Phase I/II Combination With Irinotecan- Erbitux

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Metastatic Colorectal Cancer (MCRC)

In brief

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)

Key facts

Study ID

NCT00594984

Run by

Bristol-Myers Squibb

People needed

38

Starts

2008-05-01

Expected to finish

2012-12-01

Last updated by the study team

2015-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy proven MCRC
• Prior irinotecan allowed
• Prior Erbitux allowed

You may not qualify if…

• 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

Where it is running

• 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 — St Louis, Missouri, United States
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Odense C, Denmark
• Local Institution — Meldola Fc, Italy
• Local Institution — Milan, Italy
• Local Institution — Seoul, South Korea
• Local Institution — Madrid, Spain
• Local Institution — Stockholm, Sweden
• Local Institution — Uppsala, Sweden

Full record on ClinicalTrials.gov

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