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Brief Title: A Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Bone and Soft Tissue Sarcoma
Official Title: 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
Study ID: NCT04900766
Brief 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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Jishuitan Hospital, Beijing, Beijing, China
Name: Xiaohui Niu, Bachelor
Affiliation: Beijing Jishuitan Hospital
Role: PRINCIPAL_INVESTIGATOR