Phase I/II Combination With Irinotecan- Erbitux

Condition(s) targeted: Metastatic Colorectal Cancer (MCRC)

Intervention: Cetuximab + Irinotecan + Brivinab (Drug); Cetuximab + Irinotecan + Brivanib Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

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)

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial

Safety and tolerability of interventions will be collected

Secondary outcome: Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

Local Institution, Odense C 5000, Denmark; Recruiting
Site 012

Local Institution, Milano 20141, Italy; Not yet recruiting
Site 017

Local Institution, Genova 16132, Italy; Not yet recruiting
Site 018

Local Institution, Napoli 80131, Italy; Not yet recruiting
Site 019

Local Institution, Bari 70126, Italy; Not yet recruiting
Site 024

Local Institution, Meldola Fc 47014, Italy; Suspended

Local Institution, Seoul 135-710, Korea, Republic of; Not yet recruiting
Site 010

Local Institution, Madrid 28050, Spain; Not yet recruiting
Site 021

Local Institution, Madrid 28041, Spain; Not yet recruiting
Site 022

Local Institution, Madrid 28033, Spain; Not yet recruiting
Site 023

Local Institution, Stockholm 171 76, Sweden; Not yet recruiting
Site 013

Local Institution, Uppsala 751 85, Sweden; Recruiting
Site 014

Local Institution, Little Rock, Arkansas 72205, United States; Not yet recruiting
Site 008

Local Institution, Ciudad Aut�noma De Buenos Aire, Buenos Aires CP1426ANZ, Argentina; Recruiting
Site 007

Usc/Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States; Recruiting
Anthony El-Khoueiry, Site 003

Usc/Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States; Recruiting
Anthony El-Khoueiry, Site 020

James Graham Brown Cancer Center, Louisville, Kentucky 40202, United States; Recruiting
Vivek Sharma, Site 004

Washington University, St. Louis, Missouri 63110, United States; Recruiting
Joel Picus, Site 005

Local Institution, New Brunswick, New Jersey 08901, United States; Not yet recruiting
Site 015

Nyu Clinical Cancer Center, New York, New York 10016, United States; Recruiting
Howard Hochster, Site 011

South Texas Oncology And Hematology, P.A., San Antonio, Texas 78207, United States; Recruiting
Gladys I. Rodriguez, Site 001, Phone: 210-593-5200

Scott And White Memorial Hosp, Temple, Texas 76508, United States; Recruiting
Lucas Wong, Site 002, Phone: 817-774-2111

West Virginia University, Morgantown, West Virginia 26506, United States; Recruiting
Miklos Auber, Site 006, Phone: 304-293-4229

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: May 2008
Ending date: April 2011
Last updated: October 20, 2008