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A Phase I Study to Determine Absorption, Distribution, Metabolism, and Elimination of a Single Radiolabeled Dose of Brivanib (BMS-582664)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00435669
First Posted: February 15, 2007
Last Update Posted: January 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
The purpose of this trial is to determine the mass balance, pharmacokinetics, metabolism, and routes and extent of elimination of BMS-582664

Condition Intervention Phase
Tumors Drug: Brivanib Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mass Balance, Pharmacokinetics and Metabolism of [14C]BMS-582664 Prodrug of BMS-540215, in Subjects With Advanced or Metastatic Solid Tumors

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Absorption [ Time Frame: Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10 ]
  • Distribution [ Time Frame: Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10 ]
  • Metabolism [ Time Frame: Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10 ]
  • Elimination of BMS-582664 [ Time Frame: Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10 ]

Secondary Outcome Measures:
  • To assess safety and tolerability of BMS-582664 800 mg administered daily in Part B [ Time Frame: at last patient last visit ]

Enrollment: 4
Study Start Date: September 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Brivanib
    Oral Solution, Oral, 800 mg, X1 on Day 1, 10 D for ADME
    Other Name: BMS-582664
    Drug: Brivanib
    Tablet, Oral, Brivanib 800 mg, QD, until progression
  Eligibility

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

Inclusion Criteria:

  • Histologic/cytologic diagnosis of advanced or metastatic solid tumors
  • ECOG 0-2
  • 4/6 weeks since prior therapy

Exclusion Criteria:

  • Brain metastases
  • Secondary primary malignancy
  • Thromboembolic disease requiring full anticoagulation within 6 months
  • Inability to swallow or absorb oral therapy
  • Uncontrolled hypertension
  Contacts and Locations
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): NCT00435669


Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00435669     History of Changes
Other Study ID Numbers: CA182-008
First Submitted: February 14, 2007
First Posted: February 15, 2007
Last Update Posted: January 22, 2009
Last Verified: July 2008

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