Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: ODM-201

• 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

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-02
• Study First Posted: 2011-09-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2016-10-28
• Results First Submitted QC: 2016-10-28
• Results First Posted: 2016-12-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 76

Inclusion Criteria

• Written informed consent
• Successful completion of study protocol 3104001
• Response or stable disease in study 3104001 at week 12

Read More

Exclusion Criteria

• New serious concurrent medical condition
• Not able to swallow the study drug

Read More

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.

Trial Locations

Locations (17)

Turku University Hospital; 🇫🇮 Turku, Finland

The Urology Center of Colorado; 🇺🇸 Wheat Ridge, Colorado, United States

East-Tallinn Central Hospital; 🇪🇪 Tallinn, Estonia

Velindre Cancer Centre; 🇬🇧 Cardiff, United Kingdom

Christie Hospital; 🇬🇧 Manchester, United Kingdom

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Queen Elizabeth Hospital; 🇬🇧 Birmingham, United Kingdom

Saint Louis Hospital; 🇫🇷 Paris, France

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Churchill Hospital; 🇬🇧 Oxford, United Kingdom

Klinika onkologie a radioterapie LFUK a FN; 🇨🇿 Hradec Králové, Czech Republic

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Eastern CT Hematology and Oncology Associates; 🇺🇸 Norwich, Connecticut, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States