Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types

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

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

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