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   43871   clinical trials with a EudraCT protocol, of which   7290   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:
    A Phase Ib/II, open-label, multicenter trial with oral cMET inhibitor INC280 alone and in combination with erlotinib versus platinum/pemetrexed in adult patients with EGFR mutated, cMET-amplified, locally advanced/metastatic non-small cell lung cancer (NSCLC) with acquired resistance to prior EGFR tyrosine kinase inhibitor (EGFR TKI)

    Summary
    EudraCT number
    		 2015-001241-84
    Trial protocol
    		 ES   HU   NL   BE   FR   GB   PT   IT  
    Global end of trial date
    05 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Dec 2019
    First version publication date
    20 Dec 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CINC280B2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02468661
    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 6133241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma, AG, +41 6133241111, 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
    05 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Dec 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine MTD and/or RP2D of INC280 in combination with erlotinib
    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
    23 Sep 2015
    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
    France: 4
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Singapore: 4
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    23
    EEA total number of subjects
    13
    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)
    18
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 23 subjects were enrolled in the phase I part of the study and the study was terminated prior to opening of the randomized phase.

    Pre-assignment
    Screening details
    		 23 subjects were enrolled in the phase I part of the study and the study was terminated prior to opening of the randomized phase.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 INC280 200mg BID + ERL 150mg QD
    Arm description
    		 Subjects who received 200mg of INC280 twice daily (BID) and erlotinib 150mg once daily (QD)
    Arm type
    		 Experimental

    Investigational medicinal product name
    capmatinib
    Investigational medicinal product code
    INC280
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Capmatinib comes in 100 mg, 150mg, 200 mg dose taken twice daily (BID)

    Investigational medicinal product name
    erlotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Erlotinib comes in 25 mg, 100mg, 150 mg and is taken once daily.

    Arm title
    		 INC280 400mg BID + ERL 150mg QD
    Arm description
    		 Subjects who received 400mg of INC280 twice daily (BID) and erlotinib 150mg once daily (QD)
    Arm type
    		 Experimental

    Investigational medicinal product name
    capmatinib
    Investigational medicinal product code
    INC280
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Capmatinib comes in 100 mg, 150mg, 200 mg dose taken twice daily (BID)

    Investigational medicinal product name
    erlotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Erlotinib comes in 25 mg, 100mg, 150 mg and is taken once daily.

    Number of subjects in period 1
    		INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Started
    7
    16
    Completed
    0
    0
    Not completed
    7
    16
         Adverse event, serious fatal
    -
    2
         Physician decision
    -
    1
         Adverse event, non-fatal
    -
    3
         Progressive disease
    7
    8
         Subject/guardian decision
    -
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    INC280 200mg BID + ERL 150mg QD
    Reporting group description
    		 Subjects who received 200mg of INC280 twice daily (BID) and erlotinib 150mg once daily (QD)

    Reporting group title
    INC280 400mg BID + ERL 150mg QD
    Reporting group description
    		 Subjects who received 400mg of INC280 twice daily (BID) and erlotinib 150mg once daily (QD)

    Reporting group values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD Total
    Number of subjects
    		 7 16 23
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 7 11 18
        From 65-84 years
    		 0 5 5
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.7 ± 8.50 58.6 ± 11.38 -
    Gender Categorical
    Units: Subjects
        Female
    		 5 10 15
        Male
    		 2 6 8

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    INC280 200mg BID + ERL 150mg QD
    Reporting group description
    		 Subjects who received 200mg of INC280 twice daily (BID) and erlotinib 150mg once daily (QD)

    Reporting group title
    INC280 400mg BID + ERL 150mg QD
    Reporting group description
    		 Subjects who received 400mg of INC280 twice daily (BID) and erlotinib 150mg once daily (QD)

    Subject analysis set title
    DDS: INC280 200mg BID + ERL 150mg QD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Dose determining set

    Subject analysis set title
    DDS: INC280 400mg BID + ERL 150mg QD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Dose Determining Set

    Primary: Dose Limiting Toxicities (DLTs)

    		 Close Top of page
    End point title
    		 Dose Limiting Toxicities (DLTs) [1]
    End point description
    Dose limiting toxicity (DLT): an adverse event (AE) or abnorm. lab. val. assessed as unrelated to disease, disease prog., inter-current illness, or concom. meds that occurs within 1st 28 days of treatmnt with INC280 in comb. with erlotinib during dose escalation (DE) part of study & meets any of the National Cancer Institute Common Terminology Criteria for AEs ver. 4.03 used for all grading. For purpose of DE, DLTs were consid. & incl. in BLRM. *1 subject’s AEs fatigue, peripheral oedema & abnorm. blood TSH (all grade 1), were not in line with DLT def. as documented in CSR & occurred after DLT period (cycle 1). **1 subj. wasn’t incl. in DDS population. At time of DE BLRM analysis cutoff, subj. was considered not evaluable since they didn’t start study treatmnt & therefore not includ. in analysis. On Day 15 subj. dev. grd 3 dry skin & didn’t receive any concomit. med. for this toxicity. Subj. decided not to cont. clinical trial; Investig. considered this event clin. significant as DLT
    End point type
    Primary
    End point timeframe
    28 days
    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 statistical analysis was planned for this endpoint.
    End point values
    		 DDS: INC280 200mg BID + ERL 150mg QD DDS: INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    4
    12
    Units: subjects
        Any primary system organ class**
    0
    4
        Gen. disorders & admin site conditns: fatigue
    0
    1
        Gen disorders& admin site conds:Oedema peripheral*
    0
    1
        Infections & infestations: Rash pustular
    0
    1
        Investigations: Alanine aminotransferase increased
    0
    1
        Investigatns: Aspartate aminotransferase increased
    0
    1
        Investigatns: Blood thyroid stim. hormone abnormal
    0
    1
        Resp. thoracic & mediastinal disorders:Pneumonitis
    0
    1
        Skin & subcutaneous tissue disorders: rash
    0
    1
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR)

    		 Close Top of page
    End point title
    		 Overall Response Rate (ORR)
    End point description
    ORR is the percentage of subjects with a best overall response of complete response or partial response (CR+PR). CR: PR:
    End point type
    Secondary
    End point timeframe
    Provide time frame
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: percentage of subjects
        number (confidence interval 95%)
    42.9 (9.90 to 81.59)
    18.8 (4.05 to 45.65)
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR)

    		 Close Top of page
    End point title
    		 Disease Control Rate (DCR)
    End point description
    DCR is the percentage of subjects with best overall response of complete response, partial response of stable disease (CR, PR or SD). CR: PR: SD:
    End point type
    Secondary
    End point timeframe
    Provide time frame
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: percentage of subjects
        number (confidence interval 95%)
    42.9 (9.90 to 81.59)
    68.8 (41.34 to 88.98)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

    		 Close Top of page
    End point title
    		 Duration of Response (DOR)
    End point description
    DOR is defined as time from the first documented CR or PR to first documented progression or death due to any cause.
    End point type
    Secondary
    End point timeframe
    provide time frame
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: days
    136
    304
    No statistical analyses for this end point

    Secondary: INC280 Pharmacokinetics (PK) parameter: AUCinf, AUClast

    		 Close Top of page
    End point title
    		 INC280 Pharmacokinetics (PK) parameter: AUCinf, AUClast
    End point description
    AUCinf: The area under the plasma concentration-time curve extrapolated to infinity(ng*hr/mL) AUClast: The AUC from time zero to the last measurable concentration
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1, Cycle 1 Day 15
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: ng*hr/mL
    geometric mean (geometric coefficient of variation)
        AUCinf: D1C1 (n = 4, 7)
    10200 ± 47.4
    21700 ± 50.8
        AUCinf: D1C15 (n = 5, 6)
    14700 ± 35.9
    35800 ± 20.7
        AUClast: D1C1
    10400 ± 40.0
    21400 ± 47.9
        AUClast: D1C15 (n = 6, 12)
    9450 ± 88.0
    28200 ± 37.7
    No statistical analyses for this end point

    Secondary: INC280 PK parameter: Cmax

    		 Close Top of page
    End point title
    		 INC280 PK parameter: Cmax
    End point description
    Cmax: The observed maximum plasma concentration following administration (ng/mL)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1, Cycle 1 Day 15
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        C1D1
    2590 ± 40.2
    5720 ± 47.3
        C1D15 (7, 13)
    3070 ± 108.3
    7760 ± 41.5
    No statistical analyses for this end point

    Secondary: INC280 PK parameter: Tmax, T1/2

    		 Close Top of page
    End point title
    		 INC280 PK parameter: Tmax, T1/2
    End point description
    Tmax: The time to reach peak or maximum concentration (hr) T1/2: Elimination half-life determined as 0.693/lambda_z (hr)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1, Cycle 1 Day 15
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: hour (hr)
    median (full range (min-max))
        Tmax: C1D1
    1.00 (0.933 to 4.00)
    1.08 (0.5 to 6.05)
        Tmax: C1D15 (n = 7, 13)
    2.00 (1.00 to 4.00)
    1.05 (0.5 to 2.12)
        T1/2: C1D1 n= (4, 7)
    2.56 (2.26 to 2.71)
    2.66 (2.46 to 3.06)
        T1/2: C1D15 (n= 5, 6)
    2.65 (2.22 to 2.98)
    2.73 (1.85 to 3.85)
    No statistical analyses for this end point

    Secondary: INC280 PK parameter: CL/F:

    		 Close Top of page
    End point title
    		 INC280 PK parameter: CL/F:
    End point description
    CL/F: The apparent total body clearance from plasma (L/hr)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: L/hr
    geometric mean (geometric coefficient of variation)
        C1D1 (n = 4, 7)
    19.6 ± 47.4
    18.5 ± 50.8
    No statistical analyses for this end point

    Secondary: INC280 PK parameter: Vz_F_obs

    		 Close Top of page
    End point title
    		 INC280 PK parameter: Vz_F_obs
    End point description
    Vz/F: The apparent volume of distribution during the terminal elimination phase (L)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: Litres (L)
    geometric mean (geometric coefficient of variation)
        Vz_F_obs (n = 4, 7)
    70.9 ± 47.7
    72.0 ± 48.8
    No statistical analyses for this end point

    Secondary: INC280 PK parameter: AUCtau

    		 Close Top of page
    End point title
    		 INC280 PK parameter: AUCtau
    End point description
    AUCtau: The AUC within the dosing interval (tau) (mass x time x volume-1)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: ng*hr/mL
    geometric mean (geometric coefficient of variation)
        C1D15 (n = 5, 6)
    14000 ± 37.1
    33800 ± 19.6
    No statistical analyses for this end point

    Secondary: INC280 PK parameter: Vz/F

    		 Close Top of page
    End point title
    		 INC280 PK parameter: Vz/F
    End point description
    Vz/F: The apparent volume of distribution during the terminal elimination phase (L)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: Litres (L)
    geometric mean (geometric coefficient of variation)
        C1D15 (n = 5, 6)
    54.0 ± 48.8
    45.3 ± 38.5
    No statistical analyses for this end point

    Secondary: INC280 PK parameter: CLss/F

    		 Close Top of page
    End point title
    		 INC280 PK parameter: CLss/F
    End point description
    CL/F: The apparent total body clearance from plasma (L/hr)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: L/hr
    geometric mean (geometric coefficient of variation)
        C1D15 ( n = 5, 6)
    14.3 ± 37.1
    11.3 ± 25.0
    No statistical analyses for this end point

    Secondary: INC280 PK parameter: Racc

    		 Close Top of page
    End point title
    		 INC280 PK parameter: Racc
    End point description
    Racc: Accumulation ratio
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: ratio
    geometric mean (geometric coefficient of variation)
        C1D15 ( n = 6, 12)
    0.979 ± 92.2
    1.58 ± 37.8
    No statistical analyses for this end point

    Secondary: Erlotinib Pharmacokinetics (PK) parameter: AUClast

    		 Close Top of page
    End point title
    		 Erlotinib Pharmacokinetics (PK) parameter: AUClast
    End point description
    AUClast: The AUC from time zero to the last measurable concentration
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1, Cycle 1 Day 15
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: ng*hr/mL
    geometric mean (geometric coefficient of variation)
        C1D1
    18800 ± 43.5
    14700 ± 51.4
        C1D15 (n = 5, 12)
    20100 ± 59.6
    21700 ± 45.3
    No statistical analyses for this end point

    Secondary: Erlotinib PK parameter: Cmax

    		 Close Top of page
    End point title
    		 Erlotinib PK parameter: Cmax
    End point description
    Cmax: The observed maximum plasma concentration following administration (ng/mL)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1, Cycle 1 Day 15
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        C1D1
    1140 ± 40.5
    984 ± 38.3
        C1D15 (n = 6, 13)
    1510 ± 52.4
    1460 ± 44.7
    No statistical analyses for this end point

    Secondary: Erlotinib PK parameter: Tmax

    		 Close Top of page
    End point title
    		 Erlotinib PK parameter: Tmax
    End point description
    Tmax: The time to reach peak or maximum concentration (hr)
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1, Cycle 1 Day 15
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: hour (hr)
    median (full range (min-max))
        C1D1
    2.15 (1.00 to 23.9)
    2.24 (1.00 to 23.4)
        C1D1 (n = 6, 13)
    4.07 (1.00 to 23.1)
    2.00 (1.00 to 3.97)
    No statistical analyses for this end point

    Secondary: Erlotinib PK parameter: Racc

    		 Close Top of page
    End point title
    		 Erlotinib PK parameter: Racc
    End point description
    Racc: Accumulation ratio
    End point type
    Secondary
    End point timeframe
    Cycl1 1 Day 15
    End point values
    		 INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD
    Number of subjects analysed
    7
    16
    Units: ratio
    geometric mean (geometric coefficient of variation)
        C1D15 (n = 5, 12)
    1.21 ± 115.5
    1.55 ± 47.1
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    INC280 200mg BID + ERL 150mg QD
    Reporting group description
    		 Subjects who received 200mg of INC280 twice daily (BID) and erlotinib 150mg once daily (QD)

    Reporting group title
    All subjects
    Reporting group description
    		 Total number of subjects enrolled in the study

    Reporting group title
    INC280 400mg BID + ERL 150mg QD
    Reporting group description
    		 Subjects who received 400mg of INC280 twice daily (BID) and erlotinib 150mg once daily (QD)

    Serious adverse events
    		 INC280 200mg BID + ERL 150mg QD All subjects INC280 400mg BID + ERL 150mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
    11 / 23 (47.83%)
    5 / 16 (31.25%)
         number of deaths (all causes)
    0
    2
    2
         number of deaths resulting from adverse events
    0
    1
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    Pulmonary embolism
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Infectious pleural effusion
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Streptococcal sepsis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 INC280 200mg BID + ERL 150mg QD All subjects INC280 400mg BID + ERL 150mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    23 / 23 (100.00%)
    16 / 16 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Tumour pain
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Hypertension
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Hypotension
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Venous thrombosis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 7 (0.00%)
    4 / 23 (17.39%)
    4 / 16 (25.00%)
         occurrences all number
    0
    5
    5
    Face oedema
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Fatigue
         subjects affected / exposed
    1 / 7 (14.29%)
    4 / 23 (17.39%)
    3 / 16 (18.75%)
         occurrences all number
    1
    7
    6
    Influenza like illness
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Injection site reaction
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Malaise
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Oedema
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 7 (28.57%)
    8 / 23 (34.78%)
    6 / 16 (37.50%)
         occurrences all number
    2
    11
    9
    Pyrexia
         subjects affected / exposed
    3 / 7 (42.86%)
    6 / 23 (26.09%)
    3 / 16 (18.75%)
         occurrences all number
    3
    7
    4
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Cough
         subjects affected / exposed
    2 / 7 (28.57%)
    5 / 23 (21.74%)
    3 / 16 (18.75%)
         occurrences all number
    2
    6
    4
    Dyspnoea
         subjects affected / exposed
    3 / 7 (42.86%)
    4 / 23 (17.39%)
    1 / 16 (6.25%)
         occurrences all number
    3
    4
    1
    Epistaxis
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 23 (8.70%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    1
    Haemoptysis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    2
    Pleural effusion
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Pneumonitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Productive cough
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Pulmonary embolism
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 23 (8.70%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    1
    Respiratory tract irritation
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Sinus disorder
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Confusional state
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Depression
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Irritability
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 23 (13.04%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    2
    Amylase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 23 (8.70%)
    1 / 16 (6.25%)
         occurrences all number
    1
    8
    7
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 23 (8.70%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 23 (13.04%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    2
    Blood bilirubin increased
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 23 (13.04%)
    3 / 16 (18.75%)
         occurrences all number
    0
    3
    3
    Blood thyroid stimulating hormone abnormal
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 7 (28.57%)
    4 / 23 (17.39%)
    2 / 16 (12.50%)
         occurrences all number
    2
    5
    3
    Lipase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    3
    3
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    N-terminal prohormone brain natriuretic peptide increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 23 (8.70%)
    1 / 16 (6.25%)
         occurrences all number
    2
    3
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Weight decreased
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 23 (13.04%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    2
    Weight increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    White blood cell count decreased
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Rib fracture
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Palpitations
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Balance disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 23 (13.04%)
    3 / 16 (18.75%)
         occurrences all number
    0
    3
    3
    Dizziness
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Head discomfort
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Headache
         subjects affected / exposed
    0 / 7 (0.00%)
    4 / 23 (17.39%)
    4 / 16 (25.00%)
         occurrences all number
    0
    5
    5
    Neuropathy peripheral
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Paraesthesia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Somnolence
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Tremor
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Visual field defect
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 23 (8.70%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    1
    Lymphopenia
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 23 (8.70%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    1
    Neutropenia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Deafness neurosensory
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Tinnitus
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Vertigo
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Cataract nuclear
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Dry eye
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 23 (8.70%)
    0 / 16 (0.00%)
         occurrences all number
    2
    2
    0
    Eye irritation
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Eye pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Keratitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Periorbital oedema
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Vision blurred
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 23 (8.70%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 7 (28.57%)
    5 / 23 (21.74%)
    3 / 16 (18.75%)
         occurrences all number
    2
    6
    4
    Abdominal pain upper
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    3
    3
    Abnormal faeces
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Cheilitis
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Constipation
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 23 (13.04%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    2
    Diarrhoea
         subjects affected / exposed
    2 / 7 (28.57%)
    13 / 23 (56.52%)
    11 / 16 (68.75%)
         occurrences all number
    2
    15
    13
    Dry mouth
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Dysphagia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Inguinal hernia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Nausea
         subjects affected / exposed
    5 / 7 (71.43%)
    11 / 23 (47.83%)
    6 / 16 (37.50%)
         occurrences all number
    5
    15
    10
    Stomatitis
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 23 (13.04%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    2
    Vomiting
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 23 (13.04%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    2
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Dermatitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    2
    Dermatitis acneiform
         subjects affected / exposed
    2 / 7 (28.57%)
    6 / 23 (26.09%)
    4 / 16 (25.00%)
         occurrences all number
    3
    7
    4
    Dry skin
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Erythema
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    3
    3
    Hyperhidrosis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Night sweats
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Onychalgia
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Onychoclasis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Pigmentation disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Pruritus
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Rash
         subjects affected / exposed
    2 / 7 (28.57%)
    10 / 23 (43.48%)
    8 / 16 (50.00%)
         occurrences all number
    2
    19
    17
    Rash follicular
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    2
    Rash maculo-papular
         subjects affected / exposed
    4 / 7 (57.14%)
    5 / 23 (21.74%)
    1 / 16 (6.25%)
         occurrences all number
    4
    5
    1
    Rash papular
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Skin disorder
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Skin ulcer
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    2
    Renal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 23 (13.04%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    2
    Flank pain
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Joint range of motion decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Limb discomfort
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Muscle fatigue
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Muscle spasms
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Muscular weakness
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Neck pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Pain in extremity
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 23 (8.70%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    1
    Tendon disorder
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Vertebral lesion
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Cystitis
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Erysipelas
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    3
    3
    Folliculitis
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 23 (8.70%)
    1 / 16 (6.25%)
         occurrences all number
    1
    4
    3
    Fungal skin infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Groin infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Influenza
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Oral fungal infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Paronychia
         subjects affected / exposed
    2 / 7 (28.57%)
    4 / 23 (17.39%)
    2 / 16 (12.50%)
         occurrences all number
    2
    5
    3
    Pneumonia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Rash pustular
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 23 (8.70%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Rhinitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Skin infection
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 23 (4.35%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 23 (8.70%)
    0 / 16 (0.00%)
         occurrences all number
    2
    2
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    4 / 23 (17.39%)
    3 / 16 (18.75%)
         occurrences all number
    1
    4
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 7 (42.86%)
    10 / 23 (43.48%)
    7 / 16 (43.75%)
         occurrences all number
    3
    10
    7
    Hyperuricaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 23 (13.04%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    2
    Hypocalcaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    6 / 23 (26.09%)
    5 / 16 (31.25%)
         occurrences all number
    1
    9
    8
    Hypomagnesaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 23 (4.35%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 23 (8.70%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    1
    Hypophosphataemia
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 23 (8.70%)
    0 / 16 (0.00%)
         occurrences all number
    2
    2
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2015
    The main purpose of this protocol amendment was to optimize the subject safety and toxicity monitoring and to align Novartis study protocols.
    27 Oct 2017
    The main purpose of this amendment was to introduce the new dosage strength of INC280 150mg oral tablets were used to administer doses of 300mg (150mg x2) INC280 to ensure continuity of treatment. The INC280 100mg oral tablets would no longer be manufactured to support a dose of 300mg required for dose reductions from the 400mg starting dose.

    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
    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-Fri May 03 17:45:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA