- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00332748
A Phase I Study of BMS-275183 (Oral Taxane) Given on a Daily Schedule in Combination With Esomeprazole (Nexium) in Patients With Advanced Cancer
February 27, 2010 updated by: Bristol-Myers Squibb
Effect of Esomeprazole on the Pharmacokinetics of BMS-275183 in Patients With Advanced Malignancies
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.
Study Overview
Study Type
Interventional
Enrollment
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amsterdam, Netherlands
- Local Institution
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Delaware
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Newark, Delaware, United States
- Local Institution
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Kentucky
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Louisville, Kentucky, United States
- Local Institution
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Nevada
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Las Vegas, Nevada, United States
- Local Institution
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
May 31, 2006
First Submitted That Met QC Criteria
June 1, 2006
First Posted (Estimate)
June 2, 2006
Study Record Updates
Last Update Posted (Estimate)
March 2, 2010
Last Update Submitted That Met QC Criteria
February 27, 2010
Last Verified
September 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA165-030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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