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    Clinical Trial Results:
    SAFETY AND PHARMACOKINETICS OF ODM-209 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER OR ESTROGEN RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED BREAST CANCER

    Summary
    EudraCT number
    		 2018-002249-13
    Trial protocol
    		 FI   DK   ES   IT  
    Global end of trial date
    09 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2024
    First version publication date
    29 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    03125001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03878823
    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 0104261, clinicaltrials@orionpharma.com
    Scientific contact
    clinicaltrials@orionpharma.com, Orion Corporation Orion Pharma, 358 0104261, 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
    09 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jan 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part 1: Primary objectives are - to evaluate the safety and tolerability of ODM-209; - to define the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ODM-209, if feasible; - to define the recommended dose of ODM-209 for prostate cancer and breast cancer patients and replacement therapy for Part 2 of the study. Part 2: - to further evaluate the safety and tolerability of ODM-209; - to evaluate the preliminary anticancer activity of ODM-209.
    Protection of trial subjects
    Dosing of ODM-209 was started with low dose in cohort 1 and gradually increased based on tolerability results evaluated by sponsor and the independent safety monitoring board (SMB). Safety was assessed by AEs, laboratory tests, physical examination, vital signs including orthostatic test and 12-lead ECG. Concomitant glucocorticoid and mineralocorticoids replacement therapy was given to subjects to decrease the risk of developing adrenal insufficiency. Criteria for ODM-209 and replacement therapy dosing interruption and modifications were described in the protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Apr 2019
    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
    Denmark: 10
    Country: Number of subjects enrolled
    Finland: 7
    Country: Number of subjects enrolled
    France: 21
    Worldwide total number of subjects
    38
    EEA total number of subjects
    38
    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)
    14
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 38 subjects with with metastatic castration-resistant prostate cancer or estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer were enrolled in the study at 4 study centers in Europe during the years 2019-2024.

    Pre-assignment
    Screening details
    		 Male or female aged ≥ 18 years with histologically confirmed carcinoma and adequate marrow, liver, and kidney function were recruited. All of the inclusion criteria and none of the exclusion criteria fulfilled, and written informed consent given. In total, 53 subjects were screened and 38 participants enrolled and started the treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ODM-209 10 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-209 10 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose of 10 mg ODM-209 was taken with a glass of water within 30 min after a meal.

    Arm title
    		 ODM-209 15 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-209 15 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose of 15 mg ODM-209 was taken with a glass of water within 30 min after a meal.

    Arm title
    		 ODM-209 20 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-209 20 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose of 20 mg ODM-209 was taken with a glass of water within 30 min after a meal.

    Number of subjects in period 1
    		ODM-209 10 mg ODM-209 15 mg ODM-209 20 mg
    Started
    13
    6
    19
    Completed
    13
    6
    19

    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
    		 38 38
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 14 14
        From 65-84 years
    		 24 24
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 34 34

    End points

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    End points reporting groups
    Reporting group title
    ODM-209 10 mg
    Reporting group description
    		 -

    Reporting group title
    ODM-209 15 mg
    Reporting group description
    		 -

    Reporting group title
    ODM-209 20 mg
    Reporting group description
    		 -

    Primary: Frequency of adverse events

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    End point title
    		 Frequency of adverse events [1]
    End point description
    Number of subjects with treatment related adverse events.
    End point type
    Primary
    End point timeframe
    From the first dose of ODM-209 until the end of study visit.
    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: Frequency of adverse events was described by descriptive statistics. No clear difference in the overall frequency of AEs was seen between the different doses (10, 15 and 20 mg).
    End point values
    		 ODM-209 10 mg ODM-209 15 mg ODM-209 20 mg
    Number of subjects analysed
    13
    6
    19
    Units: Adverse events
    7
    4
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of ODM-209 until the last visit.
    Adverse event reporting additional description
    No clear difference in the overall frequency of AEs was seen between the different doses (10, 15 and 20 mg). Grade ≥3 AEs were more frequently reported in 10 mg and 15 mg groups compared to 20 mg group. The adverse events reported were for the most part anticipated based on the therapeutic mechanism of action of ODM-209 and the patient population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    ODM-209 10 mg
    Reporting group description
    		 -

    Reporting group title
    ODM-209 20 mg
    Reporting group description
    		 -

    Reporting group title
    ODM-209 15 mg
    Reporting group description
    		 -

    Serious adverse events
    		 ODM-209 10 mg ODM-209 20 mg ODM-209 15 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 13 (38.46%)
    8 / 19 (42.11%)
    3 / 6 (50.00%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    CANCER PAIN
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    METASTASES TO MENINGES
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PROSTATE CANCER
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    HYPOTENSION
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    CEREBELLAR INFARCTION
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SPINAL CORD COMPRESSION
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    GAIT DISTURBANCE
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PYREXIA
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    HEPATITIS
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY FAILURE
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    HYDRONEPHROSIS
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RENAL FAILURE
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    URINARY RETENTION
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    URINARY INCONTINENCE
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT OBSTRUCTION
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    ADRENOCORTICAL INSUFFICIENCY ACUTE
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ADRENAL INSUFFICIENCY
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    ESCHERICHIA URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SKIN INFECTION
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    STAPHYLOCOCCAL SEPSIS
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SUBMANDIBULAR ABSCESS
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ODM-209 10 mg ODM-209 20 mg ODM-209 15 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 13 (100.00%)
    19 / 19 (100.00%)
    6 / 6 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    TUMOUR PAIN
         subjects affected / exposed
    1 / 13 (7.69%)
    3 / 19 (15.79%)
    2 / 6 (33.33%)
         occurrences all number
    1
    3
    2
    Vascular disorders
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    HAEMATOMA
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    HOT FLUSH
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    1
    0
    2
    HYPERTENSION
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 19 (5.26%)
    2 / 6 (33.33%)
         occurrences all number
    2
    1
    2
    HYPOTENSION
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    ORTHOSTATIC HYPOTENSION
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    1 / 6 (16.67%)
         occurrences all number
    1
    4
    1
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    1
    CHILLS
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    FACE OEDEMA
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    FATIGUE
         subjects affected / exposed
    6 / 13 (46.15%)
    10 / 19 (52.63%)
    4 / 6 (66.67%)
         occurrences all number
    7
    11
    4
    GAIT DISTURBANCE
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    MALAISE
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    LOCALISED OEDEMA
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    OEDEMA PERIPHERAL
         subjects affected / exposed
    3 / 13 (23.08%)
    7 / 19 (36.84%)
    3 / 6 (50.00%)
         occurrences all number
    4
    11
    4
    PAIN
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    PYREXIA
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    0
    Reproductive system and breast disorders
    ERECTILE DYSFUNCTION
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    0
    2
    PELVIC PAIN
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    0
    Respiratory, thoracic and mediastinal disorders
    EPISTAXIS
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    DYSPNOEA
         subjects affected / exposed
    3 / 13 (23.08%)
    4 / 19 (21.05%)
    1 / 6 (16.67%)
         occurrences all number
    4
    5
    1
    COUGH
         subjects affected / exposed
    3 / 13 (23.08%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    3
    3
    0
    PLEURAL EFFUSION
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    PULMONARY EMBOLISM
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Psychiatric disorders
    AGITATION
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    ANXIETY
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    DEPRESSION
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    MANIA
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    INSOMNIA
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 19 (5.26%)
    1 / 6 (16.67%)
         occurrences all number
    3
    1
    1
    RESTLESSNESS
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Investigations
    AMYLASE INCREASED
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 13 (7.69%)
    4 / 19 (21.05%)
    1 / 6 (16.67%)
         occurrences all number
    1
    5
    1
    BLOOD CHOLESTEROL INCREASED
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    2
    1
    0
    BLOOD CREATINE PHOSPHOKINASE INCREASED
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    0
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    2
    2
    0
    BLOOD THYROID STIMULATING HORMONE INCREASED
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    BLOOD UREA INCREASED
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 19 (5.26%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    1
    BLOOD ALKALINE PHOSPHATASE INCREASED
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 19 (15.79%)
    1 / 6 (16.67%)
         occurrences all number
    0
    4
    1
    C-REACTIVE PROTEIN INCREASED
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    HAEMOGLOBIN DECREASED
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    PLATELET COUNT DECREASED
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    SARS-COV-2 TEST POSITIVE
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    WEIGHT DECREASED
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    0
    2
    WEIGHT INCREASED
         subjects affected / exposed
    3 / 13 (23.08%)
    7 / 19 (36.84%)
    2 / 6 (33.33%)
         occurrences all number
    3
    7
    2
    Injury, poisoning and procedural complications
    ARTHROPOD BITE
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    VIITH NERVE INJURY
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    BRADYCARDIA
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    PALPITATIONS
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    SINUS BRADYCARDIA
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    SUPRAVENTRICULAR EXTRASYSTOLES
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    AXONAL NEUROPATHY
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    DIZZINESS
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    2
    1
    0
    DYSGEUSIA
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    HEADACHE
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 19 (10.53%)
    1 / 6 (16.67%)
         occurrences all number
    2
    3
    1
    NEUROPATHY PERIPHERAL
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    PARAESTHESIA
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    RADICULAR PAIN
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    SCIATICA
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    SENSORY LOSS
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    SYNCOPE
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    TASTE DISORDER
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    TREMOR
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    2 / 13 (15.38%)
    4 / 19 (21.05%)
    2 / 6 (33.33%)
         occurrences all number
    2
    5
    3
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    CONJUNCTIVAL HAEMORRHAGE
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    CATARACT
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    EYELID OEDEMA
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    1
    CONSTIPATION
         subjects affected / exposed
    3 / 13 (23.08%)
    5 / 19 (26.32%)
    1 / 6 (16.67%)
         occurrences all number
    3
    5
    1
    DIARRHOEA
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 19 (10.53%)
    1 / 6 (16.67%)
         occurrences all number
    2
    3
    1
    DRY MOUTH
         subjects affected / exposed
    1 / 13 (7.69%)
    4 / 19 (21.05%)
    1 / 6 (16.67%)
         occurrences all number
    1
    5
    1
    DYSPEPSIA
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    1
    4
    0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    NAUSEA
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 19 (10.53%)
    2 / 6 (33.33%)
         occurrences all number
    2
    3
    2
    OESOPHAGITIS
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    VOMITING
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    0
    TOOTHACHE
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    DRY SKIN
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    2
    2
    0
    ECZEMA
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    PAIN OF SKIN
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    PRURITUS
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    RASH MACULO-PAPULAR
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    RASH MACULAR
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    RASH
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    PURPURA SENILE
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    SKIN ULCER
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Renal and urinary disorders
    HAEMATURIA
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    MICTURITION URGENCY
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    URINARY RETENTION
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Endocrine disorders
    ADRENAL INSUFFICIENCY
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    CUSHING'S SYNDROME
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    1 / 6 (16.67%)
         occurrences all number
    1
    2
    1
    Musculoskeletal and connective tissue disorders
    BONE PAIN
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    0
    BACK PAIN
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    ARTHRALGIA
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    1
    3
    0
    GROIN PAIN
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    MUSCLE SPASMS
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    0
    OSTEONECROSIS OF JAW
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    0
    MYALGIA
         subjects affected / exposed
    2 / 13 (15.38%)
    3 / 19 (15.79%)
    1 / 6 (16.67%)
         occurrences all number
    2
    3
    1
    PAIN IN EXTREMITY
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    FOLLICULITIS
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    NAIL INFECTION
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    ORAL CANDIDIASIS
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    MUCOSAL INFECTION
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    0
    PROSTATE INFECTION
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    PNEUMONIA
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    SPINAL CORD INFECTION
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    SUPERINFECTION
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 13 (7.69%)
    4 / 19 (21.05%)
    0 / 6 (0.00%)
         occurrences all number
    5
    5
    0
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    1 / 13 (7.69%)
    3 / 19 (15.79%)
    1 / 6 (16.67%)
         occurrences all number
    1
    3
    1
    DEHYDRATION
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    HYPERCALCAEMIA
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    HYPERGLYCAEMIA
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    HYPERKALAEMIA
         subjects affected / exposed
    3 / 13 (23.08%)
    7 / 19 (36.84%)
    0 / 6 (0.00%)
         occurrences all number
    3
    13
    0
    HYPERTRIGLYCERIDAEMIA
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    HYPOALBUMINAEMIA
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    HYPOCALCAEMIA
         subjects affected / exposed
    0 / 13 (0.00%)
    4 / 19 (21.05%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    0
    HYPONATRAEMIA
         subjects affected / exposed
    1 / 13 (7.69%)
    7 / 19 (36.84%)
    0 / 6 (0.00%)
         occurrences all number
    2
    11
    0
    HYPOKALAEMIA
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 19 (5.26%)
    2 / 6 (33.33%)
         occurrences all number
    3
    1
    3
    STEROID DIABETES
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jan 2022
    Amendment 15. Global: • Protocol was harmonised for Finland, Italy, Spain, France and Denmark. There were no study treatment given to any patient in Italy and Spain.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Mar 2020
    The recruitment was temporarily paused in all sites on 18th March 2020 due to the COVID-19 pandemic. At the time there were only 4 patients with PC on study treatment and 1 participant in the post-treatment period of the trial. The recruitment was re-started 7th May 2020.
    07 May 2020
    01 Dec 2021
    Enrolment to the STESIDES trial was discontinued, even if the patients in the trial were allowed to continue as long as they benefited from the treatment. Another molecule that has the same mode of action was favoured because it was somewhat more advanced in the development and the clinical data of both projects appeared very comparable. No maximum tolerated dose was achieved in the trial, and Part 2 was not initiated.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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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