A Phase I Study of BMS-275183 (Oral Taxane) Given on a Da... | NCT00332748 | Trialant

Home
Search
Collections
Views
Audits

Terms of Service
Privacy Policy

A Phase I Study of BMS-275183 (Oral Taxane) Given on a Da... | NCT00332748 | Trialant

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

NCT00332748

Sponsor

Bristol-Myers Squibb

Status

Terminated

Last Update Posted

Mar 2, 2010Estimated

Enrollment

36

Phase

Phase 1

Conditions

Cancer

Interventions

Oral Taxane

Countries

United States
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

NCT00332748

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

CA165-030

Secondary IDs

Not provided

Brief Title

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

Official Title

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

Acronym

Not provided

Organization

Bristol-Myers SquibbINDUSTRY

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Dec 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Not provided

First Submitted Date

May 31, 2006

First Submission Date that Met QC Criteria

Jun 1, 2006

First Posted Date

Jun 2, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Feb 27, 2010

Certification/Extension First Submitted that Passed QC Review

Feb 27, 2010

Certification/Extension First Posted Date

Mar 2, 2010Estimated

Last Update Submitted Date

Feb 27, 2010

Last Update Posted Date

Mar 2, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Bristol-Myers SquibbINDUSTRY

Collaborators

Not provided

Oversight Module

No data available

No data is available for this block.

Description Module

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.

Detailed Description

Not provided

Conditions Module

Conditions

Cancer

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral Taxane	Drug

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Newark	Delaware		United States
Local Institution

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Randomized

Intervention Model

Single Group Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

Louisville

Kentucky

United States

Local Institution

Las Vegas

Nevada

United States

Local Institution

Amsterdam

Netherlands

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
C080625	taxane

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided