A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 57
- 主要终点
- Disease Control Rate (DCR) within biomarker-defined subgroup
研究概览
简要总结
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1/PD-1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Aged ≥18 years at signing of informed consent
- •Pathologically confirmed SCLC
- •Prior treatment with one platinum-based chemotherapy and an anti-PD-L1/PD-1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens
排除标准
- •Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting
- •Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
研究组 & 干预措施
Alisertib
50 mg (Prior to Amendment 2) or 60 mg (Amendment 2) or 70 mg (Amendment 3 or later) of alisertib PO BID on days 1-7 of each 21-day cycle
干预措施: Alisertib (Drug)
结局指标
主要结局
Disease Control Rate (DCR) within biomarker-defined subgroup
时间窗: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
Disease control rate is the proportion of patients who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 8 weeks from first dose of investigational product.
Progression Free Survival (PFS) within biomarker-defined subgroup
时间窗: From date of first dose to date of recurrence, progression or death, assessed up to 36 months
Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of first dose until the first date on which recurrence, progression, or death due to any cause, is documented.
Overall Survival (OS) within biomarker-defined subgroup
时间窗: From date of first dose to death, assessed up to 36 months
Overall survival (OS) is defined as the time from date of first dose to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier.
Objective response rate (ORR) within biomarker-defined subgroup
时间窗: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study
Duration of response (DOR) within biomarker-defined subgroup
时间窗: From start date of response (after date of first dose) to first PD, assessed up to 36 months
Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.
次要结局
- Progression Free Survival (PFS) in the enrolled patient population(From date of first dose to date of recurrence, progression or death, assessed up to 36 months)
- Overall Survival (OS) in the enrolled patient population(From date of first dose to death, assessed up to 36 months)
- Objective response rate (ORR) in the enrolled patient population(From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months)
- Duration of response (DOR) in the enrolled patient population(From start date of response (after date of first dose) to first PD, assessed up to 36 months)
- Disease Control Rate (DCR) in the enrolled patient population(From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months)
- Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the enrolled patient population(From date of first dose through last dose plus 28 days, assessed up to 36 months)