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    The EU Clinical Trials Register currently displays   35522   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-001060-38
    Sponsor's Protocol Code Number:DECO
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-04-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-001060-38
    A.3Full title of the trial
    Pre-operative Decitabine in colon cancer: a proof of principal study
    Pre-operatief Decitabine bij patiënten met dikkedarmkanker
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pre-operative Decitabine in colon cancer: a proof of principal study (DECO)
    Pre-operatief Decitabine bij patiënten met dikkedarmkanker
    A.3.2Name or abbreviated title of the trial where available
    DECO
    DECO
    A.4.1Sponsor's protocol code numberDECO
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01882660
    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 SponsorAcademic Medical center
    B.1.3.4CountryNetherlands
    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 supportUniversity of Amsterdam
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointLyda ter Hofstede
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31205668229
    B.5.5Fax number+31206919743
    B.5.6E-mailtrialmedonc@amc.nl
    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 Dacogen
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameDacogen
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    colon cancer
    Dikkedarm kanker
    E.1.1.1Medical condition in easily understood language
    colon cancer
    Dikkedarm kanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess in patients with primary colon cancer whether short-course pre-operative treatment with decitabine can increase Wnt target gene expression as measured in resected tumors compared to pretreatment biopsies.
    Het bestuderen van de effecten van een eenmalige behandeling met Decitabine op Wnt target gen van dikkedarmkanker.
    E.2.2Secondary objectives of the trial
    To assess in patients with primary colon cancer whether short-course pre-operative treatment with decitabine can revert CpG methylation and induce more favorable tumor characteristics as measured in resected tumors compared to pretreatment biopsies
    Het bestuderen van de effecten van een eenmalige behandeling met Decitabine op CIMP gen methylatie en tumor differentiatie van dikkedarmkanker.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to participate in the first part of the study, five extra fresh biopsies to determine tumor methylation status, a subject must meet all of the following criteria:
    1. Biopsy proven colon cancer or high suspicion of colon cancer on a previous endoscopy.
    2. Planned endoscopy.
    3. Age ≥ 18yr.
    4. ECOG/ WHO performance 0-2.
    5. Written informed consent.

    In order to participate in the second part of the study - treatment with decitabine - a subject must meet all of the following criteria:
    1. Patients with biopsy proven colon cancer who will undergo primary tumor resection.
    2. Age ≥ 18yr.
    3. ECOG/ WHO performance 0-2.
    4. Adequate bone marrow function (ANC>1500/mm3, hemoglobin>9g/dL (which may be obtained by transfusions), platelets>100,000)
    5. Adequate hepatic function (AST and ALT <2.5x upper limit of normal (ULN)).
    6. Adequate renal function (Serum creatinine ≤1.5 x ULN or calculated creatinine of >50ml/min)
    7. Women of child-bearing age must be willing to use adequate contraception and have negative serum or urine pregnancy test within 3 days prior to registration.
    8. Written informed consent.
    Patiënten met een (hoge verdenking op) dikkedarmkanker.
    E.4Principal exclusion criteria
    A potential subject for the first part of the study - extra biopsies to determine tumor methylation status - who meets any of the following criteria will be excluded from participation in this study:
    1. Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.

    A potential subject for the second part of the study - treatment with decitabine - who meets any of the following criteria will be excluded from participation in this study:
    1. Known hypersensitivity to decitabine.
    2. Surgery not planned according to time frame of the study,
    3. Other systemic or local treatment of the primary tumor in the waiting time until surgery.
    4. Administration of any experimental drug within 60 days prior to the first dose of decitabine.
    5. Women of child-bearing age who are pregnant or lactating.
    6. Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
    Psychologische of andere redenen waardoor informed consent en (veilige) deelname niet mogelijk is.

    Overgevoeligheid voor decitabine.
    Een andere behandeling van de tumor in de wachttijd tot de operatie.
    E.5 End points
    E.5.1Primary end point(s)
    Wnt target gene expression (APCDD1, AXIN2, DKK1, LGR5 and ASCL2).
    Wnt target gen expressie (APCDD1, AXIN2, DKK1, LGR5 and ASCL2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After surgery of colon cancer
    Na operatie van de dikkedarmtumor
    E.5.2Secondary end point(s)
    Wnt target and CIMP gene methylation, -catenin localization, proliferation (Ki-67), apoptosis (TUNEL and M30 assay) and tumor differentation.
    Wnt target en CIMP gen methylatie, beta-catenin localisatie, proliferatie (Ki-67), apoptose (TUNEL en M30 assay) en tumor differentiatie
    E.5.2.1Timepoint(s) of evaluation of this end point
    After surgery of colon cancer
    Na operatie van de dikkedarmtumor
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months
    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 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 state88
    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)
    If the patient has ended the participation in the trial, he/she will be treated no different from the expected normal treatment of that condition at that time
    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 Decision2013-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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