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    Clinical Trial Results:
    Phase II, open, single group, multicentre study to evaluate the efficacy and safety of Lanreotide Autogel® (120 mg) administered every 4 weeks by deep subcutaneous injection in the tumour´s growth stabilization of patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy

    Summary
    EudraCT number
    		 2004-002871-18
    Trial protocol
    		 ES  
    Global end of trial date
    06 Nov 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2016
    First version publication date
    14 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A-92-52030-166
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma
    Sponsor organisation address
    65, Quai Georges Gorse, Boulogne-Billancourt Cedex, France, 92650
    Public contact
    Medical Director, Neurosurgery., Ipsen Pharma, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Neurosurgery., Ipsen Pharma, clinical.trials@ipsen.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
    23 Dec 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Nov 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of Somatulina Autogel® in tumour growth stabilisation, in patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy at the time of their inclusion in the study.
    Protection of trial subjects
    This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21 and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 May 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 22 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    17
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Thirty patients from 17 Spanish investigational centres were included in this study, with a maximum of four patients recruited by each of three centres.

    Pre-assignment
    Screening details
    		 Thirty patients were screened and all thirty were included in the study.

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

    Arms
    Arm title
    		 All Subjects
    Arm description
    		 Lanreotide Autogel 120mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lanreotide Autogel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lanreotide Autogel 120 mg single deep subcutaneous (s.c.) injection every 4 week (28±5 days) intervals up to 23 doses

    Number of subjects in period 1
    		All Subjects
    Started
    30
    Completed
    3
    Not completed
    27
         Patient decision
    1
         Disease progression
    21
         Adverse Event
    2
         Death
    1
         Not Specified
    1
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 Lanreotide Autogel 120 mg single deep subcutaneous (s.c.) injection every 4 week (28±5 days) intervals up to 23 doses

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
    Age continuous
    Intent-To-Treat (ITT) population are patients who have received at least one dose of lanreotide Autogel®.
    Units: years
        arithmetic mean (standard deviation)
    		 62.4 ( 10.3 ) -
    Gender categorical
    ITT population
    Units: Subjects
        Female
    		 15 15
        Male
    		 15 15
    Race
    ITT population
    Units: Subjects
        Caucasian
    		 30 30
    Body Mass Index (BMI)
    ITT population
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 25.51 ( 5.64 ) -
    Longest diameter of the Target Lesions at baseline
    Units: cm
        arithmetic mean (standard deviation)
    		 11.46 ( 10.05 ) -
    Urinary 5-HIAA
    5-HIAA (5-hydroxyindole acetic acid) N=19
    Units: NA
        arithmetic mean (standard deviation)
    		 291.99 ( 462.52 ) -

    End points

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    End points reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 Lanreotide Autogel 120mg

    Primary: Median time to disease progression

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    End point title
    		 Median time to disease progression [1]
    End point description
    Time until disease progression according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Disease progression was defined as the occurrence, while on treatment with lanreotide Autogel, of one or more new lesions; a ≥20% increase in the sum of the maximum diameters of the “target lesions”, taking as reference the lowest sum of maximum diameters recorded since the start of the study; or unequivocal progression of “nontarget lesions” ITT population
    End point type
    Primary
    End point timeframe
    Time between study inclusion until disease progression (Up to Visit 24)
    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: Data reported for single arm, due to system limitation, statistical analysis details cannot be reported
    End point values
    		 All Subjects
    Number of subjects analysed
    27
    Units: Months
    median (confidence interval 95%)
        Progressive Disease
    12.9 (7.9 to 16.5)
    No statistical analyses for this end point

    Secondary: Percentage of reduction of the Serum Chromogranin A as compared to the baseline

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    End point title
    		 Percentage of reduction of the Serum Chromogranin A as compared to the baseline
    End point description
    Patients with Normalised and/or Decrease ≥30% in Serum Chromogranin A (CgA) Concentration at Each Visit ITT population Mc Nemar's Test p values: week 8 (Visit 3) = 0.0002, week 20 (Visit 6) = 0.0027, week 32 (Visit 9) = 0.0082, week 44 (Visit 12) = 0.0253, week 56 (Visit 15) = 0.0253, week 68 (Visit 18) = 0.0455, week 80 (Visit 21) =0.0833 and week 92 (Visit 24) = 0.1573
    End point type
    Secondary
    End point timeframe
    At Baseline (Visit 0), week 8, 20, 32, 44, 56, 68, 80 and 92
    End point values
    		 All Subjects
    Number of subjects analysed
    30
    Units: Percentage of subjects
    number (confidence interval 95%)
        At Visit 3
    70.4 (53.1 to 87.6)
        At Visit 6
    60.9 (40.9 to 80.8)
        At Visit 9
    63.2 (41.5 to 84.8)
        At Visit 12
    53.3 (28.1 to 78.6)
        At Visit 15
    61.5 (35.1 to 88)
        At Visit 18
    60 (29.6 to 90.4)
        At Visit 21
    57.1 (20.5 to 93.8)
        At Visit 24
    66.7 (13.3 to 100)
    No statistical analyses for this end point

    Secondary: Factors Predictive of Tumour Growth Control for Cox regression

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    End point title
    		 Factors Predictive of Tumour Growth Control for Cox regression
    End point description
    To identify the factors predictive of tumour growth control on treatment with lanreotide Autogel ® ITT population The values reported are Hazard ratio (95% confidence interval) func (functionality) Cox regression p values: Age = 0.8267, Sex = 0.7232, Presence or absence of tumour functionality = 0.0354, ECOG scale = 0.9453, Tumour origin - FOREGUT (REF:UNKNOWN) = 0.0809, Tumour origin - MIDGUT (REF:UNKNOWN) = 0.0323, Tumour origin - MIDGUT (REF:FOREGUT) = 0.4457, Time between tumour diagnosis and study inclusion = 0.2562, Ki-67 index rank = 0.0890, Initial tumour mass = 0.3639, Previous treatment of the tumour: Chemotherapy = 0.9019, Previous treatment of the tumour: Interferon = 0.8273, Previous treatment of the tumour: Radiotherapy = 0.7576, Previous treatment of the tumour: Somatostatin = 0.8946, Previous treatment of the tumour: Surgery = 0.9727, Lanreotide serum levels = 0.7470, CgA response (ref: Yes) = 0.5869
    End point type
    Secondary
    End point timeframe
    Duration between study inclusion and the date of the last assessment with a response at “stable disease” (Up to Visit 24)
    End point values
    		 All Subjects
    Number of subjects analysed
    30
    Units: Hazard ratio
    number (confidence interval 95%)
        Age
    0.995 (0.95 to 1.04)
        Sex (ref: MALE)
    1.156 (0.52 to 2.59)
        Presence/absence-tumour func (ref: Functional)
    2.529 (1.07 to 6)
        ECOG scale
    1.03 (0.45 to 2.36)
        Tumour origin - FOREGUT (REF:UNKNOWN)
    0.277 (0.07 to 1.17)
        Tumour origin - MIDGUT (REF:UNKNOWN)
    0.198 (0.04 to 0.87)
        Tumour origin - MIDGUT (REF:FOREGUT)
    0.713 (0.3 to 1.7)
        Time between tumour diagnosis and study inclusion
    1 (1 to 1)
        Ki-67 index rank
    1.096 (0.99 to 1.22)
        Initial tumour mass
    1.019 (0.98 to 1.06)
        Previous treatment of tumour:Chemotherapy(ref:Yes)
    1.054 (0.46 to 2.42)
        Previous treatment of tumour: Interferon(ref:Yes)
    0.886 (0.3 to 2.64)
        Previous treatment of tumour:Radiotherapy(ref:Yes)
    1.375 (0.18 to 10.4)
        Previous treatment of tumour:Somatostatin(ref:Yes)
    0.934 (0.34 to 2.55)
        Previous treatment of tumour: Surgery(ref:Yes)
    1.016 (0.42 to 2.47)
        Lanreotide serum levels
    0.968 (0.79 to 1.18)
        CgA response (ref: Yes)
    0.772 (0.3 to 1.96)
    No statistical analyses for this end point

    Secondary: Factors Predictive of Progression Free Survival for Cox regression

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    End point title
    		 Factors Predictive of Progression Free Survival for Cox regression
    End point description
    To identify the factors predictive of PFS on treatment with lanreotide Autogel ® ITT population The values reported are Hazard ratio (95% confidence interval) func (functionality) Cox regression p values: Age = 0.3669, Sex = 0.4633, Presence or absence of tumour functionality = 0.1214, ECOG scale = 0.1961, Time between tumour diagnosis and study inclusion = 0.3968, Ki-67 index rank = 0.0178, Initial tumour mass = 0.9933, Previous treatment of the tumour: Chemotherapy = 0.3175, Previous treatment of the tumour: Interferon = 0.7742, Previous treatment of the tumour: Radiotherapy = 0.7733, Previous treatment of the tumour: Somatostatin = 0.8288, Previous treatment of the tumour: Surgery = 0.9416, Lanreotide serum levels = 0.5550, CgA response (ref: Yes) = 0.9959, Tumour origin - FOREGUT (REF:UNKNOWN) = 0.1457, Tumour origin - MIDGUT (REF:UNKNOWN) = 0.0694, Tumour origin - MIDGUT (REF:FOREGUT) = 0.5111
    End point type
    Secondary
    End point timeframe
    Duration between study inclusion and the date of disease progression (Up to Visit 24)
    End point values
    		 All Subjects
    Number of subjects analysed
    30
    Units: Hazard ratio
    number (confidence interval 95%)
        Age
    0.981 (0.94 to 1.02)
        Sex (ref: MALE)
    0.718 (0.3 to 1.74)
        Presence/absence of tumour func(ref: Functional)
    2.036 (0.83 to 5.01)
        ECOG scale
    1.659 (0.77 to 3.57)
        Tumour origin - FOREGUT (REF:UNKNOWN)
    0.352 (0.09 to 1.44)
        Tumour origin - MIDGUT (REF:UNKNOWN)
    0.257 (0.06 to 1.11)
        Tumour origin - MIDGUT (REF:FOREGUT)
    0.73 (0.29 to 1.87)
        Time between tumour diagnosis and study inclusion
    1 (1 to 1)
        Ki-67 index rank
    1.17 (1.03 to 1.33)
        Initial tumour mass
    1 (0.95 to 1.05)
        Previous treatment tumour:Chemotherapy (ref: Yes)
    1.623 (0.63 to 4.2)
        Previous treatment tumour:Interferon (ref: Yes)
    0.852 (0.29 to 2.54)
        Previous treatment tumour:Radiotherapy (ref:Yes)
    1.347 (0.18 to 10.2)
        Previous treatment tumour:Somatostatin (ref:Yes)
    0.886 (0.3 to 2.64)
        Previous treatment tumour:Surgery (ref:Yes)
    0.965 (0.37 to 2.49)
        Lanreotide serum levels
    0.933 (0.74 to 1.18)
        CgA response (ref: Yes)
    1.003 (0.38 to 2.63)
    No statistical analyses for this end point

    Secondary: Number of subjects with Partial or Complete Response of the Tumoural Lesions

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    End point title
    		 Number of subjects with Partial or Complete Response of the Tumoural Lesions
    End point description
    ITT population Complete response (CR): Disappearance of all “target lesions” and “nontarget lesions”, and normalisation of tumour marker concentrations. Partial response (PR): A reduction of at least 30% of the sum of maximum diameters of the “target lesions” taking as reference the baseline maximum diameters, and/or disappearance of all the “target lesions” with persistence of one or more “nontarget lesions” and/or tumour markers over the limits of the disease.
    End point type
    Secondary
    End point timeframe
    Up to Visit 24 (Week 92)
    End point values
    		 All Subjects
    Number of subjects analysed
    30
    Units: Number of subjects
        Partial Response
    0
        Complete Response
    0
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline of sum of the Longest Diameter of the target lesions

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    End point title
    		 Mean Change from Baseline of sum of the Longest Diameter of the target lesions
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    At Baseline (Visit 0), week 8, 20, 32, 44, 56, 68, 80 and 92
    End point values
    		 All Subjects
    Number of subjects analysed
    30
    Units: cm
    arithmetic mean (standard deviation)
        Week 8 (N=27)
    0.14 ( 1.06 )
        Week 20 (n=23)
    0.34 ( 2.02 )
        Week 32 (N=19)
    -0.25 ( 1.36 )
        Week 44 (N=15)
    -0.19 ( 1.9 )
        Week 56 (N=12)
    -0.31 ( 0.78 )
        week 68 (N=11)
    -0.17 ( 0.52 )
        Week 80 (N=7)
    0.6 ( 1.31 )
        Week 92 (N=3)
    -0.2 ( 0.17 )
    No statistical analyses for this end point

    Secondary: Mean change from Baseline of Maximum Decrease or Minimum Increase of the Longest Diameter of the target lesions

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    End point title
    		 Mean change from Baseline of Maximum Decrease or Minimum Increase of the Longest Diameter of the target lesions
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    At Baseline (Visit 0) and week 92 (visit 24)
    End point values
    		 All Subjects
    Number of subjects analysed
    27
    Units: cm
    arithmetic mean (standard deviation)
        MAXIMUM DECREASE OR MINIMUM INCREASE FROM BASELINE
    -0.35 ( 1.58 )
    No statistical analyses for this end point

    Secondary: Mean Percentage Change from Baseline of Other Tumour Markers: Urinary 5-HIAA

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    End point title
    		 Mean Percentage Change from Baseline of Other Tumour Markers: Urinary 5-HIAA
    End point description
    ITT population 5-HIAA (5- hydroxyindole acetic acid) Student's test values: week 8 (Visit 3) = 0.0006, week 20 (Visit 6) = 0.0005, week 56 (Visit 15) = 0.0220, week 68 (Visit 18) = 0.5820; Wilcoxon's test values: week 32 (Visit 9) = 0.4697, week 44 (Visit 12) = 0.3223; Within-group test Not done at week 80 (Visit 21) and week 92 (Visit 24)
    End point type
    Secondary
    End point timeframe
    At Baseline (Visit 0), week 8, 20, 32, 44, 56, 68, 80 and 92
    End point values
    		 All Subjects
    Number of subjects analysed
    30
    Units: Percentage change
    arithmetic mean (standard deviation)
        Week 8 (N=17)
    -30.1 ( 29.3 )
        Week 20 (N=12)
    -33.8 ( 24.4 )
        Week 32 (N=12)
    -9.6 ( 66.9 )
        Week 44 (N=10)
    -11.4 ( 63.1 )
        Week 56 (N=8)
    -36.6 ( 35.3 )
        week 68 (N=8)
    -10.9 ( 53.5 )
        Week 80 (N=6)
    -34.8 ( 46.9 )
        Week 92 (N=3)
    -62.9 ( 16.7 )
    No statistical analyses for this end point

    Secondary: Baseline Mean And Change in Mean of QLQ-C30 by Five Functional Scale

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    End point title
    		 Baseline Mean And Change in Mean of QLQ-C30 by Five Functional Scale
    End point description
    The QLQ-C30 is composed of both multi-item scales and single item measures. These include five functional scales (physical [PF], role [RF], emotional [EF], cognitive [CF] and social [SF]) QLQ-C30 (Quality of Life Questionnaire) ITT population
    End point type
    Secondary
    End point timeframe
    At Baseline (Visit 0), week 8, 20, 32, 44, 56, 68, 80 and 92
    End point values
    		 All Subjects
    Number of subjects analysed
    30
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Physical Functioning: Baseline (N=27)
    90.37 ( 12.59 )
        Physical Functioning: Week 8 (N=15)
    -4.22 ( 15.14 )
        Physical Functioning: Week 20 (N=15)
    -8.89 ( 22.35 )
        Physical Functioning: Week 32 (N=11)
    0.61 ( 3.6 )
        Physical Functioning: Week 44 (N=9)
    0.74 ( 5.21 )
        Physical Functioning: Week 56 (N=8)
    4.17 ( 7.07 )
        Physical Functioning: Week 68 (N=8)
    0.83 ( 6.61 )
        Physical Functioning: Week 80 (N=3)
    -8.89 ( 15.4 )
        Physical Functioning: Week 92 (N=1)
    0 ( 0 )
        Role Functioning: Baseline (N=27)
    87.04 ( 21.35 )
        Role Functioning: Week 8 (N=15)
    1.11 ( 14.73 )
        Role Functioning: Week 20 (N=15)
    2.22 ( 12.39 )
        Role Functioning: Week 32 (N=11)
    6.06 ( 15.41 )
        Role Functioning: Week 44 (N=9)
    5.56 ( 16.67 )
        Role Functioning: Week 56 (N=8)
    2.08 ( 5.89 )
        Role Functioning: Week 68 (N=8)
    -6.25 ( 12.4 )
        Role Functioning: Week 80 (N=3)
    -22.22 ( 38.49 )
        Role Functioning: Week 92 (N=1)
    0 ( 0 )
        Cognitive Functioning: Baseline (N=28)
    84.52 ( 22.19 )
        Cognitive Functioning: Week 8 (N=16)
    3.13 ( 23.74 )
        Cognitive Functioning: Week 20 (N=16)
    -6.25 ( 17.08 )
        Cognitive Functioning: Week 32 (N=11)
    0 ( 16.67 )
        Cognitive Functioning: Week 44 (N=10)
    1.67 ( 18.34 )
        Cognitive Functioning: Week 56 (N=9)
    1.85 ( 26.93 )
        Cognitive Functioning: Week 68 (N=9)
    7.41 ( 23.73 )
        Cognitive Functioning: Week 80 (N=4)
    8.33 ( 28.87 )
        Cognitive Functioning: Week 92 (N=1)
    0 ( 0 )
        Emotional Functioning: Baseline (N=28)
    72.02 ( 26.47 )
        Emotional Functioning: Week 8 (N=16)
    4.69 ( 21.29 )
        Emotional Functioning: Week 20 (N=16)
    3.65 ( 28.86 )
        Emotional Functioning: Week 32 (N=11)
    3.03 ( 15.49 )
        Emotional Functioning: Week 44 (N=10)
    8.33 ( 23.57 )
        Emotional Functioning: Week 56 (N=9)
    11.11 ( 17.68 )
        Emotional Functioning: Week 68 (N=9)
    1.85 ( 35.79 )
        Emotional Functioning: Week 80 (N=4)
    22.92 ( 29.17 )
        Emotional Functioning: Week 92 (N=1)
    8.33 ( 0 )
        Social Functioning: Baseline (N=28)
    90.48 ( 17.23 )
        Social Functioning: Week 8 (N=16)
    -1.04 ( 21.49 )
        Social Functioning: Week 20 (N=16)
    0 ( 20.18 )
        Social Functioning: Week 32 (N=11)
    -7.58 ( 20.23 )
        Social Functioning: Week 44 (N=10)
    -10 ( 14.05 )
        Social Functioning: Week 56 (N=9)
    -5.56 ( 20.41 )
        Social Functioning: Week 68 (N=9)
    -7.41 ( 26.5 )
        Social Functioning: Week 80 (N=4)
    4.17 ( 20.97 )
        Social Functioning: Week 92 (N=1)
    0 ( 0 )
    No statistical analyses for this end point

    Secondary: Baseline Mean And Change in Mean of QLQ-C30 Three Symptom Scale

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    End point title
    		 Baseline Mean And Change in Mean of QLQ-C30 Three Symptom Scale
    End point description
    The QLQ-C30 is composed of both multi-item scales and single item measures. These include three symptom scales (fatigue [FA], nausea and vomiting[NV], and pain [PA]). QLQ-C30 (Quality of Life Questionnaire) ITT population
    End point type
    Secondary
    End point timeframe
    At Baseline (Visit 0), week 8, 20, 32, 44, 56, 68, 80 and 92
    End point values
    		 All Subjects
    Number of subjects analysed
    30
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Fatigue: Baseline (N=27)
    16.46 ( 19.09 )
        Fatigue: Week 8 (N=15)
    5.93 ( 17.75 )
        Fatigue: Week 20 (N=15)
    2.96 ( 17.04 )
        Fatigue: Week 32 (N=11)
    5.05 ( 12.54 )
        Fatigue: Week 44 (N=9)
    6.17 ( 14.81 )
        Fatigue: Week 56 (N=8)
    -2.78 ( 23.57 )
        Fatigue: Week 68 (N=8)
    19.44 ( 27.7 )
        Fatigue: Week 80 (N=3)
    7.41 ( 12.83 )
        Fatigue: Week 92 (N=1)
    0 ( 0 )
        Nausea And Vomiting: Baseline (N=28)
    9.52 ( 20.5 )
        Nausea And Vomiting: Week 8 (N=16)
    -6.25 ( 17.08 )
        Nausea And Vomiting: Week 20 (N=16)
    -3.13 ( 12.5 )
        Nausea And Vomiting: Week 32 (N=11)
    0 ( 0 )
        Nausea And Vomiting: Week 44 (N=10)
    0 ( 0 )
        Nausea And Vomiting: Week 56 (N=9)
    -5.56 ( 23.57 )
        Nausea And Vomiting: Week 68 (N=9)
    -7.41 ( 22.22 )
        Nausea And Vomiting: Week 80 (N=4)
    -16.67 ( 33.33 )
        Nausea And Vomiting: Week 92 (N=1)
    0 ( 0 )
        Pain Scale: Baseline (N=28)
    20.24 ( 26.59 )
        Pain Scale: Week 8 (N=16)
    6.25 ( 30.35 )
        Pain Scale: Week 20 (N=16)
    2.08 ( 17.08 )
        Pain Scale: Week 32 (N=11)
    0 ( 16.67 )
        Pain Scale: Week 44 (N=10)
    8.33 ( 25.15 )
        Pain Scale: Week 56 (N=9)
    -5.56 ( 22.05 )
        Pain Scale: Week 68 (N=9)
    3.7 ( 34.13 )
        Pain Scale: Week 80 (N=4)
    -16.67 ( 30.43 )
        Pain Scale: Week 92 (N=1)
    -33.33 ( 0 )
    No statistical analyses for this end point

    Secondary: Baseline Mean And Change in Mean of QLQ-C30 Six Single Scale

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    End point title
    		 Baseline Mean And Change in Mean of QLQ-C30 Six Single Scale
    End point description
    The QLQ-C30 is composed of both multi-item scales and single item measures. These include six single items (dyspnoea [DY], insomnia/sleep disturbance [SL], appetite loss [AP], constipation [CO], diarrhoea [DI] and financial difficulties [FI]). QLQ-C30 (Quality of Life Questionnaire) ITT population
    End point type
    Secondary
    End point timeframe
    At Baseline (Visit 0), week 8, 20, 32, 44, 56, 68, 80 and 92
    End point values
    		 All Subjects
    Number of subjects analysed
    30
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Dyspnoea: Baseline (N=27)
    1.23 ( 6.42 )
        Dyspnoea: Week 8 (N=15)
    4.44 ( 11.73 )
        Dyspnoea: Week 20 (N=15)
    4.44 ( 11.73 )
        Dyspnoea: Week 32 (N=11)
    3.03 ( 10.05 )
        Dyspnoea: Week 44 (N=9)
    0 ( 0 )
        Dyspnoea: Week 56 (N=8)
    0 ( 0 )
        Dyspnoea: Week 68 (N=8)
    0 ( 0 )
        Dyspnoea: Week 80 (N=3)
    22.22 ( 38.49 )
        Dyspnoea: Week 92 (N=1)
    0 ( 0 )
        Insomnia: Baseline (N=27)
    25.93 ( 33.76 )
        Insomnia: Week 8 (N=15)
    6.67 ( 18.69 )
        Insomnia: Week 20 (N=15)
    -2.22 ( 23.46 )
        Insomnia: Week 32 (N=11)
    0 ( 29.81 )
        Insomnia: Week 44 (N=9)
    11.11 ( 16.67 )
        Insomnia: Week 56 (N=8)
    16.67 ( 25.2 )
        Insomnia: Week 68 (N=8)
    16.67 ( 30.86 )
        Insomnia: Week 80 (N=3)
    0 ( 0 )
        Insomnia: Week 92 (N=1)
    0 ( 0 )
        Appetite Loss: Baseline (N=27)
    8.64 ( 19.81 )
        Appetite Loss: Week 8 (N=15)
    11.11 ( 24.12 )
        Appetite Loss: Week 20 (N=15)
    8.89 ( 19.79 )
        Appetite Loss: Week 32 (N=11)
    3.03 ( 10.05 )
        Appetite Loss: Week 44 (N=9)
    7.41 ( 22.22 )
        Appetite Loss: Week 56 (N=8)
    -4.17 ( 11.79 )
        Appetite Loss: Week 68 (N=8)
    8.33 ( 29.55 )
        Appetite Loss: Week 80 (N=3)
    -11.11 ( 19.25 )
        Appetite Loss: Week 92 (N=1)
    0 ( 0 )
        Cosntipation Scale: Baseline (N=28)
    9.52 ( 19.99 )
        Cosntipation Scale: Week 8 (N=16)
    12.5 ( 36.26 )
        Cosntipation Scale: Week 20 (N=16)
    6.25 ( 13.44 )
        Cosntipation Scale: Week 32 (N=11)
    -6.06 ( 13.48 )
        Cosntipation Scale: Week 44 (N=10)
    -6.67 ( 14.05 )
        Cosntipation Scale: Week 56 (N=9)
    -3.7 ( 20.03 )
        Cosntipation Scale: Week 68 (N=9)
    -11.11 ( 23.57 )
        Cosntipation Scale: Week 80 (N=4)
    -16.67 ( 33.33 )
        Cosntipation Scale: Week 92 (N=1)
    33.33 ( 0 )
        Diarrhoea Scale: Baseline (N=28)
    27.38 ( 30.16 )
        Diarrhoea Scale: Week 8 (N=16)
    -10.42 ( 20.07 )
        Diarrhoea Scale: Week 20 (N=16)
    -6.25 ( 38.91 )
        Diarrhoea Scale: Week 32 (N=11)
    -6.06 ( 29.13 )
        Diarrhoea Scale: Week 44 (N=10)
    -3.33 ( 18.92 )
        Diarrhoea Scale: Week 56 (N=9)
    -7.41 ( 22.22 )
        Diarrhoea Scale: Week 68 (N=9)
    7.41 ( 22.22 )
        Diarrhoea Scale: Week 80 (N=4)
    0 ( 38.49 )
        Diarrhoea Scale: Week 92 (N=1)
    33.33 ( 0 )
        Financial Difficulties: Baseline (N=28)
    8.33 ( 23.35 )
        Financial Difficulties: Week 8 (N=16)
    -2.08 ( 30.96 )
        Financial Difficulties: Week 20 (N=16)
    -10.42 ( 26.44 )
        Financial Difficulties: Week 32 (N=11)
    0 ( 0 )
        Financial Difficulties: Week 44 (N=10)
    3.33 ( 18.92 )
        Financial Difficulties: Week 56 (N=9)
    0 ( 28.87 )
        Financial Difficulties: Week 68 (N=9)
    11.11 ( 37.27 )
        Financial Difficulties: Week 80 (N=4)
    16.67 ( 33.33 )
        Financial Difficulties: Week 92 (N=1)
    0 ( 0 )
    No statistical analyses for this end point

    Secondary: Baseline Mean And Change in Mean of QLQ-C30 Global Quality Of Life Scale

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    End point title
    		 Baseline Mean And Change in Mean of QLQ-C30 Global Quality Of Life Scale
    End point description
    The QLQ-C30 is composed of both multi-item scales and single item measures. ITT population
    End point type
    Secondary
    End point timeframe
    At Baseline (Visit 0), week 8, 20, 32, 44, 56, 68, 80 and 92
    End point values
    		 All Subjects
    Number of subjects analysed
    30
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Global Health Status: Baseline (N=28)
    69.05 ( 22.32 )
        Global Health Status: Week 8 (N=16)
    1.56 ( 18.06 )
        Global Health Status: Week 20 (N=16)
    2.6 ( 22.92 )
        Global Health Status: Week 32 (N=11)
    -4.55 ( 19.49 )
        Global Health Status: Week 44 (N=10)
    2.5 ( 15.24 )
        Global Health Status: Week 56 (N=9)
    8.33 ( 17.18 )
        Global Health Status: Week 68 (N=9)
    -19.44 ( 26.68 )
        Global Health Status: Week 80 (N=4)
    6.25 ( 14.23 )
        Global Health Status: Week 92 (N=1)
    0 ( 0 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Symptomatic Control related to Neuroendocrine Tumours During The Treatment Period

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    End point title
    		 Number of Subjects With Symptomatic Control related to Neuroendocrine Tumours During The Treatment Period
    End point description
    Evaluation of the symptom control ITT population NET (Neuroendocrine tumours)
    End point type
    Secondary
    End point timeframe
    Up to Visit 24 (Week 92)
    End point values
    		 All Subjects
    Number of subjects analysed
    30
    Units: Number of subjects
        Symptoms related to NET
    6
        Diarrhoea
    6
        Asthenia
    1
        Flushes
    1
        Suffocations with tachycardia
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to visit 24
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 Safety population: includes all patients who have received at least one dose of Somatuline Autogel® (same definition as ITT population)

    Serious adverse events
    		 All Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 30 (20.00%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    2
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    1 / 1
    Hepatobiliary disorders
    Gallbladder fistula
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 30 (83.33%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    7
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 30 (26.67%)
         occurrences all number
    20
    Injection site pain
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    8
    Injection site nodule
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    13 / 30 (43.33%)
         occurrences all number
    30
    Abdominal pain
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    7
    Flatulence
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    3
    Vomiting
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    6
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    Arthralgia
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Feb 2006
    Two new centers has been incorporated. To do faster the procedure to assign randomization codes to radiological copies.

    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.
    None reported
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    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
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