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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 InstitutionBaltimore, Maryland  
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionCorona, California  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionAustin, Texas  
Local InstitutionChattanooga, Tennessee  
Local InstitutionColumbia, Missouri