Optimizing abiraterone (Zytiga®) therapy by exploring the relation between an early biomarker - drug exposure - as a predictor for drug response in patients with mCRPC (OPTIMUM - STUDY) - OPTIMUM

Radboud UMC0 个研究点开始时间: 2015年1月15日最近更新: 2017年1月16日

适应症

试验速览

暂无简介。

•- patients with metastatic castration resistant prostate cancer* who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated – OR – who have been treated upfront with 6 cycles of docetaxel: conform the Chaarted or Stampede trials- Age =18 years
•- Feasible to collect blood samples from
•- Life expectancy of > 6 months
•- Measurable disease
•- Able and willing to give written informed consent prior to screening and enrollment
•*definition of CRPC according to EAU guidelines 2014
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•The study objective is to explore the effect of abiraterone exposure on treatment and biomarker response in group of patients treated with abiraterone acetate in agreement with the drug label. Therefore the exclusion criteria as listed in the package insert will be used in this study. Additionally, patients are not allowed to be treated with other anticancer therapies, potent CYP3A4 inhibitors or inducers and herbal medicine that could interfere with abiraterone exposure.

发起方

Radboud UMC