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    Clinical Trial Results:
    A Phase 2 Study of Futibatinib in Patients With Specific FGFR Aberrations

    Summary
    EudraCT number
    		 2019-004084-49
    Trial protocol
    		 SE   GB   NL   FR   BE   PT   IT  
    Global end of trial date
    11 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TAS-120-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04189445
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Taiho Oncology, Inc.
    Sponsor organisation address
    101 Carnegie Center, Suite 101, Princeton, New Jersey, United States, 08540
    Public contact
    Senior Study Manager, Taiho Oncology, Inc., +1 844-878-2446, medicalinformation@taihooncology.com
    Scientific contact
    Senior Study Manager, Taiho Oncology, Inc., +1 844-878-2446, medicalinformation@taihooncology.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
    11 Nov 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Cohorts A and B: The primary objective was to evaluate the objective response rate (ORR) in subjects with solid tumors harboring FGFR rearrangements or gastric cancer (including GEJ cancer) harboring FGFR2 amplifications based on independent central review of radiologic images (IRC). Cohort C: The overall objective of Cohort C was to assess the clinical activity of futibatinib as monotherapy in the treatment of subjects with myeloid/lymphoid neoplasms (MLN) harboring FGFR1 rearrangements.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Aug 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 26
    Country: Number of subjects enrolled
    Korea, Republic of: 27
    Country: Number of subjects enrolled
    France: 15
    Country: Number of subjects enrolled
    United States: 12
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Türkiye: 4
    Country: Number of subjects enrolled
    Singapore: 6
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Germany: 1
    Worldwide total number of subjects
    115
    EEA total number of subjects
    34
    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)
    71
    From 65 to 84 years
    44
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects took part in the study from 05 August 2020 to 11 November 2024.

    Pre-assignment
    Screening details
    		 A total of 115 subjects were enrolled in Cohort A and Cohort B to receive futibatinib. As no subjects were enrolled in Cohort C, data was not collected for any of the pre-specified primary and secondary endpoints for Cohort C and hence not included in the results.

    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
    		 Futibatinib (Cohort A)
    Arm description
    		 Subjects with advanced or metastatic solid tumors harboring fibroblast growth factor receptor (FGFR)1-4 rearrangements received futibatinib 20 milligrams (mg), oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Futibatinib
    Investigational medicinal product code
    TAS-120
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Futibatinib at an oral dose of 20 mg, administered once a day, on a continuous 28-day cycle.

    Arm title
    		 Futibatinib (Cohort B)
    Arm description
    		 Subjects with advanced or metastatic solid gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Futibatinib
    Investigational medicinal product code
    TAS-120
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Futibatinib at an oral dose of 20 mg, administered once a day, on a continuous 28-day cycle.

    Number of subjects in period 1
    		Futibatinib (Cohort A) Futibatinib (Cohort B)
    Started
    87
    28
    Completed
    0
    0
    Not completed
    87
    28
         Consent withdrawn by subject
    8
    1
         Death
    54
    24
         Study Terminated by Sponsor
    25
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Futibatinib (Cohort A)
    Reporting group description
    		 Subjects with advanced or metastatic solid tumors harboring fibroblast growth factor receptor (FGFR)1-4 rearrangements received futibatinib 20 milligrams (mg), oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.

    Reporting group title
    Futibatinib (Cohort B)
    Reporting group description
    		 Subjects with advanced or metastatic solid gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.

    Reporting group values
    		 Futibatinib (Cohort A) Futibatinib (Cohort B) Total
    Number of subjects
    		 87 28 115
    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)
    		 53 18 71
        From 65-84 years
    		 34 10 44
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.0 ( 12.47 ) 55.6 ( 13.77 ) -
    Gender categorical
    Units: Subjects
        Female
    		 47 16 63
        Male
    		 40 12 52
    Race
    Units: Subjects
        Caucasian/White
    		 29 3 32
        Black or African American
    		 1 0 1
        Asian
    		 36 24 60
        Other
    		 1 0 1
        Unknown
    		 20 1 21
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 1 4
        Not Hispanic or Latino
    		 62 26 88
        Unknown
    		 22 1 23

    End points

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    End points reporting groups
    Reporting group title
    Futibatinib (Cohort A)
    Reporting group description
    		 Subjects with advanced or metastatic solid tumors harboring fibroblast growth factor receptor (FGFR)1-4 rearrangements received futibatinib 20 milligrams (mg), oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.

    Reporting group title
    Futibatinib (Cohort B)
    Reporting group description
    		 Subjects with advanced or metastatic solid gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.

    Primary: Objective Response Rate (ORR) Based on Independent Central Review (IRC)

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    End point title
    		 Objective Response Rate (ORR) Based on Independent Central Review (IRC) [1]
    End point description
    ORR was defined as the percentage of subjects experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on IRC of radiological images. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place. All treated population included all subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    At the end of every 2 cycles until disease progression (Up to 31 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: Only descriptive statistics is provided for this end point.
    End point values
    		 Futibatinib (Cohort A) Futibatinib (Cohort B)
    Number of subjects analysed
    87
    28
    Units: percentage of subjects
        number (confidence interval 95%)
    6.9 (2.6 to 14.4)
    17.9 (6.1 to 36.9)
    No statistical analyses for this end point

    Secondary: ORR Based on Investigator Assessment

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    End point title
    		 ORR Based on Investigator Assessment
    End point description
    ORR was defined as the percentage of subjects experiencing a best overall response of PR or CR (per RECIST 1.1), based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place. All treated population included all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    At the end of every 2 cycles until disease progression (Up to 31 months)
    End point values
    		 Futibatinib (Cohort A) Futibatinib (Cohort B)
    Number of subjects analysed
    87
    28
    Units: percentage of subjects
        number (confidence interval 95%)
    9.2 (4.1 to 17.3)
    10.7 (2.3 to 28.2)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) Based on IRC

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    End point title
    		 Duration of Response (DOR) Based on IRC
    End point description
    DOR was defined as the time from the first documentation of response (CR or PR in based on IRC) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. DOR was estimated using the Kaplan–Meier method. All responders' population included all subjects who received at least 1 dose of study drug and had a response. Subjects analysed are the number of subjects with events. '9999' signifies that upper limit of 95% confidence interval (CI) was not estimable due to insufficient events.
    End point type
    Secondary
    End point timeframe
    At the end of every 2 cycles until disease progression (Up to 31 months)
    End point values
    		 Futibatinib (Cohort A) Futibatinib (Cohort B)
    Number of subjects analysed
    6
    5
    Units: months
        median (confidence interval 95%)
    5.6 (3.5 to 9999)
    3.9 (2.1 to 9999)
    No statistical analyses for this end point

    Secondary: DOR Based on Investigator Assessment

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    End point title
    		 DOR Based on Investigator Assessment
    End point description
    DOR was defined as the time from the first documentation of response (CR or PR in based on Investigator Assessment) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. DOR was estimated using the Kaplan–Meier method. All responders' population included all subjects who received at least 1 dose of study drug and had a response. Subjects analysed are the number of subjects with events. '9999' signifies that the upper limit of 95% CI was not estimable due to insufficient events.
    End point type
    Secondary
    End point timeframe
    At the end of every 2 cycles until disease progression (Up to 31 months)
    End point values
    		 Futibatinib (Cohort A) Futibatinib (Cohort B)
    Number of subjects analysed
    8
    3
    Units: months
        median (confidence interval 95%)
    5.6 (3.0 to 9999)
    5.6 (2.0 to 9999)
    No statistical analyses for this end point

    Secondary: Progression- Free Survival (PFS) Based on IRC

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    End point title
    		 Progression- Free Survival (PFS) Based on IRC
    End point description
    PFS was defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on IRC), whichever occurs first. The PFS was analysed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure. All treated population included all subjects who received at least 1 dose of study drug. Subjects analysed are the number of subjects with reported disease progression or death.
    End point type
    Secondary
    End point timeframe
    At the end of every 2 cycles until disease progression (Up to 31 months)
    End point values
    		 Futibatinib (Cohort A) Futibatinib (Cohort B)
    Number of subjects analysed
    71
    23
    Units: months
        median (confidence interval 95%)
    1.9 (1.8 to 3.5)
    2.9 (1.8 to 3.7)
    No statistical analyses for this end point

    Secondary: PFS Based on Investigator Review

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    End point title
    		 PFS Based on Investigator Review
    End point description
    PFS was defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on Investigator Review), whichever occurs first. The PFS was analysed using a Kaplan Meier method, with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure. All treated population included all subjects who received at least 1 dose of study drug. Subjects analysed are the number of subjects with reported disease progression or death.
    End point type
    Secondary
    End point timeframe
    At the end of every 2 cycles until disease progression (Up to 31 months)
    End point values
    		 Futibatinib (Cohort A) Futibatinib (Cohort B)
    Number of subjects analysed
    71
    25
    Units: months
        median (confidence interval 95%)
    3.3 (1.9 to 3.8)
    3.3 (2.1 to 3.7)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as the time from the date of first dose to the death date. Subjects without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate. The 95% CI for median OS was provided using the Kaplan-Meier procedure. All treated population included all subjects who received at least 1 dose of study drug. Subjects analysed are the number of subjects with reported death.
    End point type
    Secondary
    End point timeframe
    Up to 31 months
    End point values
    		 Futibatinib (Cohort A) Futibatinib (Cohort B)
    Number of subjects analysed
    54
    24
    Units: months
        median (confidence interval 95%)
    11.1 (7.3 to 15.6)
    5.9 (3.9 to 8.9)
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR) Based on IRC

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    End point title
    		 Disease Control Rate (DCR) Based on IRC
    End point description
    DCR was defined as the percentage of subjects experiencing a best overall response of stable disease (SD), PR, or CR (per RECIST 1.1), based on IRC. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of target lesion diameters from the smallest on study (including baseline), with an absolute increase of ≥ 5 mm, or the appearance of new lesions. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. Percentages were rounded off to the nearest single decimal place. All treated population included all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    At the end of every 2 cycles until disease progression (Up to 31 months)
    End point values
    		 Futibatinib (Cohort A) Futibatinib (Cohort B)
    Number of subjects analysed
    87
    28
    Units: percentage of subjects
        number (confidence interval 95%)
    37.9 (27.7 to 49.0)
    50.0 (30.6 to 69.4)
    No statistical analyses for this end point

    Secondary: DCR Based on Investigator Review

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    End point title
    		 DCR Based on Investigator Review
    End point description
    DCR was defined as the percentage of subjects experiencing a best overall response of SD, PR, or CR (per RECIST 1.1), based on IRC. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of target lesion diameters from the smallest on study (including baseline), with an absolute increase of ≥ 5 mm, or the appearance of new lesions. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. Percentages were rounded off to the nearest single decimal place. All treated population included all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    At the end of every 2 cycles until disease progression (Up to 31 months)
    End point values
    		 Futibatinib (Cohort A) Futibatinib (Cohort B)
    Number of subjects analysed
    87
    28
    Units: percentage of subjects
        number (confidence interval 95%)
    52.9 (41.9 to 63.7)
    64.3 (44.1 to 81.4)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a clinical study subject and does not necessarily have a causal relationship with the study drug. A treatment-emergent AE (TEAE) is defined as an AE that is starting or worsening at the time of or after the first dose of study drug administration and within 30 days after the last dose of study drug and does not necessarily have a causal relationship to the use of the study drug. All treated population included all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
    End point values
    		 Futibatinib (Cohort A) Futibatinib (Cohort B)
    Number of subjects analysed
    87
    28
    Units: Subjects
    87
    27
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
    Adverse event reporting additional description
    All treated population included all subjects who received at least 1 dose of study drug. No subjects were enrolled in Cohort C, hence no data was collected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Futibatinib (Cohort A)
    Reporting group description
    		 Subjects with advanced or metastatic solid tumors harboring fibroblast growth factor receptor (FGFR)1-4 rearrangements received futibatinib 20 milligrams (mg), oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days.

    Reporting group title
    Futibatinib (Cohort B)
    Reporting group description
    		 Subjects with advanced or metastatic solid gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days.

    Serious adverse events
    		 Futibatinib (Cohort A) Futibatinib (Cohort B)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 87 (26.44%)
    6 / 28 (21.43%)
         number of deaths (all causes)
    54
    24
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant pleural effusion
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    5 / 87 (5.75%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood lactic acid increased
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical condition abnormal
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Spinal compression fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eyelid ptosis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 28 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemobilia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rhabdomyolysis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Futibatinib (Cohort A) Futibatinib (Cohort B)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    86 / 87 (98.85%)
    27 / 28 (96.43%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1
    Tumour pain
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 28 (3.57%)
         occurrences all number
    1
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Embolism
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    15 / 87 (17.24%)
    4 / 28 (14.29%)
         occurrences all number
    15
    4
    Asthenia
         subjects affected / exposed
    13 / 87 (14.94%)
    2 / 28 (7.14%)
         occurrences all number
    13
    2
    Pyrexia
         subjects affected / exposed
    6 / 87 (6.90%)
    0 / 28 (0.00%)
         occurrences all number
    6
    0
    Oedema peripheral
         subjects affected / exposed
    4 / 87 (4.60%)
    1 / 28 (3.57%)
         occurrences all number
    4
    1
    Mucosal inflammation
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Pain
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Chest discomfort
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Effusion
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Gait disturbance
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 28 (3.57%)
         occurrences all number
    1
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Secretion discharge
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Tenderness
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Thirst
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    6 / 87 (6.90%)
    3 / 28 (10.71%)
         occurrences all number
    6
    3
    Cough
         subjects affected / exposed
    5 / 87 (5.75%)
    1 / 28 (3.57%)
         occurrences all number
    6
    1
    Epistaxis
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1
    Productive cough
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Haemoptysis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Hiccups
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Pneumonitis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Hypoxia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Pleural effusion
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Depressed mood
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Disorientation
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    19 / 87 (21.84%)
    6 / 28 (21.43%)
         occurrences all number
    30
    10
    Aspartate aminotransferase increased
         subjects affected / exposed
    15 / 87 (17.24%)
    7 / 28 (25.00%)
         occurrences all number
    27
    10
    Blood creatinine increased
         subjects affected / exposed
    11 / 87 (12.64%)
    3 / 28 (10.71%)
         occurrences all number
    13
    4
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    6 / 87 (6.90%)
    1 / 28 (3.57%)
         occurrences all number
    7
    2
    Blood creatine phosphokinase increased
         subjects affected / exposed
    5 / 87 (5.75%)
    0 / 28 (0.00%)
         occurrences all number
    5
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    4 / 87 (4.60%)
    2 / 28 (7.14%)
         occurrences all number
    6
    5
    Blood phosphorus increased
         subjects affected / exposed
    4 / 87 (4.60%)
    0 / 28 (0.00%)
         occurrences all number
    4
    0
    Lymphocyte count decreased
         subjects affected / exposed
    3 / 87 (3.45%)
    1 / 28 (3.57%)
         occurrences all number
    5
    1
    Weight decreased
         subjects affected / exposed
    3 / 87 (3.45%)
    2 / 28 (7.14%)
         occurrences all number
    3
    2
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood albumin abnormal
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood calcium increased
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood creatine increased
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood fibrinogen increased
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood magnesium decreased
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood triglycerides increased
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood urine present
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Creatinine renal clearance decreased
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Heart rate abnormal
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Myoglobin blood increased
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 28 (3.57%)
         occurrences all number
    1
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    2
    Blood cholesterol increased
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 87 (3.45%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0
    Injury
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Neurological procedural complication
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Rib fracture
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Congenital dyskeratosis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorder
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    Tachycardia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    11 / 87 (12.64%)
    1 / 28 (3.57%)
         occurrences all number
    11
    1
    Headache
         subjects affected / exposed
    5 / 87 (5.75%)
    2 / 28 (7.14%)
         occurrences all number
    5
    2
    Paraesthesia
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Ataxia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Encephalopathy
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Neuralgia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    16 / 87 (18.39%)
    3 / 28 (10.71%)
         occurrences all number
    16
    3
    Lymphadenopathy
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Ear pain
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Eye disorders
    Keratitis
         subjects affected / exposed
    4 / 87 (4.60%)
    2 / 28 (7.14%)
         occurrences all number
    5
    2
    Dry eye
         subjects affected / exposed
    3 / 87 (3.45%)
    2 / 28 (7.14%)
         occurrences all number
    3
    2
    Vision blurred
         subjects affected / exposed
    3 / 87 (3.45%)
    1 / 28 (3.57%)
         occurrences all number
    3
    1
    Cataract
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1
    Lacrimation increased
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1
    Diplopia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Eye discharge
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 28 (3.57%)
         occurrences all number
    1
    2
    Eye disorder
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 28 (3.57%)
         occurrences all number
    1
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Trichiasis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Xerophthalmia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Retinal disorder
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    2
    Blepharitis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Eye pain
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Meibomian gland dysfunction
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Serous retinal detachment
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    36 / 87 (41.38%)
    6 / 28 (21.43%)
         occurrences all number
    45
    6
    Constipation
         subjects affected / exposed
    28 / 87 (32.18%)
    3 / 28 (10.71%)
         occurrences all number
    30
    3
    Dry mouth
         subjects affected / exposed
    20 / 87 (22.99%)
    1 / 28 (3.57%)
         occurrences all number
    20
    1
    Abdominal pain
         subjects affected / exposed
    14 / 87 (16.09%)
    2 / 28 (7.14%)
         occurrences all number
    14
    4
    Stomatitis
         subjects affected / exposed
    12 / 87 (13.79%)
    2 / 28 (7.14%)
         occurrences all number
    12
    2
    Nausea
         subjects affected / exposed
    8 / 87 (9.20%)
    6 / 28 (21.43%)
         occurrences all number
    10
    7
    Vomiting
         subjects affected / exposed
    8 / 87 (9.20%)
    4 / 28 (14.29%)
         occurrences all number
    9
    4
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 87 (5.75%)
    1 / 28 (3.57%)
         occurrences all number
    5
    1
    Dyspepsia
         subjects affected / exposed
    3 / 87 (3.45%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0
    Gastritis
         subjects affected / exposed
    3 / 87 (3.45%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 28 (3.57%)
         occurrences all number
    3
    1
    Oral pain
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Anal inflammation
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Angular cheilitis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Ascites
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 28 (7.14%)
         occurrences all number
    1
    2
    Glossitis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Lip swelling
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Mouth haemorrhage
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Odynophagia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Oral dysaesthesia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Gastric stenosis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Hepatic function abnormal
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 28 (3.57%)
         occurrences all number
    3
    1
    Hepatic cytolysis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Hepatic pain
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Liver disorder
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    10 / 87 (11.49%)
    0 / 28 (0.00%)
         occurrences all number
    10
    0
    Onychomadesis
         subjects affected / exposed
    7 / 87 (8.05%)
    1 / 28 (3.57%)
         occurrences all number
    7
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    6 / 87 (6.90%)
    1 / 28 (3.57%)
         occurrences all number
    6
    1
    Alopecia
         subjects affected / exposed
    4 / 87 (4.60%)
    1 / 28 (3.57%)
         occurrences all number
    4
    1
    Nail disorder
         subjects affected / exposed
    4 / 87 (4.60%)
    1 / 28 (3.57%)
         occurrences all number
    4
    1
    Onycholysis
         subjects affected / exposed
    4 / 87 (4.60%)
    0 / 28 (0.00%)
         occurrences all number
    4
    0
    Nail discolouration
         subjects affected / exposed
    3 / 87 (3.45%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0
    Dermatitis
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Eczema
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Nail dystrophy
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Pruritus
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1
    Rash
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Rash maculo-papular
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1
    Hair texture abnormal
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Hyperkeratosis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Hypertrichosis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Palmoplantar keratoderma
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Purpura
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Skin disorder
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Skin ulcer
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Acute kidney injury
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Pyelocaliectasis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Renal colic
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Hydronephrosis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    8 / 87 (9.20%)
    1 / 28 (3.57%)
         occurrences all number
    8
    1
    Arthralgia
         subjects affected / exposed
    7 / 87 (8.05%)
    2 / 28 (7.14%)
         occurrences all number
    7
    2
    Back pain
         subjects affected / exposed
    6 / 87 (6.90%)
    0 / 28 (0.00%)
         occurrences all number
    6
    0
    Muscle spasms
         subjects affected / exposed
    3 / 87 (3.45%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0
    Pain in extremity
         subjects affected / exposed
    3 / 87 (3.45%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0
    Muscle tightness
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Arthritis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Muscular weakness
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Myopathy
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Pain in jaw
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Bone pain
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Infections and infestations
    Paronychia
         subjects affected / exposed
    7 / 87 (8.05%)
    0 / 28 (0.00%)
         occurrences all number
    8
    0
    Urinary tract infection
         subjects affected / exposed
    7 / 87 (8.05%)
    0 / 28 (0.00%)
         occurrences all number
    8
    0
    Conjunctivitis
         subjects affected / exposed
    4 / 87 (4.60%)
    3 / 28 (10.71%)
         occurrences all number
    4
    3
    COVID-19
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Gingivitis
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Abscess limb
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 28 (3.57%)
         occurrences all number
    1
    1
    Dermatophytosis of nail
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Onychomycosis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal candidiasis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Otitis externa
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 28 (3.57%)
         occurrences all number
    1
    1
    Tinea pedis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Tooth infection
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Urosepsis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperphosphataemia
         subjects affected / exposed
    70 / 87 (80.46%)
    25 / 28 (89.29%)
         occurrences all number
    97
    34
    Decreased appetite
         subjects affected / exposed
    18 / 87 (20.69%)
    10 / 28 (35.71%)
         occurrences all number
    18
    11
    Hypercalcaemia
         subjects affected / exposed
    4 / 87 (4.60%)
    2 / 28 (7.14%)
         occurrences all number
    6
    5
    Hyponatraemia
         subjects affected / exposed
    4 / 87 (4.60%)
    3 / 28 (10.71%)
         occurrences all number
    5
    4
    Hypomagnesaemia
         subjects affected / exposed
    3 / 87 (3.45%)
    2 / 28 (7.14%)
         occurrences all number
    3
    3
    Dehydration
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Hypokalaemia
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 28 (7.14%)
         occurrences all number
    2
    2
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 28 (3.57%)
         occurrences all number
    1
    4
    Hypovolaemia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    3
    Hypophosphataemia
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    2
    Hyperglycaemia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Dec 2021
    The following changes were made as per Amendment 2: 1. Increased Cohort A sample size from 60 to 100 patients; total study population updated from 115 to 155. 2. Modified benefit/risk sections and COVID-19 procedures; incorporated regulatory feedback. 3. Terminology updated throughout: “Trial” to “study” (except in “clinical trial”); “Subjects”/“participants” to “patients” (except “healthy subjects”); “Study therapy/treatment/medication” to “study drug”; “Tumor assessment” to “response assessment”; “Signing of the ICF” to “documented informed consent” 4. DOR specified as “Key Secondary” and other endpoints as “Additional Secondary” in Cohorts A & B. 5. PopPK statement revised to reflect pooled analysis and exposure-response assessment. 6. Inclusion criteria updated: “Gastric or GEJ cancer” changed to “adenocarcinoma” 7. Interim analysis section revised to allow additional regulatory analyses. 8. Added “per RECIST 1.1” to objective response rate; updated response and disease control definitions. 9. Added new section: “Population PK and Exposure-Response Analyses.”

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The Sponsor made a strategic decision to terminate the study considering enrollment challenges for some of the cohorts in the trial.
    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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