NCT00103831

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.

Trial Health

85
On Track

Trial Health Score

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

Geographic Reach
2 countries

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Last Updated

March 2, 2010

Status Verified

August 1, 2008

First QC Date

February 15, 2005

Last Update Submit

February 27, 2010

Conditions

Keywords

NSCLC - non-small cell lung cancer

Interventions

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Local Institution

Denver, Colorado, United States

Location

Local Institution

Rochester, Minnesota, United States

Location

Local Institution

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

taxane

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 15, 2005

First Posted

February 16, 2005

Primary Completion

May 1, 2005

Last Updated

March 2, 2010

Record last verified: 2008-08

Locations