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


Phase 2
45 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


x


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 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 are
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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

To compare the difference between the average Ki-67 LI (percentage of cells positively labeled with Ki-67) in all bronchial biopsy specimens collected between the enzastaurin and placebo groups.

Outcome Time Frame:

baseline, end of treatment

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

10723

NCT ID:

NCT00414960

Start Date:

November 2006

Completion Date:

September 2010

Related Keywords:

  • Lung Cancer
  • Healthy
  • Prevention
  • Lung Neoplasms

Name

Location
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. Jacksonville, Florida  32256