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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00437437

Enrollment

Registered

2007-02-21

Start date

2000-05-31

Completion date

2013-02-28

Last updated

2013-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumors

Keywords

Advanced or metastatic solid tumors

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

Interventions

DRUGBrivanib

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026