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An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

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Trial Information

An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prediction of response to Erbitux in subjects with metastatic colorectal cancer

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA225-045

NCT ID:

NCT00207155

Start Date:

December 2003

Completion Date:

February 2006

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Local Institution Baltimore, Maryland  
Local Institution Bronx, New York  
Local Institution Cincinnati, Ohio  
Local Institution Corona, California  
Local Institution Fort Lauderdale, Florida  
Local Institution New Brunswick, New Jersey  
Local Institution Duncansville, Pennsylvania  
Local Institution Austin, Texas  
Local Institution Chattanooga, Tennessee  
Local Institution Columbia, Missouri