A Phase 2 Study of LY2523355 in Patients With Extensive-Stage Small-Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate)
研究概览
简要总结
Part A: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.
Part B: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.
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
- •Have histological or cytological evidence of extensive-disease small-cell lung cancer
- •Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- •Have received at least 1 prior chemotherapy regimen with agents known to provide clinical benefit for small-cell lung cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy
- •Have discontinued all previous therapies for cancer, including chemotherapy, biologic therapy, hormone therapy, or radiotherapy. Participants must have recovered from the acute effects of therapy (except alopecia and fatigue) before study enrollment
- •Part A: Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group scale
- •Part B: Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale
排除标准
- •Have received treatment within 28 days of the first dose of LY2523355 with a drug that has not received regulatory approval for any indication
- •Have a mixed histological diagnosis of small-cell lung cancer and non-small-cell lung cancer
- •Have serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study
- •Part A: Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic participants without history of CNS metastases is not required
- •Part B: Have symptomatic, untreated, or uncontrolled CNS metastases or a history of CNS metastases. Participants who have received prophylactic radiation are not excluded. Screening of asymptomatic participants without history of CNS metastases is not required
研究组 & 干预措施
Part B LY2523355
5 or 6 mg/m² per dose based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, 3 plus granulocyte colony-stimulating factor (G-CSF) support administered subcutaneously beginning on Day 4 of each 21-day cycle, until disease progression or unacceptable toxicity.
干预措施: LY2523355 (Drug)
Part A LY2523355
8 milligrams per square meter (mg/m²) per dose based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, 9 of each 21-day cycle, until disease progression or unacceptable toxicity.
干预措施: LY2523355 (Drug)
Part B LY2523355
5 or 6 mg/m² per dose based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, 3 plus granulocyte colony-stimulating factor (G-CSF) support administered subcutaneously beginning on Day 4 of each 21-day cycle, until disease progression or unacceptable toxicity.
干预措施: Granulocyte colony-stimulating factor (G-CSF) (Drug)
结局指标
主要结局
Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate)
时间窗: Date of enrollment to date of measured progressive disease up to 99.6 weeks
The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR, then divided by the total number of participants treated, then multiplied by 100.
Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)
时间窗: Date of enrollment to date of measured progressive disease up to 18.1 weeks
Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
次要结局
- Part A: Progression-Free Survival(Date of enrollment to date of measured progressive disease or date of death from any cause up to 99.6 weeks)
- Part B: Progression-Free Survival(Date of enrollment to date of measured progressive disease or date of death from any cause up to 18.1 weeks)
- Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307)(Days 1,5 and 9 of Cycle 1 (21-day cycle))
- Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355(Day 3 of Cycle 1 (21-day cycle))
- Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)(Date of enrollment to date of measured progressive disease 99.6 weeks)
- Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate)(Date of enrollment to date of measured progressive disease up to 18.1 weeks)
- Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)](Day 3 of Cycle 1 (21-day cycle))
- Part A: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)](Days 1,5 and 9 of Cycle 1 (21-day cycle))
- Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI)(Baseline and follow-up up to 104 weeks after the first dose of study drug)