NCT05089461暂停2 期
An Open-label, Multi-center Phase II Clinical Trial to Evaluate the Cardiac Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Malignant Tumor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年3月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Cardiac adverse event
研究概览
简要总结
This is a multicenter, open-label, phase II study to evaluate the cardiac safety of Mitoxantrone Hydrochloride Liposome in patients with advanced malignant tumor who has received at least first-line treatment.
详细描述
This is a multicenter, open-label, phase II study to evaluate the cardiac safety of Mitoxantrone Hydrochloride Liposome in patients with advanced malignant tumor who has received at least first-line treatment. About 120 patients will be recruited in this study. Patients with solid tumors will receive Mitoxantrone Hydrochloride Liposome 20 mg/m^2 by an intravenous infusion (IV) every 3 weeks (q3w, 1 cycle). Patients with lymphoma will receive Mitoxantrone Hydrochloride Liposome 20 mg/m^2 by an intravenous infusion (IV) every 4 weeks (q4w, 1 cycle). All the patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator's or patient's decision.
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
- •Patients fully understand and voluntarily participate in this study and sign informed consent;
- •Age ≥18 years;
- •Histologically confirmed diagnosis of late-stage solid tumor or peripheral T cell lymphoma (PTCL);
- •Has received standard first-line treatment;
- •Previous treated with anthracyclines, and converted to doxorubicin at equivalent doses. The cumulative dose of doxorubicin is 160 mg/m^2 < doxorubicin ≤550 mg/m^2;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
- •Adequate organ function:
- •Absolute neutrophil count (ANC) >1.5 10^9/L;
- •Hemoglobin > 90 g/L;
- •Platelet count > 75 10^9/L;
- •Creatinine < 1.5 upper limit of normal (ULN);
- •Total bilirubin < 1.5 ULN (< 3 ULN in patients with hepatic metastasis);
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 ULN (< 5 ULN in patients with hepatic metastasis);
- •Patients of childbearing potential must agree to use effective contraceptive measures from screening until 6 months after the end of the last dose; Female patients must have a negative pregnancy test before enrolment.
排除标准
- •History of allergy to mitoxantrone hydrochloride or liposomal drugs;
- •Other malignant tumors in the past 3 years, excluding cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that have been radically treated;
- •Cerebral or meningeal metastases;
- •HBsAg or HBcAb positive with HBV DNA ≥ 2000 IU/mL, HCV antibody positive with HCV RNA above the lower limit of detection of the study center, or human immunodeficiency virus (HIV) antibody positive;
- •Life expectancy ≤ 12 weeks;
- •AEs from the previous treatment > Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as alopecia, hyperpigmentation);
- •Cardiac dysfunction, including:
- •Long QT interval syndrome; 2)High-degree atrioventricular block; 3)Malignant arrhythmia poorly controlled by medication; 4)A history of chronic heart failure with NYHA≥3; 5)Severe heart valve regurgitation or stenosis requiring treatment; 6)Acute coronary syndrome, severe pericardial disease, severe myocardial disease within 6 months prior to screening; 7)Poorly controlled hypertension (defined as systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than100 mmHg, measured ≥3 times, under control of antihypertensive drug); 8)Echocardiography showed LVEF < 50%; 8.Active bacterial or fungal infection requiring systemic intravenous therapy within 1 week before the first dose; 9.Use of other anticancer treatment within 4 weeks prior to the first dose; 10.Enrolled in any other clinical trials within 4 weeks prior to the first dose; 11.Patients underwent major surgery within 3 months prior to the first dose, or have a surgical schedule during the study period;; 12.Thrombosis or thromboembolism within 6 months prior to the first dose; 13.Lactating female; 14.Serious and/or uncontrolled systemic diseases; 15.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
Experimental
Patients with advanced malignant tumor will receive 20 mg/m^2 Mitoxantrone Hydrochloride Liposome by an intravenous infusion (IV) on day 1 of each treatment cycle.
干预措施: Mitoxantrone Hydrochloride Liposome (Drug)
结局指标
主要结局
Cardiac adverse event
时间窗: up to approximately 5 years.
次要结局
- Overall response rate (ORR)(up to approximately 3 years)
- Progression-free survival (PFS)(up to approximately 3 years.)
- Overall survival (OS)(up to approximately 5 years)
- Incidence of treatment emergent adverse event (TEAE)(up to approximately 3 years.)
研究者
研究点 (1)
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