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    Clinical Trial Results:
    A Clinical Trial Of The Intra-Tumoural Concentration And Activity Of Nilotinib In Intra-Cutaneous Schwannomas (PHNT NilotinibNF2)

    Summary
    EudraCT number
    		 2010-023508-28
    Trial protocol
    		 GB  
    Global end of trial date
    01 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Apr 2019
    First version publication date
    17 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAMN107GB05T
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 R&D (sponsor) ref.: 10/P/148, PenCTU ref.: 2011/CTIMP-007, REC ref. : 11/SC/0035119
    Sponsors
    Sponsor organisation name
    University Hospitals Plymouth NHS Trust (formerly Plymouth Hospitals NHS Trust)
    Sponsor organisation address
    Research Office, L2 MSCP, Bircham Park Offices, 1 Roscoff Rise, Derriford, Plymouth, United Kingdom, PL6 5FP
    Public contact
    Dr Chris Rollinson, Research Governance Manager, University Hospitals Plymouth NHS Trust, Research Development and Innovation, 01752 432842, c.rollinson@nhs.net
    Scientific contact
    Prof Oliver Hanemann, Consultant Neurologist, University of Plymouth, Faculty of Medicine and Dentistry, 01752 437418, oliver.hanemann@plymouth.ac.uk
    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
    Interim
    Date of interim/final analysis
    01 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To ensure molecular target inhibition occurs with oral nilotinib in NF2 patients with CS, and to determine whether target inhibition in serum with oral nilotinib in NF2 patients with ICS can act as a biomarker.
    Protection of trial subjects
    The study is approved by the MHRA and the South Central - Berkshire Research Ethics Committee (NRES). Study monitoring is conducted by UHPNT and an Independent Trial Management Team (TMT) is set up for the study oversight.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 May 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients from the NF2 clinic patient databases in Plymouth and Manchester will be identified by the Investigator at the relevant site, who will contact the patients by letter to ask them if they are interested in participating in the study.

    Pre-assignment
    Screening details
    		 Patients who are interested in taking part will be invited to attend for a screening visit lasting last approximately four hours in order to check their eligibility to participate. Written informed consent will be obtained at the screening visit.

    Pre-assignment period milestones
    Number of subjects started
    		 5
    Number of subjects completed
    		 5

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

    Arms
    Arm title
    		 Nilotinib
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nilotinib
    Investigational medicinal product code
    Other name
    Tasigna
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A prescription for 14 days’ supply of nilotinib 400mg will be issued at the baseline visit. The participant should commence dosing the day after the baseline visit, starting with the morning dose. To avoid Day 15 occurring on a Saturday, baseline visits will take place on Monday to Thursday. Participants will take 2 x 200mg capsules (400mg) twice daily by mouth each morning and evening approximately 12 hours.

    Number of subjects in period 1
    		Nilotinib
    Started
    5
    Completed
    1
    Not completed
    4
         Consent withdrawn by subject
    3
         Screening faliure
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nilotinib
    Reporting group description
    		 -

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

    End points

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

    Primary: Target inhibition by nilotinib in CS biopsies

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    End point title
    		 Target inhibition by nilotinib in CS biopsies [1]
    End point description
    End point type
    Primary
    End point timeframe
    Steady state nilotinib serum concentrations at Study Day 15.
    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: This study was terminated early due to funding withdrawal. Recruitment in this patient group proved difficult. Five patients were screened, four were enrolled and only 1 successfully completed the study (total needed was 15). Therefore there is no result-related data to report.
    End point values
    		 Nilotinib
    Number of subjects analysed
    1
    Units: steady state plasma concentrations
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All SAEs, SARs including SUSARs are reported to the RD Office (sponsor) within 24 hours. RD Office to report to MHRA and REC within 7 days if fatal or life-threatening and all other SUSARs within 15 days.
    Adverse event reporting additional description
    AEs should be recorded from the time a participant gives written consent for the study until the end of study follow up visit (Study Day 28). Where possible, multiple symptoms should be recorded as separate events. For the purposes of this study, an exacerbation of NF2 symptoms should be recorded as an adverse event.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Nilotinib
    Reporting group description
    		 Patients dosed with the study IMP (Nilotinib).

    Serious adverse events
    		 Nilotinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nilotinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Malaise
    Additional description: Tiredness
         subjects affected / exposed
    3 / 3 (100.00%)
         occurrences all number
    4
    Pain
    Additional description: Pain at biopsy site
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Feeling abnormal
    Additional description: feeling faint
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 3 (100.00%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Urine abnormality
    Additional description: Dark urine
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Headache
         subjects affected / exposed
    3 / 3 (100.00%)
         occurrences all number
    4
    Pain
         subjects affected / exposed
    3 / 3 (100.00%)
         occurrences all number
    10
    Muscular weakness
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hunger
    Additional description: Loss of appetite
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Apr 2012
    Substantial amendment to temporarily halt recruitment as a result of notification of urgent safety measure .
    16 May 2012
    Substantial amendment to reduce the dose from 800mg to 600mg.
    06 Mar 2013
    Substantial amendment primarily to the statistical section reducing the sample size.
    14 Aug 2013
    Substantial amendment to reflect an update to the SmPC and the addition of a PIC recruitment process.

    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.
    Study was terminated early due to a failure to recruit sufficient participants.
    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.

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