Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
- Registration Number
- NCT01429064
- Lead Sponsor
- Orion Corporation, Orion Pharma
- Brief Summary
The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 76
- Written informed consent
- Successful completion of study protocol 3104001
- Response or stable disease in study 3104001 at week 12
- New serious concurrent medical condition
- Not able to swallow the study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ODM-201 ODM-201 -
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events From first dose of study treatment up to 4 weeks after last dose of study treatment Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
The Urology Center of Colorado
🇺🇸Wheat Ridge, Colorado, United States
Eastern CT Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Klinika onkologie a radioterapie LFUK a FN
🇨🇿Hradec Králové, Czech Republic
East-Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Kuopio University Hospital
🇫🇮Kuopio, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
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