Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 40
- 主要终点
- Number of Participants with Dose Reductions
研究概览
简要总结
The purpose of this study is to determine the recommended phase 2 dose of LY3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Have histological or cytological evidence of a diagnosis of platinum sensitive small cell lung cancer that is extensive stage.
- •Have adequate organ function.
- •Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- •Have discontinued previous treatments for cancer.
- •Are able to swallow capsules.
排除标准
- •Currently enrolled in a clinical study.
- •Have a serious concomitant systemic disorder.
- •Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C.
- •Have a significant cardiac condition.
- •Have previously received an aurora kinase inhibitor.
研究组 & 干预措施
LY3295668 Erbumine Cohort A
LY3295668 erbumine administered orally.
干预措施: LY3295668 Erbumine (Drug)
LY3295668 Erbumine Cohort B
LY3295668 erbumine administered orally.
干预措施: LY3295668 Erbumine (Drug)
LY3295668 Part JP
LY3295668 erbumine administered orally.
干预措施: LY3295668 Erbumine (Drug)
结局指标
主要结局
Number of Participants with Dose Reductions
时间窗: Baseline through Cycle 1 (28 Day Cycle)
Number of Participants with Dose Reductions
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine
时间窗: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of LY3295668 Erbumine
Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
时间窗: Baseline through Measured Progressive Disease (Estimated up to 20 Months)
ORR: Percentage of participants who achieve CR or PR
Duration of Response (DoR)
时间窗: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 20 Months)
DoR
次要结局
- PK: Maximum Concentration (Cmax) of LY3295668 Erbumine(Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles))
- Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD(Baseline through Measured Progressive Disease (Estimated up to 20 Months))
- Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)(Baseline to Date of Objective Disease Progression (Estimated up to 20 Months))