Study Complete
Sponsor ID
20060579
Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI alone in KRAS-mutant Metastatic Colorectal Carcinoma
Study Details
This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI
Protocol Summary
Primary Outcome Measures
Progression Free Survival
Timeframe: Length of Study
Secondary Outcome Measures
Overall Survival, Objective Response, Duration of Response, Time to Response
Timeframe: Length of Study
Incidence of adverse events
Timeframe: Length of Study
Significant laboratory abnormalities
Timeframe: Length of Study
Incidence of antibody formation
Timeframe: Length of Study
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Amarillo, TX, United States, 79106
Status
Completed
Location
Research Site
Arkhangelsk, Russian Federation, 163045
Status
Completed
Location
Research Site
Bangalore, India, 560 029
Status
Completed
Location
Research Site
Beverly Hills, CA, United States, 90211
Status
Completed
Location
Research Site
Columbus, OH, United States, 43235
Status
Completed
Location
Research Site
Joliet, IL, United States, 60435
Status
Completed
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