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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01429064
First Posted: September 5, 2011
Last Update Posted: February 20, 2017
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.
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
September 1, 2011
September 5, 2011
October 28, 2016
December 22, 2016
February 20, 2017
June 2011
November 2015   (Final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01429064 on ClinicalTrials.gov Archive Site
Not Provided
Response in prostate specific antigen (PSA) and in soft and bone tissues [ Time Frame: until disease progression, an expected average of 6 months ]
Not Provided
Not Provided
 
Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: ODM-201
ODM-201 administered orally daily
Experimental: ODM-201
Intervention: Drug: ODM-201
Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, Garcia JA, Protheroe A, Tammela TL, Elliott T, Mattila L, Aspegren J, Vuorela A, Langmuir P, Mustonen M; ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014 Aug;15(9):975-85. doi: 10.1016/S1470-2045(14)70240-2. Epub 2014 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
November 2015
November 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Estonia,   Finland,   France,   United Kingdom,   United States
 
 
NCT01429064
3104002
Yes
Not Provided
Not Provided
Orion Corporation, Orion Pharma
Orion Corporation, Orion Pharma
Not Provided
Principal Investigator: Karim Fizazi Gustave Roussy, Cancer Campus, Grand Paris
Orion Corporation, Orion Pharma
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP