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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00437437
First received: February 14, 2007
Last updated: March 28, 2013
Last verified: February 2012
History of Changes
  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 1

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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: May 2000
Estimated Study Completion Date: April 2013
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Brivanib
Tablet, Oral, Brivanib 800 mg, QD after single dose Pk comparison of food effect, until progression
Other Name: BMS-582664

  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, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  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
ClinicalTrials.gov Identifier: NCT00437437     History of Changes
Other Study ID Numbers: CA182-022
Study First Received: February 14, 2007
Last Updated: March 28, 2013
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 21, 2013