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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Collaborator: Endo Pharmaceuticals

Criteria

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