Phase 2 Safety & Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 vs FOLFIRI in KRAS-mutant Metastatic Colorectal Carcinoma - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00813605

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Progression Free Survival [ Time Frame: Length of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of adverse events, significant laboratory abnormalities, incidence of antibody formation [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]
Overall Survival, Objective Response, Duration of Response, Time to Response [ Time Frame: Length of Study ] [ Designated as safety issue: No ]

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
Arm A: Experimental AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days	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 Biological: AMG 655 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)
Arm C: Active Comparator AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days	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 Other: Placebo Inactive dummy agent (to maintain blind)
Arm B: Experimental AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days	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 Biological: AMG 479 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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease
Mutant-type KRAS tumor at screening
ECOG Performance Status of 0 - 1
Adequate hematology, renal, hepatic, and coagulation function

Exclusion Criteria:

History or known presence of central nervous system metastases
History of other malignancy
Prior irinotecan-based chemotherapy for advanced/metastatic disease
Prior death receptor agonists, or other systemic IGF-1R agonists in any setting
Uncontrolled cardiovascular disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813605

Contacts

Contact: Amgen Call Center

866-572-6436

Locations

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

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Amgen:

AMG 655
AMG 479
Colon Cancer
Rectal Cancer
Monoclonal Antibody
Clinical Trial

Colorectal Cancer
metastatic colorectal cancer
metastatic cancer
antibody-2nd line
KRAS
adenocarcinoma

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on August 28, 2009