Phase I/II Combination With Irinotecan- Erbitux

Phase 1

Completed

• Conditions: Metastatic Colorectal Cancer (MCRC)
• Interventions: Drug: Cetuximab; Drug: Irinotecan; Drug: Brivanib; Drug: Brivanib Placebo

• Registration Number: NCT00594984
• Lead Sponsor: Bristol-Myers Squibb

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-16
• Study Start: 2008-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Status Verified: 2015-10
• Disposition First Posted: 2015-10-09
• Last Update Submitted: 2015-10-12
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 - Phase 1	Brivanib Placebo	Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Arm 2 - Phase 2	Brivanib	Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Arm 2 - Phase 2	Brivanib Placebo	Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Arm 1 - Phase 1	Brivanib	Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Arm 1 - Phase 1	Irinotecan	Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Arm 1 - Phase 1	Cetuximab	Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Arm 2 - Phase 2	Cetuximab	Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
Arm 2 - Phase 2	Irinotecan	Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial	PK C1D1-C2-D3, biomarker throughout the study
Safety and tolerability of interventions will be collected	throughout the study on Part II

Secondary Outcome Measures

Name	Time	Method
Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects	throughout the study on Part II

Trial Locations

Locations (5)

Usc/Norris Comprehensive Cancer Center Hospital; 🇺🇸 Los Angeles, California, United States

Usc/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Local Institution; 🇸🇪 Uppsala, Sweden