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

Lung Cancer Clinical Trial

Official title:

Phase IIB Randomized, Placebo-Controlled, Double-Blind Study of Enzastaurin HCL (LY317615) for Lung Cancer Prevention in Former Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414960
• Other study ID #: 10723
• Secondary ID: H6Q-MC-S009
• Status: Completed
• Phase: Phase 2
• Start date: December 2007
• Est. completion date: September 2010

Study information

• Verified date: August 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00387816

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Enzastaurin
500 mg po QD for 6 months
• Placebo
po QD for 6 months

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint	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.	Baseline, endpoint (up to 8 months)
Secondary	Number of Participants With Adverse Events (AEs)	Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.	Baseline through end of study (up to 32 months)

External Links

•   Lilly Clinical Trial Registry