Spots Global Cancer Trial Database for QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
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Trial Identification
Brief Title: QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma
Study ID: NCT00813605
Conditions
Study Description
Brief Summary: 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
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Beverly Hills, California, United States
Research Site, Los Angeles, California, United States
Research Site, Santa Maria, California, United States
Research Site, Denver, Colorado, United States
Research Site, Denver, Colorado, United States
Research Site, Miami, Florida, United States
Research Site, Ocala, Florida, United States
Research Site, Port Saint Lucie, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Joliet, Illinois, United States
Research Site, Fishers, Indiana, United States
Research Site, Wichita, Kansas, United States
Research Site, Paducah, Kentucky, United States
Research Site, Worcester, Massachusetts, United States
Research Site, Lebanon, New Hampshire, United States
Research Site, Hudson, New York, United States
Research Site, New York, New York, United States
Research Site, High Point, North Carolina, United States
Research Site, Columbus, Ohio, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Amarillo, Texas, United States
Research Site, Austin, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, Temple, Texas, United States
Research Site, Tyler, Texas, United States
Research Site, Roanoke, Virginia, United States
Research Site, Bordeaux Cedex, , France
Research Site, Boulogne Billancourt, , France
Research Site, Lille, , France
Research Site, Lyon Cedex 08, , France
Research Site, New Territories, , Hong Kong
Research Site, Budapest, , Hungary
Research Site, Gyor, , Hungary
Research Site, Pecs, , Hungary
Research Site, Szeged, , Hungary
Research Site, Hyderabad, Andhra Pradesh, India
Research Site, Mumbai, Maharashtra, India
Research Site, Nagpur, Maharashtra, India
Research Site, Nashik, Maharashtra, India
Research Site, Pune, Maharashtra, India
Research Site, Kolkata, West Bengal, India
Research Site, Bangalore, , India
Research Site, Genova, , Italy
Research Site, Milano, , Italy
Research Site, Orbassano, , Italy
Research Site, Gdansk, , Poland
Research Site, Gliwice, , Poland
Research Site, Opole, , Poland
Research Site, Arkhangelsk, , Russian Federation
Research Site, Kursk, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Obninsk, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Samara, , Russian Federation
Research Site, St Petersburg, , Russian Federation
Research Site, Ufa, , Russian Federation
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Barcelona, Cataluña, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, L'Hospitalet de Llobregat, Cataluña, Spain
Research Site, Pamplona, Navarra, Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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