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 MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com 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
anticoagulation

- 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