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

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Drug: Placebo; Drug: Enzastaurin

• Registration Number: NCT00414960
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Study First Posted: 2006-12-22
• Study Start: 2007-12
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Disposition First Submitted: 2011-02-25
• Disposition First Submitted QC: 2011-02-25
• Disposition First Posted: 2011-03-11
• Status Verified: 2020-08
• Results First Submitted: 2020-08-17
• Results First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Results First Posted: 2020-09-21
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Treatment with placebo po QD appearing identical to enzastaurin.
Enzastaurin	Enzastaurin	Treatment with enzastaurin 500 milligrams (mg) orally (po) once daily (QD) given as 4 tablets (125 mg each).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint	Baseline, endpoint (up to 8 months)	The number of cells positively stained for Ki-67 (a marker of cellular proliferation) was enumerated and divided by the total number of cells in each specimen. The average Ki-67 labeling index (LI) (percentage of cells positively labeled with Ki-67) for all histological specimens was then calculated for each participant.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Baseline through end of study (up to 32 months)	Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.

Trial Locations

Locations (1)

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.; 🇺🇸 Tampa, Florida, United States