Study on the pharmacokinetic interaction between cabazitaxel and darolutamide in metastatic castration-resistant prostate cancer (mCRPC) patients.

Erasmus MC Cancer Institute0 个研究点目标入组 17 人开始时间: 2020年4月7日最近更新: 2021年11月29日

适应症

试验速览

暂无简介。

•1.Age = 18 years;
•2.Patients with a confirmed diagnosis of mCRPC with an indication for cabazitaxel treatment at the standard dose of 20 mg/m2.
•3.WHO performance = 1.
•4.Able and willing to sign the Informed Consent Form prior to screening evaluations
•5.Adequate baseline patient characteristics (complete blood count, serum biochemistry which involves sodium, potassium, creatinine, calculation of creatinine clearance, AST, ALT, gamma glutamyltranspeptidase, lactate dehydrogenase, ALP, Total bilirubin, Albumin, glucose)
•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 8
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 9

•1.Use of (over the counter) medication or (herbal) supplements which can interact with either cabazitaxel or darolutamide, e.g. by induction or inhibition of CYP3A4 or P-gp. Dexamethasone and prednisone are allowed.
•2.Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria)
•3.Known serious illness or medical unstable conditions that could interfere with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or herpes zoster, organ transplants, kidney failure (GFR<60), serious liver disease (e.g. severe cirrhosis), cardiac and respiratory diseases)
•4.Treatment with abiraterone, enzalutamide, apalutamide or darolutamide six weeks prior to day 1 of the study.

发起方

Erasmus MC Cancer Institute