Status:
COMPLETED
Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Advanced Non-small Cell Lung Cancer
Transitional Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
597 Patients enrolled
Trial Details
Trial ID
NCT00633789
Start Date
June 1 2008
End Date
December 1 2012
Last Update
October 9 2015
Active Locations (25)
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1
University Of Chicago
Chicago, Illinois, United States, 60637
2
Northshore Univ. Healthsystem
Evanston, Illinois, United States, 60201
3
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21231
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065