Brief Title
Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types
Official Title
A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors
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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Radiographic imaging and clinical evaluation will be used for tumor assessment
Secondary Outcome
Safety profiles
Condition
Advanced Non-small Cell Lung Cancer
Intervention
brivanib
Study Arms / Comparison Groups
1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
597
Start Date
June 2008
Completion Date
December 2012
Primary Completion Date
February 2012
Eligibility Criteria
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email [email protected] 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bristol-Myers Squibb, ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT00633789
Organization ID
CA182-026
Responsible Party
Sponsor
Study Sponsor
Bristol-Myers Squibb
Study Sponsor
Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
Verification Date
September 2015