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    Clinical Trial Results:
    Predictive value of in-vitro testing anti-cancer therapy sensitivity on tumoroids from patients with metastatic pancreatic cancer

    Summary
    EudraCT number
    		 2018-003112-53
    Trial protocol
    		 DK  
    Global end of trial date
    22 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jan 2024
    First version publication date
    18 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TIP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03821870
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vejle Hospital
    Sponsor organisation address
    Beriderbakken 4, Vejle, Denmark, 7100
    Public contact
    Clinical Trial Unit, Oncology, Vejle Hospital, karin.larsen1@rsyd.dk
    Scientific contact
    Clinical Trial Unit, Oncology, Vejle Hospital, karin.larsen1@rsyd.dk
    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
    02 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Feb 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of the present study is to investigate the predictive value of pretreatment in-vitro testing of drug sensitivity to patient-derived tumoroids.
    Protection of trial subjects
    Antiemetics and other supportive treatment as necessary
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 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
    Denmark: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    2
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were included between February and October 2019.

    Pre-assignment
    Screening details
    		 Institution-based screening of all patients with non-resectable pancreatic cancer.

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

    Arms
    Arm title
    		 Precision cohort
    Arm description
    		 Patients with one histopathologic tumor type, pancreatic adenocarcinoma, are subdivided into treatment groups based on functional characteristics.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Targeted treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    FOLFIRINOX . Gemcitabine + Albumin-bound Paclitaxel. Gemcitabine + Erlotinib. Gemcitabine + Capecitabine. Gemcitabine + Cisplatin. Gemcitabine + docetaxel + capecitabine. CAPOX: Day 1: Oxaliplatin 130 mg/m2 IV. Days 1–14: Capecitabine 1,000 m FOLFIRI: Day 1: irinotecan 180 mg/m2 IV + leucovorin 400 mg/m2 IV + 5-FU 400 mg/m2 IV bolus and 5-FU 2,400 mg/m2 IV for 46 h. Repeat every 2 weeks. Olaparib: 300 mg orally twice daily.

    Number of subjects in period 1 [1]
    		Precision cohort
    Started
    9
    Completed
    9
    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: 30 patients were planned. 12 were included. 9 started treatment of which none were evaluable for the primary endpoint.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 9 9
    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)
    		 2 2
        From 65-84 years
    		 7 7
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Precision cohort
    Reporting group description
    		 Patients with one histopathologic tumor type, pancreatic adenocarcinoma, are subdivided into treatment groups based on functional characteristics.

    Primary: Response rate

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    End point title
    		 Response rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    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: Not relevant since no patients were evaluable.
    End point values
    		 Precision cohort
    Number of subjects analysed
    0 [2]
    Units: Number
    Notes
    [2] - No patients were evaluable.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Every 3-4 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Overall group
    Reporting group description
    		 -

    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: Only data on grade 3-5 events were collected.
    Serious adverse events
    		 Overall group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 9 (66.67%)
         number of deaths (all causes)
    8
         number of deaths resulting from adverse events
    1
    Cardiac disorders
    Heart failure
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)

    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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