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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01429064
Recruitment Status : Completed
First Posted : September 5, 2011
Results First Posted : December 22, 2016
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: ODM-201 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001
Study Start Date : June 2011
Primary Completion Date : November 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ODM-201 Drug: ODM-201
ODM-201 administered orally daily


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429064


Locations
United States, Colorado
The Urology Center of Colorado
Wheat Ridge, Colorado, United States, 80211
United States, Connecticut
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Czech Republic
Klinika onkologie a radioterapie LFUK a FN
Hradec Králové, Czech Republic
Estonia
East-Tallinn Central Hospital
Tallinn, Estonia
Finland
Helsinki University Central Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
France
Saint Louis Hospital
Paris, France
Institut Gustave Roussy
Villejuif, France
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Christie Hospital
Manchester, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Karim Fizazi Gustave Roussy, Cancer Campus, Grand Paris
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01429064     History of Changes
Other Study ID Numbers: 3104002
First Posted: September 5, 2011    Key Record Dates
Results First Posted: December 22, 2016
Last Update Posted: February 20, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases