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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00813605
First received: December 22, 2008
Last updated: April 12, 2013
Last verified: April 2013
  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 2

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:


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 ]

Enrollment: 155
Study Start Date: March 2009
Study Completion Date: June 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 67 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00813605     History of Changes
Other Study ID Numbers: 20060579
Study First Received: December 22, 2008
Last Updated: April 12, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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 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:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014