Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
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.