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    Clinical Trial Results:
    The efficacy of cabozantinib in advanced salivary gland cancer patients, a phase II clinical trial

    Summary
    EudraCT number
    		 2018-000682-36
    Trial protocol
    		 NL  
    Global end of trial date
    06 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jun 2022
    First version publication date
    24 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NL65109.091.18
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboud university medical center
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
    Public contact
    Hettie Maters, Radboud university medical center, hettie.maters@radboudumc.nl
    Scientific contact
    Hettie Maters, Radboud university medical center, hettie.maters@radboudumc.nl
    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
    06 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Assess the overall response rate (ORR) of cabozantinib in advanced salivary gland cancer patients. ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient.
    Protection of trial subjects
    In order to minimize risk of this experimental treatment, we took certain measures. First of all, only patients with a reasonable health (see inclusion criteria) can be included. Second, we use the Simon 2-stage design in order to minimize exposure of patients in case of minimal efficacy. Third, we took standard precautions such as moderate monitoring according to NFU guidelines. And Finally, we will only include c-MET positive tumors in order to increase the chance of treatment efficacy.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Sep 2018
    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
    Netherlands: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    18
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 general inclusion criteria - Age ≥18 years - Eastern Cooperative Oncology Group performance status of 0 or 1. - adequate organ function

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

    Arms
    Arm title
    		 single arm
    Arm description
    		 single arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    cabozantinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg once daily

    Number of subjects in period 1
    		single arm
    Started
    25
    Completed
    25

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    single arm
    Reporting group description
    		 single arm

    Primary: objective response rate

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    End point title
    		 objective response rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    the best response from start of the trial until termination
    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: in this single arm study no statistical analysis could be performed.
    End point values
    		 single arm
    Number of subjects analysed
    25
    Units: number of patients
    25
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    whole trial
    Adverse event reporting additional description
    CTCAE version 5
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    trial
    Reporting group description
    		 -

    Serious adverse events
    		 trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 25 (48.00%)
         number of deaths (all causes)
    18
         number of deaths resulting from adverse events
    1
    General disorders and administration site conditions
    Anorexia nervosa
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    dehydration
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Hypertension
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Tracheal fistula
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 25 (100.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    22 / 25 (88.00%)
         occurrences all number
    22
    Gastrointestinal disorders
    Alanine aminotransferase increased
         subjects affected / exposed
    17 / 25 (68.00%)
         occurrences all number
    17
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    16 / 25 (64.00%)
         occurrences all number
    16

    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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