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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01429064
First received: September 1, 2011
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: ODM-201
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Safety and tolerability assessed by incidence of adverse events, vital signs, 12-lead ECG, laboratory assessments and physical examination [ Time Frame: until disease progression, an expected average of 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response in prostate specific antigen (PSA) and in soft and bone tissues [ Time Frame: until disease progression, an expected average of 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: June 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ODM-201 Drug: ODM-201
ODM-201 administered orally daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01429064     History of Changes
Other Study ID Numbers: 3104002
Study First Received: September 1, 2011
Last Updated: January 24, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Finland: Finnish Medicines Agency
Finland: Ethics Committee
Czech Republic: State Institute for Drug Control
Czech Republic: Ethics Committee
United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014