Cancer Clinical Trial
Official title:
Effect of Esomeprazole on the Pharmacokinetics of BMS-275183 in Patients With Advanced Malignancies
NCT number | NCT00332748 |
Other study ID # | CA165-030 |
Secondary ID | |
Status | Terminated |
Phase | Phase 1 |
First received | May 31, 2006 |
Last updated | February 27, 2010 |
Start date | December 2006 |
Verified date | September 2007 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 36 |
Est. completion date | |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Local Institution | Amsterdam | |
United States | Local Institution | Las Vegas | Nevada |
United States | Local Institution | Louisville | Kentucky |
United States | Local Institution | Newark | Delaware |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To assess the safety of a single dose of oral taxane followed by a therapeutic regimen of oral taxane administered twice weekly |
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