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

January 3, 2017 updated by: Orion Corporation, Orion Pharma

Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ODM-201
Drug: ODM-201
ODM-201 administered orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From first dose of study treatment up to 4 weeks after last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 1, 2011

First Submitted That Met QC Criteria

September 2, 2011

First Posted (Estimate)

September 5, 2011

Study Record Updates

Last Update Posted (Actual)

February 20, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3104002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

3
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