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The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitoxantrone Hydrochloride Liposome | Experimental | Dose escalation will begin at 6mg/m2 to 16mg/m2,4 weeks apart |
|
| Mitoxantrone ,injection | Active Comparator | When the dose of experiment drup up 10mg/m2,10mg/m2 of Mitoxantrone as active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoxantrone Hydrochloride Liposome | Drug | 6-16mg/m2, IV ,one time of each 28 day cycle,3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome | 3 Weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi, Ph.D | Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701 | Principal Investigator |
| Jianliang Yang, Ph.D | Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788121 | Study Director |
| Xiaohong Han, Ph.D | Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701 | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25034977 | Derived | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008942 | Mitoxantrone |
| ID | Term |
|---|---|
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Mitoxantrone | Drug | 10mg/m2, IV ,on day 1 of each 28 day,3 cycles |
|
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |