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

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution
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  • Local Institution
  • Local Institution
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  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Prediction of response to Erbitux in subjects with metastatic colorectal cancer

Secondary Outcome Measures

Radiographic Response

Full Information

First Posted
September 12, 2005
Last Updated
October 26, 2015
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00207155
Brief Title
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer
Official Title
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (false)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
IV solution, IV, 400 mg/m2 initial dose + 250-400 mg/m2 weekly, Weekly, Until disease progression.
Primary Outcome Measure Information:
Title
Prediction of response to Erbitux in subjects with metastatic colorectal cancer
Secondary Outcome Measure Information:
Title
Radiographic Response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Duarte
State/Province
California
Country
United States
Facility Name
Local Institution
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Local Institution
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Local Institution
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Local Institution
City
Bronx
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Local Institution
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Local Institution
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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