A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs Placebo in Combination With Erbitux and Irinotecan K-Ras Wildtype Subjects With Metastatic Colorectal Cancer
Overview
- Phase
- Phase 1
- Intervention
- Cetuximab
- Conditions
- Metastatic Colorectal Cancer (MCRC)
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 38
- Locations
- 5
- Primary Endpoint
- Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC)
Part 2: To compare median duration of progression free survival (PFS)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Biopsy proven MCRC
- •Prior irinotecan allowed
- •Prior Erbitux allowed
Exclusion Criteria
- •No prior brivanib
- •No prior combination of irinotecan with Erbitux
- •No secondary malignancies
- •No anti-coagulation therapy
- •No prior history of blood clots requiring anti-coagulation
Arms & Interventions
Arm 1 - Phase 1
Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Intervention: Cetuximab
Arm 1 - Phase 1
Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Intervention: Irinotecan
Arm 1 - Phase 1
Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Intervention: Brivanib
Arm 1 - Phase 1
Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Intervention: Brivanib Placebo
Arm 2 - Phase 2
Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Intervention: Cetuximab
Arm 2 - Phase 2
Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Intervention: Irinotecan
Arm 2 - Phase 2
Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Intervention: Brivanib
Arm 2 - Phase 2
Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Intervention: Brivanib Placebo
Outcomes
Primary Outcomes
Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial
Time Frame: PK C1D1-C2-D3, biomarker throughout the study
Safety and tolerability of interventions will be collected
Time Frame: throughout the study on Part II
Secondary Outcomes
- Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects(throughout the study on Part II)