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    Summary
    EudraCT Number:2008-006268-12
    Sponsor's Protocol Code Number:CICL670ADE06T
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-07-20
    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 number2008-006268-12
    A.3Full title of the trial
    Early treatment with deferasirox (Exjade®) in low risk MDS
    A.3.2Name or abbreviated title of the trial where available
    Exjade-Early-Trial
    A.4.1Sponsor's protocol code numberCICL670ADE06T
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFriedrich-Alexander-Universitaet Erlangen-Nuernberg
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Exjade®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDeferasirox
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDeferasirox
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDeferasirox
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDeferasirox
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 presenting with low or INT-1 risk MDS with only mild iron overload will be treated with deferasirox in this study. It will be analyzed if hematological improvement can be observed during this treatment.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Fraction of patients with hematologic improvement according to modified IWG criteria (reduction of transfusions and/or increase in Hb, improvement of neutropenia and thrombocytopenia)
    E.2.2Secondary objectives of the trial
    - Evaluate the safety and tolerability profile of deferasirox in MDS patients
    -Effectiveness of iron depletion
    -Correlation between hematological improvement and effectiveness of iron depletion
    -Development of bone marrow morphology
    -Correlation between hematological improvement and pretreatment parameters.
    Extension of this analysis to MDS patients on deferasirox within the licensed
    indication (more severe iron overload)
    -overall survival
    -AML-free survival
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -MDS of subtype RA, RARS, RCMD, RCMD-RS (i.e. lower risk)
    -RAEB I allowed, if clinically stable for > 3 months
    -5q-minus syndrome allowed, if lenalidomide unsuccessful or unavailable at the time
    of inclusion
    -IPSS score < intermediate-1
    -transfusion dependent or Hb < 10,5 g/dl
    -History of less than 20 units of red blood cell transfusions or 100mL/kg of
    prepacked red blood cells (PRBCs), except for tranfusions for acute bleeding
    -Serum ferritin > 300 µg/l and < 1500 μg/l. This level should have been verified at
    least at two occasions within 3 months. Samples must be obtained in the absence
    of concomitant severe infection
    -no indication for EPO (due to high endogenous EPO levels) or EPO without benefit
    in the past
    -no indication and/or no plans for cytostatic drugs
    -no previous exposure to cytostatic drugs, thalidomide, lenalidomide, G-CSF or EPO
    or exposure to any of these drugs has been terminated since > 8 weeks (4 weeks
    for G-CSF).
    -no indication and/or no plans for stem cell transplantation
    -stable or worsening cytopenia during the past 8 weeks. If in doubt, extend
    screening period to > 8 weeks
    -Patients of either gender and age > 18 years
    -Life expectancy > 12 months
    -Females of childbearing potential must use double-barrier contraception.
    -Written informed consent by the patient
    E.4Principal exclusion criteria
    -Treatment with deferasirox or other chelation therapy for periods > 4 weeks before
    study start
    -Patients with a concomitant second malignant disease, possibly interfering with life
    expectancy
    -Patients with mean levels of alanine aminotransferase (ALT) > 5x ULN
    -Patients with uncontrolled systemic hypertension
    -Patients with serum creatinine > 1.5x the upper limit of normal (ULN) or a creatinine
    clearance < 60 ml/min according to the MDRD formula (Levey 2005)
    -History of nephrotic syndrome
    -Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
    -Patients with psychiatric or addictive disorders which prevent them from giving their
    informed consent or undergoing study treatment
    -Patients treated with systemic investigational drugs within the past 4 weeks or
    topical investigational drug within the past 7 days
    -Any other surgical or medical condition which might significantly alter the
    absorption, distribution, metabolism or excretion of any drug. The investigator
    should be guided by evidence of any of the following:
    *history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or
    rectal bleeding;
    *history of major gastrointestinal tract surgery such as gastrectomy,
    gastroenterostomy, or bowel resection;
    *history of pancreatic injury or pancreatitis; indications of impaired pancreatic
    function/injury as indicated by abnormal lipase or amylase;
    *history of urinary obstruction or difficulty in voiding
    -History of non-compliance to medical regimens and patients who are considered
    potentially unreliable and/or not cooperative
    -History of drug or alcohol abuse within the 12 months prior to dosing or evidence of
    such abuse as indicated by the laboratory assays conducted during the run-in period
    -Patients with active uncontrolled infectious disease
    -Pregnancy or breast feeding
    -QT > 470 msec on screening ECG
    -Patients with a history of Torsades de Pointes
    E.5 End points
    E.5.1Primary end point(s)
    Fraction of patients with hematologic improvement according to modified IWG criteria (reduction of transfusions and/or increase in Hb, improvement of neutropenia and thrombocytopenia)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    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 Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-07-20. Yes
    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 state45
    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)
    It is not different from the normal treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-07-17
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