Back to resultsAn Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma
Primary Purpose
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Metastatic Non Small Cell Lung Cancer
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
Sites / Locations
- 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 with non small cell lung cancer
Secondary Outcome Measures
Radiographic Response
Full Information
NCT ID
NCT00207116
First Posted
September 12, 2005
Last Updated
October 26, 2015
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00207116
Brief Title
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma
Official Title
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 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 responses to Erbitux as a single agent in patients with Non Small Cell Lung Cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
Keywords
Metastatic Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (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 followed by weekly doses of 250 mg/m2, Weekly, until disease progression.
Primary Outcome Measure Information:
Title
Prediction of response to Erbitux with non small cell lung 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
Newark
State/Province
Delaware
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma
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