Phase 2 Completed N=40 Randomized Quadruple-blind Prevention

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

Source: ClinicalTrials.gov NCT00414960 ↗

Enrolled (actual)

Serious AEs

5.1%

Results posted

Sep 2020

Primary outcomePrimary: Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint — 3.74; 6.15 percentage of cells with Ki-67 — p=0.556

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint	3.74; 6.15	0.556
SECONDARY Number of Participants With Adverse Events (AEs)	2; 0; 24; 10	—

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 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

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Data sourced from ClinicalTrials.gov (NCT00414960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.