NCT04331743Unknown1 期
A Single-arm, Open-label, Single-center Phase Ib Study to Evaluate the Safety and Efficacy of Liposome-entrapped Mitoxantrone Hydrochloride Injection (PLM60) in Advanced Hepatocellular Carcinoma (HCC)
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.0 个研究点目标入组 18 人开始时间: 2021年6月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is a dose escalation study based on 3+3 design with the aim to establish MTD and provide RP2D. PLM60 is to administered by multi-cycle intravenous infusion.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent from the patient；
- •ECOG performance status of 0 or 1;
- •Histologically/cytologically confirmed diagnosis of advanced HCC;
- •Adequate washout period for previous anti-tumor therapy;
- •Measurable disease according to RECIST v1.1;
- •Life expectancy ≥ 12 weeks;
- •Adequate organ function;
- •Child-Pugh grade A or partial grade B; BCLC stage B or C;V
排除标准
- •Prior treatment with Mitoxantrone or Liposome-entrapped Mitoxantrone, or other anthracyclines, with the total cumulative dose of > 360 mg/m2 ;
- •Any drug-related adverse event derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or other toxicity with little safety risk for subjects, that has not recovered to grade1 or less;
- •Active central nervous system (CNS) metastases (brain or leptomeningeal metastases, etc.);
- •Any history of other malignancy within 5 years;
- •Untreated hepatitis infection;
- •HIV positive;
- •History of liver transplantation, severe cirrhosis, hepatic encephalopathy;
- •Inadequate cardiac function;
- •Pregnant or lactating women.
研究组 & 干预措施
PLM60
Experimental
Three dose levels will be tested according to the "3 + 3" dose-escalation design.The dose-limiting toxicity (DLT) will be assessed from the first administration of PLM60 to the end of the first cycle (28 days).
干预措施: Liposome-entrapped Mitoxantrone Hydrochloride Injection (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: 1 year
To identify the maximum tolerated dose (MTD).
Dose-limited toxicity (DLT)
时间窗: 1year
To identify the dose-limited toxicity (DLT).
Recommended Phase II Dose (RP2D)
时间窗: 1 year
To identify the Recommended Phase II Dose (RP2D)
次要结局
- Time of peak plasma concentration (Tmax)(2 years)
- Median overall survival (OS)(2 years)
- Median progression free survival (PFS)(2 years)
- Overall response rate (ORR)(2 years)
- Area under the plasma concentration versus time curve (AUC)(2 years)
- Peak Plasma Concentration (Cmax)(2 years)
- Duration of Response (DoR)(2 years)
研究者
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