NCT00105092已完成2 期
A Phase II Evaluation of Oral Enzastaurin HCl in Second-and Third- Line Treatment of Patients With Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- To estimate the rate of progression-free survival at 6 months for patients receiving oral enzastaurin with NSCLC who are eligible for second-or third-line therapy
研究概览
简要总结
Enzastaurin given daily to patients with non-small cell lung cancer who have failed at least one prior therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years old
- •Must have been diagnosed with advanced or metastatic non-small cell lung cancer
- •Must be able to visit the doctor's office every 28 days for 6 months or longer.
排除标准
- •Pregnant or breastfeeding women
- •Have other significant medical problems as determined by your physician
- •Are unable to swallow tablets
- •Have a history of significant heart disease
结局指标
主要结局
To estimate the rate of progression-free survival at 6 months for patients receiving oral enzastaurin with NSCLC who are eligible for second-or third-line therapy
次要结局
- To estimate the objective response rate (complete response [CR] and partial response [PR])
- To evaluate the pharmacokinetics of enzastaurin using sparse sampling methodology in this population
- To assess the QTc interval at anticipated steady state levels of enzastaurin (centrally collected 12-lead ECG on Day 1 of Cycle 2)
- To estimate time-to-event variables, such as overall survival time, duration of overall response (up to 1 year), and duration of stable disease (up to 1 year)
- To evaluate the safety of enzastaurin in this patient population
- To assess PKCb expression by immunohistochemistry in readily available tumors from patients
- To evaluate enzastaurin's effect on patients' symptoms, functioning, and health-related quality of life using validated patient questionnaires
- To explore biomarkers relevant to tumor progression and PKCb signaling
研究者
研究点 (3)
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