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    Clinical Trial Results:
    A pilot study to assess the efficacy of intravenous iron isomaltoside 1000 (Monofer®) in the management of anaemia associated with the palliative management of upper gastrointestinal adenocarcinoma

    Summary
    EudraCT number
    		 2013-000209-22
    Trial protocol
    		 GB  
    Global end of trial date
    28 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Sep 2018
    First version publication date
    22 Sep 2018
    Other versions
    Summary report(s)
    		 End of study report

    Trial information

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    Trial identification
    Sponsor protocol code
    12GA029
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01927328
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Nottingham University Hospitals NHS Trust
    Sponsor organisation address
    Derby Road, Nottingham, United Kingdom,
    Public contact
    Austin Acheson, Nottingham University Hospitals NHS Trust , +44 01159249924, researchsponsor@nuh.nhs.uk
    Scientific contact
    Austin Acheson, Nottingham University Hospitals NHS Trust , +44 01159249924, researchsponsor@nuh.nhs.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
    28 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the feasibility of a larger trial, ie determine study size, ensure logistics adequate, to review patient uptake etc.
    Protection of trial subjects
    The study was conducted in full conformity with the current revision of the Declaration of Helsinki (last amended October 2000, with additional footnotes added 2002 and 2004). The study was conducted in full conformity with relevant regulations and with the ICH Guidelines for Good Clinical Practice (CPMP/ICH/135/95) July 1996. The protocol, informed consent form, participant information sheet and all substantial amendments to the original approved documents were submitted to the Research Ethics Committee (REC), regulatory authorities (MHRA in the UK), and host institution(s) and received formal written approval. The study was conducted in accordance with GCP principles and NUH processes.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jul 2013
    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 Kingdom: 27
    Worldwide total number of subjects
    27
    EEA total number of subjects
    27
    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)
    0
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were identified from the oesophagogastric MDT meetings. Included were adult patients with a proven histological diagnosis of oesophagogastric adenocarcinoma, anaemia (<12 g/dL in women and <13 g/dL in men) and a treatment decision for palliative chemotherapy.

    Pre-assignment
    Screening details
    		 Patients were randomised 1:1 to each group using random allocations concealed in opaque envelopes. Patients in the control arm had their anaemia managed by traditional regimens as decided by the clinical oncology team. The patients in the intravenous iron group received intravenous iron isomaltoside 1000 (Monofer ®). Doses were calculated using the

    Pre-assignment period milestones
    Number of subjects started
    		 27
    Number of subjects completed
    		 27

    Period 1
    Period 1 title
    Recruitment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intravenous iron
    Arm description
    		 Intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron Isomaltoside 1000 (Monofer ®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    The study intervention treatment is intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM). It will be administered in line with the product Summary of Product Characteristics Guidelines (SPC). Doses will be calculated by the Ganzoni equation of cumulative iron deficit. To replenish iron stores by a single infusion, doses up to 20mg/kg body weight of iron may be administered per week. The IIM is diluted in 250ml 0.9% sodium chloride and infused over a period of 60 minutes. The patient will be observed by clinical staff during the administration of the drug.

    Arm title
    		 Standard care
    Arm description
    		 Standard clinical care as per the treating physician
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Intravenous iron Standard care
    Started
    14
    13
    Completed
    11
    13
    Not completed
    3
    0
         Adverse event, serious fatal
    1
    -
         Physician decision
    2
    -
    Period 2
    Period 2 title
    Cycle 1 chemotherapy
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intravenous iron
    Arm description
    		 Intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron Isomaltoside 1000 (Monofer ®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    The study intervention treatment is intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM). It will be administered in line with the product Summary of Product Characteristics Guidelines (SPC). Doses will be calculated by the Ganzoni equation of cumulative iron deficit. To replenish iron stores by a single infusion, doses up to 20mg/kg body weight of iron may be administered per week. The IIM is diluted in 250ml 0.9% sodium chloride and infused over a period of 60 minutes. The patient will be observed by clinical staff during the administration of the drug.

    Arm title
    		 Standard care
    Arm description
    		 Standard clinical care as per the treating physician
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Intravenous iron Standard care
    Started
    11
    13
    Completed
    11
    13
    Period 3
    Period 3 title
    Cycle 2 chemotherapy
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intravenous iron
    Arm description
    		 Intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron Isomaltoside 1000 (Monofer ®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    The study intervention treatment is intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM). It will be administered in line with the product Summary of Product Characteristics Guidelines (SPC). Doses will be calculated by the Ganzoni equation of cumulative iron deficit. To replenish iron stores by a single infusion, doses up to 20mg/kg body weight of iron may be administered per week. The IIM is diluted in 250ml 0.9% sodium chloride and infused over a period of 60 minutes. The patient will be observed by clinical staff during the administration of the drug.

    Arm title
    		 Standard care
    Arm description
    		 Standard clinical care as per the treating physician
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Intravenous iron Standard care
    Started
    11
    13
    Completed
    11
    13
    Period 4
    Period 4 title
    Cycle 3 chemotherapy
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intravenous iron
    Arm description
    		 Intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron Isomaltoside 1000 (Monofer ®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    The study intervention treatment is intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM). It will be administered in line with the product Summary of Product Characteristics Guidelines (SPC). Doses will be calculated by the Ganzoni equation of cumulative iron deficit. To replenish iron stores by a single infusion, doses up to 20mg/kg body weight of iron may be administered per week. The IIM is diluted in 250ml 0.9% sodium chloride and infused over a period of 60 minutes. The patient will be observed by clinical staff during the administration of the drug.

    Arm title
    		 Standard care
    Arm description
    		 Standard clinical care as per the treating physician
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		Intravenous iron Standard care
    Started
    11
    13
    Completed
    11
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intravenous iron
    Reporting group description
    		 Intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM)

    Reporting group title
    Standard care
    Reporting group description
    		 Standard clinical care as per the treating physician

    Reporting group values
    		 Intravenous iron Standard care Total
    Number of subjects
    		 14 13 27
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 68 (38 to 79) 69 (48 to 85) -
    Gender categorical
    Units: Subjects
        Female
    		 4 2 6
        Male
    		 10 11 21
    Haemoglobin
    Units: g/dL
        arithmetic mean (standard deviation)
    		 9.96 ( 1.6 ) 11.45 ( 1.79 ) -
    Ferritin
    Units: ng/mL
        arithmetic mean (standard deviation)
    		 105 ( 120 ) 161 ( 123 ) -
    Transferrin saturations
    Units: Percentage
        arithmetic mean (standard deviation)
    		 11.1 ( 8.7 ) 11.9 ( 4.8 ) -

    End points

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    End points reporting groups
    Reporting group title
    Intravenous iron
    Reporting group description
    		 Intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM)

    Reporting group title
    Standard care
    Reporting group description
    		 Standard clinical care as per the treating physician
    Reporting group title
    Intravenous iron
    Reporting group description
    		 Intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM)

    Reporting group title
    Standard care
    Reporting group description
    		 Standard clinical care as per the treating physician
    Reporting group title
    Intravenous iron
    Reporting group description
    		 Intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM)

    Reporting group title
    Standard care
    Reporting group description
    		 Standard clinical care as per the treating physician
    Reporting group title
    Intravenous iron
    Reporting group description
    		 Intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM)

    Reporting group title
    Standard care
    Reporting group description
    		 Standard clinical care as per the treating physician

    Primary: Blood transfusions

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    End point title
    		 Blood transfusions
    End point description
    End point type
    Primary
    End point timeframe
    At each cycle of chemotherapy
    End point values
    		 Intravenous iron Standard care Intravenous iron Standard care Intravenous iron Standard care
    Number of subjects analysed
    11
    12
    8
    10
    7
    10
    Units: Units
    5
    3
    0
    4
    0
    0
    Statistical analysis title
    		 Chi squared
    Comparison groups
    Intravenous iron v Standard care v Intravenous iron v Standard care v Intravenous iron v Standard care
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.594
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Haemoglobin

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    End point title
    		 Haemoglobin
    End point description
    End point type
    Secondary
    End point timeframe
    Haemoglobin at each cycle of chemotherapy
    End point values
    		 Intravenous iron Standard care Intravenous iron Standard care Intravenous iron Standard care
    Number of subjects analysed
    11
    12
    8
    10
    7
    10
    Units: g/dL
        arithmetic mean (standard deviation)
    10.15 ( 1.49 )
    11.08 ( 1.10 )
    10.79 ( 0.99 )
    10.83 ( 1.15 )
    10.60 ( 1.19 )
    10.7 ( 1.49 )
    No statistical analyses for this end point

    Secondary: Ferritin

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    End point title
    		 Ferritin
    End point description
    End point type
    Secondary
    End point timeframe
    At each cycle of chemotherapy
    End point values
    		 Intravenous iron Standard care Intravenous iron Standard care Intravenous iron Standard care
    Number of subjects analysed
    11
    12
    8
    10
    7
    10
    Units: ng/mL
        arithmetic mean (standard deviation)
    1015 ( 880 )
    200 ( 170 )
    581 ( 489 )
    264 ( 213 )
    558 ( 637 )
    340 ( 325 )
    No statistical analyses for this end point

    Secondary: Transferrin saturations

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    End point title
    		 Transferrin saturations
    End point description
    End point type
    Secondary
    End point timeframe
    At each cycle of chemotherapy
    End point values
    		 Intravenous iron Standard care Intravenous iron Standard care Intravenous iron Standard care
    Number of subjects analysed
    11
    12
    8
    10
    7
    10
    Units: Percentage
        arithmetic mean (standard deviation)
    26.3 ( 29 )
    12.1 ( 4.2 )
    20.7 ( 8.6 )
    18.3 ( 8.1 )
    14 ( 7 )
    19 ( 9 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At each cycle of chemotherapy
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Intravenous iron
    Reporting group description
    		 Intravenous Iron Isomaltoside 1000 (Monofer ®) (IIM)

    Reporting group title
    Standard care
    Reporting group description
    		 Standard clinical care as per the treating physician

    Serious adverse events
    		 Intravenous iron Standard care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 11 (81.82%)
    7 / 13 (53.85%)
         number of deaths (all causes)
    5
    2
         number of deaths resulting from adverse events
    2
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic Gastric cancer
         subjects affected / exposed
    3 / 11 (27.27%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Vascular disorders
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Insertion of oesophageal stent
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (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
    Pyrexia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Shortness of breath
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Cellulitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (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
    Septicaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 13 (15.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Intravenous iron Standard care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (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? 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.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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