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   43870   clinical trials with a EudraCT protocol, of which   7289   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 gemcitabine, carboplatin and VELIPARIB (ABT-888) in refractory testicular germ cell cancer.

    Summary
    EudraCT number
    		 2016-000171-24
    Trial protocol
    		 SK  
    Global end of trial date
    15 Feb 2021

    Results information
    Results version number
    		 v1
    This version publication date
    08 Aug 2021
    First version publication date
    08 Aug 2021
    Other versions
    		 v2
    Summary report(s)
    		 GCTSK004 summary

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GCTSK004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02860819
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Národný onkologický ústav
    Sponsor organisation address
    Klenová 1, Bratislava, Slovakia, 83310
    Public contact
    Department of Clinical Trials, Národný onkologický ústav, +421 259378592, daniela.svetlovska@nou.sk
    Scientific contact
    Department of Clinical Trials, Národný onkologický ústav, +421 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
    15 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Feb 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy (as measured by 12-months progression-free survival) of gemcitabine, carboplatin and VELIPARIB (ABT-888) in patients with refractory germ cell tumors (GCTs).
    Protection of trial subjects
    All the procedures performed in studies 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 Informed consent was obtained from all individual participants included in the study.
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    01 Aug 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
    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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment period lasted from 01/AUG/2016 to 18/JUN/2020 considering 15 evaluable patients enrolled. As primary objective was not reached in first 15 patients enrolled (Stage I), study was terminated and enrollment of another 28 patients (Stage II) ) did not start.

    Pre-assignment
    Screening details
    		 The main inclusion criteria included multiple relapsed/refractory extracranial primary germ cell cancers (either seminoma or non-seminoma) pre-treated with cisplatin-based chemotherapy. Total of 16 patients were screened and 15 of them were assigned to the treatment, 1 patient was screening failure as did not fulfill all criteria.

    Pre-assignment period milestones
    Number of subjects started
    		 15
    Number of subjects completed
    		 15

    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
    		 Gemcitabine, carboplatin and veliparib
    Arm description
    		 Gemcitabine was administered intravenously at a dose of 800 mg/m2 on days 1 and 8 every 3 weeks; carboplatin at a target AUC of 4 on day 1 every 3 weeks; and veliparib at a dose of 250 mg b.i.d. throughout.
    Arm type
    		 Experimental

    Investigational medicinal product name
    gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A dose of 800 mg/m2 on days 1 and 8 every 3 weeks

    Investigational medicinal product name
    carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin AUC = 4, day 1, every 3 weeks

    Investigational medicinal product name
    veliparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Veliparib 250mg bid day continuously

    Number of subjects in period 1
    		Gemcitabine, carboplatin and veliparib
    Started
    15
    Completed
    15

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Gemcitabine, carboplatin and veliparib
    Reporting group description
    		 Gemcitabine was administered intravenously at a dose of 800 mg/m2 on days 1 and 8 every 3 weeks; carboplatin at a target AUC of 4 on day 1 every 3 weeks; and veliparib at a dose of 250 mg b.i.d. throughout.

    Reporting group values
    		 Gemcitabine, carboplatin and veliparib Total
    Number of subjects
    		 15 15
    Age categorical
    Adult men above 18 years old.
    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
        Adult men
    		 0 0
        Adults
    		 0 0
    Gender categorical
    Male subjects
    Units: Subjects
        Female
    		 0 0
        Male
    		 15 15
    Subject analysis sets

    Subject analysis set title
    Gemcitabine, carboplatin, veliparib
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All 15 patients assigned to study treatment were analysed.

    Subject analysis sets values
    		 Gemcitabine, carboplatin, veliparib
    Number of subjects
    15
    Age categorical
    Adult men above 18 years old.
    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
        Adult men
    0
        Adults
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Male subjects
    Units: Subjects
        Female
    0
        Male
    15

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Gemcitabine, carboplatin and veliparib
    Reporting group description
    		 Gemcitabine was administered intravenously at a dose of 800 mg/m2 on days 1 and 8 every 3 weeks; carboplatin at a target AUC of 4 on day 1 every 3 weeks; and veliparib at a dose of 250 mg b.i.d. throughout.

    Subject analysis set title
    Gemcitabine, carboplatin, veliparib
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All 15 patients assigned to study treatment were analysed.

    Primary: 12-months progression-free survival rate

    		 Close Top of page
    End point title
    		 12-months progression-free survival rate
    End point description
    Twelve-month PFS was achieved in 1 (6.7 %) patient.
    End point type
    Primary
    End point timeframe
    12-month progression-free survival was defined as number of living patients without progression after 12 month of start of study treatment.
    End point values
    		 Gemcitabine, carboplatin and veliparib Gemcitabine, carboplatin, veliparib
    Number of subjects analysed
    15
    1
    Units: number of subjects
    1
    1
    Statistical analysis title
    		 description statistics
    Statistical analysis description
    If fewer than 8 patients were alive and progression-free at 12 months among the first 15 patients, the study would be terminated.
    Comparison groups
    Gemcitabine, carboplatin and veliparib v Gemcitabine, carboplatin, veliparib
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 5
    Method
    		 Chi-squared
    Confidence interval
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Response rate

    		 Close Top of page
    End point title
    		 Response rate
    End point description
    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 end of study.
    End point values
    		 Gemcitabine, carboplatin and veliparib
    Number of subjects analysed
    15
    Units: number of subjects
    4
    No statistical analyses for this end point

    Secondary: Median overall survival

    		 Close Top of page
    End point title
    		 Median overall survival
    End point description
    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
    		 Gemcitabine, carboplatin and veliparib
    Number of subjects analysed
    15
    Units: month
        median (confidence interval 95%)
    10.5 (8.9 to 11.1)
    No statistical analyses for this end point

    Secondary: Median progression-free survival

    		 Close Top of page
    End point title
    		 Median 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
    		 Gemcitabine, carboplatin and veliparib
    Number of subjects analysed
    15
    Units: month
        median (confidence interval 95%)
    3.1 (2.2 to 3.9)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    AE reporting periods starts from time patient provides informed consent to 28 day of the last study drug administration. In case investigator believes, that SAE is related to study drug, it should be reported also after 28 days of the last study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 All AE for all grades were collected. We publish all SAE and most severe AE so grade 3/4.

    Serious adverse events
    		 All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 15 (20.00%)
         number of deaths (all causes)
    14
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    febrile neutropenia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    General disorders and administration site conditions
    death due to disease prigression
         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
    pneumothorax
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    sepsis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    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
    15 / 15 (100.00%)
    Investigations
    neutropenia
    Additional description: grade 3/4 neutropenia only
         subjects affected / exposed
    11 / 15 (73.33%)
         occurrences all number
    11
    thrombocytopenia
    Additional description: grade 3/4 only
         subjects affected / exposed
    10 / 15 (66.67%)
         occurrences all number
    10
    Nervous system disorders
    epileptic seizure
    Additional description: grade 4
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    syncope
    Additional description: grade 3
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    anemia
    Additional description: grade 3/4 anemia only
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    5
    febrile neutropenia
    Additional description: non serious was one, serious another one
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    pain after drainage
    Additional description: grade 3
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    chest pain non-cardiac
    Additional description: grade 3
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    vomiting
    Additional description: grade 3
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Infections and infestations
    catheter related infection
    Additional description: grade 3
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jan 2018
    Amendment protocol, version 2.0, 11.10.2017

    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.
    NA

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34052929
    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-Tue Apr 30 14:53:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA