A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00414960

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: enzastaurin Drug: placebo	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Enzastaurin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase IIB Randomized, Placebo-Controlled, Double-Blind Study of Enzastaurin HCL (LY317615) for Lung Cancer Prevention in Former Smokers

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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. [ Time Frame: baseline, end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the treatment-emergent adverse events (TEAEs) between the enzastaurin and placebo arms in this patient population [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	186
Study Start Date:	November 2006
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: enzastaurin 500 mg, daily, oral, 6 months
B: Placebo Comparator	Drug: placebo oral, daily

Detailed Description:

x

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414960

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Locations

United States, Florida
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.	Recruiting
Tampa, Florida, United States, 33612
Contact: Eli Lilly

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10723, H6Q-MC-S009
Study First Received:	December 21, 2006
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00414960
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Healthy
Prevention

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Healthy

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009