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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00633789
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Primary Completion Date : February 2012
Study Completion Date : December 2012


Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations

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


  Show 25 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00633789     History of Changes
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:
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Pancreatic Neoplasms
Sarcoma
Carcinoma, Transitional Cell
Esophageal Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Connective and Soft Tissue
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Esophageal Diseases
Gastrointestinal Diseases