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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    Phase II study of sunitinib malate (SUTENT®) in relapsed germ cell tumors in males.

    Summary
    EudraCT number
    		 2007-004981-42
    Trial protocol
    		 SK  
    Global end of trial date
    02 Jan 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Sep 2022
    First version publication date
    22 Sep 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GCTSK001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Národný onkologický ústav
    Sponsor organisation address
    Klenova 1, Bratislava, Slovakia, 833 10
    Public contact
    Prof.Michal Mego, MD:, DSc., Narodny onkologicky ustav, 00421 259378108, michal.mego@nou.sk
    Scientific contact
    Prof.Michal Mego, MD:, DSc., Narodny onkologicky ustav, 00421 259378108, michal.mego@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
    21 Nov 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Nov 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jan 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    12-month post treatment initiation continuous progression-free survival
    Protection of trial subjects
    All the procedures performed in 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
    		 Sunitinib malate (SUTENT®) 50 mg/day administered orally in a one daily dose for a 4 weeks in a 6 week-cycle (4 weeks on/2 weeks off)
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    25 Jul 2008
    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: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 From 25 July 2008 to October 2010, a total of 10 patients were screened into the study. 10 subjects were enrolled and receive study treatment. All patients were platinum-refractory with the excepton of one. Patients were pre-treated with a median of 3 cisplatin-containing therapies. The median age was 32 years (range 19–55 years).

    Pre-assignment
    Screening details
    		 Patients with radiological and/or serological proof of relapsed metastatic germ cell tumors, who were not eligible for curative chemotherapy or surgery and had failed at least 2 platinum-based regimens or 1 platinum regimen in the case of platinum-refractory disease or primary mediastinal non- seminomatous germ cell tumor,

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

    Arms
    Arm title
    		 Sunitinib malate
    Arm description
    		 Uncontrolled, Non-randomised, open-label, 1 arm (SUTENT® given orally). The single-stage Phase II design will be used.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sunitinib malate
    Investigational medicinal product code
    Other name
    SUTENT®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Sunitinib malate (SUTENT®) 50 mg/day administered orally in a one daily dose for 4 weeks in a 6 week-cycle (4 weeks on/2 weeks off). Administration of SUTENT® will be performed on an outpatient basis. The starting dose will be 50 mg daily. The dose should be taken once daily at approximately the same time of day. Patients are required to have a drug rest period of at least 14 days after each dosing period. The start of the next cycle may be delayed if additional time is required for the patient to recover from treatment-associated toxicity experienced during the previous cycle. Dosing may be modified after discussion with Principal Investigator. The study investigator implements dose suspension or reduction in order to ensure patient safety. No pre-medication or patient monitoring immediately after administration of SUTENT is required.

    Number of subjects in period 1
    		Sunitinib malate
    Started
    10
    Completed
    10

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Study (overall period)
    Reporting group description
    		 Single arm trial with Sunitinib malate (SUTENT®) 50 mg/day administered orally.

    Reporting group values
    		 Overall Study (overall period) Total
    Number of subjects
    		 10 10
    Age categorical
    male subjects from 18 years.
    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)
    		 10 10
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    The median age was 32 years (range 19–55 years).
    Units: years
        arithmetic mean (full range (min-max))
    		 32 (19 to 55) -
    Gender categorical
    male subjects
    Units: Subjects
        Female
    		 0 0
        Male
    		 10 10
    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 Sunitinib malate (SUTENT®) 50 mg/day administered orally.

    Subject analysis sets values
    		 Overall study (overall period)
    Number of subjects
    10
    Age categorical
    male subjects from 18 years.
    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)
    10
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    The median age was 32 years (range 19–55 years).
    Units: years
        arithmetic mean (full range (min-max))
    32 (19 to 55)
    Gender categorical
    male subjects
    Units: Subjects
        Female
    0
        Male
    10

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Sunitinib malate
    Reporting group description
    		 Uncontrolled, Non-randomised, open-label, 1 arm (SUTENT® given orally). The single-stage Phase II design will be used.

    Subject analysis set title
    Overall study (overall period)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Single arm trial with Sunitinib malate (SUTENT®) 50 mg/day administered orally.

    Primary: Twelve-month post treatment initiation continuous progression-free survival rate (intent-to-treat population)

    		 Close Top of page
    End point title
    		 Twelve-month post treatment initiation continuous progression-free survival rate (intent-to-treat population)
    End point description
    Twelve month post-treatment initiation continuous progression-free survival rate will be summarized as counts and proportions with exact binomial 90% confidence interval (ITT population)
    End point type
    Primary
    End point timeframe
    PFS will be calculated from the starting the treatmentl to the date of progression or death or or to the date of last follow up.
    End point values
    		 Sunitinib malate Overall study (overall period)
    Number of subjects analysed
    10 [1]
    10 [2]
    Units: weeks
        number (not applicable)
    10.8
    10.8
    Notes
    [1] - Median Progression-free survival was 10.8 weeks
    [2] - Median Progression-free survival was 10.8 weeks
    Statistical analysis title
    		 descriptive statistics
    Comparison groups
    Sunitinib malate v Overall study (overall period)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 5
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [3] - Intention to treat analysis.

    Secondary: Overall response rate

    		 Close Top of page
    End point title
    		 Overall response rate
    End point description
    Overall response rate = rate of complete remission (CR) or partial response (PR) based on RECIST criteria among all evaluable patients
    End point type
    Secondary
    End point timeframe
    Objective response rate is defined as sum of complete and partial responses. It is defined from start of the treatment until progresson of disease or start of new anticancer treatment.
    End point values
    		 Sunitinib malate Overall study (overall period)
    Number of subjects analysed
    10 [4]
    10 [5]
    Units: number of patients
    2
    2
    Notes
    [4] - 2 patients achieved PR, 0 CR
    [5] - 2 patients achieved PR, 0 CR
    No statistical analyses for this end point

    Secondary: Duration of response

    		 Close Top of page
    End point title
    		 Duration of response
    End point description
    Response Duration will be measured from the time when measurement criteria for CR/PR (whichever is first recorded) are first met until the first date that recurrent or progressive disease is objectively documented, taking as reference the smallest measurements recorded since the treatment started.
    End point type
    Secondary
    End point timeframe
    Duration of response (CR+PR), defined from the earliest time when confirmed remission criteria are met until death or progression. Patients continuing in remission at the end of the study are treated as censored (ITT population).
    End point values
    		 Sunitinib malate Overall study (overall period)
    Number of subjects analysed
    10 [6]
    10 [7]
    Units: weeks
        number (not applicable)
    10.2
    10.2
    Notes
    [6] - Duration of response was 10,2 weeks (71,5 days)
    [7] - Duration of response was 10,2 weeks (71,5 days)
    No statistical analyses for this end point

    Secondary: Overall survival

    		 Close Top of page
    End point title
    		 Overall survival
    End point description
    The length of time from the start of treatment to to the death.
    End point type
    Secondary
    End point timeframe
    Overall survival (OS) will be calculated from the beginning of the treatment until death from any cause on intention-to-treat basis.
    End point values
    		 Sunitinib malate Overall study (overall period)
    Number of subjects analysed
    10 [8]
    10 [9]
    Units: weeks
        arithmetic mean (standard deviation)
    12.9 ( 0.1 )
    12.9 ( 0.1 )
    Notes
    [8] - Overall survival was 12,9 weeks.
    [9] - Overall survival was 12,9 weeks.
    No statistical analyses for this end point

    Secondary: Toxicity

    		 Close Top of page
    End point title
    		 Toxicity
    End point description
    For evaluation of toxicity, NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) was used.
    End point type
    Secondary
    End point timeframe
    Toxicity will be evaluated in all patients from the time of first administration of the Sutent®.
    End point values
    		 Sunitinib malate Overall study (overall period)
    Number of subjects analysed
    10 [10]
    10 [11]
    Units: number of patients and events
    4
    4
    Notes
    [10] - 4 subjects experienced at least one adverse event Gr.3 or 4.
    [11] - 4 subjects experienced at least one adverse event Gr.3 or 4.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events will be evaluated in all patients from the time of first administration of the Sutent® on an ongoing basis.
    Adverse event reporting additional description
    Adverse events will be categorized using the CTCAE, Version 3.0. The worst event for each patient will be described. Both events related and unrelated to treatment will be captured. Clinical and laboratory data will be tabulated and compared to normal ranges for the institution. Adverse events Grade 3 and Grade 4 will be reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    all subjects
    Reporting group description
    		 -

    Serious adverse events
    		 all subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    8
         number of deaths resulting from adverse events
    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 / 10 (40.00%)
    Investigations
    Thrombocytopenia
    Additional description: 2 subjects experienced Thrombocytopenia, Gr.3.
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
    Additional description: 1 subject experienced Anaemia, Gr.3
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
    Additional description: 1 subject experienced Nausea, Gr.4.
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Vomiting
    Additional description: 1 subject experienced Vomiting, Gr.4.
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1

    More information

    		 Close Top of page

    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/22846980
    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-Mon Apr 29 15:29:58 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA