Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: Mitoxantrone Hydrochloride Liposome; Drug: Mitoxantrone

• Registration Number: NCT02043756
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2013-06
• Study Completion: 2013-08
• Status Verified: 2014-01
• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-21
• Last Update Submitted: 2014-01-21
• Study First Posted: 2014-01-23
• Last Update Posted: 2014-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitoxantrone Hydrochloride Liposome	Mitoxantrone Hydrochloride Liposome	Dose escalation will begin at 6mg/m2 to 16mg/m2,4 weeks apart
Mitoxantrone ,injection	Mitoxantrone	When the dose of experiment drup up 10mg/m2,10mg/m2 of Mitoxantrone as active comparator

Primary Outcome Measures

Name	Time	Method
To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome	3 Weeks