Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

NCT02043756 ↗

Phase 1 Completed 20 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

RandomizedParallel-groupSingle-blindTreatment

Summary

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

Timeline

Start: 2011-08
Primary completion: 2013-06
Completion: 2013-08

Publications

Yang J, Shi Y, Li C, Gui L, Zhao X, Liu P, Han X, Song Y, Li N, Du P, Zhang S. Phase I clinical trial of pegylated liposomal mitoxantrone plm60-s: pharmacokinetics, toxicity and preliminary efficacy. Cancer Chemother Pharmacol. 2014 Sep;74(3):637-46. doi: 10.1007/s00280-014-2523-8. Epub 2014 Jul 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Mitoxantrone	Small molecule	6 mg/m2	Intravenous
Comparator	Mitoxantrone	Small molecule	10 mg/m2	Intravenous
Comparator	Mitoxantrone	Small molecule	12 mg/m2	Intravenous
Comparator	Mitoxantrone	Small molecule	14 mg/m2	Intravenous
Comparator	Mitoxantrone	Small molecule	16 mg/m2	Intravenous
Comparator	Mitoxantrone	Small molecule	18 mg/m2	Intravenous

Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

Summary

Timeline

Publications

Drugs

Indications