Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email [email protected]. 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