PPK Study Based on Quantitative Pharmacology in Patients With Pamipril
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood drug concentration
研究概览
简要总结
This is a non-intervention, prospective, one-arm, observational real-world clinical trial. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study was to establish a population pharmacokinetic model of Pamiparib and to explore the correlation between its pharmacokinetic parameters and adverse reactions.
详细描述
In recent years, the advent of poly(ADP-ribose) polymerase(PARP) inhibitors is one of the important breakthroughs in the field of tumor-targeted therapy, and its therapeutic effect on ovarian cancer is quite significant Pamiparib is a potent, selective, oral PARP 1/2 inhibitor. In preclinical models, pamiparib demonstrated PARP-DNA complex trapping, brain penetration, antitumor activity, and inhibition of PARylation.
Therefore, at least 50 patients using pamiparib will be included. Before and after treatment, the laboratory examination data ，blood concentration ，combined medication and adverse events of the patients will be collected. The population pharmacokinetic model of pamiparib was established to evaluate the correlation between pharmacokinetic parameters and adverse reactions.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of the patient is ≥ 18 years old and less than 80 years old.
- •Receive treatment with pamipalil.
- •The patient signed a written informed consent form.
排除标准
- •The expected survival time may be less than the treatment cycle.
- •Is being treated with other systemic trial drugs.
- •There are other factors that the researchers think are not suitable for joining the group.
结局指标
主要结局
Blood drug concentration
时间窗: 6 months
After treating with Pamipali, blood samples were collected at different time periods
次要结局
- Correlation between blood drug concentration and adverse events(6 months)
研究者
Xin Huang
Chief pharmacist
Qianfoshan Hospital