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

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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Key information

Conditions

Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dana-Farber Harvard Cancer Care, Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brivanib

Drug

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

Other names: BMS-582664

Primary outcomes

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

Time frame: throughout the study

Secondary outcomes

To assess safety and tolerability of Brivanib alaninate when administered in a fasted state, or following a high fat meal

Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start: 2000
Primary completion: 2008
Study completion: 2013
First posted: Feb 21, 2007
Registry last updated: Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed