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Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types
This study is currently recruiting participants.
Verified by Bristol-Myers Squibb, July 2009
First Received: March 5, 2008   Last Updated: August 19, 2009   History of Changes
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00633789
  Purpose

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 Intervention 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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Radiographic imaging and clinical evaluation will be used for tumor assessment [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety profiles [ Time Frame: ongoing throughout trial ] [ Designated as safety issue: Yes ]
  • Disease response rate [ Time Frame: determined June 2010 ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: determined June 2010 ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: determined June 2010 ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: determined June 2010 ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: determined June 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 550
Study Start Date: June 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: brivanib
Tablets, Oral, 800 mg, once daily, until progression
2: Placebo Comparator Drug: Placebo
Tablets, Oral, 0 mg, once daily, until progression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633789

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Show 28 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CA182-026
Study First Received: March 5, 2008
Last Updated: August 19, 2009
ClinicalTrials.gov Identifier: NCT00633789     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:
Thoracic Neoplasms
Pancreatic Neoplasms
Carcinoma, Transitional Cell
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Respiratory Tract Diseases
Lung Neoplasms
Endocrine Gland Neoplasms
Digestive System Neoplasms
Endocrine System Diseases
Carcinoma
Malignant Mesenchymal Tumor
Digestive System Diseases
Esophageal Disorder
Lung Diseases
Sarcoma
Gastrointestinal Neoplasms
Pancreatic Diseases
Non-small Cell Lung Cancer
Esophageal Diseases
Endocrinopathy
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Transitional Cell Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Pancreatic Neoplasms
Endocrine System Diseases
Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Connective and Soft Tissue
Neoplasms
Digestive System Diseases
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Sarcoma
Pancreatic Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009