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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumors

Thank you

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 UniversityDetroit, Michigan  48202
Dana-Farber Harvard Cancer CareBoston, Massachusetts  02115
Duke University Medical Center-Dept Of MedicineDurham, North Carolina  27710