NCT02131688Unknown1 期
Phase I Dose Escalation Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Malignant Lymphoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年5月最近更新:
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
- 30
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose,the safety and effectiveness of Mitoxantrone Hydrochloride Liposome Injection.
详细描述
The trial of the dose escalation method is from 18mg/m2 until the maximum tolerated dose and every 3 patient is a dose group.
研究设计
- 研究类型
- Interventional
- 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
- •Patients must compliance with the requirements and restrictions listed in the consent form
- •Patients with Pathology and / or cytologically proven malignant lymphoma
- •Patients must be 18-70 years old ,both male and female
- •Failure of standard chemotherapy
- •Patients have no better choice and may be benefit from the use of anthracyclines
- •Patients with Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2
- •Objective tumor from the last chemotherapy, biological therapy or other experimental interval treatment least 4 weeks
- •Expected survival time ≥ 3 months
- •Patients agreed to take effective contraceptive measures during the trial
- •Blood routine, liver and kidney function, cardiac function examination in accordance with the following requirements.
排除标准
- •Pregnancy and breast-feeding women
- •Multiple sclerosis
- •Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease
- •Patients with heart disease induced by anthracycline
- •Patients requiring other antineoplastic treatment
- •Patients with temperature above 38 degrees or active infection that may effects in clinical tests
- •Patients are allergic to anthracycline and liposomal drugs
- •Patients are allergic to eggs,egg products,soybean and soybean products
- •Patients with uncontrolled primary or metastatic brain tumorsMultiple sclerosis
- •Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease
- •Patients with heart disease induced by anthracycline
- •Patients requiring other antineoplastic treatment
- •Patients with temperature above 38 degrees or active infection that may effects in clinical tests
- •Patients are allergic to anthracycline and liposomal drugs
- •Patients are allergic to eggs,egg products,soybean and soybean products
- •Patients with uncontrolled primary or metastatic brain tumors
- •Total amount of Doxorubicin(or Pirarubicin)≥360mg/m2,Epirubicin ≥600mg/m2
研究组 & 干预措施
Mitoxantrone Hydrochloride Liposome
Experimental
干预措施: Mitoxantrone Hydrochloride Liposome (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection
时间窗: 4 months
次要结局
- Objective Response Rate(4 months)
研究者
研究点 (1)
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