Study Complete
Sponsor ID
20060579

Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI alone in KRAS-mutant Metastatic Colorectal Carcinoma

Sponsor ID
20060579
Clinicaltrials.gov ID
NCT00813605
EUCTIS ID
N/A
EudraCT ID
N/A

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

Additional Study Details

Phase
Phase 2
Product
conatumumab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
155
Additional Study Details

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
Status
Contact Us
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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