A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 17
- 主要终点
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 ED-SCLC and have received a prior platinum-based regimen
- •Participants in Cohort 1 and in the addendum must have had an objective response to prior platinum-based therapy with subsequent progression ≥90 days after the last dose of platinum
- •Participants in Cohort 2 must have either not had an objective response to prior platinum based therapy or had progression <90 days after the last dose of platinum
- •Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale
排除标准
- •Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
- •Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids to treat CNS metastases
- •Have previously completed or withdrawn from this study or any other study investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown hypersensitivity to any of the components of the prexasertib formulation
- •Have a serious cardiac condition
研究组 & 干预措施
Prexasertib (Platinum Sensitive Disease)
105 mg/m^2 Intravenous (IV) prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had platinum-sensitive disease (has prior platinum based therapy with subsequent progression greater or less than 90 days after last dose of platinum based therapy).
干预措施: Prexasertib (Drug)
Prexasertib (Platinum Resistant Disease)
105 mg/m^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum).
干预措施: Prexasertib (Drug)
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
40 mg/m^2 IV prexasertib Day 1, 2, and Day 3 of a 14 day cycle in participants with ED-SCLC platinum sensitive disease.
干预措施: Prexasertib (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
时间窗: Baseline to 10 months
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions
次要结局
- Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2(Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime)
- Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda)(Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime)
- Duration of Response (DoR)(Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months)
- Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)(Baseline through Disease Progression or Death from Any Cause to 28 months)
- Change From Baseline in Lung Cancer Symptom Scale Score (LCSS)(Baseline up to 9 months)
- Pharmacokinetics: Area Under the Concentration Curve of Prexasertib(Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime)
- Progression-Free Survival (PFS)(Baseline to Disease Progression or Death (up to 9 months))
- Overall Survival (OS)(Baseline up to 28 months)
- Change From Baseline on the Average Symptom Burden Index (ASBI)(Baseline up to 9 months)