NCT04352413终止2 期
An Open-label, Multi-center, Phase 2 Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection (PLM60) in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年6月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is an open, multicenter phase II clinical study for PLM60. The primary aim of the study is to observe the initial efficacy of PLM60 in treatment of small cell lung cancer. The secondary aim is to explore the safety and PK characteristics of PLM60
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of SCLC;
- •Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of SCLC;
- •ECOG performance status 0~2;
- •Measurable lesion according to RECIST v1.1;
- •Life expectancy ≥ 12 weeks;
- •Adequate organ function;
- •Signed informed consent from the patient.
排除标准
- •Radical surgical treatment for primary small cell lung cancer;
- •Any anti-tumor treatment received within 4 weeks before the first use of the study drug;
- •Untreated or symptomatic central nervous system (CNS) metastases;
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- •History of serious systemic diseases;
- •History of serious autoimmune diseases;
- •Those receiving treatment of adriamycin or other anthracyclines previously, with the total cumulative adriamycin (or adriamycin-equivalent) dose of >360 mg/m2.
研究组 & 干预措施
Cohort A: PLM60
Experimental
20 mg/m2, 4 weeks/cycle, administered on day 1 of each cycle
干预措施: PLM60 (Drug)
Cohort B: PLM60
Experimental
15mg/m2, 3 weeks/cycle, administered on day 1 of each cycle
干预措施: PLM60 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Through study completion, an average of 2 year
To evaluate ORR in SCLC subjects treated with PLM60
次要结局
- Duration of Response (DoR)(Through study completion, an average of 2 year)
- Disease Control Rate (DCR)(Through study completion, an average of 2 year)
- Progression Free Survival (PFS)(Through study completion, an average of 2 year)
- Overall Survival (OS)(Through study completion, an average of 2 year)
- Adverse Events(Through study completion, an average of 2 year)
- Serious Adverse Events (SAEs)(Through study completion, an average of 2 year)
研究者
研究点 (1)
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