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    Summary
    EudraCT Number:2020-002468-30
    Sponsor's Protocol Code Number:Met-DTC
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002468-30
    A.3Full title of the trial
    Study of Metformin activity in patients with differentiated thyroid cancer metastasis with minimally progressive development
    Studio sull’attività della Metformina nei pazienti affetti da metastasi da carcinoma differenziato della tiroide ad andamento minimamente progressivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Metformin in patients with thyroid cancer metastasis
    Effetto della Metformina nei pazienti affetti da metastasi da carcinoma differenziato della tiroide
    A.3.2Name or abbreviated title of the trial where available
    Metformin in patients with DTC
    Metformina in pazienti affetti da DTC
    A.4.1Sponsor's protocol code numberMet-DTC
    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 SponsorENTE OSPEDALIERO OSPEDALI GALLIERA
    B.1.3.4CountryItaly
    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 organisationE.O. Ospedali Galliera
    B.5.2Functional name of contact pointS.C. Medicina Nucleare
    B.5.3 Address:
    B.5.3.1Street AddressMura delle Cappuccine 14
    B.5.3.2Town/ cityGenova
    B.5.3.3Post code16128
    B.5.3.4CountryItaly
    B.5.4Telephone number0105634541
    B.5.5Fax number0105634541
    B.5.6E-mailarnoldo.piccardo@galliera.it
    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 GLUCOPHAGE
    D.2.1.1.2Name of the Marketing Authorisation holderBRUNO FARMACEUTICI S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameGlucophage unidie 1000 MG
    D.3.2Product code [nd]
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor code68UCS2020
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Yes
    D.3.11.13.1Other medicinal product typeFarmaco ipoglicemizzante orale
    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 differentiated thyroid cancer metastasis with minimally progressive development
    pazienti affetti da metastasi da carcinoma differenziato della tiroide ad andamento minimamente progressivo
    E.1.1.1Medical condition in easily understood language
    patients with metastatic thyroid carcinoma
    pazienti con tumore alla tiroide in fase metastatica
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Valuate the power of metformin in asymptomatic patients with high-risk DTC, i.e.
    individuals with minimally progressive metastatic disease without specific symptoms.
    This will be evaluated on the basis of two main endpoints:
    1) "clinical benefit rate", namely the percentage of patients with complete or partial response or with stable disease
    2)Tg level over the time
    valutare la potenziale attività della metformina in pazienti asintomatici e affetti da DTC ad alto rischio, ovvero soggetti con malattia metastatica minimamente progressiva in assenza di sintomatologia specifica. L'attività e l’efficacia della metformina sarà valutata sulla base di due endpoint:
    1)“clinical benefit rate” definito come la percentuale di pazienti che abbiano raggiunto una risposta completa, una riposta parziale, o uno stato di malattia stabile in corso di terapia
    2)valutare l’andamento dei livelli di Tg nel tempo
    E.2.2Secondary objectives of the trial
    na
    na
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age> 18 years.
    2) high-risk DTC (according to ATA 2015 classification) histologically proven;
    3) total thyroidectomy and previous radiometabolic therapy with 131I (administered activity between 2.96 GBq and 3.7 GBq);
    4) no evidence of distant metastases at disease onset;
    5) evidence of structural relapse over time treated with a second administration of RAI (activity from 5.5 GBq to 7.4 GBq).
    6) absence of cancer-specific metastatic symptoms and absence of impending cancer-specific symptoms;
    7) no iodine-greedy metastases after the second RAI;
    8) Patients with evidence of slow disease progression (e.g. time to doubling of lung metastasis volume> 1 year) not susceptible to further surgery and candidates for active surveillance;
    9) biochemical progression (i.e. increase in Tg levels in the last year).
    10) preserved renal function (creatinine clearance estimated by Cockcroft-Gault formula = 60 mL / min;)
    11) normal liver function (values of AST, ALT, Total Bilirubin, gammaGT and alkaline phosphatase> 1.5 times the upper limit of the normal range)
    12) Signature of informed consent
    1) Età >18 anni.
    2) DTC ad alto rischio (secondo classificazione ATA 2015) comprovato istologicamente;
    3) tiroidectomia totale e pregressa terapia radiometabolica con 131I (attività somministrata compresa tra 2.96 GBq e 3.7 GBq);
    4) nessuna evidenza di metastasi distanti all'esordio di malattia;
    5) evidenza di recidiva strutturale nel tempo trattata con una seconda somministrazione di RAI (attività da 5,5 GBq a 7,4 GBq).
    6) assenza di sintomi metastatici specifici del cancro e assenza di imminente sintomatologia specifica del cancro;
    7) nessuna metastasi avida di iodio dopo la seconda RAI;
    8) pazienti con evidenza di una lenta progressione di malattia (e.g. tempo di raddoppio del volume delle metastasi polmonari > 1 anno) non suscettibile di ulteriore intervento chirurgico e candidati a sorveglianza attiva;
    9) progressione biochimica (ovvero aumento dei livelli di Tg nell'ultimo anno).
    10) funzione renale conservata (clearance della creatinina stimata con formula di Cockcroft-Gault = 60 mL/min;
    11) Firma del consenso informato
    E.4Principal exclusion criteria
    da mettere in inglese
    1) DTC con localizzazioni ripetitive locoregionali o a distanza responsive alla RAI.
    2) DTC con localizzazioni metastatiche iodio refrattarie a rapida progressione e/o sintomatiche candidati alla
    terapia con TKI [23];
    3) pazienti con diabete mellito;
    4) precoma diabetico;
    5) nota intolleranza o ipersensibilità alla Metformina o a uno qualsiasi degli eccipienti elencati al paragrafo 6.1
    dell’RCP del farmaco;
    6) malattie non controllate della terapia (i.e. infezioni in fase attiva, scompenso cardiaco, angina instabile,
    aritmie cardiache, insufficienza respiratoria, shock);
    7) pazienti con malattia renale cronica avanzata (GFR < 30 ml/min) o condizioni acute in grado di
    compromettere la funzionalità renale, quali la disidratazione, le infezioni gravi, lo shock.;
    8) anamnesi positiva per acidosi lattica;
    9) disfunzione epatica da epatite cronica in fase attiva e/o cirrosi non compensata;
    10) anamnesi di deficit di vitamina B12 o anemia megaloblastica;
    11) pazienti sottoposti a terapia con metformina negli ultimi 6 mesi;
    12) pazienti con livelli di alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST) pari o superiore a 3
    volte il limite superiore della norma;
    13) pazienti con qualsiasi tipo di acidosi metabolica acuta (come acidosi lattica, chetoacidosi diabetica);
    14) pazienti con comorbidità dovuta ad altri tumori;
    15) insufficienza epatica, intossicazione acuta da alcol, alcolismo accertato.
    16) pazienti con livelli di TSH non soppressi;
    17) pazienti con anticorpi tiroidei rilevabili;
    18) gravidanza o allattamento [24]
    E.5 End points
    E.5.1Primary end point(s)
    1) Progression-free survival (PFS);
    2) Tg levels have been trending over time.
    1) sopravvivenza libera da progressione (PFS);
    2) andamento dei livelli di Tg nel tempo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at least 18 months
    almeno 18 mesi
    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 No
    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 No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    studio pilota di efficacia del farmaco nello stesso gruppo di pazienti.
    pilot study of drug efficacy in the same patient group.
    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.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    LVLS
    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 days54
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days54
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 2021-06-08. 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    patients will continue to be followed by the medical staff where they are being treated as their first participation in the study
    i pazienti continueranno a essere seguiti dallo staff medico presso cui sono in cura come prima della partecipazione allo studio
    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 Decision2021-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-08
    P. End of Trial
    P.End of Trial StatusOngoing
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