathological Complete Response |
NCT00811135 (9) [back to overview] | Progression Free Survival (PFS) |
NCT00811135 (9) [back to overview] | Number of Participants With Response |
NCT00811135 (9) [back to overview] | Number of Participants With Time to Progression (TTP) |
NCT00811135 (9) [back to overview] | Overall Survival (OS) |
NCT00811135 (9) [back to overview] | Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) |
NCT00811135 (9) [back to overview] | Duration of Response (DR) |
NCT00811135 (9) [back to overview] | Time to Progression (TTP) |
NCT00811135 (9) [back to overview] | Number of Participants With Disease Progression or Death |
NCT00811135 (9) [back to overview] | Number of Participants With Overall Survival (OS) |
NCT00820222 (9) [back to overview] | Number of Participants With CNS Progression at Any Time |
NCT00820222 (9) [back to overview] | Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Occurring in >=2% of Participants in Either Treatment Arm |
NCT00820222 (9) [back to overview] | Overall Survival |
NCT00820222 (9) [back to overview] | Progression Free Survival (PFS), as Assessed by the Investigator |
NCT00820222 (9) [back to overview] | Number of Participants With Overall Response (OR), as Assessed by the Investigator |
NCT00820222 (9) [back to overview] | Duration of Response |
NCT00820222 (9) [back to overview] | Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First Relapse |
NCT00820222 (9) [back to overview] | Time to First CNS Progression, Defined as the Time From Randomization Until the Date of Documented CNS Progression as the First Site of Relapse |
NCT00820222 (9) [back to overview] | Number of Participants With Clinical Benefit (CB) |
NCT00828672 (7) [back to overview] | Death Rates and Overall Survival |
NCT00828672 (7) [back to overview] | Number of Participants With Histopathologic R0 and Negative CRM Resection |
NCT00828672 (7) [back to overview] | Number of Participants With Pathologic Complete Response at Surgery. Number of Participants With Good or Little Pathological Tumour Regression at Surgery. |
NCT00828672 (7) [back to overview] | Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery. |
NCT00828672 (7) [back to overview] | Recurrence Rates and Disease Free Survival |
NCT00828672 (7) [back to overview] | Types and Numbers of Adverse Events - General Overview |
NCT00828672 (7) [back to overview] | Clinical Response Rate |
NCT00829166 (17) [back to overview] | PFS as Assessed by the Investigator |
NCT00829166 (17) [back to overview] | Time to Treatment Failure |
NCT00829166 (17) [back to overview] | Duration of Objective Response (DOR) as Assessed by an IRC |
NCT00829166 (17) [back to overview] | Overall Survival: Final Analysis |
NCT00829166 (17) [back to overview] | Overall Survival: Second Interim Analysis (Co-primary Endpoint) |
NCT00829166 (17) [back to overview] | Percentage of Participants Who Died: Final Analysis |
NCT00829166 (17) [back to overview] | Percentage of Participants Who Died: Second Interim Analysis |
NCT00829166 (17) [back to overview] | Percentage of Participants Who Were Alive at Year 1 |
NCT00829166 (17) [back to overview] | Percentage of Participants Who Were Alive at Year 2 |
NCT00829166 (17) [back to overview] | Percentage of Participants With Clinical Benefit as Assessed by an IRC |
NCT00829166 (17) [back to overview] | Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) |
NCT00829166 (17) [back to overview] | Percentage of Participants With Objective Response (OR) as Assessed by an IRC |
NCT00829166 (17) [back to overview] | Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) |
NCT00829166 (17) [back to overview] | Time to Symptom Progression |
NCT00829166 (17) [back to overview] | Percentage of Participants With PD or Death as Assessed by the Investigator |
NCT00829166 (17) [back to overview] | Percentage of Participants With Symptom Progression |
NCT00829166 (17) [back to overview] | Percentage of Participants With Treatment Failure |
NCT00842244 (15) [back to overview] | Volume of Distribution (Vz) for Cisplatin |
NCT00842244 (15) [back to overview] | Duration of Response (DR) |
NCT00842244 (15) [back to overview] | Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin |
NCT00842244 (15) [back to overview] | Plasma Decay Half-Life (t1/2) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin |
NCT00842244 (15) [back to overview] | Maximum Observed Plasma Concentration (Cmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin |
NCT00842244 (15) [back to overview] | Clearance (CL) for Cisplatin |
NCT00842244 (15) [back to overview] | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Capecitabine, Capecitabine's Metabolites and Cisplatin |
NCT00842244 (15) [back to overview] | Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] for Axitinib |
NCT00842244 (15) [back to overview] | Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUC (0 - ∞)] for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin |
NCT00842244 (15) [back to overview] | Apparent Volume of Distribution (Vz/F) for Axitinib, Capecitabine and Capecitabine's Metabolites |
NCT00842244 (15) [back to overview] | Apparent Oral Clearance (CL/F) for Axitinib, Capecitabine and Capecitabine's Metabolites |
NCT00842244 (15) [back to overview] | Progression-Free Survival (PFS) |
NCT00842244 (15) [back to overview] | Percentage of Participants With Objective Response (OR) |
NCT00842244 (15) [back to overview] | Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Cisplatin and Capecitabine |
NCT00842244 (15) [back to overview] | Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs) |
NCT00848783 (1) [back to overview] | Number of Patients With One-year Recurrence-free Survival |
NCT00869050 (2) [back to overview] | Number of Participants With Partial Response (PR) |
NCT00869050 (2) [back to overview] | Number of Participants With Complete Response (CR) |
NCT00881621 (4) [back to overview] | Overall Survival |
NCT00881621 (4) [back to overview] | Clinical Benefit Response |
NCT00881621 (4) [back to overview] | Adverse Events |
NCT00881621 (4) [back to overview] | Progression Free Survival |
NCT00885755 (14) [back to overview] | Overall Survival in ITT Population |
NCT00885755 (14) [back to overview] | Overall Survival in Per Protocol Population |
NCT00885755 (14) [back to overview] | Part I: TTP in Intent to Treat (ITT) Population |
NCT00885755 (14) [back to overview] | Part II: PFS in ITT Population |
NCT00885755 (14) [back to overview] | Part II: TTP in Intent to Treat (ITT) Population |
NCT00885755 (14) [back to overview] | Part I and II: Percentage of Participants With a Best Overall Response of CR or PR in ITT Population |
NCT00885755 (14) [back to overview] | Part I: Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progrerssive Disease (PD) by Biomarker |
NCT00885755 (14) [back to overview] | Part I and II: Percentage of Participants With a Response by Best Overall Response by CR, PR, SD or PD in ITT Population |
NCT00885755 (14) [back to overview] | Part I: Time to Progression (TTP) by Biomarker |
NCT00885755 (14) [back to overview] | Part II: Percentage of Participants With a Best Overall Response of CR, PR, SD or PD by Biomarker |
NCT00885755 (14) [back to overview] | Part II: Progression Free Survival (PFS) by Biomarker |
NCT00885755 (14) [back to overview] | Part II: TTP by Biomarker |
NCT00885755 (14) [back to overview] | Part I: Progression Free Survival (PFS) by Biomarker |
NCT00885755 (14) [back to overview] | Part I: PFS in ITT Population |
NCT00887822 (13) [back to overview] | Time to Progression |
NCT00887822 (13) [back to overview] | Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time |
NCT00887822 (13) [back to overview] | Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time |
NCT00887822 (13) [back to overview] | Progression-Free Survival (PFS) |
NCT00887822 (13) [back to overview] | PFS During First-line Therapy |
NCT00887822 (13) [back to overview] | Percentage of Participants With Progression-Free Survival (PFS) Events (Disease Progression/Death) |
NCT00887822 (13) [back to overview] | Percentage of Participants With PFS Events (Disease Progression/Death) During First-line Therapy |
NCT00887822 (13) [back to overview] | Percentage of Participants With Event (Death) |
NCT00887822 (13) [back to overview] | Percentage of Participants With Disease Progression |
NCT00887822 (13) [back to overview] | Percentage of Participants With Disease Control During First-Line Therapy |
NCT00887822 (13) [back to overview] | Percentage of Participants With Best Overall Response as Assessed by RECIST During First-Line Therapy |
NCT00887822 (13) [back to overview] | Overall Survival |
NCT00887822 (13) [back to overview] | Duration of Response During First-Line Therapy |
NCT00889187 (2) [back to overview] | Dose Limiting Toxicity (DLT) [Phase I] |
NCT00889187 (2) [back to overview] | Neoadjuvant Short-Course Photon Radiation Therapy Maximum Tolerated Dose (MTD) [Phase I] |
NCT00891878 (6) [back to overview] | Response Rate (Complete Response or Partial Response) |
NCT00891878 (6) [back to overview] | Time to Treatment Failure |
NCT00891878 (6) [back to overview] | Comparison of Progression-free Survival |
NCT00891878 (6) [back to overview] | Duration of Response |
NCT00891878 (6) [back to overview] | Overall Survival |
NCT00891878 (6) [back to overview] | Time to Disease Progression |
NCT00916578 (1) [back to overview] | Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins. |
NCT00925769 (10) [back to overview] | Part 1: Last Quantifiable Drug Concentration (Clast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR) |
NCT00925769 (10) [back to overview] | Part 1: Maximum Serum Concentration (Cmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR] and 5'-Deoxy-5-Fluorouridine [5'-DFUR]) |
NCT00925769 (10) [back to overview] | Part 1: Time to Reach Cmax (Tmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR) |
NCT00925769 (10) [back to overview] | Part 1: MTD of Erlotinib |
NCT00925769 (10) [back to overview] | Part 1: Maximum Tolerated Dose (MTD) of Capecitabine |
NCT00925769 (10) [back to overview] | Part 1: MTD of Bevacizumab |
NCT00925769 (10) [back to overview] | Part 1: PRD of Bevacizumab for Part 2 |
NCT00925769 (10) [back to overview] | Part 1: PRD of Erlotinib for Part 2 |
NCT00925769 (10) [back to overview] | Part 1: Preliminary Recommended Dose (PRD) of Capecitabine for Part 2 |
NCT00925769 (10) [back to overview] | Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR) |
NCT00929240 (12) [back to overview] | Percentage Of Participants With PD or Death Due to PD (Maintenance Phase Data Cutoff October 4, 2013) |
NCT00929240 (12) [back to overview] | Time To Progression (Maintenance Phase Data Cutoff October 4, 2013) |
NCT00929240 (12) [back to overview] | Quality of Life Assessed As Change From Baseline in Global Health Status Using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - 30 (EORTC QLQ - C30) (Maintenance Phase Data Cutoff October 4, 2013) |
NCT00929240 (12) [back to overview] | Percentage of Participants Expected to Be Alive After 1 and 2 Years on Treatment (Maintenance Phase Data Cutoff October 4, 2013) |
NCT00929240 (12) [back to overview] | Overall Survival (Maintenance Phase Data Cutoff October 4, 2013) |
NCT00929240 (12) [back to overview] | Percentage of Participants Who Died (Maintenance Phase Data Cutoff October 4, 2013) |
NCT00929240 (12) [back to overview] | Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Maintenance Phase Data Cutoff October 4, 2013) |
NCT00929240 (12) [back to overview] | Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Data Cutoff October 4, 2013) |
NCT00929240 (12) [back to overview] | Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Initial Treatment Phase) |
NCT00929240 (12) [back to overview] | Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013) |
NCT00929240 (12) [back to overview] | Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013) |
NCT00929240 (12) [back to overview] | Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Initial Treatment Phase) |
NCT00938470 (5) [back to overview] | Overall Survival |
NCT00938470 (5) [back to overview] | Percentage of Participants With Overall Clinical Tumor Response (CR or PR) |
NCT00938470 (5) [back to overview] | Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event |
NCT00938470 (5) [back to overview] | Percentage of Participants With Pathologic Complete Response (PCR) |
NCT00938470 (5) [back to overview] | Disease-free Survival |
NCT00959946 (3) [back to overview] | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) - Part 1 |
NCT00959946 (3) [back to overview] | Best Overall Response - Part 1 |
NCT00959946 (3) [back to overview] | Maximum Tolerated Dose (MTD) - Part 1 |
NCT00961571 (1) [back to overview] | Progression-free Survival |
NCT00977379 (14) [back to overview] | Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to MRI |
NCT00977379 (14) [back to overview] | Time to CNS Progression, Assessed by Investigator According to MRI |
NCT00977379 (14) [back to overview] | Percentage of Participants With Objective Extra-cranial Disease Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to CT |
NCT00977379 (14) [back to overview] | Time to Extra-cranial Disease Progression, Assessed by Investigator According to CT |
NCT00977379 (14) [back to overview] | Time to Progression, Assessed by Investigator According to MRI and CT |
NCT00977379 (14) [back to overview] | Absolute Change From Baseline in Mini Mental State (MMS) Total Score |
NCT00977379 (14) [back to overview] | Duration of CNS Response, Assessed by Investigator According to MRI |
NCT00977379 (14) [back to overview] | Overall Survival (OS) |
NCT00977379 (14) [back to overview] | Percentage of Participants With Best Objective Central Nervous System (CNS) Response, Assessed by Centralized Independent Expert According to Magnetic Resonance Imaging (MRI) - Intent-to-Treat (ITT) Population |
NCT00977379 (14) [back to overview] | Percentage of Participants With Best Objective CNS Response, Assessed by Centralized Independent Expert According to MRI - Per-Protocol (PP) Population |
NCT00977379 (14) [back to overview] | Percentage of Participants With Best Objective CNS Response, Assessed by Investigator According to MRI |
NCT00977379 (14) [back to overview] | Percentage of Participants With Best Objective Extra-cranial Disease Response, Assessed by Investigator According to Computed Tomography (CT) |
NCT00977379 (14) [back to overview] | Percentage of Participants With Clinical Benefit, Assessed by Investigator According to MRI |
NCT00977379 (14) [back to overview] | Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI |
NCT01007552 (6) [back to overview] | Assess Overall Survival (OS) |
NCT01007552 (6) [back to overview] | Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43 |
NCT01007552 (6) [back to overview] | Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers. |
NCT01007552 (6) [back to overview] | The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers. |
NCT01007552 (6) [back to overview] | Estimate the Proportion of Patients With Clinical Response |
NCT01007552 (6) [back to overview] | Assess the Toxicity of the Regimen. |
NCT01013740 (7) [back to overview] | Duration of Response (DOR) in the Randomized Phase |
NCT01013740 (7) [back to overview] | Number of Participants With Clinical Benefit (CB) in the Randomized Phase |
NCT01013740 (7) [back to overview] | Number of Participants With Overall Response (OR), as Assessed by the Investigator in the Randomized Phase |
NCT01013740 (7) [back to overview] | Overall Survival (OS) |
NCT01013740 (7) [back to overview] | Progression Free Survival (PFS) in the Randomized Phase |
NCT01013740 (7) [back to overview] | Time to Response in the Randomized Phase |
NCT01013740 (7) [back to overview] | Number of Participants With Grade 4 and Grade 5 Adverse Events (AE) |
NCT01026142 (9) [back to overview] | Time to Progression (TTP) Based Upon Independent Review Facility (IRF) Assessment |
NCT01026142 (9) [back to overview] | Progression Free Survival (Independent Assessment) |
NCT01026142 (9) [back to overview] | Overall Survival (OS) Rate Based on a 2-year Truncated Analysis |
NCT01026142 (9) [back to overview] | Overall Objective Response Rate (ORR) |
NCT01026142 (9) [back to overview] | Clinical Benefit Rate (CBR) |
NCT01026142 (9) [back to overview] | Duration of Objective Response |
NCT01026142 (9) [back to overview] | Investigator Assessment Progression-Free Survival (PFS) |
NCT01026142 (9) [back to overview] | Time to Treatment Failure (TTF) Based Upon Independent Review Facility (IRF) Assessment |
NCT01026142 (9) [back to overview] | Overall Survival (OS) |
NCT01032850 (4) [back to overview] | Number of Participants Experiencing Adverse Events |
NCT01032850 (4) [back to overview] | Disease Control Rate of Response (DCR) |
NCT01032850 (4) [back to overview] | Progression Free Survival (PFS) |
NCT01032850 (4) [back to overview] | Overall Survival (OS) |
NCT01041404 (19) [back to overview] | Pain Intensity Scores as Assessed By Visual Analog Scale (VAS) |
NCT01041404 (19) [back to overview] | Trastuzumab Minimum Serum Concentration (Cmin) |
NCT01041404 (19) [back to overview] | Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight |
NCT01041404 (19) [back to overview] | Duration of Response - Percentage of Participants With an Event |
NCT01041404 (19) [back to overview] | Overall Survival - Time to Event |
NCT01041404 (19) [back to overview] | Body Weight (Kilograms [kg]) at BL |
NCT01041404 (19) [back to overview] | Steady State Trastuzumab Area Under the Concentration (AUC) |
NCT01041404 (19) [back to overview] | Percentage of Participants With a Change in Analgesic Medication During the Study |
NCT01041404 (19) [back to overview] | Time to Progression - Time to Event |
NCT01041404 (19) [back to overview] | European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores |
NCT01041404 (19) [back to overview] | EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores |
NCT01041404 (19) [back to overview] | Progression-Free Survival - Time to Event |
NCT01041404 (19) [back to overview] | Trastuzumab Maximum Serum Concentration (Cmax) |
NCT01041404 (19) [back to overview] | Time to Progression (TTP) - Percentage of Participants With an Event |
NCT01041404 (19) [back to overview] | Progression-Free Survival (PFS) - Percentage of Participants With an Event |
NCT01041404 (19) [back to overview] | Duration of Response |
NCT01041404 (19) [back to overview] | Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST) |
NCT01041404 (19) [back to overview] | Percentage of Participants With Clinical Benefit |
NCT01041404 (19) [back to overview] | Overall Survival (OS) - Percentage of Participants With an Event |
NCT01044433 (5) [back to overview] | Number of Participants With Adverse Events and Serious Adverse Events |
NCT01044433 (5) [back to overview] | Disease Control Rate |
NCT01044433 (5) [back to overview] | Overall Survival |
NCT01044433 (5) [back to overview] | Response Rate |
NCT01044433 (5) [back to overview] | Progression-free Survival |
NCT01060007 (9) [back to overview] | Rate of Locoregional Control |
NCT01060007 (9) [back to overview] | Preoperative Gastrointestinal Morbidity |
NCT01060007 (9) [back to overview] | Rate of Overall Control |
NCT01060007 (9) [back to overview] | Determine Quality of Anorectal Function |
NCT01060007 (9) [back to overview] | Incidence of Any Late Grade 3 or Higher Morbidity |
NCT01060007 (9) [back to overview] | Local Control |
NCT01060007 (9) [back to overview] | Rate of T Stage Downstaging |
NCT01060007 (9) [back to overview] | Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity |
NCT01060007 (9) [back to overview] | Freedom From Disease Relapse |
NCT01077739 (4) [back to overview] | Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR) |
NCT01077739 (4) [back to overview] | PFS From the Start of First-Line Therapy |
NCT01077739 (4) [back to overview] | Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression |
NCT01077739 (4) [back to overview] | Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression |
NCT01081262 (10) [back to overview] | Patient Reported Quality of Life |
NCT01081262 (10) [back to overview] | Patient Reported Quality of Life |
NCT01081262 (10) [back to overview] | Patient Reported Quality of Life |
NCT01081262 (10) [back to overview] | Patient Reported Neurotoxicity |
NCT01081262 (10) [back to overview] | Patient Reported Neurotoxicity |
NCT01081262 (10) [back to overview] | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 |
NCT01081262 (10) [back to overview] | Progression-free Survival |
NCT01081262 (10) [back to overview] | Objective Tumor Response |
NCT01081262 (10) [back to overview] | Patient Reported Neurotoxicity |
NCT01081262 (10) [back to overview] | Overall Survival |
NCT01095003 (5) [back to overview] | Duration of Response |
NCT01095003 (5) [back to overview] | Overall Survival |
NCT01095003 (5) [back to overview] | Progression Free Survival |
NCT01095003 (5) [back to overview] | Overall Response Rate (ORR) |
NCT01095003 (5) [back to overview] | Disease Control Rate |
NCT01118377 (3) [back to overview] | Progression-free Survival |
NCT01118377 (3) [back to overview] | Percentage of Participants With a Tumor Response |
NCT01118377 (3) [back to overview] | Overall Survival |
NCT01128842 (6) [back to overview] | Tolerated Dose |
NCT01128842 (6) [back to overview] | Progression Free Survival |
NCT01128842 (6) [back to overview] | Objective Response Rate |
NCT01128842 (6) [back to overview] | Maximum Plasma Concentration of Neratinib in Combination With Capecitabine |
NCT01128842 (6) [back to overview] | Dose Limiting Toxicity (DLT) - Percentage of Participants With DLT Events |
NCT01128842 (6) [back to overview] | Area Under the Curve (AUC) of Neratinib in Combination With Capecitabine |
NCT01130337 (4) [back to overview] | Percentage of Participants With Pathological Complete Response (pCR) |
NCT01130337 (4) [back to overview] | Percentage of Participants With Objective Response |
NCT01130337 (4) [back to overview] | Percentage of Participants With Disease-free Survival (DFS) at Month 18 |
NCT01130337 (4) [back to overview] | Percentage of Participants With Complete Tumor Resection (R0) |
NCT01131078 (17) [back to overview] | Time to Progression (TTP) |
NCT01131078 (17) [back to overview] | Time to Treatment Failure |
NCT01131078 (17) [back to overview] | Duration of Overall Complete Response |
NCT01131078 (17) [back to overview] | Duration of Overall Response |
NCT01131078 (17) [back to overview] | Duration of Stable Disease (SD) |
NCT01131078 (17) [back to overview] | Overall Survival |
NCT01131078 (17) [back to overview] | Percentage of Participants Who Died |
NCT01131078 (17) [back to overview] | Percentage of Participants With a Best Overall Response of CR or PR |
NCT01131078 (17) [back to overview] | Percentage of Participants With Disease Progression or Death |
NCT01131078 (17) [back to overview] | Time to Progression Excluding Deaths Not Related to Underlying Cancer |
NCT01131078 (17) [back to overview] | Percentage of Participants With Progression Excluding Deaths |
NCT01131078 (17) [back to overview] | Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer |
NCT01131078 (17) [back to overview] | Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment |
NCT01131078 (17) [back to overview] | Percentage of Participants With Stable Disease |
NCT01131078 (17) [back to overview] | Time to Progression Excluding Deaths |
NCT01131078 (17) [back to overview] | Percentage of Participants by Best Overall Response |
NCT01131078 (17) [back to overview] | Percentage of Participants With Treatment Failure |
NCT01132664 (5) [back to overview] | Progression Free Survival (PFS) - Based on Investigator Review Using Kaplan Meier - Phase l & ll |
NCT01132664 (5) [back to overview] | Overall Response Rate (ORR) - Phase ll |
NCT01132664 (5) [back to overview] | Clinical Benefit Rate (CBR) - Phase l & ll |
NCT01132664 (5) [back to overview] | Disease Control Rate (DCR) Based on Investigator Assessment- Phase l & ll |
NCT01132664 (5) [back to overview] | Dose Limiting Toxicity (DLT) - Phase l Only |
NCT01134601 (1) [back to overview] | Here is the Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). |
NCT01135498 (6) [back to overview] | Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC]) |
NCT01135498 (6) [back to overview] | Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) |
NCT01135498 (6) [back to overview] | Percentage of Participants Who Died |
NCT01135498 (6) [back to overview] | Percentage of Participants With Disease Progression or Death |
NCT01135498 (6) [back to overview] | Progression-Free Survival |
NCT01135498 (6) [back to overview] | Overall Survival (OS) |
NCT01151761 (8) [back to overview] | Freedom From Local Progression at 12 Months |
NCT01151761 (8) [back to overview] | Liver Transplant Conversion Rate |
NCT01151761 (8) [back to overview] | Median Time to Overall Survival |
NCT01151761 (8) [back to overview] | Liver Transplant Rate |
NCT01151761 (8) [back to overview] | Overall Survival at 12 Months |
NCT01151761 (8) [back to overview] | Pathologic Complete Response Rate |
NCT01151761 (8) [back to overview] | Progression-free Survival at 12 Months |
NCT01151761 (8) [back to overview] | Serum CA 19-9 Levels |
NCT01159171 (12) [back to overview] | Duration of Response |
NCT01159171 (12) [back to overview] | Duration of Response - Percentage of Participants With an Event by 24 Months |
NCT01159171 (12) [back to overview] | Duration of Stable Disease |
NCT01159171 (12) [back to overview] | Duration of Stable Disease - Percentage of Participants With an Event by 24 Months |
NCT01159171 (12) [back to overview] | Overall Survival |
NCT01159171 (12) [back to overview] | Overall Survival (OS) - Percentage of Participants With an Event by 24 Months |
NCT01159171 (12) [back to overview] | Percentage of Participants With Objective Response (OR) |
NCT01159171 (12) [back to overview] | Time to Progression |
NCT01159171 (12) [back to overview] | Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months |
NCT01159171 (12) [back to overview] | Time to Treatment Failure |
NCT01159171 (12) [back to overview] | Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months |
NCT01159171 (12) [back to overview] | Percentage of Participants by Best Overall Response |
NCT01191697 (4) [back to overview] | Median Duration of Response (DOR) |
NCT01191697 (4) [back to overview] | Median Progression Free Survival (PFS) |
NCT01191697 (4) [back to overview] | Median Overall Survival |
NCT01191697 (4) [back to overview] | Objective Response Rate (ORR) |
NCT01193517 (2) [back to overview] | Maximum Tolerated Dose (MTD) of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX) |
NCT01193517 (2) [back to overview] | Response Rate of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX) |
NCT01208103 (5) [back to overview] | Number of Participants With Adverse Events |
NCT01208103 (5) [back to overview] | Number of Participants With Progression-free Survival (PFS) at Six Months |
NCT01208103 (5) [back to overview] | To Determine the Overall Survival (OS) for CAPOX and Bevacizumab |
NCT01208103 (5) [back to overview] | To Determine the Response Rate (RR) for CAPOX and Bevacizumab |
NCT01208103 (5) [back to overview] | To Determine the Overall PFS for CAPOX and Bevacizumab |
NCT01226732 (3) [back to overview] | Preliminary Efficacy Assessment: Response Rate (RR) |
NCT01226732 (3) [back to overview] | Drug Related Toxicities |
NCT01226732 (3) [back to overview] | Dose Determination |
NCT01227707 (13) [back to overview] | Overall Survival (OS) - Percentage of Participants With an Event |
NCT01227707 (13) [back to overview] | Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment |
NCT01227707 (13) [back to overview] | Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure |
NCT01227707 (13) [back to overview] | Percentage of Participants With Pathological Complete Response (pCR) |
NCT01227707 (13) [back to overview] | Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT) |
NCT01227707 (13) [back to overview] | DFS - Time to Event |
NCT01227707 (13) [back to overview] | Disease-Free Survival (DFS) - Percentage of Participants With an Event |
NCT01227707 (13) [back to overview] | TTP - Time to Event |
NCT01227707 (13) [back to overview] | Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment |
NCT01227707 (13) [back to overview] | Time to Disease Progression (TTP) - Percentage of Participants With an Event |
NCT01227707 (13) [back to overview] | Percentage of Participants With Relapse During Follow-Up |
NCT01227707 (13) [back to overview] | Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment |
NCT01227707 (13) [back to overview] | OS - Time to Event |
NCT01234337 (12) [back to overview] | Maximum Observed Drug Concentration (Cmax) of Capecitabine and 5-fluorouracil |
NCT01234337 (12) [back to overview] | Number of Participants With Treatment-emergent Grade 3 and 4 Laboratory Abnormalities |
NCT01234337 (12) [back to overview] | Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score |
NCT01234337 (12) [back to overview] | Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score |
NCT01234337 (12) [back to overview] | Objective Response Rate (ORR) by Central Review |
NCT01234337 (12) [back to overview] | Area Under Curve From Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Capecitabine and 5-fluorouracil |
NCT01234337 (12) [back to overview] | Time to Progression (TTP) by Central Review |
NCT01234337 (12) [back to overview] | Duration of Response (DOR) by Central Reader |
NCT01234337 (12) [back to overview] | Overall Survival (OS) |
NCT01234337 (12) [back to overview] | Progression-free Survival (PFS) Assessed by the Independent Review Panel According to Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 |
NCT01234337 (12) [back to overview] | Disease Control Rate (DCR) by Central Review |
NCT01234337 (12) [back to overview] | Patient Reported Outcomes: Functional Assessment of Cancer Therapy-Breast Symptom Index (8 Item) (FBSI-8) |
NCT01234402 (13) [back to overview] | Overall Survival (OS) |
NCT01234402 (13) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) |
NCT01234402 (13) [back to overview] | Area Under the Concentration Versus Time Curve From Time Zero to Infinity of Ramucirumab or Icrucumab |
NCT01234402 (13) [back to overview] | Number of Participants With Anti-Ramucirumab and Anti-Icrucumab Antibodies |
NCT01234402 (13) [back to overview] | Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab |
NCT01234402 (13) [back to overview] | Volume of Distribution at Steady State (Vss) of Ramucirumab or Icrucumab |
NCT01234402 (13) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT01234402 (13) [back to overview] | Duration of Response |
NCT01234402 (13) [back to overview] | Clearance (Cl) of Ramucirumab or Icrucumab |
NCT01234402 (13) [back to overview] | Maximum Concentration (Cmax) Ramucirumab Drug Product (DP) or Icrucumab |
NCT01234402 (13) [back to overview] | Progression-Free Survival (PFS) |
NCT01234402 (13) [back to overview] | Terminal Half-life (t½) of Ramucirumab or Icrucumab |
NCT01234402 (13) [back to overview] | Percentage of Participants With Objective Response Rate (ORR) |
NCT01267240 (3) [back to overview] | Survival |
NCT01267240 (3) [back to overview] | Progression-free Survival |
NCT01267240 (3) [back to overview] | Response Rate According to Response Evaluation Criteria in Solid Tumors |
NCT01268943 (1) [back to overview] | Dose Related Toxicity |
NCT01279681 (4) [back to overview] | Number of Participants With Grade 3 Adverse Events At Least Possibly Related to Treatment |
NCT01279681 (4) [back to overview] | Overall Survival |
NCT01279681 (4) [back to overview] | Progression-Free Survival |
NCT01279681 (4) [back to overview] | Response Rate, Defined as the Percentage of Patients in Each Arm Who Have an Objective Status of Complete Response or Partial Response, Confirmed by a Second Assessment Measured at Least 6 Weeks From the Initial Assessment |
NCT01323530 (10) [back to overview] | Phase 2: Clinical Benefit Rate (CBR) |
NCT01323530 (10) [back to overview] | Phase 2: Stable Disease (SD) Rate |
NCT01323530 (10) [back to overview] | Phase 2: Duration of Response (DOR) |
NCT01323530 (10) [back to overview] | Phase 2: Disease Control Rate (DCR) |
NCT01323530 (10) [back to overview] | Phase 2: Objective Response Rate (ORR) |
NCT01323530 (10) [back to overview] | Phase 2: Progression-free Survival (PFS) |
NCT01323530 (10) [back to overview] | Phase 2: Time to Response |
NCT01323530 (10) [back to overview] | Phase 2: Duration of Stable Disease (SD) |
NCT01323530 (10) [back to overview] | Phase 1b and Phase 2: Percentage of Participants With Non-CR/Non-PD |
NCT01323530 (10) [back to overview] | Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) |
NCT01326481 (1) [back to overview] | TRC105 Steady State Pharmacokinetic Trough Concentration at the RP2D |
NCT01355302 (4) [back to overview] | Number of Participants With a Treatment-Emergent Adverse Event (TEAE) |
NCT01355302 (4) [back to overview] | Area Under The Concentration-Time Curve (AUC) From 0 to 24 Hours of Golvatinib |
NCT01355302 (4) [back to overview] | Maximum Concentration (Cmax) of Golvatinib |
NCT01355302 (4) [back to overview] | Time to Maximum Concentration (Tmax) of Golvatinib |
NCT01360593 (9) [back to overview] | Objective Response Rate (ORR) (Surgery After Chemotherapy and SBRT) |
NCT01360593 (9) [back to overview] | Acute Toxicities Associated With SBRT |
NCT01360593 (9) [back to overview] | Objective Response Rate (ORR) (Neoadjuvant Chemotherapy) |
NCT01360593 (9) [back to overview] | Overall Survival (OS) |
NCT01360593 (9) [back to overview] | The Functional Assessment of Cancer Therapy - General (FACT-G) |
NCT01360593 (9) [back to overview] | Number of Participants Able to Undergo a Margin-negative Resection After Neoadjuvant Therapy |
NCT01360593 (9) [back to overview] | Local Progression-free Survival (LPFS) |
NCT01360593 (9) [back to overview] | Late Toxicities Associated With SBRT |
NCT01360593 (9) [back to overview] | Time to Progression (TTP) |
NCT01369433 (1) [back to overview] | Number of Subjects With Adverse Events (AEs) and Serious AEs |
NCT01374425 (37) [back to overview] | PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and Low VEGF-A Levels |
NCT01374425 (37) [back to overview] | PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels |
NCT01374425 (37) [back to overview] | PFS According to RECIST Version 1.1 in Participants With High Vascular Endothelial Growth Factor (VEGF)-A Levels Versus Participants With Low VEGF-A Levels |
NCT01374425 (37) [back to overview] | PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and High VEGF-A Levels |
NCT01374425 (37) [back to overview] | PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and Low VEGF-A Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Objective Response According to RECIST Version 1.1 |
NCT01374425 (37) [back to overview] | PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels |
NCT01374425 (37) [back to overview] | OS in Participants With High ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Liver Metastasis Resection |
NCT01374425 (37) [back to overview] | Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Liver Metastasis Resection in Participants With Low ERCC-1 Levels |
NCT01374425 (37) [back to overview] | OS in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
NCT01374425 (37) [back to overview] | PFS According to RECIST Version 1.1 in Participants With Wild-Type V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Versus Participants With Mutant KRAS |
NCT01374425 (37) [back to overview] | PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Complete Liver Metastasis Resection |
NCT01374425 (37) [back to overview] | Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Overall Survival (OS) |
NCT01374425 (37) [back to overview] | Percentage of Participants With Complete Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Complete Liver Metastasis Resection in Participants With Low ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Disease Control According to RECIST Version 1.1 |
NCT01374425 (37) [back to overview] | Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels |
NCT01374425 (37) [back to overview] | OS in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS |
NCT01374425 (37) [back to overview] | PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and High VEGF-A Levels |
NCT01374425 (37) [back to overview] | OS in Participants With Low ERCC-1 Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels |
NCT01374425 (37) [back to overview] | Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels |
NCT01374425 (37) [back to overview] | OS in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS |
NCT01374425 (37) [back to overview] | Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels |
NCT01387295 (4) [back to overview] | Adverse Events |
NCT01387295 (4) [back to overview] | Number of Patients Suitable for Local Therapy (Radiofrequency) |
NCT01387295 (4) [back to overview] | PFS |
NCT01387295 (4) [back to overview] | Survival |
NCT01399190 (3) [back to overview] | Percentage of Participants With Adverse Events |
NCT01399190 (3) [back to overview] | Response Rate (Tumor Assessments According to RECIST) |
NCT01399190 (3) [back to overview] | Progression-free Survival |
NCT01423604 (5) [back to overview] | Summary of Clinical Benefit |
NCT01423604 (5) [back to overview] | Durable Response Rate |
NCT01423604 (5) [back to overview] | Overall Survival |
NCT01423604 (5) [back to overview] | Progression-Free Survival (PFS) |
NCT01423604 (5) [back to overview] | Objective Response Rate |
NCT01439282 (3) [back to overview] | Use of Cold Cap for Alopecia |
NCT01439282 (3) [back to overview] | Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85% |
NCT01439282 (3) [back to overview] | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
NCT01442155 (2) [back to overview] | Disease-Free Survival (Time to Event) |
NCT01442155 (2) [back to overview] | Safety: Percentage of Participants With Adverse Events |
NCT01450696 (9) [back to overview] | Percentage of Participants Who Died - Per Protocol Set (PPS) |
NCT01450696 (9) [back to overview] | Percentage of Participants With Disease Progression or Death - PPS |
NCT01450696 (9) [back to overview] | Percentage of Participants Who Died - FAS |
NCT01450696 (9) [back to overview] | Trastuzumab Cmin on Day 21 of Cycles 1 to 11 - FAS |
NCT01450696 (9) [back to overview] | Trastuzumab Serum Concentration on Day 1 of Cycle 1 - FAS |
NCT01450696 (9) [back to overview] | Overall Survival - PPS |
NCT01450696 (9) [back to overview] | Overall Survival - FAS |
NCT01450696 (9) [back to overview] | Progression-Free Survival - PPS |
NCT01450696 (9) [back to overview] | Percentage of Participants With Objective Response - PPS |
NCT01459614 (5) [back to overview] | Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity |
NCT01459614 (5) [back to overview] | Disease Control Rate (DCR) |
NCT01459614 (5) [back to overview] | Percentage of Participants Without Disease Progression (Progression-Free Survival) at 6 Months |
NCT01459614 (5) [back to overview] | Progression-free Survival (PFS) |
NCT01459614 (5) [back to overview] | Overall Survival (OS) |
NCT01461057 (2) [back to overview] | Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL) |
NCT01461057 (2) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT01463982 (2) [back to overview] | Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR) |
NCT01463982 (2) [back to overview] | Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination |
NCT01471353 (4) [back to overview] | Response Rate |
NCT01471353 (4) [back to overview] | Sorafenib Activity |
NCT01471353 (4) [back to overview] | Toxicity (Percentage of Subjects That Experienced an Adverse Event) |
NCT01471353 (4) [back to overview] | Overall Survival |
NCT01498458 (6) [back to overview] | Hematological Toxicity of the Combination of Pazopanib and Capecitabine |
NCT01498458 (6) [back to overview] | Clinical Benefit Rate (CBR) |
NCT01498458 (6) [back to overview] | Dose-limiting Toxicity (DLT) |
NCT01498458 (6) [back to overview] | Other Toxicity of the Combination of Pazopanib and Capecitabine |
NCT01498458 (6) [back to overview] | Maximum Tolerable Dose (MTD) of Pazopanib |
NCT01498458 (6) [back to overview] | Objective Response Rate (ORR) |
NCT01525082 (6) [back to overview] | Treatment-related Toxicity |
NCT01525082 (6) [back to overview] | Overall Survival (OS) |
NCT01525082 (6) [back to overview] | O6-methylguanine DNA Methyltransferase (MGMT) Status by Immunohistochemistry (IHC) |
NCT01525082 (6) [back to overview] | Radiographic Response (RR) |
NCT01525082 (6) [back to overview] | Progression-free Survival (PFS) |
NCT01525082 (6) [back to overview] | O6-methylguanine DNA Methyltransferase (MGMT) by Promoter Methylation |
NCT01534637 (3) [back to overview] | Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs |
NCT01534637 (3) [back to overview] | Number of Patients With Gastrointestinal Toxicities (Grade 3 and 4 Nausea and Vomiting) Associated With Delivering Fluorouracil/Gemcitabine Hydrochloride-based Chemotherapy With Upper Abdominal Radiation |
NCT01534637 (3) [back to overview] | Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs |
NCT01584544 (1) [back to overview] | Number of Participants Experienced Dose Limited Toxicity |
NCT01588990 (22) [back to overview] | Time to Failure of Strategy (TFS): Overall |
NCT01588990 (22) [back to overview] | AQoL-8D Global Utility Score: Phase B |
NCT01588990 (22) [back to overview] | European Quality of Life 5-Dimension (EuroQol-5D) Utility Score: Phase A |
NCT01588990 (22) [back to overview] | EuroQol-5D Utility Score: Phase B |
NCT01588990 (22) [back to overview] | FACT-C Score: Phase B |
NCT01588990 (22) [back to overview] | Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Score: Phase A |
NCT01588990 (22) [back to overview] | Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Overall |
NCT01588990 (22) [back to overview] | Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase A |
NCT01588990 (22) [back to overview] | Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase B |
NCT01588990 (22) [back to overview] | Survival Beyond First Disease Progression: Overall |
NCT01588990 (22) [back to overview] | PFS Until Second Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase B |
NCT01588990 (22) [back to overview] | PFS Until First Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase A |
NCT01588990 (22) [back to overview] | Assessment of Quality of Life - Eight Dimensions (AQoL-8D) Global Utility Score: Phase A |
NCT01588990 (22) [back to overview] | Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio |
NCT01588990 (22) [back to overview] | Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio |
NCT01588990 (22) [back to overview] | Association Between Neutrophil to Lymphocyte Ratio (NLR) [NLR ≤5 Versus NLR >5] and Progression-Free Survival (PFS) as Assessed by Hazard Ratio |
NCT01588990 (22) [back to overview] | Association Between NLR (NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio |
NCT01588990 (22) [back to overview] | Association Between NLR Normalization (First NLR Post-Baseline ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio |
NCT01588990 (22) [back to overview] | Duration of Disease Control (DDC) as Assessed by the Investigator Based on Routine Clinical Practice: Overall |
NCT01588990 (22) [back to overview] | OS: Phase B |
NCT01588990 (22) [back to overview] | Overall Survival (OS) From the Start of Treatment to Study Completion: Overall |
NCT01588990 (22) [back to overview] | Percentage of Participants Who Underwent Liver Resection: Overall |
NCT01591733 (7) [back to overview] | Preoperative Toxicity of Grade 3 or Worse Related to FOLFIRINOX and Chemoradiation |
NCT01591733 (7) [back to overview] | Median Progression-Free Survival |
NCT01591733 (7) [back to overview] | The Proportion of Participants With Surgery Related Adverse Events |
NCT01591733 (7) [back to overview] | Rate of R0 Resection |
NCT01591733 (7) [back to overview] | 30 Day Post-operative Mortality Rate |
NCT01591733 (7) [back to overview] | Median Overall Survival |
NCT01591733 (7) [back to overview] | Local Control Rates |
NCT01661972 (5) [back to overview] | Response Rate |
NCT01661972 (5) [back to overview] | Recommended Phase II Dose (RPTD) for the Capecitabine and Aflibercept Doublet Combination |
NCT01661972 (5) [back to overview] | Number of Dose-Limiting Toxicities (Phase 1) |
NCT01661972 (5) [back to overview] | Median Progression Free Survival (PFS) |
NCT01661972 (5) [back to overview] | Median Survival |
NCT01664494 (2) [back to overview] | Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment |
NCT01664494 (2) [back to overview] | Median Dose of Capecitabine |
NCT01683422 (1) [back to overview] | One-year Survival Rate |
NCT01696695 (7) [back to overview] | Mean Duration of Capecitabine Therapy |
NCT01696695 (7) [back to overview] | Percentage of Participants With Dose Modification of Capecitabine |
NCT01696695 (7) [back to overview] | Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1 |
NCT01696695 (7) [back to overview] | PFS by Therapeutic Regimens |
NCT01696695 (7) [back to overview] | Percentage of Participants Who Underwent Metastasectomy |
NCT01696695 (7) [back to overview] | Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1 |
NCT01696695 (7) [back to overview] | Median Progression-free Survival (PFS) |
NCT01702558 (34) [back to overview] | Phase 1 (LA/mGC): AUC(0-inf) of 5-Fluorouracil (Metabolite of Capecitabine) |
NCT01702558 (34) [back to overview] | Phase 1 (LA/mGC): AUC(0-inf) of Capecitabine |
NCT01702558 (34) [back to overview] | Phase 1 (LA/mGC): Cmax of 5-Fluorouracil (Metabolite of Capecitabine) |
NCT01702558 (34) [back to overview] | Phase 1 (LA/mGC): Cmax of Capecitabine |
NCT01702558 (34) [back to overview] | Phase 1 (LA/mGC): MTD of Capecitabine When Combined With Trastuzumab Emtansine (2.4 mg/kg QW) |
NCT01702558 (34) [back to overview] | Phase 1 (LA/mGC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1 |
NCT01702558 (34) [back to overview] | Phase 1 (LA/mGC): t1/2 of 5-Fluorouracil (Metabolite of Capecitabine) |
NCT01702558 (34) [back to overview] | Phase 1 (LA/mGC): Percentage of Participants With DLTs |
NCT01702558 (34) [back to overview] | Phase 1 (LA/mGC): Serum Concentration of Trastuzumab |
NCT01702558 (34) [back to overview] | Phase 1 (mBC): Cmax of 5-Fluorouracil (Metabolite of Capecitabine) |
NCT01702558 (34) [back to overview] | Phase 1 (mBC): AUC(0-inf) of 5-Fluorouracil (Metabolite of Capecitabine) |
NCT01702558 (34) [back to overview] | Phase 1 (mBC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1 |
NCT01702558 (34) [back to overview] | Phase 1 (mBC): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) of Capecitabine |
NCT01702558 (34) [back to overview] | Phase 1 (mBC): Maximum Tolerated Dose (MTD) of Capecitabine When Combined With Trastuzumab Emtansine (3.6 mg/kg Every 3 Weeks) |
NCT01702558 (34) [back to overview] | Phase 1 (mBC): Maximum Observed Plasma Concentration (Cmax) of Capecitabine |
NCT01702558 (34) [back to overview] | Phase 1 (LA/mGC): Serum Concentration of Trastuzumab Emtansine |
NCT01702558 (34) [back to overview] | Phase 1 (LA/mGC): t1/2 of Capecitabine |
NCT01702558 (34) [back to overview] | Phase 1 (mBC): Serum Concentration of Trastuzumab Emtansine |
NCT01702558 (34) [back to overview] | Phase 1 (mBC): Serum Concentration of Trastuzumab |
NCT01702558 (34) [back to overview] | Phase 2 (mBC): Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST v1.1 |
NCT01702558 (34) [back to overview] | Phase 2 (mBC): Time to Response (TTR) as Assessed by the Investigator According to RECIST v1.1 |
NCT01702558 (34) [back to overview] | Phase 2 (mBC): Time to Progression (TTP) as Assessed by the Investigator According to RECIST v1.1 |
NCT01702558 (34) [back to overview] | Phase 2 (mBC): Progression-Free Survival (PFS) as Assessed by the Investigator According to RECIST v1.1 |
NCT01702558 (34) [back to overview] | Phase 2 (mBC): Percentage of Participants With Treatment Failure as Assessed by the Investigator According to RECIST v1.1 |
NCT01702558 (34) [back to overview] | Phase 2 (mBC): Percentage of Participants With PD as Assessed by the Investigator According to RECIST v1.1 or Death From Any Cause |
NCT01702558 (34) [back to overview] | Phase 2 (mBC): Percentage of Participants With PD as Assessed by the Investigator According to RECIST v1.1 |
NCT01702558 (34) [back to overview] | Phase 2 (mBC): Percentage of Participants With Clinical Benefit as Assessed by the Investigator According to RECIST v1.1 |
NCT01702558 (34) [back to overview] | Phase 2 (mBC): Percentage of Participants With Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |
NCT01702558 (34) [back to overview] | Phase 2 (mBC): Percentage of Participants Who Died of Any Cause |
NCT01702558 (34) [back to overview] | Phase 2 (mBC): Overall Survival (OS) |
NCT01702558 (34) [back to overview] | Phase 2 (mBC): Duration of Response (DoR) as Assessed by the Investigator According to RECIST v1.1 |
NCT01702558 (34) [back to overview] | Phase 1 (mBC): t1/2 of 5-Fluorouracil (Metabolite of Capecitabine) |
NCT01702558 (34) [back to overview] | Phase 1 (mBC): Plasma Terminal Half-Life (t1/2) of Capecitabine |
NCT01702558 (34) [back to overview] | Phase 1 (mBC): Percentage of Participants With Dose-Limiting Toxicities (DLTs) |
NCT01718873 (5) [back to overview] | Toxic Effects |
NCT01718873 (5) [back to overview] | Disease Control Rate |
NCT01718873 (5) [back to overview] | Objective Response Rate |
NCT01718873 (5) [back to overview] | Progression-free Survival (PFS) |
NCT01718873 (5) [back to overview] | Overall Survival |
NCT01722162 (3) [back to overview] | Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events |
NCT01722162 (3) [back to overview] | Progression Free Survival (Arm B) |
NCT01722162 (3) [back to overview] | Progression Free Survival (Arm A) |
NCT01725386 (6) [back to overview] | Mean Survival Time |
NCT01725386 (6) [back to overview] | Percentage of Participants Receiving Concomitant Medications During the Study |
NCT01725386 (6) [back to overview] | Percentage of Participants With Adverse Events |
NCT01725386 (6) [back to overview] | Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline |
NCT01725386 (6) [back to overview] | Percentage of Participants With Relevant Medical History Assessed at Baseline |
NCT01725386 (6) [back to overview] | Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy |
NCT01726582 (4) [back to overview] | Progression-free Survival |
NCT01726582 (4) [back to overview] | Use of Biomarkers to Determine Course of Treatment |
NCT01726582 (4) [back to overview] | Overall Survival in Months |
NCT01726582 (4) [back to overview] | Number of Subjects Completing Therapy Including Surgical Resection. |
NCT01729923 (5) [back to overview] | Rate of CR, Assessed According to CEA and CA 19-9 Measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
NCT01729923 (5) [back to overview] | Overall Survival |
NCT01729923 (5) [back to overview] | Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion and Did Not Have Surgery or Radiation Therapy |
NCT01729923 (5) [back to overview] | Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion |
NCT01729923 (5) [back to overview] | Relapse Free Survival in Patients Achieving CR |
NCT01754623 (2) [back to overview] | Margin-negative (R0) Resection Rate |
NCT01754623 (2) [back to overview] | Overall Survival (OS) Rate |
NCT01765582 (7) [back to overview] | Time to PFS2 |
NCT01765582 (7) [back to overview] | Proportion of Participants Considered by the Investigator to be Unresectable on Study Enrollment Who Subsequently Underwent Attempted Curative Resections of Metastases |
NCT01765582 (7) [back to overview] | Progression-Free Survival During First-Line Therapy (PFS1) |
NCT01765582 (7) [back to overview] | Percentage of Participants With Overall Response During First-Line Therapy (ORR1) |
NCT01765582 (7) [back to overview] | Percentage of Participants With Adverse Events |
NCT01765582 (7) [back to overview] | Overall Survival (OS) |
NCT01765582 (7) [back to overview] | Proportion of Participants Who Underwent Liver Metastases Resections |
NCT01774786 (14) [back to overview] | Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score |
NCT01774786 (14) [back to overview] | Percentage of Participants With Clinical Benefit, as Determined by the Investigator According to RECIST v1.1 Criteria |
NCT01774786 (14) [back to overview] | Minimum Serum Concentration (Cmin) of Pertuzumab |
NCT01774786 (14) [back to overview] | Maximum Serum Concentration (Cmax) of Pertuzumab |
NCT01774786 (14) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score |
NCT01774786 (14) [back to overview] | Cmax of Trastuzumab |
NCT01774786 (14) [back to overview] | Cmin of Trastuzumab |
NCT01774786 (14) [back to overview] | Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria |
NCT01774786 (14) [back to overview] | Final Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria |
NCT01774786 (14) [back to overview] | Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria |
NCT01774786 (14) [back to overview] | Primary Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria |
NCT01774786 (14) [back to overview] | Overview of Safety: Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 |
NCT01774786 (14) [back to overview] | Overall Survival |
NCT01774786 (14) [back to overview] | Number of Participants With Symptomatic or Asymptomatic Left Ventricular Systolic Dysfunction (LVSD) |
NCT01776307 (14) [back to overview] | Progression Free Survival |
NCT01776307 (14) [back to overview] | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle |
NCT01776307 (14) [back to overview] | Disease Control Rate |
NCT01776307 (14) [back to overview] | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle |
NCT01776307 (14) [back to overview] | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle |
NCT01776307 (14) [back to overview] | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle |
NCT01776307 (14) [back to overview] | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle |
NCT01776307 (14) [back to overview] | Number of Patients With Adverse Events and Serious Adverse Events |
NCT01776307 (14) [back to overview] | Overall Survival |
NCT01776307 (14) [back to overview] | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle |
NCT01776307 (14) [back to overview] | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle |
NCT01776307 (14) [back to overview] | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle |
NCT01776307 (14) [back to overview] | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle |
NCT01776307 (14) [back to overview] | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle |
NCT01777945 (7) [back to overview] | Time to Treatment Failure |
NCT01777945 (7) [back to overview] | Progression-free Survival (PFS) |
NCT01777945 (7) [back to overview] | Number of Participants With Adverse Events |
NCT01777945 (7) [back to overview] | Overall Response Rate |
NCT01777945 (7) [back to overview] | Clinical Benefit Rate |
NCT01777945 (7) [back to overview] | Duration of Treatment With Xeloda |
NCT01777945 (7) [back to overview] | Percentage of Capecitabine Dose Modifications |
NCT01781403 (4) [back to overview] | Toxicity(Adeverse Event) |
NCT01781403 (4) [back to overview] | Maximum Tolerated Dose (MTD) |
NCT01781403 (4) [back to overview] | Pathological Complete Response |
NCT01781403 (4) [back to overview] | Recommended Dose (RD) |
NCT01783444 (9) [back to overview] | Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Between Week 3 and 12 |
NCT01783444 (9) [back to overview] | Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Capecitabine Alone |
NCT01783444 (9) [back to overview] | Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Everolimus Alone |
NCT01783444 (9) [back to overview] | All Collected Deaths |
NCT01783444 (9) [back to overview] | Time to 10% Definitive Deterioration in the Global Health Status / Quality of Life |
NCT01783444 (9) [back to overview] | Time to Eastern Cooperative Oncology Group (ECOG) Performance Deterioration |
NCT01783444 (9) [back to overview] | Overall Survival (OS) |
NCT01783444 (9) [back to overview] | Clinical Benefit Rate (CBR) |
NCT01783444 (9) [back to overview] | Overall Response Rate (ORR) |
NCT01808573 (7) [back to overview] | Duration of Response (DOR) - Central Assessment (Population That Had a Response With Measurable Disease at Screening) |
NCT01808573 (7) [back to overview] | Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) |
NCT01808573 (7) [back to overview] | Overall Survival |
NCT01808573 (7) [back to overview] | Centrally Assessed Progression Free Survival |
NCT01808573 (7) [back to overview] | Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening) |
NCT01808573 (7) [back to overview] | Clinical Benefit Rate (CBR) - Central Assessment (ITT Population With Measurable Disease at Screening) |
NCT01808573 (7) [back to overview] | Intervention for Symptomatic Metastatic Central Nervous System Disease |
NCT01823679 (5) [back to overview] | Progression-free Survival (PFS) at 2 Years |
NCT01823679 (5) [back to overview] | Progression-free Survival (PFS) at 1 Year |
NCT01823679 (5) [back to overview] | Overall Survival (OS) at 2 Years |
NCT01823679 (5) [back to overview] | Objective Response Rate (ORR) |
NCT01823679 (5) [back to overview] | Overall Survival (OS) at 1 Year |
NCT01824875 (3) [back to overview] | Proportion of Patients With Response |
NCT01824875 (3) [back to overview] | Overall Survival |
NCT01824875 (3) [back to overview] | Progression-free Survival |
NCT01828554 (4) [back to overview] | Response Rate |
NCT01828554 (4) [back to overview] | Progression Free Survival |
NCT01828554 (4) [back to overview] | Cmax During Cycle 1 |
NCT01828554 (4) [back to overview] | Area Under the Curve (AUC) on Cycle 1 Day 1 and Cycle 1 Day 9 |
NCT01844076 (3) [back to overview] | Phase II - Rate of Response |
NCT01844076 (3) [back to overview] | Phase I - Number of Participants Who Experienced Dose Limiting Toxicities and Adverse Reactions |
NCT01844076 (3) [back to overview] | Phase II - Time to Progression (TTP) |
NCT01869192 (2) [back to overview] | Overall Response Rate |
NCT01869192 (2) [back to overview] | Pathological Response |
NCT01873833 (5) [back to overview] | Number of Participants With Any Adverse Events as a Measure of Safety and Tolerability |
NCT01873833 (5) [back to overview] | Clinical Benefit Rate (CBR) |
NCT01873833 (5) [back to overview] | Overall Response Rate (ORR) |
NCT01873833 (5) [back to overview] | Overall Survival (OS) |
NCT01873833 (5) [back to overview] | Progression Free Survival (PFS) |
NCT01921751 (2) [back to overview] | Overall Survival |
NCT01921751 (2) [back to overview] | Patterns of Failure (Local and Metastatic Failure) |
NCT01928680 (1) [back to overview] | Overall Response Rate |
NCT01955629 (2) [back to overview] | Part 1: Number of Participants With Tumor Responses (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD]) |
NCT01955629 (2) [back to overview] | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) |
NCT01997333 (6) [back to overview] | Overall Survival |
NCT01997333 (6) [back to overview] | Duration of Response |
NCT01997333 (6) [back to overview] | Objective Response Rate (ORR) |
NCT01997333 (6) [back to overview] | Progression Free Survival (PFS) |
NCT01997333 (6) [back to overview] | Adverse Events (AE) |
NCT01997333 (6) [back to overview] | Pharmacokinetics (PK) |
NCT02000882 (5) [back to overview] | Median Time to Progression |
NCT02000882 (5) [back to overview] | Objective Response Rate (ORR) |
NCT02000882 (5) [back to overview] | Median Overall Survival |
NCT02000882 (5) [back to overview] | Number of Treatment-related Serious AEs |
NCT02000882 (5) [back to overview] | Clinical Benefit Rate (CBR) |
NCT02005549 (3) [back to overview] | Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR) |
NCT02005549 (3) [back to overview] | Percentage of Participants With Pathological Complete Response (pCR) |
NCT02005549 (3) [back to overview] | Percentage of Participants Undergoing Breast-Conserving Surgery |
NCT02010567 (7) [back to overview] | Pathological Complete Response (pCR) Rate |
NCT02010567 (7) [back to overview] | Number of Participants With Grade 3 or Higher, Treatment-related Toxicities |
NCT02010567 (7) [back to overview] | Overall Survival (OS) Based on Pathological Complete Response (pCR). |
NCT02010567 (7) [back to overview] | Disease-free Survival (DFS) Rate Based on Pathological Complete Response (pCR). |
NCT02010567 (7) [back to overview] | Disease-free Survival (DFS) Rate |
NCT02010567 (7) [back to overview] | Maximum Tolerated Dose (MTD) of CRLX101 When Added to Standard Neoadjuvant Chemoradiotherapy Consisting of Capecitabine + Radiotherapy in Locally Advanced Rectal Cancer |
NCT02010567 (7) [back to overview] | Overall Survival (OS) Rate |
NCT02013830 (8) [back to overview] | Overall Survival - Percentage of Participants Event Free at 12 Months |
NCT02013830 (8) [back to overview] | Time to Disease Progression - Percentage of Participants With an Event |
NCT02013830 (8) [back to overview] | Time to Disease Progression - Percentage of Participants Progression-free at 12 Months |
NCT02013830 (8) [back to overview] | Time to Disease Progression |
NCT02013830 (8) [back to overview] | Percentage of Participants With Objective Response (OR) |
NCT02013830 (8) [back to overview] | Percentage of Participants With Disease Control |
NCT02013830 (8) [back to overview] | Overall Survival - Percentage of Participants With an Event |
NCT02013830 (8) [back to overview] | Overall Survival |
NCT02017704 (4) [back to overview] | Change in EORTC QLQ-C30 Global Health Status Score |
NCT02017704 (4) [back to overview] | Number of Participants With Grade 3 or Higher Adverse Events |
NCT02017704 (4) [back to overview] | Change in EORTC QLQ-C30 Global Health Status Score |
NCT02017704 (4) [back to overview] | Number of Patients With Pathologic Complete Response |
NCT02024607 (6) [back to overview] | Overall Survival of Patients With FOLFIRI/XELIRI-refractory Metastatic Colorectal Cancer |
NCT02024607 (6) [back to overview] | Number of Participants With Adverse Events and Serious Adverse Events |
NCT02024607 (6) [back to overview] | Disease Control Rate of Patients With FOLFIRI/XELIRI-refractory Metastatic Colorectal Cancer |
NCT02024607 (6) [back to overview] | Disease Control Rate |
NCT02024607 (6) [back to overview] | The Objective Response Rate of Napabucasin Administered in Combination in FOLFIRI in Patients With FOLFIRI/XELIRI-refractory Metastatic Colorectal Cancer |
NCT02024607 (6) [back to overview] | Progression Free Survival of Patients With FOLFIRI/XELIRI-refractory Metastatic Colorectal Cancer |
NCT02042443 (4) [back to overview] | Objective Response Rate |
NCT02042443 (4) [back to overview] | Progression-free Survival |
NCT02042443 (4) [back to overview] | Overall Survival |
NCT02042443 (4) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
NCT02083653 (13) [back to overview] | Overall Survival (OS) Time for Patients in Europe + United States With Triple-Negative mCRC (EU+US TNmCRC) |
NCT02083653 (13) [back to overview] | Occurrence and Nature of Adverse Events (AEs), as Assessed by the Common Terminology Criteria for AEs (Version 4.03) (CTCAE v4.03). |
NCT02083653 (13) [back to overview] | Pharmacokinetic (PK) Parameters: Sym004 Concentrations |
NCT02083653 (13) [back to overview] | Pharmacokinetic (PK) Parameters: Time of Maximum Plasma Concentration (Tmax) |
NCT02083653 (13) [back to overview] | Quality of Life Assessed by FACT-EGFRI-18 for Skin Rash |
NCT02083653 (13) [back to overview] | Quality of Life Assessed by the EORTC QLQ-C30 (Version 3) |
NCT02083653 (13) [back to overview] | Quality of Life Assessed by EORTC QLQ-CR29 |
NCT02083653 (13) [back to overview] | Host Immune Response: Number of Subjects With Anti-drug Antibodies (ADAs) to Sym004 Over Time |
NCT02083653 (13) [back to overview] | Overall Survival (OS) Time |
NCT02083653 (13) [back to overview] | Overall Survival (OS) Time for Patients in Europe + United States With Double-Negative mCRC (EU+US DNmCRC) |
NCT02083653 (13) [back to overview] | Progression Free Survival (PFS) Time |
NCT02083653 (13) [back to overview] | Relative Dose Intensity of Sym004 |
NCT02083653 (13) [back to overview] | Time to Treatment Failure (TTF) |
NCT02117479 (6) [back to overview] | Progression-free Survival (PFS) |
NCT02117479 (6) [back to overview] | Objective Response Rate (ORR) |
NCT02117479 (6) [back to overview] | Overall Survival (OS) |
NCT02117479 (6) [back to overview] | Percentage of Participants Achieving Progression Free Survival (PFS) |
NCT02117479 (6) [back to overview] | Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT02117479 (6) [back to overview] | Duration of Response |
NCT02119026 (9) [back to overview] | Tumour Assessments (Based on RECIST Criteria) in 2nd-line |
NCT02119026 (9) [back to overview] | Tumour Assessments (Based on RECIST Criteria) in 1st-line |
NCT02119026 (9) [back to overview] | Time to Response |
NCT02119026 (9) [back to overview] | Second Line PFS |
NCT02119026 (9) [back to overview] | Overall Survival of XELIRI Plus Bevacizumab and XELOX Plus Bevacizumab |
NCT02119026 (9) [back to overview] | Overall Response Rate (Number of Participants With Response) |
NCT02119026 (9) [back to overview] | First Line Progression Free Survival (PFS) |
NCT02119026 (9) [back to overview] | Efficacy Duration of Disease Control by Tumor Assessment (CT/MRI/Clinical Examination) |
NCT02119026 (9) [back to overview] | Duration of Response |
NCT02119663 (6) [back to overview] | Objective Response Rate (ORR) |
NCT02119663 (6) [back to overview] | Progression Free Survival (PFS) |
NCT02119663 (6) [back to overview] | Duration of Response |
NCT02119663 (6) [back to overview] | Participants With Treatment-Emergent Adverse Events (TEAEs) |
NCT02119663 (6) [back to overview] | Percentage of Participants Achieving Progression Free Survival (PFS) |
NCT02119663 (6) [back to overview] | Overall Survival (OS) |
NCT02120417 (6) [back to overview] | Median Survival |
NCT02120417 (6) [back to overview] | Percentage of Participants Achieving Clinical Benefit Rate |
NCT02120417 (6) [back to overview] | Percentage of Participants Achieving Overall Survival |
NCT02120417 (6) [back to overview] | Percentage of Participants Achieving Objective Response Rate |
NCT02120417 (6) [back to overview] | Progression-free Survival (PFS) |
NCT02120417 (6) [back to overview] | Duration of Response (DOR) |
NCT02218164 (4) [back to overview] | Overall Survival (OS) |
NCT02218164 (4) [back to overview] | Occurence of Treatment Related Serious Adverse Events (SAEs) |
NCT02218164 (4) [back to overview] | Objective Response Rate (ORR) |
NCT02218164 (4) [back to overview] | Progression Free Survival (PFS) |
NCT02231086 (2) [back to overview] | Peritoneal Recurrence Free Survival at 18 Months |
NCT02231086 (2) [back to overview] | Treatment Related Toxicity of Adjuvant HIPEC |
NCT02243007 (8) [back to overview] | Survival Rate at 18 Month |
NCT02243007 (8) [back to overview] | Number of Participants With Serious and Non-Serious Adverse Events |
NCT02243007 (8) [back to overview] | Rate of Pathologic Downstaging |
NCT02243007 (8) [back to overview] | 30-day Post-operative Mortality Rate |
NCT02243007 (8) [back to overview] | Correlation of Biomarkers With PFS |
NCT02243007 (8) [back to overview] | Local Control Rate |
NCT02243007 (8) [back to overview] | Pathologic Complete Response Rate (pCR). |
NCT02243007 (8) [back to overview] | Surgical Morbidity Rate |
NCT02291289 (6) [back to overview] | Percentage of Participants With Improvement and/or Stayed the Same on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score |
NCT02291289 (6) [back to overview] | Progression-Free Survival (PFS) |
NCT02291289 (6) [back to overview] | Overall Response |
NCT02291289 (6) [back to overview] | Duration of Response |
NCT02291289 (6) [back to overview] | Disease Control Rate (DCR) |
NCT02291289 (6) [back to overview] | Time to Treatment Response |
NCT02294786 (17) [back to overview] | Proportion of Subjects Experiencing Diarrhoea of Grade 2 and Above (up to 24 Weeks) |
NCT02294786 (17) [back to overview] | Number of Lapatinib and Capecitabine Tablets Dispensed and Returned |
NCT02294786 (17) [back to overview] | Time to the First Subject Reported Change in Frequency and/or Consistency of Bowel Movements From Baseline as Recorded in the DMD |
NCT02294786 (17) [back to overview] | Proportion of Subjects Taking Anti-diarrhoeal Medication as Recorded in the DMD |
NCT02294786 (17) [back to overview] | Proportion of Subjects Taking Anti-diarrhoeal Medication |
NCT02294786 (17) [back to overview] | Proportion of Subjects Reporting Stopping Completely or Missing Doses of Anti-cancer Tablets Due to Diarrhoea as Recorded in the DMD |
NCT02294786 (17) [back to overview] | Proportion of Subjects Reporting Changes in Bowel Movements From Baseline (Frequency and/or Consistency) as Recorded in the Diarrhoea Management Diary (DMD) |
NCT02294786 (17) [back to overview] | Proportion of Subjects Making Dietary Changes Due to Diarrhoea as Recorded in the DMD |
NCT02294786 (17) [back to overview] | Time to Onset of the First Episode of Diarrhoea of Any Grade of Severity |
NCT02294786 (17) [back to overview] | Proportion of Subjects Experiencing Diarrhoea of Grade 3 and Above (up to 24 Weeks) |
NCT02294786 (17) [back to overview] | Proportion of Subjects Experiencing Diarrhoea of Any Grade of Severity (up to 24 Weeks) |
NCT02294786 (17) [back to overview] | Proportion of Subjects Contacting Other Non-hospital Healthcare Professionals to Discuss Diarrhoea as Recorded in the DMD |
NCT02294786 (17) [back to overview] | Duration of Diarrhoea of Any Grade of Severity |
NCT02294786 (17) [back to overview] | Clinical Benefit Response (up to 24 Weeks) |
NCT02294786 (17) [back to overview] | Proportion of Subjects Requiring Treatment Withdrawal in Lapatinib and Capecitabine |
NCT02294786 (17) [back to overview] | Proportion of Subjects Requiring Dose Reduction in Lapatinib and Capecitabine |
NCT02294786 (17) [back to overview] | Proportion of Subjects Requiring Dose Delay in Lapatinib and Capecitabine |
NCT02301143 (11) [back to overview] | Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Satisfaction With Health Care Scale |
NCT02301143 (11) [back to overview] | Disease Control Rate (DCR): Percentage of Participants With Complete (CR) or Partial Response (PR), or Stable Disease (SD) for ≥ 16 Weeks According to RECIST Version 1.1 |
NCT02301143 (11) [back to overview] | Kaplan-Meier Estimate of Progression-Free Survival (PFS) |
NCT02301143 (11) [back to overview] | Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Six Summary Scales |
NCT02301143 (11) [back to overview] | Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): 10 Individual Item Scores |
NCT02301143 (11) [back to overview] | Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Symptom Scales and Single Symptom Items |
NCT02301143 (11) [back to overview] | Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Global Health Status and 5 Functioning Scales |
NCT02301143 (11) [back to overview] | Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1 |
NCT02301143 (11) [back to overview] | Kaplan-Meier Estimates for Time to Treatment Failure (TTF) |
NCT02301143 (11) [back to overview] | Kaplan-Meier Estimates for Overall Survival (OS) |
NCT02301143 (11) [back to overview] | Participants With Treatment Emergent Adverse Events (TEAEs) |
NCT02314117 (13) [back to overview] | Time to Progression (TTP) |
NCT02314117 (13) [back to overview] | Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) |
NCT02314117 (13) [back to overview] | PK: Minimum Concentration (Cmin) of Ramucirumab |
NCT02314117 (13) [back to overview] | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab |
NCT02314117 (13) [back to overview] | Number of Participants With Anti-Ramucirumab Antibodies |
NCT02314117 (13) [back to overview] | Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale |
NCT02314117 (13) [back to overview] | Progression-free Survival (PFS) |
NCT02314117 (13) [back to overview] | Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L) |
NCT02314117 (13) [back to overview] | Duration of Response (DoR) |
NCT02314117 (13) [back to overview] | Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR]) |
NCT02314117 (13) [back to overview] | Overall Survival (OS) |
NCT02314117 (13) [back to overview] | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) |
NCT02314117 (13) [back to overview] | Progression- Free Survival 2 (PFS2) |
NCT02324543 (10) [back to overview] | Progression-free Survival (PFS) Using RECIST 1.1 Criteria |
NCT02324543 (10) [back to overview] | Response Rate (RR) Using RECIST 1.1 Criteria |
NCT02324543 (10) [back to overview] | Maximum Tolerated Dose (MTD) of Gemcitabine |
NCT02324543 (10) [back to overview] | Disease Control Rate (DCR) Using RECIST 1.1 Criteria |
NCT02324543 (10) [back to overview] | Maximum Tolerated Dose (MTD) of Capecitabine |
NCT02324543 (10) [back to overview] | Overall Survival (OS) Rate at 9 Months |
NCT02324543 (10) [back to overview] | Maximum Tolerated Dose (MTD) of Docetaxel |
NCT02324543 (10) [back to overview] | Maximum Tolerated Dose (MTD) of Cisplatin |
NCT02324543 (10) [back to overview] | Maximum Tolerated Dose (MTD) of Irinotecan |
NCT02324543 (10) [back to overview] | Overall Survival (OS) |
NCT02335411 (14) [back to overview] | Overall Survival (OS) For All Participants |
NCT02335411 (14) [back to overview] | Progression-Free Survival For PD-L1 Positive Participants |
NCT02335411 (14) [back to overview] | Progression-Free Survival (PFS) For All Participants |
NCT02335411 (14) [back to overview] | Overall Survival For PD-L1 Positive Participants |
NCT02335411 (14) [back to overview] | Objective Response Rate For PD-L1 Positive Participants in Cohorts 1 and 3 |
NCT02335411 (14) [back to overview] | Number of Participants Discontinuing Study Drug Due to AEs |
NCT02335411 (14) [back to overview] | Disease Control Rate (DCR) For All Participants |
NCT02335411 (14) [back to overview] | Number of Participants Experiencing Adverse Events (AEs) |
NCT02335411 (14) [back to overview] | Disease Control Rate For PD-L1 Positive Participants |
NCT02335411 (14) [back to overview] | Duration of Response (DOR) For All Participants |
NCT02335411 (14) [back to overview] | Duration of Response For PD-L1 Positive Participants |
NCT02335411 (14) [back to overview] | Objective Response Rate (ORR) For All Participants in Cohort 2 |
NCT02335411 (14) [back to overview] | Objective Response Rate (ORR) For All Participants in Cohorts 1 and 3 |
NCT02335411 (14) [back to overview] | Objective Response Rate For PD-L1 Positive Participants in Cohort 2 |
NCT02352831 (7) [back to overview] | Overall Response Rate (ORR) |
NCT02352831 (7) [back to overview] | Number of Participants With a CA19-9 Response |
NCT02352831 (7) [back to overview] | Phase I Only: Recommended Phase II Dose of Tosedostat |
NCT02352831 (7) [back to overview] | Time-to-progression (TTP) |
NCT02352831 (7) [back to overview] | Overall Survival Rate (OS) |
NCT02352831 (7) [back to overview] | Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLTs) |
NCT02352831 (7) [back to overview] | Progression-free Survival (PFS) Rate |
NCT02358863 (1) [back to overview] | The Number of Patients With Tumor Size Reduction (Objective Response Rate) |
NCT02359058 (5) [back to overview] | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
NCT02359058 (5) [back to overview] | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate) |
NCT02359058 (5) [back to overview] | Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab |
NCT02359058 (5) [back to overview] | Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies (TE-ADA) |
NCT02359058 (5) [back to overview] | Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab |
NCT02393755 (5) [back to overview] | Median PFS (Phase II) |
NCT02393755 (5) [back to overview] | Median OS (Phase II) |
NCT02393755 (5) [back to overview] | To Examine the DLT |
NCT02393755 (5) [back to overview] | Progression Free Survival (PFS) Rate, Defined as the Proportion of Patients Who Survive Without Disease Progression Via the RECIST Version 1.1 (Phase II) |
NCT02393755 (5) [back to overview] | Objective Response Rate |
NCT02445391 (6) [back to overview] | 3-year Overall Survival (OS) Rate in Basal-Subtype Patients |
NCT02445391 (6) [back to overview] | Health-related Quality of Life (HRQL) at 6-month Assessment |
NCT02445391 (6) [back to overview] | Health-related Quality of Life (HRQL) at 15-month Assessment |
NCT02445391 (6) [back to overview] | Proportion of Basal Subtype |
NCT02445391 (6) [back to overview] | 3-year Recurrence-Free Survival (RFS) Rate in Basal-Subtype Patients |
NCT02445391 (6) [back to overview] | 3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients |
NCT02485834 (5) [back to overview] | Progression-free Survival |
NCT02485834 (5) [back to overview] | Overall Survival |
NCT02485834 (5) [back to overview] | Number of Patients Had Pathologic Complete Response |
NCT02485834 (5) [back to overview] | Number of Patients Achieved R0 Resection During Surgery |
NCT02485834 (5) [back to overview] | Number of Participants Who Reported Grade 3 or Higher Adverse Events |
NCT02494583 (16) [back to overview] | Pembro Mono vs SOC: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) |
NCT02494583 (16) [back to overview] | Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥10 |
NCT02494583 (16) [back to overview] | Pembro Combo vs SOC: Objective Response Rate (ORR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) |
NCT02494583 (16) [back to overview] | Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants) |
NCT02494583 (16) [back to overview] | Pembro Mono vs SOC: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) |
NCT02494583 (16) [back to overview] | Pembro Mono vs SOC: DOR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) |
NCT02494583 (16) [back to overview] | Pembro Mono vs SOC: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score |
NCT02494583 (16) [back to overview] | Pembro Combo vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-STO22 Pain Symptom Subscale Score |
NCT02494583 (16) [back to overview] | Pembro Combo vs SOC: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 (All Participants) |
NCT02494583 (16) [back to overview] | Pembro Combo vs SOC: Overall Survival (OS) in Participants With PD-L1 CPS ≥1 (All Participants) |
NCT02494583 (16) [back to overview] | Number of Participants Discontinuing Study Treatment Due to an AE |
NCT02494583 (16) [back to overview] | Pembro Combo vs SOC: OS in Participants With PD-L1 CPS ≥10 |
NCT02494583 (16) [back to overview] | Number of Participants Experiencing an Adverse Event (AE) |
NCT02494583 (16) [back to overview] | Pembro Combo vs SOC: Change From Baseline to Week 18 in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score |
NCT02494583 (16) [back to overview] | Pembro Combo vs SOC: Duration of Response (DOR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) |
NCT02494583 (16) [back to overview] | Pembro Mono vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-Module for Gastric Cancer (STO22) Pain Symptom Subscale Score |
NCT02494596 (12) [back to overview] | Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab |
NCT02494596 (12) [back to overview] | Plasma Half-Life of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab |
NCT02494596 (12) [back to overview] | Time to Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab |
NCT02494596 (12) [back to overview] | AUC From Time Zero to Infinity (AUC 0-infinity) of Pertuzumab |
NCT02494596 (12) [back to overview] | Apparent Total Clearance of Pertuzumab |
NCT02494596 (12) [back to overview] | Apparent Volume of Distribution of Pertuzumab |
NCT02494596 (12) [back to overview] | Area Under the Concentration Curve From Time Zero to Last Measurement (AUC 0-last) of Pertuzumab |
NCT02494596 (12) [back to overview] | Maximum Plasma Concentration (Cmax) of Pertuzumab |
NCT02494596 (12) [back to overview] | Maximum Tolerated Dose (MTD) of the Combination of Pertuzumab and Capecitabine |
NCT02494596 (12) [back to overview] | Percentage of Participants With DLTs |
NCT02494596 (12) [back to overview] | Plasma Half-Life (t1/2) of Pertuzumab |
NCT02494596 (12) [back to overview] | Time to Maximum Plasma Concentration (Tmax) of Pertuzumab |
NCT02524275 (3) [back to overview] | Overall Response Rate of Complete or Partial Response |
NCT02524275 (3) [back to overview] | Progression-free Survival |
NCT02524275 (3) [back to overview] | Survival |
NCT02550743 (2) [back to overview] | Pathologic Complete Response for Patients With Rectal Cancer |
NCT02550743 (2) [back to overview] | Maximum Tolerated Dose of BYL719 |
NCT02555657 (17) [back to overview] | Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10 |
NCT02555657 (17) [back to overview] | Overall Survival in Participants With PD-L1 CPS ≥1 |
NCT02555657 (17) [back to overview] | Number of Participants Who Experienced One or More Adverse Events |
NCT02555657 (17) [back to overview] | Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 |
NCT02555657 (17) [back to overview] | Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 |
NCT02555657 (17) [back to overview] | Progression-Free Survival Per RECIST 1.1 in All Participants |
NCT02555657 (17) [back to overview] | Disease Control Rate Per RECIST 1.1 in All Participants |
NCT02555657 (17) [back to overview] | Duration of Response Per RECIST 1.1 in All Participants Who Had a Confirmed Response |
NCT02555657 (17) [back to overview] | Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 |
NCT02555657 (17) [back to overview] | Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 Who Had a Confirmed Response |
NCT02555657 (17) [back to overview] | Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 |
NCT02555657 (17) [back to overview] | Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 Who Had a Confirmed Response |
NCT02555657 (17) [back to overview] | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event |
NCT02555657 (17) [back to overview] | Overall Response Rate Per RECIST 1.1 in All Participants |
NCT02555657 (17) [back to overview] | Overall Response Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 |
NCT02555657 (17) [back to overview] | Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10 |
NCT02555657 (17) [back to overview] | Overall Survival in All Participants |
NCT02574455 (14) [back to overview] | Time to Objective Response by the Investigator Assessment in BM-ve Population |
NCT02574455 (14) [back to overview] | Overall Survival (OS) in ITT Population |
NCT02574455 (14) [back to overview] | Time to Progression (TTP) by IRC Assessment in BM-ve Population |
NCT02574455 (14) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score |
NCT02574455 (14) [back to overview] | Time to Progression (TTP) by Investigator Assessment in BM-ve Population |
NCT02574455 (14) [back to overview] | Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population |
NCT02574455 (14) [back to overview] | Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population |
NCT02574455 (14) [back to overview] | Overall Survival (OS) in BM-ve Population |
NCT02574455 (14) [back to overview] | Time to Objective Response by the IRC Assessment in BM-ve Population |
NCT02574455 (14) [back to overview] | Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population |
NCT02574455 (14) [back to overview] | Progression-Free Survival (PFS) by IRC Assessment in the ITT Population |
NCT02574455 (14) [back to overview] | Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline |
NCT02574455 (14) [back to overview] | Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug |
NCT02574455 (14) [back to overview] | Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population |
NCT02611960 (10) [back to overview] | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
NCT02611960 (10) [back to overview] | Percentage of Participants With PFS (PFS Rate) at 6 Months |
NCT02611960 (10) [back to overview] | Percentage of Participants With PFS (PFS Rate) at 12 Months |
NCT02611960 (10) [back to overview] | Percentage of Participants Who Experience One or More Adverse Events (AEs) |
NCT02611960 (10) [back to overview] | Percentage of Participants Who Discontinue Study Treatment Due to an AE |
NCT02611960 (10) [back to overview] | Percentage of Participants Surviving (OS Rate) at 24 Months |
NCT02611960 (10) [back to overview] | Percentage of Participants Surviving (OS Rate) at 12 Months |
NCT02611960 (10) [back to overview] | Overall Survival (OS) |
NCT02611960 (10) [back to overview] | Duration of Response (DOR) Per RECIST 1.1 |
NCT02611960 (10) [back to overview] | Objective Response Rate (ORR) Per RECIST 1.1 |
NCT02614794 (19) [back to overview] | Progression-free Survival (PFS) Per RECIST 1.1 as Determined by Blinded Independent Central Review (BICR) |
NCT02614794 (19) [back to overview] | Frequency of Dose Modifications |
NCT02614794 (19) [back to overview] | Frequency of Dose Modifications at Time of Final Analysis |
NCT02614794 (19) [back to overview] | Incidence of Adverse Events (AEs) at Time of Final Analysis |
NCT02614794 (19) [back to overview] | Incidence of Adverse Events (AEs) at Time of Primary Analysis |
NCT02614794 (19) [back to overview] | Incidence of Health Resources Utilization |
NCT02614794 (19) [back to overview] | Pharmacokinetic Measure: ONT-993 |
NCT02614794 (19) [back to overview] | Pharmacokinetic Measure: Ctrough of Tucatinib |
NCT02614794 (19) [back to overview] | CBR Per RECIST 1.1 as Determined by Investigator Assessment |
NCT02614794 (19) [back to overview] | Clinical Benefit Rate (CBR) as Determined by BICR Per RECIST 1.1 |
NCT02614794 (19) [back to overview] | Confirmed Objective Response Rate (ORR) Per RECIST 1.1 as Determined by BICR |
NCT02614794 (19) [back to overview] | Duration of Response (DOR) Per RECIST 1.1 as Determined by BICR |
NCT02614794 (19) [back to overview] | ORR Per RECIST 1.1 as Determined by Investigator Assessment |
NCT02614794 (19) [back to overview] | Overall Survival (OS) at Time of Final Analysis |
NCT02614794 (19) [back to overview] | Overall Survival (OS) at Time of Primary Analysis |
NCT02614794 (19) [back to overview] | PFS in Patients With Brain Metastases at Baseline Using RECIST 1.1 as Determined by BICR |
NCT02614794 (19) [back to overview] | PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Final Analysis |
NCT02614794 (19) [back to overview] | PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Primary Analysis |
NCT02614794 (19) [back to overview] | DOR Per RECIST 1.1 as Determined by Investigator Assessment |
NCT02625610 (12) [back to overview] | Progression Free Survival (PFS) by Independent Review Committee (IRC) |
NCT02625610 (12) [back to overview] | Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) |
NCT02625610 (12) [back to overview] | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities |
NCT02625610 (12) [back to overview] | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs |
NCT02625610 (12) [back to overview] | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values |
NCT02625610 (12) [back to overview] | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) |
NCT02625610 (12) [back to overview] | Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1 |
NCT02625610 (12) [back to overview] | Objective Response Rate (ORR) by Investigator Assessment |
NCT02625610 (12) [back to overview] | Overall Survival (OS) |
NCT02625610 (12) [back to overview] | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) |
NCT02625610 (12) [back to overview] | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) |
NCT02625610 (12) [back to overview] | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) |
NCT02694718 (7) [back to overview] | Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes |
NCT02694718 (7) [back to overview] | Number of Participants With Any Adverse Events and Serious Adverse Events |
NCT02694718 (7) [back to overview] | Percentage of Participants With Pathological Complete Tumor Response |
NCT02694718 (7) [back to overview] | Percentage of Participants With Pathological Incomplete Tumor Response |
NCT02694718 (7) [back to overview] | Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer |
NCT02694718 (7) [back to overview] | Percentage of Participants With Sphincter-preservation |
NCT02694718 (7) [back to overview] | Number of Participants With Marked Laboratory Abnormalities |
NCT02743221 (5) [back to overview] | Disease Control Rate (DCR) |
NCT02743221 (5) [back to overview] | Overall Survival (OS) |
NCT02743221 (5) [back to overview] | Overall Response Rate (ORR) |
NCT02743221 (5) [back to overview] | Progression Free Survival (PFS) |
NCT02743221 (5) [back to overview] | Duration of Response (DR) |
NCT02748213 (6) [back to overview] | Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) |
NCT02748213 (6) [back to overview] | Percentage of Participants With Death or Disease Progression According to RECIST |
NCT02748213 (6) [back to overview] | Progression-Free Survival (PFS) According to RECIST |
NCT02748213 (6) [back to overview] | Duration of Response (DOR) According to RECIST |
NCT02748213 (6) [back to overview] | Overall Survival (OS) |
NCT02748213 (6) [back to overview] | Percentage of Participants Who Died |
NCT02780700 (5) [back to overview] | Disease Control (DC) |
NCT02780700 (5) [back to overview] | Objective Response Rate (ORR) |
NCT02780700 (5) [back to overview] | Overall Survival (OS) |
NCT02780700 (5) [back to overview] | Percentage of Patients With Grade 3 or Worse Adverse Events |
NCT02780700 (5) [back to overview] | Progression Free Survival (PFS) |
NCT02872116 (7) [back to overview] | PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy |
NCT02872116 (7) [back to overview] | PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy |
NCT02872116 (7) [back to overview] | OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy |
NCT02872116 (7) [back to overview] | OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy |
NCT02872116 (7) [back to overview] | Objective Response Rate |
NCT02872116 (7) [back to overview] | Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 |
NCT02872116 (7) [back to overview] | Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 |
NCT02873195 (4) [back to overview] | Progression Free Survival (PFS) |
NCT02873195 (4) [back to overview] | The Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment (Toxicity) |
NCT02873195 (4) [back to overview] | Objective Response Rate |
NCT02873195 (4) [back to overview] | Overall Survival (OS) |
NCT02921256 (3) [back to overview] | Rate of Sphincter Preservation |
NCT02921256 (3) [back to overview] | Neoadjuvant Rectal Cancer (NAR) Score |
NCT02921256 (3) [back to overview] | Rate of Pathologic Complete Response (Nodes and Tumor) ypT0 and ypN0 |
NCT02937116 (13) [back to overview] | TTR According to RECIST 1.1 as Assessed by Investigator |
NCT02937116 (13) [back to overview] | Volume of Distribution of IBI308 in Plasma After Single Dose Administration |
NCT02937116 (13) [back to overview] | Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants |
NCT02937116 (13) [back to overview] | OS for Participants |
NCT02937116 (13) [back to overview] | Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t) |
NCT02937116 (13) [back to overview] | Clearance of IBI308 in Plasma After Single Dose Administration |
NCT02937116 (13) [back to overview] | DOR According to RECIST 1.1 as Assessed by Investigator |
NCT02937116 (13) [back to overview] | Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants |
NCT02937116 (13) [back to overview] | Number of All Study Participants Who Demonstrate a Tumor Response |
NCT02937116 (13) [back to overview] | Number of Participants Experiencing Dose-limiting Toxicities (DLTs) |
NCT02937116 (13) [back to overview] | Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator |
NCT02937116 (13) [back to overview] | PFS According to RECIST 1.1 as Assessed by Investigator |
NCT02937116 (13) [back to overview] | The Half-life (t1/2) of IBI308 in Plasma After Single Dose Administration |
NCT02954536 (1) [back to overview] | Percentage of Participants With Progression Free Survival |
NCT02981342 (11) [back to overview] | Stage 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) |
NCT02981342 (11) [back to overview] | Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months |
NCT02981342 (11) [back to overview] | Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level |
NCT02981342 (11) [back to overview] | Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414 |
NCT02981342 (11) [back to overview] | Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20)) |
NCT02981342 (11) [back to overview] | Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) |
NCT02981342 (11) [back to overview] | Stage 2: Progression Free Survival (PFS) |
NCT02981342 (11) [back to overview] | Stage 2: Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) |
NCT02981342 (11) [back to overview] | Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR |
NCT02981342 (11) [back to overview] | Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose |
NCT02981342 (11) [back to overview] | Stage 2: Overall Survival (OS) |
NCT03026803 (1) [back to overview] | Response Rate |
NCT03044730 (6) [back to overview] | 1-year Progression Free Survival (PFS) Rate |
NCT03044730 (6) [back to overview] | Objective Response Rate (ORR) |
NCT03044730 (6) [back to overview] | Objective Response Rate (ORR) |
NCT03044730 (6) [back to overview] | Median PFS (Median Progression-Free Survival) |
NCT03044730 (6) [back to overview] | Median PFS (Median Progression-Free Survival) |
NCT03044730 (6) [back to overview] | Clinical Benefit Rate (CBR) |
NCT03050814 (3) [back to overview] | Number of Participants That Are Hospitalized Because of Adverse Events Attributed to Disease Progression |
NCT03050814 (3) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) |
NCT03050814 (3) [back to overview] | Progression Free Survival Between the Standard of Care (SOC) Arm A, and Standard of Care (SOC) Arm B + lead-in |
NCT03093870 (10) [back to overview] | Number of Participants With Clinically Significant Change in Vital Signs and Physical Examinations - Part 1 |
NCT03093870 (10) [back to overview] | Progression-free Survival (PFS) - Part 1 |
NCT03093870 (10) [back to overview] | Number of Participants With ECG Parameters of Interest - Safety Lead-In |
NCT03093870 (10) [back to overview] | Number of Participants With Clinically Significant Laboratory Tests - Part 1 |
NCT03093870 (10) [back to overview] | Overall Survival (OS) - Part 1 |
NCT03093870 (10) [back to overview] | Number of Participants With Clinically Significant Laboratory Tests- Safety Lead-in |
NCT03093870 (10) [back to overview] | Duration of Response (DoR) - Part 1 |
NCT03093870 (10) [back to overview] | Number of Participants With Clinically Significant Change in Vital Signs and Physical Examinations - Safety Lead-In |
NCT03093870 (10) [back to overview] | Number of Participants With ECG Parameters of Interest - Part 1 |
NCT03093870 (10) [back to overview] | Tumor Size - Part 1 |
NCT03111732 (7) [back to overview] | Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Oxaliplatin |
NCT03111732 (7) [back to overview] | Number of Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, and Probably Related to Capecitabine |
NCT03111732 (7) [back to overview] | Number of Participants Obtaining a Complete Response (CR) and Partial Response (PR) |
NCT03111732 (7) [back to overview] | Overall Survival |
NCT03111732 (7) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) |
NCT03111732 (7) [back to overview] | Progression Free Survival (PFS) |
NCT03111732 (7) [back to overview] | Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Pembrolizumab |
NCT03262935 (6) [back to overview] | Investigator Assessed Progression Free Survival |
NCT03262935 (6) [back to overview] | Objective Response Rate |
NCT03262935 (6) [back to overview] | Overall Survival |
NCT03262935 (6) [back to overview] | Patient Reported Outcomes for Health Related Quality of Life |
NCT03262935 (6) [back to overview] | Patient Reported Outcomes for Health Related Quality of Life |
NCT03262935 (6) [back to overview] | Progression Free Survival |
NCT03376659 (3) [back to overview] | Progression Free Survival (PFS) |
NCT03376659 (3) [back to overview] | Progression Free Survival Rate (PFS) Pancreatic Cancer |
NCT03376659 (3) [back to overview] | Progression Free Survival Rate (PFS) Colorectal Cancer |
NCT03501979 (1) [back to overview] | Length of Subject Survival After Starting Study Treatment |
NCT03515941 (2) [back to overview] | Median Time to Recurrence |
NCT03515941 (2) [back to overview] | Number of Participants Who Complete the Recommended Therapy From Each Arm |
NCT03523585 (5) [back to overview] | Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine |
NCT03523585 (5) [back to overview] | Duration of Response (DoR) Based on BICR in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine |
NCT03523585 (5) [back to overview] | Overall Survival (OS) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine |
NCT03523585 (5) [back to overview] | Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine |
NCT03523585 (5) [back to overview] | Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine |
NCT03675737 (14) [back to overview] | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 |
NCT03675737 (14) [back to overview] | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 |
NCT03675737 (14) [back to overview] | Overall Survival (OS) in All Participants |
NCT03675737 (14) [back to overview] | Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 |
NCT03675737 (14) [back to overview] | Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants |
NCT03675737 (14) [back to overview] | Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 |
NCT03675737 (14) [back to overview] | Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 |
NCT03675737 (14) [back to overview] | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants |
NCT03675737 (14) [back to overview] | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 |
NCT03675737 (14) [back to overview] | Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 |
NCT03675737 (14) [back to overview] | Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE) |
NCT03675737 (14) [back to overview] | Number of Participants Who Experienced an Adverse Event (AE) |
NCT03675737 (14) [back to overview] | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants |
NCT03675737 (14) [back to overview] | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 |
NCT03734029 (12) [back to overview] | Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer |
NCT03734029 (12) [back to overview] | Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer |
NCT03734029 (12) [back to overview] | Duration of Response in Participants With HER2-low Breast Cancer (All Patients) |
NCT03734029 (12) [back to overview] | Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients) |
NCT03734029 (12) [back to overview] | Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer |
NCT03734029 (12) [back to overview] | Overall Survival (OS) in All Patients |
NCT03734029 (12) [back to overview] | Number of Overall Survival Events (Deaths) |
NCT03734029 (12) [back to overview] | All-Cause Mortality |
NCT03734029 (12) [back to overview] | Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer |
NCT03734029 (12) [back to overview] | Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status |
NCT03734029 (12) [back to overview] | Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer |
NCT03734029 (12) [back to overview] | Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients) |
NCT03770689 (20) [back to overview] | Number of Participants With Abnormalities [Grade Greater Than or Equals to (>=) 3] in Laboratory Test Values |
NCT03770689 (20) [back to overview] | Number of Participants Who Experienced Dose Limiting Toxicity (DLT) Confirmed by Safety Monitoring Committee (SMC) |
NCT03770689 (20) [back to overview] | Apparent Volume of Distribution (Vz/f) of Peposertib |
NCT03770689 (20) [back to overview] | Neoadjuvant Rectal (NAR) Score |
NCT03770689 (20) [back to overview] | Apparent Volume of Distribution (Vz/f) of Peposertib |
NCT03770689 (20) [back to overview] | Disease-free Survival |
NCT03770689 (20) [back to overview] | Area Under the Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) (AUC0-t) of Peposertib |
NCT03770689 (20) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of Peposertib |
NCT03770689 (20) [back to overview] | Number of Participants Wtih Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE) Version 5.0 |
NCT03770689 (20) [back to overview] | Time to Reach Maximum Plasma Concentration (Tmax) of Peposertib |
NCT03770689 (20) [back to overview] | Time From Surgery to Distant Metastasis |
NCT03770689 (20) [back to overview] | Apparent Terminal Half-life (t1/2) of Peposertib |
NCT03770689 (20) [back to overview] | Apparent Terminal Half-life (t1/2) of Peposertib |
NCT03770689 (20) [back to overview] | Total Body Clearance Following Oral Administration (CL/f) of Peposertib |
NCT03770689 (20) [back to overview] | Time From Surgery to Local Recurrence |
NCT03770689 (20) [back to overview] | Percentage of Participants With Pathological Complete Response (pCR) |
NCT03770689 (20) [back to overview] | Percentage of Participants With Composite Pathological Complete Response (pCR)/ Clinical Complete Response (cCR) |
NCT03770689 (20) [back to overview] | Percentage of Participants With Clinical Complete Response (cCR) |
NCT03770689 (20) [back to overview] | Number of Participants With Markedly Abnormal Vital Sign Measurements |
NCT03770689 (20) [back to overview] | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings |
NCT03783442 (1) [back to overview] | Overall Survival (OS) |
NCT03853707 (4) [back to overview] | Overall Survival (OS) |
NCT03853707 (4) [back to overview] | Overall Response |
NCT03853707 (4) [back to overview] | Progression-free Survival (PFS) |
NCT03853707 (4) [back to overview] | Clinical Benefit Rate |
NCT03930771 (4) [back to overview] | Safety, as Measured by the Number of Subjects With at Least One AE |
NCT03930771 (4) [back to overview] | Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients |
NCT03930771 (4) [back to overview] | Tolerability of the TMZ and Capecitabine Combination, as Measured by Number of Participants With a Dose-limiting Toxicity |
NCT03930771 (4) [back to overview] | Number of Subjects With Radiographic Response, as Defined by the RECIST Criteria. |
NCT04031885 (1) [back to overview] | Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) |
NCT04034251 (8) [back to overview] | Number of Grades 3-5 Serious and/or Non-serious Adverse Events Related to the Research Interventions |
NCT04034251 (8) [back to overview] | Progression Free Survival (PFS) in Participants With Peritoneal Metastases From Gastric Cancer After Repeated Intraperitoneal Chemotherapeutic Infusion (IPC) and Systemic Paclitaxel Administration With Concomitant Capecitabine Therapy |
NCT04034251 (8) [back to overview] | Overall Survival (OS) |
NCT04034251 (8) [back to overview] | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) |
NCT04034251 (8) [back to overview] | Number of Participants With Intra-peritoneal Progression Free Survival (iPFS) |
NCT04034251 (8) [back to overview] | Number of Participants With Distant Extra-peritoneal Disease-free Survival |
NCT04034251 (8) [back to overview] | Intra-peritoneal Progression Free Survival (iPFS) Reported With an 95% Confidence Interval |
NCT04034251 (8) [back to overview] | Intra-peritoneal Progression Free Survival (iPFS) Reported With an 80% Confidence Interval |
NCT04366713 (2) [back to overview] | Incidence and Severity of Diarrhea |
NCT04366713 (2) [back to overview] | Changes in Colon Pathology |
NCT05091528 (4) [back to overview] | Proportion of Participants With Dose Limiting Toxicities |
NCT05091528 (4) [back to overview] | Number of Participants With an Objective Response Rate |
NCT05091528 (4) [back to overview] | Number of Participants With Laboratory Abnormalities |
NCT05091528 (4) [back to overview] | Number of Participants With Treatment-emergent Adverse Events |
Overall Clinical Response Rate
Overall response rate is defined as the percentage of participants with a CR (complete disappearance of all target lesions), PR (a 30% decrease in the sum of the longest diameter of target lesions) determined by clinical measurements per the Response Evaluation Criteria in Solid Tumors (RECIST) and/or a complete pathologic response (disappearance of all invasive tumor pathologically or presence of ductal carcinoma in situ) per the Chevallier criteria. For details about the RECIST or Chevallier criteria see the protocol link module. (NCT00005908)
Timeframe: 6 years
Intervention | Percentage of participants (Number) |
---|
| Complete Response | Partial Response | Complete pathologic response |
---|
Dose A & B-Cohort 1 & 2-Arm 1& 2-Docetaxel & Capecitabine | 31 | 59 | 10 |
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Complementary Deoxyribonucleic Acid (cDNA) Expression
Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out. (NCT00005908)
Timeframe: 6 years
Intervention | Participants (Number) |
---|
| Responders | Non-responders |
---|
Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine | 8 | 2 |
,Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine | 7 | 13 |
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Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00005908)
Timeframe: 6 years
Intervention | Participants (Number) |
---|
Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine | 9 |
Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine | 20 |
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Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models
Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out. (NCT00005908)
Timeframe: 6 years
Intervention | Participants (Number) |
---|
| Responders | Non-responders |
---|
Dose A & B-Cohort 1 & 2-Arm 1 & 2-Docetaxel & Capecitabine | 8 | 13 |
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Disease-free Survival
Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time). (NCT00009737)
Timeframe: Approximately 3 years
Intervention | Participants (Number) |
---|
Capecitabine | 656 |
5-Fluorouracil + Leucovorin | 603 |
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Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters
Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented. (NCT00009737)
Timeframe: Up to Week 25
Intervention | Participants (Number) |
---|
| Alanine transaminase | Aspartate aminotransferase | Alkaline Phosphatase | Calcium (Hyper) | Calcium (Hypo) | Granulocytes | Hemoglobin | Lymphocytes | Neutrophils | Neutrophils/Granulocytes | Platelets | Potassium | Serum Creatinine | Sodium | Total Bilirubin | White blood cell |
---|
5-Fluorouracil + Leucovorin | 333 | 288 | 289 | 68 | 112 | 43 | 650 | 744 | 596 | 612 | 160 | 156 | 138 | 184 | 185 | 409 |
,Capecitabine | 327 | 300 | 334 | 67 | 150 | 20 | 691 | 778 | 308 | 316 | 182 | 209 | 157 | 189 | 501 | 220 |
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Mean Change From Baseline in Global Health Status at Week 25
Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used. (NCT00009737)
Timeframe: Baseline (Days -7 to 1) and at Week 25
Intervention | Score on a scale (Mean) |
---|
Capecitabine | 2.1 |
5-Fluorouracil + Leucovorin | 2.6 |
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Overall Survival
Participants with overall survival were reported. Overall survival was assessed as the number of days between randomization and death or the last time at which a participant was known to be alive (censoring time). (NCT00009737)
Timeframe: Approximately 3 years
Intervention | Participants (Number) |
---|
Capecitabine | 804 |
5-Fluorouracil + Leucovorin | 756 |
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Relapse-Free Survival
Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression. (NCT00009737)
Timeframe: Approximately 3 years
Intervention | Participants (Number) |
---|
Capecitabine | 677 |
5-Fluorouracil + Leucovorin | 621 |
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Number of Participants With Any Adverse Events and Serious Adverse Events
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) 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, or results in a congenital anomaly/birth defect. (NCT00009737)
Timeframe: Up to Week 29
Intervention | Participants (Number) |
---|
| All adverse events | Serious adverse events |
---|
5-Fluorouracil + Leucovorin | 885 | 182 |
,Capecitabine | 910 | 181 |
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Duration of Overall Complete Response
The duration of overall complete response was assessed from the time that measurement criteria were met for complete response until the first date that recurrent or progressive disease was objectively documented. Participants without observed progressive disease after an objective complete response were censored at the date of the last tumor assessment. (NCT00022698)
Timeframe: Approximately 43 Months
Intervention | months (Number) |
---|
Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) | 12.45 |
Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 12.68 |
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Duration of Overall Response
Duration of overall response was assessed from the time that measurement criteria were first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease was documented. It was analyzed for responders only. Participants without observed progressive disease after an objective response were censored at the date of the last tumor assessment. (NCT00022698)
Timeframe: Approximately 43 Months
Intervention | months (Median) |
---|
Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) | 7.0 |
Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 7.7 |
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Overall Survival
Overall Survival is defined as the time from start of treatment to the date of death. Participants who did not die were censored at the last date the participant was known to be alive. (NCT00022698)
Timeframe: Approximately 43 Months
Intervention | months (Median) |
---|
Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) | 22.9 |
Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 20.5 |
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Percentage of Participants With One-year Survival
Survival was measured as the time from start of treatment to the date of death or till one year whichever occurred first. (NCT00022698)
Timeframe: Up to Month 12
Intervention | percentage of participants (Number) |
---|
Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) | 67 |
Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 71 |
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Time to Disease Progression
Time to disease progression was assessed as the time from start of treatment to the time the participant was first recorded as having disease progression or died due to causes other than disease progression. If a participant never progressed while being followed, he/she was censored at the date of the last tumor assessment or the date of the last dose if no post-baseline tumor measurement was available. (NCT00022698)
Timeframe: Approximately 43 Months
Intervention | months (Median) |
---|
Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) | 6.1 |
Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 7.6 |
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Time To Objective Response
The time to objective response is defined as the time from start of treatment to the date of first objective response. Participants who never responded during study were censored at the last tumor assessment or the date of last dose, whichever was later, or at the date of death if occurring prior to response. (NCT00022698)
Timeframe: Approximately 43 Months
Intervention | months (Median) |
---|
Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) | 5.5 |
Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 4.3 |
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Time to Treatment Failure
Time to treatment failure was assessed as the time from start of treatment to the time the participant was withdrawn due to any of the reasons such as adverse events, progressive disease, insufficient therapeutic response, death, failure to return, or refused treatment, did not cooperate or withdrew consent. (NCT00022698)
Timeframe: Approximately 43 Months
Intervention | months (Median) |
---|
Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) | 5.8 |
Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 7.3 |
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Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths
An adverse event (AEs) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), life-threatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above. (NCT00022698)
Timeframe: Approximately 43 Months
Intervention | Number of participants (Number) |
---|
| Any AEs | SAEs | Deaths During Study | Deaths During Follow-up |
---|
Cohort 1, Initial Regimen: (Capecitabine + Irinotecan) | 15 | 10 | 0 | 13 |
,Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 52 | 25 | 3 | 23 |
,Total Participants (Cohort 1 + Cohort 2) | 67 | 35 | 3 | 36 |
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Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0)
Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as a greater than or equal to (>/=) 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as reference the baseline sum of LD. Participants who did not have a post-baseline tumor measurement were considered non-responders in the assessment of ORR. (NCT00022698)
Timeframe: Approximately 43 Months
Intervention | percentage of participants (Number) |
---|
| CR | PR |
---|
Cohort 1, Initial Regimen:(Capecitabine + Irinotecan) | 7 | 40 |
,Cohort 2, Amended Regimen: (Capecitabine + Irinotecan) | 2 | 42 |
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Relapse-free Survival Rates at 2.4 Years
"Percentage of participants who were alive and relapse-free at time of analysis were counted as Alive without relapse at 2.4 years. Participants who had a first local recurrence, first distant metastasis or death from any cause were counted as relapse, first occurrence. These rates were estimated using the Kaplan Meier method" (NCT00024102)
Timeframe: randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years)
Intervention | percentage of participants (Number) |
---|
| Relapse, first occurrence | Alive without relapse |
---|
Capecitabine | 20 | 80 |
,Standard Chemotherapy | 11 | 89 |
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Overall Survival Rate at 2.4 Years
Percentage of patients who were alive at 2.4 years. This rate was estimated using the Kaplan Meier method. (NCT00024102)
Timeframe: Time from registration to death (up to 15 years)
Intervention | percentage of participants (Number) |
---|
Standard Chemotherapy | 93 |
Capecitabine | 88 |
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Overall Survival
Measured from time of registration to death, or last contact date (NCT00033540)
Timeframe: All patients will be followed until death or three years after registration, whichever is first.
Intervention | months (Median) |
---|
Capecitabine + Gemcitabine | 7 |
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Accrual of Patients With This Disease Site
Only eligible patients who received treatment were evaluable for response and survival outcomes. (NCT00033540)
Timeframe: 1-20 months
Intervention | participants (Number) |
---|
| Eligible | Eligible and Analyzable |
---|
Capecitabine + Gemcitabine | 54 | 52 |
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Response
Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. (NCT00033540)
Timeframe: Patients assessed at least every six weeks while on protocol treatment
Intervention | participants (Number) |
---|
| Confirmed Partial Response | Unconfirmed Partial Response | Stable Disease | Progression | Symptomatic Deterioration | Early Death | Inadequate Assessment |
---|
Capecitabine + Gemcitabine | 7 | 6 | 12 | 15 | 3 | 1 | 8 |
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Percentage of Participants With Reoccurrence
Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer). (NCT00050167)
Timeframe: Median of 50 months
Intervention | participants (Log Mean) |
---|
Weekly Paclitaxel (WP) | 90.7 |
Docetaxel and Capecitabine (DX) | 87.5 |
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Maximum Tolerated Dose Determined by Dose-limiting Toxicities
1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w adequate antidiarrheal treatment & hydration & nausea/vomiting w maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0 (NCT00068588)
Timeframe: 21 days
Intervention | Patients experiencing DLT (Number) |
---|
Arm 2 | 0 |
Arm 3 | 0 |
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Response Rate of a Combination of GTI-2040 and Capecitabine
Following the dose escalation step, additional patients will be accrued at the MTD and evaluated for disease response using RECIST v1.0 criteria. Patients with confirmed complete or partial response are considered to have responded favorably to treatment.The sample size and early stopping for futility was governed by a two stage Optimum design suggested by Simon. It was assumed that a true response rate less than 25% would not warrant further study of this agent. It was also assumed that a response rate of 45% would be considered promising. In the first stage (following the dose escalation step), 15 evaluable patients were treated. Four or fewer observed responses, would stop accrual, while 5 or more observed would continue accrual for an additional 12 patients during the second stage of the study. Ten or more responses out of 27 patients will be considered evidence warranting further study of the regimen providing toxicity and survival also appear favorable. (NCT00068588)
Timeframe: Up to 6 years
Intervention | percentage of patients responding (Number) |
---|
Arm 3 | 20 |
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PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms. (NCT00069095)
Timeframe: Baseline until disease progression or death, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4+P/XELOX+P | 245.0 |
FOLFOX-4+BV/XELOX+BV | 287.0 |
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Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4
PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4- containing arms was investigated. (NCT00069095)
Timeframe: Baseline until disease progression or death, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 259 |
XELOX/XELOX+P/XELOX+BV | 241 |
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Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms. (NCT00069095)
Timeframe: Week 1 to Week 54
Intervention | Participants (Number) |
---|
| Week 1-6 | Week 7-12 | Week 13-18 | Week 19-24 | Week 25-30 | Week 31-36 | Week 37-42 | Week 49-54 |
---|
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 67 | 190 | 155 | 25 | 14 | 7 | 3 | 2 |
,XELOX/XELOX+P/XELOX+BV | 93 | 191 | 110 | 38 | 13 | 3 | 1 | 0 |
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Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Superiority of the BV-containing arms was compared with the chemotherapy alone arms. (NCT00069095)
Timeframe: Week 1 to Week 54
Intervention | Participants (Number) |
---|
| Week 1-6 | Week 7-12 | Week 13-18 | Week 19-24 | Week 25-30 | Week 31-36 | Week 37-42 | Week 49-54 |
---|
FOLFOX-4+P/XELOX+P | 58 | 146 | 105 | 26 | 7 | 2 | 1 | 0 |
,XELOX/XELOX+P/XELOX+BV | 48 | 138 | 87 | 29 | 12 | 8 | 2 | 1 |
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Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase.The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only. (NCT00069095)
Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months
Intervention | days (Median) |
---|
| General Approach | On-treatment Approach |
---|
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 191.0 | 190.0 |
,XELOX/XELOX+P/XELOX+BV | 179.0 | 176.0 |
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Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach included all tumor assessments or deaths that occurred during the primary study treatment phase, the post-study treatment phase, or the follow-up phase. The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only. (NCT00069095)
Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months
Intervention | days (Median) |
---|
| General Approach | On-treatment Approach |
---|
FOLFOX-4+BV/XELOX+BV | 209.0 | 208.0 |
,FOLFOX-4+P/XELOX+P | 183.0 | 182.0 |
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Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4
Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms. (NCT00069095)
Timeframe: Baseline until disease progression or death, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 549.0 |
XELOX/XELOX+P/XELOX+BV | 577.0 |
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Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Superiority of the BV-containing arms was compared with the chemotherapy alone arms. (NCT00069095)
Timeframe: Baseline until disease progression or death, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4+P/XELOX+P | 574.0 |
FOLFOX-4+BV/XELOX+BV | 551.0 |
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PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4
PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms. (NCT00069095)
Timeframe: Baseline until disease progression or death, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 268.0 |
XELOX/XELOX+P/XELOX+BV | 234.0 |
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PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms. (NCT00069095)
Timeframe: Baseline until disease progression or death, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4+P/XELOX+P | 241.0 |
FOLFOX-4+BV/XELOX+BV | 316.0 |
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PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4
PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms. (NCT00069095)
Timeframe: Baseline until disease progression or death, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 304.0 |
XELOX/XELOX+P/XELOX+BV | 261.0 |
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PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms. (NCT00069095)
Timeframe: Baseline until disease progression or death, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4+P/XELOX+P | 244.0 |
FOLFOX-4+BV/XELOX+BV | 285.0 |
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PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the bevacizumab-containing arms was compared with the placebo-containing arms. (NCT00069095)
Timeframe: Baseline until disease progression or death, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4+P/XELOX+P | 259.0 |
FOLFOX-4+BV/XELOX+BV | 335.0 |
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Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms. (NCT00069095)
Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 239.0 |
XELOX/XELOX+P/XELOX+BV | 226.0 |
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Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms. (NCT00069095)
Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months
Intervention | Percentage of responders (Number) |
---|
FOLFOX-4+P/XELOX+P | 49.2 |
FOLFOX-4+BV/XELOX+BV | 46.5 |
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Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4
According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms. (NCT00069095)
Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months
Intervention | Percentage of responders (Number) |
---|
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 49.4 |
XELOX/XELOX+P/XELOX+BV | 46.4 |
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BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms. (NCT00069095)
Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months
Intervention | Percentage of responders (Number) |
---|
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 38.6 |
XELOX/XELOX+P/XELOX+BV | 37.1 |
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BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms. (NCT00069095)
Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months
Intervention | Percentage of responders (Number) |
---|
FOLFOX-4+P/XELOX+P | 37.5 |
FOLFOX-4+BV/XELOX+BV | 37.5 |
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Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms. (NCT00069095)
Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 347.0 |
XELOX/XELOX+P/XELOX+BV | 589.0 |
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Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Superiority of the BV-containing arms was compared with the chemotherapy alone arms. (NCT00069095)
Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4+P/XELOX+P | 403.0 |
FOLFOX-4+BV/XELOX+BV | 386.0 |
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PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4
PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms. (NCT00069095)
Timeframe: Baseline until disease progression or death, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV | 260.0 |
XELOX/XELOX+P/XELOX+BV | 244.0 |
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Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone
Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Superiority of the BV-containing arms was compared with the chemotherapy alone arms. (NCT00069095)
Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months
Intervention | days (Median) |
---|
FOLFOX-4+P/XELOX+P | 225.0 |
FOLFOX-4+BV/XELOX+BV | 257.0 |
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Best Overall Response, Investigators' Assessments
Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include complete response (CR), partial response (PR), or stable disease (SD). CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks. For SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks. (NCT00069108)
Timeframe: Up to 3 years
Intervention | participants (Number) |
---|
| Investigator Assessed, Responders | Investigator assessed-CR | Investigator assessed-PR |
---|
FOLFOX-4 | 55 | 2 | 53 |
,XELOX | 63 | 0 | 63 |
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Best Overall Response, Independent Review Committee Assessment
Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include CR, PR, or SD. CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks, for SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks. This PFS evaluation was based on Independent Review Committee Assessment. (NCT00069108)
Timeframe: Up to 3 years
Intervention | participants (Number) |
---|
| IRC Assessed, Responders | IRC assessed-CR | IRC assessed-PR |
---|
FOLFOX-4 | 39 | 0 | 39 |
,XELOX | 48 | 0 | 48 |
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Time To Treatment Failure
Time to treatment failure was defined as the time from the date of randomization to the first occurrence of adverse event (AE), insufficient therapeutic response, death, failure to return, or refusing treatment/being uncooperative/withdrawing consent. (NCT00069108)
Timeframe: Up to 3 years
Intervention | days (Median) |
---|
XELOX | 125 |
FOLFOX-4 | 121.5 |
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Progression Free Survival Based on Treatment Analysis- Per Population
Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization (NCT00069108)
Timeframe: Up to 3 years
Intervention | days (Median) |
---|
XELOX | 153 |
FOLFOX-4 | 164 |
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Progression Free Survival Based on Treatment Analysis- Intent To Treat Population
Progression free survival (PFS) is defined as the time from date of randomization to day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. PFS was analyzed using an on-treatment approach included only disease progression and death that occurred no later than 28 days after the last confirmed intake of study medication in the primary study treatment phase. (NCT00069108)
Timeframe: Up to 3 years
Intervention | days (Median) |
---|
XELOX | 145 |
FOLFOX-4 | 152 |
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Overall Survival
Overall survival was measured as the time from the date of randomization to the date of death. Participant who were not reported to have died at the time of the analysis were censored using the date they were last known to be alive. (NCT00069108)
Timeframe: Up to 3 years
Intervention | days (Median) |
---|
XELOX | 363 |
FOLFOX-4 | 382 |
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Duration Of Response
Duration of response (DOR) is defined as the time when CR or PR was first met up to first date that PD or death is documented. CR is defined as disappearance of all TLs and non TLs, PR is defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions for the TLs or the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs. (NCT00069108)
Timeframe: Up to 3 years
Intervention | days (Median) |
---|
XELOX | 169 |
FOLFOX-4 | 190 |
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Progression Free Survival
Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0, wherein progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions (TLs), taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization (NCT00069108)
Timeframe: Up to 3 years
Intervention | days (Median) |
---|
XELOX | 154 |
FOLFOX-4 | 168 |
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Time To Response
Time to response (TOR) (best response of CR or PR) was measured as the time from randomization to the first date on which the measurement criteria for CR or PR (whichever status was recorded first) were met. CR for TLs was defined as disappearance of all TLs and for non-TLs as disappearance of all non-TLs and normalization of tumor marker level. PR was defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD. (NCT00069108)
Timeframe: Up to 3 years
Intervention | participants (Number) |
---|
| Week 1-6 | Week 7-12 | Week 13-18 | Week 19-24 |
---|
FOLFOX-4 | 11 | 23 | 18 | 3 |
,XELOX | 13 | 26 | 22 | 2 |
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Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment
Laboratory abnormalities were defined as those values that were outside the Roche defined reference range and showed a clinically relevant change from baseline. All laboratory parameters were categorized according to the National Cancer Center Common Toxicity Criteria (NCI-CTCAE) grading system. Incidence of Grade 1 to 4 laboratory abnormalities are presented in the table below. (NCT00069108)
Timeframe: Up to 3 years
Intervention | participants (Number) |
---|
| Serum Glutamic-Pyruvic Transaminase (SGPT) | Serum Glutamic Oxaloacetic Transaminase (SGOT) | Alkaline Phosphatase | Calcium (hyper) | Calcium (hypo ) | Glucose (hyper) | Glucose (hypo) | Granulocytes | Haemoglobin | Neutrophils | Neutrophils/Granulocytes | Platelets | Potassium (hyper) | Potassium (hypo) | Serum Albumin | Serum Creatinine | Sodium (hyper) | Sodium (hypo) | Total Bilirubin | White blood cell (WBC) |
---|
FOLFOX-4 | 110 | 174 | 201 | 9 | 70 | 207 | 9 | 6 | 240 | 199 | 202 | 212 | 26 | 92 | 138 | 32 | 21 | 73 | 95 | 205 |
,XELOX | 90 | 193 | 184 | 7 | 68 | 201 | 12 | 1 | 216 | 113 | 114 | 168 | 17 | 68 | 116 | 18 | 14 | 64 | 107 | 124 |
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Progression Free Survival Based on Independent Review Committee Assessment
Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. This PFS evaluation was based on Independent Review Committee Assessment. (NCT00069108)
Timeframe: Up to 3 years
Intervention | days (Median) |
---|
XELOX | 168 |
FOLFOX-4 | 162 |
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Relapse-Free Survival (RFS) [Number of Events]
A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. (NCT00069121)
Timeframe: Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).
Intervention | Participants (Count of Participants) |
---|
| Patients With Event | Patients Without Events |
---|
5-FU/LV | 356 | 586 |
,XELOX | 290 | 654 |
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Overall Survival [Number of Events]
Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. (NCT00069121)
Timeframe: Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
Intervention | Participants (Count of Participants) |
---|
| Patients With Event | Patients Without Events |
---|
5-FU/LV | 286 | 656 |
,XELOX | 242 | 702 |
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Number of Participants With at Least One Adverse Event by Most Severe Intensity
"The intensity of all adverse events (AEs) was categorized according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 3.0) grading system. If an AE had occurred which was not contained in the NCI-CTC, a four-point scale (mild, moderate, severe, life-threatening) was used. The terms severe and serious are not synonymous and are independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of an AE in one individual. See the AEs results table for details." (NCT00069121)
Timeframe: From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).
Intervention | Participants (Count of Participants) |
---|
| Mild AEs | Moderate AEs | Severe AEs | Life-Threatening |
---|
5-FU/LV MAYO CLINIC | 557 | 493 | 299 | 83 |
,5-FU/LV ROSWELL PARK | 256 | 217 | 146 | 21 |
,XELOX | 855 | 792 | 548 | 63 |
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Disease-Free Survival (DFS) [Time to Event]
Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. The median was estimated by the Kaplan-Meier method. The full range values include censored observations. (NCT00069121)
Timeframe: Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
Intervention | months (Median) |
---|
5-FU/LV | NA |
XELOX | 88.6 |
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Disease-Free Survival (DFS) [Number of Events]
Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. (NCT00069121)
Timeframe: Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
Intervention | Participants (Count of Participants) |
---|
| Patients with Event | Patients without Events |
---|
5-FU/LV | 379 | 563 |
,XELOX | 320 | 624 |
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Relapse-Free Survival (RFS) [Time to Event]
A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. The median was estimated by the Kaplan-Meier method. The full range values include censored observations. (NCT00069121)
Timeframe: Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).
Intervention | months (Median) |
---|
5-FU/LV | NA |
XELOX | 88.6 |
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Overall Survival [Time to Event]
Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. The median was estimated by the Kaplan-Meier method. The full range values include censored observations. (NCT00069121)
Timeframe: Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
Intervention | months (Median) |
---|
5-FU/LV | NA |
XELOX | NA |
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Duration of Overall Response
Duration of overall response was measured from the time that measurement criteria were first met for Complete Response or Partial Response until the first date that progressive disease or death was documented. (NCT00077857)
Timeframe: Until PD or death. Median duration of response was approximately 7 months.
Intervention | Months (Median) |
---|
1250 mg/m^2 Capecitabine + Docetaxel | 6.9 |
825 mg/m^2 Capecitabine + Docetaxel | 6.9 |
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Overall Survival
Overall Survival was measured as the time from the date of randomization to the date of death. (NCT00077857)
Timeframe: Throughout the study. Median observation time was approximately 16 months.
Intervention | Months (Median) |
---|
1250 mg/m^2 Capecitabine + Docetaxel | 16.4 |
825 mg/m^2 Capecitabine + Docetaxel | 15.1 |
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Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR is defined as the disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the nadir sum LD. (NCT00077857)
Timeframe: Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.
Intervention | Percentage of participants (Number) |
---|
1250 mg/m^2 Capecitabine + Docetaxel | 45.1 |
825 mg/m^2 Capecitabine + Docetaxel | 37.4 |
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Time to Progression of Disease or Death
Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause. (NCT00077857)
Timeframe: Event driven (after 350 events). Median observation time was approximately 16 months.
Intervention | Months (Median) |
---|
1250 mg/m^2 Capecitabine + Docetaxel | 7.9 |
825 mg/m^2 Capecitabine + Docetaxel | 5.8 |
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Time to Treatment Failure
"The time to treatment failure was the time from the date of randomization to the first occurrence of any of the following events:~adverse events~insufficient therapeutic response (disease progression)~death~failure to return~refusing treatment/being unwilling to cooperate~withdrawing consent." (NCT00077857)
Timeframe: Until premature withdrawal or end of primary study treatment (up to 16 cycles).
Intervention | Months (Median) |
---|
1250 mg/m^2 Capecitabine + Docetaxel | 5.1 |
825 mg/m^2 Capecitabine + Docetaxel | 4.6 |
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Number of Participants With Adverse Events and Serious Adverse Events
"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~Additional information about Adverse Events can be found in the Adverse Event Section." (NCT00077857)
Timeframe: First study drug intake until last study drug intake plus 28 days
Intervention | Participants (Number) |
---|
| Adverse Events | Serious Adverse Events |
---|
1250 mg/m^2 Capecitabine + Docetaxel | 206 | 41 |
,825 mg/m^2 Capecitabine + Docetaxel | 234 | 53 |
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Time to Overall Response
For patients with Best Overall Response being Complete Response (CR) or Partial Response (PR), time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR were met. The percentage of participants with overall response within the given time ranges in each of the categories: Weeks 1-6, 7-12, 13-18, 19-24, 25-30, 31-36, and 43-48 are reported. (NCT00077857)
Timeframe: Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.
Intervention | Percentage of participants (Number) |
---|
| Week 1-6 | Week 7-12 | Week 13-18 | Week 19-24 | Week 25-30 | Week 31-36 | Week 43-48 |
---|
1250 mg/m^2 Capecitabine + Docetaxel | 25 | 48 | 20 | 7 | 3 | 3 | 0 |
,825 mg/m^2 Capecitabine + Docetaxel | 30 | 30 | 17 | 7 | 1 | 2 | 1 |
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Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms. (NCT00080301)
Timeframe: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.
Intervention | units on a scale (Mean) |
---|
| Week 3 (n=282; n=273) | Week 6 (n=227; n=214) | Week 9 (n=194; n=184) | Week 12 (n=173; n=158) | Week 15 (n=148; n=145) | Week 18 (n=122; n=121) | Week 21 (n=116; n=101) | Week 24 (n=95; n=82) |
---|
Capecitabine | 0.3 | 1.1 | 1.8 | 1.4 | 1.7 | 1.7 | 1.1 | 2.3 |
,Ixabepilone + Capecitabine | -0.4 | -0.2 | -0.6 | -1.3 | -0.7 | -1.0 | -0.7 | -0.8 |
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Time to Response Per IRRC
Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response. (NCT00080301)
Timeframe: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Intervention | weeks (Median) |
---|
Ixabepilone + Capecitabine | 11.7 |
Capecitabine | 12.0 |
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Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)
PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method. (NCT00080301)
Timeframe: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Intervention | Months (Median) |
---|
Ixabepilone + Capecitabine | 5.85 |
Capecitabine | 4.17 |
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Overall Survival (OS)
OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method. (NCT00080301)
Timeframe: from date of randomization until death
Intervention | Months (Median) |
---|
Ixabepilone + Capecitabine | 12.9 |
Capecitabine | 11.1 |
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Overall Response Rate (ORR) Per IRRC
"Participants with best response of Complete or Partial according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions" (NCT00080301)
Timeframe: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Intervention | percent (Mean) |
---|
Ixabepilone + Capecitabine | 34.7 |
Capecitabine | 14.3 |
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Duration of Response Per IRRC
"Computed for all patients with a best response of Partial or Complete per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death." (NCT00080301)
Timeframe: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Intervention | months (Median) |
---|
Ixabepilone + Capecitabine | 6.4 |
Capecitabine | 5.6 |
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Pathologic Complete Response Rate
"A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study's surgical oncology co-chair for the determination of pCR.~Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%, providing 90% power with a two-sided 10% type I error rate. If both arms reject H0, then statistical selection theory would be used to choose the arm for further study in a phase III trial. If only one arm has acceptable pCR rate, then that arm would be pursued in a phase III trial." (NCT00081289)
Timeframe: After protocol surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation
Intervention | percentage of participants (Number) |
---|
Neoadjuvant Chemoradiation With Irinotecan | 10.4 |
Neoadjuvant Chemoradiation With Oxaliplatin | 20.8 |
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Second Primary Rate at 4 Years
Time to second primary is defined as time from randomization to date of the appearance of a second primary cancer, last known follow-up (censored), or death without second primary (competing risk). Second primary rates are estimated by the cumulative incidence method. (NCT00081289)
Timeframe: From randomization to four years
Intervention | percentage of participants (Number) |
---|
Neoadjuvant Chemoradiation With Irinotecan | 2 |
Neoadjuvant Chemoradiation With Oxaliplatin | 6 |
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Survival Rate at 4 Years
Survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. (NCT00081289)
Timeframe: From randomization to four years
Intervention | percentage of participants (Number) |
---|
Neoadjuvant Chemoradiation With Irinotecan | 85 |
Neoadjuvant Chemoradiation With Oxaliplatin | 75 |
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Change From Baseline in QLQ-C30 Global Health Status Score at Two Years
"Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 very poor to 7 excellent such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A negative number indicates improvement in symptoms." (NCT00081289)
Timeframe: Baseline and two years
Intervention | score on a scale (Mean) |
---|
Neoadjuvant Chemoradiation With Irinotecan | -6.8 |
Neoadjuvant Chemoradiation With Oxaliplatin | -1.3 |
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Disease-free Survival Rate at 4 Years
Disease-free survival time is defined as time from randomization to date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause/ Disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. (NCT00081289)
Timeframe: From randomization to four years
Intervention | percentage of participants (Number) |
---|
Neoadjuvant Chemoradiation With Irinotecan | 68 |
Neoadjuvant Chemoradiation With Oxaliplatin | 62 |
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Distant Failure Rate at 4 Years
Time to distant failure is defined as time from randomization to date of the appearance of distant metastases, last known follow-up (censored), or death without distant failure (competing risk). Distant failure rates are estimated by the cumulative incidence method. (NCT00081289)
Timeframe: From randomization to four years
Intervention | percentage of participants (Number) |
---|
Neoadjuvant Chemoradiation With Irinotecan | 24 |
Neoadjuvant Chemoradiation With Oxaliplatin | 30 |
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Local-regional Failure Rate at 4 Years
Local-regional failure is defined as any of the following: no clinical complete response (cCR) in the primary site and/or nodes at any time after treatment completion (persistence), recurrence and/or progression in the primary site and/or nodes after cCR, and nonprotocol surgery to the primary site after cCR. Time to local-regional failure is defined as time from randomization to date of failure, last known follow-up (censored), or death without local-regional failure (competing risk). Local-regional failure rates are estimated by the cumulative incidence method. (NCT00081289)
Timeframe: From randomization to four years
Intervention | percentage of participants (Number) |
---|
Neoadjuvant Chemoradiation With Irinotecan | 16 |
Neoadjuvant Chemoradiation With Oxaliplatin | 18 |
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Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Two Years
The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. (NCT00081289)
Timeframe: Baseline and two years
Intervention | score on a scale (Mean) |
---|
Neoadjuvant Chemoradiation With Irinotecan | 0.4 |
Neoadjuvant Chemoradiation With Oxaliplatin | 6.7 |
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Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Chemoradiation
The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. (NCT00081289)
Timeframe: Baseline and completion of chemoradiation approximately 6-8 weeks from randomization
Intervention | score on a scale (Mean) |
---|
Neoadjuvant Chemoradiation With Irinotecan | 5.9 |
Neoadjuvant Chemoradiation With Oxaliplatin | 20.3 |
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Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Two Years
"The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 not at all to 4 very much such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms." (NCT00081289)
Timeframe: Baseline and two years
Intervention | score on a scale (Mean) |
---|
Neoadjuvant Chemoradiation With Irinotecan | 0.4 |
Neoadjuvant Chemoradiation With Oxaliplatin | -1.6 |
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Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Post-operative Chemotherapy
"The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 not at all to 4 very much such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms." (NCT00081289)
Timeframe: Baseline and completion of post-operative chemotherapy, approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy
Intervention | score on a scale (Mean) |
---|
Neoadjuvant Chemoradiation With Irinotecan | -1.6 |
Neoadjuvant Chemoradiation With Oxaliplatin | 14.6 |
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Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Completion of Chemoradiation
"The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 not at all to 4 very much such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms." (NCT00081289)
Timeframe: Baseline and completion of chemoradiation, approximately 6-8 weeks from randomization
Intervention | score on a scale (Mean) |
---|
Neoadjuvant Chemoradiation With Irinotecan | 4.8 |
Neoadjuvant Chemoradiation With Oxaliplatin | 8.8 |
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Number of Participants With Grade 3+ Treatment-related Adverse Events Postoperatively
Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. (NCT00081289)
Timeframe: From post-surgery to before chemotherapy (CT), or within 60 days of surgery if no postoperative CT. Approximately 10-16 weeks to 14-22 weeks from randomization based on CT starting 4-6 weeks after surgery.
Intervention | Participants (Count of Participants) |
---|
| Hematologic | Non-Hematologic | Overall |
---|
Neoadjuvant Chemoradiation With Irinotecan | 1 | 9 | 9 |
,Neoadjuvant Chemoradiation With Oxaliplatin | 3 | 9 | 10 |
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Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Post-operative Chemotherapy
The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. (NCT00081289)
Timeframe: Baseline and completion of post-operative chemotherapy approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy
Intervention | score on a scale (Mean) |
---|
Neoadjuvant Chemoradiation With Irinotecan | -1.5 |
Neoadjuvant Chemoradiation With Oxaliplatin | 3.9 |
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Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Chemoradiation
"Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 very poor to 7 excellent such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A positive number indicates improvement in QOL." (NCT00081289)
Timeframe: Baseline and completion of chemoradiation, approximately 6-8 weeks from randomization
Intervention | score on a scale (Mean) |
---|
Neoadjuvant Chemoradiation With Irinotecan | -10.3 |
Neoadjuvant Chemoradiation With Oxaliplatin | -12.2 |
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Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Post-operative Chemotherapy
"Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 very poor to 7 excellent such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A positive number indicates improvement in QOL." (NCT00081289)
Timeframe: Baseline and completion of post-operative chemotherapy approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy
Intervention | score on a scale (Mean) |
---|
Neoadjuvant Chemoradiation With Irinotecan | -12.5 |
Neoadjuvant Chemoradiation With Oxaliplatin | -7.1 |
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Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms. (NCT00082433)
Timeframe: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment
Intervention | units on a scale (Mean) |
---|
| Week 3 (n=440; n=429) | Week 6 (n=379; n=353) | Week 9 (n=330; n=283) | Week 12 (n=283; n=250) | Week 15 (n=255; n=240) | Week 18 (n=205; n=202) | Week 21 (n=166; n=185) | Week 24 (n=149; n=141) |
---|
Capecitabine | 0.0 | 0.5 | 0.7 | 1.1 | 1.5 | 1.2 | 1.7 | 1.1 |
,Ixabepilone + Capecitabine | -0.5 | -0.9 | -1.5 | -1.4 | -1.9 | -1.3 | -1.4 | -1.4 |
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Time to Response
"Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for partial or complete (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure)." (NCT00082433)
Timeframe: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Intervention | weeks (Median) |
---|
Ixabepilone + Capecitabine | 6.6 |
Capecitabine | 6.6 |
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Response Rate (RR)
"RR=number of patients in that group whose best response is partial(30% decrease in the sum of the longest diameter of target lesions) or complete (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants" (NCT00082433)
Timeframe: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Intervention | percentage of participants (Mean) |
---|
Ixabepilone + Capecitabine | 43.3 |
Capecitabine | 28.8 |
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Progression-Free Survival (PFS)
PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment. (NCT00082433)
Timeframe: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Intervention | months (Median) |
---|
Ixabepilone + Capecitabine | 6.24 |
Capecitabine | 4.40 |
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Overall Survival (OS)
Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method. (NCT00082433)
Timeframe: from date of randomization until death
Intervention | months (Median) |
---|
Ixabepilone + Capecitabine | 16.39 |
Capecitabine | 15.64 |
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Duration of Response
"Measured from the time RECIST criteria (described in previous outcome measure) were first met for complete or partial response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method." (NCT00082433)
Timeframe: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Intervention | Months (Median) |
---|
Ixabepilone + Capecitabine | 6.1 |
Capecitabine | 6.3 |
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Overall Survival
Length of time patients survived after treatment (NCT00084617)
Timeframe: at 40 months from study activation
Intervention | months (Median) |
---|
Treatment (Oxaliplatin, Irinotecan, Capecitabine) | 8.98 |
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Complete Response (CR) and Partial Response (PR) Duration
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). (NCT00084617)
Timeframe: at 40 months from study activation
Intervention | months (Median) |
---|
Treatment (Oxaliplatin, Irinotecan, Capecitabine) | 5.95 |
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Progression-free Survival at 6 Months
Percentage of participants progression-free at 6 months. Progression-free survival (PFS) measured from date of registration to first observation of progressive disease (per RECIST criteria (V1.0)), death due to any cause, or symptomatic deterioration. Kaplan-Meier was used to estimate progression-free survival (PFS) at six months. (NCT00087152)
Timeframe: Six months
Intervention | percentage of participants (Number) |
---|
Imatinib Mesylate & Capecitabine | 16 |
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Confirmed Response Rate (Complete and Partial)
Number of participants with confirmed complete or partial response. Confirmed response (complete and partial) per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Complete Response (CR) is complete disappearance of all measurable and non-measurable disease; no new lesions; no disease related symptoms; and normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. PR is greater than or equal to 30% decrease under baseline of the sum of longest diameter of all target measurable lesions; no unequivocal progression of non-measurable disease and no new lesions. Confirmed response is two or more objective statuses a minimum of four weeks apart documented before progression or symptomatic deterioration. (NCT00087152)
Timeframe: 12 weeks
Intervention | participants (Number) |
---|
Imatinib Mesylate & Capecitabine | 2 |
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Overall Survival [Number of Events]
Number of patients who died/were alive. (NCT00089479)
Timeframe: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Intervention | participants (Number) |
---|
| Patients with event | Patients without events |
---|
AC Then T | 108 | 1196 |
,AC Then XT | 75 | 1232 |
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Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause. (NCT00089479)
Timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Intervention | participants (Number) |
---|
| Patients with event | Patients without events |
---|
AC Then T | 169 | 1135 |
,AC Then XT | 154 | 1153 |
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Disease Free Survival Including Any New Cancer as Event [Number of Events]
Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause. (NCT00089479)
Timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Intervention | participants (Number) |
---|
| Patients with event | Patients without events |
---|
AC Then T | 200 | 1104 |
,AC Then XT | 177 | 1130 |
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Breast Cancer Free Survival [Time to Event]
Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. (NCT00089479)
Timeframe: Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Intervention | months (Median) |
---|
AC Then T | NA |
AC Then XT | NA |
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Breast Cancer Free Survival [Number of Events]
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. (NCT00089479)
Timeframe: Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .
Intervention | participants (Number) |
---|
| Patients with event | Patients without events |
---|
AC Then T | 158 | 1146 |
,AC Then XT | 144 | 1163 |
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Disease Free Survival [Number of Events]
Number of patients with/without recurrence of breast cancer, or death due to any cause. (NCT00089479)
Timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Intervention | participants (Number) |
---|
| Patients with event | Patients without events |
---|
AC Then T | 164 | 1140 |
,AC Then XT | 140 | 1167 |
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Overall Survival [Time to Event]
Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive. (NCT00089479)
Timeframe: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Intervention | months (Median) |
---|
AC Then T | NA |
AC Then XT | NA |
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Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event
Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. (NCT00089479)
Timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Intervention | months (Median) |
---|
AC Then T | NA |
AC Then XT | NA |
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Disease Free Survival [Time to Event]
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. (NCT00089479)
Timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Intervention | months (Median) |
---|
AC Then T | NA |
AC Then XT | NA |
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Disease Free Survival Including Any New Cancer as Event [Time to Event]
Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. (NCT00089479)
Timeframe: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Intervention | months (Median) |
---|
AC Then T | NA |
AC Then XT | NA |
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Number of Participants With Complete Response at 2 Years
Response determined by computed tomography (CT)/magnetic resonance imaging (MRI), digital rectal examination, and proctoscopy, and a biopsy performed for clinical suspicion of residual or progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) where evaluation of target lesions Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. (NCT00093379)
Timeframe: 2 Years
Intervention | participants (Number) |
---|
Capecitabine + Oxaliplatin + XRT | 16 |
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Number of Participants With 2-year Colostomy-Free Survival
Colostomy-free survival reported as number of participants who did not develop local recurrence or require salvage resection with colostomy. (NCT00093379)
Timeframe: 2 Years with median study follow up of 19 months
Intervention | participants (Number) |
---|
Capecitabine + Oxaliplatin + XRT | 20 |
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2 Year Failure Free Survival
Treatment failure defined as: Biopsy proven residual disease identified 12 -14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence. (NCT00093379)
Timeframe: 2 years
Intervention | participants (Number) |
---|
Capecitabine + Oxaliplatin + XRT | 20 |
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Overall Survival as Assessed by Time
Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method. (NCT00093808)
Timeframe: Up to 5 years
Intervention | months (Median) |
---|
Capecitabine + Vinorelbine + Trastuzumab | 28.5 |
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Time to Progression (TTP)
Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for any evaluations, that patient will be censored for progression of disease at day one post-registration. Otherwise, for patients that do not progress, censoring will occur at the last follow up date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or unequivocal progression of existing non-target lesions. (NCT00093808)
Timeframe: Up to 5 years
Intervention | months (Median) |
---|
Capecitabine + Vinorelbine + Trastuzumab | 11.3 |
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Duration of Response as Measured by RECIST Criteria
Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. (NCT00093808)
Timeframe: Up to 5 years
Intervention | months (Median) |
---|
Capecitabine + Vinorelbine + Trastuzumab | 13.2 |
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Confirmed Response Rate
A confirmed tumor response is defined to be either a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and initiated study medication will be evaluable for response. The proportion of confirmed tumor responses will be estimated by the number of tumor regressions that meet the RECIST criteria for a confirmed CR or PR divided by the total number of evaluable patients. A 95% confidence interval for the true confirmed response rate will be calculated using the properties of the binomial distribution. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00093808)
Timeframe: Up to 5 years
Intervention | proportion of patients (Number) |
---|
Capecitabine + Vinorelbine + Trastuzumab | 0.67 |
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Percentage of Participants With Improved Quality of Life
Quality of Life was assessed using EORTC QLQ-PAN26. All measures range in score from 1 to 4 as lower scores indicate better outcomes. The improved Quality of Life is defined as a greater than 5% decrease in 2 consecutive scores compared with the baseline score. (NCT00100815)
Timeframe: assessed at baseline then weekly for 3 weeks
Intervention | percentage of participants (Number) |
---|
GEMCITABINE, CAPECITABINE and AVASTIN | 56.0 |
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Clinical Response
Response was evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Overall Response (OR) = CR + PR. (NCT00100815)
Timeframe: Pre-treatment and every 6 weeks from treatment.
Intervention | percentage of participants (Number) |
---|
GEMCITABINE, CAPECITABINE and AVASTIN | 22.0 |
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Overall Survival
(NCT00100815)
Timeframe: every 2-4 months for 1 year and then every 6 months for 5 years
Intervention | months (Median) |
---|
GEMCITABINE, CAPECITABINE and AVASTIN | 9.8 |
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Progression-free Survival
Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT00100815)
Timeframe: every 2-4 months for 1 year and then every 6 months for 5 years
Intervention | months (Median) |
---|
GEMCITABINE, CAPECITABINE and AVASTIN | 5.7 |
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Survival Time: Celecoxib and Placebo
Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. (NCT00101686)
Timeframe: assessed at least every week during treatment and at least every 3 months during follow-up
Intervention | months (Median) |
---|
Celecoxib | 21.06 |
Placebo | 18.83 |
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1 Year Survival: FOLFIRI, mIFL and CapeIRI
Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. (NCT00101686)
Timeframe: 1 year from date of randomization
Intervention | participants (Number) |
---|
| Alive at 1 year | Dead at 1 year | Censored |
---|
CapeIRI | 89 | 46 | 10 |
,FOLFIRI | 101 | 34 | 9 |
,mIFL | 86 | 47 | 8 |
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Time to Progression: Bevacizumab With FOLFIRI, mIFL
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD). (NCT00101686)
Timeframe: every 6 weeks until disease progression
Intervention | months (Median) |
---|
Bevacizumab + FOLFIRI | 11.17 |
Bevacizumab + mIFL | 8.31 |
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Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL
Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. Zero subjects analyzed indicates median could not be analyzed based on number of subjects who died. (NCT00101686)
Timeframe: Last Follow-Up Visit
Intervention | months (Median) |
---|
Bevacizumab + FOLFIRI | 27.99 |
Bevacizumab + mIRI | 19.22 |
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Overall Response: FOLFIRI, mIFL and CapeIRI
A subject will be considered achieving an overall response if the subject has a sustained Complete Response (CR) or Partial Response (PR) for at least 4 weeks, confirmed by tumor assessments. (CR: Disappearance of all target lesions. PR: greater than or equal to 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Pre-treatment sum LD. ) (NCT00101686)
Timeframe: every 6 weeks during chemotherapy until disease progression
Intervention | participants (Number) |
---|
FOLFIRI | 68 |
mIFL | 61 |
CapeIRI | 56 |
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Overall Response: Celecoxib and Placebo
A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. ) (NCT00101686)
Timeframe: every 6 weeks during chemotherapy until disease progression
Intervention | participants (Number) |
---|
Celecoxib | 84 |
Placebo | 101 |
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Overall Response: Bevacizumab With FOLFIRI, mIFL
A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. ) (NCT00101686)
Timeframe: every 6 weeks during chemotherapy until disease progression
Intervention | participants (Number) |
---|
Bevacizumab + FOLFIRI | 33 |
Bevacizumab + mIFL | 32 |
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Dose Reduction Due to Treatment Emergent Adverse Events
Number of subjects that had at least one Treatment-Emergent Adverse Event (TEAE) that led to a dose reduction. TEAE includes all reported Adverse Events that occurred within 30 days of last study medication. (NCT00101686)
Timeframe: Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI
Intervention | participants (Number) |
---|
FOLFIRI | 18 |
mIFL | 14 |
CapeIRI | 39 |
Bevacizumab + FOLFIRI | 6 |
Bevacizumab + mIRI | 8 |
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Time to Progression: FOLFIRI, mIFL and CapeIRI
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD). (NCT00101686)
Timeframe: every 6 weeks until disease progression
Intervention | months (Median) |
---|
FOLFIRI | 7.62 |
mIFL | 5.98 |
CapeIRI | 5.82 |
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Overall Relative Dose Intensity of Irinotecan
Relative dose intensity for a cycle was calculated as the percentage of the actual dose intensity of the cycle divided by the planned dose intensity of the cycle. Overall relative dose intensity was calculated as the average relative dose intensities over all cycles. (Dose intensity for each cycle was calculated as the actual dose level of the study medication received in that cycle divided by the number of weeks in the cycle.) (NCT00101686)
Timeframe: End of treatment cycle
Intervention | percent dose intensity (Mean) |
---|
FOLFIRI | 93.9 |
mIFL | 94.5 |
CapeIRI | 93.8 |
Bevacizumab + FOLFIRI | 93.3 |
Bevacizumab + mIRI | 95.5 |
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1 Year Survival: Bevacizumab With FOLFIRI, mIFL
Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. (NCT00101686)
Timeframe: 1 year from date of randomization
Intervention | participants (Number) |
---|
| Alive at 1 year | Dead at 1 year | Censored |
---|
Bevacizumab + FOLFIRI | 45 | 7 | 5 |
,Bevacizumab + mIRI | 33 | 22 | 5 |
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Survival Time: FOLFIRI, mIFL and CapeIRI
Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. (NCT00101686)
Timeframe: assessed at least every week during treatment and at least every 3 months during follow-up
Intervention | months (Median) |
---|
FOLFIRI | 23.06 |
mIFL | 17.64 |
CapeIRI | 18.92 |
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Time to Progression : Celecoxib and Placebo
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD). (NCT00101686)
Timeframe: every 6 weeks until disease progression
Intervention | months (Median) |
---|
Celecoxib | 6.64 |
Placebo | 6.70 |
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Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD). (NCT00101686)
Timeframe: every 6 weeks until disease progression
Intervention | months (Median) |
---|
FOLFIRI | 8.18 |
mIFL | 6.01 |
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Progression-free Survival and Overall Survival
"Progression-Free Survival: From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.~Overall Survival: From date of registration to date of death due to any cause. Patients last known to be alive are censored at last date of contact.~Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression." (NCT00107276)
Timeframe: two years
Intervention | months (Median) |
---|
| PFS | OS |
---|
Cyclophosphamide and Capecitabine | 5.9 | 18.8 |
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Response Rate (Complete and Partial, Confirmed and Unconfirmed)
Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. (NCT00107276)
Timeframe: Patients assessed at least every six weeks while on protocol treatment
Intervention | participants (Number) |
---|
Cyclophosphamide and Capecitabine | 29 |
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Toxicity
Number of patients for whom Grade 3 or higher toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT00107276)
Timeframe: Patients assessed after each 21-day cycle for 8 cycles (24 weeks of treatment)
Intervention | Participants (Number) |
---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Alkaline phosphatase | Dehydration | Diarrhea | Dyspnea (shortness of breath) | Fatigue (asthenia, lethargy, malaise) | Febrile neutropenia | Hemoglobin | Leukocytes (total WBC) | Lymphopenia | Mood alteration - depression | Nausea | Neuroendocrine: ADH secretion abnormality | Neutrophils/granulocytes (ANC/AGC) | Platelets | Potassium, serum-low (hypokalemia) | Pruritus/itching | Rash/desquamation | Rash: hand-foot skin reaction | Sodium, serum-low (hyponatremia) | Thrombosis/thrombus/embolism | Weight loss |
---|
Cyclophosphamide and Capecitabine | 1 | 1 | 2 | 2 | 1 | 2 | 1 | 1 | 15 | 13 | 1 | 1 | 1 | 7 | 1 | 1 | 1 | 1 | 7 | 1 | 2 | 1 |
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Overall Survival in Stage III Cancer Patients - Time to Event
Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive. (NCT00112918)
Timeframe: From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).
Intervention | months (Median) |
---|
FOLFOX4 | NA |
FOLFOX4 + Bv | NA |
XELOX+Bv | NA |
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Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis
An overall survival event was death due to any cause. (NCT00112918)
Timeframe: From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).
Intervention | participants (Number) |
---|
| Patients with events | Patients without events |
---|
FOLFOX4 | 161 | 794 |
,FOLFOX4 + Bv | 202 | 758 |
,XELOX+Bv | 182 | 770 |
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Overall Survival in Stage III Cancer Patients - Number of Events
An overall survival event was death due to any cause. (NCT00112918)
Timeframe: From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).
Intervention | participants (Number) |
---|
| Patients with events | Patients without events |
---|
FOLFOX4 | 115 | 840 |
,FOLFOX4 + Bv | 151 | 809 |
,XELOX+Bv | 145 | 807 |
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Disease-free Survival in Stage III Cancer Patients - Number of Events
A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer. (NCT00112918)
Timeframe: From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).
Intervention | participants (Number) |
---|
| Patients with a DFS event | Recurrence | New Occurrence | Death | Patients without events |
---|
FOLFOX4 | 237 | 219 | 3 | 17 | 718 |
,FOLFOX4 + Bv | 280 | 253 | 8 | 21 | 680 |
,XELOX+Bv | 253 | 223 | 6 | 25 | 699 |
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Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis
Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive. (NCT00112918)
Timeframe: From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).
Intervention | months (Median) |
---|
FOLFOX4 | NA |
FOLFOX4 + Bv | NA |
XELOX+Bv | NA |
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Disease-free Survival in Stage III Cancer Patients - Time to Event
Disease-free survival (DFS) was defined as the time from the date of randomization to the time of a recurrence, a new occurrence of colorectal cancer or death due to any cause, whichever occurred first. Patients without an event were censored at the last date the patient was known to be disease-free. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Patients with no tumor assessments after baseline but still alive at the time of the clinical cut-off were censored at day 1. (NCT00112918)
Timeframe: From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).
Intervention | months (Median) |
---|
FOLFOX4 | NA |
FOLFOX4 + Bv | NA |
XELOX+Bv | NA |
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Pathologic Local Tumor Response
At follow-up evaluation after completion of neoadjuvant and surgical therapy, resected primary tumor classified based on routine pathology staining in the following manner: Pathologic Complete Response (no evidence of residual cancer); Microscopic Residual (no grossly detected disease, but evidence of microscopic residual disease); and Gross Residual Disease. (NCT00113230)
Timeframe: Baseline to approximately 5 Months (Following 28 days of treatment, chemotherapy and surgical resection of tumor)
Intervention | Participants (Number) |
---|
| Pathological Complete Response | Microscopic Residual (<10% viable tumor cells) | Gross Residual Disease |
---|
Avastin | 8 | 6 | 11 |
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Morbidity and Mortality Rate
Morbidity and mortality after neoadjuvant cheoradiotherapy and local excision. (NCT00114231)
Timeframe: Up to 30 days
Intervention | percentage of patients (Number) |
---|
| Mortality | Morbidity |
---|
Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery) | 6 | 10 |
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Rate of Pathologic Complete Response of the Primary Tumor
The rate (percentage) of patients with pathologic complete response (pCR) is reported below. Pathologic response will be determined by comparing tumor width and stage in the surgical specimen with the same parameters as determined by pre-CRT ERUS: PATHOLOGIC COMPLETE RESPONSE (pCR): no residual tumor. (NCT00114231)
Timeframe: Up to 5 years
Intervention | percentage of patients (Number) |
---|
Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery) | 44 |
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R0 Resection Rate (Negative Margin Rate)
The rate (percentage) of patients with negative resection margins after undergoing local excision is reported below. (NCT00114231)
Timeframe: At time of surgery
Intervention | percentage of patients (Number) |
---|
Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery) | 98.7 |
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3-Year Disease-free Survival
The primary endpoint was 3-year disease-free survival (DFS). Evidence of local recurrence, distant metastasis, or death from any cause within 3 years counted as events in the time-to-event Kaplan-Meier analysis of disease-free survival. (NCT00114231)
Timeframe: Up to 3 years
Intervention | percentage of patients (Number) |
---|
Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery) | 88.2 |
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Local Recurrence Rate
The local recurrence rate (percentage) is defined as the percentage of patients who had local recurrence as initial sites of failure at the end of follow-up. (NCT00114231)
Timeframe: Up to 5 years
Intervention | percentage of patients (Number) |
---|
Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery) | 4 |
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Duration of Overall Clinical Response (CR or PR)
Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause. (NCT00118755)
Timeframe: Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days
Intervention | Days to event (Median) |
---|
XELOX Q3W + Bevacizumab | 281 |
XELOX Q2W + Bevacizumab | 316 |
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Overall Survival
Overall survival was defined as the time from the date of randomization to the date of death, for any cause. (NCT00118755)
Timeframe: Time to death (through follow-up phase): Approximate Median of 718 days
Intervention | Days (Median) |
---|
XELOX Q3W + Bevacizumab | 852 |
XELOX Q2W + Bevacizumab | 662 |
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Progression-free Survival (PFS)
Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST). (NCT00118755)
Timeframe: Time to disease progression or death (through follow-up phase)
Intervention | Days (Median) |
---|
XELOX Q3W + Bevacizumab | 287 |
XELOX Q2W + Bevacizumab | 273 |
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Best Overall Clinical Response
"Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient's overall best response was complete response (CR), partial response (PR) (CR and PR considered responders), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met." (NCT00118755)
Timeframe: Through follow-up phase: Approximate Median of 318 days
Intervention | Patients (Number) |
---|
| Nonresponders (without CR or PR) | Responders (with CR or PR) | Complete Response (CR) | Partial Response (PR) |
---|
XELOX Q2W + Bevacizumab | 167 | 51 | 3 | 48 |
,XELOX Q3W + Bevacizumab | 145 | 72 | 2 | 70 |
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The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts
(NCT00121134)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Group A- Bevacizumab Alone | 60 |
Group B-Bevacizumab+Cyclophosphamide+Methotrexate | 58 |
Group C-Bevacizumab + Capcitabine(18 Wks) | 49 |
Group D-bevacizumab + Capecitibine (24wks) | 76 |
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Number of Participants Who Survived (Overall Survival)
Overall survival (OS) is defined as the time from start of treatment to death from any cause. (NCT00121251)
Timeframe: Up to 9 years
Intervention | Participants (Count of Participants) |
---|
Sorafenib + Gemcitabine + Capecitabine | 6 |
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Objective Response for BAY 43-9006 in Combination With Gemcitabine and Capecitabine Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR (NCT00121251)
Timeframe: Up to 9 years
Intervention | Participants (Count of Participants) |
---|
Sorafenib + Gemcitabine + Capecitabine | 5 |
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Number of Subjects With Adverse Events
"The secondary outcome measure was to evaluate the safety profile, including a summary of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.~Intensity of AEs were graded according to NCI CTCAE version 3.0 on a 5-point scale: Grade 1=Mild Discomfort, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life Threatening/Disabling and Grade 5=Death. An SAE was defined as any experience that suggested a significant hazard,contraindication, side effect, or precaution." (NCT00121836)
Timeframe: Throughout study
Intervention | Participants (Number) |
---|
| At least 1 adverse event (AE) | At least 1 treatment-related AE | At least 1 Grade 3 or 4 AE | At least 1 serious adverse event (SAE) | At least 1 AE causing withdrawal |
---|
Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev | 108 | 104 | 82 | 39 | 37 |
,First Study Treatment Phase Only | 54 | 51 | 41 | 22 | 25 |
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Number of Participants With Marked Laboratory Abnormalities
The secondary outcome measure was to evaluate the safety profile, including a summary of marked laboratory abnormalities in >= 5% of patients. n=number of participants with the laboratory measure,Number=number of participants with the abnormality. Laboratory values were flagged as Low(L) or High(H) if they were below the lower limit or above the upper limit of Roche standard reference range, respectively. Marked laboratory abnormalities (flagged as HH and LL) were defined as those values that were outside the Roche marked reference range and showed a clinically relevant change from baseline. (NCT00121836)
Timeframe: until progressive disease or for up to 3 years
Intervention | Participants (Number) |
---|
| Hematocrit (fraction) (n=104); Abnormality: Low | Hemoglobin (g/L) (n=104); Abnormality: Low | Platelets (10^9/L) (n=104); Abnormality: Low | Red blood cells (10¹²/L) (n=104); Abnormality: Low | White blood cells (10^9/L)(n=104); Abnormality:Low | Neutrophils (10^9/L) (n=92); Abnormality: High | Neutrophils (10^9/L) (n=92); Abnormality: Low | Prothrombin time (ratio) (n=36); Abnormality: High | Aspartate transaminase(U/L)(n=104)Abnormality:High | Alanine transaminase(U/L)(n=104);Abnormality: High | Alkaline phosphatase(U/L)(n=104);Abnormality: High | Direct bilirubin (umol/L) (n=78);Abnormality: High | Albumin (g/L) (n=104); Abnormality: Low | Total protein (g/L) (n=104); Abnormality: Low | Chloride (mmol/L) (n=104); Abnormality: Low | Calcium (mmol/L) (n=104); Abnormality: Low | Uric acid (umol/L) (n=94); Abnormality: High |
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Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev | 16 | 18 | 9 | 15 | 23 | 14 | 25 | 3 | 19 | 10 | 11 | 4 | 13 | 8 | 5 | 10 | 5 |
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Overall Survival
Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death (NCT00121836)
Timeframe: approximately 505 days (Median Time to Death)
Intervention | Days (Median) |
---|
Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev | 505 |
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Premature Withdrawal From Study Due to Adverse Events
The secondary outcome measure was to evaluate the safety profile, including a summary of premature withdrawals due to adverse events occurring in more than 1 patient in either study group, by system organ class. (NCT00121836)
Timeframe: Throughout study
Intervention | Participants (Number) |
---|
| All system organ classes | General disorders, administration site conditions | Musculoskeletal and connective tissue disorders | Respiratory, thoracic and mediastinal disorders | Renal and urinary disorders |
---|
Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev | 25 | 4 | 2 | 2 | 2 |
,First Study Treatment Phase Only | 37 | 7 | 6 | 5 | 2 |
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Number of Participants With Serious Adverse Events (SAEs)
Review of Serious Adverse Events (SAEs) To assess the toxicity associated with Arms A and B. Response rates and toxicity rates for each arm were to be estimated and exact (using Casella's method) 95% confidence intervals for those proportions computed. With the anticipated 75 patients in each arm, these estimated proportions would have standard errors not exceeding 7%. (NCT00127036)
Timeframe: 30 Days After End of Treatment - Average of 6 Months
Intervention | participants (Number) |
---|
XELOX + Bevacizumab | 9 |
XELIRI + Bevacizumab | 11 |
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Participants With Disease-Free Survival
Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free. (NCT00127933)
Timeframe: 30 - 1102 days
Intervention | participants (Number) |
---|
HER2-Neu Negative | 92 |
HER2-Neu Positive | 25 |
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Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery
Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate. (NCT00127933)
Timeframe: at the time of definitive surgery; after four 3-week cycles (3-4 months)
Intervention | percentage of participants (Number) |
---|
HER2-Neu Negative | 15.8 |
HER2-Neu Positive | 50.0 |
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Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery
Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. (NCT00127933)
Timeframe: at the time of definitive surgery; after four 3-week cycles (3-4 months)
Intervention | percentage of participants (Number) |
---|
HER2-Neu Negative | 9.9 |
HER2-Neu Positive | 35.7 |
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Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))
The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders. (NCT00127933)
Timeframe: post 2 and 4, 3-week cycles of treatment
Intervention | percentage of participants (Number) |
---|
HER2-Neu Negative | 23.8 |
HER2-Neu Positive | 23.5 |
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Percentage of Participants With Local Recurrence
Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment. (NCT00127933)
Timeframe: 30 - 1102 days
Intervention | percentage of participants (Number) |
---|
HER2-Neu Negative | 3.1 |
HER2-Neu Positive | 3.7 |
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Participants With Overall Survival
Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment. (NCT00127933)
Timeframe: 22 - 1191 days
Intervention | participants (Number) |
---|
HER2-Neu Negative | 118 |
HER2-Neu Positive | 32 |
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Quality of Life Questionnaire: Time to Taking Off the Wig
"Time to taking off the wig was assessed by a specific Hair Toxicity Questionnaire were patients answered when they stop to use the wig.~The questionnaire was evaluated up to two years after the end of chemotherapy." (NCT00129935)
Timeframe: Up to 30 months
Intervention | Months (Median) |
---|
Arm A: EC-T | 8.35 |
Arm B: ET-X | 6.03 |
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Number of Participants With Overall Survival (OS) Event
A participant was considered to have had a OS event if patient died from any cause. (NCT00129935)
Timeframe: Up to 5 years
Intervention | Participants (Count of Participants) |
---|
Arm A: EC-T | 70 |
Arm B: ET-X | 83 |
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The Number of Participants Who Experienced Adverse Events (AE)
Safety was assessed by standard clinical and laboratory tests, and were evaluated using NCI-CTC criteria v2.0 (NCT00129935)
Timeframe: 5 years
Intervention | Participants (Count of Participants) |
---|
Arm A: EC-T | 665 |
Arm B: ET-X | 699 |
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Number of Participants With Disease-free Survival (DFS) Event
A participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason. (NCT00129935)
Timeframe: 5 years
Intervention | Participants (Count of Participants) |
---|
Arm A: EC-T | 127 |
Arm B: ET-X | 170 |
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Disease Free Survival (DFS) Events
DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first. (NCT00130533)
Timeframe: 5 years
Intervention | Participants (Count of Participants) |
---|
Xeloda (Capecitabine) | 105 |
Observation | 120 |
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The Number of Participants Who Experienced Adverse Events (AE)
Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events). (NCT00130533)
Timeframe: 5 years
Intervention | Participants (Count of Participants) |
---|
Xeloda (Capecitabine) | 416 |
Observation | 271 |
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Overall Survival (OS) Event
OS event is defined as the death from any cause. (NCT00130533)
Timeframe: 5 years
Intervention | Participants (Count of Participants) |
---|
Xeloda (Capecitabine) | 71 |
Observation | 73 |
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Frequency of Grade III/IV Toxicities Experienced by Participants
The frequency of grade 3 and grade 4 adverse events experienced by all treated participants. (NCT00148122)
Timeframe: 30 days post treatment
Intervention | participants (Number) |
---|
| Grade 3 and 4 Lymphopenia | Grade 3 and 4 Infection w/o Neutropenia | Grade 3 and 4 Fatigue | Grade 3 and 4 Leukocytes | Grade 3 and 4 Stomatitis | Grade 3 and 4 Neutrophils | Grade 3 and 4 Diarrhea | Grade 3 and 4 Hand-Foot Skin Reaction | Grade 3 and 4 Hemoglobin | Grade 3 and 4 Platelets | Grade 3 and 4 Allergic Reaction | Grade 3 and 4 Anorexia | Grade 3 and 4 Cardiac-Ischemia | Grade 3 and 4 Dysphagia | Grade 3 and 4 Dyspnea | Grade 3 and 4 Abnormal ENT Examination | Grade 3 and 4 Edema Limbs | Grade 3 and 4 Febrile Neutropenia | Grade 3 and 4 Hand-Foot Syndrome | Grade 3 and 4 Hyperglycemia | Grade 3 and 4 Hyponatremia | Grade 3 and 4 Infection with Unknown ANC | Grade 3 and 4 Infection, Lung | Grade 3 and 4 Melena | Grade 3 and 4 Mental Status Changes | Grade 3 and 4 Mucositis | Grade 3 and 4 Nausea | Grade 3 and 4 Oral Pain | Grade 3 and 4 Pain, Extremity | Grade 3 and 4 Pharyngolaryngeal Pain | Grade 3 and 4 AST Elevation | Grade 3 and 4 Vomiting |
---|
Arm 1 | 8 | 5 | 4 | 4 | 4 | 3 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
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Probability of Progression Free Survival
The estimated 1 year progression free survival. Progression was defined, using RECIST (Response Evaluation Criteria In Solid Tumors Criteria), as a 20% increase in the sum of the longest diameter of target lesions, the development of any new lesion, or the significant clinical deterioration related to the progression of patient's disease. The probability of progression-free survival was presented in a Kaplan-Meier curve to illustrate the distribution of progression time. The median time to progression was determined with a 95% CI (Confidence Interval). (NCT00148122)
Timeframe: 1 year post treatment
Intervention | percentage of patients (Number) |
---|
Arm 1 | 25 |
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Overall Response Rate at 4 Months
Disease was assessed by radiologic imaging and RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine response: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00148122)
Timeframe: 4 months
Intervention | percentage of participants (Number) |
---|
Arm 1 | 16 |
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Number of Participants With Grade 3 or Higher Toxicity
Summary of grade 3 (per CTCAE v3.0) or higher toxicities which generally is described as a severe adverse reaction or symptom. (NCT00159432)
Timeframe: Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months.
Intervention | Participants (Number) |
---|
Oxaliplatin Followed by Bevacizumab, With Capecitabine | 51 |
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Overall Survival
The time interval between the date on which a patient first received protocol treatment and the documented date of death. (NCT00177255)
Timeframe: 2 years
Intervention | Months (Median) |
---|
Docetaxel + Capecitabine | 10.7 |
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Overall Response Rate
The number of responders (complete responders + partial responders) divided by the number of evaluable patients. (NCT00177255)
Timeframe: Every 2 cycles (6 weeks)
Intervention | percentage of participants (Number) |
---|
Docetaxel + Capecitabine | 28.2 |
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1-, 2-, and 3-year Overall Survival
Probability of being alive at 1-, 2-, and 3-years from start of protocol therapy (NCT00177307)
Timeframe: Up to 40 months
Intervention | percent chance (Number) |
---|
| 1 year-overall survival | 2 year-overall survival | 3 year-overall survival |
---|
Oxaliplatin, Capecitabine, and Bevacizumab | 62 | 36 | 24 |
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Response Rate (RR)
Percentage of partial responses (PR) + complete responses (CR). (NCT00177307)
Timeframe: Up to 27 months
Intervention | percentage of participants (Number) |
---|
Oxaliplatin, Capecitabine, and Bevacizumab | 38 |
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Progression Free Survival (PFS)
time from start of protocol therapy until objective tumor progression or death (NCT00177307)
Timeframe: Up to 27 Months
Intervention | Months (Median) |
---|
Oxaliplatin, Capecitabine, and Bevacizumab | 8.6 |
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Overall Survival
time from start of protocol therapy until death from any cause (NCT00177307)
Timeframe: Up to 40 months
Intervention | Months (Median) |
---|
Oxaliplatin, Capecitabine, and Bevacizumab | 17.2 |
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Best Overall Response (Crossover Treatment)
Best overall response was the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response assessed using RECIST criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria. (NCT00191152)
Timeframe: Best response from start of treatment until disease progression/recurrence (up to 82 months)
Intervention | participants (Number) |
---|
| Complete Response (confirmed) | Partial Response (confirmed) | Stable Disease | Progressive Disease | Unknown |
---|
Capecitabine | 1 | 10 | 19 | 34 | 13 |
,Gemcitabine | 1 | 6 | 20 | 36 | 18 |
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Time to Disease Progression (Crossover Treatment)
For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression. (NCT00191152)
Timeframe: Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)
Intervention | months (Median) |
---|
Capecitabine | 4.51 |
Gemcitabine | 2.34 |
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Progression-Free Survival (Initial Treatment)
For initial treatment, progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. Time to PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for progression; or 3) first dose date of crossover treatment. (NCT00191152)
Timeframe: Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)
Intervention | months (Median) |
---|
Gemcitabine Plus Docetaxel | 9.01 |
Docetaxel Plus Capecitabine | 8.88 |
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Time to Disease Progression (Initial Treatment)
Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment. (NCT00191152)
Timeframe: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)
Intervention | months (Median) |
---|
Gemcitabine Plus Docetaxel | 9.28 |
Docetaxel Plus Capecitabine | 8.88 |
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Progression-Free Survival (Crossover Treatment)
For crossover treatment, progression-free survival (PFS) was defined as the number of months between first dose date of crossover treatment and date of documented disease progression or date of death due to any cause, whichever came first. PFS for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for participants with documented disease progression. (NCT00191152)
Timeframe: First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)
Intervention | months (Median) |
---|
Capecitabine | 4.51 |
Gemcitabine | 2.34 |
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Overall Survival
Overall survival time was defined as the number of months between the date of randomization and the date of death due to any cause. The overall survival time was censored at the date of last contact for participants who were still alive. (NCT00191152)
Timeframe: Date of randomization to date of death from any cause (up to 82 months)
Intervention | months (Median) |
---|
Gemcitabine Plus Docetaxel | 22.99 |
Docetaxel Plus Capecitabine | 23.29 |
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Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)
RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL]. (NCT00191152)
Timeframe: First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline |
---|
Capecitabine | 75.00 | -2.78 |
,Gemcitabine | 76.39 | -0.69 |
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Duration of Response (Crossover Treatment)
At crossover treatment, duration of response was measured from the time criteria were met for complete response (CR) or partial response (PR), until first date that recurrent or progressive disease was objectively documented or date of death due to any cause, whichever came first. This definition only applied to those who crossed over & achieved CR or PR in crossover treatment. Duration of response censored at earliest of: 1) date of last contact for those alive without disease progression; or 2) start date of other anti-tumor therapy for documented disease progression. (NCT00191152)
Timeframe: Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)
Intervention | months (Median) |
---|
Capecitabine | 25.89 |
Gemcitabine | 42.50 |
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Duration of Response (Initial Treatment)
Among tumor responders, duration of tumor response was measured from the date of response (complete response [CR] or partial response [PR] until the first date of documented progression or death from any cause. Duration of response was censored at the earliest of: 1) date of last contact for participants alive without disease progression (DP); or 2) start date of other anti-tumor therapy for DP; or 3) dose date of crossover treatment. (NCT00191152)
Timeframe: Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)
Intervention | months (Median) |
---|
Gemcitabine Plus Docetaxel | 9.11 |
Docetaxel Plus Capecitabine | 10.39 |
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Best Overall Response (Initial Treatment)
Best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria. (NCT00191152)
Timeframe: Best response from start of treatment until disease progression/recurrence (up to 82 months)
Intervention | participants (Number) |
---|
| Complete Response (confirmed) | Partial Response (confirmed) | Stable Disease | Progressive Disease | Unknown |
---|
Docetaxel Plus Capecitabine | 6 | 79 | 90 | 27 | 34 |
,Gemcitabine Plus Docetaxel | 6 | 71 | 96 | 32 | 34 |
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Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)
RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL]. (NCT00191152)
Timeframe: Baseline until crossover treatment began (up to 82 months)
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline |
---|
Docetaxel Plus Capecitabine | 72.32 | -2.68 |
,Gemcitabine Plus Docetaxel | 68.09 | 2.42 |
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Overall Survival (OS)
Length of time, in months, that patients were alive from their first date of protocol treatment until death. (NCT00193128)
Timeframe: 36 months
Intervention | months (Median) |
---|
Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2) | 24.1 |
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Disease-Free Survival (DFS)
Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause. (NCT00193128)
Timeframe: 18 months
Intervention | months (Median) |
---|
Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2) | 16.3 |
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Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery
The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response (NCT00193128)
Timeframe: 18 months
Intervention | Participants (Count of Participants) |
---|
Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2) | 24 |
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Overall Survival
Length of time, in months, that patients were alive from their first date of protocol treatment until death. (NCT00193609)
Timeframe: 18 months
Intervention | months (Median) |
---|
Intervention | 9.7 |
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Progression Free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00193609)
Timeframe: 18 months
Intervention | months (Median) |
---|
Intervention | 3.7 |
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Time to Progression
Median time to progression free survival. (NCT00194779)
Timeframe: Up to 5 years
Intervention | months (Median) |
---|
Treatment (Neoadjuvant Therapy, Adjuvant Therapy) | NA |
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Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR)
"Microscopic pCR: No evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection. mCR: The examining pathologist cannot identify gross residual tumor mass in the surgical specimen. This differs from a pCR where the specimen must also be negative for invasive tumor by microscopy. For this study, we are using a definition of mCR that will make the trial more translatable to other institutions. For this study, mCR will be defined as no focus of invasive cancer >= 1 cm.~Count of participants with either a pCR or mCR." (NCT00194779)
Timeframe: Up to 16 weeks
Intervention | Participants (Count of Participants) |
---|
Treatment (Neoadjuvant Therapy, Adjuvant Therapy) | 29 |
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Relapse Rate in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed by Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy
Count of patients that relapsed. (NCT00194779)
Timeframe: Up to 8 years
Intervention | Participants (Count of Participants) |
---|
Treatment (Neoadjuvant Therapy, Adjuvant Therapy) | 7 |
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Disease-free Survival
Kaplan-Meier estimate of disease-free survival, assessed at 1, 2, and 5 years. (NCT00194779)
Timeframe: 1, 2, and 5 years
Intervention | disease-free survival probability (Number) |
---|
| 1 year | 2 years | 5 years |
---|
Treatment (Neoadjuvant Therapy, Adjuvant Therapy) | .97 | .90 | .84 |
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OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN
Kaplan-Meier estimate of overall survival, assessed at 1, 2, and 5 years. (NCT00194779)
Timeframe: 1, 2, and 5 years
Intervention | survival probability (Number) |
---|
| 1 year | 2 years | 5 years |
---|
Treatment (Neoadjuvant Therapy, Adjuvant Therapy) | 1 | .94 | .90 |
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Number and Percent of Patients Reporting Grade 2, 3, 4, or Fatal Toxicities of These Regimens, Need for Dose Reduction, or Treatment Interruption or Discontinuation
(NCT00194779)
Timeframe: From the initiation of study treatments to 30 days after the end of neoadjuvant treatment or adjuvant treatment if received
Intervention | Participants (Count of Participants) |
---|
Treatment (Neoadjuvant Therapy, Adjuvant Therapy) | 32 |
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Overall Survival
From the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive. Kaplan-Meier estimate assessed at 5 years. (NCT00194792)
Timeframe: Up to 5 years
Intervention | survival probability (Number) |
---|
Treatment (Hormone Therapy and Chemotherapy) | 0.88 |
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Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities
Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities (NCT00194792)
Timeframe: Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)
Intervention | events (Number) |
---|
| Grade 2 | Grade 3 | Grade 4 | Fatal toxicity |
---|
Treatment (Hormone Therapy and Chemotherapy) | 80 | 12 | 0 | 0 |
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Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response
Defined as no evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection and the examining pathologist cannot identify gross residual tumor mass in the surgical specimen. (NCT00194792)
Timeframe: From date of treatment start to surgery
Intervention | Participants (Count of Participants) |
---|
Treatment (Hormone Therapy and Chemotherapy) | 0 |
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Number of Participants With Clinical Response
Defined as a > 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease. (NCT00194792)
Timeframe: 1 month
Intervention | Participants (Count of Participants) |
---|
Treatment (Hormone Therapy and Chemotherapy) | 19 |
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Disease-free Survival
Kaplan-Meier estimate assessed at 5 years (NCT00194792)
Timeframe: Up to 5 years
Intervention | disease free survival probability (Number) |
---|
Treatment (Hormone Therapy and Chemotherapy) | 0.76 |
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Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation
Count of patients with dose reduction, treatment interruption, or treatment discontinuation. (NCT00194792)
Timeframe: During adjuvant and neoadjuvant chemotherapy
Intervention | Participants (Count of Participants) |
---|
| Adjuvant therapy | Neoadjuvant therapy |
---|
Treatment (Hormone Therapy and Chemotherapy) | 1 | 11 |
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Objective Response Rate (ORR) for the Phase II Portion of the Study. CR+PR Per RECIST v1.0 Criteria Using a Single Arm , Two Stage Minimax Design.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00201734)
Timeframe: Every 3 weeks, for up to 24 weeks
Intervention | percent of patients (Number) |
---|
Phase I | 21 |
Phase II | 32 |
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One Year Survival for Patients
For patients enrolled on the Phase II portion of the trial the One-year survival was measured as the percentage of patients alive 1 year after their treatment in the trial. (NCT00201734)
Timeframe: Up to 1 year
Intervention | percent of patients (Number) |
---|
Phase II | 44 |
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Progression-Free Survival at 6 Months for Patients
For patients enrolled on the Phase II portion of the trial Progression Free Survival (PFS) was measured from the percentage of patients that were still alive, without evidence of disease progression for 6 months following the initiation of treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00201734)
Timeframe: up to 6 years
Intervention | percent of patients (Number) |
---|
Phase II | 38 |
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Phase I: To Determine Side Effects
The common clinically significant grade 3 and 4 toxicities graded using the National Cancer Institutes Common Toxicity Criteria version 3.0 (NCT00201734)
Timeframe: Every 3 weeks, for up to 24 weeks
Intervention | percent of patients (Number) |
---|
| Neutropenia | Thrombocytopenia | Fatigue |
---|
Phase I | 86 | 72 | 76 |
,Phase II | 72 | 72 | 84 |
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Maximum Tolerated Dose in Phase I Portion of Study
Determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks carboplatin. (NCT00201734)
Timeframe: Every 3 weeks, for up to 24 weeks
Intervention | mg/m2 (Number) |
---|
Phase I Patients | 750 |
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Time to Tumor Progression for Patients
For patients enrolled on the Phase II portion of the trial the time to progression was measured as the time from when the patient started treatment to the time the patient is first recorded as having disease progression or the date of death if the patient dies due to causes other than disease progression. (NCT00201734)
Timeframe: Up to 6 years
Intervention | months (Median) |
---|
Phase II | 5.5 |
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Time to Tumor Progression
(NCT00201825)
Timeframe: Every 35 days
Intervention | months (Median) |
---|
Docetaxel and Capecitabine | 3.3 |
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Determine Objective Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00201825)
Timeframe: Every 35 days
Intervention | patients (Number) |
---|
| Complete response (CR) | Partial response (PR) | Stable Disease | Disease Progression | Overall response (CR + PR) |
---|
Docetaxel and Capecitabine | 0 | 5 | 14 | 9 | 5 |
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One Year Survival
(NCT00201825)
Timeframe: one year
Intervention | months (Median) |
---|
Docetaxel and Capecitabine | 10.5 |
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Quality of Life of Patients
"Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Trial Outcome Index (TOI) - a questionnaire assessing quality of life concerns pertinent to colorectal cancer patients. Questions address Physical, Emotional and Functional Well-Being. Scale: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), and very much (4). Higher numbers indicate a better state of well being. Scale 0 -136. Higher numbers indicating a better state of well-being.~The Overall scores for the FACT-C Composite scale range between 0-100 with higher scores indicating a better state of well being.~The EQ VAS= Euro Quality of Life 5 Dimension Self Reported Healthstate. It records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 0 'Best imaginable health state' and 100 'Worst imaginable health state'." (NCT00203411)
Timeframe: Baseline, Cycle 2, and End of Study
Intervention | score on a scale (Mean) |
---|
| Baseline FACT-C Trial outcome index (TOI) | Cycle 2 FACT-C TOI | End of Study FACT-C TOI | Baseline FACT-C Composite | Cycle 2 FACT-C Composite | End of Study FACT-Composite | Baseline EQ-5D VAS | Cycle 2 EQ-5D VAS | End of Study EQ-5D VAS |
---|
Bevacizumab Plus Capecitabine | 62.85 | 66.31 | 62.09 | 99.87 | 105.38 | 98.61 | 61.76 | 68.59 | 66.54 |
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Response Rates
Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (NCT00203411)
Timeframe: every 21 days up to 12 months
Intervention | participants (Number) |
---|
| Complete Response | Partial Response | Stable Disease | Progression | Not Evaluable |
---|
Bevacizumab Plus Capecitabine | 2 | 14 | 16 | 9 | 4 |
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Time to Disease Progression
Progression Free Survival (PFS)- the interval from the date of enrollment to the first documented date of disease progression, death due to cancer, or the last date of a definitive assessment (not an unknown assessment) at which the patient is known to be progression-free. If there is an unknown assessment, then (a) if the next subsequent definitive assessment is complete response (CR), partial response (PR), or stable disease (SD), the patient is considered to be progression-free at the date of the subsequent definitive assessment and PFS is calculated as above; (b) if the next subsequent definitive assessment is progressive disease (PD), the patient is considered to be a failure at the time of the (earliest) assessment of unknown preceding the documented disease progression (i.e. PFS is back-dated to the date of the unknown assessment) and (c) if there is no subsequent definitive assessment, PFS for the patient is considered to be a censored observation at the date (NCT00203411)
Timeframe: 12 months
Intervention | months (Median) |
---|
Bevacizumab Plus Capecitabine | 6.87 |
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Number of Subjects Requiring Dose Modifications
Number of Subjects that required Bevacizumab or Capecitabine dose modifications, delay, reduction or discontinuation due to adverse reactions. (NCT00203411)
Timeframe: 3 months
Intervention | participants (Number) |
---|
| Delay in Bevacizumab Dose | Discontinuation of Bevacizumab | Delay in Capec itabineDose | Reduction of Capecitabine Dose | Discontinuation of Capecitabine |
---|
Bevacizumab Plus Capecitabine | 15 | 14 | 8 | 13 | 16 |
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Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.
"Pathologic complete response (pCR): Absence of invasive breast cancer in the breast.~Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%)~Stable disease (SD): No decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions.~Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site." (NCT00209092)
Timeframe: 1 year
Intervention | participants (Number) |
---|
| Pathologic Complete Response-Overall population | Overall Clinical Response | Stable disease | Progressive Disease |
---|
Arm A:Sequential Therapy | 2 | 15 | 3 | 7 |
,Arm B:Concurrent Therapy | 3 | 23 | 1 | 2 |
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Long Term Follow up Data on Recurrence and Survival
Number of Patients remained alive and relapse free (NCT00209092)
Timeframe: 2 years
Intervention | participants (Number) |
---|
Arm A:Sequential Therapy | 19 |
Arm B:Concurrent Therapy | 21 |
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Overall Survival (OS)
OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis. (NCT00215644)
Timeframe: Baseline until death due to any cause (up to approximately 3 years)
Intervention | months (Median) |
---|
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 9.4 |
ECX Only | 12.2 |
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Duration of Objective Response Assessed by Independent Review Committee
Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (PD: >25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis. (NCT00215644)
Timeframe: From first documented objective response to PD or death due to any cause (up to approximately 3 years)
Intervention | months (Median) |
---|
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | NA |
ECX Only | NA |
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Percentage of Participants With Objective Response Assessed by Independent Review Committee
Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. (NCT00215644)
Timeframe: Baseline up to PD or death due to any cause (up to approximately 3 years)
Intervention | percentage of participants (Number) |
---|
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 31 |
ECX Only | 58 |
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Progression-Free Survival
PFS was defined as the time from randomization to the first documentation of PD or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis. (NCT00215644)
Timeframe: Baseline up to PD or death due to any cause (up to approximately 3 years)
Intervention | months (Median) |
---|
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 4.8 |
ECX Only | 7.1 |
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Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score
EORTC QLQ-C30 included GHS/QoL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from EORTC QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL was linearly transformed and ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). EORTC QLQ-C30 GHS/QoL score at baseline and best overall change from baseline (throughout study) are reported. (NCT00215644)
Timeframe: Baseline (Day 1), Post Baseline (Up to 3 Years)
Intervention | units on a scale (Mean) |
---|
| Baseline | Post-Baseline |
---|
ECX Only | 67.9 | -10.0 |
,Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 53.3 | 0.0 |
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Pathological Complete Response (pCR) Rate
"· To determine the pathological response rate of preoperative chemotherapy with capecitabine and irinotecan followed by combined modality chemoradiation with capecitabine in patients with locally advanced rectal cancer.~Pathological response was defined in the protocol as the proportion of complete (pCR) and non-complete pathological response (pNCR) among all evaluable patients." (NCT00216086)
Timeframe: 36 months
Intervention | percentage of patients (Number) |
---|
| pCR | pNCR |
---|
Single Group Assignment | 33 | 56 |
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Local and Distant Disease Recurrence Rates
To determine the rates of local and distant disease recurrence after treatment. (NCT00216086)
Timeframe: 36 months
Intervention | percentage of particpants (Number) |
---|
| metastatic disease recurrence | locally recurrence |
---|
Single Group Assignment | 22 | 0 |
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Disease-Free Survival
The three year rate of Disease-Free Survival (NCT00216086)
Timeframe: 36 months
Intervention | percentage (Number) |
---|
Single Group Assignment | 75.5 |
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Survival at 5 Years
Survival at 5 years was assessed as the number of participants alive 5 years after starting treatment. (NCT00226941)
Timeframe: 5 years
Intervention | Participants (Count of Participants) |
---|
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 | 5 |
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 | 4 |
Group A - Cetuximab + Capecitabine-800 + XRT | 3 |
Group B - Cetuximab + Capecitabine-800 + XRT | 3 |
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Overall Survival (OS)
Overall Survival (OS) was assessed as the mean survival from the date of entry on study though 72 months. (NCT00226941)
Timeframe: 72 months
Intervention | months (Mean) |
---|
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 | 59.7 |
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 | 57.0 |
Group A - Cetuximab + Capecitabine-800 + XRT | 54.4 |
Group B - Cetuximab + Capecitabine-1000 + XRT | 53.7 |
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Dose-limiting Toxicity (DLT) - Number of Participants Affected
Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a < 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of participants experiencing a DLT. (NCT00226941)
Timeframe: 10 weeks
Intervention | Participants (Count of Participants) |
---|
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 | 4 |
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 | 2 |
Group A - Cetuximab + Capecitabine-800 + XRT | 0 |
Group B - Cetuximab + Capecitabine-1000 + XRT | 0 |
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Dose-limiting Toxicity (DLT) - Number of DLTs by Treatment Group
Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a < 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of DLTs by treatment group. (NCT00226941)
Timeframe: 10 weeks
Intervention | DLTs (Number) |
---|
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 | 10 |
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 | 2 |
Group A - Cetuximab + Capecitabine-800 + XRT | 0 |
Group B - Cetuximab + Capecitabine-1000 + XRT | 0 |
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Pathologic Response Rate
After treatment with capecitabine, cetuximab, radiotherapy, and oxaliplatin, the pathologic response rate was assessed based on the excised tumor taken at the time of surgical resection. Pathologic response rate was determined as the number and proportion of participants who experienced either downstaging of their disease, or complete response (CR, no detectable disease). A participant will be considered to have downstaging of the tumor as a result of the neoadjuvant therapy when the primary tumor (T) stage by pathology isless than the T stage by clinical (endoscopic) evaluation, or when the regional lymph node (N) tumor stage by pathology is less than the N stage by clinical (endoscopic) evaluation. (NCT00226941)
Timeframe: 12 to 14 weeks after radiotherapy
Intervention | Participants (Count of Participants) |
---|
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 | 4 |
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 | 5 |
Group A - Cetuximab + Capecitabine-800 + XRT | 3 |
Group B - Cetuximab + Capecitabine-1000 + XRT | 5 |
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Tumor Downstaging at Surgical Resection
Downstaging means a reduction from the stage of disease observed at baseline to the stage of disease after treatment with cetuximab, radiotherapy, oxaliplatin, and capecitabine, as determined at the time of surgical removal of the tumor. Downstaging may be observed as improvements in tumor staging at the primary site of the tumor; in nearby (regional) lymph nodes; or in metastatic disease beyond the regional lymph nodes. This outcome specifically does not include participants that achieved a complete response, nor those that experienced no response or disease progression. (NCT00226941)
Timeframe: 12 to 14 weeks after radiotherapy
Intervention | Participants (Count of Participants) |
---|
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 | 4 |
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 | 5 |
Group A - Cetuximab + Capecitabine-800 + XRT | 3 |
Group B - Cetuximab + Capecitabine-1000 + XRT | 5 |
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Time-to-Progression (TTP)
Time-to-progression was assessed as the time from the date of surgical resection to the appearance of either local disease recurrence or distant metastases by any modality (eg, clinical exam, endoscopy, radiographic imaging). All relapses were to be confirmed by biopsy and pathology review. (NCT00226941)
Timeframe: 5 years
Intervention | years (Median) |
---|
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 | 1.4 |
Group A - Cetuximab + Capecitabine-800 + XRT | 3.0 |
Group B - Cetuximab + Capecitabine-1000 + XRT | 3.9 |
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Incidence of Sphincter-sparing Surgery
Incidence of sphincter-saving surgery is defined as the proportion of subjects who do not have permanent colostomy at the final follow-up out of all evaluable patients. (NCT00250835)
Timeframe: At surgery (up to 6 weeks after end of treatment)
Intervention | percentage of evaluable participants (Number) |
---|
Chemotherapy, Celecoxib, and Radiation | 56 |
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Pelvic Local Control Rate
Pelvic local control rate is defined as the proportion of subjects who have no evidence of pelvic recurrence (by standard clinical assessment, including CT scan and clinical examination) at the final follow-up evaluation, out of all evaluable patients (NCT00250835)
Timeframe: Up to 3 years after surgery
Intervention | percentage of evaluable participants (Number) |
---|
Chemotherapy, Celecoxib, and Radiation | 6 |
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Progression-free Survival (PFS)
"The Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (Version 1.0) will be used to determine tumor response and progression. Progressive disease (PD) for target lesions: >= 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered . PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions or unequivocal progression of existing non-target lesions. Time to progression will be measured from the time of surgery or clinically documented down staging if surgery for whatever reason is not carried in the subject until there is evidence of PD.~Progression-free survival is reported as the percentage of patients who have not experienced progression of disease at three years post-surgery" (NCT00250835)
Timeframe: 3 years after surgery
Intervention | percentage of evaluable participants (Number) |
---|
Chemotherapy, Celecoxib, and Radiation | 84 |
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Toxicity
"All toxicities encountered during the study will be evaluated according to the grading system (0-5) NCI CTCAE (Common Terminology Criteria for Adverse Events) version 3.0.~Toxicity will be reported as the proportion of subjects experiencing Grades 3,4, and 5 adverse events (AEs) out of all evaluable patients" (NCT00250835)
Timeframe: Up to 3 years
Intervention | percentage of participants (Number) |
---|
| Grade 3 and 4 diarrhea | Grade 3 and 4 abnormal liver function tests | Grade 3 and 4 abdominal pain | Death (from severe infection) |
---|
Chemotherapy, Celecoxib, and Radiation | 9 | 9 | 6 | 6 |
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Surgical Downstaging Rate
Downstaging rate after neoadjuvant treatment with combination oxaliplatin, capecitabine, celecoxib and concurrent radiation is defined as the proportion of patients whose pathological stage (stage at surgery) is different from their clinical stage (stage at baseline) (NCT00250835)
Timeframe: At surgery (up to 6 weeks after treatment)
Intervention | percentage of evaluable participants (Number) |
---|
Chemotherapy, Celecoxib, and Radiation | 75 |
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Pathologic Complete Response (PCR)
The pathologic complete response (PCR) rate will be calculated as the proportion of patients who achieve complete response out of all evaluable patients. PCR is defined as the total absence of residual tumor cells by microscopic examination of the resected surgical specimen, including all of the sampled lymph nodes. (NCT00250835)
Timeframe: At surgery (up to 6 weeks after end of treatment)
Intervention | percentage of evaluable participants (Number) |
---|
Chemotherapy, Celecoxib, and Radiation | 31 |
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Recurrence-free Survival
Time to recurrence or death (NCT00258310)
Timeframe: Within 3 years of end of study.
Intervention | months (Median) |
---|
Capecitabine | NA |
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Overall Survival
Estimated time from study entry to death from any cause (NCT00258310)
Timeframe: Within 3 years of end of study
Intervention | months (Median) |
---|
Capecitabine | NA |
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Compliance With Treatment .
Compliance is defined as taking at least 80% of the prescribed dose for one year. (NCT00258310)
Timeframe: within 365 days
Intervention | percentage of participants (Number) |
---|
Capecitabine | 74 |
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Incidence of Second Primary Tumors
(NCT00258310)
Timeframe: Within 3 years of end of study
Intervention | Participants (Count of Participants) |
---|
Capecitabine | 3 |
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Qualitative and Quantitative Toxicity
Number of patients that developed common side effect of diarrhea. (NCT00266279)
Timeframe: At study enrollment, Every two 28 day treatment cycles, and at end of treatment due to disease progression
Intervention | participants (Number) |
---|
Treatment With Study Drugs | 2 |
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Overall Response Rate
"Among the 15 patients treated, 2 (13%) achieved partial response (PR), and 5 (33%) achieved stable disease (SD), for a Overall Response Rate (ORR) of 46% measured by RECIST criteria.~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.~Overall Response Rate (ORR)=PR+CR." (NCT00266279)
Timeframe: Every two 28 day treatment cycles until subject no longer on treatment due to disease progression
Intervention | Participants (Number) |
---|
| Partial Response | Stable Disease |
---|
Treatment With Study Drugs | 2 | 5 |
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Overall Survival Time in the PLD and Capecitabine Treatment Groups
Survival time was defined as duration time from onset of treatment with the study drug until death. (NCT00266799)
Timeframe: From Day 1 (Cycle 1) until Death
Intervention | Months (Median) |
---|
Pegylated Liposomal Doxorubicin (PLD) | 23.31 |
Capecitabine | 26.79 |
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Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups
Overall responses by investigator assessment/RECIST criteria of participant responses; CR=disappearance of target/nontarget lesions + PR=30% decrease in longest diameter sum (noting baseline sum) of target lesions. RECIST used changes in the largest diameter of target/non-target lesions. Target lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions. Evaluation of progress was repeated every 3 months (+/-7 days) post first date of lesion measurements, in detection absence until the participant´s death. (NCT00266799)
Timeframe: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death
Intervention | Participants (Number) |
---|
| By Investigator Assessment - CR | By Investigator Assessment - PR | By Investigator Assessment Overall Response | By RECIST Criteria - CR | By RECIST Criteria - PR | By RECIST Criteria Overall Response |
---|
Capecitabine | 0 | 12 | 12 | 0 | 11 | 11 |
,Pegylated Liposomal Doxorubicin (PLD) | 1 | 5 | 6 | 1 | 8 | 9 |
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Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ))
QoL questionnaire was an EORTC QLQ-C30 & SSQ integration. Scores on the SSQ scale ranged from 1 (very much worse) - 7 (very much better). SSQ consisted of 4 items which corresponded to core domains in the 30 Item EORTC QLQ-C30, such as improvement/deterioration in physical functioning, emotional functioning, social functioning, global QoL. Percentages were based on number of participants at each cycle & rounded to the nearest whole number. Early Withdrawal Questionnaires were obtained in 7-14 days of study drug final dose. (NCT00266799)
Timeframe: From Screening to Day 1 of every Treatment Cycle up to 12 Cycles
Intervention | Percentage of Participants (Number) |
---|
| Screening - Very Much Worse | Screening - Moderately Worse | Screening - A Little Worse | Screening - About the Same | Screening - A Little Better | Screening - Moderately Better | Screening - Very Much Better | Cycle 1 - Very Much Worse | Cycle 1 - Moderately Worse | Cycle 1 - A Little Worse | Cycle 1 - About the Same | Cycle 1 - A Little Better | Cycle 1 - Moderately Better | Cycle 1 - Very Much Better | Cycle 2 - Very Much Worse | Cycle 2 - Moderately Worse | Cycle 2 - A Little Worse | Cycle 2 - About the Same | Cycle 2 - A Little Better | Cycle 2 - Moderately Better | Cycle 2 - Very Much Better | Cycle 3 - Very Much Worse | Cycle 3 - Moderately Worse | Cycle 3 - A Little Worse | Cycle 3 - About the Same | Cycle 3 - A Little Better | Cycle 3 - Moderately Better | Cycle 3 - Very Much Better | Cycle 4 - Very Much Worse | Cycle 4 - Moderately Worse | Cycle 4 - A Little Worse | Cycle 4 - About the Same | Cycle 4 - A Little Better | Cycle 4 - Moderately Better | Cycle 4 - Very Much Better | Cycle 5 - Very Much Worse | Cycle 5 - Moderately Worse | Cycle 5 - A Little Worse | Cycle 5 - About the Same | Cycle 5 - A Little Better | Cycle 5 - Moderately Better | Cycle 5 - Very Much Better | Cycle 6 - Very Much Worse | Cycle 6 - Moderately Worse | Cycle 6 - A Little Worse | Cycle 6 - About the Same | Cycle 6 - A Little Better | Cycle 6 - Moderately Better | Cycle 6 - Very Much Better | Cycle 7 - Very Much Worse | Cycle 7 - Moderately Worse | Cycle 7 - A Little Worse | Cycle 7 - About the Same | Cycle 7 - A Little Better | Cycle 7 - Moderately Better | Cycle 7 - Very Much Better | Cycle 8 - Very Much Worse | Cycle 8 - Moderately Worse | Cycle 8 - A Little Worse | Cycle 8 - About the Same | Cycle 8 - A Little Better | Cycle 8 - Moderately Better | Cycle 8 - Very Much Better | Cycle 9 - Very Much Worse | Cycle 9 - Moderately Worse | Cycle 9 - A Little Worse | Cycle 9 - About the Same | Cycle 9 - A Little Better | Cycle 9 - Moderately Better | Cycle 9 - Very Much Better | Cycle 10 - Very Much Worse | Cycle 10 - Moderately Worse | Cycle 10 - A Little Worse | Cycle 10 - About the Same | Cycle 10 - A Little Better | Cycle 10 - Moderately Better | Cycle 10 - Very Much Better | Cycle 11 - Very Much Worse | Cycle 11 - Moderately Worse | Cycle 11 - A Little Worse | Cycle 11 - About the Same | Cycle 11 - A Little Better | Cycle 11 - Moderately Better | Cycle 11 - Very Much Better | Cycle 12 - Very Much Worse | Cycle 12 - Moderately Worse | Cycle 12 - A Little Worse | Cycle 12 - About the Same | Cycle 12 - A Little Better | Cycle 12 - Moderately Better | Cycle 12 - Very Much Better |
---|
Capecitabine | 14 | 14 | 24 | 41 | 0 | 0 | 7 | 9 | 9 | 9 | 65 | 2 | 5 | 0 | 11 | 8 | 15 | 50 | 9 | 5 | 3 | 3 | 13 | 23 | 48 | 10 | 2 | 0 | 6 | 12 | 22 | 55 | 2 | 4 | 0 | 0 | 2 | 19 | 62 | 14 | 2 | 0 | 3 | 6 | 11 | 60 | 14 | 3 | 3 | 3 | 3 | 23 | 42 | 6 | 16 | 6 | 3 | 6 | 16 | 61 | 6 | 6 | 0 | 0 | 3 | 21 | 55 | 10 | 3 | 7 | 4 | 8 | 13 | 50 | 13 | 4 | 8 | 0 | 9 | 13 | 39 | 13 | 9 | 17 | 4 | 8 | 13 | 50 | 13 | 8 | 4 |
,Pegylated Liposomal Doxorubicin (PLD) | 4 | 8 | 12 | 67 | 4 | 2 | 2 | 0 | 10 | 22 | 63 | 5 | 0 | 0 | 3 | 9 | 25 | 51 | 9 | 1 | 1 | 4 | 13 | 13 | 58 | 8 | 4 | 0 | 4 | 11 | 26 | 47 | 9 | 2 | 0 | 5 | 0 | 21 | 40 | 19 | 10 | 5 | 5 | 7 | 9 | 58 | 14 | 5 | 2 | 0 | 4 | 17 | 52 | 13 | 13 | 0 | 0 | 13 | 17 | 57 | 9 | 0 | 4 | 6 | 0 | 25 | 50 | 6 | 6 | 6 | 0 | 8 | 17 | 67 | 8 | 0 | 0 | 0 | 11 | 0 | 67 | 11 | 11 | 0 | 0 | 0 | 11 | 78 | 11 | 0 | 0 |
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Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST)
TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions. (NCT00266799)
Timeframe: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death
Intervention | Months (Median) |
---|
| By Investigator Assessment (ITT) | By RECIST Criteria (ITT) | By Investigator Assessment (TTP N = 63, N = 59) | By RECIST Criteria (TTP N = 63, N = 59) |
---|
Capecitabine | 6.05 | 7.10 | 5.88 | 6.05 |
,Pegylated Liposomal Doxorubicin (PLD) | 6.02 | 6.58 | 5.85 | 6.02 |
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Time to Treatment Failure in the PLD and the Capecitabine Treatment Groups
Time to treatment failure was defined as the duration of time from the date of the first administration of the study drug to the date of discontinuation of the study drug for any reason. (NCT00266799)
Timeframe: From Day 1 (Cycle 1) until End of Treatment
Intervention | Months (Median) |
---|
Pegylated Liposomal Doxorubicin (PLD) | 4.60 |
Capecitabine | 3.68 |
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Adherence and Compliance to Oral Medication Using Electronic Monitoring
This was assessed by number of participants who did not miss any doses of Capecitabine during treatment using the Medication Event Monitoring System (MEMS). (NCT00274768)
Timeframe: 3-week cycles of treatment up to 16 cycles
Intervention | Participants (Count of Participants) |
---|
Capecitabine | 13 |
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Clinical Benefit as Assessed by Lack of Progression for at Least 24 Weeks
The overall clinical benefit rate as assessed by number of participants with lack of progression for at least 24 weeks. (NCT00274768)
Timeframe: 3-week cycles of treatment up to 16 cycles
Intervention | Participants (Count of Participants) |
---|
Capecitabine | 4 |
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Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00274768)
Timeframe: Participants were followed to progression, evaluated every 12 weeks
Intervention | participants (Number) |
---|
Capecitabine | 21 |
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Time to Treatment Failure
Time to treatment failure in weeks (NCT00274768)
Timeframe: 3-week cycles of treatment up to 16 cycles
Intervention | weeks (Median) |
---|
Capecitabine | 12 |
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6-month Overall Survival
Percentage of patients survived at 6 months for patients whose tumors were xenografted and treated in the mouse when treated with the most active agent identified in that model (NCT00276744)
Timeframe: 6 months
Intervention | percentage of participants (Number) |
---|
Arm 1 | 53 |
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Number of Patients With Adverse Events
Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years (NCT00278863)
Timeframe: Up to 2 years
Intervention | participants (Number) |
---|
S-1 for 2 Week on/1 Week Off | 42 |
Capecitabine 2 Weeks on/1 Week Off | 44 |
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Response Rate
"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD~Response rate is defined as the proportion of patients who showed OR." (NCT00278863)
Timeframe: Up to 2 years
Intervention | percentage of participants (Number) |
---|
S-1 for 2 Week on/1 Week Off | 28.9 |
Capecitabine 2 Weeks on/1 Week Off | 26.1 |
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Response Rate (Percentage of Participants With Partial or Complete Response)
"Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.~Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~The definitions were:~Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions" (NCT00290615)
Timeframe: After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.
Intervention | percentage of participants with response (Number) |
---|
Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab | 43 |
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Progression-free Survival
"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~This is the average number of months participants survived without showing progressive disease." (NCT00290615)
Timeframe: From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.
Intervention | months (Median) |
---|
Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab | 10.3 |
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Overall Survival
Average months of survival of participants after receiving study drug. (NCT00290615)
Timeframe: From time of treatment until death from any cause, assesed up to 60 months.
Intervention | months (Median) |
---|
Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab | 18.8 |
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Safety and Tolerability
Number of participants with adverse events (NCT00290615)
Timeframe: After all participants went off study drug regimine.
Intervention | participants with adverse event (Number) |
---|
Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab | 30 |
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Number of Study Participants Experiencing Toxicity After Receiving Protocol Therapy
Number of study participants experiencing toxicity (serious adverse events or adverse events). Study participants assessed for this outcome measure must have received at least one dose of protocol therapy. Toxicity assessed according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE). (NCT00290693)
Timeframe: Up to 1 year
Intervention | participants (Number) |
---|
CapTere (Capecitabine + Docetaxel) | 38 |
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Overall Surival (OS)
Overall survival is measured from the time from date of initial protocol therapy to date of death. In the absence of confirmation of death, survival time will be censored to last date of follow-up. (NCT00290693)
Timeframe: Up to 1 year
Intervention | months (Median) |
---|
CapTere (Capecitabine + Docetaxel) | 5.3 |
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Progression-free Survival (PFS)
Progression-free survival (PFS) is measured the time from the start of protocol therapy to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00290693)
Timeframe: Up to 1 year
Intervention | months (Median) |
---|
CapTere (Capecitabine + Docetaxel) | 3.7 |
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Rate of Participants Achieving a 50% or More Reduction in CA 19-9 Levels
Rate of participants achieving a 50% or more reduction in CA 19-9 levels after receiving protocol therapy. Baseline CA-19-9 will be compared to the lowest recorded value on patients receiving therapy on protocol. A 50% drop in CA 19-9 in patients with baseline levels above 100 U/ml will be recorded as a CA 19-9 response if the > 50% drop can be confirmed with at least one more CA 19-9 level thereafter with > 50% drop compared to baseline. (NCT00290693)
Timeframe: Up to 1 year
Intervention | percentage of participants (Number) |
---|
CapTere (Capecitabine + Docetaxel) | 35.48 |
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Rate of Participants Achieving Complete Response or Partial Response to Therapy.
Rate of participants achieving complete response (CR) or partial response (PR) to Captere therapy according to RECIST criteria v 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. (NCT00290693)
Timeframe: Up to 1 year
Intervention | participants (Number) |
---|
| Partial Response (PR) >= 2 cycles | Stable Disease (SD), >= 2 cycles | Complete Response (CR), >= 2 cycles |
---|
CapTere (Capecitabine + Docetaxel) | 6 | 25 | 0 |
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Impact of Capecitabine on 131I-huA33 Clearance (CL) as Measured by Initial and Therapy Dose Clearance (CL)
"Blood samples for pharmacokinetics (PK) were drawn in week 0 immediately pre-initial 131I-huA33 infusion; then 5 minutes, 60 minutes and 2 hours post-initial 131I-huA33 infusion, Day 1, Day 2 or Day 3, Day 4 or Day 5. In week 1, PK samples were collected immediately pre-therapy 131I-huA33 infusion, 5 minutes, 24 ± 2 hours and approximately 7 days post-therapy 13II-huA33 infusion, then weekly until 4 weeks post therapy.~Pharmacokinetic calculations were performed on serum 131I-huA33 data using a curve fitting Program (WinNonLin version 5.2; Pharsight Co., Mountain View, CA)." (NCT00291486)
Timeframe: 5 weeks
Intervention | ml/hr (Mean) |
---|
| Initial dose CL | Therapy dose CL |
---|
Cohort 5; 1250 mg/m2/Day Capecitabine | 34.65 | 35.53 |
,Cohorts 1 and 2; 1500 mg/m2/Day Capecitabine | 34.88 | 26.88 |
,Cohorts 3 and 4; 1000 mg/m2/Day Capecitabine | 40.54 | 39.41 |
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Mean Specific Absorbed Dose of 131I-huA33 for Normal Organs Calculated From the Initial Infusion
"Gamma camera imaging with anterior and posterior whole body scans using conjugate view methodology were performed on four occasions (1-4 hours, Day 1, Day 2 or 3, and Day 4 or 5) following completion of the intravenous initial infusion.~Dosimetric analysis was performed on the series of gamma camera whole-body planar images acquired in all patients following the first infusion.~Organ radioactivity content was estimated from the geometric mean of anterior and posterior regions of interest counts. The counts for each organ were corrected for background using regions of interest drawn adjacent to each organ where whole body thickness was comparable." (NCT00291486)
Timeframe: 1 week
Intervention | cGy/MBq (Mean) |
---|
| Liver | Spleen | Kidney | Lung | Red Marrow |
---|
Cohorts 1-5 | 0.12 | 0.18 | 0.14 | 0.09 | 0.056 |
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Pharmacokinetics (PK) of 131I-huA33 as Measured by Area Under the Serum Concentration Curve Extrapolated to Infinite Time (AUC)
"Blood samples for pharmacokinetics (PK) were drawn in week 0 immediately pre-initial 131I-huA33 infusion; then 5 minutes, 60 minutes and 2 hours post-initial 131I-huA33 infusion, Day 1, Day 2 or Day 3, Day 4 or Day 5. In week 1, PK samples were collected immediately pre-therapy 131I-huA33 infusion, 5 minutes, 24 ± 2 hours and approximately 7 days post-therapy 131I-huA33 infusion, then weekly until 4 weeks post therapy.~Pharmacokinetic calculations were performed on serum 131I-huA33 data using a curve fitting Program (WinNonLin version 5.2; Pharsight Co., Mountain View, CA)." (NCT00291486)
Timeframe: 5 weeks
Intervention | mcg.hr/mL (Mean) |
---|
| AUC after initial 131I-huA33 infusion | AUC after therapy 131I-huA33 infusion |
---|
Cohorts 1-5 | 130.43 | 592.46 |
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Pharmacokinetics (PK) of 131I-huA33 as Measured by Clearance (CL)
"Blood samples for pharmacokinetics (PK) were drawn in week 0 immediately pre-initial 131I-huA33 infusion; then 5 minutes, 60 minutes and 2 hours post-initial 131I-huA33 infusion, Day 1, Day 2 or Day 3, Day 4 or Day 5. In week 1, PK samples were collected immediately pre-therapy 131I-huA33 infusion, 5 minutes, 24 ± 2 hours and approximately 7 days post-therapy 13II-huA33 infusion, then weekly until 4 weeks post therapy.~Pharmacokinetic calculations were performed on serum 131I-huA33 data using a curve fitting Program (WinNonLin version 5.2; Pharsight Co., Mountain View, CA)." (NCT00291486)
Timeframe: 5 weeks
Intervention | mL/hr (Mean) |
---|
| CL after initial 131I-huA33 infusion | CL after therapy 131I-huA33 infusion |
---|
Cohorts 1-5 | 36.72 | 32.60 |
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Number of Patients With Dose-Limiting Toxicities (DLT)
"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0). DLT was defined as any of the following related events:~Any grade 2 or greater allergic reaction related to huA33. Any grade ≥ 3 non-haematological toxicity related to 131I-huA33 or capecitabine.~These toxicities included palmar plantar erythema, but skin rash thought to be related to huA33 protein was not a DLT as previous studies have shown no relation of this toxicity to dose of huA33 or radioiodine dose.~Capecitabine cardiotoxicity grade ≥ 3 - including vasospasm, acute coronary syndrome and arrhythmia, necessitated the cessation of study drug in the affected patient but were not considered DLT as these are recognized as idiosyncratic in nature and not known to be related to capecitabine dose.~Any grade ≥ 4 neutropenia ≥ 7 days in duration or any thrombocytopenia with a platelet count < 10 x 10^9/L." (NCT00291486)
Timeframe: 7 weeks
Intervention | Participants (Count of Participants) |
---|
Cohort 1 | 0 |
Cohort 2 | 2 |
Cohort 3 | 0 |
Cohort 4 | 0 |
Cohort 5 | 0 |
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Pharmacokinetics (PK) of 131I-huA33 as Measured by Maximum Serum Concentration (Cmax)
"Blood samples for pharmacokinetics (PK) were drawn in week 0 immediately pre-initial 131I-huA33 infusion; then 5 minutes, 60 minutes and 2 hours post-initial 131I-huA33 infusion, Day 1, Day 2 or Day 3, Day 4 or Day 5. In week 1, PK samples were collected immediately pre-therapy 131I-huA33 infusion, 5 minutes, 24 ± 2 hours and approximately 7 days post-therapy 131I-huA33 infusion, then weekly until 4 weeks post therapy.~Pharmacokinetic calculations were performed on serum 131I-huA33 data using a curve fitting Program (WinNonLin version 5.2; Pharsight Co., Mountain View, CA)." (NCT00291486)
Timeframe: 5 weeks
Intervention | mcg/mL (Mean) |
---|
| Cmax after initial 131I-huA33 infusion | Cmax after therapy 131I-huA33 infusion |
---|
Cohorts 1-5 | 1.53 | 5.52 |
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Pharmacokinetics (PK) of 131I-huA33 as Measured by T½α and T½β (Half Lives of the Initial and Terminal Phases of Disposition, Respectively)
"Blood samples for pharmacokinetics (PK) were drawn in week 0 immediately pre-initial 131I-huA33 infusion; then 5 minutes, 60 minutes and 2 hours post-initial 131I-huA33 infusion, Day 1, Day 2 or Day 3, Day 4 or Day 5. In week 1, PK samples were collected immediately pre-therapy 131I-huA33 infusion, 5 minutes, 24 ± 2 hours and approximately 7 days post-therapy 131I-huA33 infusion, then weekly until 4 weeks post therapy.~Pharmacokinetic calculations were performed on serum 131I-huA33 data using a curve fitting Program (WinNonLin version 5.2; Pharsight Co., Mountain View, CA)." (NCT00291486)
Timeframe: 5 weeks
Intervention | hours (Mean) |
---|
| T½α after initial 131I-huA33 infusion | T½α after therapy 131I-huA33 infusion | T½β after initial 131I-huA33 infusion | T½β after therapy 131I-huA33 infusion |
---|
Cohorts 1-5 | 15.78 | 28.63 | 100.24 | 152.60 |
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Pharmacokinetics (PK) of 131I-huA33 as Measured by the Volume of the Central Compartment (V1)
"Blood samples for pharmacokinetics (PK) were drawn in week 0 immediately pre-initial 131I-huA33 infusion; then 5 minutes, 60 minutes and 2 hours post-initial 131I-huA33 infusion, Day 1, Day 2 or Day 3, Day 4 or Day 5. In week 1, PK samples were collected immediately pre-therapy 131I-huA33 infusion, 5 minutes, 24 ± 2 hours and approximately 7 days post-therapy 131I-huA33 infusion, then weekly until 4 weeks post therapy.~Pharmacokinetic calculations were performed on serum 131I-huA33 data using a curve fitting Program (WinNonLin version 5.2; Pharsight Co., Mountain View, CA)." (NCT00291486)
Timeframe: 5 weeks
Intervention | mL (Mean) |
---|
| V1 after initial 131I-huA33 infusion | V1 after therapy 131I-huA33 infusion |
---|
Cohorts 1-5 | 3204.26 | 3363.69 |
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Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Serum samples for human anti-human antibody (HAHA) assessment were collected prior to each 131I-huA33 infusion, at weekly intervals during weeks 0-7, then alternate weeks until the end-of-study visit. Measurement of immune responses to huA33 in patients serum was performed using a BIAcore 2000 biosensor (Biacore AB, Uppsala, Sweden). (NCT00291486)
Timeframe: 13 weeks
Intervention | Participants (Count of Participants) |
---|
| Pre-treatment72460703 | Pre-treatment72460704 | Pre-treatment72460705 | Pre-treatment72460706 | Pre-treatment72460702 | Week 172460703 | Week 172460704 | Week 172460705 | Week 172460706 | Week 172460702 | Week 272460703 | Week 272460704 | Week 272460705 | Week 272460706 | Week 272460702 | Week 372460703 | Week 372460704 | Week 372460705 | Week 372460706 | Week 372460702 | Week 472460703 | Week 472460704 | Week 472460702 | Week 472460705 | Week 472460706 | Week 572460703 | Week 572460704 | Week 572460705 | Week 572460702 | Week 572460706 | Week 672460703 | Week 672460704 | Week 672460706 | Week 672460702 | Week 672460705 | Week 872460702 | Week 872460703 | Week 872460704 | Week 872460705 | Week 872460706 | Week 10-1172460703 | Week 10-1172460704 | Week 10-1172460705 | Week 10-1172460706 | Week 10-1172460702 | Week 12-1372460703 | Week 12-1372460704 | Week 12-1372460705 | Week 12-1372460706 | Week 12-1372460702 |
---|
| Negative HAHA | Positive HAHA |
---|
Cohort 2 | 0 |
Cohort 4 | 0 |
Cohort 5 | 0 |
Cohort 2 | 6 |
Cohort 3 | 3 |
Cohort 4 | 3 |
Cohort 5 | 4 |
Cohort 4 | 1 |
Cohort 3 | 2 |
Cohort 4 | 2 |
Cohort 3 | 0 |
Cohort 5 | 2 |
Cohort 5 | 1 |
Cohort 1 | 3 |
Cohort 1 | 0 |
Cohort 2 | 4 |
Cohort 2 | 3 |
Cohort 3 | 1 |
Cohort 5 | 3 |
Cohort 1 | 2 |
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Biodistribution of 131I-huA33 Measured by Whole Body Clearance and Normal Organ Clearance Reported as Mean Biological Half-life (T1/2 Biological) After Initial 131I-huA33 Infusion
T1/2 biological is the clearance of the isotope from the whole body. Following the initial 131I-huA33 infusion, gamma camera scans were acquired over a 1 week period (1-4 hours, Day 1, Day 2 or 3, and Day 4 or 5). Whole body clearance, or biological half time, T1/2 biological, was calculated from the whole body anterior and posterior planar images. A region of interest (ROI) was calculated to encompass the whole body, and for each ROI at each time point, the mean counts per pixel per minute was normalised to imaging time point Day 1. (NCT00291486)
Timeframe: 1 week
Intervention | hours (Mean) |
---|
| Whole Body Clearance (T1/2 biologic) | Normal Organ Clearance in the Liver (T1/2 biological - liver) | Normal Organ Clearance in the kidney (T1/2 biological - kidney) |
---|
Cohorts 1-5 | 219.56 | 62.29 | 104.89 |
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Mean Total Tumor Dose of 131I-huA33
"Gamma camera imaging were performed on four occasions (1-4 hours, Day 1, Day 2 or 3, and Day 4 or 5) following completion of the initial infusion and 7+2 days post-therapy infusion in week 2, and again in week 3 or 4 and week 5 following the therapy infusion.~Dosimetry analysis was performed on the series of gamma camera whole-body planar images.~Tumor radioactivity content after the initial infusion was estimated from the geometric mean of anterior and posterior regions of interest counts. The counts for each organ were corrected for background using regions of interest drawn adjacent to each tumor. Resultant counts were converted to activity using a camera sensitivity factor calculated from a gamma camera standard of known activity which was scanned at the same time." (NCT00291486)
Timeframe: 5 weeks
Intervention | Gy (Mean) |
---|
All Patients | 13.83 |
Cohorts 2 and 3; 30 mCi 131I-huA33 | 13.15 |
Cohorts 4 and 5: 40 mCi 131I-huA33 | 14.89 |
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Two-year Overall Survival Rate
Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival. (NCT00305877)
Timeframe: Assessed every 3 months for 2 years
Intervention | Proportion of patients (Number) |
---|
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 0.38 |
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 0.37 |
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Two-year Disease-free Survival (DFS)
Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence). (NCT00305877)
Timeframe: Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years
Intervention | Proportion of patients (Number) |
---|
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 0.17 |
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 0.23 |
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Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy
"Specific toxicities to be monitored pursuant to the primary endpoint include:~Any grade 5 toxicities~Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension~Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis~ECOG performance status decline by 2 or greater for >24 hours~Weight loss >10%" (NCT00305877)
Timeframe: Every 2 weeks while on treatment and for 30 days after the end of treatment
Intervention | Proportion of patients (Number) |
---|
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 0.30 |
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 0.25 |
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Common Toxicities
The NCI Common Terminology Criteria for Adverse Events version 3.0 was used for adverse event reporting and toxicity grading. (NCT00320749)
Timeframe: Weekly up to 24 weeks
Intervention | percent of patients (Number) |
---|
| leukopenia | neutropenia | fatigue |
---|
Capecitabine, Docetaxel, Gemcitabine | 29 | 29 | 25 |
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Maximum Tolerated Dose (MTD)
MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT). (NCT00320749)
Timeframe: Weekly up to 24 weeks
Intervention | mg/m^2 (Number) |
---|
| docetaxel | gemcitabine | capecitabine |
---|
Capecitabine, Docetaxel, Gemcitabine | 36 | 750 | 625 |
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Therapeutic Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00320749)
Timeframe: every 8 weeks, up to 24 weeks
Intervention | percent of patients (Number) |
---|
| Partial Response | Complete Response | Stable Disease |
---|
Capecitabine, Docetaxel, Gemcitabine | 11 | 0 | 72 |
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Overall Survival
Follow-up for survival to be done at 3 month intervals for 2 years, then 6 month intervals for up to 5 years from study registration (NCT00321100)
Timeframe: From dose of first study drug to last timepoint known to be alive (median follow-up for all patients was 25.9 months)
Intervention | months (Median) |
---|
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab | 18 |
Cetuximab, Oxaliplatin, Capecitabine | 42.5 |
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Objective Response Rate (ORR)
"Objective response rate calculated by the proportion of overall response: CR+PR. Patients were categorized by one of the following (1-4 per RECISTv1.0 criteria on CT, MRI, x-ray; 4-9 considered failure to respond/disease progression):~complete response (CR): Disappearance of all lesions~partial response (PR): >=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL~stable disease (SD): Neither PR, PD, or CR~progressive disease (PD): >=20% increase in the SoL; from smallest SoL. Or appearance of new lesion~early death from malignant disease~early death from toxicity~early death from other cause~9) unknown (not assessable, insufficient data)" (NCT00321100)
Timeframe: every 6-9 weeks; from date of first study drug dose until off treatment date (median of 8 cycles; range <1-19)
Intervention | Participants (Count of Participants) |
---|
| Overall response | Complete response | Partial response | Stable disease |
---|
Cetuximab, Oxaliplatin, Capecitabine | 8 | 1 | 7 | 3 |
,Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab | 4 | 1 | 3 | 7 |
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Time to Progression (TTP)
"Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0) assessed by CT, MRI, x-ray scan:~Complete response (CR): Disappearance of all lesions Partial response (PR): >=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL Stable disease (SD): Neither PR, PD, or CR Progressive disease (PD): >=20% increase in the SoL; from smallest SoL. Or appearance of new lesion" (NCT00321100)
Timeframe: every 6-9 weeks; from dose of first study drug to event
Intervention | months (Median) |
---|
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab | 8.7 |
Cetuximab, Oxaliplatin, Capecitabine | 14.4 |
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Resection Rate for T4 Rectal Cancers
Resection rate is defined as number of patients with T4 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T4 rectal cancers (NCT00321685)
Timeframe: Assessed at surgery time
Intervention | percentage of participants (Number) |
---|
Arm I | 75 |
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Resection Rate for T3 Rectal Cancers
Resection rate is defined as number of patients with T3 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T3 rectal cancers (NCT00321685)
Timeframe: Assessed at surgery time
Intervention | percentage of participants (Number) |
---|
Arm I | 92 |
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Pathologic Complete Response Rate
Pathologic complete response to preoperative therapy was determined at the time of surgical resection. Pathologic complete response (pCR) is defined as no evidence of invasive cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response). Pathologic complete response rate is calculated as number of patients achieving pathologic complete response divided by all eligible and treated patients (NCT00321685)
Timeframe: Assessed at surgery time
Intervention | percentage of participants (Number) |
---|
Arm I | 17 |
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5-year Overall Survival Rate
Overall survival is defined as time from registration to death from any cause. 5-year overall survival rate is estimated using Kaplan-Meier method. (NCT00321685)
Timeframe: survival follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration
Intervention | percentage of participants (Number) |
---|
Arm I | 80 |
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5-year Recurrence-free Survival Rate
Recurrence free survival is defined as time from surgery to disease recurrence or death without recurrence (whichever occurred first) among resected patients. 5-year recurrence-free survival rate is estimated using Kaplan-Meier method, with 90% confidence interval calculated using Greenwood's formula. (NCT00321685)
Timeframe: recurrence follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration
Intervention | percentage of participants (Number) |
---|
Arm I | 81 |
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Pathologic Complete Response
Pathologic complete response rates (pCR) of primary gastric adenocarcinoma when treated with oxaliplatin and capecitabine followed by capecitabine and radiation pre-operatively. On review of the resected gastric specimen and accompanying lymph nodes, pCR is no cancer recognized by the pathologist. Margins are free of tumor. (NCT00335959)
Timeframe: 17-19 weeks
Intervention | participants (Number) |
---|
| Unconfirmed Complete Response | Unconfirmed Partial Response | Stable/No Response | Increasing Disease | Assessment Inadequate |
---|
Chemotherapy, Chemoradiation, Surgery | 1 | 2 | 2 | 1 | 1 |
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Progression Free Survival (PFS)
PFS was defined as the time (in days) from the date of randomization to the date of the first sign of disease progression based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (v 1.1) or date of death, regardless of cause. Disease progression was measured by computed tomography (CT) and magnetic resonance imaging (MRI) performed on lesions targeted at baseline for tumor assessment. Disease progression (as assessed by independent review of the imaging scans) per RECIST v 1.1 was defined as at least a 20% increase in the sum of the diameters of the target lesions (taking as reference the smallest sum on study, including the baseline sum if that is the smallest), and an absolute increase of at least 5 millimeter (mm). Note that the appearance of one or more new lesions was also considered as disease progression. (NCT00337103)
Timeframe: From date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date of 12 Mar 2012 or up to approximately 6 years
Intervention | Days (Median) |
---|
Eribulin Mesylate 1.4 mg/m^2 | 126 |
Capecitabine 2.5 g/m^2/Day | 129 |
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Overall Survival (OS)
OS was measured from the date of randomization until the date of death from any cause, or the last date the participant was known to be alive. Participants who were lost to follow-up or who were alive at the date of data cutoff were censored. The censoring rules for OS were as follows: 1) if the participant was still alive at data cutoff, the date of data cutoff was considered the end date, and 2) if the participant was lost to follow-up before data cutoff, the date they were last known to be alive was considered the end date. Participants who survived past the end of the study were counted as in the full study period. If death occurred after data cutoff, the end date was to be censored at the time of data cutoff. (NCT00337103)
Timeframe: From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years
Intervention | days (Median) |
---|
Eribulin Mesylate 1.4 mg/m^2 | 484 |
Capecitabine 2.5 g/m^2/Day | 440 |
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Objective Response Rate (ORR): Independent Review
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v 1.1). CR is defined as disappearance of all target legions and non-target lesions. All pathological lymph nodes (whether target and non-target), must have reduction in their short axis to less than 10 mm. PR is defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD. (NCT00337103)
Timeframe: From date of randomization until date of first documentation of CR or PR, assessed up to data cutoff date of 12 Mar 2012 or up to approximately 6 years
Intervention | percentage of participants (Number) |
---|
Eribulin Mesylate 1.4 mg/m^2 | 11.0 |
Capecitabine 2.5 g/m^2/Day | 11.5 |
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Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Parameter Values
(NCT00337103)
Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Intervention | Participants (Count of Participants) |
---|
Eribulin Mesylate 1.4 mg/m^2 | 362 |
Capecitabine 2.5 g/m^2/Day | 224 |
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Number of Participants With Consumption of Analgesics During the Study
Participants took analgesics as concomitant pain medications which are defined as pain medications that (1) started before the first dose of study drug and were continuing at the time of the first dose of study drug, or (2) started on/after the day of the first dose of study drug up to 30 days after the last dose of study drug medication (NCT00337103)
Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Intervention | Participants (Count of Participants) |
---|
Eribulin Mesylate 1.4 mg/m^2 | 222 |
Capecitabine 2.5 g/m^2/Day | 196 |
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Number of Participants Who Took at Least One Concomitant Medication
Concomitant medications included medications that either (1) started before the first dose of study drug and were continuing at the time of the first dose of study drug, or (2) started on or after the first dose of study drug up to 30 days after the last dose of study drug. (NCT00337103)
Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Intervention | Participants (Count of Participants) |
---|
Eribulin Mesylate 1.4 mg/m^2 | 496 |
Capecitabine 2.5 g/m^2/Day | 483 |
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Duration of Response (DOR): Independent Review
DOR was defined as the time from first documented CR or PR until disease progression or death from any cause for those participants with a confirmed PR or CR measured by RECIST v1.1. CR defined as disappearance of all target and non-target lesions. All pathological lymph nodes(whether target and non-target), must have reduction in their short axis to less than 10 mm. PR defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD. (NCT00337103)
Timeframe: From first documented CR or PR until date of recurrent or progressive disease or death, assessed up to data cutoff of date of 12 Mar 2012 or up to approximately 6 years
Intervention | days (Median) |
---|
Eribulin Mesylate 1.4 mg/m^2 | 198 |
Capecitabine 2.5 g/m^2/Day | 330 |
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Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for the Treatment of Cancer Quality of Life Core Questionnaire Scores Based on Core 30 Items (EORTC-QLQ-C30) at Week 6
EORTC-QLQ-C30:cancer-specific instrument with 30 questions to assess the participant QoL. First 28 questions used to evaluate 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items(dyspnoea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Each of these 28 questions assessed on 4-point scale(1=not at all, 2=a little, 3=quite a bit, 4=very much); functional scales: higher score=better level of functioning; symptom scale: higher score=more severe symptoms; for single items: higher score= more severe problem. Last 2 questions used to evaluate global health status (GHS)/QoL. Each question was assessed on 7-point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning. (NCT00337103)
Timeframe: Baseline and Week 6
Intervention | units on a scale (Mean) |
---|
Eribulin Mesylate 1.4 mg/m^2 | 0.1 |
Capecitabine 2.5 g/m^2/Day | 1.7 |
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Change From Baseline in Pain Intensity by Visual Analog Scale (VAS) Until 30 Days After the Last Dose of Study Drug
"Pain intensity was measured by marking a single vertical line that crosses a 1-100 mm unmarked VAS scale. The left-end of the visual analog scale was labelled least possible pain and the right-end of the visual analog scale was labelled worst possible pain. The pain rating ranged from 0 to 100, with a higher score indicating more pain. A negative change score indicated improvement." (NCT00337103)
Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Intervention | units on a scale (Mean) |
---|
Eribulin Mesylate 1.4 mg/m^2 | -3.7 |
Capecitabine 2.5 g/m^2/Day | 0.4 |
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Change From Baseline in European Organization for the Treatment of Cancer Quality of Life Core Questionnaire Scores Based on Breast Cancer Specific 23 Items (EORTC-QLQ- BR 23) at Week 6
EORTC-QLQ-BR23:disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess quality of life of participants with breast cancer. The scores from 23 items of QLQ-BR23 included functional scales (body image, sexual functioning, sexual enjoyment, future perspective), symptom scales (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss). Each item was rated on a scale of 1 to 4 to record level of intensity (1= not at all, 2= a little, 3= quite a bit, 4= very much) within each scales. Scores averaged and transformed to 0-100 scale. High score indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. (NCT00337103)
Timeframe: Baseline and Week 6
Intervention | units on a scale (Mean) |
---|
| Body Image | Sexual functioning | Sexual enjoyment | Future perspective | Systemic therapy side effects | Breast Symptoms | Arm Symptoms | Upset by hair loss |
---|
Capecitabine 2.5 g/m^2/Day | 4.8 | -0.1 | 3.1 | 10.0 | -1.2 | -3.6 | -3.4 | -10.1 |
,Eribulin Mesylate 1.4 mg/m^2 | 0.7 | 1.2 | 0.8 | 7.7 | 4.5 | -3.4 | -4.2 | -4.4 |
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Plasma Concentrations of Eribulin Mesylate
(NCT00337103)
Timeframe: Cycle 1 Day 1: 5-10 minutes(min), 15-30 min, 30-60 min, 60-90 min, 2-4 hours(hrs), 4-8 hrs, 10-24 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs after the start of infusion of Eribulin mesylate (Duration of each cycle is 21 days)
Intervention | nanogram per milliliter (ng/mL) (Mean) |
---|
| 5-10 minutes | 15-30 minutes | 30-60 minutes | 60-90 minutes | 2-4 hours | 4-8 hours | 10-24 hours | 48-72 hours | 72-96 hours | 96-120 hours |
---|
Eribulin Mesylate 1.4 mg/m^2 | 415.8 | 152.6 | 95.5 | 52.7 | 20.7 | 10.0 | 5.8 | 3.7 | 2.4 | 7.6 |
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Overall Survival Rate
One-, two-, and three- year's survival rates were defined as the percentage of participants who were alive at one, two, and three years respectively, and estimated using the Kaplan-Meier method and Greenwood Formula. (NCT00337103)
Timeframe: From the date of randomization to Year 1, 2 and 3
Intervention | percentage of participants (Number) |
---|
| At 1-year | At 2-years | At 3-years |
---|
Capecitabine 2.5 g/m^2/Day | 0.580 | 0.298 | 0.145 |
,Eribulin Mesylate 1.4 mg/m^2 | 0.644 | 0.328 | 0.178 |
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs included both SAEs as well as non-SAEs. (NCT00337103)
Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Intervention | Participants (Count of Participants) |
---|
| TEAEs | SAEs |
---|
Capecitabine 2.5 g/m^2/Day | 494 | 115 |
,Eribulin Mesylate 1.4 mg/m^2 | 512 | 95 |
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Duration of Eribulin Mesylate Exposure
Data have been reported per primary analysis completion stage and final analysis completion stage. After primary analysis completion (at cutoff date of 12 March 2012), only 10 participants were still receiving study treatment. (NCT00337103)
Timeframe: Up to approximately 6 years for primary analysis completion stage, Up to approximately 6 years 2 months for final analysis completion stage
Intervention | days (Median) |
---|
| At primary analysis completion stage | At final analysis completion stage |
---|
Capecitabine 2.5 g/m^2/Day | 119.0 | 1506.0 |
,Eribulin Mesylate 1.4 mg/m^2 | 125.0 | 1743.0 |
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Overall Survival Rate
1-year, 2-year, and 4-year actuarial overall survival (OS) rates defined as number of participants out of total participants alive at 1, 2 or 4 years post baseline treatment. (NCT00338039)
Timeframe: 1 to 4 years
Intervention | percentage of participants (Number) |
---|
| 1-year OS Rate | 2-year OS Rate | 4-year OS Rate |
---|
Chemotherapy + Chemoradation | 66.0 | 25.02 | 11.3 |
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Number of Participants With Objective Response
Objective Response = Complete Response + Partial Response. Response evaluated using modification of new international criteria proposed by RECIST [changes in only largest diameter (unidimensional measurement) of tumor lesions used in the RECIST criteria]. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT00338988)
Timeframe: Baseline with restaging every 3 cycles (cycle=21 days)
Intervention | participants (Number) |
---|
Capecitabine + Oxaliplatin | 1 |
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Complete Clinical Response Rate (CCR)
Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. (NCT00347438)
Timeframe: After the first three cycles of therapy, an average of 9 weeks
Intervention | percentage of participants (Number) |
---|
Capecitabine | 0 |
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Complete Pathologic Response Rate (cPR)
Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. (NCT00347438)
Timeframe: After the first three cycles of therapy, an average of 9 weeks
Intervention | percentage of participants (Number) |
---|
Capecitabine | 0 |
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Partial Clinical Response Rate (PR)
Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions. (NCT00347438)
Timeframe: After the first three cycles of therapy, an average of 9 weeks
Intervention | participants (Number) |
---|
Capecitabine | 5 |
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Overall Clinical Response Rate (OCR)
Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions. (NCT00347438)
Timeframe: After the first three cycles of therapy, an average of 9 weeks
Intervention | percentage of participants (Number) |
---|
Capecitabine | 31.3 |
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Clearance of Total And Free Platinum
CL is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (hour). (NCT00353262)
Timeframe: Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3
Intervention | mL/Hr (Geometric Mean) |
---|
| Total Platinum: Cycle 1, Day 2 | Total Platinum: Cycle 2, Day 1 | Total Platinum: Cycle 3, Day 1 | Free Platinum: Cycle 1, Day 2 | Free Platinum: Cycle 2, Day 1 | Free Platinum: Cycle 3, Day 1 |
---|
Capecitabine+ Oxaliplatin+ Bevacizumab | 1603 | 1331 | 1198 | 22183 | 21176 | 21823 |
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Marked Laboratory Abnormalities
Number of participants with marked laboratory abnormalities (hematology, coagulation, liver function, renal function, protein, electrolytes, miscellaneous). (NCT00353262)
Timeframe: Up to 28 days after last chemotherapy administration
Intervention | Participants (Number) |
---|
| Hematocrit - high | Hematocrit - low | Hemoglobin - low | Platelets - high | Platelets - low | RBC - low | WBC - high | WBC - low | Neutrophils - high | Neutrophils - low | PT (INR) - high | ASAT (SGOT) - high | LDH - high | ALAT (SGPT) - high | Alk. Phos. - high | Dir. Bilirubin - high | Total Bilirubin - high | Creatinine - high | Albumin - low | Potassium - low | Sodium - low | Calcium - low | Glucose Fasting - high |
---|
Capecitabine+ Oxaliplatin+ Bevacizumab | 2 | 5 | 6 | 1 | 9 | 12 | 1 | 7 | 1 | 3 | 2 | 6 | 2 | 7 | 6 | 3 | 2 | 0 | 4 | 2 | 2 | 1 | 4 |
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Cmax of Total And Free Platinum
Cmax is defined as maximum observed analyte concentration of Total And Free Platinum. (NCT00353262)
Timeframe: Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.
Intervention | ng/mL (Geometric Mean) |
---|
| Total Platinum: Cycle 1, Day 2 | Total Platinum: Cycle 2, Day 1 | Total Platinum: Cycle 3, Day 1 | Free Platinum: Cycle 1, Day 2 | Free Platinum: Cycle 2, Day 1 | Free Platinum: Cycle 3, Day 1 |
---|
Capecitabine+ Oxaliplatin+ Bevacizumab | 3652 | 3741 | 3706 | 1818 | 1840 | 1813 |
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AUC0-inf for Free Platinum
AUC0-infinity represents the area under the concentration-time curve of the analyte (free platinum) in plasma over the time interval from 0 extrapolated to infinity. AUC0-inf for free platinum was calculated for each participant from the concentration-data obtained on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. Free platinum is not bound to plasma proteins and is considered to be the most clinically significant measure of pharmacological and toxicological activity. (NCT00353262)
Timeframe: Predose , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the 2 hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.
Intervention | ng/mL * hr (Geometric Mean) |
---|
| Cycle 1, Day 2 | Cycle 2 , Day 1 | Cycle 3, Day 1. |
---|
Capecitabine+ Oxaliplatin+ Bevacizumab | 10069 | 10537 | 10225 |
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AUC0-infinity for Total Platinum
AUC0-infinity represents the area under the concentration-time curve of the analyte (total platinum) in plasma over the time interval from 0 extrapolated to infinity. (NCT00353262)
Timeframe: Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3
Intervention | ng/mL* hr (Geometric Mean) |
---|
| Cycle 1, Day 2 | Cycle 2, Day 1 | Cycle 3, Day 1 |
---|
Capecitabine+ Oxaliplatin+ Bevacizumab | 139329 | 167610 | 186268 |
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AUC0-last of Total And Free Platinum
Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of Total And Free Platinum. (NCT00353262)
Timeframe: pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.
Intervention | ng/mL* hr (Geometric Mean) |
---|
| Total Platinum: Cycle 1, Day 2 | Total Platinum: Cycle 2, Day 1 | Total Platinum: Cycle 3, Day 1 | Free Platinum: Cycle 1, Day 2 | Free Platinum: Cycle 2, Day 1 | Free Platinum: Cycle 3, Day 1 |
---|
Capecitabine+ Oxaliplatin+ Bevacizumab | 85406 | 97083 | 97011 | 9399 | 9818 | 9604 |
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Volume of Distribution at Steady State (VSS) of Total And Free Platinum
VSS is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. (NCT00353262)
Timeframe: Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours
Intervention | mL (Geometric Mean) |
---|
| Total Platinum: Cycle 1, Day 2 | Total Platinum: Cycle 2, Day 1 | Total Platinum: Cycle 3, Day 1 | Free Platinum: Cycle 1, Day 2 | Free Platinum: Cycle 2, Day 1 | Free Platinum: Cycle 3, Day 1 |
---|
Capecitabine+ Oxaliplatin+ Bevacizumab | 109007 | 105097 | 112141 | 387158 | 389193 | 401040 |
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Number Of Participants With Adverse Events (AEs)
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. This includes any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during the study were also to be reported as AEs. (NCT00353262)
Timeframe: Approximately 3 Years (up to 28 days after the last intake of study medication)
Intervention | Participants (Number) |
---|
| Any AE | Any SAE |
---|
Capecitabine+ Oxaliplatin+ Bevacizumab | 36 | 16 |
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Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0-Inf) of 5'-Deoxy-5-fluorouridine 5'-(DFUR)
AUC0-infinity represents the area under the concentration-time curve of the analyte (5'-DFUR) in plasma over the time interval from 0 extrapolated to infinity. The analyte 5'-DFUR, the direct precursor of 5-fluorouracil (5-FU), is considered to be the most important metabolite of capecitabine in plasma. The unit of measure was nanograms per millilitre per hour (ng/mL * hr). (NCT00353262)
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose.
Intervention | ng/mL*hr (Geometric Mean) |
---|
| Cycle 1, Day 1 | Cycle 2, Day 1 | Cycle 3, Day 1 |
---|
Capecitabine+ Oxaliplatin+ Bevacizumab | 13605 | 12177 | 11817 |
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T1/2 Beta of Total And Free Platinum
T1/2 beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of total and free platinum. (NCT00353262)
Timeframe: Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3
Intervention | hour (Geometric Mean) |
---|
| Total Platinum: Cycle 1, Day 2 | Total Platinum: Cycle 2, Day 1 | Total Platinum: Cycle 3, Day 1 | Free Platinum: Cycle 1, Day 2 | Free Platinum: Cycle 2, Day 1 | Free Platinum: Cycle 3, Day 1 |
---|
Capecitabine+ Oxaliplatin+ Bevacizumab | 48.70 | 55.73 | 67.28 | 17.64 | 18.41 | 18.47 |
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Number of Adverse Events
(NCT00354224)
Timeframe: From the start of study treatment through study completion for up to about 18 weeks
Intervention | Serious Adverse Events (Number) |
---|
Oxaliplatin + Capecitabine | 4 |
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Number of Participants With Grade 3 or Higher Toxicity
summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom. (NCT00354601)
Timeframe: Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)
Intervention | participants (Number) |
---|
Docetaxel and Capecitabine | 1 |
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Number of Participants With Overall Response
Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR. (NCT00354887)
Timeframe: Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses
Intervention | participants (Number) |
---|
| Participants with CR | Participants with PR |
---|
Oxaliplatin + Capecitabine | 3 | 12 |
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Number of Patients With at Least One Surgical Complications (Wound Dehiscence, Infection, Seroma, or Hematoma).
Number of patients with at least one surgical complications (wound dehiscence, infection, seroma, or hematoma) (NCT00365417)
Timeframe: Two (2) years
Intervention | participants (Number) |
---|
Chemo Plus Bevacizumab | 24 |
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Clinical Response Rate (cRR) of the Sequential Regimen
Clinical tumor measurements were required before study entry & before cycle 5 of chemotherapy (between AC & TX). Final tumor measurements were obtained 4-5 weeks after the last dose of chemotherapy. Clinical tumor assessments by physical examination were recommended before each chemotherapy cycle. The criteria proposed by the Response Evaluation Criteria in Solid Tumors Committee(RECIST) were used to define clinical response status. CR was defined as the disappearance of all lesions with no evidence of PD. PR was defined as at least 30% decrease in the sum of the longest diameter of target lesions, using as reference the baseline sum longest diameter and/or the persistence of greater than or equal to 1 nontarget lesion without worsening of any other clinical manifestations of disease. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions, or unequivocal progression of existing lesions. (NCT00365417)
Timeframe: Approximately 6 months
Intervention | percentage of patients (Number) |
---|
Chemo Plus Bevacizumab | 77.27 |
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Cardiac Events
Events: Congestive Heart Failure; Cardiac Death (NCT00365417)
Timeframe: Assessments throughout; up to 18 months following study entry
Intervention | cardiac events (Number) |
---|
Chemo Plus Bevacizumab | 0 |
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pCR in the Breast and Nodes
Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel nodes (NCT00365417)
Timeframe: Approximately 7 months
Intervention | participants (Number) |
---|
| pCR in the breast and nodes | No pCR in the breast and nodes | No data available |
---|
Neoadjuvant Study Treatment | 4 | 38 | 3 |
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Progression-free Survival
Percentage of patients free from disease progression. Progression is determined using international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. At least a 20% increase in the sum of the longest diameter of the target lesions. Other manifestations of progressive disease would also be classified as disease progression, eg., appearance of one or more new lesions in the breast, regional lymph nodes or distant sites, unequivocal progression of existing non-target lesions, and appearance of inflammatory carcinoma on clinical exam. (NCT00365417)
Timeframe: 2 years
Intervention | percentage of patients (Number) |
---|
Chemo Plus Bevacizumab | 57.69 |
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Overall Survival
Percentage of patients alive. (NCT00365417)
Timeframe: 2 years
Intervention | percentage of patients (Number) |
---|
Chemo Plus Bevacizumab | 74.52 |
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Pathologic Complete Response (pCR) in the Breast
Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen (NCT00365417)
Timeframe: Approximately 7 months
Intervention | participants (Number) |
---|
| pCR in the breast | No pCR in the breast | No data available |
---|
Neoadjuvant Study Treatment | 4 | 38 | 3 |
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Reported Adverse Events
Number of Adverse Events (NCT00365417)
Timeframe: Approximately 14 months
Intervention | events (Number) |
---|
Neoadjuvant Study Treatment | 566 |
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Time to Tumor Progression (TTP)
Time from randomization to first documentation of objective tumor progression. (NCT00373113)
Timeframe: From time of randomization to every 6 weeks thereafter through 22 months
Intervention | Months (Median) |
---|
Sunitinib | 2.8 |
Capecitabine | 4.2 |
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Number of Participants With Overall Response (OR)
OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00373113)
Timeframe: From time of randomization to every 6 weeks thereafter through 22 months
Intervention | Participants (Number) |
---|
Sunitinib | 27 |
Capecitabine | 40 |
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Overall Survival (OS)
Average time from randomization to first documentation of death due to any cause. (NCT00373113)
Timeframe: From time of randomization until death
Intervention | Months (Median) |
---|
Sunitinib | 15.3 |
Capecitabine | 16.9 |
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Progression-Free Survival (PFS)
Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first. (NCT00373113)
Timeframe: From time of randomization to every 6 weeks thereafter through 22 months or until death
Intervention | Months (Median) |
---|
Sunitinib | 2.8 |
Capecitabine | 4.2 |
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Duration of Response (DR)
Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. (NCT00373113)
Timeframe: From time of randomization to every 6 weeks thereafter through 22 months or death
Intervention | Months (Median) |
---|
Sunitinib | 6.9 |
Capecitabine | 9.3 |
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Overall Survival (OS)
The number of months measured from the date of randomization to the date of death due to any cause. (NCT00382720)
Timeframe: up to a maximum of 36 months
Intervention | months (Median) |
---|
(TE) Taxotere and Eloxatin | 8.97 |
(TEF) Taxotere, Eloxatin and 5-fluorouracil | 14.59 |
(TEX) Taxotere, Eloxatin and Xeloda | 11.30 |
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Time to Progression
"The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause.~WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion." (NCT00382720)
Timeframe: every 8 weeks up to a maximum of 36 months
Intervention | Months (Median) |
---|
(TE) Taxotere and Eloxatin | 4.50 |
(TEF) Taxotere, Eloxatin and 5-fluorouracil | 7.66 |
(TEX) Taxotere, Eloxatin and Xeloda | 5.55 |
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Best Overall Response Rate (ORR)
"Percentage of partial and complete responses, according to WHO criteria:~Complete Response: Disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.~Partial Response: Decrease by at least 50% of the diameters of all measurable lesions, determined by 2 observations not less than 4 weeks apart." (NCT00382720)
Timeframe: every 8 weeks up to a maximum of 36 months
Intervention | percentage of participants (Number) |
---|
(TE) Taxotere and Eloxatin | 23.1 |
(TEF) Taxotere, Eloxatin and 5-fluorouracil | 46.6 |
(TEX) Taxotere, Eloxatin and Xeloda | 25.6 |
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12-month Progression Free Survival (PFS)
Percentage of participants with 12-month progression-free survival (PFS) was assessed. PFS is defined as the time from enrollment until documented disease progression or death (whichever occurred first). RECIST criteria (version 1). Complete response (CR) defined as disappearance of all target lesions. Partial Response (PR) defined as ≥ 30% decrease of SLD. Progressive disease (PD) defined as ≥ 20% increase in Sum Longest Diameters (SLD). Stable Disease (SD) defined as being between 20% increase and < 30% decrease in SLD. (NCT00398320)
Timeframe: PFS assessed every 3 months through 12 months
Intervention | percentage of participants w/ 12 mo PFS (Number) |
---|
Capecitabine / Oxaliplatin / Bevacizumab | 64.7 |
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Overall Survival (OS)
OS is defined as time from enrollment until death from any cause. (NCT00398320)
Timeframe: Continuous
Intervention | months (Median) |
---|
Capecitabine / Oxaliplatin / Bevacizumab | 42.2 |
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Biochemical Markers
(NCT00398320)
Timeframe: Assessed every 3 weeks while on treatment
Intervention | participants (Number) |
---|
| 25 to 49% reduction in 1 or more hormones | ≥ 50% reduction in 1 or more hormones |
---|
Capecitabine / Oxaliplatin / Bevacizumab | 6 | 12 |
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Response Rates
Response rate is defined as percent of patients with complete response (CR) and partial response (PR) as their best response as defined by RECIST criteria (version 1). Complete response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as ≥ 30 decrease in the sum of longest diameters of target lesions (SLD). Overall response (OR) = CR + PR. (NCT00398320)
Timeframe: Response rates by RECIST criteria assessed every 3 months while on treatment
Intervention | percentage of participants (Number) |
---|
Capecitabine / Oxaliplatin / Bevacizumab | 17.5 |
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Progression-free Survival
(NCT00398398)
Timeframe: 1 year
Intervention | months (Median) |
---|
Xelox Plus Cetuximab | 6.5 |
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Toxicity Profile
Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of XELOX plus Cetuximab (NCT00398398)
Timeframe: 1 years
Intervention | participants (Number) |
---|
Xelox Plus Cetuximab | 44 |
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Overall Survival
(NCT00398398)
Timeframe: 1 year
Intervention | months (Median) |
---|
Xelox Plus Cetuximab | 11.8 |
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Overall Response Rate
Tumor response was evaluated every two cycles by CT scans and other indicated methods, and the patients with complete or partial response required a confirmatory response evaluation at least 4 weeks later. Patients without confirmatory evaluation were not regarded as responders. (NCT00398398)
Timeframe: 6 months
Intervention | participants (Number) |
---|
Xelox Plus Cetuximab | 23 |
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Time to Wound Healing Complications
Number of days from post-randomisation surgery until wound healing complications (NCT00399035)
Timeframe: Post-randomisation until end of study
Intervention | Days (Median) |
---|
Cediranib 20 mg | 18 |
Placebo | 18 |
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Overall Survival
Number of months from randomisation to the date of death from any cause (NCT00399035)
Timeframe: Baseline through to date of death upto and including data cut off date of 21/03/10
Intervention | Months (Median) |
---|
Cediranib 20 mg | 19.7 |
Placebo | 18.9 |
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Overall Response Rate
Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi (NCT00399035)
Timeframe: Baseline through to date of death upto and including data cut off date of 21/03/10
Intervention | Participants (Number) |
---|
Cediranib 20 mg | 254 |
Placebo | 178 |
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Progression-free Survival
RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression [non-PD]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions. (NCT00399035)
Timeframe: RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.
Intervention | Months (Median) |
---|
Cediranib 20 mg | 8.6 |
Placebo | 8.2 |
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Duration of Response
Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies. (NCT00399035)
Timeframe: Treatment period from initial response up until data cut-off date of 21/03/10
Intervention | Months (Median) |
---|
Cediranib 20 mg | 8.5 |
Placebo | 6.9 |
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Best Percentage Change in Tumour Size
Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions (NCT00399035)
Timeframe: Baseline through to date of death upto and including data cut off date of 21/03/10
Intervention | Percentage [change in tumour size (mm) ] (Mean) |
---|
Cediranib 20 mg | -42.49 |
Placebo | -40.61 |
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Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone
The number of patients who experienced Grade 1 or above Adverse Events. Referring to the Adverse Events tables for specifics. (NCT00408408)
Timeframe: 24 months after study entry
Intervention | participants (Number) |
---|
Arm 1A: Docetaxel Then AC | 180 |
Arm 1B Docetaxel + Bev Then AC + Bev | 157 |
Arm 2A: Docetaxel + Capecitabine Then AC | 172 |
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 185 |
Arm 3A: Docetaxel + Gem Then AC | 158 |
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 185 |
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Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens
The percentage of patients assessed by physical exam as Clinical Complete Response according to RECIST. (NCT00408408)
Timeframe: Three to four weeks after the last chemotherapy dose, on average at 6 or 13 months
Intervention | percentage of patients (Number) |
---|
Arm 1A: Docetaxel Then AC | 52.3 |
Arm 1B Docetaxel + Bev Then AC + Bev | 64.6 |
Arm 2A: Docetaxel + Capecitabine Then AC | 51.3 |
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 59.1 |
Arm 3A: Docetaxel + Gem Then AC | 52.6 |
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 60 |
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Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy
Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST. (NCT00408408)
Timeframe: Assessed at cycle 5 of chemotherapy, on average at 15 weeks
Intervention | percentage of patients (Number) |
---|
Arm 1A: Docetaxel Then AC | 30 |
Arm 1B Docetaxel + Bev Then AC + Bev | 43.3 |
Arm 2A: Docetaxel + Capecitabine Then AC | 29.8 |
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 34.5 |
Arm 3A: Docetaxel + Gem Then AC | 37.9 |
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 42 |
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Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens
The percentage of patients assessed by physical exam as Clinical Complete Response or Clinical Partial Response according to RECIST. (NCT00408408)
Timeframe: Three to four weeks after the last chemotherapy dose on average 6 or 13 months
Intervention | percentage of patients (Number) |
---|
Arm 1A: Docetaxel Then AC | 79.9 |
Arm 1B Docetaxel + Bev Then AC + Bev | 87.7 |
Arm 2A: Docetaxel + Capecitabine Then AC | 75.4 |
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 90.7 |
Arm 3A: Docetaxel + Gem Then AC | 83.3 |
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 80.5 |
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Pathologic Complete Response (pCR) of the Primary Tumor in the Breast
Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen. (NCT00408408)
Timeframe: Time of surgery, on average 6 or 13 months
Intervention | percentage of patients (Number) |
---|
Arm 1A: Docetaxel Then AC | 33.7 |
Arm 1B Docetaxel + Bev Then AC + Bev | 31.6 |
Arm 2A: Docetaxel + Capecitabine Then AC | 23.5 |
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 36.1 |
Arm 3A: Docetaxel + Gem Then AC | 27.6 |
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 35.8 |
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pCR in the Breast and Nodes
Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes. (NCT00408408)
Timeframe: Time of surgery, on average 6 or 13 months
Intervention | percentage of patients (Number) |
---|
Arm 1A: Docetaxel Then AC | 27.3 |
Arm 1B Docetaxel + Bev Then AC + Bev | 24.4 |
Arm 2A: Docetaxel + Capecitabine Then AC | 18.7 |
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 27.4 |
Arm 3A: Docetaxel + Gem Then AC | 22.9 |
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 30.3 |
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Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy
Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST. (NCT00408408)
Timeframe: Assessed at cycle 5 of chemotherapy, on average at 15 weeks
Intervention | percentage of patients (Number) |
---|
Arm 1A: Docetaxel Then AC | 77 |
Arm 1B Docetaxel + Bev Then AC + Bev | 87.6 |
Arm 2A: Docetaxel + Capecitabine Then AC | 73.7 |
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 84 |
Arm 3A: Docetaxel + Gem Then AC | 82.6 |
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 88 |
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Disease-free Survival (DFS)
Percentage of patients free from local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer after 5 years. (NCT00408408)
Timeframe: Measured through 5 years after study enrollment
Intervention | percentage of patients (Number) |
---|
Arm 1A: Docetaxel Then AC | 73.4 |
Arm 1B Docetaxel + Bev Then AC + Bev | 72.2 |
Arm 2A: Docetaxel + Capecitabine Then AC | 68.5 |
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 77.1 |
Arm 3A: Docetaxel + Gem Then AC | 72.9 |
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 74.8 |
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Surgical Complication
Number of patients with Grade 4 or above surgery-related toxicities (NCT00408408)
Timeframe: 24 months after study entry
Intervention | participants (Number) |
---|
Arm 1A: Docetaxel Then AC | 1 |
Arm 1B Docetaxel + Bev Then AC + Bev | 1 |
Arm 2A: Docetaxel + Capecitabine Then AC | 0 |
Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 1 |
Arm 3A: Docetaxel + Gem Then AC | 0 |
Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 1 |
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Number of Participants With Grade 3-4 Adverse Events Reported
(NCT00408564)
Timeframe: from start of study treatment until end of study visit, about 30 weeks
Intervention | participants (Number) |
---|
Gemcitabine,Oxaliplatin and Cetuximab | 9 |
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Response Rate
defined as the total number of subjects whose best response is PR or CR. (NCT00408564)
Timeframe: up to 46 weeks after the start of study treatment
Intervention | Participants (Count of Participants) |
---|
Gemcitabine,Oxaliplatin and Cetuximab | 5 |
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Progression-free Survival at 6 Months
(NCT00408564)
Timeframe: up to 46 weeks after the start of study treatment
Intervention | percentage of participants (Number) |
---|
Gemcitabine,Oxaliplatin and Cetuximab | 82 |
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Overall Survival
(NCT00408564)
Timeframe: up to 46 weeks after the start of study treatment
Intervention | percentage of participants (Number) |
---|
Gemcitabine,Oxaliplatin and Cetuximab | 49 |
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Feasibility and Safety of Pre-operative Chemotherapy in Locally Advanced Gastric Cancer as Assessed by Number of Participants Who Experienced Adverse Events Grade 3 or Higher as Defined by CTCAE.
Number of participants who experience Grade 3/4 neutropenia, Grade 3 nausea or Grade 3 diarrhea. (NCT00414271)
Timeframe: up to 5 years
Intervention | Participants (Count of Participants) |
---|
| Grade 3/4 neutropenia | Grade 3 nausea | Grade 3 diarrhea |
---|
Open Label, Single Arm | 10 | 1 | 2 |
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Overall Survival
Median number of months participants alive at the time of observation. Calculated using Kaplan-Meier method. (NCT00414271)
Timeframe: up to 8 years
Intervention | months (Median) |
---|
Open Label, Single Arm | 17.1 |
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Progression-free Survival as Measured by Number of Participants Without Disease Progression.
(NCT00414271)
Timeframe: up to 5 years
Intervention | Participants (Count of Participants) |
---|
Open Label, Single Arm | 3 |
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Number of Participants With Pathological Response
Number of participants who completed neoadjuvant chemotherapy and underwent repeat CT and endoscopic ultrasound (EUS) with pathological complete response (pCR), partial response in the primary tumor, stable disease or progressive disease as defined by EUS criteria. (NCT00414271)
Timeframe: up to 5 years
Intervention | Participants (Count of Participants) |
---|
| pathological complete response (pCR) | partial response | stable disease | progressive disease |
---|
Open Label, Single Arm | 0 | 4 | 8 | 3 |
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Time to Progression
"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions." (NCT00416494)
Timeframe: From time of treatment until documented progression, assesed up to 60 months.
Intervention | months (Median) |
---|
Initial Cohort | 10.1 |
Second Cohort | 10.4 |
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Safety and Tolerability
Number of participants with adverse events (NCT00416494)
Timeframe: After all participants went off study drug regimine.
Intervention | participants with adverse event (Number) |
---|
Initial Cohort | 19 |
Second Cohort | 29 |
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Overall Survival
Average months of survival of participants after receiving study drug. (NCT00416494)
Timeframe: From time of treatment until death from any cause, assesed up to 60 months.
Intervention | months (Median) |
---|
Initial Cohort | 19.6 |
Second Cohort | 24.8 |
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Disease Free Survival
"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions." (NCT00416494)
Timeframe: From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.
Intervention | months (Median) |
---|
Initial Cohort | 10.1 |
Second Cohort | 10.4 |
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Response Rate (Percentage of Participants With Partial or Complete Response)
"Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.~Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~The definitions were:~Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions" (NCT00416494)
Timeframe: After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.
Intervention | percentage of participants with response (Number) |
---|
Initial Cohort | 63 |
Second Cohort | 42 |
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Response Rate
Response was evaluated using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), every 3 cycles of chemotherapy (each cycle lasts 3 weeks) and at the end of treatment (at 21 weeks from the start of treatment). (NCT00418028)
Timeframe: Through the study treatment, an average of 5 months.
Intervention | Participants (Count of Participants) |
---|
Arm A (Cint) | 30 |
Arm B (Ccont) | 31 |
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Response Duration
"Response duration is computed for all patients with Partial Response or Complete Response, during the treatment period, as the time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first.~A patient is censored if she does not progress or die. In these cases Response duration is computed as the time from the moment the Partial or Complete Response is reported to the last contact date." (NCT00418028)
Timeframe: Time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first, assessed up to 72 weeks.
Intervention | Months (Median) |
---|
Arm A (Cint) | 10.07 |
Arm B (Ccont) | 7.20 |
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Progression Free Survival
Progression Free Survival is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies for any reason. (NCT00418028)
Timeframe: Time (in months) from the moment the patient starts the study treatment to the date of progressive disease assessed up to 84 months.
Intervention | Months (Median) |
---|
Arm A (Cint) | 8.52 |
Arm B (Ccont) | 6.84 |
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Overall Survival
An event is defined as death. A patient is censored if she does not die. The censoring date is last contact date. (NCT00418028)
Timeframe: Time to survival is the number of months from the study treatment start date to the date of death, assessed up to 100 months.
Intervention | Months (Median) |
---|
Arm A (Cint) | 27.34 |
Arm B (Ccont) | 24.11 |
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Time to Progression
Time to Progression (TTP) is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies due to progressive disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). (NCT00418028)
Timeframe: After 1 year from the treatment start day.
Intervention | months (Median) |
---|
Arm A (Cint) | 8.68 |
Arm B (Ccont) | 6.84 |
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Time to Treatment Failure
"Time to treatment failure (TTF) is defined as the time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient's decision or investigator criteria.~If a patient did not end the treatment, it is censored. The censoring date is the date of the last dose received." (NCT00418028)
Timeframe: Time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient's decision or investigator criteria, assessed up to 72 months.
Intervention | Months (Median) |
---|
Arm A (Cint) | 5.41 |
Arm B (Ccont) | 5.87 |
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Clinical Benefit
"A patient experiences a Clinical Benefit if the following is satisfied:~Criterion: The patient has Complete response, Partial Response or Stable Disease and it continues during more than 3 months." (NCT00418028)
Timeframe: "Months from CR,PR or SD (the first one) until Progression date, new treatment or last contact date."
Intervention | Participants (Count of Participants) |
---|
Arm A (Cint) | 56 |
Arm B (Ccont) | 56 |
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Duration of Response
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods. (NCT00433550)
Timeframe: Up to 2 years
Intervention | months (Median) |
---|
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | 9.0 |
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Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)
Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants. (NCT00433550)
Timeframe: 36 weeks
Intervention | proportion of patients (Number) |
---|
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | .38 |
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Time to Treatment Failure
Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to have had a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. Time to treatment failure will be analyzed using Kaplan-Meier methods. (NCT00433550)
Timeframe: Up to 2 years
Intervention | months (Median) |
---|
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | 6.7 |
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Progression Free Survival
Time to disease progression is defined as the time from registration to the earlier of documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The distribution of time to progression will be estimated using Kaplan-Meier methodology. (NCT00433550)
Timeframe: Up to 2 years
Intervention | months (Median) |
---|
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | 8.9 |
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Overall Survival
Overall survival will be defined as the time from registration to death. Patients lost to follow-up for this endpoint will be censored at the date of last contact (i.e., last known alive). The distribution of overall survival will be estimated using Kaplan-Meier methodology. (NCT00433550)
Timeframe: Up to 2 years
Intervention | months (Median) |
---|
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | 13.4 |
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Overall Survival (OS)
Time from the date of randomization to the date of death due to any cause. OS (in months) calculated as (date of death minus randomization date plus 1) divided by 30.4. For patients lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Patients lacking survival data beyond randomization had their OS times censored at randomization. (NCT00435409)
Timeframe: Baseline until death or up to 3 years from first dose
Intervention | months (Median) |
---|
Sunitinib + Capecitabine | 16.5 |
Capecitabine | 17.2 |
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Duration of Response (DR)
Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in months) was calculated as [the date response ended (date of PD or death) minus first CR or PR date that was subsequently confirmed plus 1)] divided by 30.4. (NCT00435409)
Timeframe: Baseline until response or disease progression (up to 3 years from first dose)
Intervention | months (Median) |
---|
| Independent radiology assessment | Investigator's assessment |
---|
Capecitabine | 8.8 | 7.6 |
,Sunitinib + Capecitabine | 9.0 | 5.7 |
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Percent Chance of Participant Survival
Probability of survival 2 years and 3 years after the first dose of study treatment. (NCT00435409)
Timeframe: Year 1, Year 2, Year 3
Intervention | probability of survival (Number) |
---|
| Year 1 | Year 2 | Year 3 |
---|
Capecitabine | 0.654 | 0.373 | 0.174 |
,Sunitinib + Capecitabine | 0.635 | 0.368 | 0.150 |
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Percentage of Participants With Objective Response (OR)
Proportion of participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST); CR: disappearance of all target lesions, PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD. Confirmed responses = persist on repeat imaging study at least 4 weeks after initial documentation of response. Designation of best response of stable disease (SD) required the criteria to be met at least 5 weeks after randomization. (NCT00435409)
Timeframe: Baseline until response or disease progression (up to 3 years from first dose)
Intervention | percentage of participants (Number) |
---|
| Independent radiology assessment | Investigator's assessment |
---|
Capecitabine | 16.3 | 20.4 |
,Sunitinib + Capecitabine | 18.6 | 25.3 |
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Progression Free Survival (PFS)
Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4. (NCT00435409)
Timeframe: Baseline until disease progression (up to 3 years from first dose)
Intervention | months (Median) |
---|
| Independent radiology assessment | Investigator's assessment |
---|
Capecitabine | 5.9 | 5.5 |
,Sunitinib + Capecitabine | 5.5 | 5.4 |
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Number of Participants With the Indicated Central Nervous System (CNS) Objective Response (OR)
CNS OR is defined as the number of participants with either a complete response (CR) or partial response (PR) as assessed by volumetric analysis of brain magnetic resonance imaging (MRI) and Response Evaluation Criteria In Solid Tumors (RECIST). CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline. (NCT00437073)
Timeframe: From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88
Intervention | participants (Number) |
---|
Lapatinib Plus Capecitabine | 5 |
Lapatinib Plus Topotecan | 0 |
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Number of Participants With the Indicated CNS Responses
"CNS responses were assessed by volumetric (V) analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases (BMs). PR: =>50% reduction in the V sum of all evaluable BMs compared to baseline. A response of Other was used for participants who discontinued the study prior to the first efficacy assessment. Stable Disease (SD): disease that does not meet CR, PR, or CNS progression criteria. Progressive disease (PD): a requirement for a new steroid or an increasing steroid dose for the treatment of worsening neurological signs/symptoms due to BMs." (NCT00437073)
Timeframe: From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88
Intervention | participants (Number) |
---|
| Complete response | Partial response | Stable Disease | Progressive Disease | Unknown | Other |
---|
Lapatinib Plus Capecitabine | 0 | 5 | 6 | 2 | 0 | 0 |
,Lapatinib Plus Topotecan | 0 | 0 | 3 | 1 | 3 | 2 |
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Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State
Area Under the Concentration versus time curve during 1 dosing interval at steady state (AUCτ,ss) for Cycle 2 Day 1 for Enzastaurin, its metabolite LY326020 and total analytes (enzastaurin + LY326020). AUCτ,ss was calculated using concentration versus time data by post hoc estimation of enzastaurin, its metabolite LY326020, and total analytes (enzastaurin + LY326020). (NCT00437294)
Timeframe: From pre-dose to 24 hours post-dose on Day 1 of Cycle 2
Intervention | nanomoles*hour per liter (nmol*hr/L) (Geometric Mean) |
---|
| Enzastaurin | Enzastaurin Metabolite LY326020 | Total Analytes (enzastaurin + LY326020) |
---|
Capecitabine + Enzastaurin | 90000 | 40700 | 137000 |
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Pharmacology Toxicity and Adverse Events (AEs)
Data presented are the number of participants who experienced serious AEs, AEs, death due to progressive disease (PD), death due to AEs while on treatment and death during the 30-day post-treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. (NCT00437294)
Timeframe: Baseline to study completion [Cycle 19 (21 days/cycle) and 30-day safety follow-up]
Intervention | Participants (Count of Participants) |
---|
| Serious AEs | Other non-serious AEs | Deaths Due to PD | Deaths Due to AEs | Deaths in 30-day follow-up |
---|
Capecitabine + Enzastaurin | 12 | 38 | 13 | 4 | 6 |
,Capecitabine + Placebo | 12 | 40 | 12 | 2 | 1 |
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Duration of Response (DOR)
The DOR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. According to the Response Evaluation Criteria in Solid Tumors (RECIST V1.0) criteria, CR was the disappearance of all tumor lesions. PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions, with occurrence of no new lesions. For participants not known to have died as of the data cut-off date and who did not have progressive disease, DOR was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, DOR was censored at the date of last visit with adequate assessment. (NCT00437294)
Timeframe: Randomization to last visit (up to 9.66 months)
Intervention | months (Median) |
---|
Capecitabine + Enzastaurin | 4.27 |
Capecitabine + Placebo | 3.47 |
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Pharmacokinetics: Maximum Observed Concentration (Cmax) of Capecitabine
Cmax for Capecitabine, 5'-deoxy-5-fluorouridine (5'-DFUR) and its metabolites 5-fluorouracil (5-FU) was calculated from the plasma concentration-time data for each analyte for Day 1 of Cycle 2. (NCT00437294)
Timeframe: From pre-dose to 6 hours post-dose on Day 1 of Cycle 2
Intervention | micrograms/milliliter(ug/mL) (Geometric Mean) |
---|
| Capecitabine | 5-DFUR | 5-FU |
---|
Capecitabine + Enzastaurin | 4.42 | 6.09 | 0.374 |
,Capecitabine + Placebo | 2.75 | 6.05 | 0.206 |
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Overall Survival (OS)
OS was defined as the time in months from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last contact date. (NCT00437294)
Timeframe: Randomization to date of death from any cause up to 20.83 months
Intervention | months (Median) |
---|
Capecitabine + Enzastaurin | 9.86 |
Capecitabine + Placebo | 14.88 |
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Response rate was defined as percent of participants with objective response [CR or PR] over randomized and treated participants using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) Guidelines. CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of one or more non-target lesions. No new lesions may have appeared. (NCT00437294)
Timeframe: Randomization to last visit (up to 9.66 months)
Intervention | percentage of participants (Number) |
---|
Capecitabine + Enzastaurin | 11.9 |
Capecitabine + Placebo | 11.6 |
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Progression Free Survival (PFS)
PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy. (NCT00437294)
Timeframe: Randomization to measured progressive disease or death up to 14 months
Intervention | months (Median) |
---|
Capecitabine + Enzastaurin | 2.79 |
Capecitabine + Placebo | 4.27 |
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Pharmacokinetics: Area Under the Concentration Curve Versus Time From Time 0 to Last Quantifiable Value (AUC0-tlast) of Capecitabine
AUC0-tlast for Capecitabine, 5'-deoxy-5-fluorouridine (5'-DFUR) and 5-fluorouracil (5-FU) was calculated from the plasma concentration-time data for each analyte for Cycle 2, Day 1. (NCT00437294)
Timeframe: Pre-dose to 6 hours post-dose on Day 1 of Cycle 2
Intervention | micrograms*hour/milliliter (ug*hr/mL) (Geometric Mean) |
---|
| Capecitabine | 5'-deoxy-5-fluorouridine (5'-DFUR) | 5-fluorouracil (5-FU) |
---|
Capecitabine + Enzastaurin | 6.09 | 11.6 | 0.683 |
,Capecitabine + Placebo | 4.18 | 11.0 | 0.358 |
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Progression Free Survival
(NCT00438100)
Timeframe: The follow up period will be two years after the last dose has been administered.
Intervention | years (Median) |
---|
Capecitabine Arm | 1.2 |
S-1 Arm | 1.3 |
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30-Day Post Operative Mortality
The number of participants that died within 30 days of undergoing a pancreaticoduodenectomy. (NCT00438256)
Timeframe: 30 days after the time of surgery (Surgery is 28-42 days after start of treatment)
Intervention | Participants (Count of Participants) |
---|
Proton Beam Radiation/ Capecitabine | 0 |
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Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm
"The number of participants that experienced a dose limiting toxicity in the arm where radiation was administered over 5 consecutive for a total dose of 25 Gray Equivalents (GyE) (Group 4). Participants were monitored for potential Dose Limiting Toxicities (DLT) for three weeks after the start of radiation. DLTs included:~Any grade 3 non-hematologic or hematologic toxicity requiring a greater than 7 day interruption in therapy (excluding alopecia and nausea/vomiting not controlled by optimal supportive care or~Any grade 4 non-hematologic toxicity or~Any grade 4 neutropenia or thrombocytopenia as defined by Common Terminology Criteria for Adverse Events (CTCAE v3.0)" (NCT00438256)
Timeframe: 3 Weeks
Intervention | Participants (Count of Participants) |
---|
Proton Beam Radiation/ Capecitabine | 0 |
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Number of Participants With a Pathological Complete Response
All patients that received surgery underwent a full pathological review of their pancreaticoduodenectomy specimen according to the American Joint Committee on Cancer (AJCC) Staging Classification, 6th. Initial gross evaluation and identification of resection margins was performed jointly by the surgeon and the pathologist. Pathological complete response will be defined as the absence of any viable tumor cells within the pathologic specimen. (NCT00438256)
Timeframe: at the time of surgery (28-42 days after start of treatment)
Intervention | Participants (Count of Participants) |
---|
Proton Beam Radiation/ Capecitabine | 0 |
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Number of Participants With Grade 3 or Greater Toxicity in Phase II
Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). The regimen was considered to be tolerated if less than 20% of participants experienced a grade 3 or greater toxicity. (NCT00438256)
Timeframe: 30 days after the end of treatment, up to approximately 6 months total
Intervention | Participants (Count of Participants) |
---|
Phase II: Proton Beam Radiation/ Capecitabine | 2 |
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Number of Participants With Surgical Morbidity
Number of participants with pancreatic or any other anastomotic leakage within 30 days of surgery (NCT00438256)
Timeframe: 30 days post surgery (surgery was 28-42 days after the start of treatment)
Intervention | Participants (Count of Participants) |
---|
Proton Beam Radiation/ Capecitabine | 0 |
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Toxicity Rates
# of subjects who experienced >= grade 1 adverse event that is positively related to treatment. (NCT00444678)
Timeframe: 1 year since the first treatment and every year after for up to 10 years
Intervention | Participants (Count of Participants) |
---|
Cetuximab, Capecitabine and Oxaliplatin | 36 |
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Time to Progression
Time to Treatment Failure (progression or death) will be defined as the time from the first day of treatment until the date Progressive Disease (PD) or death is first reported. Subjects who die without a reported prior progression will be considered to have progressed on the day of their death. Subjects who did not progress will be censored at the day of their last tumor assessment. (NCT00444678)
Timeframe: 6 months since the start of treatment and every 3 months after treatment for up to 10 years
Intervention | Days (Median) |
---|
Cetuximab, Capecitabine and Oxaliplatin | 275 |
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Survival
Survival will be defined as the number of days from the first day of therapy to the date of death. If the subject is lost to follow-up, survival will be censored on the last date the subject was known to be alive. (NCT00444678)
Timeframe: 6 months since the start of treatment and every 3 months after treatment for up to 10 years
Intervention | Days (Median) |
---|
Cetuximab, Capecitabine and Oxaliplatin | 417 |
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Response Rate for the Combination Treatment
The tumor response rate (RR) will be defined as the total number of subjects whose best response is partial response (PR) or complete response (CR) during the first six months of treatment, divided by the number of subjects. (NCT00444678)
Timeframe: 6 months since the start of treatment
Intervention | Participants (Count of Participants) |
---|
Cetuximab, Capecitabine and Oxaliplatin | 21 |
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Number of Participants With DLTs
Dose limiting toxicity (DLTs) was determined during the Wrst two cycles of treat- ment. The definitions of DLTs were as follows: (1) grade 4 neutropenia lasting for more than 5 days, or grade 3/4 neu- tropenia with fever; (2) grade 4 thrombocytopenia; (3) any other grade 3 non-hematological toxicity (excluding alope- cia); or (4) treatment delay of more than 2 weeks following the time of planned treatment. Maximal tolerated dose was defined as that the DLTs were observed in two or more patients from a cohort of two to six patients (NCT00446290)
Timeframe: 2 years
Intervention | participants (Number) |
---|
DXO Arm | 3 |
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Response Rate
The proportion of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disese) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol. (NCT00447330)
Timeframe: Every 9 weeks for up to 1 year
Intervention | percentage of participants (Number) |
---|
1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti | 41.7 |
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Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population
Objective response rate was the percentage of participants, (n/N; number with objective response per Number evaluated) whose best response is either a Complete Response (CR) or a Partial Response (PR). Disease control rate was defined as percentage (n/N) of participants with stable disease greater than (>) 6 months, PR, or CR. Efficacy Evaluable Population: All participants with at least one measurable lesion at baseline, who received at least one dose of combination study drug and have at least one on-study tumor assessment or stopped study treatment prior to first assessment, were evaluated. Those who stop treatment prior to tumor assessment for reasons unrelated to disease or drug were excluded. (NCT00452673)
Timeframe: Day 1 up to 30 days post last dose
Intervention | percentage of participants (Number) |
---|
| Objective Response Rate | Disease control rate |
---|
100 mg Dasatinib + 1000 mg/m^2Capecitabine | 24.0 | 56.00 |
,50 mg Dasatinib + 825 mg/m^2Capecitabine | 50.0 | 75.0 |
,70 mg Dasatinib + 1000 mg/m^2Capecitabine | 0 | 40.0 |
,70 mg Dasatinib + 825 mg/m^2Capecitabine | 16.67 | 33.33 |
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Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population
Safety was assessed from first dose of study drug through at least 30 days after the last dose, until resolution of drug-related toxicity or when toxicity was deemed irreversible, whichever was longer. An adverse event (AE) was considered a dose limiting toxicity (DLT) if it occurred in the first 21 days and was at least possibly related to study drugs and were: Clinically-evident toxicity of Grade >= 3, or of Grade 2 which required interruption of treatment for >= 7 days (consecutive or non-consecutive); non-hematologic abnormal laboratory value of Grade >= 3, or hematologic toxicity of Grade 4, which persisted 7 days; any grade toxicity which in the judgment of the investigator required a dose reduction or removal from further study therapy. (NCT00452673)
Timeframe: Day 1 to 30 days post last dose
Intervention | participants (Number) |
---|
50 mg Dasatinib + 825 mg/m^2Capecitabine | 1 |
70 mg Dasatinib + 825 mg/m^2Capecitabine | 1 |
70 mg Dasatinib + 1000 mg/m^2Capecitabine | 1 |
100 mg Dasatinib + 1000 mg/m^2Capecitabine | 2 |
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Number of Participants On-study With Grade 3 - 4 Chemistry Laboratory Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population
CTC, Version 3 used to assess parameters. (ULN)=upper limit of normal: (ALT)= alanine transaminase; (AST)=aspartate aminotransferase; (ALP)=alkaline phosphatase. ALT Grade (Gr)1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >ULN to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10.0*ULN; Gr 4: >10.0*ULN. ALP (U/L) Gr1:>ULN to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:NCT00452673)
Timeframe: Day 1 to 30 days post last dose
Intervention | participants (Number) |
---|
| Alkaline Phosphatase (N=4, 6, 5, 21) | Alanine Aminotransferase (N=6, 9, 6, 25) | Aspartate Aminotransferase (N=4, 8, 6, 25) | Total Bilirubin (N=6, 9, 6, 29) |
---|
100 mg Dasatinib + 1000 mg/m^2Capecitabine | 0 | 2 | 1 | 0 |
,50 mg Dasatinib + 825 mg/m^2Capecitabine | 0 | 0 | 0 | 0 |
,70 mg Dasatinib + 1000 mg/m^2Capecitabine | 0 | 0 | 0 | 0 |
,70 mg Dasatinib + 825 mg/m^2Capecitabine | 0 | 0 | 0 | 0 |
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Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population
Complete Response (CR): disappearance of all target and non-target lesions, with confirmation at >=4 weeks interval; Partial Response (PR): >= 30% decrease in sum of longest diameter (LDs) of target lesions, taking as reference the baseline sum LD, with confirmation at >= 4 weeks interval. Progressive Disease (PD): Appearance of new lesion(s), or >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, without unequivocal progression of non-target lesions, after >=6 weeks on study. Radiological tumor assessment by computed tomography (CT) or magnetic resonance imaging (MRI) occurred every 6 weeks. For those patients who were on treatment > 24 weeks, the tumor assessment occurred every 9 weeks. (NCT00452673)
Timeframe: Day 1 to 30 days post last dose
Intervention | participants (Number) |
---|
| Complete Response | Unconfirmed partial response | Partial Response | Stable Disease | Progressive Disease | Clinical Progression | Discontinuation due to study drug toxicity |
---|
100 mg Dasatinib + 1000 mg/m^2Capecitabine | 0 | 3 | 6 | 11 | 3 | 1 | 1 |
,50 mg Dasatinib + 825 mg/m^2Capecitabine | 0 | 1 | 2 | 0 | 1 | 0 | 0 |
,70 mg Dasatinib + 1000 mg/m^2Capecitabine | 0 | 1 | 0 | 2 | 2 | 0 | 0 |
,70 mg Dasatinib + 825 mg/m^2Capecitabine | 0 | 1 | 1 | 1 | 2 | 1 | 0 |
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Number of Participants On-Study With Grade 3 - 4 Hematology Laboratory Test Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population
National Cancer Institute Common terminology criteria (CTC), Version 3 used to assess parameters. Lower limit of normal (LLN). CTC criteria: Absolute neutrophil count (ANC). Leukocytes (White blood cells) Grade (Gr) 1:NCT00452673)
Timeframe: Day 1 up to 30 days post last dose
Intervention | participants (Number) |
---|
| Leukocytes ( N=7, 9, 5, 29) | ANC (N=6, 9, 6, 30) | Platelet Count (N=7, 9, 6, 30) | Hemoglobin (N=7, 6, 4, 18) |
---|
100 mg Dasatinib + 1000 mg/m^2Capecitabine | 1 | 3 | 1 | 3 |
,50 mg Dasatinib + 825 mg/m^2Capecitabine | 0 | 0 | 0 | 0 |
,70 mg Dasatinib + 1000 mg/m^2Capecitabine | 0 | 0 | 0 | 0 |
,70 mg Dasatinib + 825 mg/m^2Capecitabine | 0 | 0 | 0 | 0 |
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Time to Response
Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. (NCT00454636)
Timeframe: Approximately 3.25 years
Intervention | days (Mean) |
---|
Cisplatin / Capecitabine | 132.92 |
Epirubicin / Cisplatin / Capecitabine | 126.64 |
Epirubicin / Oxaliplatin / Capecitabine | 123.50 |
Docetaxel / Cisplatin / Capecitabine | 138.16 |
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Progression-Free Survival (PFS)
PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00454636)
Timeframe: Approximately 3.25 years
Intervention | months (Median) |
---|
Cisplatin / Capecitabine | 4.43 |
Epirubicin / Cisplatin / Capecitabine | 5.17 |
Epirubicin / Oxaliplatin / Capecitabine | 7.07 |
Docetaxel / Cisplatin / Capecitabine | 7.87 |
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Overall Survival (OS)
OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up. (NCT00454636)
Timeframe: Approximately 3.25 years
Intervention | months (Median) |
---|
Cisplatin / Capecitabine | 10.23 |
Epirubicin / Cisplatin / Capecitabine | 8.87 |
Epirubicin / Oxaliplatin / Capecitabine | 13.87 |
Docetaxel / Cisplatin / Capecitabine | 12.43 |
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Duration of Response
Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00454636)
Timeframe: Approximately 3.25 years
Intervention | days (Mean) |
---|
Cisplatin / Capecitabine | 308.92 |
Epirubicin / Cisplatin / Capecitabine | 154.09 |
Epirubicin / Oxaliplatin / Capecitabine | 203.06 |
Docetaxel / Cisplatin / Capecitabine | 205.52 |
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Overall Response Rate (ORR)
ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. (NCT00454636)
Timeframe: Approximately 3.25 years
Intervention | percentage of participants (Number) |
---|
Cisplatin / Capecitabine | 43.3 |
Epirubicin / Cisplatin / Capecitabine | 40.7 |
Epirubicin / Oxaliplatin / Capecitabine | 69.6 |
Docetaxel / Cisplatin / Capecitabine | 59.6 |
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Intervention | ng*hr/mL (Mean) |
---|
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3) | 55580.26 |
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
Intervention | ng*hr/mL (Mean) |
---|
Axitinib + Docetaxel (Cohort 5) | 3478.49 |
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
Intervention | ng*hr/mL (Mean) |
---|
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 10991.16 |
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
Intervention | ng*hr/mL (Mean) |
---|
Axitinib + Paclitaxel (Cohort 4) | 5683.55 |
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3) | 19959.91 |
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). (NCT00454649)
Timeframe: 0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
Intervention | ng*hr/mL (Mean) |
---|
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 133032.97 |
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Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736)
AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24). (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
Intervention | nanogram*hour/milliliter (ng*hr/mL) (Mean) |
---|
Axitinib + Paclitaxel + Carboplatin (Cohort 1) | 61.58 |
Axitinib + Paclitaxel + Carboplatin (Cohort 2) | 242.41 |
Axitinib + Paclitaxel + Carboplatin (Cohort 3) | 475.18 |
Axitinib + Paclitaxel (Cohort 4) | 154.43 |
Axitinib + Docetaxel (Cohort 5) | 780.99 |
Axitinib + Capecitabine (Cohort 6) | 365.95 |
Axitinib + Capecitabine (Cohort 7) | 449.99 |
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 416.30 |
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 420.64 |
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Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine
AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24). (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
Intervention | ng*hr/mL (Mean) |
---|
Axitinib + Capecitabine (Cohort 6) | 20534.52 |
Axitinib + Capecitabine (Cohort 7) | 22163.88 |
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Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin
AUC (0-8) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 8 hours (0-8). (NCT00454649)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
Intervention | ng*hr/mL (Mean) |
---|
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 2932.43 |
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 2703.92 |
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Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)
(NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
Intervention | ng/mL (Mean) |
---|
Axitinib + Paclitaxel + Carboplatin (Cohort 1) | 5.97 |
Axitinib + Paclitaxel + Carboplatin (Cohort 2) | 23.36 |
Axitinib + Paclitaxel + Carboplatin (Cohort 3) | 42.58 |
Axitinib + Paclitaxel (Cohort 4) | 44.58 |
Axitinib + Docetaxel (Cohort 5) | 67.96 |
Axitinib + Capecitabine (Cohort 6) | 37.51 |
Axitinib + Capecitabine (Cohort 7) | 43.97 |
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 40.97 |
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 31.53 |
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Maximum Observed Plasma Concentration (Cmax) for Capecitabine
(NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
Intervention | ng/mL (Mean) |
---|
Axitinib + Capecitabine (Cohort 6) | 10808.00 |
Axitinib + Capecitabine (Cohort 7) | 10588.38 |
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Maximum Observed Plasma Concentration (Cmax) for Carboplatin
(NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Intervention | ng/mL (Mean) |
---|
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3) | 23383.33 |
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Maximum Observed Plasma Concentration (Cmax) for Cisplatin
(NCT00454649)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
Intervention | ng/mL (Mean) |
---|
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 1680.54 |
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 1176.00 |
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Maximum Observed Plasma Concentration (Cmax) for Docetaxel
(NCT00454649)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
Intervention | ng/mL (Mean) |
---|
Axitinib + Docetaxel (Cohort 5) | 3130.00 |
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Maximum Observed Plasma Concentration (Cmax) for Gemcitabine
(NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
Intervention | ng/mL (Mean) |
---|
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 20635.29 |
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Maximum Observed Plasma Concentration (Cmax) for Paclitaxel
(NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
Intervention | ng/mL (Mean) |
---|
Axitinib + Paclitaxel (Cohort 4) | 3698.33 |
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3) | 6105.00 |
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Maximum Observed Plasma Concentration (Cmax) for Pemetrexed
(NCT00454649)
Timeframe: 0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
Intervention | ng/mL (Mean) |
---|
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 83925.00 |
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Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy
MTD defined as the dose level at which more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 nonhematological toxicities or >=0.5 teaspoon/day hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity. (NCT00454649)
Timeframe: Baseline to withdrawal from study or Day 21 of Cycle 1 [all cohorts except cohort 4 (Day 28 of Cycle 1)]
Intervention | mg BID (Number) |
---|
Axitinib + Paclitaxel + Carboplatin (Cohort 1) | 5 |
Axitinib + Paclitaxel + Carboplatin (Cohort 2) | 5 |
Axitinib + Paclitaxel + Carboplatin (Cohort 3) | 5 |
Axitinib + Paclitaxel (Cohort 4) | 5 |
Axitinib + Docetaxel (Cohort 5) | NA |
Axitinib + Capecitabine (Cohort 6) | 5 |
Axitinib + Capecitabine (Cohort 7) | 5 |
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 5 |
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 5 |
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Percentage of Participants With Objective Response
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00454649)
Timeframe: Baseline and thereafter every 2 cycles up to disease progression or discontinuation from study or up to 155 weeks
Intervention | Percentage of Participants (Number) |
---|
Axitinib + Paclitaxel + Carboplatin (Cohort 1) | 100.0 |
Axitinib + Paclitaxel + Carboplatin (Cohort 2) | 0 |
Axitinib + Paclitaxel + Carboplatin (Cohort 3) | 35.0 |
Axitinib + Paclitaxel (Cohort 4) | 66.7 |
Axitinib + Docetaxel (Cohort 5) | 50.0 |
Axitinib + Capecitabine (Cohort 6) | 11.1 |
Axitinib + Capecitabine (Cohort 7) | 11.8 |
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 23.8 |
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 0 |
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Plasma Clearance (CL) for Carboplatin
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Intervention | L/hr (Mean) |
---|
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3) | 12.57 |
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Plasma Clearance (CL) for Cisplatin
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
Intervention | L/hr (Mean) |
---|
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 46.31 |
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 46.80 |
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Plasma Clearance (CL) for Docetaxel
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
Intervention | L/hr (Mean) |
---|
Axitinib + Docetaxel (Cohort 5) | 42.96 |
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Plasma Clearance (CL) for Gemcitabine
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
Intervention | L/hr (Mean) |
---|
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 224.36 |
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Plasma Decay Half Life (t1/2) for Paclitaxel
t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
Intervention | hr (Mean) |
---|
Axitinib + Paclitaxel (Cohort 4) | 12.51 |
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3) | 8.36 |
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Plasma Decay Half Life (t1/2) for Pemetrexed
t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
Intervention | hr (Mean) |
---|
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 2.77 |
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Plasma Clearance (CL) for Pemetrexed
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
Intervention | L/hr (Mean) |
---|
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 7.26 |
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Plasma Decay Half Life (t1/2) for Axitinib (AG-013736)
t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
Intervention | hr (Mean) |
---|
Axitinib + Paclitaxel + Carboplatin (Cohort 1) | 2.75 |
Axitinib + Paclitaxel + Carboplatin (Cohort 2) | 2.90 |
Axitinib + Paclitaxel + Carboplatin (Cohort 3) | 2.80 |
Axitinib + Paclitaxel (Cohort 4) | 1.45 |
Axitinib + Docetaxel (Cohort 5) | 4.07 |
Axitinib + Capecitabine (Cohort 6) | 3.85 |
Axitinib + Capecitabine (Cohort 7) | 3.64 |
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 2.68 |
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 5.02 |
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Plasma Decay Half Life (t1/2) for Capecitabine
t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
Intervention | hr (Mean) |
---|
Axitinib + Capecitabine (Cohort 6) | 0.85 |
Axitinib + Capecitabine (Cohort 7) | 1.44 |
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Plasma Decay Half Life (t1/2) for Carboplatin
t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Intervention | hr (Mean) |
---|
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3) | 2.62 |
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Plasma Decay Half Life (t1/2) for Cisplatin
t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
Intervention | hr (Mean) |
---|
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 2.61 |
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 3.91 |
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Plasma Decay Half Life (t1/2) for Docetaxel
t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
Intervention | hr (Mean) |
---|
Axitinib + Docetaxel (Cohort 5) | 11.49 |
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Plasma Decay Half Life (t1/2) for Gemcitabine
t1/2 is the time measured for the plasma concentration to decrease by one half. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
Intervention | hr (Mean) |
---|
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 0.29 |
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Apparent Oral Clearance (CL/F) for Axitinib (AG-013736)
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration. (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
Intervention | Liter/hour (L/hr) (Mean) |
---|
Axitinib + Paclitaxel + Carboplatin (Cohort 1) | 49.39 |
Axitinib + Paclitaxel + Carboplatin (Cohort 2) | 40.72 |
Axitinib + Paclitaxel + Carboplatin (Cohort 3) | 29.73 |
Axitinib + Paclitaxel (Cohort 4) | 65.69 |
Axitinib + Docetaxel (Cohort 5) | 14.35 |
Axitinib + Capecitabine (Cohort 6) | 26.64 |
Axitinib + Capecitabine (Cohort 7) | 83.46 |
Axitinib + Gemcitabine + Cisplatin (Cohort 8) | 50.05 |
Axitinib + Pemetrexed + Cisplatin (Cohort 9) | 25.10 |
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Apparent Oral Clearance (CL/F) for Capecitabine
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration. (NCT00454649)
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
Intervention | Liter/hr (Mean) |
---|
Axitinib + Capecitabine (Cohort 6) | 209.05 |
Axitinib + Capecitabine (Cohort 7) | 314.12 |
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Plasma Clearance (CL) for Paclitaxel
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. (NCT00454649)
Timeframe: 0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
Intervention | L/hr (Mean) |
---|
Axitinib + Paclitaxel (Cohort 4) | 30.48 |
Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3) | 21.61 |
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Number of Participants With Recurrent Disease
(NCT00462865)
Timeframe: 6 months and again at the end of the study (1 year)
Intervention | Participants (Count of Participants) |
---|
Gemcitabine, Capectiabine, Avastin | 4 |
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Overall Objective Response
This is defined as the percentage of patients who achieve either an objective complete or partial target lesion response that is confirmed based on the RECIST criteria. (NCT00468585)
Timeframe: 2 years
Intervention | participants (Number) |
---|
| Partial Response (PR) | Stable Disease (SD) | Progression of Disease (POD) |
---|
Group 0 | 0 | 2 | 1 |
,Group 1 | 0 | 1 | 2 |
,Group 2 | 8 | 22 | 15 |
,Group 3 | 0 | 3 | 2 |
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Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1
(NCT00470184)
Timeframe: 5.5 weeks
Intervention | percentage of patients (Number) |
---|
COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy | 58.33 |
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Quality of Life Improved Rate
(NCT00470184)
Timeframe: 5.5 weeks
Intervention | percentage of patients (Number) |
---|
COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy | 66.67 |
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Complete Response
(NCT00470184)
Timeframe: 5.5 weeks
Intervention | percentage of patients (Number) |
---|
COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy | 27.78 |
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Trough Concentration of Lapatinib
PK samples were collected at pre-dose on Day 14 and Day 21 (minus 2 days). Trough concentration is defined as the minimum serum concentration at steady state after a repeated dose of lapatinib. (NCT00477464)
Timeframe: Week 2
Intervention | ng/ml (Mean) |
---|
| Week 2, n=42 | Week 3, n=41 |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 1065.558 | 1243.540 |
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6-Month Progression-free Survival (Independent Reviewer-assessed)
6-Month progression-free survival is defined as the percentage of participants surviving without progressive disease at 6 months (24 weeks) after the start of treatment. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions. (NCT00477464)
Timeframe: Baseline and then every 6 weeks until Month 6 (Week 24)
Intervention | percentage of participants (Number) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 68.2 |
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Area Under the Plasma Concentration-time Curve From Zero to 24 Hours AUC0-24 of Lapatinib
PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to 24 hour after dosing (AUC 0-24). AUC is a measure of exposure. (NCT00477464)
Timeframe: Week 2
Intervention | hr*ng/ml (Geometric Mean) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 48063.990 |
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Area Under the Plasma Concentration-time Curve Within the Dosing Interval AUC0-tau of Lapatinib
PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). AUC is a measure of exposure. (NCT00477464)
Timeframe: Week 2
Intervention | hr*ng/ml (Geometric Mean) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 48153.776 |
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Clinical Benefit Response (Independent Reviewer-assessed)
"CBR is defined as the percentage of participants receiving at least one dose of study medication who achieved a best overall response classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months (24 weeks). A complete response is defined as the disappearance of all target or non-target lesions, partial response and disease progression as at least a 30% decrease and at least a 20% increase, respectively, in the sum of the longest diameter of target lesions, and stable disease as neither partial response nor disease progression." (NCT00477464)
Timeframe: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression (up to Week 119)
Intervention | percentage of participants (Number) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 59 |
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Duration of Response (Independent Reviewer-assessed)
For the subset of participants who showed a complete or partial response, duration of response is defined as the time from the first documented evidence of partial or complete tumor response until the first documented sign of disease progression or death due to breast cancer, if sooner. (NCT00477464)
Timeframe: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)
Intervention | weeks (Median) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 42.7 |
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Maximum Plasma Concentration (Cmax) of Lapatinib
Pharmacokinetic (PK) samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hours (hr) (plus or minus 30 minutes) after dosing. Cmax is defined as the maximum concentration of lapatinib. (NCT00477464)
Timeframe: Week 2
Intervention | nanograms/milliliter (ng/ml) (Geometric Mean) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 3520.872 |
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Objective Response (Independent Reviewer-assessed)
Objective response is defined as the percentage of participants achieving a best overall response classified as a complete or partial (confirmed) tumor response. Complete response is defined as the disappearance of all target or non-target lesions, and partial response is defined as at least a 30% decrease in the sum of the longest diameter of target lesions. (NCT00477464)
Timeframe: Baseline every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)
Intervention | percentage of participants (Number) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 24 |
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Overall Survival (Independent Reviewer-assessed)
Overall survival is defined as the time from the start of treatment until death regardless of cause. For participants who did not die, time to death was censored at the time of last confirmation of survival. (NCT00477464)
Timeframe: Baseline and then followed every 4 weeks until death (up to Week 157.9) while on treatment. After treatment termination, followed every 12 weeks until death (up to Week 157.9)
Intervention | weeks (Median) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 78.6 |
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Progression-free Survival (PFS) (Independent Reviewer-assessed)
PFS is defined as the interval between the start of treatment and the earliest date of disease progression or death of any cause, if sooner. (NCT00477464)
Timeframe: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)
Intervention | weeks (Median) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 36.0 |
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Terminal Elimination Half-life (t1/2) of Lapatinib
Terminal elimination half-life is defined as the duration until observation of half of the maximum concentration. PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. (NCT00477464)
Timeframe: Week 2
Intervention | hr (Geometric Mean) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 11.948 |
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Time to Maximum Plasma Concentration (Tmax) of Lapatinib
PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. Tmax is defined as the time to peak concentration from initiation of lapatinib dosing. (NCT00477464)
Timeframe: Week 2
Intervention | hr (Geometric Mean) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 4.727 |
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Time to Progression (Independent Reviewer-assessed)
Time to progression is defined as the interval between the start of treatment and the earliest date of disease progression or death due to breast cancer, if sooner. Time to progression was calculated by using the Kaplan Meier estimate. (NCT00477464)
Timeframe: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death due to breast cancer (up to Week 119)
Intervention | weeks (Median) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 36.0 |
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Time to Response (Independent Reviewer-assessed)
Time to response is defined as the time from the start of treatment until the first documented evidence of complete response or partial response. (NCT00477464)
Timeframe: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)
Intervention | weeks (Median) |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 6.9 |
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Area Under the Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12) of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)
PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to 12 hours after dosing (AUC 0-12). 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine. (NCT00477464)
Timeframe: Week 2
Intervention | hr*ng/ml (Geometric Mean) |
---|
| Capecitabine | 5-FU | FBAL |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 3999.383 | 544.318 | 30478.416 |
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AUC0-tau of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)
PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine. (NCT00477464)
Timeframe: Week 2
Intervention | hr*ng/ml (Geometric Mean) |
---|
| Capecitabine | 5-FU | FBAL |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 3997.313 | 514.670 | 29035.744 |
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Cmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)
PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. Cmax is defined as the maximum concentration of drug. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine. (NCT00477464)
Timeframe: Week 2
Intervention | ng/ml (Geometric Mean) |
---|
| Capecitabine | 5-FU | FBAL |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 2698.033 | 282.967 | 5771.578 |
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t1/2 of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)
Terminal elimination half-life is defined as the duration until observation of half of the maximum concentration. PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine. (NCT00477464)
Timeframe: Week 2
Intervention | hr (Geometric Mean) |
---|
| Capecitabine | 5-FU | FBAL |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 0.865 | 0.838 | 2.437 |
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Tmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)
PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. Tmax is defined as the time to peak concentration from initiation of dosing. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine. (NCT00477464)
Timeframe: Week 2
Intervention | hr (Geometric Mean) |
---|
| Capecitabine | 5-FU | FBAL |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | 1.305 | 1.305 | 2.899 |
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Trough Concentration of Capecitabine, 5-FU, and FBAL
PK samples were collected at pre-dose on Day 14 (minus 2 days). Trough concentration is defined as the minimum serum concentration at steady state after a repeated dose. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine. (NCT00477464)
Timeframe: Week 2
Intervention | ng/ml (Mean) |
---|
| Capecitabine | 5-FU | FBAL |
---|
Lapatinib 1250 mg and Capecitabine 2000 mg/m^2 | NA | NA | 668.73 |
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Overall Tumor Response
Overall tumor response is defined as the percentage of participants with a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as the disappearance of all target lesions. CR could only be declared if all target and non-target lesions had disappeared. Partial response (PR) is defined as a decrease of 30% or greater in the sum of the longest diameter of target lesions. (NCT00479856)
Timeframe: from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 wks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, of other reason)
Intervention | percentage of participants (Number) |
---|
Lapatinib + Chemotherapy | 33.3 |
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Time to Progression
Time to progression will be calculated from the time of enrollment until confirmed disease progression. Defined by RECIST (Response Evaluation Criteria in Solid Tumors), Progressive Disease (PD) - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. (NCT00483405)
Timeframe: Median 23 month follow-up
Intervention | months (Median) |
---|
Single Arm Trial | 4.5 |
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Disease Response Rate
"Radiographic response will be measured every six weeks while subject is on treatment. Response will be measured using RECIST criteria.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions." (NCT00483405)
Timeframe: 42 days (2 cycles)
Intervention | percentage of participants with response (Number) |
---|
Single Arm Trial | 12.5 |
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Number of Subjects Experiencing Adverse Events
Adverse events will be assessed using CTCAE criteria. (NCT00483405)
Timeframe: every 3 weeks of treatment with an average of 15 weeks on treatment
Intervention | Participants (Count of Participants) |
---|
Single Arm Trial | 29 |
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Overall Survival
Overall survival will be calculated from time of enrollment to death or last contact date. (NCT00483405)
Timeframe: Median 23 month follow-up
Intervention | months (Median) |
---|
Single Arm Trial | 4.4 |
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Duration of Follow-up
Duration of follow-up is defined as the time in days from randomization until disease progression or death, or time to censoring for overall survival. (NCT00484939)
Timeframe: Baseline to the end of the study (up to 5 years 8 months)
Intervention | Days (Mean) |
---|
Bevacizumab + Capecitabine | 540.5 |
Capecitabine | 479.2 |
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Duration of Response
Duration of response was defined as the time in months from the first confirmed complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. (NCT00484939)
Timeframe: Baseline to the end of the study (up to 5 years 8 months)
Intervention | Months (Median) |
---|
Bevacizumab + Capecitabine | 9.7 |
Capecitabine | 9.4 |
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Time to Response
Time to response was defined as the time in months from the date of first study treatment to the date of the first documentation of complete response (CR) or partial response (PR), whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. Participants who did not have a confirmed response were censored at the date of the last evaluable tumor assessment, or if that was unavailable, at the date of the first dose of study medication. (NCT00484939)
Timeframe: Baseline to the end of the study (up to 5 years 8 months)
Intervention | Months (Median) |
---|
Bevacizumab + Capecitabine | NA |
Capecitabine | NA |
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Progression-free Survival
Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions. (NCT00484939)
Timeframe: Baseline to the end of the study (up to 5 years 8 months)
Intervention | Months (Median) |
---|
Bevacizumab + Capecitabine | 9.1 |
Capecitabine | 5.1 |
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Percentage of Participants Requiring Additional Treatment for Malignancy
Reported is the percentage of participants requiring additional treatment for malignancy in the survival follow-up period. (NCT00484939)
Timeframe: Baseline to the end of the study (up to 5 years 8 months)
Intervention | Percentage of participants (Number) |
---|
Bevacizumab + Capecitabine | 50.7 |
Capecitabine | 49.3 |
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Overall Survival
Overall survival was defined as the time in months from randomization to death from any cause. (NCT00484939)
Timeframe: Baseline to the end of the study (up to 5 years 8 months)
Intervention | Months (Median) |
---|
Bevacizumab + Capecitabine | 20.7 |
Capecitabine | 17.0 |
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Best Overall Response (BOR)
BOR was defined as the best response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], not evaluable [NE], or not assessed [NA]) recorded from the start of study treatment until disease progression (PD) or death. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions. (NCT00484939)
Timeframe: Baseline to the end of the study (up to 5 years 8 months)
Intervention | Percentage of participants (Number) |
---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease | Not assessed |
---|
Bevacizumab + Capecitabine | 2.9 | 17.1 | 54.3 | 10.0 | 15.7 |
,Capecitabine | 1.4 | 8.6 | 48.6 | 21.4 | 20.0 |
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Progression Free Survival
(NCT00493636)
Timeframe: From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.
Intervention | Days (Median) |
---|
A (Sorafenib + Gemcitabine or Capecitabine) | 103 |
B (Placebo + Gemcitabine or Capecitabine) | 81 |
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Overall Survival
(NCT00493636)
Timeframe: From the date of randomization to date of death due to any cause, assessed up to 56 months.
Intervention | Days (Median) |
---|
A (Sorafenib + Gemcitabine or Capecitabine) | 407 |
B (Placebo + Gemcitabine or Capecitabine) | 348 |
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Overall Response Rate
Overall response rate was defined as the proportion of participants experiencing complete response (CR) and partial response (PR) as best overall response. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions. (NCT00493636)
Timeframe: The overall tumor burden at baseline will be compared with subsequent measurements up to the date of first documented disease progression or the date of death due to any cause, if before progression, assessed up to 39 months.
Intervention | percentage of participants (Number) |
---|
A (Sorafenib + Gemcitabine or Capecitabine) | 19.8 |
B (Placebo + Gemcitabine or Capecitabine) | 12.7 |
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Duration of Overall Response
Duration of overall response was calculated as the time (days) from first documentation of CR or PR (whichever status is recorded first) until the first date that recurrent or progressive disease (PD) or death is objectively documented. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions. (NCT00493636)
Timeframe: Period measured from the first documentation of complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease or death is objectively documented.
Intervention | Days (Median) |
---|
A (Sorafenib + Gemcitabine or Capecitabine) | 94 |
B (Placebo + Gemcitabine or Capecitabine) | 147 |
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Time to Progression
(NCT00493636)
Timeframe: Calculated as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier), assessed up to 39 months.
Intervention | Days (Median) |
---|
A (Sorafenib + Gemcitabine or Capecitabine) | 111 |
B (Placebo + Gemcitabine or Capecitabine) | 82 |
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-Determine the Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease for at Least 6 Months) of Capecitabine and Lapatinib. -Determine Time to Disease Progression After Treatment With Capecitabine and Lapatinib. -Evaluate Overall
(NCT00496366)
Timeframe: 2 years
Intervention | () |
---|
Capecitabine (Xeloda) + Lapatinib (Tykerb) | 0 |
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Time to Treatment Failure (TTF)
Time to treatment failure, TTF, with failure defined as death or disease progression where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline. (NCT00496587)
Timeframe: 12 months or until progression of disease
Intervention | Months (Median) |
---|
Capecitabine + Gemcitabine + Bevacizumab | 4.2 |
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Objective Response Rate (ORR)
Objective response defined as Complete Response + Partial Response, with response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response: The disappearance of all target lesions. Partial Response: >30% decrease in the sum of the longest diameter of target lesions, reference baseline sum longest diameter. Progressive Disease: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since the treatment started. (NCT00496587)
Timeframe: 12 months or until progression of disease
Intervention | percentage of participants (Number) |
---|
Capecitabine + Gemcitabine + Bevacizumab | 20 |
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Progression Free Survival (PFS)
Event or disease-free survival given as progression free survival (PFS) which was defined as the length of time after primary treatment that the participant survives without disease progression. Evaluation of response will follow the Response Evaluation Criteria in Solid Tumors (RECIST) where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline. (NCT00496587)
Timeframe: 12 months or until progression of disease
Intervention | Months (Median) |
---|
Capecitabine + Gemcitabine + Bevacizumab | 5.5 |
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Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100. (NCT00502671)
Timeframe: Up to 25 weeks (from Baseline to the end of safety follow-up)
Intervention | percentage of participants (Number) |
---|
| Any AE | Serious AE | Death due to an AE |
---|
Capecitabine | 56.1 | 6.1 | 0.4 |
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Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100. (NCT00502671)
Timeframe: Up to 25 weeks (from Baseline to the end of safety follow-up)
Intervention | percentage of participants (Number) |
---|
| Early withdrawal due to an AE | Discontinuation due to an AE |
---|
Capecitabine | 8.3 | 10.1 |
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6 Month Progression-free Survival for Participants With Glioblastoma
Progression-free Survival (PFS) at 6 months measured as percentage of participants that are alive and progression-free at 6 months (glioblastoma multiforme). A combination of neurological examination and MRI brain scan used to define overall response or progression. (NCT00504660)
Timeframe: 6 months
Intervention | percentage of participants (Number) |
---|
Participants With Glioblastoma Multiforme | 14 |
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12 Month-progression-free Survival for Participants With Anaplastic Tumors
Progression-free Survival (PFS) at 12 months measured as percentage of participants that are alive and progression-free at 12 months (anaplastic tumors). A combination of neurological examination and MRI brain scan used to define overall response or progression. (NCT00504660)
Timeframe: 12 months
Intervention | percentage of participants (Number) |
---|
Participants With Recurrent Anaplastic Glioma | 44 |
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Number of Participants With Central Nervous System (CNS) as First Site of Relapse
Number of participants who had Central Nervous System metastasis as the first site of relapse. CT, Magnetic Resonance Imaging, etc. were used for the assessment. (NCT00508274)
Timeframe: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 90 months
Intervention | participants (Number) |
---|
| Participants with any site of relapse | Participants with CNS disease as first site of relapse |
---|
Lapatinib + Capecitabine | 17 | 2 |
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All Collected Deaths
On treatment deaths were collected from the start of treatment up to 30 days after study drug discontinuation, for a maximum duration of 4276 days (treatment duration ranged from 13 - 4246 days) for Lapatinib and 3384 days (treatment duration ranged form 8 - 3354 days) for Capecitabine. Total deaths was collected from study start to study end (LPLV). (NCT00508274)
Timeframe: up to 4276 days for Lapatinib/up to 3384 days for Capecitabine (on-treatment), approx. 12 years (all collected deaths)
Intervention | Participants (Count of Participants) |
---|
| Total Deaths | On-treatment Deaths |
---|
Lapatinib + Capecitabine | 11 | 2 |
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Time to Response (TTR)
Time to response is defined as the time from first dose date until first documentation of disease response. TTR only applied to participants for whom best overall response was complete response (CR), partial response (PR) or stable disease (SD). Participants who had not had a partial response, complete response or stable disease at the cut-off date for this endpoint analysis were censored for time to response. (NCT00508274)
Timeframe: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was approx. 14.78 months
Intervention | Months (Median) |
---|
Lapatinib + Capecitabine | 4.07 |
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Six Months Progression-Free Survival
Six Months Progression-Free Survival is defined as the percentage of surviving participants who are progression-free longer than six months (greather than 180 days) after the first start date of study treatment. (NCT00508274)
Timeframe: at Baseline and every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed up to 90.38 months, with 6 months PFS reported.
Intervention | Percentage of participants (Number) |
---|
Lapatinib + Capecitabine | 53.55 |
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Progression-Free Survival (PFS)
PFS is defined as the time from first dose date until the date of disease progression or death due to any reason, whichever occurs first. (NCT00508274)
Timeframe: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 90.38 months.
Intervention | Months (Median) |
---|
Lapatinib + Capecitabine | 6.34 |
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Duration of Response (DOR)
Duration of response (complete response, partial response or stable disease) is defined as the time of first documentation of disease response until the date of disease progression or death due to breast cancer, whichever occurs first. DOR only applied to participants for whom best overall response was complete response (CR), partial response (PR) or stable disease (SD). Participants who had not had a partial response, complete response or stable disease at the cut-off date for this endpoint analysis were censored for duration of response. (NCT00508274)
Timeframe: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 88.80 months.
Intervention | Months (Median) |
---|
Lapatinib + Capecitabine | 8.18 |
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Clinical Benefit Rate (CBR)
"CBR is defined by the percentage of participants achieving either a confirmed tumor response of complete response (CR) or partial response (PR) or stable disease (SD) for at least 24 weeks. Response Criteria in Solid Tumors (RECIST) is a system for measuring tumor shrinkage or progression in terms of the longest dimensions of the tumor on imaging scans such as computerized tomography (CT). A partial response requires a decrease of 30% or more, complete response requires all target lesions disappear, Progression requires an increase of at least 20%, and Stable disease falls in between these two. All responses have a repeat assessment to confirm the response." (NCT00508274)
Timeframe: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was approx. 90 months
Intervention | Percentage of participants (Number) |
---|
Lapatinib + Capecitabine | 57.7 |
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Progression-free Survival
Progression is defined as a measurable increase in the sum of longest diameters of all target lesions, or unequivocable progression of non-target lesions, or the appearance of new lesions, since baseline (NCT00523640)
Timeframe: 60 months
Intervention | months (Median) |
---|
Combination of Gemcitabine, Capecitabine, and Bevacizumab | 5.3 |
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Overall Survival
Time from enrollment until death from any cause. (NCT00523640)
Timeframe: 60 months
Intervention | months (Median) |
---|
Combination of Gemcitabine, Capecitabine, and Bevacizumab | 9.8 |
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Objective Response Rate
Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR. (NCT00523640)
Timeframe: 12 weeks
Intervention | proportion (Number) |
---|
Combination of Gemcitabine, Capecitabine, and Bevacizumab | 0.24 |
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PFS
PFS is defined as the time from the initial treatment until the first observation of disease progression or death due to any cause. The date of documented disease progression was defined as the earliest date of radiographic disease assessment progression or symptomatic progression, whichever came first. For participants who did not die/progress, survival was censored at the time of the last assessment (or contact). (NCT00526669)
Timeframe: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)
Intervention | weeks (Median) |
---|
Lapatinib + Capecitabine | 14.3 |
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Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response])
Response is defined as documented evidence of complete response (CR) or partial response (PR). The investigator evaluated response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). Partial response for TLs is defined as >= a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs it is defined as the persistence of 1 or more non-TL and no new TLs or non-TLs. (NCT00526669)
Timeframe: From Baseline (Day 0) until disease progression or death due to any cause evaluated every 6 or 12 weeks (up to approximately 85 weeks)
Intervention | percentage of participants (Number) |
---|
Lapatinib + Capecitabine | 17.9 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points
Blood samples were collected for the evaluation of creatinine. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For creatinine: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 6.0x ULN), severe; G 4 (>6.0x ULN), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=54 | Week 2, AGI; n=56 | Week 3, AGI; n=61 | Week 6, AGI; n=47 | Week 9, AGI; n=40 | Week 12, AGI; n=31 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=14 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=3 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84 AGI; n=1 | WD/study conclusion, AGI; n=50 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=54 | Week 2, ItoG3; n=56 | Week 3, ItoG3; n=61 | Week 6, ItoG3; n=47 | Week 9, ItoG3; n=40 | Week 12, ItoG3; n=31 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=14 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=3 | Week 60, ItoG3; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | WD/study conclusion, ItoG3; n=50 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=54 | Week 2, ItoG4; n=56 | Week 3, ItoG4; n=61 | Week 6, ItoG4; n=47 | Week 9, ItoG4; n=40 | Week 12, ItoG4; n=31 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=14 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=3 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | WD/study conclusion, ItoG4; n=50 | Worst-case on-therapy, ItoG4; n=65 |
---|
Lapatinib + Capecitabine | 2 | 1 | 1 | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 6 | 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 | 0 | 0 | 0 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points
Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For potassium (high and low [per blood samples], respectively): G 1 (>ULN to 5.5 millimoles per liter [mmol/L]; 5.5 to 6.0 mmol/L; value not available), moderate; G 3 (>6.0 to 7.0 mmol/L; <3.0 to 2.5 mmol/L), severe; G 4 (>7.0 mmol/L; <2.5 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=54 | Week 2, AGI; n=54 | Week 3, AGI; n=59 | Week 6, AGI; n=46 | Week 9, AGI; n=41 | Week 12, AGI; n=31 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=13 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=3 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | WD/study conclusion, AGI; n=48 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=54 | Week 2, ItoG3; n=54 | Week 3, ItoG3; n=59 | Week 6, ItoG3; n=46 | Week 9, ItoG3; n=41 | Week 12, ItoG3; n=31 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=13 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=3 | Week 60, ItoG3; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | WD/study conclusion, ItoG3; n=48 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=54 | Week 2, ItoG4; n=54 | Week 3, ItoG4; n=59 | Week 6, ItoG4; n=46 | Week 9, ItoG4; n=41 | Week 12, ItoG4; n=31 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=13 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=3 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | WD/study conclusion, ItoG4; n=48 | Worst-case on-therapy, ItoG4; n=65 |
---|
Lapatinib + Capecitabine | 9 | 3 | 5 | 3 | 4 | 4 | 1 | 2 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 25 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 5 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points
Toxicity was measured in grades (AE severity) per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For albumin (per blood samples): G 1 (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=54 | Week 2, AGI; n=57 | Week 3, AGI; n=61 | Week 6, AGI; n=47 | Week 9, AGI; n=41 | Week 12, AGI; n=31 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=14 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=3 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | Withdrawal /study conclusion, AGI; n=50 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=54 | Week 2, ItoG3; n=57 | Week 3, ItoG3; n=61 | Week 6, ItoG3; n=47 | Week 9, ItoG3; n=41 | Week 12, ItoG3; n=31 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=14 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=3 | Week 60, ItoG3; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | WD/study conclusion, ItoG3; n=50 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=54 | Week 2, ItoG4; n=57 | Week 3, ItoG4; n=61 | Week 6, ItoG4; n=47 | Week 9, ItoG4; n=41 | Week 12, ItoG4; n=31 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=14 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=3 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | WD/study conclusion, ItoG4; n=50 | Worst-case on-therapy ItoG4; n=65 |
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Lapatinib + Capecitabine | 10 | 9 | 10 | 4 | 2 | 4 | 3 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 11 | 29 | 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 | 0 | 0 | 0 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points
Blood samples were collected for the evaluation of lymphocytes. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For lymphocytes: G 1, mild; G 2, moderate; G 3, severe; G 4, life threatening/disabling; G 5, death related to AE; ranges were provided by local laboratories. Change from Baseline was measured as any grade increase (AGI), increase to G 3 (ItoG3), and increase to G 4 (ItoG4). Worst-case on-therapy reflects the most severe change at any time point measured post treatment. (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=14 | Week 2, AGI; n=16 | Week 3, AGI; n=16 | Week 6, AGI; n=12 | Week 9, AGI; n=11 | Week 12, AGI; n=7 | Week 15, AGI; n=6 | Week 18, AGI; n=5 | Week 21, AGI; n=4 | Week 24, AGI; n=3 | Week 30, AGI; n=2 | Week 36, AGI; n=1 | Week 42, AGI; n=0 | Week 48, AGI; n=0 | Week 54, AGI; n=0 | Week 60, AGI; n=0 | Week 66, AGI; n=0 | Week 72, AGI; n=0 | Week 78, AGI; n=0 | Week 84, AGI; n=0 | Withdrawal/study conclusion, AGI; n=10 | Worst-case on-therapy, AGI; n=16 | Week 1, ItoG3; n=14 | Week 2, ItoG3; n=16 | Week 3, ItoG3; n=16 | Week 6, ItoG3; n=12 | Week 9, ItoG3; n=11 | Week 12, ItoG3; n=7 | Week 15, ItoG3; n=6 | Week 18, ItoG3; n=5 | Week 21, ItoG3; n=4 | Week 24, ItoG3; n=3 | Week 30, ItoG3; n=2 | Week 36, ItoG3; n=1 | Week 42, ItoG3; n=0 | Week 48, ItoG3; n=0 | Week 54, ItoG3; n=0 | Week 60, ItoG3; n=0 | Week 66, ItoG3; n=0 | Week 72, ItoG3; n=0 | Week 78, ItoG3; n=0 | Week 84, ItoG3; n=0 | Withdrawal/study conclusion, ItoG3; n=10 | Worst-case on-therapy, ItoG3; n=16 | Week 1, ItoG4; n=14 | Week 2, ItoG4; n=16 | Week 3, ItoG4; n=16 | Week 6, ItoG4; n=12 | Week 9, ItoG4; n=11 | Week 12, ItoG4; n=7 | Week 15, ItoG4; n=6 | Week 18, ItoG4; n=5 | Week 21, ItoG4; n=4 | Week 24, ItoG4; n=3 | Week 30, ItoG4; n=2 | Week 36, ItoG4; n=1 | Week 42, ItoG4; n=0 | Week 48, ItoG4; n=0 | Week 54, ItoG4; n=0 | Week 60, ItoG4; n=0 | Week 66, ItoG4; n=0 | Week 72, ItoG4; n=0 | Week 78, ItoG4; n=0 | Week 84, ItoG4; n=0 | Withdrawal/study conclusion, ItoG4; n=10 | Worst-case on-therapy, ItoG4; n=16 |
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Overall Study Arm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 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 | 0 | 0 | 0 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points
Blood samples were collected for magnesium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For magnesium (high and low, respectively): G 1 (>ULN to 3.0 mg/dL; 3.0 to 8.0 mg/dL; <0.9 to 0.7 mg/dL), severe; G 4 (>8.0 mg/dL; <0.7 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=33 | Week 2, AGI; n=33 | Week 3, AGI; n=44 | Week 6, AGI; n=37 | Week 9, AGI; n=36 | Week 12, AGI; n=27 | Week 15, AGI; n=18 | Week 18, AGI; n=16 | Week 21, AGI; n=11 | Week 24, AGI; n=9 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=2 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | WD/study conclusion, AGI; n=35 | Worst-case on-therapy, AGI; n=59 | Week 1, ItoG3; n=33 | Week 2, ItoG3; n=33 | Week 3, ItoG3; n=44 | Week 6, ItoG3; n=37 | Week 9, ItoG3; n=36 | Week 12, ItoG3; n=27 | Week 15, ItoG3; n=18 | Week 18, ItoG3; n=16 | Week 21, ItoG3; n=11 | Week 24, ItoG3; n=9 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=2 | Week 60, ItoG3; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | WD/study conclusion, ItoG3; n=35 | Worst-case on-therapy, ItoG3; n=59 | Week 1, ItoG4; n=33 | Week 2, ItoG4; n=33 | Week 3, ItoG4; n=44 | Week 6, ItoG4; n=37 | Week 9, ItoG4; n=36 | Week 12, ItoG4; n=27 | Week 15, ItoG4; n=18 | Week 18, ItoG4; n=16 | Week 21, ItoG4; n=11 | Week 24, ItoG4; n=9 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=2 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | WD/study conclusion, ItoG4; n=35 | Worst-case on-therapy, ItoG4; n=59 |
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Lapatinib + Capecitabine | 1 | 6 | 3 | 4 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 17 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Duration of Response
Duration of response is defined as the time from the first documented evidence of tumor response (CR or PR) until the first documented sign of disease progression or death due to any cause, whichever came first. (NCT00526669)
Timeframe: From date of first documented evidence of response until the date of first documented sign of disease progression or death due to any cause (up to approximately 78 weeks)
Intervention | weeks (Median) |
---|
Lapatinib + Capecitabine | 18.4 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points
Blood samples were collected for the evaluation of platelet count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For platelet count: G 1 (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=62 | Week 2, AGI; n=64 | Week 3, AGI; n=62 | Week 6, AGI; n=47 | Week 9, AGI; n=41 | Week 12, AGI; n=30 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=13 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=3 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | Withdrawal/study conclusion, AGI; n=51 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=62 | Week 2, ItoG3; n=64 | Week 3, ItoG3; n=62 | Week 6, ItoG3; n=47 | Week 9, ItoG3; n=41 | Week 12, ItoG3; n=30 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=13 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=3 | Week 60, ItoG3; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | Withdrawal/study conclusion, ItoG3; n=51 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=62 | Week 2, ItoG4; n=64 | Week 3, ItoG4; n=62 | Week 6, ItoG4; n=47 | Week 9, ItoG4; n=41 | Week 12, ItoG4; n=30 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=13 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=3 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | Withdrawal/study conclusion, ItoG4; n=51 | Worst-case on-therapy, ItoG4; n=65 |
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Lapatinib + Capecitabine | 1 | 2 | 0 | 2 | 3 | 2 | 2 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 10 | 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 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points
Blood samples were collected for sodium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of each AE severity. For sodium (high and low, respectively): G 1 (>ULN to 150 mmol/L; 150 to 155 mmol/L; value not available), moderate; G 3 (>155 to 160 mmol/L; <130 to 120 mmol/L), severe; G 4 (>160 mmol/L; <120 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=54 | Week 2, AGI; n=53 | Week 3, AGI; n=59 | Week 6, AGI; n=47 | Week 9, AGI; n=41 | Week 12, AGI; n=31 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=13 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=3 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | WD/study conclusion, AGI; n=48 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=54 | Week 2, ItoG3; n=53 | Week 3, ItoG3; n=59 | Week 6, ItoG3; n=47 | Week 9, ItoG3; n=41 | Week 12, ItoG3; n=31 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=13 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=3 | Week 60, ItoG3; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | WD/study conclusion, ItoG3; n=48 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=54 | Week 2, ItoG4; n=53 | Week 3, ItoG4; n=59 | Week 6, ItoG4; n=47 | Week 9, ItoG4; n=41 | Week 12, ItoG4; n=31 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=13 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=3 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | WD/study conclusion, ItoG4; n=48 | Worst-case on-therapy, ItoG4; n=65 |
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Lapatinib + Capecitabine | 9 | 7 | 5 | 7 | 4 | 1 | 3 | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 28 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points
Blood samples were collected for the evaluation of total bilirubin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For total bilirubin: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 10.0x ULN), severe; G 4 (>10.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=54 | Week 2, AGI; n=57 | Week 3, AGI; n=61 | Week 6, AGI; n=47 | Week 9, AGI; n=41 | Week 12, AGI; n=31 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=14 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=3 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | WD/study conclusion, AGI; n=50 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=54 | Week 2, ItoG3; n=57 | Week 3, ItoG3; n=61 | Week 6, ItoG3; n=47 | Week 9, ItoG3; n=41 | Week 12, ItoG3; n=31 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=14 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=3 | Week 60, ItoG3I; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | WD/study conclusion, ItoG3; n=50 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=54 | Week 2, ItoG4; n=57 | Week 3, ItoG4; n=61 | Week 6, ItoG4; n=47 | Week 9, ItoG4; n=41 | Week 12, ItoG4; n=31 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=14 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=3 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | WD/study conclusion, ItoG4; n=50 | Worst-case on-therapy, ItoG4; n=65 |
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Lapatinib + Capecitabine | 0 | 2 | 1 | 2 | 8 | 3 | 3 | 2 | 3 | 3 | 4 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 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 |
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Time to Progression (All Deaths Are Treated as Competing Risk)
Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks. (NCT00526669)
Timeframe: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)
Intervention | weeks (Median) |
---|
Lapatinib + Capecitabine | 18.9 |
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Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk)
Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks. (NCT00526669)
Timeframe: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)
Intervention | weeks (Median) |
---|
Lapatinib + Capecitabine | 14.3 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points
Blood samples were collected for the evaluation of total neutrophils. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For neutrophils: G 1 (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=15 | Week 2, AGI; n=17 | Week 3, AGI; n=17 | Week 6, AGI; n=12 | Week 9, AGI; n=11 | Week 12, AGI; n=7 | Week 15, AGI; n=6 | Week 18, AGI; n=5 | Week 21, AGI; n=4 | Week 24, AGI; n=3 | Week 30, AGI; n=2 | Week 36, AGI; n=1 | Week 42, AGI; n=0 | Week 48, AGI; n=0 | Week 54, AGI; n=0 | Week 60, AGI; n=0 | Week 66, AGI; n=0 | Week 72, AGI; n=0 | Week 78, AGI; n=0 | Week 84, AGI; n=0 | Withdrawal/study conclusion,, AGI; n=12 | Worst-case on-therapy, AGI; n=17 | Week 1, ItoG3; n=15 | Week 2, ItoG3; n=17 | Week 3, ItoG3; n=17 | Week 6, ItoG3; n=12 | Week 9, ItoG3; n=11 | Week 12, ItoG3; n=7 | Week 15, ItoG3; n=6 | Week 18, ItoG3; n=5 | Week 21, ItoG3; n=4 | Week 24, ItoG3; n=3 | Week 30, ItoG3; n=2 | Week 36, ItoG3; n=1 | Week 42, ItoG3; n=0 | Week 48, ItoG3; n=0 | Week 54, ItoG3; n=0 | Week 60, ItoG3; n=0 | Week 66, ItoG3; n=0 | Week 72, ItoG3; n=0 | Week 78, ItoG3; n=0 | Week 84, ItoG3; n=0 | Withdrawal/study conclusion, ItoG3; n=12 | Worst-case on-therapy, ItoG3; n=17 | Week 1, ItoG4; n=15 | Week 2, ItoG4; n=17 | Week 3, ItoG4; n=17 | Week 6, ItoG4; n=12 | Week 9, ItoG4; n=11 | Week 12, ItoG4; n=7 | Week 15, ItoG4; n=6 | Week 18, ItoG4; n=5 | Week 21, ItoG4; n=4 | Week 24, ItoG4; n=3 | Week 30, ItoG4; n=2 | Week 36, ItoG4; n=1 | Week 42, ItoG4; n=0 | Week 48, ItoG4; n=0 | Week 54, ItoG4; n=0 | Week 60, ItoG4; n=0 | Week 66, ItoG4; n=0 | Week 72, ItoG4; n=0 | Week 78, ItoG4; n=0 | Week 84, ItoG4; n=0 | Withdrawal/study conclusion, ItoG4; n=12 | Worst-case on-therapy, ItoG4; n=17 |
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Lapatinib + Capecitabine | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 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 | 0 | 0 | 0 |
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Overall Survival (OS)
Overall survival is defined as the time from the initial treatment until death due to any cause. A death occurring during the study is defined as a death occurring during treatment or within 30 days of the last administration of study medication. (NCT00526669)
Timeframe: From Baseline (Day 0) until death due to any cause evaluated at approximately 12 months (up to approximately 100 weeks)
Intervention | weeks (Median) |
---|
Lapatinib + Capecitabine | 27.6 |
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Time to Response
Time to response is defined as the time from the initial treatment until the first documented evidence of CR (disappearance of all TLs and non-TLs and the appearance of no new lesions) or PR (>= a 30% decrease in the sum of the longest diameter of TLs, taking as reference the Baseline sum longest diameter) (whichever status was recorded first). Time to response data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point. (NCT00526669)
Timeframe: Baseline (Day 0) until first documented evidence of response (up to approximately 60 weeks)
Intervention | weeks (Median) |
---|
Lapatinib + Capecitabine | NA |
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Change From Start of Run-in Period in Biomarker Expression Levels at Day 0
Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the target gene to that of beta actin. (NCT00526669)
Timeframe: evaluated at baseline and after 7 days of study treatment
Intervention | ratio (Median) |
---|
| Thymidylate synthase (TS), n=34 | Deoxypyridinoline (DPD), n=26 | EGFR/HER1, n=32 | HER2, n=28 | HER3, n=33 |
---|
Lapatinib | 0.38 | 0.12 | 0.15 | 0.01 | 0.87 |
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Number of Participants in the Indicated Categories for Best Overall Response (BOR)
Best overall response was evaluated by the investigator based on RECIST criteria: CR; PR; Stable Disease (SD), defined as no sufficient shrinkage to qualify for PR, no sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD, defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions; Unknown, defined as participants who do not have CR, PR, SD, or PD. (NCT00526669)
Timeframe: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)
Intervention | participants (Number) |
---|
| CR | PR | SD | PD | Unknown |
---|
Lapatinib + Capecitabine | 0 | 12 | 31 | 16 | 8 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points
Blood samples were collected for the evaluation of ALT. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALT: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
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| Week 1, AGI; n=54 | Week 2, AGI; n=57 | Week 3, AGI; n=61 | Week 6, AGI; n=47 | Week 9, AGI; n=41 | Week 12, AGI; n=31 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=14 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=3 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | WD/study conclusion, AGI; n=50 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=54 | Week 2, ItoG3; n=57 | Week 3, ItoG3; n=61 | Week 6, ItoG3; n=47 | Week 9, ItoG3; n=41 | Week 12, ItoG3; n=31 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=14 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=3 | Week 60, ItoG3I; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | WD/study conclusion, ItoG3; n=50 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=54 | Week 2, ItoG4; n=57 | Week 3, ItoG4; n=61 | Week 6, ItoG4; n=47 | Week 9, ItoG4; n=41 | Week 12, ItoG4; n=31 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=14 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=3 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | WD/study conclusion, ItoG4; n=50 | Worst-case on-therapy, ItoG4; n=65 |
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Lapatinib + Capecitabine | 1 | 0 | 2 | 3 | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 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 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points
Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALP: G 1 (upper limit of normal [ULN] to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=54 | Week 2, AGI; n=57 | Week 3, AGI; n=61 | Week 6, AGI; n=47 | Week 9, AGI; n=41 | Week 12, AGI; n=31 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=14 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=2 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | WD/study conclusion, AGI; n=49 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=54 | Week 2, ItoG3; n=57 | Week 3, ItoG3; n=61 | Week 6, ItoG3; n=47 | Week 9, ItoG3; n=41 | Week 12, ItoG3; n=31 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=14 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=2 | Week 60, ItoG3; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | WD/study conclusion, ItoG3; n=49 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=54 | Week 2, ItoG4; n=57 | Week 3, ItoG4; n=61 | Week 6, ItoG4; n=47 | Week 9, ItoG4; n=41 | Week 12, ItoG4; n=31 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=14 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=2 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | WD/study conclusion, ItoG4; n=49 | Worst-case on-therapy, ItoG4; n=65 |
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Lapatinib + Capecitabine | 6 | 5 | 8 | 5 | 2 | 5 | 2 | 3 | 4 | 4 | 3 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 8 | 21 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points
Blood samples were collected for the evaluation of AST. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For AST: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=54 | Week 2, AGI; n=57 | Week 3, AGI; n=61 | Week 6, AGI; n=47 | Week 9, AGI; n=41 | Week 12, AGI; n=31 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=14 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=3 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | WD/study conclusion, AGI; n=50 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=54 | Week 2, ItoG3; n=57 | Week 3, ItoG3; n=61 | Week 6, ItoG3; n=47 | Week 9, ItoG3; n=41 | Week 12, ItoG3; n=31 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=14 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=3 | Week 60, ItoG3I; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | WD/study conclusion, ItoG3; n=50 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=54 | Week 2, ItoG4; n=57 | Week 3, ItoG4; n=61 | Week 6, ItoG4; n=47 | Week 9, ItoG4; n=41 | Week 12, ItoG4; n=31 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=14 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=3 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | WD/study conclusion, ItoG4; n=50 | Worst-case on-therapy, ItoG4; n=65 |
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Lapatinib + Capecitabine | 1 | 3 | 3 | 6 | 3 | 2 | 4 | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 7 | 16 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 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 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points
Blood samples were collected for calcium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For calcium (low and high, respectively): G 1 (ULN to 11.5x ULN), mild; G 2 (<8.0 to 7.0 mg/dL; >11.5 to 12.5 ULN), moderate; G 3 (<7.0 to 6.0 mg/dL; >12.5 to 13.5 mg/dL), severe; G 4 (<6 mg/dL; >13.5 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=55 | Week 2, AGI; n=56 | Week 3, AGI; n=60 | Week 6, AGI; n=47 | Week 9, AGI; n=41 | Week 12, AGI; n=31 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=14 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=2 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | WD/study conclusion, AGI; n=49 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=55 | Week 2, ItoG3; n=56 | Week 3, ItoG3; n=60 | Week 6, ItoG3; n=47 | Week 9, ItoG3; n=41 | Week 12, ItoG3; n=31 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=14 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=2 | Week 60, ItoG3; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | WD/study conclusion, ItoG3; n=49 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=55 | Week 2, ItoG4; n=56 | Week 3, ItoG4; n=60 | Week 6, ItoG4; n=47 | Week 9, ItoG4; n=41 | Week 12, ItoG4; n=31 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=14 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=2 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | WD/study conclusion, ItoG4; n=49 | Worst-case on-therapy, ItoG4; n=65 |
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Lapatinib + Capecitabine | 7 | 4 | 5 | 3 | 3 | 2 | 1 | 2 | 0 | 1 | 1 | 0 | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 1 | 12 | 23 | 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 | 0 | 0 | 0 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points
Blood samples were collected for the evaluation of glucose. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For glucose (high and low, respectively): G 1 (>ULN to 160 mg/dL; 160 to 250 mg/dL; <55 to 40 mg/dL), moderate; G 3 (>250 to 500 mg/dL; <40 to 30 mg/dL), severe; G 4 (>500 mg/dL; <30 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
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| Week 1, AGI; n=54 | Week 2, AGI; n=57 | Week 3, AGI; n=61 | Week 6, AGI; n=47 | Week 9, AGI; n=40 | Week 12, AGI; n=31 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=14 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=3 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | WD/study conclusion, AGI; n=49 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=54 | Week 2, ItoG3; n=57 | Week 3, ItoG3; n=61 | Week 6, ItoG3; n=47 | Week 9, ItoG3; n=40 | Week 12, ItoG3; n=31 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=14 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=3 | Week 60, ItoG3; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | WD/study conclusion, ItoG3; n=49 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=54 | Week 2, ItoG4; n=57 | Week 3, ItoG4; n=61 | Week 6, ItoG4; n=47 | Week 9, ItoG4; n=40 | Week 12, ItoG4; n=31 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=14 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=3 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | WD/study conclusion, ItoG4; n=49 | Worst-case on-therapy, ItoG4; n=65 |
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Lapatinib + Capecitabine | 13 | 10 | 10 | 7 | 6 | 4 | 3 | 1 | 1 | 2 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 15 | 32 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 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 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points
Blood samples were collected for the evaluation of hemoglobin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For hemoglobin: G 1 (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
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| Week 1, AGI; n=62 | Week 2, AGI; n=64 | Week 3, AGI; n=62 | Week 6, AGI; n=47 | Week 9, AGI; n=41 | Week 12, AGI; n=30 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=13 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=3 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | Withdrawal/study conclusion, AGI; n=51 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=62 | Week 2, ItoG3; n=64 | Week 3, ItoG3; n=62 | Week 6, ItoG3; n=47 | Week 9, ItoG3; n=41 | Week 12, ItoG3; n=30 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=13 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=3 | Week 60, ItoG3; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | Withdrawal/study conclusion, ItoG3; n=51 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=62 | Week 2, ItoG4; n=64 | Week 3, ItoG4; n=62 | Week 6, ItoG4; n=47 | Week 9, ItoG4; n=41 | Week 12, ItoG4; n=30 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=13 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=3 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | Withdrawal/study conclusion, ItoG4; n=51 | Worst-case on-therapy, ItoG4; n=65 |
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Lapatinib + Capecitabine | 10 | 16 | 12 | 10 | 7 | 6 | 5 | 2 | 4 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 16 | 33 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points
Blood samples were collected for the evaluation of WBC count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For WBCs: G 1 (NCT00526669)
Timeframe: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Intervention | participants (Number) |
---|
| Week 1, AGI; n=62 | Week 2, AGI; n=64 | Week 3, AGI; n=62 | Week 6, AGI; n=47 | Week 9, AGI; n=41 | Week 12, AGI; n=30 | Week 15, AGI; n=22 | Week 18, AGI; n=17 | Week 21, AGI; n=13 | Week 24, AGI; n=11 | Week 30, AGI; n=9 | Week 36, AGI; n=5 | Week 42, AGI; n=4 | Week 48, AGI; n=3 | Week 54, AGI; n=3 | Week 60, AGI; n=2 | Week 66, AGI; n=1 | Week 72, AGI; n=1 | Week 78, AGI; n=1 | Week 84, AGI; n=1 | Withdrawal/study conclusion, AGI; n=51 | Worst-case on-therapy, AGI; n=65 | Week 1, ItoG3; n=62 | Week 2, ItoG3; n=64 | Week 3, ItoG3; n=62 | Week 6, ItoG3; n=47 | Week 9, ItoG3; n=41 | Week 12, ItoG3; n=30 | Week 15, ItoG3; n=22 | Week 18, ItoG3; n=17 | Week 21, ItoG3; n=13 | Week 24, ItoG3; n=11 | Week 30, ItoG3; n=9 | Week 36, ItoG3; n=5 | Week 42, ItoG3; n=4 | Week 48, ItoG3; n=3 | Week 54, ItoG3; n=3 | Week 60, ItoG3; n=2 | Week 66, ItoG3; n=1 | Week 72, ItoG3; n=1 | Week 78, ItoG3; n=1 | Week 84, ItoG3; n=1 | Withdrawal/study conclusion, ItoG3; n=51 | Worst-case on-therapy, ItoG3; n=65 | Week 1, ItoG4; n=62 | Week 2, ItoG4; n=64 | Week 3, ItoG4; n=62 | Week 6, ItoG4; n=47 | Week 9, ItoG4; n=41 | Week 12, ItoG4; n=30 | Week 15, ItoG4; n=22 | Week 18, ItoG4; n=17 | Week 21, ItoG4; n=13 | Week 24, ItoG4; n=11 | Week 30, ItoG4; n=9 | Week 36, ItoG4; n=5 | Week 42, ItoG4; n=4 | Week 48, ItoG4; n=3 | Week 54, ItoG4; n=3 | Week 60, ItoG4; n=2 | Week 66, ItoG4; n=1 | Week 72, ItoG4; n=1 | Week 78, ItoG4; n=1 | Week 84, ItoG4; n=1 | Withdrawal/study conclusion, ItoG4; n=51 | Worst-case on-therapy, ItoG4; n=65 |
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Lapatinib + Capecitabine | 5 | 9 | 6 | 5 | 3 | 7 | 4 | 3 | 3 | 1 | 3 | 2 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 17 | 0 | 0 | 0 | 0 | 0 | 1 | 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 |
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Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS)
5-month (mo.) PFS was defined as the percentage of par. who were alive/progression free for 5 months from the time of initial treatment. PFS is defined as the time from the initial treatment until the first observation of disease progression (DP)/death due to any cause; the percentage of par. whose follow-up ended or was ongoing was reported. DP is defined as symptomatic progression or the appearance of >=1 NL and/or unequivocal progression of existing non-TLs, and a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started. (NCT00526669)
Timeframe: From initial treatment up to 24 weeks (next available assessment after the 5-month assessment for progressive disease)
Intervention | percentage of participants (Number) |
---|
Lapatinib + Capecitabine | 29 |
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Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters
For blood chemistry, the parameters assessed were: Sodium, potassium, calcium, magnesium, chloride, bicarbonate, total protein, albumin, alkaline phosphatase, alanine transaminase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), Lactate dehydrogenase (LDH), total bilirubin, direct bilirubin, indirect bilirubin, creatinine (serum creatinine or creatinine clearance), glucose. (NCT00532948)
Timeframe: Up to 06 years
Intervention | Participants (Number) |
---|
| Lactic dehydrogenase, normal to low, n=0,0,0 | Lactic dehydrogenase, normal to high, n=0,0,0 | Indirect bilirubin, normal to low, n=1,1,1 | Indirect bilirubin, normal to high, n=1,1,1 | BUN, normal to low, n=3,1,5 | BUN, normal to high, n=3,1,5 | Alkaline phosphatase, normal to low, n=1,1,4 | Alkaline phosphatase, normal to high, n=1,1,4 | Direct blirubin, normal to low, n=2,1,1 | Direct bilirubin, normal to high, n=2,1,1 | Total bilirubin, normal to low, n=4,2,6 | Total bilirubin, normal to high, n=4,2,6 | Fasting glucose, normal to low, n=1,0,4 | Fasting glucose, normal to high, n=1,0,4 | Protein, normal to low, n=1,0,2 | Protein, normal to high, n=1,0,2 | Serum albumin, normal to low, n=3,1,5 | Serum albumin, normal to high, n=3,1,5 | Serum creatinine, normal to low, n=4,2,6 | Serum creatinine, normal to high, n=4,2,6 | ASAT (SGOT), normal to low, n=1,0,4 | ASAT (SGOT), normal to high, n=1,0,4 | ALAT (SGPT), normal to low, n=4,2,6 | ALAT (SGPT), normal to high, n=4,2,6 | Calcium, normal to low, n=3, 1,5 | Calcium, normal to high, n=3,1,5 | Phosphate, normal to low, n=3,1,5 | Phosphate, normal to high, n=3,1,5 | Potassium, normal to low, n=3, 1,5 | Potassium, normal to high, n=3,1,5 | Sodium, normal to low, n=3,1,5 | Sodium, normal to high, n=3,1,5 | Magnesium, normal to low, n=3,1,5 | Magnesium, normal to high, n=3,1,5 | Chloride, normal to low, n=3,1,5 | Chloride, normal to high, n=3,1,5 | Bicarbonate, normal to low, n=3,0,5 | Bicarbonate, normal to high, n=3,0,5 |
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Capecitabine 500 mg/m^2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
,Capecitabine 650 mg/m^2 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
,Capecitabine 850 mg/m^2 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 2 | 0 | 4 | 0 | 1 | 1 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 1 | 0 | 3 |
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Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters
For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, RBC, WBC, lymphocytes, monocytes,granulocytes (blasts), neutrophils(segs, bands),eosinophils and basophils. (NCT00532948)
Timeframe: Up to 06 years
Intervention | Participants (Number) |
---|
| Haematocrit, normal to low, n=3,1,5 | Haematocrit, normal to high, n=3,1,5 | Hemoglobin, normal to low, n=4,2,6 | Hemoglobin, normal to high, n=4,2,6 | White blood cell, normal to low, n=3,1,5 | White blood cell, normal to high, n=3,1,5 | Platelets, normal to low, n=4,2,6 | Platelets, normal to high, n=4,2,6 | Red blood cells, normal to low, n=3,1,3 | Red blood cells, normal to high, n=3,1,3 | Neutrophils (segmented), normal to low , n=3,0,5 | Neutrophils (segmented), normal to high, n=3,0,5 | Basophils (relative), normal to low, n=0,1,2 | Basophils (relative), normal to high, n=0,1,2 | Lymphocytes (relative), normal to low, n=3,1,5 | Lymphocytes (relative), normal to high, n=3,1,5 | Monocytes (relative), normal to low, n=3,1,4 | Monocytes (relative), normal to high, n=3,1,4 | Eosinophils (relative), normal to low, n=1,1,3 | Eosinophils (relative), normal to high, n=1,1,3 |
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Capecitabine 500 mg/m^2 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,Capecitabine 650 mg/m^2 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
,Capecitabine 850 mg/m^2 | 4 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 3 | 0 | 0 |
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Dose Limiting Toxicities (DLTs)
DLT was defined as any of the following events occurring during the 11 week dose-finding period: any event that leads to interruption of planned radiation for 5 consecutive days or 10 days total; Grade 4 neutropenia or thrombocytopenia; Grade 3 thrombocytopenia that required a platelet transfusion on 2 or more occasions; any Grade 3 or 4 non-hematologic toxicity (with the exception of grade 3 nausea or vomiting of less than 5 days duration, Grade 3 transaminases that returned to baseline value within 7 days of study drug interruption and that did not recur upon re-challenge with study drug, and/or Grade 3 fever or infection of <5 days duration); Grade 2 non-hematologic toxicities that persisted for >7 days and required treatment interruption, or any other capecitabine-related adverse events that required need for dose reduction or permanent cessation of therapy, interruption of study drug for >7 days or recurred on re-challenge with capecitabine rapidly disintegrating tablets (RDTs). (NCT00532948)
Timeframe: Upto 11 weeks
Intervention | Participants (Number) |
---|
Capecitabine 500 mg/m^2 | 0 |
Capecitabine 650 mg/m^2 | 3 |
Capecitabine 850 mg/m^2 | 3 |
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Maximum Tolerated Dose (MTD) of Capecitabine.
The MTD was the dose level at which six evaluable patients had been treated and at most one patient experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 patients experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD. (NCT00532948)
Timeframe: Upto 11 weeks.
Intervention | milligrams (Number) |
---|
Capecitabine (Overall) | 650 |
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Number of Participants With Adverse Events (AE)
An AE is an unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was monitored and graded according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Adverse events that were not included in the CTCAEv3.0 were reported and graded under the other AE within the appropriate category. (NCT00532948)
Timeframe: Up to 06 years
Intervention | Participants (Number) |
---|
Capecitabine 500 mg/m^2 | 3 |
Capecitabine 650 mg/m^2 | 12 |
Capecitabine 850 mg/m^2 | 6 |
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Patients Experiencing Severe Symptom Burden (Physical Symptoms)
The subject rates each question about physical symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item. (NCT00534417)
Timeframe: The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.
Intervention | percentage of participants (Number) |
---|
| Hives/Welts | Sinus problems | Swelling | Fatigue | Weight loss | Change in taste | Difficulty hearing | Reduced sexual enjoyment, interest, or performance | Dry eyes | Tearing | Trouble seeing | Constipation | Decrease in appetite | Diarrhea | Heartburn | Increase in appetite | Problem with urination | Vaginal dryness | Bruising | New lump/mass | Breast tenderness | Dry skin | Hair loss | Itching | Nails change | Joint pain | Muscle aches | Weakness of body parts | Burning sensation in hands or feet | Daytime sleepiness | Dizziness/lightheadedness | Memory loss | Numbness/tingling | Trouble thinking | Headache | Pain | Coughing | Shortness of breath | Wheezing |
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Capecitabine and Fulvestrant | 3.3 | 3.3 | 10.0 | 26.7 | 10.0 | 6.7 | 3.3 | 10.0 | 10.0 | 10.0 | 16.7 | 20.0 | 6.7 | 3.3 | 6.7 | 3.3 | 3.3 | 3.3 | 3.3 | 6.7 | 3.3 | 13.3 | 3.3 | 13.3 | 10.0 | 26.7 | 26.7 | 10.0 | 10.0 | 10.0 | 3.3 | 6.7 | 13.3 | 10.0 | 6.7 | 26.7 | 13.3 | 6.7 | 6.7 |
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Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)
The subject rates each question about psychiatric symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item. (NCT00534417)
Timeframe: The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.
Intervention | percentage of participants (Number) |
---|
| Crying/feeling like crying | Feeling helpless | Feeling hopeless | Feeling I would be better off dead | Lost interest in people | Lost interest in pleasurable activities | Nervous, tense, anxious | Sad/depressed | Worry |
---|
Capecitabine and Fulvestrant | 10.3 | 6.9 | 10.3 | 3.4 | 3.4 | 10.3 | 13.8 | 10.3 | 10.3 |
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Patients Experiencing Severe Symptom Burden (Physical Functioning)
The subject rates each question about physical functioning on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item. (NCT00534417)
Timeframe: The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.
Intervention | percentage of participants (Number) |
---|
| Attend paid job (N=27) | Attend social activity | Bathe or dress self | Cook for self | Driving (N=27) | Function normally | Hard work or activity (N=27) | Household work | Light work or activity | Run (N=27) | Run errands | Sit up | Stay out of bed | Walk |
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Capecitabine and Fulvestrant | 37.0 | 7.1 | 10.7 | 10.7 | 25.9 | 14.3 | 33.3 | 21.4 | 10.7 | 33.3 | 17.9 | 10.7 | 7.1 | 17.9 |
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Best Overall Response
Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions. (NCT00534417)
Timeframe: Response to treatment was assessed after every 8 weeks of treatment
Intervention | participants (Number) |
---|
| Complete response (CR) | Partial response (PR) | Stable disease (SD) | Progressive disease (PD) |
---|
Capecitabine and Fulvestrant | 2 | 8 | 28 | 3 |
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Time to Progression (TTP)
Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per Response Evaluation Criteria in Solid Tumors (RECIST)v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP. (NCT00534417)
Timeframe: TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), up to 29 months.
Intervention | Months (Median) |
---|
Capecitabine and Fulvestrant | 26.94 |
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Clinical Benefit Rate
Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of >=20%. (NCT00534417)
Timeframe: Response to treatment was assessed after every 8 weeks of treatment
Intervention | percentage of participants (Number) |
---|
Capecitabine and Fulvestrant | 58.5 |
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Progression-free Survival (PFS)
Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. (NCT00534417)
Timeframe: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, up to 32.5 months.
Intervention | Months (Median) |
---|
Capecitabine and Fulvestrant | 14.98 |
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Overall Survival (OS)
Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. (NCT00534417)
Timeframe: OS was measured from day 1 of treatment until time of death from any cause, up to 32.5 months.
Intervention | Months (Median) |
---|
Capecitabine and Fulvestrant | 28.65 |
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Overall Response Rate
Overall response rate was defined as the percentage of participants experiencing complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions. (NCT00534417)
Timeframe: Response to treatment was assessed after every 8 weeks of treatment
Intervention | percentage of participants (Number) |
---|
Capecitabine and Fulvestrant | 24.4 |
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Overall Response in Phase II
The overall response is defined as the number of participants whose tumor response was classified as a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria in Solid Tumors. Response was measured for participants in Phase II only. To determine response, radiographic images were taken at baseline, 8 weeks, and every 8 weeks thereafter until the participant withdrew from the study. (NCT00536809)
Timeframe: Baseline to response (up to 135 days)
Intervention | participants (Number) |
---|
Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2 | 2 |
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Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by spiral CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00538291)
Timeframe: Assessment after every 2 cycles of treatment, up to 1 year.
Intervention | number of responding participants (Number) |
---|
Arm 1 | 1 |
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Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort
The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine. (NCT00546364)
Timeframe: Baseline to 6 weeks (end of Cycle 2)
Intervention | Percentage of NTN Participants (Number) |
---|
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 33 |
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 54 |
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 42 |
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Percentage of Participants With Best Response to Treatment of Complete or Partial
The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm. (NCT00546364)
Timeframe: Baseline to 6 weeks (end of Cycle 2)
Intervention | Percentage of patients (Number) |
---|
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 35 |
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 41 |
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 30 |
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Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial
The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2). (NCT00546364)
Timeframe: Baseline to 6 weeks (end of Cycle 2)
Intervention | Percentage of TN Participants (Number) |
---|
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 38 |
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 22 |
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 13 |
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Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated. (NCT00546364)
Timeframe: Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle
Intervention | Participants (Number) |
---|
| Neutropenia (Grades 1-4) | Neutropenia (Grade 3 or 4) | Leukopenia (Grades 1-4) | Leukopenia (Grade 3 or 4) | Thrombocytopenia (Grades 1-4) | Thrombocytopenia (Grade 3 or 4) | Anemia (Grades 1-4) | Anemia (Grade 3 or 4) |
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Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 17 | 15 | 17 | 12 | 7 | 0 | 17 | 0 |
,Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 15 | 10 | 19 | 9 | 11 | 1 | 21 | 1 |
,Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 18 | 12 | 20 | 9 | 9 | 0 | 18 | 0 |
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Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator. (NCT00546364)
Timeframe: Baseline to 6 weeks (end of Cycle 2)
Intervention | Participants (Number) |
---|
| Complete response (CR) | Partial response (PR) | Stable disease (SD) | Progressive disease (PD) | Discontinued before first tumor assessment | No tumor assessment due to other reasons | Unable to determine |
---|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 0 | 6 | 3 | 9 | 1 | 1 | 0 |
,Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 1 | 8 | 3 | 9 | 0 | 0 | 1 |
,Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 1 | 6 | 6 | 4 | 3 | 0 | 0 |
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Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Aspartate aminotransferase (AST) Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. Creatine Grade 1: >ULN to 1.5*ULN; Grade 2: 1.5 to 3.0*ULN; Grade 3: >3.0 to 6.0*ULN; Grade 4: >6.0*ULN. (NCT00546364)
Timeframe: Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle
Intervention | Participants (Number) |
---|
| ALT, high (Grades 1-4) | ALT, high (Grade 3 or 4) | AST, high (Grades 1-4) | AST, high (Grade 3 or 4) | Total bilirubin, high (Grades 1-4) | Total bilirubin, high (Grade 3 or 4) | Creatinine, high (Grades 1-4) | Creatinine, high (Grade 3 or 4) |
---|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 5 | 0 | 5 | 0 | 0 | 0 | 2 | 0 |
,Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 3 | 0 | 5 | 0 | 1 | 0 | 1 | 0 |
,Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 4 | 0 | 7 | 0 | 0 | 0 | 1 | 0 |
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Overall Survival
The primary efficacy endpoint for this study was overall survival (time to death), defined as the time between randomization and the date of death irrespective of the cause of death. Patients for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Median survival was estimated by the Kaplan-Meier method. (NCT00548548)
Timeframe: From randomization until death, up to 26 months
Intervention | months (Median) |
---|
Bevacizumab | 12.1 |
Placebo | 10.1 |
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Participants With Adverse Events
The intensity of Adverse Events (AEs) was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0 on a five-point scale from Grade 1 (Mild) to Grade 5 (Death). A serious AE (SAE) was defined as any event that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. (NCT00548548)
Timeframe: From randomization until 3 months after last dose (up to 26 months)
Intervention | participants (Number) |
---|
| Any Adverse event | Serious AE | Grade 3/4/5 AE | Grade 5 AE | Deaths not due to Progression |
---|
Bevacizumab | 380 | 134 | 293 | 18 | 31 |
,Placebo | 377 | 137 | 294 | 25 | 29 |
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Progression-free Survival
Progression-free survival (PFS) is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first. Patients who neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease. Median PFS was estimated using the Kaplan-Meier method. (NCT00548548)
Timeframe: From randomization until disease progression or death, up to 26 months.
Intervention | months (Median) |
---|
Bevacizumab | 6.7 |
Placebo | 5.3 |
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Progression-free Survival During First-line Therapy
Progression-free survival (PFS) during first-line therapy is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first and only if it occurs no later than 28 days after last confirmed intake of any study medication and only if it occurs before the start of non-study antineoplastic treatment. Participants who did not progress or die in this interval or were lost to follow-up were censored at the date of the last tumor assessment within this time window. Median PFS was estimated using the Kaplan-Meier method. (NCT00548548)
Timeframe: From randomization until 28-days after the last study treatment was administered, up to 26 months.
Intervention | months (Median) |
---|
Bevacizumab | 6.9 |
Placebo | 5.4 |
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Participants With Disease Control
Disease control for participants with measurable disease was defined as a complete response (CR), partial response (PR) or stable disease (SD) for 6 weeks or longer, as determined by the RECIST criteria. For participants without measurable disease, disease control was defined as no disease progression for ≥ 6 weeks. (NCT00548548)
Timeframe: From randomization until the end of study, up to 26 months.
Intervention | participants (Number) |
---|
| Participants with Disease Control | Participants without Disease Control |
---|
Bevacizumab | 300 | 87 |
,Placebo | 271 | 116 |
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Duration of Response
Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. Median duration of response was estimated using the Kaplan-Meier method. (NCT00548548)
Timeframe: From randomization to the end of study, up to 26 months
Intervention | months (Median) |
---|
Bevacizumab | 7.1 |
Placebo | 5.8 |
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Time to Disease Progression
Time to progression is defined as the time from randomization to the first occurrence of progressive disease (PD). PD was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Patients with no PD at study completion (including those who died before PD) were censored at the date of the last tumor assessment. Median time to PD was estimated using the Kaplan-Meier method. (NCT00548548)
Timeframe: From randomization until disease progression; assessed every 6 weeks for the first year and every 12 weeks thereafter, up to 26 months.
Intervention | months (Median) |
---|
Bevacizumab | 7.0 |
Placebo | 5.6 |
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Participants With a Best Overall Response of Complete or Partial Response
Best overall response during first-line therapy is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response, as determined by the RECIST criteria. CR is defined as the disappearance of all target and non-target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions and no new or progression of non-target lesions, or the disappearance of all target lesions and persistence of one or more non-target lesion(s). (NCT00548548)
Timeframe: From randomization until the end of study, up to 26 months.
Intervention | participants (Number) |
---|
| Responders | Non-responders |
---|
Bevacizumab | 143 | 168 |
,Placebo | 111 | 186 |
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Number of Participants Who Experienced One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. (NCT00551213)
Timeframe: Up to 30 days after last dose of study drug (Up to approximately 22 weeks)
Intervention | Participants (Number) |
---|
Robatumumab→Robatumumab | 49 |
Chemotherapy→Robatumumab | 15 |
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Number of Participants Who Discontinued Study Drug Due to an AE
An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. (NCT00551213)
Timeframe: Up to last dose of study drug (Up to approximately 18 weeks)
Intervention | Participants (Number) |
---|
Robatumumab→Robatumumab | 6 |
Chemotherapy→Robatumumab | 3 |
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Best Overall Tumor Response Per Central Review
Tumor response was assessed by CT or MRI scan using RECIST v1.0 criteria at Screening, at every 8 weeks of robatumumab treatment during Period 2 and at post study. A sum of the LD for all target lesions was calculated and reported as the baseline sum LD. Overall tumor responses were defined as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. (NCT00551213)
Timeframe: Up to 30 days after last dose of study drug (Up to approximately 22 weeks)
Intervention | Participants (Number) |
---|
| Partial Response | Stable Disease | Progressive Disease | No post-Baseline assessment |
---|
Chemotherapy→Robatumumab | 0 | 5 | 9 | 1 |
,Robatumumab→Robatumumab | 0 | 10 | 31 | 8 |
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Change From Baseline in Tumor Growth Rate
Tumor growth rate was assessed by CT or MRI scans using RECIST criteria at Screening, at every 8 weeks of robatumumab treatment and at post study. For Pre Baseline 1, tumor growth rate=(sum of longest diameter of target lesions at Baseline - the most recent prior to Baseline)/duration between Baseline and Pre Baseline. For all other cycles, tumor growth rate=(sum of longest diameter of target lesions at a cycle - Baseline)/ duration between Baseline and the cycle. The cycles presented below are relative to the first dose of robatumumab in Period 1. (NCT00551213)
Timeframe: Baseline and up to approximately 22 weeks
Intervention | mm/day (Mean) |
---|
| Pre Baseline 1 (n=46) | Cycle 1 (n=24) | Cycle 2 (n=25) | Cycle 5 (n=25) | Cycle 9 (n=7) |
---|
Robatumumab→Robatumumab | 0.49 | 0.07 | 0.41 | 0.53 | 0.19 |
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Best Overall Tumor Response Per Investigator Review
Tumor response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) scans using RECIST v 1.0 criteria at Screening, at every 8 weeks of robatumumab treatment during Period 2 and at post study. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. Overall tumor responses were defined as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. (NCT00551213)
Timeframe: Up to 30 days after last dose of study drug (Up to approximately 22 weeks)
Intervention | Participants (Number) |
---|
| Partial Response | Stable Disease | Progressive Disease | No post-Baseline assessment |
---|
Chemotherapy→Robatumumab | 0 | 7 | 6 | 2 |
,Robatumumab→Robatumumab | 1 | 10 | 33 | 5 |
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Progression-Free Survival (PFS)
PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. (NCT00555620)
Timeframe: Baseline up to Month 15
Intervention | months (Median) |
---|
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 | 3.2 |
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 | 6.6 |
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 6.4 |
SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 8.0 |
SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 2.8 |
SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 5.5 |
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Percentage of Participants With Objective Response
Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. (NCT00555620)
Timeframe: Baseline, Day 21 of every even-numbered cycle up to 15 months
Intervention | percentage of participants (Number) |
---|
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 | 16.7 |
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 | 42.9 |
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 46.7 |
SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 43.5 |
SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 0 |
SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 45.5 |
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Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having >3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery >14 days. (NCT00555620)
Timeframe: Baseline up to Day 21
Intervention | participants (Number) |
---|
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 | 1 |
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 | 0 |
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 3 |
SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 2 |
SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 2 |
SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 0 |
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Duration of Response (DR)
DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. (NCT00555620)
Timeframe: Baseline up to Month 15
Intervention | months (Median) |
---|
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 | 14.1 |
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 | 6.3 |
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 10.5 |
SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 5.9 |
SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 6.3 |
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Tmax for CAP
(NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | hr (Median) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 4.3 | 0.3 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 0.5 | 0.4 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 2.0 | 2.0 |
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Tmax for 5'DFUR
(NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | hr (Median) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 4.5 | 0.4 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 0.8 | 0.5 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 2.0 | 3.0 |
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Tmax for 5'DFCR
(NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | hr (Median) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 4.3 | 0.4 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 0.6 | 0.5 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 2.0 | 3.0 |
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Tmax for 5-FU
(NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | hr (Median) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 4.5 | 0.4 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 0.6 | 0.5 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 2.0 | 3.0 |
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)
(NCT00555620)
Timeframe: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
Intervention | hour (hr) (Median) |
---|
| Tmax SU011248 | Tmax SU012662 | Tmax total drug (SU011248+SU012662) |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 4.0 | 9.0 | 4.0 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 8.0 | 6.0 | 6.0 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 8.0 | 8.0 | 8.0 |
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Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)
(NCT00555620)
Timeframe: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
Intervention | ng/mL (Mean) |
---|
| Cmin SU011248 | Cmin SU012662 | Cmin total drug (SU011248+SU012662) |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 29.0 | 11.9 | 41.6 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 30.2 | 11.1 | 41.8 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 49.2 | 18.7 | 68.5 |
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t1/2 for CAP
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | hr (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 0.3 | 0.4 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 0.4 | 0.4 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 0.3 | 0.5 |
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t1/2 for 5'DFUR
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | hr (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 0.7 | 0.6 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 0.7 | 0.7 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 1.0 | 1.0 |
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AUClast for 5'DFUR
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) (NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)
Intervention | ng*hr/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 8855 | 8500 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 8951 | 10017 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 5658 | 4829 |
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Cmin of 5-FU
(NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | ng/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 0.0 | 0.0 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 0.8 | 0.0 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 0.0 | 0.0 |
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Cmin of 5'DFCR
(NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | ng/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 11.1 | 50.5 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 55.60 | 0.00 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 13.0 | 0.00 |
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Cmin of 5'DFUR
(NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | ng/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 0.0 | 33.5 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 34.4 | 0.0 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 2.4 | 0.0 |
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Cmin of CAP
(NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | ng/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 24.8 | 32.0 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 0.0 | 0.0 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 0.0 | 0.0 |
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t1/2 for 5-FU
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | hr (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 0.8 | 0.6 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 0.6 | 0.6 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 1.2 | 1.1 |
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t1/2 for 5'DFCR
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | hr (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 0.7 | 0.7 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 0.8 | 0.8 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 1.0 | 1.1 |
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Cmax of CAP
(NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | ng/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 7000 | 20491 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 11681 | 16276 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 2051 | 1989 |
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) (NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)
Intervention | ng*hr/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 7555 | 13532 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 7373 | 8213 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 2899 | 3157 |
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AUClast for 5'DFCR
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) (NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)
Intervention | ng*hr/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 12815 | 8614 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 11229 | 9776 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 8028 | 6464 |
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AUClast for 5-FU
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) (NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)
Intervention | ng*hr/mL (Mean) |
---|
| Cycle 1, Day 1 | Cycle 1, Day 14 |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 355 | 688 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 506 | 854 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 291 | 350 |
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). (NCT00555620)
Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | ng*hr/mL (Mean) |
---|
| CAP (n = 1, 4, 10) | 5'DFCR (n = 1, 7, 10) | 5'DFUR (n = 1, 6, 10) | 5-FU (n = 1, 5, 9) |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 7480 | 9200 | 7770 | 386 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 8069 | 11467 | 9099 | 489 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 2828 | 8853 | 5703 | 285 |
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Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU
AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12) (NCT00555620)
Timeframe: Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)
Intervention | ng*hr/mL (Mean) |
---|
| CAP (n = 1, 4, 9) | 5'DFCR (n = 1, 7, 10) | 5'DFUR (n = 1, 6, 10) | 5-FU (n = 1, 5, 10) |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 25435 | 15522 | 15522 | 1299 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 8865 | 10091 | 10291 | 842 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 2663 | 7087 | 4822 | 353 |
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Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)
Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state. (NCT00555620)
Timeframe: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
Intervention | nanogram hours per milliliter (ng*hr/mL) (Mean) |
---|
| AUC (0-24) SU011248 | AUC (0-24) SU012662 | AUC (0-24) total drug (SU011248+SU012662) |
---|
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 | 844 | 321 | 1163 |
,SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 | 902 | 327 | 1230 |
,SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 | 1420 | 524 | 1944 |
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Recurrence
This population has aggressive disease with a high rate of recurrence and death within 1 year of completing radiation therapy (NCT00562718)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Surgery and Chemotherapy | 14 |
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Cosmesis
(NCT00562718)
Timeframe: 1 year
Intervention | participants (Number) |
---|
Surgery and Chemotherapy | 22 |
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Overall Safety
Primarily Grade 1 and 2 toxicities attributable to capecitabine (NCT00562718)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Surgery and Chemotherapy | 12.6 |
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Overall Survival
(NCT00565370)
Timeframe: 28 months
Intervention | Months (Median) |
---|
XP Plus Sorafenib | 14.7 |
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Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Number of Participants who Experienced Dose Limiting Toxicities (DLTs) (NCT00565370)
Timeframe: 28weeks
Intervention | participants (Number) |
---|
XP Plus Sorafenib | 3 |
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Progression-free Survival
(NCT00565370)
Timeframe: 1 year
Intervention | Months (Median) |
---|
XP Plus Sorafenib | 10.0 |
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Response Rate
"Tumor response was assessed every two cycles by RECIST(v1.0) using the same imaging techniques and methods used at baseline.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate" (NCT00565370)
Timeframe: 6 months
Intervention | percentage of participants (Number) |
---|
XP Plus Sorafenib | 62.8 |
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Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)
Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib (NCT00565370)
Timeframe: 28weeks
Intervention | participants (Number) |
---|
XP Plus Sorafenib | 21 |
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Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval
T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval. (NCT00568022)
Timeframe: During Cycle 1 at specified timepoints (Day 1 to Day 8).
Intervention | Hours (Mean) |
---|
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 41.77 |
Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 44.17 |
Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day | 54.27 |
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Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval
Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval. (NCT00568022)
Timeframe: During Cycle 1 at specified timepoints (Day 1 to Day 8).
Intervention | Liters (Mean) |
---|
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 1910.13 |
Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 1498.46 |
Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day | 2055.55 |
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Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval
AUC = the average area under the concentration curve (AUC [INF]) of ixabepilone as determined from participant serum samples in one dosing interval over 24 hours. (NCT00568022)
Timeframe: During Cycle 1 at specified timepoints (Day 1 to Day 8).
Intervention | ng·h/mL (Geometric Mean) |
---|
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 1260.71 |
Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 1676.46 |
Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day | 1417.78 |
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Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval
Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval. (NCT00568022)
Timeframe: During Cycle 1 at specified timepoints (Day 1 to Day 8).
Intervention | ng/mL (Geometric Mean) |
---|
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 164.01 |
Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 219.44 |
Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day | 192.13 |
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Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval
CLT = total body clearance as determined from participant serum samples in one dosing interval. (NCT00568022)
Timeframe: During Cycle 1 at specified timepoints (Day 1 to Day 8).
Intervention | L/h (Mean) |
---|
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 41.52 |
Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 37.21 |
Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day | 42.79 |
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Participants Experiencing Dose Limiting Toxicity (DLT)
DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles. (NCT00568022)
Timeframe: From initiation of drug through last day of Cycle 2 (Day 42)
Intervention | Participants (Number) |
---|
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 0 |
Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 0 |
Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day | 0 |
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Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE = any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related=Possible, Probable, or Certain relationship to drug (NCT00568022)
Timeframe: Baseline to Day 42, continuously
Intervention | Participants (Number) |
---|
| AEs | Related AEs | Discontinued Due to AEs | SAEs | Related SAEs | Discontinued Due to SAEs | Deaths |
---|
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 3 | 3 | 0 | 0 | 0 | 0 | 0 |
,Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 3 | 3 | 0 | 1 | 1 | 0 | 0 |
,Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day | 3 | 3 | 0 | 1 | 1 | 0 | 0 |
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Participant Tumor Response at Study Endpoint
Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) in which complete response (CR) = disappearance of all target lesions; partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; and stable disease (SD) = small changes that do not meet above criteria. (NCT00568022)
Timeframe: At baseline and after every 42 days (every 2 21-day cycles) after baseline
Intervention | Participants (Number) |
---|
| CR | PR | PD | SD |
---|
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 0 | 1 | 1 | 1 |
,Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day | 0 | 1 | 1 | 1 |
,Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day | 1 | 2 | 0 | 0 |
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Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
The MTD was defined as the highest dose evaluated for which less than 1/3 of the participants experienced DLT during the first two treatment cycles. If toxicities (e.g. hand-foot syndrome, existing peripheral neuropathy, etc.) occurred or became more severe in later cycles, the recommended Phase II dose was to be determined after due consideration of their severity. (NCT00568022)
Timeframe: At the end of Cycle 2 (Day 42)
Intervention | Participants (Number) |
---|
| Ixa 40 mg/m^2 + Cap 2000 mg/m^2 MTD | Ixa 40 mg/m^2 + Cap 2000 ng/m^2 RP2D |
---|
All Participants With Measurable Disease and Tumor Response | 3 | 3 |
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Progression Free Survival
Progression free survival is defined as form initiation of WBRT with capecitabine to the time of first documented progression at any site (CNS or non-CNS site) or death due to any cause, where progression is defined stringently by progression in either CNS or extra-CNS metastases. (NCT00570908)
Timeframe: 2 years
Intervention | months (Median) |
---|
WBRT + Capecitabine + Sunitinib | 4.7 |
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Response Rate of Lapatinib/Capecitabine.
(NCT00574171)
Timeframe: duration of study; on average 1 year
Intervention | participants (Number) |
---|
| PD | SD |
---|
Lapatinib/Capecitabine | 4 | 1 |
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Number of Participants With Dose-limiting Toxicities (DLTs)
(NCT00578071)
Timeframe: Within 30 days of the last day of radiation
Intervention | participants (Number) |
---|
Chemoradiation | 2 |
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Overall Survival Rates for the Patients Studied on This Protocol.
Number of patients alive one year after completing study protocol treatment. (NCT00578071)
Timeframe: One year
Intervention | participants (Number) |
---|
Arm 1 Chemoradiation | 18 |
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Panitumumab Maximum Tolerated Dose in Milligrams (mg)
(NCT00578071)
Timeframe: 60 days
Intervention | mg (Number) |
---|
Chemoradiation | 3.6 |
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Pathological Complete Response Rates Associated With This Regimen.
Absence of residual viable tumor cells at the time of surgical resection of the esophagus performed 7-9 weeks following completion of chemoradiotherapy. (NCT00578071)
Timeframe: 90 days
Intervention | percentage of participants (Number) |
---|
Arm 1 Chemoradiation | 40 |
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Response Rate
Response rate (RR) is defined as the proportion of participants achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. (NCT00585078)
Timeframe: Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.
Intervention | proportion of participants (Number) |
---|
CAPOX | .125 |
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Overall Survival
Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods. (NCT00585078)
Timeframe: Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median survival follow-up was 10.8 months (95% CI: 7.1-37.7) in this study cohort.
Intervention | months (Median) |
---|
CAPOX | 7.4 |
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Progression-Free Survival
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from treatment or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. (NCT00585078)
Timeframe: Disease evaluations occurred every two cycles (42 days ±2 days) on treatment. In this study cohort, participants were followed for progression up to 38 months.
Intervention | months (Median) |
---|
CAPOX | 3.8 |
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Best Response
Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria. (NCT00585078)
Timeframe: Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.
Intervention | participants (Number) |
---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease |
---|
CAPOX | 0 | 3 | 13 | 8 |
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Unconfirmed Objective Response Rate and Disease Control Rate (ITT Population)
Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment. (NCT00600340)
Timeframe: Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.
Intervention | Participants (Count of Participants) |
---|
| Objective response | Disease control |
---|
Bevacizumab Plus Capecitabine | 105 | 214 |
,Bevacizumab Plus Paclitaxel | 163 | 252 |
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Observation Time (ITT Population)
Median observation time estimated with reverse Kaplan-Meier methods. Observation time (in months) is defined as time from randomization to the day the patient was last confirmed to be alive. In case of patient deaths the time was censored at the day of death. (NCT00600340)
Timeframe: Up to approximately 6 years
Intervention | months (Median) |
---|
Bevacizumab Plus Paclitaxel | 54.3 |
Bevacizumab Plus Capecitabine | 55.7 |
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Duration of Response (PP Population)
Duration of response (DR) was defined as time from date of first occurrence of any response (complete response (CR) or partial response (PR)) until the occurrence of progression of disease or death. Patients with response who neither progressed nor died were censored at the date of their last tumor assessment. Median DR, associated stratified Hazard Ratio (HR). (NCT00600340)
Timeframe: Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response.
Intervention | months (Median) |
---|
Bevacizumab Plus Paclitaxel | 11.2 |
Bevacizumab Plus Capecitabine | 10.3 |
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Duration of Response (ITT Population)
Duration of response (DR) was defined as time from date of first occurrence of any response (complete response (CR) or partial response (PR)) until the occurrence of progression of disease or death. Patients with response who neither progressed nor died were censored at the date of their last tumor assessment. Median DR, associated stratified Hazard Ratio (HR). (NCT00600340)
Timeframe: Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response.
Intervention | months (Median) |
---|
Bevacizumab Plus Paclitaxel | 11.2 |
Bevacizumab Plus Capecitabine | 10.3 |
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Overall Survival (PP Population)
Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250. (NCT00600340)
Timeframe: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years
Intervention | months (Median) |
---|
Bevacizumab Plus Paclitaxel | 30.2 |
Bevacizumab Plus Capecitabine | 26.1 |
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Progression Free Survival (ITT Population)
Progression Free Survival (PFS) is defined as time from randomization to date of documented progression or date of death due to any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients who were randomized and had no post-baseline tumor assessment were censored on the day of randomization. Median PFS, associated stratified Hazard Ratio (HR). (NCT00600340)
Timeframe: Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years.
Intervention | months (Median) |
---|
Bevacizumab Plus Paclitaxel | 10.9 |
Bevacizumab Plus Capecitabine | 8.1 |
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Progression Free Survival (PP Population)
Progression Free Survival (PFS) is defined as time from randomization to date of documented progression or date of death due to any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients who were randomized and had no post-baseline tumor assessment were censored on the day of randomization. Median PFS, associated stratified Hazard Ratio (HR). (NCT00600340)
Timeframe: Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years.
Intervention | months (Median) |
---|
Bevacizumab Plus Paclitaxel | 10.9 |
Bevacizumab Plus Capecitabine | 8.2 |
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Time to Treatment Failure (ITT Population)
Time to treatment failure (TTF) was defined as time from first drug intake to progression, death or withdrawal from study treatment, whichever occurred first. Patients without an event were censored at the date of the last tumor assessment or last treatment administration, whichever occurred last. Median TTF, associated stratified Hazard Ratio (HR). (NCT00600340)
Timeframe: From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 years
Intervention | months (Median) |
---|
Bevacizumab Plus Paclitaxel | 8.4 |
Bevacizumab Plus Capecitabine | 7.2 |
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Overall Survival (ITT Population)
Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 50% of information was 0.0014. Alpha spent at final analysis after 99% of information was 0.0250. (NCT00600340)
Timeframe: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years
Intervention | months (Median) |
---|
Bevacizumab Plus Paclitaxel | 29.5 |
Bevacizumab Plus Capecitabine | 26.0 |
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Time to Treatment Failure (PP Population)
Time to treatment failure (TTF) was defined as time from first drug intake to progression, death or withdrawal from study treatment, whichever occurred first. Patients without an event were censored at the date of the last tumor assessment or last treatment administration, whichever occurred last. Median TTF, associated stratified Hazard Ratio (HR). (NCT00600340)
Timeframe: From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 years
Intervention | months (Median) |
---|
Bevacizumab Plus Paclitaxel | 8.3 |
Bevacizumab Plus Capecitabine | 7.3 |
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Objective Response Rate and Disease Control Rate (ITT Population)
Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase (NCT00600340)
Timeframe: Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.
Intervention | Participants (Count of Participants) |
---|
| Objective response | Disease control |
---|
Bevacizumab Plus Capecitabine | 76 | 214 |
,Bevacizumab Plus Paclitaxel | 125 | 252 |
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Time to Response (ITT Population)
Time to response (TR) was defined as time from randomization until occurrence of response (complete response (CR) or partial response (PR)) according to RECIST criteria. Patients without response were censored after the longest time to response observed in any patient. Median TR, associated stratified Hazard Ratio (HR). Since the median TR was not observed, the number of subjects with a response at given timepoints were reported. (NCT00600340)
Timeframe: Time from randomization until occurrence of response, assessed up 1.7 years
Intervention | Participants (Count of Participants) |
---|
| Month 3 | Month 6 | Month 9 | Month 12 | Month 15 |
---|
Bevacizumab Plus Capecitabine | 57 | 69 | 74 | 75 | 75 |
,Bevacizumab Plus Paclitaxel | 83 | 111 | 121 | 123 | 123 |
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Unconfirmed Objective Response Rate and Disease Control Rate (PP Population)
Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment (NCT00600340)
Timeframe: Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.
Intervention | Participants (Count of Participants) |
---|
| Objective response | Disease control |
---|
Bevacizumab Plus Capecitabine | 100 | 204 |
,Bevacizumab Plus Paclitaxel | 157 | 238 |
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Time to Response (PP Population)
Time to response (TR) was defined as time from randomization until occurrence of response (complete response (CR) or partial response (PR)) according to RECIST criteria. Patients without response were censored after the longest time to response observed in any patient. Median TR, associated stratified Hazard Ratio (HR). Since the median TR was not observed, the number of subjects with a response at given timepoints were reported. (NCT00600340)
Timeframe: Time from randomization until occurrence of response, assessed up 1.7 years
Intervention | Participants (Count of Participants) |
---|
| Month 3 | Month 6 | Month 9 | Month 12 | Month 15 |
---|
Bevacizumab Plus Capecitabine | 56 | 68 | 72 | 73 | 73 |
,Bevacizumab Plus Paclitaxel | 81 | 108 | 118 | 119 | 119 |
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Objective Response Rate and Disease Control Rate (PP Population)
Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase (NCT00600340)
Timeframe: Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.
Intervention | Participants (Count of Participants) |
---|
| Objective response | Disease control |
---|
Bevacizumab Plus Capecitabine | 74 | 204 |
,Bevacizumab Plus Paclitaxel | 121 | 238 |
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One Year Survival Rate
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the exact binomial method. (NCT00601627)
Timeframe: Baseline to 12 months
Intervention | proportion of patients (Number) |
---|
Panitumumab | 0.502 |
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Time to Treatment Failure
Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of survival time will be estimated using the method of Kaplan-Meier. (NCT00601627)
Timeframe: baseline to 2 years
Intervention | months (Median) |
---|
Panitumumab | 2.71 |
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Confirmed Response Rate
"A confirmed tumor response is defined to be a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.~A complete response is defined as the disappearance of all target and non-target lesions.~A partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesion from baseline.~Confirmed tumor response will be evaluated using the first 6 cycles of treatment." (NCT00601627)
Timeframe: baseline to 2 years
Intervention | rate of confirmed response (Number) |
---|
Panitumumab | 0.059 |
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Overall Survival
Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (NCT00601627)
Timeframe: baseline to 2 years
Intervention | months (Median) |
---|
Panitumumab | 12.1 |
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Progression Free Survival (PFS)
Progression Free Survival is defined as the time from registration to the earliest documented evidence of disease progression. (NCT00601627)
Timeframe: baseline to 2 years
Intervention | months (Median) |
---|
Panitumumab | 7.4 |
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Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy
The resected pancreaticoduodenectomy specimen and accompanying lymph nodes will be staged according to American Joint Committee on Cancer 6th Edition incorporating the prefix y to indicate a specimen status-post neoadjuvant treatment (ypTNM). Cancer 2012;118:1382-90 (NCT00609336)
Timeframe: Up to 7 years
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy) | 20 |
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Percent of Patients Surviving at 5 Years
Kaplan-Meier estimate of overall survival at 5 years (NCT00609336)
Timeframe: Up to 5 years
Intervention | percentage of eligible pts alive (Number) |
---|
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy) | 31.6 |
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Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
(NCT00609336)
Timeframe: Up to 26 weeks after surgery (the end of adjuvant chemotherapy)
Intervention | occurrence of toxicities (Number) |
---|
| Any Grade 2 CTCAE toxicity | Any Grade 3 CTCAE toxicity | Any Grade 4 CTCAE toxicity |
---|
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy) | 21 | 121 | 14 |
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Percent of Patients Surviving at Annual Intervals
(NCT00609336)
Timeframe: 5 years
Intervention | percentage of participants (Number) |
---|
| Year 1 | Year 2 | Year 3 | Year 4 | Year 5 |
---|
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy) | 81 | 62 | 45 | 37 | 31 |
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Surgical Completion Rate and Complication Rate
(NCT00609336)
Timeframe: Up to 6 weeks following the completion of chemoradiotherapy
Intervention | Participants (Count of Participants) |
---|
| Completion rate | Complication rate |
---|
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy) | 22 | 2 |
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Disease-free Survival: 4-year Rate
Disease is defined as local-regional failure or distant failure. Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Local-regional failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) / any recurrence after a nodal CR - reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of primary/nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Disease-free survival time is defined as time from registration to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. (NCT00613080)
Timeframe: From registration to four years
Intervention | percentage of participants (Number) |
---|
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 60.6 |
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Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning
Real-time quality assurance was performed remotely by the study chair or the radiation oncology co-chair prior to initiation of treatment for the first 40 cases. The final cases enrolled were reviewed within 3 months after accrual was completed. Review included evaluation of clinical target volume (CTV) and planning target volume (PTV), Organs at Risk (OARs), and treatment plan dosimetry. (NCT00613080)
Timeframe: Pretreatment
Intervention | Participants (Count of Participants) |
---|
| Tumor volume: Contouring score72417637 | Organs at risk: Contouring score72417637 | Tumor volume: Dose volume analysis score72417637 | Organs at risk: Dose volume analysis score72417637 |
---|
| Unacceptable variation | Per Protocol | Acceptable variation |
---|
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 58 |
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 5 |
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 62 |
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 6 |
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 0 |
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 59 |
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 8 |
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 1 |
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 48 |
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 17 |
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 3 |
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Overall Survival: 4-year Rate
Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (NCT00613080)
Timeframe: From registration to four years
Intervention | percentage of participants (Number) |
---|
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 82.9 |
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Number of Patients With Pathologic Complete Response
Pathologic complete response is defined as no evidence of residual cancer histologically in the resection specimen. (NCT00613080)
Timeframe: At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.
Intervention | Participants (Count of Participants) |
---|
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 10 |
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Number of Patients Who Underwent Abdominoperineal Resection
All patients were to undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) was at the discretion of the surgeon. If more than 28 patients received abdominoperineal resection, this would result in a conclusion of an excessive number of abdominoperineal resections. (NCT00613080)
Timeframe: Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.
Intervention | Participants (Count of Participants) |
---|
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 14 |
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Local-regional Failure: 4-year Rate
Local failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Regional failure is defined as: (1) any recurrence after a nodal CR reported at surgery or reported after the end of protocol treatment; or (2) persistence, absence of nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Local-regional failure time is defined as time from registration to local or regional failure, last known follow-up (censored), or death (competing risk). Local-regional failure rates are estimated by the cumulative incidence method. (NCT00613080)
Timeframe: From registration to four years
Intervention | percentage of participants (Number) |
---|
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 7.4 |
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Distant Failure: 4-year Rate
Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Time to distant failure is defined as time from registration to the date of distant failure, last known follow-up (censored), or death (competing risk). Distant failure rates are estimated by the cumulative incidence method. (NCT00613080)
Timeframe: From registration to four years
Intervention | percentage of participants (Number) |
---|
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy | 29.7 |
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Time Until a Complete Response or a Partial Response
Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response. (NCT00623805)
Timeframe: Baseline to Month 13
Intervention | Months (Mean) |
---|
Bevacizumab+Capecitabine+Oxaliplatin | 3.5 |
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C | 2.9 |
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Progression-free Survival
Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. (NCT00623805)
Timeframe: Baseline to the end of the study (up to 4 years, 2 months)
Intervention | Months (Mean) |
---|
Bevacizumab+Capecitabine+Oxaliplatin | 9.0 |
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C | 12.6 |
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Percentage of Participants With a Complete Response or a Partial Response
A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. (NCT00623805)
Timeframe: Baseline to the end of the study (up to 4 years, 2 months)
Intervention | Percentage of participants (Number) |
---|
Bevacizumab+Capecitabine+Oxaliplatin | 53.2 |
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C | 59.0 |
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Overall Survival
Overall survival was defined as the time from the first administration of study drug to death. (NCT00623805)
Timeframe: Baseline to the end of the study (up to 4 years, 2 months)
Intervention | Months (Mean) |
---|
Bevacizumab+Capecitabine+Oxaliplatin | 21.0 |
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C | 25.4 |
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Safety and Tolerability as Assessed by NCI CTCAE Version 3.0
Number of participants with any adverse event as assessed by NCI CTCAE version 3.0. (NCT00625183)
Timeframe: Adverse events were queried for and collected every cycle for the duration of treatment.
Intervention | Participants (Count of Participants) |
---|
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy | 5 |
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To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil
MTD for Panobinostat, twice weekly (NCT00632489)
Timeframe: 18 months
Intervention | mg (Number) |
---|
LBH589 With Capecitabine | 30 |
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To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil
MTD for Capecitabine, BID (NCT00632489)
Timeframe: 18 months
Intervention | mg/m2 (Number) |
---|
LBH589 With Capecitabine | 100 |
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Number of Participants With Abnormalities in Hematology Laboratory Results by Worst CTC Grade
CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. WBC (c/L): Grade (Gr)1:NCT00634088)
Timeframe: Baseline and weekly from Days 1 to 21 (Cycle 1)
Intervention | Participants (Number) |
---|
| White blood cell count (WBC) (Grade 1) | WBC (Grade 2) | WBC (Grade 3) | WBC (Grade 4) | Absolute neutrophil count (ANC) (Grade 1) | ANC (Grade 2) | ANC (Grade 3) | ANC (Grade 4) | Platelet count (Grade 1) | Platelet count (Grade 2) | Platelet count (Grade 3) | Platelet count (Grade 4) | Hemoglobin (Grade 1) | Hemoglobin (Grade 2) | Hemoglobin (Grade 3) | Hemoglobin (Grade 4) |
---|
Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | 1 | 1 | 2 | 1 | 0 | 1 | 2 | 2 | 1 | 0 | 0 | 0 | 3 | 3 | 0 | 0 |
,Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
,Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 6 | 4 | 0 | 0 |
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Area Under the Concentration-time Curve From 0 to Infinity (AUC[INF]) and AUC From 0 to Last Quantifiable Concentration (AUC[O-T] of Ixabepilone
(NCT00634088)
Timeframe: Day 1 of 21-day cycle
Intervention | ng*h/mL (Geometric Mean) |
---|
| AUC(INF) | AUC(O-T) |
---|
Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | 2212.9 | 1851.8 |
,Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | 2427.0 | 2082.0 |
,Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | 1610.7 | 1284.2 |
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Volume of Distribution at Steady State of Ixabepilone
(NCT00634088)
Timeframe: Day 1 of 21-day cycle
Intervention | Liters (Mean) |
---|
Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | 1484.3 |
Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | 1780.8 |
Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | 1915.8 |
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Time to Peak Concentration of Ixabepilone
(NCT00634088)
Timeframe: Day 1 of 21-day cycle
Intervention | Hours (Median) |
---|
Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | 3.0 |
Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | 3.0 |
Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | 2.9 |
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Number of Participants With DLT
DLT=Any of the following events, attributable to study drug and occurring within 21 days after ixabepilone administration: Grade 3 or 4 nausea, vomiting, or diarrhea despite the use of adequate medical intervention; other Grade 3 or greater nonhematologic toxicity requiring removal from study drug; recovery from study drug-related toxicity that delayed scheduled retreatment for longer than 3 weeks; Grade 4 neutropenia for 5 or more consecutive days or Grade 3 or 4 neutropenia of any duration with sepsis or fever; thrombocytopenia or bleeding requiring platelet transfusion. (NCT00634088)
Timeframe: Baseline to Day 21, continuously
Intervention | Participants (Number) |
---|
Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | 1 |
Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | 0 |
Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | 0 |
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Terminal Half-life of Ixabepilone
(NCT00634088)
Timeframe: Day 1 of 21-day cycle
Intervention | Hours (Mean) |
---|
Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | 51.6 |
Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | 63.1 |
Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | 33.1 |
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Maximum Concentration of Ixabepilone
(NCT00634088)
Timeframe: Day 1 of 21-day cycle
Intervention | ng/mL (Geometric Mean) |
---|
Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | 200.6 |
Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | 109.2 |
Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | 133.4 |
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Overall Tumor Response By Number of Participants
Target lesion criteria: Complete Response(CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial Response (PR)=A 30% or greater decrease in the sum of longest diameter(LD) of all lesions in reference to the baseline sum LD. Stable Disease (SD)=Insufficient increase to qualify for Progressive Disease (PD) and insufficient shrinkage to qualify for PR; PD=A 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. (NCT00634088)
Timeframe: Baseline and Day 21 (21-day cycle)
Intervention | Participants (Number) |
---|
| CR | PR | SD | PD |
---|
Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | 3 | 0 | 3 | 0 |
,Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | 2 | 0 | 1 | 0 |
,Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | 0 | 0 | 1 | 0 |
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Number of Participants With Abnormalities in Serum Chemistry Laboratory Results by Worst CTC Grade
CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. ALT(U/L) Gr 1:>ULN-2.5*ULN,Gr 2:>2.5-5.0*ULN,Gr 3:>5.0-20.0*ULN,Gr 4:>20.0* ULN; AST(U/L) Gr 1:>ULN-2.5* ULN,Gr 2:>2.5-5.0*ULN,Gr 3:>5.0-20.0*ULN,Gr 4:>20.0* ULN; ALP(U/L)Gr 1:>ULN-2.5*ULN, Gr 2:>2.5-5.0*ULN, Gr 3:>5.0-20.0*ULN, Gr 4:>20.0*ULN; Creatinine (mg/dL): Gr 1:>ULN-1.5*ULN, Gr 2:>1.5-3.0*ULN, Gr 3:>3.0-6.0*ULN, Gr 4:>6.0*ULN; Total bilirubin (mg/dL): Gr 1:>ULN-1.5*ULN, Gr 2:>1.5-3.0*ULN, Gr 3:>3.0-10.0*ULN, Gr 4:>10.0*ULN (NCT00634088)
Timeframe: At baseline and within 72 hours of Day 1 of 21-day cycle
Intervention | Participants (Number) |
---|
| Alanine aminotransferase (ALT) (Grade 1) | ALT (Grade 2) | ALT (Grade 3) | ALT (Grade 4) | Aspartate aminotransferase (AST) (Grade 1) | AST (Grade 2) | AST (Grade 3) | AST (Grade 4) | Alkaline phosphatase (ALP) (Grade 1) | ALP (Grade 2) | ALP (Grade 3) | ALP (Grade 4) | Creatinine (Grade 1) | Creatinine (Grade 2) | Creatinine (Grade 3) | Creatinine (Grade 4) | Total bilirubin (Grade 1) | Total bilirubin (Grade 2) | Total bilirubin (Grade 3) | Total bilirubin (Grade 4) |
---|
Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Overall Survival
Overall survival, defined as number of days from the day of first study drug administration to the day the patient dies, summarized using point estimates of the median time to progression, and associated 95% confidence intervals (NCT00634751)
Timeframe: Up to 18 months
Intervention | Months (Median) |
---|
Phase II: Pancreatic Cancer | 8.1 |
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Progression-free Survival (PFS)
Time to progression, defined as number of days from day of first study drug administration to the day the patient experiences an event of disease progression or death; summarized using point estimates of the median time to progression and associated 95% confidence intervals for each stratum separately. (NCT00634751)
Timeframe: Up to 18 months
Intervention | Months (Median) |
---|
Phase II: Pancreatic Cancer | 6.0 |
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Overall Response Rate
Response rate of participant to treatment (NCT00634751)
Timeframe: Up to 18 months
Intervention | participants (Number) |
---|
| Partial Response | Stable Disease | Progressive Disease |
---|
Phase I: 200mg Sorafenib+2DOC | 1 | 5 | 1 |
,Phase I: 400mg Sorafenib BID+2DOC | 1 | 2 | 0 |
,Phase II: Biliary Tract Cancer | 1 | 5 | 1 |
,Phase II: Pancreatic Cancer | 3 | 11 | 6 |
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Time to Objective Tumor Response (TTR)
Based on Data Review Committee's Assessment. TTR is defined as the time from the start of study treatment to first documentation of objective tumor response (confirmed CR or PR). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response. (NCT00662025)
Timeframe: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Intervention | months (Median) |
---|
SUNITINIB+CAPECITABINE | 1.4 |
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AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
"SU012662 is a metabolite of sunitinib. AUC(0-24) means an area under the plasma concentration time curve from time zero to 24 hours post-dose.~The AUC(0-24) for total drug (sunitinib+SU012662) was calculated as the mean of the AUC(0-24) of total drug from individual participant." (NCT00662025)
Timeframe: Days 14 and 15 of Cycle 1
Intervention | nanogram∙hour/milliliter (Mean) |
---|
| Sunitinib | SU012662 | Total drug (Sunitinib+SU012662) |
---|
SUNITINIB+CAPECITABINE | 1886 | 704 | 2590 |
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Time to Tumor Progression (TTP)
Based on Data Review Committee's Assessment. TTP is defined as the time from the start of study treatment to first documentation of objective tumor progression. (NCT00662025)
Timeframe: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Intervention | months (Median) |
---|
SUNITINIB+CAPECITABINE | 5.3 |
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Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
"SU012662 is a metabolite of sunitinib. Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).~The Tmax for total drug (sunitinib+SU012662) was calculated as the median of the Tmax of total drug from individual participant." (NCT00662025)
Timeframe: Days 14 and 15 of Cycle 1
Intervention | hours (Median) |
---|
| Sunitinib | SU012662 | Total Drug (Sunitinib+SU012662) |
---|
SUNITINIB+CAPECITABINE | 10 | 3 | 6 |
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Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
"SU012662 is a metabolite of sunitinib. Trough plasma concentration (Ctrough) means the concentration prior to study drug administration.~The Ctrough for total drug (sunitinib+SU012662) was calculated as the mean of the Ctrough of total drug from individual participant." (NCT00662025)
Timeframe: Days 14 and 15 of Cycle 1
Intervention | nanogram/milliliter (Mean) |
---|
| Sunitinib | SU012662 | Total Drug (Sunitinib+SU012662) |
---|
SUNITINIB+CAPECITABINE | 68.7 | 30.8 | 99.5 |
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Overall Survival (OS)
OS is defined as the time from the start of study treatment to death due to any cause. OS data is censored on the last day they were known to be alive in the absence of confirmation of death. (NCT00662025)
Timeframe: A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study.
Intervention | months (Median) |
---|
SUNITINIB+CAPECITABINE | 20.0 |
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Progression-Free Survival (PFS)
Based on Data Review Committee's Assessment. PFS is defined as the time from the start of study treatment to first documentation of objective tumor progression, or to death on study due to any cause, whichever occurred first. (NCT00662025)
Timeframe: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Intervention | months (Median) |
---|
SUNITINIB+CAPECITABINE | 5.3 |
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Duration of Objective Tumor Response (DR)
Based on Data Review Committee's Assessment. DR is defined as the time from the first documentation of objective tumor response (confirmed CR or PR) to the first documentation of disease progression or to death due to cancer, whichever occurred first. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response. (NCT00662025)
Timeframe: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Intervention | months (Median) |
---|
SUNITINIB+CAPECITABINE | 4.1 |
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Number of Subjects With CBR Based on Investigator's Assessment
Number of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started. (NCT00662025)
Timeframe: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.
Intervention | participants (Number) |
---|
| Total Number of Participatnts with CBR | Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) >= 168 days |
---|
SUNITINIB+CAPECITABINE | 33 | 0 | 17 | 16 |
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Number of Participants With Objective Response Based on Investigator's Assessment
Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response. (NCT00662025)
Timeframe: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.
Intervention | participants (Number) |
---|
| Total Number of Participants with CR+PR | Complete Response (CR) | Partial Response (PR) |
---|
SUNITINIB+CAPECITABINE | 17 | 0 | 17 |
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Number of Participants With Objective Response Based on Data Review Committee's Assessment
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response. (NCT00662025)
Timeframe: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.
Intervention | participants (Number) |
---|
| Total Number of Participants with CR+PR | Complete Response (CR) | Partial Response (PR) |
---|
SUNITINIB+CAPECITABINE | 19 | 0 | 19 |
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Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment
Number of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started. (NCT00662025)
Timeframe: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.
Intervention | participants (Number) |
---|
| Total Number of Participants with CBR | Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) >= 168 days |
---|
SUNITINIB+CAPECITABINE | 32 | 0 | 19 | 13 |
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Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
"SU012662 is a metabolite of sunitinib. Cmax means a maximum observed plasma concentration.~The Cmax for total drug (sunitinib+SU012662) was calculated as the mean of the Cmax of total drug from individual participant." (NCT00662025)
Timeframe: Days 14 and 15 of Cycle 1
Intervention | nanogram/milliliter (Mean) |
---|
| Sunitinib | SU012662 | Total Drug (Sunitinib+SU012662) |
---|
SUNITINIB+CAPECITABINE | 87.7 | 33.9 | 119 |
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Number of Participants With Grade 4 Adverse Events
Grading of adverse events was determine by the principal investigator according to NCI common toxicity criteria (CTC version 3.0). Safety analysis is based on any participant experiencing a grade 4 AE. (NCT00665457)
Timeframe: every 3 weeks X 4, then every 2 weeks X4
Intervention | Participants (Count of Participants) |
---|
Celecoxib | 1 |
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Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Mean global health status and social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL. (NCT00678535)
Timeframe: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Intervention | units on a scale (Mean) |
---|
| Global health status: Baseline | Global health status: Week 6 | Global health status: Week 12 | Global health status: Week 18 | Global health status: Week 24 | Global health status: Week 30 | Global health status: Week 36 | Global health status: Week 42 | Global health status: Week 48 | Global health status: Week 54 | Global health status: Week 60 | Social functioning status: Baseline | Social functioning status: Week 6 | Social functioning status: Week 12 | Social functioning status: Week 18 | Social functioning status: Week 24 | Social functioning status: Week 30 | Social functioning status: Week 36 | Social functioning status: Week 42 | Social functioning status at Week 48 | Social functioning status: Week 54 | Social functioning status: Week 60 |
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Capecitabine Plus Cisplatin | 57.19 | 61.80 | 63.35 | 61.83 | 63.61 | 64.11 | 57.72 | 62.64 | 66.67 | 66.67 | 61.81 | 76.52 | 75.70 | 75.65 | 75.51 | 78.26 | 76.67 | 73.58 | 78.16 | 78.00 | 80.56 | 68.06 |
,Cetuximab Plus Capecitabine Plus Cisplatin | 57.49 | 59.00 | 60.17 | 60.45 | 62.46 | 63.65 | 65.06 | 59.29 | 63.39 | 60.63 | 62.50 | 74.36 | 68.94 | 71.48 | 71.22 | 74.20 | 78.51 | 76.28 | 68.57 | 80.36 | 74.71 | 78.33 |
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Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire
EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 single items are combined to obtain a single index score that is health utility index (HUI) score reflecting subject's preferences for different health states. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QoL. (NCT00678535)
Timeframe: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 30 | Week 36 | Week 42 | Week 48 | Week 54 | Week 60 |
---|
Capecitabine Plus Cisplatin | 0.749 | 0.769 | 0.775 | 0.755 | 0.761 | 0.790 | 0.711 | 0.689 | 0.770 | 0.730 | 0.742 |
,Cetuximab Plus Capecitabine Plus Cisplatin | 0.743 | 0.739 | 0.752 | 0.742 | 0.733 | 0.737 | 0.710 | 0.722 | 0.719 | 0.733 | 0.760 |
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Safety - Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered. (NCT00678535)
Timeframe: Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Intervention | participants (Number) |
---|
Cetuximab Plus Capecitabine Plus Cisplatin | 446 |
Capecitabine Plus Cisplatin | 432 |
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Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments
The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment. (NCT00678535)
Timeframe: Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
Intervention | months (Median) |
---|
Cetuximab Plus Capecitabine Plus Cisplatin | 4.4 |
Capecitabine Plus Cisplatin | 5.6 |
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Overall Survival (OS)
The OS time is defined as the time from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. (NCT00678535)
Timeframe: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)
Intervention | months (Median) |
---|
Cetuximab Plus Capecitabine Plus Cisplatin | 9.4 |
Capecitabine Plus Cisplatin | 10.7 |
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Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments
The BOR rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) from the IRC. (NCT00678535)
Timeframe: Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)
Intervention | percentage of participants (Number) |
---|
Cetuximab Plus Capecitabine Plus Cisplatin | 29.9 |
Capecitabine Plus Cisplatin | 29.2 |
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Number of Participants With Any Non-serious Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) or Any Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. (NCT00680901)
Timeframe: From the first dose of study medication until 30 days after the last dose (average of 229 days)
Intervention | Participants (Number) |
---|
| Non-serious AEs | SAEs |
---|
CapeOx + Lapatinib | 245 | 72 |
,CapeOx + Placebo | 216 | 52 |
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Number of Participants With Adverse Events of the Indicated Severity, Per the National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to NCI CTCAE, version 3.0: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity. (NCT00680901)
Timeframe: From the first dose of study medication until 30 days after the last dose (average of 229 days)
Intervention | Participants (Number) |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
---|
CapeOx + Lapatinib | 44 | 88 | 91 | 17 | 15 |
,CapeOx + Placebo | 57 | 76 | 69 | 25 | 9 |
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Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Hematology Parameters
Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for indicated hematology parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Hematology parameter included: Hemoglobin (Hemo), Total Neutrophils (TN) Absolute, Platelet Count (PC), and White Blood Cell (WBC) Count. (NCT00680901)
Timeframe: From Baseline (Day 1) until 28 days after the last dose (average of 239 days)
Intervention | Participants (Number) |
---|
| Hemo, G3, n=261, 263 | Hemo, G4, n=261, 263 | TN Absolute, G3, n=240, 248 | TN Absolute, G4, n=240, 248 | PC, G3, n=261, 261 | PC, G4, n=261, 261 | WBC Count, G3, n=261, 262 | WBC Count, G4, n=261, 262 |
---|
CapeOx + Lapatinib | 26 | 9 | 22 | 6 | 21 | 5 | 12 | 1 |
,CapeOx + Placebo | 19 | 8 | 27 | 2 | 29 | 2 | 4 | 1 |
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Overall Survival
Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. (NCT00680901)
Timeframe: From randomization until death due to any cause (average of 51 weeks)
Intervention | months (Median) |
---|
CapeOx + Lapatinib | 12.2 |
CapeOx + Placebo | 10.5 |
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Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Clinical Chemistry Parameters
Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for the indicated clinical chemistry parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transeferase (AST), Total Bilirubin (TB), Calcium (Hypercalcemia and Hypocalcemia), Creatine Kinase (CK), Creatinine, Glucose (Hyperglycemia [high] and Hypoglycemia [low]), Potassium (Hyperkalemia [high] and Hypokalemia [low]), Magnesium (Hypermagnesemia [high] and Hypomagnesemia [low]), and Sodium (Hypernatremia [high] and Hyponatremia [low]). (NCT00680901)
Timeframe: From Baseline (Day 1) until 28 days after the last dose (average of 239 days)
Intervention | Participants (Number) |
---|
| Albumin, G3, n=257, 258 | Albumin, G4, n=257, 258 | AP, G3, n=260, 260 | AP, G4, n=260, 260 | ALT, G3, n=260, 262 | ALT, G4, n=260, 262 | AST, G3, n=260, 262 | AST, G4, n=260, 262 | TB, G3, n=260, 261 | TB, G4, n=260, 261 | Calcium (Hypercalcemia), G3, n=256, 262 | Calcium (Hypercalcemia), G4, n=256, 262 | Calcium (Hypocalcemia), G3, n=256, 262 | Calcium (Hypocalcemia), G4, n=256, 262 | CK, G3, n=1, 3 | CK, G4, n=1, 3 | Creatinine, G3, n=260, 262 | Creatinine, G4, n=260, 262 | Glucose (Hyperglycemia), G3, n=259, 262 | Glucose (Hyperglycemia), G4, n=259, 262 | Glucose (Hypoglycemia), G3, n=259, 262 | Glucose (Hypoglycemia), G4, n=259, 262 | Potassium (Hyperkalemia), G3, n=259, 261 | Potassium (Hyperkalemia), G4, n=259, 261 | Potassium (Hypokalemia), G3, n=259, 261 | Potassium (Hypokalemia), G4, n=259, 261 | Magnesium (Hypermagnesemia), G3, n=254, 256 | Magnesium (Hypermagnesemia), G4, n=254, 256 | Magnesium (Hypomagnesemia), G3, n=254, 256 | Magnesium (Hypomagnesemia), G4, n=254, 256 | Sodium (Hypernatremia), G3, n=259, 261 | Sodium (Hypernatremia), G4, n=259, 261 | Sodium (Hyponatremia), G3, n=259, 261 | Sodium (Hyponatremia), G4, n=259, 261 |
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CapeOx + Lapatinib | 3 | 0 | 5 | 0 | 2 | 0 | 2 | 0 | 6 | 2 | 0 | 0 | 3 | 0 | 0 | 0 | 2 | 0 | 6 | 1 | 1 | 0 | 2 | 1 | 21 | 3 | 5 | 0 | 1 | 0 | 1 | 2 | 19 | 2 |
,CapeOx + Placebo | 4 | 0 | 12 | 0 | 4 | 0 | 6 | 0 | 3 | 5 | 0 | 0 | 4 | 0 | 0 | 0 | 1 | 0 | 8 | 0 | 1 | 2 | 1 | 0 | 11 | 1 | 5 | 0 | 0 | 0 | 2 | 0 | 16 | 4 |
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Mean Change in Scores on the Questionnaire EuroQoL-5 Dimensions (EQ-5D) From Baseline to Week 36
The EQ-5D is a generic preference-based HROOL self administered tool comprising of a 5-dimensional health status measure (5D utility measure) and a visual analog rating scale feeling thermometer (T.). 5D utility measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. T. assesses participant's current health state. Each 5D utility question was responded to on a 3-point scale, indicating the level of impairment (1=no problem; 2=some or moderate problem(s); 3=unable, or extreme problems). The index utility values corresponding to the 243 health states were defined by the EuroQol classification and calculated based on country-specific regression coefficients. In the UK-based value set, the possible EQ-5D index utility values range from -0.594 to 1. The T. value ranges from 0 to 100. EQ-5D utility index score 0=death, 1=perfect health, -0.594 = worse than death. The T. score: 100=best imaginable health state, 0=worse imaginable health state. (NCT00680901)
Timeframe: From Baseline (Day1) to Week 36
Intervention | Scores on a scale (Mean) |
---|
| Utility Index, n=50, 19 | Thermometer, n=50, 20 |
---|
CapeOx + Lapatinib | 0.1 | 5.5 |
,CapeOx + Placebo | -0.1 | 2.6 |
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Mean Change in Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) From Baseline to Week 36
"The QLQ-C30, a self administered tool used to assess HROL, consists of 30 items that assesses 15 domains consisting of 5 functional scales (s.) (physical, role, emotional, cognitive, social) and nine symptom s. or single items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status or QOL s.. For the functional s. and symptom s. or single items, participants assessed using a 4-point s. (1=not at all; 2=a little; 3=quite a bit; 4=very much), whereas global health status or QOL was assessed using a 7-item Likert s., ranging from poor to excellent. All s. and single-item scores ranged from 0 to 100. For the functional scores, a higher score indicated a better HRQOL, i.e. 0=worst HRQOL, 100=best HRQOL; for the symptom s. or single items , a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms." (NCT00680901)
Timeframe: From Baseline (Day1) to Week 36
Intervention | Scores on a scale (Mean) |
---|
| Global health status/quality of life, n= 49, 19 | Physical functioning, n=50, 19 | Role functioning, n=50, 19 | Emotional functioning, n=50, 19 | Cognitive functioning, n=50, 19 | Social functioning, n=50, 19 | Fatigue symptom scale, n=50, 19 | Nausea and vomiting symptom scale, n=50, 19 | Pain symptom scale, n=50, 19 | Dyspnea symptom scale, n=50, 18 | Insomnia symptom scale, n=50, 19 | Appetite loss symptom scale, n=50, 19 | Constipation symptom scale, n=49, 19 | Diarrhea symptom scale, n=50, 19 |
---|
CapeOx + Lapatinib | 6.6 | 0.6 | 4.7 | 4.1 | -0.2 | 6.7 | -6.0 | -4.7 | -6.7 | 0.7 | -4.0 | -8.0 | -6.8 | 6.0 |
,CapeOx + Placebo | 1.8 | -4.4 | -1.8 | 0.4 | -5.3 | -4.4 | 2.3 | 6.1 | 0.0 | 5.6 | -1.8 | -5.3 | 0.0 | 1.8 |
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Mean Change in Scores on the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) From Baseline to Week 36
The EORTC QLQ-STO22, the Gastric module of QLQ-C30, is a self administered tool use to assess HROOL of patients with gastric cancer. It consists of 22 items consisting of nine symptom scales or single items (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, taste, body image, hair loss) that were developed for participants with gastric cancer. For the symptom scales or single items, participants assessed using a 4-point scale (1=not at all; 2=a little; 3=quite a bit; 4=very much). All scales and single-item scores ranged from 0 to 100. For the symptom scales or single items, a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms. (NCT00680901)
Timeframe: From Baseline (Day1) to Week 36
Intervention | Scores on a scale (Mean) |
---|
| Dysphagia symptom scale, n=48, 15 | Pain symptom scale, n=26, 15 | Reflux symptom scale, n=48, 16 | Eating restrictions symptom scale, n=48, 16 | Anxiety symptom scale, n=48, 16 | Dry mouth symptom scale, n=46, 16 | Taste symptom scale, n=48, 16 | Body image symptom scale, n=48, 16 | Hair loss symptom scale, n=2, 0 |
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CapeOx + Lapatinib | -6.7 | -12.6 | -8.3 | -7.8 | -16.7 | -8.0 | -3.5 | -10.4 | -16.7 |
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Mean Change in Scores on the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) From Baseline to Week 36
The EORTC QLQ-STO22, the Gastric module of QLQ-C30, is a self administered tool use to assess HROOL of patients with gastric cancer. It consists of 22 items consisting of nine symptom scales or single items (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, taste, body image, hair loss) that were developed for participants with gastric cancer. For the symptom scales or single items, participants assessed using a 4-point scale (1=not at all; 2=a little; 3=quite a bit; 4=very much). All scales and single-item scores ranged from 0 to 100. For the symptom scales or single items, a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms. (NCT00680901)
Timeframe: From Baseline (Day1) to Week 36
Intervention | Scores on a scale (Mean) |
---|
| Dysphagia symptom scale, n=48, 15 | Pain symptom scale, n=26, 15 | Reflux symptom scale, n=48, 16 | Eating restrictions symptom scale, n=48, 16 | Anxiety symptom scale, n=48, 16 | Dry mouth symptom scale, n=46, 16 | Taste symptom scale, n=48, 16 | Body image symptom scale, n=48, 16 |
---|
CapeOx + Placebo | 1.4 | -4.0 | 4.2 | 0.3 | -7.3 | 8.3 | 4.2 | -2.1 |
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Time to Response (TTR)
TTR is defined as the time from randomization until the date of the first documented evidence of CR (the disappearance if all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking a reference the Baseline sum LD) as assessed by the investigator. (NCT00680901)
Timeframe: From Baseline (Day 1) until the first documented evidence of confirmed CR or PR (average of 9 weeks)
Intervention | Months (Median) |
---|
CapeOx + Lapatinib | 1.4 |
CapeOx + Placebo | 1.4 |
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Progression Free Survival (PFS)
PFS is defined as the interval between the date of randomization and the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >= 1 new lesion. Participants who did not have a radiological assessed PD but had symptomatic PD were also counted. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored. (NCT00680901)
Timeframe: From randomization until the earliest date of disease progression or death due to any cause (average of 30 weeks)
Intervention | months (Median) |
---|
CapeOx + Lapatinib | 6.0 |
CapeOx + Placebo | 5.4 |
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Overall Survival in All Randomized Participants
Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. (NCT00680901)
Timeframe: From randomization until death due to any cause (average of 51 weeks)
Intervention | months (Median) |
---|
CapeOx + Lapatinib | 11.9 |
CapeOx + Placebo | 10.4 |
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Duration of Response (DOR)
DOR is defined as the time from the first documented evidence of a CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) until the first documented sign of PD or death due to any cause. Per RECIST, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored. (NCT00680901)
Timeframe: From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause (average of 36 weeks)
Intervention | Months (Median) |
---|
CapeOx + Lapatinib | 7.3 |
CapeOx + Placebo | 5.6 |
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Number of Participants With a Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR)
A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target and non-target lesions) or a PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) as assessed by the investigator (confirmed by radiographic imaging within 4 weeks from initial observations). (NCT00680901)
Timeframe: From randomization until the date of the first documented response of CR or PR (average of 9 weeks)
Intervention | Participants (Number) |
---|
CapeOx + Lapatinib | 131 |
CapeOx + Placebo | 93 |
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Number of Participants With Clinical Benefit (CB)
CB is defined as evidence of a CR (disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started) as assessed by the investigator. (NCT00680901)
Timeframe: From randomization until disease progression (PD) or death due to any cause (average of 30 weeks)
Intervention | Participants (Number) |
---|
CapeOx + Lapatinib | 199 |
CapeOx + Placebo | 188 |
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Overall Survival
Median Survival time (months) (NCT00684983)
Timeframe: From randomization to death due to any cause, up to 5 years
Intervention | Months (Median) |
---|
Arm A | 16.8 |
Arm B | 14.7 |
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Adverse Event Profile of Capecitabine and Lapatinib With and Without IMC-A12 (Using NCI CTCAE v3.0)
"All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s) according to CTCAE v3.0 within each treatment arm. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.~4/19 (21.05%) 14/45 (31.11%)" (NCT00684983)
Timeframe: Baseline to 30 days past end of treatment
Intervention | percentage of patients with AEs (Number) |
---|
Arm I (Lapatinib Ditosylate, Capecitabine) | 21 |
Arm II (Cixutumumab, Lapatinib Ditosylate, Capecitabine) | 31 |
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Confirmed Tumor Response, Defined as Either a Complete Response (CR) or Partial Response (PR) Noted as the Objective Status on 2 Consecutive Evaluations at Least 6 Weeks Apart, Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
(NCT00684983)
Timeframe: Up to 5 years
Intervention | % of evaluable participants (Number) |
---|
Arm A | 43.8 |
Arm B | 29 |
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Duration of Response
Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm. (NCT00684983)
Timeframe: Up to 5 years
Intervention | Months (Median) |
---|
Arm A | 4.8 |
Arm B | 6.9 |
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Progression-free Survival (PFS)
Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate. (NCT00684983)
Timeframe: From randomization to the earliest date of documentation of disease progression, up to 5 years
Intervention | Median survival and CI in months (Median) |
---|
Arm A | 6.0 |
Arm B | 4.9 |
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Time to Treatment Failure
Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm. (NCT00684983)
Timeframe: From the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, up to 5 years
Intervention | Months (Median) |
---|
Arm A | 4.6 |
Arm B | 4.4 |
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Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start)
(NCT00685763)
Timeframe: 1 year following the completion of radiation therapy
Intervention | participants (Number) |
---|
Proton Radiation and Chemotherapy | 0 |
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3-year Disease-free Survival
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. (NCT00686166)
Timeframe: 3 years
Intervention | percentage of participants (Number) |
---|
Chemo + Chemo and Radiation + Surgery | 68 |
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Pathologic Complete Response Rate
Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes. (NCT00686166)
Timeframe: 15-20 weeks from registration
Intervention | percentage of participants (Number) |
---|
Chemo + Chemo and Radiation + Surgery | 25 |
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Percentage of Participants With Disease Progression
Objective tumor response was assessed using RECIST version 1.1. Disease progression was defined as a ≥20 percent (%) increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. The percentage of participants with disease progression was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100. (NCT00700570)
Timeframe: Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of end of treatment [EOT])
Intervention | percentage of participants (Number) |
---|
Resected | 52.6 |
Unresected | 46.2 |
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Time to Disease Progression
Objective tumor response was assessed using RECIST version 1.1. Disease progression was defined as a ≥20% increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. Time to disease progression was defined as the time from first dose to time of disease progression. Participants without progression were censored at the time of last tumor assessment. Time to disease progression was estimated using Kaplan-Meier analysis and expressed in months. (NCT00700570)
Timeframe: Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of EOT)
Intervention | months (Median) |
---|
Resected | 10.1 |
Unresected | 8.7 |
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Percentage of Participants by Best Overall Tumor Response According to RECIST Version 1.1
Objective tumor response was assessed using RECIST version 1.1. CR was defined as the disappearance of all target lesions, and PR was defined as a ≥30% decrease in the sum of longest diameters compared to Baseline. Response was to be confirmed at a minimum of 4 weeks after the first documented response. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, as well as no new target lesions. Disease progression or PD was defined as a ≥20% increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. Non-evaluability for tumor assessment was also documented when applicable. The percentage of participants with each level of response was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. (NCT00700570)
Timeframe: Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)
Intervention | percentage of participants (Number) |
---|
| CR | PR | SD | PD | Non-evaluable |
---|
Resected | 36.8 | 10.5 | 0 | 52.6 | 0 |
,Unresected | 0 | 34.6 | 15.4 | 46.2 | 3.8 |
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Percentage of Participants With a Best Overall Tumor Response of Complete Response (CR) or PR According to RECIST Version 1.1
Objective tumor response was assessed using RECIST version 1.1. CR was defined as the disappearance of all target lesions, and PR was defined as a ≥30% decrease in the sum of longest diameters compared to Baseline. Response was confirmed at a minimum of 4 weeks after the first documented response. The percentage of participants with confirmed CR or PR was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. (NCT00700570)
Timeframe: Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)
Intervention | percentage of participants (Number) |
---|
Resected | 47.4 |
Unresected | 34.6 |
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Toxicity Profile
"Toxicity will be assessed at the beginning of every cycle during chemotherapy for a total of 4 cycles (1 cycle =21 days) and then 30 days post last dose of chemotherapy. All toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE 3.0)~In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~Only incidents of AEs determined to be related to chemotherapy are recorded here." (NCT00711412)
Timeframe: During chemotherapy treatment and up to 30 days post-last dose of chemotherapy.
Intervention | participants (Number) |
---|
| Thrombocytopenia | Anemia | lymphopenia | Leukopenia | Neutropenia | Thrombosis | Nausea | Diarrhea | Dysphagia | Vomiting | Constipatation | Abdominal pain | Stomatitis | Esophgitis |
---|
Induction and Combination Treatment | 20 | 17 | 16 | 15 | 8 | 5 | 18 | 15 | 15 | 8 | 7 | 6 | 6 | 4 |
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Time to Progression
Time to Progression will be measured as time from the first day of therapy until death, disease progression or last contact. (NCT00711412)
Timeframe: From start of first treatment until time of first documentation of progression of disease or death, whichever comes first, until the study closes, up to a maximum of 6 years and 7 months.
Intervention | Participants (Count of Participants) |
---|
Induction, Combination and Surgery | 28 |
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Recurrence Rate
Recurrence rate will be defined as disease recurrence, progressive disease or death. Patients will be followed for disease recurrence or death until the end of the study. (NCT00711412)
Timeframe: From the time of start of treatment until first documentation of disease recurrence, progression or death, whichever comes first until the end of the study, a maximum of 6 years and 7 months.
Intervention | Participants (Count of Participants) |
---|
Induction and Combination Treatment | 23 |
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Determine Pathologic Complete Response
"Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections.~Pathologic response will be defined as:~P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer" (NCT00711412)
Timeframe: At time of surgery
Intervention | Participants (Count of Participants) |
---|
Induction, Combination and Surgery | 9 |
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Clinical Response Rate
"Clinical response Rate will be expressed as the proportion of patients demonstrating a complete and/or partial response based on all evaluable patients treated.Clinical response will be evaluated according to Response Evaluation Criteria In Solid Tumors 1.0 (RECIST) .~Complete Response (CR) is defined as the disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,taking as reference the baseline sum LD" (NCT00711412)
Timeframe: four to six weeks following completion of 4 cycles (1 cycle = 21days) of chemotherapy treatment and prior to surgery
Intervention | Participants (Count of Participants) |
---|
Induction and Combination Treatment | 28 |
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Overall Survival
(NCT00711412)
Timeframe: From the start of treatment and then every 3 months until death or a maximum of 24 months.
Intervention | percentage of patients alive (Number) |
---|
| 3 months | 6 months | 12 months | 24 months |
---|
Induction and Combination Treatment | 93.02 | 83.72 | 66.81 | 58.51 |
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Determine Progressive Free Survival
(NCT00711412)
Timeframe: After cycles 2, and 4 (pre-surgery) 30 days after surgery and then every 3 months until first documentation of progressive disease, death and up to a maximum of 24 months.
Intervention | percentage of patents progression free (Number) |
---|
| 3 months | 6 months | 12 months | 24 months |
---|
Induction and Combination Treatment | 86.05 | 67.44 | 62.62 | 51.83 |
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Percentage of Participants With Progression-free Survival.
Gadolinium-contrasted MRIs were used to assess radiographic response every 2 cycles (~6 weeks). Tumor progression was defined by increasing tumor size, new areas of tumor, or unequivocal neurologic deterioration. (NCT00717197)
Timeframe: From date of first dose of study drug until month 6.
Intervention | percentage of participants with PFS6 (Number) |
---|
Capecitabine | 21.7 |
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Number of Participants With Toxicities Associated With Capecitabine and Lapatinib
Toxicities evaluated according to NCI CTC v.3 (NCT00721630)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Capecitabine + Lapatinib | 23 |
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Overall Response Will be Characterized by the Patient's FDG-PET Scan
A good early FDG Response is a reduction in FDG uptake on the week 3 PET scan of > or = to 35% from baseline. An FDG PET non-responder will be defined as having a decrease of < 35% on the week 3 PET scan compared with baseline. (NCT00737438)
Timeframe: 2 years
Intervention | participants (Number) |
---|
| Metabolic Responder | Non-Metabolic Responder |
---|
All Patients | 11 | 9 |
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Maximum Tolerated Dose (MTD) of Neratinib
MTD reflects the highest dose of neratinib plus capeciteabine that did not cause a selected Grade 3 toxicity in >= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting >3 days, 2) Grade 3 diarrhea lasting >2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery [to ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline] from one of the above listed toxicities that were related to neratinib and/or capecitabine that delayed the initiation of the next dose by more than 3 weeks. (NCT00741260)
Timeframe: From first dose date to day 21.
Intervention | mg (Number) |
---|
Neratinib in Combination With Capecitabine | 240 |
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Maximum Tolerated Dose (MTD) of Capecitabine
MTD reflects the highest dose of capecitabine in combination with neratinib that did not cause a selected Grade 3 toxicity in >= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting >3 days, 2) Grade 3 diarrhea lasting >2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery [to ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline] from one of the above listed toxicities that were related to neratinib and/or capecitabine that delayed the initiation of the next dose by more than 3 weeks. (NCT00741260)
Timeframe: From first dose date to day 21.
Intervention | mg/m^2 (Number) |
---|
Capecitabine in Combination With Neratinib | 1500 |
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Duration of Response
Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. (NCT00741260)
Timeframe: From start date of response to first PD/death, up to three years.
Intervention | weeks (Median) |
---|
Prior Lapatinib Subjects | 48.3 |
Lapatinib Naive Subjects P1 | 46.3 |
Lapatinib Naive Subjects Part 2 + Part 1 | 46.3 |
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Overall Response Rate
Number of Subjects with Complete or Partial Response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions. (NCT00741260)
Timeframe: From first dose date to progression or last tumor assessment, up to three years.
Intervention | percentage of participants (Number) |
---|
Prior Lapatinib Subjects | 57.1 |
Lapatinib Naive Subjects P1 | 63.9 |
Lapatinib Naive Subjects Part 2 + Part 1 | 63.5 |
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Clinical Benefit Rate
The percentage of subjects with Complete Response, Partial Response, or Stable Disease at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (NCT00741260)
Timeframe: From first dose date to progression or last tumor assessment, up to three years.
Intervention | percentage of participants (Number) |
---|
Prior Lapatinib Subjects | 71.4 |
Lapatinib Naive Subjects P1 | 72.1 |
Lapatinib Naive Subjects Part 2 + Part 1 | 73.0 |
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Number of Participants With Dose Limiting Toxicities
Number of participants reporting Adverse Events Causing Dose Limiting Toxicities (DLT). (NCT00741260)
Timeframe: From first dose date to day 21
Intervention | Participants (Count of Participants) |
---|
N160 + C1500 | 0 |
N160 + C2000 | 2 |
N200 + C2000 | 2 |
N240 + C1500 | 0 |
N240 + C2000 | 2 |
N + C MTD - No Prior Lap | 0 |
N + C MTD - Prior Lap | 0 |
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Tumor Regression Grade
tumor regression grade (1= pCR, 2= near pCR, 3= partial response, 4= no response, 5=progression). (NCT00745134)
Timeframe: Baseline to 11.5 weeks
Intervention | Participants (Count of Participants) |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
---|
Arm I (Curcumin) | 1 | 2 | 4 | 8 | 0 |
,Arm II (Placebo) | 2 | 1 | 1 | 2 | 0 |
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Progression Free Survival (PFS)
PFS was calculated from start of CRT to date of disease progression or death, censored at last endoscopy/imaging evaluation. (NCT00745134)
Timeframe: 5 years
Intervention | percentage of participants (Number) |
---|
Arm I (Curcumin) | 66.7 |
Arm II (Placebo) | 71.4 |
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Overall Survival (OS)
OS was calculated from start of CRT to date of death, censored at last follow-up. Estimated with the Kaplan-Meier method. (NCT00745134)
Timeframe: 5 years
Intervention | percentage of participants (Number) |
---|
Arm I (Curcumin) | 85.7 |
Arm II (Placebo) | 85.7 |
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Number of Participants With Tumor Downstaging
Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1. (NCT00745134)
Timeframe: Baseline to 11.5 weeks
Intervention | Participants (Count of Participants) |
---|
Arm I (Curcumin) | 7 |
Arm II (Placebo) | 4 |
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Number of Participants With Pathologic Complete Response (pCR) Rate
Compared the rate of pCR between treatment arms with Fisher's exact test. (NCT00745134)
Timeframe: At time of surgery
Intervention | Participants (Count of Participants) |
---|
Arm I (Curcumin) | 1 |
Arm II (Placebo) | 2 |
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Change in Curcumin Level in Tumor Tissue
A logistic regression model with pCR as the dependent variable will be used to assess the association between pCR and NF-kB activity and treatment. (NCT00745134)
Timeframe: Baseline to 11.5 weeks
Intervention | ng/mg tissue (Median) |
---|
Arm I (Curcumin) | 33.7 |
Arm II (Placebo) | 0.0 |
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Change in Curcumin Level in Serum
"Plasma levels were assessed pre and post curcumin/placebo administration. During week 2 (after at least 5 fractions of radiation therapy) of chemoradiation therapy:~Optional endoscopic biopsy~Optional blood collection for pharmacology (1 hour before and 1 hour after intake of curcumin or placebo)" (NCT00745134)
Timeframe: assessed 1 hr pre/post curcumin administration on one of the days during week 2 of radiation therapy (fractions 6-10)
Intervention | ng/mL (Median) |
---|
| Serum curcumin concentrations before curcumin/placebo administration. | Serum curcumin concentrations after curcumin/placebo administration. |
---|
Arm I (Curcumin) | 3.04 | 3.32 |
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Clinical Benefit Rate
"Clinical benefit rate (CR, PR, or SD = 24 weeks) for women For ErbB2 Positive Advanced Breast Cancer. Clinical benefit rate was the percentage of subjects who achieved overall tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.~Clinical Benefit (CB) = CR + PR + SD >= 24 weeks." (NCT00777101)
Timeframe: From randomization date to progression or last tumor assessment, assessed up to 69 months
Intervention | percentage of participants (Median) |
---|
Neratinib | 44.4 |
Lapatinib+Capecitabine | 63.8 |
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Duration of Response
Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death. For subjects without death or progression, censorship was at the last valid tumor assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. (NCT00777101)
Timeframe: From start date of response to first PD, assessed up to 69 months after the first subject was randomized.
Intervention | months (Median) |
---|
Neratinib | 12.48 |
Lapatinib+Capecitabine | 7.98 |
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Progression Free Survival
Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment. (NCT00777101)
Timeframe: From randomization date to progression or death, assessed up to 69 months
Intervention | months (Median) |
---|
Neratinib | 4.53 |
Lapatinib+Capecitabine | 6.83 |
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Overall Survival (OS)
Overall Survival (OS) was defined as the time from randomization to death due to any cause. Subjects last known to be alive were censored at the last date of last contact or the data cutoff employed for the analysis, whichever was earlier. (NCT00777101)
Timeframe: From randomization date to death, assessed up to 69 months
Intervention | months (Median) |
---|
Neratinib | 19.74 |
Lapatinib+Capecitabine | 23.62 |
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Objective Response Rate (ORR).
Objective Response Rate, investigator assessment. The ORR was defined as the percentage of participants demonstrating a confirmed objective response, either Complete Response (CR) or Partial Response (PR) during the study per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions. (NCT00777101)
Timeframe: From randomization date to progression or last tumor assessment, assessed up to 69 months
Intervention | percentage of participants (Number) |
---|
Neratinib | 29.1 |
Lapatinib+Capecitabine | 40.5 |
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Progression-Free Survival (PFS)
"Tumor progression was assessed according to the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), presented below.~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Objective Response (OR) = CR + PR~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)~Stable disease (SD) = Small changes that do not meet any of the above criteria.~Progression-Free Survival is assessed as the number of evaluable participants who were alive without disease progression at 1 year. Participants without out assessment at 12 months will not be included." (NCT00780494)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Bevacizumab+ Carboplatin +Capecitabine | 9 |
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Objective (Overall) Therapeutic Response
"Tumor response was assessed per the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions, and assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays/radiologic scan. Response was determined based on the criteria below.~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Objective Response (OR) = CR + PR~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)~Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is provided as the number of participants who achieved each of the defined responses, with objective (overall) response defined as the sum of CR and PR. The outcome is reported as values without dispersion." (NCT00780494)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
| Partial Response | Complete Response (CR) | Objective Response (OR) = CR + PR | Stable Disease | Progressive Disease |
---|
Bevacizumab+ Carboplatin +Capecitabine | 18 | 0 | 18 | 6 | 5 |
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Overall Survival (OS)
Overall survival (OS) will be assessed from time from the date of enrollment to the date of death due to any cause or the last date the patient was known to be alive (censored observation) at the date of data cutoff for the final analysis. The outcome is presented as the median survival in days with standard deviation. (NCT00780494)
Timeframe: 7.5 years
Intervention | Days (Median) |
---|
Bevacizumab+ Carboplatin +Capecitabine | 458 |
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2-year Stratum-specific Disease-free Survival
Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00789958)
Timeframe: Up to 2 years from registration
Intervention | percentage of participants (Number) |
---|
Patients With Negative Margins of Resection (R0) | 54 |
Patients w/Microscopically Positive Margin of Resection (R1) | 48 |
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2-year Stratum-specific Local Relapse Rate
Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields). (NCT00789958)
Timeframe: Up to 2 years from registration
Intervention | percentage of participants (Number) |
---|
Patients With Negative Margins of Resection (R0) | 9 |
Patients w/Microscopically Positive Margin of Resection (R1) | 16 |
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Stratum-specific (R0 and R1) 2-year Overall Survival
Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00789958)
Timeframe: Up to 2 years from registration
Intervention | percentage of participants (Number) |
---|
Patients With Negative Margins of Resection (R0) | 67 |
Patients w/Microscopically Positive Margin of Resection (R1) | 60 |
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2-year Disease-free Survival in All Patients
Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00789958)
Timeframe: Up to 2 years from registration
Intervention | percentage of participants (Number) |
---|
Adjuvant Chemotherapy + Chemoradiotherapy | 52 |
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2-year Overall Local Relapse Rate
Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields). (NCT00789958)
Timeframe: Up to 2 years from registration
Intervention | percentage of participants (Number) |
---|
Adjuvant Chemotherapy + Chemoradiotherapy | 11 |
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2-year Overall Survival for All Patients
Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00789958)
Timeframe: Up to 2 years from registration
Intervention | percentage of participants (Number) |
---|
Adjuvant Chemotherapy + Chemoradiotherapy | 65 |
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Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)
Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD. (NCT00796718)
Timeframe: Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy)
Intervention | percentage of participants (Number) |
---|
| Complete Response | Partial Remission | No Response |
---|
Capecitabine | 2 | 12.2 | 77.6 |
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Percentage of Participants With Adverse Events
An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment. (NCT00796718)
Timeframe: Up to 15 weeks
Intervention | percentage of participants (Number) |
---|
Capecitabine | 91.9 |
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Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)
Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD. (NCT00796718)
Timeframe: Up to 15 weeks (assessed 1 month after surgery)
Intervention | percentage of participants (Number) |
---|
| Complete Response | Partial Remission | No Response |
---|
Capecitabine | 56 | 10 | 14 |
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Percentage of Participants With Pathological Complete Response
Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures. (NCT00796718)
Timeframe: Up to 11 weeks (assessed at the time of post-treatment surgery)
Intervention | percentage of participants (Number) |
---|
Capecitabine | 16 |
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Progression Free Survival (PFS)
PFS was defined as the time from enrollment to time of first documented disease progression or death due to any cause, whichever occurred first. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier methods. (NCT00811135)
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
Intervention | months (Median) |
---|
Trastuzumab + Bevacizumab + Capecitabine | 14.2 |
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Number of Participants With Response
Participants who had CR or PR were considered as responders. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. (NCT00811135)
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
Intervention | participants (Number) |
---|
Trastuzumab + Bevacizumab + Capecitabine | 66 |
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Number of Participants With Time to Progression (TTP)
TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions). TTP was estimated using Kaplan-Meier methods. (NCT00811135)
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
Intervention | participants (Number) |
---|
Trastuzumab + Bevacizumab + Capecitabine | 62 |
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Overall Survival (OS)
OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment. OS was estimated using Kaplan-Meier methods. (NCT00811135)
Timeframe: Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
Intervention | months (Median) |
---|
Trastuzumab + Bevacizumab + Capecitabine | 31.8 |
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Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)
Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met. (NCT00811135)
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
Intervention | percentage of participants (Number) |
---|
Trastuzumab + Bevacizumab + Capecitabine | 75.0 |
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Duration of Response (DR)
DR was defined as the time from the first recorded response (CR/PR) to the date of first documented progression or death. CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. DR was estimated using Kaplan-Meier methods. (NCT00811135)
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
Intervention | months (Median) |
---|
Trastuzumab + Bevacizumab + Capecitabine | 12.7 |
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Time to Progression (TTP)
TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions). (NCT00811135)
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
Intervention | months (Median) |
---|
Trastuzumab + Bevacizumab + Capecitabine | 14.5 |
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Number of Participants With Disease Progression or Death
Disease progression was defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT00811135)
Timeframe: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
Intervention | participants (Number) |
---|
Trastuzumab + Bevacizumab + Capecitabine | 70 |
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Number of Participants With Overall Survival (OS)
OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment. (NCT00811135)
Timeframe: Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
Intervention | participants (Number) |
---|
Trastuzumab + Bevacizumab + Capecitabine | 40 |
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Number of Participants With CNS Progression at Any Time
CNS progression was documented by a brain scan and was indicated by the investigator on the follow-up electronic Case Report Form. CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease, with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met. (NCT00820222)
Timeframe: From the time of randomization until death due to any cause (average of 10 months). Cut-off 11-Jun-2012
Intervention | participants (Number) |
---|
Lapatinib Plus Capecitabine | 17 |
Trastuzumab Plus Capecitabine | 15 |
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Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Occurring in >=2% of Participants in Either Treatment Arm
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was related to study drug. AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE. (NCT00820222)
Timeframe: From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months).
Intervention | Participants (Count of Participants) |
---|
| Palmar-plantar erythrodysaesthesia syndrome | Diarrhoea | Aspartate aminotransferase increased | Neutropenia | Asthenia | Fatigue | Alanine aminotransferase increased | Hypokalaemia |
---|
Lapatinib Plus Capecitabine | 29 | 19 | 11 | 9 | 9 | 7 | 4 | 3 |
,Trastuzumab Plus Capecitabine | 45 | 22 | 4 | 18 | 6 | 4 | 6 | 11 |
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Overall Survival
Overall survival is defined as the time from randomization until death due to any cause or to the date of censor. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact. (NCT00820222)
Timeframe: From randomization until death due to any cause (average of 10 months). Cut-off 11-Jun-2012
Intervention | months (Median) |
---|
Lapatinib Plus Capecitabine | 22.7 |
Trastuzumab Plus Capecitabine | 27.3 |
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Progression Free Survival (PFS), as Assessed by the Investigator
PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), or death due to any cause. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions based on investigator assessment of both CNS and non-CNS for response. (NCT00820222)
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012
Intervention | months (Median) |
---|
Lapatinib Plus Capecitabine | 6.60 |
Trastuzumab Plus Capecitabine | 8.05 |
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Number of Participants With Overall Response (OR), as Assessed by the Investigator
OR is defined as the number of participants with either a confirmed complete response (CR; disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD). CR and PR were assessed per Response Evaluation Criteria in Solid Tumors (RECIST). To be assigned a status of PR or CR, a confirmatory disease assessment was to be performed 28 days (4 weeks) or greater after the criteria for response were first met. In addition, a bone scan must have been obtained to rule out the presence of new bone lesions or progression of existing bone lesions, even if the participant had no bone lesions present at Baseline. If a bone scan was performed at the time of initial response or near the time of response, the bone scan did not need to be repeated. (NCT00820222)
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012
Intervention | Participants (Count of Participants) |
---|
| CR | PR | Overall Response (CR+PR) |
---|
Lapatinib Plus Capecitabine | 8 | 65 | 73 |
,Trastuzumab Plus Capecitabine | 12 | 73 | 85 |
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Duration of Response
Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) until the first documented sign of PD (at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions) or death due to breast cancer. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact. (NCT00820222)
Timeframe: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 10 months). Cut-off 11-Jun-2012
Intervention | months (Median) |
---|
Lapatinib Plus Capecitabine | 6.2 |
Trastuzumab Plus Capecitabine | 8.4 |
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Time to First CNS Progression, Defined as the Time From Randomization Until the Date of Documented CNS Progression as the First Site of Relapse
CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met. (NCT00820222)
Timeframe: From randomization until the date of documented CNS progression (average of 10 months). Cut-off 11-Jun-2012
Intervention | months (Mean) |
---|
Lapatinib Plus Capecitabine | 8.2 |
Trastuzumab Plus Capecitabine | 6.7 |
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Number of Participants With Clinical Benefit (CB)
CB is defined as the number of participants with evidence of confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD [defined as at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions] based on investigator assessment), for at least 24 weeks. (NCT00820222)
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012
Intervention | Participants (Count of Participants) |
---|
| CR | PR | SD >= 24 weeks | Clinical Benefit (CR + PR + SD >= 24 weeks) |
---|
Lapatinib Plus Capecitabine | 8 | 65 | 39 | 112 |
,Trastuzumab Plus Capecitabine | 12 | 73 | 33 | 118 |
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Death Rates and Overall Survival
Counts and proportions of patients deceased (post-study). (NCT00828672)
Timeframe: up to 5 years
Intervention | Participants (Count of Participants) |
---|
| Deceased (Dec 2017) | Alive (Dec 2017) | Lost to FU |
---|
AX (ARM 2) | 7 | 34 | 0 |
,AXE (ARM 1) | 6 | 36 | 1 |
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Number of Participants With Histopathologic R0 and Negative CRM Resection
Histopathologic R0 resection rate was defined as margins histologically negative for tumour involvement after resection. The circumferential resection margin (CRM) is considered to be involved if microscopic tumour is present <1mm from or at the inked circumferential or radial resection margin. Data on quality of mesorectal excision were expected but not collected consistently. (NCT00828672)
Timeframe: 4 months
Intervention | Participants (Count of Participants) |
---|
| Negative resection margins | Positive resection margins |
---|
AX (ARM 2) | 37 | 2 |
,AXE (ARM 1) | 40 | 1 |
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Number of Participants With Pathologic Complete Response at Surgery. Number of Participants With Good or Little Pathological Tumour Regression at Surgery.
Dworak tumour regression grades (TRG) were used to assess pathologic response: TRG0=no regression. TRG1=dominant tumor mass with obvious fibrosis and/or vasculopathy; TRG2=dominant fibrotic changes with few tumour cells or groups; TRG3=very few (difficult to find microscopically) tumour cells in fibrotic tissue with or without mucus substance. TRG4=no intact viable tumour cells, only fibrotic mass or presence of mucin lakes without associated malignant cells (total tumour regression). Pathologic assessments of tumour response post chemoradiotherapy as provided by investigators (read by local pathologists on operative specimens) were reviewed centrally for all pts for whom surgical materials were available (centrally reviewed set). The diagnosis of independent central reviewers primed. Pathologic complete response rates (TRG4) are reported (%). Good (TRG3 and TRG4 together) and little (TRG 0,1 and 2) tumour regression rates are summarized. For these 2 last rows, % add to 100. (NCT00828672)
Timeframe: 4 months
Intervention | Participants (Count of Participants) |
---|
| Complete response, no tumour left Dworak TRG=4 | Good tumour regression TRG=3-4 | No or little tumour regression Dworak TRG=0-1-2 |
---|
AX (ARM 2) | 4 | 9 | 29 |
,AXE (ARM 1) | 14 | 17 | 24 |
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Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery.
Dworak tumour regression grades (TRG) were used to assess pathologic response: TRG0=no regression. TRG1=dominant tumor mass with obvious fibrosis and/or vasculopathy; TRG2=dominant fibrotic changes with few tumour cells or groups; TRG3=very few (difficult to find microscopically) tumour cells in fibrotic tissue with or without mucus substance. TRG4=no intact viable tumour cells, only fibrotic mass or presence of mucin lakes without associated malignant cells (total tumour regression). Pathologic assessments of tumour response post chemoradiotherapy as provided by investigators (read by local pathologists on operative specimens) were reviewed centrally for all pts for whom surgical materials were available (centrally reviewed set). The diagnosis of independent central reviewers primed. Pathologic complete response rates (TRG4) are reported (%). Good (TRG3 and TRG4 together) and little (TRG 0,1 and 2) tumour regression rates are summarized. For these 2 last rows, % add to 100. (NCT00828672)
Timeframe: 4 months
Intervention | percentage of cases (Number) |
---|
| Pathological complete response (Dworak TRG=4) % | Good tumour regression (Dworak TRG=3-4) % | Little tumour regression (Dworak TRG=0-1-2) % |
---|
AX (ARM 2) | 11 | 24 | 76 |
,AXE (ARM 1) | 34 | 41 | 59 |
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Recurrence Rates and Disease Free Survival
Counts and proportions of patients experiencing recurrence of disease (local and distant). (NCT00828672)
Timeframe: up to 5 years
Intervention | Participants (Count of Participants) |
---|
| Recurred Dec 2017 | Not recurred Dec 2017 | Lost to FU |
---|
AX (ARM 2) | 9 | 32 | 0 |
,AXE (ARM 1) | 9 | 33 | 1 |
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Types and Numbers of Adverse Events - General Overview
Adverse events graded as per NCI CTCAE (US National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0. All Serious Adverse Events occurrences are reported and counts are summarized here; all Adverse Events (all grades) related and not related to study treatment are reported and summarized here; all severe laboratory events (hematology and biochemistry Gr 3 and higher) are reported and summarized here; all severe postoperative complications (Gr 3 and higher) occurred within the first month post surgery are reported and summarized here. See section Adverse events for details. (NCT00828672)
Timeframe: continuous up to 1 year
Intervention | counts of events (Number) |
---|
| Serious adverse events | All adverse events | Severe lab events | Post operative complications at 1 month |
---|
AX (ARM 2) | 12 | 426 | 16 | 9 |
,AXE (ARM 1) | 22 | 564 | 27 | 14 |
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Clinical Response Rate
"Baseline tumour measurements were performed within 4 weeks prior to treatment start (RECIST). The same methods of assessment (CT and/or MRI) were used for each measurable lesion at baseline and during follow-up.~Complete Response (CR) is disappearance of all clinical and radiological evidence of tumour (both target and non-target lesions).~Partial Response (PR) is at least a 30% decrease in the sum of LD of target lesions, taking as reference the baseline sum of tumour longest diameters (LD).~Stable Disease (SD) is steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Progressive Disease (PD) is at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started. Appearance of new lesions constitutes PD. In exceptional circumstances, unequivocal progression of non-target lesions was considered evidence of PD." (NCT00828672)
Timeframe: 3 months
Intervention | Participants (Count of Participants) |
---|
| CR | PR | SD | PD | NA |
---|
AX (ARM 2) | 5 | 17 | 13 | 1 | 5 |
,AXE (ARM 1) | 3 | 24 | 9 | 0 | 7 |
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PFS as Assessed by the Investigator
Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Intervention | Months (Median) |
---|
Trastuzumab Emtansine | 9.4 |
Lapatinib + Capecitabine | 5.8 |
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Time to Treatment Failure
"Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For Lapatinib + Capecitabine arm, a participant was considered as treatment failure only if both drugs were discontinued with treatment failure date as the later of the 2 discontinuation dates. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The median time to treatment failure was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley." (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Intervention | Months (Median) |
---|
Trastuzumab Emtansine | 7.9 |
Lapatinib + Capecitabine | 5.8 |
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Duration of Objective Response (DOR) as Assessed by an IRC
Tumor response was assessed by an IRC according to modified RECIST. DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier. OR was defined as a CR or PR determined on 2 consecutive tumor assessments at least 4 weeks apart. For TLs, CR was defined as the disappearance of all TLs; PR was defined as >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; and PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, CR was defined as the disappearance of all non-TLs; PR was defined as the persistence of 1 or more non-TLs; and PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Intervention | Months (Median) |
---|
Trastuzumab Emtansine | 12.6 |
Lapatinib + Capecitabine | 6.5 |
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Overall Survival: Final Analysis
OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive. (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
Intervention | Months (Median) |
---|
Trastuzumab Emtansine | 29.9 |
Lapatinib + Capecitabine | 25.9 |
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Overall Survival: Second Interim Analysis (Co-primary Endpoint)
OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory. (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
Intervention | Months (Median) |
---|
Trastuzumab Emtansine | 30.9 |
Lapatinib + Capecitabine | 25.1 |
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Percentage of Participants Who Died: Final Analysis
The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive. (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
Intervention | percentage of participants (Number) |
---|
Trastuzumab Emtansine | 61.2 |
Lapatinib + Capecitabine | 67.1 |
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Percentage of Participants Who Died: Second Interim Analysis
The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory. (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
Intervention | percentage of participants (Number) |
---|
Trastuzumab Emtansine | 30.1 |
Lapatinib + Capecitabine | 36.7 |
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Percentage of Participants Who Were Alive at Year 1
1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis. (NCT00829166)
Timeframe: Year 1
Intervention | percentage of participants (Number) |
---|
Trastuzumab Emtansine | 85.3 |
Lapatinib + Capecitabine | 78.9 |
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Percentage of Participants Who Were Alive at Year 2
2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis. (NCT00829166)
Timeframe: Year 2
Intervention | percentage of participants (Number) |
---|
Trastuzumab Emtansine | 59.6 |
Lapatinib + Capecitabine | 52.4 |
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Percentage of Participants With Clinical Benefit as Assessed by an IRC
Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method. (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Intervention | percentage of participants (Number) |
---|
Trastuzumab Emtansine | 58.2 |
Lapatinib + Capecitabine | 44.2 |
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Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)
Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: >/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley. (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Intervention | Months (Median) |
---|
Trastuzumab Emtansine | 9.6 |
Lapatinib + Capecitabine | 6.4 |
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Percentage of Participants With Objective Response (OR) as Assessed by an IRC
Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as >/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method. (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Intervention | percentage of participants (Number) |
---|
Trastuzumab Emtansine | 43.6 |
Lapatinib + Capecitabine | 30.8 |
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Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)
PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported. (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Intervention | percentage of participants (Number) |
---|
Trastuzumab Emtansine | 53.5 |
Lapatinib + Capecitabine | 61.3 |
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Time to Symptom Progression
"Time to symptom progression was defined as the time from randomization to the first documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 (not at all) to 4 (very much). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley." (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Intervention | Months (Median) |
---|
Trastuzumab Emtansine | 7.1 |
Lapatinib + Capecitabine | 4.6 |
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Percentage of Participants With PD or Death as Assessed by the Investigator
PD was assessed by the investigator using modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The percentage of participants who died or experienced PD by Investigator was reported. (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Intervention | percentage of participants (Number) |
---|
Trastuzumab Emtansine | 58.0 |
Lapatinib + Capecitabine | 67.5 |
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Percentage of Participants With Symptom Progression
"Symptom progression was defined as the documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale [BCS]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 (not at all) to 4 (very much). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported." (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Intervention | percentage of participants (Number) |
---|
Trastuzumab Emtansine | 54.7 |
Lapatinib + Capecitabine | 57.8 |
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Percentage of Participants With Treatment Failure
"Treatment failure was defined as discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For Lapatinib + Capecitabine arm, a participant was considered as treatment failure only if both drugs were discontinued. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of participants with treatment failure was reported." (NCT00829166)
Timeframe: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Intervention | percentage of participants (Number) |
---|
Trastuzumab Emtansine | 63.2 |
Lapatinib + Capecitabine | 74.8 |
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Volume of Distribution (Vz) for Cisplatin
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Clearance for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate) in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin alone) on Cycle 2 Day 1. (NCT00842244)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start on C1D1, C2D1
Intervention | Liter (Geometric Mean) |
---|
| Cisplatin alone | Cisplatin in presence of axitinib |
---|
Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort) | 55.35 | 70.32 |
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Duration of Response (DR)
Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR = disappearance of all target lesions. PR = at least 30% decrease in sum of the longest dimensions of target lesions taking the baseline sum of the longest dimensions as a reference. (NCT00842244)
Timeframe: Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784
Intervention | months (Median) |
---|
Axitinib + Capecitabine + Cisplatin | 9.07 |
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Clearance (CL) for Cisplatin
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It is defined as the volume of blood from which drug can be completely removed per unit of time. Clearance for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate) in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin alone) on Cycle 2 Day 1. (NCT00842244)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start on C1D1, C2D1
Intervention | Liter/hr (Geometric Mean) |
---|
| Cisplatin alone | Cisplatin in presence of axitinib |
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Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort) | 30.94 | 32.50 |
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Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] for Axitinib
AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours. AUC (0-24) for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Results for axitinib were normalized to axitinib 5 mg dose. (NCT00842244)
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1
Intervention | ng*hr/mL (Geometric Mean) |
---|
| Axitinib alone | Axitinib in combination with chemotherapy |
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Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort) | 206.20 | 265.89 |
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Progression-Free Survival (PFS)
"Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD was a>=20% increase in sum of the longest dimensions of target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions." (NCT00842244)
Timeframe: Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784
Intervention | months (Median) |
---|
Axitinib + Capecitabine + Cisplatin | 3.75 |
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Percentage of Participants With Objective Response (OR)
Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent (%) decrease in sum of the longest dimensions of target lesions taking the baseline sum of the longest dimensions as a reference. (NCT00842244)
Timeframe: Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784
Intervention | percentage of participants (Number) |
---|
Axitinib + Capecitabine + Cisplatin | 36.36 |
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Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Cisplatin and Capecitabine
MTD = highest dose at which no more than 30 percent (%) of 12 participants experience DLT during Cycle 1. DLT = GR2 proteinuria; GR3 NHT (excluding alopecia and those that can be controlled with appropriate treatment)for >=7 days, GR3 thrombocytopenia with active bleeding; GR >=3 febrile NP/NP infection; GR 3 or 4 nausea, vomiting or diarrhea despite anti-emetics, anti-diarrheals; GR4 NHT, thrombocytopenia, NP for >=7 days; >= 1/2 teaspoon per day hemoptysis; any treatment-related toxicity with >3 consecutive days of capecitabine or 5 consecutive days of axitinib missed doses per cycle; delayed toxicity recovery >14 days. (NCT00842244)
Timeframe: Baseline up to Day 21 of Cycle 1
Intervention | mg (Number) |
---|
Axitinib + Capecitabine + Cisplatin (MTD Determination) | 5 |
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Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs)
DLT = Grade (GR) 2 proteinuria; GR3 nonhematological toxicity (NHT) (excluding alopecia and those that can be controlled with appropriate treatment) for greater than or equal to (>=)7 days, GR3 thrombocytopenia with active bleeding; GR >=3 febrile neutropenia (NP) or NP infection; GR 3 or 4 nausea, vomiting or diarrhea despite anti-emetics, anti-diarrheals; GR4 NHT, thrombocytopenia, NP for >=7 days; >= 1/2 teaspoon per day hemoptysis; any treatment related toxicity with >3 consecutive days of capecitabine or 5 consecutive days of axitinib missed doses per cycle; delayed toxicity recovery >14 days. (NCT00842244)
Timeframe: Baseline up to Day 21 of Cycle 1
Intervention | participants (Number) |
---|
Axitinib + Capecitabine + Cisplatin (MTD Determination) | 3 |
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Number of Patients With One-year Recurrence-free Survival
This is defined as the patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy. (NCT00848783)
Timeframe: 1 year
Intervention | participants (Number) |
---|
A-with IP Floxuridine | 3 |
B-Without IP Floxuridine | 2 |
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Number of Participants With Partial Response (PR)
PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting > 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements. (NCT00869050)
Timeframe: 12 months
Intervention | participants (Number) |
---|
Capecitabine and Temozolomide | 9 |
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Number of Participants With Complete Response (CR)
CR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as disappearance of all target lesions (primary and metastases), signs, symptoms, and biochemical changes related to the tumor for >4 weeks, during which no new lesions may appear and no existing lesion may enlarge. (NCT00869050)
Timeframe: 12 months
Intervention | participants (Number) |
---|
Capecitabine and Temozolomide | 3 |
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Overall Survival
Time of study entry to time of death (NCT00881621)
Timeframe: 24 months
Intervention | months (Median) |
---|
Lapatinib and Capecitabine | 5.2 |
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Clinical Benefit Response
"number of participants who had stable disease or partial response or complete response per Response Evaluation Criteria In Solid Tumors.~Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study." (NCT00881621)
Timeframe: 3 months
Intervention | participants (Number) |
---|
Lapatinib and Capecitabine | 6 |
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Adverse Events
Grade 3 or 4 toxicities (NCT00881621)
Timeframe: 2 years
Intervention | participants (Number) |
---|
Lapatinib and Capecitabine | 3 |
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Progression Free Survival
Time of study entry to cancer progression. (NCT00881621)
Timeframe: 24 months
Intervention | months (Median) |
---|
Lapatinib and Capecitabine | 2.6 |
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Overall Survival in ITT Population
Overall survival was calculated in months from the day of screening until death. (NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)
Intervention | months (Median) |
---|
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | NA |
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Overall Survival in Per Protocol Population
Overall survival was calculated in months from the day of screening until death. (NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)
Intervention | months (Median) |
---|
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | 36.40 |
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Part I: TTP in Intent to Treat (ITT) Population
TTP was determined as the time in months from the date of screening until first progression. In participants with measurable disease, progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment. (NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Intervention | months (Median) |
---|
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | 22.21 |
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks | 1.22 |
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Part II: PFS in ITT Population
PFS was calculated from first study medication in Part II to date of progression or death. In participants with measurable disease progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment. (NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Intervention | months (Median) |
---|
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | 5.65 |
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks | 13.83 |
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Part II: TTP in Intent to Treat (ITT) Population
TTP was calculated from first study medication in Part II to date of progression. In participants with measurable disease progression was defined according to RECIST(SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment. (NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Intervention | months (Median) |
---|
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | 5.65 |
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks | 13.83 |
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Part I and II: Percentage of Participants With a Best Overall Response of CR or PR in ITT Population
Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. (NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Intervention | percentage of participants (Number) |
---|
| Part I: Responders (n=20) | Part I: Non-Responders (n=20) | Part I: Missing (n=20) | Part II: Responders (n=9) | Part II: Non-Responders (n=9) | Part II: Missing (n=9) |
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Group A: Trastuzumab+Taxane /Capcetabine (6 Weeks) | 75.0 | 20.0 | 5.0 | 11.1 | 88.9 | 0.0 |
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Part I: Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progrerssive Disease (PD) by Biomarker
BOR was defined according to the Response Evaluation Criteria In Solid Tumors (RECIST). CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. The relationship between best response and the following biomarkers was investigated: p95 HER2 (+ve/-ve), IGF1R, c-MET, PTEN, HER2 (median/≥median), PI3K catalytic subunit (WT/M), and FC gamma receptors IIIa, IIa and IIb (phenotypes FF, VF, VV, HH, HR, RR and II, IT and TT respectively). The correlation between the biomarker variables and percentage of participants with best response were investigated using a univariate regression analysis. (NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks
Intervention | percentage of participants (Number) |
---|
| p95 HER2 +ve CR (n=5) | p95 HER2 +ve PR (n=5) | p95 HER2 +ve SD (n=5) | p95 HER2 +ve PD (n=5) | p95 HER2 -ve CR (n=12) | p95 HER2 -ve PR (n=12) | p95 HER2 -ve SD (n=12) | p95 HER2 -ve PD (n=12) | IGF1R < median CR (n=9) | IGF1R < median PR (n=9) | IGF1R < median SD (n=9) | IGF1R < median PD (n=9) | IGF1R ≥median CR (n=9) | IGF1R ≥median PR (n=9,0) | IGF1R ≥median SD (n=9) | IGF1R ≥median PD (n=9) | c-MET c-METt c-MET c-MET c-MET ≥median CR (n=11) | c-MET ≥median PR (n=11) | c-MET ≥median SD (n=11) | c-MET ≥median PD (n=11) | PTEN PTEN PTEN PTEN PTEN ≥median CR (n=12) | PTEN ≥median PR (n=12) | PTEN ≥median SD (n=12) | PTEN ≥median PD (n=12) | HER2 HER2 HER2 HER2 HER2 ≥median CR (n=10) | HER2 ≥median PR (n=10) | HER2 ≥median SD (n=10) | HER2 ≥median PD (n=10) | PI3K Amino Acids WT CR (n=11) | PI3K Amino Acids WT PR (n=11,0) | PI3K Amino Acids WT SD (n=11) | PI3K Amino Acids WT PD (n=11) | PI3K Amino Acids M CR (n=7) | PI3K Amino Acids M PR (n=7,0) | PI3K Amino Acids M SD (n=7) | PI3K Amino Acids M PD (n=7) | FC Gamma Receptor IIIa F176V FF CR (n=6) | FC Gamma Receptor IIIa F176V FF PR (n=6) | FC Gamma Receptor IIIa F176V FF SD (n=6) | FC Gamma Receptor IIIa F176V FF PD (n=6) | FC Gamma Receptor IIIa F176V VF CR (n=4) | FC Gamma Receptor IIIa F176V VF PR (n=4) | FC Gamma Receptor IIIa F176V VF SD (n=4) | FC Gamma Receptor IIIa F176V VF PD (n=4) | FC Gamma Receptor IIIa F176V VV CR (n=2) | FC Gamma Receptor IIIa F176V VV PR (n=2) | FC Gamma Receptor IIIa F176V VV SD (n=2) | FC Gamma Receptor IIIa F176V VV PD (n=2) | FC Gamma Receptor IIa R166H HH CR (n=3) | FC Gamma Receptor IIa R166H HH PR (n=3) | FC Gamma Receptor IIa R166H HH SD (n=3) | FC Gamma Receptor IIa R166H HH PD (n=3) | FC Gamma Receptor IIa R166H HR CR (n=5) | FC Gamma Receptor IIa R166H HR PR (n=5) | FC Gamma Receptor IIa R166H HR SD (n=5) | FC Gamma Receptor IIa R166H HR PD (n=5) | FC Gamma Receptor IIa R166H RR CR (n=5) | FC Gamma Receptor IIa R166H RR PR (n=5) | FC Gamma Receptor IIa R166H SD RR (n=5) | FC Gamma Receptor IIa R166H RR PD (n=5) | FC Gamma Receptor IIb I232T II CR (n=8) | FC Gamma Receptor IIb I232T II PR (n=8) | FC Gamma Receptor IIb I232T II SD (n=8) | FC Gamma Receptor IIb I232T II PD (n=8) | FC Gamma Receptor IIb I232T IT CR (n=1) | FC Gamma Receptor IIb I232T IT PR (n=1) | FC Gamma Receptor IIb I232T IT SD (n=1) | FC Gamma Receptor IIb I232T IT PD (n=1) | | | | | | | | | | | | |
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Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | 0.0 | 25.0 | 50.0 | 25.0 | 0.0 | 91.7 | 8.3 | 0.0 | 0.0 | 62.5 | 37.5 | 0.0 | 0.0 | 88.9 | 0.0 | 11.1 | 0.0 | 83.3 | 0.0 | 16.7 | 0.0 | 70.0 | 30.0 | 0.0 | 0.0 | 83.3 | 16.7 | 0.0 | 0.0 | 72.7 | 18.2 | 9.1 | 0.0 | 75.0 | 12.5 | 12.5 | 0.0 | 77.8 | 22.2 | 0.0 | 0.0 | 90.0 | 0.0 | 10.0 | 0.0 | 57.1 | 42.9 | 0.0 | 16.7 | 50.0 | 16.7 | 16.7 | 0.0 | 66.7 | 33.3 | 0.0 | 0.0 | 100.0 | 0.0 | 0.0 | 33.3 | 66.7 | 0.0 | 0.0 | 0.0 | 25.0 | 50.0 | 25.0 | 0.0 | 80.0 | 20.0 | 0.0 | 12.5 | 50.0 | 37.5 | 0.0 | 0.0 | 100.0 | 0.0 | 0.0 |
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Part I and II: Percentage of Participants With a Response by Best Overall Response by CR, PR, SD or PD in ITT Population
Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. (NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Intervention | percentage of participants (Number) |
---|
| Part I: CR (n=20) | Part I: PR (n=20) | Part I: SD (n=20) | Part I: PD (n=20) | Part I: Missing (n=20) | Part II: CR (n=9) | Part II: PR (n=9) | Part II: SD (n=9) | Part II: PD (n=9) | Part II: Missing (n=9) |
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Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | 5.0 | 70.0 | 15.0 | 5.0 | 5.0 | 0.0 | 11.1 | 66.7 | 22.2 | 0.0 |
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Part I: Time to Progression (TTP) by Biomarker
Progression was defined as an increase by at least 20% from the smallest value in the SLD of lesions.TTP was determined as the time in months from the date of screening until first progression.The relationship between PFS and the following biomarker variables was investigated in each of study Part 1 and 2: p95 HER2 +ve and -ve population, IGF1R NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks
Intervention | months (Median) |
---|
| p95 +ve (n=9,0) | p95 -ve (n=15,1) | IGF1R IGF1R ≥median (n=14,1) | c-MET c-MET ≥median (n=15,0) | PTEN PTEN ≥median (n=14,1) | HER2 HER2 ≥median (n=14,0) | PI3K Amino Acids WT (n=17,1) | PI3K Amino Acids M (n=9,00) | FC Gamma Receptor IIIa F176V FF (n=9,0) | FC Gamma Receptor IIIa F176V VF (n=5,1) | FC Gamma Receptor IIIa F176V VV (n=4,0) | FC Gamma Receptor IIa R166H HH (n=3,0) | FC Gamma Receptor IIa R166H HR (n=8,1) | FC Gamma Receptor IIa R166H RR (n=8,0) | FC Gamma Receptor IIb I232T II (n=12,1) | FC Gamma Receptor IIb I232T IT (n=1,0) | FC Gamma Receptor IIb I232T TT (n=1,0) | | | | |
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Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | NA | 13.963 | 11.335 | 22.407 | 31.179 | 22.209 | 22.209 | 13.963 | NA | 22.209 | 13.963 | 22.407 | 13.963 | 11.335 | 22.407 | NA | 22.209 | 13.963 | 13.963 | NA | NA |
,Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks | NA | 1.216 | NA | 1.216 | 1.216 | NA | NA | 1.216 | 1.216 | NA | 1.216 | NA | NA | 1.216 | NA | NA | 1.216 | NA | 1.216 | NA | NA |
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Part II: Percentage of Participants With a Best Overall Response of CR, PR, SD or PD by Biomarker
Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm.PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. The relationship between best response and the following biomarkers was investigated: p95 HER2 (+ve/-ve), IGF1R, c-MET, PTEN, HER2 (NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Intervention | percentage of participants (Number) |
---|
| p95 HER2 +ve CR (n=2) | p95 HER2 +ve PR (n=2) | p95 HER2 +ve SD (n=2) | p95 HER2 +ve PD (n=2) | p95 HER2 -ve CR (n=4) | p95 HER2 -ve PR (n=4) | p95 HER2 -ve SD (n=4) | p95 HER2 -ve PD (n=4) | IGF1R IGF1R IGF1R IGF1R IGF1R ≥median CR (n=3) | IGF1R ≥median PR (n=3) | IGF1R ≥median SD (n=3) | IGF1R ≥median PD (n=3) | c-MET c-MET c-MET c-MET c-MET ≥median CR (n=4) | c-MET ≥median PR (n=4) | c-MET ≥median SD (n=4) | c-MET ≥median PD (n=4) | PTEN PTEN PTEN PTEN PTEN ≥median CR (n=2) | PTEN ≥median PR (n=2) | PTEN ≥median SD (n=2) | PTEN ≥median PD (n=2) | HER2 HER2 HER2 HER2 HER2 ≥median CR (n=4) | HER2 ≥median PR (n=4) | HER2 ≥median SD (n=4) | HER2 ≥median PD (n=4) | PI3K Amino Acids WT CR (n=7) | PI3K Amino Acids WT PR (n=7) | PI3K Amino Acids WT SD (n=7) | PI3K Amino Acids WT PD (n=7) | PI3K Amino Acids M CR (n=2) | PI3K Amino Acids M PR (n=2) | PI3K Amino Acids M SD (n=2) | PI3K Amino Acids M PD (n=2) | FC Gamma Receptor IIIa F176V FF CR (n=3) | FC Gamma Receptor IIIa F176V FF PR (n=3) | FC Gamma Receptor IIIa F176V FF SD (n=3) | FC Gamma Receptor IIIa F176V FF PD (n=3) | FC Gamma Receptor IIIa F176V VF CR (n=1) | FC Gamma Receptor IIIa F176V VF PR (n=1) | FC Gamma Receptor IIIa F176V VF SD (n=1) | FC Gamma Receptor IIIa F176V VF PD (n=1) | FC Gamma Receptor IIIa F176V VV CR (n=1) | FC Gamma Receptor IIIa F176V VV PR (n=1) | FC Gamma Receptor IIIa F176V VV SD (n=1) | FC Gamma Receptor IIIa F176V VV PD (n=1) | FC Gamma Receptor IIa R166H HH CR (n=0) | FC Gamma Receptor IIa R166H HH PR (n=0) | FC Gamma Receptor IIa R166H HH SD (n=0) | FC Gamma Receptor IIa R166H HH PD (n=0) | FC Gamma Receptor IIa R166H HR CR (n=5) | FC Gamma Receptor IIa R166H HR PR (n=4) | FC Gamma Receptor IIa R166H HR SD (n=4) | FC Gamma Receptor IIa R166H HR PD (n=4) | FC Gamma Receptor IIa R166H RR CR (n=4) | FC Gamma Receptor IIa R166H RR PR (n=2) | FC Gamma Receptor IIa R166H RR SD (n=2) | FC Gamma Receptor IIa R166H RR PD (n=2) | FC Gamma Receptor IIb I232T II CR (n=4) | FC Gamma Receptor IIb I232T II PR (n=4) | FC Gamma Receptor IIb I232T II SD (n=4) | FC Gamma Receptor IIb I232T II PD (n=4) | FC Gamma Receptor IIb I232T IT CR (N=0) | FC Gamma Receptor IIb I232T IT PR (n=0) | FC Gamma Receptor IIb I232T IT SD (n=0) | FC Gamma Receptor IIb I232T IT PD (n=0) | FC Gamma Receptor IIb I232T TT CR (n=4) | FC Gamma Receptor IIb I232T TT PR (n=4) | FC Gamma Receptor IIb I232T TT SD (n=4) | FC Gamma Receptor IIb I232T TT PD (n=4) | | | | | | | | | | | | | | | | |
---|
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | 0.0 | 0.0 | 100.0 | 0.0 | 0.0 | 0.0 | 50.0 | 50.0 | 0.0 | 0.0 | 66.7 | 33.3 | 0.0 | 0.0 | 66.7 | 33.3 | 0.0 | 0.0 | 100.0 | 0.0 | 0.0 | 0.0 | 50.0 | 50.0 | 0.0 | 0.0 | 75.0 | 25.0 | 0.0 | 0.0 | 50.0 | 50.0 | 0.0 | 0.0 | 100.0 | 0.0 | 0.0 | 0.0 | 50.0 | 50.0 | 0.0 | 14.3 | 71.4 | 14.3 | 0.0 | 0.0 | 50.0 | 50.0 | 0.0 | 0.0 | 66.7 | 33.3 | 0.0 | 0.0 | 100.0 | 0.0 | 0.0 | 100.0 | 0.0 | 0.0 | NA | NA | NA | NA | 0.0 | 25.0 | 50.0 | 25.0 | 0.0 | 0.0 | 100.0 | 0.0 | 0.0 | 0.0 | 75.0 | 25.0 | NA | NA | NA | NA | 0.0 | 0.0 | 75.0 | 25.0 |
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Part II: Progression Free Survival (PFS) by Biomarker
PFS was calculated from first study medication in Part II to date of progression or death.The relationship between PFS and the following biomarker variables was investigated in each of study Part 1 and 2: p95HER2 +ve and -ve population, IGF1R NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Intervention | months (Median) |
---|
| p95 +ve (n=2,0) | p95 -ve (n=5,1) | IGF1R IGF1R ≥median (n=4,1) | c-METc-MET≥median (n=4,0) | PTEN PTEN ≥median (n=3,1) | HER2 HER2 ≥median (n=5,0) | PI3K Amino Acids WT (n=10,1) | PI3K Amino Acids M (n=2,0) | FC Gamma Receptor IIIa F176V FF (n=4,0) | FC Gamma Receptor IIIa F176V VF (n=2,1) | FC Gamma Receptor IIIa F176V VV (n=2,0) | FC Gamma Receptor IIa R166H HH (n=1,0) | FC Gamma Receptor IIa R166H HR (n=5,1) | FC Gamma Receptor IIa R166H RR (n=3,0) | FC Gamma Receptor IIb I232T II (n=7,1) | | | | |
---|
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | 8.148 | 3.450 | 8.115 | 4.074 | 4.698 | 5.043 | 4.698 | 3.450 | 8.148 | 3.450 | 5.651 | 4.485 | 4.320 | 13.832 | NA | 3.450 | 8.115 | 5.651 | 5.651 |
,Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks | NA | 13.832 | NA | 13.832 | 13.832 | NA | NA | 13.832 | 13.832 | NA | 13.832 | NA | NA | 13.832 | NA | NA | 13.832 | NA | 13.832 |
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Part II: TTP by Biomarker
TTP was calculated from first study medication in Part II to date of progression. The relationship between TTP and the following biomarker variables was investigated in each of study Part 1 and 2: p95 HER2 +ve and -ve population, IGF1R NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Intervention | months (Median) |
---|
| p95 HER2 +ve (n=2,0) | p95 HER2 -ve (n=5,1) | IGF1R IGF1R ≥median (n=4,1) | c-MET c-MET ≥median (n=4,0) | PTEN PTEN ≥median (n=3,1) | HER2 HER2 ≥median (n=5,0) | PI3K Amino Acids WT (n=10,1) | PI3K Amino Acids M (n=2,0) | FC Gamma Receptor IIIa F176V FF (n=4,0) | FC Gamma Receptor IIIa F176V VF (n=2,1) | FC Gamma Receptor IIIa F176V VV (n=2,0) | FC Gamma Receptor IIa R166H HH (n=1,0) | FC Gamma Receptor IIa R166H HR (n=5,1) | FC Gamma Receptor IIa R166H RR (n=3,0) | FC Gamma Receptor IIb I232T II (n=7,1) | | | | |
---|
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | 8.148 | 3.450 | 8.115 | 4.074 | 4.698 | 5.043 | 4.698 | 3.450 | 8.148 | 3.450 | 5.651 | 4.485 | 4.320 | NA | NA | 3.450 | 8.115 | 5.651 | 5.651 |
,Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks | NA | 13.832 | NA | 13.832 | 13.832 | NA | NA | 13.832 | 13.832 | NA | 13.832 | NA | NA | 13.832 | NA | NA | 13.832 | NA | 13.832 |
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Part I: Progression Free Survival (PFS) by Biomarker
Progression was defined as an increase by at least 20 percent (%) from the smallest value in the Sum of Longest Diameter (SLD) of lesions. Biomarkers investigated: p95 human epidermal growth factor receptor 2 (p95HER2) positive (+ve) and negative (-ve) , insulin growth factor-1 receptor (IGF1R) less than (<) median and greater than or equal to (≥) median membrane H score, c-MET NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Intervention | months (Median) |
---|
| p95 HER2 +ve (n=9,0) | p95 HER2 -ve (n=15,1) | IGF1R IGF1R ≥median (n=14,1) | c-MET c-MET ≥median (n=15,0) | PTEN PTEN ≥median (n=14,1) | HER2 HER2 ≥median (n=14,0) | PI3K Amino Acids WT (n=17,1) | PI3K Amino Acids M (n=9,0) | FC Gamma Receptor IIIa F176V FF (n=9,0) | FC Gamma Receptor IIIa F176V VF (n=5,1) | FC Gamma Receptor IIIa F176V VV (n=4,0) | FC Gamma Receptor IIa R166H HH (n=3,0) | FC Gamma Receptor IIa R166H HR (n=8,1) | FC Gamma Receptor IIa R166H RR (n=8,0) | FC Gamma Receptor IIb I232T II (n=12,1) | FC Gamma Receptor IIb I232T IT (n=1,0) | FC Gamma Receptor IIb I232T TT (n=1,0) | | | | |
---|
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | NA | 13.963 | 12.649 | 22.209 | 18.595 | 13.733 | 22.209 | 13.963 | 13.733 | 22.209 | 13.848 | 22.407 | 10.612 | 11.335 | 22.407 | NA | 22.209 | 13.963 | 11.335 | NA | NA |
,Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks | NA | 1.216 | NA | 1.216 | 1.216 | NA | NA | 1.216 | 1.216 | NA | 1.216 | NA | NA | 1.216 | NA | NA | 1.216 | NA | 1.216 | NA | NA |
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Part I: PFS in ITT Population
PFS was determined as the time in months from the date of screening until first progression. In participants with measurable disease, progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]).. In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment. (NCT00885755)
Timeframe: End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Intervention | months (Median) |
---|
Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks) | 18.60 |
Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks | 1.22 |
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Time to Progression
Time to progression was defined as the time between randomization and the first occurrence of disease progression. Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Time to progression was estimated using Kaplan Meier method. Reported data included censored observations. Participants who had not progressed at the time of study completion (including participants who had died before disease progression) or who were lost to follow-up were censored at the date of the last tumor assessment or last follow-up for progression of disease. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization. (NCT00887822)
Timeframe: From randomization until disease progression or death (up to 26 months)
Intervention | months (Median) |
---|
Bevacizumab, Capecitabine and Cisplatin | 6.5 |
Placebo, Capecitabine and Cisplatin | 7.0 |
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Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global Qol/functional scales=better level of QoL/functioning, or a higher score for symptom scale=greater degree of symptoms. (NCT00887822)
Timeframe: From Cycle 1 until disease progression (up to 26 months)
Intervention | scores on scale (Mean) |
---|
| GHS/QOL | Physical Funtioning | Role Functioning | Emotional Functioning | Cognitive Functioning | Social Functioning | Fatigue | Nausea and Vomiting | Pain | Dyspnoea | Insomnia | Appetite Loss | Constipation | Diarrhoea | Financial Difficulties |
---|
Bevacizumab, Capecitabine and Cisplatin | 1.24 | -0.89 | -0.65 | -0.22 | -0.51 | -0.27 | -0.36 | -0.82 | -0.55 | -0.10 | -0.57 | -0.65 | -0.14 | -0.29 | 0.31 |
,Placebo, Capecitabine and Cisplatin | 0.73 | -0.99 | -0.37 | 0.19 | -0.41 | 0.08 | -0.27 | -0.55 | -0.22 | -0.07 | 0.26 | -1.17 | -0.02 | 0.00 | 0.04 |
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Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time
The EORTC QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. (NCT00887822)
Timeframe: From Cycle 1 until disease progression (up to 26 months)
Intervention | scores on scale (Mean) |
---|
| Dysphagia | Pain | Reflux Symptoms | Eating Restrictions | Anxiety | Dry Mouth | Taste | Body Image | Hair Loss |
---|
Bevacizumab, Capecitabine and Cisplatin | -0.31 | -0.97 | -0.27 | -0.30 | -0.17 | -0.19 | -0.44 | 0.27 | -0.35 |
,Placebo, Capecitabine and Cisplatin | -0.05 | -0.52 | -0.43 | -0.36 | -0.73 | 0.68 | -0.66 | 0.13 | -0.61 |
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Progression-Free Survival (PFS)
PFS was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first, according to RECIST. Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. Reported data included censored observations. Participants who had neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow-up for progression of disease. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization. (NCT00887822)
Timeframe: From randomization until disease progression or death (up to 26 months)
Intervention | months (Median) |
---|
Bevacizumab, Capecitabine and Cisplatin | 6.3 |
Placebo, Capecitabine and Cisplatin | 6.0 |
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PFS During First-line Therapy
PFS during first-line therapy was defined as time between randomization and date of first documented disease progression or death, whichever occurred first and only if it occurred no later than 28 days after last intake of any study medication and only if it occurred before start of non-study antineoplastic treatment, according to RECIST. Progression of disease was defined as at least 20% increase in sum of longest diameters of target lesions compared to smallest sum of longest diameters on-study & absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. Reported data included censored observations. Participants who neither progressed nor died in this interval, or who were lost to follow-up were censored at date of last tumor assessment/last follow-up within this time window. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization. (NCT00887822)
Timeframe: From randomization until disease progression or death (up to 26 months)
Intervention | months (Median) |
---|
Bevacizumab, Capecitabine and Cisplatin | 6.3 |
Placebo, Capecitabine and Cisplatin | 6.1 |
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Percentage of Participants With Progression-Free Survival (PFS) Events (Disease Progression/Death)
Progression of disease was defined as at least 20 percent (%) increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 millimeters (mm), progression of existing non-target lesions, or presence of new lesions. PFS was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first, according to Response Evaluation Criteria In Solid Tumors (RECIST). (NCT00887822)
Timeframe: From randomization until disease progression or death (up to 26 months)
Intervention | percentage of participants (Number) |
---|
Bevacizumab, Capecitabine and Cisplatin | 81.0 |
Placebo, Capecitabine and Cisplatin | 81.4 |
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Percentage of Participants With PFS Events (Disease Progression/Death) During First-line Therapy
Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS during first-line therapy was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first and only if it occurred no later than 28 days after last confirmed intake of any study medication and before the start of non-study antineoplastic treatment, according to RECIST. (NCT00887822)
Timeframe: From randomization until disease progression or death (up to 26 months)
Intervention | percentage of participants (Number) |
---|
Bevacizumab, Capecitabine and Cisplatin | 51.0 |
Placebo, Capecitabine and Cisplatin | 59.8 |
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Percentage of Participants With Event (Death)
Percentage of participants who died due to any cause was reported. As planned, ad hoc analysis was done for overall survival up to clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months). Overall survival was defined as the time between randomization and the date of death due to any cause. (NCT00887822)
Timeframe: From randomization until death (up to 34 months)
Intervention | percentage of participants (Number) |
---|
Bevacizumab, Capecitabine and Cisplatin | 77.0 |
Placebo, Capecitabine and Cisplatin | 75.5 |
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Percentage of Participants With Disease Progression
Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. (NCT00887822)
Timeframe: From randomization until disease progression or death (up to 26 months)
Intervention | percentage of participants (Number) |
---|
Bevacizumab, Capecitabine and Cisplatin | 56.0 |
Placebo, Capecitabine and Cisplatin | 53.9 |
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Percentage of Participants With Disease Control During First-Line Therapy
Disease control was defined as stable disease(SD) for 6 weeks or longer, CR plus PR as assessed by RECIST criteria for participants with measurable disease.CR:disappearance of all TLs & normalization of tumor markers. Pathological lymph nodes must have short axis measures<10 mm. PR:at least 30% decrease in sum of measures(longest diameter for tumor lesions and short axis measure for nodes)of TLs, taking as reference baseline sum of longest diameters.SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression taking as reference smallest sum of longest diameters on study. For participants without measurable disease, clinical benefit rate was defined as no clinical disease progression for >/=6 weeks. Disease progression was defined as at least 20% increase in sum of diameters of TLs compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. (NCT00887822)
Timeframe: From randomization until disease progression or death (up to 26 months)
Intervention | percentage of participants (Number) |
---|
Bevacizumab, Capecitabine and Cisplatin | 73.0 |
Placebo, Capecitabine and Cisplatin | 72.5 |
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Percentage of Participants With Best Overall Response as Assessed by RECIST During First-Line Therapy
Best overall response during first-line therapy was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR), as assessed by the RECIST criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 mm. PR: at least a 30 % decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of longest diameters. (NCT00887822)
Timeframe: From randomization until disease progression or death (up to 26 months)
Intervention | percentage of participants (Number) |
---|
Bevacizumab, Capecitabine and Cisplatin | 40.7 |
Placebo, Capecitabine and Cisplatin | 33.7 |
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Overall Survival
Overall survival was defined as the time between randomization and the date of death due to any cause. Overall survival was estimated using Kaplan Meier method. Reported data included censored observations. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. As planned, ad hoc analysis was done for overall survival up to clinical clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months). (NCT00887822)
Timeframe: From randomization until death (up to 34 months)
Intervention | months (Median) |
---|
Bevacizumab, Capecitabine and Cisplatin | 10.5 |
Placebo, Capecitabine and Cisplatin | 11.4 |
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Duration of Response During First-Line Therapy
Duration of response during first-line therapy was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first-line therapy. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30 % decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of longest diameters. Duration of response was estimated using Kaplan Meier method. Reported data included censored observations. Participants who did not progress or die after they had had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy. (NCT00887822)
Timeframe: From randomization until disease progression or death (up to 26 months)
Intervention | months (Median) |
---|
Bevacizumab, Capecitabine and Cisplatin | 7.2 |
Placebo, Capecitabine and Cisplatin | 5.8 |
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Dose Limiting Toxicity (DLT) [Phase I]
DLT occurring within 3 weeks of the start of chemoradiation therapy was defined as: Grade 3 non-hematologic or hematologic toxicity requiring interruption of >7 days (d) of chemo or >3d chemoradiation; Grade 4 non-hematologic; Grade 4 neutropenia or thrombocytopenia; Treatment-related death; Delays in surgery >3 weeks due to treatment-related toxicity. A 30% increase in any surgical complication rate beyond those previously established rates (readmission rate: 16%; pancreatic fistula/intra-abdominal abscess/infection rate: 27%, major intra-abdominal bleeding requiring return to OR: 1.6%, delayed gastric emptying: 4.4%, and superficial wound infection rate: 8%) was also considered a DLT. (NCT00889187)
Timeframe: within 3 weeks of the start of chemoradiation therapy
Intervention | patients with DLT (Number) |
---|
Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine | 0 |
Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine | 0 |
Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine | 0 |
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Neoadjuvant Short-Course Photon Radiation Therapy Maximum Tolerated Dose (MTD) [Phase I]
Neoadjuvant short-course photon radiation therapy MTD in combination with capecitabine 825 mg/m2 orally BID for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If none of 3 initial patients or only 1 of 6 patients have a DLT on dose level 3 then 6 additional patients are treated at this dose. If during this expansion, the rate of DLT exceeds 30% then the next lower dose level is declared the MTD. If no DLTs are observed, the MTD is not reached. (NCT00889187)
Timeframe: within 3 weeks of the start of chemoradiation therapy
Intervention | Gy per fraction (Number) |
---|
All Phase I: Photon Rad+Capecitabine | NA |
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Response Rate (Complete Response or Partial Response)
A confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations ≥4 weeks apart. Confirmed tumor response will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rates between the 2 arms will be compared using a Chi-Square or Fisher's Exact test. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. (NCT00891878)
Timeframe: Up to 3 years
Intervention | percentage of patients (Number) |
---|
Arm A (Capecitabine) | 0 |
Arm B (Capecitabine+Sunitinib Malate) | 33 |
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Time to Treatment Failure
Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. (NCT00891878)
Timeframe: Up to 3 years
Intervention | months (Median) |
---|
Arm A (Capecitabine) | 1.63 |
Arm B (Capecitabine+Sunitinib Malate) | 2.53 |
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Comparison of Progression-free Survival
The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves. All patients meeting the eligibility criteria, who started treatment will be considered evaluable for the primary endpoint. If a patient is still alive 3 years after registration, no further follow-up is required. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00891878)
Timeframe: Up to 3 years
Intervention | Months (Median) |
---|
Arm A (Capecitabine) | 6.1 |
Arm B (Capecitabine+Sunitinib Malate) | 2.4 |
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Duration of Response
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. (NCT00891878)
Timeframe: Up to 3 years
Intervention | months (Median) |
---|
Arm B (Capecitabine+Sunitinib Malate) | 4.75 |
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Overall Survival
Overall survival is defined as the time from randomization to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier. (NCT00891878)
Timeframe: Up to 3 years
Intervention | Months (Median) |
---|
Arm A (Capecitabine) | 6.2 |
Arm B (Capecitabine+Sunitinib Malate) | 5.9 |
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Time to Disease Progression
Time to disease progression is defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier. (NCT00891878)
Timeframe: Up to 3 years
Intervention | months (Median) |
---|
Arm A (Capecitabine) | 7.56 |
Arm B (Capecitabine+Sunitinib Malate) | 2.46 |
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Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins.
The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy. (NCT00916578)
Timeframe: Participants were monitored from 2009 to 2012.
Intervention | participants (Number) |
---|
Single Arm Institution, Open Label, Phase II | 26 |
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Part 1: MTD of Erlotinib
MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. (NCT00925769)
Timeframe: Up to Week 6 (Cycle 1-3)
Intervention | mg/day (Number) |
---|
Triple Combination (Bevacizumab/Erlotinib/Capecitabine) | NA |
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Part 1: Maximum Tolerated Dose (MTD) of Capecitabine
MTD for each of the medications was defined as the lowest dose studied which resulted in dose limiting toxicity (DLT) in at least 33 percent (%) of participants of the same quality category. DLT was defined as any greater than or equal to (>=) Grade (G) 3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to adverse events (AEs). (NCT00925769)
Timeframe: Up to Week 6 (Cycle 1-3)
Intervention | mg/m^2 BID (Number) |
---|
Triple Combination (Bevacizumab/Erlotinib/Capecitabine) | 900 |
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Part 1: MTD of Bevacizumab
MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. (NCT00925769)
Timeframe: Up to Week 6 (Cycle 1-3)
Intervention | mg/kg once every 2 weeks (Q2W) (Number) |
---|
Triple Combination (Bevacizumab/Erlotinib/Capecitabine) | NA |
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Part 1: PRD of Bevacizumab for Part 2
Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2. (NCT00925769)
Timeframe: Up to Week 6 (Cycle 1-3)
Intervention | mg/kg Q2W (Number) |
---|
Triple Combination (Bevacizumab/Erlotinib/Capecitabine) | 10 |
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Part 1: PRD of Erlotinib for Part 2
Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2. (NCT00925769)
Timeframe: Up to Week 6 (Cycle 1-3)
Intervention | mg/day (Number) |
---|
Triple Combination (Bevacizumab/Erlotinib/Capecitabine) | 150 |
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Part 1: Preliminary Recommended Dose (PRD) of Capecitabine for Part 2
Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in dose limiting toxicity (DLT) in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2. (NCT00925769)
Timeframe: Up to Week 6 (Cycle 1-3)
Intervention | mg/m^2 BID (Number) |
---|
Triple Combination (Bevacizumab/Erlotinib/Capecitabine) | 800 |
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Percentage Of Participants With PD or Death Due to PD (Maintenance Phase Data Cutoff October 4, 2013)
PD was defined per RECIST 1.0 as 20% increase in the sum of the longest diameter of target lesions. (NCT00929240)
Timeframe: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013
Intervention | percentage of participants (Number) |
---|
Maintenance Phase: Bevacizumab | 88.3 |
Maintenance Phase: Bevacizumab + Capecitabine | 74.7 |
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Time To Progression (Maintenance Phase Data Cutoff October 4, 2013)
Time to Progression was defined as the time from randomization to the first documented disease progression (using investigator assessments of disease progression by RECIST 1.0). PD was defined as 20% increase in the sum of the longest diameter of target lesions. (NCT00929240)
Timeframe: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013
Intervention | months (Median) |
---|
Maintenance Phase: Bevacizumab | 4.3 |
Maintenance Phase: Bevacizumab + Capecitabine | 11.9 |
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Quality of Life Assessed As Change From Baseline in Global Health Status Using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - 30 (EORTC QLQ - C30) (Maintenance Phase Data Cutoff October 4, 2013)
The EORTC QLQ-C30 incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ''baseline'' refers to the time of randomization to the maintenance phase. (NCT00929240)
Timeframe: Baseline, Randomization and Cycles 3, 6, 9 and 12
Intervention | units on a scale (Mean) |
---|
| Randomization (n= 83, 86) | Cycle 3 (n= 44, 52) | Cycle 6 (n= 26, 54) | Cycle 9 (n= 18, 37) | Cycle 12 (n= 12, 31) |
---|
Maintenance Phase: Bevacizumab | -3.51 | 0.76 | 4.17 | 8.80 | 0.69 |
,Maintenance Phase: Bevacizumab + Capecitabine | -4.46 | -3.21 | -5.40 | -1.80 | 0.00 |
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Percentage of Participants Expected to Be Alive After 1 and 2 Years on Treatment (Maintenance Phase Data Cutoff October 4, 2013)
Probability of being alive after 1 and 2 years on treatment with 95% CIs was calculated using Kaplan Meier approach with LOGLOG transformation. (NCT00929240)
Timeframe: Years 1 and 2
Intervention | percentage of participants (Number) |
---|
| 1 Year | 2 Years |
---|
Maintenance Phase: Bevacizumab | 71.6 | 49.4 |
,Maintenance Phase: Bevacizumab + Capecitabine | 90.4 | 69.0 |
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Overall Survival (Maintenance Phase Data Cutoff October 4, 2013)
Duration of Overall Survival (OS) was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. Kaplan Meier estimation was used to determine OS. (NCT00929240)
Timeframe: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Intervention | months (Median) |
---|
Maintenance Phase: Bevacizumab | 23.7 |
Maintenance Phase: Bevacizumab + Capecitabine | 39.0 |
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Percentage of Participants Who Died (Maintenance Phase Data Cutoff October 4, 2013)
(NCT00929240)
Timeframe: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Intervention | percentage of participants (Number) |
---|
Maintenance Phase: Bevacizumab | 56.4 |
Maintenance Phase: Bevacizumab + Capecitabine | 36.3 |
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Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Maintenance Phase Data Cutoff October 4, 2013)
Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. Progressive disease (PD) was defined as 20% increase in the sum of the longest diameter of target lesions and SD was defined as small changes that do not meet above criteria. Pearson-Clopper one-sample method was used for Confidence intervals (CIs). (NCT00929240)
Timeframe: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Intervention | percentage of participants (Number) |
---|
Maintenance Phase: Bevacizumab | 76.6 |
Maintenance Phase: Bevacizumab + Capecitabine | 85.7 |
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Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Data Cutoff October 4, 2013)
CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥ 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria. (NCT00929240)
Timeframe: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Intervention | percentage of participants (Number) |
---|
Maintenance Phase: Bevacizumab | 97.9 |
Maintenance Phase: Bevacizumab + Capecitabine | 98.9 |
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Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Initial Treatment Phase)
CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥30% decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria. (NCT00929240)
Timeframe: Screening and at the end of every third cycle until randomization for an average of 18 weeks
Intervention | percentage of participants (Number) |
---|
Initial Treatment Phase: Bevacizumab + Docetaxel | 56.9 |
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Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013)
Progression Free Survival (PFS) was defined as the time from first study drug dosing (during the maintenance treatment phase) to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST). Progressive Disease (PD) was defined as a 20 percent (%) or greater increase in the sum of the Longest Diameter (LD) of the target lesions taking as reference the smallest sum LD recorded or appearance of new lesions. (NCT00929240)
Timeframe: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Intervention | percentage of participants (Number) |
---|
Maintenance Phase: Bevacizumab | 88.3 |
Maintenance Phase: Bevacizumab + Capecitabine | 75.8 |
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Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013)
PFS was defined as the time from first study drug dosing to the first documented disease progression or death, whichever occurred first.Time to progression was defined as the time from randomization to the first documented disease progression defined per RECIST 1.0 criteria. Participants without an event at data cut-off or who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression free. Participants who took other non-protocol anti-cancer drugs while being on study medication, and who were still event free were censored on the date of first dose of the anti-cancer drug. Participants without post-randomization tumor assessments but alive were censored at the time of randomization. Participants without post-randomization assessments, who died after randomization were considered to have the PFS event at date of death. Kaplan-Meier estimation was used for median time to PFS (NCT00929240)
Timeframe: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Intervention | months (Median) |
---|
Maintenance Phase: Bevacizumab | 4.3 |
Maintenance Phase: Bevacizumab + Capecitabine | 11.9 |
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Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Initial Treatment Phase)
Objective Response was determined by the investigator using RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥ 30% decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. Pearson-Clopper one-sample method was used for CI. (NCT00929240)
Timeframe: Screening and at the end of every third cycle until randomization for an average of 18 weeks
Intervention | percentage of participants (Number) |
---|
Initial Treatment Phase: Bevacizumab + Docetaxel | 8.8 |
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Overall Survival
Overall survival was defined as the time from randomization to the time of death from any cause. Overall survival was censored at the date of last follow-up visit for patients who are still alive or loss of follow-up. (NCT00938470)
Timeframe: Up to 2 years
Intervention | months (Median) |
---|
Arm I (DOC, 5FU/O/RT, Surgery) | NA |
Arm II (5FU/O/RT, Surgery) | 18.8 |
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Percentage of Participants With Overall Clinical Tumor Response (CR or PR)
Overall clinical tumor response rate was defined as the percentage of evaluable participants who achieved either complete response (CR) or partial response (PR) noted on the objective status from pre-surgical staging (for arm II) or either from pre-RT or pre-surgical staging (for arm I).> CR was defined as disappearance of all non-target lesion (TL) and normalization of tumor biomarker level, all lymph nodes (LN) must be non-pathological in size (<1 cm short axis); or disappearance of all TL and normalization of tumor biomarkers, any pathological LN (whether target or non-target) must have reduction in short axis to <1 cm; or >=30% decrease in the sum of the diameters of TL taking as reference the baseline sum of the diameters. (NCT00938470)
Timeframe: Up to 2 years
Intervention | percentage of participants (Number) |
---|
Arm I (DOC, 5FU/O/RT, Surgery) | 32.1 |
Arm II (5FU/O/RT, Surgery) | 33.3 |
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Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event
Adverse events were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. (NCT00938470)
Timeframe: Up to 2 years
Intervention | Participants (Count of Participants) |
---|
| Grade 3=Severe | Grade 4=Life threatening | Grade 5=Death |
---|
Arm I (DOC, 5FU/O/RT, Surgery) | 10 | 10 | 4 |
,Arm II (5FU/O/RT, Surgery) | 12 | 7 | 4 |
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Percentage of Participants With Pathologic Complete Response (PCR)
Pathologic complete response was defined as no gross or microscopic tumor identified with the surgical specimen. All lymph nodes should be free of tumor to document a PCR. If no gross tumor is visible, section around the area of inflammation (nodularity) should be made every 2-3 cm and specimens examined. (NCT00938470)
Timeframe: Up to 2 years
Intervention | percentage of participants (Number) |
---|
Arm I (DOC, 5FU/O/RT, Surgery) | 28.6 |
Arm II (5FU/O/RT, Surgery) | 40.7 |
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Disease-free Survival
Disease-free survival was defined as the time from randomization to the date of recurrent or death, whichever comes first. (NCT00938470)
Timeframe: Up to 2 years
Intervention | months (Median) |
---|
Arm I (DOC, 5FU/O/RT, Surgery) | 31.2 |
Arm II (5FU/O/RT, Surgery) | 17.0 |
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Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) - Part 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. (NCT00959946)
Timeframe: Part 1 Baseline up to 28 days after last dose of study treatment
Intervention | Percentage of Participants (Number) |
---|
| AEs | SAEs |
---|
Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1) | 100.0 | 50.0 |
,Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1) | 100.0 | 0.0 |
,Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1) | 100.0 | 50.0 |
,Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1) | 100.0 | 33.3 |
,Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1) | 100.0 | 40.0 |
,Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1) | 100.0 | 0.0 |
,Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1) | 100.0 | 50.0 |
,Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1) | 100.0 | 0.0 |
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Best Overall Response - Part 1
Best overall response based on investigator's disease status assessment. CR: disappearance of all lesions. PR: at least 30% decrease in sum of LDs of target lesions taking as reference baseline sum LDs. Progressive disease (PD): at least 20% increase in sum of LD of target lesions taking as a reference smallest sum of the recorded LDs since treatment start, or the appearance of 1 or more new lesions. Stable disease (SD): neither sufficient shrinkage for PR nor sufficient increase for PD taking as reference smallest sum of LD since treatment started. (NCT00959946)
Timeframe: Part 1 Baseline, every 6 weeks up to 6 months
Intervention | Participants (Number) |
---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease | Indeterminate |
---|
Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1) | 0 | 0 | 2 | 2 | 0 |
,Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1) | 0 | 0 | 0 | 1 | 0 |
,Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1) | 0 | 0 | 1 | 3 | 0 |
,Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1) | 0 | 0 | 6 | 2 | 1 |
,Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1) | 0 | 0 | 0 | 5 | 0 |
,Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1) | 0 | 2 | 1 | 1 | 0 |
,Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1) | 0 | 0 | 1 | 0 | 0 |
,Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1) | 0 | 0 | 1 | 1 | 0 |
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Maximum Tolerated Dose (MTD) - Part 1
The MTD contour is defined as the dose combinations that achieve a toxicity rate (dose-limiting toxicity [DLT] rate) of less than (<) 1/3. The observed toxicity rates for all the reporting groups (to which at least 1 cohort of participants was allocated) was estimated by calculating the proportion of DLTs observed in the first 21 days of treatment at those reporting groups. DLT includes grade (Gr) 3/4 nausea, vomiting, diarrhea, or asthenia more than 3 days, Gr 4 hematologic toxicities, delayed study treatment administration due to dose toxicities by more than 3 weeks. Pre-defined criterion for MTD: if a higher dose level of capecitabine existed such that the same dose level of bosutinib had a DLT rate of <1/3, no MTD was recommended for that capecitabine dose and if even the lowest dose of bosutinib achieved a toxicity rate of greater than (>) 1/3, no MTD was recommended for that capecitabine dose level. (NCT00959946)
Timeframe: Part 1 Baseline up to Day 21
Intervention | mg (Number) |
---|
Bosutinib + Capecitabine 625 mg/m^2 | NA |
Bosutinib + Capecitabine 750 mg/m^2 | NA |
Bosutinib + Capecitabine 1000 mg/m^2 | 300 |
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Progression-free Survival
Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death. (NCT00961571)
Timeframe: 36 months
Intervention | months (Median) |
---|
Sunitinib and Cepecitabine | 18.35 |
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Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to MRI
Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. (NCT00977379)
Timeframe: "Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)"
Intervention | percentage of participants (Number) |
---|
WBRT Followed by Standard of Care | 41.7 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 27.3 |
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Time to CNS Progression, Assessed by Investigator According to MRI
Time to CNS progression was defined as the time from start of study treatment to first documentation of PD or death due to CNS metastasis. PD was assessed by contrast-enhanced MRI according to RECIST. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions. (NCT00977379)
Timeframe: "Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"
Intervention | months (Median) |
---|
WBRT Followed by Standard of Care | 3.8 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 3.4 |
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Percentage of Participants With Objective Extra-cranial Disease Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to CT
Objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST. CR: disappearance of all extra-cranial lesions. PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD. (NCT00977379)
Timeframe: "Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)"
Intervention | percentage of participants (Number) |
---|
WBRT Followed by Standard of Care | 0.0 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 9.1 |
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Time to Extra-cranial Disease Progression, Assessed by Investigator According to CT
Time to extra-cranial progression was defined as the time from start of study treatment to first documentation of PD or death due to extra-cranial lesions. PD was assessed by CT according to RECIST. PD: a 20% or greater increase in the sum of the LD of extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more extra-cranial lesions and/or unequivocal progression of existing extra-cranial lesions. (NCT00977379)
Timeframe: "Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"
Intervention | months (Median) |
---|
WBRT Followed by Standard of Care | 3.5 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 2.7 |
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Time to Progression, Assessed by Investigator According to MRI and CT
Time to progression was defined as the time from start of study treatment to first documentation of PD or death due to tumor (CNS or extra-cranial). PD was assessed by MRI or CT according to RECIST. PD: a 20% or greater increase in the sum of the LD of CNS or extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS or extra-cranial lesions and/or unequivocal progression of existing CNS or extra-cranial lesions. (NCT00977379)
Timeframe: "Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"
Intervention | months (Median) |
---|
WBRT Followed by Standard of Care | 3.3 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 2.7 |
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Absolute Change From Baseline in Mini Mental State (MMS) Total Score
MMS was an 11-question measure that tested five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Four items were scored on a scale of 0 to 1; 1 item was scored on a scale of 0 to 2; 3 items were scored on a scale of 0 to 3; and 3 items were scored on a scale of 0 to 5. MMS total score was obtained by adding the scores of all individual items and ranged from 0 to 30, where higher scores indicate better cognitive state. (NCT00977379)
Timeframe: Baseline, Up to end of Treatment (up to 10.6 months overall)
Intervention | units on a scale (Mean) |
---|
WBRT Followed by Standard of Care | -1.5 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 0.9 |
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Duration of CNS Response, Assessed by Investigator According to MRI
Duration of CNS response was defined as the time from first documented cranial CR or PR (whichever was recorded first) until the first date CNS recurrence or progression was documented as assessed by contrast-enhanced MRI according to RECIST criteria but without exam for response confirmation. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions. (NCT00977379)
Timeframe: "Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"
Intervention | months (Median) |
---|
WBRT Followed by Standard of Care | 6.2 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 2.6 |
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Overall Survival (OS)
OS was defined as the time from the start of study treatment to date of death due to any cause. OS was assessed using Kaplan-Meier analysis. (NCT00977379)
Timeframe: Baseline until death (up to approximately 1 year 5.5 months overall)
Intervention | months (Median) |
---|
WBRT Followed by Standard of Care | 9.8 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 4.6 |
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Percentage of Participants With Best Objective Central Nervous System (CNS) Response, Assessed by Centralized Independent Expert According to Magnetic Resonance Imaging (MRI) - Intent-to-Treat (ITT) Population
Best objective CNS response was defined as having complete response (CR) or partial response (PR) for CNS metastasis, assessed by contrast-enhanced MRI using response evaluation criteria in solid tumors (RECIST). CR: disappearance of all CNS lesions. PR: greater than or equal to (>/=) 30 percent (%) decrease in sum of longest diameters (LD) of CNS lesions taking as reference the baseline sum LD. (NCT00977379)
Timeframe: "Baseline until disease progression (PD), unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"
Intervention | percentage of participants (Number) |
---|
WBRT Followed by Standard of Care | 25.0 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 36.4 |
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Percentage of Participants With Best Objective CNS Response, Assessed by Centralized Independent Expert According to MRI - Per-Protocol (PP) Population
Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. (NCT00977379)
Timeframe: "Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"
Intervention | percentage of participants (Number) |
---|
WBRT Followed by Standard of Care | 20.0 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 33.3 |
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Percentage of Participants With Best Objective CNS Response, Assessed by Investigator According to MRI
Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. (NCT00977379)
Timeframe: "Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"
Intervention | percentage of participants (Number) |
---|
WBRT Followed by Standard of Care | 50.0 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 54.5 |
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Percentage of Participants With Best Objective Extra-cranial Disease Response, Assessed by Investigator According to Computed Tomography (CT)
Best objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST. CR: disappearance of all extra-cranial lesions. PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD. (NCT00977379)
Timeframe: "Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"
Intervention | percentage of participants (Number) |
---|
WBRT Followed by Standard of Care | 0.0 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 9.1 |
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Percentage of Participants With Clinical Benefit, Assessed by Investigator According to MRI
Clinical benefit was defined as having CR, PR, or stable disease (SD), assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum LD since treatment started. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions. (NCT00977379)
Timeframe: "Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"
Intervention | percentage of participants (Number) |
---|
WBRT Followed by Standard of Care | 83.3 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 72.7 |
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Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI
Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. (NCT00977379)
Timeframe: "Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)"
Intervention | percentage of participants (Number) |
---|
WBRT Followed by Standard of Care | 25.0 |
WBRT+Capecitabine Followed by Capecitabine Maintenance | 36.4 |
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Assess Overall Survival (OS)
(NCT01007552)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Intervention | months (Mean) |
---|
Gemcitabine, Capecitabine and Bevacizumab | 10.2 |
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Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43
Mean number of CTCs in 7.5 ml of whole blood (NCT01007552)
Timeframe: baseline, day 22 and day 43
Intervention | cells (Mean) |
---|
| Baseline | Day 22 | Day 43 |
---|
Gemcitabine, Capecitabine and Bevacizumab | 2.3 | 1.0 | 0.8 |
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Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers.
"We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores of the reflect better quality of life.~For a Detailed description see:~Nancy Heffernan, David Cella, Kimberly Webster, Linda Odom, Mary Martone, Steven Passik, Marilyn Bookbinder, Yuman Fong, William Jarnagin, and Leslie Blumgart: Measuring Health-Related Quality of Life in Patients With Hepatobiliary Cancers: The Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire. Journal of Clinical Oncology, Vol 20, No 9 (May 1), 2002: pp 2229-2239.~No subscales were analyzed.~." (NCT01007552)
Timeframe: Baseline, Day 22 and Day 43
Intervention | units on a scale (Mean) |
---|
| Baseline | Cycle 2 | Cycle 3 |
---|
Gemcitabine, Capecitabine and Bevacizumab | 136.7 | 135.6 | 139.9 |
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Estimate the Proportion of Patients With Clinical Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01007552)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Intervention | percentage of participants (Number) |
---|
Gemcitabine, Capecitabine and Bevacizumab | 24 |
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Assess the Toxicity of the Regimen.
Number of patients with Serious Adverse Events. Please refer to the adverse event reporting for more detail. (NCT01007552)
Timeframe: up to 5 years
Intervention | participants (Number) |
---|
Gemcitabine, Capecitabine and Bevacizumab | 30 |
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Duration of Response (DOR) in the Randomized Phase
DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD. (NCT01013740)
Timeframe: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 27 study weeks)
Intervention | months (Median) |
---|
Lapatinib Plus Capecitabine | 10.8 |
Lapatinib Plus Vinorelbine | 6.7 |
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Number of Participants With Clinical Benefit (CB) in the Randomized Phase
CB is defined as the the number of participants achieving either a confirmed CR or PR or having stable disease (SD) for at least 24 weeks (i.e., approximately 6 months). CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD=at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion). Participants with unknown or missing responses were treated as non-responders. (NCT01013740)
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)
Intervention | participants (Number) |
---|
Lapatinib Plus Capecitabine | 18 |
Lapatinib Plus Vinorelbine | 29 |
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Number of Participants With Overall Response (OR), as Assessed by the Investigator in the Randomized Phase
OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as reference the baseline sum LD) as assessed by the investigator as the best OR. (NCT01013740)
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)
Intervention | participants (Number) |
---|
Lapatinib Plus Capecitabine | 13 |
Lapatinib Plus Vinorelbine | 15 |
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Overall Survival (OS)
OS is defined as the time from randomization to the date of death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off. (NCT01013740)
Timeframe: From the date of randomization until death (average of 55 study weeks)
Intervention | months (Median) |
---|
Lapatinib Plus Capecitabine | 19.4 |
Lapatinib Plus Vinorelbine | 24.3 |
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Progression Free Survival (PFS) in the Randomized Phase
PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20 % increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion. (NCT01013740)
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)
Intervention | months (Median) |
---|
Lapatinib Plus Capecitabine | 6.2 |
Lapatinib Plus Vinorelbine | 6.2 |
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Time to Response in the Randomized Phase
Time to response is defined as the time from randomization until the first documented evidence of CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the basline sum LD) (whichever status is recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed. (NCT01013740)
Timeframe: From randomization until the time of the first documented confirmed CR or PR (average of 27 study weeks)
Intervention | weeks (Median) |
---|
Lapatinib Plus Capecitabine | 9.3 |
Lapatinib Plus Vinorelbine | 9.4 |
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Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grades: 0 = no AE or within normal limits; 1 = mild AE; 2 = moderate AE; 3 = severe and undesirable AE; 4 = life-threatening or disabling AE; 5 = death related to AE. (NCT01013740)
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 55 study weeks)
Intervention | participants (Number) |
---|
| Helicobacter gastritis, Grade 4 | Neutropenia, Grade 4 | Leukopenia, Grade 4 | Febrile neutropenia, Grade 4 | Mucosal inflammation, Grade 4 | Pulmonary embolism, Grade 4 | Intestinal obstruction, Grade 5 |
---|
Lapatinib Plus Capecitabine | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,Lapatinib Plus Vinorelbine | 0 | 9 | 1 | 1 | 1 | 1 | 1 |
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Time to Progression (TTP) Based Upon Independent Review Facility (IRF) Assessment
Time to Progression (TTP) was defined as time between randomization and the first occurrence of progressive disease (PD), based on IRF assessment. (NCT01026142)
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Intervention | Weeks (Median) |
---|
A: Capecitabine + Trastuzumab | 39.0 |
B: Capecitabine + Trastuzumab + Pertuzumab | 50.6 |
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Progression Free Survival (Independent Assessment)
Progression Free Survival (PFS) was defined as the time from randomization to first documented disease progression (PD), as determined by an Independent Review Facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. IRF review of tumor assessment ceased after the primary PFS analysis. The primary endpoint was analyzed after approximately 337 IRF-assessed PFS events were observed. (NCT01026142)
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Intervention | months (Median) |
---|
A: Capecitabine + Trastuzumab | 9.0 |
B: Capecitabine + Trastuzumab + Pertuzumab | 11.1 |
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Overall Survival (OS) Rate Based on a 2-year Truncated Analysis
The Overall Survival (OS) 2-year truncated analysis is the Kaplan-Meier estimate of the percentage of participants who were surviving at 2 years. OS is defined as the time from the date of randomization to the date of death from any cause, with censoring of all events and follow-up beyond the end of the second year. (NCT01026142)
Timeframe: From randomization until death from any cause (up to 2 years)
Intervention | Percentage of participants (Number) |
---|
A: Capecitabine + Trastuzumab | 55.0 |
B: Capecitabine + Trastuzumab + Pertuzumab | 74.9 |
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Overall Objective Response Rate (ORR)
Overall Objective Response Rate is based upon investigator and IRF assessments. Objective Response Rate (ORR) was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) among those who had measurable disease at baseline. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT01026142)
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Intervention | Percentage of participants (Number) |
---|
| Complete Response (CR) - IRF Assessment | Partial Response (PR) - IRF assessment | Complete Response (CR) - Investigator Assessed | Partial Response (PR) - Investigator Assessed |
---|
A: Capecitabine + Trastuzumab | 0 | 32.9 | 1.2 | 36.0 |
,B: Capecitabine + Trastuzumab + Pertuzumab | 1.8 | 38.7 | 6.7 | 38.0 |
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Clinical Benefit Rate (CBR)
Clinical Benefit Rate is based upon Independent Review Facility (IRF) assessments; defined as the percentage of participants a complete response (CR), partial response (PR), or stable disease for at least 8 cycles or 6 months. (NCT01026142)
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Intervention | Percentage of participants (Number) |
---|
A: Capecitabine + Trastuzumab | 54.0 |
B: Capecitabine + Trastuzumab + Pertuzumab | 63.6 |
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Duration of Objective Response
Duration of Objective Response was defined for the subpopulation of responders as time from first Independent Review Facility (IRF)-assessed complete response (CR) or partial response (PR) to subsequent first documented, IRF-confirmed evidence of disease progression. Only participants with an objective response were included in the analysis of duration of objective response. (NCT01026142)
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Intervention | Weeks (Median) |
---|
A: Capecitabine + Trastuzumab | 30.0 |
B: Capecitabine + Trastuzumab + Pertuzumab | 51.6 |
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Investigator Assessment Progression-Free Survival (PFS)
Investigator Assessment Progression-Free Survival (PFS) was defined as the time from randomization to the first documented progressive disease, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, or death from any cause, whichever occurred first. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT01026142)
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 7.5 years).
Intervention | Months (Median) |
---|
A: Capecitabine + Trastuzumab | 9.0 |
B: Capecitabine + Trastuzumab + Pertuzumab | 11.8 |
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Time to Treatment Failure (TTF) Based Upon Independent Review Facility (IRF) Assessment
Time to Treatment Failure (TTF) was defined as time between randomization and date of disease progression based on independent review, death, or withdrawal of treatment due to adverse events, withdrawn informed consent, refusal of treatment/failure to cooperate, or failure to return, whichever occurred first. (NCT01026142)
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Intervention | Weeks (Median) |
---|
A: Capecitabine + Trastuzumab | 39.0 |
B: Capecitabine + Trastuzumab + Pertuzumab | 50.9 |
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Overall Survival (OS)
Overall Survival (OS) was defined as the time from the date of randomization to the date of death from any cause. The results of the final OS analysis are presented here. Participants who were alive or lost to follow-up at the time of the analysis were censored at the last known alive date. Participants with no postbaseline information were censored at the time of randomization plus 1 day. Prior to the final data analysis cut-off, it was ensured that all participants who were in survival follow-up had been contacted as recently as possible within the last 3 months to confirm current survival status. (NCT01026142)
Timeframe: From randomization until death from any cause (up to 7.5 years).
Intervention | Months (Median) |
---|
A: Capecitabine + Trastuzumab | 28.1 |
B: Capecitabine + Trastuzumab + Pertuzumab | 37.2 |
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Number of Participants Experiencing Adverse Events
The primary objective of the study is to evaluate safety and tolerability of the study treatment regimen. The analyses will be descriptive and no formal hypotheses testing will be performed. Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit. (NCT01032850)
Timeframe: 6 months
Intervention | participants (Number) |
---|
| Thrombocytopenia | Neutropenia | Low phosphate levels | Low magnesium levels | Low calcium levels | Low sodium levels | High bilirubin levels | Elevated aspartate aminotransferase | Hand and foot syndrome | Mucositis | Alopecia (Hair loss) | Skin rash | Deep vein thrombosis | Treatment related deaths |
---|
Arm 1: Sorafenib & Capecitabine | 9 | 1 | 3 | 2 | 2 | 1 | 3 | 2 | 3 | 1 | 1 | 1 | 3 | 0 |
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Disease Control Rate of Response (DCR)
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Disease control rate (DCR) is the sum of the percentages of patients achieving complete and partial responses and stable disease (NCT01032850)
Timeframe: 6 months
Intervention | percentage of participants (Number) |
---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Disease Control Rate of Response (DCR) |
---|
Arm 1: Sorafenib & Capecitabine | 8 | 8 | 61 | 77 |
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Progression Free Survival (PFS)
The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT01032850)
Timeframe: 5 years
Intervention | months (Median) |
---|
Arm 1: Sorafenib & Capecitabine | 4.15 |
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Overall Survival (OS)
The time from treatment initiation to death by any cause (NCT01032850)
Timeframe: 5 years
Intervention | Months (Median) |
---|
Arm 1: Sorafenib & Capecitabine | 12.7 |
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Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)
"The participant assessed their pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change indicated improvement." (NCT01041404)
Timeframe: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | mm (Mean) |
---|
| BL (n=275,284) | Week 4 (n=234,249) | Week 7 (n=181,219) | Week 10 (n=174, 202) | Week 13 (n=152,181) | Week 16 (n=121,165) | Week 19 (n=114,142) | Week 22 (n=79,141) | Week 25 (n=64,124) | Week 28 (n=47,111) | Week 31 (n=45,95) | Week 34 (n=37,86) | Week 37 (n=29,64) | Week 40 (n=24,54) | Week 43 (n=12,43) | Week 46 (n=14,41) | Week 49 (n=10,36) | Week 52 (n=8,30) | Week 55 (n=6,24) | Week 58 (n=6,20) | Week 61 (n=4,17) | Week 64 (n=3,20) | Week 67 (n=4,17) | Week 70 (n=3,13) | Week 73 (n=3,10) | Week 76 (n=3,8) | Week 79 (n=3,9) | Week 82 (n=2,6) | Week 85 (n=2,6) | Week 88 (n=2,6) | Week 91 (n=2,4) | Week 94 (n=2,6) | Week 97 (n=1,5) | Week 100 (n=1,4) | Week 103 (n=1,4) | Week 106 (n=1,4) | Week 109 (n=1,4) | Week 112 (n=1,5) | Week 115 (n=1,4) | Week 118 (n=1,5) | Week 121 (n=1,5) | Week 124 (n=1,4) | Week 127 (n=1,3) | Week 130 (n=0,3) | Week 133 (n=1,3) | Week 136 (n=0,2) | Week 139 (n=0,2) | Week 142 (n=0,2) | Week 145 (n=0,1) | Final visit/withdrawal (n=157,161) |
---|
Fluoropyrimidine/Cisplatin (FP) | 21.1 | 14.6 | 11.1 | 14.5 | 11.3 | 14.0 | 15.4 | 13.3 | 12.7 | 8.6 | 8.7 | 9.4 | 15.5 | 16.4 | 12.6 | 16.1 | 7.2 | 5.8 | 2.3 | 4.7 | 5.3 | 2.0 | 1.5 | 1.3 | 1.0 | 1.7 | 1.0 | 0.0 | 1.0 | 0.5 | 0.5 | 0.5 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | NA | 0.0 | NA | NA | NA | NA | 23.8 |
,Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 17.9 | 13.3 | 13.8 | 12.9 | 12.2 | 12.8 | 12.0 | 15.1 | 11.0 | 12.3 | 12.5 | 10.7 | 10.9 | 8.8 | 7.2 | 7.4 | 6.5 | 6.9 | 3.3 | 3.8 | 7.2 | 6.8 | 8.9 | 1.3 | 16.5 | 12.9 | 5.9 | 4.8 | 6.3 | 5.7 | 7.5 | 5.8 | 0.2 | 0.3 | 6.5 | 7.8 | 7.3 | 4.2 | 5.8 | 3.8 | 3.2 | 4.5 | 6.3 | 5.7 | 5.0 | 6.0 | 8.0 | 7.5 | 15.0 | 21.9 |
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Trastuzumab Minimum Serum Concentration (Cmin)
Median Cmin (measured as milligrams per liter [mg/L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion. (NCT01041404)
Timeframe: Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106
Intervention | mg/L (Median) |
---|
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 23.0 |
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Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight
Change in body weight was categorized as an increase of greater than (>)5 percent (%), no change (plus or minus [±]5%), decrease of >5-10%, or a decrease of >10% from BL to the end of study. Time windows were applied in order to assign visits to weight measurements, and the lowest post-screening value recorded was used for the analysis. The percentage change in weight from screening was summarized over time. (NCT01041404)
Timeframe: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | percentage of participants (Number) |
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| Increase >5% | No change (±5%) | Decrease >5-10% | Decrease >10% |
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Fluoropyrimidine/Cisplatin (FP) | 1.5 | 51.6 | 28.2 | 18.7 |
,Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 1.1 | 50.5 | 27.2 | 21.2 |
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Duration of Response - Percentage of Participants With an Event
Duration of response was defined for responders as the time from the date on which the CR or PR was first recorded to the date on which PD is first noted. Participants were censored on the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up. (NCT01041404)
Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | percentage of participants (Number) |
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Fluoropyrimidine/Cisplatin (FP) | 80.0 |
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 71.9 |
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Overall Survival - Time to Event
The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up. (NCT01041404)
Timeframe: BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | months (Median) |
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Fluoropyrimidine/Cisplatin (FP) | 11.1 |
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 13.8 |
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Body Weight (Kilograms [kg]) at BL
(NCT01041404)
Timeframe: BL
Intervention | kg (Median) |
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Fluoropyrimidine/Cisplatin (FP) | 60 |
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 61 |
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Steady State Trastuzumab Area Under the Concentration (AUC)
Individual steady state predicted exposure, as assessed by median AUC (measured as mg multiplied by [*] day per liter [L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion. Individual steady state AUC was calculated using all available PK samples from all timepoints. (NCT01041404)
Timeframe: Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106
Intervention | mg*day/L (Median) |
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Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 1030 |
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Percentage of Participants With a Change in Analgesic Medication During the Study
Analgesic medications were recorded throughout the study until disease progression. (NCT01041404)
Timeframe: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | percentage of participants (Number) |
---|
| Taking any analgesic medication | Discontinued at least 1 medication | Decreased dose of at least 1 medication | No change in any medication | Increased dose or added at least 1 medication |
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Fluoropyrimidine/Cisplatin (FP) | 29.0 | 5.9 | 0.3 | 5.5 | 17.2 |
,Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 29.3 | 1.7 | 0.3 | 7.1 | 20.1 |
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Time to Progression - Time to Event
The median time, in months, from the date of randomized to the date of a TTP event. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up. (NCT01041404)
Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | months (Median) |
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Fluoropyrimidine/Cisplatin (FP) | 5.6 |
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 7.1 |
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European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms. (NCT01041404)
Timeframe: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | scores on a scale (Mean) |
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| Global Health Status: BL (n=274,287) | Global Health Status: Week 4 (n=235,249) | Global Health Status: Week 7 (n=180,220) | Global Health Status: Week 10 (n=176,202) | Global Health Status: Week 13 (n=152,182) | Global Health Status: Week 16 (n=121,165) | Global Health Status: Week 19 (n=114,143) | Global Health Status: Week 22 (n=78,143) | Global Health Status: Week 25 (n=64,124) | Global Health Status: Week 28 (n=47,111) | Global Health Status: Week 31 (n=45,95) | Global Health Status: Week 34 (n=36,87) | Global Health Status: Week 37 (n=29,64) | Global Health Status: Week 40 (n=23,55) | Global Health Status: Week 43 (n=12,43) | Global Health Status: Week 46 (n=13,42) | Global Health Status: Week 49 (n=9,36) | Global Health Status: Week 52 (n=7,29) | Global Health Status: Week 55 (n=5,24) | Global Health Status: Week 58 (n=5,21) | Global Health Status: Week 61 (n=4,17) | Global Health Status: Week 64 (n=3,20) | Global Health Status: Week 67 (n=4,17) | Global Health Status: Week 70 (n=3,14) | Global Health Status: Week 73 (n=3,12) | Global Health Status: Week 76 (n=3,8) | Global Health Status: Week 79 (n=3,9) | Global Health Status: Week 82 (n=2,5) | Global Health Status: Week 85 (n=2,6) | Global Health Status: Week 88 (n=2,6) | Global Health Status: Week 91 (n=2,4) | Global Health Status: Week 94 (n=2,6) | Global Health Status: Week 97 (n=1,5) | Global Health Status: Week 100 (n=1,4) | Global Health Status: Week 103 (n=1,3) | Global Health Status: Week 106 (n=1,4) | Global Health Status: Week 109 (n=1,4) | Global Health Status: Week 112 (n=1,5) | Global Health Status: Week 115 (n=1,4) | Global Health Status: Week 118 (n=1,5) | Global Health Status: Week 121 (n=1,5) | Global Health Status: Week 124 (n=1,5) | Global Health Status: Week 127 (n=1,3) | Global Health Status: Week 130 (n=0,3) | Global Health Status: Week 133 (n=1,3) | Global Health Status: Week 136 (n=0,2) | Global Health Status: Week 139 (n=0,2) | Global Health Status: Week 142 (n=0,2) | Global Health Status: Week 145 (n=0,1) | Global Health Status: Final Visit (n=158,160) | Physical Functioning: BL (n=276,287) | Physical Functioning: Week 4 (n=235,250) | Physical Functioning: Week 7 (n=181,220) | Physical Functioning: Week 10 (n=174,201) | Physical Functioning: Week 13 (n=151,183) | Physical Functioning: Week 16 (n=121,165) | Physical Functioning: Week 19 (n=114,143) | Physical Functioning: Week 22 (n=79,143) | Physical Functioning: Week 25 (n=64,124) | Physical Functioning: Week 28 (n=47,110) | Physical Functioning: Week 31 (n=45,95) | Physical Functioning: Week 34 (n=37,87) | Physical Functioning: Week 37 (n=29,64) | Physical Functioning: Week 40 (n=24,55) | Physical Functioning: Week 43 (n=12,43) | Physical Functioning: Week 46 (n=14,42) | Physical Functioning: Week 49 (n=10,36) | Physical Functioning: Week 52 (n=8,30) | Physical Functioning: Week 55 (n=6,24) | Physical Functioning: Week 58 (n=6,21) | Physical Functioning: Week 61 (n=4,17) | Physical Functioning: Week 64 (n=3,20) | Physical Functioning: Week 67 (n=4,17) | Physical Functioning: Week 70 (n=3,14) | Physical Functioning: Week 73 (n=3,12) | Physical Functioning: Week 76 (n=3,8) | Physical Functioning: Week 79 (n=3,9) | Physical Functioning: Week 82 (n=2,6) | Physical Functioning: Week 85 (n=2,6) | Physical Functioning: Week 88 (n=2,6) | Physical Functioning: Week 91 (n=2,4) | Physical Functioning: Week 94 (n=2,6) | Physical Functioning: Week 97 (n=1,5) | Physical Functioning: Week 100 (n=1,4) | Physical Functioning: Week 103 (n=1,4) | Physical Functioning: Week 106 (n=1,4) | Physical Functioning: Week 109 (n=1,4) | Physical Functioning: Week 112 (n=1,5) | Physical Functioning: Week 115 (n=1,4) | Physical Functioning: Week 118 (n=1,5) | Physical Functioning: Week 121 (n=1,5) | Physical Functioning: Week 124 (n=1,5) | Physical Functioning: Week 127 (n=1,3) | Physical Functioning: Week 130 (n=0,3) | Physical Functioning: Week 133 (n=1,3) | Physical Functioning: Week 136 (n=0,2) | Physical Functioning: Week 139 (n=0,2) | Physical Functioning: Week 142 (n=0,2) | Physical Functioning: Week 145 (n=0,1) | Physical Functioning: Final Visit (n=158,161) | Role Functioning: BL (n=276,287) | Role Functioning: Week 4 (n=234,250) | Role Functioning: Week 7 (n=181,220) | Role Functioning: Week 10 (n=176,202) | Role Functioning: Week 13 (n=152,182) | Role Functioning: Week 16 (n=121,165) | Role Functioning: Week 19 (n=114,143) | Role Functioning: Week 22 (n=79,142) | Role Functioning: Week 25 (n=64,124) | Role Functioning: Week 28 (n=47,110) | Role Functioning: Week 31 (n=45,95) | Role Functioning: Week 34 (n=37,87) | Role Functioning: Week 37 (n=29,64) | Role Functioning: Week 40 (n=24,55) | Role Functioning: Week 43 (n=12,43) | Role Functioning: Week 46 (n=14,42) | Role Functioning: Week 49 (n=10,36) | Role Functioning: Week 52 (n=8,30) | Role Functioning: Week 55 (n=6,24) | Role Functioning: Week 58 (n=6,21) | Role Functioning: Week 61 (n=4,17) | Role Functioning: Week 64 (n=3,20) | Role Functioning: Week 67 (n=4,17) | Role Functioning: Week 70 (n=3,14) | Role Functioning: Week 73 (n=3,12) | Role Functioning: Week 76 (n=3,8) | Role Functioning: Week 79 (n=3,9) | Role Functioning: Week 82 (n=2,6) | Role Functioning: Week 85 (n=2,6) | Role Functioning: Week 88 (n=2,6) | Role Functioning: Week 91 (n=2,4) | Role Functioning: Week 94 (n=2,6) | Role Functioning: Week 97 (n=1,5) | Role Functioning: Week 100 (n=1,4) | Role Functioning: Week 103 (n=1,4) | Role Functioning: Week 106 (n=1,4) | Role Functioning: Week 109 (n=1,4) | Role Functioning: Week 112 (n=1,5) | Role Functioning: Week 115 (n=1,4) | Role Functioning: Week 118 (n=1,5) | Role Functioning: Week 121 (n=1,5) | Role Functioning: Week 124 (n=1,5) | Role Functioning: Week 127 (n=1,3) | Role Functioning: Week 130 (n=0,3) | Role Functioning: Week 133 (n=1,3) | Role Functioning: Week 136 (n=0,2) | Role Functioning: Week 139 (n=0,2) | Role Functioning: Week 142 (n=0,2) | Role Functioning: Week 145 (n=0,1) | Role Functioning: Final Visit (n=158,161) | Emotional Functioning: BL (n=276,287) | Emotional Functioning: Week 4 (n=235,250) | Emotional Functioning: Week 7 (n=180,220) | Emotional Functioning: Week 10 (n=176,202) | Emotional Functioning: Week 13 (n=152,183) | Emotional Functioning: Week 16 (n=121,165) | Emotional Functioning: Week 19 (n=114,143) | Emotional Functioning: Week 22 (n=79,143) | Emotional Functioning: Week 25 (n=64,124) | Emotional Functioning: Week 28 (n=47,111) | Emotional Functioning: Week 31 (n=45,95) | Emotional Functioning: Week 34 (n=37,87) | Emotional Functioning: Week 37 (n=29,64) | Emotional Functioning: Week 40 (n=24,55) | Emotional Functioning: Week 43 (n=12,43) | Emotional Functioning: Week 46 (n=14,42) | Emotional Functioning: Week 49 (n=10,36) | Emotional Functioning: Week 52 (n=8,29) | Emotional Functioning: Week 55 (n=6,24) | Emotional Functioning: Week 58 (n=6,21) | Emotional Functioning: Week 61 (n=4,17) | Emotional Functioning: Week 64 (n=3,20) | Emotional Functioning: Week 67 (n=4,17) | Emotional Functioning: Week 70 (n=3,14) | Emotional Functioning: Week 73 (n=3,12) | Emotional Functioning: Week 76 (n=3,8) | Emotional Functioning: Week 79 (n=3,9) | Emotional Functioning: Week 82 (n=2,6) | Emotional Functioning: Week 85 (n=2,6) | Emotional Functioning: Week 88 (n=2,6) | Emotional Functioning: Week 91 (n=2,4) | Emotional Functioning: Week 94 (n=2,6) | Emotional Functioning: Week 97 (n=1,5) | Emotional Functioning: Week 100 (n=1,4) | Emotional Functioning: Week 103 (n=1,4) | Emotional Functioning: Week 106 (n=1,4) | Emotional Functioning: Week 109 (n=1,4) | Emotional Functioning: Week 112 (n=1,5) | Emotional Functioning: Week 115 (n=1,4) | Emotional Functioning: Week 118 (n=1,5) | Emotional Functioning: Week 121 (n=1,5) | Emotional Functioning: Week 124 (n=1,5) | Emotional Functioning: Week 127 (n=1,3) | Emotional Functioning: Week 130 (n=0,3) | Emotional Functioning: Week 133 (n=1,3) | Emotional Functioning: Week 136 (n=0,2) | Emotional Functioning: Week 139 (n=0,2) | Emotional Functioning: Week 142 (n=0,2) | Emotional Functioning: Week 145 (n=0,1) | Emotional Functioning: Final Visit (n=158,161) | Cognitive Functioning: BL (n=276,287) | Cognitive Functioning: Week 4 (n=235,250) | Cognitive Functioning: Week 7 (n=180,220) | Cognitive Functioning: Week 10 (n=176,202) | Cognitive Functioning: Week 13 (n=152,183) | Cognitive Functioning: Week 16 (n=121,165) | Cognitive Functioning: Week 19 (n=114,143) | Cognitive Functioning: Week 22 (n=79,143) | Cognitive Functioning: Week 25 (n=64,124) | Cognitive Functioning: Week 28 (n=47,111) | Cognitive Functioning: Week 31 (n=45,95) | Cognitive Functioning: Week 34 (n=37,87) | Cognitive Functioning: Week 37 (n=29,64) | Cognitive Functioning: Week 40 (n=24,55) | Cognitive Functioning: Week 43 (n=12,43) | Cognitive Functioning: Week 46 (n=14,42) | Cognitive Functioning: Week 49 (n=10,36) | Cognitive Functioning: Week 52 (n=8,29) | Cognitive Functioning: Week 55 (n=6,24) | Cognitive Functioning: Week 58 (n=6,21) | Cognitive Functioning: Week 61 (n=4,17) | Cognitive Functioning: Week 64 (n=3,20) | Cognitive Functioning: Week 67 (n=4,17) | Cognitive Functioning: Week 70 (n=3,14) | Cognitive Functioning: Week 73 (n=3,12) | Cognitive Functioning: Week 76 (n=3,8) | Cognitive Functioning: Week 79 (n=3,9) | Cognitive Functioning: Week 82 (n=2,6) | Cognitive Functioning: Week 85 (n=2,6) | Cognitive Functioning: Week 88 (n=2,6) | Cognitive Functioning: Week 91 (n=2,4) | Cognitive Functioning: Week 94 (n=2,6) | Cognitive Functioning: Week 97 (n=1,5) | Cognitive Functioning: Week 100 (n=1,4) | Cognitive Functioning: Week 103 (n=1,4) | Cognitive Functioning: Week 106 (n=1,4) | Cognitive Functioning: Week 109 (n=1,4) | Cognitive Functioning: Week 112 (n=1,5) | Cognitive Functioning: Week 115 (n=1,4) | Cognitive Functioning: Week 118 (n=1,5) | Cognitive Functioning: Week 121 (n=1,5) | Cognitive Functioning: Week 124 (n=1,5) | Cognitive Functioning: Week 127 (n=1,3) | Cognitive Functioning: Week 130 (n=0,3) | Cognitive Functioning: Week 133 (n=1,3) | Cognitive Functioning: Week 136 (n=0,2) | Cognitive Functioning: Week 139 (n=0,2) | Cognitive Functioning: Week 142 (n=0,2) | Cognitive Functioning: Week 145 (n=0,1) | Cognitive Functioning: Final Visit (n=158,161) | Social Functioning: BL (n=276,286) | Social Functioning: Week 4 (n=235,250) | Social Functioning: Week 7 (n=179,220) | Social Functioning: Week 10 (n=176,202) | Social Functioning: Week 13 (n=152,183) | Social Functioning: Week 16 (n=180,165) | Social Functioning: Week 19 (n=114,143) | Social Functioning: Week 22 (n=79,143) | Social Functioning: Week 25 (n=64,124) | Social Functioning: Week 28 (n=47,111) | Social Functioning: Week 31 (n=45,95) | Social Functioning: Week 34 (n=37,87) | Social Functioning: Week 37 (n=29,64) | Social Functioning: Week 40 (n=24,55) | Social Functioning: Week 43 (n=12,43) | Social Functioning: Week 46 (n=14,42) | Social Functioning: Week 49 (n=10,36) | Social Functioning: Week 52 (n=8,29) | Social Functioning: Week 55 (n=6,24) | Social Functioning: Week 58 (n=6,21) | Social Functioning: Week 61 (n=4,17) | Social Functioning: Week 64 (n=3,20) | Social Functioning: Week 67 (n=4,17) | Social Functioning: Week 70 (n=3,14) | Social Functioning: Week 73 (n=3,12) | Social Functioning: Week 76 (n=3,8) | Social Functioning: Week 79 (n=3,9) | Social Functioning: Wek 82 (n=2,6) | Social Functioning: Week 85 (n=2,6) | Social Functioning: Week 88 (n=2,6) | Social Functioning: Week 91 (n=2,4) | Social Functioning: Week 94 (n=2,6) | Social Functioning: Week 97 (n=1,5) | Social Functioning: Week 100 (n=1,4) | Social Functioning: Week 103 (n=1,4) | Social Functioning: Week 106 (n=1,4) | Social Functioning: Week 109 (n=1,4) | Social Functioning: Week 112 (n=1,5) | Social Functioning: Week 115 (n=1,4) | Social Functioning: Week 118 (n=1,5) | Social Functioning: Week 121 (n=1,5) | Social Functioning: Week 124 (n=1,5) | Social Functioning: Week 127 (n=1,3) | Social Functioning: Week 130 (n=0,3) | Social Functioning: Week 133 (n=1,3) | Social Functioning: Week 136 (n=0,2) | Social Functioning: Week 139 (n=0,2) | Social Functioning: Week 142 (n=0,2) | Social Functioning: Week 145 (n=0,1) | Social Functioning: Final Visit (n=158,161) | Fatigue: BL (n=276,287) | Fatigue: Week 4 (n=235,250) | Fatigue: Week 7 (n=181,220) | Fatigue: Week 10 (n=176,201) | Fatigue: Week 13 (n=152,183) | Fatigue: Week 16 (n=121,165) | Fatigue: Week 19 (n=114,143) | Fatigue: Week 22 (n=79,143) | Fatigue: Week 25 (n=64,124) | Fatigue: Week 28 (n=47,110) | Fatigue: Week 31 (n=45,95) | Fatigue: Week 34 (n=37,87) | Fatigue: Week 37 (n=29,64) | Fatigue: Week 40 (n=24,55) | Fatigue: Week 43 (n=12,43) | Fatigue: Week 46 (n=14,42) | Fatigue: Week 49 (n=10,36) | Fatigue: Week 52 (n=8,30) | Fatigue: Week 55 (n=6,24) | Fatigue: Week 58 (n=6,21) | Fatigue: Week 61 (n=4,17) | Fatigue: Week 64 (n=3,20) | Fatigue: Week 67 (n=4,17) | Fatigue: Week 70 (n=3,14) | Fatigue: Week 73 (n=3,12) | Fatigue: Week 76 (n=3,8) | Fatigue: Week 79 (n=3,9) | Fatigue: Week 82 (n=2,6) | Fatigue: Week 85 (n=2,6) | Fatigue: Week 88 (n=2,6) | Fatigue: Week 91 (n=2,4) | Fatigue: Week 94 (n=2,6) | Fatigue: Week 97 (n=1,5) | Fatigue: Week 100 (n=1,4) | Fatigue: Week 103 (n=1,4) | Fatigue: Week 106 (n=1,4) | Fatigue: Week 109 (n=1,4) | Fatigue: Week 112 (n=1,5) | Fatigue: Week 115 (n=1,4) | Fatigue: Week 118 (n=1,5) | Fatigue: Week 121 (n=1,5) | Fatigue: Week 124 (n=1,5) | Fatigue: Week 127 (n=1,3) | Fatigue: Week 130 (n=0,3) | Fatigue: Week 133 (n=1,3) | Fatigue: Week 136 (n=0,2) | Fatigue: Week 139 (n=0,2) | Fatigue: Week 142 (n=0,2) | Fatigue: Week 145 (n=0,1) | Fatigue: Final Visit (n=158,160) | Nausea & Vomiting: BL (n=276,287) | Nausea & Vomiting: Week 4 (n=235,250) | Nausea & Vomiting: Week 7 (n=181,220) | Nausea & Vomiting: Week 10 (n=176,201) | Nausea & Vomiting: Week 13 (n=121,183) | Nausea & Vomiting: Week 16 (n=121,165) | Nausea & Vomiting: Week 19 (n=114,143) | Nausea & Vomiting: Week 22 (n=79,143) | Nausea & Vomiting: Week 25 (n=64,124) | Nausea & Vomiting: Week 28 (n=47,110) | Nausea & Vomiting: Week 31 (n=45,95) | Nausea & Vomiting: Week 34 (n=37,87) | Nausea & Vomiting: Week 37 (n=29,64) | Nausea & Vomiting: Week 40 (n=24,55) | Nausea & Vomiting: Week 43 (n=12,43) | Nausea & Vomiting: Week 46 (n=14,42) | Nausea & Vomiting: Week 49 (n=10,36) | Nausea & Vomiting: Week 52 (n=8,30) | Nausea & Vomiting: Week 55 (n=6,24) | Nausea & Vomiting: Week 58 (n=6,21) | Nausea & Vomiting: Week 61 (n=4,17) | Nausea & Vomiting: Week 64 (n=3,20) | Nausea & Vomiting: Week 67 (n=4,17) | Nausea & Vomiting: Week 70 (n=3,14) | Nausea & Vomiting: Week 73 (n=3,12) | Nausea & Vomiting: Week 76 (n=3,8) | Nausea & Vomiting: Week 79 (n=3,9) | Nausea & Vomiting: Week 82 (n=2,6) | Nausea & Vomiting: Week 85 (n=2,6) | Nausea & Vomiting: Week 88 (n=2,6) | Nausea & Vomiting: Week 91 (n=2,4) | Nausea & Vomiting: Week 94 (n=2,6) | Nausea & Vomiting: Week 97 (n=1,5) | Nausea & Vomiting: Week 100 (n=1,4) | Nausea & Vomiting: Week 103 (n=1,4) | Nausea & Vomiting: Week 106 (n=1,4) | Nausea & Vomiting: Week 109 (n=1,4) | Nausea & Vomiting: Week 112 (n=1,5) | Nausea & Vomiting: Week 115 (n=1,4) | Nausea & Vomiting: Week 118 (n=1,5) | Nausea & Vomiting: Week 121 (n=1,5) | Nausea & Vomiting: Week 124 (n=1,5) | Nausea & Vomiting: Week 127 (n=1,3) | Nausea & Vomiting: Week 130 (n=0,3) | Nausea & Vomiting: Week 133 (n=1,3) | Nausea & Vomiting: Week 136 (n=0,2) | Nausea & Vomiting: Week 139 (n=0,2) | Nausea & Vomiting: Week 142 (n=0,2) | Nausea & Vomiting: Week 145 (n=0,1) | Nausea & Vomiting: Final Visit (n=158,161) | Pain: BL (n=276,287) | Pain: Week 4 (n=235,250) | Pain: Week 7 (n=181,220) | Pain: Week 10 (n=176,202) | Pain: Week 13 (n=152,183) | Pain: Week 16 (n=121,165) | Pain: Week 19 (n=114,143) | Pain: Week 22 (n=79,143) | Pain: Week 25 (n=64,124) | Pain: Week 28 (n=47,111) | Pain: Week 31 (n=45,95) | Pain: Week 34 (n=37,87) | Pain: Week 37 (n=29,64) | Pain: Week 40 (n=24,55) | Pain: Week 43 (n=12,43) | Pain: Week 46 (n=14,42) | Pain: Week 49 (n=10,36) | Pain: Week 52 (n=8,30) | Pain: Week 55 (n=6,24) | Pain: Week 58 (n=6,21) | Pain: Week 61 (n=4,17) | Pain: Week 64 (n=3,20) | Pain: Week 67 (n=4,17) | Pain: Week 70 (n=3,14) | Pain: Week 73 (n=3,12) | Pain: Week 76 (n=3,8) | Pain: Week 79 (n=3,9) | Pain: Week 82 (n=2,6) | Pain: Week 85 (n=2,6) | Pain: Week 88 (n=2,6) | Pain: Week 91 (n=2,4) | Pain: Week 94 (n=2,6) | Pain: Week 97 (n=1,5) | Pain: Week 100 (n=1,4) | Pain: Week 103 (n=1,4) | Pain: Week 106 (n=1,4) | Pain: Week 109 (n=1,4) | Pain: Week 112 (n=1,5) | Pain: Week 115 (n=1,4) | Pain: Week 118 (n=1,5) | Pain: Week 121 (n=1,5) | Pain: Week 124 (n=1,5) | Pain: Week 127 (n=1,3) | Pain: Week 130 (n=0,3) | Pain: Week 133 (n=1,3) | Pain: Week 136 (n=0,2) | Pain: Week 139 (n=0,2) | Pain: Week 142 (n=0,2) | Pain: Week 145 (n=0,1) | Pain: Final Visit (n=158,161) | Dyspnoea: BL (n=274,281) | Dyspnoea: Week 4 (n=232,249) | Dyspnoea: Week 7 (n=181,217) | Dyspnoea: Week 10 (n=176,198) | Dyspnoea: Week 13 (n=151,182) | Dyspnoea: Week 16 (n=121,165) | Dyspnoea: Week 19 (n=113,143) | Dyspnoea: Week 22 (n=79,143) | Dyspnoea: Week 25 (n=63,124) | Dyspnoea: Week 28 (n=47,110) | Dyspnoea: Week 31 (n=45,95) | Dyspnoea: Week 34 (n=36,87) | Dyspnoea: Week 37 (n=29,64) | Dyspnoea: Week 40 (n=24,55) | Dyspnoea: Week 43 (n=12,43) | Dyspnoea: Week 46 (n=14,42) | Dyspnoea: Week 49 (n=10,36) | Dyspnoea: Week 52 (n=8,30) | Dyspnoea: Week 55 (n=6,24) | Dyspnoea: Week 58 (n=6,21) | Dyspnoea: Week 61 (n=4,17) | Dyspnoea: Week 64 (n=3,20) | Dyspnoea: Week 67 (n=4,17) | Dyspnoea: Week 70 (n=3,14) | Dyspnoea: Week 73 (n=3,12) | Dyspnoea: Week 76 (n=3,8) | Dyspnoea: Week 79 (n=3,9) | Dyspnoea: Week 82 (n=2,6) | Dyspnoea: Week 85 (n=180,6) | Dyspnoea: Week 88 (n=2,6) | Dyspnoea: Week 91 (n=2,4) | Dyspnoea: Week 94 (n=2,6) | Dyspnoea: Week 97 (n=1,5) | Dyspnoea: Week 100 (n=1,4) | Dyspnoea: Week 103 (n=1,4) | Dyspnoea: Week 106 (n=1,4) | Dyspnoea: Week 109 (n=1,4) | Dyspnoea: Week 112 (n=1,5) | Dyspnoea: Week 115 (n=1,4) | Dyspnoea: Week 118 (n=1,5) | Dyspnoea: Week 121 (n=1,5) | Dyspnoea: Week 124 (n=1,5) | Dyspnoea: Week 127 (n=1,3) | Dyspnoea: Week 130 (n=0,3) | Dyspnoea: Week 133 (n=1,3) | Dyspnoea: Week 136 (n=0,2) | Dyspnoea: Week 139 (n=0,2) | Dyspnoea: Week 142 (n=0,2) | Dyspnoea: Week 145 (n=0,1) | Dyspnoea: Final Visit (n=157,160) | Insomnia: BL (n=276,285) | Insomnia: Week 4 (n=234,248) | Insomnia: Week 7 (n=181,219) | Insomnia: Week 10 (n=175,200) | Insomnia: Week 13 (n=152,183) | Insomnia: Week 16 (n=120,164) | Insomnia: Week 19 (n=113,143) | Insomnia: Week 22 (n=79,143) | Insomnia: Week 25 (n=64,124) | Insomnia: Week 28 (n=47,110) | Insomnia: Week 31 (n=45,94) | Insomnia: Week 34 (n=37,87) | Insomnia: Week 37 (n=29,63) | Insomnia: Week 40 (n=24,55) | Insomnia: Week 43 (n=12,43) | Insomnia: Week 46 (n=13,42) | Insomnia: Week 49 (n=10,36) | Insomnia: Week 52 (n=8,30) | Insomnia: Week 55 (n=6,24) | Insomnia: Week 58 (n=6,21) | Insomnia: Week 61 (n=4,17) | Insomnia: Week 64 (n=3,20) | Insomnia: Week 67 (n=4,17) | Insomnia: Week 70 (n=3,14) | Insomnia: Week 73 (n=3,12) | Insomnia: Week 76 (n=3,8) | Insomnia: Week 79 (n=3,9) | Insomnia: Week 82 (n=2,6) | Insomnia: Week 85 (n=2,6) | Insomnia: Week 88 (n=2,6) | Insomnia: Week 91 (n=2,4) | Insomnia: Week 94 (n=2,6) | Insomnia: Week 97 (n=1,5) | Insomnia: Week 100 (n=1,4) | Insomnia: Week 103 (n=1,4) | Insomnia: Week 106 (n=1,4) | Insomnia: Week 109 (n=1,4) | Insomnia: Week 112 (n=1,5) | Insomnia: Week 115 (n=1,4) | Insomnia: Week 118 (n=1,5) | Insomnia: Week 121 (n=1,5) | Insomnia: Week 124 (n=1,5) | Insomnia: Week 127 (n=1,3) | Insomnia: Week 130 (n=0,3) | Insomnia: Week 133 (n=1,3) | Insomnia: Week 136 (n=0,2) | Insomnia: Week 139 (n=0,2) | Insomnia: Week 142 (n=0,2) | Insomnia: Week 145 (n=0,1) | Insomnia: Final Visit (n=157,160) | Appetite Loss: BL (n=275,286) | Appetite Loss: Week 4 (n=235,250) | Appetite Loss: Week 7 (n=180,216) | Appetite Loss: Week 10 (n=176,201) | Appetite Loss: Week 13 (n=151,183) | Appetite Loss: Week 16 (n=121,165) | Appetite Loss: Week 19 (n=114,141) | Appetite Loss: Week 22 (n=79,143) | Appetite Loss: Week 25 (n=64,124) | Appetite Loss: Week 28 (n=47,109) | Appetite Loss: Week 31 (n=45,95) | Appetite Loss: Week 34 (n=37,87) | Appetite Loss: Week 37 (n=29,64) | Appetite Loss: Week 40 (n=24,55) | Appetite Loss: Week 43 (n=12,43) | Appetite Loss: Week 46 (n=14,42) | Appetite Loss: Week 49 (n=9,36) | Appetite Loss: Week 52 (n=8,30) | Appetite Loss: Week 55 (n=6,24) | Appetite Loss: Week 58 (n=6,21) | Appetite Loss: Week 61 (n=4,17) | Appetite Loss: Week 64 (n=3,20) | Appetite Loss: Week 67 (n=4,17) | Appetite Loss: Week 70 (n=3,14) | Appetite Loss: Week 73 (n=3,12) | Appetite Loss: Week 76 (n=3,8) | Appetite Loss: Week 79 (n=3,9) | Appetite Loss: Week 82 (n=2,6) | Appetite Loss: Week 85 (n=2,6) | Appetite Loss: Week 88 (n=2,6) | Appetite Loss: Week 91 (n=2,4) | Appetite Loss: Week 94 (n=2,6) | Appetite Loss: Week 97 (n=1,5) | Appetite Loss: Week 100 (n=1,4) | Appetite Loss: Week 103 (n=1,4) | Appetite Loss: Week 106 (n=1,4) | Appetite Loss: Week 109 (n=1,4) | Appetite Loss: Week 112 (n=1,5) | Appetite Loss: Week 115 (n=1,4) | Appetite Loss: Week 118 (n=1,5) | Appetite Loss: Week 121 (n=1,5) | Appetite Loss: Week 124 (n=1,5) | Appetite Loss: Week 127 (n=1,3) | Appetite Loss: Week 130 (n=0,3) | Appetite Loss: Week 133 (n=1,3) | Appetite Loss: Week 136 (n=0,2) | Appetite Loss: Week 139 (n=0,2) | Appetite Loss: Week 142 (n=0,2) | Appetite Loss: Week 145 (n=0,1) | Appetite Loss: Week Final Visit (n=156,161) | Constipation: BL (n=276,285) | Constipation: Week 4 (n=235,247) | Constipation: Week 7 (n=179,220) | Constipation: Week 10 (n=175,203) | Constipation: Week 13 (n=152,183) | Constipation: Week 16 (n=121,165) | Constipation: Week 19 (n=114,143) | Constipation: Week 22 (n=78,143) | Constipation: Week 25 (n=64,124) | Constipation: Week 28 (n=47,111) | Constipation: Week 31 (n=45,95) | Constipation: Week 34 (n=37,86) | Constipation: Week 37 (n=29,64) | Constipation: Week 40 (n=24,55) | Constipation: Week 43 (n=12,43) | Constipation: Week 46 (n=14,42) | Constipation: Week 49 (n=10,36) | Constipation: Week 52 (n=8,29) | Constipation: Week 55 (n=6,24) | Constipation: Week 58 (n=6,21) | Constipation: Week 61 (n=4,17) | Constipation: Week 64 (n=3,20) | Constipation: Week 67 (n=4,17) | Constipation: Week 70 (n=3,14) | Constipation: Week 73 (n=3,12) | Constipation: Week 76 (n=3,8) | Constipation: Week 79 (n=3,9) | Constipation: Week 82 (n=2,6) | Constipation: Week 85 (n=2,6) | Constipation: Week 88 (n=2,6) | Constipation: Week 91 (n=2,4) | Constipation: Week 94 (n=2,6) | Constipation: Week 97 (n=1,5) | Constipation: Week 100 (n=1,4) | Constipation: Week 103 (n=1,4) | Constipation: Week 106 (n=1,4) | Constipation: Week 109 (n=1,4) | Constipation: Week 112 (n=1,5) | Constipation: Week 115 (n=1,4) | Constipation: Week 118 (n=1,5) | Constipation: Week 121 (n=1,5) | Constipation: Week 124 (n=1,5) | Constipation: Week 127 (n=1,3) | Constipation: Week 130 (n=0,3) | Constipation: Week 133 (n=1,3) | Constipation: Week 136 (n=0,2) | Constipation: Week 139 (n=0,2) | Constipation: Week 142 (n=0,2) | Constipation: Week 145 (n=0,1) | Constipation: Final Visit (n=158,160) | Diarrhoea: BL (n=276,283) | Diarrhoea: Week 4 (n=234,246) | Diarrhoea: Week 7 (n=180,220) | Diarrhoea: Week 10 (n=174,202) | Diarrhoea: Week 13 (n=152,183) | Diarrhoea: Week 16 (n=120,165) | Diarrhoea: Week 19 (n=114,143) | Diarrhoea: Week 22 (n=78,143) | Diarrhoea: Week 25 (n=64,124) | Diarrhoea: Week 28 (n=47,111) | Diarrhoea: Week 31 (n=45,95) | Diarrhoea: Week 34 (n=37,87) | Diarrhoea: Week 37 (n=29,64) | Diarrhoea: Week 40 (n=24,55) | Diarrhoea: Week 43 (n=12,42) | Diarrhoea: Week 46 (n=14,42) | Diarrhoea: Week 49 (n=10,36) | Diarrhoea: Week 52 (n=8,29) | Diarrhoea: Week 55 (n=6,24) | Diarrhoea: Week 58 (n=6,21) | Diarrhoea: Week 61 (n=4,17) | Diarrhoea: Week 64 (n=3,20) | Diarrhoea: Week 67 (n=4,17) | Diarrhoea: Week 70 (n=3,14) | Diarrhoea: Week 73 (n=3,12) | Diarrhoea: Week 76 (n=3,8) | Diarrhoea: Week 79 (n=3,9) | Diarrhoea: Week 82 (n=2,6) | Diarrhoea: Week 85 (n=2,6) | Diarrhoea: Week 88 (n=2,6) | Diarrhoea: Week 91 (n=2,4) | Diarrhoea: Week 94 (n=2,6) | Diarrhoea: Week 97 (n=1,5) | Diarrhoea: Week 100 (n=1,4) | Diarrhoea: Week 103 (n=1,4) | Diarrhoea: Week 106 (n=1,4) | Diarrhoea: Week 109 (n=1,4) | Diarrhoea: Week 112 (n=1,5) | Diarrhoea: Week 115 (n=1,4) | Diarrhoea: Week 118 (n=1,5) | Diarrhoea: Week 121 (n=1,5) | Diarrhoea: Week 124 (n=1,5) | Diarrhoea: Week 127 (n=1,3) | Diarrhoea: Week 130 (n=0,3) | Diarrhoea: Week 133 (n=1,3) | Diarrhoea: Week 136 (n=0,2) | Diarrhoea: Week 139 (n=0,2) | Diarrhoea: Week 142 (n=0,2) | Diarrhoea: Week 145 (n=0,1) | Diarrhoea: Final Visit (n=157,160) | Financial Difficulties: BL (n=274,286) | Financial Difficulties: Week 4 (n=234,249) | Financial Difficulties: Week 7 (n=178,220) | Financial Difficulties: Week 10 (n=175,202) | Financial Difficulties: Week 13 (n=151,181) | Financial Difficulties: Week 16 (n=120,165) | Financial Difficulties: Week 19 (n=113,143) | Financial Difficulties: Week 22 (n=78,142) | Financial Difficulties: Week 25 (n=63,124) | Financial Difficulties: Week 28 (n=45,111) | Financial Difficulties: Week 31 (n=45,94) | Financial Difficulties: Week 34 (n=36,87) | Financial Difficulties: Week 37 (n=29,64) | Financial Difficulties: Week 40 (n=24,55) | Financial Difficulties: Week 43 (n=12,43) | Financial Difficulties: Week 46 (n=14,42) | Financial Difficulties: Week 49 (n=10,35) | Financial Difficulties: Week 52 (n=8,29) | Financial Difficulties: Week 55 (n=6,24) | Financial Difficulties: Week 58 (n=6,21) | Financial Difficulties: Week 61 (n=4,17) | Financial Difficulties: Week 64 (n=3,20) | Financial Difficulties: Week 67 (n=4,17) | Financial Difficulties: Week 70 (n=3,14) | Financial Difficulties: Week 73 (n=3,12) | Financial Difficulties: Week 76 (n=3,8) | Financial Difficulties: Week 79 (n=3,9) | Financial Difficulties: Week 82 (n=2,6) | Financial Difficulties: Week 85 (n=2,6) | Financial Difficulties: Week 88 (n=2,6) | Financial Difficulties: Week 91 (n=2,4) | Financial Difficulties: Week 94 (n=2,6) | Financial Difficulties: Week 97 (n=1,5) | Financial Difficulties: Week 100 (n=1,4) | Financial Difficulties: Week 103 (n=1,4) | Financial Difficulties: Week 106 (n=1,4) | Financial Difficulties: Week 109 (n=1,4) | Financial Difficulties: Week 112 (n=1,5) | Financial Difficulties: Week 115 (n=1,4) | Financial Difficulties: Week 118 (n=1,5) | Financial Difficulties: Week 121 (n=1,5) | Financial Difficulties: Week 124 (n=1,5) | Financial Difficulties: Week 127 (n=1,3) | Financial Difficulties: Week 130 (n=0,3) | Financial Difficulties: Week 133 (n=1,3) | Financial Difficulties: Week 136 (n=0,2) | Financial Difficulties: Week 139 (n=0,2) | Financial Difficulties: Week 142 (n=0,2) | Financial Difficulties: Week 145 (n=0,1) | Financial Difficulties: Final Visit (n=158,160) |
---|
Fluoropyrimidine/Cisplatin (FP) | 55.3 | 61.0 | 60.9 | 62.3 | 63.8 | 60.8 | 61.0 | 65.1 | 68.0 | 72.0 | 69.6 | 70.8 | 66.1 | 62.0 | 72.9 | 75.0 | 68.5 | 72.6 | 76.7 | 76.7 | 79.2 | 77.8 | 75.0 | 77.8 | 80.6 | 77.8 | 77.8 | 83.3 | 83.3 | 83.3 | 83.3 | 83.3 | 83.3 | 83.3 | 83.3 | 83.3 | 83.3 | 83.3 | 83.3 | 83.3 | 83.3 | 83.3 | 83.3 | NA | 83.3 | NA | NA | NA | NA | 53.2 | 78.9 | 76.0 | 79.3 | 78.2 | 80.2 | 79.8 | 78.8 | 80.7 | 85.8 | 86.2 | 85.6 | 86.3 | 85.7 | 84.4 | 85.6 | 87.6 | 88.7 | 88.3 | 85.6 | 86.7 | 91.7 | 95.6 | 93.3 | 97.8 | 97.8 | 95.6 | 95.6 | 93.3 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 93.3 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | NA | 100.0 | NA | NA | NA | NA | 72.1 | 73.2 | 67.4 | 70.9 | 70.2 | 73.4 | 72.0 | 71.1 | 74.7 | 81.3 | 80.5 | 82.2 | 83.3 | 81.6 | 79.9 | 80.6 | 82.1 | 81.7 | 85.4 | 80.6 | 77.8 | 83.3 | 83.3 | 83.3 | 88.9 | 88.9 | 83.3 | 83.3 | 91.7 | 100.0 | 91.7 | 91.7 | 100.0 | 83.3 | 83.3 | 100.0 | 100.0 | 100.0 | 83.3 | 100.0 | 100.0 | 83.3 | 83.3 | 100.0 | NA | 100.0 | NA | NA | NA | NA | 63.5 | 75.4 | 80.5 | 81.3 | 82.9 | 82.6 | 83.1 | 82.2 | 85.9 | 88.2 | 86.0 | 85.7 | 88.5 | 83.9 | 83.6 | 81.9 | 82.1 | 88.3 | 86.5 | 76.4 | 85.6 | 95.8 | 100 | 95.8 | 97.2 | 94.4 | 100.0 | 97.2 | 95.8 | 95.8 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | NA | 100.0 | NA | NA | NA | NA | 75.1 | 86.9 | 86.0 | 85.7 | 85.6 | 88.2 | 82.8 | 84.2 | 85.9 | 85.9 | 86.5 | 87.0 | 88.3 | 88.5 | 83.3 | 88.9 | 89.3 | 85.0 | 91.7 | 94.4 | 91.7 | 91.7 | 100.0 | 91.7 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | NA | 100.0 | NA | NA | NA | NA | 79.5 | 72.4 | 72.1 | 73.1 | 74.5 | 72.7 | 72.7 | 74.4 | 79.3 | 83.3 | 83.0 | 81.5 | 84.7 | 85.1 | 85.4 | 87.5 | 86.9 | 85.0 | 87.5 | 86.1 | 88.9 | 91.7 | 94.4 | 95.8 | 94.4 | 100.0 | 94.4 | 94.4 | 100.0 | 91.7 | 91.7 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | NA | 100.0 | NA | NA | NA | NA | 68.1 | 36.3 | 37.1 | 34.4 | 35.3 | 32.9 | 33.0 | 33.1 | 30.0 | 22.2 | 24.1 | 22.0 | 22.8 | 21.8 | 23.6 | 19.4 | 20.6 | 19.4 | 16.7 | 18.5 | 16.7 | 8.3 | 7.4 | 13.9 | 11.1 | 7.4 | 7.4 | 7.4 | 0.0 | 5.6 | 0.0 | 0.0 | 0.0 | 11.1 | 0.0 | 0.0 | 11.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | NA | 0.0 | NA | NA | NA | NA | 40.4 | 15.0 | 16.6 | 16.9 | 16.4 | 12.8 | 14.2 | 14.2 | 10.3 | 8.6 | 3.5 | 3.7 | 4.5 | 2.9 | 4.2 | 2.8 | 1.2 | 3.3 | 2.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 5.6 | 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 | NA | 0.0 | NA | NA | NA | NA | 14.9 | 24.9 | 17.8 | 14.5 | 13.4 | 12.0 | 13.6 | 14.2 | 15.0 | 10.7 | 8.2 | 12.2 | 12.2 | 11.5 | 18.8 | 16.7 | 13.1 | 13.3 | 6.3 | 2.8 | 8.3 | 0.0 | 5.6 | 0.0 | 0.0 | 5.6 | 5.6 | 5.6 | 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 | NA | 0.0 | NA | NA | NA | NA | 27.4 | 12.4 | 12.1 | 12.7 | 14.6 | 11.3 | 15.4 | 15.3 | 13.9 | 12.7 | 9.2 | 10.4 | 10.2 | 10.3 | 9.7 | 19.4 | 11.9 | 6.7 | 12.5 | 5.6 | 5.6 | 16.7 | 0.0 | 8.3 | 0.0 | 0.0 | 11.1 | 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 | NA | 0.0 | NA | NA | NA | NA | 20.0 | 27.2 | 22.1 | 21.9 | 19.8 | 14.7 | 15.3 | 17.1 | 14.8 | 15.1 | 9.9 | 10.4 | 9.0 | 8.0 | 13.9 | 13.9 | 7.7 | 10.0 | 12.5 | 16.7 | 11.1 | 8.3 | 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 | 0.0 | 0.0 | NA | 0.0 | NA | NA | NA | NA | 21.9 | 35.2 | 31.5 | 27.2 | 26.7 | 24.7 | 24.5 | 26.9 | 19.0 | 12.0 | 14.2 | 11.1 | 11.7 | 12.6 | 13.9 | 5.6 | 4.8 | 3.7 | 0.0 | 0.0 | 5.6 | 8.3 | 0.0 | 8.3 | 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 | NA | 0.0 | NA | NA | NA | NA | 35.3 | 22.9 | 20.6 | 19.0 | 19.2 | 16.7 | 14.6 | 13.5 | 12.0 | 7.3 | 7.8 | 10.4 | 5.4 | 11.5 | 8.3 | 8.3 | 4.8 | 3.3 | 4.2 | 5.6 | 11.1 | 8.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 16.7 | 16.7 | 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 | NA | 0.0 | NA | NA | NA | NA | 19.0 | 10.9 | 9.1 | 8.7 | 10.5 | 6.6 | 8.1 | 7.3 | 6.0 | 7.3 | 5.7 | 5.9 | 5.4 | 5.7 | 6.9 | 8.3 | 4.8 | 10.0 | 8.3 | 11.1 | 11.1 | 16.7 | 11.1 | 16.7 | 11.1 | 11.1 | 22.2 | 11.1 | 0.0 | 0.0 | 0.0 | 16.7 | 16.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | NA | 0.0 | NA | NA | NA | NA | 10.0 | 27.3 | 23.6 | 23.6 | 21.5 | 22.5 | 23.1 | 20.6 | 19.7 | 16.4 | 17.0 | 15.6 | 10.2 | 13.8 | 22.2 | 16.7 | 16.7 | 16.7 | 8.3 | 16.7 | 11.1 | 16.7 | 11.1 | 16.7 | 11.1 | 11.1 | 11.1 | 11.1 | 16.7 | 16.7 | 16.7 | 16.7 | 16.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | NA | 0.0 | NA | NA | NA | NA | 26.6 |
,Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 54.9 | 60.9 | 60.5 | 61.9 | 63.6 | 61.9 | 63.8 | 64.9 | 67.8 | 68.5 | 70.0 | 72.0 | 70.6 | 70.6 | 73.6 | 73.8 | 76.6 | 71.3 | 73.8 | 73.8 | 72.5 | 70.0 | 72.5 | 68.5 | 68.1 | 67.7 | 69.4 | 60.0 | 79.2 | 73.6 | 79.2 | 79.2 | 78.3 | 85.4 | 75.0 | 77.1 | 77.1 | 75.0 | 72.9 | 75.0 | 75.0 | 81.7 | 72.2 | 72.2 | 72.2 | 66.7 | 66.7 | 66.7 | 66.7 | 53.1 | 79.6 | 79.5 | 79.3 | 80.2 | 80.5 | 80.7 | 81.5 | 83.6 | 84.8 | 83.7 | 85.4 | 85.1 | 85.8 | 88.2 | 89.9 | 91.9 | 92.0 | 89.2 | 93.1 | 91.4 | 91.0 | 91.0 | 93.3 | 92.9 | 91.1 | 90.0 | 92.6 | 90.0 | 95.6 | 95.6 | 98.3 | 97.8 | 97.3 | 96.7 | 96.7 | 98.3 | 95.0 | 97.3 | 93.3 | 96.0 | 94.7 | 96.0 | 93.3 | 93.3 | 95.6 | 93.3 | 93.3 | 93.3 | 100.0 | 73.8 | 73.9 | 76.1 | 73.3 | 74.3 | 75.1 | 74.6 | 75.8 | 79.7 | 82.4 | 79.7 | 81.1 | 82.2 | 81.5 | 82.1 | 86.8 | 86.5 | 88.0 | 84.4 | 88.2 | 89.7 | 87.3 | 87.5 | 90.2 | 86.9 | 80.6 | 81.3 | 81.5 | 80.6 | 91.7 | 94.4 | 91.7 | 100.0 | 90.0 | 100.0 | 100.0 | 100.0 | 95.8 | 93.3 | 83.3 | 86.7 | 90.0 | 90.0 | 88.9 | 88.9 | 88.9 | 83.3 | 83.3 | 83.3 | 100.0 | 68.7 | 73.1 | 77.9 | 80.2 | 81.2 | 80.5 | 81.9 | 82.4 | 84.0 | 84.8 | 85.5 | 85.7 | 85.4 | 86.3 | 86.7 | 87.8 | 87.5 | 91.4 | 88.2 | 88.5 | 88.9 | 90.7 | 86.3 | 89.2 | 89.3 | 82.9 | 87.5 | 84.3 | 83.3 | 91.7 | 90.3 | 95.8 | 88.9 | 91.7 | 87.5 | 87.5 | 89.6 | 91.7 | 95.0 | 93.8 | 90.0 | 95.0 | 90.0 | 100.0 | 88.9 | 91.7 | 95.8 | 95.8 | 95.8 | 100.0 | 74.3 | 85.7 | 86.3 | 86.5 | 86.8 | 85.7 | 86.8 | 87.6 | 87.4 | 87.4 | 88.0 | 90.0 | 88.7 | 91.4 | 91.5 | 91.5 | 91.7 | 92.6 | 89.7 | 91.0 | 90.5 | 91.2 | 93.3 | 91.2 | 91.7 | 83.3 | 83.3 | 81.5 | 88.9 | 91.7 | 94.4 | 95.8 | 94.4 | 90.0 | 95.8 | 91.7 | 95.8 | 95.8 | 93.3 | 95.8 | 96.7 | 96.7 | 96.7 | 100.0 | 88.9 | 94.4 | 100.0 | 100.0 | 100.0 | 100.0 | 80.0 | 72.0 | 74.1 | 75.1 | 76.7 | 76.3 | 77.5 | 79.5 | 80.1 | 80.2 | 80.2 | 78.9 | 80.7 | 81.8 | 82.7 | 84.1 | 86.9 | 84.7 | 82.2 | 85.4 | 87.3 | 90.2 | 85.8 | 85.3 | 86.9 | 80.6 | 81.3 | 85.2 | 80.6 | 88.9 | 88.9 | 91.7 | 91.7 | 90.0 | 95.8 | 100.0 | 91.7 | 95.8 | 96.7 | 95.8 | 96.7 | 100.0 | 96.7 | 83.3 | 94.4 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 71.4 | 34.2 | 34.5 | 34.1 | 33.2 | 33.7 | 32.8 | 29.4 | 26.7 | 25.1 | 23.2 | 22.2 | 19.7 | 19.8 | 18.6 | 17.1 | 13.8 | 14.5 | 17.2 | 14.4 | 16.4 | 14.4 | 17.2 | 15.0 | 16.7 | 16.7 | 18.1 | 18.5 | 29.6 | 11.1 | 9.3 | 11.1 | 7.4 | 11.1 | 11.1 | 19.4 | 13.9 | 16.7 | 17.8 | 25.0 | 17.8 | 17.8 | 13.3 | 14.8 | 18.5 | 14.8 | 22.2 | 22.2 | 22.2 | 11.1 | 37.6 | 15.7 | 19.7 | 18.9 | 16.4 | 14.7 | 14.5 | 13.9 | 12.2 | 8.2 | 6.5 | 8.8 | 7.5 | 6.8 | 4.8 | 1.2 | 2.8 | 0.9 | 5.0 | 2.1 | 3.2 | 0.0 | 4.2 | 2.9 | 2.4 | 1.4 | 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 | 0.0 | 0.0 | 0.0 | 0.0 | 19.8 | 25.1 | 17.9 | 16.1 | 14.4 | 13.3 | 12.4 | 12.8 | 13.2 | 12.2 | 12.0 | 11.8 | 11.3 | 12.2 | 10.3 | 8.9 | 6.7 | 6.5 | 10.0 | 8.3 | 7.1 | 4.9 | 6.7 | 4.9 | 4.8 | 9.7 | 8.3 | 9.3 | 2.8 | 0.0 | 2.8 | 4.2 | 0.0 | 3.3 | 8.3 | 0.0 | 0.0 | 0.0 | 3.3 | 0.0 | 3.3 | 3.3 | 0.0 | 0.0 | 5.6 | 5.6 | 0.0 | 0.0 | 0.0 | 0.0 | 25.4 | 13.4 | 11.8 | 10.8 | 11.3 | 13.7 | 13.5 | 11.9 | 12.1 | 9.4 | 10.3 | 9.1 | 9.6 | 10.4 | 4.8 | 6.2 | 5.6 | 4.6 | 5.6 | 8.3 | 6.3 | 3.9 | 8.3 | 5.9 | 7.1 | 8.3 | 8.3 | 7.4 | 16.7 | 5.6 | 5.6 | 8.3 | 5.6 | 0.0 | 0.0 | 8.3 | 8.3 | 8.3 | 6.7 | 8.3 | 6.7 | 6.7 | 6.7 | 11.1 | 11.1 | 11.1 | 16.7 | 16.7 | 16.7 | 33.3 | 18.3 | 23.6 | 23.3 | 20.4 | 18.0 | 18.9 | 17.7 | 20.0 | 17.0 | 15.9 | 13.3 | 14.9 | 13.4 | 11.1 | 10.3 | 9.3 | 9.5 | 7.4 | 7.8 | 8.3 | 9.5 | 7.8 | 10.0 | 9.8 | 9.5 | 11.1 | 8.3 | 11.1 | 11.1 | 11.1 | 5.6 | 0.0 | 5.6 | 6.7 | 8.3 | 0.0 | 0.0 | 0.0 | 6.7 | 0.0 | 6.7 | 6.7 | 0.0 | 0.0 | 11.1 | 11.1 | 0.0 | 0.0 | 0.0 | 0.0 | 24.6 | 33.8 | 33.6 | 31.3 | 29.4 | 28.4 | 27.9 | 25.1 | 20.7 | 16.7 | 11.6 | 13.0 | 9.6 | 10.9 | 9.7 | 7.0 | 5.6 | 6.5 | 10.0 | 10.0 | 4.8 | 0.0 | 8.3 | 5.9 | 7.1 | 5.6 | 4.2 | 0.0 | 5.6 | 5.6 | 11.1 | 0.0 | 5.6 | 0.0 | 0.0 | 8.3 | 8.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 11.1 | 11.1 | 0.0 | 0.0 | 0.0 | 0.0 | 33.5 | 21.5 | 20.2 | 17.6 | 15.1 | 15.8 | 15.4 | 14.5 | 10.0 | 10.2 | 9.6 | 6.3 | 4.7 | 10.4 | 7.9 | 7.0 | 7.1 | 5.6 | 10.3 | 6.9 | 6.3 | 5.9 | 5.0 | 5.9 | 4.8 | 11.1 | 4.2 | 3.7 | 16.7 | 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 | 0.0 | 20.0 | 10.7 | 12.2 | 14.2 | 11.9 | 12.0 | 12.9 | 10.3 | 9.6 | 6.2 | 4.8 | 4.9 | 5.7 | 4.2 | 3.0 | 2.4 | 1.6 | 3.7 | 2.3 | 4.2 | 4.8 | 0.0 | 3.3 | 2.0 | 3.3 | 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 | 6.7 | 0.0 | 0.0 | 0.0 | 6.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 10.0 | 29.3 | 27.7 | 23.9 | 23.3 | 22.7 | 24.4 | 22.4 | 24.9 | 22.3 | 21.6 | 23.4 | 24.5 | 23.4 | 23.6 | 19.4 | 18.3 | 20.0 | 20.7 | 18.1 | 22.2 | 23.5 | 16.7 | 17.6 | 19.0 | 19.4 | 25.0 | 25.9 | 22.2 | 16.7 | 16.7 | 25.0 | 16.7 | 20.0 | 16.7 | 8.3 | 16.7 | 16.7 | 13.3 | 16.7 | 13.3 | 13.3 | 13.3 | 11.1 | 11.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 27.9 |
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EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. (NCT01041404)
Timeframe: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | scores on a scale (Mean) |
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| Dysphagia Scale: BL (n=276,287) | Dysphagia Scale: Week 4 (n=234,250) | Dysphagia Scale: Week 7 (n=181,220) | Dysphagia Scale: Week 10 (n=176,203) | Dysphagia Scale: Week 13 (n=152,183) | Dysphagia Scale: Week 16 (n=120,165) | Dysphagia Scale: Week 19 (n=114,143) | Dysphagia Scale: Week 22 (n=79,143) | Dysphagia Scale: Week 25 (n=64,124) | Dysphagia Scale: Week 28 (n=47,111) | Dysphagia Scale: Week 31 (n=45,95) | Dysphagia Scale: Week 34 (n=37,87) | Dysphagia Scale: Week 37 (n=29,64) | Dysphagia Scale: Week 40 (n=24,55) | Dysphagia Scale: Week 43 (n=12,43) | Dysphagia Scale: Week 46 (n=14,42) | Dysphagia Scale: Week 49 (n=10,36) | Dysphagia Scale: Week 52 (n=8,30) | Dysphagia Scale: Week 55 (n=6,24) | Dysphagia Scale: Week 58 (n=6,21) | Dysphagia Scale: Week 61 (n=4,17) | Dysphagia Scale: Week 64 (n=3,20) | Dysphagia Scale: Week 67 (n=4,16) | Dysphagia Scale: Week 70 (n=3,14) | Dysphagia Scale: Week 73 (n=3,12) | Dysphagia Scale: Week 76 (n=3,8) | Dysphagia Scale: Week 79 (n=3,9) | Dysphagia Scale: Week 82 (n=2,6) | Dysphagia Scale: Week 85 (n=2,6) | Dysphagia Scale: Week 88 (n=2,6) | Dysphagia Scale: Week 91 (n=2,4) | Dysphagia Scale: Week 94 (n=2,6) | Dysphagia Scale: Week 97 (n=1,5) | Dysphagia Scale: Week 100 (n=1,4) | Dysphagia Scale: Week 103 (n=1,4) | Dysphagia Scale: Week 106 (n=1,4) | Dysphagia Scale: Week 109 (n=1,4) | Dysphagia Scale: Week 112 (n=1,5) | Dysphagia Scale: Week 115 (n=1,4) | Dysphagia Scale: Week 118 (n=1,5) | Dysphagia Scale: Week 121 (n=1,5) | Dysphagia Scale: Week 124 (n=1,5) | Dysphagia Scale: Week 127 (n=1,3) | Dysphagia Scale: Week 130 (n=0,3) | Dysphagia Scale: Week 133 (n=1,3) | Dysphagia Scale: Week 136 (n=0,2) | Dysphagia Scale: Week 139 (n=0,2) | Dysphagia Scale: Week 142 (n=0,2) | Dysphagia Scale: Week 145 (n=0,1) | Dysphagia Scale: Final Visit (n=157,159 | Pain Scale: BL (n=276,287) | Pain Scale: Week 4 (n=234,250) | Pain Scale: Week 7 (n=181,219) | Pain Scale: Week 10 (n=176,203) | Pain Scale: Week 13 (n=152,183) | Pain Scale: Week 16 (n=120,165) | Pain Scale: Week 19 (n=114,143) | Pain Scale: Week 22 (n=79,143) | Pain Scale: Week 25 (n=64,124) | Pain Scale: Week 28 (n=47,111) | Pain Scale: Week 31 (n=45,95) | Pain Scale: Week 34 (n=37,87) | Pain Scale: Week 37 (n=29,64) | Pain Scale: Week 40 (n=24,55) | Pain Scale: Week 43 (n=12,43) | Pain Scale: Week 46 (n=14,42) | Pain Scale: Week 49 (n=10,36) | Pain Scale: Week 52 (n=8,30) | Pain Scale: Week 55 (n=6,24) | Pain Scale: Week 58 (n=6,21) | Pain Scale: Week 61 (n=4,17) | Pain Scale: Week 64 (n=3,20) | Pain Scale: Week 67 (n=4,16) | Pain Scale: Week 70 (n=3,14) | Pain Scale: Week 73 (n=3,12) | Pain Scale: Week 76 (n=3,8) | Pain Scale: Week 79 (n=3,9) | Pain Scale: Week 82 (n=2,6) | Pain Scale: Week 85 (n=2,6) | Pain Scale: Week 88 (n=2,6) | Pain Scale: Week 91 (n=2,6) | Pain Scale: Week 94 (n=2,6) | Pain Scale: Week 97 (n=1,5) | Pain Scale: Week 100 (n=1,4) | Pain Scale: Week 103 (n=1,4) | Pain Scale: Week 106 (n=1,4) | Pain Scale: Week 109 (n=1,4) | Pain Scale: Week 112 (n=1,5) | Pain Scale: Week 115 (n=1,4) | Pain Scale: Week 118 (n=1,5) | Pain Scale: Week 121 (n=1,5) | Pain Scale: Week 124 (n=1,5) | Pain Scale: Week 127 (n=1,3) | Pain Scale: Week 130 (n=0,3) | Pain Scale: Week 133 (n=1,3) | Pain Scale: Week 136 (n=0,2) | Pain Scale: Week 139 (n=0,2) | Pain Scale: Week 142 (n=0,2) | Pain Scale: Week 145 (n=0,1) | Pain Scale: Final Visit (n=157,160) | Reflux Symptoms Scale: BL (n=275,287) | Reflux Symptoms Scale: Week 4 (n=234,250) | Reflux Symptoms Scale: Week 7 (n=180,220) | Reflux Symptoms Scale: Week 10 (n=176,203) | Reflux Symptoms Scale: Week 13 (n=152,182) | Reflux Symptoms Scale: Week 16 (n=120,165) | Reflux Symptoms Scale: Week 19 (n=114,165) | Reflux Symptoms Scale: Week 22 (n=79,143) | Reflux Symptoms Scale: Week 25 (n=64,124) | Reflux Symptoms Scale: Week 28 (n=47,111) | Reflux Symptoms Scale: Week 31 (n=45,95) | Reflux Symptoms Scale: Week 34 (n=45,95) | Reflux Symptoms Scale: Week 37 (n=29,64) | Reflux Symptoms Scale: Week 40 (n=24,55) | Reflux Symptoms Scale: Week 43 (n=12,42) | Reflux Symptoms Scale: Week 46 (n=14,42) | Reflux Symptoms Scale: Week 49 (n=10,36) | Reflux Symptoms Scale: Week 52 (n=8,30) | Reflux Symptoms Scale: Week 55 (n=6,24) | Reflux Symptoms Scale: Week 58 (n=6,21) | Reflux Symptoms Scale: Week 61 (n=4,17) | Reflux Symptoms Scale: Week 64 (n=3,20) | Reflux Symptoms Scale: Week 67 (n=4,16) | Reflux Symptoms Scale: Week 70 (n=3,13) | Reflux Symptoms Scale: Week 73 (n=3,12) | Reflux Symptoms Scale: Week 76 (n=3,8) | Reflux Symptoms Scale: Week 79 (n=3,9) | Reflux Symptoms Scale: Week 82 (n=2,6) | Reflux Symptoms Scale: Week 85 (n=2,6) | Reflux Symptoms Scale: Week 88 (n=2,6) | Reflux Symptoms Scale: Week 91 (n=2,4) | Reflux Symptoms Scale: Week 94 (n=2,6) | Reflux Symptoms Scale: Week 97 (n=1,5) | Reflux Symptoms Scale: Week 100 (n=1,4) | Reflux Symptoms Scale: Week 103 (n=1,4) | Reflux Symptoms Scale: Week 106 (n=1,4) | Reflux Symptoms Scale: Week 109 (n=1,4) | Reflux Symptoms Scale: Week 112 (n=1,5) | Reflux Symptoms Scale: Week 115 (n=1,4) | Reflux Symptoms Scale: Week 118 (n=1,5) | Reflux Symptoms Scale: Week 121 (n=1,5) | Reflux Symptoms Scale: Week 124 (n=1,5) | Reflux Symptoms Scale: Week 127 (n=1,3) | Reflux Symptoms Scale: Week 130 (n=0,3) | Reflux Symptoms Scale: Week 133 (n=1,3) | Reflux Symptoms Scale: Week 136 (n=0,2) | Reflux Symptoms Scale: Week 139 (n=0,2) | Reflux Symptoms Scale: Week 142 (n=0,2) | Reflux Symptoms Scale: Week 145 (n=0,1) | Reflux Symptoms Scale: Final Visit (n=1,5) | Eating Restrictions (ER) Scale: BL (n=276,287) | ER Scale: Week 4 (n=234,250) | ER Scale: Week 7 (n=181,220) | ER Scale: Week 10 (n=176,203) | ER Scale: Week 13 (n=152,183) | ER Scale: Week 16 (n=120,165) | ER Scale: Week 19 (n=114,143) | ER Scale: Week 22 (n=79,143) | ER Scale: Week 25 (n=64,124) | ER Scale: Week 28 (n=47,111) | ER Scale: Week 31 (n=45,95) | ER Scale: Week 34 (n=37,87) | ER Scale: Week 37 (n=29,64) | ER Scale: Week 40 (n=24,55) | ER Scale: Week 43 (n=12,43) | ER Scale: Week 46 (n=14,42) | ER Scale: Week 49 (n=10,36) | ER Scale: Week 52 (n=8,30) | ER Scale: Week 55 (n=6,24) | ER Scale: Week 58 (n=6,21) | ER Scale: Week 61 (n=4,17) | ER Scale: Week 64 (n=3,20) | ER Scale: Week 67 (n=4,16) | ER Scale: Week 70 (n=3,14) | ER Scale: Week 73 (n=3,12) | ER Scale: Week 76 (n=3,8) | ER Scale: Week 79 (n=3,9) | ER Scale: Week 82 (n=2,6) | ER Scale: Week 85 (n=2,6) | ER Scale: Week 88 (n=2,6) | ER Scale: Week 91 (n=2,4) | ER Scale: Week 94 (n=2,6) | ER Scale: Week 97 (n=1,5) | ER Scale: Week 100 (n=1,4) | ER Scale: Week 103 (n=1,4) | ER Scale: Week 106 (n=1,4) | ER Scale: Week 109 (n=1,4) | ER Scale: Week 112 (n=1,5) | ER Scale: Week 115 (n=1,4) | ER Scale: Week 118 (n=1,5) | ER Scale: Week 121 (n=1,5) | ER Scale: Week 124 (n=1,5) | ER Scale: Week 127 (n=1,3) | ER Scale: Week 130 (n=0,3) | ER Scale: Week 133 (n=1,3) | ER Scale: Week 136 (n=0,2) | ER Scale: Week 139 (n=0,2) | ER Scale: Week 142 (n=0,2) | ER Scale: Week 145 (n=0,1) | ER Scale: Final Visit (n=157,160) | Anxiety Scale: BL (n=276,287) | Anxiety Scale: Week 4 (n=234,250) | Anxiety Scale: Week 7 (n=181,220) | Anxiety Scale: Week 10 (n=176,203) | Anxiety Scale: Week 13 (n=152,183) | Anxiety Scale: Week 16 (n=120,165) | Anxiety Scale: Week 19 (n=114,143) | Anxiety Scale: Week 22 (n=79,143) | Anxiety Scale: Week 25 (n=64,124) | Anxiety Scale: Week 28 (n=47,111) | Anxiety Scale: Week 31 (n=45,95) | Anxiety Scale: Week 34 (n=37,87) | Anxiety Scale: Week 37 (n=29,64) | Anxiety Scale: Week 40 (n=24,55) | Anxiety Scale: Week 43 (n=12,43) | Anxiety Scale: Week 46 (n=14,42) | Anxiety Scale: Week 49 (n=14,42) | Anxiety Scale: Week 52 (n=8,30) | Anxiety Scale: Week 55 (n=6,24) | Anxiety Scale: Week 58 (n=6,21) | Anxiety Scale: Week 61 (n=4,17) | Anxiety Scale: Week 64 (n=3,20) | Anxiety Scale: Week 67 (n=4,16) | Anxiety Scale: Week 70 (n=3,14) | Anxiety Scale: Week 73 (n=3,12) | Anxiety Scale: Week 76 (n=3,8) | Anxiety Scale: Week 79 (n=3,9) | Anxiety Scale: Week 82 (n=2,6) | Anxiety Scale: Week 85 (n=2,6) | Anxiety Scale: Week 88 (n=2,6) | Anxiety Scale: Week 91 (n=2,4) | Anxiety Scale: Week 94 (n=2,6) | Anxiety Scale: Week 97 (n=1,5) | Anxiety Scale: Week 100 (n=1,4) | Anxiety Scale: Week 103 (n=1,4) | Anxiety Scale: Week 106 (n=1,4) | Anxiety Scale: Week 109 (n=1,4) | Anxiety Scale: Week 112 (n=1,5) | Anxiety Scale: Week 115 (n=1,4) | Anxiety Scale: Week 118 (n=1,5) | Anxiety Scale: Week 121 (n=1,5) | Anxiety Scale: Week 124 (n=1,5) | Anxiety Scale: Week 127 (n=1,3) | Anxiety Scale: Week 130 (n=0,3) | Anxiety Scale: Week 133 (n=1,3) | Anxiety Scale: Week 136 (n=0,2) | Anxiety Scale: Week 139 (n=0,2) | Anxiety Scale: Week 142 (n=0,2) | Anxiety Scale: Week 145 (n=0,2) | Anxiety Scale: Final Visit (n=157,160) | Dry Mouth: BL (n=274,287) | Dry Mouth: Week 4 (n=232,249) | Dry Mouth: Week 7 (n=180,219) | Dry Mouth: Week 10 (n=176,203) | Dry Mouth: Week 13 (n=152,183) | Dry Mouth: Week 16 (n=120,165) | Dry Mouth: Week 19 (n=113,143) | Dry Mouth: Week 22 (n=79,143) | Dry Mouth: Week 25 (n=64,124) | Dry Mouth: Week 28 (n=47,111) | Dry Mouth: Week 31 (n=45,95) | Dry Mouth: Week 34 (n=37,87) | Dry Mouth: Week 37 (n=29,64) | Dry Mouth: Week 40 (n=23,55) | Dry Mouth: Week 43 (n=12,43) | Dry Mouth: Week 46 (n=14,42) | Dry Mouth: Week 49 (n=10,36) | Dry Mouth: Week 52 (n=8,30) | Dry Mouth: Week 55 (n=6,24) | Dry Mouth: Week 58 (n=6,21) | Dry Mouth: Week 61 (n=4,17) | Dry Mouth: Week 64 (n=3,20) | Dry Mouth: Week 67 (n=4,16) | Dry Mouth: Week 70 (n=3,14) | Dry Mouth: Week 73 (n=3,12) | Dry Mouth: Week 76 (n=3,8) | Dry Mouth: Week 79 (n=3,9) | Dry Mouth: Week 82 (n=2,6) | Dry Mouth: Week 85 (n=2,6) | Dry Mouth: Week 88 (n=2,6) | Dry Mouth: Week 91 (n=2,4) | Dry Mouth: Week 94 (n=2,6) | Dry Mouth: Week 97 (n=1,5) | Dry Mouth: Week 100 (n=1,4) | Dry Mouth: Week 103 (n=1,4) | Dry Mouth: Week 106 (n=1,4) | Dry Mouth: Week 109 (n=1,4) | Dry Mouth: Week 112 (n=1,5) | Dry Mouth: Week 115 (n=1,4) | Dry Mouth: Week 118 (n=1,5) | Dry Mouth: Week 121 (n=1,5) | Dry Mouth: Week 124 (n=1,5) | Dry Mouth: Week 127 (n=1,3) | Dry Mouth: Week 130 (n=0,3) | Dry Mouth: Week 133 (n=1,3) | Dry Mouth: Week 136 (n=0,2) | Dry Mouth: Week 139 (n=0,2) | Dry Mouth: Week 142 (n=0,2) | Dry Mouth: Week 145 (n=0,1) | Dry Mouth: Final Visit (n=157,157) | Taste: BL (n=275,286) | Taste: Week 4 (n=234,249) | Taste: Week 7 (n=179,217) | Taste: Week 10 (n=176,200) | Taste: Week 13 (n=151,181) | Taste: Week 16 (n=119,165) | Taste: Week 19 (n=113,143) | Taste: Week 22 (n=79,143) | Taste: Week 25 (n=64,124) | Taste: Week 28 (n=47,111) | Taste: Week 31 (n=45,95) | Taste: Week 34 (n=37,87) | Taste: Week 37 (n=28,64) | Taste: Week 40 (n=24,55) | Taste: Week 43 (n=12,43) | Taste: Week 46 (n=14,42) | Taste: Week 49 (n=9,36) | Taste: Week 52 (n=8,30) | Taste: Week 55 (n=6,24) | Taste: Week 58 (n=6,21) | Taste: Week 61 (n=4,17) | Taste: Week 64 (n=3,20) | Taste: Week 67 (n=4,16) | Taste: Week 70 (n=3,14) | Taste: Week 73 (n=3,12) | Taste: Week 76 (n=3,8) | Taste: Week 79 (n=3,9) | Taste: Week 82 (n=2,6) | Taste: Week 85 (n=2, 6) | Taste: Week 88 (n=2,6) | Taste: Week 91 (n=2,4) | Taste: Week 94 (n=2,6) | Taste: Week 97 (n=1,5) | Taste: Week 100 (n=1,4) | Taste: Week 103 (n=1,4) | Taste: Week 106 (n=1,4) | Taste: Week 109 (n=1,4) | Taste: Week 112 (n=1,5) | Taste: Week 115 (n=1,4) | Taste: Week 118 (n=1,5) | Taste: Week 121 (n=1,5) | Taste: Week 124 (n=1,5) | Taste: Week 127 (n=1,3) | Taste: Week 130 (n=0,3) | Taste: Week 133 (n=1,3) | Taste: Week 136 (n=0,2) | Taste: Week 139 (n=0,2) | Taste: Week 142 (n=0,2) | Taste: Week 145 (n=0,1) | Taste: Final Visit (n=157,158) | Body Image: BL (n=272,286) | Body Image: Week 4 (n=233,249) | Body Image: Week 7 (n=180,219) | Body Image: Week 10 (n=175,203) | Body Image: Week 13 (n=152,182) | Body Image: Week 16 (n=119,165) | Body Image: Week 19 (n=114,140) | Body Image: Week 22 (n=79,143) | Body Image: Week 25 (n=64,124) | Body Image: Week 28 (n=47,111) | Body Image: Week 31 (n=45,95) | Body Image: Week 34 (n=37,87) | Body Image: Week 37 (n=29,64) | Body Image: Week 40 (n=24,55) | Body Image: Week 43 (n=12,43) | Body Image: Week 46 (n=14,42) | Body Image: Week 49 (n=10,36) | Body Image: Week 52 (n=8,30) | Body Image: Week 55 (n=6,24) | Body Image: Week 58 (n=6,21) | Body Image: Week 61 (n=4,17) | Body Image: Week 64 (n=3,20) | Body Image: Week 67 (n=4,16) | Body Image: Week 70 (n=4,14) | Body Image: Week 73 (n=3,12) | Body Image: Week 76 (n=3,8) | Body Image: Week 79 (n=3,9) | Body Image: Week 82 (n=2,6) | Body Image: Week 85 (n=2,6) | Body Image: Week 88 (n=2,5) | Body Image: Week 91 (n=2,4) | Body Image: Week 94 (n=2,6) | Body Image: Week 97 (n=1,5) | Body Image: Week 100 (n=1,4) | Body Image: Week 103 (n=1,4) | Body Image: Week 106 (n=1,4) | Body Image: Week 109 (n=1,4) | Body Image: Week 112 (n=1,5) | Body Image: Week 115 (n=1,4) | Body Image: Week 118 (n=1,5) | Body Image: Week 121 (n=1,5) | Body Image: Week 124 (n=1,5) | Body Image: Week 127 (n=1,3) | Body Image: Week 130 (n=0,3) | Body Image: Week 133 (n=1,3) | Body Image: Week 136 (n=0,2) | Body Image: Week 139 (n=0,2) | Body Image: Week 142 (n=0,2) | Body Image: Week 145 (n=0,1) | Body Image: Final Visit (n=157,159) | Hair Loss: BL (n=64,76) | Hair Loss: Week 4 (n=68,71) | Hair Loss: Week 7 (n=65,82) | Hair Loss: Week 10 (n=75,78) | Hair Loss: Week 13 (n=66,80) | Hair Loss: Week 16 (n=53,72) | Hair Loss: Week 19 (n=50,56) | Hair Loss: Week 22 (n=38,54) | Hair Loss: Week 25 (n=24,49) | Hair Loss: Week 28 (n=20,39) | Hair Loss: Week 31 (n=17,26) | Hair Loss: Week 34 (n=13,24) | Hair Loss: Week 37 (n=12,16) | Hair Loss: Week 40 (n=11,13) | Hair Loss: Week 43 (n=5,9) | Hair Loss: Week 46 (n=5,13) | Hair Loss: Week 49 (n=4,7) | Hair Loss: Week 52 (n=3,4) | Hair Loss: Week 55 (n=2,6) | Hair Loss: Week 58 (n=2,3) | Hair Loss: Week 61 (n=1,2) | Hair Loss: Week 64 (n=1,4) | Hair Loss: Week 67 (n=1,4) | Hair Loss: Week 70 (n=1,2) | Hair Loss: Week 73 (n=1,5) | Hair Loss: Week 76 (n=1,3) | Hair Loss: Week 79 (n=1,4) | Hair Loss: Week 82 (n=1,1) | Hair Loss: Week 85 (n=1,1) | Hair Loss: Week 88 (n=1,2) | Hair Loss: Week 91 (n=1,1) | Hair Loss: Week 94 (n=1,2) | Hair Loss: Week 97 (n=1,2) | Hair Loss: Week 100 (n=1,2) | Hair Loss: Week 103 (n=1,1) | Hair Loss: Week 106 (n=1,1) | Hair Loss: Week 109 (n=0,2) | Hair Loss: Week 112 (n=1,3) | Hair Loss: Week 115 (n=1,2) | Hair Loss: Week 118 (n=1,3) | Hair Loss: Week 121 (n=1,2) | Hair Loss: Week 124 (n=1,2) | Hair Loss: Week 127 (n=1,1) | Hair Loss: Week 130 (n=0,1) | Hair Loss: Week 133 (n=1,1) | Hair Loss: Final Visit (n=61,60) |
---|
Fluoropyrimidine/Cisplatin (FP) | 18.7 | 11.8 | 10.9 | 8.5 | 8.8 | 10.2 | 9.5 | 10.0 | 6.9 | 6.6 | 6.4 | 3.9 | 5.4 | 3.7 | 4.6 | 2.4 | 4.4 | 1.4 | 0.0 | 3.7 | 2.8 | 0.0 | 2.8 | 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 | NA | 0.0 | NA | NA | NA | NA | 15.4 | 29.7 | 21.6 | 19.4 | 17.0 | 16.0 | 17.0 | 19.2 | 15.8 | 11.3 | 11.2 | 12.6 | 12.2 | 13.8 | 14.9 | 13.0 | 15.5 | 11.7 | 9.4 | 9.7 | 5.6 | 4.2 | 2.8 | 4.2 | 2.8 | 0.0 | 5.6 | 2.8 | 0.0 | 4.2 | 8.3 | 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 | NA | 0.0 | NA | NA | NA | NA | 24.7 | 18.3 | 14.8 | 12.8 | 12.6 | 12.8 | 12.0 | 11.3 | 9.0 | 5.6 | 6.6 | 7.4 | 7.2 | 6.1 | 7.9 | 7.4 | 4.8 | 2.2 | 2.8 | 5.6 | 0.0 | 2.8 | 3.7 | 2.8 | 3.7 | 0.0 | 3.7 | 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 | NA | 0.0 | NA | NA | NA | NA | 15.3 | 27.4 | 20.6 | 18.8 | 17.5 | 16.0 | 17.8 | 20.8 | 15.5 | 11.6 | 13.9 | 13.4 | 10.6 | 12.5 | 13.5 | 9.7 | 10.9 | 11.7 | 5.2 | 8.3 | 9.7 | 4.2 | 0.0 | 8.3 | 2.8 | 5.6 | 2.8 | 5.6 | 4.2 | 4.2 | 4.2 | 8.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | NA | 0.0 | NA | NA | NA | NA | 23.8 | 47.5 | 42.0 | 40.6 | 38.2 | 35.7 | 32.9 | 35.8 | 31.7 | 25.2 | 27.4 | 29.1 | 23.1 | 27.2 | 29.6 | 30.6 | 26.2 | 20.0 | 23.6 | 31.5 | 20.4 | 8.3 | 5.6 | 11.1 | 3.7 | 7.4 | 0.0 | 11.1 | 11.1 | 11.1 | 11.1 | 11.1 | 5.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | NA | 0.0 | NA | NA | NA | NA | 41.5 | 24.5 | 24.0 | 24.6 | 23.5 | 23.2 | 23.9 | 22.4 | 19.0 | 16.1 | 10.6 | 12.6 | 9.9 | 12.6 | 8.7 | 11.1 | 9.5 | 16.7 | 12.5 | 5.6 | 11.1 | 8.3 | 0.0 | 8.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 16.7 | 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 | NA | 0.0 | NA | NA | NA | NA | 24.0 | 17.2 | 20.7 | 20.1 | 21.8 | 19.9 | 20.4 | 24.5 | 19.0 | 10.9 | 12.1 | 8.1 | 6.3 | 8.3 | 8.3 | 5.6 | 4.8 | 7.4 | 4.2 | 11.1 | 11.1 | 8.3 | 11.1 | 8.3 | 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 | NA | 0.0 | NA | NA | NA | NA | 25.3 | 30.9 | 32.6 | 30.7 | 30.1 | 28.9 | 29.1 | 30.7 | 28.7 | 22.4 | 23.4 | 25.2 | 18.9 | 23.0 | 20.8 | 27.8 | 21.4 | 16.7 | 16.7 | 16.7 | 11.1 | 8.3 | 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 | 0.0 | 0.0 | NA | 0.0 | NA | NA | NA | NA | 31.0 | 15.1 | 20.1 | 25.1 | 21.8 | 22.2 | 28.3 | 23.3 | 20.2 | 13.9 | 26.7 | 15.7 | 7.7 | 8.3 | 12.1 | 6.7 | 26.7 | 0.0 | 11.1 | 16.7 | 16.7 | 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 | NA | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | NA | 0.0 | 23.0 |
,Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 16.6 | 12.5 | 12.8 | 10.6 | 9.0 | 9.1 | 8.8 | 7.8 | 6.8 | 5.3 | 6.8 | 7.5 | 7.3 | 6.5 | 5.2 | 2.9 | 2.2 | 4.4 | 3.7 | 3.2 | 0.7 | 3.3 | 2.8 | 3.2 | 4.6 | 2.8 | 2.5 | 3.7 | 1.9 | 1.9 | 0.0 | 1.9 | 2.2 | 2.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 2.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 5.6 | 5.6 | 0.0 | 17.0 | 27.0 | 21.8 | 20.1 | 17.5 | 16.2 | 15.9 | 16.3 | 15.1 | 14.4 | 14.0 | 14.6 | 12.5 | 13.8 | 11.8 | 9.7 | 10.1 | 9.5 | 8.6 | 4.5 | 6.3 | 5.4 | 9.6 | 8.3 | 6.5 | 9.7 | 5.2 | 7.4 | 6.9 | 5.6 | 5.6 | 2.1 | 5.6 | 8.3 | 6.3 | 8.3 | 6.3 | 4.2 | 10.0 | 4.2 | 8.3 | 10.0 | 8.3 | 8.3 | 11.1 | 13.9 | 12.5 | 8.3 | 8.3 | 0.0 | 26.8 | 16.9 | 16.0 | 15.4 | 13.5 | 12.9 | 14.4 | 10.6 | 10.6 | 9.7 | 9.6 | 10.1 | 9.3 | 10.9 | 9.3 | 9.0 | 6.6 | 6.5 | 8.1 | 6.5 | 5.3 | 2.6 | 3.9 | 6.3 | 4.3 | 7.9 | 1.4 | 3.7 | 5.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 2.8 | 0.0 | 0.0 | 0.0 | 4.4 | 0.0 | 6.7 | 7.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 18.3 | 23.9 | 21.1 | 19.0 | 17.4 | 17.0 | 15.1 | 15.5 | 13.6 | 12.9 | 11.3 | 12.5 | 10.9 | 9.5 | 9.5 | 7.0 | 6.0 | 8.1 | 9.3 | 5.2 | 6.0 | 5.4 | 8.3 | 10.4 | 6.5 | 9.0 | 5.2 | 5.6 | 2.8 | 4.2 | 4.2 | 4.2 | 4.2 | 6.7 | 6.3 | 6.3 | 4.2 | 4.2 | 3.3 | 4.2 | 6.7 | 5.0 | 1.7 | 0.0 | 8.3 | 5.6 | 0.0 | 4.2 | 0.0 | 0.0 | 22.8 | 48.2 | 43.8 | 39.3 | 38.2 | 37.5 | 37.1 | 34.9 | 32.8 | 29.2 | 26.9 | 28.4 | 27.8 | 28.2 | 26.3 | 25.1 | 23.3 | 25.9 | 27.4 | 28.2 | 21.7 | 25.5 | 23.9 | 18.8 | 27.0 | 28.7 | 27.8 | 33.3 | 25.9 | 24.1 | 14.8 | 22.2 | 22.2 | 31.1 | 16.7 | 22.2 | 19.4 | 16.7 | 22.2 | 19.4 | 20.0 | 15.6 | 17.8 | 22.2 | 18.5 | 18.5 | 16.7 | 11.1 | 16.7 | 0.0 | 40.9 | 23.9 | 23.3 | 26.9 | 25.0 | 21.1 | 23.4 | 20.5 | 16.3 | 12.1 | 10.8 | 11.2 | 9.6 | 9.4 | 7.3 | 6.2 | 4.8 | 6.5 | 10.0 | 8.3 | 14.3 | 11.8 | 6.7 | 8.3 | 11.9 | 13.9 | 20.8 | 11.1 | 5.6 | 0.0 | 5.6 | 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 | 23.6 | 17.9 | 24.8 | 24.0 | 25.3 | 25.2 | 23.8 | 22.6 | 19.6 | 15.9 | 14.7 | 13.0 | 9.6 | 7.8 | 7.9 | 7.0 | 7.9 | 4.6 | 7.8 | 4.2 | 4.8 | 0.0 | 1.7 | 4.2 | 0.0 | 2.8 | 0.0 | 0.0 | 5.6 | 0.0 | 5.6 | 0.0 | 5.6 | 6.7 | 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 | 20.3 | 31.9 | 31.7 | 27.9 | 28.4 | 28.2 | 28.1 | 25.0 | 22.4 | 22.6 | 20.1 | 19.3 | 18.0 | 18.2 | 19.4 | 15.5 | 15.9 | 13.9 | 16.7 | 16.7 | 15.9 | 13.7 | 18.3 | 14.6 | 16.7 | 27.8 | 37.5 | 25.9 | 16.7 | 11.1 | 6.7 | 16.7 | 16.7 | 13.3 | 8.3 | 8.3 | 16.7 | 8.3 | 6.7 | 16.7 | 6.7 | 6.7 | 6.67 | 11.1 | 0.0 | 11.1 | 16.7 | 0.0 | 16.7 | 0.0 | 30.4 | 25.0 | 16.4 | 19.1 | 20.1 | 20.4 | 23.6 | 21.4 | 22.2 | 18.4 | 14.5 | 10.3 | 16.7 | 12.5 | 12.8 | 3.7 | 5.1 | 9.5 | 8.3 | 0.0 | 0.0 | 16.7 | 0.0 | 0.0 | 0.0 | 6.7 | 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 | 19.4 |
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Progression-Free Survival - Time to Event
The median time, in months, from the date of randomization to the date of a PFS event. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. (NCT01041404)
Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | months (Median) |
---|
Fluoropyrimidine, Cisplatin | 5.5 |
Trastuzumab, Fluoropyrimidine, Cisplatin | 6.7 |
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Trastuzumab Maximum Serum Concentration (Cmax)
Median Cmax (measured as mg/L) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion. (NCT01041404)
Timeframe: Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106
Intervention | mg/L (Median) |
---|
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 128 |
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Time to Progression (TTP) - Percentage of Participants With an Event
TTP was defined as the time from the date of randomization and the date of the first occurrence of PD. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up. (NCT01041404)
Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | percentage of participants (Number) |
---|
Fluoropyrimidine/Cisplatin (FP) | 74.1 |
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 70.7 |
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Progression-Free Survival (PFS) - Percentage of Participants With an Event
PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. (NCT01041404)
Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | percentage of participants (Number) |
---|
Fluoropyrimidine/Cisplatin (FP) | 81.0 |
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 76.9 |
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Duration of Response
The median time, in months, of the duration of response. Participants were censored at the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up. (NCT01041404)
Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | months (Median) |
---|
Fluoropyrimidine/Cisplatin (FP) | 4.8 |
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 6.9 |
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Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)
For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. (NCT01041404)
Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | percentage of participants (Number) |
---|
Fluoropyrimidine/Cisplatin (FP) | 34.5 |
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 47.3 |
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Percentage of Participants With Clinical Benefit
Clinical benefit was defined as stable disease (SD), CR, or PR for 6 weeks or longer as determined by RECIST. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as a reference the smallest SLD recorded since treatment had started. For NTLs, SD was defined as a persistence of one or more NTLs and/or maintenance of tumor marker levels above the normal limits. (NCT01041404)
Timeframe: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | percentage of participants (Number) |
---|
Fluoropyrimidine/Cisplatin (FP) | 69.3 |
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 78.9 |
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Overall Survival (OS) - Percentage of Participants With an Event
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. (NCT01041404)
Timeframe: Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Intervention | percentage of participants (Number) |
---|
Fluoropyrimidine/Cisplatin (FP) | 62.8 |
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 56.8 |
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Number of Participants With Adverse Events and Serious Adverse Events
ADVERSE EVENTS (AE) AND SERIOUS ADVERSE EVENTS (SAE) Adverse Events (AEs) will use the descriptions and grading scales found in the NCI CTCAE v3.0 (NCT01044433)
Timeframe: 5 years
Intervention | Participants (Count of Participants) |
---|
| Diarrhea | Rash | Pain | Fatigue | Infection | Nausea | Mucositis | Vomiting | Constipation | Hand-foot syndrome | Cough | Acute kidney injury | Dry skin | Anorexia | Dehydration | Edema of limb | Heartburn | Hyponatremia | Neuropathy | Neutropenia | Febrile |
---|
Arm I | 31 | 31 | 26 | 23 | 19 | 19 | 14 | 13 | 10 | 8 | 7 | 6 | 6 | 6 | 5 | 5 | 5 | 5 | 5 | 2 | 1 |
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Disease Control Rate
(NCT01044433)
Timeframe: 5 years
Intervention | percentage (Number) |
---|
Arm I | 68 |
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Overall Survival
(NCT01044433)
Timeframe: 5 years
Intervention | Months (Mean) |
---|
Lapatinib Ditosylate and Capecitabine | 10.7 |
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Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01044433)
Timeframe: 5 years
Intervention | percentage (Number) |
---|
Arm I | 25 |
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Progression-free Survival
(NCT01044433)
Timeframe: 5 years
Intervention | months (Number) |
---|
Arm I | 4.2 |
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Rate of Locoregional Control
(NCT01060007)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Neoadjuvant Radiation Followed by FOLFOX | 96 |
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Preoperative Gastrointestinal Morbidity
As measured by participants who experience grade 3 or higher gastrointestinal morbidity (NCT01060007)
Timeframe: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
Intervention | participants (Number) |
---|
Neoadjuvant Radiation Followed by FOLFOX | 7 |
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Rate of Overall Control
(NCT01060007)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Neoadjuvant Radiation Followed by FOLFOX | 89 |
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Determine Quality of Anorectal Function
"Anorectal function was measured by the participant's response to the FACT-C questionnaire question I have control of my bowels. The answers ranged from 0=not at all to 4=very much." (NCT01060007)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
| 0 = not at all | 1 = a little bit | 2 = somewhat | 3 = quite a bit | 4 = very much |
---|
1 Year Post-treatment | 2 | 4 | 13 | 7 | 5 |
,Pre-surgery | 4 | 4 | 8 | 21 | 22 |
,Pre-treatment | 7 | 3 | 22 | 14 | 26 |
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Incidence of Any Late Grade 3 or Higher Morbidity
(NCT01060007)
Timeframe: Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)
Intervention | participants (Number) |
---|
| Non-hematologic toxicities | Hematologic toxicities |
---|
Neoadjuvant Radiation Followed by FOLFOX | 16 | 21 |
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Local Control
"Kaplan-Meier projections~Local control = control of primary tumor" (NCT01060007)
Timeframe: 30 months
Intervention | percentage of participants (Number) |
---|
Neoadjuvant Radiation Followed by FOLFOX | 95 |
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Rate of T Stage Downstaging
T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT). (NCT01060007)
Timeframe: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
Intervention | percentage of participants (Number) |
---|
Neoadjuvant Radiation Followed by FOLFOX | 71 |
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Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity
(NCT01060007)
Timeframe: 1 year (completion of all treatment)
Intervention | participants (Number) |
---|
Neoadjuvant Radiation Followed by FOLFOX | 21 |
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Freedom From Disease Relapse
Kaplan-Meier projections. (NCT01060007)
Timeframe: 30 months
Intervention | percentage of participants (Number) |
---|
Neoadjuvant Radiation Followed by FOLFOX | 87 |
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Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR)
"Percentage of participants with an overall response of CR or PR according to RECIST criteria.~CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions." (NCT01077739)
Timeframe: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 27.3 |
Bevacizumab + FOLFOX | 6.4 |
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PFS From the Start of First-Line Therapy
PFS from the start of first-line therapy was defined as the interval between the start of first-line therapy and the date at which second disease progression (after the start of beyond progression therapy) was documented. Progression of disease was evaluated using RECIST version 1.1 and abdominal/pelvic CT or MRI scanning. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method. (NCT01077739)
Timeframe: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Intervention | months (Median) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 17.8 |
Bevacizumab + FOLFOX | 18.0 |
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Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression
PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method. (NCT01077739)
Timeframe: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Intervention | months (Median) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 6.3 |
Bevacizumab + FOLFOX | 5.1 |
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Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression
Pro-angiogenic cytokine concentrations of placental growth factor (PlGF), basic fibroblast growth factor (bFGF), and hepatocyte growth factor (HGF) in participant sera were measured and reported in units of picograms/milliliter (pg/mL). The geometric mean was calculated as exp10 (mean of log10 transformed concentration) and the standard deviation (SD) is SD of log10 transformed concentration. (NCT01077739)
Timeframe: Baseline, every 9 weeks until disease progression, at final visit or at withdrawal, for up to 24 months
Intervention | pg/mL (Geometric Mean) |
---|
| Baseline bFGF (n=13,23) | bFGF, Prior to progression levels (n=12,18) | Baseline HGF (n=13,23) | HGF, Prior to progression levels (n=12,18) | Baseline PIGF (n=13,23) | PIGF, Prior to progression levels (n=12,18) |
---|
Bevacizumab + FOLFOX | 6.1 | 4.2 | 186.0 | 230.3 | 26.3 | 37.1 |
,Bevacizumab + Oxaliplatin + Capecitabine | 6.8 | 3.6 | 133.0 | 187.3 | 29.8 | 34.7 |
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Patient Reported Quality of Life
Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL (NCT01081262)
Timeframe: baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
Intervention | units on a scale (Mean) |
---|
| Baseline (pre-treatment) | Pre-Cycle 4 | Post-Cycle 6 | End of Bevacizumab (BEV) | Six Months after BEV | 2 Years after BEV |
---|
Arm II (Oxaliplatin and Capecitabine) | 62.3 | 72.9 | 73.5 | 53.3 | 53.0 | 56.0 |
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Patient Reported Quality of Life
Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL (NCT01081262)
Timeframe: baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
Intervention | units on a scale (Mean) |
---|
| Baseline (pre-treatment) | Pre-Cycle 4 | Post-Cycle 6 | Six Months Post-Chemo | End of Bevacizumab (BEV) | Six Months after BEV | 2 Years after BEV | 3 Years after BEV |
---|
Arm I (Carboplatin and Paclitaxel) | 62.6 | 57.5 | 65.2 | 74.1 | 68.9 | 54.0 | 71.7 | 76.4 |
,Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | 75.4 | 76.0 | 71.8 | 68.7 | 49.9 | 70.5 | 77.0 | 76.0 |
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Patient Reported Quality of Life
Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL (NCT01081262)
Timeframe: baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
Intervention | units on a scale (Mean) |
---|
| Baseline (pre-treatment) | Pre-Cycle 4 | Post-Cycle 6 | Six Months Post-Chemo | End of Bevacizumab (BEV) | Six Months after BEV | 2 Years after BEV | 3 Years after BEV | 4 Years after BEV | 5 Years after BEV |
---|
Arm III (Carboplatin, Paclitaxel, Bevacizumab) | 68.7 | 68.7 | 68.3 | 80.3 | 73.0 | 87.5 | 76.3 | 80.5 | 71.5 | 78.0 |
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Patient Reported Neurotoxicity
Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity. (NCT01081262)
Timeframe: baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
Intervention | units on a scale. (Mean) |
---|
| Baseline (pre-treatment) | Pre-cycle 4 | Post cycle 6 | Six months post chemo | End of bevacizumab (BEV) | Six months after BEV | 2 years after BEV | 3 years after BEV |
---|
Arm I (Carboplatin and Paclitaxel) | 16.0 | 7.3 | 6.5 | 5.0 | 16.0 | 10.0 | 8.0 | 14.0 |
,Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | 16.0 | 5.7 | 8.0 | 10.7 | 11.7 | 7.0 | 16.0 | 16.0 |
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Patient Reported Neurotoxicity
Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity. (NCT01081262)
Timeframe: baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
Intervention | units on a scale. (Mean) |
---|
| Baseline (pre-treatment) | Pre-cycle 4 | Post cycle 6 | End of bevacizumab (BEV) | Six months after BEV | 2 years after BEV |
---|
Arm II (Oxaliplatin and Capecitabine) | 15.3 | 11.8 | 11.7 | 10.0 | 10.0 | 14.0 |
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Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Grade 1 or higher non-serious adverse events were graded by CTC AE v 4. (NCT01081262)
Timeframe: Every cycle while on treatment, up to 5 years
Intervention | Participants (Count of Participants) |
---|
| Abnormal lab values | Allergic reaction | Allergic rhinitis | Alopecia | Anemia | Bleeding | Cold-like symptoms | Constipation | Diarrhea | dyspnea | Edema Limbs | Fatigue | Fever | Hand/Foot Syndrome | Headache | Hypertension | Hypomagnesemia | Infection | Laryngeal Spasm | Low Lymphocytes | Low Mood | Low Neutrophils | Low platelets | Low white Blood Cells | Mucositis | Nausea/Vomiting | Oral Problems | Other | Other GI Problems | Pain | Peripheral/Sensory Neuropathy | Pneumothorax | Raised CA19-9 | Raised Blood Counts | Rash | Stomatitis | Taste Alteration | Urinary Problems | Vaginal Bleeding | Weight Gain | Weight Loss |
---|
Arm I (Carboplatin and Paclitaxel) | 8 | 3 | 0 | 11 | 12 | 1 | 2 | 3 | 5 | 2 | 0 | 10 | 3 | 1 | 3 | 3 | 1 | 4 | 0 | 1 | 1 | 7 | 8 | 5 | 1 | 8 | 3 | 4 | 8 | 9 | 11 | 0 | 0 | 1 | 4 | 0 | 3 | 1 | 0 | 0 | 2 |
,Arm II (Oxaliplatin and Capecitabine) | 10 | 1 | 1 | 1 | 7 | 1 | 3 | 4 | 6 | 1 | 1 | 10 | 0 | 0 | 4 | 8 | 0 | 0 | 4 | 1 | 2 | 5 | 3 | 5 | 1 | 8 | 2 | 4 | 6 | 6 | 11 | 1 | 0 | 1 | 2 | 2 | 2 | 0 | 1 | 1 | 3 |
,Arm III (Carboplatin, Paclitaxel, Bevacizumab) | 10 | 0 | 1 | 9 | 4 | 3 | 7 | 7 | 5 | 3 | 0 | 8 | 2 | 0 | 5 | 9 | 2 | 3 | 0 | 2 | 1 | 4 | 5 | 4 | 1 | 9 | 4 | 7 | 7 | 7 | 8 | 0 | 2 | 0 | 3 | 1 | 1 | 1 | 1 | 1 | 4 |
,Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | 10 | 4 | 1 | 5 | 6 | 5 | 6 | 9 | 8 | 0 | 0 | 11 | 1 | 7 | 4 | 10 | 0 | 3 | 0 | 0 | 1 | 7 | 7 | 6 | 3 | 9 | 9 | 7 | 6 | 7 | 10 | 0 | 0 | 1 | 4 | 0 | 2 | 2 | 2 | 2 | 5 |
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Progression-free Survival
Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT01081262)
Timeframe: Is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.
Intervention | Months (Median) |
---|
Arm I (Carboplatin and Paclitaxel) | 36.1 |
Arm II (Oxaliplatin and Capecitabine) | 7.4 |
Arm III (Carboplatin, Paclitaxel, Bevacizumab) | 15.4 |
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | 23.3 |
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Objective Tumor Response
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),.>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR (NCT01081262)
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression, and any other time clinically indicated, up to 5 years
Intervention | Percentage of Participants (Number) |
---|
Arm I (Carboplatin and Paclitaxel) | 22 |
Arm II (Oxaliplatin and Capecitabine) | 27 |
Arm III (Carboplatin, Paclitaxel, Bevacizumab) | 43 |
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | 40 |
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Patient Reported Neurotoxicity
Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity. (NCT01081262)
Timeframe: baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
Intervention | units on a scale. (Mean) |
---|
| Baseline (pre-treatment) | Pre-cycle 4 | Post cycle 6 | Six months post chemo | End of bevacizumab (BEV) | Six months after BEV | 2 years after BEV | 3 years after BEV | 4 years after BEV | 5 years after BEV |
---|
Arm III (Carboplatin, Paclitaxel, Bevacizumab) | 14.3 | 12.7 | 11.0 | 11.3 | 9.5 | 9.0 | 5.5 | 9.5 | 6.5 | 7.5 |
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Overall Survival
Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact. (NCT01081262)
Timeframe: Up to five years
Intervention | months (Median) |
---|
Arm I (Carboplatin and Paclitaxel) | 37.6 |
Arm II (Oxaliplatin and Capecitabine) | 27.8 |
Arm III (Carboplatin, Paclitaxel, Bevacizumab) | 27.7 |
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | 55.7 |
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Duration of Response
Measured from the first time that measurement criteria were first met for objective response (documented CR or PR) until recurrence/progression or death whatever the cause. (NCT01095003)
Timeframe: Baseline up to 2 years 7 months
Intervention | Months (Median) |
---|
Vinflunine Plus Capecitabine | 57.3 |
Capecitabine Single-agent | 47.9 |
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Overall Survival
The overall survival (OS) was defined as the duration between the date of randomisation and the date of death from any cause. The OS analysis was performed in the ITT population and the eligible and per protocol populations once the required number of events (631 deaths) was observed Patients lost to follow-up, or without a known record of death at time of analysis had the OS censored at the date of last contact. (NCT01095003)
Timeframe: Baseline upto 3 years 10 months
Intervention | Months (Median) |
---|
Vinflunine Plus Capecitabine | 13.9 |
Capecitabine Single-agent | 11.7 |
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Progression Free Survival
"PFS is defined as time from date of randomization to date of the first documentation of objective tumor progression (according to the Independent Response Review Committee (IRC) and based on RECIST version 1.1) or death due to any cause.~The PFS was primarily analysed in the Intent-to-treat (ITT) population. Patients lost to follow-up, or without a known record of progression or death at time of analysis had the progression-free survival censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression, whichever occurs last." (NCT01095003)
Timeframe: Baseline up to 2 years 7 months
Intervention | Months (Median) |
---|
Vinflunine Plus Capecitabine | 5.6 |
Capecitabine Single-agent | 4.3 |
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Overall Response Rate (ORR)
ORR defined as documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first. (NCT01095003)
Timeframe: Baseline upto 2 years 7 months
Intervention | Percent (Number) |
---|
Vinflunine Plus Capecitabine | 22.9 |
Capecitabine Single-agent | 17.9 |
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Disease Control Rate
Disease control rate defined (DCR) as the sum of confirmed complete response, confirmed partial response and stabilisation rate. (NCT01095003)
Timeframe: Baseline up to 2 years 7 months
Intervention | Percent (Number) |
---|
Vinflunine Plus Capecitabine | 57.3 |
Capecitabine Single-agent | 47.9 |
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Progression-free Survival
Progression-free survival was defined as the time from the initiation of treatment to the earliest date of failure (disease progression, death from any cause, or a second malignancy) or to the last assessment date for patients who did not fail. Disease progression was defined as progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (eg, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, weaning of steroids, radiation necrosis, etc); or a greater than 25% increase in the bi-dimensional measurement of the tumor, as compared with the previous scan; or the appearance of a new lesion; or an increase in the doses of dexamethasone required to maintain stable neurologic status or imaging. (NCT01118377)
Timeframe: Baseline to the end of the study (up to 20 weeks)
Intervention | Months (Median) |
---|
Capecitabine + Radiation Therapy | 4.9 |
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Percentage of Participants With a Tumor Response
Tumor response was defined as either a complete response or a partial response prior to failure (disease progression, death from any cause, or a second malignancy). A complete response was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. A partial response was defined as a greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. (NCT01118377)
Timeframe: Baseline to the end of the study (up to 20 weeks)
Intervention | Percentage of participants (Number) |
---|
Capecitabine + Radiation Therapy | 2.3 |
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Overall Survival
Overall survival was defined as the time from the initiation of therapy to the date of death from any cause or to the date the patient was last known to be alive for surviving patients. (NCT01118377)
Timeframe: Baseline to the end of the study (up to 20 weeks)
Intervention | Months (Median) |
---|
Capecitabine + Radiation Therapy | 10.3 |
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Tolerated Dose
"Six subjects will be initially enrolled (neratinib 240 mg/day; capecitabine 1500 mg/m²/day on days 1 through 14). AEs and DLTs will be assessed from the first dose of investigational product through day 21. Based on the DLT rate in these first 6 subjects, dose tolerability will be confirmed as follows:~If ≤1 of the first 6 evaluable subjects experience a DLT by day 21, then this dose is considered tolerable, and enrollment will stop.~If ≥3 of the first 6 evaluable subjects experience a DLT by day 21, this dose is considered intolerable.~If 2 of the first 6 evaluable subjects experience a DLT by day 21, then an additional 4 subjects will be enrolled at the same dose level.~If a total of 10 subjects are enrolled, then the tolerability will be confirmed as follows:~If ≤3 of the total 10 subjects experience a DLT by day 21, then this dose will be considered tolerable.~If ≥4 of the total 10 subjects experience a DLT by day 21, then the dose will be considered intolerable." (NCT01128842)
Timeframe: From first dose date to day 21.
Intervention | mg (Number) |
---|
Neratinib + Capecitabine | 240 |
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Progression Free Survival
Number of weeks between the date of the first dose of test article and the first date of disease recurrence or disease progression (PD), or death due to any cause, was documented, censored at the last evaluation, investigator assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions. (NCT01128842)
Timeframe: From first dose date to PD or death, up to 41 weeks.
Intervention | weeks (Median) |
---|
Neratinib + Capecitabine | 15.6 |
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Objective Response Rate
Percentage of participants with partial response (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; and Non Progressive Disease (PD) for non-target lesions, and no new lesions. (NCT01128842)
Timeframe: From first dose date to progression or last tumor assessment, up to 41 weeks.
Intervention | percentage of participants (Number) |
---|
Neratinib + Capecitabine | 14.3 |
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Maximum Plasma Concentration of Neratinib in Combination With Capecitabine
Maximum plasma concentration (nanograms/milliliter) of Neratinib at day 14 following Administration of Neratinib 240 mg in combination with Capecitabine 1500 mg/m^2 per day to Japanese Subjects with Cancer. (NCT01128842)
Timeframe: Measured at 1, 2, 4, 6, 8 and 21-24 hours after dose on day 14.
Intervention | ng/mL (Mean) |
---|
Neratinib + Capecitabine | 61.9 |
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Dose Limiting Toxicity (DLT) - Percentage of Participants With DLT Events
DLT was defined as 1. Grade 3 or 4 non-hematologic toxicity (exceptions listed below as a.-c.), a. Grade 3 asthenia was NOT considered to be a DLT UNLESS it lasted >3 days. b. Grade 3 nausea or vomiting was NOT considered to be a DLT UNLESS the subject was already receiving optimal medical therapy. c. Grade 3 or 4 infection was NOT considered to be a DLT UNLESS it is associated with grade 3 or 4 neutropenia. 2. Grade 3 diarrhea that lasted >2 days while the subject was on optimal medical therapy or that was associated with fever (greater than or equal 38.0 ºC) or grade 3 dehydration. 3. Grade 4 neutropenia lasting ≥3 days or grade 4 febrile neutropenia. 4. Grade 4 thrombocytopenia lasting ≥3 days or complicated with bleeding or requiring platelet transfusion. 5. Delayed recovery (to National Cancer Institute [NCI] grade 1 or less, or baseline) from any of the toxicities listed above (items 1-4), that was related to study drug, and that delayed the next dose by more than 3 weeks. (NCT01128842)
Timeframe: From first dose date to day 21.
Intervention | Participants (Count of Participants) |
---|
Neratinib + Capecitabine | 1 |
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Area Under the Curve (AUC) of Neratinib in Combination With Capecitabine
AUC of Neratinib at day 14 following Administration of Neratinib 240 mg in combination with Capecitabine 1500 mg/m^2 per day to Japanese Subjects with Cancer. (NCT01128842)
Timeframe: At 1, 2, 4, 6, 8 and 21-24 hours after dose on day 14.
Intervention | ng*hr/mL (Mean) |
---|
Neratinib + Capecitabine | 1070 |
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Percentage of Participants With Pathological Complete Response (pCR)
pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery. (NCT01130337)
Timeframe: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25
Intervention | percentage of participants (Number) |
---|
Capecitabine+Oxaliplatin+Trastuzumab | 8.33 |
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Percentage of Participants With Objective Response
An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR was defined as the disappearance of all target lesions and persistence of greater than or equal to (≥) 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. (NCT01130337)
Timeframe: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25
Intervention | percentage of participants (Number) |
---|
Capecitabine+Oxaliplatin+Trastuzumab | 38.89 |
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Percentage of Participants With Disease-free Survival (DFS) at Month 18
DFS was the time elapsed from the time of surgery (for complete resection [R0] participants) until the date on which progression or death from any cause was documented (whichever occured first). Progression was defined as target lesions greater than (>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir. When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase. Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment). (NCT01130337)
Timeframe: Month 18
Intervention | percentage of participants (Number) |
---|
Capecitabine+Oxaliplatin+Trastuzumab | 76.12 |
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Percentage of Participants With Complete Tumor Resection (R0)
R0 resection was defined as having performed a complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation. (NCT01130337)
Timeframe: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25
Intervention | percentage of participants (Number) |
---|
Capecitabine+Oxaliplatin+Trastuzumab | 90.32 |
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Time to Progression (TTP)
TTP is defined as the time from date of randomization until objective tumor progression or death due to any cause. It includes deaths and thus can be correlated to overall survival. (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | months (Median) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 8.35 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 8.15 |
Bevacizumab + Capecitabine (650 mg/m^2) | 7.27 |
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Time to Treatment Failure
Time to treatment failure is defined as a composite endpoint measuring time from date of randomization to discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent. Analysis was performed using Kaplan-Meier estimates. (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | months (Median) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 6.67 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 6.87 |
Bevacizumab + Capecitabine (650 mg/m^2) | 5.75 |
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Duration of Overall Complete Response
Duration of complete response was calculated as the time in months from the date of randomization to the date of first documentation of CR. Kaplan-Meier estimates were used for analysis. (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years
Intervention | months (Median) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 8.35 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 6.05 |
Bevacizumab + Capecitabine (650 mg/m^2) | 12.89 |
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Duration of Overall Response
Duration of overall response included participants who achieved a CR or PR. (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | months (Median) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 6.51 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 6.61 |
Bevacizumab + Capecitabine (650 mg/m^2) | 9.12 |
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Duration of Stable Disease (SD)
Duration of SD was calculated as the number of months the participants remained in CR, PR or SD. Kaplan-Meier estimates were used for analysis. (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | months (Median) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 8.81 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 8.65 |
Bevacizumab + Capecitabine (650 mg/m^2) | 8.98 |
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Overall Survival
Overall survival is defined as the time from date of randomization until death from any cause; Kaplan-Meier estimates were used for analysis. (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | months (Median) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 22.75 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 19.76 |
Bevacizumab + Capecitabine (650 mg/m^2) | 18.02 |
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Percentage of Participants Who Died
Overall survival is defined as the time from date of randomization until death from any cause (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 67.33 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 71.57 |
Bevacizumab + Capecitabine (650 mg/m^2) | 73.79 |
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Percentage of Participants With a Best Overall Response of CR or PR
CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions; (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 52.0 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 34.0 |
Bevacizumab + Capecitabine (650 mg/m^2) | 34.0 |
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Percentage of Participants With Disease Progression or Death
Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices. (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 86.14 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 90.20 |
Bevacizumab + Capecitabine (650 mg/m^2) | 88.35 |
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Percentage of Participants With Progression Excluding Deaths
The failure event was defined as tumor progression excluding deaths due to any reason. (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 71.29 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 81.37 |
Bevacizumab + Capecitabine (650 mg/m^2) | 75.73 |
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Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment
Early progression was the proportion of participants with progressive disease within 12 weeks from the start of treatment. (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and 12
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 9.0 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 13.0 |
Bevacizumab + Capecitabine (650 mg/m^2) | 18.0 |
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Percentage of Participants With Stable Disease
Stable disease rate was the proportion of participants who achieved CR, PR, or SD. (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 91.0 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 86.0 |
Bevacizumab + Capecitabine (650 mg/m^2) | 80.0 |
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Time to Progression Excluding Deaths
The failure event was defined as tumor progression excluding deaths due to any reason. Kaplan-Meier estimates were used for analysis. (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | months (Median) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 8.81 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 8.48 |
Bevacizumab + Capecitabine (650 mg/m^2) | 7.40 |
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Percentage of Participants by Best Overall Response
Best overall response is defined as the best response recorded from the date of randomization until disease progression or recurrence. Complete response (CR): at least 2 determinations of CR at least 4 weeks apart before progression; Partial response (PR): at least 2 determinations of PR at least 4 weeks apart before progression; Stable disease (SD): at least one SD assessment; Progressive Disease (PD): Disease progression or death due to underlying cancer. CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions; PD: At least 20% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of longest diameter of all target lesions or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for CR or PR or increase in lesions; (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | percentage of participants (Number) |
---|
| CR | PR | SD | PD |
---|
Bevacizumab + Capecitabine (1250 mg/m^2) | 1.09 | 32.61 | 52.17 | 14.13 |
,Bevacizumab + Capecitabine (650 mg/m^2) | 5.32 | 28.72 | 45.74 | 20.21 |
,Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 5.49 | 46.15 | 39.56 | 8.79 |
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Percentage of Participants With Treatment Failure
Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent. (NCT01131078)
Timeframe: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | 100.0 |
Bevacizumab + Capecitabine (1250 mg/m^2) | 99.02 |
Bevacizumab + Capecitabine (650 mg/m^2) | 99.03 |
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Progression Free Survival (PFS) - Based on Investigator Review Using Kaplan Meier - Phase l & ll
(NCT01132664)
Timeframe: 18 months
Intervention | Months (Median) |
---|
| Phase l | Phase ll: PIK3CA wildtype (n =18) | Phase ll: PIK3CA mutated (n =8) |
---|
Phase Ib - 100mg | 3.3 | NA | NA |
,Phase Ib - 50 mg | 1.7 | NA | NA |
,Phase II - 100mg | NA | 1.7 | 1.8 |
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Overall Response Rate (ORR) - Phase ll
"Objective response rate (ORR) was defined as the rate of patients with best overall response (BOR) equal to complete response (CR) or partial response (PR) according to RECIST 1.0 from the Investigators review.~Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed of the disease status by imaging (i.e. CT/MRI): Complete Response (CR) = Disappearance of all tumor lesions; Partial Response (PR)= >=30% shrinkage of lesions; Overall Response (OR) = patients with CR and PR." (NCT01132664)
Timeframe: 18 months
Intervention | Participants (Number) |
---|
Phase II - 100mg | 5 |
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Clinical Benefit Rate (CBR) - Phase l & ll
"CBR = patients with CR, PR or SD ≥ 24 weeks according to RECIST by the investigator.~Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed the disease status by imaging (i.e. CT/MRI): CR = Disappearance of all tumor lesions; PR= >=30% shrinkage of lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline." (NCT01132664)
Timeframe: 18 months
Intervention | Participants (Number) |
---|
| Phase l | Phase ll |
---|
Phase Ib - 100mg | 3 | 0 |
,Phase Ib - 50 mg | 0 | 0 |
,Phase II - 100mg | 0 | 7 |
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Disease Control Rate (DCR) Based on Investigator Assessment- Phase l & ll
"Disease control rate (DCR) = patients with complete response (CR), partial response (PR) or stable disease (SD) as per RECIST criteria.~Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed the disease status by imaging (i.e. CT/MRI): CR = disappearance of all tumor lesions; PR = >=30% shrinkage of lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD); PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline." (NCT01132664)
Timeframe: 18 months
Intervention | Participants (Number) |
---|
| Phase l | Phase ll |
---|
Phase Ib - 100mg | 7 | 0 |
,Phase Ib - 50 mg | 1 | 0 |
,Phase II - 100mg | 0 | 25 |
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Dose Limiting Toxicity (DLT) - Phase l Only
Determination of the maximum tolerated dose (MTD) in the dose escalation part of the study was based upon the estimation of the probability of DLT in Cycle 1 in patients of the dose-determining set. (NCT01132664)
Timeframe: cycle 1 - 28 days
Intervention | Participants (Number) |
---|
| Primary system orgran class (SOC) PT - grade 1 | Primary SOC PT - grade 2 | Primary SOC PT (asthenia) - grade 3 | Primary SOC PT - grade 4 | Primary SOC PT - missing | Primary SOC PT (somatits/diarrhea) - grade 3 |
---|
BM Cohort - 100mg | 0 | 0 | 0 | 0 | 0 | 1 |
,BM Cohort - 80mg | 0 | 0 | 0 | 0 | 0 | 0 |
,Phase Ib - 100mg | 0 | 0 | 1 | 0 | 0 | 0 |
,Phase Ib - 50 mg | 0 | 0 | 0 | 0 | 0 | 0 |
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Here is the Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).
Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01134601)
Timeframe: Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 14 months and 26 days.
Intervention | Participants (Count of Participants) |
---|
Selumetinib (AZD6244): 50 mg & Capecitabine: 825 mg/m^2 | 1 |
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Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC])
Percent of participants with confirmed CR, PR, or NC. Per RECIST version (v)1.0: CR was defined as disappearance of all target and non-target lesions. PR was defined as ≥30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. NC was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions. (NCT01135498)
Timeframe: From study start up to approximately 4 years
Intervention | percentage of participants (Number) |
---|
Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib | 92.86 |
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Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])
Percentage of participants with objective response based assessment of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]) and no new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. (NCT01135498)
Timeframe: From study start up to approximately 4 years
Intervention | percentage of participants (Number) |
---|
Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib | 55.95 |
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Percentage of Participants Who Died
(NCT01135498)
Timeframe: From study start up to approximately 4 years
Intervention | percentage of participants (Number) |
---|
Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib | 58.89 |
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Percentage of Participants With Disease Progression or Death
Disease progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions. (NCT01135498)
Timeframe: Start of study to approximately 4 years
Intervention | percentage of participants (Number) |
---|
Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib | 61.1 |
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Progression-Free Survival
Progression-free survival was defined as the time from the date of informed consent until the date when the participant had progression of disease or died from disease progression. Participants who received surgical treatment after treatment ended were censored at the time of surgery. Participants who left the study for reasons other than progression of the disease were censored on the date on which they received a later antitumor therapy (with the same or different drugs, radiotherapy, or surgery). (NCT01135498)
Timeframe: From study start up to approximately 4 years
Intervention | months (Median) |
---|
Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib | 9.18 |
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Overall Survival (OS)
Overall survival was defined as the time from the date of informed consent to the date of death (regardless of the cause of death). There was no restriction; survival was calculated until the date of death, even if another line of treatment was received, or until the date censored (last contact with the participant even if drugs different from the study treatment schedule were received). For all participants, survival information was collected until the date of death, the last contact, or the last follow-up. (NCT01135498)
Timeframe: From study start up to approximately 4 years
Intervention | months (Median) |
---|
Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib | 25.79 |
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Freedom From Local Progression at 12 Months
the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk (NCT01151761)
Timeframe: 12 months
Intervention | percentage of patients (Number) |
---|
SBRT and Chemo | 0 |
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Liver Transplant Conversion Rate
The ability to successfully perform liver transplant among patients who initially have tumor >3 cm (NCT01151761)
Timeframe: 12 months
Intervention | participants (Number) |
---|
SBRT and Chemo | 0 |
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Liver Transplant Rate
The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm (NCT01151761)
Timeframe: 12 months
Intervention | participants (Number) |
---|
SBRT and Chemo | 0 |
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Overall Survival at 12 Months
the estimated probability for the percentage of participants with overall survival at 12 months. (NCT01151761)
Timeframe: 12 months
Intervention | probability (Number) |
---|
SBRT and Chemo | 0 |
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Pathologic Complete Response Rate
Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen. (NCT01151761)
Timeframe: 12 months
Intervention | participants (Number) |
---|
SBRT and Chemo | 0 |
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Progression-free Survival at 12 Months
Progression free survival is defined to be the time to progression of disease or death. (NCT01151761)
Timeframe: 12 months
Intervention | participants (Number) |
---|
SBRT and Chemo | 0 |
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Serum CA 19-9 Levels
Initial level of Cancer antigen 19-9 (NCT01151761)
Timeframe: 12 months
Intervention | U/ml (Mean) |
---|
SBRT and Chemo | 3329.1 |
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Duration of Response
Duration of overall response (CR or PR) was calculated for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method. (NCT01159171)
Timeframe: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Intervention | months (Mean) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 8.31 |
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Duration of Response - Percentage of Participants With an Event by 24 Months
Duration of overall response (CR or PR) was calculated only for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. (NCT01159171)
Timeframe: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 57.14 |
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Duration of Stable Disease
Duration of stable response (CR, PR, or SD) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method. (NCT01159171)
Timeframe: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Intervention | months (Mean) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 10.09 |
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Duration of Stable Disease - Percentage of Participants With an Event by 24 Months
Duration of stable response (CR, PR, or stable disease [SD]) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. (NCT01159171)
Timeframe: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 52.50 |
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Overall Survival
OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit. Mean OS was estimated using the Kaplan-Meier method. (NCT01159171)
Timeframe: Baseline, monthly to end of study (up to 24 months)
Intervention | months (Mean) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 20.23 |
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Overall Survival (OS) - Percentage of Participants With an Event by 24 Months
OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit. (NCT01159171)
Timeframe: Baseline, monthly to end of study (up to 24 months)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 89.90 |
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Percentage of Participants With Objective Response (OR)
Percentage of participants with OR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met. (NCT01159171)
Timeframe: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 42.86 |
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Time to Progression
TTP was defined as the time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1. Mean TTP was estimated using the Kaplan-Meier method. (NCT01159171)
Timeframe: Baseline, monthly to end of study (up to 24 months)
Intervention | months (Mean) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 9.61 |
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Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months
TTP was defined as the time time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1. (NCT01159171)
Timeframe: Baseline, monthly to end of study (up to 24 months)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 91.84 |
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Time to Treatment Failure
TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). Mean TTF was estimated using the Kaplan-Meier method. (NCT01159171)
Timeframe: Baseline, monthly to end of study (up to 24 months)
Intervention | months (Mean) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 7.44 |
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Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months
TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). (NCT01159171)
Timeframe: Baseline, every month to end of treatment (up to 24 months)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 81.63 |
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Percentage of Participants by Best Overall Response
Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to RECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: ≥30% decrease under baseline of the sum of the LD diameters of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum longest diameter recorded or the appearance of one or more new lesions. (NCT01159171)
Timeframe: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Intervention | percentage of participants (Number) |
---|
| CR | PR | SD | PD |
---|
Bevacizumab + Oxaliplatin + Capecitabine | 4.08 | 38.78 | 38.78 | 8.16 |
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Objective Response Rate (ORR)
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. (NCT01191697)
Timeframe: Patients received a median of 19 cycles of therapy (Interquartile range (IQR): 8 - 34.5 cycles). Median duration of follow-up of 23.2 months (IQR: 11.0 - 46.9 months ).
Intervention | percentage of patients (Number) |
---|
Trastuzumab, Bevacizumab, Oxaliplatin and Capecitabine | 81 |
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Maximum Tolerated Dose (MTD) of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)
Dose just below the one at which ≥ 1/3 of subjects experience a dose limiting toxicity (DLT) considered the MTD. (NCT01193517)
Timeframe: Up to 3 weeks from the first dose
Intervention | mg/m^2 (Number) |
---|
| Azacitidine | Oxaliplatin | Capecitabine |
---|
Azacitidine+CAPOX (Capecitabine, Oxaliplatin) | 75 | 110 | 1500 |
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Response Rate of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)
Per Response Evaluation Criteria in solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by CT or MRI: Partial Response (PR), >= 30%decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither PD nor PR, the sum of the longest diameters no change or increase by <20% from baseline or from nadir (smallest sum on treatment); Progressive Disease (PD), the sum of the longest diameters increases by>= 20% from nadir (smallest sum on treatment). For non-target lesions assessed by CT or MRI: Stable Disease (SD), Persistence of >=1 non-target lesion; Progressive Disease (PD), Enlargement of non-target lesions and/or appearance of new lesions. (NCT01193517)
Timeframe: After 9 weeks (three, 21 day cycles)
Intervention | Participants (Count of Participants) |
---|
| NA (Early Progression) | PD (Progression Disease) | SD (Stable Disease) |
---|
Phase I: Highest Dose Level | 0 | 6 | 6 |
,Phase I: Starting Dose | 1 | 1 | 1 |
,Phase II | 0 | 1 | 10 |
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Number of Participants With Adverse Events
Toxicity was graded according to the NCI Common terminology Criteria for Adverse Events (CTCAE) 4.0 except for neurosensory and skin toxicity. Neurosensory toxicity was graded according to the Neurologic Toxicity Scale for Oxaliplatin Dose Adjustments. (NCT01208103)
Timeframe: 39 months
Intervention | participants (Number) |
---|
Bevacizumab + Capecitabine + Oxaliplatin | 30 |
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Number of Participants With Progression-free Survival (PFS) at Six Months
A Bayesian sequential monitoring design will be used. PFS will be estimated using the Kaplan-Meier method.The length of time interval in months from date of first treatment, during and after the treatment a participant lives without progression. (NCT01208103)
Timeframe: 6 months
Intervention | percentage of participants (Number) |
---|
Bevacizumab + Capecitabine + Oxaliplatin | 68 |
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To Determine the Overall Survival (OS) for CAPOX and Bevacizumab
The length of time interval in months from date of first treatment until the date of death or lost follow-up (NCT01208103)
Timeframe: 39 months
Intervention | months (Median) |
---|
Bevacizumab + Capecitabine + Oxaliplatin | 12.9 |
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To Determine the Response Rate (RR) for CAPOX and Bevacizumab
Complete response + Partial response using RECIST 1.1 (Response Evaluation Criteria in Solid Tumor) (NCT01208103)
Timeframe: 39 months
Intervention | Participants (Count of Participants) |
---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease | Unevaluable |
---|
Bevacizumab + Capecitabine + Oxaliplatin | 1 | 13 | 10 | 5 | 1 |
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To Determine the Overall PFS for CAPOX and Bevacizumab
Time interval in months from date of first treatment until the date of first documented progression (NCT01208103)
Timeframe: 39 months
Intervention | months (Median) |
---|
Bevacizumab + Capecitabine + Oxaliplatin | 8.7 |
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Preliminary Efficacy Assessment: Response Rate (RR)
Response Rate (RR) is defined as the total number of patients with Complete Response (CR) or Partial Response (PR) as defined in RECIST v2. CR is defined as the dissappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor markers. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT01226732)
Timeframe: 18 months
Intervention | participants (Number) |
---|
Dose Level 1 | 1 |
Dose Level 2 | 0 |
Dose Level 3 | 0 |
Dose Level 4 | 2 |
Dose Level 5 | 1 |
Dose Level 6 | 0 |
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Dose Determination
To determine the maximum tolerated dose (MTD) of AUY922 plus capecitabine in patients with advanced solid tumors. (NCT01226732)
Timeframe: 18 months
Intervention | mg/m^2 (Number) |
---|
| AUY922 dose | Capecitabine dose |
---|
All Patients | 70 | 1250 |
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Overall Survival (OS) - Percentage of Participants With an Event
OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. (NCT01227707)
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
Intervention | percentage of participants (Number) |
---|
Bv+Capecitabine/Bv+Leucovorin+5-FU | 25.58 |
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Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment
Percentage of participants with an overall response of CR was evaluated as the proportion of participants with CR for the target and non-target lesions plus absence of new lesions at the end of NAT according to RECIST. CR was defined as disappearance of all target lesions, all non-target lesions, and normalization of tumor marker levels. (NCT01227707)
Timeframe: BL and within 6 weeks after the completion of study treatment
Intervention | percentage of participants (Number) |
---|
Bv+Capecitabine/Bv+Leucovorin+5-FU | 9.30 |
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Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure
(NCT01227707)
Timeframe: 6 to 8 weeks after completion of study treatment
Intervention | percentage of participants (Number) |
---|
| Anterior resection | Abdomen-peritoneal amputation (Miles) | Other | Colostomy, temporary (n=32) | Colostomy, definitive (n=32) | No colostomy |
---|
Bv+Capecitabine/Bv+Leucovorin+5-FU | 70.0 | 22.5 | 3.0 | 47.50 | 32.50 | 20.0 |
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Percentage of Participants With Pathological Complete Response (pCR)
pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected. (NCT01227707)
Timeframe: 6 to 8 weeks following completion of neoadjuvant treatment
Intervention | percentage of participants (Number) |
---|
Bv+Capecitabine/Bv+Leucovorin+5-FU | 10.00 |
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DFS - Time to Event
The time in months from date of start-of-treatment to the date of event defined as the first documented disease progression or death due to any cause. If a participant did not have an event, the time was censored at the date of last adequate tumor assessment. DFS was estimated using the Kaplan-Meier method. (NCT01227707)
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
Intervention | months (Mean) |
---|
Bv+Capecitabine/Bv+Leucovorin+5-FU | 27.43 |
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Disease-Free Survival (DFS) - Percentage of Participants With an Event
DFS was defined as the time from treatment start date to the date of first progression of disease or date of death due to any cause. (NCT01227707)
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
Intervention | percentage of participants (Number) |
---|
Bv+Capecitabine/Bv+Leucovorin+5-FU | 30.23 |
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TTP - Time to Event
TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. TTP was estimated using the Kaplan-Meier method. (NCT01227707)
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
Intervention | months (Mean) |
---|
Bv+Capecitabine/Bv+Leucovorin+5-FU | 27.68 |
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Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment
The percentage of participants with new lesions located at the primary tumor site were evaluated at the end of NAT. (NCT01227707)
Timeframe: BL and within 6 weeks after the completion of study treatment
Intervention | percentage of participants (Number) |
---|
Bv+Capecitabine/Bv+Leucovorin+5-FU | 4.65 |
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Time to Disease Progression (TTP) - Percentage of Participants With an Event
TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. (NCT01227707)
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
Intervention | percentage of participants (Number) |
---|
Bv+Capecitabine/Bv+Leucovorin+5-FU | 27.91 |
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Percentage of Participants With Relapse During Follow-Up
The percentage of participants with local and/or regional relapse during follow-up. New lesions located at rectum or at colon or at lymph node detected at the end of NAT were evaluated as local and/or regional relapse. (NCT01227707)
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
Intervention | percentage of participants (Number) |
---|
| No Relapse | 1 Relapse | 2 Relapses |
---|
Bv+Capecitabine/Bv+Leucovorin+5-FU | 84.21 | 7.89 | 7.89 |
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Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment
Percentage of participants with CR was evaluated as the proportion of participants with complete response for the target and non-target lesions, separately, at the end of NAT according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions or all non-target lesions and normalization of tumor marker levels. (NCT01227707)
Timeframe: BL and within 6 weeks after the completion of study treatment
Intervention | percentage of participants (Number) |
---|
| CR of target lesion(s) | CR of non-target lesion(s) |
---|
Bv+Capecitabine/Bv+Leucovorin+5-FU | 11.63 | 18.60 |
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OS - Time to Event
OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. OS was estimated using the Kaplan-Meier method. (NCT01227707)
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
Intervention | months (Mean) |
---|
Bv+Capecitabine/Bv+Leucovorin+5-FU | 32.14 |
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Maximum Observed Drug Concentration (Cmax) of Capecitabine and 5-fluorouracil
Maximum observed drug concentration, directly taken from analytical data. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. In the listed categories below, 'N' signifies the number of evaluable participants for the drug administered. (NCT01234337)
Timeframe: Pre-dose and 0.5, 1, 2, and 4 hours after capecitabine dosing at Cycle 2, Day 14
Intervention | milligram per liter (Geometric Mean) |
---|
| Capecitabine | 5-fluorouracil |
---|
Placebo + Capecitabine | 4.68 | 0.382 |
,Sorafenib (Nexavar, BAY43-9006) + Capecitabine | 6.05 | 0.434 |
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Number of Participants With Treatment-emergent Grade 3 and 4 Laboratory Abnormalities
Hematological (anemia, hemoglobin, international normalized ratio [INR], lymphocyte, neutrophil, platelet, white blood cell [WBC]), biochemical (ALT [alanine aminotransferase], AST [aspartate aminotransferase], GGT [gamma-glutamyl-transferase], lipase, hypoalbuminemia, hypocalcemia, hyperglycemia, hyperuricemia) evaluations were done. Common terminology criteria for adverse events (CTCAE) version 4-Grade 3: Severe or medically significant; hospitalization or prolongation of hospitalization and CTCAE version 4-Grade 4: life-threatening consequences; urgent intervention were indicated. (NCT01234337)
Timeframe: From the start of study treatment up to 30 days after the last dose
Intervention | Participants (Number) |
---|
| Anemia (grade 3) | Hemoglobin increased (grade 3) | INR increased (grade 3) | Lymphocyte count decreased (grade 3) | Neutrophil count decreased (grade 3) | Platelet count decreased (grade 3) | WBC decreased (grade 3) | ALT increased (grade 3) | AST increased (grade 3) | Alkaline phosphatase increased (grade 3) | Bilirubin increased (grade 3) | GGT increased (grade 3) | Lipase increased (grade 3) | Serum amylase increased (grade 3) | Hypoalbuminemia (grade 3) | Hypocalcemia (grade 3) | Hypokalemia (grade 3) | Hyponatremia (grade 3) | Hypophosphatemia (grade 3) | Hyperglycemia (grade 3) | Lymphocyte count decreased (grade 4) | Neutrophil count decreased (grade 4) | Platelet count decreased (grade 4) | WBC decreased (grade 4) | ALT increased (grade 4) | GGT increased (grade 4) | Lipase increased (grade 4) | Hypokalemia (grade 4) | Hyponatremia (grade 4) | Hypophosphatemia (grade 4) | Hyperuricemia (grade 4) |
---|
Placebo + Capecitabine | 7 | 3 | 9 | 17 | 19 | 2 | 13 | 5 | 5 | 13 | 1 | 21 | 12 | 4 | 2 | 6 | 11 | 7 | 15 | 10 | 2 | 7 | 7 | 3 | 0 | 2 | 1 | 4 | 0 | 0 | 0 |
,Sorafenib (Nexavar, BAY43-9006) + Capecitabine | 12 | 0 | 9 | 20 | 11 | 6 | 15 | 4 | 10 | 12 | 9 | 22 | 19 | 8 | 4 | 9 | 20 | 9 | 47 | 9 | 3 | 7 | 1 | 2 | 3 | 6 | 5 | 2 | 4 | 5 | 5 |
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Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score
The EQ-5D was a generic QoL preference based instrument and has been validated in the cancer populations. VAS was generated from 0 (worst imaginable health state) to 100 (best imaginable health state). This VAS score was referred to as the EQ-5D self-reported health status score. The results on ANCOVA of time-adjusted AUC were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'. (NCT01234337)
Timeframe: Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, and EOT (21 days after last dose of study drug)
Intervention | Scores on a scale (Least Squares Mean) |
---|
Sorafenib (Nexavar, BAY43-9006) + Capecitabine | 67.532 |
Placebo + Capecitabine | 69.228 |
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Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score
The EQ-5D was a generic Quality of life (QoL) based instrument validated in cancer populations. EQ-5D questionnaire contained a 5-item descriptive system of health states (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and visual analogue scale (VAS). A single HRQoL score ranging from -0.59 to 1 was generated from standard scoring algorithm developed by the EuroQoL was the EQ-5D index score, higher scores represent better health status. A change of at least 0.10 to 0.12 points was considered clinically meaningful. The results on the ANCOVA of time-adjusted AUC for the EQ-5D - Index Score were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'. (NCT01234337)
Timeframe: Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, and EOT (21 days after last dose of study drug)
Intervention | Scores on a scale (Least Squares Mean) |
---|
Sorafenib (Nexavar, BAY43-9006) + Capecitabine | 0.665 |
Placebo + Capecitabine | 0.69 |
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Objective Response Rate (ORR) by Central Review
ORR was defined as the best tumor response (Complete Response [CR] or Partial Response [PR]) observed during treatment or within 30 days after termination of study treatment, assessed according to the RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR=CR+PR. CR and PR were confirmed by another scan at least 4 weeks later. (NCT01234337)
Timeframe: From randomization of the first participant until approximately 3 years later or until disease radiological progression
Intervention | Percentage (%) of participants (Number) |
---|
Sorafenib (Nexavar, BAY43-9006) + Capecitabine | 13.5 |
Placebo + Capecitabine | 15.5 |
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Area Under Curve From Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Capecitabine and 5-fluorouracil
AUC(0-tlast) is defined as AUC from time 0 to the last data point, calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. In the listed categories below, 'N' signifies the number of evaluable participants for the drug administered. (NCT01234337)
Timeframe: Pre-dose and 0.5, 1, 2, and 4 hours after capecitabine dosing at Cycle 2, Day 14
Intervention | milligram*hour per liter (Geometric Mean) |
---|
| Capecitabine | 5-fluorouracil |
---|
Placebo + Capecitabine | 5.13 | 0.557 |
,Sorafenib (Nexavar, BAY43-9006) + Capecitabine | 7.12 | 0.621 |
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Time to Progression (TTP) by Central Review
TTP was defined as the time from date of randomization to disease radiological progression by central review. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates. (NCT01234337)
Timeframe: From randomization of the first participant until approximately 3 years later or until disease radiological progression
Intervention | days (Median) |
---|
Sorafenib (Nexavar, BAY43-9006) + Capecitabine | 168 |
Placebo + Capecitabine | 165 |
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Duration of Response (DOR) by Central Reader
DOR was defined as the time from date of first response (CR or PR) to the date when PD is first documented, or to the date of death, whichever occurred first according to RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. DOR defined for confirmed responders only (that is, CR or PR). 'NA' indicates that value could not be estimated due to censored data. Median and 95% CIs were computed using Kaplan-Meier estimates. (NCT01234337)
Timeframe: From randomization of the first participant until approximately 3 years later or until disease radiological progression
Intervention | days (Median) |
---|
Sorafenib (Nexavar, BAY43-9006) + Capecitabine | 313 |
Placebo + Capecitabine | 290 |
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Overall Survival (OS)
OS was defined as the time from date of randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last known alive date. Median and other 95% CIs computed using Kaplan-Meier estimates. (NCT01234337)
Timeframe: From randomization of the first participant until approximately 3 years later
Intervention | days (Median) |
---|
Sorafenib (Nexavar, BAY43-9006) + Capecitabine | 575 |
Placebo + Capecitabine | 616 |
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Progression-free Survival (PFS) Assessed by the Independent Review Panel According to Response Evaluation Criteria for Solid Tumors (RECIST) 1.1
PFS was defined as the time from date of randomization to disease progression, radiological or death due to any cause, whichever occurs first. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates. (NCT01234337)
Timeframe: From randomization of the first participant until approximately 3 years or until disease radiological progression
Intervention | days (Median) |
---|
Sorafenib (Nexavar, BAY43-9006) + Capecitabine | 166 |
Placebo + Capecitabine | 165 |
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Disease Control Rate (DCR) by Central Review
DCR was defined as the proportion of participants whose best response was CR, PR, stable disease (SD) or Non-CR/Non-PD. Per RECIST version 1.1, CR=all target lesions disappeared, any pathological lymph node, target/non-target, a reduction in short axis to <10 mm. PR=at least 30% decrease in the sum of diameters of target lesions taking as reference baseline sum diameters. PD=at least 20% increase in the sum of diameters of the target lesions, taking as a reference smallest sum on study. Appearance of new lesions and unequivocal progression of existing non-target lesions. SD=neither sufficient shrinkage qualified for PR nor sufficient increase qualified for PD, taking smallest sum of diameters as a reference. Non-CR/Non-PD=persistence of 1/more non-target lesion(s) and/or maintenance of tumor marker level above normal limits. DCR=CR+PR+SD or Non-CR/Non-PD. CR and PR confirmed by another scan at least 4 weeks later. SD and Non-CR/Non-PD documented at least 6 weeks after randomization. (NCT01234337)
Timeframe: From randomization of the first participant until approximately 3 years later or until disease radiological progression
Intervention | percentage (%) of participants (Number) |
---|
Sorafenib (Nexavar, BAY43-9006) + Capecitabine | 60.5 |
Placebo + Capecitabine | 58.3 |
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Patient Reported Outcomes: Functional Assessment of Cancer Therapy-Breast Symptom Index (8 Item) (FBSI-8)
The FBSI-8 was an 8-item questionnaire. Participants responded to each item using a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). A total scale score was calculated (range from 0 to 32), with higher scores indicating low symptomatology and reflecting a better Health-Related Quality of Life (HRQoL). The results on the analysis of covariance (ANCOVA) of time-adjusted area under curve (AUC) for the FBSI-8 score were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'. (NCT01234337)
Timeframe: Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, 31, 34, 37, and end of treatment (EOT, 21 days after last dose of study drug)
Intervention | Scores on a scale (Least Squares Mean) |
---|
Sorafenib (Nexavar, BAY43-9006) + Capecitabine | 20.915 |
Placebo + Capecitabine | 21.356 |
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Overall Survival (OS)
Overall survival is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive. (NCT01234402)
Timeframe: From Date of Randomization until Death Due to Any Cause (Up To 160 weeks)
Intervention | Weeks (Median) |
---|
Ramucirumab + Capecitabine | 67.4 |
Icrucumab + Capecitabine | 62.1 |
Capecitabine | 71.6 |
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Number of Participants With Serious Adverse Events (SAEs)
"SAE was defined as any untoward medical occurrence that at any dose:~Resulted in death; Was life-threatening; Required inpatient hospitalization or caused prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Required intervention to prevent permanent impairment/damage; Was an important medical event (defined as a medical event that may not have been immediately life-threatening or resulted in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention to prevent one of the other serious outcomes listed in the definition above).~A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section." (NCT01234402)
Timeframe: Up To 160 Weeks
Intervention | Participants (Count of Participants) |
---|
Ramucirumab + Capecitabine | 20 |
Icrucumab + Capecitabine | 25 |
Capecitabine | 6 |
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Area Under the Concentration Versus Time Curve From Time Zero to Infinity of Ramucirumab or Icrucumab
Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity of Ramucirumab and Icrucumab. (NCT01234402)
Timeframe: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Intervention | microgram*hour/mL (Geometric Mean) |
---|
Ramucirumab + Capecitabine | 54400 |
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Number of Participants With Anti-Ramucirumab and Anti-Icrucumab Antibodies
(NCT01234402)
Timeframe: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Intervention | Participants (Count of Participants) |
---|
| Treatment emergent antibody | Neutralizing antibody |
---|
Ramucirumab + Capecitabine | 0 | 0 |
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Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab. (NCT01234402)
Timeframe: Cycle 2,4,6,8,0,12,14,16,18,22: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Intervention | Micro gram per milliliter (Geometric Mean) |
---|
| Cycle 2 | Cycle 4 | Cycle 6 | Cycle 8 | Cycle 10 | Cycle 12 | Cycle 14 | Cycle 16 | Cycle 18 | Cycle 22 |
---|
Ramucirumab + Capecitabine | 23.7 | 80.6 | 44.7 | 65.8 | 66.8 | 74.3 | 62.5 | 50.5 | 50.5 | 55.0 |
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Volume of Distribution at Steady State (Vss) of Ramucirumab or Icrucumab
Volume of Distribution at Steady State (Vss) of Ramucirumab and Icrucumab. (NCT01234402)
Timeframe: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Intervention | Liters (Geometric Mean) |
---|
Ramucirumab + Capecitabine | 3.17 |
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Number of Participants With Adverse Events (AEs)
"Adverse event (AE) will be regarded as treatment-emergent if onset date occurs any time on or after the administration of the first dose of study treatment up to 30 days after the last dose of study treatment (or up to any time if related to study treatment); or it occurs prior to first dose date and worsens while on therapy or up to 30 days after the last dose of study treatment (or up to any time if related to study treatment).~A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section." (NCT01234402)
Timeframe: Up To 160 Weeks
Intervention | Participants (Count of Participants) |
---|
Ramucirumab + Capecitabine | 52 |
Icrucumab + Capecitabine | 49 |
Capecitabine | 48 |
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Duration of Response
Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the criteria for progressive disease (PD) is met (taking as a reference for PD that smallest measurement recorded since the treatment started), or death, is objectively documented.CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression. (NCT01234402)
Timeframe: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 97 weeks)
Intervention | weeks (Median) |
---|
Ramucirumab + Capecitabine | 43.1 |
Icrucumab + Capecitabine | 20.1 |
Capecitabine | 17.1 |
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Clearance (Cl) of Ramucirumab or Icrucumab
Clearance (Cl) of Ramucirumab and Icrucumab. (NCT01234402)
Timeframe: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Intervention | Liters per hour (Geometric Mean) |
---|
Ramucirumab + Capecitabine | 0.0141 |
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Maximum Concentration (Cmax) Ramucirumab Drug Product (DP) or Icrucumab
(NCT01234402)
Timeframe: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Intervention | Microgram per milliliter (Geometric Mean) |
---|
Ramucirumab + Capecitabine | 308 |
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Progression-Free Survival (PFS)
PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) and the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up, or had missed 2 or more scheduled tumor assessments were censored at the day of their last adequate tumor assessment. (NCT01234402)
Timeframe: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 97 weeks)
Intervention | Weeks (Median) |
---|
Ramucirumab + Capecitabine | 22.1 |
Icrucumab + Capecitabine | 7.3 |
Capecitabine | 19.0 |
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Terminal Half-life (t½) of Ramucirumab or Icrucumab
Terminal half-life (t½) of Ramucirumab and Icrucumab. (NCT01234402)
Timeframe: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Intervention | Days (Geometric Mean) |
---|
Ramucirumab + Capecitabine | 6.80 |
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Percentage of Participants With Objective Response Rate (ORR)
The ORR is the number of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1 from the start of the treatment until disease progression/recurrence. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression. (NCT01234402)
Timeframe: From Date of Randomization until Disease Progression/Recurrence (Up to 97 weeks)
Intervention | Percentage of Participants (Number) |
---|
Ramucirumab + Capecitabine | 28.8 |
Icrucumab + Capecitabine | 20.4 |
Capecitabine | 34.7 |
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Survival
Overall survival is defined as the length of time from start of treatment to death from any cause. Estimated using the Kaplan-Meier method. (NCT01267240)
Timeframe: Up to 1 year
Intervention | months (Median) |
---|
Arm I (Capecitabine, Vorinostat) | 10.8 |
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Progression-free Survival
"PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions." (NCT01267240)
Timeframe: From time of treatment initiation to disease progression, death, or completion of the 1 year follow-up, whichever occurs first.
Intervention | months (Median) |
---|
Arm I (Capecitabine, Vorinostat) | 2.3 |
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Response Rate According to Response Evaluation Criteria in Solid Tumors
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR. (NCT01267240)
Timeframe: Up to 1 year
Intervention | participants (Number) |
---|
Arm I (Capecitabine, Vorinostat) | 2 |
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Overall Survival
Overall survival was defined as the time (in months) from randomization to death. (NCT01279681)
Timeframe: Up to 5 years
Intervention | months (Median) |
---|
Arm A [Fluoropyrimidine + Bevacizumab (BEV)] | 18.8 |
Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV] | 15.4 |
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Progression-Free Survival
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the time (in months) from the date of randomization to the date of documented disease progression or death, whichever occurs first. Patients were followed until progression (and progression was declared) regardless of whether the patient was on the first line treatment or not. Patients who progress following a missed scan will have their date of progression back-dated to the date of missing scan. Patients without a progression who are still alive at the time of analysis will be censored at the date of last follow-up. (NCT01279681)
Timeframe: Up to 5 years
Intervention | months (Median) |
---|
Arm A [Fluoropyrimidine + Bevacizumab (BEV)] | 6.7 |
Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV] | 6.7 |
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Response Rate, Defined as the Percentage of Patients in Each Arm Who Have an Objective Status of Complete Response or Partial Response, Confirmed by a Second Assessment Measured at Least 6 Weeks From the Initial Assessment
"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Response rate is reported as the percentage of participants who achieved Complete Response or Partial Response." (NCT01279681)
Timeframe: Up to 5 years
Intervention | percentage of participants (Number) |
---|
Arm A [Fluoropyrimidine + Bevacizumab (BEV)] | 47 |
Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV] | 38 |
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Phase 2: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of participants with a confirmed CR, PR, or SD of at least 6 months duration (durable SD) divided by the number of participants in the analysis set. CBR was determined by an investigator based on RECIST v1.1. CR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). CBR was summarized using the Clopper-Pearson method. (NCT01323530)
Timeframe: From the first dose of study drug until PD or 30 days after the last dose of study treatment (up to approximately 3.75 years)
Intervention | percentage of participants (Number) |
---|
Phase 2: Eribulin Mesilate 1.4 mg/m^2 | 57.1 |
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Phase 2: Stable Disease (SD) Rate
SD rate was defined as the percentage of participants with a SD that lasted for a minimum of 5 weeks. SD rate was assessed based on RECIST version 1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR: at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). (NCT01323530)
Timeframe: From the first dose of study drug until PD or up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
Intervention | percentage of participants (Number) |
---|
Phase 2: Eribulin Mesilate 1.4 mg/m^2 | 38.1 |
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Phase 2: Duration of Response (DOR)
DOR: time from first documented evidence of CR or PR until first documented sign of PD or death. DOR was assessed based on RECIST v 1.1. CR: disappearance of all target lesions. All pathological lymph nodes (whether target/non-target) must have a reduction in their short axis to >10 mm. PR: at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). DOR was summarized using the Kaplan-Meier method. (NCT01323530)
Timeframe: From date of the first CR or PR until the date of first documentation of PD or death or up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
Intervention | days (Median) |
---|
Phase 2: Eribulin Mesilate 1.4 mg/m^2 | 261.0 |
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Phase 2: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with a confirmed CR, PR, or SD divided by the number of participants in the analysis set. DCR was assessed by an investigator based on RECIST v1.1. CR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). DCR was summarized using the Clopper-Pearson method. (NCT01323530)
Timeframe: From the first dose of study drug until PD or 30 days after the last dose of study treatment (up to approximately 3.75 years)
Intervention | percentage of participants (Number) |
---|
Phase 2: Eribulin Mesilate 1.4 mg/m^2 | 81.0 |
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Phase 2: Objective Response Rate (ORR)
ORR was defined as the percentage of participants who had either a confirmed complete response (CR) or partial response (PR). ORR was assessed based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). CR was defined as disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. ORR was summarized using the Clopper-Pearson method. (NCT01323530)
Timeframe: From the first dose of study drug until PD or up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
Intervention | percentage of participants (Number) |
---|
Phase 2: Eribulin Mesilate 1.4 mg/m^2 | 42.9 |
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Phase 2: Progression-free Survival (PFS)
PFS was defined as the time from the first dose date until PD or death due to any cause. PFS was determined by an investigator based on RECIST v1.1. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). PFS was summarized using the Kaplan-Meier method. (NCT01323530)
Timeframe: From the first dose of study drug until PD or death due to any cause or 30 days after the last dose of study treatment (up to approximately 3.75 years)
Intervention | days (Median) |
---|
Phase 2: Eribulin Mesilate 1.4 mg/m^2 | 219.0 |
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Phase 2: Time to Response
Time to response (CR or PR) was defined as the time from the first dose until first documented evidence of CR or PR (whichever status was recorded first). Time to response was assessed based on RECIST v 1.1. CR was defined as disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. Time to response was summarized using the Kaplan-Meier method. (NCT01323530)
Timeframe: From the first dose of study drug treatment start date until date of first documented evidence of CR or PR or up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
Intervention | days (Median) |
---|
Phase 2: Eribulin Mesilate 1.4 mg/m^2 | 44.0 |
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Phase 2: Duration of Stable Disease (SD)
Duration of SD was measured from date of the first dose until progression. Duration of SD was assessed based on RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR: at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). Duration of SD was summarized using the Kaplan-Meier method. (NCT01323530)
Timeframe: From the first dose of study drug until PD or 30 days after the last dose of study treatment (up to approximately 3.75 years)
Intervention | days (Median) |
---|
Phase 2: Eribulin Mesilate 1.4 mg/m^2 | 162.0 |
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Phase 1b and Phase 2: Percentage of Participants With Non-CR/Non-PD
Non-CR/Non-PD was for participants who had non-target disease only (minimum duration from randomization to Non-CR/Non-PD >=7 weeks) and assessed by investigator based on RECIST v1.1. Non-CR/Non-PD: persistence of one or more non-target lesions, maintenance of tumor marker level above the normal limits. (NCT01323530)
Timeframe: From the first dose of study drug until PD or up to 30 days after the last dose of study treatment (up to approximately 3.75 years)
Intervention | percentage of participants (Number) |
---|
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2) | 0 |
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2) | 0 |
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2) | 0 |
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2) | 0 |
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2) | 16.7 |
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2) | 0 |
Phase 2: Eribulin Mesilate 1.4 mg/m^2 | 0 |
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Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0)
DLTs as per NCI CTCAE v3.0 were defined as:1) Neutropenia Grade 4 that lasted at least 7 days, 2) Neutropenia Grade 3 or 4 complicated by fever and/or infection (absolute neutrophil count [ANC] less than 1.0*10^9/liter [L], fever of at least 38.5 degree celsius [°C]), 3)Thrombocytopenia Grade 4, 4) Thrombocytopenia Grade 3 complicated by bleeding and/or requiring platelet or blood transfusion, 5) Non-hematological toxicity Grade 3 or higher (excluding Grade 3 nausea, and Grade 3 or 4 vomiting or diarrhea in participants who had not received optimal treatment with antiemetic and/or antidiarrheal medication; excluding laboratory abnormalities without clinical symptoms), 6) Delayed recovery from treatment-related toxicity resulting in dose delay greater than 14 days, 7) Failure to administer at least 75 percent (%) of planned study drugs during Cycle 1 as result of Grade 2 or higher treatment-related toxicity that constituted increase of at least 2 grades from baseline. (NCT01323530)
Timeframe: Cycle 1 (21 days)
Intervention | Participants (Count of Participants) |
---|
Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2) | 1 |
Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2) | 1 |
Phase 1b (Schedule 1): Eribulin Mesilate (2.0 mg/m^2) | 2 |
Phase 1b (Schedule 2): Eribulin Mesilate (0.7 mg/m^2) | 0 |
Phase 1b (Schedule 2): Eribulin Mesilate (1.1 mg/m^2) | 1 |
Phase 1b (Schedule 2): Eribulin Mesilate (1.4 mg/m^2) | 1 |
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TRC105 Steady State Pharmacokinetic Trough Concentration at the RP2D
Mean trough concentration for patients dosed at 10 mg/kg at cycle 2 day 1 (NCT01326481)
Timeframe: Cycle 2 day 1 (3 weeks)
Intervention | ng/mL (Mean) |
---|
Single | 66668.75 |
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Number of Participants With a Treatment-Emergent Adverse Event (TEAE)
Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious AEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. A TEAE was defined as an adverse event (AE) that had an onset date, or a worsening in severity from Baseline (pretreatment), on or after the first dose of study drug up to 30 days after the date of last study treatment. (NCT01355302)
Timeframe: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 1 year 1 month.
Intervention | Participants (Number) |
---|
Phase 1b: Golvatinib+Capecitabine+Cisplatin | 7 |
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Area Under The Concentration-Time Curve (AUC) From 0 to 24 Hours of Golvatinib
On days when pharmacokinetic (PK) samples were to be drawn, a predose blood sample was obtained prior to administration of golvatinib and capecitabine. After administration of study drugs, a second postdose blood sample was taken. The amount of golvatinib in the participant's blood was analyzed and the AUC was calculated. The AUC reflects the actual body exposure to drug after administration of a dose of the drug and is dependent on the rate of elimination of the drug from the body and the dose administered. Predose samples that were below the limit of quantitation (BLQ) or missing were assigned a numerical value of zero for the calculation of AUC. Any other BLQ concentrations were assigned a value of zero. Results were expressed in nanograms·hour/milliter (ng·h/mL). (NCT01355302)
Timeframe: Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment.
Intervention | ng·h/mL (Median) |
---|
| Cycle 1, Day -2 | Cycle 2, Day 1 |
---|
Phase 1b: Golvatinib+Capecitabine+Cisplatin | 23400 | 26300 |
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Maximum Concentration (Cmax) of Golvatinib
Blood samples were drawn to analyze the amount of golvatinib in the participant's serum. Maximum concentration refers to the maximum (or peak) serum concentration of study drug in the participant's system after administration of the study drug and prior to the administration of a second dose of the study drug. Results were expressed in nanograms/milliliter (ng/mL). (NCT01355302)
Timeframe: Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment.
Intervention | ng/mL (Median) |
---|
| Cycle 1, Day -2 | Cycle 2, Day 1 |
---|
Phase 1b: Golvatinib+Capecitabine+Cisplatin | 1680 | 1620 |
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Time to Maximum Concentration (Tmax) of Golvatinib
Tmax was defined as the time at which Cmax was observed for golvatinib in combination with cisplatin and capecitabine. (NCT01355302)
Timeframe: Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment.
Intervention | Hours (Median) |
---|
| Cycle 1, Day -2 | Cycle 2, Day 1 |
---|
Phase 1b: Golvatinib+Capecitabine+Cisplatin | 3.00 | 6.07 |
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Objective Response Rate (ORR) (Surgery After Chemotherapy and SBRT)
Percentage of participants with response per RECIST v1.0. Per RECIST v1.0: Complete Response (CR): the disappearance of a lesion; Near Complete Response (NCR): at least an 80% decrease in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. Partial Response (PR): at least a 30% decrease in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. (NCT01360593)
Timeframe: Up to 24 months
Intervention | percentage of participants (Number) |
---|
Gem + Xeloda + SBRT | 20.0 |
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Acute Toxicities Associated With SBRT
Percentage of patients that experience treatment-related toxicities as graded according to Common Terminology Criteria for Adverse Events (CTCAE v4), within 3 months after treatment, by grade. Patients were monitored for potential toxicity throughout treatment. (NCT01360593)
Timeframe: Up to 3 months following SBRT treatment
Intervention | percentage of participants (Number) |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|
Gem + Xeloda + SBRT | 88.24 | 29.41 | 14.71 | 2.94 |
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Objective Response Rate (ORR) (Neoadjuvant Chemotherapy)
Percentage of participants with response per RECIST v1.0. Per RECIST v1.0: Complete Response (CR): the disappearance of a lesion; Near Complete Response (NCR): at least an 80% decrease in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. Partial Response (PR): at least a 30% decrease in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. (NCT01360593)
Timeframe: Up to 24 months
Intervention | percentage of participants (Number) |
---|
Gem + Xeloda + SBRT | 28.13 |
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Overall Survival (OS)
The (median) length of time from enrollment to confirmed death from any cause. (NCT01360593)
Timeframe: Up to 32 months
Intervention | months (Median) |
---|
Gem + Xeloda + SBRT | 18.82546 |
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The Functional Assessment of Cancer Therapy - General (FACT-G)
The Functional Assessment of Cancer Therapy - General (FACT-G) is a self-administered, 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Quality of Life (QOL) evaluation will be administered prior to SBRT, after completion of SBRT, and at each follow-up. Scaling of items: Five-point scale for each questions from 0 (not at all) to 4 (very much); overall scoring 0-108. Higher scores indicated better quality of life. (NCT01360593)
Timeframe: Baseline; 2 - 4 weeks post chemotherapy; 4-6 weeks post SBRT; after surgery (up to 24 months)
Intervention | score on a scale (Median) |
---|
| Baseline | 2-4 weeks after Chemo | 4-6 weeks after SBRT | after Surgery, up to 24 months |
---|
Gem + Xeloda + SBRT | 54.0 | 54.0 | 51.5 | 49.5 |
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Number of Participants Able to Undergo a Margin-negative Resection After Neoadjuvant Therapy
Number of patients that are able to undergo a margin-negative resection after neoadjuvant therapy. Surgical evaluation: pathology records reviewed by operating surgeon to determine margin status as negative (not close (1-2.5mm), microscopically positive, and/or grossly positive). (NCT01360593)
Timeframe: Up to 24 months
Intervention | Participants (Count of Participants) |
---|
Gem + Xeloda + SBRT | 11 |
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Local Progression-free Survival (LPFS)
LPFS is defined as the time from enrollment to first documentation of progressive disease (PD) in the target lesion. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume. Death or development of distant disease is not regarded as an event. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, progressive disease is defined as at least a 25% increase in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. (NCT01360593)
Timeframe: Up to 32 months
Intervention | months (Median) |
---|
Gem + Xeloda + SBRT | 22.30801 |
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Late Toxicities Associated With SBRT
Percentage of patients that experience treatment-related toxicities as graded according to Common Terminology Criteria for Adverse Events (CTCAE v4), greater than 3 months after treatment, by grade. Patients were monitored for potential toxicity throughout treatment. (NCT01360593)
Timeframe: From 3 months following SBRT treatment up to 24 months
Intervention | percentage of participants (Number) |
---|
Gem + Xeloda + SBRT | 0 |
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Time to Progression (TTP)
The (median) length of time from enrollment to disease progression per Response Evaluation Criteria in Solid Tumors (v1.0). Per RECIST, Progressive Disease (PD) is defined at least a 25% increase in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. For lesions without size response the maintenance of CA 19-9 level above the normal limits indicates disease progression. (NCT01360593)
Timeframe: Up to 5 years
Intervention | months (Median) |
---|
Gem + Xeloda + SBRT | 16 |
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Number of Subjects With Adverse Events (AEs) and Serious AEs
Safety and tolerability will be assessed in accordance to the protocol of the parent study in which the subjects had participated, before enrolling in the AV-951-09-901 rollover study. (NCT01369433)
Timeframe: 24 Months
Intervention | Participants (Count of Participants) |
---|
| AEs | Treatment-related AEs | AEs ≥Grade 3 toxicity | AEs-study drug interruption | AEs-study drug dose reduction | AEs-discontinuation of study drug | AEs-death | Serious Adverse events (SAEs) | SAEs ≥Grade 3 toxicity | Serious treatment-related AEs |
---|
Combination Therapy | 16 | 15 | 12 | 6 | 0 | 1 | 1 | 5 | 5 | 0 |
,Monotherapy | 178 | 159 | 111 | 54 | 13 | 31 | 13 | 44 | 38 | 16 |
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PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and Low VEGF-A Levels
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX6 (ERCC-1 High, VEGF-A Low) | 12.52 |
Bevacizumab + FOLFIRI (ERCC-1 High, VEGF-A Low) | 12.68 |
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PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High) | 10.87 |
Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low) | 11.56 |
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PFS According to RECIST Version 1.1 in Participants With High Vascular Endothelial Growth Factor (VEGF)-A Levels Versus Participants With Low VEGF-A Levels
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High) | 10.02 |
Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low) | 12.68 |
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PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and High VEGF-A Levels
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX6 (ERCC-1 Low, VEGF-A High) | 9.76 |
Bevacizumab + FOLFIRI (ERCC-1 Low, VEGF-A High) | 11.07 |
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PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and Low VEGF-A Levels
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX6 (ERCC-1 Low, VEGF-A Low) | 11.10 |
Bevacizumab + FOLFIRI (ERCC-1 Low, VEGF-A Low) | 14.32 |
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Percentage of Participants With Objective Response According to RECIST Version 1.1
Objective response was defined as complete response (CR) or partial response (PR) according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution. (NCT01374425)
Timeframe: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + mFOLFOX6 | 61.2 |
Bevacizumab + FOLFIRI | 65.4 |
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PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX6 (ERCC-1 Low) | 10.97 |
Bevacizumab + FOLFIRI (ERCC-1 Low) | 12.68 |
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Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution. (NCT01374425)
Timeframe: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High) | 91.9 |
Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low) | 93.0 |
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OS in Participants With High ERCC-1 Levels
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX6 (ERCC-1 High) | 22.54 |
Bevacizumab + FOLFIRI (ERCC-1 High) | 26.51 |
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OS in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High) | 23.23 |
Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low) | 27.27 |
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Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of largest diameters (LD) of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 millimeters (mm). Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX6 | 10.09 |
Bevacizumab + FOLFIRI | 12.55 |
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PFS According to RECIST Version 1.1 in Participants With Wild-Type V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Versus Participants With Mutant KRAS
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type) | 12.45 |
Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant) | 10.94 |
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PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX6 (ERCC-1 High) | 9.92 |
Bevacizumab + FOLFIRI (ERCC-1 High) | 11.17 |
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Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution. (NCT01374425)
Timeframe: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + mFOLFOX6 (ERCC-1 High) | 56.3 |
Bevacizumab + FOLFIRI (ERCC-1 High) | 65.7 |
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Overall Survival (OS)
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX6 | 23.85 |
Bevacizumab + FOLFIRI | 27.47 |
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Percentage of Participants With Disease Control According to RECIST Version 1.1
Disease control was defined as CR, PR, or stable disease (SD) according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution. (NCT01374425)
Timeframe: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + mFOLFOX6 | 93.1 |
Bevacizumab + FOLFIRI | 91.0 |
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Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution. (NCT01374425)
Timeframe: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + mFOLFOX6 (ERCC-1 High) | 93.8 |
Bevacizumab + FOLFIRI (ERCC-1 High) | 85.1 |
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Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution. (NCT01374425)
Timeframe: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High) | 89.3 |
Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low) | 93.9 |
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Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution. (NCT01374425)
Timeframe: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High) | 61.1 |
Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low) | 64.8 |
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OS in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High) | 22.83 |
Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low) | 27.93 |
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Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS
Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution. (NCT01374425)
Timeframe: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type) | 66.3 |
Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant) | 60.9 |
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PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and High VEGF-A Levels
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX6 (ERCC-1 High, VEGF-A High) | 8.80 |
Bevacizumab + FOLFIRI (ERCC-1 High, VEGF-A High) | 11.17 |
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OS in Participants With Low ERCC-1 Levels
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX6 (ERCC-1 Low) | 25.53 |
Bevacizumab + FOLFIRI (ERCC-1 Low) | 27.93 |
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Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution. (NCT01374425)
Timeframe: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High) | 60.5 |
Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low) | 66.5 |
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Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution. (NCT01374425)
Timeframe: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + mFOLFOX6 (ERCC-1 Low) | 63.7 |
Bevacizumab + FOLFIRI (ERCC-1 Low) | 65.8 |
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OS in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley. (NCT01374425)
Timeframe: From Baseline until death (maximum up to 45 months overall)
Intervention | months (Median) |
---|
Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type) | 28.75 |
Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant) | 24.64 |
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Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution. (NCT01374425)
Timeframe: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Intervention | percentage of participants (Number) |
---|
Bevacizumab + mFOLFOX6 (ERCC-1 Low) | 92.7 |
Bevacizumab + FOLFIRI (ERCC-1 Low) | 95.0 |
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Adverse Events
Number of participants with at least 1 AE related to study treatment - The details on which AEs occured are listed in the Adverse Event section below (NCT01387295)
Timeframe: from start of treatment to 28 days after last treatment, an average of 7 months
Intervention | Participants (Count of Participants) |
---|
Chemotherapy | 38 |
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Number of Patients Suitable for Local Therapy (Radiofrequency)
Total number of patients receiving RF treatment or surgical treatment (NCT01387295)
Timeframe: upon completion of treatment, an average of 7 months
Intervention | Participants (Count of Participants) |
---|
Chemotherapy | 2 |
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PFS
From start of therapy to progression or death of any cause. (NCT01387295)
Timeframe: up to 6 years
Intervention | months (Median) |
---|
Chemotherapy | 12.8 |
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Survival
All patients in intent-to-treat population , calculated from start of treatment to death of any course (NCT01387295)
Timeframe: up to 7 years
Intervention | months (Median) |
---|
Chemotherapy | 24.0 |
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Percentage of Participants With Adverse Events
An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01399190)
Timeframe: Up to approximately 30 months
Intervention | percentage of participants (Number) |
---|
Bevacizumab | 74.6 |
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Response Rate (Tumor Assessments According to RECIST)
Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR (NCT01399190)
Timeframe: Up to approximately 30 months
Intervention | percentage of participants (Number) |
---|
| Response Rate | Complete remission | Partial remission |
---|
Bevacizumab | 48.4 | 6.7 | 41.7 |
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Progression-free Survival
Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions. (NCT01399190)
Timeframe: From randomization to progression or death during the study (up to approximately 30 months)
Intervention | months (Median) |
---|
Bevacizumab | 7.000 |
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Summary of Clinical Benefit
"A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria:~Subject showed improvement in at least one of the following parameters on successive scheduled observations without worsening in the others: pain intensity, analgesic use, or performance status~Subject was stable or improved on the pain intensity, analgesic use, and performance status and had a ≥ 7% increase in body weight maintained for 2 consecutive reporting periods that was not because of fluid accumulation." (NCT01423604)
Timeframe: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)
Intervention | percentage of participants (Number) |
---|
| Subjects with clinical benefit | Pain intensity - Improved | Analgesic use - Improved | Karnofsky performance status - Improved | Body weight - Improved |
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Placebo | 1.6 | 1.6 | 0.0 | 0.0 | 0.0 |
,Ruxolitinib | 12.5 | 10.9 | 4.7 | 3.1 | 3.1 |
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Durable Response Rate
Durable response was defined as subjects with a response of Partial response (PR) or better at 2 subsequent measurements that were at least 4 weeks apart. (NCT01423604)
Timeframe: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)
Intervention | percentage of participants (Number) |
---|
Ruxolitinib | 7.8 |
Placebo | 0.0 |
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Overall Survival
Overall survival was measured as the length of time (in days) between the randomization date and the date of death. (NCT01423604)
Timeframe: Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).
Intervention | days (Median) |
---|
Ruxolitinib | 136.5 |
Placebo | 129.5 |
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Progression-Free Survival (PFS)
Progression-free survival was defined as the length of time between the date of randomization and the earlier of death or progressive disease (PD), whichever was earlier, as assessed by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT01423604)
Timeframe: Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.
Intervention | days (Median) |
---|
Ruxolitinib | 51.0 |
Placebo | 46.0 |
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Objective Response Rate
Objective response rate (ORR) was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01423604)
Timeframe: Measured every 4 weeks for duration of study treatment (up to 8 months)
Intervention | percentage of participants (Number) |
---|
| Overall response | Complete response | Partial response |
---|
Placebo | 1.6 | 0.0 | 1.6 |
,Ruxolitinib | 7.8 | 1.6 | 6.3 |
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Use of Cold Cap for Alopecia
Alopecia (hair loss) is a potential side effect of some chemotherapy agents. Chemotherapeutic drugs are toxic and could potentially harm the hair follicles (wear hair grows from) resulting in the hair falling out. It can occur in small patches on various parts of the body or all over the body and is usually temporary when related to cancer treatment. Cold cap therapy is one form of therapy for alopecia involving hair loss from the scalp. Wearing a cap or head covering with cold packs before, during, or after chemotherapy may help prevent hair loss as the cold narrows the blood vessels in the skin on your head which may lead to less of the drug reaching the hair follicles. Alopecia was one of the most common adverse events (AEs) related to eribulin only. (NCT01439282)
Timeframe: On the day of study drug infusion treatments during Cycles 1 through 4
Intervention | Participants (Number) |
---|
| Participants with alopecia | Participants who used a cold cap | Participants who did not use a cold cap |
---|
Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine | 52 | 3 | 49 |
,Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine | 9 | 0 | 9 |
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Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%
Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant's body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2. For each individual participant, the regimen was considered feasible if that participant was able to achieve an RDI of at least 85% of the 4 cycles of eribulin plus capecitabine treatment. Missing doses due to any reason was counted as zero in the RDI calculation. (NCT01439282)
Timeframe: 21-Day Cycle 1 through 21-Day Cycle 4
Intervention | Percentage of participants (Number) |
---|
Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine | 77.6 |
Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine | 90.0 |
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
(NCT01439282)
Timeframe: Day 1 through 30 days after last dose of study drugs (approximately up to 3 years)
Intervention | participants (Number) |
---|
| TEAE | SAE |
---|
Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine | 67 | 14 |
,Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine | 10 | 1 |
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Disease-Free Survival (Time to Event)
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause). (NCT01442155)
Timeframe: Up to 3 years
Intervention | months (Median) |
---|
Capecitabine + Oxaliplatin | 25 |
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Safety: Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT01442155)
Timeframe: Up to 3 years
Intervention | percentage of participants (Number) |
---|
Capecitabine + Oxaliplatin | 39.19 |
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Percentage of Participants Who Died - Per Protocol Set (PPS)
The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS. (NCT01450696)
Timeframe: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)
Intervention | percentage of participants (Number) |
---|
Capecitabine + Cisplatin + Herceptin (6 mg/kg) | 51.5 |
Capecitabine + Cisplatin + Herceptin (10 mg/kg) | 59.4 |
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Percentage of Participants With Disease Progression or Death - PPS
Disease progression was defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 millimeters (mm). The percentage of participants who died or experienced disease progression as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS. (NCT01450696)
Timeframe: From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)
Intervention | percentage of participants (Number) |
---|
Capecitabine + Cisplatin + Herceptin (6 mg/kg) | 75.8 |
Capecitabine + Cisplatin + Herceptin (10 mg/kg) | 81.3 |
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Percentage of Participants Who Died - FAS
The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the FAS with available data. (NCT01450696)
Timeframe: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)
Intervention | percentage of participants (Number) |
---|
Capecitabine + Cisplatin + Herceptin (6 mg/kg) | 46.8 |
Capecitabine + Cisplatin + Herceptin (10 mg/kg) | 54.0 |
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Trastuzumab Cmin on Day 21 of Cycles 1 to 11 - FAS
Cmin samples were obtained in all participants randomized to receive Herceptin (FAS). The observed Cmin was recorded, averaged among all participants, and expressed in μg/mL. (NCT01450696)
Timeframe: Day 21 of Cycle 1, 2, 3, 4, 5, 7, 9, 11 (cycle length = 21 days)
Intervention | μg/mL (Mean) |
---|
| Cycle 1 (n=100,99) | Cycle 2 (n=93,76) | Cycle 3 (n=77,71) | Cycle 4 (n=73,61) | Cycle 5 (n=70,60) | Cycle 7 (n=51,44) | Cycle 9 (n=31,24) | Cycle 11 (n=24,16) |
---|
Capecitabine + Cisplatin + Herceptin (10 mg/kg) | 18.1 | 35.3 | 40.7 | 47.6 | 49.3 | 58.1 | 61.0 | 68.4 |
,Capecitabine + Cisplatin + Herceptin (6 mg/kg) | 17.1 | 19.2 | 23.2 | 25.9 | 26.7 | 31.4 | 33.7 | 32.5 |
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Trastuzumab Serum Concentration on Day 1 of Cycle 1 - FAS
Trastuzumab serum concentration samples were obtained in all participants randomized to receive Herceptin (FAS). The observed concentration values were recorded, averaged among all participants, and expressed in μg/mL. (NCT01450696)
Timeframe: Pre-dose (0 minutes) and within 15 minutes after end of 2-hour Herceptin infusion on Day 1 of Cycle 1 (cycle length = 21 days)
Intervention | μg/mL (Mean) |
---|
| Pre-dose (n=109,110) | End of infusion (n=110,111) |
---|
Capecitabine + Cisplatin + Herceptin (10 mg/kg) | 0.0204 | 137 |
,Capecitabine + Cisplatin + Herceptin (6 mg/kg) | 0.168 | 126 |
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Overall Survival - PPS
Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the PPS using the Kaplan-Meier approach. The 95% CI for median was computed using the method of Brookmeyer and Crowley. (NCT01450696)
Timeframe: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)
Intervention | months (Median) |
---|
Capecitabine + Cisplatin + Herceptin (6 mg/kg) | 10.809 |
Capecitabine + Cisplatin + Herceptin (10 mg/kg) | 9.363 |
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Overall Survival - FAS
Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the FAS using the Kaplan-Meier approach. The 95 percent (%) confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley. (NCT01450696)
Timeframe: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)
Intervention | months (Median) |
---|
Capecitabine + Cisplatin + Herceptin (6 mg/kg) | 12.485 |
Capecitabine + Cisplatin + Herceptin (10 mg/kg) | 10.612 |
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Progression-Free Survival - PPS
Progression-free survival was defined as the time between the day of randomization and the date of first documentation of disease progression or date of death, whichever occurred first, measured following RECIST Version 1.1 criteria. Disease progression was defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 mm. The 95% CI for median was computed using the method of Brookmeyer and Crowley. (NCT01450696)
Timeframe: From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)
Intervention | months (Median) |
---|
Capecitabine + Cisplatin + Herceptin (6 mg/kg) | 5.388 |
Capecitabine + Cisplatin + Herceptin (10 mg/kg) | 4.370 |
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Percentage of Participants With Objective Response - PPS
Objective response was defined as the occurrence of either a complete response (CR) or partial response (PR) as determined by RECIST Version 1.1 based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) were required to have reduction in short axis to <10 mm. PR was defined as a ≥30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. The 95% CI was constructed using Blyth-Still-Casella method. (NCT01450696)
Timeframe: From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)
Intervention | percentage of participants (Number) |
---|
Capecitabine + Cisplatin + Herceptin (6 mg/kg) | 57.6 |
Capecitabine + Cisplatin + Herceptin (10 mg/kg) | 50.0 |
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Disease Control Rate (DCR)
DCR is defined as the percentage of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. (NCT01459614)
Timeframe: Up to 22 months
Intervention | Percentage of Participants (Number) |
---|
Primary Cohort (21 Day Cycle) | 89 |
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Percentage of Participants Without Disease Progression (Progression-Free Survival) at 6 Months
PFS is defined as the percentage of patients with disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause at 6 months. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve. (NCT01459614)
Timeframe: 6 months
Intervention | percentage of participants (Number) |
---|
Primary Cohort (21 Day Cycle) | 78.6 |
Expansion Cohort (28 Day Cycle) | 30 |
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Progression-free Survival (PFS)
PFS is defined as the the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause . Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve. (NCT01459614)
Timeframe: Up to 21 months
Intervention | Months (Median) |
---|
Primary Cohort (21 Day Cycle) | 8.4 |
Expansion Cohort (28 Day Cycle) | 4.1 |
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Overall Survival (OS)
OS (in months) will be measured from date of first dose until death (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (NCT01459614)
Timeframe: Up to 28 months
Intervention | Months (Median) |
---|
Primary Cohort (21 Day Cycle) | 13.42 |
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Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL)
(NCT01461057)
Timeframe: Day 43
Intervention | percentage of participants (Number) |
---|
Pertuzumab 840/420 mg | 91.6 |
Pertuzumab 840/840 mg | 98.3 |
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Number of Participants With Adverse Events (AEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment. (NCT01461057)
Timeframe: From randomization of first participant to end of study (approximately 6 years)
Intervention | participants (Number) |
---|
Pertuzumab 840/420 mg | 15 |
Pertuzumab 840/840 mg | 15 |
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Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)
"by RECIST guideline Objective response rate = (Number of subjects with best overall response as confirmed CR or PR / Total number of subjects)*100.~Response rate = (Number of subjects with best overall response as CR or PR / Total number of subjects)*100.~Disease control rate = (Number of subjects with best overall response as confirmed CR or PR or SD / Total number of subjects)*100." (NCT01463982)
Timeframe: tumor response evaluation can continue to receive the study drug until PD confirmation
Intervention | percentage of participants (Number) |
---|
| Objective Response rate | Response Rate | Disease Control Rate |
---|
Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ | 33.3 | 33.3 | 50.0 |
,Capecitabine 800mg/㎡ + Oratecan 10mg/㎡ | 0.0 | 0.0 | 66.7 |
,Capecitabine 800mg/㎡ + Oratecan 15mg/㎡ | 0.0 | 0.0 | 42.9 |
,Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ | 0.0 | 0.0 | 100 |
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Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination
If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0) (NCT01463982)
Timeframe: Cycle 1 (21 days)
Intervention | percentage of participants (Number) |
---|
Capecitabine 800mg/㎡ + Oratecan 10mg/㎡ | 0.0 |
Capecitabine 800mg/㎡ + Oratecan 15mg/㎡ | 0.0 |
Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ | 50.0 |
Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ | 0.0 |
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Response Rate
This is the percentage of subjects that achieved either a complete response or a partial response per RECIST 1.1 criteria (NCT01471353)
Timeframe: 3 months
Intervention | percentage of participants (Number) |
---|
Sorafenib Plus Capecitabine (SorCape) | 2.38 |
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Sorafenib Activity
Determine activity of sorafenib plus capecitabine on progression free survival (PFS) in patients with advanced colorectal cancer. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT01471353)
Timeframe: 2 years
Intervention | days (Median) |
---|
Sorafenib Plus Capecitabine (SorCape) | 123 |
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Toxicity (Percentage of Subjects That Experienced an Adverse Event)
Evaluate acute toxicity of treatment. The toxicity assessments were graded by the NCI CTCAE (Clinical Trial Common Adverse Event) grading system - a global standard for assessments of clinical and laboratory toxicities. All toxicities are scored 1(mild) through 5 (death related to the event) based upon well-defined and reproducible definitions. (NCT01471353)
Timeframe: 12 months
Intervention | percentage of participants (Number) |
---|
| Adverse Events - Any Grade | Adverse Events - Grade 3 | Adverse Events - Grade 4 |
---|
Sorafenib Plus Capecitabine (SorCape) | 100 | 74 | 2 |
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Overall Survival
Evaluate overall survival after treatment. (NCT01471353)
Timeframe: 5 years
Intervention | days (Median) |
---|
Sorafenib Plus Capecitabine (SorCape) | 261 |
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Hematological Toxicity of the Combination of Pazopanib and Capecitabine
(NCT01498458)
Timeframe: 3 years
Intervention | Number of cycles (Number) |
---|
| Anemia Grade 1 to 4 | Leucopenia Grade 1 to 4 | Number of Cycles |
---|
Pazopanib + Capecitabine | 88 | 55 | 132 |
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Clinical Benefit Rate (CBR)
To determine the clinical benefit rate (CBR) in patients with measurable disease. CBR consists of complete response , partial response, and stable disease lasting greater than 24 weeks. All patients are included when determining this rate. 2 patients were on study treatment for a long time.Hence the outcome rate of 25 percent ( 2 from 8 patients) (NCT01498458)
Timeframe: 3 years
Intervention | percentage of participants (Number) |
---|
Pazopanib Plus Capecitabine | 25 |
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Dose-limiting Toxicity (DLT)
(NCT01498458)
Timeframe: 3 years
Intervention | participants (Number) |
---|
Pazopanib Plus Capecitabine | 5 |
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Other Toxicity of the Combination of Pazopanib and Capecitabine
(NCT01498458)
Timeframe: 3 years
Intervention | participants (Number) |
---|
| Hepatotoxicity | Hypertension | Pancreatectomy | Thrombocytopenia |
---|
Pazopanib Plus Capecitabine | 3 | 1 | 1 | 1 |
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Maximum Tolerable Dose (MTD) of Pazopanib
The maximum tolerated dose (MTD) is defined as the highest dose level with DLT in no more than 1 out of 6 patients. A maximal tolerated dose (MTD) could not be established. (NCT01498458)
Timeframe: 3 years
Intervention | mg (Number) |
---|
Pazopanib Plus Capecitabine | NA |
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Objective Response Rate (ORR)
To determine the objective response rate (ORR) in patients with measurable disease. ORR consists of complete response and partial response according to the RECIST criteria. Complete Response refers to the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to less than 10 mm. Partial Response refers to an at least 30 percent decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT01498458)
Timeframe: 3 years
Intervention | percentage of participants (Number) |
---|
Pazopanib Plus Capecitabine | 0 |
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Overall Survival (OS)
"Time from the date of enrollment to the date of death due to any cause or the last date the patient was known to be alive (censored observation) at the date of data cutoff for the final analysis. The results will be reported as median in months~The length of overall survival (OS) of participants was assessed by Kaplan-Meier analysis. The outcome is given as the median in months with full range." (NCT01525082)
Timeframe: 82 mo
Intervention | months (Median) |
---|
Bevacizumab + Capecitabine + Temozolomide | 49.8 |
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O6-methylguanine DNA Methyltransferase (MGMT) Status by Immunohistochemistry (IHC)
"O6-alkylguanine DNA alkyltransferase is a protein that in humans is encoded by the gene O6-methylguanine DNA methyltransferase (MGMT). Deficiency of the gene product, ie, the protein, is refereed to as MGMT deficiency, and is thought to be predictive of response to temozolomide and is more often associated with pancreatic NETs.~MGMT status in pre-treatment biopsy specimens was to be assessed by immuno-histochemistry (IHC), and associated to best clinical response. The outcome is reported by the the number of patients that were IHC-positive (MGMT detected) or IHC-negative (MGMT not detected), and by best clinical response [ie, complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)]. The outcome is reported as a number without dispersion." (NCT01525082)
Timeframe: 18 months
Intervention | participants (Number) |
---|
| IHC-positive and CR | IHC-positive and PR | IHC-positive and SD | IHC-positive and PD | IHC-negative and CR | IHC-negative and PR | IHC-negative and SD | IHC-negative and PD |
---|
Bevacizumab + Capecitabine + Temozolomide | 0 | 2 | 2 | 1 | 0 | 4 | 2 | 0 |
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Radiographic Response (RR)
"Tumor response to treatment with the combination of capecitabine & temozolomide plus bevacizumab in patients with metastatic or unresectable pancreatic neuroendocrine tumors was assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions. Response is defined as:~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Overall Response (OR) = CR + PR~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)~Stable disease (SD) = Small changes that do not meet any of the above criteria~The outcome is reported as the number of participants who between 3 and 18 months after treatment initiation achieve CR, PR, or clinical response (PR + CR), each a number without dispersion." (NCT01525082)
Timeframe: 18 months
Intervention | Participants (Count of Participants) |
---|
| Overall response (OR) | Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive disease (PD) |
---|
Bevacizumab + Capecitabine + Temozolomide | 9 | 0 | 9 | 9 | 1 |
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Progression-free Survival (PFS)
Progression-free survival (PFS) means the length of time that participants survive without disease (tumor) progression, and was assessed using Kaplan-Meier analysis. The outcome is given as the mean in months with standard error of the mean. (NCT01525082)
Timeframe: 82 months
Intervention | months (Mean) |
---|
Bevacizumab + Capecitabine + Temozolomide | 25.2 |
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Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs
(NCT01534637)
Timeframe: Week 1
Intervention | participants (Number) |
---|
Treatment (Antiemetic, Chemotherapy, and Radiation Therapy) | 6 |
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Number of Patients With Gastrointestinal Toxicities (Grade 3 and 4 Nausea and Vomiting) Associated With Delivering Fluorouracil/Gemcitabine Hydrochloride-based Chemotherapy With Upper Abdominal Radiation
Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Descriptive statistics (means, standard deviations, frequencies, etc.) will be presented for pretreatment patient characteristics. The rate of grade 3 and 4 nausea will be compared to the cut points during interim and final analyses. (NCT01534637)
Timeframe: Over 10 weeks
Intervention | participants (Number) |
---|
Treatment (Antiemetic, Chemotherapy, and Radiation Therapy) | 3 |
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Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs
(NCT01534637)
Timeframe: Week 5
Intervention | participants (Number) |
---|
Treatment (Antiemetic, Chemotherapy, and Radiation Therapy) | 5 |
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Number of Participants Experienced Dose Limited Toxicity
Dose related toxicity is defined as follows:1. luecopenia > grade 2; granular cell decrease > grade 2; anemia > grade 1; platelet > grade 1;SGPT/SGOT elevation > grade 1; ALP > grade 1; GGT > grade 1; Tbil > grade 1;renal function damag > grade 2;Non-gradular cell decreased fever > grade 1;nausea/vomiting > grade 1; fatigue > grade 2; weight loss > grade 2;gastritis > grade 2; dairrea > grade 2; abdominal pain > grade 2; upper gastrointestinal bleeding > grade 1;other toxic reaction > grade 2;KPS < 50 during the treatment (NCT01584544)
Timeframe: up to 7 weeks from start of the treatment
Intervention | participants (Number) |
---|
1000mg | 0 |
1200mg | 1 |
1350mg | 1 |
1500mg | 0 |
1650mg | 1 |
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Time to Failure of Strategy (TFS): Overall
TFS was defined as time from the start of initial treatment to documentation of first disease progression without entering Phase B, or second disease progression having entered Phase B. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate TFS. (NCT01588990)
Timeframe: Baseline up to disease progression, death or end of study (up to 4 years)
Intervention | months (Median) |
---|
Bevacizumab: Phase A and Phase B | 14.8 |
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AQoL-8D Global Utility Score: Phase B
AQoL-8D provides a global utility score and consists of 8 separately scored dimensions including Independent Living, Life Satisfaction, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses. Each of the 8 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best]) and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). (NCT01588990)
Timeframe: Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
Intervention | units on a scale (Mean) |
---|
| Phase B Baseline | Phase B Visit 2 (up to 4 years) | Phase B Visit 3 (up to 4 years) | Phase B Visit 4 (up to 4 years) | Phase B Visit 5 (up to 4 years) | Phase B Visit 6 (up to 4 years) | Phase B Visit 7 (up to 4 years) | Phase B Visit 8 (up to 4 years) | Phase B Visit 9 (up to 4 years) | Phase B Visit 10 (up to 4 years) | Phase B Visit 11 (up to 4 years) | Phase B Visit 12 (up to 4 years) | Phase B Visit 13 (up to 4 years) | Phase B Visit 14 (up to 4 years) | Phase B Visit 15 (up to 4 years) | Phase B Visit 16 (up to 4 years) | Phase B Visit 17 (up to 4 years) | Phase B Visit 18 (up to 4 years) | Phase B Visit 19 (up to 4 years) | Phase B Visit 20 (up to 4 years) | Phase B Visit 21 (up to 4 years) | Phase B Visit 22 (up to 4 years) | Phase B Visit 23 (up to 4 years) | Phase B Visit 24 (up to 4 years) | Phase B EOT Visit (up to 4 years) | Survival Follow-Up 1 (up to 4 years) | Survival Follow-Up 2 (up to 4 years) | Survival Follow-Up 3 (up to 4 years) | Survival Follow-Up 4 (up to 4 years) | Survival Follow-Up 6 (up to 4 years) |
---|
Bevacizumab: Phase B | 0.736 | 0.773 | 0.813 | 0.878 | 0.808 | 0.809 | 0.825 | 0.910 | 0.819 | 0.856 | 0.730 | 0.960 | 0.965 | 0.958 | 0.967 | 0.942 | 0.927 | 0.931 | 0.866 | 0.887 | 0.940 | 0.919 | 0.937 | 0.950 | 0.708 | 0.788 | 0.791 | 0.989 | 0.981 | 0.875 |
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European Quality of Life 5-Dimension (EuroQol-5D) Utility Score: Phase A
"EQ-5D is a standardized generic preference based health related quality of life instrument. It records how one's health is today and consists of a descriptive system. The descriptive system is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life." (NCT01588990)
Timeframe: Baseline, every 8-9 weeks thereafter, end of treatment (EOT) (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
Intervention | units on a scale (Mean) |
---|
| Phase A Baseline | Phase A Visit 2 (Weeks 8-9) | Phase A Visit 3 (Weeks 16-17) | Phase A Visit 4 (Weeks 24-25) | Phase A Visit 5 (Weeks 32-33) | Phase A Visit 6 (Weeks 40-41) | Phase A Visit 7 (Weeks 48-49) | Phase A Visit 8 (Weeks 56-57) | Phase A Visit 9 (Weeks 64-65) | Phase A Visit 10 (Weeks 72-73) | Phase A Visit 11 (Weeks 80-81) | Phase A Visit 12 (Weeks 88-89) | Phase A Visit 13 (Weeks 96-97) | Phase A Visit 14 (Weeks 104-105) | Phase A Visit 15 (Weeks 112-113) | Phase A Visit 16 (Weeks 120-121) | Phase A Visit 17 (Weeks 128-129) | Phase A Visit 18 (Weeks 136-137) | Phase A Visit 19 (Weeks 144-145) | Phase A Visit 20 (Weeks 152-153) | Phase A Visit 21 (Weeks 160-161) | Phase A Visit 22 (Weeks 168-169) | Phase A Visit 23 (Weeks 176-177) | Phase A EOT Visit (up to 4 years) | Survival Follow-Up 1 (up to 4 years) | Survival Follow-Up 2 (up to 4 years) | Survival Follow-Up 3 (up to 4 years) | Survival Follow-Up 4 (up to 4 years) | Survival Follow-Up 5 (up to 4 years) | Survival Follow-Up 6 (up to 4 years) | Survival Follow-Up 7 (up to 4 years) |
---|
Bevacizumab: Phase A | 0.830 | 0.857 | 0.865 | 0.853 | 0.869 | 0.892 | 0.872 | 0.881 | 0.894 | 0.843 | 0.898 | 0.915 | 0.844 | 0.899 | 0.878 | 0.899 | 0.873 | 0.909 | 0.947 | 0.852 | 0.933 | 0.813 | 0.900 | 0.817 | 0.768 | 0.901 | 0.819 | 0.843 | 1.000 | 0.835 | 0.816 |
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EuroQol-5D Utility Score: Phase B
"EQ-5D is a standardized generic preference based health related quality of life instrument. It records how one's health is today and consists of a descriptive system. The descriptive system is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life." (NCT01588990)
Timeframe: Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
Intervention | units on a scale (Mean) |
---|
| Phase B Baseline | Phase B Visit 2 (up to 4 years) | Phase B Visit 3 (up to 4 years) | Phase B Visit 4 (up to 4 years) | Phase B Visit 5 (up to 4 years) | Phase B Visit 6 (up to 4 years) | Phase B Visit 7 (up to 4 years) | Phase B Visit 8 (up to 4 years) | Phase B Visit 9 (up to 4 years) | Phase B Visit 10 (up to 4 years) | Phase B Visit 11 (up to 4 years) | Phase B Visit 12 (up to 4 years) | Phase B Visit 13 (up to 4 years) | Phase B Visit 14 (up to 4 years) | Phase B Visit 15 (up to 4 years) | Phase B Visit 16 (up to 4 years) | Phase B Visit 17 (up to 4 years) | Phase B Visit 18 (up to 4 years) | Phase B Visit 19 (up to 4 years) | Phase B Visit 20 (up to 4 years) | Phase B Visit 21 (up to 4 years) | Phase B Visit 22 (up to 4 years) | Phase B Visit 23 (up to 4 years) | Phase B Visit 24 (up to 4 years) | Phase B EOT Visit (up to 4 years) | Survival Follow-Up 1 (up to 4 years) | Survival Follow-Up 2 (up to 4 years) | Survival Follow-Up 3 (up to 4 years) | Survival Follow-Up 4 (up to 4 years) | Survival Follow-Up 6 (up to 4 years) |
---|
Bevacizumab: Phase B | 0.814 | 0.859 | 0.894 | 0.897 | 0.866 | 0.837 | 0.876 | 0.874 | 0.908 | 0.811 | 0.806 | 0.844 | 1.000 | 1.000 | 0.844 | 0.833 | 0.844 | 0.833 | 0.827 | 0.816 | 0.844 | 0.844 | 0.827 | 0.844 | 0.809 | 0.740 | 0.772 | 0.827 | 0.827 | 1.000 |
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FACT-C Score: Phase B
FACT-C is one part of the FACIT Measurement System, which comprehensively assesses the health-related QoL of cancer participants and participants with other chronic illnesses. It is composed of 27 items of the general version of the FACT-C as a general core QoL measure and has a disease-specific subscale containing 9 colorectal cancer-specific items. It consists of total 36 items, summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range from 0 to 28, emotional well-being (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL. (NCT01588990)
Timeframe: Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
Intervention | units on a scale (Mean) |
---|
| Phase B Baseline | Phase B Visit 2 (up to 4 years) | Phase B Visit 3 (up to 4 years) | Phase B Visit 4 (up to 4 years) | Phase B Visit 5 (up to 4 years) | Phase B Visit 6 (up to 4 years) | Phase B Visit 7 (up to 4 years) | Phase B Visit 8 (up to 4 years) | Phase B Visit 9 (up to 4 years) | Phase B Visit 10 (up to 4 years) | Phase B Visit 11 (up to 4 years) | Phase B Visit 12 (up to 4 years) | Phase B Visit 13 (up to 4 years) | Phase B Visit 14 (up to 4 years) | Phase B Visit 15 (up to 4 years) | Phase B Visit 16 (up to 4 years) | Phase B Visit 17 (up to 4 years) | Phase B Visit 18 (up to 4 years) | Phase B Visit 19 (up to 4 years) | Phase B Visit 20 (up to 4 years) | Phase B Visit 21 (up to 4 years) | Phase B Visit 22 (up to 4 years) | Phase B Visit 23 (up to 4 years) | Phase B Visit 24 (up to 4 years) | Phase B EOT Visit (up to 4 years) | Survival Follow-Up 1 (up to 4 years) | Survival Follow-Up 2 (up to 4 years) | Survival Follow-Up 3 (up to 4 years) | Survival Follow-Up 4 (up to 4 years) | Survival Follow-Up 6 (up to 4 years) |
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Bevacizumab: Phase B | 103.47 | 108.71 | 108.19 | 114.89 | 110.60 | 111.28 | 114.78 | 120.39 | 108.08 | 110.50 | 109.33 | 125.00 | 119.00 | 117.00 | 126.00 | 123.00 | 127.00 | 126.00 | 127.00 | 126.00 | 123.00 | 124.00 | 126.00 | 130.00 | 101.67 | 98.72 | 102.50 | 126.33 | 125.00 | 124.67 |
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Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Score: Phase A
FACT-C is one part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, which comprehensively assesses the health-related QoL of cancer participants and participants with other chronic illnesses. It is composed of 27 items of the general version of the FACT-C as a general core QoL measure and has a disease-specific subscale containing 9 colorectal cancer-specific items. It consists of total 36 items, summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range from 0 to 28, emotional well-being (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL. (NCT01588990)
Timeframe: Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
Intervention | units on a scale (Mean) |
---|
| Phase A Baseline | Phase A Visit 2 (Weeks 8-9) | Phase A Visit 3 (Weeks 16-17) | Phase A Visit 4 (Weeks 24-25) | Phase A Visit 5 (Weeks 32-33) | Phase A Visit 6 (Weeks 40-41) | Phase A Visit 7 (Weeks 48-49) | Phase A Visit 8 (Weeks 56-57) | Phase A Visit 9 (Weeks 64-65) | Phase A Visit 10 (Weeks 72-73) | Phase A Visit 11 (Weeks 80-81) | Phase A Visit 12 (Weeks 88-89) | Phase A Visit 13 (Weeks 96-97) | Phase A Visit 14 (Weeks 104-105) | Phase A Visit 15 (Weeks 112-113) | Phase A Visit 16 (Weeks 120-121) | Phase A Visit 17 (Weeks 128-129) | Phase A Visit 18 (Weeks 136-137) | Phase A Visit 19 (Weeks 144-145) | Phase A Visit 20 (Weeks 152-153) | Phase A Visit 21 (Weeks 160-161) | Phase A Visit 22 (Weeks 168-169) | Phase A Visit 23 (Weeks 176-177) | Phase A EOT Visit (up to 4 years) | Survival Follow-Up 1 (up to 4 years) | Survival Follow-Up 2 (up to 4 years) | Survival Follow-Up 3 (up to 4 years) | Survival Follow-Up 4 (up to 4 years) | Survival Follow-Up 5 (up to 4 years) | Survival Follow-Up 6 (up to 4 years) | Survival Follow-Up 7 (up to 4 years) |
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Bevacizumab: Phase A | 103.84 | 103.33 | 106.34 | 109.66 | 109.39 | 111.30 | 111.40 | 113.51 | 113.92 | 115.11 | 114.00 | 115.99 | 113.54 | 112.36 | 119.48 | 116.38 | 113.69 | 112.94 | 117.55 | 115.86 | 106.00 | 112.00 | 105.00 | 103.94 | 102.89 | 104.00 | 105.50 | 109.00 | 119.00 | 103.61 | 115.00 |
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Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Overall
Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment. (NCT01588990)
Timeframe: Baseline up to disease progression, death or end of study (up to 4 years)
Intervention | percentage of participants (Number) |
---|
| Complete response | Partial response |
---|
Bevacizumab: Phase A and Phase B | 3.1 | 8.6 |
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Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase A
Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment. (NCT01588990)
Timeframe: Baseline up to disease progression, death or end of study (up to 4 years)
Intervention | percentage of participants (Number) |
---|
| Complete response | Partial response |
---|
Bevacizumab: Phase A | 3.1 | 8.6 |
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Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase B
Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment. (NCT01588990)
Timeframe: From the start of Phase B treatment to disease progression, death or end of study (up to 4 years)
Intervention | percentage of participants (Number) |
---|
| Complete response | Partial response |
---|
Bevacizumab: Phase B | 0 | 0 |
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Survival Beyond First Disease Progression: Overall
Survival beyond first progression was defined as the time from the date of first disease progression to death due to any cause. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate survival beyond first disease progression. (NCT01588990)
Timeframe: Baseline until death or end of study (up to 4 years)
Intervention | months (Median) |
---|
Bevacizumab: Phase A and Phase B | 12.6 |
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PFS Until Second Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase B
PFS in Phase B (PFS-B) was defined as the time from the start of Phase B treatment to documentation of second disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate PFS. (NCT01588990)
Timeframe: From the start of Phase B treatment to disease progression, death or end of study (up to 4 years)
Intervention | months (Median) |
---|
Bevacizumab: Phase B | 6.7 |
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PFS Until First Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase A
PFS until first progression was defined as the time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate PFS. (NCT01588990)
Timeframe: Baseline up to first disease progression, death or end of study (up to 4 years)
Intervention | months (Median) |
---|
Bevacizumab: Phase A | 9.2 |
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Assessment of Quality of Life - Eight Dimensions (AQoL-8D) Global Utility Score: Phase A
AQoL-8D provides a global utility score and comprised of 35 questions from which 8 dimensions (Independent Living, Life Satisfaction, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses) are derived. Each of the 8 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best]) and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). (NCT01588990)
Timeframe: Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
Intervention | units on a scale (Mean) |
---|
| Phase A Baseline | Phase A Visit 2 (Weeks 8-9) | Phase A Visit 3 (Weeks 16-17) | Phase A Visit 4 (Weeks 24-25) | Phase A Visit 5 (Weeks 32-33) | Phase A Visit 6 (Weeks 40-41) | Phase A Visit 7 (Weeks 48-49) | Phase A Visit 8 (Weeks 56-57) | Phase A Visit 9 (Weeks 64-65) | Phase A Visit 10 (Weeks 72-73) | Phase A Visit 11 (Weeks 80-81) | Phase A Visit 12 (Weeks 88-89) | Phase A Visit 13 (Weeks 96-97) | Phase A Visit 14 (Weeks 104-105) | Phase A Visit 15 (Weeks 112-113) | Phase A Visit 16 (Weeks 120-121) | Phase A Visit 17 (Weeks 128-129) | Phase A Visit 18 (Weeks 136-137) | Phase A Visit 19 (Weeks 144-145) | Phase A Visit 20 (Weeks 152-153) | Phase A Visit 21 (Weeks 160-161) | Phase A Visit 22 (Weeks 168-169) | Phase A Visit 23 (Weeks 176-177) | Phase A EOT Visit (up to 4 years) | Survival Follow-Up 1 (up to 4 years) | Survival Follow-Up 2 (up to 4 years) | Survival Follow-Up 3 (up to 4 years) | Survival Follow-Up 4 (up to 4 years) | Survival Follow-Up 5 (up to 4 years) | Survival Follow-Up 6 (up to 4 years) | Survival Follow-Up 7 (up to 4 years) |
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Bevacizumab: Phase A | 0.747 | 0.760 | 0.767 | 0.796 | 0.800 | 0.831 | 0.818 | 0.851 | 0.822 | 0.827 | 0.839 | 0.856 | 0.831 | 0.815 | 0.871 | 0.869 | 0.859 | 0.880 | 0.915 | 0.864 | 0.806 | 0.811 | 0.709 | 0.739 | 0.718 | 0.792 | 0.696 | 0.620 | 0.800 | 0.810 | 0.874 |
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Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio
NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. Longitudinal NLR was assessed by treating the NLR measurements taken over the time-course of treatment as a time-dependent covariate. OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. The association between longitudinal NLR (longitudinal NLR ≤5 vs NLR >5) and OS was reported as hazard ratio. (NCT01588990)
Timeframe: Baseline up to death or end of study (up to 4 years)
Intervention | hazard ratio (Number) |
---|
Bevacizumab: Phase A and Phase B | 2.2 |
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Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio
NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. Longitudinal NLR was assessed by treating the NLR measurements taken over the time-course of treatment as a time-dependent covariate. PFS was defined as time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as: an unequivocal and clinically meaningful increase in size of known tumors, appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. The association between longitudinal NLR (longitudinal NLR ≤5 vs N>5) and PFS was reported as hazard ratio. (NCT01588990)
Timeframe: Baseline up to disease progression, death or end of study (up to 4 years)
Intervention | hazard ratio (Number) |
---|
Bevacizumab: Phase A and Phase B | 1.3 |
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Association Between Neutrophil to Lymphocyte Ratio (NLR) [NLR ≤5 Versus NLR >5] and Progression-Free Survival (PFS) as Assessed by Hazard Ratio
NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. PFS was defined as the time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (carcinoembryonic antigen [CEA]) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. The association between NLR (NLR less than or equal to [≤] 5 vs greater than [>] 5) and PFS was reported as hazard ratio. (NCT01588990)
Timeframe: Baseline up to disease progression, death or end of study (up to 4 years)
Intervention | hazard ratio (Number) |
---|
Bevacizumab: Phase A and Phase B | 1.4 |
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Association Between NLR (NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio
NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. The association between NLR (NLR ≤ 5 vs > 5) and OS was reported as hazard ratio. (NCT01588990)
Timeframe: Baseline up to disease progression, death or end of study (up to 4 years)
Intervention | hazard ratio (Number) |
---|
Bevacizumab: Phase A and Phase B | 1.6 |
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Association Between NLR Normalization (First NLR Post-Baseline ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio
NLR was calculated from laboratory values as ratio of Neutrophils to Lymphocytes. NLR normalization was assessed by adding first post-baseline measurement of NLR to the primary model. This is equivalent to testing whether first change in NLR is significantly associated with outcome. PFS was defined as time from start of initial treatment to documentation of first disease progression or death from any cause. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was defined as: an unequivocal and clinically meaningful increase in size of known tumors, appearance of ≥1 new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.The association between NLR normalization (first NLR post-baseline ≤5 vs >5) and PFS was reported as hazard ratio. (NCT01588990)
Timeframe: Baseline up to disease progression, death or end of study (up to 4 years)
Intervention | hazard ratio (Number) |
---|
Bevacizumab: Phase A and Phase B | 0.9 |
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Duration of Disease Control (DDC) as Assessed by the Investigator Based on Routine Clinical Practice: Overall
DDC was defined as PFS + PFS-B. In cases where a participant did not enter Phase B, then DDC was defined as PFS. PFS was defined as time from start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. PFS-B was time from start of Phase B treatment to documentation of second disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate DDC. (NCT01588990)
Timeframe: Baseline up to disease progression, death or end of study (up to 4 years)
Intervention | months (Median) |
---|
Bevacizumab: Phase A and Phase B | 14.0 |
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OS: Phase B
Overall Survival in Phase B was defined as the time from the start of treatment in Phase B to death due to any cause. Kaplan-Meier methodology was used to estimate OS. (NCT01588990)
Timeframe: From the start of Phase B treatment death or end of study (up to 4 years)
Intervention | months (Median) |
---|
Bevacizumab: Phase B | 14.9 |
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Overall Survival (OS) From the Start of Treatment to Study Completion: Overall
OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. Kaplan-Meier methodology was used to estimate OS. (NCT01588990)
Timeframe: Baseline until death or end of study (up to 4 years)
Intervention | months (Median) |
---|
Bevacizumab: Phase A and Phase B | 25.0 |
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Percentage of Participants Who Underwent Liver Resection: Overall
The results include percentage of participants who underwent potentially curative liver resection. (NCT01588990)
Timeframe: Baseline up to disease progression, death or end of study (up to 4 years)
Intervention | percentage of participants (Number) |
---|
Bevacizumab: Phase A and Phase B | 1.6 |
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Rate of R0 Resection
The rate of R0 resection of patients with borderline-resectable adenocarcinoma of the head of the pancreas, along with borderline-resectable and resectable adenocarcinoma of the body and tail of the pancreas. R0 resection means that following surgery, no cancer cells are seen microscopically at the resection margin. (NCT01591733)
Timeframe: Post-surgery (about 4 months post baseline)
Intervention | Participants (Count of Participants) |
---|
All Eligible - FOLFIRINOX + Radiation | 31 |
Resected Participants - FOLFIRINOX + Radiation | 31 |
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30 Day Post-operative Mortality Rate
The number of participants that died within 30 days after undergoing pancreaticoduodenectomy or distal pancreatectomy. (NCT01591733)
Timeframe: 30 days post surgery (about 6 months from baseline)
Intervention | Participants (Count of Participants) |
---|
FOLFIRINOX + Radiation | 0 |
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Local Control Rates
The number of participants that achieved local control. Local control was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Local Failure is defined as progression of the primary tumor, or to the reappearance of tumor at the primary site. (NCT01591733)
Timeframe: From the start of treatment until the end of treatment with FOLFIRINOX, or until disease progression (median duration of follow-up of approximately 14 months)
Intervention | Participants (Count of Participants) |
---|
FOLFIRINOX + Radiation | 32 |
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Response Rate
The percentage of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disease) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol. (NCT01661972)
Timeframe: approximately every 9 weeks and/or restaging, through study completion
Intervention | percentage of participants (Number) |
---|
Phase 2 | 2.22 |
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Recommended Phase II Dose (RPTD) for the Capecitabine and Aflibercept Doublet Combination
Phase 1 of this study will be the dose escalation component to determine safety and the Recommended Phase II dose (RPTD) for the capecitabine plus aflibercept combination. Cohort 1 will receive 850mg/m2 capecitabine and 6mg/kg aflibercept. If less than 2 of 6 patients experience a dose limiting toxicity in Cohort 1, then the next patients will be enrolled in Cohort 2 at 1000mg/m2 capecitabine and 6mg/kg aflibercept. RPTD is determined by the number of dose limiting toxicities (Primary obj 2 for Phase I). (NCT01661972)
Timeframe: RPTD for the study will be determined at the completion of Phase I; up to 1 year.
Intervention | mg/m2 (Number) |
---|
Phase 1 | 850 |
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Number of Dose-Limiting Toxicities (Phase 1)
"Number of patients experiencing a dose-limiting toxicity in each cohort.~A dose-limiting toxicity is defined as Grade 4 neutropenia, thrombocytopenia or anemia or grade 3 neutropenia or thrombocytopenia lasting over 7 days Grade 3 thrombocytopenia associated with bleeding Febrile Neutropenia Nausea/Vomiting or Diarrhea ≥ grade 3 and lasting ≥ 4 days despite adequate supportive measures Grade ≥ 3 Bilirubin, ALT or AST > 7 days Other non-hematologic toxicity ≥ grade 3 excluding alopecia, anorexia, fatigue, hypertension, isolated lab abnormalities (not clinically significant) and/ rare, idiosyncratic reactions to any of the study drugs. Anorexia, fatigue and hypertension will be considered as DLT only if they reach grade 4 or are considered unmanageable Treatment delay of ≥ 14 days for cycle 2 due to unresolved toxicity Treatment-related death or clinically significant,treatment-related hospitalization" (NCT01661972)
Timeframe: 28 days
Intervention | Participants (Count of Participants) |
---|
Phase 1 Cohort 1 | 1 |
Phase 1 Cohort 2 | 2 |
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Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment
Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed. (NCT01664494)
Timeframe: Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
Intervention | Participants (Number) |
---|
| Adjuvant therapy | First line therapy | Second line therapy | Third line therapy |
---|
Capecitabine | 220 | 176 | 89 | 78 |
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One-year Survival Rate
Subjects will be followed after treatment completed to determine length of survival rate. The primary study objective was 1-year overall survival (OS, failure: death due to any cause). The Kaplan-Meier method was used to estimate the one-year OS. Secondary Objectives were the frequency of serious adverse events, disease control rate and progression-free survival. (NCT01683422)
Timeframe: One year after treatment completed.
Intervention | percentage of participants (Number) |
---|
Proton Radiation | 55.6 |
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Mean Duration of Capecitabine Therapy
(NCT01696695)
Timeframe: Baseline up to 1254 days
Intervention | Days (Mean) |
---|
mCRC Participants | 188.8 |
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Percentage of Participants With Dose Modification of Capecitabine
(NCT01696695)
Timeframe: Baseline up to 1254 days
Intervention | Percentage of participants (Number) |
---|
mCRC Participants | 85.6 |
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Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1
Overall response is defined as a complete response (CR) or a partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. Participants were evaluated for tumor response per RECIST v1.1 and assessed by computed tomography (CT) or magnetic resonance imaging (MRI):CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions.PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. (NCT01696695)
Timeframe: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
Intervention | Percentage of participants (Number) |
---|
mCRC Participants | 24.3 |
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PFS by Therapeutic Regimens
PFS was assessed using RECIST v1.1 and is defined as the time from the first dose of indicated treatment to PD or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm; progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method. (NCT01696695)
Timeframe: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
Intervention | Days (Median) |
---|
| Capecitabine monotherapy (n=246) | Capecitabine + bevacizumab (n=25) | Capecitabine + irinotecan (n=106) | Capecitabine + irinotecan + bevacizumab (n= 91) | Capecitabine + oxaliplatin (n=173) | Capecitabine + oxaliplatin + bevacizumab (n= 49) |
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mCRC Participants | 194 | 391 | 242 | 392 | 240 | 392 |
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Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1
Clinical benefit was defined as having a confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST v1.1.CR: complete disappearance of all target lesions and non-target disease,with the exception of nodal disease.All nodes,both target and non-target, must decrease to normal (short axis <10 mm).No new lesions.PR: >=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes,while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters while on study.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions,or presence of new lesions. (NCT01696695)
Timeframe: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
Intervention | Percentage of participants (Number) |
---|
mCRC Participants | 82.9 |
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Phase 1 (LA/mGC): AUC(0-inf) of Capecitabine
AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation. (NCT01702558)
Timeframe: Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1
Intervention | h*ng/mL (Mean) |
---|
Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape | 5131 |
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Phase 1 (LA/mGC): Cmax of Capecitabine
Cmax for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation. (NCT01702558)
Timeframe: Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1
Intervention | ng/mL (Mean) |
---|
Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape | 4925 |
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Phase 1 (LA/mGC): MTD of Capecitabine When Combined With Trastuzumab Emtansine (2.4 mg/kg QW)
MTD was defined as the dose level for which the probability of DLT is equal to a protocol-specified target probability. A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting >7 consecutive days; febrile neutropenia with ANC <1000 cells/mm^3; Grade >/=3 diarrhea or Grade 3 hand-foot syndrome; any other Grade >/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for >14 days; <14 full doses of capecitabine; Cycle 2 dose level <100%. (NCT01702558)
Timeframe: Continuously during 3 weeks
Intervention | mg/m^2 (Number) |
---|
Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape | 700 |
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Phase 1 (LA/mGC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1
Tumor response was assessed by the investigator according to RECIST v1.1. BOR in Phase 1 was defined as percentage of participants with a CR or PR. CR was defined as the disappearance of all TLs and non-TLs; SA reduction to <10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as >/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. (NCT01702558)
Timeframe: Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 1.5 years overall)
Intervention | percentage of participants (Number) |
---|
Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape | 83.3 |
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Phase 1 (LA/mGC): Percentage of Participants With DLTs
A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting >7 consecutive days; febrile neutropenia with ANC <1000 cells/mm^3; Grade >/=3 diarrhea or Grade 3 hand-foot syndrome; any other Grade >/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for >14 days; <14 full doses of capecitabine; Cycle 2 dose level <100%. (NCT01702558)
Timeframe: Continuously during 3 weeks
Intervention | percentage of participants (Number) |
---|
Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape | 0.0 |
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Phase 1 (LA/mGC): Serum Concentration of Trastuzumab
Trastuzumab was derived from trastuzumab emtansine. (NCT01702558)
Timeframe: Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)
Intervention | mcg/mL (Mean) |
---|
| Cycle 1, Post-dose | Cycle 2, Pre-dose | Cycle 2, Post-dose |
---|
Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape | 33.1 | 18.5 | 57.6 |
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Phase 1 (mBC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1
Tumor response was assessed by the investigator according to RECIST v1.1. BOR in Phase 1 was defined as percentage of participants with a CR or PR. CR was defined as the disappearance of all TLs and non-TLs; SA reduction to <10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as >/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. (NCT01702558)
Timeframe: Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 3.5 years overall)
Intervention | percentage of participants (Number) |
---|
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape | 83.3 |
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape | 100.0 |
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Phase 1 (mBC): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) of Capecitabine
AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation. (NCT01702558)
Timeframe: Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1
Intervention | hours*nanograms per milliliter (h*ng/mL) (Mean) |
---|
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape | 3973 |
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape | 5440 |
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Phase 1 (mBC): Maximum Tolerated Dose (MTD) of Capecitabine When Combined With Trastuzumab Emtansine (3.6 mg/kg Every 3 Weeks)
MTD was defined as the dose level for which the probability of DLT is equal to a protocol-specified target probability. A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting >7 consecutive days; febrile neutropenia with ANC <1000 cells/mm^3; Grade >/=3 diarrhea or Grade 3 hand-foot syndrome (in absence of DPD deficiency only for DL 1); any other Grade >/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for >14 days (>7 days for DL 1); for DL -1 only: <14 full doses of capecitabine; Cycle 2 dose level <100%. (NCT01702558)
Timeframe: Continuously during Cycle 1 (up to 3 weeks)
Intervention | mg/m^2 (Number) |
---|
Phase 1 (mBC) Cohort 1: T-DM1 + Cape | 700 |
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Phase 1 (mBC): Maximum Observed Plasma Concentration (Cmax) of Capecitabine
Cmax for Capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for percent coefficient of variation (CV%) and not for standard deviation. (NCT01702558)
Timeframe: Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1
Intervention | nanograms per milliliter (ng/mL) (Mean) |
---|
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape | 2990 |
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape | 5652 |
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Phase 1 (LA/mGC): Serum Concentration of Trastuzumab Emtansine
(NCT01702558)
Timeframe: Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)
Intervention | mcg/mL (Mean) |
---|
| Cycle 1, Post-dose | Cycle 2, Pre-dose | Cycle 2, Post-dose |
---|
Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape | 30.1 | 10.1 | 46.4 |
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Phase 1 (LA/mGC): t1/2 of Capecitabine
Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation. (NCT01702558)
Timeframe: Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1
Intervention | hours (Mean) |
---|
Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape | 0.65 |
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Phase 1 (mBC): Serum Concentration of Trastuzumab Emtansine
(NCT01702558)
Timeframe: Pre-trastuzumab emtansine dose (0 hour [h]) on Day 1 Cycle 2; 15-30 minutes (min) after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)
Intervention | micrograms per milliliter (mcg/mL) (Mean) |
---|
| Cycle 1, Post-dose | Cycle 2, Pre-dose | Cycle 2, Post-dose |
---|
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape | 78.6 | 2.1 | 78.5 |
,Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape | 81.3 | 1.17 | 70.5 |
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Phase 1 (mBC): Serum Concentration of Trastuzumab
Trastuzumab was derived from trastuzumab emtansine. (NCT01702558)
Timeframe: Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)
Intervention | mcg/mL (Mean) |
---|
| Cycle 1, Post-dose | Cycle 2, Pre-dose | Cycle 2, Post-dose |
---|
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape | 92.9 | 14.0 | 94.7 |
,Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape | 89.1 | 11.8 | 74.8 |
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Phase 2 (mBC): Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST v1.1
TTF was defined as the time (in months) from randomization until treatment failure (PD, death, withdrawal due to AE or laboratory abnormality, or refusal of treatment). PD as assessed by the investigator according to RECIST v1.1 was defined as >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants who did not experience any of the above events while on study were censored on the date of their last tumor assessment. The median TTF and 90% CI was estimated using Kaplan-Meier method. (NCT01702558)
Timeframe: Baseline until treatment failure, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)
Intervention | months (Median) |
---|
Phase 2 (mBC): T-DM1 + Cape | 9.86 |
Phase 2 (mBC): T-DM1 | 7.66 |
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Phase 2 (mBC): Time to Response (TTR) as Assessed by the Investigator According to RECIST v1.1
Tumor response was assessed by the investigator according to RECIST v1.1. TTR was defined as the time (in months) from randomization to first documentation of confirmed PR or CR (whichever occurred first). CR was defined as the disappearance of all TLs and non-TLs; SA reduction to <10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as >/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. (NCT01702558)
Timeframe: Baseline until first documentation of confirmed PR or CR, whichever occurred first (up to approximately 2.5 years overall)
Intervention | months (Median) |
---|
Phase 2 (mBC): T-DM1 + Cape | 2.10 |
Phase 2 (mBC): T-DM1 | 2.10 |
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Phase 2 (mBC): Time to Progression (TTP) as Assessed by the Investigator According to RECIST v1.1
Tumor response was assessed by the investigator according to RECIST v1.1. TTP was defined as the time (in months) from randomization to the first occurrence of PD. PD was defined as >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants with no documented PD at the time of study end (including participants who died before PD) or who were lost to follow-up were censored on the date of the last tumor assessment. The median TTP and 90% CI was estimated using Kaplan-Meier method. (NCT01702558)
Timeframe: Baseline until PD, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)
Intervention | months (Median) |
---|
Phase 2 (mBC): T-DM1 + Cape | 10.38 |
Phase 2 (mBC): T-DM1 | 10.32 |
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Phase 2 (mBC): Progression-Free Survival (PFS) as Assessed by the Investigator According to RECIST v1.1
Tumor response was assessed by the investigator according to RECIST v1.1. PFS was defined as the time (in months) from randomization until the first documented PD or death from any cause, whichever occurred first. PD was defined as >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants with no PFS events were censored on the date of the last tumor assessment. Participants without post-baseline tumor assessment were censored at randomization plus 1 day. The median PFS and 90% CI was estimated using Kaplan-Meier method. (NCT01702558)
Timeframe: Baseline until PD, death from any cause, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)
Intervention | months (Median) |
---|
Phase 2 (mBC): T-DM1 + Cape | 10.15 |
Phase 2 (mBC): T-DM1 | 9.82 |
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Phase 2 (mBC): Percentage of Participants With Treatment Failure as Assessed by the Investigator According to RECIST v1.1
Treatment failure was defined as occurrence of any of the following event while on treatment: PD, death, withdrawal due to adverse event (AE) or laboratory abnormality, or refusal of treatment. PD as assessed by the investigator according to RECIST v1.1 was defined as >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. (NCT01702558)
Timeframe: Baseline until treatment failure, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)
Intervention | percentage of participants (Number) |
---|
Phase 2 (mBC): T-DM1 + Cape | 77.8 |
Phase 2 (mBC): T-DM1 | 83.8 |
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Phase 2 (mBC): Percentage of Participants With PD as Assessed by the Investigator According to RECIST v1.1 or Death From Any Cause
Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. (NCT01702558)
Timeframe: Baseline until PD, death from any cause, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)
Intervention | percentage of participants (Number) |
---|
Phase 2 (mBC): T-DM1 + Cape | 67.9 |
Phase 2 (mBC): T-DM1 | 73.8 |
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Phase 2 (mBC): Percentage of Participants With PD as Assessed by the Investigator According to RECIST v1.1
Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. (NCT01702558)
Timeframe: Baseline until PD, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)
Intervention | percentage of participants (Number) |
---|
Phase 2 (mBC): T-DM1 + Cape | 64.2 |
Phase 2 (mBC): T-DM1 | 70.0 |
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Phase 2 (mBC): Percentage of Participants With Clinical Benefit as Assessed by the Investigator According to RECIST v1.1
The clinical benefit was defined as a confirmed response of CR, PR, or stable disease (SD) that lasted for at least 6 months. Tumor response was assessed by the investigator according to RECIST v1.1. CR: the disappearance of all TLs and non-TLs; SA reduction to <10 mm for nodal TLs/non-TLs; and no new lesions. PR: >/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. PD: >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SoD on study. The 90% CI was computed using Clopper-Pearson approach. (NCT01702558)
Timeframe: Baseline until clinical benefit response, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)
Intervention | percentage of participants (Number) |
---|
Phase 2 (mBC): T-DM1 + Cape | 66.7 |
Phase 2 (mBC): T-DM1 | 62.5 |
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Phase 2 (mBC): Percentage of Participants With Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Tumor response was assessed by the investigator according to RECIST v1.1. BOR was defined as percentage of participants with a complete response (CR) or partial response (PR) that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as the disappearance of all target lesions (TLs) and non-TLs; short axis (SA) reduction to <10 millimeters (mm) for nodal TLs/non-TLs; and no new lesions. PR was defined as >/=30% decrease in sum of diameters (SoD) of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. The 90% confidence Interval (CI) was computed using Clopper-Pearson approach. (NCT01702558)
Timeframe: Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)
Intervention | percentage of participants (Number) |
---|
Phase 2 (mBC): T-DM1 + Cape | 44.4 |
Phase 2 (mBC): T-DM1 | 36.3 |
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Phase 2 (mBC): Percentage of Participants Who Died of Any Cause
(NCT01702558)
Timeframe: Baseline until death or study end whichever occurred first (up to approximately 2.5 years overall)
Intervention | percentage of participants (Number) |
---|
Phase 2 (mBC): T-DM1 + Cape | 22.2 |
Phase 2 (mBC): T-DM1 | 26.3 |
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Phase 2 (mBC): Overall Survival (OS)
OS was defined as the time (in months) from randomization until death from any cause. Participants who were alive at the time of data cut-off were censored on the date of the last follow-up assessment. Participants who were lost to follow-up were censored as having no event (alive) on the date of last contact. The median OS and 90% CI was estimated using Kaplan-Meier method, which use the patients at risk as denominator rather than the whole number of patients. (NCT01702558)
Timeframe: Baseline until death or study end whichever occurred first (up to approximately 2.5 years overall)
Intervention | months (Median) |
---|
Phase 2 (mBC): T-DM1 + Cape | NA |
Phase 2 (mBC): T-DM1 | 24.71 |
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Phase 2 (mBC): Duration of Response (DoR) as Assessed by the Investigator According to RECIST v1.1
Tumor response was assessed by the investigator according to RECIST v1.1. DoR was defined as the time (in months) from the date of first recorded PR/CR until the date of PD or death from any cause. CR: the disappearance of all TLs and non-TLs; SA reduction to <10 mm for nodal TLs/non-TLs; and no new lesions. PR: >/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. PD: >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants with no documented PD after CR/PR were censored at the time of last tumor assessment. Participants without post-baseline tumor assessment were censored at randomization plus 1 day. The median DOR and 90% CI were estimated using Kaplan-Meier method. (NCT01702558)
Timeframe: From the documentation of response until PD, death, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)
Intervention | months (Median) |
---|
Phase 2 (mBC): T-DM1 + Cape | 11.30 |
Phase 2 (mBC): T-DM1 | 12.22 |
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Phase 1 (mBC): Plasma Terminal Half-Life (t1/2) of Capecitabine
Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation. (NCT01702558)
Timeframe: Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1
Intervention | hours (Mean) |
---|
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape | 0.70 |
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape | 0.39 |
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Phase 1 (mBC): Percentage of Participants With Dose-Limiting Toxicities (DLTs)
A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting more than (>) 7 consecutive days; febrile neutropenia with absolute neutrophil count (ANC) less than (<) 1000 cells/millimeter cube (mm^3); Grade greater than or equal to (>/=) 3 diarrhea or Grade 3 hand-foot syndrome (in absence of dihydropyrimidine dehydrogenase [DPD] deficiency only for DL 1); any other Grade >/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for >14 days (>7 days for DL 1); for DL -1 only: <14 full doses of capecitabine; Cycle 2 dose level <100 percent (%). (NCT01702558)
Timeframe: Continuously during Cycle 1 (up to 3 weeks)
Intervention | percentage of participants (Number) |
---|
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape | 33.3 |
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape | 0.0 |
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Toxic Effects
Toxic effects were scored according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. For the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 scale score range from 1 to 4. A high score, that is 3 and 4, represents a high level of toxicity, whereas the minimum values, that is 1 and 2, represents a mild/modest level of toxicity. (NCT01718873)
Timeframe: up to 4 weeks after the end of the treatment
Intervention | Participants (Count of Participants) |
---|
Bevacizumab Before Chemotherapy | 108 |
Bevacizumab With Chemotherapy | 113 |
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Disease Control Rate
Disease control rate was calculated by adding complete and partial responses and stable disease. (NCT01718873)
Timeframe: At weeks 12 and 24 from randomization and every 3 months thereafter, assessed up to 90 months
Intervention | Participants (Count of Participants) |
---|
Bevacizumab Before Chemotherapy | 107 |
Bevacizumab With Chemotherapy | 103 |
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Objective Response Rate
"Objective response rate (ORR), according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, was the primary end point and was defined as the number of complete plus partial responses divided by the number of enrolled patients.~Per RECIST v 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." (NCT01718873)
Timeframe: Objective response was assessed by computed tomographic scan or other appropriate imaging at weeks 12 and 24 from randomization, and every 3 months thereafter, assessed up to 90 months.
Intervention | participants (Number) |
---|
Bevacizumab Before Chemotherapy | 65 |
Bevacizumab With Chemotherapy | 66 |
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Progression-free Survival (PFS)
"Progression-free survival was defined as the time from randomization to the date of progression or death, whichever occurred first. Patients without progression were censored on the date of the last follow-up visit.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions." (NCT01718873)
Timeframe: assessed up to 90 months
Intervention | months (Median) |
---|
Bevacizumab Before Chemotherapy | 11.7 |
Bevacizumab With Chemotherapy | 10.5 |
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Overall Survival
Overall survival was defined as the time from randomization to the date of death. Patients alive at the time of the final analysis were censored on the date of the last follow-up information available. (NCT01718873)
Timeframe: assessed up to 90 months
Intervention | months (Median) |
---|
Bevacizumab Before Chemotherapy | 29.8 |
Bevacizumab With Chemotherapy | 24.1 |
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Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (NCT01722162)
Timeframe: Up to 6 months
Intervention | participants (Number) |
---|
| Small intestinal obstruction | Fatigue | Urinary tract infection | Blood bilirubin increased | Peripheral motor neuropathy | Peripheral sensory neuropathy | Dyspnea | Hypertension | Thromboembolic event | Anemia | Heart failure | Colonic fistula | Colonic perforation | Gram-negative bacilli infection | Clostridium bloodstream infection | Alanine aminotransferase increased | Anorexia | Bone pain | Generalized muscle weakness | Muscle weakness lower limbs | Urinary retention | Respiratory failure |
---|
Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine) | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
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Progression Free Survival (Arm B)
"Time from start of treatment to the time of progression or death, whichever occurs first~Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase." (NCT01722162)
Timeframe: Until progressive disease (PD) (up to 60 days)
Intervention | proportion of patients with PFS (Number) |
---|
| PFS Days = 29 | PFS Days = 33 | PFS Days = 44 | PFS Days = 50 | PFS Days = 54 | PFS Days = 60 |
---|
Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) | 0.946 | 0.892 | 0.838 | 0.686 | 0.631 | 0.576 |
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Progression Free Survival (Arm A)
"Time from start of treatment to the time of progression or death, whichever occurs first~Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase." (NCT01722162)
Timeframe: Until progressive disease (PD) (estimated to be 92 days)
Intervention | proportion of patients with PFS (Number) |
---|
| PFS Days = 29 | PFS Days = 36 | PFS Days = 43 | PFS Days = 46 | PFS Days = 50 | PFS Days = 92 |
---|
Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) | 0.946 | 0.892 | 0.739 | 0.685 | 0.630 | 0.575 |
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Mean Survival Time
(NCT01725386)
Timeframe: Up to approximately 4 years
Intervention | Months (Mean) |
---|
Monotherapy | 15.493 |
Combination Therapy | 15.417 |
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Percentage of Participants Receiving Concomitant Medications During the Study
Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported. (NCT01725386)
Timeframe: Up to approximately 4 years
Intervention | percentage of participants (Number) |
---|
Monotherapy | 17.5 |
Combination Therapy | 23.8 |
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Percentage of Participants With Adverse Events
(NCT01725386)
Timeframe: Up to approximately 4 years
Intervention | percentage of participants (Number) |
---|
Monotherapy | 45.2 |
Combination Therapy | 66.7 |
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Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline
To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized. (NCT01725386)
Timeframe: Day 1
Intervention | percentage of participants (Number) |
---|
| Moderately Differentiated | Well Differentiated | Poorly Differentiated/Undifferentiated |
---|
Combination Therapy | 42.9 | 11.1 | 46.0 |
,Monotherapy | 42.6 | 9.0 | 48.4 |
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Percentage of Participants With Relevant Medical History Assessed at Baseline
To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized. (NCT01725386)
Timeframe: Day 1
Intervention | percentage of participants (Number) |
---|
| History of Other Types of Cancer | Family History of Breast Cancer | History of Co-morbidities | Premenopausal Status | Postmenopausal Status |
---|
Combination Therapy | 1.6 | 12.7 | 28.6 | 41.3 | 58.7 |
,Monotherapy | 0.5 | 9.6 | 18.1 | 54.8 | 45.2 |
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Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment. (NCT01725386)
Timeframe: Up to approximately 4 years
Intervention | percentage of participants (Number) |
---|
| First Line | Second Line | Third Line |
---|
Combination Therapy | 55.6 | 41.3 | 3.1 |
,Monotherapy | 10.6 | 71.8 | 17.6 |
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Progression-free Survival
This measure is the number of subjects not experiencing tumor progression at five years from initiating therapy. (NCT01726582)
Timeframe: 5 years
Intervention | Participants (Count of Participants) |
---|
Milestones Related to Usual Therapy | 36 |
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Use of Biomarkers to Determine Course of Treatment
The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment. (NCT01726582)
Timeframe: Initiation of therapy (approximately 4 to 12 weeks after screening) until surgery (approximately 10 to 20 weeks after screening)
Intervention | Participants (Count of Participants) |
---|
Milestones Related to Usual Therapy | 92 |
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Overall Survival in Months
This measure is the median time of survival (in months) at five years from the initiation of therapy. Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection. (NCT01726582)
Timeframe: 5 years
Intervention | Months (Median) |
---|
Milestones Related to Therapy (Resected) | 45 |
Milestones Related to Therapy (Non-Resected) | 11 |
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Number of Subjects Completing Therapy Including Surgical Resection.
This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure. (NCT01726582)
Timeframe: At time of surgery (approximately 10 to 20 weeks after screening)
Intervention | Participants (Count of Participants) |
---|
Milestones Related to Usual Therapy | 107 |
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Rate of CR, Assessed According to CEA and CA 19-9 Measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level in response to ADAPT therapy. (NCT01729923)
Timeframe: 3 years
Intervention | Participants (Count of Participants) |
---|
Capecitabine and Celecoxib | 1 |
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Overall Survival
Estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation until death or last reported survival. (NCT01729923)
Timeframe: Until death or last reported survival, up to 5 years
Intervention | months (Median) |
---|
Capecitabine and Celecoxib | 15 |
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Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion and Did Not Have Surgery or Radiation Therapy
RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change. (NCT01729923)
Timeframe: Serial measures at 9 week intervals up to 5 years
Intervention | percentage of baseline lesion size (Mean) |
---|
Capecitabine and Celecoxib | 11 |
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Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion
RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change. (NCT01729923)
Timeframe: Serial measures at 9 week intervals up to 5 years
Intervention | percentage of baseline lesion size (Mean) |
---|
Capecitabine and Celecoxib | -17 |
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Relapse Free Survival in Patients Achieving CR
Relapse-free survival estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation. (NCT01729923)
Timeframe: Up to 5 years
Intervention | months (Number) |
---|
Capecitabine and Celecoxib | 7 |
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Margin-negative (R0) Resection Rate
R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement. (NCT01754623)
Timeframe: Up to 3 years
Intervention | percentage of participants (Number) |
---|
Chemotherapy Followed by Radiation Treatment | 67 |
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Overall Survival (OS) Rate
OS at time of analysis, calculated from date of enrollment to date of death from any cause. (NCT01754623)
Timeframe: 12 months
Intervention | percentage of participants (Number) |
---|
All Participants -Chemotherapy Followed by Radiation Treatment | 33 |
Resection Group -Chemotherapy Followed by Radiation Treatment | 100 |
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Time to PFS2
Time to PFS2 was defined as time from randomization to the first occurrence of disease progression after reinduction of second-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5mm. (NCT01765582)
Timeframe: Randomization up to disease progression during second-line therapy or death, whichever occurs first (up to approximately 3 years)
Intervention | months (Median) |
---|
Arm A: Concurrent FOLFOXIRI + Bevacizumab | 18.76 |
Arm B: Sequential FOLFOXIRI + Bevacizumab | 13.17 |
Arm C: FOLFOX + Bevacizumab | 14.75 |
Arms A + B: Pooled FOLFOXIRI + Bevacizumab | 15.08 |
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Progression-Free Survival During First-Line Therapy (PFS1)
PFS1 was defined as time from randomization to the first occurrence of disease progression during first-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5 mm. (NCT01765582)
Timeframe: Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)
Intervention | months (Median) |
---|
Arm A: Concurrent FOLFOXIRI + Bevacizumab | 11.86 |
Arm B: Sequential FOLFOXIRI + Bevacizumab | 11.37 |
Arm C: FOLFOX + Bevacizumab | 9.46 |
Arms A + B: Pooled FOLFOXIRI + Bevacizumab | 11.70 |
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Percentage of Participants With Overall Response During First-Line Therapy (ORR1)
ORR1 was the percentage of participants with complete response (CR) or partial response (PR) during first-line therapy as assessed by investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). CR was defined as disappearance of all extranodal target lesions and all pathological lymph nodes had to have decreased to <10 millimeter (mm) in short axis. PR was defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters. ORR1 = CR + PR (NCT01765582)
Timeframe: Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)
Intervention | Percentage of participants (Number) |
---|
Arm A: Concurrent FOLFOXIRI + Bevacizumab | 72.0 |
Arm B: Sequential FOLFOXIRI + Bevacizumab | 72.8 |
Arm C: FOLFOX + Bevacizumab | 62.1 |
Arms A + B: Pooled FOLFOXIRI + Bevacizumab | 72.4 |
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Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT01765582)
Timeframe: Randomization up to approximately 3 years
Intervention | Percentage of participants (Number) |
---|
Arm A: Concurrent FOLFOXIRI + Bevacizumab | 100 |
Arm B: Sequential FOLFOXIRI + Bevacizumab | 98.9 |
Arm C: FOLFOX + Bevacizumab | 100 |
Arms A + B: Pooled FOLFOXIRI + Bevacizumab | 99.4 |
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Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause. (NCT01765582)
Timeframe: Randomization until death due to any cause (up to approximately 3 years)
Intervention | months (Median) |
---|
Arm A: Concurrent FOLFOXIRI + Bevacizumab | 33.97 |
Arm B: Sequential FOLFOXIRI + Bevacizumab | 28.32 |
Arm C: FOLFOX + Bevacizumab | 30.65 |
Arms A + B: Pooled FOLFOXIRI + Bevacizumab | 28.32 |
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Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score
The EORTC QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. A positive value means an increase, while a negative values means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1). (NCT01774786)
Timeframe: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years)
Intervention | score on a scale (Mean) |
---|
| Anxiety: Cycle 1 (Baseline) | Anxiety: Change at Cycle 2 | Anxiety: Change at Cycle 3 | Anxiety: Change at Cycle 4 | Anxiety: Change at Cycle 5 | Anxiety: Change at Cycle 6 | Anxiety: Change at Cycle 7 | Anxiety: Change at Cycle 8 | Anxiety: Change at Cycle 9 | Anxiety: Change at Cycle 10 | Anxiety: Change at Cycle 11 | Anxiety: Change at Cycle 12 | Anxiety: Change at Cycle 13 | Anxiety: Change at Cycle 14 | Anxiety: Change at Cycle 15 | Anxiety: Change at Cycle 16 | Anxiety: Change at Cycle 17 | Anxiety: Change at Cycle 18 | Anxiety: Change at Cycle 19 | Anxiety: Change at Cycle 20 | Anxiety: Change at Cycle 21 | Anxiety: Change at Cycle 22 | Anxiety: Change at Cycle 23 | Anxiety: Change at Cycle 24 | Anxiety: Change at Cycle 25 | Anxiety: Change at Cycle 26 | Anxiety: Change at Cycle 27 | Anxiety: Change at Cycle 28 | Anxiety: Change at PT Visit 1 | Anxiety: Change at PT Visit 2 | Body Image: Cycle 1 (Baseline) | Body Image: Change at Cycle 2 | Body Image: Change at Cycle 3 | Body Image: Change at Cycle 4 | Body Image: Change at Cycle 5 | Body Image: Change at Cycle 6 | Body Image: Change at Cycle 7 | Body Image: Change at Cycle 8 | Body Image: Change at Cycle 9 | Body Image: Change at Cycle 10 | Body Image: Change at Cycle 11 | Body Image: Change at Cycle 12 | Body Image: Change at Cycle 13 | Body Image: Change at Cycle 14 | Body Image: Change at Cycle 15 | Body Image: Change at Cycle 16 | Body Image: Change at Cycle 17 | Body Image: Change at Cycle 18 | Body Image: Change at Cycle 19 | Body Image: Change at Cycle 20 | Body Image: Change at Cycle 21 | Body Image: Change at Cycle 22 | Body Image: Change at Cycle 23 | Body Image: Change at Cycle 24 | Body Image: Change at Cycle 25 | Body Image: Change at Cycle 26 | Body Image: Change at Cycle 27 | Body Image: Change at Cycle 28 | Body Image: Change at PT Visit 1 | Body Image: Change at PT Visit 2 | Dry Mouth: Cycle 1 (Baseline) | Dry Mouth: Change at Cycle 2 | Dry Mouth: Change at Cycle 3 | Dry Mouth: Change at Cycle 4 | Dry Mouth: Change at Cycle 5 | Dry Mouth: Change at Cycle 6 | Dry Mouth: Change at Cycle 7 | Dry Mouth: Change at Cycle 8 | Dry Mouth: Change at Cycle 9 | Dry Mouth: Change at Cycle 10 | Dry Mouth: Change at Cycle 11 | Dry Mouth: Change at Cycle 12 | Dry Mouth: Change at Cycle 13 | Dry Mouth: Change at Cycle 14 | Dry Mouth: Change at Cycle 15 | Dry Mouth: Change at Cycle 16 | Dry Mouth: Change at Cycle 17 | Dry Mouth: Change at Cycle 18 | Dry Mouth: Change at Cycle 19 | Dry Mouth: Change at Cycle 20 | Dry Mouth: Change at Cycle 21 | Dry Mouth: Change at Cycle 22 | Dry Mouth: Change at Cycle 23 | Dry Mouth: Change at Cycle 24 | Dry Mouth: Change at Cycle 25 | Dry Mouth: Change at Cycle 26 | Dry Mouth: Change at Cycle 27 | Dry Mouth: Change at Cycle 28 | Dry Mouth: Change at PT Visit 1 | Dry Mouth: Change at PT Visit 2 | Dysphagia: Cycle 1 (Baseline) | Dysphagia: Change at Cycle 2 | Dysphagia: Change at Cycle 3 | Dysphagia: Change at Cycle 4 | Dysphagia: Change at Cycle 5 | Dysphagia: Change at Cycle 6 | Dysphagia: Change at Cycle 7 | Dysphagia: Change at Cycle 8 | Dysphagia: Change at Cycle 9 | Dysphagia: Change at Cycle 10 | Dysphagia: Change at Cycle 11 | Dysphagia: Change at Cycle 12 | Dysphagia: Change at Cycle 13 | Dysphagia: Change at Cycle 14 | Dysphagia: Change at Cycle 15 | Dysphagia: Change at Cycle 16 | Dysphagia: Change at Cycle 17 | Dysphagia: Change at Cycle 18 | Dysphagia: Change at Cycle 19 | Dysphagia: Change at Cycle 20 | Dysphagia: Change at Cycle 21 | Dysphagia: Change at Cycle 22 | Dysphagia: Change at Cycle 23 | Dysphagia: Change at Cycle 24 | Dysphagia: Change at Cycle 25 | Dysphagia: Change at Cycle 26 | Dysphagia: Change at Cycle 27 | Dysphagia: Change at Cycle 28 | Dysphagia: Change at PT Visit 1 | Dysphagia: Change at PT Visit 2 | Eating Restrictions: Cycle 1 (Baseline) | Eating Restrictions: Change at Cycle 2 | Eating Restrictions: Change at Cycle 3 | Eating Restrictions: Change at Cycle 4 | Eating Restrictions: Change at Cycle 5 | Eating Restrictions: Change at Cycle 6 | Eating Restrictions: Change at Cycle 7 | Eating Restrictions: Change at Cycle 8 | Eating Restrictions: Change at Cycle 9 | Eating Restrictions: Change at Cycle 10 | Eating Restrictions: Change at Cycle 11 | Eating Restrictions: Change at Cycle 12 | Eating Restrictions: Change at Cycle 13 | Eating Restrictions: Change at Cycle 14 | Eating Restrictions: Change at Cycle 15 | Eating Restrictions: Change at Cycle 16 | Eating Restrictions: Change at Cycle 17 | Eating Restrictions: Change at Cycle 18 | Eating Restrictions: Change at Cycle 19 | Eating Restrictions: Change at Cycle 20 | Eating Restrictions: Change at Cycle 21 | Eating Restrictions: Change at Cycle 22 | Eating Restrictions: Change at Cycle 23 | Eating Restrictions: Change at Cycle 24 | Eating Restrictions: Change at Cycle 25 | Eating Restrictions: Change at Cycle 26 | Eating Restrictions: Change at Cycle 27 | Eating Restrictions: Change at Cycle 28 | Eating Restrictions: Change at PT Visit 1 | Eating Restrictions: Change at PT Visit 2 | Hair Loss: Cycle 1 (Baseline) | Hair Loss: Change at Cycle 2 | Hair Loss: Change at Cycle 3 | Hair Loss: Change at Cycle 4 | Hair Loss: Change at Cycle 5 | Hair Loss: Change at Cycle 6 | Hair Loss: Change at Cycle 7 | Hair Loss: Change at Cycle 8 | Hair Loss: Change at Cycle 9 | Hair Loss: Change at Cycle 10 | Hair Loss: Change at Cycle 11 | Hair Loss: Change at Cycle 12 | Hair Loss: Change at Cycle 13 | Hair Loss: Change at Cycle 14 | Hair Loss: Change at Cycle 15 | Hair Loss: Change at Cycle 16 | Hair Loss: Change at Cycle 17 | Hair Loss: Change at Cycle 18 | Hair Loss: Change at Cycle 19 | Hair Loss: Change at Cycle 20 | Hair Loss: Change at Cycle 21 | Hair Loss: Change at Cycle 22 | Hair Loss: Change at Cycle 23 | Hair Loss: Change at Cycle 24 | Hair Loss: Change at Cycle 25 | Hair Loss: Change at Cycle 26 | Hair Loss: Change at Cycle 27 | Hair Loss: Change at Cycle 28 | Hair Loss: Change at PT Visit 1 | Hair Loss: Change at PT Visit 2 | Pain: Cycle 1 (Baseline) | Pain: Change at Cycle 2 | Pain: Change at Cycle 3 | Pain: Change at Cycle 4 | Pain: Change at Cycle 5 | Pain: Change at Cycle 6 | Pain: Change at Cycle 7 | Pain: Change at Cycle 8 | Pain: Change at Cycle 9 | Pain: Change at Cycle 10 | Pain: Change at Cycle 11 | Pain: Change at Cycle 12 | Pain: Change at Cycle 13 | Pain: Change at Cycle 14 | Pain: Change at Cycle 15 | Pain: Change at Cycle 16 | Pain: Change at Cycle 17 | Pain: Change at Cycle 18 | Pain: Change at Cycle 19 | Pain: Change at Cycle 20 | Pain: Change at Cycle 21 | Pain: Change at Cycle 22 | Pain: Change at Cycle 23 | Pain: Change at Cycle 24 | Pain: Change at Cycle 25 | Pain: Change at Cycle 26 | Pain: Change at Cycle 27 | Pain: Change at Cycle 28 | Pain: Change at PT Visit 1 | Pain: Change at PT Visit 2 | Reflux Symptoms: Cycle 1 (Baseline) | Reflux Symptoms: Change at Cycle 2 | Reflux Symptoms: Change at Cycle 3 | Reflux Symptoms: Change at Cycle 4 | Reflux Symptoms: Change at Cycle 5 | Reflux Symptoms: Change at Cycle 6 | Reflux Symptoms: Change at Cycle 7 | Reflux Symptoms: Change at Cycle 8 | Reflux Symptoms: Change at Cycle 9 | Reflux Symptoms: Change at Cycle 10 | Reflux Symptoms: Change at Cycle 11 | Reflux Symptoms: Change at Cycle 12 | Reflux Symptoms: Change at Cycle 13 | Reflux Symptoms: Change at Cycle 14 | Reflux Symptoms: Change at Cycle 15 | Reflux Symptoms: Change at Cycle 16 | Reflux Symptoms: Change at Cycle 17 | Reflux Symptoms: Change at Cycle 18 | Reflux Symptoms: Change at Cycle 19 | Reflux Symptoms: Change at Cycle 20 | Reflux Symptoms: Change at Cycle 21 | Reflux Symptoms: Change at Cycle 22 | Reflux Symptoms: Change at Cycle 23 | Reflux Symptoms: Change at Cycle 24 | Reflux Symptoms: Change at Cycle 25 | Reflux Symptoms: Change at Cycle 26 | Reflux Symptoms: Change at Cycle 27 | Reflux Symptoms: Change at Cycle 28 | Reflux Symptoms: Change at PT Visit 1 | Reflux Symptoms: Change at PT Visit 2 | Taste: Cycle 1 (Baseline) | Taste: Change at Cycle 2 | Taste: Change at Cycle 3 | Taste: Change at Cycle 4 | Taste: Change at Cycle 5 | Taste: Change at Cycle 6 | Taste: Change at Cycle 7 | Taste: Change at Cycle 8 | Taste: Change at Cycle 9 | Taste: Change at Cycle 10 | Taste: Change at Cycle 11 | Taste: Change at Cycle 12 | Taste: Change at Cycle 13 | Taste: Change at Cycle 14 | Taste: Change at Cycle 15 | Taste: Change at Cycle 16 | Taste: Change at Cycle 17 | Taste: Change at Cycle 18 | Taste: Change at Cycle 19 | Taste: Change at Cycle 20 | Taste: Change at Cycle 21 | Taste: Change at Cycle 22 | Taste: Change at Cycle 23 | Taste: Change at Cycle 24 | Taste: Change at Cycle 25 | Taste: Change at Cycle 26 | Taste: Change at Cycle 27 | Taste: Change at Cycle 28 | Taste: Change at PT Visit 1 | Taste: Change at PT Visit 2 |
---|
Pertuzumab + Trastuzumab + Chemotherapy | 40.10 | -2.58 | -4.14 | -4.52 | -4.10 | -4.54 | -6.40 | -9.00 | -10.09 | -11.17 | -10.78 | -12.62 | -13.32 | -14.32 | -13.42 | -12.75 | -13.41 | -13.53 | -14.50 | -15.34 | -16.03 | -13.30 | -17.28 | -16.11 | -16.03 | -19.73 | -21.71 | -22.51 | -0.73 | -4.04 | 23.53 | 1.33 | 1.48 | 4.20 | 2.86 | 0.75 | -0.56 | -1.74 | -3.58 | -5.07 | -4.62 | -5.31 | -4.73 | -5.43 | -3.08 | -1.74 | -2.70 | -2.64 | -2.81 | -3.97 | 1.69 | -1.49 | -5.82 | -0.56 | -3.21 | -4.76 | 0.78 | -4.27 | 2.48 | 2.36 | 21.80 | 7.72 | 6.10 | 4.76 | 2.47 | 2.96 | -1.96 | -2.43 | -3.70 | -6.27 | -7.69 | -8.18 | -9.69 | -8.33 | -7.89 | -6.32 | -7.44 | -5.56 | -5.90 | -6.35 | -7.17 | -3.98 | -7.94 | -6.67 | -8.33 | -2.72 | -6.98 | -8.55 | 0.19 | -1.35 | 16.29 | -2.27 | -3.39 | -2.94 | -3.22 | -4.20 | -4.83 | -5.96 | -6.17 | -6.03 | -6.25 | -7.06 | -6.93 | -8.01 | -6.45 | -4.41 | -5.36 | -4.90 | -4.40 | -2.51 | -3.80 | -3.65 | -4.23 | -5.00 | -5.98 | -5.67 | -5.68 | -8.26 | 0.44 | -2.81 | 23.26 | -1.41 | -1.04 | -2.24 | -1.39 | -1.35 | -2.45 | -4.29 | -6.99 | -7.06 | -8.22 | -7.74 | -8.55 | -8.62 | -6.85 | -5.77 | -5.56 | -7.27 | -7.03 | -4.56 | -5.80 | -3.65 | -3.70 | -5.00 | -5.77 | -6.80 | -5.62 | -7.91 | 1.52 | -2.10 | 4.73 | 0.20 | 4.34 | 5.40 | 6.12 | 6.93 | 5.72 | 5.00 | 2.38 | 0.64 | -0.10 | 0.21 | 0.36 | -1.37 | -0.39 | -1.47 | -1.07 | -1.68 | -0.90 | -0.20 | -1.07 | -0.50 | -0.54 | -1.39 | -1.96 | -1.02 | -3.10 | -4.70 | 4.98 | 15.82 | 26.48 | -4.63 | -6.96 | -6.45 | -7.28 | -7.24 | -9.52 | -10.53 | -10.08 | -10.63 | -11.65 | -11.76 | -11.92 | -11.66 | -11.15 | -8.72 | -8.88 | -8.31 | -6.63 | -5.72 | -8.19 | -9.08 | -9.66 | -9.86 | -10.58 | -9.01 | -12.02 | -11.54 | -1.70 | -7.49 | 16.68 | -0.13 | -0.52 | -0.98 | -1.92 | -2.90 | -4.18 | -4.96 | -5.02 | -6.12 | -6.44 | -4.82 | -6.42 | -5.39 | -5.00 | -3.07 | -3.35 | -2.94 | -2.43 | -1.85 | -1.83 | -3.81 | -5.11 | -4.07 | -5.56 | -4.99 | -7.75 | -7.12 | 0.88 | 0.56 | 13.79 | 12.09 | 16.72 | 18.43 | 17.61 | 17.97 | 16.25 | 11.64 | 9.22 | 7.93 | 4.96 | 5.27 | 4.08 | 0.49 | 3.08 | 5.51 | 4.80 | 3.59 | 3.13 | 5.56 | 6.33 | 9.45 | 8.99 | 7.78 | 3.21 | 4.08 | 4.65 | 3.42 | 12.76 | 8.42 |
,Placebo + Trastuzumab + Chemotherapy | 40.48 | -4.11 | -3.87 | -7.25 | -7.39 | -8.42 | -10.40 | -11.92 | -11.43 | -12.64 | -12.09 | -13.16 | -13.33 | -12.43 | -10.65 | -12.57 | -12.79 | -12.38 | -12.48 | -12.37 | -14.47 | -15.46 | -14.47 | -17.09 | -17.78 | -13.26 | -12.70 | -12.89 | -4.73 | -3.98 | 23.68 | 1.20 | 3.88 | 1.15 | 1.06 | 2.78 | 0.29 | 0.00 | -0.69 | -3.25 | -1.53 | -2.66 | -2.73 | -4.62 | -2.43 | -1.19 | -2.28 | -5.71 | -5.21 | -5.38 | -8.18 | -10.87 | -8.53 | -11.11 | -11.43 | -6.45 | -7.14 | -4.00 | 3.42 | 6.35 | 23.32 | 3.00 | 4.87 | 2.66 | 2.57 | 1.19 | 0.44 | -2.66 | -4.32 | -3.46 | -1.96 | -4.35 | -8.48 | -3.63 | -7.29 | -8.33 | -3.20 | -8.10 | -7.69 | -9.68 | -9.43 | -8.70 | -3.88 | -9.40 | -9.52 | -7.53 | -7.14 | -8.00 | 2.38 | 1.89 | 14.15 | -0.53 | -2.15 | -1.08 | -1.83 | -2.25 | -1.97 | -3.29 | -3.86 | -4.61 | -2.83 | -4.19 | -3.54 | -4.95 | -2.14 | -3.70 | -3.20 | -3.33 | -3.59 | -3.76 | -2.10 | -4.83 | -3.88 | -3.70 | -2.22 | -2.87 | -4.37 | -3.56 | 2.83 | 3.25 | 22.33 | -1.54 | -2.20 | -1.39 | -0.09 | -3.32 | -2.67 | -5.56 | -6.48 | -5.89 | -5.05 | -6.34 | -8.41 | -8.58 | -5.56 | -6.94 | -7.42 | -6.90 | -5.38 | -4.44 | -5.03 | -6.16 | -5.23 | -7.91 | -5.95 | -2.42 | -3.87 | -5.00 | 0.94 | 0.94 | 4.04 | 1.27 | 4.52 | 6.53 | 7.18 | 10.07 | 9.26 | 7.38 | 6.46 | 4.22 | 2.54 | 1.96 | 2.29 | 1.83 | 1.58 | 1.42 | 0.23 | -0.71 | 0.51 | -1.61 | -1.57 | -3.26 | -1.19 | 1.71 | -0.95 | -0.54 | -0.60 | -1.33 | 4.51 | 22.22 | 26.47 | -5.86 | -5.86 | -7.48 | -6.89 | -7.22 | -6.62 | -8.16 | -8.98 | -8.59 | -8.01 | -7.19 | -9.24 | -9.82 | -8.51 | -10.52 | -9.93 | -11.19 | -10.38 | -10.35 | -7.55 | -9.42 | -8.53 | -8.76 | -8.10 | -9.41 | -9.23 | -7.33 | -2.99 | -0.03 | 17.34 | -1.99 | -2.28 | -1.90 | -1.72 | -3.59 | -3.20 | -5.74 | -5.18 | -6.48 | -6.03 | -7.49 | -6.77 | -7.37 | -4.98 | -4.89 | -4.57 | -6.51 | -6.15 | -5.38 | -4.19 | -7.00 | -6.98 | -7.98 | -5.71 | -4.30 | -6.75 | -4.44 | -0.45 | -1.47 | 16.22 | 6.61 | 9.99 | 11.07 | 11.85 | 11.82 | 9.19 | 3.29 | 1.73 | 1.63 | 2.61 | 0.24 | -0.91 | -5.28 | -1.04 | -3.57 | -3.65 | -4.29 | -4.62 | -3.76 | -5.03 | -4.35 | 0.00 | -5.13 | -4.76 | -3.23 | -3.57 | -6.67 | 9.06 | 6.67 |
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Percentage of Participants With Clinical Benefit, as Determined by the Investigator According to RECIST v1.1 Criteria
The clinical benefit rate was defined as best response of complete response (CR) or partial response (PR) or stable disease (SD) for 6 weeks or longer, as determined by the investigator using RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum diameters while on study. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be >/=15 mm in short axis when assessed by CT scan. The clinical benefit rate was not updated at the final analysis. (NCT01774786)
Timeframe: Baseline up to death or progressive disease, whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] months vs. 21.3 [0-39] months)
Intervention | percentage of participants (Number) |
---|
Pertuzumab + Trastuzumab + Chemotherapy | 84.6 |
Placebo + Trastuzumab + Chemotherapy | 81.3 |
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Minimum Serum Concentration (Cmin) of Pertuzumab
(NCT01774786)
Timeframe: Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days)
Intervention | μg/mL (Mean) |
---|
| Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 6 | Cycle 8 |
---|
Pertuzumab + Trastuzumab + Chemotherapy | NA | 42.4 | 74.0 | 90.4 | 114 | 142 |
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Maximum Serum Concentration (Cmax) of Pertuzumab
(NCT01774786)
Timeframe: Post-dose (0.5 hour after end of 30-60 minutes infusion) on Day 1 of Cycles 1, 2, 4, and 8 (1 cycle = 21 days)
Intervention | micrograms per milliliter (μg/mL) (Mean) |
---|
| Cycle 1 | Cycle 2 | Cycle 4 | Cycle 8 |
---|
Pertuzumab + Trastuzumab + Chemotherapy | 258 | 288 | 341 | 371 |
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Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1). (NCT01774786)
Timeframe: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years)
Intervention | score on a scale (Mean) |
---|
| Appetite Loss: Cycle 1 (Baseline) | Appetite Loss: Change at Cycle 2 | Appetite Loss: Change at Cycle 3 | Appetite Loss: Change at Cycle 4 | Appetite Loss: Change at Cycle 5 | Appetite Loss: Change at Cycle 6 | Appetite Loss: Change at Cycle 7 | Appetite Loss: Change at Cycle 8 | Appetite Loss: Change at Cycle 9 | Appetite Loss: Change at Cycle 10 | Appetite Loss: Change at Cycle 11 | Appetite Loss: Change at Cycle 12 | Appetite Loss: Change at Cycle 13 | Appetite Loss: Change at Cycle 14 | Appetite Loss: Change at Cycle 15 | Appetite Loss: Change at Cycle 16 | Appetite Loss: Change at Cycle 17 | Appetite Loss: Change at Cycle 18 | Appetite Loss: Change at Cycle 19 | Appetite Loss: Change at Cycle 20 | Appetite Loss: Change at Cycle 21 | Appetite Loss: Change at Cycle 22 | Appetite Loss: Change at Cycle 23 | Appetite Loss: Change at Cycle 24 | Appetite Loss: Change at Cycle 25 | Appetite Loss: Change at Cycle 26 | Appetite Loss: Change at Cycle 27 | Appetite Loss: Change at Cycle 28 | Appetite Loss: Change at PT Visit 1 | Appetite Loss: Change at PT Visit 2 | Cognitive Functional Scale: Cycle 1 (Baseline) | Cognitive Functional Scale: Change at Cycle 2 | Cognitive Functional Scale: Change at Cycle 3 | Cognitive Functional Scale: Change at Cycle 4 | Cognitive Functional Scale: Change at Cycle 5 | Cognitive Functional Scale: Change at Cycle 6 | Cognitive Functional Scale: Change at Cycle 7 | Cognitive Functional Scale: Change at Cycle 8 | Cognitive Functional Scale: Change at Cycle 9 | Cognitive Functional Scale: Change at Cycle 10 | Cognitive Functional Scale: Change at Cycle 11 | Cognitive Functional Scale: Change at Cycle 12 | Cognitive Functional Scale: Change at Cycle 13 | Cognitive Functional Scale: Change at Cycle 14 | Cognitive Functional Scale: Change at Cycle 15 | Cognitive Functional Scale: Change at Cycle 16 | Cognitive Functional Scale: Change at Cycle 17 | Cognitive Functional Scale: Change at Cycle 18 | Cognitive Functional Scale: Change at Cycle 19 | Cognitive Functional Scale: Change at Cycle 20 | Cognitive Functional Scale: Change at Cycle 21 | Cognitive Functional Scale: Change at Cycle 22 | Cognitive Functional Scale: Change at Cycle 23 | Cognitive Functional Scale: Change at Cycle 24 | Cognitive Functional Scale: Change at Cycle 25 | Cognitive Functional Scale: Change at Cycle 26 | Cognitive Functional Scale: Change at Cycle 27 | Cognitive Functional Scale: Change at Cycle 28 | Cognitive Functional Scale: Change at PT Visit 1 | Cognitive Functional Scale: Change at PT Visit 2 | Constipation Symptom Scale: Cycle 1 (Baseline) | Constipation Symptom Scale: Change at Cycle 2 | Constipation Symptom Scale: Change at Cycle 3 | Constipation Symptom Scale: Change at Cycle 4 | Constipation Symptom Scale: Change at Cycle 5 | Constipation Symptom Scale: Change at Cycle 6 | Constipation Symptom Scale: Change at Cycle 7 | Constipation Symptom Scale: Change at Cycle 8 | Constipation Symptom Scale: Change at Cycle 9 | Constipation Symptom Scale: Change at Cycle 10 | Constipation Symptom Scale: Change at Cycle 11 | Constipation Symptom Scale: Change at Cycle 12 | Constipation Symptom Scale: Change at Cycle 13 | Constipation Symptom Scale: Change at Cycle 14 | Constipation Symptom Scale: Change at Cycle 15 | Constipation Symptom Scale: Change at Cycle 16 | Constipation Symptom Scale: Change at Cycle 17 | Constipation Symptom Scale: Change at Cycle 18 | Constipation Symptom Scale: Change at Cycle 19 | Constipation Symptom Scale: Change at Cycle 20 | Constipation Symptom Scale: Change at Cycle 21 | Constipation Symptom Scale: Change at Cycle 22 | Constipation Symptom Scale: Change at Cycle 23 | Constipation Symptom Scale: Change at Cycle 24 | Constipation Symptom Scale: Change at Cycle 25 | Constipation Symptom Scale: Change at Cycle 26 | Constipation Symptom Scale: Change at Cycle 27 | Constipation Symptom Scale: Change at Cycle 28 | Constipation Symptom Scale: Change at PT Visit 1 | Constipation Symptom Scale: Change at PT Visit 2 | Diarrhea Symptom Scale: Cycle 1 (Baseline) | Diarrhea Symptom Scale: Change at Cycle 2 | Diarrhea Symptom Scale: Change at Cycle 3 | Diarrhea Symptom Scale: Change at Cycle 4 | Diarrhea Symptom Scale: Change at Cycle 5 | Diarrhea Symptom Scale: Change at Cycle 6 | Diarrhea Symptom Scale: Change at Cycle 7 | Diarrhea Symptom Scale: Change at Cycle 8 | Diarrhea Symptom Scale: Change at Cycle 9 | Diarrhea Symptom Scale: Change at Cycle 10 | Diarrhea Symptom Scale: Change at Cycle 11 | Diarrhea Symptom Scale: Change at Cycle 12 | Diarrhea Symptom Scale: Change at Cycle 13 | Diarrhea Symptom Scale: Change at Cycle 14 | Diarrhea Symptom Scale: Change at Cycle 15 | Diarrhea Symptom Scale: Change at Cycle 16 | Diarrhea Symptom Scale: Change at Cycle 17 | Diarrhea Symptom Scale: Change at Cycle 18 | Diarrhea Symptom Scale: Change at Cycle 19 | Diarrhea Symptom Scale: Change at Cycle 20 | Diarrhea Symptom Scale: Change at Cycle 21 | Diarrhea Symptom Scale: Change at Cycle 22 | Diarrhea Symptom Scale: Change at Cycle 23 | Diarrhea Symptom Scale: Change at Cycle 24 | Diarrhea Symptom Scale: Change at Cycle 25 | Diarrhea Symptom Scale: Change at Cycle 26 | Diarrhea Symptom Scale: Change at Cycle 27 | Diarrhea Symptom Scale: Change at Cycle 28 | Diarrhea Symptom Scale: Change at PT Visit 1 | Diarrhea Symptom Scale: Change at PT Visit 2 | Dyspnoea Symptom Scale: Cycle 1 (Baseline) | Dyspnoea Symptom Scale: Change at Cycle 2 | Dyspnoea Symptom Scale: Change at Cycle 3 | Dyspnoea Symptom Scale: Change at Cycle 4 | Dyspnoea Symptom Scale: Change at Cycle 5 | Dyspnoea Symptom Scale: Change at Cycle 6 | Dyspnoea Symptom Scale: Change at Cycle 7 | Dyspnoea Symptom Scale: Change at Cycle 8 | Dyspnoea Symptom Scale: Change at Cycle 9 | Dyspnoea Symptom Scale: Change at Cycle 10 | Dyspnoea Symptom Scale: Change at Cycle 11 | Dyspnoea Symptom Scale: Change at Cycle 12 | Dyspnoea Symptom Scale: Change at Cycle 13 | Dyspnoea Symptom Scale: Change at Cycle 14 | Dyspnoea Symptom Scale: Change at Cycle 15 | Dyspnoea Symptom Scale: Change at Cycle 16 | Dyspnoea Symptom Scale: Change at Cycle 17 | Dyspnoea Symptom Scale: Change at Cycle 18 | Dyspnoea Symptom Scale: Change at Cycle 19 | Dyspnoea Symptom Scale: Change at Cycle 20 | Dyspnoea Symptom Scale: Change at Cycle 21 | Dyspnoea Symptom Scale: Change at Cycle 22 | Dyspnoea Symptom Scale: Change at Cycle 23 | Dyspnoea Symptom Scale: Change at Cycle 24 | Dyspnoea Symptom Scale: Change at Cycle 25 | Dyspnoea Symptom Scale: Change at Cycle 26 | Dyspnoea Symptom Scale: Change at Cycle 27 | Dyspnoea Symptom Scale: Change at Cycle 28 | Dyspnoea Symptom Scale: Change at PT Visit 1 | Dyspnoea Symptom Scale: Change at PT Visit 2 | Emotional Functional Scale: Cycle 1 (Baseline) | Emotional Functional Scale: Change at Cycle 2 | Emotional Functional Scale: Change at Cycle 3 | Emotional Functional Scale: Change at Cycle 4 | Emotional Functional Scale: Change at Cycle 5 | Emotional Functional Scale: Change at Cycle 6 | Emotional Functional Scale: Change at Cycle 7 | Emotional Functional Scale: Change at Cycle 8 | Emotional Functional Scale: Change at Cycle 9 | Emotional Functional Scale: Change at Cycle 10 | Emotional Functional Scale: Change at Cycle 11 | Emotional Functional Scale: Change at Cycle 12 | Emotional Functional Scale: Change at Cycle 13 | Emotional Functional Scale: Change at Cycle 14 | Emotional Functional Scale: Change at Cycle 15 | Emotional Functional Scale: Change at Cycle 16 | Emotional Functional Scale: Change at Cycle 17 | Emotional Functional Scale: Change at Cycle 18 | Emotional Functional Scale: Change at Cycle 19 | Emotional Functional Scale: Change at Cycle 20 | Emotional Functional Scale: Change at Cycle 21 | Emotional Functional Scale: Change at Cycle 22 | Emotional Functional Scale: Change at Cycle 23 | Emotional Functional Scale: Change at Cycle 24 | Emotional Functional Scale: Change at Cycle 25 | Emotional Functional Scale: Change at Cycle 26 | Emotional Functional Scale: Change at Cycle 27 | Emotional Functional Scale: Change at Cycle 28 | Emotional Functional Scale: Change at PT Visit 1 | Emotional Functional Scale: Change at PT Visit 2 | Fatigue Symptom Scale: Cycle 1 (Baseline) | Fatigue Symptom Scale: Change at Cycle 2 | Fatigue Symptom Scale: Change at Cycle 3 | Fatigue Symptom Scale: Change at Cycle 4 | Fatigue Symptom Scale: Change at Cycle 5 | Fatigue Symptom Scale: Change at Cycle 6 | Fatigue Symptom Scale: Change at Cycle 7 | Fatigue Symptom Scale: Change at Cycle 8 | Fatigue Symptom Scale: Change at Cycle 9 | Fatigue Symptom Scale: Change at Cycle 10 | Fatigue Symptom Scale: Change at Cycle 11 | Fatigue Symptom Scale: Change at Cycle 12 | Fatigue Symptom Scale: Change at Cycle 13 | Fatigue Symptom Scale: Change at Cycle 14 | Fatigue Symptom Scale: Change at Cycle 15 | Fatigue Symptom Scale: Change at Cycle 16 | Fatigue Symptom Scale: Change at Cycle 17 | Fatigue Symptom Scale: Change at Cycle 18 | Fatigue Symptom Scale: Change at Cycle 19 | Fatigue Symptom Scale: Change at Cycle 20 | Fatigue Symptom Scale: Change at Cycle 21 | Fatigue Symptom Scale: Change at Cycle 22 | Fatigue Symptom Scale: Change at Cycle 23 | Fatigue Symptom Scale: Change at Cycle 24 | Fatigue Symptom Scale: Change at Cycle 25 | Fatigue Symptom Scale: Change at Cycle 26 | Fatigue Symptom Scale: Change at Cycle 27 | Fatigue Symptom Scale: Change at Cycle 28 | Fatigue Symptom Scale: Change at PT Visit 1 | Fatigue Symptom Scale: Change at PT Visit 2 | Financial Difficulties Scale: Cycle 1 (Baseline) | Financial Difficulties Scale: Change at Cycle 2 | Financial Difficulties Scale: Change at Cycle 3 | Financial Difficulties Scale: Change at Cycle 4 | Financial Difficulties Scale: Change at Cycle 5 | Financial Difficulties Scale: Change at Cycle 6 | Financial Difficulties Scale: Change at Cycle 7 | Financial Difficulties Scale: Change at Cycle 8 | Financial Difficulties Scale: Change at Cycle 9 | Financial Difficulties Scale: Change at Cycle 10 | Financial Difficulties Scale: Change at Cycle 11 | Financial Difficulties Scale: Change at Cycle 12 | Financial Difficulties Scale: Change at Cycle 13 | Financial Difficulties Scale: Change at Cycle 14 | Financial Difficulties Scale: Change at Cycle 15 | Financial Difficulties Scale: Change at Cycle 16 | Financial Difficulties Scale: Change at Cycle 17 | Financial Difficulties Scale: Change at Cycle 18 | Financial Difficulties Scale: Change at Cycle 19 | Financial Difficulties Scale: Change at Cycle 20 | Financial Difficulties Scale: Change at Cycle 21 | Financial Difficulties Scale: Change at Cycle 22 | Financial Difficulties Scale: Change at Cycle 23 | Financial Difficulties Scale: Change at Cycle 24 | Financial Difficulties Scale: Change at Cycle 25 | Financial Difficulties Scale: Change at Cycle 26 | Financial Difficulties Scale: Change at Cycle 27 | Financial Difficulties Scale: Change at Cycle 28 | Financial Difficulties Scale: Change at PT Visit 1 | Financial Difficulties Scale: Change at PT Visit 2 | Nausea and Vomiting Scale: Cycle 1 (Baseline) | Nausea And Vomiting Scale: Change at Cycle 2 | Nausea And Vomiting Scale: Change at Cycle 3 | Nausea And Vomiting Scale: Change at Cycle 4 | Nausea And Vomiting Scale: Change at Cycle 5 | Nausea And Vomiting Scale: Change at Cycle 6 | Nausea And Vomiting Scale: Change at Cycle 7 | Nausea And Vomiting Scale: Change at Cycle 8 | Nausea And Vomiting Scale: Change at Cycle 9 | Nausea And Vomiting Scale: Change at Cycle 10 | Nausea And Vomiting Scale: Change at Cycle 11 | Nausea And Vomiting Scale: Change at Cycle 12 | Nausea And Vomiting Scale: Change at Cycle 13 | Nausea And Vomiting Scale: Change at Cycle 14 | Nausea And Vomiting Scale: Change at Cycle 15 | Nausea And Vomiting Scale: Change at Cycle 16 | Nausea And Vomiting Scale: Change at Cycle 17 | Nausea And Vomiting Scale: Change at Cycle 18 | Nausea And Vomiting Scale: Change at Cycle 19 | Nausea And Vomiting Scale: Change at Cycle 20 | Nausea And Vomiting Scale: Change at Cycle 21 | Nausea And Vomiting Scale: Change at Cycle 22 | Nausea And Vomiting Scale: Change at Cycle 23 | Nausea And Vomiting Scale: Change at Cycle 24 | Nausea And Vomiting Scale: Change at Cycle 25 | Nausea And Vomiting Scale: Change at Cycle 26 | Nausea And Vomiting Scale: Change at Cycle 27 | Nausea And Vomiting Scale: Change at Cycle 28 | Nausea and Vomiting Scale: Change at PT Visit 1 | Nausea and Vomiting Scale: Change at PT Visit 2 | Pain Symptom Scale: Cycle 1 (Baseline) | Pain Symptom Scale: Change at Cycle 2 | Pain Symptom Scale: Change at Cycle 3 | Pain Symptom Scale: Change at Cycle 4 | Pain Symptom Scale: Change at Cycle 5 | Pain Symptom Scale: Change at Cycle 6 | Pain Symptom Scale: Change at Cycle 7 | Pain Symptom Scale: Change at Cycle 8 | Pain Symptom Scale: Change at Cycle 9 | Pain Symptom Scale: Change at Cycle 10 | Pain Symptom Scale: Change at Cycle 11 | Pain Symptom Scale: Change at Cycle 12 | Pain Symptom Scale: Change at Cycle 13 | Pain Symptom Scale: Change at Cycle 14 | Pain Symptom Scale: Change at Cycle 15 | Pain Symptom Scale: Change at Cycle 16 | Pain Symptom Scale: Change at Cycle 17 | Pain Symptom Scale: Change at Cycle 18 | Pain Symptom Scale: Change at Cycle 19 | Pain Symptom Scale: Change at Cycle 20 | Pain Symptom Scale: Change at Cycle 21 | Pain Symptom Scale: Change at Cycle 22 | Pain Symptom Scale: Change at Cycle 23 | Pain Symptom Scale: Change at Cycle 24 | Pain Symptom Scale: Change at Cycle 25 | Pain Symptom Scale: Change at Cycle 26 | Pain Symptom Scale: Change at Cycle 27 | Pain Symptom Scale: Change at Cycle 28 | Pain Symptom Scale: Change at PT Visit 1 | Pain Symptom Scale: Change at PT Visit 2 | Physical Functional Scale: Cycle 1 (Baseline) | Physical Functional Scale: Change at Cycle 2 | Physical Functional Scale: Change at Cycle 3 | Physical Functional Scale: Change at Cycle 4 | Physical Functional Scale: Change at Cycle 5 | Physical Functional Scale: Change at Cycle 6 | Physical Functional Scale: Change at Cycle 7 | Physical Functional Scale: Change at Cycle 8 | Physical Functional Scale: Change at Cycle 9 | Physical Functional Scale: Change at Cycle 10 | Physical Functional Scale: Change at Cycle 11 | Physical Functional Scale: Change at Cycle 12 | Physical Functional Scale: Change at Cycle 13 | Physical Functional Scale: Change at Cycle 14 | Physical Functional Scale: Change at Cycle 15 | Physical Functional Scale: Change at Cycle 16 | Physical Functional Scale: Change at Cycle 17 | Physical Functional Scale: Change at Cycle 18 | Physical Functional Scale: Change at Cycle 19 | Physical Functional Scale: Change at Cycle 20 | Physical Functional Scale: Change at Cycle 21 | Physical Functional Scale: Change at Cycle 22 | Physical Functional Scale: Change at Cycle 23 | Physical Functional Scale: Change at Cycle 24 | Physical Functional Scale: Change at Cycle 25 | Physical Functional Scale: Change at Cycle 26 | Physical Functional Scale: Change at Cycle 27 | Physical Functional Scale: Change at Cycle 28 | Physical Functional Scale: Change at PT Visit 1 | Physical Functional Scale: Change at PT Visit 2 | Global Health Status Scale: Cycle 1 (Baseline) | Global Health Status Scale: Change at Cycle 2 | Global Health Status Scale: Change at Cycle 3 | Global Health Status Scale: Change at Cycle 4 | Global Health Status Scale: Change at Cycle 5 | Global Health Status Scale: Change at Cycle 6 | Global Health Status Scale: Change at Cycle 7 | Global Health Status Scale: Change at Cycle 8 | Global Health Status Scale: Change at Cycle 9 | Global Health Status Scale: Change at Cycle 10 | Global Health Status Scale: Change at Cycle 11 | Global Health Status Scale: Change at Cycle 12 | Global Health Status Scale: Change at Cycle 13 | Global Health Status Scale: Change at Cycle 14 | Global Health Status Scale: Change at Cycle 15 | Global Health Status Scale: Change at Cycle 16 | Global Health Status Scale: Change at Cycle 17 | Global Health Status Scale: Change at Cycle 18 | Global Health Status Scale: Change at Cycle 19 | Global Health Status Scale: Change at Cycle 20 | Global Health Status Scale: Change at Cycle 21 | Global Health Status Scale: Change at Cycle 22 | Global Health Status Scale: Change at Cycle 23 | Global Health Status Scale: Change at Cycle 24 | Global Health Status Scale: Change at Cycle 25 | Global Health Status Scale: Change at Cycle 26 | Global Health Status Scale: Change at Cycle 27 | Global Health Status Scale: Change at Cycle 28 | Global Health Status Scale: Change at PT Visit 1 | Global Health Status Scale: Change at PT Visit 2 | Role Functional Scale: Cycle 1 (Baseline) | Role Functional Scale: Change at Cycle 2 | Role Functional Scale: Change at Cycle 3 | Role Functional Scale: Change at Cycle 4 | Role Functional Scale: Change at Cycle 5 | Role Functional Scale: Change at Cycle 6 | Role Functional Scale: Change at Cycle 7 | Role Functional Scale: Change at Cycle 8 | Role Functional Scale: Change at Cycle 9 | Role Functional Scale: Change at Cycle 10 | Role Functional Scale: Change at Cycle 11 | Role Functional Scale: Change at Cycle 12 | Role Functional Scale: Change at Cycle 13 | Role Functional Scale: Change at Cycle 14 | Role Functional Scale: Change at Cycle 15 | Role Functional Scale: Change at Cycle 16 | Role Functional Scale: Change at Cycle 17 | Role Functional Scale: Change at Cycle 18 | Role Functional Scale: Change at Cycle 19 | Role Functional Scale: Change at Cycle 20 | Role Functional Scale: Change at Cycle 21 | Role Functional Scale: Change at Cycle 22 | Role Functional Scale: Change at Cycle 23 | Role Functional Scale: Change at Cycle 24 | Role Functional Scale: Change at Cycle 25 | Role Functional Scale: Change at Cycle 26 | Role Functional Scale: Change at Cycle 27 | Role Functional Scale: Change at Cycle 28 | Role Functional Scale: Change at PT Visit 1 | Role Functional Scale: Change at PT Visit 2 | Social Functional Scale: Cycle 1 (Baseline) | Social Functional Scale: Change at Cycle 2 | Social Functional Scale: Change at Cycle 3 | Social Functional Scale: Change at Cycle 4 | Social Functional Scale: Change at Cycle 5 | Social Functional Scale: Change at Cycle 6 | Social Functional Scale: Change at Cycle 7 | Social Functional Scale: Change at Cycle 8 | Social Functional Scale: Change at Cycle 9 | Social Functional Scale: Change at Cycle 10 | Social Functional Scale: Change at Cycle 11 | Social Functional Scale: Change at Cycle 12 | Social Functional Scale: Change at Cycle 13 | Social Functional Scale: Change at Cycle 14 | Social Functional Scale: Change at Cycle 15 | Social Functional Scale: Change at Cycle 16 | Social Functional Scale: Change at Cycle 17 | Social Functional Scale: Change at Cycle 18 | Social Functional Scale: Change at Cycle 19 | Social Functional Scale: Change at Cycle 20 | Social Functional Scale: Change at Cycle 21 | Social Functional Scale: Change at Cycle 22 | Social Functional Scale: Change at Cycle 23 | Social Functional Scale: Change at Cycle 24 | Social Functional Scale: Change at Cycle 25 | Social Functional Scale: Change at Cycle 26 | Social Functional Scale: Change at Cycle 27 | Social Functional Scale: Change at Cycle 28 | Social Functional Scale: Change at PT Visit 1 | Social Functional Scale: Change at PT Visit 2 | Insomnia Symptom Scale: Cycle 1 (Baseline) | Insomnia Symptom Scale: Change at Cycle 2 | Insomnia Symptom Scale: Change at Cycle 3 | Insomnia Symptom Scale: Change at Cycle 4 | Insomnia Symptom Scale: Change at Cycle 5 | Insomnia Symptom Scale: Change at Cycle 6 | Insomnia Symptom Scale: Change at Cycle 7 | Insomnia Symptom Scale: Change at Cycle 8 | Insomnia Symptom Scale: Change at Cycle 9 | Insomnia Symptom Scale: Change at Cycle 10 | Insomnia Symptom Scale: Change at Cycle 11 | Insomnia Symptom Scale: Change at Cycle 12 | Insomnia Symptom Scale: Change at Cycle 13 | Insomnia Symptom Scale: Change at Cycle 14 | Insomnia Symptom Scale: Change at Cycle 15 | Insomnia Symptom Scale: Change at Cycle 16 | Insomnia Symptom Scale: Change at Cycle 17 | Insomnia Symptom Scale: Change at Cycle 18 | Insomnia Symptom Scale: Change at Cycle 19 | Insomnia Symptom Scale: Change at Cycle 20 | Insomnia Symptom Scale: Change at Cycle 21 | Insomnia Symptom Scale: Change at Cycle 22 | Insomnia Symptom Scale: Change at Cycle 23 | Insomnia Symptom Scale: Change at Cycle 24 | Insomnia Symptom Scale: Change at Cycle 25 | Insomnia Symptom Scale: Change at Cycle 26 | Insomnia Symptom Scale: Change at Cycle 27 | Insomnia Symptom Scale: Change at Cycle 28 | Insomnia Symptom Scale: Change at PT Visit 1 | Insomnia Symptom Scale: Change at PT Visit 2 |
---|
Pertuzumab + Trastuzumab + Chemotherapy | 26.68 | 6.57 | 3.63 | 5.24 | 4.55 | 3.94 | 2.07 | -2.42 | -6.67 | -8.06 | -9.36 | -9.22 | -10.17 | -12.10 | -8.21 | -6.03 | -6.55 | -4.90 | -8.33 | -3.97 | -5.91 | -4.98 | -6.35 | -7.78 | -7.05 | -7.48 | -10.08 | -10.00 | 7.30 | -0.33 | 87.95 | -1.90 | -0.83 | -2.04 | -3.04 | -5.10 | -4.34 | -3.15 | -2.22 | -3.32 | -2.83 | -3.35 | -1.79 | -1.98 | -1.15 | -2.73 | -2.53 | -2.78 | -1.04 | -2.18 | -2.11 | -4.73 | -2.38 | -2.78 | -5.45 | -2.38 | -3.88 | -3.75 | -9.13 | -8.42 | 20.43 | -5.39 | -7.48 | -5.32 | -5.94 | -7.13 | -8.13 | -8.05 | -10.00 | -9.32 | -9.16 | -10.27 | -11.19 | -11.60 | -10.51 | -8.62 | -8.33 | -7.52 | -3.47 | -3.97 | -3.80 | -4.98 | -6.35 | -7.78 | -7.05 | -6.12 | -7.75 | -6.67 | -6.78 | -6.93 | 8.87 | 15.12 | 14.64 | 14.13 | 13.17 | 14.81 | 12.26 | 8.91 | 6.83 | 6.63 | 5.26 | 3.98 | 4.29 | 3.95 | 3.33 | 5.46 | 2.68 | 3.59 | 3.82 | 5.95 | 3.80 | 6.97 | 6.88 | 7.22 | 8.97 | 5.44 | 3.88 | 7.50 | 8.14 | 7.26 | 12.07 | -0.50 | -0.31 | 1.23 | 2.58 | 3.20 | 0.00 | -0.14 | -1.12 | -0.54 | -2.16 | -2.53 | -1.43 | -1.98 | -2.84 | -1.45 | -1.82 | -0.98 | -1.74 | -1.19 | 1.27 | -1.99 | -1.59 | 1.11 | 0.64 | 0.00 | 0.78 | 1.67 | 6.97 | 3.30 | 76.90 | 3.53 | 2.65 | 3.10 | 2.62 | 1.01 | 1.72 | 3.43 | 4.72 | 3.72 | 5.85 | 4.93 | 5.00 | 5.93 | 6.03 | 5.17 | 6.01 | 3.68 | 4.69 | 3.47 | 4.54 | 5.35 | 5.82 | 5.28 | 5.93 | 5.44 | 7.56 | 7.08 | -5.48 | -2.64 | 31.96 | 3.13 | 1.41 | 2.77 | 3.87 | 4.37 | 2.36 | -0.19 | -2.38 | -3.41 | -4.35 | -3.14 | -4.57 | -6.75 | -5.47 | -3.54 | -4.27 | -4.14 | -5.32 | -5.56 | -3.94 | -1.49 | -5.82 | -1.67 | -4.70 | -4.99 | -6.98 | -6.39 | 10.02 | 7.70 | 26.67 | -0.90 | 0.31 | 0.89 | 1.75 | 1.11 | 1.11 | 1.15 | 1.11 | 0.90 | 0.39 | -1.05 | -0.95 | -1.73 | -1.81 | -3.16 | -3.87 | -2.29 | -0.35 | 1.19 | 1.27 | 2.49 | -0.53 | 1.11 | 3.21 | 2.72 | -3.10 | -1.67 | 1.70 | 1.98 | 11.14 | 5.85 | 5.12 | 4.10 | 5.13 | 4.11 | 2.07 | -0.86 | -2.54 | -4.30 | -3.51 | -3.04 | -4.02 | -3.46 | -3.59 | -0.43 | -0.60 | -0.65 | -0.87 | -1.79 | -1.05 | -3.48 | -4.23 | -4.72 | -4.17 | -3.40 | -5.04 | -1.25 | 4.68 | 4.29 | 23.92 | -6.80 | -9.89 | -10.26 | -8.86 | -8.95 | -10.95 | -9.97 | -9.29 | -9.41 | -10.33 | -10.27 | -10.28 | -10.49 | -11.15 | -9.91 | -7.59 | -8.82 | -8.16 | -6.94 | -9.92 | -7.71 | -10.85 | -10.00 | -9.94 | -10.54 | -11.24 | -10.42 | 1.13 | -1.49 | 80.86 | -3.58 | -2.99 | -3.28 | -3.10 | -5.00 | -3.66 | -2.24 | -1.59 | 0.11 | 0.35 | -1.05 | -0.80 | -0.02 | 0.41 | -1.08 | -0.46 | 0.13 | 1.39 | 0.71 | 0.42 | -2.79 | -1.48 | -2.67 | -2.18 | -1.90 | 0.16 | -1.17 | -11.37 | -11.49 | 59.77 | 1.81 | 1.56 | 1.39 | 1.17 | 0.68 | 1.83 | 3.06 | 4.39 | 4.80 | 5.78 | 3.11 | 3.51 | 5.97 | 4.26 | 3.12 | 2.93 | 3.02 | 3.25 | 5.12 | 5.38 | 3.79 | 4.03 | 4.24 | 3.59 | 7.27 | 7.54 | 4.49 | -7.24 | -2.72 | 77.06 | -3.78 | -3.62 | -4.64 | -4.72 | -6.13 | -4.82 | -1.85 | -1.19 | -1.79 | -0.78 | -1.05 | -2.01 | -0.86 | -1.03 | -3.16 | -1.04 | -0.16 | 1.04 | -1.19 | -0.84 | -2.24 | -3.44 | -4.44 | -3.53 | -1.36 | -1.55 | -0.42 | -14.61 | -10.73 | 77.96 | -3.45 | -4.62 | -2.59 | -5.54 | -5.72 | -2.69 | -1.72 | 0.56 | -0.81 | 0.58 | 0.52 | 0.83 | 1.98 | 1.79 | -0.72 | -0.45 | -0.98 | 2.26 | 1.59 | 1.27 | 1.24 | 6.08 | 5.83 | 1.60 | 3.74 | 5.81 | 6.25 | -9.13 | -5.45 | 22.94 | -0.69 | -3.53 | -2.88 | -2.21 | -2.94 | -4.56 | -6.13 | -8.97 | -8.24 | -8.97 | -8.81 | -10.17 | -9.14 | -9.74 | -8.91 | -11.01 | -8.82 | -11.46 | -10.32 | -11.81 | -10.95 | -10.58 | -9.44 | -10.26 | -9.52 | -13.18 | -11.67 | 2.81 | 5.67 |
,Placebo + Trastuzumab + Chemotherapy | 27.59 | 0.97 | 3.81 | 0.79 | 2.90 | -0.39 | 1.61 | -3.69 | -4.76 | -6.63 | -9.68 | -9.05 | -10.81 | -12.09 | -9.18 | -10.59 | -9.91 | -14.08 | -13.13 | -13.23 | -14.20 | -16.31 | -11.36 | -13.33 | -12.04 | -12.50 | -9.20 | -11.54 | 2.64 | 4.55 | 88.22 | -1.81 | -3.17 | -2.99 | -4.59 | -3.84 | -4.31 | -3.30 | -4.59 | -3.11 | -3.44 | -2.52 | -3.60 | -2.29 | -2.38 | -2.55 | -1.13 | 0.47 | 0.00 | 0.79 | 0.62 | -0.71 | 1.14 | 1.25 | -0.93 | -1.56 | -1.15 | 0.00 | -9.16 | -11.21 | 18.41 | 0.29 | -2.11 | -3.73 | -1.28 | -2.33 | -4.09 | -4.45 | -5.61 | -7.43 | -6.88 | -7.25 | -5.76 | -6.21 | -7.14 | -7.45 | -5.86 | -6.57 | -3.03 | -4.76 | -9.26 | -8.51 | -8.33 | -10.00 | -9.26 | -6.25 | -10.34 | -6.41 | -4.62 | -0.91 | 9.16 | 5.20 | 4.99 | 4.63 | 4.99 | 2.47 | 2.92 | 2.61 | 2.04 | 0.60 | 2.60 | 1.92 | 1.50 | 0.98 | 1.02 | 3.14 | 2.25 | 3.29 | 2.02 | 3.70 | 1.85 | 4.26 | 8.33 | 3.33 | 2.78 | 5.21 | 3.45 | 2.56 | 1.98 | 4.24 | 12.65 | 0.29 | -0.32 | 1.81 | 1.39 | 0.39 | 0.59 | 0.93 | 0.17 | 1.00 | -1.29 | -0.71 | -1.20 | -2.61 | 2.72 | 1.18 | 0.90 | -2.35 | 0.51 | -1.06 | -0.62 | 0.71 | 1.52 | -1.67 | -3.70 | 1.04 | 3.45 | 3.85 | 6.77 | 9.39 | 76.56 | 3.05 | 3.96 | 3.67 | 2.74 | 4.93 | 4.41 | 5.66 | 4.78 | 6.74 | 4.96 | 5.24 | 5.18 | 6.29 | 5.19 | 5.29 | 6.31 | 5.87 | 5.56 | 5.42 | 6.48 | 6.91 | 6.63 | 8.54 | 8.80 | 5.99 | 5.75 | 7.05 | -3.92 | -4.47 | 32.27 | 2.32 | 3.19 | 1.58 | 3.05 | 2.62 | 0.97 | -1.18 | -2.01 | -3.08 | -3.44 | -4.60 | -4.50 | -6.54 | -4.99 | -6.93 | -3.45 | -8.92 | -9.01 | -6.53 | -7.41 | -10.64 | -9.60 | -12.50 | -12.35 | -11.46 | -5.36 | -4.70 | 5.25 | 9.70 | 26.21 | -2.46 | 0.00 | 0.11 | 2.58 | 0.92 | 0.30 | 0.47 | -0.51 | -2.42 | -0.22 | -0.97 | 0.30 | -0.98 | 1.36 | 0.39 | 1.35 | 2.35 | -0.51 | 1.59 | -4.94 | -4.26 | -2.27 | -5.83 | -4.63 | -2.22 | 1.15 | -1.28 | 1.33 | 4.24 | 11.92 | 4.08 | 5.06 | 3.56 | 5.15 | 2.59 | 2.49 | -0.77 | -2.98 | -2.81 | -3.66 | -3.45 | -3.60 | -5.72 | -3.91 | -2.55 | -3.15 | -3.52 | -4.04 | -3.97 | -6.48 | -8.16 | -6.44 | -7.92 | -7.41 | -9.38 | -7.47 | -6.41 | 4.13 | 2.73 | 23.72 | -6.38 | -7.23 | -7.46 | -6.25 | -7.33 | -7.46 | -8.53 | -7.82 | -8.13 | -6.34 | -5.24 | -4.80 | -5.56 | -3.74 | -4.71 | -5.63 | -8.22 | -5.05 | -6.08 | -6.48 | -8.51 | -7.95 | -10.00 | -12.96 | -8.33 | -5.75 | -9.62 | 2.06 | 5.45 | 82.05 | -3.01 | -3.92 | -3.50 | -4.62 | -3.84 | -3.79 | -1.56 | -0.75 | -0.27 | 0.27 | 0.89 | 0.27 | 1.70 | -0.95 | -0.08 | -0.81 | 0.75 | 1.31 | 0.85 | 0.25 | 1.42 | 0.61 | 3.00 | 4.81 | -1.88 | -3.68 | -2.82 | -7.51 | -11.82 | 59.90 | 4.29 | 2.86 | 4.15 | 3.92 | 3.61 | 3.33 | 5.18 | 4.68 | 5.07 | 3.82 | 5.34 | 3.83 | 4.82 | 1.70 | 3.04 | 3.83 | 2.58 | 3.97 | 4.89 | 5.40 | 3.19 | 4.07 | 2.92 | 8.10 | 5.47 | 1.72 | 4.81 | -6.14 | -5.68 | 79.33 | -2.82 | -4.55 | -5.99 | -7.41 | -6.03 | -5.34 | -2.38 | -2.47 | 0.90 | -2.69 | 0.24 | -2.40 | -1.31 | -3.23 | -2.35 | -3.38 | 0.23 | -0.25 | 0.79 | 0.00 | 1.06 | 1.14 | 2.08 | 4.63 | 0.52 | -4.02 | -3.85 | -9.49 | -15.45 | 75.90 | -0.44 | -2.07 | -1.70 | -3.26 | -1.04 | -0.15 | 1.08 | 0.77 | 2.31 | 1.94 | 2.40 | 2.10 | 2.12 | 0.00 | 0.39 | 1.58 | 2.11 | 3.28 | 0.79 | 5.86 | 2.84 | 1.89 | 4.17 | 2.78 | 1.56 | -1.72 | -0.64 | -3.80 | -8.48 | 25.41 | -0.39 | -3.48 | -3.62 | -2.66 | -5.58 | -4.82 | -6.45 | -6.12 | -4.42 | -5.81 | -6.43 | -5.11 | -7.84 | -5.10 | -4.31 | -5.41 | -8.45 | -7.58 | -5.29 | -4.94 | -7.80 | -6.06 | -7.50 | -8.33 | -4.17 | -4.60 | -1.28 | -1.32 | 3.03 |
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Cmax of Trastuzumab
(NCT01774786)
Timeframe: Post-dose (0.5 hour after end of 30-60 minutes infusion) on Day 1 of Cycles 1, 2, 4, and 8 (1 cycle = 21 days)
Intervention | μg/mL (Mean) |
---|
| Cycle 1 | Cycle 2 | Cycle 4 | Cycle 8 |
---|
Pertuzumab + Trastuzumab + Chemotherapy | 142 | 120 | 127 | 130 |
,Placebo + Trastuzumab + Chemotherapy | 139 | 120 | 129 | 147 |
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Cmin of Trastuzumab
(NCT01774786)
Timeframe: Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days)
Intervention | μg/mL (Mean) |
---|
| Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 6 | Cycle 8 |
---|
Pertuzumab + Trastuzumab + Chemotherapy | NA | 15.4 | 19.9 | 22.9 | 26.3 | 32.7 |
,Placebo + Trastuzumab + Chemotherapy | NA | 17.2 | 20.7 | 24.1 | 29.8 | 37.4 |
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Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria
Duration of objective response is defined as the time from first occurrence of documented objective response to documented disease progression, as determined by the investigator using RECIST v1.1, or death from any cause. Objective response: PR or CR occurring on 2 consecutive occasions ≥4 weeks apart. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. Measurable disease defined as tumor lesions with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node, it must be ≥15 mm in short axis when assessed by CT scan. (NCT01774786)
Timeframe: Baseline to death or progressive disease (PD), whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] vs. 21.3 [0-39] months; Final Analysis: 50.4 [0-70] vs. 47.4 [0-66] months)
Intervention | months (Median) |
---|
| Primary Analysis | Final Analysis |
---|
Pertuzumab + Trastuzumab + Chemotherapy | 10.2 | 10.2 |
,Placebo + Trastuzumab + Chemotherapy | 8.4 | 8.4 |
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Final Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria
The overall objective response rate was defined as the percentage of participants with partial response (PR) or complete response (CR) occurring on two consecutive occasions ≥4 weeks apart, as determined by the investigator using RECIST v1.1. Tumor assessments with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis were performed every 9 weeks. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be greater than or equal to (≥) 15 mm in short axis when assessed by CT scan. (NCT01774786)
Timeframe: Baseline up to death or progressive disease, whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Final Analysis: 50.4 [0-70] months vs. 47.4 [0-66] months)
Intervention | Percentage of participants (Number) |
---|
| Objective Response (CR + PR) | Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Not Evaluable/Missing |
---|
Pertuzumab + Trastuzumab + Chemotherapy | 57.0 | 5.7 | 51.3 | 27.6 | 4.8 | 10.5 |
,Placebo + Trastuzumab + Chemotherapy | 48.6 | 2.0 | 46.6 | 32.7 | 8.2 | 10.5 |
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Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria
Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of progressive disease (PD), as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Tumor assessments with CT or MRI scans of the chest, abdomen, and pelvis were performed every 9 weeks. Participants without documented PD or death were censored at the tumor assessment date for which the participant was last known to be progression-free. Participants who did not have any post-baseline tumor assessment data were censored at the date of randomization plus 1 day. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 millimeters (mm) in the sum of diameters of target lesions; the appearance of one or more new lesions. (NCT01774786)
Timeframe: Baseline to death or progressive disease (PD), whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] vs. 21.3 [0-39] months; Final Analysis: 50.4 [0-70] vs. 47.4 [0-66] months)
Intervention | months (Median) |
---|
| Primary Analysis | Final Analysis |
---|
Pertuzumab + Trastuzumab + Chemotherapy | 8.5 | 8.5 |
,Placebo + Trastuzumab + Chemotherapy | 7.0 | 7.2 |
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Primary Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria
The overall objective response rate was defined as the percentage of participants with partial response (PR) or complete response (CR) occurring on two consecutive occasions ≥4 weeks apart, as determined by the investigator using RECIST v1.1. Tumor assessments with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis were performed every 9 weeks. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be greater than or equal to (≥) 15 mm in short axis when assessed by CT scan. (NCT01774786)
Timeframe: Baseline up to death or progressive disease, whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] months vs. 21.3 [0-39] months)
Intervention | Percentage of participants (Number) |
---|
| Objective Response (CR + PR) | Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Not Evaluable/Missing |
---|
Pertuzumab + Trastuzumab + Chemotherapy | 56.7 | 5.1 | 51.6 | 27.9 | 4.8 | 10.5 |
,Placebo + Trastuzumab + Chemotherapy | 48.3 | 0.9 | 47.4 | 33.0 | 8.0 | 10.8 |
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Overview of Safety: Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. The investigator graded all AEs for severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. (NCT01774786)
Timeframe: From Baseline until end of post-treatment follow-up (up to 70 months)
Intervention | Participants (Count of Participants) |
---|
| Any Adverse Event (AE) | AE with Fatal Outcome | Serious AE | Grade 3-5 AE | AE Leading to Pertuz/Pbo & Trastuz Discontinuation | AE Leading to Dose Interruption &/or Dose Delay |
---|
Pertuzumab + Trastuzumab + Chemotherapy | 381 | 27 | 178 | 310 | 48 | 110 |
,Placebo + Trastuzumab + Chemotherapy | 385 | 31 | 156 | 288 | 46 | 94 |
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Overall Survival
Overall survival (OS) was defined as the time from randomization to death from any cause. For participants who were still alive on the date of clinical data cut-off for the OS analysis, the last date when the participant was known to be alive on, or prior to the clinical cut-off date, was used to determine the censoring date. Participants who did not have any post-baseline data (e.g., dosing records, imaging dates, visit dates) were censored at the date of randomization plus 1 day. (NCT01774786)
Timeframe: From Baseline until death from any cause (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.4 [0-42] months vs. 25.0 [0-41] months; Final Analysis: 46.1 [0-70] months vs. 44.4 [0-68] months)
Intervention | Months (Median) |
---|
| Primary Analysis | Final Analysis |
---|
Pertuzumab + Trastuzumab + Chemotherapy | 17.5 | 18.1 |
,Placebo + Trastuzumab + Chemotherapy | 14.2 | 14.2 |
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Number of Participants With Symptomatic or Asymptomatic Left Ventricular Systolic Dysfunction (LVSD)
The number and percentage of participants with symptomatic left ventricular systolic dysfunction (LVSD) and asymptomatic LVSD events (defined as a left ventricular ejection fraction [LVEF] ≥10% decrease from baseline to an absolute value <50%) at any time during the study was summarized by treatment arm. (NCT01774786)
Timeframe: From Baseline until end of post-treatment follow-up (up to 70 months)
Intervention | Participants (Count of Participants) |
---|
| Symptomatic LVSD | Asymptomatic LVSD |
---|
Pertuzumab + Trastuzumab + Chemotherapy | 3 | 20 |
,Placebo + Trastuzumab + Chemotherapy | 1 | 18 |
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Progression Free Survival
The effect of napabucasin given in combination with cetuximab, panitumumab or capecitabine on Progression Free Survival (PFS) of patients with advanced colorectal cancer. (NCT01776307)
Timeframe: The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 24 months
Intervention | months (Median) |
---|
Napabucasin Plus Cetuximab | 1.87 |
Napabucasin Plus Panitumumab | 2.27 |
Napabucasin Plus Capecitabine | 1.94 |
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Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle
To determine the maximum concentration of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. (NCT01776307)
Timeframe: Blood samples drawn on day 21 during the first study cycle
Intervention | ng/mL (Geometric Mean) |
---|
Napabucasin Plus Cetuximab | 627 |
Napabucasin Plus Panitumumab | 398 |
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Disease Control Rate
Assessment of Disease Control Rate, defined as the proportion of patients with a documented complete response, partial response and stable disease based on RECIST 1.1, in patients with advanced colorectal cancer given napabucasin in combination with cetuximab, panitumumab or capecitabine (NCT01776307)
Timeframe: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months
Intervention | Percentage of participants (Number) |
---|
Napabucasin Plus Cetuximab | 34.5 |
Napabucasin Plus Panitumumab | 36.6 |
Napabucasin Plus Capecitabine | 25.6 |
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Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle
To determine the maximum concentration of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. (NCT01776307)
Timeframe: Blood samples drawn on day 5 during the first study cycle
Intervention | ng/mL (Geometric Mean) |
---|
Napabucasin Plus Panitumumab | 1020 |
Napabucasin Plus Capecitabine | 858 |
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Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle
To determine the maximum concentration of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. (NCT01776307)
Timeframe: Blood samples drawn on day 21 during the first study cycle
Intervention | ng/mL (Geometric Mean) |
---|
Napabucasin Plus Panitumumab | 1060 |
Napabucasin Plus Capecitabine | 789 |
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Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle
To determine the maximum concentration of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. (NCT01776307)
Timeframe: Blood samples drawn on day 5 during the first study cycle
Intervention | ng/mL (Geometric Mean) |
---|
Napabucasin Plus Cetuximab | 661 |
Napabucasin Plus Panitumumab | 468 |
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Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle
To determine the maximum concentration of napabucasin when given at 240mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. (NCT01776307)
Timeframe: Blood samples drawn on day 21 during the first study cycle
Intervention | ng/mL (Geometric Mean) |
---|
Napabucasin Plus Cetuximab | 494 |
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Number of Patients With Adverse Events and Serious Adverse Events
Assessment of safety of napabucasin given in combination with cetuximab, panitumumab or capecitabine to patients with advanced colorectal cancer by reporting of adverse events and serious adverse events (NCT01776307)
Timeframe: The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 4 months.
Intervention | Participants (Count of Participants) |
---|
Napabucasin Plus Cetuximab | 49 |
Napabucasin Plus Panitumumab | 75 |
Napabucasin Plus Capecitabine | 75 |
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Overall Survival
The effect of napabucasin given in combination with cetuximab, panitumumab or capecitabine on the Overall Survival of patients with advanced colorectal cancer (NCT01776307)
Timeframe: 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 60 months.
Intervention | Months (Median) |
---|
Napabucasin Plus Cetuximab | 7.79 |
Napabucasin Plus Panitumumab | 9.10 |
Napabucasin Plus Capecitabine | 6.34 |
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Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. (NCT01776307)
Timeframe: Blood samples drawn on day 5 during the first study cycle
Intervention | h*ng/mL (Geometric Mean) |
---|
Napabucasin Plus Panitumumab | 5420 |
Napabucasin Plus Capecitabine | 5350 |
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Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. (NCT01776307)
Timeframe: Blood samples drawn on day 21 during the first study cycle
Intervention | h*ng/mL (Geometric Mean) |
---|
Napabucasin Plus Panitumumab | 6290 |
Napabucasin Plus Capecitabine | 4720 |
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Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. (NCT01776307)
Timeframe: Blood samples drawn on day 5 during the first study cycle
Intervention | h*ng/mL (Geometric Mean) |
---|
Napabucasin Plus Cetuximab | 3380 |
Napabucasin Plus Panitumumab | 2730 |
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Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. (NCT01776307)
Timeframe: Blood samples drawn on day 21 during the first study cycle
Intervention | h*ng/mL (Geometric Mean) |
---|
Napabucasin Plus Cetuximab | 2930 |
Napabucasin Plus Panitumumab | 2630 |
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Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 240mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer. (NCT01776307)
Timeframe: Blood samples drawn on day 21 during the first study cycle
Intervention | h*ng/mL (Geometric Mean) |
---|
Napabucasin Plus Cetuximab | 2870 |
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Time to Treatment Failure
The time from enrollment to discontinuation of any drug of the treatment combination. (NCT01777945)
Timeframe: approximately 2 years
Intervention | months (Mean) |
---|
Participants Receiving Capecitabine/Docetaxel | 4.64 |
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Progression-free Survival (PFS)
The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause. (NCT01777945)
Timeframe: approximately 2 years
Intervention | months (Median) |
---|
Participants Receiving Capecitabine/Docetaxel | 9.89 |
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Number of Participants With Adverse Events
(NCT01777945)
Timeframe: approximately 2 years
Intervention | participants (Number) |
---|
Participants Receiving Capecitabine/Docetaxel | 33 |
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Overall Response Rate
The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice. (NCT01777945)
Timeframe: approximately 2 years
Intervention | percentage of participants (Number) |
---|
Participants Receiving Capecitabine/Docetaxel | 28.9 |
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Clinical Benefit Rate
The percentage of participants with an overall response (complete or partial remission) or with stable disease. (NCT01777945)
Timeframe: approximately 2 years
Intervention | percentage of participants (Number) |
---|
Participants Receiving Capecitabine/Docetaxel | 73.3 |
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Duration of Treatment With Xeloda
(NCT01777945)
Timeframe: approximately 2 years
Intervention | treatment cycle (Mean) |
---|
Participants Receiving Capecitabine/Docetaxel | 6.24 |
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Percentage of Capecitabine Dose Modifications
(NCT01777945)
Timeframe: approximately 2 years
Intervention | percentage of doses (Number) |
---|
Participants Receiving Capecitabine/Docetaxel | 44.4 |
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Toxicity(Adeverse Event)
"Toxicity will be monitored and recorded every week during study treatment (5 or 6 weeks) as following according to the NCI-CTCAE version 4.0~An interval history and physical examination with particular attention to drug-induced side effects along with documentation of the patient's weight and performance status will be performed on each visit.~CBC with differential count, blood chemistry including calcium, phosphorus, glucose, BUN, creatinine, total protein, albumin, AST, ALT, alkaline phosphatase, total bilirubin, and electrolyte will be performed before next planned treatment.~All relevant information regarding drug dosage, laboratory examinations, and treatment-related toxicities must be recorded before each treatment is given.~Summaries of the frequency and severity of adverse effects are based on the worst episodes recorded." (NCT01781403)
Timeframe: 5-6 weeks during study treatment
Intervention | events (Number) |
---|
| Any grade 1 adverse event | Any grade 2 adverse event | Any grade 3 adverse event | Any grade 4 adverse event |
---|
Dose Level 1 | 6 | 2 | 1 | 0 |
,Dose Level 2 | 8 | 2 | 0 | 0 |
,Dose Level 3/Recommended Dose | 60 | 17 | 3 | 0 |
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Maximum Tolerated Dose (MTD)
The MTD is defined as the maximum dose level in the doses of temozolomide tested with capecitabine and radiation in which the incidence proportion of DLT exceeds 30%. (NCT01781403)
Timeframe: 5-6 weeks during study treatment
Intervention | mg/m^2 (Number) |
---|
Dose Level 1 | 0 |
Dose Level 2 | 0 |
Dose Level 3/Recommended Dose | 0 |
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Pathological Complete Response
"Pathologic responses and stages were classified according to Dworak's classification and the 7th edition of the American Joint Committee on Cancer staging system, respectively.~The pathologic complete response (pCR) was defined as the total regression of the primary tumor regardless of regional lymph nodal status (ypT0), with residual fibrotic mass or acellular mucin pools only, thus without detectable tumor cells." (NCT01781403)
Timeframe: at the time of surgery (6-8 weeks after study treatment)
Intervention | participants (Number) |
---|
Unmethylated MGMT | 1 |
Hypermethylated MGMT | 6 |
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Recommended Dose (RD)
RD will be defined as one level below the MTD. (NCT01781403)
Timeframe: 5-6 weeks after CRT
Intervention | mg/m^2 (Number) |
---|
Dose Level 1 | 0 |
Dose Level 2 | 0 |
Dose Level 3/Recommended Dose | 75 |
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Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Between Week 3 and 12
TSQM was used to measure the Patients' self-reported satisfaction or dissatisfaction with the study treatment. The differences in mean scale scores between weeks 3 and 12 comparing treatment satisfaction in the different treatment arms: everolimus + exemestane combination therapy versus everolimus monotherapy, and everolimus + exemestane combination therapy versus capecitabine monotherapy. The TSQM version 1.4 domain scores range from 0 to 100 with higher scores representing a higher satisfaction on that domain. (NCT01783444)
Timeframe: Week 3, Week 12
Intervention | Unit on a scale (Mean) |
---|
| Side-effects | Effectiveness | Convenience | Global satisfaction |
---|
Capecitabine 1250 mg/m2 | -2.6 | 1.2 | 0.5 | 2.3 |
,Everolimus 10 mg | -9.1 | 1.2 | 1.0 | 1.8 |
,Everolimus 10 mg + Exemestane 25 mg | -4.8 | -2.2 | -0.6 | -1.0 |
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Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Capecitabine Alone
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy. (NCT01783444)
Timeframe: Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to 39 months
Intervention | Months (Median) |
---|
Everolimus 10 mg + Exemestane 25 mg | 8.41 |
Capecitabine 1250 mg/m2 | 9.59 |
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Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Everolimus Alone
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy. (NCT01783444)
Timeframe: Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to 39 months
Intervention | Months (Median) |
---|
Everolimus 10 mg + Exemestane 25 mg | 8.41 |
Everolimus 10 mg | 6.77 |
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All Collected Deaths
"On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks).~Deaths post treatment survival follow up were collected after the on- treatment period, up to approximately 5 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored." (NCT01783444)
Timeframe: up to 224 weeks (on-treatment), up to approximately 5 years (study duration)
Intervention | Participants (Count of Participants) |
---|
| On-treatment deaths | Post-treatment deaths | All deaths |
---|
Capecitabine 1250 mg/m2 | 2 | 57 | 59 |
,Everolimus 10 mg | 5 | 55 | 60 |
,Everolimus 10 mg + Exemestane 25 mg | 9 | 62 | 71 |
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Time to 10% Definitive Deterioration in the Global Health Status / Quality of Life
The global health status/QoL scale score of the QLQ-C30 is identified as the primary PRO variable of interest. Physical Functioning (PF), Emotional Functioning (EF) and Social Functioning (SF) scale scores of the QLQ-C30. The time to definitive 10% deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen. Definitive 10% (5-point) deterioration is defined as a decrease in score by at least 10% (5-points) compared to baseline, with no later increase above this threshold observed during the course of the study. (NCT01783444)
Timeframe: Baseline, every 6 weeks up to about 43 months
Intervention | Weeks (Median) |
---|
Everolimus 10 mg + Exemestane 25 mg | 30.86 |
Everolimus 10 mg | 23.86 |
Capecitabine 1250 mg/m2 | 61.29 |
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Overall Survival (OS)
Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. (NCT01783444)
Timeframe: Every 3 months following end of treatment visit, assessed for approximately 54 months
Intervention | Months (Median) |
---|
Everolimus 10 mg + Exemestane 25 mg | 23.06 |
Everolimus 10 mg | 29.27 |
Capecitabine 1250 mg/m2 | 25.56 |
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Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or Non-CR/non-PD lasting more than 24 weeks based on local investigator's assessment according to RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, Stable disease (SD), neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; CBR = CR+PR+SD. Only descriptive statistics. (NCT01783444)
Timeframe: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 43 months
Intervention | Percentage of Participants (Number) |
---|
Everolimus 10 mg + Exemestane 25 mg | 59 |
Everolimus 10 mg | 43 |
Capecitabine 1250 mg/m2 | 53 |
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Overall Response Rate (ORR)
Overall Response Rate (ORR) as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST 1.1 This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at baseline are absent at subsequent visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Only descriptive statistics. (NCT01783444)
Timeframe: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 43 months
Intervention | Percentage of Participants (Number) |
---|
Everolimus 10 mg + Exemestane 25 mg | 21 |
Everolimus 10 mg | 12 |
Capecitabine 1250 mg/m2 | 23 |
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Duration of Response (DOR) - Central Assessment (Population That Had a Response With Measurable Disease at Screening)
"The Duration of Response (DOR) is for Central Assessment for the Population that Had a Response with Measurable Disease at Screening.~Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per RECIST v1.1. This value is censored at the last valid tumor assessment if PD or death has not been documented." (NCT01808573)
Timeframe: From start date of response after randomization to first PD, up to 33 months.The result is based on primary analysis data cut.
Intervention | months (Median) |
---|
Neratinib Plus Capecitabine | 8.54 |
Lapatinib Plus Capecitabine | 5.55 |
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Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events)
Adverse Events to be measured are Treatment-Emergent and Serious AEs that occurred on or after first dose of investigational product and up to 28 days after the last dose (NCT01808573)
Timeframe: From first dose through last dose + 28 days, up to 41 months. The result is based on final data cut.
Intervention | percentage of participants (Number) |
---|
| All Treatment-Emergent Adverse Events | Serious Treatment-Emergent Adverse Events |
---|
Lapatinib Plus Capecitabine | 99.4 | 29.9 |
,Neratinib Plus Capecitabine | 99.7 | 34.0 |
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Overall Survival
Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 48 months. (NCT01808573)
Timeframe: From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut.
Intervention | months (Mean) |
---|
Neratinib Plus Capecitabine | 24.0 |
Lapatinib Plus Capecitabine | 22.2 |
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Centrally Assessed Progression Free Survival
Progression Free Survival (PFS), Measured in Months, for Randomized Subjects of the Central Assessment. The time interval from the date of randomization until the first date on which recurrence, progression (per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1), or death due to any cause, is documented. For subjects without recurrence, progression or death, it is censored at the last valid tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 24 months. (NCT01808573)
Timeframe: From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.
Intervention | months (Mean) |
---|
Neratinib Plus Capecitabine | 8.8 |
Lapatinib Plus Capecitabine | 6.6 |
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Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening)
Objective response rate is defined as the percentage of participants demonstrating an objective response during the study. Objective response includes confirmed complete responses (CR) and partial responses (PR) as defined in the RECIST criteria included in the study protocol. The ORR is for Central Assessment for subjects that had measurable disease at screening. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01808573)
Timeframe: From randomization date to first confirmed Complete or Partial Response, whichever came earlier, up to 42 months.The result is based on primary analysis data cut.
Intervention | percentage of participants (Number) |
---|
Neratinib Plus Capecitabine | 32.8 |
Lapatinib Plus Capecitabine | 26.7 |
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Clinical Benefit Rate (CBR) - Central Assessment (ITT Population With Measurable Disease at Screening)
Clinical benefit rate is the percentage of participants who achieve overall tumor response (confirmed CR or PR) or stable disease (SD) lasting for at least 24 weeks from randomization. The CBR was for Central Assessment for subjects who had Measurable Disease at Screening. (NCT01808573)
Timeframe: From randomization date to either first confirmed CR or PR or Stable Disease, whichever came earlier, up to 42 months.The result is based on primary analysis data cut.
Intervention | percentage of participants (Number) |
---|
Neratinib Plus Capecitabine | 44.5 |
Lapatinib Plus Capecitabine | 35.6 |
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Progression-free Survival (PFS) at 2 Years
Proportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates. (NCT01823679)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
Capecitabine 1000 mg/m2 | 0 |
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Progression-free Survival (PFS) at 1 Year
Proportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates. (NCT01823679)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Capecitabine 1000 mg/m2 | 50 |
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Overall Survival (OS) at 2 Years
Proportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates. (NCT01823679)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
Capecitabine 1000 mg/m2 | 0 |
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Objective Response Rate (ORR)
Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (NCT01823679)
Timeframe: 9 weeks (3 cycles)
Intervention | percentage of participants (Number) |
---|
Capecitabine 1000 mg/m² | 0 |
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Overall Survival (OS) at 1 Year
Proportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates. (NCT01823679)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Capecitabine 1000 mg/m2 | 50 |
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Proportion of Patients With Response
"Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as either complete response (CR) or partial response (PR).~CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters." (NCT01824875)
Timeframe: Assessed every 3 months for 3 years and then every 6 months for years 3-5
Intervention | proportion of participants (Number) |
---|
Arm A (Temozolomide) | 0.338 |
Arm B (Temozolomide and Capecitabine) | 0.397 |
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Overall Survival
Overall survival is defined as time from randomization to death or date last known alive. (NCT01824875)
Timeframe: Assessed every 3 months for 3 years and then every 6 months for years 3-5
Intervention | months (Median) |
---|
Arm A (Temozolomide) | 53.8 |
Arm B (Temozolomide and Capecitabine) | 58.7 |
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Progression-free Survival
Progression-free survival (PFS) is defined as the time from randomization to progression or death without evidence of progression. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier method was used to estimate PFS. (NCT01824875)
Timeframe: Assessed every 3 months for 3 years and then every 6 months for years 3-5
Intervention | months (Median) |
---|
Arm A (Temozolomide) | 15.1 |
Arm B (Temozolomide and Capecitabine) | 23.2 |
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Response Rate
Responses will be determined using RECIST v. 1.1 criteria and summarized in tabular format. The complete and partial response rates will be calculated and reported along with the corresponding 95% confidence intervals. (NCT01828554)
Timeframe: Up to 6 months
Intervention | percentage (Number) |
---|
Xeloda (Capecitabine) | 0 |
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Progression Free Survival
Progression-free survival will be analyzed using the Kaplan-Meier method. (NCT01828554)
Timeframe: Up to 6 months
Intervention | months (Median) |
---|
Xeloda (Capecitabine) | NA |
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Cmax During Cycle 1
Cmax will be reported for Capecitabine dosed for Ideal Body Weight during the first cycle (days 1-7) and for Capecitabine dosed for Actual Body Weight for first cycle (days 9-15). [nonlinear mixed effects modeling approach] (NCT01828554)
Timeframe: Up to 15 days
Intervention | Cmax (ug/ml) (Mean) |
---|
| Cycle 1 Day 1 | Cycle 1 Day 9 |
---|
Xeloda (Capecitabine) | 2.44 | 2.71 |
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Area Under the Curve (AUC) on Cycle 1 Day 1 and Cycle 1 Day 9
AUC will be calculated for Capecitabine dosed for Ideal Body Weight during the first cycle (days 1-7) and for Capecitabine dosed for Actual Body Weight for first cycle (days 9-15). [nonlinear mixed effects modeling approach] (NCT01828554)
Timeframe: Up to 15 days
Intervention | AUC (ug/ml)*h (Mean) |
---|
| Cycle 1 Day 1 | Cycle 1 Day 9 |
---|
Xeloda (Capecitabine) | 6.84 | 8.28 |
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Phase II - Rate of Response
Determine rate of response in patients receiving quinacrine in combination with capecitabine. Using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) complete response (CR) is a disappearance of all target lesions, partial response (PR) is at least 30% decrease in the sum of diameters of target lesions, and overall response is the number of patients who experience a complete response or partial response. (NCT01844076)
Timeframe: 2-3 years
Intervention | Participants (Count of Participants) |
---|
Phase I Level -2 | 0 |
Phase I Level -1 | 0 |
Phase I Level 0 | 0 |
Phase II | 1 |
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Phase I - Number of Participants Who Experienced Dose Limiting Toxicities and Adverse Reactions
Establish the tolerability of both agents in combination when used at established clinical doses. The objective is to determine toxicities and adverse reactions of patients in each group with different dose levels to find the maximum tolerated dose (MTD). (NCT01844076)
Timeframe: One year
Intervention | Participants (Count of Participants) |
---|
Phase I Level -2 | 0 |
Phase I Level -1 | 0 |
Phase I Level 0 | 3 |
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Phase II - Time to Progression (TTP)
Determine time to progression from start of treatment in patients receiving quinacrine in combination with capecitabine. Using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), progression is defined as a 20% increase in sum of target lesions, with at least a 5 mm absolute increase. (NCT01844076)
Timeframe: 2-3 years
Intervention | months (Median) |
---|
Phase II | 2.12 |
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Overall Response Rate
To describe the overall response rate as measured by physical exam and MRI if indicated using the following definition: Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01869192)
Timeframe: Up to 8 months
Intervention | Participants (Count of Participants) |
---|
Arm A | 25 |
Arm B | 21 |
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Pathological Response
Pathological response (pCR or microscopic only primary) in both primary and nodes using the Miller-Payne criteria for pathologic response. (NCT01869192)
Timeframe: Up to 8 months
Intervention | Participants (Count of Participants) |
---|
Arm A | 2 |
Arm B | 8 |
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Number of Participants With Any Adverse Events as a Measure of Safety and Tolerability
Assessment based on CTCAE version 4.0 toxicity criteria. For the detailed list of adverse events see the adverse event module. (NCT01873833)
Timeframe: ****Time Frame: Adverse events were collected from first dose of study treatment up to 30 days after last dose of treatment, up to 63 months (number or treatment given ranged from 2 cycles to 85 cycles).
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Lapatinib Ditosylate, Trastuzumab) | 10 |
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Clinical Benefit Rate (CBR)
Participants with a best response of CR, PR, or stable disease (SD) sustained for ≥24 weeks, as assessed using RECIST v1.1. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 mm in short axis. PR: >=30% decrease in sum of diameters of target lesions, compared to the sum at baseline. SD: Neither PR nor progression of disease (PD) criteria met. SD follow PR only when sum increases by less than 20% from the nadir, but previously seen 30% decrease from baseline no longer hold. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. (NCT01873833)
Timeframe: From study entry until the date of the first documented disease progression of date of death whichever came first, assessed for approximately 351 weeks
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Lapatinib Ditosylate, Trastuzumab) | 7 |
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Overall Response Rate (ORR)
Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. (NCT01873833)
Timeframe: From study entry until disease progression/recurrence (maximum duration: 351 weeks)
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Lapatinib Ditosylate, Trastuzumab) | 4 |
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Overall Survival (OS)
OS is the duration from study entry to death. Participants last known to be alive are censored at date of last contact. (NCT01873833)
Timeframe: From study entry until death from any cause or date of last contact (up to 70 months)
Intervention | Months (Median) |
---|
Treatment (Chemotherapy, Lapatinib Ditosylate, Trastuzumab) | 29.6 |
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Progression Free Survival (PFS)
PFS was defined as duration of time from the first dose of study drug to the first documentation of Progressive Disease (PD) by investigator assessment using RECIST 1.1 or death on study due to any cause on or before the data cutoff date, whichever occurred first. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. (NCT01873833)
Timeframe: From study entry to the date of first documented disease progression (assessed every 6 weeks) or death due to any cause, whichever came first, approximately 63 months.
Intervention | months (Median) |
---|
Treatment (Chemotherapy, Lapatinib Ditosylate, Trastuzumab) | 13.7 |
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Overall Survival
Survival time is defined as time from randomization to date of death from any cause and was to be estimated by the Kaplan-Meier method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients last reported to be alive at time of study termination is reported. (NCT01921751)
Timeframe: From randomization until last follow-up. Analysis was to occur after a total of 140 deaths were reported within the pairing of each radiation arm with the chemotherapy alone arm. Maximum follow-up at time of study termination was 8.3 months.
Intervention | Participants (Count of Participants) |
---|
Chemotherapy + High Intensity Radiation | 4 |
Chemotherapy + Low Intensity Radiation | 4 |
Chemotherapy | 5 |
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Overall Response Rate
(NCT01928680)
Timeframe: 6 months
Intervention | percentage of response (Number) |
---|
Cisplatin/Capecitabine | 63.6 |
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Part 1: Number of Participants With Tumor Responses (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD])
Tumor assessment was performed by abdomino-pelvic computed tomography scan or magnetic resonance imaging (MRI) and chest X-ray or chest CT-scan to assess the disease status at baseline and then every 9 weeks during study treatment up to DP. Target lesions were evaluated using response evaluation criteria in solid tumors (RECIST) version 1.1, wherein CR = disappearance of all target lesions; PR = 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; PD =20% increase in the sum of the LD of target lesions taking as reference the smallest sum in the study and SD = small changes that did not meet above criteria. (NCT01955629)
Timeframe: Baseline and every 9 weeks up to DP (up to 15 months).
Intervention | Participants (Number) |
---|
| CR | PR | PD | SD |
---|
Aflibercept + XELOX (Oxaliplatin and Capecitabine) | 0 | 1 | 0 | 3 |
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Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were assessed using the national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03. DLTs were defined as any of following AEs: grade 4 neutropenia lasting >7 consecutive days; febrile neutropenia or neutropenic infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia associated with bleeding requiring transfusion; grade 4 non-hematological treatment related event; grade 3 nausea/vomiting or diarrhea lasting >/= 4 days despite corrective measures; grade 3 other non-hematological toxicities: anorexia, fatigue, hypertension only if G4 or not medically controlled and G3 peripheral sensory neuropathy that did not improve to G<2 at time of retreatment; urinary protein excretion of >3.5 gram per 24 hours that did not recover to <2.0 gram per 24 hours within 2 weeks; symptomatic arterial thromboembolic events including cerebrovascular accidents, myocardial infarction, transient ischemic attacks, new onset or worsening of pre-existing angina. (NCT01955629)
Timeframe: Cycle 1 (Up to 3 weeks)
Intervention | Participants (Number) |
---|
Aflibercept + XELOX (Oxaliplatin and Capecitabine) | 1 |
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Overall Survival
Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause. (NCT01997333)
Timeframe: During treatment and 3 months from end of treatment through end of study or approximately up to 5 years.
Intervention | months (Median) |
---|
Capecitabine | 8.7 |
CDX-011 | 8.9 |
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Duration of Response
Duration of response (DOR) is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented. The analysis of DOR was determined retrospectively by the central independent review committee,blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions. (NCT01997333)
Timeframe: Evaluated every 6 - 9 weeks following treatment initiation
Intervention | months (Median) |
---|
Capecitabine | 4.2 |
CDX-011 | 2.8 |
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Objective Response Rate (ORR)
ORR is defined as the percentage of patients who achieve best overall response of complete or partial response. The analysis of ORR was based on ORR events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions. (NCT01997333)
Timeframe: Evaluated every 6 - 9 weeks following treatment initiation
Intervention | percentage of participants (Median) |
---|
Capecitabine | 21 |
CDX-011 | 26 |
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Progression Free Survival (PFS)
PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. (NCT01997333)
Timeframe: Evaluated every 6 - 9 weeks following treatment initiation
Intervention | months (Median) |
---|
Capecitabine | 2.8 |
CDX-011 | 2.9 |
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Adverse Events (AE)
The percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity. (NCT01997333)
Timeframe: Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up)
Intervention | Participants (Count of Participants) |
---|
| Patients with at least 1 AE | Patients with at least 1 treatment related AE | Patients with Grade 1 treatment related AE | Patients with Grade 2 treatment related AE | Patients with Grade 3 treatment related AE | Patients with Grade 4 treatment related AE | Patients with Grade 5 treatment related AE |
---|
Capecitabine | 92 | 84 | 7 | 33 | 44 | 8 | 0 |
,CDX-011 | 211 | 204 | 7 | 54 | 114 | 32 | 4 |
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Pharmacokinetics (PK)
Concentration of the antibody drug conjugate (ADC), total antibody (TA) and free MMAE will be determined. (NCT01997333)
Timeframe: Following 1 dose of CDX-011.
Intervention | ug/ml (Mean) |
---|
| Cycle 1 post infusion ADC levels | Cycle 1 post infusion TA levels | Cycle 1 post infusion MMAE levels |
---|
CDX-011 | 58.6 | 49.4 | 0.0015 |
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Objective Response Rate (ORR)
"To assess ORR (CR + PR) associated with BKM120 plus capecitabine in the central nervous system based on local investigator assessment. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters." (NCT02000882)
Timeframe: until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death, or discontinuation from study for any other reason, up to 2 years from date of patient registration
Intervention | proportion of patients with ORR (Number) |
---|
BKM120 Plus Capecitabine | 0.0 |
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Clinical Benefit Rate (CBR)
"CBR in the patients following WBRT or SRS or both will be the primary endpoint and is calculated as the total number of responders (CR or PR, assessed by RECIST 1.1) plus stable disease greater than or equal to 24 weeks (CR + PR + SD ≥ 24 weeks) divided by the total number of evaluable patients.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters." (NCT02000882)
Timeframe: until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death, or discontinuation from study for any other reason, up to 2 years from date of patient registration
Intervention | proportion of patients with CBR (Number) |
---|
BKM120 Plus Capecitabine | 0.1 |
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Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)
Percentage of participants with pCR plus the percentage of participants without pCR who achieved CR or PR as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<] 10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. (NCT02005549)
Timeframe: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])
Intervention | percentage of participants (Number) |
---|
Bevacizumab+Docetaxel+Capecitabine | 72.22 |
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Percentage of Participants With Pathological Complete Response (pCR)
pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle. (NCT02005549)
Timeframe: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])
Intervention | percentage of participants (Number) |
---|
Bevacizumab+Docetaxel+Capecitabine | 22.22 |
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Percentage of Participants Undergoing Breast-Conserving Surgery
Percentage of participants undergoing a breast-conserving procedure versus a modified radical mastectomy at final surgery, performed 2 to 4 weeks after the last chemotherapy cycle (Week 18) (NCT02005549)
Timeframe: 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])
Intervention | percentage of participants (Number) |
---|
Bevacizumab+Docetaxel+Capecitabine | 83 |
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Pathological Complete Response (pCR) Rate
Primary Objective Phase II: Pathological response will be made based on microscopic assessment of the surgical specimen at the primary treatment site. A pCR must include no gross or microscopic tumor identified anywhere within the surgical specimen. This must include:No evidence of malignant cells in the primary tumor specimen and No lymph nodes that contain tumor. (NCT02010567)
Timeframe: 12 weeks
Intervention | percentage of participants with pCR (Number) |
---|
All Participants | 19 |
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Overall Survival (OS) Based on Pathological Complete Response (pCR).
Phase II only - a comparison of OS for patients who achieve pCR and those who do not. OS is defined as the time from surgical resection until death reported as the count of participants still alive at the end of study follow-up. (NCT02010567)
Timeframe: an average of 2.6 years (full range 2.1 to 3.1 years)
Intervention | Participants (Count of Participants) |
---|
| pathological complete response (pCR) | Did not achieve pCR |
---|
Cohort A, Phase II, Dose Level 2 | 2 | 11 |
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Disease-free Survival (DFS) Rate Based on Pathological Complete Response (pCR).
Phase II only - a comparison of DFS for patients who achieve pCR and those who do not. DFS will be defined as the time from surgical resection until disease recurrence or death as a result of any cause, reported as the count of participants still alive without recurrence at the end of study follow-up. (NCT02010567)
Timeframe: an average of 2.6 years (full range 2.1 to 3.1 years)
Intervention | Participants (Count of Participants) |
---|
| pathological complete response (pCR) | Did not achieve pCR |
---|
Cohort A, Phase II, Dose Level 2 | 2 | 8 |
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Disease-free Survival (DFS) Rate
Phase II only - DFS will be defined as the time from surgical resection until disease recurrence or death as a result of any cause, reported as the count of participants still alive without recurrence at the end of study follow-up. (NCT02010567)
Timeframe: An average of 2.6 years (full range 2.1 to 3.1 years)
Intervention | Participants (Count of Participants) |
---|
Cohort A, Phase II, Dose Level 2 | 10 |
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Maximum Tolerated Dose (MTD) of CRLX101 When Added to Standard Neoadjuvant Chemoradiotherapy Consisting of Capecitabine + Radiotherapy in Locally Advanced Rectal Cancer
The MTD is the highest dose of CRLX101 at which ≤1 out of 6 patients had a dose limiting toxicity (DLT) using CTCAE v4.0 toxicity criteria. DLTs include Grade (G) >3 neutropenia for ≥7 days; G 3 or 4 neutropenia with fever; G 4 anemia not related to cancer-associated bleeding; G 4 thrombocytopenia or G 3 with clinically significant bleeding; G ≥3 nausea or vomiting >48 hours despite anti-emetics; G 2 cystitis not resolved within 14 days; second G 2 cystitis; G 3 or 4 cystitis; diarrhea requiring dose reduction; Any other non-hematologic toxicity G ≥3 requiring a dose reduction (G ≥3 infusion-related reactions were not a DLT unless they recur despite slowing down the infusion); Other CRLX101 related treatment emergent adverse effect (TEAE) that requires patient withdrawal prior to completing all doses; Radiotherapy interruption due to TEAEs ≥5 days; or Dose interruption or reduction of capecitabine due to TEAE that results in <50% of the scheduled capecitabine dose for entire course (NCT02010567)
Timeframe: 12 weeks
Intervention | mg/m^2 every other week (Number) |
---|
Dose Escalation Phase Ib | 15 |
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Overall Survival (OS) Rate
Phase II only - OS is defined as the time from surgical resection until death reported as the count of participants still alive at the end of study follow-up. (NCT02010567)
Timeframe: an average of 2.6 years (full range 2.1 to 3.1 years)
Intervention | Participants (Count of Participants) |
---|
Cohort A, Phase II, Dose Level 2 | 13 |
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Overall Survival - Percentage of Participants Event Free at 12 Months
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. (NCT02013830)
Timeframe: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Intervention | percentage of participants (Number) |
---|
Bevacizumab/Capecitabine | 27 |
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Time to Disease Progression - Percentage of Participants With an Event
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment. (NCT02013830)
Timeframe: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Intervention | percentage of participants (Number) |
---|
Bevacizumab/Capecitabine | 77.8 |
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Time to Disease Progression - Percentage of Participants Progression-free at 12 Months
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment. (NCT02013830)
Timeframe: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Intervention | percentage of participants (Number) |
---|
Bevacizumab/Capecitabine | 24.0 |
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Time to Disease Progression
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment. (NCT02013830)
Timeframe: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Intervention | months (Median) |
---|
Bevacizumab/Capecitabine | 2.8 |
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Percentage of Participants With Objective Response (OR)
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. (NCT02013830)
Timeframe: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Intervention | percentage of participants (Number) |
---|
Bevacizumab/Capecitabine | 9.1 |
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Percentage of Participants With Disease Control
The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease. (NCT02013830)
Timeframe: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Intervention | percentage of participants (Number) |
---|
Bevacizumab/Capecitabine | 52.3 |
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Overall Survival - Percentage of Participants With an Event
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. (NCT02013830)
Timeframe: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Intervention | percentage of participants (Number) |
---|
Bevacizumab/Capecitabine | 77.8 |
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Overall Survival
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method. (NCT02013830)
Timeframe: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Intervention | months (Median) |
---|
Bevacizumab/Capecitabine | 5.9 |
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Change in EORTC QLQ-C30 Global Health Status Score
"Patients were given the EORTC QLQ-C30 at baseline, preop, postop, and at follow ups Y1-5. The forms were scored as per the manual available at EORTC. Raw scores are transformed to fall in a range of 0-100. Generally, higher scores on QoL scales represent higher levels of QoL.~The scores are reported as the mean of the Global Health Status/QoL scale score when more than 1 patient completed the form for a time point. If only 1 form was available for a time point, then the score for that form is reported." (NCT02017704)
Timeframe: baseline, preop, postop, and at follow ups Y1-5
Intervention | score on a scale (Mean) |
---|
| baseline | pre-op | post-op | year 1 | year 2 | year 3 | year 4 | year 5 |
---|
Endo-HDR | 71.2 | 49.6 | 72.5 | 73 | 66.3 | 77.3 | 91 | 91.5 |
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Number of Participants With Grade 3 or Higher Adverse Events
"Number of participants with grade 3 or higher adverse events will be listed by relationship.~Grading is by CTCAE 4 guidelines.~Relationship, as determined by PI, is unrelated/unlikely/possible/probable/definite." (NCT02017704)
Timeframe: Up to 60 months
Intervention | Participants (Count of Participants) |
---|
| Grade: 3; Relationship: probable | Grade: 3; Relationship: possible | Grade 3; Relationship: Unlikely |
---|
Endo-HDR | 1 | 1 | 0 |
,IMRT and Capecitabine | 1 | 1 | 1 |
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Change in EORTC QLQ-C30 Global Health Status Score
"Patients were given the EORTC QLQ-C30 at baseline, preop, postop, and at follow ups Y1-5. The forms were scored as per the manual available at EORTC. Raw scores are transformed to fall in a range of 0-100. Generally, higher scores on QoL scales represent higher levels of QoL.~The scores are reported as the mean of the Global Health Status/QoL scale score when more than 1 patient completed the form for a time point. If only 1 form was available for a time point, then the score for that form is reported." (NCT02017704)
Timeframe: baseline, preop, postop, and at follow ups Y1-5
Intervention | score on a scale (Mean) |
---|
| baseline | pre-op | post-op | year 2 | year 3 | year 4 |
---|
IMRT and Capecitabine | 83 | 33 | 54 | 50 | 66.5 | 83 |
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Number of Patients With Pathologic Complete Response
"Pathologic complete response rate is reported as the number of patients who achieve pathologic complete response after the treatment for each arm.~As per the NCCN guidelines, pathologic response is graded by the system recommended by the AJCC Cancer Staging Manual and CAP guidelines:~Complete response - no remaining viable cancer cells~Moderate response - only small clusters/single cancer cells remain~Minimal response - residual cancer remaining, but with predominant fibrosis~Poor response - minimal/no tumor kills, extensive residual cancer" (NCT02017704)
Timeframe: Up to 60 months
Intervention | Participants (Count of Participants) |
---|
IMRT and Capecitabine | 0 |
Endo-HDR | 2 |
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Number of Participants With Adverse Events and Serious Adverse Events
Assessment of safety of napabucasin administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan in participants with advanced gastrointestinal malignancies by reporting of adverse events and serious adverse events (NCT02024607)
Timeframe: The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 4 months.
Intervention | Participants (Count of Participants) |
---|
Napabucasin Plus FOLFOX6 | 115 |
Napabucasin Plus FOLFOX6 Plus Bevacizumab | 41 |
Napabucasin Plus CAPOX | 87 |
Napabucasin Plus FOLFIRI | 156 |
Napabucasin Plus FOLFIRI Plus Bevacizumab | 40 |
Napabucasin Plus Regorafenib | 54 |
Napabucasin Plus Irinotecan | 2 |
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Disease Control Rate
To determine the anti-tumor activity (specifically the disease control rate) of napabucasin administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan. Percentage of participants with a documented complete response, partial response and stable disease based on RECIST 1.1. (NCT02024607)
Timeframe: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months.
Intervention | percentage of participants (Number) |
---|
Napabucasin Plus FOLFOX6 | 54.7 |
Napabucasin Plus FOLFOX6 Plus Bevacizumab | 76.2 |
Napabucasin Plus CAPOX | 55.3 |
Napabucasin Plus FOLFIRI | 65.7 |
Napabucasin Plus FOLFIRI Plus Bevacizumab | 87.0 |
Napabucasin Plus Regorafenib | 34.4 |
Napabucasin Plus Irinotecan | 100 |
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Objective Response Rate
Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR. (NCT02042443)
Timeframe: Up to 2 years from registration
Intervention | Participants (Count of Participants) |
---|
| Partial Response | Unconfirmed Partial Response | Stable/No Response | Increasing Disease | Symptomatic Deterioration |
---|
Chemotherapy | 2 | 0 | 9 | 8 | 1 |
,Trametinib | 0 | 2 | 2 | 19 | 1 |
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Progression-free Survival
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. (NCT02042443)
Timeframe: Up to 2 years from registration
Intervention | months (Median) |
---|
Trametinib | 1.3 |
Chemotherapy | 2.8 |
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Overall Survival
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT02042443)
Timeframe: Up to 2 years from registration
Intervention | months (Median) |
---|
Trametinib | 4.3 |
Chemotherapy | 7.9 |
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Overall Survival (OS) Time for Patients in Europe + United States With Triple-Negative mCRC (EU+US TNmCRC)
"OS based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley.~This outcome measure is considered exploratory. Because of the unanticipated long OS in the control group, initial exploratory subgroup analyses identified that findings in patients enrolled in Russia differed when compared with patients enrolled in the ITT subpopulation and the EU+US subpopulation. For this reason, subjects in Russia were excluded from further exploratory subset analyses that evaluated the effects of genomic parameters known to impact patient responses to anti-EGFR monoclonal antibodies. Removal of the outlier Russian subpopulation of patients provided a patient population that was more homogeneous with respect to their prior treatment regimens, thereby facilitating further exploratory analyses. If a subject had not died, survival time was censored at the last date the subject was known to be alive." (NCT02083653)
Timeframe: From randomization until the date of death (assessed up to 32 months).
Intervention | months (Median) |
---|
Arm A: Sym004 (12 mg/kg) | 10.6 |
Arm B: Sym004 (9/6 mg/kg) | 12.8 |
Arm C: Investigator's Choice | 7.3 |
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Occurrence and Nature of Adverse Events (AEs), as Assessed by the Common Terminology Criteria for AEs (Version 4.03) (CTCAE v4.03).
AEs were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. The incidence and type of AEs (i.e., serious AE [SAE], treatment-emergent AE [TEAE]) were summarized by dose cohort according to MedDRA system organ classes and preferred terms. An AE was considered as treatment-emergent if it occurred during or after the first IMP administration. An AE that occurred before the first IMP administration and worsened thereafter was also considered an AE. Worsening was reported as a new AE. (NCT02083653)
Timeframe: From Baseline up to 28 days after the last IMP administration.
Intervention | Participants (Count of Participants) |
---|
| At least one TEAE | At least one Serious TEAE | TEAE leading to dose reduction | TEAE leading to interruption of trial treatment | TEAE leading to trial treatment withdrawal | TEAE related to trial treatment | TEAE, Grade >=3 | Dermatologic toxicity | Infusion-related reaction | TEAE resulting in death | Related Serious TEAE | Related TEAE leading to dose reduction | Related TEAE leading to interruption of treatment | Related TEAE leading to treatment withdrawal | Related TEAE, Grade >=3 | Related TEAE resulting in death |
---|
Arm A: Sym004 (12 mg/kg) | 83 | 27 | 29 | 58 | 12 | 81 | 67 | 78 | 27 | 4 | 9 | 29 | 53 | 9 | 58 | 0 |
,Arm B: Sym004 (9/6 mg/kg) | 84 | 23 | 17 | 47 | 5 | 80 | 53 | 78 | 26 | 4 | 6 | 17 | 42 | 2 | 41 | 0 |
,Arm C: Investigator's Choice | 67 | 12 | 8 | 10 | 6 | 46 | 25 | 8 | 0 | 3 | 2 | 6 | 7 | 3 | 9 | 0 |
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Pharmacokinetic (PK) Parameters: Sym004 Concentrations
"The Sym004 serum concentration used for the PK evaluation was calculated as the sum of the serum concentrations of the 2 component monoclonal antibodies of Sym004 (futuximab and modotuximab).~Trough Concentration (Ctrough) is equivalent to the concentration collected at the pre-dose timepoint.~Maximum Concentration (Cmax) is equivalent to the concentration collected at the end of infusion (EOI) timepoint." (NCT02083653)
Timeframe: Weeks 3, 5, and 7 and at the End of Treatment visit, including a Week 1 and Week 2 subset.
Intervention | ug/mL (Mean) |
---|
| Screening (Pre-dose) | Week 1 Day 1 (Pre-dose) | Week 1 Day 1 (EOI) | Week 1 Day 1 (0.5 hours after EOI) | Week 1 Day 1 (1 hour after EOI) | Week 1 Day 1 (2 hours after EOI) | Week 1 Day 1 (4 hours after EOI) | Week 2 Day 1 (Pre-dose) | Week 2 Day 1 (EOI) | Week 3 Day 1 (Pre-dose) | Week 3 Day 1 (EOI) | Week 5 Day 1 (Pre-dose) | Week 5 Day 1 (EOI) | Week 7 Day 1 (Pre-dose) | Week 7 Day 1 (EOI) | End of Treatment |
---|
Arm A: Sym004 (12 mg/kg) | 0.50 | 0.50 | 182.95 | 214.98 | 209.80 | 197.31 | 188.75 | 45.37 | 275.42 | 92.66 | 323.35 | 125.73 | 354.91 | 128.30 | 346.83 | 64.55 |
,Arm B: Sym004 (9/6 mg/kg) | 0.50 | 0.75 | 174.44 | 184.84 | 189.24 | 181.68 | 171.63 | 38.76 | 145.91 | 44.26 | 170.18 | 49.26 | 168.94 | 58.38 | 163.11 | 17.61 |
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Pharmacokinetic (PK) Parameters: Time of Maximum Plasma Concentration (Tmax)
Tmax was defined as the time the PK sample was taken at end of infusion (EOI) relative to the start time of infusion (i.e., time between the start of infusion and the time of the EOI sample). For presentation of individual PK parameters and calculation of mean parameters, half of the lower limit of quantitation (LLOQ) value was used for concentration values below the LLOQ. The Sym004 serum concentration used for the PK evaluation was calculated as the sum of the serum concentrations of the 2 component monoclonal antibodies of Sym004, futuximab and modotuximab. (NCT02083653)
Timeframe: Day 1 on Weeks 1-3 followed by Week 5 Day 1 and Week 7 Day 1.
Intervention | hours (Mean) |
---|
| Week 1 Day 1 | Week 2 Day 1 | Week 3 Day 1 | Week 5 Day 1 | Week 7 Day 1 |
---|
Arm A: Sym004 (12 mg/kg) | 3.14 | 2.82 | 3.01 | 2.74 | 2.83 |
,Arm B: Sym004 (9/6 mg/kg) | 2.79 | 2.33 | 2.34 | 2.06 | 2.06 |
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Quality of Life Assessed by FACT-EGFRI-18 for Skin Rash
"Scale: Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFRI-18).~The FACT-EGFRI-18 is an 18-question scale used to assess EGFR-inhibitor-treated cancer patients' quality of life relative to their experience of skin rash based on three (3) multi-item subscales. The subscales combined (i.e., Symptom Index) range in score from 0 to 72. A higher score represents a high level of symptomatology (problems).~High scores for all subscales represent a worse outcome:~The Physical subscale ranges in score from 0 to 28.~The Social/Emotional subscale ranges in score from 0 to 24.~The Functional subscale ranges in score from 0 to 20." (NCT02083653)
Timeframe: Assessed every 3 weeks (week 1 and week 4 reported)
Intervention | score on a scale (Mean) |
---|
| Physical (Week 1 Day 1) | Physical (Week 4 Day 1) | Social/Emotional (Week 1 Day 1) | Social/Emotional (Week 4 Day 1) | Functional (Week 1 Day 1) | Functional (Week 4 Day 1) | Symptom Index (Week 1 Day 1) | Symptom Index (Week 4 Day 1) |
---|
Arm A: Sym004 (12 mg/kg) | 22.9 | 18.0 | 21.5 | 19.9 | 17.9 | 16.3 | 62.3 | 54.2 |
,Arm B: Sym004 (9/6 mg/kg) | 23.1 | 19.7 | 21.5 | 20.3 | 18.3 | 17.0 | 62.9 | 57.0 |
,Arm C: Investigator's Choice | 24.3 | 25.1 | 22.6 | 23.2 | 18.7 | 19.3 | 65.6 | 67.6 |
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Quality of Life Assessed by the EORTC QLQ-C30 (Version 3)
"Scale: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (Version 3) [QLQ-C30, Version 3].~The QLQ-C30 is a 30-question scale used to assess cancer patients' quality of life based on 15 factors (e.g., global health status, physical functioning, role functioning, etc.). The scale is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100:~A high score for a functional scale represents a healthy level of functioning.~A high score for the global health status represents a high quality of life.~A high score for a symptom scale/item represents a high level of symptomatology (problems)." (NCT02083653)
Timeframe: Assessed every 6 weeks (week 1 and week 7 reported)
Intervention | score on a scale (Mean) |
---|
| Global Health Status (Week 1 Day 1) | Global Health Status (Week 7 Day 1) | Physical Functioning (Week 1 Day 1) | Physical Functioning (Week 7 Day 1) | Role Functioning (Week 1 Day 1) | Role Functioning (Week 7 Day 1) | Emotional Functioning (Week 1 Day 1) | Emotional Functioning (Week 7 Day 1) | Cognitive Functioning (Week 1 Day 1) | Cognitive Functioning (Week 7 Day 1) | Social Functioning (Week 1 Day 1) | Social Functioning (Week 7 Day 1) | Fatigue Symptoms (Week 1 Day 1) | Fatigue Symptoms (Week 7 Day 1) | Nausea & Vomiting Symptoms (Week 1 Day 1) | Nausea & Vomiting Symptoms (Week 7 Day 1) | Pain Symptoms (Week 1 Day 1) | Pain Symptoms (Week 7 Day 1) | Dyspnoea Symptoms (Week 1 Day 1) | Dyspnoea Symptoms (Week 7 Day 1) | Insomnia Symptoms (Week 1 Day 1) | Insomnia Symptoms (Week 7 Day 1) | Appetite Loss Symptoms (Week 1 Day 1) | Appetite Loss Symptoms (Week 7 Day 1) | Constipation Symptoms (Week 1 Day 1) | Constipation Symptoms (Week 7 Day 1) | Diarrhoea Symptoms (Week 1 Day 1) | Diarrhoea Symptoms (Week 7 Day 1) | Financial Difficulties (Week 1 Day 1) | Financial Difficulties (Week 7 Day 1) |
---|
Arm A: Sym004 (12 mg/kg) | 55.5 | 57.4 | 76.4 | 82.1 | 75.0 | 81.1 | 76.6 | 74.8 | 87.4 | 88.1 | 78.2 | 77.9 | 35.3 | 26.3 | 7.9 | 5.6 | 27.2 | 12.7 | 15.9 | 10.4 | 29.3 | 27.4 | 22.3 | 16.9 | 15.0 | 11.5 | 12.5 | 8.8 | 19.7 | 19.4 |
,Arm B: Sym004 (9/6 mg/kg) | 59.7 | 59.4 | 78.7 | 83.0 | 76.4 | 82.4 | 77.8 | 82.7 | 86.2 | 88.5 | 80.2 | 83.4 | 32.2 | 25.3 | 6.4 | 5.1 | 23.6 | 14.6 | 17.2 | 8.8 | 19.1 | 16.9 | 17.6 | 17.5 | 16.0 | 8.3 | 8.5 | 11.1 | 16.6 | 15.2 |
,Arm C: Investigator's Choice | 55.8 | 59.7 | 77.7 | 76.7 | 72.5 | 72.8 | 73.2 | 75.3 | 87.5 | 87.0 | 75.4 | 72.7 | 34.7 | 33.2 | 7.8 | 8.4 | 27.8 | 24.1 | 16.4 | 15.7 | 21.7 | 16.6 | 22.2 | 23.0 | 11.4 | 11.1 | 15.9 | 11.0 | 23.3 | 19.3 |
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Quality of Life Assessed by EORTC QLQ-CR29
"Scale: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Colorectal Cancer Module (QLQ-CR29).~The QLQ-CR29 is a 29-question scale used to assess colorectal cancer patients' quality of life based on 22 factors (e.g., body image, anxiety, weight, etc.). The scale is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100:~A high score for a functional scale/item represents an unhealthy level of functioning, with the exception of one (1) scale pertaining to sexual interest (separated by sex).~A high score for a symptom scale/item represents a high level of symptomatology (problems)." (NCT02083653)
Timeframe: Assessed every 6 weeks (week 1 and week 7 reported)
Intervention | score on a scale (Mean) |
---|
| Body Image (Week 1 Day 1) | Body Image (Week 7 Day 1) | Anxiety (Week 1 Day 1) | Anxiety (Week 7 Day 1) | Weight (Week 1 Day 1) | Weight (Week 7 Day 1) | Sexual Function (Men) (Week 1 Day 1) | Sexual Function (Men) (Week 7 Day 1) | Sexual Function (Women) (Week 1 Day 1) | Sexual Function (Women) (Week 7 Day 1) | Urinary Frequency (Week 1 Day 1) | Urinary Frequency (Week 7 Day 1) | Blood and Mucus (Week 1 Day 1) | Blood and Mucus (Week 7 Day 1) | Stool Frequency (Week 1 Day 1) | Stool Frequency (Week 7 Day 1) | Urinary Incontinence (Week 1 Day 1) | Urinary Incontinence (Week 7 Day 1) | Dysuria (Week 1 Day 1) | Dysuria (Week 7 Day 1) | Abdominal Pain (Week 1 Day 1) | Abdominal Pain (Week 7 Day 1) | Buttock Pain (Week 1 Day 1) | Buttock Pain (Week 7 Day 1) | Bloated Feeling (Week 1 Day 1) | Bloated Feeling (Week 7 Day 1) | Dry Mouth (Weel 1 Day 1) | Dry Mouth (Weel 7 Day 1) | Hair Loss (Week 1 Day 1) | Hair Loss (Week 7 Day 1) | Trouble with Taste (Week 1 Day 1) | Trouble with Taste (Week 7 Day 1) | Flatulence (Week 1 Day 1) | Flatulence (Week 7 Day 1) | Faecal Incontinence (Week 1 Day 1) | Faecal Incontinence (Week 7 Day 1) | Sore Skin (Week 1 Day 1) | Sore Skin (Week 7 Day 1) | Embarrassed by Bowel Movement (Week 1 Day 1) | Embarrassed by Bowel Movement (Week 7 Day 1) | Stoma Care Problem (Week 1 Day 1) | Stoma Care Problem (Week 7 Day 1) | Impotence (Week 1 Day 1) | Impotence (Week 7 Day 1) | Dyspareunia (Week 1 Day 1) | Dyspareunia (Week 7 Day 1) |
---|
Arm A: Sym004 (12 mg/kg) | 76.2 | 76.4 | 50.0 | 57.1 | 79.5 | 86.6 | 31.7 | 33.2 | 16.5 | 16.6 | 34.4 | 28.2 | 4.1 | 2.6 | 15.5 | 13.4 | 8.2 | 7.0 | 4.0 | 3.2 | 18.8 | 10.4 | 11.6 | 4.4 | 20.4 | 13.3 | 25.1 | 26.8 | 17.1 | 7.0 | 20.0 | 18.5 | 18.3 | 12.4 | 8.9 | 2.5 | 9.6 | 11.6 | 8.5 | 7.5 | 16.6 | 9.9 | 46.9 | 40.4 | 12.1 | 14.3 |
,Arm B: Sym004 (9/6 mg/kg) | 80.1 | 77.6 | 48.2 | 61.1 | 85.6 | 89.6 | 21.2 | 26.6 | 12.3 | 13.6 | 30.3 | 28.8 | 1.5 | 3.1 | 11.3 | 11.8 | 7.5 | 4.8 | 2.9 | 2.1 | 12.8 | 10.8 | 10.8 | 8.8 | 14.8 | 12.1 | 17.0 | 29.2 | 11.1 | 7.6 | 13.9 | 15.2 | 19.5 | 16.1 | 8.8 | 7.3 | 8.8 | 9.7 | 7.8 | 8.1 | 3.3 | 2.4 | 38.7 | 42.7 | 7.2 | 10.3 |
,Arm C: Investigator's Choice | 75.8 | 78.2 | 43.0 | 50.9 | 78.3 | 88.0 | 23.5 | 34.9 | 10.1 | 11.0 | 32.6 | 18.5 | 2.0 | 2.3 | 14.1 | 13.1 | 7.4 | 1.9 | 3.0 | 0.9 | 23.0 | 16.6 | 9.9 | 7.4 | 21.7 | 12.9 | 22.1 | 13.8 | 14.6 | 4.6 | 15.1 | 12.9 | 23.1 | 12.4 | 7.1 | 3.1 | 6.0 | 4.2 | 13.9 | 10.4 | 6.6 | 8.3 | 49.5 | 50.7 | 11.0 | 13.3 |
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Host Immune Response: Number of Subjects With Anti-drug Antibodies (ADAs) to Sym004 Over Time
A validated double antigen bridging ELISA was used for screening, confirmation, and titration of patient samples for anti-Sym004 ADA. Using rabbit anti-Sym004 as an ADA control antibody, the lower limit of detection was 54 ng/mL in the absence of Sym004 and 500 ng/mL in the presence of Sym004 at 5 µg/mL The timepoints for ADA sampling were chosen by the original sponsor for this trial. After the trial was transferred to Symphogen A/S, it was determined that not all samples were necessary for analysis. This is why the collection time points specified in the Outcome Measure Time Frame do not match with the Outcome Measure Data Table. (NCT02083653)
Timeframe: Every two weeks (Days 15, 29, and 43) followed by every six weeks thereafter (Days 78, 120, 162, etc.) until the End of Treatment Visit
Intervention | Participants (Count of Participants) |
---|
| Screening71950433 | Screening71950434 | Week 5 Day 171950434 | Week 5 Day 171950433 | Week 1271950433 | Week 1271950434 | Week 1371950433 | Week 1371950434 | Week 2471950433 | Week 2471950434 | End of Treatment Visit71950434 | End of Treatment Visit71950433 |
---|
| Missing | Negative | Positive | Not Reportable |
---|
Arm A: Sym004 (12 mg/kg) | 78 |
Arm B: Sym004 (9/6 mg/kg) | 81 |
Arm A: Sym004 (12 mg/kg) | 2 |
Arm B: Sym004 (9/6 mg/kg) | 3 |
Arm B: Sym004 (9/6 mg/kg) | 62 |
Arm A: Sym004 (12 mg/kg) | 24 |
Arm B: Sym004 (9/6 mg/kg) | 22 |
Arm B: Sym004 (9/6 mg/kg) | 35 |
Arm A: Sym004 (12 mg/kg) | 59 |
Arm B: Sym004 (9/6 mg/kg) | 49 |
Arm A: Sym004 (12 mg/kg) | 1 |
Arm B: Sym004 (9/6 mg/kg) | 1 |
Arm A: Sym004 (12 mg/kg) | 0 |
Arm A: Sym004 (12 mg/kg) | 82 |
Arm B: Sym004 (9/6 mg/kg) | 83 |
Arm A: Sym004 (12 mg/kg) | 83 |
Arm A: Sym004 (12 mg/kg) | 60 |
Arm B: Sym004 (9/6 mg/kg) | 55 |
Arm B: Sym004 (9/6 mg/kg) | 0 |
Arm A: Sym004 (12 mg/kg) | 23 |
Arm B: Sym004 (9/6 mg/kg) | 29 |
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Overall Survival (OS) Time
"OS based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley.~If a subject had not died, survival time was censored at the last date the subject was known to be alive." (NCT02083653)
Timeframe: From randomization until the date of death (assessed up to 32 months).
Intervention | months (Median) |
---|
Arm A: Sym004 (12 mg/kg) | 7.9 |
Arm B: Sym004 (9/6 mg/kg) | 10.3 |
Arm C: Investigator's Choice | 9.6 |
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Overall Survival (OS) Time for Patients in Europe + United States With Double-Negative mCRC (EU+US DNmCRC)
"OS based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley.~This outcome measure is considered exploratory. Because of the unanticipated long OS in the control group, initial exploratory subgroup analyses identified that findings in patients enrolled in Russia differed when compared with patients enrolled in the ITT subpopulation and the EU+US subpopulation. For this reason, subjects in Russia were excluded from further exploratory subset analyses that evaluated the effects of genomic parameters known to impact patient responses to anti-EGFR monoclonal antibodies. Removal of the outlier Russian subpopulation of patients provided a patient population that was more homogeneous with respect to their prior treatment regimens, thereby facilitating further exploratory analyses. If a subject had not died, survival time was censored at the last date the subject was known to be alive." (NCT02083653)
Timeframe: From randomization until the date of death (assessed up to 32 months).
Intervention | months (Median) |
---|
Arm A: Sym004 (12 mg/kg) | 8.9 |
Arm B: Sym004 (9/6 mg/kg) | 11.9 |
Arm C: Investigator's Choice | 8.4 |
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Progression Free Survival (PFS) Time
PFS based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley. Death will only be considered as an event if it occurs within 12 weeks after last tumor response assessment without progression. (NCT02083653)
Timeframe: From randomization until first event, where an event can be a progression (radiological confirmed or clinical progression) or death due to any cause (assessed up to 32 months).
Intervention | months (Median) |
---|
Arm A: Sym004 (12 mg/kg) | 2.8 |
Arm B: Sym004 (9/6 mg/kg) | 2.7 |
Arm C: Investigator's Choice | 2.6 |
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Relative Dose Intensity of Sym004
"Treatment duration (weeks) is calculated as [(last dose date of Sym004 - first dose date of Sym004)+7] / 7 days.~Sym004 dose received (mg/kg) is calculated as (total dose administered (mg)/weight (kg)).~Dose Intensity is calculated as (cumulative Sym004 dose (mg/kg) / treatment duration (weeks)).~Relative Dose Intensity is calculated as (dose intensity / planned dose intensity at randomization)*100.~Percentages are based on the number of subjects in the safety analysis set." (NCT02083653)
Timeframe: From first dose of study drug until disease progression (assessed up to 32 months).
Intervention | percentage of relative dose intensity (Mean) |
---|
Arm A: Sym004 (12 mg/kg) | 80.49 |
Arm B: Sym004 (9/6 mg/kg) | 88.91 |
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Time to Treatment Failure (TTF)
TTF based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley. (NCT02083653)
Timeframe: From randomization until treatment discontinuation for any reason, including disease progression or death (assessed up to 32 months).
Intervention | months (Median) |
---|
Arm A: Sym004 (12 mg/kg) | 2.1 |
Arm B: Sym004 (9/6 mg/kg) | 2.6 |
Arm C: Investigator's Choice | 1.6 |
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Progression-free Survival (PFS)
Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions. (NCT02117479)
Timeframe: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Intervention | days (Median) |
---|
Ruxolitinib Plus Capecitabine | 43.0 |
Placebo Plus Capecitabine | 44.0 |
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Objective Response Rate (ORR)
Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR. (NCT02117479)
Timeframe: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Intervention | percentage of participants (Number) |
---|
| Objective response | Complete response | Partial response |
---|
Placebo Plus Capecitabine | 1.9 | 0 | 1.9 |
,Ruxolitinib Plus Capecitabine | 3.7 | 0 | 3.7 |
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Overall Survival (OS)
Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016. (NCT02117479)
Timeframe: Randomization until death due to any cause; up to the data cutoff 11FEB2016.
Intervention | Participants (Count of Participants) |
---|
| Observed | Censored |
---|
Placebo Plus Capecitabine | 124 | 36 |
,Ruxolitinib Plus Capecitabine | 113 | 48 |
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Percentage of Participants Achieving Progression Free Survival (PFS)
PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions. (NCT02117479)
Timeframe: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Intervention | percentage of participants (Median) |
---|
| Survival rate at 3 months | Survival rate at 6 months | Survival rate at 9 months | Survival rate at 12 months |
---|
Placebo Plus Capecitabine | 19.8 | 5.7 | 3.4 | NA |
,Ruxolitinib Plus Capecitabine | 18.9 | 6.1 | 2.5 | 2.5 |
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Participants With Treatment-Emergent Adverse Events (TEAEs)
A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening). (NCT02117479)
Timeframe: Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.
Intervention | Participants (Count of Participants) |
---|
| Participants who had any TEAEs | Participants who had treatment-related TEAEs | Participants who had SAEs | Participants who had Grade 3 or higher TEAEs | Participants hospitalized because of a TEAE | Participants discontinued treatment due to TEAE | Participants with a dose modification due to TEAE | Participants on concomitant medication due to TEAE | Participants with procedure performed due to TEAE | Participants who had a fatal TEAE |
---|
Placebo Plus Capecitabine | 152 | 59 | 83 | 113 | 75 | 22 | 48 | 122 | 46 | 15 |
,Ruxolitinib Plus Capecitabine | 152 | 73 | 94 | 112 | 89 | 12 | 68 | 131 | 60 | 20 |
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Duration of Response
Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death. (NCT02117479)
Timeframe: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Intervention | days (Median) |
---|
Ruxolitinib Plus Capecitabine | NA |
Placebo Plus Capecitabine | NA |
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Tumour Assessments (Based on RECIST Criteria) in 2nd-line
Best response in second line was based on the tumor assessments (based on RECIST criteria) for target lesions and assessed by CT scans, MRI scans, X-ray, bone scan and clinical examination: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (sum LD) of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the LD of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. (NCT02119026)
Timeframe: Baseline, every 8-9 weeks, 28d Safety follow-up
Intervention | participants (Number) |
---|
| Progressive Disease (PD) | Stable Disease (SD) | Partial Response (PR) | Complete Response (CR) | Not available (NA) |
---|
A: XELIRI + BEV Followed by XELOX + BEV | 7 | 11 | 6 | 0 | 8 |
,B: XELOX + BEV Followed by XELIRI + BEV | 8 | 13 | 2 | 0 | 1 |
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Tumour Assessments (Based on RECIST Criteria) in 1st-line
Best response in first line was based on the tumor assessments (based on RECIST criteria) for target lesions and assessed by CT scans, MRI scans, X-ray, bone scan and clinical examination: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (sum LD) of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the LD of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. (NCT02119026)
Timeframe: Baseline, every 8-9 weeks, 28d Safety follow-up
Intervention | participants (Number) |
---|
| Progressive Disease (PD) | Stable Disease (SD) | Partial Response (PR) | Complete Response (CR) |
---|
A: XELIRI + BEV Followed by XELOX + BEV | 4 | 21 | 26 | 2 |
,B: XELOX + BEV Followed by XELIRI + BEV | 1 | 23 | 30 | 0 |
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Time to Response
Time to overall response was measured from the time of randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Patients without response were censored at the date of the last tumor assessment, the date of death or the date of refusal. (NCT02119026)
Timeframe: at the day of documented complete or partial response or at 28 days safety follow-up in cases without PD
Intervention | days (Median) |
---|
A: XELIRI + BEV Followed by XELOX + BEV | 185.0 |
B: XELOX + BEV Followed by XELIRI + BEV | 178.0 |
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Second Line PFS
"The second line PFS was defined as the progression free survival interval during second line treatment. Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date). Missing onset of progression data because of refusal or because of death was replaced.~If several response evaluations for a patient showed progressive disease (PD), the time to PD was assessed by using the first of these measurements." (NCT02119026)
Timeframe: at progression of disease (PD) in second line therapy or at 28 days safety follow-up in cases without PD
Intervention | days (Median) |
---|
A: XELIRI + BEV Followed by XELOX + BEV | 129 |
B: XELOX + BEV Followed by XELIRI + BEV | 155 |
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Overall Survival of XELIRI Plus Bevacizumab and XELOX Plus Bevacizumab
Overall survival was measured as the time from the randomization date to the date of death. Patients without death date were censored at the date of the last tumor assessment (exception: availability of validated information about a later exitus date or a prolonged survival - in such a case the date of the follow-up assessment was either defined as the exitus date or replaced the last tumor assessment date) or the date of refusal. (NCT02119026)
Timeframe: date of death or date of last tumor assessment (28d safety f-u) in patients without death
Intervention | days (Median) |
---|
A: XELIRI + BEV Followed by XELOX + BEV | 593.0 |
B: XELOX + BEV Followed by XELIRI + BEV | 643 |
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Overall Response Rate (Number of Participants With Response)
The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). (NCT02119026)
Timeframe: at the day of documented complete or partial response or at 28 days safety follow-up in cases without PD
Intervention | Participants (Count of Participants) |
---|
A: XELIRI + BEV Followed by XELOX + BEV | 32 |
B: XELOX + BEV Followed by XELIRI + BEV | 36 |
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First Line Progression Free Survival (PFS)
The first line PFS was defined as the progression free survival interval during first line treatment. Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date). Missing onset of progression data because of refusal or because of death was replaced. If several response evaluations for a patient showed progressive disease (PD), the time to PD was assessed by using the first of these measurements. (NCT02119026)
Timeframe: at progression of disease (PD) in first line therapy or at 28 days safety follow-up in cases without PD
Intervention | days (Median) |
---|
A: XELIRI + BEV Followed by XELOX + BEV | 241 |
B: XELOX + BEV Followed by XELIRI + BEV | 280 |
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Efficacy Duration of Disease Control by Tumor Assessment (CT/MRI/Clinical Examination)
The primary variable was duration of disease control (DDC) and was defined as the sum of progression free survival intervals during first line and second line treatment (= time from the beginning of first line treatment until onset of progression during second line treatment). Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date). (NCT02119026)
Timeframe: screening, every 8 to 9 weeks until progression, at end of treatment (other than progression), every 3 months until progression, death or up to 24 months (whatever comes first)
Intervention | days (Median) |
---|
A: XELIRI + BEV Followed by XELOX + BEV | 373.00 |
B: XELOX + BEV Followed by XELIRI + BEV | 370.00 |
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Duration of Response
"Duration of overall response was measured from the time that measurement criteria are met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the onset of progression. Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date).~Missing onset of progression data because of refusal or because of death was replaced.~If several response evaluations for a patient showed progressive disease (PD), the time to PD was assessed by using the first of these measurements." (NCT02119026)
Timeframe: at the day of documented complete or partial response or at 28 days safety follow-up in cases without PD
Intervention | days (Median) |
---|
A: XELIRI + BEV Followed by XELOX + BEV | 244.0 |
B: XELOX + BEV Followed by XELIRI + BEV | 315 |
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Objective Response Rate (ORR)
Objective response rate determined by radiographic disease assessments per Response Evaluation Criteria in Solid Tumours RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by RECIST at any post baseline visit. Per RECIST for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR. (NCT02119663)
Timeframe: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Intervention | percentage of participants (Number) |
---|
| Objective response | Complete response | Partial response |
---|
Placebo Plus Capecitabine | 2.3 | 0.0 | 2.3 |
,Ruxolitinib Plus Capecitabine | 4.7 | 2.3 | 2.3 |
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Progression Free Survival (PFS)
PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions. (NCT02119663)
Timeframe: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Intervention | days (Median) |
---|
Ruxolitinib Plus Capecitabine | 48.0 |
Placebo Plus Capecitabine | 61.0 |
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Duration of Response
Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death. Per RECIST for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR. (NCT02119663)
Timeframe: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Intervention | days (Median) |
---|
Ruxolitinib Plus Capecitabine | NA |
Placebo Plus Capecitabine | NA |
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Participants With Treatment-Emergent Adverse Events (TEAEs)
A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening). (NCT02119663)
Timeframe: Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.
Intervention | Participants (Count of Participants) |
---|
| Participants who had any TEAEs | Participants who had treatment-related TEAEs | Participants who had SAEs | Participants who had Grade 3 or higher TEAEs | Participants hospitalized because of a TEAE | Participants discontinued treatment due to TEAE | Participants with a dose modification due to TEAE | Participants on concomitant medication due to TEAE | Participants with procedure performed due to TEAE | Participants who had a fatal TEAE |
---|
Placebo Plus Capecitabine | 40 | 25 | 20 | 31 | 18 | 5 | 14 | 35 | 14 | 2 |
,Ruxolitinib Plus Capecitabine | 41 | 21 | 28 | 31 | 26 | 7 | 17 | 36 | 22 | 8 |
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Percentage of Participants Achieving Progression Free Survival (PFS)
PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions. (NCT02119663)
Timeframe: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Intervention | percentage of participants (Median) |
---|
| Survival rate at 3 months | Survival rate at 6 months |
---|
Placebo Plus Capecitabine | 0.297 | 0.204 |
,Ruxolitinib Plus Capecitabine | 0.337 | 0.131 |
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Overall Survival (OS)
Overall survival is reported here based on the number of deaths from randomization until the data cut-off. (NCT02119663)
Timeframe: Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016.
Intervention | Participants (Count of Participants) |
---|
| Observed deaths | Censored deaths |
---|
Placebo Plus Capecitabine | 23 | 20 |
,Ruxolitinib Plus Capecitabine | 29 | 14 |
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Percentage of Participants Achieving Clinical Benefit Rate
Clinical benefit rate was defined as a complete response, partial response, or stable disease, determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1) that lasted for ≥ 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR. (NCT02120417)
Timeframe: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Intervention | percentage of participants (Number) |
---|
Treatment A - Capecitabine and Ruxolitinib | 13.2 |
Treatment B - Capecitabine and Placebo | 6.8 |
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Percentage of Participants Achieving Overall Survival
Overall survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method. (NCT02120417)
Timeframe: Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.
Intervention | percentage of participants (Number) |
---|
| Month 3 Survival Rate | Month 6 Survival Rate | Month 9 Survival Rate | Month 12 Survival Rate | Month 15 Survival Rate |
---|
Treatment A - Capecitabine and Ruxolitinib | 0.855 | 0.674 | 0.537 | 0.435 | 0.319 |
,Treatment B - Capecitabine and Placebo | 0.750 | 0.635 | 0.546 | 0.427 | 0.294 |
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Percentage of Participants Achieving Objective Response Rate
Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR. (NCT02120417)
Timeframe: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Intervention | percentage of participants (Number) |
---|
| Complete Response rate | Partial Response rate |
---|
Treatment A - Capecitabine and Ruxolitinib | 0.0 | 28.9 |
,Treatment B - Capecitabine and Placebo | 0.0 | 13.7 |
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Progression-free Survival (PFS)
Progression-free survival was defined as the time from the randomization date to the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death from any cause if earlier. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. (NCT02120417)
Timeframe: Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.
Intervention | months (Median) |
---|
Treatment A - Capecitabine and Ruxolitinib | 4.5 |
Treatment B - Capecitabine and Placebo | 2.5 |
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Duration of Response (DOR)
The DOR was defined as the difference (in number of months) between the end of response and the start of response for participants who had at least 1 response measurement. The start of a response was the first visit where the participant achieved a partial response or better based on RECIST (v1.1) criteria. The end of response was the earlier of death or progressive disease based on RECIST (v1.1) criteria. The date of progressive disease was the date on which progression was first recorded. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR. (NCT02120417)
Timeframe: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Intervention | months (Median) |
---|
Treatment A - Capecitabine and Ruxolitinib | 4.2 |
Treatment B - Capecitabine and Placebo | 4.4 |
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Overall Survival (OS)
OS: The time from registration to death or date of last contact. Participants with overall survival at 1 year. Kaplan-Meier estimator will be utilized. (NCT02218164)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
| Expired in less than a year | Alive at the end of the year | Had not completed survival follow-up at closeout |
---|
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 4 | 2 | 2 |
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Objective Response Rate (ORR)
ORR: Stable Disease (SD); Partial Response (PR); Complete Response (CR). Response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. (NCT02218164)
Timeframe: 9 weeks per participant
Intervention | Participants (Count of Participants) |
---|
| Stable Disease | Complete Response | Partial Response |
---|
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 4 | 1 | 1 |
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Progression Free Survival (PFS)
PFS: Alive without RECIST progression. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT02218164)
Timeframe: 1 year
Intervention | months (Median) |
---|
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 11.3 |
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Peritoneal Recurrence Free Survival at 18 Months
Peritoneal recurrence-free survival at 18 months determined by CT and CEA. If CEA was normal and CT did not show any signs of peritoneal metastase at 18 months, a diagnostic laparoscopy was performed in those patients who consented to this intervention. Complete peritoneal staging was performed during laparoscopy, and biopsies were taken from suspicious lesions. If no peritoneal lesions were seen or biopsies were negative, this indicated that the patient was free from peritoneal recurrence. (NCT02231086)
Timeframe: 18 months
Intervention | participants (Number) |
---|
Standard Adjuvant Systemic Chemotherapy | 79 |
Adjuvant HIPEC (Open/Laparoscopic) | 80 |
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Survival Rate at 18 Month
Number of participants surviving after 18 months of study follow-up (NCT02243007)
Timeframe: 18 Month
Intervention | Participants (Count of Participants) |
---|
Folfirinox-ARM A | 2 |
Gemcitabine/Nab-Paclitaxel- Arm B | 3 |
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Number of Participants With Serious and Non-Serious Adverse Events
Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days (NCT02243007)
Timeframe: Baseline, 28 Days
Intervention | participants (Number) |
---|
| Serious Adverse Events | Other Adverse Events |
---|
Folfirinox-ARM A | 0 | 4 |
,Gemcitabine/Nab-Paclitaxel- Arm B | 2 | 3 |
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Rate of Pathologic Downstaging
The number of participants achieving a reduction in the pathological staging of the primary cancer. (NCT02243007)
Timeframe: 2 Years
Intervention | () |
---|
Folfirinox-ARM A | 0 |
Gemcitabine/Nab-Paclitaxel- Arm B | 0 |
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30-day Post-operative Mortality Rate
Number of patients who died following surgery. (NCT02243007)
Timeframe: 30 Days
Intervention | () |
---|
Folfirinox-ARM A | 0 |
Gemcitabine/Nab-Paclitaxel- Arm B | 0 |
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Correlation of Biomarkers With PFS
Analysis of the correlation between selected bio-markers and progression free survival. (NCT02243007)
Timeframe: 2 Years
Intervention | () |
---|
Folfirinox-ARM A | 0 |
Gemcitabine/Nab-Paclitaxel- Arm B | 0 |
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Local Control Rate
The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response. (NCT02243007)
Timeframe: 2 Years
Intervention | () |
---|
Folfirinox-ARM A | 0 |
Gemcitabine/Nab-Paclitaxel- Arm B | 0 |
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Pathologic Complete Response Rate (pCR).
Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes. (NCT02243007)
Timeframe: 18 Months
Intervention | () |
---|
Folfirinox-ARM A | 0 |
Gemcitabine/Nab-Paclitaxel- Arm B | 0 |
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Surgical Morbidity Rate
Number of patients experiencing a specific surgery related morbidity (NCT02243007)
Timeframe: within 30 days of surgery
Intervention | () |
---|
Folfirinox-ARM A | 0 |
Gemcitabine/Nab-Paclitaxel- Arm B | 0 |
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Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1, or death from any cause, whichever occurs first. Progressive disease (PD) for target lesion: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/=5 mm. PD for non-target lesion: Unequivocal progression of existing non-target lesions. (NCT02291289)
Timeframe: From randomization until disease progression or death from any cause, up to 5 years
Intervention | months (Median) |
---|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib | 9.99 |
Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 11.60 |
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab | 7.13 |
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 7.36 |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab | 4.44 |
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 4.04 |
Cohort 4 (MP): Cobimetinib,Atezolizumab | 3.75 |
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 7.79 |
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Overall Response
Calculated as the number of participants with a best overall response of CR or PR according to RECIST 1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR= CR + PR. (NCT02291289)
Timeframe: From randomization until disease progression, up to 5 years
Intervention | Participants (Count of Participants) |
---|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib | 20 |
Cohort 1 Control(MP): 5-FU/LV or Capecitabin, Bevacizumab | 5 |
Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab | 49 |
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 22 |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab | 1 |
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 0 |
Cohort 4 (MP): Cobimetinib,Atezolizumab | 7 |
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 8 |
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Duration of Response
Defined as the time from the first assessment of CR or PR until disease progression or death from any cause, whichever occurs first. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. (NCT02291289)
Timeframe: From first objective response until disease progression or death from any cause, up to 5 years
Intervention | months (Median) |
---|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib | 11.50 |
Cohort 1 Control(MP):5-FU/LV or Capecitabin, Bevacizumab | 8.74 |
Cohort 2(MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab | 9.30 |
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 7.59 |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab | 9.205 |
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 0 |
Cohort 4 (MP): Cobimetinib,Atezolizumab | 7.11 |
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 6.06 |
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Disease Control Rate (DCR)
DCR is defined as the percentage of participants with CR, PR, or stable disease (SD) at 16 weeks. Per RECIST v1.1, CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum on study. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline, or the appearance of one or more new lesions. (NCT02291289)
Timeframe: From randomization until disease progression, up to 5 years
Intervention | Participants (Count of Participants) |
---|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib | 36 |
Cohort 1 Control(MP): 5-FU/LV or Capecitabin, Bevacizumab | 15 |
Cohort 2(MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab | 227 |
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 111 |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab | 1 |
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 0 |
Cohort 4 (MP): Cobimetinib,Atezolizumab | 44 |
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 26 |
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Time to Treatment Response
Calculated as the time from randomization to the first Occurrence of a documented Objective Response (CR or PR) determined according to RECIST 1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. (NCT02291289)
Timeframe: From randomization until disease progression or death from any cause, up to 5 years
Intervention | months (Median) |
---|
Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib | 3.943 |
Cohort 1 Control(MP):5-FU/LV or Capecitabin, Bevacizumab | 5.552 |
Cohort 2(MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab | 5.224 |
Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 4.616 |
Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab | 5.490 |
Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 0 |
Cohort 4 (MP): Cobimetinib,Atezolizumab | 3.745 |
Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 2.530 |
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Proportion of Subjects Experiencing Diarrhoea of Grade 2 and Above (up to 24 Weeks)
Proportion of subjects experiencing at least one episode of diarrhoea with a severity of Grade 2 and above, as defined by the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03, recorded as AEs in the Electronic case report form (eCRF) (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
| Cyclce 1-3 (up to 9 weeks)with impuation | Cyclce 1-8 (up to 24 weeks)without imputation |
---|
No Octreotide Treatment | 9 | 5 |
,Octreotide Treatment | 7 | 6 |
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Number of Lapatinib and Capecitabine Tablets Dispensed and Returned
Number of Lapatinib and Capecitabine tablets dispensed and returned as recorded in the eCRF (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | tablets (Mean) |
---|
| Number of Lapatinib tablets dispensed | Number of Lapatinib tablets returned | Number of Capecitabine tablets dispensed | Number of Capecitabine tablets returned |
---|
No Octreotide Treatment | 1115.6 | 403.3 | 1011.2 | 210 |
,Octreotide Treatment | 1197.5 | 477.1 | 1022.6 | 186.1 |
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Time to the First Subject Reported Change in Frequency and/or Consistency of Bowel Movements From Baseline as Recorded in the DMD
Event is defined as Subjects reporting change in frequency and/or consistency of bowel movements from baseline at least once in DMD. Subject are censored if there is no change in bowel movement frequency/consistency as compared to baseline. Median time and 95% confidence intervals were calculated using Kaplan-Meier estimates. (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Days (Median) |
---|
Octreotide Treatment | 22.0 |
No Octreotide Treatment | 8.0 |
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Proportion of Subjects Taking Anti-diarrhoeal Medication as Recorded in the DMD
The proportion of subjects taking medication at least once as a result of diarrhoea are summarised (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
Octreotide Treatment | 2 |
No Octreotide Treatment | 2 |
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Proportion of Subjects Taking Anti-diarrhoeal Medication
Proportion of subjects taking anti-diarrhoeal medication as recorded in the eCRF (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
Octreotide Treatment | 7 |
No Octreotide Treatment | 11 |
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Proportion of Subjects Reporting Stopping Completely or Missing Doses of Anti-cancer Tablets Due to Diarrhoea as Recorded in the DMD
The proportion of subjects reducing or completely stopping the number of anti-cancer tablets to help with diarrhoea are summarised (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
Octreotide Treatment | 2 |
No Octreotide Treatment | 3 |
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Proportion of Subjects Reporting Changes in Bowel Movements From Baseline (Frequency and/or Consistency) as Recorded in the Diarrhoea Management Diary (DMD)
All subjects completed the baseline DMD during the 3 days prior to randomisation, before any study-related treatment is administered. Subjects randomised to receive Octreotide completed a second baseline DMD before starting the first cycle of treatment with Lapatinib and Capecitabine. The baseline DMD comprised of 3 questions to record stool form and consistency. The DMD to be completed throughout the rest of the study comprised of 3 questions in the baseline DMD and a further 5 questions and 6 sub-questions to evaluate the consequences and management of diarrhoea. (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
Octreotide Treatment | 23 |
No Octreotide Treatment | 29 |
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Proportion of Subjects Making Dietary Changes Due to Diarrhoea as Recorded in the DMD
The proportion of subjects making dietary changes to help with the diarrhoea are summarised (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
Octreotide Treatment | 9 |
No Octreotide Treatment | 11 |
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Time to Onset of the First Episode of Diarrhoea of Any Grade of Severity
Time to onset of the first episode of diarrhoea of any grade of severity, recorded as an AE in the eCRF. Subject are censored if there was no event. Median time and 95% confidence intervals were calculated using Kaplan-Meier estimates. (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Days (Median) |
---|
Octreotide Treatment | NA |
No Octreotide Treatment | 170 |
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Proportion of Subjects Experiencing Diarrhoea of Grade 3 and Above (up to 24 Weeks)
Proportion of subjects experiencing diarrhoea with a severity of Grade 3 and above, as defined by the NCI CTCAE, version 4.03 and recorded as AEs in the eCRF (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
Octreotide Treatment | 2 |
No Octreotide Treatment | 0 |
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Proportion of Subjects Experiencing Diarrhoea of Any Grade of Severity (up to 24 Weeks)
Proportion of subjects experiencing diarrhoea of any grade of severity as defined by the NCI CTCAE, version 4.03 and recorded as AEs in the eCRF (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
Octreotide Treatment | 18 |
No Octreotide Treatment | 14 |
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Duration of Diarrhoea of Any Grade of Severity
Duration of diarrhoea of any grade of severity, recorded as AEs in the eCRF (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | days (Mean) |
---|
Octreotide Treatment | 8.7 |
No Octreotide Treatment | 36.8 |
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Clinical Benefit Response (up to 24 Weeks)
"Clinical benefit response as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Clinical Benefit Response rate (CBR) is defined as the percentage of subjects with a CR, PR or SD at week 24." (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
Octreotide Treatment | 7 |
No Octreotide Treatment | 9 |
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Proportion of Subjects Requiring Treatment Withdrawal in Lapatinib and Capecitabine
Proportion of subjects requiring diarrhoea related Lapatinib and Capecitabine treatment withdrawal as recorded in the eCRF (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
| Requiring treatment withdrawal in Lapatinib | Requiring treatment withdrawal in Capecitabine |
---|
No Octreotide Treatment | 0 | 0 |
,Octreotide Treatment | 0 | 0 |
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Proportion of Subjects Requiring Dose Reduction in Lapatinib and Capecitabine
Proportion of subjects requiring diarrhoea related Lapatinib and Capecitabine dose reduction as recorded in the eCRF (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
| Subjects requiring dose reduction in Lapatinib | Subjects requiring dose reduction in Capecitabine |
---|
No Octreotide Treatment | 0 | 2 |
,Octreotide Treatment | 1 | 1 |
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Proportion of Subjects Requiring Dose Delay in Lapatinib and Capecitabine
Proportion of subjects requiring diarrhoea related Lapatinib and Capecitabine dose delay as recorded in the eCRF (NCT02294786)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
| Subjects requiring dose delay in Lapatinib | Subjects requiring dose delay in Capecitabine |
---|
No Octreotide Treatment | 2 | 2 |
,Octreotide Treatment | 2 | 2 |
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Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Satisfaction With Health Care Scale
The EORTC pancreatic cancer module is a validated tool intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module includes 26 questions, organized into 7 scales and 10 individual item scores. The summary scale for Satisfaction with Health Care is reported. All reported measures are transformed to a 0 to 100 scale. Scores of 0 = not satisfied, worst possible health state and 100 = extremely satisfied, best possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: >=MID increase from baseline - Stable: no increase or decrease >MID - Worsened: >=MID decrease from baseline MID = half the baseline standard deviation (NCT02301143)
Timeframe: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
Intervention | Participants (Count of Participants) |
---|
| Satisfaction with Health Care Scale: Improved | Satisfaction with Health Care Scale: Stable | Satisfaction with Health Care Scale: Worsened |
---|
Nab-Paclitaxel Plus Gemcitabine | 42 | 40 | 13 |
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Disease Control Rate (DCR): Percentage of Participants With Complete (CR) or Partial Response (PR), or Stable Disease (SD) for ≥ 16 Weeks According to RECIST Version 1.1
"DCR was defined as the percentage of participants with a CR or PR or SD from of date of first treatment to 16 weeks. Tumor assessments after start of non-protocol-defined anticancer therapy were excluded.~RECIST 1.1 Definition:~CR: disappearance of all target and non-target lesions; any pathological lymph nodes (target or non-target) must have reduction in short axis to < 10 mm and no new lesions diagnosed.~PR: a >= 30% decrease in the sum of diameters of target lesions from baseline; no evidence of progression in any of the non-target lesions diagnosed at baseline; and no new lesions diagnosed.~SD: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for PD.~The two-sided 90% binomial confidence intervals (CIs) were estimated by Wilson score method." (NCT02301143)
Timeframe: Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks
Intervention | percentage of participants (Number) |
---|
Nab-Paclitaxel Plus Gemcitabine | 77.6 |
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Kaplan-Meier Estimate of Progression-Free Survival (PFS)
"Progression-free Survival (PFS) was defined as the time from the date of the first dose to the date of disease progression or death (by any cause), whichever is earlier. The analysis day was calculated from enrollment date for one participant who was not treated. Participants who have no disease progression or have not died were censored to last tumor assessment date with progression-free.~The definition for progressive disease (PD) was at least a 20% increase in the sum of diameters of target lesions from nadir; the sum must also demonstrate an absolute increase of >= 5 mm; the progression of a non-target lesion or the appearance of any new lesions is also considered progression.~Median and its 90% confidence interval of PFS were estimated using the method of Brookmeyer and Crowley." (NCT02301143)
Timeframe: Day 1 of study treatment up to 28.75 months (maximum time for the last tumor assessment)
Intervention | months (Median) |
---|
Nab-Paclitaxel Plus Gemcitabine | 10.9 |
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Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Six Summary Scales
The EORTC pancreatic cancer module is a validated tool intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module includes 26 questions, organized into 7 scales and 10 individual item scores. All reported measures are transformed to a 0 to 100 scale. Six summary scales reported are: - Pancreatic Pain - Digestive Symptoms - Altered Bowel Habits - Hepatic Scale - Body Image - Sexuality Scores of 0 = optimal health state and 100 = worst possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline. Responder categories: - Improved: >=MID decrease from baseline - Stable: no increase or decrease >MID - Worsened: >=MID increase from baseline MID = half the baseline standard deviation (NCT02301143)
Timeframe: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
Intervention | Participants (Count of Participants) |
---|
| Pancreatic Pain Scale: Improved | Pancreatic Pain Scale: Stable | Pancreatic Pain Scale: Worsened | Digestive Symptom Scale: Improved | Digestive Symptom Scale: Stable | Digestive Symptom Scale: Worsened | Altered Bowel Habits Scale: Improved | Altered Bowel Habits Scale: Stable | Altered Bowel Habits Scale: Worsened | Hepatic Scale: Improved | Hepatic Scale: Stable | Hepatic Scale: Worsened | Body Image Scale: Improved | Body Image Scale: Stable | Body Image Scale: Worsened | Sexuality Scale: Improved | Sexuality Scale: Stable | Sexuality Scale: Worsened |
---|
Nab-Paclitaxel Plus Gemcitabine | 62 | 33 | 0 | 49 | 36 | 10 | 28 | 53 | 14 | 25 | 66 | 4 | 22 | 50 | 23 | 31 | 51 | 13 |
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Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): 10 Individual Item Scores
The EORTC pancreatic cancer module is a validated tool intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module includes 26 questions, organized into 7 scales and 10 individual item scores. The 10 individual item scores are reported. All reported measures are transformed to a 0 to 100 scale. Scores of 0 = best possible health state and 100 = worst possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: >=MID decrease from baseline - Stable: no increase or decrease >MID - Worsened: >=MID increase from baseline MID = half the baseline standard deviation (NCT02301143)
Timeframe: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
Intervention | Participants (Count of Participants) |
---|
| Abdominal Bloating: Improved | Abdominal Bloating: Stable | Abdominal Bloating: Worsened | Taste Changes: Improved | Taste Changes: Stable | Taste Changes: Worsened | Indigestion: Improved | Indigestion: Stable | Indigestion: Worsened | Flatulence: Improved | Flatulence: Stable | Flatulence: Worsened | Weight Loss: Improved | Weight Loss: Stable | Weight Loss: Worsened | Limb Weakness: Improved | Limb Weakness: Stable | Limb Weakness: Worsened | Dry Mouth: Improved | Dry Mouth: Stable | Dry Mouth: Worsened | Treatment Side-Effects: Improved | Treatment Side-Effects: Stable | Treatment Side-Effects: Worsened | Worry About Future Health: Improved | Worry About Future Health: Stable | Worry About Future Health: Worsened | Limits on Activity Planning: Improved | Limits on Activity Planning: Stable | Limits on Activity Planning: Worsened |
---|
Nab-Paclitaxel Plus Gemcitabine | 50 | 42 | 3 | 20 | 54 | 21 | 41 | 47 | 7 | 47 | 37 | 11 | 36 | 56 | 3 | 22 | 55 | 18 | 37 | 45 | 13 | 8 | 48 | 39 | 42 | 45 | 8 | 42 | 42 | 11 |
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Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Symptom Scales and Single Symptom Items
The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) is a validated health-related quality of life (HRQoL) measure. The EORTC QLQ-C30 is composed of both multi-item scales and single-item measures, including 5 functional scales, 3 symptom scales, 6 single symptom items, and 1 global health status / quality of life scale. No item occurs in more than one scale. All reported measures are transformed to a 0 to 100 scale. In the symptom scales and single symptom items, 0 = optimal health state and 100 = worst possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: >=10 decrease from baseline - Stable: neither increase nor decrease >10 - Worsened: >=10 increase from baseline (NCT02301143)
Timeframe: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
Intervention | Participants (Count of Participants) |
---|
| Symptom Scale-Fatigue: Improved | Symptom Scale-Fatigue: Stable | Symptom Scale-Fatigue: Worsened | Scale-Nausea+Vomiting: Improved | Scale-Nausea+Vomiting: Stable | Scale-Nausea+Vomiting: Worsened | Symptom Scale-Pain: Improved | Symptom Scale-Pain: Stable | Symptom Scale-Pain: Worsened | Symptom - Dyspnoea: Improved | Symptom - Dyspnoea: Stable | Symptom - Dyspnoea: Worsened | Symptom - Insomnia: Improved | Symptom - Insomnia: Stable | Symptom - Insomnia: Worsened | Symptom - Appetite loss: Improved | Symptom - Appetite loss: Stable | Symptom - Appetite loss: Worsened | Symptom - Constipation: Improved | Symptom - Constipation: Stable | Symptom - Constipation: Worsened | Symptom - Diarrhoea: Improved | Symptom - Diarrhoea: Stable | Symptom - Diarrhoea: Worsened | Symptom - Financial difficulties: Improved | Symptom - Financial difficulties: stable: | Symptom - Financial difficulties: Worsened |
---|
Nab-Paclitaxel Plus Gemcitabine | 46 | 24 | 25 | 29 | 64 | 2 | 62 | 29 | 4 | 12 | 74 | 9 | 53 | 35 | 7 | 48 | 39 | 8 | 46 | 45 | 4 | 18 | 69 | 8 | 17 | 74 | 4 |
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Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Global Health Status and 5 Functioning Scales
The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) is a validated health-related quality of life (HRQoL) measure. The EORTC QLQ-C30 is composed of both multi-item scales and single-item measures, including 5 functional scales, 3 symptom scales, 6 single symptom items, and 1 global health status / quality of life scale. No item occurs in more than one scale. All reported measures are transformed to a 0 - 100 scale. In the Global Health Status and 5 functional scales, 0 = worst possible quality of life/health status and 100 = best possible quality of life/health status. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: >=10 increase from baseline - Stable: neither increase nor decrease >10 - Worsened: >=10 decrease from baseline (NCT02301143)
Timeframe: Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
Intervention | Participants (Count of Participants) |
---|
| Global Health Status: Improved | Global Health Status: Stable | Global Health Status: Worsened | Physical Functioning Scale: Improved | Physical Functioning Scale: Stable | Physical Functioning Scale: Worsened | Role Functioning Scale: Improved | Role Functioning Scale: Stable | Role Functioning Scale: Worsened | Emotional Functioning Scale: Improved | Emotional Functioning Scale: Stable | Emotional Functioning Scale: Worsened | Cognitive Functioning Scale: Improved | Cognitive Functioning Scale: Stable | Cognitive Functioning Scale: Worsened | Social Functioning Scale: Improved | Social Functioning Scale: Stable | Social Functioning Scale: Worsened |
---|
Nab-Paclitaxel Plus Gemcitabine | 43 | 34 | 18 | 20 | 66 | 9 | 36 | 46 | 13 | 50 | 40 | 5 | 33 | 51 | 11 | 38 | 43 | 14 |
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Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1
"ORR was defined as the percentage of participants that achieved a combined incidence of complete (CR) and partial response (PR) using RECIST 1.1 guidelines as assessed by the investigator. Assessments after new non-protocol-defined anticancer therapy are excluded. For participants who had resectable surgery in Investigator Choice period, assessments after surgical intervention are excluded.~RECIST 1.1 Definition:~CR: disappearance of all target and non-target lesions; any pathological lymph nodes (target or non-target) must have reduction in short axis to < 10 mm and no new lesions diagnosed.~PR: a >= 30% decrease in the sum of diameters of target lesions from baseline; no evidence of progression in any of the non-target lesions diagnosed at baseline; and no new lesions diagnosed.~The two-sided 90% binomial confidence intervals (CIs) were estimated by Wilson score method" (NCT02301143)
Timeframe: Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks
Intervention | percentage of participants (Number) |
---|
Nab-Paclitaxel Plus Gemcitabine | 39.3 |
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Kaplan-Meier Estimates for Time to Treatment Failure (TTF)
"TTF was defined as the time after the first dose of study therapy to discontinuation of study therapy due to disease progression, death by any cause, or the start of a new non-protocol-defined anticancer therapy/surgery. If a participant does not progress, die or start a new non-protocol-defined anticancer therapy, the participant was censored on the last tumor assessment date.~Tumor evaluations of CT or MRI scans were assessed by the investigative sites and response determined according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1.~The definition for progressive disease (PD) was >= 20% increase in the sum of diameters of target lesions from nadir, and the sum showed an absolute increase of >= 5 mm; the progression of a non-target lesion or the appearance of any new lesions is also considered progression.~Median and its 90% confidence interval (CI) of TTF were estimated using the method of Brookmeyer and Crowley." (NCT02301143)
Timeframe: Day 1 of study treatment up to 28.75 months; (maximum time for the last tumor assessment)
Intervention | months (Median) |
---|
Nab-Paclitaxel Plus Gemcitabine | 9.0 |
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Kaplan-Meier Estimates for Overall Survival (OS)
Overall survival was defined as the time from the date of first dose of study therapy to the date of death (by any cause). Participants who were alive at the end of study or clinical data cut were censored on the last known time that the participant was alive or the clinical cutoff date, whichever was earlier. Median and its 90% confidence interval of OS were estimated using the method of Brookmeyer and Crowley (NCT02301143)
Timeframe: Day 1 of study treatment up to 31.34 months (maximum time for survival follow-up)
Intervention | months (Median) |
---|
Nab-Paclitaxel Plus Gemcitabine | 18.8 |
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Participants With Treatment Emergent Adverse Events (TEAEs)
"TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to one or both of the study drugs and reported as 'Suspected' on the case report form. AEs with a missing relationship were treated as 'treatment-related' in data summaries. IP (investigational product) refers to nab-Paclitaxel and/or Gemcitabine. Related TEAE refers to relation to study drug (IP)." (NCT02301143)
Timeframe: Day 1 of study drug up to end of the study; up to 31.3 months
Intervention | Participants (Count of Participants) |
---|
| >= 1 TEAE | >=1 related TEAE | >=1 TEAE of severity grade 3 or higher | >=1 related TEAE of severity grade 3 or higher | >=1 serious TEAE | >= 1 related serious TEAE | >=1 TEAE leading to discontinuation of IP | >=1 related TEAE leading to discontinuation of IP | >=1 TEAE leading to dose reduction of IP | >=1 related TEAE leading to dose reduction of IP | >=1 TEAE leading to interruption of IP | >=1 related TEAE leading to interruption of IP | >= TEAE leading to death | >=1 related TEAE leading to death |
---|
Nab-Paclitaxel Plus Gemcitabine (Induction Period) | 105 | 102 | 85 | 72 | 38 | 14 | 25 | 15 | 69 | 68 | 66 | 48 | 2 | 0 |
,Nab-Paclitaxel Plus Gemcitabine (Overall) | 105 | 103 | 90 | 75 | 39 | 14 | 28 | 18 | 72 | 71 | 68 | 50 | 2 | 0 |
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Time to Progression (TTP)
TTP was time from the date of randomization to the date of radiographic progression (according to RECIST v.1.1). If a participant died due to any reason without radiographic progression, TTP is censored at the last adequate tumor assessment. Target lesions: Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions: PD: Unequivocal progression of existing lesions or the appearance of new lesion(s). (NCT02314117)
Timeframe: Randomization to Disease Progression (Up To 24 Months)
Intervention | months (Median) |
---|
Ramucirumab + Cisplatin + Capecitabine | 6.77 |
Placebo + Cisplatin + Capecitabine | 5.78 |
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PK: Minimum Concentration (Cmin) of Ramucirumab
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab (NCT02314117)
Timeframe: Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI
Intervention | µg/mL (Geometric Mean) |
---|
| Cycle 1, Day 8 | Cycle 2, Day 1 | Cycle 3, Day 1 | Cycle 5, Day 1 | Cycle 9, Day 1 |
---|
Ramucirumab + Cisplatin + Capecitabine | 40.7 | 35.7 | 51.2 | 69.7 | 77.6 |
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Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab
Pharmacokinetics (PK): Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab (NCT02314117)
Timeframe: Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI
Intervention | Microgram/milliliter (µg/mL) (Geometric Mean) |
---|
| Cycle 1, Day 1 | Cycle 3, Day 1 | Cycle 9, Day 1 |
---|
Ramucirumab + Cisplatin + Capecitabine | 133 | 173 | 169 |
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Number of Participants With Anti-Ramucirumab Antibodies
Participants who developed treatment-emergent antibody responses to Ramucirumab postbaseline. (NCT02314117)
Timeframe: Predose Cycle 1 through 30 Days After Treatment Discontinuation (Up To 24 Months)
Intervention | Participants (Count of Participants) |
---|
Ramucirumab + Cisplatin + Capecitabine | 4 |
Placebo + Cisplatin + Capecitabine | 5 |
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Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale
Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment. (NCT02314117)
Timeframe: Randomization, First worsening in QoL (Up To 26 Months)
Intervention | months (Median) |
---|
Ramucirumab + Cisplatin + Capecitabine | 9.00 |
Placebo + Cisplatin + Capecitabine | 9.46 |
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Progression-free Survival (PFS)
PFS time was measured from the date of randomization to the date of radiographic(rgr) documentation of progression(by RECIST v.1.1) or the date of death due to any cause, whichever was earlier.If a participant did not have a complete baseline tumor assessment,then the PFS time was censored at the randomization date.If a participant was not known to have died or have rgr documented progression as of the data cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. If death or progressive disease(PD) occurred after 2 or more consecutive missing rgr visits,censoring occurred at the date of the last rgr visit prior to the missed visits.If death or PD occurred after postdiscontinuation(pdis) systemic anticancer therapy,censoring occurred at the date of last rgr visit prior to the start of pdis systemic anticancer therapy. PD was defined according to RECIST v.1.1. (NCT02314117)
Timeframe: Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months)
Intervention | months (Median) |
---|
Ramucirumab + Cisplatin + Capecitabine | 5.72 |
Placebo + Cisplatin + Capecitabine | 5.39 |
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Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L)
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status. (NCT02314117)
Timeframe: Randomization, 30 Days After Treatment Discontinuation (Up To 5 Months)
Intervention | units on a scale (Mean) |
---|
| EQ-5D index | EQ-5D VAS |
---|
Placebo + Cisplatin + Capecitabine | -0.010 | 1.5 |
,Ramucirumab + Cisplatin + Capecitabine | -0.008 | 0.8 |
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Duration of Response (DoR)
Participants achieved an objective response if they had a best overall response of CR or PR.Target lesions- CR:Disappearance of all lesions;any pathological lymph nodes must have reduction in short axis to <10 mm.PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum.PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s).Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels;all lymph nodes must be non-pathological in size. Non-CR/Non-PD:Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels.PD:Unequivocal progression of existing lesions or the appearance of new lesion(s).If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date,DOR was censored at the date of the last adequate tumor assessment. (NCT02314117)
Timeframe: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)
Intervention | months (Median) |
---|
Ramucirumab + Cisplatin + Capecitabine | 5.72 |
Placebo + Cisplatin + Capecitabine | 4.27 |
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Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
DCR was the percentage of participants with a best overall response of CR, PR, or SD as per Response using RECIST v1.1 criteria. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s). (NCT02314117)
Timeframe: Randomization to Disease Progression (Up To 26 Months)
Intervention | percentage of participants (Number) |
---|
Ramucirumab + Cisplatin + Capecitabine | 81.9 |
Placebo + Cisplatin + Capecitabine | 76.5 |
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Overall Survival (OS)
OS was time from the date of randomization to the date of death from any cause. If the participant was alive at the cutoff for analysis (or was lost to follow-up), OS data were censored for analysis on the last date the participant was known to be alive. (NCT02314117)
Timeframe: Randomization to Death from Any Cause (Up To 30 Months)
Intervention | months (Median) |
---|
Ramucirumab + Cisplatin + Capecitabine | 11.17 |
Placebo + Cisplatin + Capecitabine | 10.74 |
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1).Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).ORR calculated as:(sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100. (NCT02314117)
Timeframe: Randomization to Disease Progression (Up To 26 Months)
Intervention | percentage of participants (Number) |
---|
Ramucirumab + Cisplatin + Capecitabine | 41.1 |
Placebo + Cisplatin + Capecitabine | 36.4 |
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Progression- Free Survival 2 (PFS2)
PFS2 was defined as the time from the date of randomization to second disease progression (defined as objective radiological or symptomatic progression), or death of any cause, whichever occurs first. Participants alive and for whom a second disease progression has not been observed (including participants who did not receive any additional systemic anticancer treatments) were censored at the last time known to be alive and without second disease progression. The second progression refers to disease progression on or after additional systemic anticancer therapy, regardless if any earlier progression is observed or not(e.g. at the end of study treatment). It is assessed by investigator based on overall clinical evaluation, not limited to RECIST. (NCT02314117)
Timeframe: Randomization to Second Radiological or Symptomatic Disease Progression After the Start of Additional Systemic Anticancer Treatment or Death from Any Cause (Up To 26 Months)
Intervention | months (Median) |
---|
Ramucirumab + Cisplatin + Capecitabine | 10.18 |
Placebo + Cisplatin + Capecitabine | 9.20 |
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Progression-free Survival (PFS) Using RECIST 1.1 Criteria
PFS is defined as the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve. (NCT02324543)
Timeframe: 5 years
Intervention | Months (Median) |
---|
Phase 2 | 8.34 |
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Response Rate (RR) Using RECIST 1.1 Criteria
RR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. (NCT02324543)
Timeframe: 43 months
Intervention | percentage of participants (Number) |
---|
Phase 2 | 57 |
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Maximum Tolerated Dose (MTD) of Gemcitabine
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. (NCT02324543)
Timeframe: 28 days
Intervention | mg/m^2 (Number) |
---|
Phase 1 | 500 |
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Disease Control Rate (DCR) Using RECIST 1.1 Criteria
DCR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. (NCT02324543)
Timeframe: 43 months
Intervention | percentage of participants (Number) |
---|
Phase 2 | 87 |
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Maximum Tolerated Dose (MTD) of Capecitabine
Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use. (NCT02324543)
Timeframe: 28 days
Intervention | mg (Number) |
---|
Phase 1 | 500 |
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Overall Survival (OS) Rate at 9 Months
OS will be measured as the percentage of subjects alive at 9 months. (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (Phase 2 data only) (NCT02324543)
Timeframe: 9 months
Intervention | percentage of participants (Number) |
---|
Phase 2 | 57 |
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Maximum Tolerated Dose (MTD) of Docetaxel
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. (NCT02324543)
Timeframe: 28 days
Intervention | mg/m^2 (Number) |
---|
Phase 1 | 20 |
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Maximum Tolerated Dose (MTD) of Cisplatin
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. (NCT02324543)
Timeframe: 28 days
Intervention | mg/m^2 (Number) |
---|
Phase 1 | 20 |
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Maximum Tolerated Dose (MTD) of Irinotecan
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. (NCT02324543)
Timeframe: 28 days
Intervention | mg/m^2 (Number) |
---|
Phase 1 | 20 |
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Overall Survival (OS)
OS will be measured (in months) from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (NCT02324543)
Timeframe: 5 years
Intervention | Months (Median) |
---|
Phase 2 | 11.02 |
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Overall Survival (OS) For All Participants
Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for all participants (regardless of PD-L1 tumor status) during first course pembrolizumab treatment per protocol, is presented. (NCT02335411)
Timeframe: Up to approximately 75 months
Intervention | Months (Median) |
---|
Cohort 1: Pembrolizumab Monotherapy, Previously Treated | 5.5 |
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive | 13.8 |
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive | 20.7 |
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Progression-Free Survival For PD-L1 Positive Participants
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. The PFS for only PD-L1 positive participants during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status. (NCT02335411)
Timeframe: Up to approximately 75 months
Intervention | Months (Median) |
---|
Cohort 1: Pembrolizumab Monotherapy, Previously Treated | 2.1 |
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive | 6.5 |
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive | 2.9 |
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Progression-Free Survival (PFS) For All Participants
Progression-Free Survival (PFS) was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. The PFS for all participants (regardless of PD-L1 tumor status) during first course pembrolizumab treatment per protocol, is presented. (NCT02335411)
Timeframe: Up to approximately 75 months
Intervention | Months (Median) |
---|
Cohort 1: Pembrolizumab Monotherapy, Previously Treated | 2.0 |
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive | 6.6 |
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive | 2.9 |
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Overall Survival For PD-L1 Positive Participants
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for only PD-L1 positive participants during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status. (NCT02335411)
Timeframe: Up to approximately 75 months
Intervention | Months (Median) |
---|
Cohort 1: Pembrolizumab Monotherapy, Previously Treated | 5.8 |
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive | 11.1 |
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive | 20.7 |
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Objective Response Rate For PD-L1 Positive Participants in Cohorts 1 and 3
The ORR was defined as the percentage of participants in the analysis population who had a CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, as assessed by central radiology review. The percentage of all participants in Cohorts 1 and 3 with PD-L1+ tumor status who experienced a CR or PR during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status. (NCT02335411)
Timeframe: Up to approximately 75 months
Intervention | Percentage of Participants (Number) |
---|
Cohort 1: Pembrolizumab Monotherapy, Previously Treated | 15.5 |
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive | 22.6 |
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Number of Participants Discontinuing Study Drug Due to AEs
An AE was defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinued study drug due to an AE is presented. Per protocol, the number of participants who discontinued drug during first course pembrolizumab treatment is presented. (NCT02335411)
Timeframe: Up to approximately 52 months
Intervention | Participants (Count of Participants) |
---|
Cohort 1: Pembrolizumab Monotherapy, Previously Treated | 18 |
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive | 4 |
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive | 0 |
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Disease Control Rate (DCR) For All Participants
Disease Control Rate (DCR) was defined as the percentage of participants in the analysis population who had a CR or a PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) or stable disease (SD); (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) for ≥6 months, (for Cohort 1 ≥2 months) as assessed by central radiology review. The percentage of all participants (regardless of PD-L1 tumor status) who had a CR or PR or SD during first course pembrolizumab treatment per protocol, is presented. (NCT02335411)
Timeframe: Up to approximately 75 months
Intervention | Percentage of Participants (Number) |
---|
Cohort 1: Pembrolizumab Monotherapy, Previously Treated | 27.0 |
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive | 80.0 |
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive | 32.3 |
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Number of Participants Experiencing Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. The number of participants who experienced at least one AE is presented. Per protocol, the number of participants who experienced at least one AE during first course pembrolizumab treatment is presented. (NCT02335411)
Timeframe: Up to approximately 65 months
Intervention | Participants (Count of Participants) |
---|
Cohort 1: Pembrolizumab Monotherapy, Previously Treated | 248 |
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive | 25 |
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive | 31 |
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Disease Control Rate For PD-L1 Positive Participants
DCR was defined as the percentage of participants in the analysis population who had a CR or a PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) or stable disease (SD); (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) for ≥6 months, (for Cohort 1 ≥2 months) as assessed by central radiology review. The percentage of participants with PD-L1+ tumor status who experienced a CR or PR or SD during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status. (NCT02335411)
Timeframe: Up to approximately 75 months
Intervention | Percentage of Participants (Number) |
---|
Cohort 1: Pembrolizumab Monotherapy, Previously Treated | 33.1 |
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive | 80.0 |
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive | 32.3 |
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Duration of Response (DOR) For All Participants
Duration of Response (DOR) was defined as the time from first documented evidence of CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, based on central imaging vendor assessment, until disease progression (PD) or death, whichever occurred first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. The DOR for all participants (regardless of PD-L1 tumor status) during first course pembrolizumab treatment per protocol, is presented. (NCT02335411)
Timeframe: Up to approximately 75 months
Intervention | Months (Median) |
---|
Cohort 1: Pembrolizumab Monotherapy, Previously Treated | 16.1 |
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive | 4.6 |
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive | 38.0 |
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Duration of Response For PD-L1 Positive Participants
DOR was defined as the time from first documented evidence of CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, based on central imaging vendor assessment, until disease progression (PD) or death, whichever occurred first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. The DOR for only PD-L1 positive participants during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status. (NCT02335411)
Timeframe: Up to approximately 75 months
Intervention | Months (Median) |
---|
Cohort 1: Pembrolizumab Monotherapy, Previously Treated | NA |
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive | 4.6 |
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive | 38.0 |
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Objective Response Rate (ORR) For All Participants in Cohort 2
The Objective Response Rate (ORR) was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by central radiology review. The percentage of all participants (regardless of PD-L1 tumor status) in Cohort 2 who had a CR or PR during first course pembrolizumab treatment per protocol, is presented. (NCT02335411)
Timeframe: Up to approximately 75 months
Intervention | Percentage of Participants (Number) |
---|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive | 60.0 |
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Objective Response Rate (ORR) For All Participants in Cohorts 1 and 3
The Objective Response Rate (ORR) was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by central radiology review. The percentage of all participants (regardless of programmed death-ligand 1 [PD-L1] tumor status) in Cohorts 1 and 3 who had a CR or PR during first course pembrolizumab treatment per protocol, is presented. (NCT02335411)
Timeframe: Up to approximately 75 months
Intervention | Percentage of Participants (Number) |
---|
Cohort 1: Pembrolizumab Monotherapy, Previously Treated | 11.6 |
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive | 22.6 |
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Objective Response Rate For PD-L1 Positive Participants in Cohort 2
The ORR was defined as the percentage of participants in the analysis population who had a CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, as assessed by central radiology review. The percentage of participants in Cohort 2 with PD-L1+ tumor status who experienced a CR or PR during first course pembrolizumab treatment per protocol, is presented. (NCT02335411)
Timeframe: Up to approximately 75 months
Intervention | Percentage of Participants (Number) |
---|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive | 73.3 |
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Overall Response Rate (ORR)
"ORR = Complete response + partial response~Target lesions~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Non target lesions *Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis)." (NCT02352831)
Timeframe: Up to 18 months
Intervention | Participants (Count of Participants) |
---|
Phase I (Tosedostat + Capecitabine) | 0 |
Phase II (Tosedostat + Capecitabine) | 0 |
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Number of Participants With a CA19-9 Response
"CA19-9 is a tumor marker that is used in the management of pancreatic cancer. Rising CA19-9 levels may mean the tumor is growing and decreasing CA19-9 levels may mean the tumor is shrinking or the amount of cancer in the body is decreasing~A CA19-9 response means that the tumor marker has decreased over baseline (before treatment started) levels" (NCT02352831)
Timeframe: Completion of treatment (median treatment length 81.50 days (28.00-346.00)
Intervention | Participants (Count of Participants) |
---|
Phase I (Tosedostat + Capecitabine) | 6 |
Phase II (Tosedostat + Capecitabine) | 10 |
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Phase I Only: Recommended Phase II Dose of Tosedostat
"The recommended phase 2 dose (RP2D) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. If 0 or 1 of 6 patients in Dose Level 1 experience DLT during the first cycle, Dose Level 1 will be presumed to be the RP2D.~DLTs are followed through completion of the first cycle." (NCT02352831)
Timeframe: Completion of cycle 1 of all participants in Phase I portion of study (approximately 14 months)
Intervention | mg daily (Number) |
---|
Phase I (Tosedostat + Capecitabine) | 120 |
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Time-to-progression (TTP)
"-Progressive disease (PD)~Target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).~Non target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase" (NCT02352831)
Timeframe: Up to 24 months
Intervention | days (Median) |
---|
Phase I (Tosedostat + Capecitabine) | 210.50 |
Phase II (Tosedostat + Capecitabine) | 94.50 |
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Overall Survival Rate (OS)
(NCT02352831)
Timeframe: Up to 1 year from completion of treatment (median treatment length 81.50 days (28.00-346.00)
Intervention | Participants (Count of Participants) |
---|
Phase I (Tosedostat + Capecitabine) | 3 |
Phase II (Tosedostat + Capecitabine) | 2 |
Phase I and Phase II (Tosedostat + Capecitabine) | 5 |
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Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLTs)
"Possibly/probably/definitely related to study treatment in 1st cycle (cyc)~*Grade (Gr) 4 neutropenia >7 day, Febrile neutropenia of any duration with temperature ≥ 38.5 °C, Gr 4 anemia requires transfusion therapy on more than 2 occasions in 7 days, Gr 4 thrombocytopenia~Possibly/probably/definitely related gr. 3/4 non-hematologic toxicity that occurs 1st cyc with the following EXCEPTIONS:~Gr 3 nausea/vomiting/diarrhea/anorexia <72 hours that returns to Gr 1 prior to the start of cyc 2, Gr 3 hand-foot syndrome will only be considered a DLT for patients who have received 1 week of supportive care treatment with no improvement, Gr 3 fatigue that returns to Gr 1 prior to the start of cyc 2, Gr 3 flu-like symptoms <72 hours that returns to Gr 1 prior to start of cyc 2, Gr 3 arthralgia or myalgias <72 hours that return to Gr 1 prior to the start of cyc 2, Gr 3 potassium/phosphorus/magnesium that is asymptomatic or of non-clinical significance <72 hours, Gr 3 hypoalbuminemia" (NCT02352831)
Timeframe: Completion of cycle 1 of all participants in Phase I portion of study (approximately 14 months)
Intervention | Participants (Count of Participants) |
---|
Phase I (Tosedostat + Capecitabine) | 1 |
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Progression-free Survival (PFS) Rate
"PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.~Progressive disease (PD)~Target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).~Non target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase." (NCT02352831)
Timeframe: 3 months
Intervention | Participants (Count of Participants) |
---|
Phase I (Tosedostat + Capecitabine) | 3 |
Phase II (Tosedostat + Capecitabine) | 8 |
Phase I and Phase II Combined | 11 |
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The Number of Patients With Tumor Size Reduction (Objective Response Rate)
Objective response rate is the sum of partial responses plus complete responses and will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. (NCT02358863)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Chemotherapy | 0 |
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD and no progression in non-target lesions. (NCT02359058)
Timeframe: First Dose to Date of Objective Progressive Disease or Death Due to Any Cause (Up To 22 Months)
Intervention | Percentage of participants (Number) |
---|
Ramucirumab + Capecitabine + Cisplatin | 20 |
Ramucirumab + S-1 + Cisplatin | 100 |
Ramucirumab + S-1 + Oxaliplatin | 60 |
Total | 45.5 |
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Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab
Maximum Serum Concentration (Cmax) of Ramucirumab. (NCT02359058)
Timeframe: Day 1, Day 8, Day 43, Day 50, Day 85 and Day 92: End of Infusion
Intervention | microgram per milliliter (μg/mL) (Geometric Mean) |
---|
| Day 1 | Day 8 | Day 43 | Day 50 | Day 85 | Day 92 |
---|
Ramucirumab + Capecitabine + Cisplatin | 149 | 229 | 205 | 273 | NA | NA |
,Ramucirumab + S-1 + Cisplatin | 139 | 200 | 253 | 249 | 272 | 289 |
,Ramucirumab + S-1 + Oxaliplatin | 137 | 211 | 180 | 207 | NA | NA |
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Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies (TE-ADA)
Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. (NCT02359058)
Timeframe: First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
Intervention | Participants (Count of Participants) |
---|
Ramucirumab + Capecitabine + Cisplatin | 0 |
Ramucirumab + S-1 + Cisplatin | 0 |
Ramucirumab + S-1 + Oxaliplatin | 0 |
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Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Minimum Serum Concentration (Cmin) of Ramucirumab. (NCT02359058)
Timeframe: Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 92 and Day 106: Pre-Dose
Intervention | μg/mL (Geometric Mean) |
---|
| Day 8 | Day 22 | Day 29 | Day 43 | Day 50 | Day 64 | Day 71 | Day 85 | Day 92 | Day 106 |
---|
Ramucirumab + Capecitabine + Cisplatin | 43.8 | 40.9 | 84.6 | 60.8 | 91.7 | 47.7 | 71.1 | 55.5 | 97.6 | 68.6 |
,Ramucirumab + S-1 + Cisplatin | 51.6 | 63.9 | 105 | 87.6 | 91.3 | 85.4 | 109 | 102 | 119 | 118 |
,Ramucirumab + S-1 + Oxaliplatin | 43.2 | 41.8 | 81.6 | 68.5 | 86.2 | 81.5 | 124 | NA | NA | NA |
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To Examine the DLT
"The recommended Phase II dose is of the Nintedanib and Capecitabine combination is defined as the dose level that causes dose limiting toxicities (DLTs) in ≤ 1 out of 6 patients at highest dose level below the maximally administered dose.~Capecitabine is fixed dose at 2000 mg/m2; while Nintedanib is evaluated at 150mg (dose level 1) and 200 mg (dose level 2)." (NCT02393755)
Timeframe: At least 21 days.
Intervention | mg (Number) |
---|
Treatment (Capecitabine, Nintedanib) | 200 |
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Progression Free Survival (PFS) Rate, Defined as the Proportion of Patients Who Survive Without Disease Progression Via the RECIST Version 1.1 (Phase II)
"Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm) or the appearance of new lesions.~Will be summarized using standard Kaplan-Meier methods." (NCT02393755)
Timeframe: At 18 weeks
Intervention | percentage of participants (Number) |
---|
Treatment (Capecitabine, Nintedanib) | 41.7 |
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Objective Response Rate
Overall Response is defined as Complete Response: Disappearance of all target lesions and any lymph nodes must have a reduction in short axis to < 10 mm; or Partial Response: At least a 30% decrease in the sum of diameters of target lesions; or Stable Disease: Neither sufficient shrinkage to qualify for partial response, nor sufficient increase to qualify for progressive disease. (NCT02393755)
Timeframe: After every 3 cycles (9 weeks) of therapy.
Intervention | percentage of participants (Number) |
---|
Treatment (Capecitabine, Nintedanib) | 58.3 |
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3-year Overall Survival (OS) Rate in Basal-Subtype Patients
OS was defined as time from randomization to death from any cause. Patient alive were censored at date of known alive. The 3-year OS rate was estimated using Kaplan-Meier method. (NCT02445391)
Timeframe: Assessed every 3 months within 2 years from randomization, every 6 months if 2-3 years
Intervention | percentage of participants (Number) |
---|
Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) | 57.8 |
Arm C (Capecitabine) (Open to Accrual 6/22/2016) | 66.2 |
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Proportion of Basal Subtype
Proportion of basal subtype was calculated as number of patients who had basal subtype disease divided by all triple-negative breast cancers who were randomized to arms B and C after 6/22/2016 and had intrinsic subtype results. (NCT02445391)
Timeframe: Assessed at registration to step 0 (baseline)
Intervention | percentage of participants (Number) |
---|
All Patients Concurrently Randomized to Arms B and C | 78 |
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3-year Recurrence-Free Survival (RFS) Rate in Basal-Subtype Patients
RFS was defined as time from randomization to local/regional recurrence, distant recurrence or death, whichever occurred first. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of RFS events. 3-year RFS rate was estimated using Kaplan-Meier method. (NCT02445391)
Timeframe: No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.
Intervention | percentage of participants (Number) |
---|
Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) | 46.2 |
Arm C (Capecitabine) (Open to Accrual 6/22/2016) | 49.3 |
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3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients
IDFS was defined to be time from randomization to the earliest of documented disease recurrence (local, regional and/or distant), invasive contralateral breast cancer, invasive any other second cancer, or death. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of IDFS events. 3-year IDFS rate was estimated using Kaplan-Meier method. (NCT02445391)
Timeframe: No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.
Intervention | percentage of participants (Number) |
---|
Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) | 42.0 |
Arm C (Capecitabine) (Open to Accrual 6/22/2016) | 49.4 |
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Progression-free Survival
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. (NCT02485834)
Timeframe: Up to 3 years
Intervention | months (Median) |
---|
Randomized Patients | NA |
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Overall Survival
Overall survival is defined as the time from date of randomization to death due to any cause. (NCT02485834)
Timeframe: Up to 3 years
Intervention | months (Median) |
---|
Randomized Patients | NA |
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Number of Patients Had Pathologic Complete Response
The number of patients had pathologic complete response (pCR). (pCR is defined as no gross or microscopic tumor identified with the surgical specimen. All lymph nodes should be free of tumor to document a PCR. If no gross tumor is visible, section around the area of inflammation (nodularity) should be made every 2-3 cm and specimens examined.) (NCT02485834)
Timeframe: Up to 3 years
Intervention | Participants (Count of Participants) |
---|
Randomized Patients | 4 |
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Number of Patients Achieved R0 Resection During Surgery
The number of patients achieved R0 resection during surgery (NCT02485834)
Timeframe: At time of surgery
Intervention | Participants (Count of Participants) |
---|
Randomized Patients | 3 |
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Number of Participants Who Reported Grade 3 or Higher Adverse Events
The number of patients who reported grade 3 or higher Adverse Events according to Common Terminology Criteria for Adverse Events version 4.0. (NCT02485834)
Timeframe: Up to 30 days after completion of protocol treatment
Intervention | Participants (Count of Participants) |
---|
Randomized Patients | 3 |
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Pembro Mono vs SOC: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. PFS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record." (NCT02494583)
Timeframe: Up to approximately 42 months
Intervention | Months (Median) |
---|
Pembrolizumab Monotherapy (Pembro Mono) | 2.0 |
Placebo + SOC Chemotherapy (SOC) | 6.4 |
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Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥10
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥10. Per protocol, OS was compared separately between CPS ≥10 participants of the pembro combo arm and SOC arm and is presented earlier in the record. (NCT02494583)
Timeframe: Up to approximately 42 months
Intervention | Months (Median) |
---|
Pembrolizumab Monotherapy (Pembro Mono) | 17.4 |
Placebo + SOC Chemotherapy (SOC) | 10.8 |
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Pembro Combo vs SOC: Objective Response Rate (ORR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro combo arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record. (NCT02494583)
Timeframe: Up to approximately 42 months
Intervention | Percentage of Participants (Number) |
---|
Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 48.6 |
Placebo + SOC Chemotherapy (SOC) | 37.2 |
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Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record. (NCT02494583)
Timeframe: Up to approximately 42 months
Intervention | Months (Median) |
---|
Pembrolizumab Monotherapy (Pembro Mono) | 10.6 |
Placebo + SOC Chemotherapy (SOC) | 11.1 |
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Pembro Mono vs SOC: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record. (NCT02494583)
Timeframe: Up to approximately 42 months
Intervention | Percentage of Participants (Number) |
---|
Pembrolizumab Monotherapy (Pembro Mono) | 14.8 |
Placebo + SOC Chemotherapy (SOC) | 37.2 |
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Pembro Mono vs SOC: DOR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro combo arm and SOC arm and is presented earlier in the record. (NCT02494583)
Timeframe: Up to approximately 42 months
Intervention | Months (Median) |
---|
Pembrolizumab Monotherapy (Pembro Mono) | NA |
Placebo + SOC Chemotherapy (SOC) | NA |
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Pembro Mono vs SOC: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
"The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question How would you rate your overall health during the past week? (Item 29) and the Quality of Life (QoL) question How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro mono arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and SOC arm and is presented later in the record." (NCT02494583)
Timeframe: Baseline, Week 18
Intervention | Score on a Scale (Least Squares Mean) |
---|
Pembrolizumab Monotherapy (Pembro Mono) | -1.91 |
Placebo + SOC Chemotherapy (SOC) | -1.75 |
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Pembro Combo vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-STO22 Pain Symptom Subscale Score
EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared separately between the pembro mono arm and SOC arm and is presented earlier in the record. (NCT02494583)
Timeframe: Baseline, Week 18
Intervention | Score on a Scale (Least Squares Mean) |
---|
Pembrolizumab + SOC Chemotherapy (Pembro Combo) | -10.12 |
Placebo + SOC Chemotherapy (SOC) | -3.56 |
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Pembro Combo vs SOC: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 (All Participants)
"PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population. PFS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record." (NCT02494583)
Timeframe: Up to approximately 36 months
Intervention | Months (Median) |
---|
Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 6.9 |
Placebo + SOC Chemotherapy (SOC) | 6.4 |
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Pembro Combo vs SOC: Overall Survival (OS) in Participants With PD-L1 CPS ≥1 (All Participants)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record. (NCT02494583)
Timeframe: Up to approximately 42 months
Intervention | Months (Median) |
---|
Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 12.5 |
Placebo + SOC Chemotherapy (SOC) | 11.1 |
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Number of Participants Discontinuing Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who discontinued study treatment due to an AE was reported for each arm according to the treatment received. (NCT02494583)
Timeframe: Up to approximately 30 months
Intervention | Participants (Count of Participants) |
---|
Pembrolizumab Monotherapy (Pembro Mono) | 29 |
Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 85 |
Placebo + SOC Chemotherapy (SOC) | 58 |
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Pembro Combo vs SOC: OS in Participants With PD-L1 CPS ≥10
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥10. Per protocol, OS was compared separately between CPS ≥10 participants of the pembro mono arm and SOC arm and is presented later in the record. (NCT02494583)
Timeframe: Up to approximately 42 months
Intervention | Months (Median) |
---|
Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 12.3 |
Placebo + SOC Chemotherapy (SOC) | 10.8 |
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Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received. (NCT02494583)
Timeframe: Up to approximately 33 months
Intervention | Participants (Count of Participants) |
---|
Pembrolizumab Monotherapy (Pembro Mono) | 242 |
Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 244 |
Placebo + SOC Chemotherapy (SOC) | 240 |
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Pembro Combo vs SOC: Change From Baseline to Week 18 in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score
"The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the GHS question How would you rate your overall health during the past week? (Item 29) and the QoL question How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro mono arm and SOC arm and is presented earlier in the record." (NCT02494583)
Timeframe: Baseline, Week 18
Intervention | Score on a Scale (Least Squares Mean) |
---|
Pembrolizumab + SOC Chemotherapy (Pembro Combo) | -0.09 |
Placebo + SOC Chemotherapy (SOC) | -2.07 |
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Pembro Combo vs SOC: Duration of Response (DOR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro mono arm and SOC arm and is presented later in the record. (NCT02494583)
Timeframe: Up to approximately 42 months
Intervention | Months (Median) |
---|
Pembrolizumab + SOC Chemotherapy (Pembro Combo) | NA |
Placebo + SOC Chemotherapy (SOC) | NA |
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Pembro Mono vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-Module for Gastric Cancer (STO22) Pain Symptom Subscale Score
EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between the pembro mono arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared separately between the pembro combo arm and SOC arm and is presented later in the record. (NCT02494583)
Timeframe: Baseline, Week 18
Intervention | Score on a Scale (Least Squares Mean) |
---|
Pembrolizumab Monotherapy (Pembro Mono) | -1.14 |
Placebo + SOC Chemotherapy (SOC) | -3.49 |
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AUC From Time Zero to Infinity (AUC 0-infinity) of Pertuzumab
The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as nanograms times days per milliliter (ng*day/mL). (NCT02494596)
Timeframe: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
Intervention | ng*day/mL (Mean) |
---|
Capecitabine + Pertuzumab | 4096501 |
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Apparent Total Clearance of Pertuzumab
Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day). (NCT02494596)
Timeframe: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
Intervention | mL/day (Mean) |
---|
Capecitabine + Pertuzumab | 283.0 |
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Apparent Volume of Distribution of Pertuzumab
The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Vss was measured in mL (NCT02494596)
Timeframe: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
Intervention | mL (Mean) |
---|
Capecitabine + Pertuzumab | 5202 |
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Area Under the Concentration Curve From Time Zero to Last Measurement (AUC 0-last) of Pertuzumab
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC was measured as ng*day/mL. (NCT02494596)
Timeframe: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
Intervention | ng*day/mL (Mean) |
---|
Capecitabine + Pertuzumab | 2742561 |
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Maximum Plasma Concentration (Cmax) of Pertuzumab
Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and was measured as nanograms per milliliter (ng/mL). (NCT02494596)
Timeframe: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
Intervention | ng/mL (Mean) |
---|
Capecitabine + Pertuzumab | 355111 |
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Maximum Tolerated Dose (MTD) of the Combination of Pertuzumab and Capecitabine
MTD was defined as the highest tolerated dose combination of capecitabine (825 mg, 1000 mg or 1250 mg) and pertuzumab, without causing Dose Limiting Toxicities (DLTs). DLTs were defined as follows: 1) Any non-hematological toxicity greater than or equal to (≥) Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management; 2) Grade 4 neutropenia lasting > 7 days; 3) Febrile neutropenia; 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion; 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. Participants who withdrew from the study without completing the first treatment cycle for reasons other than DLT were not considered evaluable for DLT. MTD was measured in mg/m^2. (NCT02494596)
Timeframe: Cycle 1 (3 Weeks)
Intervention | mg/m^2 (Number) |
---|
Capecitabine + Pertuzumab | 1250 |
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Percentage of Participants With DLTs
DLTs were defined as follows: 1)Any non-hematological toxicity greater than or equal to (≥) Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management; 2) Grade 4 neutropenia lasting > 7 days; 3) Febrile neutropenia; 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion; 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. Participants who withdrew from the study without completing the first treatment cycle for reasons other than DLT were not considered evaluable for DLT. (NCT02494596)
Timeframe: Cycle 1 (3 Weeks)
Intervention | percentage of participants (Number) |
---|
Capecitabine 825 Plus (+) Pertuzumab 1050 | 0.0 |
Capecitabine 1000 + Pertuzumab 1050 | 0.0 |
Capecitabine 1250 + Pertuzumab 1050 | 0.0 |
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Plasma Half-Life (t1/2) of Pertuzumab
The biological half-life or terminal half-life of pertuzumab is the time in days it takes for it to lose half of its pharmacologic activity. t1/2 was measured in days. (NCT02494596)
Timeframe: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and Predose on Days 8, 15 and 22
Intervention | days (Mean) |
---|
Capecitabine + Pertuzumab | 14.6 |
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Time to Maximum Plasma Concentration (Tmax) of Pertuzumab
Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination. Tmax was measured in days. (NCT02494596)
Timeframe: Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22
Intervention | days (Mean) |
---|
Capecitabine + Pertuzumab | 0.137 |
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Overall Response Rate of Complete or Partial Response
The response rates of complete or partial response rate as defined by the Response Evaluation Criteria for Solid Tumors at 15 weeks of a chemotherapy regimen involving docetaxel and capecitabine as front line therapy at 95% confidence interval. Complete Response (CR): the disappearance of all target lesions Partial Response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter (NCT02524275)
Timeframe: At 15 weeks
Intervention | Participants (Count of Participants) |
---|
Treatment (Docetaxel, Capecitabine) | 1 |
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Progression-free Survival
The Kaplan-Meier method will be used to estimate time to event distributions for progression-free survival. Progression-free survival will be defined as from the first date of therapy until the first notation of clinical progression, relapse or death from any cause. (NCT02524275)
Timeframe: First date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed up to 5 years
Intervention | days (Median) |
---|
Treatment (Docetaxel, Capecitabine) | 211 |
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Survival
The Kaplan-Meier method will be used to estimate time to event distributions for survival. Survival will be defined as from the first date of therapy until the date of death from any cause. (NCT02524275)
Timeframe: First date of therapy until the date of death from any cause, assessed up to 5 years
Intervention | days (Median) |
---|
Treatment (Docetaxel, Capecitabine) | 264.5 |
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Pathologic Complete Response for Patients With Rectal Cancer
Pathologic complete response is defined as the lack of all signs of cancer in tissue samples removed during surgery or biopsy after treatment with radiation or chemotherapy. (NCT02550743)
Timeframe: Approximately 6-10 weeks post treatment
Intervention | Participants (Count of Participants) |
---|
Dose 1 | 0 |
Dose 2 | 0 |
Dose 3 | 0 |
Dose -1 | 0 |
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Maximum Tolerated Dose of BYL719
(NCT02550743)
Timeframe: approximately 6 weeks
Intervention | mg (Number) |
---|
Maximum Tolerated Dose of BYL719 | NA |
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Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10
Overall survival (OS) was defined as the time from randomization to death due to any cause. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Intervention | Months (Median) |
---|
Pembrolizumab | 12.7 |
Chemotherapy | 11.6 |
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Overall Survival in Participants With PD-L1 CPS ≥1
Overall survival (OS) was defined as the time from randomization to death due to any cause. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Intervention | Months (Median) |
---|
Pembrolizumab | 10.7 |
Chemotherapy | 10.2 |
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Number of Participants Who Experienced One or More Adverse Events
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. (NCT02555657)
Timeframe: Up to approximately 60 months
Intervention | Participants (Count of Participants) |
---|
Pembrolizumab | 285 |
Chemotherapy | 281 |
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Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥10
Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Intervention | Months (Median) |
---|
Pembrolizumab | 2.1 |
Chemotherapy | 3.4 |
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Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Intervention | Months (Median) |
---|
Pembrolizumab | 2.1 |
Chemotherapy | 3.1 |
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Progression-Free Survival Per RECIST 1.1 in All Participants
Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Intervention | Months (Median) |
---|
Pembrolizumab | 2.1 |
Chemotherapy | 3.3 |
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Disease Control Rate Per RECIST 1.1 in All Participants
Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.]) (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Intervention | Percentage of participants (Number) |
---|
Pembrolizumab | 12.2 |
Chemotherapy | 18.7 |
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Duration of Response Per RECIST 1.1 in All Participants Who Had a Confirmed Response
For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR. (NCT02555657)
Timeframe: Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)
Intervention | Months (Median) |
---|
Pembrolizumab | 12.2 |
Chemotherapy | NA |
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Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.]) (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Intervention | Percentage of participants (Number) |
---|
Pembrolizumab | 14.3 |
Chemotherapy | 15.8 |
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Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 Who Had a Confirmed Response
For participants with PD-L1 CPS ≥1 who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR. (NCT02555657)
Timeframe: Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)
Intervention | Months (Median) |
---|
Pembrolizumab | 12.2 |
Chemotherapy | NA |
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Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥10
Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.]) (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Intervention | Percentage of participants (Number) |
---|
Pembrolizumab | 19.8 |
Chemotherapy | 17.3 |
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Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 Who Had a Confirmed Response
For participants with PD-L1 CPS ≥10 who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR. (NCT02555657)
Timeframe: Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)
Intervention | Months (Median) |
---|
Pembrolizumab | NA |
Chemotherapy | 7.1 |
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Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. (NCT02555657)
Timeframe: Up to approximately 60 months
Intervention | Participants (Count of Participants) |
---|
Pembrolizumab | 14 |
Chemotherapy | 16 |
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Overall Response Rate Per RECIST 1.1 in All Participants
Overall Response Rate (ORR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Intervention | Percentage of participants (Number) |
---|
Pembrolizumab | 9.6 |
Chemotherapy | 10.6 |
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Overall Response Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
Overall Response Rate (ORR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Intervention | Percentage of participants (Number) |
---|
Pembrolizumab | 12.3 |
Chemotherapy | 9.4 |
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Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10
Overall Response Rate (ORR), based on a Blinded Independent Central Review (BICR) assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Intervention | Percentage of participants (Number) |
---|
Pembrolizumab | 17.7 |
Chemotherapy | 9.2 |
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Overall Survival in All Participants
Overall survival (OS) was defined as the time from randomization to death due to any cause. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
Intervention | Months (Median) |
---|
Pembrolizumab | 9.9 |
Chemotherapy | 10.8 |
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Time to Objective Response by the Investigator Assessment in BM-ve Population
Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. (NCT02574455)
Timeframe: From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Intervention | months (Mean) |
---|
Sacituzumab Govitecan | 2.14 |
Treatment of Physician's Choice (TPC) | 2.72 |
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Overall Survival (OS) in ITT Population
Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. (NCT02574455)
Timeframe: From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
Intervention | months (Median) |
---|
Sacituzumab Govitecan | 11.8 |
Treatment of Physician's Choice (TPC) | 6.9 |
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Time to Progression (TTP) by IRC Assessment in BM-ve Population
Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. (NCT02574455)
Timeframe: From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Intervention | months (Median) |
---|
Sacituzumab Govitecan | 5.8 |
Treatment of Physician's Choice (TPC) | 2.1 |
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score
The EORTC QLQ-C30 is a questionnaire to assess quality of life (QoL), it is composed of 30 questions (items) resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom and single-item scales indicate a better quality of life; a negative change from baseline indicates improvement. (NCT02574455)
Timeframe: Baseline; End of Treatment (EOT) (up to 29.6 months)
Intervention | score on a scale (Mean) |
---|
| Global Health Status/QoL: Baseline | Global Health Status/QoL: Change From Baseline at EOT | Physical Functioning: Baseline | Physical Functioning: Change From Baseline at EOT | Role Functioning: Baseline | Role Functioning: Change From Baseline at EOT | Emotional Functioning: Baseline | Emotional Functioning: Change From Baseline at EOT | Cognitive Functioning: Baseline | Cognitive Functioning: Change From Baseline at EOT | Social Functioning: Baseline | Social Functioning: Change From Baseline at EOT | Fatigue: Baseline | Fatigue: Change From Baseline at EOT | Nausea and Vomiting: Baseline | Nausea and Vomiting: Change From Baseline at EOT | Pain: Baseline | Pain: Change From Baseline at EOT | Dyspnoea: Baseline | Dyspnoea: Change From Baseline at EOT | Insomnia: Baseline | Insomnia: Change From Baseline at EOT | Appetite Loss: Baseline | Appetite Loss: Change From Baseline at EOT | Constipation: Baseline | Constipation: Change From Baseline at EOT | Diarrhoea: Baseline | Diarrhoea: Change From Baseline at EOT | Financial Difficulties: Baseline | Financial Difficulties: Change From Baseline at EOT |
---|
Sacituzumab Govitecan | 61.9 | -5.8 | 73.2 | -4.6 | 68.1 | -8.4 | 71.9 | -3.8 | 81.7 | -7.5 | 69.1 | -5.9 | 39.4 | 5.1 | 8.3 | 5.2 | 37.9 | 2.8 | 25.4 | 0.7 | 33.2 | 4.4 | 20.8 | 3.1 | 17.7 | 3.3 | 7.2 | 11.4 | 27.6 | 0.4 |
,Treatment of Physician's Choice (TPC) | 56.4 | -9.4 | 71.2 | -13.5 | 65.1 | -18.8 | 68.9 | -3.5 | 79.5 | -6.1 | 69.6 | -10.3 | 42.1 | 14.0 | 10.3 | 7.3 | 42.5 | 6.8 | 25.0 | 5.9 | 35.6 | -4.3 | 25.8 | 10.0 | 19.0 | 7.0 | 6.5 | 3.6 | 22.4 | 1.1 |
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Time to Progression (TTP) by Investigator Assessment in BM-ve Population
Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. (NCT02574455)
Timeframe: From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Intervention | months (Median) |
---|
Sacituzumab Govitecan | 5.7 |
Treatment of Physician's Choice (TPC) | 1.8 |
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Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population
DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. (NCT02574455)
Timeframe: From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Intervention | months (Median) |
---|
| IRC Assessment | Investigator Assessment |
---|
Sacituzumab Govitecan | 6.3 | 6.9 |
,Treatment of Physician's Choice (TPC) | 3.6 | 3.0 |
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Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population
CBR was defined as the percentage of participants with best response as either CR, PR, or stable disease (SD) with a duration of ≥6 months. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; and Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD: ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT02574455)
Timeframe: From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Intervention | percentage of participants (Number) |
---|
| IRC Assessment | Investigator Assessment |
---|
Sacituzumab Govitecan | 44.7 | 45.5 |
,Treatment of Physician's Choice (TPC) | 8.6 | 10.3 |
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Overall Survival (OS) in BM-ve Population
Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. (NCT02574455)
Timeframe: From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
Intervention | months (Median) |
---|
Sacituzumab Govitecan | 12.1 |
Treatment of Physician's Choice (TPC) | 6.7 |
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Time to Objective Response by the IRC Assessment in BM-ve Population
Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. (NCT02574455)
Timeframe: From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Intervention | months (Mean) |
---|
Sacituzumab Govitecan | 2.67 |
Treatment of Physician's Choice (TPC) | 1.86 |
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Progression-Free Survival (PFS) by IRC Assessment in the ITT Population
PFS was defined as the time from randomization until objective tumor progression by RECIST v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. (NCT02574455)
Timeframe: From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Intervention | months (Median) |
---|
Sacituzumab Govitecan | 4.8 |
Treatment of Physician's Choice (TPC) | 1.7 |
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Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline
Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported. (NCT02574455)
Timeframe: First dose date up to last follow-up (maximum up to 30.8 months)
Intervention | percentage of participants (Number) |
---|
| Anemia | Lymphocyte Count Decreased | Neutrophil Count Decreased | Platelet Count Decreased | White Blood Cell Decreased | Alanine Aminotransferase Increased | Alkaline Phosphatase Increased | Aspartate Aminotransferase Increased | Blood Bilirubin Increased | Creatinine Increased | Hypercalcemia | Hyperglycemia | Hyperkalemia | Hypermagnesemia | Hypernatremia | Hypoalbumenemia | Hypocalcemia | Hypoglycemia | Hypokalemia | Hypomagnesemia | Hyponatremia | Hypophosphatemia |
---|
Sacituzumab Govitecan | 8.9 | 33.3 | 48.8 | 1.2 | 41.1 | 1.2 | 3.1 | 3.5 | 1.9 | 0.4 | 0 | 3.1 | 0.8 | 0.4 | 0 | 0.8 | 1.6 | 0.4 | 4.3 | 0.8 | 3.9 | 8.1 |
,Treatment of Physician's Choice (TPC) | 5.4 | 25.0 | 35.3 | 2.7 | 25.4 | 2.2 | 3.6 | 2.2 | 2.7 | 0 | 0.4 | 3.1 | 0 | 0.4 | 0 | 1.3 | 1.3 | 0 | 0.9 | 0 | 3.6 | 3.6 |
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Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug
"Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:~Fatal~Life-threatening~Disabling/incapacitating~Results in hospitalization or prolongs a hospital stay~A congenital abnormality~Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above" (NCT02574455)
Timeframe: First dose date up to last follow-up (maximum up to 30.8 months)
Intervention | percentage of participants (Number) |
---|
| Any TEAEs | SAEs | TEAEs Leading to Discontinuation of Study Drug |
---|
Sacituzumab Govitecan | 99.6 | 26.7 | 4.7 |
,Treatment of Physician's Choice (TPC) | 97.8 | 28.6 | 5.4 |
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Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population
ORR was defined as the percentage of participants who had the overall best response as either a confirmed complete response (CR) or partial response (PR) relative to the size of population under evaluation. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and no new lesions. (NCT02574455)
Timeframe: From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Intervention | percentage of participants (Number) |
---|
| ORR by IRC Assessment | ORR by Investigator Assessment |
---|
Sacituzumab Govitecan | 34.9 | 33.2 |
,Treatment of Physician's Choice (TPC) | 4.7 | 6.4 |
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Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded independent central review (BICR), or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. PFS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)
Intervention | Months (Median) |
---|
Pembrolizumab | 4.1 |
Standard Treatment | 5.5 |
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Percentage of Participants With PFS (PFS Rate) at 6 Months
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 6 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: 6 months
Intervention | Percentage of Participants (Number) |
---|
Pembrolizumab | 36.3 |
Standard Treatment | 43.9 |
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Percentage of Participants With PFS (PFS Rate) at 12 Months
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: 12 months
Intervention | Percentage of Participants (Number) |
---|
Pembrolizumab | 18.7 |
Standard Treatment | 30.8 |
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Percentage of Participants Who Experience One or More Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm. (NCT02611960)
Timeframe: Up to approximately 73 months
Intervention | Percentage of Participants (Number) |
---|
Pembrolizumab | 97.4 |
Standard Treatment | 97.3 |
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Percentage of Participants Who Discontinue Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm. (NCT02611960)
Timeframe: Up to approximately 72 months
Intervention | Percentage of Participants (Number) |
---|
Pembrolizumab | 8.6 |
Standard Treatment | 15.2 |
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Percentage of Participants Surviving (OS Rate) at 24 Months
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 24 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: 24 months
Intervention | Percentage of Participants (Number) |
---|
Pembrolizumab | 40.2 |
Standard Treatment | 32.2 |
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Percentage of Participants Surviving (OS Rate) at 12 Months
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: 12 months
Intervention | Percentage of Participants (Number) |
---|
Pembrolizumab | 58.1 |
Standard Treatment | 57.4 |
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Overall Survival (OS)
Overall Survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. OS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)
Intervention | Months (Median) |
---|
Pembrolizumab | 17.2 |
Standard Treatment | 15.3 |
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Duration of Response (DOR) Per RECIST 1.1
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)
Intervention | Months (Median) |
---|
Pembrolizumab | 12.0 |
Standard Treatment | 13.1 |
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Objective Response Rate (ORR) Per RECIST 1.1
ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. ORR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. (NCT02611960)
Timeframe: Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)
Intervention | Percentage of Participants (Number) |
---|
Pembrolizumab | 21.4 |
Standard Treatment | 23.3 |
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Progression-free Survival (PFS) Per RECIST 1.1 as Determined by Blinded Independent Central Review (BICR)
Defined as the time from the date of randomization to the date of documented disease progression. (NCT02614794)
Timeframe: 34.6 months
Intervention | months (Median) |
---|
Tuc+Cap+Tra | 7.8 |
Pbo+Cap+Tra | 5.6 |
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Frequency of Dose Modifications
(NCT02614794)
Timeframe: 35.1 months
Intervention | Participants (Count of Participants) |
---|
| TEAEs resulting in tuc/pbo dose modification | TEAEs resulting in tucatinib/placebo dose hold | TEAEs resulting in tuc/pbo dose reduction | TEAEs resulting capecitabine dose modification | TEAEs resulting in capecitabine dose hold | TEAEs resulting in capecitabine dose reduction | TEAEs resulting trastuzumab dose modification | TEAEs resulting in trastuzumab dose hold |
---|
Pbo+Cap+Tra | 81 | 80 | 21 | 122 | 113 | 77 | 38 | 38 |
,Tuc+Cap+Tra | 220 | 216 | 84 | 313 | 276 | 243 | 104 | 104 |
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Frequency of Dose Modifications at Time of Final Analysis
(NCT02614794)
Timeframe: Up to 60.1 months
Intervention | Participants (Count of Participants) |
---|
| TEAEs resulting in tuc/pbo dose modification | TEAEs resulting in tucatinib/placebo dose hold | TEAEs resulting in tuc/pbo dose reduction | TEAEs resulting capecitabine dose modification | TEAEs resulting in capecitabine dose hold | TEAEs resulting in capecitabine dose reduction | TEAEs resulting trastuzumab dose modification | TEAEs resulting in trastuzumab dose hold |
---|
Pbo+Cap+Tra | 85 | 84 | 21 | 125 | 117 | 79 | 41 | 41 |
,Tuc+Cap+Tra | 237 | 232 | 92 | 322 | 288 | 251 | 117 | 117 |
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Incidence of Adverse Events (AEs) at Time of Final Analysis
As determined by assessment of AEs, clinical laboratory tests, and vital signs measurements. AEs were classified by system organ class (SOC) and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) Version 22.0 or higher; AE severities were classified using Version 4.03 of the (Common Terminology Criteria for Adverse Events) CTCAE criteria. (NCT02614794)
Timeframe: Up to 60.1 months
Intervention | Participants (Count of Participants) |
---|
| Any treatment-emergent AE (TEAE) | Any Grade 3 or higher TEAE | Any treatment-emergent serious AE | TEAE leading to death |
---|
Pbo+Cap+Tra | 191 | 101 | 58 | 6 |
,Tuc+Cap+Tra | 401 | 248 | 123 | 8 |
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Incidence of Adverse Events (AEs) at Time of Primary Analysis
As determined by assessment of AEs, clinical laboratory tests, and vital signs measurements. AEs were classified by system organ class (SOC) and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) Version 22.0 or higher; AE severities were classified using Version 4.03 of the (Common Terminology Criteria for Adverse Events) CTCAE criteria. (NCT02614794)
Timeframe: 36.1 months
Intervention | Participants (Count of Participants) |
---|
| Any treatment-emergent AE (TEAE) | Any Grade 3 or higher TEAE | Any treatment-emergent serious AE | TEAE leading to death |
---|
Pbo+Cap+Tra | 191 | 96 | 53 | 6 |
,Tuc+Cap+Tra | 401 | 223 | 104 | 8 |
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Incidence of Health Resources Utilization
Cumulative incidence of health resource utilization, including length of stay, hospitalizations, and ER visits using the EQ-5D-5L questionnaire. (NCT02614794)
Timeframe: 36.1 months
Intervention | hospitalizations (Number) |
---|
| Total number of hospitalizations | Hospitalization for AE | Planned hospitalization (other than AE) | Ambulatory Surgery | Other |
---|
Pbo+Cap+Tra | 75 | 64 | 6 | 0 | 5 |
,Tuc+Cap+Tra | 143 | 124 | 10 | 3 | 6 |
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Pharmacokinetic Measure: ONT-993
Individual plasma primary metabolite concentrations at each sampling time (NCT02614794)
Timeframe: 3.5 months
Intervention | ng/mL (Mean) |
---|
| Cycle 2, Day 1 (Pre-dose) | Cycle 3, Day 1 (Pre-dose) | Cycle 3, Day 1 (Post-dose) | Cycle 4, Day 1 (Pre-dose) | Cycle 5, Day 1 (Pre-dose) | Cycle 6, Day 1 (Pre-dose) |
---|
Tuc+Cap+Tra | 25.5 | 22.6 | 47.7 | 25.2 | 24.5 | 20.9 |
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Pharmacokinetic Measure: Ctrough of Tucatinib
Individual plasma tucatinib concentrations at each sampling time (NCT02614794)
Timeframe: 3.5 months
Intervention | ng/mL (Mean) |
---|
| Cycle 2, Day 1 (Pre-dose) | Cycle 3, Day 1 (Pre-dose) | Cycle 3, Day 1 (Post-dose) | Cycle 4, Day 1 (Pre-dose) | Cycle 5, Day 1 (Pre-dose) | Cycle 6, Day 1 (Pre-dose) |
---|
Tuc+Cap+Tra | 246.1 | 227.6 | 507.1 | 253.2 | 257.6 | 247.8 |
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CBR Per RECIST 1.1 as Determined by Investigator Assessment
Clinical benefit was defined as achieving stable disease (SD) or non-CR/non-PD for at least 6 months or a best overall response of confirmed CR or confirmed PR. (NCT02614794)
Timeframe: 34.6 months
Intervention | percentage of participants (Number) |
---|
Tuc+Cap+Tra | 58.0 |
Pbo+Cap+Tra | 37.6 |
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Clinical Benefit Rate (CBR) as Determined by BICR Per RECIST 1.1
Clinical benefit was defined as achieving stable disease (SD) or non-complete response (CR)/non-progressive disease (PD) for at least 6 months or a best overall response of confirmed CR or confirmed partial response (PR). (NCT02614794)
Timeframe: 34.6 months
Intervention | percentage of participants (Number) |
---|
Tuc+Cap+Tra | 59.8 |
Pbo+Cap+Tra | 38.1 |
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Confirmed Objective Response Rate (ORR) Per RECIST 1.1 as Determined by BICR
Defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR). (NCT02614794)
Timeframe: 34.6 months
Intervention | percentage of participants (Number) |
---|
Tuc+Cap+Tra | 40.7 |
Pbo+Cap+Tra | 23.4 |
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Duration of Response (DOR) Per RECIST 1.1 as Determined by BICR
Defined as the time from the first objective response to documented disease progression or death from any cause, whichever occurred first. (NCT02614794)
Timeframe: 24.6 months
Intervention | months (Median) |
---|
Tuc+Cap+Tra | 8.3 |
Pbo+Cap+Tra | 6.3 |
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ORR Per RECIST 1.1 as Determined by Investigator Assessment
Defined as achieving a best overall response of confirmed CR or confirmed PR. (NCT02614794)
Timeframe: 34.6 months
Intervention | percentage of participants (Number) |
---|
Tuc+Cap+Tra | 41.4 |
Pbo+Cap+Tra | 23.0 |
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Overall Survival (OS) at Time of Final Analysis
Defined as time from randomization to death from any cause (NCT02614794)
Timeframe: Up to 60.1 months
Intervention | months (Median) |
---|
Tuc+Cap+Tra | 24.7 |
Pbo+Cap+Tra | 19.2 |
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Overall Survival (OS) at Time of Primary Analysis
Defined as time from randomization to death from any cause (NCT02614794)
Timeframe: 35.9 months
Intervention | months (Median) |
---|
Tuc+Cap+Tra | 21.9 |
Pbo+Cap+Tra | 17.4 |
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PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Final Analysis
Defined as the time from the date of randomization to the date of documented disease progression (NCT02614794)
Timeframe: Up to 58.0 months
Intervention | months (Median) |
---|
Tuc+Cap+Tra | 7.6 |
Pbo+Cap+Tra | 4.9 |
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PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Primary Analysis
Defined as the time from the date of randomization to the date of documented disease progression (NCT02614794)
Timeframe: 34.6 months
Intervention | months (Median) |
---|
Tuc+Cap+Tra | 7.5 |
Pbo+Cap+Tra | 4.3 |
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DOR Per RECIST 1.1 as Determined by Investigator Assessment
Defined as the time from the first objective response to documented disease progression or death from any cause, whichever occurred first. (NCT02614794)
Timeframe: 33.2 months
Intervention | months (Median) |
---|
Tuc+Cap+Tra | 7.0 |
Pbo+Cap+Tra | 6.9 |
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Progression Free Survival (PFS) by Independent Review Committee (IRC)
The PFS time was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurs first). PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as per IRC. PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates. (NCT02625610)
Timeframe: From randomization into maintenance phase up to 1276 days
Intervention | months (Median) |
---|
Chemotherapy + Best Supportive Care (BSC) | 4.4 |
Avelumab | 3.2 |
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Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported. (NCT02625610)
Timeframe: From randomization into maintenance phase up to 1276 days
Intervention | Participants (Count of Participants) |
---|
| Any TEAEs | Any Serious TEAE |
---|
Avelumab | 223 | 89 |
,Chemotherapy + Best Supportive Care (BSC) | 214 | 75 |
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Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
ECG parameters included heart rate, pulse rate intervals, QRS interval, QT interval corrected based on Fridericia's formula (QTcF) intervals and QTcB intervals. Clinical significance was determined by the investigator. Number of participants with potentially clinically significant ECG abnormalities were reported. (NCT02625610)
Timeframe: From randomization into maintenance phase up to 1276 days
Intervention | Participants (Count of Participants) |
---|
| Decreased heart rate | Increased heart rate | Increased Pulse Rate interval | Increased QRS interval | QTcF interval greater than (>)450milisecond (ms)less than or equal to(<=)480ms | QTcF interval: > 480 ms <= 500 ms | QTcF interval: > 500 ms | QTcB Interval: > 450 msec <= 480 msec | QTcB Interval: > 480 msec <= 500 msec | QTcB Interval: > 500 msec |
---|
Avelumab | 1 | 2 | 3 | 8 | 9 | 3 | 1 | 18 | 2 | 3 |
,Chemotherapy + Best Supportive Care (BSC) | 0 | 2 | 1 | 5 | 9 | 2 | 3 | 19 | 2 | 5 |
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Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
Vital signs assessment included Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Pulse Rate (PR). Number of Participants with any potentially clinically significant abnormalities in vital signs were reported. Clinical significance was determined by the investigator. (NCT02625610)
Timeframe: From randomization into maintenance phase up to 1276 days
Intervention | Participants (Count of Participants) |
---|
| Increased in Systolic blood pressure | Decreased in Systolic blood pressure | Increased in Diastolic blood pressure | Decreased in Diastolic blood pressure | Increased in pulse rate | Decreased in pulse rate |
---|
Avelumab | 62 | 69 | 24 | 26 | 48 | 30 |
,Chemotherapy + Best Supportive Care (BSC) | 57 | 43 | 14 | 21 | 46 | 32 |
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Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values
Blood samples were collected for the analysis of following hematology parameters: lymphocyte count, neutrophil count, white blood cells, platelet count, lipase, serum amylase, creatinine phosphokinase and creatinine. The hematology parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case (Grade 4) post Baseline is presented. Only those participants with increase to grade 4 have been presented. (NCT02625610)
Timeframe: From baseline up to 1276 days
Intervention | Participants (Count of Participants) |
---|
| lymphocyte count decreased | neutrophil count decreased | white blood cells decreased | platelet count decreased | lipase increased | serum amylase increased | creatinine phosphokinase increased | creatinine increased |
---|
Avelumab | 1 | 1 | 0 | 0 | 8 | 2 | 2 | 1 |
,Chemotherapy + Best Supportive Care (BSC) | 0 | 6 | 2 | 1 | 6 | 3 | 0 | 0 |
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Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks)
EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. (NCT02625610)
Timeframe: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Intervention | Millimeter (Mean) |
---|
| Week 3/4 | Week 7 | Week 13 | Week 19 | Week 25 | Week 31 | Week 37 | Week 43 | Week 49 | Week 55 | Week 61 | Week 67 | End Of Treatment | Safety Follow-Up |
---|
Avelumab | 0.6 | -2.1 | -0.7 | -0.1 | -1.4 | 1.4 | 0.9 | 3.2 | 2.1 | 3.4 | 3.5 | 4.9 | -10.3 | -9.6 |
,Chemotherapy + Best Supportive Care (BSC) | 0.9 | -0.5 | -3.2 | -3.5 | -4.5 | -2.3 | -1.7 | -4.4 | -2.9 | -9.4 | -6.4 | -7.3 | -12.2 | -8.0 |
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Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1
ECOG PS score is widely used by doctors and researchers to assess how a participants' disease is progressing, and is used to assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 5, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair, Grade 5 = Death. Number of participants with shift in ECOG PS Score to 1 or Higher Than 1 were reported. (NCT02625610)
Timeframe: From randomization into maintenance phase up to 1276 days
Intervention | Participants (Count of Participants) |
---|
Chemotherapy + Best Supportive Care (BSC) | 140 |
Avelumab | 144 |
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Objective Response Rate (ORR) by Investigator Assessment
The ORR defined as the percentage of all randomized participants with a confirmed best overall response (BOR) of partial response (PR),or complete response (CR) according to RECIST v1.1 and as per Investigator assessment. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. (NCT02625610)
Timeframe: From randomization into maintenance phase up to 1276 days
Intervention | percentage of participants (Number) |
---|
Chemotherapy + Best Supportive Care (BSC) | 14.4 |
Avelumab | 13.3 |
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Overall Survival (OS)
Overall Survival was defined as the time from randomization to the date of death due to any cause. For participants who were still alive at the time of data analysis or who were lost to follow-up, OS time was censored at the date of last contact. OS was measured using Kaplan-Meier (KM) estimates. (NCT02625610)
Timeframe: From randomization into maintenance phase up to 1276 days
Intervention | months (Median) |
---|
Chemotherapy + Best Supportive Care (BSC) | 10.9 |
Avelumab | 10.4 |
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Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks)
European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL. (NCT02625610)
Timeframe: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Intervention | units on a scale (Mean) |
---|
| Week 3/4 | Week 7 | Week 13 | Week 19 | Week 25 | Week 31 | Week 37 | Week 43 | Week 49 | Week 55 | Week 61 | Week 67 | End Of Treatment | Safety Follow-Up |
---|
Avelumab | 0.85 | -1.01 | 0.24 | 1.37 | 0.41 | 1.85 | 1.77 | 3.33 | 4.01 | 4.00 | 2.38 | 4.90 | -11.67 | -9.29 |
,Chemotherapy + Best Supportive Care (BSC) | 1.30 | -1.44 | -2.50 | -5.85 | -4.43 | -3.09 | -1.39 | -1.19 | 1.52 | 0.00 | -5.00 | 0.00 | -11.54 | -7.51 |
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Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. (NCT02625610)
Timeframe: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Intervention | units on a scale (Mean) |
---|
| Dysphagia: Week 3/4 | Dysphagia Week 7 | Dysphagia Week 13 | Dysphagia Week 19 | Dysphagia Week 25 | Dysphagia Week 31 | Dysphagia Week 37 | Dysphagia Week 43 | Dysphagia Week 49 | Dysphagia Week 55 | Dysphagia Week 61 | Dysphagia Week 67 | Dysphagia End Of Treatment | Dysphagia Safety Follow-Up | Pain Week 3/4 | Pain Week 7 | Pain Week 13 | Pain Week 19 | Pain Week 25 | Pain Week 31 | Pain Week 37 | Pain Week 43 | Pain Week 49 | Pain Week 55 | Pain Week 61 | Pain Week 67 | Pain End Of Treatment | Pain Safety Follow-Up | Reflux Week 3/4 | Reflux Week 7 | Reflux Week 13 | Reflux Week 19 | Reflux Week 25 | Reflux Week 31 | Reflux Week 37 | Reflux Week 43 | Reflux Week 49 | Reflux Week 55 | Reflux Week 61 | Reflux Week 67 | Reflux End of Treatment | Reflux Safety Follow-up | Eating Restrictions Week 3/4 | Eating Restrictions Week 7 | Eating Restrictions Week 13 | Eating Restrictions Week 19 | Eating Restrictions Week 25 | Eating Restrictions Week 31 | Eating Restrictions Week 37 | Eating Restrictions Week 43 | Eating Restrictions Week 49 | Eating Restrictions Week 55 | Eating Restrictions Week 61 | Eating Restrictions Week 67 | Eating Restrictions EOT | Eating Restrictions Safety Follow-up | Anxiety Week 3/4 | Anxiety Week 7 | Anxiety Week 13 | Anxiety Week 19 | Anxiety Week 25 | Anxiety Week 31 | Anxiety Week 37 | Anxiety Week 43 | Anxiety Week 49 | Anxiety Week 55 | Anxiety Week 61 | Anxiety Week 67 | Anxiety End of Treatment | Anxiety Safety Follow-Up |
---|
Avelumab | 0.60 | 1.34 | 0.65 | 1.52 | 1.69 | 4.39 | -0.67 | -2.59 | 1.23 | 0.89 | 1.06 | 1.31 | 8.21 | 7.25 | -0.04 | 2.60 | 0.16 | -0.51 | -1.55 | 0.97 | -1.26 | -1.94 | -0.62 | -1.00 | -1.59 | -0.49 | 9.45 | 10.99 | 0.12 | 0.50 | -1.09 | -1.68 | 1.69 | -1.29 | -4.38 | -5.56 | -2.06 | -3.56 | -6.35 | 0.00 | 4.73 | 2.90 | 0.13 | -0.27 | 0.00 | -0.63 | -1.55 | 0.39 | -3.28 | -3.89 | -5.25 | -6.00 | -5.56 | -2.45 | 10.01 | 11.59 | -4.06 | -1.20 | -2.83 | -1.68 | -1.69 | -0.52 | -1.01 | -1.11 | -6.17 | -4.00 | -4.76 | -1.96 | 5.89 | 4.99 |
,Chemotherapy + Best Supportive Care (BSC) | 0.76 | 2.84 | 1.60 | -0.58 | -1.39 | 0.82 | -7.19 | -4.76 | -3.03 | 0.00 | 0.00 | -1.85 | 7.27 | 9.39 | 1.51 | 2.53 | 2.96 | 3.22 | -1.56 | 4.01 | -4.90 | 1.79 | 1.52 | 0.00 | 3.33 | 0.00 | 9.25 | 8.22 | 1.04 | 0.31 | 0.99 | 1.75 | 0.69 | -2.06 | -6.54 | -3.17 | 1.01 | 2.22 | 6.67 | 7.41 | 3.43 | 1.56 | 0.73 | 0.98 | 1.02 | -2.34 | -2.08 | -2.47 | -8.82 | -4.76 | 0.76 | 3.33 | 0.00 | 1.39 | 8.27 | 7.04 | -0.28 | -1.30 | -0.86 | -1.56 | -2.78 | 4.12 | -3.92 | -3.97 | 0.00 | 2.22 | -4.44 | 9.26 | 4.58 | 5.48 |
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Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks)
EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall composite health state index score, with scores ranging from -0.594 to 1. A higher score indicates better health state. (NCT02625610)
Timeframe: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Intervention | Units on Scale (Mean) |
---|
| Week 3/4 | Week 7 | Week 13 | Week 19 | Week 25 | Week 31 | Week 37 | Week 43 | Week 49 | Week 55 | Week 61 | Week 67 | End Of Treatment | Safety Follow-Up |
---|
Avelumab | 0.004 | -0.009 | -0.017 | -0.011 | 0.014 | 0.013 | 0.013 | 0.058 | 0.026 | 0.028 | 0.031 | 0.039 | -0.138 | -0.099 |
,Chemotherapy + Best Supportive Care (BSC) | -0.002 | -0.032 | -0.053 | -0.039 | -0.049 | -0.023 | -0.035 | -0.046 | -0.100 | -0.164 | -0.091 | -0.076 | -0.125 | -0.062 |
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Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes
Downstaging of primary tumor (T) and/or lymph nodes (N) was defined as decrease by 1 point in T-value and/or N-value (comparing at screening and after treatment). It was assessed by colonoscopy, pathology, endosonography of rectum, chest X-ray, abdominopelvic Computed Tomography and Magnetic Resonance Imaging. Staging for tumor are: TX (primary tumor cannot be assessed), T0 (no evidence of primary tumor), Tis (carcinoma in situ), T1 (tumor invades submucosa), T2 (tumor invades muscularis propria), T3 (tumor invades through muscularis propria into subserosa/into non-peritonealized pericolic/perirectal tissues, T4 (tumor directly invades other organs or structures). Staging for lymph nodes are: NX (regional lymph nodes cannot be assessed), N0 (no regional lymph node metastasis), N1 (metastasis in 1 to 3 regional lymph nodes), N2 (metastasis in 4 or more regional lymph nodes). (NCT02694718)
Timeframe: From screening to Week 16
Intervention | Percentage of participants (Number) |
---|
| T stage | N stage | Overall |
---|
Capecitabine + Oxaliplatin | 47 | 48 | 65 |
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Number of Participants With Any Adverse Events and Serious Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. (NCT02694718)
Timeframe: Up to Week 16
Intervention | Participants (Number) |
---|
| Any AEs | Any SAEs |
---|
Capecitabine + Oxaliplatin | 59 | 8 |
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Percentage of Participants With Pathological Complete Tumor Response
Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response). (NCT02694718)
Timeframe: Up to Week 16
Intervention | Percentage of participants (Number) |
---|
Capecitabine + Oxaliplatin | 23 |
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Percentage of Participants With Pathological Incomplete Tumor Response
Pathological incomplete tumor response was defined as grade 1 or 2 in the histological grading of regression according to Dworak grading of regression. Pathological incomplete tumor response rate, Grade 1: dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2: dominantly fibrotic changes with few tumor cells or groups (easy to find) were assessed. (NCT02694718)
Timeframe: Up to Week 16
Intervention | Percentage of participants (Number) |
---|
Capecitabine + Oxaliplatin | 72 |
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Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer
R0 resection was defined as complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation as confirmed by pathology after pre-operative chemotherapy plus capecitabine + oxaliplatin therapy. (NCT02694718)
Timeframe: Up to Week 16
Intervention | Percentage of participants (Number) |
---|
Capecitabine + Oxaliplatin | 100 |
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Percentage of Participants With Sphincter-preservation
Percentage of participants with sphincter-preservation is reported. (NCT02694718)
Timeframe: Up to Week 16
Intervention | Percentage of participants (Number) |
---|
Capecitabine + Oxaliplatin | 84.48 |
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Number of Participants With Marked Laboratory Abnormalities
Number of participants with marked laboratory abnormalities is reported. (NCT02694718)
Timeframe: Up to Week 16
Intervention | Participants (Number) |
---|
| Hemoglobin | Hematocrit | Erythrocytes | Leucocytes total | Neutrophils | Basophils | Eosinophils | Monocytes | Lymphocytes | Platelets | ASAT/SGOT | ALAT/SGPT | Serum albumin | Total protein | Serum creatinine | Glucose | Sodium | Potassium | Calcium |
---|
Capecitabine + Oxaliplatin | 7 | 7 | 16 | 8 | 9 | 1 | 2 | 2 | 42 | 13 | 2 | 10 | 3 | 2 | 2 | 13 | 2 | 2 | 2 |
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Disease Control Rate (DCR)
DCR was the proportion of patients with confirmed CR, PR or stable disease (SD) as best overall response. SD defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD. (NCT02743221)
Timeframe: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Intervention | Participants (Count of Participants) |
---|
Trifluridine/Tipiracil + Bevacizumab | 66 |
Capecitabine + Bevacizumab | 59 |
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Overall Survival (OS)
The OS was defined as the time from the date of randomisation to the date of death. If death was not confirmed, or patient was alive at study cut-off date, survival time was censored at the date of last follow-up or at the study cut-off date, whichever was earlier. (NCT02743221)
Timeframe: Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)
Intervention | months (Median) |
---|
Trifluridine/Tipiracil + Bevacizumab | 18.0 |
Capecitabine + Bevacizumab | 16.2 |
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Overall Response Rate (ORR)
As per RECIST v1.1, Complete Response (CR) was disappearance of all target lesions; Partial Response (PR) was at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ORR was the proportion of patients who presented CR or PR with confirmation at subsequent time point or at least 4 weeks later. (NCT02743221)
Timeframe: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Intervention | Participants (Count of Participants) |
---|
Trifluridine/Tipiracil + Bevacizumab | 26 |
Capecitabine + Bevacizumab | 23 |
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Progression Free Survival (PFS)
The progression free survival (PFS), defined as the time from the date of randomisation until the date of the investigator-assessed radiological disease progression or death due to any cause according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease (PD) was defined at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and an absolute increase of at least 5 mm in the sum of lesions or the appearance of new lesions. (NCT02743221)
Timeframe: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Intervention | months (Median) |
---|
Trifluridine/Tipiracil + Bevacizumab | 9.2 |
Capecitabine + Bevacizumab | 7.8 |
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Duration of Response (DR)
The DR was calculated among patients with CR or PR as the time (months) from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. (NCT02743221)
Timeframe: Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)
Intervention | months (Median) |
---|
Trifluridine/Tipiracil + Bevacizumab | 7.9 |
Capecitabine + Bevacizumab | 9.9 |
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Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method. (NCT02748213)
Timeframe: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Intervention | percentage of participants (Number) |
---|
Herceptin + Taxotere + Xeloda | 70.5 |
Herceptin + Taxotere | 72.7 |
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Percentage of Participants With Death or Disease Progression According to RECIST
Tumor response was assessed by RECIST during the study. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants who died or experienced PD was reported. (NCT02748213)
Timeframe: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Intervention | percentage of participants (Number) |
---|
Herceptin + Taxotere + Xeloda | 67.9 |
Herceptin + Taxotere | 77.3 |
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Progression-Free Survival (PFS) According to RECIST
Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. Participants without event at the time of analysis were censored at the latest date of last tumor assessment or last date in drug log. The median duration of PFS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months. (NCT02748213)
Timeframe: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Intervention | months (Median) |
---|
Herceptin + Taxotere + Xeloda | 17.9 |
Herceptin + Taxotere | 12.8 |
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Duration of Response (DOR) According to RECIST
Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. DOR was defined as the time from first assessment of CR or PR until the first occurrence of documented PD, death, or withdrawal. The median DOR was reported and expressed in months. (NCT02748213)
Timeframe: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Intervention | months (Median) |
---|
Herceptin + Taxotere + Xeloda | 15.9 |
Herceptin + Taxotere | 13.4 |
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Overall Survival (OS)
OS was defined as the time from start of treatment to date of death for any reason. Participants who were alive at the time of analysis were censored at the latest date of last tumor assessment, last drug intake, or last follow-up information. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months. (NCT02748213)
Timeframe: Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)
Intervention | months (Median) |
---|
Herceptin + Taxotere + Xeloda | 43.5 |
Herceptin + Taxotere | 47.3 |
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Percentage of Participants Who Died
The percentage of participants who died from any cause was reported. (NCT02748213)
Timeframe: Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)
Intervention | percentage of participants (Number) |
---|
Herceptin + Taxotere + Xeloda | 35.7 |
Herceptin + Taxotere | 41.8 |
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Disease Control (DC)
"Disease control is defined as CR or PR or Stable disease (SD) per RECIST version 1.1.~Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out." (NCT02780700)
Timeframe: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Intervention | Percentage of participants (Number) |
---|
Nintedanib Plus Capecitabine | NA |
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Objective Response Rate (ORR)
"ORR is defined as complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.~Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out." (NCT02780700)
Timeframe: tumor response was to be assessed by imaging according to RECIST (version 1.1) every 6 weeks.
Intervention | Percentage of participants (Number) |
---|
Nintedanib Plus Capecitabine | NA |
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Overall Survival (OS)
"Overall survival is defined as the time from randomization until death from any cause.~Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out." (NCT02780700)
Timeframe: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Intervention | months (Median) |
---|
Nintedanib Plus Capecitabine | NA |
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Percentage of Patients With Grade 3 or Worse Adverse Events
Percentage of patients with grade 3 or worse adverse events. (NCT02780700)
Timeframe: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Intervention | Percentage of participants (Number) |
---|
Nintedanib Plus Capecitabine | 0 |
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Progression Free Survival (PFS)
"PFS is defined as the time from randomization until objective tumor progression or death.~Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out." (NCT02780700)
Timeframe: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Intervention | months (Median) |
---|
Nintedanib Plus Capecitabine | NA |
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PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Ipilumab vs Chemotherapy with PD-L1 CPS ≥ 10, 5, 1 or all randomized participants. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. (NCT02872116)
Timeframe: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 9 months)
Intervention | Months (Median) |
---|
| All randomized participants | PD-L1 CPS ≥ 1 | PD-L1 CPS ≥ 5 | PD-L1 CPS ≥ 10 |
---|
Arm 2b: Chemotherapy (XELOX or FOLFOX) | 7.06 | 6.93 | 6.28 | 6.28 |
,Arm 3: Nivolumab + Ipilimumab | 2.83 | 2.79 | 2.83 | 2.89 |
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PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Progression free survival (PFS), defined as the time from randomization to the date of the first documented progressive disease (PD) or death due to any cause, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy by BICR per RECIST1.1 in participants with PD-L1 CPS ≥ 10, 1, or all randomized subjects. Progreessive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. (NCT02872116)
Timeframe: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)
Intervention | Months (Median) |
---|
| All randomized participants | Participants with CPS ≥ 1 | Participants with CPS ≥ 10 |
---|
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 7.66 | 7.49 | 8.31 |
,Arm 2a: Chemotherapy (XELOX or FOLFOX) | 6.93 | 6.90 | 5.78 |
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OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Ipilimumab vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 1, 5, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. (NCT02872116)
Timeframe: From the date of randomization up to the date of death, up to approximately 14 months
Intervention | Months (Median) |
---|
| All randomized participants | Participants with CPS ≥ 1 | Participants with CPS ≥ 5 | Participants with CPS ≥ 10 |
---|
Arm 2b: Chemotherapy (XELOX or FOLFOX) | 11.83 | 11.47 | 11.63 | 11.33 |
,Arm 3: Nivolumab + Ipilimumab | 11.73 | 11.73 | 11.24 | 11.63 |
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OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS ≥ 1, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. (NCT02872116)
Timeframe: From the date of randomization up to the date of death, up to approximately 17 months
Intervention | Months (Median) |
---|
| All randomized participants | Participants with CPS ≥ 1 | Participants with PD-L1 CPS ≥ 10 |
---|
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 13.83 | 13.96 | 15.01 |
,Arm 2a: Chemotherapy (XELOX or FOLFOX) | 11.56 | 11.33 | 10.87 |
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Objective Response Rate
Objective response rate (ORR) as assessed by BICR in participants with PD-L1 CPS ≥ 10, 5, 1, or all randomized participants. ORR is a percentage of participants determined by the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of measurable participants with target lesion at baseline. BOR is defined as the best response designation as determined by the BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1 as determined by the BICR) or the date of subsequent anti-cancer therapy, whichever occurs first. CR is defined as the disappearance of all target lesions. PR is define as at 30% decrease in the sum of diameters of target lesions. The 806 chemotherapy treated participants are split into two separate arms (Arm 2a and Arm 2b) to act as comparison groups to the other treatment arms. (NCT02872116)
Timeframe: From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months)
Intervention | Percentage of Participants (Number) |
---|
| Participants with CPS ≥ 1 | Participants with CPS ≥ 5 | Participants with CPS ≥ 10 | All randomized participants |
---|
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 59.5 | 59.8 | 58.3 | 46.9 |
,Arm 2a: Chemotherapy (XELOX or FOLFOX) | 46.4 | 45.3 | 44.2 | 37.0 |
,Arm 2b: Chemotherapy (XELOX or FOLFOX) | 37.3 | 37.7 | 35.9 | 34.9 |
,Arm 3: Nivolumab + Ipilimumab | 21.7 | 23.1 | 24.3 | 20.8 |
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Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS ≥ 5. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. (NCT02872116)
Timeframe: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)
Intervention | Months (Median) |
---|
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 7.69 |
Arm 2a: Chemotherapy (XELOX or FOLFOX) | 6.05 |
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Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 5. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. (NCT02872116)
Timeframe: From the date of randomization up to the date of death, up to approximately 17 months
Intervention | Months (Median) |
---|
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 14.39 |
Arm 2a: Chemotherapy (XELOX or FOLFOX) | 11.10 |
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Progression Free Survival (PFS)
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The primary comparisons will be superiority of the active treatment for PFS of atezolizumab versus placebo. PFS will be compared between treatment arms using the un-stratified log-rank test at one-sided level of 0.10 and the p-value will be used for decision making. The hazard ratio (HR) for PFS will be estimated using a Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria. (NCT02873195)
Timeframe: From randomization to first documentation of disease progression by RECIST v1.1, or death from any cause, assessed up to 20 months
Intervention | months (Median) |
---|
Atezolizumab, Bevacizumab, Capecitabine | 4.37 |
Placebo, Bevacizumab, Capecitabine | 3.32 |
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Objective Response Rate
The objective response rate is defined as the percentage of participants who achieve a partial response or compete response as assessed (partial response [PR] or complete response [CR] per RECIST v1.1) during treatment with study therapy. Rates of response will be compared across arms using a fisher's exact test for proportion. Point estimates will be generated for objective response rates within each arm along with 95% binomial confidence intervals. Complete response (CR): Disappearance of all evidence of disease, Partial response (PR): Regression of measurable disease and no new sites (NCT02873195)
Timeframe: Up to 20 months
Intervention | percentage of participants (Number) |
---|
Atezolizumab, Bevacizumab, Capecitabine | 8.54 |
Placebo, Bevacizumab, Capecitabine | 4.35 |
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Overall Survival (OS)
The distribution of survival time will be estimated using the method of Kaplan-Meier. OS will be compared between treatment arms using the unstratified log-rank test. OS medians, survival rates and HR will be estimated along with 95% confidence intervals. (NCT02873195)
Timeframe: From randomization to death due to any cause, assessed up to 20 months
Intervention | months (Median) |
---|
Atezolizumab, Bevacizumab, Capecitabine | 10.55 |
Placebo, Bevacizumab, Capecitabine | 10.61 |
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Rate of Sphincter Preservation
Sphincter preservation means that the surgical procedure used to remove the tumor did not disturb the sphincter muscle. Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment. (NCT02921256)
Timeframe: Up to 3 years
Intervention | percentage of participants (Mean) |
---|
Arm Ia (mFOLFOX6, RT, Capecitabine) | 52.5 |
Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) | 59.3 |
Arm Ib (mFOLFOX6, RT, Capecitabine, Pembrolizumab) | 71.0 |
Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) | 59.4 |
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Neoadjuvant Rectal Cancer (NAR) Score
A linear regression model that controls for the stratification factors (cT-stage and cN-stage) will be used. Mean NAR scores along with standard errors and confidence intervals will be reported by treatment. The NAR score ranges from zero to 100 with lower values corresponding to better prognosis. (NCT02921256)
Timeframe: Baseline to up to 3 years
Intervention | score on a scale (Mean) |
---|
Arm Ia (mFOLFOX6, RT, Capecitabine) | 12.6 |
Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) | 13.7 |
Arm Ib (mFOLFOX6, RT, Capecitabine) | 14.1 |
Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) | 11.5 |
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Rate of Pathologic Complete Response (Nodes and Tumor) ypT0 and ypN0
Pathologic Complete Response means no remaining cancer detectable in the pathology sample. Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment. (NCT02921256)
Timeframe: Up to 3 years
Intervention | percentage of participants (Mean) |
---|
Arm Ia (mFOLFOX6, RT, Capecitabine) | 21.6 |
Arm II (mFOLFOX6, RT, Capecitabine, Veliparib) | 33.8 |
Arm Ib (mFOLFOX6, RT, Capecitabine) | 29.4 |
Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab) | 31.9 |
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TTR According to RECIST 1.1 as Assessed by Investigator
(NCT02937116)
Timeframe: Through out the study (up to 2 years)
Intervention | Days (Median) |
---|
MEL: Sintilimab 200mg Q3W (Cohort A) | 63.0 |
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) | 64.0 |
NSCLC: Sintilimab 200mg Q3W (Cohort C) | 63.0 |
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D) | 63.0 |
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E) | 62.0 |
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F) | 63.0 |
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G) | 62.0 |
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H) | 62.0 |
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Volume of Distribution of IBI308 in Plasma After Single Dose Administration
(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
Intervention | L (Geometric Mean) |
---|
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 5.02 |
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 5.14 |
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 5.95 |
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 7.2 |
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Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants
(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
Intervention | hours (Median) |
---|
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 1.05 |
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 2.07 |
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 2.27 |
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 1.93 |
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OS for Participants
(NCT02937116)
Timeframe: Through out the study
Intervention | Days (Median) |
---|
MEL: Sintilimab 200mg Q3W (Cohort A) | 518.0 |
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) | 342.0 |
NSCLC: Sintilimab 200mg Q3W (Cohort C) | 431.0 |
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D) | 566.0 |
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E) | 461.0 |
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F) | NA |
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G) | NA |
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H) | NA |
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Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t)
(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, and 6 hours, and Days 2, 3, 8, 15, and 22, and 29
Intervention | h*ug/ml (Geometric Mean) |
---|
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 4800 |
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 12300 |
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 39800 |
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 10800 |
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Clearance of IBI308 in Plasma After Single Dose Administration
(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
Intervention | ml/h (Geometric Mean) |
---|
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 8.53 |
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 11.7 |
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 13.7 |
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 12.9 |
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DOR According to RECIST 1.1 as Assessed by Investigator
(NCT02937116)
Timeframe: Through out the study (up to 2 years)
Intervention | Days (Median) |
---|
MEL: Sintilimab 200mg Q3W (Cohort A) | NA |
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) | NA |
NSCLC: Sintilimab 200mg Q3W (Cohort C) | 368.0 |
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D) | NA |
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E) | 170.5 |
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F) | 181.0 |
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G) | NA |
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H) | NA |
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Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants
(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
Intervention | ug/ml (Geometric Mean) |
---|
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 21.9 |
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 69.7 |
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 220 |
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 54.6 |
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Number of All Study Participants Who Demonstrate a Tumor Response
(NCT02937116)
Timeframe: Through out the study (up to 2 years)
Intervention | Participants (Number) |
---|
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 0 |
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 1 |
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 0 |
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 1 |
MEL: Sintilimab 200mg Q3W (Cohort A) | 1 |
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) | 13 |
NSCLC: Sintilimab 200mg Q3W (Cohort C) | 5 |
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D) | 13 |
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E) | 11 |
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F) | 17 |
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G) | 3 |
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H) | 1 |
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Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
(NCT02937116)
Timeframe: Up to 28 days in Cycle 1
Intervention | Participants (Number) |
---|
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 0 |
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 0 |
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 0 |
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 0 |
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Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator
ORR was defined as the percentage of participants in the analysis population who had achieved BOR of CR or PR according to RECIST 1.1. (NCT02937116)
Timeframe: Through out the study (up to 2 years)
Intervention | percentage of participants (Number) |
---|
MEL: Sintilimab 200mg Q3W (Cohort A) | 4.5 |
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) | 14.9 |
NSCLC: Sintilimab 200mg Q3W (Cohort C) | 13.5 |
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D) | 61.9 |
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E) | 55.0 |
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F) | 85.0 |
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G) | 42.9 |
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H) | 14.3 |
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PFS According to RECIST 1.1 as Assessed by Investigator
(NCT02937116)
Timeframe: Through out the study (up to 2 years)
Intervention | Days (Median) |
---|
MEL: Sintilimab 200mg Q3W (Cohort A) | 62.0 |
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) | 66.0 |
NSCLC: Sintilimab 200mg Q3W (Cohort C) | 84.0 |
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D) | 377.0 |
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E) | 194.0 |
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F) | 230.0 |
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G) | NA |
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H) | NA |
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The Half-life (t1/2) of IBI308 in Plasma After Single Dose Administration
(NCT02937116)
Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29
Intervention | Days (Geometric Mean) |
---|
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 17 |
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 12.7 |
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 12.5 |
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 16.1 |
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Percentage of Participants With Progression Free Survival
We will define progression of disease per RECIST 1.1 criteria (NCT02954536)
Timeframe: 6 months
Intervention | percentage of participants with PRS (Number) |
---|
Pembrolizumab, Trastuzumab,Capecitabine/Cisplatin | 70 |
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Stage 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. (NCT02981342)
Timeframe: Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)
Intervention | percentage of Participants (Number) |
---|
200mg Abemaciclib | 15.2 |
150mg Abemaciclib + 150mg LY3023414 | 12.1 |
Gemcitabine or Capecitabine | 36.4 |
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Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months
"Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD ≥6 months. CR is defined as the disappearance of all target and non-target lesions & no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.~No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1." (NCT02981342)
Timeframe: Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 6 Months)
Intervention | percentage of participants (Number) |
---|
200mg Abemaciclib | 3 |
150mg Abemaciclib + 150mg LY3023414 | 0 |
Gemcitabine or Capecitabine | 3 |
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Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1. (NCT02981342)
Timeframe: Baseline, 6 Months
Intervention | U/mL (Mean) |
---|
200mg Abemaciclib | 4281.53 |
150mg Abemaciclib + 150mg LY3023414 | 3225.29 |
Gemcitabine or Capecitabine | -501.17 |
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Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414
Mean steady state exposure was reported by trough pre-dose plasma concentrations. (NCT02981342)
Timeframe: C2D1: 0h, C3D1: 0h, C4D1: 0h
Intervention | ng/mL (Geometric Mean) |
---|
150mg Abemaciclib + 150mg LY3023414 | 27.3 |
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Stage 2: Progression Free Survival (PFS)
PFS was defined as the time from the date of randomization until first observation of objective progressive disease as defined by RECIST v1.1 or death from any cause, whichever comes first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a patient does not have a complete baseline disease assessment, then the PFS time will be censored at the randomization date, regardless of whether or not objectively determined disease progression or death has been observed for the patient; otherwise, if a patient is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date. (NCT02981342)
Timeframe: Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 6 Months)
Intervention | Months (Median) |
---|
200mg Abemaciclib | 1.68 |
150mg Abemaciclib + 150mg LY3023414 | 1.81 |
Gemcitabine or Capecitabine | 3.25 |
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Stage 2: Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
"The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:~Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).~Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)~Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).~Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden.~No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1." (NCT02981342)
Timeframe: Baseline, 6 Months
Intervention | units on a scale (Least Squares Mean) |
---|
| Global Health Status | Functional Scales: Physical Functioning | Functional Scales: Role Functioning | Functional Scales: Emotional Functioning | Functional Scales: Cognitive Functioning | Functional Scale: Social Functioning | Symptom Scales: Fatigue | Symptom Scales: Nausea and Vomiting | Symptom Scales: Pain | Symptom Scale: Dysopnea | Symptom Scale: Insomnia | Symptom Scale: Appetite Loss | Symptom Scale: Constipation | Symptom Scale: Diarrhoea | Symptom Scale: Financial difficulties |
---|
150mg Abemaciclib + 150mg LY3023414 | -4.82 | -11.65 | -18.05 | -0.63 | -8.39 | -17.09 | 14.90 | 9.42 | 2.68 | 11.19 | 1.83 | 15.32 | -6.51 | 26.28 | 2.45 |
,200mg Abemaciclib | -6.21 | -14.44 | -17.09 | -4.89 | -10.43 | -21.12 | 14.13 | 7.98 | 9.79 | 0.35 | -5.19 | 12.54 | 2.96 | 15.71 | 3.96 |
,Gemcitabine or Capecitabine | -2.40 | -5.42 | -17.10 | 2.06 | -5.18 | -2.00 | 5.64 | 11.88 | 5.43 | -4.51 | -6.71 | 9.51 | 12.93 | 20.51 | -3.30 |
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Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR
Objective response rate (ORR) is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. (NCT02981342)
Timeframe: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months)
Intervention | percentage of Participants (Number) |
---|
200mg Abemaciclib | 3 |
150mg Abemaciclib + 150mg LY3023414 | 0 |
Gemcitabine or Capecitabine | 3 |
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Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose
Mean single dose exposure was reported by plasma concentrations collected approximately 2 hours post-dose. (NCT02981342)
Timeframe: C1D1: 2h Post dose
Intervention | ng/mL (Geometric Mean) |
---|
150mg Abemaciclib + 150mg LY3023414 | 518 |
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Stage 2: Overall Survival (OS)
"OS duration is measured from the date of randomization to the date of death from any cause. for participants who is not known to have died as of the data-inclusion cutoff date, OS was censored at the last known alive date.~No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1." (NCT02981342)
Timeframe: Baseline to Death from Any Cause (Up to 10 Months)
Intervention | Months (Median) |
---|
200mg Abemaciclib | 2.71 |
150mg Abemaciclib + 150mg LY3023414 | 3.29 |
Gemcitabine or Capecitabine | NA |
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Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT03026803)
Timeframe: Up to 2 years
Intervention | percentage of participants (Number) |
---|
Oxaliplatin and Capecitabine | 0 |
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1-year Progression Free Survival (PFS) Rate
"To evaluate the 1-year progression free survival (PFS) rate per RECIST v. 1.1.~PFS is defined as the length of time during and after the treatment that a patient does not experience progression.~Progressive Disease (PD) as defined per RECIST 1.1 is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).~PFS was analyzed using a Kaplan-Meier curve." (NCT03044730)
Timeframe: Up to 1 year after starting treatment
Intervention | percentage of participants (Number) |
---|
Treatment: Pembrolizumab + Capecitabine | 20.7 |
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Objective Response Rate (ORR)
"The ORR is the percentage of patients whose cancer shrinks or disappears after treatment. Objective response rate was calculated based on the number of patients who had a Complete Response (CR) or a Partial Response (PR). CR and PR were measured according to RECIST v. 1.1 guidelines:~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters." (NCT03044730)
Timeframe: Up to 9 Cycles (1 cycle = 21 days)
Intervention | participants (Number) |
---|
| Complete Response | Partial Response |
---|
Treatment: Pembrolizumab + Capecitabine | 0 | 4 |
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Objective Response Rate (ORR)
"The ORR is the percentage of patients whose cancer shrinks or disappears after treatment. Objective response rate was calculated based on percentage of patients who had a Complete Response (CR) or a Partial Response (PR). CR and PR were measured according to RECIST v. 1.1 guidelines:~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters." (NCT03044730)
Timeframe: Up to 9 Cycles (1 cycle = 21 days)
Intervention | percentage of participants (Number) |
---|
Treatment: Pembrolizumab + Capecitabine | 14 |
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Clinical Benefit Rate (CBR)
To evaluate the clinical benefit rate (CBR) per RECIST v. 1.1. CBR is the rate of participants with complete response (CR), partial response (PR) or stable disease (SD) > 6 months. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (NCT03044730)
Timeframe: Up to 14 cycles (1 cycle= 21 days)
Intervention | percentage of participants (Number) |
---|
Treatment: Pembrolizumab + Capecitabine | 28 |
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Number of Participants That Are Hospitalized Because of Adverse Events Attributed to Disease Progression
Participants hospitalized because of adverse events measured by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 attributed to disease progression. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. (NCT03050814)
Timeframe: Up to 51.5 months
Intervention | Participants (Count of Participants) |
---|
Standard of Care (SOC) - Arm A | 4 |
Standard of Care (SOC) - Arm B + Lead in | 4 |
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Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT03050814)
Timeframe: Date treatment consent signed to date off study, approximately 33 months and 20 days for Arm A and 51 months and 7 days for Arm B.
Intervention | Participants (Count of Participants) |
---|
Standard of Care (SOC) - Arm A | 10 |
Standard of Care (SOC) - Arm B + Lead in | 16 |
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Progression Free Survival Between the Standard of Care (SOC) Arm A, and Standard of Care (SOC) Arm B + lead-in
Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. (NCT03050814)
Timeframe: Up to 1.5 years
Intervention | Months (Median) |
---|
Standard of Care (SOC) - Arm A | 8.8 |
Standard of Care (SOC) - Arm B + Lead in | 10.1 |
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Number of Participants With Clinically Significant Change in Vital Signs and Physical Examinations - Part 1
Number of participants with clinically significant change in vital signs (blood pressure [diastolic and systolic], heart rate, respiratory rate, body temperature) and physical examination. (NCT03093870)
Timeframe: Subject screening visit to 28 days post last study drug administration
Intervention | Participants (Count of Participants) |
---|
Varlitinib and Capecitabine | 0 |
Placebo and Capecitabine | 0 |
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Progression-free Survival (PFS) - Part 1
Part 1: Progression-free survival (PFS) was defined as the time from randomization (or starting treatment for the Safety Lead-in) until the date of objective disease progression or death (by any cause in the absence of disease progression) regardless of whether the subject withdrew from randomized therapy or received another antitumor therapy prior to disease progression. Subjects who did not experience disease progression or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. However, if the patient progressed or died after ≥ 2 missed visits (12 weeks ± 5 days maximum), the subject was censored at the time of the latest evaluable RECIST assessment. The PFS time was based on the scan/assessment dates rather than visit dates. (NCT03093870)
Timeframe: Time from randomization until date of objective disease progression or death (by any cause in absence of disease progression) regardless of whether subject withdrew from randomized therapy or received another antitumor therapy prior to PD, up to 2 years.
Intervention | Months (Median) |
---|
Varlitinib and Capecitabine | 2.83 |
Placebo and Capecitabine | 2.79 |
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Number of Participants With ECG Parameters of Interest - Safety Lead-In
Number of participants with ECG parameters of interest: Max. on-treatment QTcF Value: >450 to 480 msec, max. on-treatment QTcF Value: >480 to 500 msec, max. on-treatment QTcF Value: >500 msec, max. on-treatment QTcB Value: >450 to 480 msec, max. on-treatment QTcB Value: >480 to 500 msec, max. on-treatment QTcB Value: >500 msec, max. QTcF CFB Value: >30 to 60 msec, max. QTcF CFB Value: >60 msec, max. QTcB CFB Value: >30 to 60 msec, max. QTcB CFB Value: >60 msec. (NCT03093870)
Timeframe: Subject screening visit to 28 days post last study drug administration
Intervention | participants (Number) |
---|
| Maximum on-treatment QTcF Value: >450 to 480 msec | Maximum on-treatment QTcF Value: >480 to 500 msec | Maximum on-treatment QTcF Value: >500 msec | Maximum on-treatment QTcB Value: >450 to 480 msec | Maximum on-treatment QTcB Value: >480 to 500 msec | Maximum on-treatment QTcB Value: >500 msec | Maximum QTcF CFB Value: >30 to 60 msec | Maximum QTcF CFB Value: >60 msec | Maximum QTcB CFB Value: >30 to 60 msec | Maximum QTcB CFB Value: >60 msec |
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Varlitinib + Capecitabine | 8 | 0 | 0 | 10 | 2 | 0 | 8 | 1 | 6 | 1 |
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Number of Participants With Clinically Significant Laboratory Tests - Part 1
Clinical laboratory tests (hematology, clinical chemistry, urinalysis) - Number of Participants with Clinically Significant Laboratory Tests. (NCT03093870)
Timeframe: Subject screening visit to 28 days post last study drug administration
Intervention | Participants (Count of Participants) |
---|
Varlitinib and Capecitabine | 0 |
Placebo and Capecitabine | 0 |
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Overall Survival (OS) - Part 1
Part 1: Overall survival (OS) was defined as the time from the date of randomization until death due to any cause. Any subject not known to have died at the time of the data cut-off was censored based on the last recorded date on which the subject was known to be alive. (NCT03093870)
Timeframe: Time from the date of randomization until death due to any cause, up to 2 years
Intervention | Months (Median) |
---|
Varlitinib and Capecitabine | 7.8 |
Placebo and Capecitabine | 7.5 |
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Number of Participants With Clinically Significant Laboratory Tests- Safety Lead-in
Clinical laboratory tests (hematology, clinical chemistry, urinalysis) - Number of Participants with Clinically Significant Laboratory Tests. (NCT03093870)
Timeframe: Subject screening visit to 28 days post last study drug administration
Intervention | Participants (Count of Participants) |
---|
Varlitinib + Capecitabine | 0 |
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Duration of Response (DoR) - Part 1
"Part 1: Duration of response (DoR) was defined as the time from the date of first documented response until the date of documented PD or death in the absence of disease progression. The end of the response should have coincided with the date of disease progression or death from any cause used for the PFS endpoint.~For Part 1, DoR was calculated based on data from the ICR of radiological data." (NCT03093870)
Timeframe: Time from the date of first documented response until the date of documented PD or death in the absence of disease progression, up to 2 years
Intervention | Days (Median) |
---|
Varlitinib and Capecitabine | 158 |
Placebo and Capecitabine | 90 |
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Number of Participants With Clinically Significant Change in Vital Signs and Physical Examinations - Safety Lead-In
Number of participants with clinically significant change in vital signs (blood pressure [diastolic and systolic], heart rate, respiratory rate, body temperature) and physical examination. (NCT03093870)
Timeframe: Subject screening visit to 28 days post last study drug administration
Intervention | Participants (Count of Participants) |
---|
Varlitinib + Capecitabine | 0 |
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Number of Participants With ECG Parameters of Interest - Part 1
Number of participants with ECG parameters of interest: Max. on-treatment QTcF Value: <=450 msec, max. on-treatment QTcF Value: >450 to 480 msec, max. on-treatment QTcF Value: >480 to 500 msec, max. on-treatment QTcF Value: >500 msec, max. on-treatment QTcB Value: <=450 msec, max. on-treatment QTcB Value: >450 to 480 msec, max. on-treatment QTcB Value: >480 to 500 msec, max. on-treatment QTcB Value: >500 msec, max. QTcF CFB Value: <=30 msec, max. QTcF CFB Value: >30 to 60 msec, max. QTcF CFB Value: >60 msec, max. QTcB CFB Value: <=30 msec, max. QTcB CFB Value: >30 to 60 msec, max. QTcB CFB Value: >60 msec. (NCT03093870)
Timeframe: Subject screening visit to 28 days post last study drug administration
Intervention | Participants (Number) |
---|
| Maximum on-treatment QTcF Value: <=450 msec | Maximum on-treatment QTcF Value: >450 to 480 msec | Maximum on-treatment QTcF Value: >480 to 500 msec | Maximum on-treatment QTcF Value: >500 msec | Maximum on-treatment QTcB Value: <=450 msec | Maximum on-treatment QTcB Value: >450 to 480 msec | Maximum on-treatment QTcB Value: >480 to 500 msec | Maximum on-treatment QTcB Value: >500 msec | Maximum QTcF CFB Value: <=30 msec | Maximum QTcF CFB Value: >30 to 60 msec | Maximum QTcF CFB Value: >60 msec | Maximum QTcB CFB Value: <=30 msec | Maximum QTcB CFB Value: >30 to 60 msec | Maximum QTcB CFB Value: >60 msec |
---|
Placebo and Capecitabine | 57 | 6 | 0 | 0 | 40 | 22 | 1 | 0 | 57 | 4 | 1 | 54 | 7 | 1 |
,Varlitinib and Capecitabine | 53 | 10 | 0 | 1 | 42 | 21 | 0 | 1 | 56 | 7 | 0 | 55 | 8 | 0 |
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Tumor Size - Part 1
Part 1: The percentage change from baseline in tumor size at Week 12 (%ΔTSWk12) was a secondary endpoint for Part 1 and was used to present waterfall plots of the target lesion data in the Evaluable for Response (EFR) Population (NCT03093870)
Timeframe: Week 12
Intervention | Percentage change from Baseline (Mean) |
---|
Varlitinib and Capecitabine | 18.1 |
Placebo and Capecitabine | 22.6 |
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Number of Participants Obtaining a Complete Response (CR) and Partial Response (PR)
Number of participants obtaining CR and PR per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria of all evaluable patients. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions,taking as reference the baseline sum of diameters. (NCT03111732)
Timeframe: Every 9 Weeks, until disease progression or patient is taken off the trial, whichever comes first, approximately 36 weeks.
Intervention | Participants (Count of Participants) |
---|
| Complete Response | Partial Response |
---|
1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine | 0 | 3 |
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Overall Survival
Median amount of time subject survives after therapy. (NCT03111732)
Timeframe: Death, approximately 48 weeks after stopping therapy.
Intervention | Weeks (Median) |
---|
1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine | 43 |
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Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT03111732)
Timeframe: Date treatment consent signed to date off study, approximately 38 months and 25 days.
Intervention | Participants (Count of Participants) |
---|
1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine | 11 |
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Progression Free Survival (PFS)
Median amount of time subject survives without disease progression for 5 months after treatment. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions. (NCT03111732)
Timeframe: 5 Months
Intervention | Months (Median) |
---|
1/Arm 1 - Pembrolizumab Plus Oxaliplatin Plus Capecitabine | 4.54 |
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Investigator Assessed Progression Free Survival
Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by investigator assessment according to RECIST v1.1 or death due to any cause, whichever occurred earlier. (NCT03262935)
Timeframe: baseline until primary analysis data cut-off date of 31March2021
Intervention | months (Median) |
---|
(Vic-)Trastuzumab Duocarmazine | 6.9 |
Physician's Choice | 4.6 |
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Objective Response Rate
Objective Response Rate is defined as the proportion of patients with a centrally assessed best overall response of complete response or partial response according to RECIST v1.1. (NCT03262935)
Timeframe: baseline until primary analysis data cut-off date of 31March2021
Intervention | percentage of patients (Number) |
---|
(Vic-)Trastuzumab Duocarmazine | 27.8 |
Physician's Choice | 29.5 |
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Overall Survival
Overall survival is defined as the time from date of randomization to death due to any cause. (NCT03262935)
Timeframe: baseline until final Overall Survival analysis data cut-off date of 30June2022
Intervention | months (Median) |
---|
(Vic-)Trastuzumab Duocarmazine | 21.0 |
Physician's Choice | 19.5 |
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Progression Free Survival
Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by central assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred earlier. (NCT03262935)
Timeframe: baseline until primary analysis data cut-off date of 31March2021
Intervention | months (Median) |
---|
(Vic-)Trastuzumab Duocarmazine | 7.0 |
Physician's Choice | 4.9 |
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Progression Free Survival (PFS)
To determine the progression free survival (NCT03376659)
Timeframe: 24 months
Intervention | months (Median) |
---|
Phase I - Safety- Overall | 4.7 |
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Progression Free Survival Rate (PFS) Pancreatic Cancer
To determine the 4 month progression free survival rate (PFS4mos) of durvalumab plus CV301 in combination with maintenance capecitabine in patients with metastatic pancreatic cancer, whose disease is stable on, or responding to 1st line therapy for metastatic disease (NCT03376659)
Timeframe: 24 months
Intervention | months (Median) |
---|
Phase I - Safety- Pancreatic Cancer | 4.5 |
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Progression Free Survival Rate (PFS) Colorectal Cancer
To determine the progression free survival rate (PFS) of durvalumab plus CV301 in combination with maintenance capecitabine and bevacizumab in patients with metastatic colorectal cancer, whose disease is stable on, or responding to 1st line therapy for metastatic disease (NCT03376659)
Timeframe: 24 months
Intervention | months (Median) |
---|
Phase I - Safety- Colorectal Cancer | 7.4 |
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Length of Subject Survival After Starting Study Treatment
Number of participants alive. A Gehan-like trial design with an interim futility analysis will be used. (NCT03501979)
Timeframe: Through study completions, an average of 2 years
Intervention | Participants (Count of Participants) |
---|
Tucatinib + Trastuzumab + Capecitabine | 6 |
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Number of Participants Who Complete the Recommended Therapy From Each Arm
The number of patients who complete the recommended therapy will be counted for each arm. (NCT03515941)
Timeframe: From date of assigned therapy up to 17 weeks
Intervention | Participants (Count of Participants) |
---|
Arm 1: Adjuvant Chemotherapy | 3 |
Arm 2: Adjuvant Chemoradiation | 2 |
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR. (NCT03675737)
Timeframe: Up to 49.5 months
Intervention | Percentage of Participants (Number) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 52.1 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 42.6 |
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR. (NCT03675737)
Timeframe: Up to 49.5 months
Intervention | Percentage of Participants (Number) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 60.6 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 43.0 |
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Overall Survival (OS) in All Participants
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data. (NCT03675737)
Timeframe: Up to 45.9 months
Intervention | Months (Median) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 12.9 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 11.5 |
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Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data. (NCT03675737)
Timeframe: Up to 45.9 months
Intervention | Months (Median) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 15.7 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 11.8 |
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Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data. (NCT03675737)
Timeframe: Up to 49.5 months
Intervention | Months (Median) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 6.9 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 5.6 |
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Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data. (NCT03675737)
Timeframe: Up to 49.5 months
Intervention | Months (Median) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 6.9 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 5.6 |
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Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data. (NCT03675737)
Timeframe: Up to 49.5 months
Intervention | Months (Median) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 8.1 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 5.6 |
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Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data. (NCT03675737)
Timeframe: Up to 49.5 months
Intervention | Months (Median) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 8.0 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 5.7 |
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Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data. (NCT03675737)
Timeframe: Up to 49.5 months
Intervention | Months (Median) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 8.3 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 5.6 |
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Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data. (NCT03675737)
Timeframe: Up to 45.9 months
Intervention | Months (Median) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 13.0 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 11.4 |
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Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented. (NCT03675737)
Timeframe: Up to 33.7 months
Intervention | Participants (Count of Participants) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 257 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 204 |
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Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any untoward medical occurrence, in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE is presented. (NCT03675737)
Timeframe: Up to 36.7 months
Intervention | Participants (Count of Participants) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 776 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 771 |
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR. (NCT03675737)
Timeframe: Up to 49.5 months
Intervention | Percentage of Participants (Number) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 51.3 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 42.0 |
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Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data. (NCT03675737)
Timeframe: Up to 49.5 months
Intervention | Months (Median) |
---|
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 10.9 |
Placebo + Chemotherapy (FP or CAPOX Regimen) | 5.8 |
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Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment. (NCT03734029)
Timeframe: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
Intervention | Participants (Count of Participants) |
---|
| BICR: Complete response | BICR: Partial response | BICR: Stable disease | BICR: Progressive disease | BICR: Not evaluable | Investigator: Complete response | Investigator: Partial response | Investigator: Stable disease | Investigator: Progressive disease | Investigator: Not evaluable | BICR: Confirmed Objective response rate | Investigator: Confirmed Objective response rate |
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Physician's Choice | 1 | 26 | 81 | 34 | 21 | 0 | 30 | 80 | 34 | 19 | 27 | 30 |
,Trastuzumab Deruxtecan (T-DXd) | 12 | 164 | 115 | 26 | 14 | 5 | 163 | 124 | 28 | 11 | 175 | 168 |
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Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method. (NCT03734029)
Timeframe: From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years
Intervention | months (Median) |
---|
| BICR: DoR | Investigator: DoR |
---|
Physician's Choice | 6.8 | 5.6 |
,Trastuzumab Deruxtecan (T-DXd) | 10.7 | 8.3 |
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Duration of Response in Participants With HER2-low Breast Cancer (All Patients)
Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method. (NCT03734029)
Timeframe: From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years
Intervention | months (Median) |
---|
| BICR: DoR | Investigator: DoR |
---|
Physician's Choice | 6.8 | 5.6 |
,Trastuzumab Deruxtecan (T-DXd) | 10.7 | 8.3 |
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Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients)
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment. (NCT03734029)
Timeframe: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
Intervention | Participants (Count of Participants) |
---|
| BICR: Complete response | BICR: Partial response | BICR: Stable disease | BICR: Progressive disease | BICR: Not evaluable | Investigator: Complete response | Investigator: Partial response | Investigator: Stable disease | Investigator: Progressive disease | Investigator: Not evaluable | BICR: Confirmed Objective response rate | Investigator: Confirmed Objective response rate |
---|
Physician's Choice | 2 | 28 | 91 | 41 | 22 | 0 | 31 | 93 | 40 | 20 | 30 | 31 |
,Trastuzumab Deruxtecan (T-DXd) | 13 | 183 | 129 | 31 | 17 | 6 | 187 | 135 | 32 | 13 | 195 | 193 |
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Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. (NCT03734029)
Timeframe: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Intervention | months (Median) |
---|
Trastuzumab Deruxtecan (T-DXd) | 9.6 |
Physician's Choice | 4.2 |
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Overall Survival (OS) in All Patients
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive. (NCT03734029)
Timeframe: From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Intervention | months (Median) |
---|
Trastuzumab Deruxtecan (T-DXd) | 23.4 |
Physician's Choice | 16.8 |
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Number of Overall Survival Events (Deaths)
(NCT03734029)
Timeframe: From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Intervention | events (deaths) (Number) |
---|
Trastuzumab Deruxtecan (T-DXd) | 149 |
Physician's Choice | 90 |
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All-Cause Mortality
All-cause mortality is defined as all anticipated and unanticipated deaths due to any cause, with the number and frequency of such events by arm or comparison group of the clinical study. (NCT03734029)
Timeframe: From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Intervention | Participants (Count of Participants) |
---|
Trastuzumab Deruxtecan (T-DXd) | 148 |
Physician's Choice | 88 |
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Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive. (NCT03734029)
Timeframe: From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Intervention | months (Median) |
---|
Trastuzumab Deruxtecan (T-DXd) | 23.9 |
Physician's Choice | 17.5 |
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Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. (NCT03734029)
Timeframe: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Intervention | months (Median) |
---|
Trastuzumab Deruxtecan (T-DXd) | 9.9 |
Physician's Choice | 5.1 |
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Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. (NCT03734029)
Timeframe: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Intervention | months (Median) |
---|
Trastuzumab Deruxtecan (T-DXd) | 10.1 |
Physician's Choice | 5.4 |
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Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients)
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. (NCT03734029)
Timeframe: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Intervention | months (Median) |
---|
Trastuzumab Deruxtecan (T-DXd) | 8.8 |
Physician's Choice | 4.2 |
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Number of Participants With Abnormalities [Grade Greater Than or Equals to (>=) 3] in Laboratory Test Values
The laboratory measurements included hematology and biochemistry values were graded with National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 toxicity grades (where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = death). Number of participants with abnormalities Grade >= 3 in laboratory test values were reported. (NCT03770689)
Timeframe: Time from first study intervention up to long term safety follow-up period (Up to Month 35)
Intervention | Participants (Count of Participants) |
---|
Peposertib 50 mg + RT + Capecitabine: | 1 |
Peposertib 100 mg + RT + Capecitabine: | 6 |
Peposertib 150 mg + RT + Capecitabine: | 6 |
Peposertib 250 mg + RT + Capecitabine: | 6 |
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Number of Participants Who Experienced Dose Limiting Toxicity (DLT) Confirmed by Safety Monitoring Committee (SMC)
DLT is defined as any of following treatment emergent adverse events (TEAEs) considered possibly related to study treatment by Investigator and/or Sponsor up to completion of assigned chemoradiotherapy treatment. DLT were based on SMC: Adverse drug reaction that, in the opinion of SMC, is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk; Any occurrence of drug-induced liver injury meeting the Hy's law criteria; Any Grade 3 toxicity excluding diarrhea, neutropenia lasting for ≤ 5 days, nausea & vomiting, Grade 3 thrombocytopenia without bleeding; Grade ≥ 4 AEs at least possibly related to study drug, irrespective of duration, excluding: Isolated Grade 4 lymphocytopenia without clinical symptoms; Neutropenia lasting for ≤ 5 days and not associated with fever; Any toxicity related to study drug that causes participant to receive > 80% of planned peposertib, capecitabine or RT dose. (NCT03770689)
Timeframe: Time from first study intervention up to 19 weeks (including 5.5 weeks of treatment and 13.5 weeks of short term safety follow-up period)
Intervention | Participants (Count of Participants) |
---|
Peposertib 50 mg + RT + Capecitabine: | 0 |
Peposertib 100 mg + RT + Capecitabine: | 1 |
Peposertib 150 mg + RT + Capecitabine: | 1 |
Peposertib 250 mg + RT + Capecitabine: | 3 |
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Apparent Volume of Distribution (Vz/f) of Peposertib
The apparent volume of distribution during the terminal phase following extravascular administration, based on the fraction of dose absorbed. Vz/f = Dose/(AUC0-inf multiplied by Lambda z) following single dose. Vz/f= Dose/(AUCtau*Lambda z) following multiple dose. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). (NCT03770689)
Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9
Intervention | Liter (Geometric Mean) |
---|
| Fraction Day 1 | Fraction Day 9 |
---|
Peposertib 100 mg + RT + Capecitabine: | 256 | 261 |
,Peposertib 150 mg + RT + Capecitabine: | 274 | 217 |
,Peposertib 250 mg + RT + Capecitabine: | 245 | 234 |
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Neoadjuvant Rectal (NAR) Score
"The NAR formula includes the clinical tumor (cT) stage, pathologic tumor (pT), and node (pN) stage according to the tumor, node, metastasis classification system for colorectal cancers. The NAR formula is as follows:~[5pN- 3 (cT- pT) + 12]2 / 9.61~NAR score ranges from 0 to 100, whereas a score close to 100 is indicative of a poorer prognosis." (NCT03770689)
Timeframe: At Week 15
Intervention | score on a scale (Mean) |
---|
Peposertib 100 mg + RT + Capecitabine: | 9.4 |
Peposertib 150 mg + RT + Capecitabine: | 13.8 |
Peposertib 250 mg + RT + Capecitabine: | 21.2 |
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Apparent Volume of Distribution (Vz/f) of Peposertib
The apparent volume of distribution during the terminal phase following extravascular administration, based on the fraction of dose absorbed. Vz/f = Dose/(AUC0-inf multiplied by Lambda z) following single dose. Vz/f= Dose/(AUCtau*Lambda z) following multiple dose. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). (NCT03770689)
Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9
Intervention | Liter (Geometric Mean) |
---|
| Fraction Day 9 |
---|
Peposertib 50 mg + RT + Capecitabine: | NA |
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Disease-free Survival
Disease-free Survival time, defined as the time from first treatment day to the date of the first documentation of objective progressive disease or death due to any cause, whichever occurs first. Median disease-free survival time was estimated according to Kaplan-Meier method. (NCT03770689)
Timeframe: Time from first study intervention up to approximately 35 months
Intervention | Months (Median) |
---|
Overall Participants | 21.2 |
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Area Under the Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) (AUC0-t) of Peposertib
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. (NCT03770689)
Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9
Intervention | hour*nanogram per milliliter (h*ng/mL) (Geometric Mean) |
---|
| Fraction Day 1 | Fraction Day 9 |
---|
Peposertib 100 mg + RT + Capecitabine: | 2950 | 3450 |
,Peposertib 150 mg + RT + Capecitabine: | 4000 | 5540 |
,Peposertib 250 mg + RT + Capecitabine: | 7300 | 9450 |
,Peposertib 50 mg + RT + Capecitabine: | NA | NA |
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Maximum Observed Plasma Concentration (Cmax) of Peposertib
Cmax was obtained directly from the concentration versus time curve. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). (NCT03770689)
Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Fraction Day 1 and Fraction Day 9
Intervention | nanogram per milliliter (ng/mL) (Geometric Mean) |
---|
| Fraction Day 1 | Fraction Day 9 |
---|
Peposertib 100 mg + RT + Capecitabine: | 593 | 653 |
,Peposertib 150 mg + RT + Capecitabine: | 728 | 792 |
,Peposertib 250 mg + RT + Capecitabine: | 1350 | 1760 |
,Peposertib 50 mg + RT + Capecitabine: | NA | NA |
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Time to Reach Maximum Plasma Concentration (Tmax) of Peposertib
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve. (NCT03770689)
Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9
Intervention | hours (Median) |
---|
| Fraction Day 1 | Fraction Day 9 |
---|
Peposertib 100 mg + RT + Capecitabine: | 1.00 | 2.05 |
,Peposertib 150 mg + RT + Capecitabine: | 2.33 | 2.09 |
,Peposertib 250 mg + RT + Capecitabine: | 2.43 | 2.01 |
,Peposertib 50 mg + RT + Capecitabine: | NA | NA |
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Apparent Terminal Half-life (t1/2) of Peposertib
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). (NCT03770689)
Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9
Intervention | hours (Geometric Mean) |
---|
| Fraction Day 1 | Fraction Day 9 |
---|
Peposertib 100 mg + RT + Capecitabine: | 5.60 | 6.28 |
,Peposertib 150 mg + RT + Capecitabine: | 5.51 | 5.04 |
,Peposertib 250 mg + RT + Capecitabine: | 5.14 | 6.12 |
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Apparent Terminal Half-life (t1/2) of Peposertib
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z. One participant was assigned to receive peposertib 100 mg; however, this participant took peposertib 50 mg for FD 1 through FD 10 and then took peposertib 100 mg for remainder of study participation. PK results for this participant was summarized by actual dose received (50 mg) whereas non-PK results are summarized by planned dose (100 mg). (NCT03770689)
Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1 and Fraction Day 9
Intervention | hours (Geometric Mean) |
---|
| Fraction Day 9 |
---|
Peposertib 50 mg + RT + Capecitabine: | NA |
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Total Body Clearance Following Oral Administration (CL/f) of Peposertib
The apparent total body clearance of study intervention following extravascular administration on FD1, taking into account the fraction of dose absorbed. CL/f = Dose oral (p.o.)/AUC0-inf. The predicted AUC0-inf should be used. (NCT03770689)
Timeframe: Pre-dose, 1, 2, 3, 4 and 6 hour post-dose on Fraction Day 1
Intervention | Liter per hour (Geometric Mean) |
---|
Peposertib 100 mg + RT + Capecitabine: | 31.7 |
Peposertib 150 mg + RT + Capecitabine: | 34.5 |
Peposertib 250 mg + RT + Capecitabine: | 33.0 |
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Time From Surgery to Local Recurrence
Time from surgery to local recurrence defined as time from day of surgery to the date of the first documentation of progression of disease, flagged as local recurrence. Median time from surgery to local recurrence was estimated according to Kaplan-Meier method. (NCT03770689)
Timeframe: Time from surgery up to 15 months
Intervention | months (Median) |
---|
All Participants | NA |
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Percentage of Participants With Pathological Complete Response (pCR)
pCR is defined as the absence of viable tumor cells in the primary tumor and lymph nodes. Participants are considered to have a pCR if they undergo surgery and no residual cancer is found on histological examination of the removed specimen. (NCT03770689)
Timeframe: At Week 15
Intervention | percentage of participants (Number) |
---|
Peposertib 50 mg + RT + Capecitabine: | 0.0 |
Peposertib 100 mg + RT + Capecitabine: | 0.0 |
Peposertib 150 mg + RT + Capecitabine: | 0.0 |
Peposertib 250 mg + RT + Capecitabine: | 0.0 |
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Percentage of Participants With Composite Pathological Complete Response (pCR)/ Clinical Complete Response (cCR)
pCR: It is defined as absence of viable tumor cells in the primary tumor and lymph nodes. Participants considered to have a pCR if they undergo surgery and no residual cancer is found on histological examination of removed specimen. cCR: Participants are considered to have a cCR if: 1) Absence of any residual tumor in primary site and draining lymph nodes on imaging with magnetic resonance imaging; 2) No visible lesion at endoscopy except a flat scar, telangiectasia, and/or whitening of mucosa; 3) Absence of any palpable tumor or irregularity on digital rectal examination (DRE) and endoscopic ultrasonography (EUS); 4) If a biopsy is taken, it must be negative. Participants are considered as responders to composite endpoint pCR/cCR if participant had surgery and had pCR; participant did not undergo surgery but had cCR. Number of participants with composite pathological complete response (pCR)/ clinical complete response (cCR) were reported. (NCT03770689)
Timeframe: At Week 15
Intervention | percentage of participants (Number) |
---|
Peposertib 50 mg + RT + Capecitabine: | 0.0 |
Peposertib 100 mg + RT + Capecitabine: | 16.7 |
Peposertib 150 mg + RT + Capecitabine: | 0.0 |
Peposertib 250 mg + RT + Capecitabine: | 0.0 |
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Percentage of Participants With Clinical Complete Response (cCR)
cCR: It is defined as participants considered to have a cCR if: 1) Absence of any residual tumor in the primary site and draining lymph nodes on imaging with magnetic resonance; 2) No visible lesion at endoscopy except a flat scar, telangiectasia, and/or whitening of the mucosa; 3) Absence of any palpable tumor or irregularity on digital rectal examination (DRE) and endoscopic ultrasonography (EUS); 4) If a biopsy is taken, it must be negative. (NCT03770689)
Timeframe: At Week 15
Intervention | percentage of participants (Number) |
---|
Peposertib 50 mg + RT + Capecitabine: | 0.0 |
Peposertib 100 mg + RT + Capecitabine: | 16.7 |
Peposertib 150 mg + RT + Capecitabine: | 16.7 |
Peposertib 250 mg + RT + Capecitabine: | 16.7 |
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Number of Participants With Markedly Abnormal Vital Sign Measurements
Vital sign assessments included assessments of heart rate, diastolic blood pressure, systolic blood pressure, respiratory rate and temperature. Number of participants with markedly abnormal vital sign measurements were reported. (NCT03770689)
Timeframe: Time from first study intervention up to long term safety follow-up period (Up to Month 35)
Intervention | Participants (Count of Participants) |
---|
Peposertib 50 mg + RT + Capecitabine: | 0 |
Peposertib 100 mg + RT + Capecitabine: | 0 |
Peposertib 150 mg + RT + Capecitabine: | 0 |
Peposertib 250 mg + RT + Capecitabine: | 0 |
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Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings
Electrocardiograms (ECG) was obtained after the participant has been in a semi-supine position for at least 5 min. ECG parameters included heart rate, PQ/PR duration, QRS and QT duration, QT Interval. Clinical significance was determined by the investigator. Number of participants with clinically significant abnormalities in 12-lead ECG were reported. (NCT03770689)
Timeframe: Time from first study intervention up to long term safety follow-up period (Up to Month 35)
Intervention | Participants (Count of Participants) |
---|
Peposertib 50 mg + RT + Capecitabine: | 0 |
Peposertib 100 mg + RT + Capecitabine: | 0 |
Peposertib 150 mg + RT + Capecitabine: | 0 |
Peposertib 250 mg + RT + Capecitabine: | 0 |
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Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death due to any cause (NCT03783442)
Timeframe: Up to approximately 3 years and 2 months (as of primary analysis data cut-off date of 28FEB2022)
Intervention | Months (Median) |
---|
Tislelizumab + Chemotherapy | 17.2 |
Placebo + Chemotherapy | 10.6 |
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Overall Survival (OS)
Estimated using the product-limit method of Kaplan and Meier. Failure defined as death from any cause. (NCT03853707)
Timeframe: Up to 36 months
Intervention | Months (Median) |
---|
Arm A (Ipatasertib, Carboplatin, Paclitaxel) | 11.2 |
Arm B (Ipatasertib and Carboplatin) | 17.0 |
Arm C (Ipatasertib, Capecitabine, Atezolizumab) | NA |
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Overall Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT03853707)
Timeframe: Up to 36 months
Intervention | Participants (Count of Participants) |
---|
Arm A (Ipatasertib, Carboplatin, Paclitaxel) | 7 |
Arm B (Ipatasertib and Carboplatin) | 2 |
Arm C (Ipatasertib, Capecitabine, Atezolizumab) | 3 |
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Progression-free Survival (PFS)
Estimated using the product-limit method of Kaplan and Meier. Failure defined as disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT03853707)
Timeframe: Up to 36 months
Intervention | Months (Median) |
---|
Arm A (Ipatasertib, Carboplatin, Paclitaxel) | 4.8 |
Arm B (Ipatasertib and Carboplatin) | 3.9 |
Arm C (Ipatasertib, Capecitabine, Atezolizumab) | 8.2 |
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Clinical Benefit Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR; Stable disease (SD): Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD; Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). Clinical Benefit Rate (CBR) = CR + PR + SD at 6 months. (NCT03853707)
Timeframe: Up to 6 months
Intervention | percentage of participants (Number) |
---|
Arm A (Ipatasertib, Carboplatin, Paclitaxel) | 20.0 |
Arm B (Ipatasertib and Carboplatin) | 41.7 |
Arm C (Ipatasertib, Capecitabine, Atezolizumab) | 50.0 |
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Safety, as Measured by the Number of Subjects With at Least One AE
(NCT03930771)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
All Patients | 1 |
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Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients
Serum prolactin, IGF-1, ACTH, FSH, LH and TSH levels are used to assess changes in pituitary hormone function. These tests will only be repeated if found to be abnormal at baseline. (NCT03930771)
Timeframe: At baseline and every 8 weeks, up to 6 months
Intervention | ng/mL (Number) |
---|
| Baseline | Cycle 3 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | End of Treatment | Follow-Up Week 6 |
---|
All Patients | 134.7 | 86.9 | 69.4 | 69.8 | 80.1 | 77.0 |
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Tolerability of the TMZ and Capecitabine Combination, as Measured by Number of Participants With a Dose-limiting Toxicity
(NCT03930771)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
All Patients | 1 |
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Number of Subjects With Radiographic Response, as Defined by the RECIST Criteria.
"Evaluation of Target lesions:~Complete Response (CR):~Disappearance of all target lesions.~Partial Response (PR):~At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease (PD):~At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum onstudy (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).~Stable Disease (SD):~Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study." (NCT03930771)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
All Patients | 0 |
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Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to the corresponding treatment arm [intent-to-treat (ITT) population], based on investigator-assessed tumor responses.CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking in reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Confirmations of CR and PR are not required. (NCT04031885)
Timeframe: Randomization to Measured Progressive Disease (Up to 12 Months)
Intervention | percentage of participants (Number) |
---|
Abemaciclib + Fulvestrant | 0 |
Standard Chemotherapy | 0 |
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Overall Survival (OS)
OS is the median amount of time a participant survives after treatment. (NCT04034251)
Timeframe: From first treatment until death, an average of 1.5 years
Intervention | Months (Median) |
---|
Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | 10.6 |
Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | 14.7 |
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Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT04034251)
Timeframe: Date treatment consent signed to date off study, 18 months and 8 days; and 25 months and 10 days for the first and second group, respectively.
Intervention | Participants (Count of Participants) |
---|
Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | 4 |
Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | 7 |
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Number of Participants With Intra-peritoneal Progression Free Survival (iPFS)
iPFS was determined based on identification of only intraperitoneal sites such as new, malignant ascites, peritoneal nodules, or ovarian metastases. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined as an increase in peritoneal cancer index (PCI) score of greater than 4 points from baseline PCI. New ascites requiring repeat (more than 1) therapeutic paracentesis, malignant bowel obstruction, new intraperitoneal nodules or masses concerning for peritoneal metastasis, and decline in performance status not attributable to other medical causes. (NCT04034251)
Timeframe: At extra-peritoneal progression, an average of 1 year
Intervention | Participants (Count of Participants) |
---|
Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | 1 |
Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | 0 |
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Number of Participants With Distant Extra-peritoneal Disease-free Survival
dDFS was determined based on identification of only distant sites of disease progression, such as lungs or intra-parenchymal liver. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined as an increase in peritoneal cancer index (PCI) score of greater than 4 points from baseline PCI. New ascites requiring repeat (more than 1) therapeutic paracentesis, malignant bowel obstruction, new intraperitoneal nodules or masses concerning for peritoneal metastasis, and decline in performance status not attributable to other medical causes. (NCT04034251)
Timeframe: From start of treatment to until time of extra-peritoneal progression, an average of 1 year
Intervention | Participants (Count of Participants) |
---|
Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | 1 |
Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | 0 |
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Intra-peritoneal Progression Free Survival (iPFS) Reported With an 95% Confidence Interval
Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined as an increase in peritoneal cancer index (PCI) score of greater than 4 points from baseline PCI. New ascites requiring repeat (more than 1) therapeutic paracentesis, malignant bowel obstruction, new intraperitoneal nodules or masses concerning for peritoneal metastasis, and decline in performance status not attributable to other medical causes. (NCT04034251)
Timeframe: From the first treatment to progression of disease, up to 2 years and 1 month
Intervention | Months (Median) |
---|
Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | 4.2 |
Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | 13.3 |
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Intra-peritoneal Progression Free Survival (iPFS) Reported With an 80% Confidence Interval
iPFS is the median amount of time a participant survives without intra-peritoneal disease progression reported with an 80% confidence interval. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined as an increase in peritoneal cancer index (PCI) score of greater than 4 points from baseline PCI. New ascites requiring repeat (more than 1) therapeutic paracentesis, malignant bowel obstruction, new intraperitoneal nodules or masses concerning for peritoneal metastasis, and decline in performance status not attributable to other medical causes. (NCT04034251)
Timeframe: From the first treatment to progression of disease, up to 2 years and 1 month
Intervention | Months (Median) |
---|
Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | 4.2 |
Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | 13.3 |
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Incidence and Severity of Diarrhea
Incidence and severity of treatment emergent (TEAE) diarrhea will be summarized according to the NCI-CTCAE version 4.0 in the first cycle of neratinib treatment, which is from the time of the first colonoscopy to the second colonoscopy, or 28 days for subjects with only one colonoscopy. Incidence is defined as the number of patients experiencing diarrhea divided by the number of patients at risk. (NCT04366713)
Timeframe: From baseline to second colonoscopy, which is 88 days after start of neratinib treatment.
Intervention | percentage of participants (Number) |
---|
| TEAE Diarrhea | Serious Diarrhea |
---|
Safety | 80 | 0 |
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Changes in Colon Pathology
The primary endpoint is to describe the changes in colon pathology between the baseline colonoscopy and the second colonoscopy. (NCT04366713)
Timeframe: From baseline to second colonoscopy, which is 88 days after start of neratinib treatment.
Intervention | participants (Number) |
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| No Significant Findings | Mild Changes |
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Neratinib Patients With 2 Colonoscopies | 2 | 2 |
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Proportion of Participants With Dose Limiting Toxicities
Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts. (NCT05091528)
Timeframe: 21 days
Intervention | Participants (Count of Participants) |
---|
SBT6050 + T-DXd (6.4 mg/kg) | 0 |
SBT6050 + Tucatinib + Trastuzumab | 0 |
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Number of Participants With an Objective Response Rate
Complete response and partial response as assessed by RECIST Version 1.1 Criteria. This outcome measure applies only to participants in the dose escalation cohorts. (NCT05091528)
Timeframe: 18 weeks
Intervention | Participants (Count of Participants) |
---|
SBT6050 + T-DXd (6.4 mg/kg) | 1 |
SBT6050 + Tucatinib + Trastuzumab | 0 |
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Number of Participants With Laboratory Abnormalities
Clinically significant treatment-emergent laboratory abnormalities as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts. (NCT05091528)
Timeframe: 18 weeks
Intervention | Participants (Count of Participants) |
---|
SBT6050 + T-DXd (6.4 mg/kg) | 0 |
SBT6050 + Tucatinib + Trastuzumab | 0 |
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Number of Participants With Treatment-emergent Adverse Events
Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts. (NCT05091528)
Timeframe: 18 weeks
Intervention | Participants (Count of Participants) |
---|
SBT6050 + T-DXd (6.4 mg/kg) | 1 |
SBT6050 + Tucatinib + Trastuzumab | 1 |
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