NCT04921878

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Mitoxantrone Hydrochloride Liposome injection	Mitoxantrone hydrochloride liposome injection will be administered intravenously once every 3 weeks (a cycle) for a maximum of 6 cycles.

Timeline

• Start date: 2021-07-30
• Primary completion: 2023-04-03
• Completion: 2023-04-03
• First posted: 2021-06-10
• Last updated: 2024-02-09

Locations

1 site across 1 country: China