Phase IIB Randomized, Placebo-Controlled, Double-Blind Study of Enzastaurin HCL (LY317615) for Lung Cancer Prevention in Former Smokers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Enzastaurin
Treatment with enzastaurin 500 milligrams (mg) orally (po) once daily (QD) given as 4 tablets (125 mg each).
干预措施: Enzastaurin (Drug)
Placebo
Treatment with placebo po QD appearing identical to enzastaurin.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint
时间窗: Baseline, endpoint (up to 8 months)
The number of cells positively stained for Ki-67 (a marker of cellular proliferation) was enumerated and divided by the total number of cells in each specimen. The average Ki-67 labeling index (LI) (percentage of cells positively labeled with Ki-67) for all histological specimens was then calculated for each participant.
次要结局
- Number of Participants With Adverse Events (AEs)(Baseline through end of study (up to 32 months))