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    Clinical Trial Results:
    DANSAC-open: A multicenter, open label study to investigate the efficacy and tolerability of olanzapine in patients with advanced cancer not receiving chemotherapy or irradiation.

    Summary
    EudraCT number
    		 2015-002294-38
    Trial protocol
    		 DK  
    Global end of trial date
    05 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2020
    First version publication date
    01 Jan 2020
    Other versions
    Summary report(s)
    		 DANSAC_open, article

    Trial information

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    Trial identification
    Sponsor protocol code
    DANSAC-open
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    JB Winsløws Vej 4, Odense, Denmark, 5000
    Public contact
    Signe Harder, Odense University Hospital, +45 4525382590, signe.harder@rsyd.dk
    Scientific contact
    Signe Harder, Odense University Hospital, +45 4525382590, signe.harder@rsyd.dk
    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
    05 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Sep 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Objectives: The primary objective is to test if olanzapine 10 mg is effective in patients with advanced cancer not receiving chemotherapy or irradiation. Hypotheses: Administration of olanzapine will result in a change in nausea score from baseline to 24 hours later exceeding 30%. In patients included because of vomiting only (nausea score less than moderate), the primary parameter will be change in number of emetic episodes from baseline to 24 hours later.
    Protection of trial subjects
    Close follow-up, minimal procedures involved for the patient
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2016
    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
    Denmark: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    15
    From 65 to 84 years
    24
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Slow recruitment

    Pre-assignment
    Screening details
    		 Patients both screened and directly referred for the trial (29 screened, 11 referred)

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

    Arms
    Arm title
    		 All patients
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    olanzapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection, Orodispersible tablet
    Routes of administration
    Oral use, Intravenous use
    Dosage and administration details
    First dose intravenous, following four doses as an orodispersable tablet

    Number of subjects in period 1
    		All patients
    Started
    40
    Completed
    34
    Not completed
    6
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    1
         Failing inclusion criteria during the study
    4

    Baseline characteristics

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

    Reporting group values
    		 Overall Total
    Number of subjects
    		 40 40
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 67 (37 to 88) -
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 18 18

    End points

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    End points reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Primary: Effect

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    End point title
    		 Effect [1]
    End point description
    Number of patients reporting a lower degree of nausea or a lower number of emetic episodes at 24 hous compared to baseline
    End point type
    Primary
    End point timeframe
    From baseline to 24 hours
    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: Reporting a single arm study, and even though the information button say I can choose just one arm, the validation of data keep making warnings despite many efforts to correct the error.
    End point values
    		 All patients
    Number of subjects analysed
    40
    Units: Number of patients
    36
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events evaluated 24 hours after first dose and at seven days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 40 (37.50%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 40 (20.00%)
         occurrences all number
    8
    Dizziness
         subjects affected / exposed
    8 / 40 (20.00%)
         occurrences all number
    8
    Sedation
         subjects affected / exposed
    7 / 40 (17.50%)
         occurrences all number
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2016
    1: change in time of medication from morning to bedtime 2: Removal of bloodsamples
    01 Sep 2017
    1: Change in exclusion criteria not allowing antineoplastic treatment from 4 weeks to 2 weeks 2: Expanding inclusion time to 36 months 3: Allowing dose reductions in case of adverse events

    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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