Colorectal Cancer Clinical Trial
Official title:
A Phase 1b/2 Study of AMG 655 in Combination With Modified FOLFOX6 and Bevacizumab for the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed
to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab
compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated
metastatic colorectal cancer (CRC).
The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be
measured by progression-free survival, objective response rate, time to response, duration
of response, and overall survival. This study is also designed to evaluate the safety and
tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate
anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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