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

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ClinicalTrials.gov Identifier: NCT00326131
Recruitment Status : Terminated
First Posted : May 16, 2006
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Drug: Oral Taxane Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 6 participants
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
Study Start Date : April 2006
Actual Primary Completion Date : March 2007



Primary Outcome Measures :
  1. 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 :
  1. To assess the safety of a single dose of [14C] BMS-275183 followed by a therapeutic regimen of BMS-275183 administered twice weekly


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326131


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00326131     History of Changes
Other Study ID Numbers: CA165-017
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: August 2007