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    Clinical Trial Results:
    A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

    Summary
    EudraCT number
    		 2019-004630-42
    Trial protocol
    		 FR   PT   DE   PL   IT  
    Global end of trial date
    22 Apr 2024

    Results information
    Results version number
    		 v2(current)
    This version publication date
    22 Feb 2025
    First version publication date
    31 Jan 2025
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Update in recruitment details.

    Trial information

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    Trial identification
    Sponsor protocol code
    TAS-120-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04093362
    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
    28 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of subjects with advanced, metastatic, or recurrent unresectable intrahepatic cholangiocarcinoma (iCCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene 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
    06 Jan 2021
    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
    United States: 2
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Worldwide total number of subjects
    10
    EEA total number of subjects
    2
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    5
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 10 subjects took part in the study from 06 January 2021 to 22 April 2024.

    Pre-assignment
    Screening details
    		 Total 10 subjects with advanced cholangiocarcinoma were enrolled & randomised to receive either futibatinib or gemcitabine-cisplatin. The study was later terminated by the sponsor due to poor recruitment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Futibatinib
    Arm description
    		 Subjects received futibatinib at an oral dose of 20 milligrams (mg), administered once daily (QD) in each 21-day cycle up to a maximum of 649 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Futibatinib
    Investigational medicinal product code
    Other name
    TAS-120
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Futibatinib at an oral dose of 20 milligrams (mg), administered daily (QD) on every day of a 21-day cycle.

    Arm title
    		 Gemcitabine-Cisplatin
    Arm description
    		 Subjects received cisplatin 25 milligrams per square meter (mg/m2) intravenous (IV) infusion followed by gemcitabine 1000 mg/m2 IV infusion on Days 1 and 8 of each 21-day cycle up to a maximum of 155 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 25 mg/m2, IV infusion on Days 1 and 8 of each 21-day cycle.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000 mg/m2, IV infusion on Days 1 and 8 of each 21-day cycle.

    Number of subjects in period 1
    		Futibatinib Gemcitabine-Cisplatin
    Started
    4
    6
    Completed
    0
    0
    Not completed
    4
    6
         Withdrawal of Consent
    1
    -
         Study Termination
    1
    1
         Death
    1
    3
         Reason not Specified
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Futibatinib
    Reporting group description
    		 Subjects received futibatinib at an oral dose of 20 milligrams (mg), administered once daily (QD) in each 21-day cycle up to a maximum of 649 days.

    Reporting group title
    Gemcitabine-Cisplatin
    Reporting group description
    		 Subjects received cisplatin 25 milligrams per square meter (mg/m2) intravenous (IV) infusion followed by gemcitabine 1000 mg/m2 IV infusion on Days 1 and 8 of each 21-day cycle up to a maximum of 155 days.

    Reporting group values
    		 Futibatinib Gemcitabine-Cisplatin Total
    Number of subjects
    		 4 6 10
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.3 ( 9.46 ) 56.3 ( 12.77 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 4 5
        Male
    		 3 2 5
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 3 4
        Not Hispanic or Latino
    		 3 2 5
        Unknown or Not Reported
    		 0 1 1
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 2 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 2 5 7
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Futibatinib
    Reporting group description
    		 Subjects received futibatinib at an oral dose of 20 milligrams (mg), administered once daily (QD) in each 21-day cycle up to a maximum of 649 days.

    Reporting group title
    Gemcitabine-Cisplatin
    Reporting group description
    		 Subjects received cisplatin 25 milligrams per square meter (mg/m2) intravenous (IV) infusion followed by gemcitabine 1000 mg/m2 IV infusion on Days 1 and 8 of each 21-day cycle up to a maximum of 155 days.

    Primary: Progression-free Survival (PFS)

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    End point title
    		 Progression-free Survival (PFS) [1]
    End point description
    PFS was defined as the time from date of randomization to the date of documentation of disease progression by independent central review (ICR), or date of death, whichever occurs first. Response assessments were made based on Response Evaluation Criteria in Solid Tumours (RECIST) guidelines (version 1.1, 2009). As pre-specified in protocol, a total of 162 PFS events were required to perform PFS analysis. As only 10 subjects were enrolled in this study, hence no data was collected or analysed as planned for this end point.
    End point type
    Primary
    End point timeframe
    Up to approximately 28 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: As pre-specified in protocol, a total of 162 PFS events were required to perform PFS analysis. As only 10 subjects were enrolled in this study, hence no data was collected or analysed as planned for this end point.
    End point values
    		 Futibatinib Gemcitabine-Cisplatin
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Subjects
    Notes
    [2] - Only 10 subjects were enrolled in this study, no data was collected or analysed as planned.
    [3] - Only 10 subjects were enrolled in this study, no data was collected or analysed as planned.
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    ORR was defined as the proportion of subjects experiencing a best overall response of partial response (PR) or complete response (CR) as per RECIST 1.1, based on ICR. 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 and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to less than (<)10 millimeters (mm) and disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10-mm short axis). The data for this end point was not collected or analysed as planned because the study was terminated early due to poor recruitment.
    End point type
    Secondary
    End point timeframe
    Up to approximately 28 months
    End point values
    		 Futibatinib Gemcitabine-Cisplatin
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Subjects
    Notes
    [4] - The data for this end point was not collected as planned due to poor recruitment.
    [5] - The data for this end point was not collected as planned due to poor recruitment.
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR)

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    End point title
    		 Disease Control Rate (DCR)
    End point description
    DCR was defined as the proportion of subjects experiencing a best overall response of stable disease (SD), PR or CR as per RECIST 1.1, based on central assessment of radiologic images. 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 and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm and disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10-mm short axis). The data for this end point was not collected or analysed as planned because the study was terminated early due to poor recruitment.
    End point type
    Secondary
    End point timeframe
    Up to approximately 28 months
    End point values
    		 Futibatinib Gemcitabine-Cisplatin
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Subjects
    Notes
    [6] - The data for this end point was not collected due to poor recruitment.
    [7] - The data for this end point was not collected due to poor recruitment.
    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 randomisation until the date of death due to any cause. All Treated Population included all subjects who received at least one dose of study drug. The data for this end point was not collected or analysed as planned because the study was terminated early due to poor recruitment.
    End point type
    Secondary
    End point timeframe
    Up to approximately 28 months
    End point values
    		 Futibatinib Gemcitabine-Cisplatin
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: months
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [8] - The data for this end point was not collected due to poor recruitment.
    [9] - The data for this end point was not collected due to poor recruitment.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS) Per Investigator Assessment

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    End point title
    		 Progression-Free Survival (PFS) Per Investigator Assessment
    End point description
    PFS per investigator assessment is defined as the time from date of randomisation to the date of disease progression based on investigator assessment of radiographic images or death, whichever occurs first. As pre-specified in protocol, a total of 162 PFS events were required to perform PFS analysis. As only 10 subjects were enrolled in this study, hence no data was collected for this end point.
    End point type
    Secondary
    End point timeframe
    Up to approximately 28 months
    End point values
    		 Futibatinib Gemcitabine-Cisplatin
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: Subjects
    Notes
    [10] - Only 10 subjects were enrolled in this study, hence no data was collected for this end point.
    [11] - Only 10 subjects were enrolled in this study, hence no data was collected for this end point.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Treatment-emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
    End point description
    Adverse event (AE): any untoward medical condition in clinical investigation subject administered drug; it does not necessarily have causal relationship with treatment. TEAE: AE that started orworsened at time of/after first dose of study drug administration &within 30 days after last dose of study drug &does not necessarily have a causal relationship to use of study drug. TEAEs were assessed by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0). SAE: untoward medical occurrence that at any dose: results in death,is life-threatening,required in subject hospitalisation or prolongation of existing hospitalisation,results in persistent or significant disability/incapacity, is congenital anomaly/birth defect,important medical event. TEAEs included any clinically significant changes in clinical laboratory tests,vital signs,ophthalmological exams &12lead electrocardiogram (ECG). All Treated Population included all subjects who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to approximately 28 months
    End point values
    		 Futibatinib Gemcitabine-Cisplatin
    Number of subjects analysed
    4
    5
    Units: Subjects
        TEAEs
    4
    5
        SAEs
    2
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to end of study (Up to approximately 28 months)
    Adverse event reporting additional description
    All Treated Population included all subjects who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    V25.0
    Reporting groups
    Reporting group title
    Gemcitabine-Cisplatin
    Reporting group description
    		 -

    Reporting group title
    Futibatinib
    Reporting group description
    		 -

    Serious adverse events
    		 Gemcitabine-Cisplatin Futibatinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    2 / 4 (50.00%)
         number of deaths (all causes)
    3
    1
         number of deaths resulting from adverse events
    3
    1
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (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
    General physical health deterioration
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal sepsis
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    		 Gemcitabine-Cisplatin Futibatinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    4 / 4 (100.00%)
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    Face oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    1
    Influenza like illness
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    3 / 5 (60.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    Mucosal inflammation
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    Productive cough
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Hiccups
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Pulmonary embolism
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Blood bilirubin increased
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    Blood follicle stimulating hormone decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Lipase increased
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    4
    Platelet count decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    1
    Weight decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    Anaemia
         subjects affected / exposed
    3 / 5 (60.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    Leukopenia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Neutropenia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Serous retinopathy
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Retinal haemorrhage
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Visual impairment
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 4 (25.00%)
         occurrences all number
    4
    1
    Diarrhoea
         subjects affected / exposed
    2 / 5 (40.00%)
    2 / 4 (50.00%)
         occurrences all number
    2
    2
    Ascites
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    1
    Stomatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    Nausea
         subjects affected / exposed
    5 / 5 (100.00%)
    0 / 4 (0.00%)
         occurrences all number
    6
    0
    Constipation
         subjects affected / exposed
    3 / 5 (60.00%)
    0 / 4 (0.00%)
         occurrences all number
    5
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Dyspepsia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Gingival bleeding
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Jaundice cholestatic
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    2
    Pruritus
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    2
    Onycholysis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Night sweats
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Petechiae
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Dysuria
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Back pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Paronychia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperphosphataemia
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 4 (75.00%)
         occurrences all number
    0
    12
    Decreased appetite
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    Hyperkalaemia
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    2
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 4 (25.00%)
         occurrences all number
    3
    1
    Hypochloraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    Hypomagnesaemia
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jan 2020
    The following changes were made as per Amendment 1: 1. The EudraCT number on the cover page was corrected. 2. The requirement that phosphorus be assessed on Day 4 of Cycle 1 was removed from Table 1 (Schedule of Events) and throughout the protocol (the schedule for all other chemistry assessments remains the same as in the original version).

    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 data for the end points related to PFS, OS, ORR, and DCR per Investigator assessment was not collected or analysed as planned because the study was terminated early due to poor recruitment.
    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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