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A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors

Phase 2
18 Years
Not Enrolling
Advanced Non-small Cell Lung Cancer, Transitional Cell Carcinoma, Soft Tissue Sarcoma, Gastric/Esophageal Adenocarcinoma, Pancreatic Cancer Including Ampulla of Vater

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Trial Information

A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email Please visit for more information on clinical trial participation.

Inclusion Criteria:

- Life expectancy at least 3 months

- Diagnosis of a solid tumor which is unresectable in which no approved effective
therapy exists or for subjects who are intolerable to such therapy. The initial
enrollment will focus on non-small cell lung, gastric/esophageal adenocarcinoma, soft
tissue sarcoma, transitional cell carcinoma, and pancreatic cancer including ampulla
of Vater tumors

- Adequate tumor sample

- Adequate recovery (baseline or Grade 1) from recent therapy. At least 1 week must
have elapsed from the time of a minor surgery, and at least 8 weeks for major surgery
or radiation therapy

Exclusion Criteria:

- Subjects with known brain metastasis.

- Subjects with signs or symptoms suggestive of brain metastasis are not eligible
unless brain metastases are ruled out by CT or MRI

Medical History and Concurrent Diseases:

- History of thrombo-embolic disease within the last six months requiring therapeutic

- Subjects with history of poor wound healing or non healing ulcers

- Uncontrolled or significant cardiovascular disease

Allergies and Adverse Drug Reactions:

- History of allergy to brivanib its drug class, or related compounds

Prohibited Treatments and/or Therapies:

- Exposure to any investigational drug within 4 weeks of enrollment

- Other concurrent chemotherapy, hormonal therapy, immunotherapy regimens or
radiotherapy, standard or investigational. Subjects may continue to receive hormone
replacement therapy

- Prior exposure to brivanib

Type of Study:


Study Design:

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

Outcome Measure:

Radiographic imaging and clinical evaluation will be used for tumor assessment

Outcome Time Frame:

every 6 weeks

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

December 2012

Related Keywords:

  • Advanced Non-Small Cell Lung Cancer
  • Transitional Cell Carcinoma
  • Soft Tissue Sarcoma
  • Gastric/Esophageal Adenocarcinoma
  • Pancreatic Cancer Including Ampulla of Vater
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Transitional Cell
  • Esophageal Diseases
  • Lung Neoplasms
  • Pancreatic Neoplasms
  • Sarcoma



Memorial Sloan Kettering Cancer Center New York, New York  10021
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
University of Pennsylvania Philadelphia, Pennsylvania  19104
University of Chicago Chicago, Illinois  60637
Memorial Sloan Kettering Cancer Ctr New York, New York  10021
Northshore Univ. Healthsystem Evanston, Illinois  60201