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NCT00332748 Clinical Trial

A Phase I Study of BMS-275183 (Oral Taxane) Given on a Daily Schedule in Combination With Esomeprazole (Nexium) in Patients With Advanced Cancer

Cancer Clinical Trial

Official title:
Effect of Esomeprazole on the Pharmacokinetics of BMS-275183 in Patients With Advanced Malignancies

Clinical Trial Details — Status: Terminated

Administrative data
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

Study information
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

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Oral Taxane

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome
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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