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Clinical Trials/CTR20160342
CTR20160342CompletedPhase 1

盐酸米托蒽醌脂质体注射液多次静脉给药耐受性临床研究

Not provided1 site in 1 country34 target enrollmentStarted: June 6, 2016
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Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
34
Locations
1
Primary Endpoint
最大耐受剂量
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Detailed Description

观察盐酸米托蒽醌脂质体注射液在恶性淋巴瘤患者中的安全性和耐受性，探索初步疗效。

Study Design

Study Type
安全性和有效性
Allocation
非随机化
Intervention Model
单臂试验
Masking
开放

Eligibility Criteria

Ages
18岁(最小年龄) to 70岁(最大年龄) (—)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •病理学和 / 或细胞学证实，有疗效观察指标的
  • •志愿受试并签署知情同意书
  • •晚期患者，无更好选择者

Exclusion Criteria

  • •有缺血性心脏病史，充血性心力衰竭心脏病史，需要治疗的心律失常，显著的瓣膜病变

Outcomes

Primary Outcomes

最大耐受剂量

Time Frame: 给药第一周期

Secondary Outcomes

  • 客观缓解率(每 2 周期)

Investigators

Sponsor
Not provided
Responsible Party
Sponsor
Principal Investigator

汪玉梅

石药集团中奇制药技术（石家庄）有限公司

Study Sites (1)

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