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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.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: May 15, 2006
Last updated: February 27, 2010
Last verified: August 2007
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00326131

United States, Texas
Local Institution
San Antonio, Texas, United States
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information: Identifier: NCT00326131     History of Changes
Other Study ID Numbers: CA165-017
Study First Received: May 15, 2006
Last Updated: February 27, 2010 processed this record on August 18, 2017