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

Sponsor:	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 Other: Placebo Biological: AMG 479	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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:

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

Estimated Enrollment:	150
Study Start Date:	March 2009
Estimated Study Completion Date:	February 2014
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm A 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)
Active Comparator: Arm C 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)
Experimental: Arm B 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 Other: Placebo Inactive dummy agent (to maintain blind) Biological: AMG 479 AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1

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
Eastern Cooperative Oncology Group (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

Show 61 Study Locations

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:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00813605 History of Changes
Other Study ID Numbers:	20060579
Study First Received:	December 22, 2008
Last Updated:	September 29, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: CCPPRB Central Ethics Committee; France: Central Ethic Committee; Hong Kong: Department of Health; Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health); Hungary: National Institute of Pharmacy; India: Central Drugs Standard Control Organization; India: Indian Council of Medical Research; Italy: Ethics Committee; Poland: Drug Institut; Poland: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ethics Committee; Russia: FSI National Center of Expertise of Medicinal Products; Russia: Ministry of Health and Social Development of the Russian Federation; Singapore: Health Science Authority; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Spain: Comite Etico de Investigacion Clinica; Spain: Comité ético del Hospital Vall d'Hebron; 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

Additional relevant MeSH terms:

Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012