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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2013-02-28

Brief Summary

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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

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Detailed Description

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Conditions

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Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Brivanib

Intervention Type DRUG

Tablet, Oral, Brivanib 800 mg, QD after single dose Pk comparison of food effect, until progression

Interventions

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Brivanib

Tablet, Oral, Brivanib 800 mg, QD after single dose Pk comparison of food effect, until progression

Intervention Type DRUG

Other Intervention Names

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BMS-582664

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No