drugset / Trial / NCT02581215
Phase II Randomized Trial of mFOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer
Phase 2
Completed
84 enrolled
Walid Shaib, MD
Eli Lilly and Company · collabHoosier Cancer Research Network · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo (Arm B) in 94 subjects with advanced pancreatic cancer, not amenable to curative treatment. Both arms will continue treatment until disease progression or unacceptable toxicity.
Timeline
- Start
- 2016-09-11
- Primary completion
- 2021-08-05
- Completion
- 2022-01-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ramucirumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Background | Irinotecan | Small molecule | 165 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | — |