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    Clinical Trial Results:
    Phase II, open label clinical study to investigate anti-tumour effect and tolerability of the PARP inhibitor 2X-121 in patients with metastatic breast cancer selected by the 2X-121 DRP®.

    Summary
    EudraCT number
    		 2017-003508-39
    Trial protocol
    		 DK  
    Global end of trial date
    24 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jun 2024
    First version publication date
    23 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SMR-3475
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allarity Therapeutics Europe AS
    Sponsor organisation address
    Venlighdsvej 1, Horsholm, Denmark, 2970
    Public contact
    Marie Foegh, Allarity Therapeutics Europe AS, +45 NA, mfoegh@allarity.com
    Scientific contact
    Marie Foegh, Allarity Therapeutics Europe AS, +45 NA, mfoegh@allarity.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
    17 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    •To evaluate the anti-tumour efficacy after treatment with 600 mg 2X-121 as single agent in a 21-days cycle in metastatic breast cancer patients selected by the 2X-121 DRP.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    13
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited at two sited in Denmark. First patient first visit was 22Jun2018. Last patient last visit was 24Jun2020. A total of 16 subjects were include in the study, of these 14 subjects received treatment.

    Pre-assignment
    Screening details
    		 A drug response prediction (DRP) was used as a companion diagnostic for selection of subjects.

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open trail

    Arms
    Arm title
    		 Treatment 2X-121
    Arm description
    		 Every patient will receive daily oral administrations of 3 x 200 mg 2X-121 in a 21 days cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    2X-121
    Investigational medicinal product code
    2X-121
    Other name
    Stenoparib
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Every patient will receive daily oral administrations of 3 x 200 mg 2X-121 in a 21 days cycle until progression

    Number of subjects in period 1
    		Treatment 2X-121
    Started
    16
    Completed
    14
    Not completed
    2
         Screening failure
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study period
    Reporting group description
    		 -

    Reporting group values
    		 Study period Total
    Number of subjects
    		 16 16
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.5 ( 13.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients would be included in the intention-to-treat (ITT) population for analysis if they had measurable disease at baseline and receive treatment for at least one dose of 2X-121.

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    In order to qualify for the stringent per protocol population, patients should follow the study protocol without any major violation, and should receive at least 2 cycles of treatment.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients will be included in the safety population if they have measurable disease at baseline and receive treatment for at least one dose of 2X-121.

    Subject analysis set title
    Evaluable
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Evaluable population includes PP population and patients with disease progression before completing 2 cycles.

    Subject analysis sets values
    		 ITT Per Protocol Safety population Evaluable
    Number of subjects
    14
    14
    9
    11
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.5 ( 13.4 )
    ND ( ND )
    ND ( ND )
    ND ( ND )
    Gender categorical
    Units: Subjects
        Female
    16
    14
    16
    11
        Male
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Treatment 2X-121
    Reporting group description
    		 Every patient will receive daily oral administrations of 3 x 200 mg 2X-121 in a 21 days cycle.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients would be included in the intention-to-treat (ITT) population for analysis if they had measurable disease at baseline and receive treatment for at least one dose of 2X-121.

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    In order to qualify for the stringent per protocol population, patients should follow the study protocol without any major violation, and should receive at least 2 cycles of treatment.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients will be included in the safety population if they have measurable disease at baseline and receive treatment for at least one dose of 2X-121.

    Subject analysis set title
    Evaluable
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Evaluable population includes PP population and patients with disease progression before completing 2 cycles.

    Primary: Clinical Benefit Rate (CBR) > 24 weeks

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    End point title
    		 Clinical Benefit Rate (CBR) > 24 weeks [1]
    End point description
    End point type
    Primary
    End point timeframe
    Clinical Benefit Rate (CBR) > 24 weeks
    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: Not available
    End point values
    		 Treatment 2X-121 ITT
    Number of subjects analysed
    11
    14
    Units: Subject (%)
        CR> 24W
    0
    0
        PR>24W
    0
    0
        SD>24W
    1
    1
        CBR>24W
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from first administration of IMP
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 -

    Serious adverse events
    		 All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 14 (35.71%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Metastases to central nervous system
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Vascular disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Surgical and medical procedures
    Cataract
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    General disorders and administration site conditions
    Axillary pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Burning sensation
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Decreased appetite
         subjects affected / exposed
    8 / 14 (57.14%)
         occurrences all number
    8
    Disease progression
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    11 / 14 (78.57%)
         occurrences all number
    11
    General physical health deterioration
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Influenza like illness
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Oedema
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Dyspnoea
         subjects affected / exposed
    6 / 14 (42.86%)
         occurrences all number
    6
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences all number
    4
    Headache
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Neuralgia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Inner ear disorder
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Eye disorders
    Photophobia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Diarrhoea
         subjects affected / exposed
    6 / 14 (42.86%)
         occurrences all number
    6
    Dry mouth
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    8 / 14 (57.14%)
         occurrences all number
    8
    Vomiting
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nail disorder
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Photosensitivity reaction
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Pruritus
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    pruritus generalised
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Rash maculo-papular
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences all number
    4
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    13 / 14 (92.86%)
         occurrences all number
    13
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences all number
    4
    Bone pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Neck pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Oral fungal infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Oct 2018
    Change to inclusion criteria 3 and 11d Add restriction on intake of IMP related to food
    24 Jun 2019
    Change in dosing schedule for IMP

    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.
    The study was not completed
    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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