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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer (MCRC)

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

PK C1D1-C2-D3, biomarker throughout the study

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA182-025

NCT ID:

NCT00594984

Start Date:

May 2008

Completion Date:

December 2012

Related Keywords:

  • Metastatic Colorectal Cancer (MCRC)
  • Colorectal Neoplasms

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Washington UniversitySt. Louis, Missouri  63110
Usc/Norris Comprehensive Cancer Center HospitalLos Angeles, California  90033