Oral Taxane in Combination With Pemetrexed (Alimta) in Pa... | NCT00103831

Studies
Oral Taxane in Combination With Pemetrexed (Alimta) in Patients With Recurrent Non-Small Cell Lung Cancer

NCT00103831

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Mar 2, 2010Estimated

Enrollment

Not provided

Phase

Phase 1Phase 2

Conditions

Non-small Cell Lung Cancer

Interventions

Oral Taxane

Countries

United States
Canada

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

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

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

May 2005Actual

Completion Date

Not provided

First Submitted Date

Feb 15, 2005

First Submission Date that Met QC Criteria

Feb 15, 2005

First Posted Date

Feb 16, 2005Estimated

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

Description Module

Brief Summary

A phase I-II dose ranging study of BMS-275183 (oral taxane) in combination with pemetrexed (Alimta) in patients with recurrent Non-Small Cell Lung Cancer (NSCLC). The safety and efficacy of this combination will be studied.

Detailed Description

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 1Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Oral Taxane	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced or metastatic pretreated NSCLC
Measurable disease
Adequate hematologic, hepatic and renal functions.
ECOG Performance Status 0-2

Exclusion Criteria:

Inability to swallow capsules
Recent significant cardiovascular disease
Women who are pregnant or breastfeeding

Accepts Healthy Volunteers

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		Denver	Colorado		United States
Local Institution

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C080625	taxane

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided