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    Clinical Trial Results:
    Study on the pharmacokinetic interaction between cabazitaxel and darolutamide in metastatic castration-resistant prostate cancer (mCRPC) patients.

    Summary
    EudraCT number
    		 2020-000823-38
    Trial protocol
    		 NL  
    Global end of trial date
    10 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2023
    First version publication date
    15 Dec 2023
    Other versions
    Summary report(s)
    		 publication

    Trial information

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    Trial identification
    Sponsor protocol code
    CABADARO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Erasmus MC
    Sponsor organisation address
    Dr Molewaterplein 40, Rotterdam, Netherlands,
    Public contact
    A.H.J. Mathijssen, Erasmus MC Cancer Institute, a.mathijssen@erasmusmc.nl
    Scientific contact
    A.H.J. Mathijssen, Erasmus MC Cancer Institute, a.mathijssen@erasmusmc.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
    22 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the influence of darolutamide on the pharmacokinetics of cabazitaxel compared to cabazitaxel alone in mCRPC patients.
    Protection of trial subjects
    na
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Oct 2020
    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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    9
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Age ≥ 18 years; 2. Patients with a confirmed diagnosis of mCRPC with an indication for cabazitaxel treatment at the standard dose of 20 mg/m2. 3. WHO performance ≤ 1 (see appendix B). 4. Able and willing to sign the Informed Consent Form

    Pre-assignment
    Screening details
    		 In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Age ≥ 18 years; 2. Patients with a confirmed diagnosis of mCRPC with an indication for cabazitaxel treatment at the standard dose of 20 mg/m2. 3. WHO performance ≤ 1 (see appendix B). 4. Able and willing to sign the Informed Consent Form

    Period 1
    Period 1 title
    Caba
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All patients
    Arm description
    		 Each patient is its own control
    Arm type
    		 All patients

    Investigational medicinal product name
    Cabazitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20mg/m2 BSA

    Number of subjects in period 1
    		All patients
    Started
    20
    Completed
    20
    Period 2
    Period 2 title
    Caba + daro
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All patients
    Arm description
    		 Each patient is its own control
    Arm type
    		 All patients

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2 [1]
    		All patients
    Started
    18
    Completed
    18
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: This is inherent to the study design. Each patient is its own control.

    Baseline characteristics

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

    Reporting group values
    		 Caba Total
    Number of subjects
    		 20 20
    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)
    		 11 11
        From 65-84 years
    		 9 9
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 20 20
    Subject analysis sets

    Subject analysis set title
    Caba concentrations
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Caba concentrations

    Subject analysis set title
    Caba concentrations with daro
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Caba concentrations with daro

    Subject analysis sets values
    		 Caba concentrations Caba concentrations with daro
    Number of subjects
    18
    18
    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)
    11
        From 65-84 years
    9
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    20

    End points

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    End points reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 Each patient is its own control
    Reporting group title
    All patients
    Reporting group description
    		 Each patient is its own control

    Subject analysis set title
    Caba concentrations
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Caba concentrations

    Subject analysis set title
    Caba concentrations with daro
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Caba concentrations with daro

    Primary: Caba concentrations

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    End point title
    		 Caba concentrations
    End point description
    End point type
    Primary
    End point timeframe
    day 1 vs after 6 weeks
    End point values
    		 Caba concentrations Caba concentrations with daro
    Number of subjects analysed
    18
    18
    Units: ng/mL*h
        geometric mean (geometric coefficient of variation)
    173 ± 26
    165 ± 27
    Statistical analysis title
    		 paired t-test on log transformed data
    Statistical analysis description
    paired t-test on log transformed data
    Comparison groups
    Caba concentrations v Caba concentrations with daro
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    NA
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2
    Frequency threshold for reporting non-serious adverse events: 5%
    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: This was not recorded in this study as per the study protocol

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35895277
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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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