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    Clinical Trial Results:
    A Phase 2, multicenter, open-label study of BGJ398 in patients with recurrent resectable or unresectable glioblastoma

    Summary
    EudraCT number
    		 2013-002200-13
    Trial protocol
    		 IT   NL   ES   BE   DE  
    Global end of trial date
    03 Oct 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    BGJ398X2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01975701
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    clinical disclosure office, Novartis Pharma, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Study Director, Novartis Pharmaceuticals, 41 613241111, novartis.email@novartis.com
    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
    03 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    the main objective for this trial was to assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1,2 or 3, based on progression-free survival rate at 6 month (PFS6)
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the 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
    09 Dec 2013
    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
    Belgium: 1
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Switzerland: 3
    Country: Number of subjects enrolled
    United States: 16
    Worldwide total number of subjects
    26
    EEA total number of subjects
    7
    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)
    21
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All 26 patients included were enrolled in the non Surgical arm. Note : Australia participated in this trial, however no patients received treatment.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 26
    Number of subjects completed
    		 26

    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
    		 BGJ398 non surgical
    Arm description
    		 125 mg BGJ398 non surgical
    Arm type
    		 experimental

    Investigational medicinal product name
    BGJ398
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    BGJ398 25 mg BGJ398 100 mg hard gelatin capsules for oral use

    Number of subjects in period 1
    		BGJ398 non surgical
    Started
    26
    Completed
    1
    Not completed
    25
         Adverse event, serious fatal
    23
         Physician decision
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BGJ398 non surgical
    Reporting group description
    		 125 mg BGJ398 non surgical

    Reporting group values
    		 BGJ398 non surgical Total
    Number of subjects
    		 26 26
    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)
    		 21 21
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.7 ( 13.59 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 10 10
        Male
    		 16 16
    Race/Ethnicity, Customized
    Units: Subjects
        caucasian
    		 26 26

    End points

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    End points reporting groups
    Reporting group title
    BGJ398 non surgical
    Reporting group description
    		 125 mg BGJ398 non surgical

    Primary: progression free survival

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    End point title
    		 progression free survival [1]
    End point description
    To assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3 based on PFS6 (PFS rate at 6 months as defined by RANO criteria as assessed by the investigator)
    End point type
    Primary
    End point timeframe
    6 months
    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: no Analysis was performed
    End point values
    		 BGJ398 non surgical
    Number of subjects analysed
    24
    Units: months
        median (confidence interval 95%)
    1.7 (1.05 to 2.80)
    No statistical analyses for this end point

    Secondary: Overall response rate

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    End point title
    		 Overall response rate
    End point description
    To further assess the anti-tumor activity of BGJ398 for patients with GBM with an amplification, translocation, or activating mutation in FGFR1,2,3 or 4, based on Objective Response Rate (ORR - patients with measurable disease - as defined by RANO criteria as assessed by the investigator
    End point type
    Secondary
    End point timeframe
    8 months after last patient last visit
    End point values
    		 BGJ398 non surgical
    Number of subjects analysed
    26
    Units: participants
        partial response
    2
        stable disease
    7
        progressive disease
    13
        unknown
    3
        missing
    1
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    To further assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 and 3 based on Overall Survival
    End point type
    Secondary
    End point timeframe
    8 months after LPLV
    End point values
    		 BGJ398 non surgical
    Number of subjects analysed
    26
    Units: months
        median (confidence interval 95%)
    6.74 (4.17 to 11.73)
    No statistical analyses for this end point

    Secondary: safety and tolerability

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    End point title
    		 safety and tolerability
    End point description
    Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values
    End point type
    Secondary
    End point timeframe
    8 months after LPLV
    End point values
    		 BGJ398 non surgical
    Number of subjects analysed
    26
    Units: participants
        participants with dose interruptions
    13
        participants with dose reductions
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    5 years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    All@Patients
    Reporting group description
    		 All@Patients

    Reporting group title
    Non Surg BGJ398@125 mg
    Reporting group description
    		 Non Surg BGJ398@125 mg

    Serious adverse events
    		 All@Patients Non Surg BGJ398@125 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 26 (34.62%)
    9 / 26 (34.62%)
         number of deaths (all causes)
    3
    3
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Decreased appetite
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cataract operation
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological decompensation
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Neurological symptom
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperphosphataemia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All@Patients Non Surg BGJ398@125 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 26 (100.00%)
    26 / 26 (100.00%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    4
    4
    Fatigue
         subjects affected / exposed
    9 / 26 (34.62%)
    9 / 26 (34.62%)
         occurrences all number
    9
    9
    Gait disturbance
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         occurrences all number
    3
    3
    Mucosal inflammation
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    5
    5
    Oedema peripheral
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         occurrences all number
    3
    3
    Cyst
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Pain
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Bartholin's cyst
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    2
    2
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Epistaxis
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    4
    4
    Oropharyngeal pain
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    3
    3
    Hiccups
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Nasal inflammation
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Sinus congestion
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Confusional state
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Depression
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Insomnia
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 26 (15.38%)
         occurrences all number
    4
    4
    Agitation
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Investigations
    Thrombocytopenia
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         occurrences all number
    3
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         occurrences all number
    4
    4
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Leukopenia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    3
    3
    Neutropenia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Amylase increased
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Blood bilirubin increased
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    2
    2
    Weight decreased
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    White blood cell count decreased
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    3
    3
    Traumatic haematoma
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         occurrences all number
    3
    3
    Dizziness
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Headache
         subjects affected / exposed
    6 / 26 (23.08%)
    6 / 26 (23.08%)
         occurrences all number
    6
    6
    Hemiparesis
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Memory impairment
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Seizure
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 26 (15.38%)
         occurrences all number
    4
    4
    Somnolence
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Tremor
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Anosmia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Ataxia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Cognitive disorder
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Dysaesthesia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Dysgeusia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Facial paresis
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Hemianopia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Horner's syndrome
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Paraesthesia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         occurrences all number
    3
    3
    Eye disorders
    Dry eye
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         occurrences all number
    3
    3
    Eyelid ptosis
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Cataract
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    2
    2
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Corneal infiltrates
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Eye irritation
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Keratopathy
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    2
    2
    Ocular hyperaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    7 / 26 (26.92%)
    7 / 26 (26.92%)
         occurrences all number
    8
    8
    Diarrhoea
         subjects affected / exposed
    8 / 26 (30.77%)
    8 / 26 (30.77%)
         occurrences all number
    11
    11
    Dyspepsia
         subjects affected / exposed
    7 / 26 (26.92%)
    7 / 26 (26.92%)
         occurrences all number
    7
    7
    Stomatitis
         subjects affected / exposed
    5 / 26 (19.23%)
    5 / 26 (19.23%)
         occurrences all number
    10
    10
    Aphthous ulcer
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Dry mouth
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Gastritis
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Glossodynia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Haematochezia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Lip dry
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Lip pain
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Odynophagia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Oral disorder
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Oral pain
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 26 (15.38%)
         occurrences all number
    4
    4
    Dermatitis acneiform
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Dry skin
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 26 (15.38%)
         occurrences all number
    5
    5
    Nail disorder
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Onycholysis
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         occurrences all number
    6
    6
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         occurrences all number
    4
    4
    Skin ulcer
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Blister
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Dermatitis bullous
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Erythema
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Hyperkeratosis
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    2
    2
    Hypertrichosis
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Nail dystrophy
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Onychalgia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    2
    2
    Rash maculo-papular
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Skin disorder
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Skin exfoliation
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Skin irritation
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Xeroderma
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 26 (15.38%)
         occurrences all number
    4
    4
    Chromaturia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    4
    4
    Muscular weakness
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 26 (15.38%)
         occurrences all number
    6
    6
    Musculoskeletal pain
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Myalgia
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Pain in extremity
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         occurrences all number
    4
    4
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Oral candidiasis
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Folliculitis
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    2
    2
    Herpes simplex
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Hordeolum
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Lip infection
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Oral herpes
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Paronychia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Pharyngitis
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Rash pustular
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Rhinitis
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Wound infection
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 26 (15.38%)
         occurrences all number
    4
    4
    Hyperglycaemia
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         occurrences all number
    5
    5
    Hyperlipasaemia
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 26 (15.38%)
         occurrences all number
    5
    5
    Hyperphosphataemia
         subjects affected / exposed
    20 / 26 (76.92%)
    20 / 26 (76.92%)
         occurrences all number
    43
    43
    Hyponatraemia
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    4
    4
    Hypophosphataemia
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 26 (15.38%)
         occurrences all number
    11
    11
    Hypercalcaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Hypercreatininaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    2
    2
    Hyperkalaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Hypernatraemia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Hyperuricaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    3
    3
    Hypokalaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Aug 2014
    exclusion criteria were updated to exclude patients with current evidence of corneal/keratopathy or retinal disorder, ophthalmologic eye exam assessments were added, patients with clinically significant hypokalemia were excluded
    01 Apr 2015
    Inclusion/Exclusion criteria were modified to exclude patients with FGFR1, 2, 3, and 4 amplifications and to include GBM and/or other glioma subtype patients with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutations in FGFR1, 2 or 3 gene.

    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.
    decision was made not to pursue further development for this disease indication. BGJ398 was out licensed and the indication was no longer pursued. Remaining patient continued treatment in post-trial settings.
    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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