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    Clinical Trial Results:
    Molecular-biological tumor profiling for drug treatment selection in patients with advanced and refractory carcinoma

    Summary
    EudraCT number
    		 2014-005341-44
    Trial protocol
    		 AT  
    Global end of trial date
    08 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Mar 2020
    First version publication date
    14 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ICT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Graz
    Sponsor organisation address
    Auenbruggerplatz 2, Graz, Austria, 8036
    Public contact
    Koordinierungszentrum f. Kli. Stud., Medical University of Graz, +43 31638578017, astrid.friedel@medunigraz.at
    Scientific contact
    Koordinierungszentrum f. Kli. Stud., Medical University of Graz, +43 31638578017, astrid.friedel@medunigraz.at
    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
    26 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This phase II study is designed to increase the PFS of an anti-tumor drug therapy based on a molecular-biologic tumor profile in patients with proven progressed carcinoma of different origin after all evidence-based therapies 1.2-fold to the PFS of the last evidence-based drug therapy. Furthermore, the number of patients in which an anti-tumor drug therapy based on a molecular-biologic tumor profile can be defined, overall survival (OS), overall response rate (ORR) and safety will be evaluated. PFS ratio (PFS on targeted drug therapy / PFS on last evidence-based drug therapy). The PFS of the last evidence-based therapy will be assessed by predefined specialist of the Division of Clinical Oncology of the Medical University of Graz who take part in the study at the time when a patient is included in the study.
    Protection of trial subjects
    tracking Adverse Events
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 May 2015
    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
    Austria: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    6
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruitmenpthase 3.7.2015-9.3.2018, 24 patients, single site

    Pre-assignment
    Screening details
    		 24 patients screened, one patient excluded during screeningphase because of death one patient excluded during screeningphase because of non adequate liver function 14 because of no results of molecular profiling

    Pre-assignment period milestones
    Number of subjects started
    		 24 [1]
    Number of subjects completed
    		 8

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 inclusion exclusion criteria: 15
    Reason: Number of subjects
    		 death: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Enrollment starts after Screening ( pre assignment )
    Period 1
    Period 1 title
    treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 individual treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    individual treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    individual treatment

    Number of subjects in period 1
    		individual treatment
    Started
    8
    Completed
    8
    Period 2
    Period 2 title
    follow up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 after progression
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		after progression
    Started
    8
    Completed
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    treatment period
    Reporting group description
    		 -

    Reporting group values
    		 treatment period Total
    Number of subjects
    		 8 8
    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)
    		 6 6
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    individual treatment
    Reporting group description
    		 -
    Reporting group title
    after progression
    Reporting group description
    		 -

    Primary: Progression-free survival (PFS)

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    End point title
    		 Progression-free survival (PFS)
    End point description
    End point type
    Primary
    End point timeframe
    12 month
    End point values
    		 individual treatment after progression
    Number of subjects analysed
    8
    8
    Units: patients
    8
    8
    Statistical analysis title
    		 individual treatment PFS ratio
    Statistical analysis description
    The null hypothesis H0: p ≤ p0, that ≤10% of this patient population would have a PFS ratio of ≥ 1.2, will be tested using a one-sided binomial test (α=5%).
    Comparison groups
    individual treatment v after progression
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.05 [2]
    Method
    		 one-sided binomial test
    Confidence interval
    Notes
    [1] - The null hypothesis H0: p ≤ p0, that ≤10% of this patient population would have a PFS ratio of ≥ 1.2, will be tested using a one-sided binomial test (α=5%).
    [2] - The null hypothesis H0: p ≤ p0, that ≤10% of this patient population would have a PFS ratio of ≥ 1.2, will be tested using a one-sided binomial test (α=5%).

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    until 30 days after last study medication was taken
    Adverse event reporting additional description
    Events not treated as AE/SAEs: 1) Death and Progression of underlying disease is not an SAE. Signs and symptoms of tumor progression may meet a criterion of a SAE and if so, should be reported as such. 2) Elective hospitalization for treatment of underlying disease or administration of study medication/procedures is not considered as AE/SAE.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    individual treatment
    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: Frequency of non serious AE did not exceed 5% and are therefore not reported.
    Serious adverse events
    		 individual treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 8 (62.50%)
         number of deaths (all causes)
    8
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subileus
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    2 / 8 (25.00%)
         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
    		 individual treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jan 2015
    Change of PI
    07 Jul 2015
    Changes in safety or integrity of trial subjects Amendment to information in the CT application form Amendment to the protocol
    06 Jul 2016
    Amendment to the protocol  Amendment to other documents appended to the initial application form specify: ICD and ICD Gentetic
    08 May 2018
    Amendment to information in the CT application form Amendment to the protocol

    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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