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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.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00332748
First received: May 31, 2006
Last updated: February 27, 2010
Last verified: September 2007
History of Changes
  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 1

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
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 May 19, 2013