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

NCT ID: NCT00332748

Last Updated: 2010-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Oral Taxane

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

Newark, Delaware, United States

Site Status

Local Institution

Louisville, Kentucky, United States

Site Status

Local Institution

Las Vegas, Nevada, United States

Site Status

Local Institution

Amsterdam, , Netherlands

Site Status

Countries

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United States Netherlands

Other Identifiers

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CA165-030

Identifier Type: -

Identifier Source: org_study_id

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