A Phase I Study of a Single Dose of Radio-labeled BMS-275183 in Patients With Advanced Cancer

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00326131
First received: May 15, 2006
Last updated: February 27, 2010
Last verified: August 2007

May 15, 2006
February 27, 2010
April 2006
March 2007   (final data collection date for primary outcome measure)
To assess the Pharmacokinetics, metabolism, and routes and extent of elimination of a single dose of [14C] BMS-275183 over a 10 day period.
Same as current
Complete list of historical versions of study NCT00326131 on ClinicalTrials.gov Archive Site
To assess the safety of a single dose of [14C] BMS-275183 followed by a therapeutic regimen of BMS-275183 administered twice weekly
Same as current
Not Provided
Not Provided
 
A Phase I Study of a Single Dose of Radio-labeled BMS-275183 in Patients With Advanced Cancer
Pharmacokinetics and Metabolism of [14C] BMS-275183 in Patients With Advanced Cancer

The first purpose of this study is to determine how the body absorbs, metabolizes, and eliminates a single dose of BMS-275183 (labeled with radioactive carbon). Secondly, to measure the levels of BMS-275183 in your blood, study the safety of the drug, and to see what effects it has on your cancer.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
Drug: Oral Taxane
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
Not Provided
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-hematological malignancy that has progressed on standard therapy
  • No more that 3 prior chemotherapies given for advanced cancer
  • Adequate renal, hepatic and hematologic function

Exclusion Criteria:

  • Uncontrolled or significant pulmonary or cardiovascular disease
  • Active Brain metastases
  • Inability to swallow capsules
  • Serious uncontrolled medical disorder or active infection
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00326131
CA165-017
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
August 2007

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