Metastatic Colorectal Carcinoma Clinical Trial
Official title:
An Open-Label, Multi-Center, Randomized Phase 1b/2 Study Of PF-05212384 Plus 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal
carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus
FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of
PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI.
The study population will consist of patients with mCRC previously treated with an
oxaliplatin-based regimen in the first line setting or who have progressed within 6 months
of the end of an adjuvant oxaliplatin-based regimen.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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