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

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ClinicalTrials.gov Identifier: NCT00437437
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Tumors Drug: Brivanib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : May 2000
Actual Primary Completion Date : May 2008
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: 1 Drug: Brivanib
Tablet, Oral, Brivanib 800 mg, QD after single dose Pk comparison of food effect, until progression
Other Name: BMS-582664



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 48201-2194
United States, North Carolina
Duke University Medical Center-Dept Of Medicine
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00437437     History of Changes
Other Study ID Numbers: CA182-022
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013

Keywords provided by Bristol-Myers Squibb:
Advanced or metastatic solid tumors