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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

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 computed tomography (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 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