CompletedPhase 2NCT00633789

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

Checked against the public recordLast updated Oct 9, 2015 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations25
SponsorBristol-Myers Squibb
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Bristol-Myers Squibb
Interventions being studied
Drug: brivanib; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

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.

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