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    Clinical Trial Results:
    Transplantation of umbilical cord blood from unrelated donors in patients with haematological diseases using a myeloablative conditioning regimen

    Summary
    EudraCT number
    2009-011818-21
    Trial protocol
    GB  
    Global end of trial date
    12 May 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Feb 2018
    First version publication date
    16 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UCL/09/0128
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02310997
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University College London Cancer Trial Centre (UCL CTC)
    Sponsor organisation address
    90 Tottenham Court Road, London, United Kingdom, W1T 4TJ
    Public contact
    University College London & Cancer Trial Centre, University College London & Cancer Trial Centre, +44 2076799860, ctc.cordblood@ucl.ac.uk
    Scientific contact
    University College London & Cancer Trial Centre, University College London & Cancer Trial Centre, +44 2076799860, ctc.cordblood@ucl.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
    16 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the safety and efficacy of unrelated donor umbilical cord blood transplantation (UCBT) in a multi-institution UK setting where the use a myeloablative preparative regimen is indicated. The anti-malignancy effect of this treatment is achieved by a combination of intensive chemoradiotherapy and the 'graft vs. malignancy' (GVM) effect. The advantage of this approach is the increased likelihood of destroying the malignant cells and a reduced risk of graft rejection as the bone marrow is better prepared to accept the transplant than with reduced intensity conditioning. However, the treatment may be less well tolerated by some patients and therefore patients of advanced age or with impaired organ function were not eligible for this trial.
    Protection of trial subjects
    Patients underwent screening evaluations to confirm eligibility for the trial, these included: medical history, full blood count, biochemistry tests (liver and renal function), clotting screen, bone marrow biopsy to confirm diagnosis, infection screening, and electrocardiogram (ECG). Furthermore, all patients undergoing total body irradiation as part of their conditioning regimen had to be assessed by a radiation oncologist prior to admission to the trial. A cord blood unit selection committee was established to assist in selecting appropriate units for specific patients. Sites were strongly encouraged to consult the selection committee. Units were selected preferentially from cord blood banks that had achieved FACT-NetCord accreditation to ensure the quality of the products used. An appropriate back up umbilical cord blood graft for each patient was reserved until engraftment had been observed. Patients were monitored regularly post-transplant with FBC and biochemistry investigations carried out daily until engraftment and discharge. The protocol provided instructions for supportive care measures to address anaemia, thrombocytopenia, fever and nutrition. The protocol advised levels of antibiotic, anti-fungal, anti-viral and anticonvulsant prophylaxis, and treatment for the prevention of tumour lysis and engraftment syndromes. Ciclosporin dose modifications were permitted based upon serum creatinine levels.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable - no comparator used
    Actual start date of recruitment
    08 Aug 2011
    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
    United Kingdom: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    1
    Children (2-11 years)
    1
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 60 patients were to be recruited over a period of 36 months. The first site was opened on 29/07/2011, and the first patient recruited on 08/08/2011. The trial closed to recruitment early on 19/12/2013 due to poor recruitment. A total of 11 patients were recruited across 7 sites.

    Pre-assignment
    Screening details
    Screening logs were requested from all active sites on 09/09/2013. Twenty patients were screened for the study. Nine of the twenty screened patients did not enter the trial for the following reasons: Unsuitable for total body irradiation = 5 Eligibility criteria = 3 Incorrect consent version = 1

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    n/a

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Flu/Cyc/TBI
    Arm description
    Patients aged 2-45 years (excluding AML, JMML and MDS patients aged <16 years) received a myeloablative conditioning regimen comprising: Fludarabine Cyclophosphamide Total body irradiation (13 - 14.4 Gy in 8 fractions) It was permissible to follow local policy for scheduling of TBI and cyclophosphamide providing there was no change in the dose or number of fractions. Conditioning regimens began 9 days pre-transplant with patients receiving an unrelated donor umbilical cord blood transplant on day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    Fludarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Fludarabine 25 mg/m^2/day Intravenous infusion over 30 minutes to 1 hour Days -8, -7 and -6, pre-transplant Total dose 75 mg/m2

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Cyclophosphamide 60mg/kg/day To be administered intravenously with high volume fluid flush and mesna according to local policy on day -7 and -6 pre-transplant, or day -3 and -2 pre-transplant Total dose 120mg/kg

    Arm title
    Bu/Cyc/Mel
    Arm description
    Patients aged < 2 years and AML, JMML and MDS patients <16 years received a myeloablative conditioning regimen comprising: Busulfan Cyclophosphamide Melphalan Conditioning regimens began 10 days pre-transplant with patients receiving an unrelated donor umbilical cord blood transplant on day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Cyclophosphamide 60mg/kg/day To be administered intravenously with high volume fluid flush and mesna according to local policy on either, day -4 and -3 pre-transplant Total dose 120mg/kg

    Investigational medicinal product name
    Busulfan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Busulfan 3.2mg/kg/day on day -9, -8, -7 and -6 pre transplant Busulfan was given in 2 or 4 doses per day as per local policy (suggested schedules for administration were: 0.8mg/kg IV over 2 hours qds, or 1.6mg/kg IV over 3 hours bd)

    Investigational medicinal product name
    Melphalan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Melphalan 140mg/m^2 on day -2 pre transplant IV infusion over 15 minutes - 1 hour

    Number of subjects in period 1
    Flu/Cyc/TBI Bu/Cyc/Mel
    Started
    10
    1
    Completed
    10
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Flu/Cyc/TBI
    Reporting group description
    Patients aged 2-45 years (excluding AML, JMML and MDS patients aged <16 years) received a myeloablative conditioning regimen comprising: Fludarabine Cyclophosphamide Total body irradiation (13 - 14.4 Gy in 8 fractions) It was permissible to follow local policy for scheduling of TBI and cyclophosphamide providing there was no change in the dose or number of fractions. Conditioning regimens began 9 days pre-transplant with patients receiving an unrelated donor umbilical cord blood transplant on day 0.

    Reporting group title
    Bu/Cyc/Mel
    Reporting group description
    Patients aged < 2 years and AML, JMML and MDS patients <16 years received a myeloablative conditioning regimen comprising: Busulfan Cyclophosphamide Melphalan Conditioning regimens began 10 days pre-transplant with patients receiving an unrelated donor umbilical cord blood transplant on day 0.

    Reporting group values
    Flu/Cyc/TBI Bu/Cyc/Mel Total
    Number of subjects
    10 1 11
    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 1 1
        Children (2-11 years)
    1 0 1
        Adolescents (12-17 years)
    1 0 1
        Adults (18-64 years)
    8 0 8
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    4 0 4
        Male
    6 1 7
    Disease type
    Units: Subjects
        Acute Myelogenous Leukaemia
    6 0 6
        Acute Lymphoblastic Leukaemia
    4 1 5
    Lines of prior treatment
    Units: Subjects
        One
    1 0 1
        Two
    6 1 7
        Three
    1 0 1
        Four
    2 0 2

    End points

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    End points reporting groups
    Reporting group title
    Flu/Cyc/TBI
    Reporting group description
    Patients aged 2-45 years (excluding AML, JMML and MDS patients aged <16 years) received a myeloablative conditioning regimen comprising: Fludarabine Cyclophosphamide Total body irradiation (13 - 14.4 Gy in 8 fractions) It was permissible to follow local policy for scheduling of TBI and cyclophosphamide providing there was no change in the dose or number of fractions. Conditioning regimens began 9 days pre-transplant with patients receiving an unrelated donor umbilical cord blood transplant on day 0.

    Reporting group title
    Bu/Cyc/Mel
    Reporting group description
    Patients aged < 2 years and AML, JMML and MDS patients <16 years received a myeloablative conditioning regimen comprising: Busulfan Cyclophosphamide Melphalan Conditioning regimens began 10 days pre-transplant with patients receiving an unrelated donor umbilical cord blood transplant on day 0.

    Primary: Non-relapse mortality at day 100

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    End point title
    Non-relapse mortality at day 100 [1]
    End point description
    The proportion of patients that have not relapsed but died within 100 days of transplant. Non-relapse mortality greater or equal to 50% within 100 days of transplant would have stopped the study.
    End point type
    Primary
    End point timeframe
    Measured at 100 days post-transplant.
    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: This primary endpoint represents numbers of patients. No specific statistical analysis is necessary to establish numbers of patients. Furthermore, due to the small sample size, statistical analysis would not be possible.
    End point values
    Flu/Cyc/TBI Bu/Cyc/Mel
    Number of subjects analysed
    10
    1
    Units: Percentage
    10
    0
    No statistical analyses for this end point

    Secondary: Overall survival at one year

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    End point title
    Overall survival at one year
    End point description
    Proportion of patients alive one year after transplant
    End point type
    Secondary
    End point timeframe
    1 year after transplant
    End point values
    Flu/Cyc/TBI Bu/Cyc/Mel
    Number of subjects analysed
    10
    1
    Units: Percentage
    70
    100
    Attachments
    MAC-UCBT survival curve
    No statistical analyses for this end point

    Secondary: Neutrophil recovery

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    End point title
    Neutrophil recovery
    End point description
    Proportion of patients with neutrophil recovery by day 42.
    End point type
    Secondary
    End point timeframe
    From day of transplant to day 42 post-transplant.
    End point values
    Flu/Cyc/TBI Bu/Cyc/Mel
    Number of subjects analysed
    9
    1
    Units: Percentage
    89
    100
    No statistical analyses for this end point

    Secondary: Incidence of GvHD

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    End point title
    Incidence of GvHD
    End point description
    The number of patients experiencing acute or chronic GvHD 100 days or 1 year after their transplant respectively.
    End point type
    Secondary
    End point timeframe
    Incidence of acute GvHD = from transplant to 100 days post-transplant Incidence of chronic GvHD = from transplant to 1 year post-transplant
    End point values
    Flu/Cyc/TBI Bu/Cyc/Mel
    Number of subjects analysed
    10
    1
    Units: Percentage
        Acute GvHD
    50
    100
        Chronic GvHD
    40
    0
    No statistical analyses for this end point

    Secondary: Platelet recovery

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    End point title
    Platelet recovery
    End point description
    Proportion of patients with platelet recovery by day 100. Platelet recovery was defined as 75 x 10^9/l.
    End point type
    Secondary
    End point timeframe
    From day of transplant to day 100 post-transplant.
    End point values
    Flu/Cyc/TBI Bu/Cyc/Mel
    Number of subjects analysed
    8
    1
    Units: Percentage
    100
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The reporting period for adverse events was from informed consent to 42 days post-transplant.
    Adverse event reporting additional description
    The following events were exempt from SAE reporting: • disease progression (including disease related deaths) • the following treatment-related events: infection (grades 1-3) graft failure acute GvHD chronic GvHD secondary malignancy
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Flu/Cyc/TBI
    Reporting group description
    -

    Reporting group title
    Bu/Cyc/Mel
    Reporting group description
    -

    Serious adverse events
    Flu/Cyc/TBI Bu/Cyc/Mel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    3
    0
         number of deaths resulting from adverse events
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
    Additional description: non-CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Nervous system disorders
    Intracranial hemorrhage
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Flu/Cyc/TBI Bu/Cyc/Mel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 10 (100.00%)
    1 / 1 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    3 / 10 (30.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    Tachycardia
    Additional description: non-CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergy
    Additional description: non CTCAE term
         subjects affected / exposed
    4 / 10 (40.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    General disorders and administration site conditions
    Cold sore
    Additional description: non CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    4 / 10 (40.00%)
    1 / 1 (100.00%)
         occurrences all number
    4
    1
    Fever
         subjects affected / exposed
    10 / 10 (100.00%)
    1 / 1 (100.00%)
         occurrences all number
    10
    1
    Pain
    Additional description: non CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Chest pain
    Additional description: non CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Anxiety
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Hallucination
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Engraftment syndrome
    Additional description: non CTCAE term
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Post-operative haemorrhage
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Haemorrhage
    Additional description: non CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Weight loss
         subjects affected / exposed
    5 / 10 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Pleural effusion
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Shortness of breath
    Additional description: non-CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 10 (70.00%)
    1 / 1 (100.00%)
         occurrences all number
    7
    1
    Fluid overload
    Additional description: non-CTCAE term
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Neutropenia
         subjects affected / exposed
    7 / 10 (70.00%)
    1 / 1 (100.00%)
         occurrences all number
    7
    1
    Thrombocytopenia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Leukopenia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Dysgeusia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Visual disturbance
    Additional description: non CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 10 (40.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    Anal pain
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 1 (100.00%)
         occurrences all number
    1
    1
    Constipation
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    6 / 10 (60.00%)
    1 / 1 (100.00%)
         occurrences all number
    6
    1
    Dry mouth
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Heartburn
    Additional description: non-CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Mucositis
    Additional description: includes both oral and anal mucositis
         subjects affected / exposed
    10 / 10 (100.00%)
    1 / 1 (100.00%)
         occurrences all number
    10
    1
    Nausea
         subjects affected / exposed
    10 / 10 (100.00%)
    1 / 1 (100.00%)
         occurrences all number
    10
    1
    Vomiting
         subjects affected / exposed
    5 / 10 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Dysurea
    Additional description: non CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Haematuria
    Additional description: non-CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Hepatic impairment
    Additional description: non CTCAE term
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
    Additional description: non CTCAE term
         subjects affected / exposed
    8 / 10 (80.00%)
    1 / 1 (100.00%)
         occurrences all number
    8
    1
    Alopecia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Pain of skin
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Leg cramps
    Additional description: non CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Muscular and bone pain
    Additional description: non CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    4 / 10 (40.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Hypokalaemia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Hypomagnesaemia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Hypophosphataemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Neutropenic sepsis
    Additional description: non CTCAE term
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    1. Trial closed to recruitment early. Patients were still followed up. 2. Occurrence of non-serious AEs cannot be provided as only data on the highest grade experienced by patient was collected; the number of subjects affected is entered instead.
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