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    Clinical Trial Results:
    A Phase 1/2 Proof-of-Concept Study of the Combination of Acalabrutinib and Vistusertib in Subjects with Relapsed/Refractory B-cell Malignancies

    Summary
    EudraCT number
    		 2016-003736-21
    Trial protocol
    		 GB  
    Global end of trial date
    16 Oct 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    ACE-LY-110
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Acerta Pharma B.V.
    Sponsor organisation address
    121 Oyster Point Boulevard, South San Francisco, United States, 94080
    Public contact
    Acerta Clinical Trials, Acerta Pharma B.V., +1 18882929613, acertamc@dlss.com
    Scientific contact
    Acerta Clinical Trials, Acerta Pharma B.V., +1 18882929613, acertamc@dlss.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
    14 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Oct 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine a dose and schedule for vistusertib in combination with acalabrutinib 100 mg bid, for evaluation of the safety of acalabrutinib and vistusertib when coadministered.
    Protection of trial subjects
    The conduct of this clinical study met all local and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization guideline: Good Clinical Practice, and applicable regulatory requirements. Participants signed an informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Sep 2017
    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
    United Kingdom: 11
    Country: Number of subjects enrolled
    United States: 14
    Worldwide total number of subjects
    25
    EEA total number of subjects
    11
    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)
    9
    From 65 to 84 years
    15
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adult subjects with a diagnosis of relapsed/refractory DLBCL as documented by medical records, who have no curative option with conventional therapy, and with at least 1 prior treatment with combination chemoimmunotherapy.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Acalabrutinib 100 mg BID plus Vistusertib BID Continuous
    Arm description
    		 Continuous
    Arm type
    		 Experimental

    Investigational medicinal product name
    acalabrutinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg BID

    Investigational medicinal product name
    vistusertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BID continuous

    Arm title
    		 Acalabrutinib 100 mg BID plus Vistusertib BID Intermittent
    Arm description
    		 Intermittent
    Arm type
    		 Experimental

    Investigational medicinal product name
    vistusertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BID intermittent

    Investigational medicinal product name
    acalabrutinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg BID

    Number of subjects in period 1
    		Acalabrutinib 100 mg BID plus Vistusertib BID Continuous Acalabrutinib 100 mg BID plus Vistusertib BID Intermittent
    Started
    13
    12
    Completed
    0
    2
    Not completed
    13
    10
         Consent withdrawn by subject
    1
    2
         Death
    10
    6
         Study terminated by sponsor
    2
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Acalabrutinib 100 mg BID plus Vistusertib BID Continuous
    Reporting group description
    		 Continuous

    Reporting group title
    Acalabrutinib 100 mg BID plus Vistusertib BID Intermittent
    Reporting group description
    		 Intermittent

    Reporting group values
    		 Acalabrutinib 100 mg BID plus Vistusertib BID Continuous Acalabrutinib 100 mg BID plus Vistusertib BID Intermittent Total
    Number of subjects
    		 13 12 25
    Age categorical
    Units: Subjects
        Adults (between 18 and 64)
    		 5 4 9
        >=65
    		 8 8 16
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 63.6 ± 15.9 67.3 ± 12.0 -
    Sex: Female, Male
    Units:
        Male
    		 9 10 19
        Female
    		 4 2 6
    Region of Enrollment
    Units: Subjects
        United States
    		 5 9 14
        United Kingdom
    		 8 3 11
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 1
        Not Hispanic or Latino
    		 11 11 22
        Unknown or Not Reported
    		 2 0 2
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 1 0 1
        White
    		 12 11 23
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 1 1
    Subject analysis sets

    Subject analysis set title
    Acalabrutinib 100 mg BID* plus Vistusertib BID* Continuous
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Continuous

    Subject analysis set title
    Acalabrutinib 100 mg BID* plus Vistusertib BID* Intermittent
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Intermittent

    Subject analysis sets values
    		 Acalabrutinib 100 mg BID* plus Vistusertib BID* Continuous Acalabrutinib 100 mg BID* plus Vistusertib BID* Intermittent
    Number of subjects
    13
    12
    Age categorical
    Units: Subjects
        Adults (between 18 and 64)
    5
    4
        >=65
    8
    8
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    63.6 ± 15.9
    67.3 ± 12.0
    Sex: Female, Male
    Units:
        Male
    9
    10
        Female
    4
    2
    Region of Enrollment
    Units: Subjects
        United States
    5
    9
        United Kingdom
    8
    3
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0
    1
        Not Hispanic or Latino
    11
    11
        Unknown or Not Reported
    2
    0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
    0
        Asian
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
        Black or African American
    1
    0
        White
    12
    11
        More than one race
    0
    0
        Unknown or Not Reported
    0
    1

    End points

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    End points reporting groups
    Reporting group title
    Acalabrutinib 100 mg BID plus Vistusertib BID Continuous
    Reporting group description
    		 Continuous

    Reporting group title
    Acalabrutinib 100 mg BID plus Vistusertib BID Intermittent
    Reporting group description
    		 Intermittent

    Subject analysis set title
    Acalabrutinib 100 mg BID* plus Vistusertib BID* Continuous
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Continuous

    Subject analysis set title
    Acalabrutinib 100 mg BID* plus Vistusertib BID* Intermittent
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Intermittent

    Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs)

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (AEs) [1]
    End point description
    Safety assessments comprised type, frequency, severity, and relationship to either or both study drug of any AEs or abnormalities of laboratory tests; serious adverse events (SAEs); dose-limiting toxicities (DLTs); or AEs that led to dose modification, dose delay, or discontinuation of study drug(s).
    End point type
    Primary
    End point timeframe
    From enrollment through up to 12 cycles of treatment
    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 were used; there is no p value.
    End point values
    		 Acalabrutinib 100 mg BID* plus Vistusertib BID* Continuous Acalabrutinib 100 mg BID* plus Vistusertib BID* Intermittent
    Number of subjects analysed
    13
    12
    Units: Participants
    13
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until 30 days post last dose
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Acalabrutinib 100 mg BID plus Vistusertib BID Continuous
    Reporting group description
    		 Continuous

    Reporting group title
    Acalabrutinib 100 mg BID plus Vistusertib BID Intermittent
    Reporting group description
    		 Intermittent

    Serious adverse events
    		 Acalabrutinib 100 mg BID plus Vistusertib BID Continuous Acalabrutinib 100 mg BID plus Vistusertib BID Intermittent
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 13 (15.38%)
    6 / 12 (50.00%)
         number of deaths (all causes)
    2
    3
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Computerised tomogram thorax abnormal
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 12 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymph node pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 12 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Acalabrutinib 100 mg BID plus Vistusertib BID Continuous Acalabrutinib 100 mg BID plus Vistusertib BID Intermittent
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 13 (100.00%)
    12 / 12 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour ulceration
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 13 (0.00%)
    5 / 12 (41.67%)
         occurrences all number
    0
    6
    Orthostatic hypotension
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    4 / 13 (30.77%)
    8 / 12 (66.67%)
         occurrences all number
    4
    10
    Influenza like illness
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Injection site bruising
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Oedema
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 12 (16.67%)
         occurrences all number
    2
    4
    Peripheral swelling
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Breast mass
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 13 (15.38%)
    4 / 12 (33.33%)
         occurrences all number
    2
    4
    Dysphonia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 12 (16.67%)
         occurrences all number
    1
    2
    Dyspnoea exertional
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Hypoxia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Increased bronchial secretion
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Pleural effusion
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Pneumonitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Confusional state
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    3
    Depressed mood
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    3 / 13 (23.08%)
    0 / 12 (0.00%)
         occurrences all number
    3
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Bacterial test positive
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    4 / 13 (30.77%)
    7 / 12 (58.33%)
         occurrences all number
    5
    11
    Blood urea increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Ejection fraction decreased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    3
    Platelet count decreased
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    1
    3
    Weight decreased
         subjects affected / exposed
    1 / 13 (7.69%)
    3 / 12 (25.00%)
         occurrences all number
    1
    3
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 13 (7.69%)
    4 / 12 (33.33%)
         occurrences all number
    1
    6
    Neuralgia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Neuropathy peripheral
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Presyncope
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 13 (15.38%)
    5 / 12 (41.67%)
         occurrences all number
    2
    7
    Increased tendency to bruise
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    7
    Lymphopenia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Neutropenia
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 12 (16.67%)
         occurrences all number
    1
    3
    Thrombocytopenia
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    13
    Eye disorders
    Periorbital oedema
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 13 (0.00%)
    6 / 12 (50.00%)
         occurrences all number
    0
    7
    Dry mouth
         subjects affected / exposed
    2 / 13 (15.38%)
    4 / 12 (33.33%)
         occurrences all number
    2
    4
    Diarrhoea
         subjects affected / exposed
    6 / 13 (46.15%)
    2 / 12 (16.67%)
         occurrences all number
    8
    5
    Dysphagia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Nausea
         subjects affected / exposed
    1 / 13 (7.69%)
    8 / 12 (66.67%)
         occurrences all number
    1
    10
    Stomatitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 13 (7.69%)
    5 / 12 (41.67%)
         occurrences all number
    2
    6
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    2
    Erythema
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    3 / 13 (23.08%)
    2 / 12 (16.67%)
         occurrences all number
    3
    2
    Rash
         subjects affected / exposed
    3 / 13 (23.08%)
    2 / 12 (16.67%)
         occurrences all number
    3
    4
    Rash maculo-papular
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Chronic kidney disease
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Myalgia
         subjects affected / exposed
    2 / 13 (15.38%)
    3 / 12 (25.00%)
         occurrences all number
    3
    3
    Infections and infestations
    Candida infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Enterovirus infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Pneumonia
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 12 (16.67%)
         occurrences all number
    1
    3
    Rhinovirus infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Sinusitis bacterial
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 13 (0.00%)
    6 / 12 (50.00%)
         occurrences all number
    0
    6
    Dehydration
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    3
    Hypercalcaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    4
    Hyperglycaemia
         subjects affected / exposed
    3 / 13 (23.08%)
    5 / 12 (41.67%)
         occurrences all number
    5
    7
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    5
    Hypoglycaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 12 (16.67%)
         occurrences all number
    2
    2
    Hyponatraemia
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    4
    Hypophosphataemia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Mar 2017
    Amendment 1
    06 Feb 2018
    Amendment 2

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    21 May 2018
    study terminated by sponsor
    -

    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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