Spots Global Cancer Trial Database for A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers

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Trial Identification

Brief Title: A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers

Official Title: A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Recurrent/Metastatic Head and Neck Cancers

Study ID: NCT04902027

Conditions

Recurrent Head and Neck Cancer

Metastatic Head and Neck Cancer

Interventions

Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)

Study Description

Brief Summary: This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with recurrent/metastatic Head and Neck Cancers

Detailed Description: This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with recurrent/metastatic head and neck cancers. At least 30 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 patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawa by investigator or patient decision (a maximum of 8 cycles). Delays in drug administration is allowed from the cycle 2, however, the delays should be no more than 3 weeks. Dose adjustments after the cycle 2 is permitted, and the minimum dose is 12mg/m2.