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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- adverse events (AEs),,graded according to the NCI CTCAE version 5.0
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects fully understand and voluntarily participate in this study and sign informed consent;
- •. Age ≥18, female or male;
- •Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)
- •Fail to respond to or progressed on at least one line of the standard therapy;
- •At least one measurable lesion according to RECIST v1.1;
- •ECOG performance status of 0 to 1;
- •AEs from the previous treatment have resolved to ≤ Grade 1 based on
排除标准
- •History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
- •Untreated or symptomatic central nervous system (CNS) metastases;
- •History of allotransplantation;
- •Life expectancy < 3 months
- •Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
- •Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;
- •Use of other anticancer treatment within 4 weeks prior to the first dose administration;
- •Enrolled in any other clinical trials within 4 weeks prior to the first dose administration;
- •Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;
- •Thrombosis or thromboembolism within 6 months prior to screening;
- •History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;
- •Impaired cardiac function or serious cardiac disease
- •Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is >350 mg/m2
- •Pregnant or lactating female;
- •Serious and/or uncontrolled systemic diseases;
- •Not suitable for this study as decided by the investigator due to other reasons.
研究组 & 干预措施
Mitoxantrone Hydrochloride Liposome Injection
Subjects with Rrecurrent/metastatic Head and Neck Cancers will receive 20 mg/m2 Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles
干预措施: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV) (Drug)
结局指标
主要结局
adverse events (AEs),,graded according to the NCI CTCAE version 5.0
时间窗: from the initiation of the first dose to 28 days after the last dose
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
次要结局
- overall survival (OS)(from date of enrollment until date of first death from any cause, assessed up to 2 years)
- (best total response) (BOR)(From the enrollment to the final documentation of response of the last subject ( at least 6 weeks between follow-up and enrolment)
- progression-free survival (PFS)(from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years)
- duration of response (DoR)(From the enrollment to CR, PR, PD, death, lost to follow-up, withdrawal, or study end, assessed up to 2 years)