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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01429064
First received: September 1, 2011
Last updated: October 28, 2016
Last verified: October 2016
Results First Received: October 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: ODM-201

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 17 hospitals in Europe and in the USA

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with response or stable disease at week 12 in ARADES 3104001 study as judged by the investigator, were allowed to continue in the ARADES-EXT 3104002 extension study.

Reporting Groups
  Description
Patients From Arades 3104001 Dose Escalation 200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
Patients From Arades 3104001 Dose Expansion (200mg/Day) Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
Patients From Arades 3104001 Dose Expansion (400mg/Day) Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
Patients From Arades 3104001 Dose Expansion (1400mg/Day) Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.

Participant Flow:   Overall Study
    Patients From Arades 3104001 Dose Escalation   Patients From Arades 3104001 Dose Expansion (200mg/Day)   Patients From Arades 3104001 Dose Expansion (400mg/Day)   Patients From Arades 3104001 Dose Expansion (1400mg/Day)
STARTED   19   22   19   16 
COMPLETED   19   22   19   16 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety

Reporting Groups
  Description
Patients From Arades 3104001 Dose Escalation 200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
Patients From Arades 3104001 Dose Expansion (200mg/Day) Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
Patients From Arades 3104001 Dose Expansion (400mg/Day) Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
Patients From Arades 3104001 Dose Expansion (1400mg/Day) Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
Total Total of all reporting groups

Baseline Measures
   Patients From Arades 3104001 Dose Escalation   Patients From Arades 3104001 Dose Expansion (200mg/Day)   Patients From Arades 3104001 Dose Expansion (400mg/Day)   Patients From Arades 3104001 Dose Expansion (1400mg/Day)   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   22   19   16   76 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.8  (6.1)   66.5  (6.6)   68.9  (8.3)   74.6  (6.3)   69.4  (7.3) 
Gender 
[Units: Participants]
Count of Participants
         
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      19 100.0%      22 100.0%      19 100.0%      16 100.0%      76 100.0% 


  Outcome Measures

1.  Primary:   Frequency of Adverse Events   [ Time Frame: From first dose of study treatment up to 4 weeks after last dose of study treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Head of Oncology
Organization: Orion Pharma, Development, R&D
phone: +358 10 4261
e-mail: mika.mustonen@orionpharma.com


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
Study First Received: September 1, 2011
Results First Received: October 28, 2016
Last Updated: October 28, 2016