NCT00332748

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_1 cancer

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

March 2, 2010

Status Verified

September 1, 2007

Enrollment Period

1 year

First QC Date

May 31, 2006

Last Update Submit

February 27, 2010

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

Interventions

Oral TaxaneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced cancers excluding cancers within the blood
  • Adequate kidney and liver function
  • \> = 4 weeks from last course of chemotherapy

You may not qualify if:

  • Inability to swallow capsules
  • Other active medical disorder
  • Abnormal heart function or use of drugs that affect the heart

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Local Institution

Newark, Delaware, United States

Location

Local Institution

Louisville, Kentucky, United States

Location

Local Institution

Las Vegas, Nevada, United States

Location

Local Institution

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Neoplasms

Interventions

taxane

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 2, 2006

Study Start

December 1, 2006

Primary Completion

December 1, 2007

Last Updated

March 2, 2010

Record last verified: 2007-09

Locations

US(3)NL(1)