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Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01317641
First received: March 7, 2011
Last updated: February 9, 2017
Last verified: February 2017
Results First Received: March 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: ODM-201

  Participant Flow
  Hide Participant Flow

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 23 hospitals in Europe and in the USA from Apr 5, 2011 to Mar 12, 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
136 participants participated in the study, including 24 enrolled in Phase 1 and 112 in Phase 2 randomly assigned to 200 mg, 400 mg or 1400 mg daily doses and stratified by previous chemotherapy and treatment with CYP17 inhibitor. Two participants assigned to treatment did not start ODM-201, and were therefore excluded from analyses populations.

Reporting Groups
  Description
Phase 1: ODM-201 200 mg/Day Dose escalation
Phase 1: ODM-201 400 mg/Day Dose escalation
Phase 1: ODM-201 600 mg/Day Dose escalation
Phase 1: ODM-201 1000 mg/Day Dose escalation
Phase 1: ODM-201 1400 mg/Day Dose escalation
Phase 1: ODM-201 1800 mg/Day Dose escalation
Phase 2: ODM-201 200mg/Day Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
Phase 2: ODM-201 400mg/Day Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
Phase 2: ODM-201 1400mg/Day Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor

Participant Flow:   Overall Study
    Phase 1: ODM-201 200 mg/Day   Phase 1: ODM-201 400 mg/Day   Phase 1: ODM-201 600 mg/Day   Phase 1: ODM-201 1000 mg/Day   Phase 1: ODM-201 1400 mg/Day   Phase 1: ODM-201 1800 mg/Day   Phase 2: ODM-201 200mg/Day   Phase 2: ODM-201 400mg/Day   Phase 2: ODM-201 1400mg/Day
STARTED   4   7   3   4   3   3   38   38   36 
COMPLETED   3   6   3   3   3   3   35   33   31 
NOT COMPLETED   1   1   0   1   0   0   3   5   5 
Not treated                0                0                0                0                0                0                0                1                1 
Adverse Event                0                1                0                1                0                0                2                1                0 
Protocol Violation                1                0                0                0                0                0                0                0                0 
Disease progression                0                0                0                0                0                0                0                3                4 
Withdrawal by Subject                0                0                0                0                0                0                1                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
Phase 1, 200mg/Day ODM-201 Dose escalation. Participants received twice daily of oral ODM-201 continuously.
Phase 1, 400mg/Day ODM-201 Dose escalation. Participants received twice daily of oral ODM-201 continuously.
Phase 1, 600mg/Day ODM-201 Dose escalation. Participants received twice daily of oral ODM-201 continuously.
Phase 1, 1000mg/Day ODM-201 Dose escalation. Participants received twice daily of oral ODM-201 continuously.
Phase 1, 1400mg/Day ODM-201 Dose escalation. Participants received twice daily of oral ODM-201 continuously.
Phase 1, 1800mg/Day ODM-201 Dose escalation. Participants received twice daily of oral ODM-201 continuously.
Phase 2 (200mg/Day ODM-201) Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously
Phase 2 (400mg/Day ODM-201) Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
Phase 2 (1400mg/Day ODM-201) Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
Total Total of all reporting groups

Baseline Measures
   Phase 1, 200mg/Day ODM-201   Phase 1, 400mg/Day ODM-201   Phase 1, 600mg/Day ODM-201   Phase 1, 1000mg/Day ODM-201   Phase 1, 1400mg/Day ODM-201   Phase 1, 1800mg/Day ODM-201   Phase 2 (200mg/Day ODM-201)   Phase 2 (400mg/Day ODM-201)   Phase 2 (1400mg/Day ODM-201)   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   7   3   4   3   3   38   37   35   134 
Age 
[Units: Years]
Mean (Standard Deviation)
 73  (1.4)   71.9  (8.5)   65.3  (3.5)   65.8  (11.2)   67.7  (5.5)   67.7  (3.2)   68.3  (7.0)   69.1  (7.4)   71.3  (8.0)   69.4  (7.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                   
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      4 100.0%      7 100.0%      3 100.0%      4 100.0%      3 100.0%      3 100.0%      38 100.0%      37 100.0%      35 100.0%      134 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)   [ Time Frame: Up to 28 days for each cohort ]

2.  Primary:   Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose   [ Time Frame: Up to 28 days for each cohort ]

3.  Secondary:   Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group   [ Time Frame: 3 months ]

4.  Secondary:   Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group   [ Time Frame: 3 months ]

5.  Secondary:   Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group   [ Time Frame: 3 months ]

6.  Secondary:   Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group   [ Time Frame: 3 months ]

7.  Secondary:   Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group   [ Time Frame: 3 months ]

8.  Secondary:   Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group   [ Time Frame: 3 months ]

9.  Secondary:   Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group   [ Time Frame: 3 months ]

10.  Secondary:   Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group   [ Time Frame: 3 months ]

11.  Secondary:   Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group   [ Time Frame: 3 months ]

12.  Secondary:   Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state   [ Time Frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose ]

13.  Secondary:   Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state   [ Time Frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose ]

14.  Secondary:   Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1   [ Time Frame: 1 day ]

15.  Secondary:   Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state   [ Time Frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose ]

16.  Secondary:   Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state   [ Time Frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose ]

17.  Secondary:   Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1   [ Time Frame: 1 day ]


  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
No text entered.


  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: NCT01317641     History of Changes
Other Study ID Numbers: 3104001
Study First Received: March 7, 2011
Results First Received: March 23, 2016
Last Updated: February 9, 2017