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

Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437437
• Other study ID #: CA182-022
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2007
• Last updated: June 20, 2013
• Start date: May 2000
• Est. completion date: February 2013

Study information

• Verified date: June 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2013
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

Intervention

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

Locations

Country	Name	City	State
United States	Dana-Farber Harvard Cancer Care	Boston	Massachusetts
United States	Wayne State University	Detroit	Michigan
United States	Duke University Medical Center-Dept Of Medicine	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess safety and tolerability of Brivanib alaninate when administered in a fasted state, or following a high fat meal		throughout the study	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form