A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Gastric Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 9
- 主要终点
- adverse events (AEs)
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 advanced gastric carcinoma.
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 advanced gastric carcinoma. 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 withdrawal by investigator or patient decision (a maximum of 8 cycles).
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, without gender limitation;
- •Histologically confirmed diagnosis of unresectable locally advanced or metastatic gastric carcinoma, including gastroesophageal junction carcinoma;
- •Suitable to receive the study drug as decided by the investigator;
- •At least one measurable lesion according to RECIST v1.1;
- •ECOG performance status of 0 to 2;
- •Life expectancy ≥ 12 weeks;
- •AEs from the previous treatment have resolved to ≤ Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as hair loss, hyperpigmentation);
- •Adequate organ function;
- •Subjects of childbearing potential must agree to use effective contraceptive measures. Female subjects must have a negative pregnancy test before enrolment;
- •Fully comply with the protocol.
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;
- •Amenable to curative surgery ( radical excision);
- •Pleural effusion, pericardial effusion or peritoneal effusion with overt clinical symptoms (except for those have a drainage within 1 month before screening, asymptomatic and the effusion only detectable by imageological examination);
- •Intestinal obstruction with overt clinical symptom and requiring treatment;
- •CTCAE Grade 3 or Grade 4 gastrointestinal hemorrhage within 12 weeks prior to the first dose administration;
- •History of allotransplantation;
- •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 trails and had recieved treatment 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/m
- •Pregnant or lactating female;
- •Serious and/or uncontrolled systemic diseases;
研究组 & 干预措施
Mitoxantrone Hydrochloride Liposome Injection
Subjects with advanced gastric carcinoma will receive 20mg/m2Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles.
干预措施: Mitoxantrone Hydrochloride Liposome, intravenous injection (Drug)
结局指标
主要结局
adverse events (AEs)
时间窗: From the initiation of the first dose to 28 days after the last dose, assessed up to 36 months
The incidence and severity of AEs, abnormalities in physical exams, vital sign assessments, clinical laboratory assessments, ultrasonic cardiograms (UCGs) and electrocardiographs (ECGs).
次要结局
- overall response rate (ORR)(From the enrollment to the final documentation of response of the last subject (assessed up to 36 months))
- duration of response (DoR)(From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months)
- duration of complete response (DCR)(From the enrollment to the final documentation of response of the last subject (assessed up to 36 months))
- progression-free survival (PFS)(From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months)
- overall survival (OS)(From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months)