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

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ClinicalTrials.gov Identifier: NCT00633789
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Advanced Non-small Cell Lung Cancer Transitional Cell Carcinoma Soft Tissue Sarcoma Gastric/Esophageal Adenocarcinoma Pancreatic Cancer Including Ampulla of Vater Drug: brivanib Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 597 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors
Study Start Date : June 2008
Actual Primary Completion Date : February 2012
Actual Study Completion Date : December 2012


Arm Intervention/treatment
Experimental: 1 Drug: brivanib
Tablets, Oral, 800 mg, once daily, until progression
Other Name: BMS-582664

Placebo Comparator: 2 Drug: Placebo
Tablets, Oral, 0 mg, once daily, until progression




Primary Outcome Measures :
  1. Radiographic imaging and clinical evaluation will be used for tumor assessment [ Time Frame: every 6 weeks ]

Secondary Outcome Measures :
  1. Safety profiles [ Time Frame: ongoing throughout trial ]
  2. Disease response rate [ Time Frame: determined June 2010 ]
  3. Disease control rate [ Time Frame: determined June 2010 ]
  4. Pharmacokinetics [ Time Frame: determined June 2010 ]
  5. Pharmacodynamics [ Time Frame: determined June 2010 ]
  6. Biomarkers [ Time Frame: determined June 2010 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633789


Locations
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United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
Northshore Univ. Healthsystem
Evanston, Illinois, United States, 60201
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States, 10065
United States, Pennsylvania
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, 1264
Local Institution
Capital Federal, Buenos Aires, Argentina, 1425
Local Institution
Capital Federal, Buenos Aires, Argentina, 1426
Local Institution
Buenos Aires, Argentina, 1650
Belgium
Local Institution
Brussel, Belgium, 1090
Local Institution
Bruxelles, Belgium, 1000
Local Institution
Bruxelles, Belgium, 1200
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2M9
France
Local Institution
Paris Cedex 13, France, 75651
Local Institution
Paris, France, 75908
Germany
Local Institution
Freiburg, Germany, 79106
Local Institution
Halle/saale, Germany, 06120
Netherlands
Local Institution
Maastricht, Netherlands, 6202 AZ
Local Institution
Rotterdam, Netherlands, 3075 EA
Local Institution
Utrecht, Netherlands, 3508 GA
Poland
Local Institution
Gdansk, Poland, 80-952
United Kingdom
Local Institution
Glasgow, Scotland, Strathclyde, United Kingdom, GN11 6NT
Local Institution
Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00633789    
Other Study ID Numbers: CA182-026
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Sarcoma
Carcinoma, Transitional Cell
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue