A pharmacokinetic study of Docetaxel and Prednisone in men with metastatic castration-resistant or hormone-sensitive prostate cancer.

Erasmus MC Cancer Institute0 个研究点目标入组 18 人开始时间: 2016年6月20日最近更新: 2018年5月7日

适应症

试验速览

暂无简介。

•1.Histologicallly or cytologically confirmed adenocarcinoma of the prostate without neuro-endocrine differentitation or small cell features.
•2.Continued androgen deprivation therapy either by gonadotropin releasing hormone (GnRH) analogues or orchiedectomy
•3.Age =18 years
•4.Metastatic disease progression
•5.ECOG performance status 0-1
•6.Written informed consent according to ICH-GCP
•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 12

•1.Impossibility or unwillingness to take oral drugs
•2.Serious concurrent illness or medical unstable condition requiring treatment
•3.Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent
•4.Known hypersensitivity to studiemedication
•5.Use of medication or dietary supplements known to induce CYP3A
•6.Any active systemic or local bacterial, viral, fungal - or yeast infection.
•7.Abnormal renal function defined as (within 21 days before randomization)
•8.Abnormal liver functions consisting of any of the following (within 21 days before randomization):
•9.Abnormal hematological blood counts consisting of any of the following (within 21 days before randomization):
•10.Geographical, psychological or other non-medical conditions interfering with follow-up

发起方

Erasmus MC Cancer Institute