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    Summary
    EudraCT Number:2018-001669-17
    Sponsor's Protocol Code Number:18GS001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-06-18
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2018-001669-17
    A.3Full title of the trial
    ICaRAS (IV Iron for Cancer Related Anaemia Symptoms) – A Feasibility Study of Intravenous Iron Therapy for Anaemia in Palliative Cancer Care.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ICaRAS - A Feasibility Study of Intravenous Iron Therapy for Anaemia in Palliative Cancer Care
    A.3.2Name or abbreviated title of the trial where available
    ICaRAS - IV Iron for Cancer Related Anaemia Symptoms
    A.4.1Sponsor's protocol code number18GS001
    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 SponsorNottingham University Hospitals NHS Trust
    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 supportNIHR - Research for Patient Benefit
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNottingham University Hospitals NHS Foundation Trust
    B.5.2Functional name of contact pointEdward Dickson
    B.5.3 Address:
    B.5.3.1Street AddressQueens Medical Centre, E Floor, West Block
    B.5.3.2Town/ cityNottingham
    B.5.3.3Post codeNG7 2UH
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailedward.dickson@nhs.net
    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.2.1.1.1Trade name Iron Isomaltoside 100mg in 1ml solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderPharmocosmos
    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 nameIron Isomaltoside 100mg in 1ml solution for infusion
    D.3.4Pharmaceutical form Solution for 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.3.9.1CAS number 1370654-58-2
    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 number100
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Iron deficiency anaemia secondary to cancer
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 the current study design and aid design of a larger, definitive study.
    Feasibility will be assessed according to the following criteria
    1. Eligible patients from screening
    2. Study exclusion
    3. Acceptability of recruitment
    4. Study retention
    E.2.2Secondary objectives of the trial
    Secondary objectives will be as follows

    1. To explore whether the use of intravenous iron affects the quality of life of anaemic patients undergoing palliation when compared to placebo.

    2. To compare the haemoglobin responses between therapies.

    3. To compare changes in blood iron storage (haematinics) between the two groups.

    4. To compare differences in red blood cell transfusion rates between groups

    5. To compare patient activity levels using a pedometer

    6. To assess the tolerability of intravenous iron isomaltoside 1000 in this patient group.

    7. To collect blood and faecal samples to investigate the effect of intravenous iron therapy on
    a) iron regulation in the body
    b) its effect on the immune system
    c) blood markers for tumour spread (tumour metastasis markers)
    d) gut bacteria in response to intravenous iron
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years
    2. Histologically proven solid tumour
    3. Haemoglobin < 130g/L men and <120 g/L women
    4. ECOG (Eastern Cooperative Oncology Group, Oken 1982) performance status 0-2
    5. Moderate to severe fatigue (numeric rating scale score ≥ 4 out of 10)
    6. Cancer not amenable to curative treatment
    E.4Principal exclusion criteria
    1. Evidence of iron overload or disturbance of iron utilisation e.g. haemachromotosis
    2. Previous allergy to iron or related iron products
    3. Evidence of active bleeding or untreated infection
    4. Concurrent anti-cancer chemotherapy and/or immunotherapy and/or radiotherapy (within 8 weeks)
    5. Untreated haematological malignancy
    6. Female participants who are pregnant, lactating or planning a pregnancy during the course of the study.
    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. Thromboembolic event within 3 months unless on-going treatment with anticoagulation
    E.5 End points
    E.5.1Primary end point(s)
    To determine the feasibility of the current study design and aid design of a larger, definitive study.
    Assessment of feasibility of study design will include
    1. Eligible patients from screening
    2. Study exclusion
    3. Acceptability of recruitment
    4. Study retention
    E.5.1.1Timepoint(s) of evaluation of this end point
    Feasibility measures will be assessed throughout the trial period from recruitment to follow up of patients over the 8 weeks following infusion.
    E.5.2Secondary end point(s)
    1. Quality of life scores as governed by the EQ-5D-5L, EORTC QLQc30 and FACIT-F questionnaires.
    2. Change in the level of haemoglobin and haematinic markers following treatment with intravenous iron or placebo.
    3. Allogenic blood transfusion number and volume.
    4. To compare impact on exercise capacity and free living physical activity levels
    5. Comparison of tolerability and adverse events in patients in both groups
    6. Comparison of blood samples for hepcidin levels, cytokines and adhesion molecules between groups. Comparison of faecal samples for microbiome
    E.5.2.1Timepoint(s) of evaluation of this end point
    Questionnaires, exercise capacity, blood and stool samples will be evaluated at baseline and at the 4 and 8 week follow up visits.
    Pedometer activity will be evaluated for one week prior to baseline assessments and follow up visits.
    Blood transfusion number and volume will be evaluated at the end of patient participation at 8 weeks.
    Tolerability and adverse events will be evaluated for the duration of the trial following infusion until the end of follow up at 8 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 Yes
    E.6.13.1Other scope of the trial description
    Feasibility study to aid design of definitive trial.
    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.7.1.3.1Other 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 Yes
    E.8.2.3Other No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 40
    F.4.2.2In the whole clinical trial 40
    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 Decision2018-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-28
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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