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

This study is ongoing, but not recruiting participants.

First Received: February 14, 2007 Last Updated: May 6, 2009 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00437437

Purpose

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

Condition	Intervention	Phase
Tumors	Drug: Brivanib	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Brivanib alaninate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study
Official 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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To determine the effect on pharmacokinetics of BMS-540215, the active metabolite of brivanib alaninate, when administered following a hight fat meal versus administration in a fasted state [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	26
Study Start Date:	July 2007
Estimated Study Completion Date:	September 2009
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Brivanib Tablet, Oral, Brivanib 800 mg, QD after single dose Pk comparison of food effect, until progression

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437437

Locations

United States, Massachusetts
Dana-Farber Harvard Cancer Care
Boston, Massachusetts, United States, 02115
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA182-022
Study First Received:	February 14, 2007
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00437437 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Advanced or metastatic solid tumors

ClinicalTrials.gov processed this record on May 07, 2009