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    Clinical Trial Results:
    A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)

    Summary
    EudraCT number
    		 2010-018418-53
    Trial protocol
    		 FR   NL   HU   DE  
    Global end of trial date
    07 May 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    01 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CSTI571A2110
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01066468
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000463-PIP01-08
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 May 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2011
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to characterize the pharmacokinetics (PK) of imatinib in pediatric subjects of age 1 to less than (<) 4 years using appropriate integrated physiologically-based pharmacokinetic (PBPK) and population PK approaches.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Oct 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
    Canada: 1
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    3
    EEA total number of subjects
    0
    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)
    3
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 3 centres in 3 countries.

    Pre-assignment
    Screening details
    		 Only 3 subjects were enrolled into the study.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was a non-randomized, open-label study, hence no blinding was performed.

    Arms
    Arm title
    		 Imatinib
    Arm description
    		 Subjects received imatinib once daily orally in dose ranging from 260 milligrams per square metre (mg/m^2) to 340 mg/m^2. Lower dose of imatinib (60 mg/m^2/day) was allowed at the discretion of investigator.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imatinib
    Investigational medicinal product code
    STI571
    Other name
    Pharmaceutical forms
    Coated tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Imatinib mesylate oral suspension (260-320 mg/m^2) was administered once daily

    Number of subjects in period 1
    		Imatinib
    Started
    3
    Completed
    3

    Baseline characteristics

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

    Reporting group values
    		 Overall Total
    Number of subjects
    		 3 3
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 3 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 2.7 ± 0.58 -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Imatinib
    Reporting group description
    		 Subjects received imatinib once daily orally in dose ranging from 260 milligrams per square metre (mg/m^2) to 340 mg/m^2. Lower dose of imatinib (60 mg/m^2/day) was allowed at the discretion of investigator.

    Primary: Pharmacokinetic parameters of Imatinib

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    End point title
    		 Pharmacokinetic parameters of Imatinib [1]
    End point description
    This study was discontinued early due to the lack of patient population and accrual. Due to scarcity of PK data, planned non-compartmental analysis was not done. Only listings on 3 patients were completed.
    End point type
    Primary
    End point timeframe
    Predose (0 hour), 1-2 hours, 2-4 hours, 6-24 hours post-dose at steady state
    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: Only descriptive summary statistics was planned for this outcome measure for each subject.
    End point values
    		 Imatinib
    Number of subjects analysed
    0 [2]
    Units: Not Applicable
        number (not applicable)
    Notes
    [2] - Lack of data from incomplete enrollment prevents the representation of any summary statistics
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until Last Subject Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Imatinib
    Reporting group description
    		 Subjects received imatinib once daily orally in dose ranging from 260 mg/m^2 to 340 mg/m^2. Lower dose of imatinib (60 mg/m^2/day) was allowed at the discretion of investigator.

    Serious adverse events
    		 Imatinib
    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
    		 Imatinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2010
    Study inclusion criteria was broadened to allow subjects with other imatinib indicated hematological disorders (i.e. myelodysplastic/myeloproliferative neoplasms, hypereosinophilic syndrome and chronic eosinophilic leukemia). This amendment also allowed the imatinib dose as low as 60 mg/m^2/day below the dose range of 260 mg/m^2 to 340 mg/m^2 (as defined in the original protocol) to ensure an acceptable safety profile and clinical benefit at the treating physician’s discretion and with approval by the Novartis clinical trial team.

    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.
    The study was discontinued early due to the lack of subject population and accrual. Due to the rarity of the disease in children (1-4 years), minimum enrollment (10 subjects) was not met.
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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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