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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00207116
First received: September 12, 2005
Last updated: April 7, 2011
Last verified: July 2008

September 12, 2005
April 7, 2011
September 2005
March 2006   (final data collection date for primary outcome measure)
Prediction of response to Erbitux with non small cell lung cancer
Same as current
Complete list of historical versions of study NCT00207116 on ClinicalTrials.gov Archive Site
Radiographic Response
Same as current
Not Provided
Not Provided
 
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasm Metastasis
Drug: Cetuximab
IV solution, IV, 400 mg/m2 initial dose followed by weekly doses of 250 mg/m2, Weekly, until disease progression.
Other Name: Erbitux
Experimental: A
Intervention: Drug: Cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2006
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Measurable disease tumor available for biopsies
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Known or documented brain metastases prior to Cetuximab therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00207116
CA225-065
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP