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    Clinical Trial Results:
    A multi-center, intra-patient dose escalation Phase II study to evaluate the preliminary efficacy, safety and pharmacokinetics of pasireotide (SOM230) subcutaneous (sc) followed by pasireotide LAR in patients with dumping syndrome

    Summary
    EudraCT number
    		 2012-001534-34
    Trial protocol
    		 BE   NL  
    Global end of trial date
    07 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Aug 2016
    First version publication date
    15 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CSOM230X2203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01637272
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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
    07 Aug 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the treatment effect of pasireotide sc on plasma glucose levels during a 3-hour oral glucose tolerance test (OGTT) at the end of sc dose escalation phase.
    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 the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jan 2013
    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
    Belgium: 11
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    United States: 12
    Worldwide total number of subjects
    43
    EEA total number of subjects
    31
    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)
    42
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 43 patients were enrolled as planned; 33 patients completed the core sc phase, 31 patients completed the core LAR phase. Of the 31 patients who completed core LAR phase, 27 patients entered the extension phase. Of the 27 patients who entered the extension phase, 23 patients completed the study.

    Pre-assignment
    Screening details
    		 All patients underwent an OGTT (75g of glucose) and were evaluated at different time points. If the glucose level was <60 mg/dL at 90, 120, 150 or 180 min during the OGTT and all the other eligibility criteria were met, patients were allowed to start study medication. The study was divided in 2 phases, core phase and extension phase.

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

    Arms
    Arm title
    		 SOM230
    Arm description
    		 Subjects with dumping syndrome treated with pasireotide sc followed by pasireotide LAR
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pasireotide
    Investigational medicinal product code
    SOM230
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use, Subcutaneous use
    Dosage and administration details
    Pasireotide (SOM230) sc injection: was provided as solution for injection in individual one-point-cut 1 mL ampule, containing nominally 200 μg of pasireotide. Pasireotide (SOM230) im LAR depot injection was provided as micro particles powder in vials containing nominally 10, 20, 40 and 60 mg of pasireotide (as free base) and solvent for suspension for injection in ampules for the reconstitution of the LAR micro particles.

    Number of subjects in period 1
    		SOM230
    Started
    43
    Completed
    23
    Not completed
    20
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    6
         Unsatisfactory therapeutic effect
    2
         completed core, did not enter ext. phase
    4
         Administrative problems
    1
         Lost to follow-up
    2
         Protocol deviation
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOM230
    Reporting group description
    		 Subjects with dumping syndrome treated with pasireotide sc followed by pasireotide LAR

    Reporting group values
    		 SOM230 Total
    Number of subjects
    		 43 43
    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)
    		 42 42
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 45.9 ( 9.99 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 38 38
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    SOM230
    Reporting group description
    		 Subjects with dumping syndrome treated with pasireotide sc followed by pasireotide LAR

    Primary: Response rate in plasma glucose level at the end of subcutaneous (s.c.) dose escalation phase

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    End point title
    		 Response rate in plasma glucose level at the end of subcutaneous (s.c.) dose escalation phase [1]
    End point description
    Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    at month 3
    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: No statistical analysis was planned for this primary outcome.
    End point values
    		 SOM230
    Number of subjects analysed
    43
    Units: percentage of participants
        number (confidence interval 95%)
    60.5 (44.41 to 75.02)
    No statistical analyses for this end point

    Secondary: Response rate in plasma glucose level at the end of 12 months (extension phase)

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    End point title
    		 Response rate in plasma glucose level at the end of 12 months (extension phase)
    End point description
    Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 12 months (extension phase)
    End point type
    Secondary
    End point timeframe
    at month 12
    End point values
    		 SOM230
    Number of subjects analysed
    43
    Units: percentage of participants
        number (confidence interval 95%)
    39.4 (22.91 to 57.86)
    No statistical analyses for this end point

    Secondary: Response rate in pulse rate at end of Month 12 (extension phase)

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    End point title
    		 Response rate in pulse rate at end of Month 12 (extension phase)
    End point description
    Pulse rate was defined as percentage of patients with change in pulse rate <10 bpm from pre-OGTT to 30 minutes during the 3 hour OGTT at Month 12.
    End point type
    Secondary
    End point timeframe
    at end of month 12
    End point values
    		 SOM230
    Number of subjects analysed
    33
    Units: Percentage of participants
    number (not applicable)
        < 10 bits per minute (bpm)
    75.8
        >= 10bpm
    24.2
    No statistical analyses for this end point

    Secondary: Response rate in hematocrit level at the end of the Month 12 (extension phase)

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    End point title
    		 Response rate in hematocrit level at the end of the Month 12 (extension phase)
    End point description
    Percentage of patients with change in hematocrit < 3% from pre-OGTT to 30 min during the OGTT at month 12
    End point type
    Secondary
    End point timeframe
    at the end of Month 12
    End point values
    		 SOM230
    Number of subjects analysed
    33
    Units: Percentage of participants
    number (not applicable)
        < 3%
    78.8
        >= 3%
    21.2
    No statistical analyses for this end point

    Secondary: Insulin levels at the end of the Month 12 (extension phase)

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    End point title
    		 Insulin levels at the end of the Month 12 (extension phase)
    End point description
    Percentage changes of insulin at the end of Month 12 from end of Month 3 at different time points.
    End point type
    Secondary
    End point timeframe
    Month 3 (M3), Month 12 (M12)
    End point values
    		 SOM230
    Number of subjects analysed
    33
    Units: pmol/L
    arithmetic mean (standard deviation)
        Pre-OGTT at M3 (n=30)
    37.6 ( 24.74 )
        30 Minutes at M3 (n=29)
    197 ( 257.55 )
        60 Minutes at M3 (n= 30)
    369.2 ( 360.67 )
        90 Minutes at M3 (n=30)
    316.4 ( 265.25 )
        120 Minutes at M3 (n=31)
    188.5 ( 211.6 )
        150 Minutes at M3 (n=32)
    105.6 ( 168.77 )
        180 Minutes at M3 (n=31)
    59.7 ( 53.02 )
        Pre-OGTT at M12 (n =21)
    29 ( 14.43 )
        30 Minutes at M12 (n=23)
    294.1 ( 177.25 )
        60 Minutes at M12 (n=22)
    602.1 ( 381.09 )
        90 Minutes at M12 (n=22)
    472 ( 438.82 )
        120 Minutes at M12 (n=22)
    195.1 ( 247.43 )
        150 Minutes at M12 (n=22)
    76 ( 106.05 )
        180 Minutes at M12 (n=22)
    52 ( 58.81 )
    No statistical analyses for this end point

    Secondary: Glucagon levels at the end Month 12 (extension phase)

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    End point title
    		 Glucagon levels at the end Month 12 (extension phase)
    End point description
    Percentage changes of glucagon at the end of Month 12 (extension phase) from end of Month 3 at different time points.
    End point type
    Secondary
    End point timeframe
    Month 3 (M3), Month 12 (M12)
    End point values
    		 SOM230
    Number of subjects analysed
    33
    Units: pmol/L
    arithmetic mean (standard deviation)
        Pre-OGTT at M3 (n=30)
    20.4 ( 6.02 )
        30 Minutes at M3 (n=32)
    20.7 ( 7.14 )
        60 Minutes at M3 (n= 32)
    20.9 ( 7.44 )
        90 Minutes at M3 (n=31)
    20.1 ( 8.03 )
        120 Minutes at M3 (n=31)
    19.7 ( 7.49 )
        150 Minutes at M3 (n=31)
    19.9 ( 7.29 )
        180 Minutes at M3 (n=31)
    20 ( 7.18 )
        Pre-OGTT at M12 (n =23)
    21.4 ( 6.82 )
        30 Minutes at M12 (n=22)
    23.8 ( 6.97 )
        60 Minutes at M12 (n=22)
    22.9 ( 7.07 )
        90 Minutes at M12 (n=22)
    21.5 ( 7.69 )
        120 Minutes at M12 (n=22)
    22 ( 7.31 )
        150 Minutes at M12 (n=22)
    21.8 ( 7.27 )
        180 Minutes at M12 (n=22)
    22.3 ( 6.58 )
    No statistical analyses for this end point

    Secondary: Glucagon-like peptide 1 (GLP-1) levels at the end of Month 12 (extension phase)

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    End point title
    		 Glucagon-like peptide 1 (GLP-1) levels at the end of Month 12 (extension phase)
    End point description
    Percentage changes of Glucagon-like peptide 1 (GLP-1) at the end of the Month 12 (extension phase) from end of Month 3 at different time points.
    End point type
    Secondary
    End point timeframe
    Month 3 (M3), Month 12 (M12)
    End point values
    		 SOM230
    Number of subjects analysed
    33
    Units: pmol/L
    arithmetic mean (standard deviation)
        Pre-OGTT at M3 (n=30)
    2.9 ( 2.11 )
        30 Minutes at M3 (n=31)
    12.7 ( 6.71 )
        60 Minutes at M3 (n= 31)
    11.2 ( 11.31 )
        90 Minutes at M3 (n=30)
    6.8 ( 4.98 )
        120 Minutes at M3 (n=30)
    4.9 ( 4.1 )
        150 Minutes at M3 (n=30)
    3.5 ( 2.34 )
        180 Minutes at M3 (n=30)
    2.9 ( 1.96 )
        Pre-OGTT at M12 (n =23)
    1.6 ( 1.26 )
        30 Minutes at M12 (n=22)
    17.4 ( 17.64 )
        60 Minutes at M12 (n=22)
    12.6 ( 8.76 )
        90 Minutes at M12 (n=22)
    7.2 ( 3.71 )
        120 Minutes at M12 (n=22)
    5 ( 2.98 )
        150 Minutes at M12 (n=22)
    3.7 ( 2.46 )
        180 Minutes at M12 (n=22)
    3.2 ( 2.44 )
    No statistical analyses for this end point

    Secondary: Gastric Inhibitory Polypeptide (GIP) levels at the end of Month 12 (extension phase)

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    End point title
    		 Gastric Inhibitory Polypeptide (GIP) levels at the end of Month 12 (extension phase)
    End point description
    Percentage changes of Gastric Inhibitory Polypeptide (GIP) at the end of Month 12 (extension phase) from end of Month 3 at different time points.
    End point type
    Secondary
    End point timeframe
    Month 3 (M3), Month 12 (M12)
    End point values
    		 SOM230
    Number of subjects analysed
    33
    Units: pmol/L
    arithmetic mean (standard deviation)
        Pre-OGTT at M3 (n=30)
    2.6 ( 1.77 )
        30 Minutes at M3 (n=31)
    15.3 ( 10.59 )
        60 Minutes at M3 (n= 31)
    9.4 ( 6.28 )
        90 Minutes at M3 (n=30)
    4.1 ( 2.95 )
        120 Minutes at M3 (n=30)
    2 ( 1.48 )
        150 Minutes at M3 (n=29)
    1.4 ( 1.23 )
        180 Minutes at M3 (n=30)
    1.2 ( 1.23 )
        Pre-OGTT at M12 (n =23)
    1.7 ( 1.51 )
        30 Minutes at M12 (n=22)
    24.8 ( 18.88 )
        60 Minutes at M12 (n=22)
    11.6 ( 9.05 )
        90 Minutes at M12 (n=22)
    5.2 ( 5.18 )
        120 Minutes at M12 (n=22)
    3 ( 2.81 )
        150 Minutes at M12 (n=22)
    1.9 ( 1.44 )
        180 Minutes at M12 (n=22)
    2.5 ( 3.72 )
    No statistical analyses for this end point

    Secondary: Health-related quality of live (HRQoL) Short Form- 36 (SF-36) Score(s) at the end of Month 12 (extension phase)

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    End point title
    		 Health-related quality of live (HRQoL) Short Form- 36 (SF-36) Score(s) at the end of Month 12 (extension phase)
    End point description
    Change in HRQoL SF-36 Score(s) at end of the Month 12 (extension phase) from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
    End point type
    Secondary
    End point timeframe
    s.c. baseline Month 12
    End point values
    		 SOM230
    Number of subjects analysed
    33
    Units: Percentage change in HRQoL SF-36 Score
    arithmetic mean (standard deviation)
        s.c. baseline - Physical Functioning (n=33)
    44.038 ( 9.0587 )
        Month 12 - Physical Functioning (n=23)
    46.505 ( 8.5105 )
        s.c. baseline - Mental Functioning (n=33)
    41.162 ( 11.011 )
        Month 12 - Mental Functioning (n=23)
    47.021 ( 11.5053 )
    No statistical analyses for this end point

    Secondary: Dumping Score Questionnaire (DSQ) at the end of Month 12 (extension phase)

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    End point title
    		 Dumping Score Questionnaire (DSQ) at the end of Month 12 (extension phase)
    End point description
    Change in Dumping Score Questionnaire at the end of Month 12 (extension phase) from s.c. baseline. DSQ is a disease specific patient reported outcome (PRO) scale that was developed according to the FDA and EMEA guidelines. The questionnaire utilizes a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; and 4, very severe) to ask a patient to evaluate the intensity of 10 early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). In addition, the questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). An early and late dumping score is calculated by adding the severities of all early and late dumping symptoms, respectively. A cumulative dumping score is obtained by adding early and late scores.
    End point type
    Secondary
    End point timeframe
    s.c. baseline, Month 12
    End point values
    		 SOM230
    Number of subjects analysed
    33
    Units: percentage change in DSQ
    arithmetic mean (standard deviation)
        s.c. baseline - Early symptoms (n=13)
    14.2 ( 10.26 )
        s.c. baseline - Late symptoms (n=13)
    6.7 ( 5.6 )
        s.c. baseline - Overall score (n=13)
    20.9 ( 15.22 )
        M12 - Early symptoms (n=23)
    10.7 ( 10.94 )
        M12 - Late symptoms (n=23)
    5.7 ( 5.93 )
        M12 - Overall Score (n=23)
    16.3 ( 16.23 )
    No statistical analyses for this end point

    Secondary: Dumping Severity Score (DSS) at Month 12 (end of the extension phase)

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    End point title
    		 Dumping Severity Score (DSS) at Month 12 (end of the extension phase)
    End point description
    Change in Dumping Severity Score at the end of Month 12 (extension phase) from s.c. baseline. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. Dumping Severity Score was developed by based on symptom pattern descriptions in the literature. The questionnaire utilizes a 4-point Likert scale to ask a patient to evaluate the intensity of 8 early dumping symptoms (within 1 hour after food ingestion) on a scale, 0–3; (0, absent; 1, mild; 2, relevant; and 3, severe), In addition, the questionnaire also evaluates 6 late dumping symptoms (more than 1 hour after food ingestion). An early and late dumping severity score is calculated by adding the severities of all early and late dumping symptoms, respectively. A cumulative dumping severity score is obtained by adding early and late scores. The last patient that answered the DSS was at month 8.
    End point type
    Secondary
    End point timeframe
    s.c. baseline, Month 8
    End point values
    		 SOM230
    Number of subjects analysed
    33
    Units: percentage change in DSS
    arithmetic mean (standard deviation)
        s.c. baseline - Early symptoms (n=21)
    10.6 ( 5.85 )
        s.c. baseline - Late symptoms (n=21)
    8.9 ( 4.12 )
        s.c. baseline - Overall Score (n=21)
    19.5 ( 9.36 )
        M8 - Early symptoms (n=2)
    9 ( 8.49 )
        M8 - Late symptoms (n=2)
    6 ( 4.24 )
        M8 - Overall Score (n=2)
    15 ( 12.73 )
    No statistical analyses for this end point

    Secondary: Patient Global Assessment at the end of Month 12 (extension phase)

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    End point title
    		 Patient Global Assessment at the end of Month 12 (extension phase)
    End point description
    Treatment with pasireotide LAR (both early and late dumping scores), was assessed by patient global assessment.
    End point type
    Secondary
    End point timeframe
    s.c. baseline, Month 12
    End point values
    		 SOM230
    Number of subjects analysed
    33
    Units: percentage of participants
    arithmetic mean (standard deviation)
        s.c. baseline (n=31)
    3.9 ( 0.54 )
        Month 12 (n=23)
    5.9 ( 0.95 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetic (PK) parameter: Ctrough d28 associated with each LAR injection at steady state

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    End point title
    		 Pharmacokinetic (PK) parameter: Ctrough d28 associated with each LAR injection at steady state
    End point description
    Assess PK of pasireotide (in extension phase) with monthly injections of 10, 20, 30 40 mg. Due to one patient at LAR 40 mg, Ctrough, ss for this patient is not provided as it is in listings only.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 SOM230
    Number of subjects analysed
    41
    Units: ng/mL
    arithmetic mean (standard deviation)
        LAR 10 mg (n=6)
    3.34 ( 1.52 )
        LAR 20 mg (n=6)
    3.76 ( 1.48 )
        LAR 30 mg (n=6)
    8.19 ( 3.22 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    s.c. phase
    Reporting group description
    		 s.c. phase

    Reporting group title
    LAR phase
    Reporting group description
    		 LAR phase

    Reporting group title
    Overall
    Reporting group description
    		 Overall

    Serious adverse events
    		 s.c. phase LAR phase Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 43 (13.95%)
    10 / 33 (30.30%)
    12 / 43 (27.91%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Visual field defect
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haemorrhagic anaemia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         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 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 33 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 33 (0.00%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 33 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Subdiaphragmatic abscess
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 33 (3.03%)
    3 / 43 (6.98%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 33 (3.03%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 s.c. phase LAR phase Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 43 (72.09%)
    25 / 33 (75.76%)
    34 / 43 (79.07%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 33 (6.06%)
    3 / 43 (6.98%)
         occurrences all number
    1
    2
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 43 (11.63%)
    4 / 33 (12.12%)
    8 / 43 (18.60%)
         occurrences all number
    5
    5
    9
    Chills
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    3
    3
    6
    Fatigue
         subjects affected / exposed
    3 / 43 (6.98%)
    8 / 33 (24.24%)
    10 / 43 (23.26%)
         occurrences all number
    3
    8
    11
    Injection site irritation
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 33 (3.03%)
    3 / 43 (6.98%)
         occurrences all number
    2
    1
    3
    Injection site pain
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 33 (3.03%)
    5 / 43 (11.63%)
         occurrences all number
    4
    1
    5
    Injection site reaction
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 33 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    3
    0
    3
    Oedema peripheral
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    2
    Thirst
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 33 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    3
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 33 (3.03%)
    3 / 43 (6.98%)
         occurrences all number
    2
    1
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    2
    Depressed mood
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 33 (6.06%)
    3 / 43 (6.98%)
         occurrences all number
    1
    2
    3
    Depression
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 33 (3.03%)
    3 / 43 (6.98%)
         occurrences all number
    3
    1
    3
    Insomnia
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 33 (9.09%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    3
    Investigations
    Weight increased
         subjects affected / exposed
    3 / 43 (6.98%)
    2 / 33 (6.06%)
    5 / 43 (11.63%)
         occurrences all number
    3
    2
    5
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 33 (9.09%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    3
    Fall
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    2
    Post-traumatic pain
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    2
    Rib fracture
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    2
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 33 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    3
    0
    3
    Palpitations
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 33 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    4
    0
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 43 (9.30%)
    0 / 33 (0.00%)
    4 / 43 (9.30%)
         occurrences all number
    7
    0
    7
    Headache
         subjects affected / exposed
    10 / 43 (23.26%)
    9 / 33 (27.27%)
    15 / 43 (34.88%)
         occurrences all number
    15
    9
    24
    Syncope
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 33 (3.03%)
    4 / 43 (9.30%)
         occurrences all number
    4
    2
    6
    Abdominal pain
         subjects affected / exposed
    7 / 43 (16.28%)
    7 / 33 (21.21%)
    9 / 43 (20.93%)
         occurrences all number
    10
    13
    23
    Abdominal pain upper
         subjects affected / exposed
    5 / 43 (11.63%)
    3 / 33 (9.09%)
    8 / 43 (18.60%)
         occurrences all number
    6
    3
    9
    Constipation
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 33 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    3
    0
    3
    Diarrhoea
         subjects affected / exposed
    9 / 43 (20.93%)
    8 / 33 (24.24%)
    12 / 43 (27.91%)
         occurrences all number
    12
    17
    28
    Dyspepsia
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    2
    Nausea
         subjects affected / exposed
    6 / 43 (13.95%)
    6 / 33 (18.18%)
    10 / 43 (23.26%)
         occurrences all number
    7
    7
    14
    Steatorrhoea
         subjects affected / exposed
    4 / 43 (9.30%)
    0 / 33 (0.00%)
    4 / 43 (9.30%)
         occurrences all number
    4
    0
    4
    Vomiting
         subjects affected / exposed
    3 / 43 (6.98%)
    3 / 33 (9.09%)
    5 / 43 (11.63%)
         occurrences all number
    7
    4
    11
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 43 (0.00%)
    5 / 33 (15.15%)
    5 / 43 (11.63%)
         occurrences all number
    0
    8
    8
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    2
    Hyperhidrosis
         subjects affected / exposed
    3 / 43 (6.98%)
    2 / 33 (6.06%)
    4 / 43 (9.30%)
         occurrences all number
    3
    2
    5
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 43 (6.98%)
    4 / 33 (12.12%)
    6 / 43 (13.95%)
         occurrences all number
    3
    5
    8
    Muscle spasms
         subjects affected / exposed
    2 / 43 (4.65%)
    4 / 33 (12.12%)
    5 / 43 (11.63%)
         occurrences all number
    4
    4
    8
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    1
    2
    3
    Gastroenteritis
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    2
    Nasopharyngitis
         subjects affected / exposed
    3 / 43 (6.98%)
    6 / 33 (18.18%)
    8 / 43 (18.60%)
         occurrences all number
    3
    6
    9
    Sinusitis
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    0
    3
    3
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    2 / 43 (4.65%)
    3 / 33 (9.09%)
    5 / 43 (11.63%)
         occurrences all number
    2
    3
    5
    Hypoglycaemia
         subjects affected / exposed
    5 / 43 (11.63%)
    9 / 33 (27.27%)
    12 / 43 (27.91%)
         occurrences all number
    7
    12
    19
    Hypophosphataemia
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 33 (6.06%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    2
    Iron deficiency
         subjects affected / exposed
    2 / 43 (4.65%)
    5 / 33 (15.15%)
    6 / 43 (13.95%)
         occurrences all number
    2
    5
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Oct 2012
    The purpose of this amendment was to increase the duration of contraception after the last dose of the study drug for both formulations: pasireotide sc (1 month) and pasireotide LAR (3 months) to ensure patient’s safety should they plan to conceive. In addition, an exclusion criterion was added to ensure that potentially unreliable or vulnerable subjects (e.g. person kept in detention) and those judged by the Investigator to be unsuitable for the study were not included in the protocol. Additionally, since some patients with dumping syndrome can present with hypoglycemia at 90 minutes after receiving the 75 g of glucose during an OGTT, the protocol was updated to allow for the inclusion of these patients.
    28 Mar 2013
    The purpose of this amendment was to update the Dumping Score Questionnaire (DSQ). The Dumping Severity Score (DSS) is an instrument to evaluate the intensity of DS symptoms based on a 4-point Likert scale 1 hour after and more than 1 hour after digestion). Upon thorough data safety (DS) expert panel review of the DSS, the instrument was updated to consider measurements that were more sensitive to DS symptoms and a 5-point scale was included. The development and validation of the DSQ according to the FDA and EMEA guidelines was planned at the study inception and was performed in parallel with protocol development. The first phase of the DSQ development was completed while the study was ongoing and some changes were incorporated into the questionnaire. After this amendment all patients were to assessed with the DSQ instead of DSS. An additional purpose of this amendment was to extend the duration of the follow up period for a newborn of a patient who becomes pregnant during the study (from Day 0 to Month 3 after delivery) to be in alignment with the current ICF.
    04 Dec 2013
    The purpose of this amendment was to add an additional option to prepare 30 mg pasireotide LAR dosage strength using 1 x 20 mg + 1 x 40 mg vials due to unforeseen drug allocation issues. In an effort to avoid forthcoming amendments due to unpredictable drug supply issues, the IFU for pasireotide sc and pasireotide LAR were removed. These instructions were then provided in a standalone Oncology Clinical Instructions for Use manual titled “Pasireotide

    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.
    All safety parameters were analyzed by study phase (sc/LAR)
    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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