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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00332748

Enrollment

Registered

2006-06-02

Start date

2006-12-31

Completion date

Unknown

Last updated

2010-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief 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.

Interventions

DRUGOral Taxane

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026