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

This study has been terminated.

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00326131

Purpose

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.

Condition	Intervention	Phase
Cancer	Drug: Oral Taxane	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: BMS 275183

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title:	Pharmacokinetics and Metabolism of [14C] BMS-275183 in Patients With Advanced Cancer

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To assess the Pharmacokinetics, metabolism, and routes and extent of elimination of a single dose of [14C] BMS-275183 over a 10 day period.

Secondary Outcome Measures:

To assess the safety of a single dose of [14C] BMS-275183 followed by a therapeutic regimen of BMS-275183 administered twice weekly

Estimated Enrollment:	6
Study Start Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326131

Locations

United States, Texas
Local Institution
San Antonio, Texas, United States

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

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

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	CA165-017
Study First Received:	May 15, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00326131
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Taxane

ClinicalTrials.gov processed this record on January 14, 2009