A Phase I Study of BMS-275183 (Oral Taxane) Given on a Daily Schedule in Combination With Esomeprazole (Nexium) in Patients With Advanced Cancer
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: Oral Taxane (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: Bristol-Myers Squibb
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.
Clinical Details
Official title: Effect of Esomeprazole on the Pharmacokinetics of BMS-275183 in Patients With Advanced Malignancies
Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: 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: To assess the safety of a single dose of oral taxane followed by a therapeutic regimen of oral taxane administered twice weekly
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Local Institution, Amsterdam, Netherlands
Local Institution, Newark, Delaware, United States
Local Institution, Louisville, Kentucky, United States
Local Institution, Las Vegas, Nevada, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date: December 2006
Last updated: September 19, 2007
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