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

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ClinicalTrials.gov Identifier: NCT00414960
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : March 11, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: enzastaurin Drug: placebo Phase 2

Detailed Description:
x

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: A Drug: enzastaurin
500 mg, daily, oral, 6 months
Other Name: LY317615
Placebo Comparator: B Drug: placebo
oral, daily



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To compare the treatment-emergent adverse events (TEAEs) between the enzastaurin and placebo arms in this patient population [ Time Frame: every cycle ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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 ( Other Identifier: Eli Lilly and Company )
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: March 11, 2011
Last Verified: October 2010

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