Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Cancer, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | June 2008 |
End Date: | December 2012 |
A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors
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
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
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
We found this trial at
6
sites
University of Chicago One of the world's premier academic and research institutions, the University of...
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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