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

Phase 1

Completed

• Conditions: Tumors
• Interventions: Drug: Brivanib

• Registration Number: NCT00437437
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2007-02-14
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-21
• Primary Completion: 2008-05
• Study Completion: 2013-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Brivanib	-

Primary Outcome Measures

Name	Time	Method
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	throughout the study

Secondary Outcome Measures

Name	Time	Method
To assess safety and tolerability of Brivanib alaninate when administered in a fasted state, or following a high fat meal	throughout the study

Trial Locations

Locations (3)

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