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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Enzastaurin

Treatment with enzastaurin 500 milligrams (mg) orally (po) once daily (QD) given as 4 tablets (125 mg each).

Group Type EXPERIMENTAL

Enzastaurin

Intervention Type DRUG

500 mg po QD for 6 months

Placebo

Treatment with placebo po QD appearing identical to enzastaurin.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po QD for 6 months

Interventions

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Enzastaurin

500 mg po QD for 6 months

Intervention Type DRUG

Placebo

po QD for 6 months

Intervention Type DRUG

Other Intervention Names

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LY317615

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No