A Phase 2 interventional study of CT-011 and FOLFOX in Metastatic Colorectal Cancer, sponsored by Medivation, Inc.. Completed at 31 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-08.
Sponsored by Medivation, Inc. · Phase 2, Interventional, and Treatment
This clinical trial will be performed in previously untreated patients with metastatic colorectal cancer. The study will evaluate the safety, tolerability and efficacy of the study drug, CT-011, in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone.
The proposed clinical trial will be a multi-center, randomized, open label, active control study in previously untreated patients with metastatic colorectal cancer aimed to evaluate the safety, tolerability and efficacy of the monoclonal antibody, CT-011, administered at 3mg/kg in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone. Approximately 168 patients are planned to be enrolled to this study.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 171 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Medivation, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Exclusion Criteria:
CT-011 (3 mg/kg) administered intravenously every 4 weeks for 4 weeks and every 12 weeks thereafter until disease progression or maximum tolerance. FOLFOX (FOLFOX4 or mFOLFOX6) administered 7 days after the first administration of CT-011 and repeated every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation.
Drug: CT-011 · Drug: FOLFOX
FOLFOX (FOLFOX-4 or mFOLFOX6) administered every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation.
Drug: FOLFOX
FOLFOX-4: each cycle consists of the following: oxaliplatin 85 mg/m2 on Day 1, leucovorin 200 mg/m2/day on Day 1 and Day 2 followed by 5-FU 400 mg/m2 bolus and a 22 hour infusion of 5-FU 600 mg/m2 for two consecutive days. mFOLFOX-6: each cycle consists of the following: oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 on Day 1, followed by 5-FU 400 mg/m2 bolus, followed by 5-FU 1200 mg/m2/day for two consecutive days (total 2,400 mg/m2 over 46-48 hours).
The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone.
Time frame: 32 months
Composite of safety, tolerability, pharmacokinetics and immunogenicity of CT-011.
Time frame: 32 months
Anti tumor activity of the antibody.
Time frame: 32 months
Objective response rate by RECIST.
Time frame: 32 months
Progression-free survival rates.
Time frame: 32 months
Response duration.
Time frame: 32 months
Overall survival.
Time frame: 32 months
Tumor and immunological markers.
Time frame: 32 months
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Medivation, Inc.