New Treatment for Prostate Cancer
Protocol: STUDY00005288
Full Title
SAFETY AND PHARMACOKINETICS OF ODM-208 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Description
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.

Technical Description

(CSR 210256940668) 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
Compensation: No
Eligibility
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
Age Group: Adults
Principal Investigator: ROBERTO PILI
ClinicalTrials.gov: Open Study
Contact(s)
Deonna Coleman
dc84@buffalo.edu
Want to Learn More?
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.