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

September 23, 2015 updated by: Bristol-Myers Squibb

A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

597

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1650
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1426
        • Local Institution
      • Capital Federal, Buenos Aires, Argentina, 1425
        • Local Institution
      • Capital Federal, Buenos Aires, Argentina, 1264
        • Local Institution
  • Belgium
      • Brussel, Belgium, 1090
        • Local Institution
      • Bruxelles, Belgium, 1200
        • Local Institution
      • Bruxelles, Belgium, 1000
        • Local Institution
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution
  • France
      • Paris, France, 75908
        • Local Institution
      • Paris Cedex 13, France, 75651
        • Local Institution
  • Germany
      • Freiburg, Germany, 79106
        • Local Institution
      • Halle/saale, Germany, 06120
        • Local Institution
  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • Local Institution
      • Rotterdam, Netherlands, 3075 EA
        • Local Institution
      • Utrecht, Netherlands, 3508 GA
        • Local Institution
  • Poland
      • Gdansk, Poland, 80-952
        • Local Institution
  • United Kingdom
      • Surrey, United Kingdom, SM2 5PT
        • Local Institution
    • Strathclyde
      • Glasgow, Scotland, Strathclyde, United Kingdom, GN11 6NT
        • Local Institution
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Evanston, Illinois, United States, 60201
        • Northshore Univ. Healthsystem
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: brivanib
Tablets, Oral, 800 mg, once daily, until progression
Other Names:
  • BMS-582664
Placebo Comparator: 2
Drug: Placebo
Tablets, Oral, 0 mg, once daily, until progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic imaging and clinical evaluation will be used for tumor assessment
Time Frame: every 6 weeks
every 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety profiles
Time Frame: ongoing throughout trial
ongoing throughout trial
Disease response rate
Time Frame: determined June 2010
determined June 2010
Disease control rate
Time Frame: determined June 2010
determined June 2010
Pharmacokinetics
Time Frame: determined June 2010
determined June 2010
Pharmacodynamics
Time Frame: determined June 2010
determined June 2010
Biomarkers
Time Frame: determined June 2010
determined June 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 12, 2008

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA182-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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