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Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

NCT02043756 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-01-23

No results posted yet for this study

Summary

The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.

Conditions

  • Neoplasms

Interventions

DRUG

Mitoxantrone Hydrochloride Liposome

6-16mg/m2, IV ,one time of each 28 day cycle,3 cycles

DRUG

Mitoxantrone

10mg/m2, IV ,on day 1 of each 28 day,3 cycles

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi, Ph.D · Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701

  • Jianliang Yang, Ph.D · Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788121

  • Xiaohong Han, Ph.D · Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-06-30
Completion
2013-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02043756 on ClinicalTrials.gov