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

Completed · Phase 2 · Has a placebo group

Conditions studied: Advanced Non-small Cell Lung Cancer, Transitional Cell Carcinoma, Soft Tissue Sarcoma, Gastric/Esophageal Adenocarcinoma, Pancreatic Cancer Including Ampulla of Vater

In brief

The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib

Key facts

Study ID

NCT00633789

Run by

Bristol-Myers Squibb

People needed

597

Starts

2008-06-01

Expected to finish

2012-12-01

Last updated by the study team

2015-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Of Chicago — Chicago, Illinois, United States
• Northshore Univ. Healthsystem — Evanston, Illinois, United States
• Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins — Baltimore, Maryland, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Ctr — New York, New York, United States
• University Of Pennsylvania — Philadelphia, Pennsylvania, United States
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Brussels, Belgium
• Local Institution — Brussels, Belgium
• Local Institution — Brussels, Belgium
• Local Institution — Edmonton, Alberta, Canada
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Paris, France
• Local Institution — Paris, France
• Local Institution — Freiburg im Breisgau, Germany
• Local Institution — Halle, Germany
• Local Institution — Maastricht, Netherlands
• Local Institution — Rotterdam, Netherlands
• Local Institution — Utrecht, Netherlands
• Local Institution — Gdansk, Poland
• Local Institution — Glasgow, Scotland, Strathclyde, United Kingdom
• Local Institution — Surrey, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.