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A Study of Mitoxantrone Hydrochloride Liposome Injection in Chinese Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:
Safety, Tolerability, Pharmacokinetics and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Chinese Patients With Advanced Solid Tumors: A Multicenter, Open-label, Phase I Dose-escalation and Dose-expansion Study

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of mitoxantrone hydrochloride liposome injection in patients with advanced solid tumors.

Clinical Trial Description

This is a multicenter, open-label, phase I dose-escalation and dose-expansion study aimed to evaluate the safety, tolerability, pharmacokinetics and efficacy of mitoxantrone hydrochloride liposome injection. This study consists of two phases: dose-escalation phase and dose expansion phase. The dose-escalation phase will be conducted to determine the maximum tolerated dose (MTD) of mitoxantrone hydrochloride liposome injection in patients with advanced solid tumors based on a 3+3 design. Patients enrolled in this phase will receive mitoxantrone hydrochloride liposome injection followed by a 3-week DLT observation period. After DLT observation, two to four dose cohorts will be selected for dose-expansion to further explore the safety and efficacy of study drug according to the dose-escalation results. In the dose-expansion phase, patients will receive the study drug every 3 weeks (q3w, a cycle) until disease progression, intolerable toxicity, death, or withdrawal by investigator or patient decision (a maximum of 6 cycles). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04921878
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date July 30, 2021
Completion date April 3, 2023
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