NCT04900766

A Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Bone and Soft Tissue Sarcoma

A Multicenter, Open-label, Phase Ib Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Bone and Soft Tissue Sarcoma Who Has Failed At Least One Prior Line of Therapy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with unresectable or metastatic bone and soft tissue sarcoma who has failed at least one prior line of therapy.

Detailed description

This is a multicenter, open-label, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with unresectable or metastatic bone and soft tissue sarcoma who has failed at least one prior line of therapy. About 50 subjects will be recruited in this study. The subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2 by an intravenous infusion (IV), every 21 days (q3w, 1 cycle). All the subjects will receive the treatment until disease progression, intolerable toxicity, death, or withdrawal by investigator or subject decision (a maximum of 6 cycles).

Conditions

• Unresectable or Metastatic Bone and Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Mitoxantrone Hydrochloride Liposome Injection	20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).

Timeline

• Start date: 2021-08-11
• Primary completion: 2023-02-03
• Completion: 2023-02-03
• First posted: 2021-05-25
• Last updated: 2024-03-07

Locations

1 site across 1 country: China