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    Clinical Trial Results:
    Everolimus and temozolomide as first-line treatment in advanced gastrointestinal neuroendocrine carcinoma (G3) with a Ki67 of 20-55%

    Summary
    EudraCT number
    		 2013-002524-16
    Trial protocol
    		 SE   DK  
    Global end of trial date
    01 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2021
    First version publication date
    08 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    240562-2013-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Oncology, Hauekalnd Univ Hospital
    Sponsor organisation address
    Jonas Lies v, Bergen, Norway,
    Public contact
    Dept of Oncology. Haukeland Univ, Nordic Neuroendocrine Tumor Group, halfdan.sorbye@helse-bergen.no
    Scientific contact
    Dept of Oncology. Haukeland Univ, Nordic Neuroendocrine Tumor Group, halfdan.sorbye@helse-bergen.no
    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
    21 Apr 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To study the efficacy of everolimus combined with temozolomide as first-line treatment in advanced gastrointestinal neuroendocrine carcinoma with a Ki67 of 20-55%, measured as disease control rate (non-progressive disease) at 6 months.
    Protection of trial subjects
    Dose reduction plan if side effects
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Nov 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
    Sweden: 6
    Country: Number of subjects enrolled
    Denmark: 24
    Country: Number of subjects enrolled
    Norway: 8
    Worldwide total number of subjects
    38
    EEA total number of subjects
    38
    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)
    23
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started 14NOv14 and stopped 20DEC17. 39 cases recruited. 1 casewronlgy included and deleted.

    Pre-assignment
    Screening details
    		 1 patient excluded as reclassified as adenoicarcinom and not neuroendcorine carcinoma

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

    Arms
    Arm title
    		 Temozolomide and everolimus
    Arm description
    		 -
    Arm type
    		 experimental

    Investigational medicinal product name
    everolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg daily

    Investigational medicinal product name
    temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg daily

    Number of subjects in period 1
    		Temozolomide and everolimus
    Started
    38
    Completed
    38

    Baseline characteristics

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

    Reporting group values
    		 Baseline period Total
    Number of subjects
    		 38 38
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 25 25
        From 65-84 years
    		 13 13
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    Temozolomide and everolimus
    Reporting group description
    		 -

    Subject analysis set title
    PFS 6 m
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All correctly included patients

    Primary: PFS 6 m

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    End point title
    		 PFS 6 m
    End point description
    End point type
    Primary
    End point timeframe
    Last update 2020
    End point values
    		 Temozolomide and everolimus PFS 6 m
    Number of subjects analysed
    38
    38
    Units: months
        number (not applicable)
    38
    38
    Statistical analysis title
    		 PFS 6 m
    Comparison groups
    Temozolomide and everolimus v PFS 6 m
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 Fleming one stage
    Confidence interval
    Notes
    [1] - PFS 6 m

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2014-2017 on active treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Adverse avents
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse avents
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 38 (18.42%)
         number of deaths (all causes)
    28
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    TIA
    Additional description: 1 case
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pain management
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Trombocytepenia
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Fever
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adverse avents
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 38 (7.89%)
    Blood and lymphatic system disorders
    Trombocytopenia
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
    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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