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    Clinical Trial Results:
    DANSAC-RCT: Fosaprepitant in patients with advanced cancer not receiving chemotherapy or irradiation; A multicenter, randomized, double-blind, placebo-controlled study.

    Summary
    EudraCT number
    		 2015-003070-33
    Trial protocol
    		 DK  
    Global end of trial date
    31 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Oct 2017
    First version publication date
    29 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DANSAC-RCT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    Sdr Boulevard 29, Odense C, Denmark, 5000
    Public contact
    Signe Harder, Odense University Hospital, 45 25382590, signe.harder@rsyd.dk
    Scientific contact
    Signe Harder, Odense University Hospital, 45 25382590, 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
    02 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to compare whether the administration of the neurokinin1-receptor antagonist (NK1-RA) fosaprepitant dimeglumine results in a significant improvement in nausea scores from baseline to 24 hours as compared with placebo. 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.
    Protection of trial subjects
    Patients were followed ud at 24 hours and 7 days and were given contactinformation to studypersonell available around the clock.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 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: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    2
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients recruited from hospitals, 3 study sites opened, all 3 recruited patients included by 1 study site.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 3
    Number of subjects completed
    		 3

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    All personell blinded except two study nurses in charge of mixing the active/placebo drug and one monitor checking for correct assignment during first controlvisit. Subjects were unblinded after all records had been electronic entered and locked

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Fosaprepitant 150 ml infused over 30 min
    Arm type
    		 Experimental

    Investigational medicinal product name
    fosaprepitant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150 mg given as a 30 min infusion

    Arm title
    		 Placebo
    Arm description
    		 Saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Matching saline

    Number of subjects in period 1
    		Active Placebo
    Started
    1
    2
    Completed
    1
    2

    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
    		 3 3
    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)
    		 2 2
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 60 (43 to 72) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Fosaprepitant 150 ml infused over 30 min

    Reporting group title
    Placebo
    Reporting group description
    		 Saline

    Primary: Nausea at 24 hours compared to baseline

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    End point title
    		 Nausea at 24 hours compared to baseline [1]
    End point description
    End point type
    Primary
    End point timeframe
    0-24 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: Very low number of patientes included, no analyses performed
    End point values
    		 Active Placebo
    Number of subjects analysed
    1
    2
    Units: 0-4
        number (not applicable)
    0
    0.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    7 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Active
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Active
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Active
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Very low number of patients included, no adverse events recorded

    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.
    Very early termination due to a very low number of patients included, no analyses done on the data.
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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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