Phase 2 Safety & Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 vs FOLFIRI in KRAS-mutant Metastatic Colorectal Carcinoma
Tracking InformationStart Date ICMJE | January 2009 |
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Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: December 22, 2008) | Progression Free Survival [ Time Frame: Length of Study ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00813605 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: December 22, 2008) | - 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 ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | Phase 2 Safety & Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 vs FOLFIRI in KRAS-mutant Metastatic Colorectal Carcinoma |
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Official Title ICMJE | 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 |
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Brief Summary | 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 |
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Detailed Description | |
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Study Phase | Phase II |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Metastatic Colorectal Cancer |
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Intervention ICMJE | - 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) - 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)
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Study Arms / Comparison Groups | - Arm A: Experimental
AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days Interventions: - Other: FOLFIRI
- Biological: AMG 655
- Other: Placebo
- Arm C: Active Comparator
AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days Interventions: - Other: FOLFIRI
- Other: Placebo
- Arm B: Experimental
AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days Interventions: - Other: FOLFIRI
- Biological: AMG 479
- Other: Placebo
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Recruitment InformationEstimated Enrollment ICMJE | 150 |
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Estimated Completion Date | May 2013 |
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Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | 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
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Gender | Both |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: Amgen Call Center | 866-572-6436 | | |
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Location Countries ICMJE | United States, France, Hong Kong, Hungary, Italy, Poland, Russian Federation, Singapore, Spain |
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Administrative InformationNCT ID ICMJE | NCT00813605 |
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Responsible Party | Global Development Leader, Amgen Inc. |
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Study ID Numbers ICMJE | 20060579 |
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Study Sponsor ICMJE | Amgen |
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Collaborators ICMJE | |
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Investigators ICMJE | |
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Information Provided By | Amgen |
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