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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00813605 |
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
Condition | Intervention | Phase |
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Metastatic Colorectal Cancer |
Other: FOLFIRI Biological: AMG 655 Biological: AMG 479 Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 150 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | May 2013 |
Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental
AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
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Other: FOLFIRI
Day 1 of each Cycle Combination Therapy of: irinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion
AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)
Other: Placebo
Inactive dummy agent (to maintain blind)
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Arm C: Active Comparator
AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days
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Other: FOLFIRI
Day 1 of each Cycle Combination Therapy of: irinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion
Inactive dummy agent (to maintain blind)
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Arm B: Experimental
AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days
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Other: FOLFIRI
Day 1 of each Cycle Combination Therapy of: irinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion
AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1
Other: Placebo
Inactive dummy agent (to maintain blind)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amgen Call Center | 866-572-6436 |
United States, California | |
Research Site | Recruiting |
Beverly Hills, California, United States | |
United States, Colorado | |
Research Site | Recruiting |
Denver, Colorado, United States | |
United States, Florida | |
Research Site | Recruiting |
Port St. Lucie, Florida, United States | |
United States, Georgia | |
Research Site | Recruiting |
Atlanta, Georgia, United States | |
United States, Illinois | |
Research Site | Recruiting |
Joliet, Illinois, United States | |
United States, Indiana | |
Research Site | Recruiting |
Indianapolis, Indiana, United States | |
United States, Kansas | |
Research Site | Recruiting |
Wichita, Kansas, United States | |
United States, New York | |
Research Site | Recruiting |
Hudson, New York, United States | |
United States, North Carolina | |
Research Site | Recruiting |
High Point, North Carolina, United States | |
United States, Pennsylvania | |
Research Site | Recruiting |
Philadelphia, Pennsylvania, United States | |
United States, Texas | |
Research Site | Recruiting |
Amarillo, Texas, United States | |
Research Site | Recruiting |
Austin, Texas, United States | |
Research Site | Recruiting |
Dallas, Texas, United States | |
Research Site | Recruiting |
Tyler, Texas, United States | |
United States, Virginia | |
Research Site | Recruiting |
Salem, Virginia, United States | |
France | |
Research Site | Recruiting |
Lille, France | |
Poland | |
Research Site | Recruiting |
Gliwice, Poland |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20060579 |
Study First Received: | December 22, 2008 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00813605 History of Changes |
Health Authority: | France: CCPPRB Central Ethics Committee; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy; India: Central Drugs Standard Control Organization; Poland: Drug Institut; Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health); Spain: Spanish Drug Agency; United States: Food and Drug Administration; United States: Institutional Review Board; United States: Western Institutional Review Board |
AMG 655 AMG 479 Colon Cancer Rectal Cancer Monoclonal Antibody Clinical Trial |
Colorectal Cancer metastatic colorectal cancer metastatic cancer antibody-2nd line KRAS adenocarcinoma |
Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Irinotecan Benzocaine Leucovorin Rectal Diseases Insulin Antibodies, Monoclonal Neoplasm Metastasis Mitogens Immunoglobulins |
Digestive System Neoplasms Rectal Neoplasm Folinic Acid Intestinal Diseases Intestinal Neoplasms Carcinoma Antibodies Digestive System Diseases Rectal Cancer Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms |
Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Antibodies, Monoclonal Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |