Pharmacokinetic boosting of olaparib to improve exposure, tolerance and cost-effectiveness (PROACTIVE-study) - PROACTIVE

Radboud University Medical Center0 个研究点目标入组 160 人开始时间: 2021年8月24日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•Part A – proof of concept
•Subjects who start or are on treatment with olaparib tablets 300mg BID, according to the drug label and physician’s discretion;
•Subjects who are able and willing to provide written informed consent prior to screening;
•Age of 18 years or older;
•Able to measure the outcome of the study in this subject (e.g. patient availability; willing and being able to undergo repeated plasma sample collection);
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
•Part B – clinical evaluation
•Subjects who start on treatment with olaparib tablets, according to the drug label and physician’s discretion;
•Subjects who are able and willing to provide written informed consent prior to screening;
•Age of 18 years or older;
•Able to measure the outcome of the study in this subject (e.g. patient availability; willing and being able to undergo sample collection for PK and PD purposes);
•Expected to be on olaparib treatment for = 3 months;
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
•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 128
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 32

•Part A + B
•Concurrent use of other anti-cancer therapies;
•Concurrent use of potent inducers or inhibitors of CYP3A4 as assessed with the KNMP G-standaard”;
•Known contra-indications for treatment with cobicistat in line with the summary of product characteristics;

发起方