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NCT00207116 Clinical Trial

An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00207116
Other study ID # CA225-065
Secondary ID
Status Completed
Phase Phase 1
First received September 12, 2005
Last updated October 26, 2015
Start date September 2005
Est. completion date March 2006

Study information
Verified date October 2015
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to predict responses to Erbitux as a single agent in patients with Non Small Cell Lung Cancer

Other known NCT identifiers
  • NCT00118118

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• Cetuximab
IV solution, IV, 400 mg/m2 initial dose followed by weekly doses of 250 mg/m2, Weekly, until disease progression.

Locations
Country Name City State
United States Local Institution Newark Delaware

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prediction of response to Erbitux with non small cell lung cancer
Secondary Radiographic Response
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