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

Lilly

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: Placebo; Drug: Enzastaurin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00414960

10723

H6Q-MC-S009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Enzastaurin

Experimental group

Description:

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

Treatment:

Drug: Enzastaurin

Placebo

Placebo Comparator group

Description:

Treatment with placebo po QD appearing identical to enzastaurin.

Treatment:

Drug: Placebo