This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

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

Resource links provided by NLM:

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 ]

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 ]

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:

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00414960

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
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:
Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00414960     History of Changes
Obsolete Identifiers: NCT00387816
Other Study ID Numbers: 10723
H6Q-MC-S009 ( Other Identifier: Eli Lilly and Company )
Study First Received: December 21, 2006
Last Updated: February 25, 2011

Keywords provided by Eli Lilly and Company:

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on August 22, 2017