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    Clinical Trial Results:
    Efficacy of medical treatment with SOM230 LAR in patients with primary inoperable thymoma and/or with local recurrent thymoma to reduce tumor size

    Summary
    EudraCT number
    		 2010-019017-25
    Trial protocol
    		 DE  
    Global end of trial date
    30 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Mar 2017
    First version publication date
    10 Mar 2017
    Other versions
    Summary report(s)
    		 CSOM230CIC01T_CSR synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    CSOM230CIC01T
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02021942
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Freistaat Bayern, represented by Universitaet Regensburg
    Sponsor organisation address
    Universitaetsstrasse 84, Regensburg, Germany, 93053
    Public contact
    Prof. Dr. Berthold Schalke, Klinik und Poliklinik fuer Neurologie der Universitaet Regensburg, 49 9419413010, berthold.schalke@medbo.de
    Scientific contact
    Prof. Dr. Berthold Schalke, Klinik und Poliklinik fuer Neurologie der Universitaet Regensburg, 49 9419413010, berthold.schalke@medbo.de
    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
    24 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Tumor shrinkage from baseline to EOS
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial. Before implementing this study, the protocol, the proposed informed consent form and other information to subjects, were reviewed by a properly constituted Independent Ethics Committee. The occurrence of adverse events was sought by non-directive questioning of the patient at each visit during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory tests, or other assessments. Adverse event monitoring had to be continued for 4 weeks following the last dose of study drug. SAEs were monitored continuously.
    Background therapy
    		 Prednisolone may be have been added to the therapeutic regime according to the investigator's decision after the 8 week control examination if the therapeutic response was not adequate. Prednisolone had to be taken from the investigator’s stock.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Mar 2012
    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
    Germany: 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
    		 This monocentric trial was conducted in Regensburg, Germany. The patients were asked for study participation by the investigator. Recruitment started March 2012 and ended July 2014. The study runtime was extended by one year due to delayed patient recruitment.

    Pre-assignment
    Screening details
    		 The study population consisted of 16 adult patients with inoperable thymoma. All patients screened have been enrolled. For one patient initial diagnosis of thymoma could not be confirmed, but a squamous cell carcinoma was diagnosed later by the central pathologist.

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

    Arms
    Arm title
    		 SOM230 LAR
    Arm description
    		 SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pasireotide
    Investigational medicinal product code
    SOM230 LAR
    Other name
    Signifor LAR
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 mg i.m. once every 4 weeks

    Number of subjects in period 1
    		SOM230 LAR
    Started
    16
    Completed
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study (overall period) Total
    Number of subjects
    		 16 16
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 13 13
        From 65-84 years
    		 3 3
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.6 ( 12.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 9 9
    WHO tumor classification
    The histological classification of thymomas was based on the WHO classification (Rosai, 1999; Travis et al., 2004).
    Units: Subjects
        AB
    		 1 1
        B1
    		 1 1
        B2
    		 6 6
        B3
    		 8 8
    Staging of thymoma
    Staging of thymoma was performed by modified Masaoka (1981) staging system as proposed by Shimosato and Mukai (1994/1997).
    Units: Subjects
        Stage I
    		 0 0
        Stage II
    		 0 0
        Stage III
    		 1 1
        Stage IVa
    		 15 15
        Stage IVb
    		 0 0
    Type of tumor biopsy
    Units: Subjects
        Fine needle biopsy
    		 5 5
        Open biopsy
    		 5 5
        Previous surgery
    		 6 6
    Subject analysis sets

    Subject analysis set title
    FAS Screening
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS Screening comprises 16 patients out of 16 patients. None of the enrolled patients was rejected from the primary analysis (ITT population).

    Subject analysis set title
    FAS EOS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS EOS comprises 16 patients out of 16 patients. None of the enrolled patients was rejected from the primary analysis (ITT population).

    Subject analysis sets values
    		 FAS Screening FAS EOS
    Number of subjects
    16
    16
    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)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    WHO tumor classification
    The histological classification of thymomas was based on the WHO classification (Rosai, 1999; Travis et al., 2004).
    Units: Subjects
        AB
    1
    1
        B1
    1
    1
        B2
    6
    6
        B3
    8
    8
    Staging of thymoma
    Staging of thymoma was performed by modified Masaoka (1981) staging system as proposed by Shimosato and Mukai (1994/1997).
    Units: Subjects
        Stage I
    0
    0
        Stage II
    0
    0
        Stage III
    1
    1
        Stage IVa
    15
    15
        Stage IVb
    0
    0
    Type of tumor biopsy
    Units: Subjects
        Fine needle biopsy
    5
    5
        Open biopsy
    5
    5
        Previous surgery
    6
    6

    End points

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    End points reporting groups
    Reporting group title
    SOM230 LAR
    Reporting group description
    		 SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks

    Subject analysis set title
    FAS Screening
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS Screening comprises 16 patients out of 16 patients. None of the enrolled patients was rejected from the primary analysis (ITT population).

    Subject analysis set title
    FAS EOS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS EOS comprises 16 patients out of 16 patients. None of the enrolled patients was rejected from the primary analysis (ITT population).

    Primary: Evaluation of tumor shrinkage from screening to EOS

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    End point title
    		 Evaluation of tumor shrinkage from screening to EOS
    End point description
    Tumor shrinkage was assessed by MRI. Primary endpoint was to prove a decrease in tumor volume of 20% at EOS as compared to baseline which is considered as response. For each patient at each visit only one lesion was observed. No multiple lesions were observed. EOS is defined as 4 weeks after patient fulfils criteria for operability of thymoma or after SOM230 LAR treatment discontinuation [either during 6-month treatment/observation period or FU, respectively].
    End point type
    Primary
    End point timeframe
    Screening to EOS
    End point values
    		 SOM230 LAR FAS Screening FAS EOS
    Number of subjects analysed
    16
    16
    16
    Units: percent volume/volume
        arithmetic mean (standard deviation)
    -37.38 ( 44.1 )
    100 ( 0 )
    -37.38 ( 44.1 )
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    A response rate of lower than 0.05 is considered not to warrant further investigation of a drug, whereas a response rate of at least 0.3 is considered to warrant further investigation. Accordingly, the following hypothesis will be tested: H0: P <= 0.050 versus H1: P >= 0.300. 16 patients were required to decide whether the response proportion, P, is less than or equal to 0.050 or greater than or equal to 0.300.
    Comparison groups
    SOM230 LAR v FAS Screening v FAS EOS
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 ≤ 0.05
    Method
    		 Fleming’s “one-sample multiple testing
    Confidence interval
    Notes
    [1] - As this was a proof of concept study it was designed according to Fleming’s “one-sample multiple testing procedure for phase II clinical trials” (Fleming, 1989).

    Secondary: Evaluation of Tumor Resection Status

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    End point title
    		 Evaluation of Tumor Resection Status
    End point description
    To evaluate the resection status based on the categories R0, R1 and ≥ R2 at EOS. EOS is defined as 4 weeks after patient fulfils criteria for operability of thymoma or after SOM230 LAR treatment discontinuation [either during 6-month treatment/observation period or FU, respectively].
    End point type
    Secondary
    End point timeframe
    EOS
    End point values
    		 SOM230 LAR
    Number of subjects analysed
    16
    Units: Number of participants
        Surgery performed with resection status R0
    6
        Surgery performed with resection status R1
    4
        No surgery performed
    6
    No statistical analyses for this end point

    Secondary: Evaluation of tumor operability

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    End point title
    		 Evaluation of tumor operability
    End point description
    Evaluation of tumor operability as assessed by the treating surgeon. In addition the response criteria (see primary endpoint) had to be fulfilled.
    End point type
    Secondary
    End point timeframe
    EOS EOS is defined as 4 weeks after patient fulfils criteria for operability of thymoma or after SOM230 LAR treatment discontinuation [either during 6-month treatment/observation period or FU, respectively].
    End point values
    		 SOM230 LAR
    Number of subjects analysed
    16 [2]
    Units: Number of participants
        Tumor assesed as operable
    11
        Tumor assesed as not operable
    5
    Notes
    [2] - The tumors of 11 patients were operable. One of these patients decided not to undergo surgery.
    No statistical analyses for this end point

    Other pre-specified: Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

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    End point title
    		 Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Screening to EOS.
    End point values
    		 SOM230 LAR
    Number of subjects analysed
    16
    Units: Number of Participants
        Number of participants with AEs
    16
        Number of participants with SAEs
    7
    No statistical analyses for this end point

    Other pre-specified: Assessment of Myasthenia Gravis (MG) status by determining Titin-antibody status

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    End point title
    		 Assessment of Myasthenia Gravis (MG) status by determining Titin-antibody status
    End point description
    MG severity status is assessed by determining change of Titin-antibody status from Screening to EOS.
    End point type
    Other pre-specified
    End point timeframe
    Screening until EOS.
    End point values
    		 SOM230 LAR
    Number of subjects analysed
    16
    Units: Titin-antibody status
        Missing data at baseline or EOS
    8
        Change from negative to negative
    4
        Change from negative to positive
    0
        Change from positive to positive
    2
        Change from positive to negative
    2
    No statistical analyses for this end point

    Other pre-specified: Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations

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    End point title
    		 Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations
    End point description
    MG severity status is assessed by Change of ACHR-antibody concentrations at Baseline and EOS.
    End point type
    Other pre-specified
    End point timeframe
    Baseline until EOS.
    End point values
    		 SOM230 LAR
    Number of subjects analysed
    16
    Units: ACHR-antibody concentration
        Missing data at baseline or EOS
    8
        ACHR-antibody level increased
    1
        ACHR-antibody level decreased
    4
        ACHR-antibody level constant
    3
    No statistical analyses for this end point

    Other pre-specified: Health Related Quality of Life

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    End point title
    		 Health Related Quality of Life
    End point description
    Health related quality of life information was collected at Baseline and EOS using SF-36 questionnaire. Questionnaires had to be completed by the patients. Patient reported answers were transformed into domain scores according to the guidelines provided by RAND/MOS. For statistical analysis only paired values were considered, i.e. patients for which both data from Baseline and EOS was available.
    End point type
    Other pre-specified
    End point timeframe
    Baseline and EOS.
    End point values
    		 SOM230 LAR
    Number of subjects analysed
    11 [3]
    Units: Score
    arithmetic mean (standard deviation)
        Physical function (SCR)
    58.6 ( 28.9 )
        Physical function (EOS)
    49.1 ( 25.6 )
        Role limitations due to physical health (SCR)
    31.8 ( 38.9 )
        Role limitations due to physical health (EOS)
    34.1 ( 45.1 )
        Pain (SCR)
    57.3 ( 28.8 )
        Pain (EOS)
    52.3 ( 35.7 )
        General health (SCR)
    53.2 ( 12.9 )
        General health (EOS)
    47.1 ( 14.5 )
        Energy/Fatigue (SCR)
    43.6 ( 15.5 )
        Energy/Fatigue (EOS)
    39.2 ( 21.3 )
        Social functioning (SCR)
    61.4 ( 27.6 )
        Social functioning (EOS)
    60.2 ( 30.5 )
        Role limitations due to emotional problems (SCR)
    63.6 ( 45.8 )
        Role limitations due to emotional problems (EOS)
    60.6 ( 44.3 )
        Emotional well-being (SCR)
    60.4 ( 18.7 )
        Emotional well-being (EOS)
    56.6 ( 20.9 )
        Change in health (general) (SCR)
    38.6 ( 20.5 )
        Change in health (general) (EOS)
    50 ( 15.8 )
    Notes
    [3] - 5 out of 16 patients were excluded from Analysis due to missing EOS data.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to EOS.
    Adverse event reporting additional description
    An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    SOM230 LAR
    Reporting group description
    		 SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks

    Serious adverse events
    		 SOM230 LAR
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 16 (43.75%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastasis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tumor pain
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Embolism venous
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 SOM230 LAR
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 16 (100.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Fatigue
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Influenza like illness
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Immune system disorders
    Immunodeficiency
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    2
    Haemoptysis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Laryngeal inflammation
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Glycosylated haemoglobin increased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Troponin increased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Muscle strain
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Eye disorders
    Cataract
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    4
    Abdominal pain upper
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Abnormal faeces
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    10 / 16 (62.50%)
         occurrences all number
    12
    Flatulence
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Oral dysaesthesia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Skin hyperpigmentation
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Renal and urinary disorders
    Glycosuria
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Haematuria
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Endocrine disorders
    Cushing's syndrome
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Muscle spasms
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Neck pain
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Infections and infestations
    Bacterial infection
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Oral candidiasis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Penile infection
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Skin infection
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Vaginal infection
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Gout
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    4 / 16 (25.00%)
         occurrences all number
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Sep 2012
    The protocol was amended once during the study. The main purpose of the amendment was to update the safety information for patients after new data about SOM230 were available (safety update only). The study protocol was amended to implement urgent safety communication from the pharmaceutical manufacturer of the study drug (Novartis Pharma). It was observed in other SOM230-studies that healthy subjects treated with SOM230 fulfilled criteria for Hy’s Law (i.e., that patients treated with a specific drug suffer from certain abnormities of liver enzymes, resulting in a higher risk of hepatotoxicity). Thus, Hy’s Law should be considered as prognostic indicator for a pure drug-induced liver injury. In addition, the sponsor’s procedures and responsibilities of safety monitoring were described in more detail.

    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.
    Eval. of 3 intended secondary efficacy parameters was suspended due to scarcity of resources: Histopath. eval. of tumor samples, immunohistochem. eval. of tumor derived cells and eval. of changes in the subset composition of intratumorous T-cells
    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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