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

Phase 1

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Cetuximab

• Registration Number: NCT00207155
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to predict response to Erbitux as a single agent in patients with metastatic colon cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-21
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Cetuximab	-

Primary Outcome Measures

Name	Time	Method
Prediction of response to Erbitux in subjects with metastatic colorectal cancer

Secondary Outcome Measures

Name	Time	Method
Radiographic Response

Trial Locations

Locations (1)

Local Institution; 🇪🇸 Barcelona, Spain