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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Tumors

Treatments: Drug: Brivanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00437437

CA182-022

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email [e-mail]. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Brivanib