NCT02043756已完成1 期
Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Solid Tumor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.0 个研究点目标入组 20 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome
研究概览
简要总结
The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.
详细描述
The trial of the dose escalation method is from the minimum dose until the maximum tolerated dose and every 3 patient is a dose group.
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
- Single (Participant)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mitoxantrone Hydrochloride Liposome
Experimental
Dose escalation will begin at 6mg/m2 to 16mg/m2,4 weeks apart
干预措施: Mitoxantrone Hydrochloride Liposome (Drug)
Mitoxantrone ,injection
Active Comparator
When the dose of experiment drup up 10mg/m2,10mg/m2 of Mitoxantrone as active comparator
干预措施: Mitoxantrone (Drug)
结局指标
主要结局
To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome
时间窗: 3 Weeks
次要结局
未报告次要终点
研究者
相似试验
Unknown
1 期
Phase I Study of Mitoxantrone Hydrochloride Liposome InjectionMalignant LymphomaNCT02131688CSPC ZhongQi Pharmaceutical Technology Co., Ltd.30
已完成
不适用
Mitoxantrone Hydrochloride Liposome Combined With Chemotherapy in Untreated de Novo Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT05941585Institute of Hematology & Blood Diseases Hospital, China60
进行中（未招募）
2 期
Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T TherapiesB-cell Acute Lymphoblastic LeukemiaB-cell Lymphoma RefractoryNCT06220097Wuhan Union Hospital, China28
尚未招募
1 期
CMOEP in the Treatment of Untreated Peripheral T-cell LymphomaPeripheral T-cell LymphomaNCT05458180Tianjin Medical University Cancer Institute and Hospital18
Unknown
2 期
A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic CancerAdvanced Pancreatic CancerNCT05100329CSPC ZhongQi Pharmaceutical Technology Co., Ltd.38