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

Launched by CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY CO., LTD. · May 20, 2021

Keywords

ClinConnect 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. 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 al...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects fully understand and voluntarily participate in this study and sign informed consent;
• • 2. . Age ≥18, female or male;
• • 3. Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)
• • 4. Fail to respond to or progressed on at least one line of the standard therapy;
• • 5. At least one measurable lesion according to RECIST v1.1;
• • 6. ECOG performance status of 0 to 1;
• • 7. AEs from the previous treatment have resolved to ≤ Grade 1 based on
• Exclusion Criteria:
• • 1. History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
• • 2. Untreated or symptomatic central nervous system (CNS) metastases;
• • 3. History of allotransplantation;
• • 4. Life expectancy \< 3 months
• • 5. Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
• • 6. Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;
• • 7. Use of other anticancer treatment within 4 weeks prior to the first dose administration;
• • 8. Enrolled in any other clinical trials within 4 weeks prior to the first dose administration;
• • 9. Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;
• • 10. Thrombosis or thromboembolism within 6 months prior to screening;
• • 11. History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;
• • 12. Impaired cardiac function or serious cardiac disease
• • 13. Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is \>350 mg/m2
• • 14. Pregnant or lactating female;
• • 15. Serious and/or uncontrolled systemic diseases;
• • 16. Not suitable for this study as decided by the investigator due to other reasons.