Population Pharmacokinetics, Effectiveness and Safety of Antineoplastic Drugs in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The random plasma drug concentration of antineoplastic drugs.
研究概览
简要总结
The purpose is to study the population pharmacokinetics, effectiveness and safety of antineoplastic drugs (Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etc) in elderly patients and recommend optimized dosage regimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to be enrolled in the study:
- •Age ≥65 years old;
- •Diagnosed with cancer;
- •Using antineoplastic drugs for treatment.
排除标准
- •Subjects with any of the following criteria will not be enrolled in this study:
- •Patients who are expected to die within 48 hours;
- •Patients with allergy to antineoplastic drugs;
- •Patients receiving other investigational drugs;
- •Other factors that the researcher considers unsuitable for inclusion.
研究组 & 干预措施
treatment
The use of antineoplastic agents depends on the clinical practice.
干预措施: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs) (Drug)
结局指标
主要结局
The random plasma drug concentration of antineoplastic drugs.
时间窗: at (4-10) hours after administration
To detect the random plasma drug concentration of antineoplastic drugs.
The trough plasma drug concentration of antineoplastic drugs.
时间窗: at (1-2) hours before the next administration
To detect the trough plasma drug concentration of antineoplastic drugs.
The peak plasma drug concentration of antineoplastic drugs.
时间窗: at (0-4) hours after administration
To detect the peak plasma drug concentration of antineoplastic drugs.
次要结局
- Objective ResponseRate ,ORR(Enrollment to end of treatment up to 5 years)
- Overall Survival ,OS(First day of study treatment to the date of death due to any cause, assessed up to 5 years)
- Progression-free Survival ,PFS(First day of study treatment to the date of disease progression or death due to any cause, assessed up to 5 years)
- Time to Progression ,TTP(Enrollment to end of treatment up to 5 years)
- The incidence of adverse drug reaction(Enrollment to end of treatment up to 5 years)
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University