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

This study has been terminated.

First Received on May 31, 2006. Last Updated on February 27, 2010 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00332748

Purpose

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.

Condition	Intervention	Phase
Cancer	Drug: Oral Taxane	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Esomeprazole on the Pharmacokinetics of BMS-275183 in Patients With Advanced Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium BMS 275183

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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:

To assess the safety of a single dose of oral taxane followed by a therapeutic regimen of oral taxane administered twice weekly

Estimated Enrollment:	36
Study Start Date:	December 2006
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332748

Locations

United States, Delaware
Local Institution
Newark, Delaware, United States
United States, Kentucky
Local Institution
Louisville, Kentucky, United States
United States, Nevada
Local Institution
Las Vegas, Nevada, United States
Netherlands
Local Institution
Amsterdam, Netherlands

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00332748 History of Changes
Other Study ID Numbers:	CA165-030
Study First Received:	May 31, 2006
Last Updated:	February 27, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Omeprazole
Taxane
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012