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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-016727-53
    Sponsor's Protocol Code Number:P-Monofer-CIA-01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-19
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2009-016727-53
    A.3Full title of the trial
    A phase III, randomized, open-label study of intravenous iron isomaltoside 1000 (Monofer®) as mono therapy (without erythropoeisis stimulating agents) in comparison with oral iron sulfate in subjects with non-myeloid malignancies associated with Chemotherapy Induced Anemia (CIA).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare isomaltoside 1000 (Monofer®)(taken as injections) with iron sulfate taken as tablets in patients who have cancer and anemia caused by their treatment.
    A.3.2Name or abbreviated title of the trial where available
    P-Monofer-CIA-01
    A.4.1Sponsor's protocol code numberP-Monofer-CIA-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01145638
    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 SponsorPharmacosmos A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPharmacosmos A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacosmos A/S
    B.5.2Functional name of contact pointVP, CMO (Lars Lykke Thomsen)
    B.5.3 Address:
    B.5.3.1Street AddressRoervangsvej 30
    B.5.3.2Town/ cityHolbaek
    B.5.3.3Post code4300
    B.5.3.4CountryDenmark
    B.5.4Telephone number+455948 5935
    B.5.6E-mailllt@pharmacosmos.com
    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 Monofer 100 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacosmos A/S
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIron Isomaltoside 1000
    D.3.9.1CAS number 9004-66-4
    D.3.9.3Other descriptive nameiron isomalto-oligosaccharide complex
    D.3.9.4EV Substance CodeSUB14268MIG
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Ferro Duretter, prolonged release tablet
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Consumer Healthcare AB
    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 nameFerro Duretter, prolonged release tablet
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNferrous sulphate
    D.3.9.3Other descriptive nameFERROUS SULPHATE
    D.3.9.4EV Substance CodeSUB11967MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with non-myeloid malignancies associated with Chemotherapy Induced Anemia (CIA).
    E.1.1.1Medical condition in easily understood language
    Patients with malignancies that have not their origin in the bone marrow or spinal cord, or a resemblance to the marrow or spinal cord, and who has anemia caused by chemotherapy.
    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 15.1
    E.1.2Level LLT
    E.1.2Classification code 10064014
    E.1.2Term Cancer anemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10022972
    E.1.2Term Iron deficiency anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that intravenous iron isomaltoside 1000 is non-inferior to oral iron sulfate in the ability to increase/maintain hemoglobin (Hb) concentration in patients with CIA and either absolute or functional iron deficiency.
    E.2.2Secondary objectives of the trial
    - To obtain safety reassurance with the use of iron isomaltoside 1000 (Monofer®) in subjects with non-myeloid malignancies and CIA.
    - To compare study drug related adverse events after iron isomaltoside 1000 (Monofer®) to study drug related adverse events in subjects treated with oral iron sulfate.
    - To compare iron related hematological parameters (hemoglobin (Hb), transferrin saturation (TfS), serum iron, total iron binding capacity (TIBC), and serum ferritin levels).
    - To assess subjects who discontinue study due to lack of response or intolerance.
    - To assess Quality of Life.
    - Assessment of RLS symptoms and change in these symptoms during the study.
    - To detect the impact of the study drug upon the ability to complete the planned chemotherapy
    - To detect the impact of the study drug upon response to the chemotherapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women, aged more than 18 years.
    2. Subjects diagnosed with non-myeloid malignancies ( including all solid tumors, Low Grade Lymphoma (LGL), High Grade Lymphoma (HGL), Chronic Lymphatic Leukemia (CLL) and Myeloma) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles.
    3. Hb < 12 g/dL (7.4 mmol/L).
    4. TfS <50%.
    5. Serum Ferritin <800 ng/ml.
    6. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
    7. Willingness to participate after informed consent (including HIPAA, if applicable).
    E.4Principal exclusion criteria
    1. Anemia caused primarily by other factors than CIA.
    2. IV or oral iron treatment within 4 weeks prior to screening visit.
    3. Erythrypoietin treatment within 4 weeks prior to screening visit.
    4. Blood transfusion within 4 weeks prior to screening visit.
    5. Imminent expectation of blood transfusion on part of treating physician.
    6. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
    7. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulfate).
    8. Known hypersensitivity to any excipients in the investigational drug products.
    9. Subjects with a history of multiple allergies.
    10. Decompensated liver cirrhosis or active hepatitis (alanine aminotransferase (ALAT) > 3 times upper normal limit).
    11. Active acute or chronic infections (assessed by clinical judgement and if deemed necessary by investigator supplied with white blood cells (WBC) and C-reactive protein (CRP)).
    12. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
    13. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
    14. Planned elective surgery during the study.
    15. Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening.
    16. Known intolerance to oral iron treatment.
    17. Untreated B12 or folate deficiency.
    18. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
    E.5 End points
    E.5.1Primary end point(s)
    Change in Hb concentration from baseline to week 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 4.
    E.5.2Secondary end point(s)
    - Proportion of subjects who achieve target limits of Hb (men 13-18 g/dL, women 12-16 g/dL) and have change in Hb concentration ≥ 1.0 g/dL at week 2, 4, 8, or 12.
    - Proportion of subjects who have a change in Hb concentration ≥ 2.0 g/dL at week 2 or 4.
    - Proportion of subjects who have a change in Hb concentration ≥ 2.0 g/dL at week 2, 4, 8, or 12.
    - Safety laboratory assessments at baseline and 1, 2, 4, 8, 12 and 24 weeks.
    - Number of study drug related adverse events (including serious adverse reactions) in iron isomaltoside 1000 (Monofer®) group and iron sulfate group.
    - Number of adverse events of special interest (i.e. hypersensitivity reactions or hypotension at pre-specified time points in relation to administration of study drug).
    - Number of subjects receiving transfusions.
    - Change from baseline in Hb at week 1, 2, 8, 12, and 24.
    - Change from baseline in serum ferritin, serum iron, TIBC, and TfS measured at week 1, 2, 4, 8, 12 and 24.
    - Number of subjects in each randomization group who discontinue study because of lack of response or intolerance of investigational drugs.
    - Changes in Quality of Life at baseline, 4 and 12 weeks.
    - Change in RLS symptoms (RLS score) from baseline to week 12 in subjects with RLS symptoms at baseline.
    - Impact of study drug on ability to complete chemotherapy assessed as yes or no response at 24 weeks.
    - Impact of study drug on response to chemotherapy, assessed as complete remission, partial remission, stable remission and progressive disease as per the investigator discretion at 24 weeks.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time point(s) are specified in each secondary endpoint.
    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 No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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) Yes
    E.8.2.2Placebo No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    European Union
    India
    United States
    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
    The end of study is defined by the completion of the last subject's last visit in any participating centre.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 350
    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)
    After the end of the study or if subject is withdrawn from the study, the subject will be treated according to standard hospital practice.
    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 Decision2012-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-23
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