A Phase I Study of BMS-275183 (Oral Taxane) Given on a Daily Schedule in Combination With Esomeprazole (Nexium) in Patients With Advanced Cancer
Phase 1
Terminated
- Conditions
- Cancer
- Registration Number
- NCT00332748
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine what effects Esomeprazole (Nexium) has on increasing or decreasing the amount of oral taxane in the blood, and to determine the safety of oral taxane and effect of oral taxane on the cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Advanced cancers excluding cancers within the blood
- Adequate kidney and liver function
- > = 4 weeks from last course of chemotherapy
Exclusion Criteria
- Inability to swallow capsules
- Other active medical disorder
- Abnormal heart function or use of drugs that affect the heart
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess the safety of taking Nexium in combination with oral taxane and the effect this combination has on oral taxane's exposure levels in the body.
- Secondary Outcome Measures
Name Time Method To assess the safety of a single dose of oral taxane followed by a therapeutic regimen of oral taxane administered twice weekly
Trial Locations
- Locations (1)
Local Institution
🇳🇱Amsterdam, Netherlands