NCT00594984

Phase I/II Combination With Irinotecan- Erbitux

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Metastatic Colorectal Cancer (MCRC)

Interventions

Type	Name	Description
DRUG	Cetuximab	IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression
DRUG	Irinotecan	IV solution, IV, Q3W, 350 mg/m2, until progression
DRUG	Brivanib	Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression
DRUG	Brivanib	Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression
DRUG	Brivanib Placebo	Oral, tablet, QD, until progression

Timeline

• Start date: 2008-05-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-01-16
• Last updated: 2015-11-04

Locations

12 sites across 7 countries: United States, Argentina, Denmark, Italy, South Korea, Spain, Sweden