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

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00103831

First received: February 15, 2005

Last updated: February 27, 2010

Last verified: August 2008

History of Changes

Purpose

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.

Condition	Intervention	Phase
Non-small Cell Lung Cancer	Drug: Oral Taxane	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase I Alimta Combination With BMS-275183 (Oral Taxane)

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:


Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103831

Locations


United States, Colorado
Local Institution
Denver, Colorado, United States
United States, Minnesota
Local Institution
Rochester, Minnesota, United States
Canada, Ontario
Local Institution
Toronto, Ontario, Canada

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site


ClinicalTrials.gov Identifier:	NCT00103831 History of Changes
Other Study ID Numbers:	CA165-021
Study First Received:	February 15, 2005
Last Updated:	February 27, 2010

Keywords provided by Bristol-Myers Squibb:


NSCLC - non-small cell lung cancer

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms	Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Taxane Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2017

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