Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase II study in mCRPC on the pharmacodynamic effects of budesonide on cabazitaxel (Jevtana®): A randomised, open-label multicenter study: CABARESC

    Summary
    EudraCT number
    		 2011-003346-40
    Trial protocol
    		 NL  
    Global end of trial date
    30 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jan 2020
    First version publication date
    22 Jan 2020
    Other versions
    Summary report(s)
    		 Paper on results
    Latest amended protocol

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CABARESC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 NA: NA
    Sponsors
    Sponsor organisation name
    Erasmus MC
    Sponsor organisation address
    's Gravendijkwal 230, Rotterdam, Netherlands,
    Public contact
    Department of Medical Oncology, Roo, Erasmus MC-Daniël den Hoed, +31 107041338NA, a.mathijssen@erasmusmc.nl
    Scientific contact
    Department of Medical Oncology, Roo, Erasmus MC-Daniël den Hoed, +31 107041338NA, 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
    30 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the effects of budesonide on the incidence of cabazitaxel induced diarrhea
    Protection of trial subjects
    See study protocol (attached)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Sep 2011
    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: 246
    Worldwide total number of subjects
    246
    EEA total number of subjects
    246
    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)
    59
    From 65 to 84 years
    187
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients planned to start with cabazitaxel therapy were screened for the inclusion and exclusion criteria.

    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
    		 Budesonide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    budesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Budesonide will be administered once daily in the morning, one hour before breakfast as oral medication consisting three capsules (3x3 mg), during 44 consecutive days, beginning two days before the first cycle of cabazitaxel. In case of delay of cabazitaxel, budesonide should be continued unless this is contraindicated. . Patient compliance will be assessed through a (short) patient diary

    Arm title
    		 Control
    Arm description
    		 Cabazitaxel without budesonide
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Budesonide Control
    Started
    122
    124
    Completed
    114
    113
    Not completed
    8
    11
         Cabazitaxel dose too low
    1
    5
         Cabazitaxel not started
    7
    4
         Protocol deviation
    -
    2

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Budesonide
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 Cabazitaxel without budesonide

    Primary: incidence of grade 2–4

    		 Close Top of page
    End point title
    		 incidence of grade 2–4
    End point description
    End point type
    Primary
    End point timeframe
    First two cycles of cabazitaxel (i.e. the complete study period)
    End point values
    		 Budesonide Control
    Number of subjects analysed
    114
    113
    Units: persons
    21
    14
    Statistical analysis title
    		 X2 primary endpoint
    Comparison groups
    Control v Budesonide
    Number of subjects included in analysis
    227
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.21
    Method
    		 Chi-squared
    Confidence interval

    Secondary: other cabazitaxel-induced adverse events

    		 Close Top of page
    End point title
    		 other cabazitaxel-induced adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    Complete study period
    End point values
    		 Budesonide Control
    Number of subjects analysed
    114
    113
    Units: persons
    114
    113
    No statistical analyses for this end point

    Secondary: PSA response

    		 Close Top of page
    End point title
    		 PSA response
    End point description
    End point type
    Secondary
    End point timeframe
    complete study
    End point values
    		 Budesonide Control
    Number of subjects analysed
    114
    113
    Units: persons
    31
    38
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    complete study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Adverse event data (of both serious and non-serious adverse events) are reported extensively in the attached published paper

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Feb 2012
    Addition of blood withdrawal for side study on circulating tumor cells

    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/27702823
    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.

    European Medicines Agency © 1995-Fri Apr 19 05:26:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA