search
Back to results

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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enzastaurin
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring Healthy, Prevention

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Enzastaurin

Placebo

Arm Description

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

Treatment with placebo po QD appearing identical to enzastaurin.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 21, 2006
Last Updated
August 31, 2020
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT00414960
Brief Title
A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers
Official Title
Phase IIB Randomized, Placebo-Controlled, Double-Blind Study of Enzastaurin HCL (LY317615) for Lung Cancer Prevention in Former Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Healthy, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzastaurin
Arm Type
Experimental
Arm Description
Treatment with enzastaurin 500 milligrams (mg) orally (po) once daily (QD) given as 4 tablets (125 mg each).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo po QD appearing identical to enzastaurin.
Intervention Type
Drug
Intervention Name(s)
Enzastaurin
Other Intervention Name(s)
LY317615
Intervention Description
500 mg po QD for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po QD for 6 months
Primary Outcome Measure Information:
Title
Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint
Description
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.
Time Frame
Baseline, endpoint (up to 8 months)
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.
Time Frame
Baseline through end of study (up to 32 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs