drugset / Trial / NCT00890305
Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2009-05
- Primary completion
- 2012-05
- Completion
- 2013-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leucovorin | Small molecule | 200 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Pidilizumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 600 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 1200 mg/m2 | — |