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A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II


Prevention


Active


45 and over


Pharmaceutical / Industry


10723
H6Q-MC-S009, NCT00414960

Trial Description

Summary

To compare the difference of a marker of cellular proliferation in all bronchial biopsy specimens of former smokers stratified by lung cancer risk, collected before and after treatment per patient between the enzastaurin and placebo groups.

Further Study Information

x

Eligibility Criteria

Inclusion Criteria:

  • Sputum atypia participants with normal sputum cytology will be removed from the study)
  • Metaplasia or dysplasia on at least one bronchoscopy specimen
  • History of cigarette smoking >30 Pack Years
  • Quit smoking >1 year prior to study entry
  • Able to undergo bronchoscopy and helical CT scanning of the chest
  • Able to swallow tablets

Exclusion Criteria:

  • Blood clotting abnormalities
  • Current smoking within the past 1 year
  • Unwillingness to abstain from smoking while enrolled in the clinical trial or are unwillingness to avoid significant second hand smoke exposure
  • Evidence for lung cancer or carcinoma in situ
  • Active cardiovascular disease
  • Current illicit drug or alcohol abuse

Trial Contact Information

Trial Lead Organizations/Sponsors

Eli Lilly and Company

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)Study Director

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) orPh: 1-317-615-4559

Trial Sites

U.S.A.
Florida
  Tampa
 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
 Eli Lilly

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00414960
Information obtained from ClinicalTrials.gov on November 18, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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