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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Oral Taxane
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC - non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 15, 2005
Last Updated
February 27, 2010
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00103831
Brief Title
Oral Taxane in Combination With Pemetrexed (Alimta) in Patients With Recurrent Non-Small Cell Lung Cancer
Official Title
Phase I Alimta Combination With BMS-275183 (Oral Taxane)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
NSCLC - non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oral Taxane

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Local Institution
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Local Institution
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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