NCT02043756

Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Solid Tumor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-06-01
• Completion: 2013-08-01
• First posted: 2014-01-23
• Last updated: 2014-01-23