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    Clinical Trial Results:
    Phase II study of nilotinib efficacy in Pigmented Villo-Nodular Synovitis / Tenosynovial Giant Cell Tumor (PVNS / TGCT)

    Summary
    EudraCT number
    		 2010-018869-29
    Trial protocol
    		 FR   IT   NL   GB  
    Global end of trial date
    04 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Oct 2019
    First version publication date
    20 Oct 2019
    Other versions
    Summary report(s)
    		 PVNS

    Trial information

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    Trial identification
    Sponsor protocol code
    ET2009-095
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01261429
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Léon Bérard
    Sponsor organisation address
    28 rue Laennec , LYON Cedex 08, France,
    Public contact
    Centre Léon Bérard S.GUILLEMAUT , Centre Léon Bérard S.GUILLEMAUT , + 4 78 78 28 28, DRCIreglementaire@lyon.unicancer.fr
    Scientific contact
    Centre Léon Bérard J.Y BLAY , Centre Léon Bérard J.Y BLAY , +33 4 78 78 28 28, DRCIreglementaire@lyon.unicancer.fr
    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 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study will be to determine the efficacy of 12 weeks (3 months) of nilotinib treatment as measured by the non progression rate (Complete response + Partial Response + Stable disease according to Response Evaluation Criteria In Solid Tumours - RECIST version 1.1) in patients with progressive or relapsing PVNS/TGCT who cannot be treated by surgery.
    Protection of trial subjects
    Several follow-up (consultation with physician)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2010
    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
    Australia: 7
    Country: Number of subjects enrolled
    Netherlands: 16
    Country: Number of subjects enrolled
    France: 25
    Country: Number of subjects enrolled
    Italy: 8
    Worldwide total number of subjects
    56
    EEA total number of subjects
    49
    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)
    56
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The inclusion will take during a follow-up consultation of the patient by her oncologist. The investigator will verify the eligibility of the patient, inform him about the study and collect him consent to participation.

    Pre-assignment
    Screening details
    		 Patients will be selected among those contacting the study centre for the treatment of PVNS/TGCT according to the inclusion and non-inclusion criteria described above. After being informed of the study and having asked all their questions to the investigator, they will have enough time to decide whether or not they want to be included in the study.

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

    Arms
    Arm title
    		 Treatment with Nilotinib
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nilotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg twice a day Oral administration

    Number of subjects in period 1
    		Treatment with Nilotinib
    Started
    56
    Completed
    56

    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
    		 56 56
    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)
    		 56 56
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 28 28
        Male
    		 28 28
    Subject analysis sets

    Subject analysis set title
    final statistical analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All included patients were analyzed for baseline characteristics and efficacy data. Since all these patients have received at least one dose of the study drug, they were also all analyzed for safety data.

    Subject analysis sets values
    		 final statistical analysis
    Number of subjects
    56
    Age categorical
    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)
    56
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    28
        Male
    28

    End points

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    End points reporting groups
    Reporting group title
    Treatment with Nilotinib
    Reporting group description
    		 -

    Subject analysis set title
    final statistical analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All included patients were analyzed for baseline characteristics and efficacy data. Since all these patients have received at least one dose of the study drug, they were also all analyzed for safety data.

    Primary: Endpoint analysis

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    End point title
    		 Endpoint analysis [1]
    End point description
    End point type
    Primary
    End point timeframe
    The primary endpoint of the study was the 12-week progression-free rate (12w-PFR).
    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: There is only one arm, so it is not possible to have a statistical analysis.
    End point values
    		 Treatment with Nilotinib final statistical analysis
    Number of subjects analysed
    56
    51
    Units: 92.6
        log mean (full range (min-max))
    95 (84.3 to 97.9)
    95 (84.3 to 97.9)
    No statistical analyses for this end point

    Secondary: Endpoint analysis

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    End point title
    		 Endpoint analysis
    End point description
    End point type
    Secondary
    End point timeframe
    Secondary endpoints of the study were: 24w-PFR, best overall response (BOR), objective response rate (ORR), duration of response (Drep), progression-free survival (PFS), time to progression (TTP), time to treatment failure (TTF).
    End point values
    		 Treatment with Nilotinib final statistical analysis
    Number of subjects analysed
    48
    43
    Units: 89.6
        log mean (full range (min-max))
    89.6 (77.3 to 96.5)
    89.6 (77.3 to 96.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The investigator immediately informs the sponsor of any serious adverse events occurring during the study in a written report, whether or not they are attributable to the research.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Frequency threshold for reporting non-serious adverse events: 1%
    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: Adverse events concerned 55/56 patients (98.2%); 54 patients (96.4%) experienced treatment-related adverse events and 6 patients (10.7%) experienced grade 3-4 treatmentrelated adverse events. Serious Adverse Events (SAEs) concerned 3 patients among the 56 included in the study, including one patient not directly concerned (particular case, the wife of the patient was pregnant). Only 1 AE was considered as potentially related to the drug according to the sponsor. No death was reported.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2011
    - to prolong the inclusion period by one year ; - to add the calcium dosage for each biological test.

    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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