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    Clinical Trial Results:
    A Phase II Study of Pazopanib in Metastatic Merkel Cell Carcinoma

    Summary
    EudraCT number
    		 2011-003226-27
    Trial protocol
    		 GB  
    Global end of trial date
    08 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Apr 2026
    First version publication date
    09 Apr 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RG_10-151
    Additional study identifiers
    ISRCTN number
    		 ISRCTN10125877
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 CRCTU No: SK2006, SAF: ERN_11-1282, CTA Number: 21761/0277/001-0001, REC No.: 12/NW/0514, EudraCT No.: 2011-003226-27
    Sponsors
    Sponsor organisation name
    University of Birmingham
    Sponsor organisation address
    Edgbaston, Birmingham, United Kingdom, B15 2TT
    Public contact
    UKMCC-01 Trial Coordinator, University of Birmingham, 44 0121 414 3057, UKMCC-01@trials.bham.ac.uk
    Scientific contact
    UKMCC-01 Trial Coordinator, University of Birmingham, 44 0121 414 3057, UKMCC-01@trials.bham.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jul 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the UKMCC-01 study is to find out whether treatment with a drug called pazopanib is beneficial for patients with advanced MCC and thus warrants further investigation in a large, randomised, phase III trial. Advanced MCC patients have a poor prognosis and new treatment options for this group are desperately needed. To assess whether pazopanib works we will determine the number of patients whose tumours disappear or reduce in size during treatment (technically called Clinical Response Rate).
    Protection of trial subjects
    At each visit during the treatment period, patients were evaluated for the occurrence of AEs and laboratory abnormalities. Dose reduction to a minimum of 400mg once daily to aid management of AEs was allowed. Patients on pazopanib may have dose interruptions for up to 3 weeks (21 days) to recover from treatment emergent side effects. Dose modification algorithms were presented to sites for potential treatment-related adverse events: Hypertension Proteinuria Haemorrhage/Bleeding Venous Thrombosis Arterial Thrombosis Thrombocytopenia Anaemia Other Clinically Significant Adverse events (graded 1-4) Prolongation of QTc Interval Recommendations for pazopanib dose interruptions/modifications in case of liver-related treatment-emergent AEs were also provided to sites. Patient's were to discontinue study medication if necessary.
    Background therapy
    		 N/A
    Evidence for comparator
    		 No comparator in the trial as this is a single-arm phase II clinical trial.
    Actual start date of recruitment
    01 Aug 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    5
    From 65 to 84 years
    12
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient was recruited into the trial on 28-Jan-2013 and the last patient 09-Feb-2016 (>2 years). All patients were recruited from hospitals within the UK. 18 patients were entered into the trial and an additional 4 were only registered.

    Pre-assignment
    Screening details
    		 Potential patients were identified via clinic referrals and Multi-disciplinary team meetings. The majority of screening tests were standard practice and were commenced prior to obtaining consent. Additional tests included: Electrocardiogram (ECG)

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Intervention
    Arm description
    		 Pazopanib (VotrientTM) is a multi-targeted oral kinase inhibitor licensed by the European Medicines Agency and by the Food and Drug Administration for use in renal cell carcinoma. Merkel Cell Carcinoma (MCC) is not a licensed indication for this drug. Although many patients with MCC are elderly there is no reason to consider that the safety profile in the MCC population will be significantly different from that seen in the renal cell carcinoma. Pazopanib is considered an Investigational Medicinal Product (IMP) for the UKMCC-01 trial.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib (VotrientTM) is a multi-targeted oral kinase inhibitor. Pazopanib monohydrochloride is supplied as a series of aqueous film-coated tablets containing 200 mg of the freebase. The recommended dose of pazopanib is 800 mg per day, orally, continuous dosing. Pazopanib 800 mg (4 x 200 mg tablets) to be taken once daily by mouth. Treatment will continue until disease progression. For patients with concerns about tolerability but fulfil eligibility criteria, a starting dose of 600mg of pazopanib is permitted. If patients tolerate this dose and no toxicity is observed, the dose can be increased to 800mg. Pazopanib taken orally one hour before or two hours after a meal. Tablets should be swallowed whole and not be crushed or broken. If dose is missed, the patient should take the dose as soon as possible, but not if there are less than 12 hours before the next dose is due. If the next dose is due in less than 12 hours, skip the missed dose and take the next dose as scheduled.

    Number of subjects in period 1
    		Intervention
    Started
    18
    Completed
    18
    Period 2
    Period 2 title
    End of Trial Outcome
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Intervention
    Arm description
    		 Pazopanib (VotrientTM) is a multi-targeted oral kinase inhibitor licensed by the European Medicines Agency and by the Food and Drug Administration for use in renal cell carcinoma. Merkel Cell Carcinoma (MCC) is not a licensed indication for this drug. Although many patients with MCC are elderly there is no reason to consider that the safety profile in the MCC population will be significantly different from that seen in the renal cell carcinoma. Pazopanib is considered an Investigational Medicinal Product (IMP) for the UKMCC-01 trial.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib (VotrientTM) is a multi-targeted oral kinase inhibitor. Pazopanib monohydrochloride is supplied as a series of aqueous film-coated tablets containing 200 mg of the freebase. The recommended dose of pazopanib is 800 mg per day, orally, continuous dosing. Pazopanib 800 mg (4 x 200 mg tablets) to be taken once daily by mouth. Treatment will continue until disease progression. For patients with concerns about tolerability but fulfil eligibility criteria, a starting dose of 600mg of pazopanib is permitted. If patients tolerate this dose and no toxicity is observed, the dose can be increased to 800mg. Pazopanib taken orally one hour before or two hours after a meal. Tablets should be swallowed whole and not be crushed or broken. If dose is missed, the patient should take the dose as soon as possible, but not if there are less than 12 hours before the next dose is due. If the next dose is due in less than 12 hours, skip the missed dose and take the next dose as scheduled.

    Number of subjects in period 2
    		Intervention
    Started
    18
    Completed
    18

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 18 18
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 12 12
        85 years and over
    		 1 1
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 72 (63 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 11 11
    ECOG Performance Status
    Units: Subjects
        PS0
    		 5 5
        PS1
    		 11 11
        PS2
    		 1 1
        Not known
    		 1 1
    Stage at presentation
    Units: Subjects
        0/IA
    		 4 4
        IIA
    		 1 1
        IIB
    		 1 1
        IIIB
    		 3 3
        IV
    		 7 7
        Not known
    		 2 2
    Disease Status
    Units: Subjects
        Unresectable Primary
    		 2 2
        Unresectable regional lymph nodes
    		 2 2
        Distant metastases
    		 14 14
    Other cancer present
    Units: Subjects
        Cutaneous Basal Cell Carcinoma
    		 1 1
        Cutaneous Squamous Cell Carcinoma
    		 2 2
        None
    		 15 15
    Site(s) of current disease
    Units: Subjects
        Skin and/or lymph nodes only
    		 11 11
        Visceral metastases (liver, lung, muscle, adrenal)
    		 7 7
    Prior Treatment - Surgery for Primary MCC
    Units: Subjects
        Received Surgery
    		 12 12
        No Surgery
    		 6 6
    Prior Treatment - Radiotherapy
    Units: Subjects
        Radiotherapy received
    		 12 12
        No Radiotherapy
    		 6 6
    Prior Treatment - Cytotoxic Chemotherapy
    Units: Subjects
        Cytotoxic Chemotherapy received
    		 13 13
        No Cytotoxic Chemotherapy
    		 5 5
    Height
    Units: metres
        median (inter-quartile range (Q1-Q3))
    		 1.7 (1.6 to 1.8) -
    Weight
    Units: kg
        median (inter-quartile range (Q1-Q3))
    		 86.2 (75.2 to 104.7) -

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Pazopanib (VotrientTM) is a multi-targeted oral kinase inhibitor licensed by the European Medicines Agency and by the Food and Drug Administration for use in renal cell carcinoma. Merkel Cell Carcinoma (MCC) is not a licensed indication for this drug. Although many patients with MCC are elderly there is no reason to consider that the safety profile in the MCC population will be significantly different from that seen in the renal cell carcinoma. Pazopanib is considered an Investigational Medicinal Product (IMP) for the UKMCC-01 trial.
    Reporting group title
    Intervention
    Reporting group description
    		 Pazopanib (VotrientTM) is a multi-targeted oral kinase inhibitor licensed by the European Medicines Agency and by the Food and Drug Administration for use in renal cell carcinoma. Merkel Cell Carcinoma (MCC) is not a licensed indication for this drug. Although many patients with MCC are elderly there is no reason to consider that the safety profile in the MCC population will be significantly different from that seen in the renal cell carcinoma. Pazopanib is considered an Investigational Medicinal Product (IMP) for the UKMCC-01 trial.

    Primary: Clinical Response Rate

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    End point title
    		 Clinical Response Rate [1]
    End point description
    Clinical Response Rate is defined as the proportion of patients with complete response (CR) or confirmed partial response (PR). Response will be determined using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Results for CRR cannot be captured in statistical test so have added here for completeness. 3/18 patients, CRR = 17% (1-sided 85% LCI; 10)
    End point type
    Primary
    End point timeframe
    CT scans are to be assessed by RECIST1.1 at every 8 weeks until progression. Patients can experience a complete or partial response at any time.
    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: EudraCT FAQ explanation for reporting single-arm trials "The statistical analysis for an endpoint is not mandatory. You could choose to delete the statistical analysis (go to the analysis page, scroll down, and select "delete statistical analysis"). This will generate a warning which you can reply to with a justification for not entering the analysis." The statistical evaluation for this outcome is a CRR of 17% with a 1-sided 85% CI of 10. The outcome DCR was 50% with 2-sided 95%; 29, 71.
    End point values
    		 Intervention
    Number of subjects analysed
    18
    Units: patients
        Clinical Response Rate
    3
    No statistical analyses for this end point

    Secondary: Disease Control Rate

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    End point title
    		 Disease Control Rate
    End point description
    DCR is defined as the percentage of patients who have stable disease, a PR, or a CR for more than 12 weeks. Results for DCR cannot be captured in statistical test so have added here for completeness. 9/18 patients, DCR = 50% (2-sided 95% CI; 29; 71)
    End point type
    Secondary
    End point timeframe
    DCR is assessed by CT Scan throughout the patient treatment plan until progression or death.
    End point values
    		 Intervention
    Number of subjects analysed
    18
    Units: patients
        DCR
    9
    No statistical analyses for this end point

    Secondary: Progression free survival time

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    End point title
    		 Progression free survival time
    End point description
    PFS: defined as the time from entry into the trial until disease progression or death from any cause. Patients not having died or progressed will be censored at the date last seen alive.
    End point type
    Secondary
    End point timeframe
    Endpoint of the whole trial
    End point values
    		 Intervention
    Number of subjects analysed
    18
    Units: months
        median (confidence interval 95%)
    2.76 (1.45 to 5.22)
    No statistical analyses for this end point

    Secondary: Progression-free Survival at 3 months

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    End point title
    		 Progression-free Survival at 3 months
    End point description
    PFS: defined as the time from entry into the trial until disease progression or death from any cause. Patients not having died or progressed will be censored at the date last seen alive.
    End point type
    Secondary
    End point timeframe
    PFS at 3 months.
    End point values
    		 Intervention
    Number of subjects analysed
    18
    Units: Survival Proportion
        number (confidence interval 95%)
    0.49 (0.25 to 0.69)
    No statistical analyses for this end point

    Secondary: Duration of response

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    End point title
    		 Duration of response
    End point description
    Duration of response: defined as the time from date of first response (partial or complete) to date of progression or death from any cause.
    End point type
    Secondary
    End point timeframe
    Trial Endpoint
    End point values
    		 Intervention
    Number of subjects analysed
    18
    Units: days
    number (not applicable)
        Response Duration 1
    40
        Response Duration 2
    77
        Response Duration 3
    115
    No statistical analyses for this end point

    Secondary: Overall survival time

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    End point title
    		 Overall survival time
    End point description
    Overall survival defined as the time from entry into the trial until death from any cause. Patients will be censored at the date last seen alive. All patients will be followed up until death or for a maximum of 5 years.
    End point type
    Secondary
    End point timeframe
    Trial Endpoint
    End point values
    		 Intervention
    Number of subjects analysed
    18
    Units: months
        median (confidence interval 95%)
    6.41 (3.91 to 13.17)
    No statistical analyses for this end point

    Secondary: Overall survival time at 3 months

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    End point title
    		 Overall survival time at 3 months
    End point description
    Overall survival defined as the time from entry into the trial until death from any cause. Patients will be censored at the date last seen alive. All patients will be followed up until death or for a maximum of 5 years.
    End point type
    Secondary
    End point timeframe
    Trial Endpoint
    End point values
    		 Intervention
    Number of subjects analysed
    18
    Units: proportion
        number (confidence interval 95%)
    0.83 (0.57 to 0.94)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Details of AEs were to be documented and reported from the date of consent until 28 days after the administration of the last dose of pazopanib. SAEs which meet the definition of a SUSAR should continue to be reported after this period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Pazopanib (VotrientTM) is a multi-targeted oral kinase inhibitor licensed by the European Medicines Agency and by the Food and Drug Administration for use in renal cell carcinoma. Merkel Cell Carcinoma (MCC) is not a licensed indication for this drug. Although many patients with MCC are elderly there is no reason to consider that the safety profile in the MCC population will be significantly different from that seen in the renal cell carcinoma. Pazopanib is considered an Investigational Medicinal Product (IMP) for the UKMCC-01 trial.

    Serious adverse events
    		 Intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 18 (55.56%)
         number of deaths (all causes)
    16
         number of deaths resulting from adverse events
    0
    Investigations
    Raised LFTs
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Hematoma
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thromboembolic Event
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Cardiac dysfunction
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Bronchopulmonary Hemorrhage
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Dyspnoea
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Renal and urinary disorders
    Renal Failure
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 18 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign Prostate Hypertrophy
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Tumour Pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    4
    Vascular disorders
    Hematoma
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Hypertension
         subjects affected / exposed
    6 / 18 (33.33%)
         occurrences all number
    10
    Lymphedema
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Thromboembolic Event
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    4
    General disorders and administration site conditions
    Edema face
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Edema Limbs
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Fatigue
         subjects affected / exposed
    17 / 18 (94.44%)
         occurrences all number
    100
    Flu Like Symptoms
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Localised Edema
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    5 / 18 (27.78%)
         occurrences all number
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 18 (33.33%)
         occurrences all number
    7
    Dyspnoea
         subjects affected / exposed
    8 / 18 (44.44%)
         occurrences all number
    22
    Sore Throat
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Voice Alteration
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Blood Bilirubin Increased
         subjects affected / exposed
    5 / 18 (27.78%)
         occurrences all number
    7
    Cholesterol High
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Electrocardiogram Qt Corrected Interval Prolonged
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Elevated LFTs and GGT
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Lymphocyte Count Decreased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Neutrophil Count Decreased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Platelet Count Decreased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Weight Loss
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    5
    White Blood Cell Decreased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Bruising
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Myocardial Infarction
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Dysgeusia
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    4
    Headache
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Neuralgia
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Paresthesia
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    27
    Phantom Pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    7
    Lymphadenopathy
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Eye disorders
    Deterioration of eyesight
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Eye pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Glaucoma
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Puffy eyes
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 18 (27.78%)
         occurrences all number
    11
    Ascites
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    9 / 18 (50.00%)
         occurrences all number
    21
    Diarrhea
         subjects affected / exposed
    8 / 18 (44.44%)
         occurrences all number
    56
    Dyspepsia
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Gastroesophageal Reflux Disease
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Oral Mucositis
         subjects affected / exposed
    6 / 18 (33.33%)
         occurrences all number
    12
    Nausea
         subjects affected / exposed
    12 / 18 (66.67%)
         occurrences all number
    30
    Oral Pain
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Vomiting
         subjects affected / exposed
    4 / 18 (22.22%)
         occurrences all number
    7
    Hepatobiliary disorders
    Bile Duct Stenosis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Raised LDH
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    7 / 18 (38.89%)
         occurrences all number
    14
    Dry Skin
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Palmar-Plantar Erythrodysesthesia Syndrome
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    21
    Periorbital Edema
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Rash Acneform
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    5
    Skin Nodules on Abdomen
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Spots on Abdomen / In Axilla
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Ulcerating Skin Nodules on Abdomen
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Urticaria
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Raised Urea
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 18 (22.22%)
         occurrences all number
    11
    Arthritis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Back Pain
         subjects affected / exposed
    5 / 18 (27.78%)
         occurrences all number
    17
    Pain in Extremity
         subjects affected / exposed
    6 / 18 (33.33%)
         occurrences all number
    29
    Infections and infestations
    Biliary Tract Infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Lung Infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Mucosal infection
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Pharyngitis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Skin infection
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    5
    Urinary Tract Infection
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    5
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    10 / 18 (55.56%)
         occurrences all number
    31
    Dehydration
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Hyponatremia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Nov 2013
    Introduced additional LFT (Wk. 3) Change in eligibility criteria (INR & UPC/ACR ratio) Additional guidance on blood sample collection and CT scan timings Updated CRF Completion guidance Updated AST hepatotoxicity guidance Other minor amendments and corrections
    25 Oct 2018
    Change in Data Protection Regulations

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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