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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
202
Inactive dummy AMG 655 (to maintain blind)
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)\] administered by intravenous infusion once every 14 days (+3 days)
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
Research Site
Hot Springs, Arkansas, United States
Research Site
Downey, California, United States
Research Site
La Jolla, California, United States
Research Site
Loma Linda, California, United States
Research Site
Orange, California, United States
Research Site
Progression-free survival
Time frame: Length of study
Objective response rate
Time frame: Length of study
Duration of response
Time frame: Length of study
Time-to-response
Time frame: Length of study
Overall survival
Time frame: Length of study
AMG 655 pharmacokinetic parameters
Time frame: Length of study
The incidence of anti-AMG 655 antibody formation
Time frame: Length of study
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Rancho Mirage, California, United States
Research Site
San Diego, California, United States
Research Site
Denver, Colorado, United States
Research Site
Newark, Delaware, United States
Research Site
Washington D.C., District of Columbia, United States
...and 51 more locations