SAFETY AND PHARMACOKINETICS OF ODM-208 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
This clinical study investigates a new treatment for prostate cancer. ODM-208 (CYP11A1 inhibitor) is the oral study medication that will be taken together with oral glucocorticoid (dexamethasone) and mineralocorticoid (fludrocortisone) replacement therapy. The purpose of this study is to find a safe and effective dose of ODM-208 for the treatment of prostate cancer. The purpose of this study is also to use the results of this study to support development programs of CYP11A1 inhibitors in prostate cancer and other relevant indications.
This first-in-human study has an open-label, non-randomised, uncontrolled design. Men with mCRPC who have received at least one prior line of novel hormonal AR targeted therapy (e.g. abiraterone, enzalutamide) can be enrolled into this study. This study has an integrated phase I-II study design and it is divided into 2 parts: a dose escalation part (Part 1) and a cohort epansion
1) Males greater than or equal to 18 years.
2) Metastatic disease documented either by a positive bone scan, CT, PET/CT or MRI scan
3) Treatment with at least 1 line of taxane-based chemotherapy in castration-sensitive prostate cancer (CSPC) or in CRPC
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