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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):
Orion Corporation, Orion Pharma

Tracking Information
First Submitted Date  ICMJE September 1, 2011
First Posted Date  ICMJE September 5, 2011
Results First Submitted Date  ICMJE October 28, 2016
Results First Posted Date  ICMJE December 22, 2016
Last Update Posted Date February 20, 2017
Study Start Date  ICMJE June 2011
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2011)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2011)
Response in prostate specific antigen (PSA) and in soft and bone tissues [ Time Frame: until disease progression, an expected average of 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
Official Title  ICMJE Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: ODM-201
ODM-201 administered orally daily
Study Arms  ICMJE Experimental: ODM-201
Intervention: Drug: ODM-201
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2016)
76
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2011)
54
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Estonia,   Finland,   France,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01429064
Other Study ID Numbers  ICMJE 3104002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Orion Corporation, Orion Pharma
Study Sponsor  ICMJE Orion Corporation, Orion Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karim Fizazi Gustave Roussy, Cancer Campus, Grand Paris
PRS Account Orion Corporation, Orion Pharma
Verification Date January 2017

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