- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00437437
A Phase I Study to Determine the Effect of Food on Brivanib (BMS-582664)
June 20, 2013 updated by: Bristol-Myers Squibb
Phase I Study to Determine the Effect of a High Fat Meal on the Pharmacokinetics of BMS-540215, the Active Metabolite of Brivanib Alaninate in Subjects With Advanced or Metastatic Solid Tumors
The purpose of this trial is to determine the effect of food versus a fasted state on single-dose pharmacokinetics of BMS-540215, the active metabolite of Brivanib alaninate
Study Overview
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 1
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
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Harvard Cancer Care
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Michigan
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Detroit, Michigan, United States, 48201-2194
- Wayne State University
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center-Dept Of Medicine
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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:
- Histologic/cytologic diagnosis of advanced or metastatic solid tumors
- ECOG 0-2
- 4/6 weeks since prior therapy
Exclusion Criteria:
- Brain metastases
- Second primary malignancy
- Thromboembolic disease requiring full anticoagulation within 6 months
- Inability to swallow or absorb oral therapy
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Tablet, Oral, Brivanib 800 mg, QD after single dose Pk comparison of food effect, until progression
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the effect on pharmacokinetics of BMS-540215, the active metabolite of brivanib alaninate, when administered following a high fat meal versus administration in a fasted state
Time Frame: throughout the study
|
throughout the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess safety and tolerability of Brivanib alaninate when administered in a fasted state, or following a high fat meal
Time Frame: throughout the study
|
throughout the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2000
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
February 14, 2007
First Submitted That Met QC Criteria
February 20, 2007
First Posted (Estimate)
February 21, 2007
Study Record Updates
Last Update Posted (Estimate)
June 21, 2013
Last Update Submitted That Met QC Criteria
June 20, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CA182-022
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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