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:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00813605
First received: December 22, 2008
Last updated: April 12, 2013
Last verified: April 2013
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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 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 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 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 67 Study Locations
Show 67 Study LocationsSponsors 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:
|
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 May 19, 2013