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    Clinical Trial Results:
    SAFETY AND PHARMACOKINETICS OF ODM-204 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC): OPEN, NONRANDOMISED, UNCONTROLLED, MULTICENTRE, DOSE ESCALATION, FIRST-IN-MAN STUDY WITH A DOSE EXPANSION

    Summary
    EudraCT number
    		 2014-003642-26
    Trial protocol
    		 FI   GB   LV  
    Global end of trial date
    21 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Feb 2020
    First version publication date
    05 Feb 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    3116001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02344017
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Orion Corporation, Orion Pharma
    Sponsor organisation address
    Orionintie 1, Espoo, Finland, 02200
    Public contact
    clinicaltrials@orionpharma.com, Orion Corporation, Orion Pharma, +358 104261, clinicaltrials@orionpharma.com
    Scientific contact
    clinicaltrials@orionpharma.com, Orion Corporation, Orion Pharma, +358 104261, clinicaltrials@orionpharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate safety and tolerability of ODM-204 including dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD), if possible. Study included a planned phase II dose expansion component. The recruitment was discontinued after phase I, in September 2016 after 5 dose levels. The discontinuation decision was done due to decreased steady state exposure in human, especially at higher dose levels. The antitumour activity was modest due to decreased exposures.
    Protection of trial subjects
    Adequate medical expertise and facilities to handle possible emergency situations were available throughout the study. Study subjects were carefully monitored during the study. The dose escalation for following cohort were decided with a support of the safety monitoring board after a minimum of 3 patients had provided evaluable dose limiting toxicity -data.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jan 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Finland: 6
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Latvia: 5
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    4
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Male patients with histologically or cytologically confirmed adenocarcinoma of prostate were recruited to this study.

    Pre-assignment
    Screening details
    		 Confirmed adenocarcinoma of prostate with documented metastatic disease and prostate cancer progression. Males >18 years with informed consent (IC) obtained. Ongoing GnRH therapy, or after bilateral orchiectomy. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and estimated life expectancy of at least 3 months.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 50 mg b.i.d
    Arm description
    		 50 mg of ODM-204 twice a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-204
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg twice daily with food

    Arm title
    		 100 mg b.i.d
    Arm description
    		 100 mg of ODM-204 twice a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-204
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg twice daily with food

    Arm title
    		 200 mg b.i.d
    Arm description
    		 200 mg of ODM-204 twice a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-204
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg twice daily (3 patients with food, 3 patients fasted)

    Arm title
    		 300 mg b.i.d
    Arm description
    		 300 mg of ODM-204 twice a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-204
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg twice daily with food

    Arm title
    		 500 mg b.i.d
    Arm description
    		 500 mg of ODM-204 twice a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-204
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg twice daily with food

    Number of subjects in period 1
    		50 mg b.i.d 100 mg b.i.d 200 mg b.i.d 300 mg b.i.d 500 mg b.i.d
    Started
    3
    3
    6
    7
    4
    Completed
    3
    3
    6
    7
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 23 23
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 4 4
        From 65-84 years
    		 19 19
    Gender categorical
    Units: Subjects
        Male
    		 23 23

    End points

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    End points reporting groups
    Reporting group title
    50 mg b.i.d
    Reporting group description
    		 50 mg of ODM-204 twice a day

    Reporting group title
    100 mg b.i.d
    Reporting group description
    		 100 mg of ODM-204 twice a day

    Reporting group title
    200 mg b.i.d
    Reporting group description
    		 200 mg of ODM-204 twice a day

    Reporting group title
    300 mg b.i.d
    Reporting group description
    		 300 mg of ODM-204 twice a day

    Reporting group title
    500 mg b.i.d
    Reporting group description
    		 500 mg of ODM-204 twice a day

    Primary: Frequency of adverse events

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    End point title
    		 Frequency of adverse events [1]
    End point description
    End point type
    Primary
    End point timeframe
    Treatment emergent adverse events
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics because only part 1 was conducted.
    End point values
    		 50 mg b.i.d 100 mg b.i.d 200 mg b.i.d 300 mg b.i.d 500 mg b.i.d
    Number of subjects analysed
    3
    3
    6
    7
    4
    Units: Subjects
    3
    3
    6
    7
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    50 mg b.i.d
    Reporting group description
    		 50 mg of ODM-204 twice a day

    Reporting group title
    200 mg b.i.d
    Reporting group description
    		 200 mg of ODM-204 twice a day

    Reporting group title
    100 mg b.i.d
    Reporting group description
    		 100 mg of ODM-204 twice a day

    Reporting group title
    300 mg b.i.d
    Reporting group description
    		 300 mg of ODM-204 twice a day

    Reporting group title
    500 mg b.i.d
    Reporting group description
    		 500 mg of ODM-204 twice a day

    Serious adverse events
    		 50 mg b.i.d 200 mg b.i.d 100 mg b.i.d 300 mg b.i.d 500 mg b.i.d
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    2 / 3 (66.67%)
    2 / 7 (28.57%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    1
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Spinal cord compression
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    2 / 3 (66.67%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 50 mg b.i.d 200 mg b.i.d 100 mg b.i.d 300 mg b.i.d 500 mg b.i.d
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    6 / 6 (100.00%)
    3 / 3 (100.00%)
    7 / 7 (100.00%)
    4 / 4 (100.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Peripheral coldness
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 3 (33.33%)
    3 / 7 (42.86%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    4
    0
    Fatigue
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 6 (33.33%)
    1 / 3 (33.33%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
         occurrences all number
    1
    3
    1
    1
    1
    General physical health deterioration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Infusion site extravasation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Suprapubic pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Thirst
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Haemoptysis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Depressed mood
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    1
    1
    Depression
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    2
    1
    Restlessness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood potassium decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    1
    1
    Blood urine present
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    General physical condition abnormal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Lymph node palpable
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    2 / 4 (50.00%)
         occurrences all number
    0
    1
    0
    1
    2
    Weight increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Tooth fracture
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Wrist fracture
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cardiac disorders
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Dysaesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dysarthria
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    0
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    2
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 3 (33.33%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    2
    1
    1
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    1
    2
    0
    Dysphagia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    1 / 4 (25.00%)
         occurrences all number
    0
    3
    1
    2
    1
    Oesophagitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    1 / 4 (25.00%)
         occurrences all number
    0
    4
    1
    2
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Photosensitivity reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Micturition urgency
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    1
    0
    0
    2
    Bone pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    2 / 3 (66.67%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Groin pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    0
    2
    Myalgia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    1
    1
    0
    0
    Pathological fracture
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Tendon pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hordeolum
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    2 / 3 (66.67%)
    3 / 7 (42.86%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    2
    4
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Increased appetite
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Dec 2014
    Max daily dose informed, interruption rule of study treatment, dose escalation stopping criteria and SMB role added.
    09 Jan 2015
    Additional inclusion criteria: Experimental treatment was to be assessed only in patients for whom no standard treatment was sufficient.
    02 Apr 2015
    Use of Prednison was clarified, the dosing regimen was clarified, and some discrepancies were corrected.
    06 Nov 2015
    Additional cohorts were added to investigate whether dosing in the fasted state or with higher dosing frequency (t.i.d.) increases the plasma ODM-204 exposure.
    08 Mar 2016
    One dose increase at the time of progression was allowed. Back-up investigational product details added.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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