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

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Lilly

Status and phase

Completed
Phase 2

Conditions

Lung Cancer

Treatments

Drug: Placebo
Drug: Enzastaurin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00414960
10723
H6Q-MC-S009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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 computed tomography (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 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

Enzastaurin
Experimental group
Description:
Treatment with enzastaurin 500 milligrams (mg) orally (po) once daily (QD) given as 4 tablets (125 mg each).
Treatment:
Drug: Enzastaurin
Placebo
Placebo Comparator group
Description:
Treatment with placebo po QD appearing identical to enzastaurin.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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