NCT00414960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
10.1 years until next milestone

Results Posted

Study results publicly available

September 21, 2020

Completed
Last Updated

September 21, 2020

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

December 21, 2006

Results QC Date

August 17, 2020

Last Update Submit

August 31, 2020

Conditions

Lung Cancer

Keywords

HealthyPrevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Participants With Adverse Events (AEs)

    Baseline through end of study (up to 32 months)

Study Arms (2)

Enzastaurin

EXPERIMENTAL

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

Drug: Enzastaurin

Placebo

PLACEBO COMPARATOR

Treatment with placebo po QD appearing identical to enzastaurin.

Drug: Placebo

Interventions

EnzastaurinDRUG

500 mg po QD for 6 months

Also known as: LY317615
Enzastaurin
PlaceboDRUG

po QD for 6 months

Placebo

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

enzastaurin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Limitations and Caveats

The planned enrollment for the study was 186 participants, but enrollment was terminated early due to the difficulty of accruing participants once 40 were enrolled into the study.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Study Start

December 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 21, 2020

Results First Posted

September 21, 2020

Record last verified: 2020-08

Locations

US(1)