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   43851   clinical trials with a EudraCT protocol, of which   7283   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:
    Lean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC)

    Summary
    EudraCT number
    		 2011-005168-14
    Trial protocol
    		 NL  
    Global end of trial date
    01 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    UMCN-AKF11.01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
    Public contact
    Angela Colbers, Radboud University Nijmegen Medical Centre, angela.colbers@radboudumc.nl
    Scientific contact
    Angela Colbers, Radboud University Nijmegen Medical Centre, angela.colbers@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
    01 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females.
    Protection of trial subjects
    Subjects experience only limited burden or risk during study related assessments of one DEXA scan, one BIA measurement and withdrawal of 4 pharmacokinetic blood samples. Subjects will not have direct benefit of participating in the study. Subjects may experience side effects of the medication administered for the treatment of cancer. The choice for treatment will be made by their treating physician, this will not be influenced by this study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2012
    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: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    26
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 32 patients included in 2 centres in the Netherlands

    Pre-assignment
    Screening details
    		 Subjects who are diagnosed with breast or metastatic castration-resistant prostate carcinoma who will receive docetaxel containing treatment according to standard hospital protocol

    Period 1
    Period 1 title
    screening
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 docetaxel
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20mg/mL

    Number of subjects in period 1
    		docetaxel
    Started
    32
    Completed
    23
    Not completed
    9
         Physician decision
    9
    Period 2
    Period 2 title
    PK day
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 docetaxel
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20mg/mL

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: baseline was performed on PK day, not at screening.
    Number of subjects in period 2 [2]
    		docetaxel
    Started
    23
    Completed
    23
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: we do not have these data in the database from the patients screened but not included.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    PK day
    Reporting group description
    		 -

    Reporting group values
    		 PK day Total
    Number of subjects
    		 23 23
    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
        arithmetic mean (full range (min-max))
    		 57 (31.5 to 77.8) -
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 5 5

    End points

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

    Primary: correlation with BSA

    		 Close Top of page
    End point title
    		 correlation with BSA [1]
    End point description
    correlation dosing on BSA and docetaxel clearance
    End point type
    Primary
    End point timeframe
    entire study
    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: correlation between AUC and TBW was done, it is not possible to put that analysis in the statics fields. Pearson correlation coefficients were reported, p value all >0.05
    End point values
    		 docetaxel
    Number of subjects analysed
    23
    Units: number
        number (not applicable)
    -0.326
    No statistical analyses for this end point

    Primary: Correlation LBM

    		 Close Top of page
    End point title
    		 Correlation LBM [2]
    End point description
    correlation dosing on LBM and docetaxel clearance
    End point type
    Primary
    End point timeframe
    entire study
    Notes
    [2] - 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: correlation between AUC and BSA was done, it is not possible to put that analysis in the statics fields. Pearson correlation coefficients were reported, p value all >0.05
    End point values
    		 docetaxel
    Number of subjects analysed
    23
    Units: number
        number (not applicable)
    -0.171
    No statistical analyses for this end point

    Primary: correlation TBW

    		 Close Top of page
    End point title
    		 correlation TBW [3]
    End point description
    correlation dosing on TBW and docetaxel clearance
    End point type
    Primary
    End point timeframe
    entire study
    Notes
    [3] - 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: correlation between AUC and LBM was done, it is not possible to put that analysis in the statics fields. Pearson correlation coefficients were reported, p value all >0.05
    End point values
    		 docetaxel
    Number of subjects analysed
    23
    Units: number
        number (not applicable)
    -0.336
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    entire study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    1
    Reporting groups
    Reporting group title
    LEANDOC
    Reporting group description
    		 -

    Serious adverse events
    		 LEANDOC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LEANDOC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 23 (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: no adverse events were reported.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Dec 2013
    In the synopsis the requirement of 20 female breast carcinoma patients and 20 castration resistant prostate carcinoma patients has been changed. We will include 40 subjects either patients with breast carcinoma or castration resistant prostate carcinoma which receive docetaxel as part of their treatment.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Aug 2016
    trial was stopped due to very slow recruitment.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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-Sat Apr 20 01:39:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA