Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

Inclusion Criteria:

• Written informed consent
• Histologically confirmed adenocarcinoma of prostate
• Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral orchiectomy
• Progressive metastatic disease
• Adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

• Known metastases in the brain
• History of other malignancy within the previous 5 years
• Known gastrointestinal disease or procedure that affects the absorption
• Not able to swallow the study drug