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    Clinical Trial Results:
    A randomized phase II study between regorafenib and continuing biologic treatment to multi treated patients with colorectal cancer.

    Summary
    EudraCT number
    		 2016-002222-37
    Trial protocol
    		 DK  
    Global end of trial date
    08 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Oct 2019
    First version publication date
    12 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1626
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Hospital
    Sponsor organisation address
    Herlev Ringvej 75, Herlev, Denmark, 2730
    Public contact
    Dorte Nielsen, Oncology dept. Herlev og Gentofte Hospital, +45 38682344, dorte.nielsen.01@regionh.dk
    Scientific contact
    Dorte Nielsen, Oncology dept. Herlev og Gentofte Hospital, +45 38682344, dorte.nielsen.01@regionh.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
    08 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Feb 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Overall survival between the two groups
    Protection of trial subjects
    Eligibility criteria, no additional specific measures
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Sep 2016
    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
    Denmark: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    4
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was open from september 2016 to october 2017, single center trial at Herlev University Hospital

    Pre-assignment
    Screening details
    		 not applicable

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Regorafenib
    Arm description
    		 Experimental arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Regorafenib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    160 mg daily for 3 weeks in a 4-weeks cycle

    Arm title
    		 Standard
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    180 mg/m2 every 2 weeks

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5 mg/kg every 2 weeks

    Investigational medicinal product name
    Panitumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/kg every 2 weeks

    Number of subjects in period 1
    		Regorafenib Standard
    Started
    3
    4
    Completed
    3
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Regorafenib
    Reporting group description
    		 Experimental arm

    Reporting group title
    Standard
    Reporting group description
    		 -

    Reporting group values
    		 Regorafenib Standard Total
    Number of subjects
    		 3 4 7
    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 (56 to 68) 59.5 (58 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 1 2 3
        Male
    		 2 2 4

    End points

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    End points reporting groups
    Reporting group title
    Regorafenib
    Reporting group description
    		 Experimental arm

    Reporting group title
    Standard
    Reporting group description
    		 -

    Primary: OS

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    End point title
    		 OS [1]
    End point description
    End point type
    Primary
    End point timeframe
    From time of randomisation to death or last FU
    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: Statistical analyses not performed due to low number of patient
    End point values
    		 Regorafenib Standard
    Number of subjects analysed
    3
    4
    Units: year
        median (full range (min-max))
    5.6 (3.1 to 7.1)
    7.1 (2.3 to 8.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment start to 30 days after last treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Regorafenib
    Reporting group description
    		 Experimental arm

    Reporting group title
    Standard
    Reporting group description
    		 -

    Serious adverse events
    		 Regorafenib Standard
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 4 (25.00%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Syncope
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Paresis OE dex
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Regorafenib Standard
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    Investigations
    Neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    2
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Febrile neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 4 (75.00%)
         occurrences all number
    1
    3
    Nausea
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 4 (75.00%)
         occurrences all number
    1
    3
    Stomatitis
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 4 (100.00%)
         occurrences all number
    0
    4
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    2
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 4 (50.00%)
         occurrences all number
    1
    2

    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.
    recruitment goal not reached
    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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