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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2005-002830-36
    Sponsor's Protocol Code Number:EORTC 06011
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-11-25
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-002830-36
    A.3Full title of the trial
    Intravenous low-dose decitabine versus supportive care in elderly patients with
    primary Myelodysplastic Syndrome (MDS) (>10 % blasts or high-risk cytogenetics),
    secondary MDS or Chronic Myelomonocytic Leukemia (CMML) who are not
    eligible for intensive therapy: an EORTC-German MDS Study Group randomized
    phase III study
    A.4.1Sponsor's protocol code numberEORTC 06011
    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 SponsorEuropean Organisation for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/03/135
    D.3 Description of the IMP
    D.3.1Product nameDacogen
    D.3.2Product code Decitabine
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INN5-aza-2'-deoxyxytidine=DAC
    D.3.9.1CAS number 2353-33-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeantineoplastic agent
    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
    The myelodysplastic syndrome (MDS) comprises a heterogenous group of hematopoietic stem cell disorders.
    - quantitative and morphologic abnormalities of bone marrow and peripheral blood cells
    - chromosomal abnormalities in about half of the cases: deletions , numerical aberrations and balanced translocations similar to those found in acute myeloid leukemia (AML).
    - DNA hypermethylation, mutations of ras genes, and loss of heterozygosity at tumor suppressor genes.

    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level HLT
    E.1.2Classification code 10028536
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main goal of this open-label randomized phase III trial is to assess the efficacy, toxicity,
    duration of hospitalization and quality of life of low dose Decitabine versus supportive care in
    elderly patients with a myelodysplastic syndrome.
    E.2.2Secondary objectives of the trial
    As part of the translational research:
    Unravel the cellular and molecular mechanisms by which
    the drug is active in MDS, with the long-term aim of improving treatment by defining rational drug
    combinations and schedules based upon a better understanding of the effect of Decitabine.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    ♦ Patients aged 60 years and older with either:
    ♦ primary MDS without any pretreatment
    ♦ primary MDS pretreated with either growth factors, immunosuppressive
    agents or hydroxyurea. These drugs have to be stopped > 6 weeks before
    randomisation.
    ♦ secondary MDS (previous radio-/chemotherapy for solid tumors or
    lymphoma)
    and based on a BM aspiration or, in case of dry tap, on a BM biopsy, with either:
    ♦ Bone marrow blast count of 11-20%,
    ♦ Bone marrow blast count of ≤ 10% with poor cytogenetics: any numerical or
    structural abnormality of chromosome 7 and/or complex abnormalities (≥ 3
    abnormalities)
    ♦ Bone marrow blast count of 21-30% (AML from MDS according to WHO
    proposal, RAEB-t according to FAB) in centers not participating in the AML
    elderly study of the EORTC. For these patients an observation period of one
    month is necessary to exclude those patients with a rapid progression
    towards full-blown AML.

    NB: - The BM sample should be done within 3 weeks prior to randomization, the cytogenetics
    examination should be done within 8 weeks prior to randomization, the blood sample
    should be done within 1 week prior to randomization.
    - Patients for whom the cytogenetic examination was unsuccesful (this means that
    cytogenetic examination has been performed on BM or on blood material, but that the
    result was considered as a failure; ex: NN with < 10 mitoses), may be included in this
    trial, provided that the % of BM blasts is ≥5 % and/or 2-3 cytopenias are present.
    ♦ Absence of blast crisis of chronic myeloid leukemia.
    ♦ Absence of t(8;21), alone or in combination with other abnormalities
    ♦ Absence of pretreatment for MDS or AML with chemotherapy other than hydroxyurea.
    ♦ Absence of active malignancy in previous three years with the exception of basal or squamous
    cell skin cancer or cervical carcinoma in situ within two years of study registration.
    ♦ Ineligible for intensive chemotherapy (ex: an anthracycline and Ara-C)
    ♦ Performance status according to the WHO scale: 0, 1 or 2.
    ♦ Adequate renal and liver function: creatinine and bilirubin < 1.5 times the upper limit of normal.
    ♦ Absence of severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment,
    congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease, where
    New-York Heart Association (NYHA)
    Class III: marked limitation of activity; less than ordinary activity results in symptoms
    Class IV: unable to carry on any physical activity without discomfort; symptoms at rest.
    ♦ HIV negative and HBsAg negative.
    ♦ Absence of active uncontrolled infection.
    ♦ No prior history or current evidence of central nervous system and psychiatric disorders
    requiring hospitalization.
    ♦ Absence of any psychological, familial, sociological or geographical condition potentially
    hampering compliance with the study protocol and follow-up schedule; those conditions should
    be discussed with the patient before registration in the trial.
    ♦ Before patient randomization, signed written informed consent must be given according to ICH
    GCP, and national/local regulations.
    N.B. Patients can be randomized only once in this trial.
    E.4Principal exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    ♦ Overall survival
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    supportive care
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. Thirty days after all patients have stopped protocol treatment
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol
    3. The database has been fully cleaned and frozen for this analysis
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 220
    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 Decision2005-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-04
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