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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
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Metabolism of [14C] BMS-275183 in Patients With Advanced Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  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

Additional 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

No publications provided

ClinicalTrials.gov Identifier: NCT00326131     History of Changes
Other Study ID Numbers: CA165-017
Study First Received: May 15, 2006
Last Updated: February 27, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013