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NCT00326131 Clinical Trial

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

Cancer Clinical Trial

Official title:
Pharmacokinetics and Metabolism of [14C] BMS-275183 in Patients With Advanced Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00326131
Other study ID # CA165-017
Secondary ID
Status Terminated
Phase Phase 1
First received May 15, 2006
Last updated February 27, 2010
Start date April 2006

Study information
Verified date August 2007
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date
Est. primary completion date March 2007
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Oral Taxane

Locations
Country Name City State
United States Local Institution San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To assess the safety of a single dose of [14C] BMS-275183 followed by a therapeutic regimen of BMS-275183 administered twice weekly
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