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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00414960
First received: December 21, 2006
Last updated: February 25, 2011
Last verified: October 2010
History of Changes

December 21, 2006
February 25, 2011
November 2006
September 2010   (final data collection date for primary 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. [ Time Frame: baseline, end of treatment ] [ Designated as safety issue: No ]
To compare the difference between the average Ki-67 LI (percentage of cells positively labeled with Ki-67) in all bronchial biopsy specimens collected before and after treatment between the enzastaurin and placebo groups.
Complete list of historical versions of study NCT00414960 on ClinicalTrials.gov Archive Site
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 ]
To compare the treatment-emergent adverse events (TEAEs) between the enzastaurin and placebo arms in this patient population
Not Provided
Not Provided
 
A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers
Phase IIB Randomized, Placebo-Controlled, Double-Blind Study of Enzastaurin HCL (LY317615) for Lung Cancer Prevention in Former Smokers

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.

x
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Lung Cancer
  • Drug: enzastaurin
    500 mg, daily, oral, 6 months
    Other Name: LY317615
  • Drug: placebo
    oral, daily
  • Experimental: A
    Intervention: Drug: enzastaurin
  • Placebo Comparator: B
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00414960
10723, H6Q-MC-S009
Yes
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP