Who is sponsoring NCT00594984?

NCT00594984 is sponsored by Bristol-Myers Squibb.

What condition does NCT00594984 study?

NCT00594984 studies Metastatic Colorectal Cancer (MCRC).

What drugs are being tested in NCT00594984?

Interventions: Cetuximab, Irinotecan, Brivanib, Brivanib, Brivanib Placebo.

What is the status of NCT00594984?

NCT00594984 is currently COMPLETED.

Last reviewed 2015-10-12 · How we verify

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

NCT00594984 Phase 1/Phase 2 COMPLETED

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)

Details

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	38
Start date	2008-05
Completion	2012-12

Conditions

Metastatic Colorectal Cancer (MCRC)

Interventions

Cetuximab
Irinotecan
Brivanib
Brivanib
Brivanib Placebo

Primary outcomes

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

Countries

United States, Argentina, Denmark, Italy, South Korea, Spain, Sweden