Safety and Pharmacokinetics Study of ODM-201 in Castrate... | NCT01317641 | Trialant
NCT01317641
Sponsor
Orion Corporation, Orion Pharma
Status
Completed
Last Update Posted
Mar 29, 2017Actual
Enrollment
136Actual
Phase
Phase 1Phase 2
Conditions
Prostate Cancer
Interventions
ODM-201
Countries
United States
Czechia
Estonia
Finland
France
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01317641
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3104001
Secondary IDs
Not provided
Brief Title
Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
Official Title
Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component
Acronym
Not provided
Organization
Orion Corporation, Orion PharmaINDUSTRY
Status Module
Record Verification Date
Feb 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2011
Primary Completion Date
Jul 2013Actual
Completion Date
Jul 2013Actual
First Submitted Date
Mar 7, 2011
First Submission Date that Met QC Criteria
Mar 16, 2011
First Posted Date
Mar 17, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 23, 2016
Results First Submitted that Met QC Criteria
Feb 9, 2017
Results First Posted Date
Mar 29, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 9, 2017
Last Update Posted Date
Mar 29, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Orion Corporation, Orion PharmaINDUSTRY
Collaborators
Name
Class
Endo USA Inc., a Keenova Therapeutics Company
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.
Detailed Description
Not provided
Conditions Module
Conditions
Prostate Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
136Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ODM-201 Phase I
Experimental
Drug: ODM-201
ODM-201 Phase II Dose 1
Experimental
Drug: ODM-201
ODM-201 Phase II Dose 2
Experimental
Drug: ODM-201
ODM-201 Phase II Dose 3
Experimental
Drug: ODM-201
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ODM-201
Drug
ODM-201 administered orally daily
ODM-201 Phase I
ODM-201 Phase II Dose 1
ODM-201 Phase II Dose 2
ODM-201 Phase II Dose 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE version 4.03]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.
Up to 28 days for each cohort
Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose
The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)
Up to 28 days for each cohort
Secondary Outcomes
Measure
Description
Time Frame
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants who were naïve to both chemotherapy and CYP17 inhibitor
3 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Histologically confirmed adenocarcinoma of prostate
Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral orchiectomy
Progressive metastatic disease
Adequate bone marrow, hepatic, and renal function
Exclusion Criteria:
Known metastases in the brain
History of other malignancy within the previous 5 years
Known gastrointestinal disease or procedure that affects the absorption
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.
See Also Links
Label
URL
PubMed link to the Lancet Oncology publication containing study results
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.
Recruitment Details
Participants were enrolled at 23 hospitals in Europe and in the USA from Apr 5, 2011 to Mar 12, 2013
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1: ODM-201 200 mg/Day
Dose escalation
FG001
Phase 1: ODM-201 400 mg/Day
Dose escalation
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with chemotherapy but not CYP17 inhibitor
3 months
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with CYP17 inhibitor
3 months
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
3 months
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
3 months
Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
3 months
Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
3 months
Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
3 months
Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
3 months
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state
AUC(0-8h)
Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state
Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1
1 day
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state
AUC(0-8h)
Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state
Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1
Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo
Znojmo
Czechia
East-Tallinn Central Hospital
Talinn
Estonia
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
Saint Louis Hospital
Paris
France
Institut Gustave Roussy
Villejuif
France
Queen Elizabeth Hospital
Birmingham
United Kingdom
Velindre Cancer Centre
Cardiff
United Kingdom
Christie Hospital
Manchester
United Kingdom
Churchill Hospital
Oxford
United Kingdom
FG002
Phase 1: ODM-201 600 mg/Day
Dose escalation
FG003
Phase 1: ODM-201 1000 mg/Day
Dose escalation
FG004
Phase 1: ODM-201 1400 mg/Day
Dose escalation
FG005
Phase 1: ODM-201 1800 mg/Day
Dose escalation
FG006
Phase 2: ODM-201 200mg/Day
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
FG007
Phase 2: ODM-201 400mg/Day
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
FG008
Phase 2: ODM-201 1400mg/Day
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
FG0004 subjects
FG0017 subjects
FG0023 subjects
FG0034 subjects
FG0043 subjects
FG0053 subjects
FG00638 subjects
FG00738 subjects
FG00836 subjects
COMPLETED
FG0003 subjects
FG0016 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG00635 subjects
FG00733 subjects
FG00831 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0063 subjects
FG0075 subjects
FG0085 subjects
Type
Comment
Reasons
Not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1, 200mg/Day ODM-201
Dose escalation. Participants received twice daily of oral ODM-201 continuously.
BG001
Phase 1, 400mg/Day ODM-201
Dose escalation. Participants received twice daily of oral ODM-201 continuously.
BG002
Phase 1, 600mg/Day ODM-201
Dose escalation. Participants received twice daily of oral ODM-201 continuously.
BG003
Phase 1, 1000mg/Day ODM-201
Dose escalation. Participants received twice daily of oral ODM-201 continuously.
BG004
Phase 1, 1400mg/Day ODM-201
Dose escalation. Participants received twice daily of oral ODM-201 continuously.
BG005
Phase 1, 1800mg/Day ODM-201
Dose escalation. Participants received twice daily of oral ODM-201 continuously.
BG006
Phase 2 (200mg/Day ODM-201)
Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously
BG007
Phase 2 (400mg/Day ODM-201)
Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
BG008
Phase 2 (1400mg/Day ODM-201)
Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0017
BG0023
BG0034
BG0043
BG0053
BG00638
BG00737
BG00835
BG009134
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00073± 1.4
BG00171.9± 8.5
BG00265.3± 3.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE version 4.03]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.
Safety population included all participants in Phase 1 who received any study drug.
Posted
Number
events
Up to 28 days for each cohort
ID
Title
Description
OG000
Phase 1: ODM-201 200 mg/Day
Participants received twice daily of oral ODM-201 continuously.
OG001
Phase 1: ODM-201 400 mg/Day
Participants received twice daily of oral ODM-201 continuously.
OG002
Phase 1: ODM-201 600 mg/Day
Participants received twice daily of oral ODM-201 continuously.
OG003
Phase 1: ODM-201 1000 mg/Day
Participants received twice daily of oral ODM-201 continuously.
OG004
Phase 1: ODM-201 1400 mg/Day
Participants received twice daily of oral ODM-201 continuously.
OG005
Phase 1: ODM-201 1800 mg/Day
Participants received twice daily of oral ODM-201 continuously.
Units
Counts
Participants
OG0004
OG0017
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose
The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)
Safety population included all participants in Phase 1 who received any study drug.
Posted
Number
DLTs
Up to 28 days for each cohort
ID
Title
Description
OG000
Phase 1: ODM-201 200 mg/Day
Participants received twice daily of oral ODM-201 continuously.
OG001
Phase 1: ODM-201 400 mg/Day
Participants received twice daily of oral ODM-201 continuously.
OG002
Phase 1: ODM-201 600 mg/Day
Participants received twice daily of oral ODM-201 continuously.
OG003
Phase 1: ODM-201 1000 mg/Day
Participants received twice daily of oral ODM-201 continuously.
OG004
Phase 1: ODM-201 1400 mg/Day
Secondary
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants who were naïve to both chemotherapy and CYP17 inhibitor
Evaluable chemotherapy-naïve and CYP17i-naïve patients
Posted
Number
participants
3 months
ID
Title
Description
OG000
200mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG001
400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG002
600mg/Day ODM-201
phase 1
OG003
1000mg/Day ODM-201
phase 1
OG004
1400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
Secondary
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with chemotherapy but not CYP17 inhibitor
Evaluable post-chemotherapy and CYP17i-naïve patients
Posted
Number
participants
3 months
ID
Title
Description
OG000
200mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG001
400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG002
600mg/Day ODM-201
Phase 1
OG003
1000mg/Day ODM-201
Phase 1
OG004
1400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
Secondary
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with CYP17 inhibitor
Evaluable post-CYP17 inhibitor patients
Posted
Number
participants
3 months
ID
Title
Description
OG000
200mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG001
400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG002
1000mg/Day ODM-201
Phase 1
OG003
1400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
Units
Counts
Secondary
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Evaluable Chemotherapy-naïve and CYP17i-naïve patients
Posted
Number
participants
3 months
ID
Title
Description
OG000
200mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG001
400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG002
600mg/Day ODM-201
Phase 1
OG003
1400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG004
1800mg/Day ODM-201
Secondary
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Evaluable Post-chemotherapy and CYP17i-naïve patients
Posted
Number
participants
3 months
ID
Title
Description
OG000
200mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG001
400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG002
1000mg/Day ODM-201
Phase 1
OG003
1400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG004
1800mg/Day ODM-201
Secondary
Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Evaluable Post-CYP17i patients
Posted
Number
participants
3 months
ID
Title
Description
OG000
200mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG001
400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG002
1400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
Units
Counts
Participants
OG000
Secondary
Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Evaluable chemotherapy-naïve and CYP17i-naïve patients with bone metastasis at baseline
Posted
Number
participants
3 months
ID
Title
Description
OG000
200mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG001
400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG002
1000mg/Day ODM-201
Phase 1
OG003
1400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG004
1800mg/Day ODM-201
Phase 1
Secondary
Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Evaluable Post-chemotherapy and CYP17i-naïve patients with bone metastasis at baseline
Posted
Number
participants
3 months
ID
Title
Description
OG000
200mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG001
400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG002
600mg/Day ODM-201
Phase 1
OG003
1000mg/Day ODM-201
Phase 1
OG004
1400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
Secondary
Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Evaluable post-CYP17i patients with bone metastasis at baseline
Posted
Number
participants
3 months
ID
Title
Description
OG000
200mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG001
400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
OG002
1000mg/Day ODM-201
Phase 1
OG003
1400mg/Day ODM-201
expanded dose level (phase 1 + phase 2)
Units
Counts
Secondary
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state
AUC(0-8h)
PK population (Day 8)
Posted
Mean
Standard Deviation
h*ng/mL
Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
ID
Title
Description
OG000
200 mg/Day ODM-201
Phase 1
OG001
400 mg/Day ODM-201
Phase 1
OG002
600 mg/Day ODM-201
Phase 1
OG003
1000 mg/Day ODM-201
Phase 1
OG004
1400 mg/Day ODM-201
Phase 1
OG005
1800 mg/Day ODM-201
Secondary
Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state
PK population (Day 8)
Posted
Mean
Standard Deviation
ng/mL
Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
ID
Title
Description
OG000
200 mg/Day ODM-201
Phase 1
OG001
400 mg/Day ODM-201
Phase 1
OG002
600 mg/Day ODM-201
Phase 1
OG003
1000 mg/Day ODM-201
Phase 1
OG004
1400 mg/Day ODM-201
Phase 1
OG005
1800 mg/Day ODM-201
Phase 1
Secondary
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1
PK population (Day 1)
Posted
Median
Standard Deviation
h
1 day
ID
Title
Description
OG000
200 mg/Day ODM-201
Phase 1
OG001
400 mg/Day ODM-201
Phase 1
OG002
600 mg/Day ODM-201
Phase 1
OG003
1000 mg/Day ODM-201
Phase 1
OG004
1400 mg/Day ODM-201
Phase 1
OG005
1800 mg/Day ODM-201
Phase 1
Secondary
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state
AUC(0-8h)
PK population (Day 8)
Posted
Mean
Standard Deviation
h*ng/mL
Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
ID
Title
Description
OG000
200 mg/Day ODM-201
Phase 1
OG001
400 mg/Day ODM-201
Phase 1
OG002
600 mg/Day ODM-201
Phase 1
OG003
1000 mg/Day ODM-201
Phase 1
OG004
1400 mg/Day ODM-201
Phase 1
OG005
1800 mg/Day ODM-201
Secondary
Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state
PK population (Day 8)
Posted
Mean
Standard Deviation
ng/mL
Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
ID
Title
Description
OG000
200 mg/Day ODM-201
Phase 1
OG001
400 mg/Day ODM-201
Phase 1
OG002
600 mg/Day ODM-201
Phase 1
OG003
1000 mg/Day ODM-201
Phase 1
OG004
1400 mg/Day ODM-201
Phase 1
OG005
1800 mg/Day ODM-201
Phase 1
Secondary
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1
PK population (Day 1)
Posted
Median
Standard Deviation
h
1 day
ID
Title
Description
OG000
200 mg/Day ODM-201
Phase 1
OG001
400 mg/Day ODM-201
Phase 1
OG002
600 mg/Day ODM-201
Phase 1
OG003
1000 mg/Day ODM-201
Phase 1
OG004
1400 mg/Day ODM-201
Phase 1
OG005
1800 mg/Day ODM-201
Phase 1
Time Frame
3 months
Description
Phase 1 dose escalation and Phase 2 per dose
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1, 200mg/Day ODM-201
Dose escalation
0
4
4
4
EG001
Phase 1, 400mg/Day ODM-201
Dose escalation
2
7
5
7
EG002
Phase 1, 600mg/Day ODM-201
Dose escalation
0
3
2
3
EG003
Phase 1, 1000mg/Day ODM-201
Dose escalation
1
4
4
4
EG004
Phase 1, 1400mg/Day ODM-201
Dose escalation
1
3
3
3
EG005
Phase 1, 1800mg/Day ODM-201
Dose escalation
0
3
2
3
EG006
Phase 2, 200mg/Day ODM-201
Dose expansion
2
38
33
38
EG007
Phase 2, 400mg/Day ODM-201
Dose expansion
3
37
35
37
EG008
Phase 2, 1400mg/Day ODM-201
Dose expansion
4
35
27
35
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected38 at risk
EG0071 affected37 at risk
EG0080 affected35 at risk
Cardiac failure
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
General physical health deterioration
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected7 at risk
EG0020 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Liver abscess
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected7 at risk
EG0020 affected3 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected7 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0063 affected38 at risk
EG0074 affected37 at risk
EG0081 affected35 at risk
Constipation
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected7 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0003 affected4 at risk
EG0011 affected7 at risk
EG0021 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected7 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0021 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected7 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected7 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Motion sickness
Ear and labyrinth disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Eye pruritus
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0021 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected7 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Viral infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0021 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected7 at risk
EG0020 affected3 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Cardiac murmur
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Urine output increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected7 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected7 at risk
EG0020 affected3 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected7 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected7 at risk
EG0020 affected3 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0021 affected3 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected7 at risk
EG0021 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Head of Oncology
Orion Pharma, Development, R&D
+358 10 4261
mika.mustonen@orionpharma.com
ID
Term
D011471
Prostatic Neoplasms
Ancestor Terms
ID
Term
D005834
Genital Neoplasms, Male
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D005832
Genital Diseases, Male
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D011469
Prostatic Diseases
D052801
Male Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000607739
darolutamide
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0062 subjects
FG0071 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG0084 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
65.8
± 11.2
BG00467.7± 5.5
BG00567.7± 3.2
BG00668.3± 7.0
BG00769.1± 7.4
BG00871.3± 8.0
BG00969.4± 7.4
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Male
BG0004
BG0017
BG0023
BG0034
BG0043
BG0053
BG00638
BG00737
BG00835
BG009134
4
OG0043
OG0053
0
OG0040
OG0050
Participants received twice daily of oral ODM-201 continuously.
OG005
Phase 1: ODM-201 1800 mg/Day
Participants received twice daily of oral ODM-201 continuously.