NCT06098599已完成1 期
A Multicenter, Randomized, Open-lable, Single-dose, Two-cycle, Double-cross Bioequivalence Study Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- plasma maximum concentration (Cmax) of encapsulated doxorubicin.
研究概览
简要总结
A multicenter, randomized, open-lable, single-dose, two-cycle, double-cross bioequivalence study comparing the pharmacokinetic profile of LY01612 (Doxorubicin hydrochloride liposome injection) and CAELYX® in Chinese subjects with advanced breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntary agreement to provide written informed consent;
- •Patients aged ≥18 years and ≤75 years with locally advanced or metastatic breast cancer diagnosed by histology or cytology，and who may benefit from monotherapy of Doxorubicin liposomes;
- •Life expectancy of at least 3 months; Eastern Cooperative Oncology Group (ECOG) performance status (PS)<2;
- •adequate bone marrow function [leukocyte ≥3,000/mm3, absolute neutrophil count (ANC) ≥1,500/mm3, hemoglobin ≥90g/L, and platelet count ≥90,000/mm3；
- •adequate renal function (serum creatinine ≤1.5×Institutional upper limit of normal (ULN));
- •adequate coagulation function [prothrombin time (PT), activated partial thromboplastin time (APTT) ≤1.5×ULN];
- •adequate hepatic function [aspartate aminotransferase (AST), alanine aminotransferase (ALT) level ≤ 2.5×ULN (or ≤5×ULN for subjects with liver metastases), and total bilirubin level ≤ 1.5×ULN (or ≤ 3×ULN for subjects with liver metastases).
排除标准
- •Patients with a diagnosis of severe cardiovascular, lung, liver, kidney, gastrointestinal, endocrine, immune system, skin, musculoskeletal, neurological or psychiatric conditions that the researchers did not consider appropriate for inclusion;
- •With a history of myocardial infarction, unstable angina pectoris, coronary revascularization, New York Heart Association (NYHA) grade ≥Ⅱ cardiac insufficiency, severe pericardial disease, and severe unstable ventricular arrhythmia, cerebrovascular accident or transient cerebral ischemia or pulmonary embolism within 6 months before randomization;
- •Unstable brain metastases;
- •Electrocardiogram (ECG) QTC >480ms; left ventricular ejection fraction <50% or below the lower limit of study center value;
- •The total cumulative dose of doxorubicin was ﹥350mg/m2 before screening；
- •Persistent or active infection requiring systemic treatment;
- •Pregnancy or breast feeding;
- •Other situations that investigators consider as contra-indication for this study.
研究组 & 干预措施
Doxorubicin hydrochloride liposome injection(LY01612)
Experimental
20mg/10mL, 50mg/m2, intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial.
干预措施: Doxorubicin hydrochloride liposome injection (Drug)
Doxorubicin hydrochloride liposome injection(CAELYX®)
Active Comparator
20mg/10mL, 50mg/m2, intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial
干预措施: Doxorubicin hydrochloride liposome injection (Drug)
结局指标
主要结局
plasma maximum concentration (Cmax) of encapsulated doxorubicin.
时间窗: from baseline to day 56
Area under Plasma d concentration-time curves of encapsulated doxorubicin
时间窗: from baseline to day 56
Area under Plasma concentration-time curves of unencapsulated doxorubicin.
时间窗: from baseline to day 56
plasma maximum concentration (Cmax) of unencapsulated doxorubicin.
时间窗: from baseline to day 56
次要结局
- Partial area under plasma concentration-time curves （AUC0-48h and AUC48h-t）of encapsulated doxorubicin(from baseline to day 56)
- Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin t1/2z(from baseline to day 56)
- Area under plasma concentration-time curves of total doxorubicin；(from baseline to day 56)
- Encapsulated doxorubicin、unencapsulated doxorubicin and total doxorubicin Tmax(from baseline to day 56)
- plasma maximum concentration（Cmax） of total doxorubicin；(from baseline to day 56)
- Adverse event(from baseline to day 56)
研究者
研究点 (1)
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