NCT02043756|CompletedPhase 1
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Sponsor study identifier
interventional
20
0 countries
N/A
Study Start
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
August 2013
Actual (reported)The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 2013
Actual (reported)August 2013
Actual (reported)January 16, 2014
Actual (reported)January 23, 2014
Actual (reported)To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome
3 Weeks
Dose escalation will begin at 6mg/m2 to 16mg/m2,4 weeks apart
When the dose of experiment drup up 10mg/m2,10mg/m2 of Mitoxantrone as active comparator
6-16mg/m2, IV ,one time of each 28 day cycle,3 cycles
10mg/m2, IV ,on day 1 of each 28 day,3 cycles
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.
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
20 participants (actual enrollment reported by the registry).
First Submitted
January 16, 2014
First Posted
January 23, 2014
Study Start
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
June 2013
Actual (reported)Study Completion
August 2013
Actual (reported)Last Updated
January 23, 2014
Record last verified: 2014-01
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Source: ClinicalTrials.gov.
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