Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types
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
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 9, 2015 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Drug: brivanib; Drug: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University Of ChicagoChicago, Illinois
- Northshore Univ. HealthsystemEvanston, Illinois
- Sidney Kimmel Comprehensive Cancer Center At Johns HopkinsBaltimore, Maryland
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Memorial Sloan Kettering Cancer CtrNew York, New York
- University Of PennsylvaniaPhiladelphia, Pennsylvania
- Local InstitutionBuenos Aires, Buenos Aires
- Local InstitutionCapital Federal, Buenos Aires
- Local InstitutionCapital Federal, Buenos Aires
- Local InstitutionCapital Federal, Buenos Aires
- Local InstitutionBrussels
- Local InstitutionBrussels
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 9, 2015. Always confirm current availability with the study team.