An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma

This study has been completed.

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00207116

Purpose

The purpose of this study is to predict responses to Erbitux as a single agent in patients with Non Small Cell Lung Cancer

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis	Drug: Cetuximab	Phase I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cetuximab

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title:	An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	120
Study Start Date:	September 2005

Arms	Assigned Interventions
A: Experimental	Drug: Cetuximab IV solution, IV, 400 mg/m2 initial dose followed by weekly doses of 250 mg/m2, Weekly, until disease progression.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207116

Locations

United States, Delaware
Local Institution
Newark, Delaware, United States

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

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

Study ID Numbers:	CA225-065
Study First Received:	September 12, 2005
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00207116
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Metastatic Non Small Cell Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Cetuximab
Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009