Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types
A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors
1 other identifier
interventional
597
9 countries
25
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 in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2008
Typical duration for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2008
CompletedFirst Posted
Study publicly available on registry
March 12, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 9, 2015
September 1, 2015
3.7 years
March 5, 2008
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Radiographic imaging and clinical evaluation will be used for tumor assessment
every 6 weeks
Secondary Outcomes (6)
Safety profiles
ongoing throughout trial
Disease response rate
determined June 2010
Disease control rate
determined June 2010
Pharmacokinetics
determined June 2010
Pharmacodynamics
determined June 2010
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
University Of Chicago
Chicago, Illinois, 60637, United States
Northshore Univ. Healthsystem
Evanston, Illinois, 60201, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21231, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Local Institution
Buenos Aires, Buenos Aires, 1650, Argentina
Local Institution
Capital Federal, Buenos Aires, 1264, Argentina
Local Institution
Capital Federal, Buenos Aires, 1425, Argentina
Local Institution
Capital Federal, Buenos Aires, 1426, Argentina
Local Institution
Brussels, 1000, Belgium
Local Institution
Brussels, 1090, Belgium
Local Institution
Brussels, 1200, Belgium
Local Institution
Edmonton, Alberta, T6G 1Z2, Canada
Local Institution
Toronto, Ontario, M5G 2M9, Canada
Local Institution
Paris, 75651, France
Local Institution
Paris, 75908, France
Local Institution
Freiburg im Breisgau, 79106, Germany
Local Institution
Halle, 06120, Germany
Local Institution
Maastricht, 6202 AZ, Netherlands
Local Institution
Rotterdam, 3075 EA, Netherlands
Local Institution
Utrecht, 3508 GA, Netherlands
Local Institution
Gdansk, 80-952, Poland
Local Institution
Glasgow, Scotland, Strathclyde, GN11 6NT, United Kingdom
Local Institution
Surrey, SM2 5PT, United Kingdom
Related Publications (1)
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2008
First Posted
March 12, 2008
Study Start
June 1, 2008
Primary Completion
February 1, 2012
Study Completion
December 1, 2012
Last Updated
October 9, 2015
Record last verified: 2015-09