Effects of the co-administration of budesonide on the plasma exposure of cabazitaxel (Jevtana??) in castrate resistant prostate cancer patients - PK effects of budesonide on cabazitaxel plasma exposure

Medical Oncology BV0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Metastatic castrate resistant prostate cancer (mCRPC) patients with documented disease progression
•o If measureable: (RECIST v 1.1) progression
•o If non-measurable: documented rising PSA levels (at least 2 consecutive rises in PSA over a reference value taken at least 1 week apart) or appearance of new lesions
•Previous treatment with a docetaxel-containing regimen
•Age > 18 years;
•WHO performance * 1 (see appendix B);
•Adequate renal and hepatic functions (serum creatinin < 1.25x upper limit of normal (ULN), total bilirubin < 1.25xULN; alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) < 2.5x ULN, in case of liver metastasis < 5 ULN; alkaline phosphatase (AF) < 5xULN);
•Adequate hematological blood counts (absolute neutrophil count (ANC) > 1.5 x 109/L, platelets > 100 x 1012/L);
•Written informed consent;
•No chemotherapy within the last 4 weeks before start
•No radiotherapy within the last 4 weeks before start
•Castration, either surgically or by continued LHRH agonist therapy

•• Impossibility or unwillingness to take oral drugs;
•Serious illness or medical unstable condition requiring treatment, symptomatic CNS-metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;
•Use of medications or dietary supplements known to induce or inhibit CYP3A (see section 5.4)
•Use of other hormonal agents than Gn-RH agonists
•Hypersensitiveness to corticosteroids
•Systemic or local bacterial, viral, fungal - or yeast infection.
•Liver cirrhosis
•Portal hypertension

发起方

Medical Oncology BV