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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
  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 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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 ]

Enrollment: 39
Study Start Date: November 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: enzastaurin
500 mg, daily, oral, 6 months
Other Name: LY317615
Placebo Comparator: B 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

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.
Tampa, Florida, United States, 33612
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

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

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00414960     History of Changes
Obsolete Identifiers: NCT00387816
Other Study ID Numbers: 10723, H6Q-MC-S009
Study First Received: December 21, 2006
Last Updated: February 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Healthy
Prevention

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013