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    Clinical Trial Results:
    Phase II study of Everolimus in refractory testicular germ cell cancer.

    Summary
    EudraCT number
    		 2011-001502-10
    Trial protocol
    		 SK  
    Global end of trial date
    15 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Sep 2021
    First version publication date
    04 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GCTSK002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01466231
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Národný onkologický ústav
    Sponsor organisation address
    Klenova 1, Bratislava, Slovakia, 83310
    Public contact
    Oddelenie klinického skúšania, Národný onkologický ústav, 00421 259378592, daniela.svetlovska@nou.sk
    Scientific contact
    Oddelenie klinického skúšania, Národný onkologický ústav,, 00421 259378592, daniela.svetlovska@nou.sk
    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
    29 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the efficacy (as measured by response rate) of Everolimus in patients with refractory germ cell tumors (GCTs).
    Protection of trial subjects
    All the procedures performed in the study involving human participants were conducted in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    28 Nov 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
    Slovakia: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From 28.11.2011 to 3.3.2015, a total of 16 patients were screened into to the study. One patient did not meet study eligibility criteria, 15 patients were analysed. As no objective response was observed in the first 15 patients enrolled to the study, the study was terminated prematurely.

    Pre-assignment
    Screening details
    		 Refractory testicular cancer patients.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Arm title
    		 Everolimus
    Arm description
    		 Non-randomized, open-label, single arm trial with everolimus given orally (10 mg per day).
    Arm type
    		 Experimental

    Investigational medicinal product name
    everolimus
    Investigational medicinal product code
    L01XE10
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The starting dose was 10 mg daily. One cycle of therapy consisted of 28 days. The dose was administered orally once daily at the same time every day, consistently either with or without food. The patients were monitored closely for toxicity. Intrapatient dose reduction to 5 mg/day was allowed depending on the type and severity of toxicity encountered.

    Number of subjects in period 1
    		Everolimus
    Started
    15
    Completed
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study (overall period)
    Reporting group description
    		 Single arm trial with everolimus given orally (10 mg per day).

    Reporting group values
    		 Overall study (overall period) Total
    Number of subjects
    		 15 15
    Age categorical
    Male patients age 18 years or older were eligible.
    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)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Only male patients were enrolled.
    Units: Subjects
        Female
    		 0 0
        Male
    		 15 15
    Subject analysis sets

    Subject analysis set title
    Overall study (overall period)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Single arm trial with everolimus given orally (10 mg per day).

    Subject analysis sets values
    		 Overall study (overall period)
    Number of subjects
    15
    Age categorical
    Male patients age 18 years or older were eligible.
    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)
    15
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Only male patients were enrolled.
    Units: Subjects
        Female
    0
        Male
    15

    End points

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    End points reporting groups
    Reporting group title
    Everolimus
    Reporting group description
    		 Non-randomized, open-label, single arm trial with everolimus given orally (10 mg per day).

    Subject analysis set title
    Overall study (overall period)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Single arm trial with everolimus given orally (10 mg per day).

    Primary: Response rate

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    End point title
    		 Response rate
    End point description
    None of the enrolled patients had partial or complete response to the study treatment.
    End point type
    Primary
    End point timeframe
    Objective response rate is defined as sum of complete and partial responses. It is defined from start of the treatment until progression of disease or start of new anticancer treatment.
    End point values
    		 Everolimus Overall study (overall period)
    Number of subjects analysed
    15
    15 [1]
    Units: number of subjects
    0
    0
    Notes
    [1] - No objective response was observed in first 15 patients, therefore study was terminated.
    Statistical analysis title
    		 descriptive statistics
    Statistical analysis description
    No objective response was observed in first 15 patients, therefore study wasterminated due to futility.
    Comparison groups
    Everolimus v Overall study (overall period)
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 5
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [2] - 15 patients were analysed, subject in analysis 30 is number automatically doubling by the system

    Secondary: Favourable response rate

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    End point title
    		 Favourable response rate
    End point description
    Favorable response will be classified complete remission and/or partial response with normalized serum tumor markers in case they were elevated before treatment. All other responses are considered as unfavourable. None of the enrolled patients had partial or caomplete response to the study treatment.
    End point type
    Secondary
    End point timeframe
    From start of study treatment to the best response of the study treatment.
    End point values
    		 Everolimus Overall study (overall period)
    Number of subjects analysed
    15
    15
    Units: number of patients
    0
    0
    No statistical analyses for this end point

    Secondary: Progression- free survival

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    End point title
    		 Progression- free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Progression-free survival (PFS) will be calculated from the beginning of the treatment until progression or death from disease-specific cause on intention-to-treat basis.
    End point values
    		 Everolimus Overall study (overall period)
    Number of subjects analysed
    15
    15
    Units: month
        number (confidence interval 95%)
    1.7 (1.1 to 4.0)
    1.7 (1.1 to 4.0)
    No statistical analyses for this end point

    Secondary: Serum tumor markers response

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    End point title
    		 Serum tumor markers response
    End point description
    >90% decline of AFP and/or HCG had none the enrolled patients.
    End point type
    Secondary
    End point timeframe
    From start of treatment until disease progression.
    End point values
    		 Everolimus Overall study (overall period)
    Number of subjects analysed
    15
    15
    Units: month
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded from start of study treatment until 28 days after study treatment discontinuation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 Grade 3 and 4 non serious or any grade serious adverse events are reported. Subjects affected by all grades non serious adverse events are 12, by grade 3-4 non serious adverse events are 4 subjects, by any grade SAE 9 patients.

    Serious adverse events
    		 All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 15 (60.00%)
         number of deaths (all causes)
    12
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor pain
    Additional description: 1 patient experienced SAE tumor related pain.
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intracerebral hemorrhage
    Additional description: 1 patient experienced SAE intracerebral hemorrhage.
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Disease progression
    Additional description: 5 patient experienced SAE disease progression.
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 5
    Vascular disorders
    Thrombosis of vena jugularis
    Additional description: 1 patient experienced SAE thrombosis of vena jugularis.
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Epileptic seizure
    Additional description: 1 patient experienced SAE epileptic seizure.
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
    Additional description: 1 patient experienced SAE pneumonitits.
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
    Additional description: 1 patient experienced SAE anorexia.
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 15 (26.67%)
    Investigations
    Platelet count decreased
    Additional description: grade 3 non serious
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Blood bilirubin increased
    Additional description: grade 3
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
    Additional description: grade 3 and 4
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    General disorders and administration site conditions
    Fatigue
    Additional description: grade 3
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
    Additional description: grade 3 non serious
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Hyperlipidaemia
    Additional description: grade 3 and 4
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Anorexia
    Additional description: grade 3 non serious
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    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/26612480
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