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    Clinical Trial Results:
    Selecting cancer patients for treatment using Tumor Organoids, the SENSOR study

    Summary
    EudraCT number
    		 2014-003811-13
    Trial protocol
    		 NL  
    Global end of trial date
    16 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2021
    First version publication date
    20 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    N14SNS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ABR : NL50400.031.14
    Sponsors
    Sponsor organisation name
    Antoni van Leeuwenhoek - Netherlands Cancer Institute
    Sponsor organisation address
    Plesmanlaan 121, Amsterdam, Netherlands,
    Public contact
    Emile Voest, Antoni van Leeuwenhoek - Netherlands Cancer Institute, +31 205129111, e.voest@nki.nl
    Scientific contact
    Emile Voest, Antoni van Leeuwenhoek - Netherlands Cancer Institute, +31 205129111, e.voest@nki.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
    16 Apr 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the efficacy of patient-derived tumor organoids to successfully allocate patients for treatment with specific targeted agents.
    Protection of trial subjects
    Histological biopsies were obtained with the same high quality standards as biopsy procedures in regular care. Upon experimental treatment, patients were tightly monitored within a designated clinical research department (Clinical Research Unit).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 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
    Netherlands: 61
    Worldwide total number of subjects
    61
    EEA total number of subjects
    61
    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)
    44
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Metastatic colorectal cancer (CRC) patients without curative treatment options were accrued at The Netherlands Cancer Institute before start of their last SOC treatment

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 61
    Number of subjects completed
    		 6

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No biopsy: 7
    Reason: Number of subjects
    		 Unsuccessful organoid culture: 23
    Reason: Number of subjects
    		 No drug screen performed: 6
    Reason: Number of subjects
    		 No hit in drug screen: 6
    Reason: Number of subjects
    		 No treatment started: 13
    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Capivasertib
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capivasertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Twice daily, 125 mg in 28-day cycles using an intermittent dosing schedule (2 days on/5 days off)

    Arm title
    		 Vistusertib
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vistusertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Twice daily, at a dose of 480 mg in 28-day cycles using an intermittent dosing schedule (4 days on/3 days off)

    Number of subjects in period 1 [1]
    		Capivasertib Vistusertib
    Started
    3
    3
    Completed
    1
    3
    Not completed
    2
    0
         Lack of efficacy
    2
    -
    Notes
    [1] - 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: There was a high drop-out of patients before initiating treatment within the trial. This is explained in the pre-assignement period

    Baseline characteristics

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

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 6 6
    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))
    		 57 (51 to 65) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Capivasertib
    Reporting group description
    		 -

    Reporting group title
    Vistusertib
    Reporting group description
    		 -

    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
    Response evaluation
    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: Please see final manuscript at PMID:33887686
    End point values
    		 Capivasertib Vistusertib
    Number of subjects analysed
    3
    3
    Units: 20%
        Objective response (RECIST 1.1)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Anytime during treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    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: Please see final manuscript at PMID:33887686

    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/33887686
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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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