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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:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00435669
First received: February 14, 2007
Last updated: January 21, 2009
Last verified: July 2008

February 14, 2007
January 21, 2009
September 2007
June 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Absorption
  • Distribution
  • Metabolism
  • Elimination of BMS-582664
Complete list of historical versions of study NCT00435669 on ClinicalTrials.gov Archive Site
To assess safety and tolerability of BMS-582664 800 mg administered daily in Part B [ Time Frame: at last patient last visit ] [ Designated as safety issue: Yes ]
To assess safety and tolerability of BMS-582664 800 mg administered daily in Part B
Not Provided
Not Provided
 
A Phase I Study to Determine Absorption, Distribution, Metabolism, and Elimination of a Single Radiolabeled Dose of Brivanib (BMS-582664)
Mass Balance, Pharmacokinetics and Metabolism of [14C]BMS-582664 Prodrug of BMS-540215, in Subjects With Advanced or Metastatic Solid Tumors

The purpose of this trial is to determine the mass balance, pharmacokinetics, metabolism, and routes and extent of elimination of BMS-582664

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tumors
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00435669
CA182-008
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP