Pharmacokinetic boosting of osimertinib in patients with non-small cell lung cancer. - POP-NSCLC

未提供0 个研究点目标入组 20 人开始时间: 2019年4月26日最近更新: 2021年6月21日

适应症

试验速览

暂无简介。

•1. Patients with EGFR-mutated NSCLC receiving standard treatment with osimertinib for at least 2 months, without any signs of disease progression.
•2. Stable disease, partial response or complete response on the most-recent tumour-response evaluation.
•3. Age = 18 years
•4.WHO performance status = 2.
•5. Able and willing to give written informed consent.
•6. Able and willing to undergo blood sampling for pharmacokinetic analysis.
•7. Patients with osimertinib plasma trough concentration below 135 ng/mL. Plasma trough concentration of osimertinib will be determined in another study (METC MUMC: 2018-0800, nWMO).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 6
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

•1. Any concurrent medication that is known to strongly inhibit or induce CYP3A4. Appendix A shows a list of drugs which are known to strongly inhibit or induce CYP3A4.
•2. Any concurrent medication that is primarily metabolised by CYP3A4 with a narrow therapeutic window. Those drugs are also included in appendix A.
•3. Impairment of gastrointestinal function that may alter the absorption of osimertiniborcobicistat (e.g. ulcerative disease, uncontrolled nausea or vomiting, malabsorption syndrome, small bowel resection).
•4. Refusing to refrain from consuming CYP3A influencing products, e.g. grapefruit(juice), St. John's wort.
•5. Pregnancy or breast feeding.
•6. Child-Pugh score class C, chronic liver disease.

发起方

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