A Phase I Study to Determine the Effect of Food on Brivanib (BMS-582664)

Completed · Phase 1

Conditions studied: Tumors

In brief

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

Key facts

Study ID

NCT00437437

Run by

Bristol-Myers Squibb

People needed

29

Starts

2000-05-01

Expected to finish

2013-02-01

Last updated by the study team

2013-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic/cytologic diagnosis of advanced or metastatic solid tumors
• ECOG 0-2
• 4/6 weeks since prior therapy

You may not qualify if…

• Brain metastases
• Second primary malignancy
• Thromboembolic disease requiring full anticoagulation within 6 months
• Inability to swallow or absorb oral therapy

Where it is running

• Dana-Farber Harvard Cancer Care — Boston, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Duke University Medical Center-Dept Of Medicine — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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