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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00435669

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 I

MedlinePlus related topics: Cancer

Drug Information available for: Brivanib alaninate

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
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 ] [ 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 ]

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 ] [ Designated as safety issue: Yes ]

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:

Oral Solution, Oral, 800 mg, X1 on Day 1, 10 D for ADME

Tablet, Oral, Brivanib 800 mg, QD, until progression

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA182-008
Study First Received:	February 14, 2007
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00435669
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 January 13, 2009