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
18 Years
N/A
Both
Tumors
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
throughout the study
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA182-022
NCT ID:
NCT00437437
Start Date:
May 2000
Completion Date:
February 2013
Related Keywords:
- Tumors
- Advanced or metastatic solid tumors
Name | Location |
|---|---|
| Wayne State University | Detroit, Michigan 48202 |
| Dana-Farber Harvard Cancer Care | Boston, Massachusetts 02115 |
| Duke University Medical Center-Dept Of Medicine | Durham, North Carolina 27710 |
