NCT05344742

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

A Multicenter, Open-label, Phase I Dose-escalation and Dose-expansion Study of Mitoxantrone Hydrochloride Liposome Injection Combination Therapy in Chinese Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (estimated)
• 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 tolerability, safety, pharmacokinetics (PK) and efficacy of mitoxantrone hydrochloride liposome injection combination therapy in Chinese 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 tolerability, safety, pharmacokinetics and efficacy of mitoxantrone hydrochloride liposome injection combination therapy. 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 combination therapy in patients with advanced solid tumors based on a Rolling-6 design. Patients enrolled in this phase will be allocated to two arms A and B. The patients of A arm will receive mitoxantrone hydrochloride liposome injection and capecitabine followed by a 3-week DLT observation period. The patients of B arm will receive mitoxantrone hydrochloride liposome injection and albumin-paclitaxel followed by a 3-week DLT observation period. After DLT observation, one dose cohort 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 mitoxantrone hydrochloride liposome injection combination therapy 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 Tumor

Interventions

Type	Name	Description
DRUG	Mitoxantrone Hydrochloride Liposome injection	Mitoxantrone hydrochloride liposome injection will be administered intravenously once every 3 weeks (a cycle)
DRUG	Capecitabine	The fixed dose of oral capecitabine will be administered 1000mg/m\^2, twice daily, from day 1 to day 14.
DRUG	Albumin-paclitaxel	The fixed dose of albumin-paclitaxel will be set as 260 mg/m\^2, once every three weeks.

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-03-01
• Completion: 2025-03-01
• First posted: 2022-04-25
• Last updated: 2022-04-25