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    The EU Clinical Trials Register currently displays   37701   clinical trials with a EudraCT protocol, of which   6178   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2013-000209-22
    Sponsor's Protocol Code Number:12GA029
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-14
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-000209-22
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intravenous iron in the management of anaemia in palliative oesophageal and gastric cancer
    A.3.2Name or abbreviated title of the trial where available
    Intravenous iron in the management of anaemia in palliative UGI cancer
    A.4.1Sponsor's protocol code number12GA029
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorResearch and Development Nottingham University Hospital
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPharmacosmos UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNottingham University
    B.5.2Functional name of contact pointOliver Ng
    B.5.3 Address:
    B.5.3.1Street AddressDivision of GI Surgery, E floor West Block
    B.5.3.2Town/ cityQueen's Medical Centre, Nottingham
    B.5.3.3Post codeNG7 2UH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01158231143
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name Monofer®
    D. of the Marketing Authorisation holderPharmacosmos A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMonofer
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIRON
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100mg/ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The medical condition to be investigated is anaemia in patients with oesophageal or gastric cancer planned to undergo palliative chemotherapy.
    E.1.1.1Medical condition in easily understood language
    The medical condition to be investigated is anaemia (low blood count) in patients with gullet or stomach cancer planned to undergo chemotherapy aimed at symptom control and prolonging life (not cure).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10002062
    E.1.2Term Anaemia iron deficiency
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the feasibility of a larger trial, ie determine study size, ensure logistics adequate, to review patient uptake etc.
    E.2.2Secondary objectives of the trial
    To investigate whether the use of intravenous Iron (Monofer®) improves the quality of life of patients undergoing palliative treatment of upper gastrointestinal adenocarcinoma.

    To investigate whether the use of intravenous Iron (Monofer®) reduces the need for blood transfusions in patients undergoing palliative treatment of upper gastrointestinal acancer (adenocarcinoma).

    To assess whether the use of intravenous Iron (Monofer®) improves the outcome, e.g in terms of complication rates and chemotherapy completion rates, in patients undergoing palliative treatment of upper gastrointestinal adenocarcinoma.

    To investigate whether the use of intravenous Iron (Monofer®) improves the blood results of patients undergoing palliative treatment of upper gastrointestinal adenocarcinoma. These blood results reflect iron stores in the body
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Anaemic as defined by local laboratory normal range(Males<13g/dL, Females<12g/dL)
    2. Male or Female aged over 18years
    3. Participant is willing and able to give informed consent for participation.
    4. Diagnosed with histologically proven oesophageal, gastric or GOJ adenocarcinoma.
    5. Treatment selected is palliative chemotherapy
    6. Medically fit for initiation of palliative chemotherapy.
    7. Able (in the Investigators opinion) and willing to comply with study requirements.
    8. Willing to allow his/her General Practitioner and consultant, if appropriate, to
    be notified of participation in the study.
    E.4Principal exclusion criteria
    1. Patients who following investigation do not have a histological diagnosis of
    upper GI adenocarcinoma.
    2. Female participants who are pregnant, lactating or planning a pregnancy during
    the course of the study.
    3. Patients with evidence of iron overload or disturbances in utilisation of iron as
    stated in the product SPC.
    4. Known haematological disease that, in the investigators opinion would confound
    any changes in blood results.
    5. Features necessitating urgent surgery at inclusion
    6. Previous allergy to intravenous iron or related iron products.
    7. Patients who are unable to consent.
    8. Any other significant disease or disorder which, in the opinion of the
    Investigator, may either put the participants at risk because of participation in
    the study, or may influence the result of the study, or the participant’s ability
    to participate in the study.
    9. Donation of blood during the study.
    10. Prisoners and minors (<18 years)
    11. Non-iron deficiency anaemia (e.g. haemolytic anaemia)
    12. Hypersensitivity to the active substance or to any of the excipients.
    13. Patients with a history of asthma, allergic eczema or other atopic allergy
    14. Decompensated liver cirrhosis and hepatitis
    15. Rheumatoid arthritis with symptoms or signs of active inflammation
    E.5 End points
    E.5.1Primary end point(s)
    This is a Pilot study to assess feasibilty of a larger trial. We hope to review patient uptake, drop out, logistics of iron administration etc to aid in the design of a larger study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At recruitment (T=0).
    On the first day of chemotherapy cycle 1 (T= approx +4 weeks)
    On the first day of chemotherapy cycle 3 (T= approx +7 weeks)
    On the first day of chemotherapy cycle 3 (T= approx +10 weeks)
    E.5.2Secondary end point(s)
    Changes in quality of life as defined by the EQ-5D and FACT-an validated quality of life questionnaires.
    Variations in levels of haemoglobin and haematinic markers (full blood count, ferritin, iron, transferrin, transferrin saturation, erythropoietin).
    Rates of blood transfusion pre and intra-operatively.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At recruitment (T=0).
    On the first day of chemotherapy cycle 1 (T= approx +4 weeks)
    On the first day of chemotherapy cycle 3 (T= approx +7 weeks)
    On the first day of chemotherapy cycle 3 (T= approx +10 weeks)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    Standard clinical practice as determined by the clinical team
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    As the intravenous iron is fully licensed, clinicians may chose to prescribe it to the trial participants if promising responses are seen to therapy.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-28
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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