A Phase I Study of a Single Dose of Radio-labeled BMS-275183 in Patients With Advanced Cancer
Phase 1
Terminated
- Conditions
- Cancer
- Registration Number
- NCT00326131
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method To assess the safety of a single dose of [14C] BMS-275183 followed by a therapeutic regimen of BMS-275183 administered twice weekly
Trial Locations
- Locations (1)
Local Institution
🇺🇸San Antonio, Texas, United States