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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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:2015-002307-28
    Sponsor's Protocol Code Number:GBMTMZ/DOX2015
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 number2015-002307-28
    A.3Full title of the trial
    An open-label, single-center, single-arm Phase II study to evaluate safety and efficacy of doxorubicin in combination with radiotherapy, temozolomide and valproic acid in patients with glioblastoma multiforme (GBM) and diffuse intrinsic pontine glioma (DIPG).
    Studio interventistico, singolo braccio, in aperto, di Fase II, per valutare la sicurezza e l¿efficacia dell¿associazione radioterapia, temozolomide e acido valproico alla somministrazione prolungata di doxorubicina in pazienti affetti da glioblastoma multiforme (GBM) e da glioma intrinseco diffuso pontino (DIPG).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of doxorubicin in combination with radiotherapy, temozolomide and valproic acid in pediatric and adolescent patients with newly diagnosed high grade glioma (glioblastoma multiforme (GBM) and diffuse intrinsic pontine glioma (DIPG)).
    Studio clinico per valutare la sicurezza e l¿efficacia dell¿associazione radioterapia, temozolomide e acido valproico alla somministrazione prolungata di doxorubicina in pazienti pediatrici e giovani adulti affetti da tumori cerebrali (glioblastoma multiforme (GBM) e glioma intrinseco diffuso pontino (DIPG)) di prima diagnosi.
    A.3.2Name or abbreviated title of the trial where available
    GMBTMZ/DOX2015
    GMBTMZ/DOX2015
    A.4.1Sponsor's protocol code numberGBMTMZ/DOX2015
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA MEYER
    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 supportAZIENDA OSPEDALIERO UNIVERSITARIA MEYER
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA OSPEDALIERO UNIVERSITARIA MEYER
    B.5.2Functional name of contact pointCLINICAL TRIAL OFFICE
    B.5.3 Address:
    B.5.3.1Street AddressVIALE PIERACCINI 24
    B.5.3.2Town/ cityFIRENZE
    B.5.3.3Post code50139
    B.5.3.4CountryItaly
    B.5.4Telephone number0555662425
    B.5.5Fax number0555662746
    B.5.6E-mailclinicaltrialoffice@meyer.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 ADRIBLASTINA - 50 MG/25 ML SOLUZIONE INIETTABILE PER USO ENDOVENOSO 1 FLACONE 25 ML
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA S.R.L.
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNDOXORUBICINA CLORIDRATO
    D.3.9.2Current sponsor codeDOXO
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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
    Glioblastoma multiforme, diffuse intrisic pontine glioma, diffuse glioma of the brain stem and spinal cord, bilateral thalamic glioma, gliomatosis cerebri, anaplastic astrocytoma
    Glioblastoma multiforme, glioma intrinseco diffuso pontino, gliomi diffusi del tronco encefalico, spinali e talamici bilaterali, gliomatosis cerebri e astrocitomi anaplastici
    E.1.1.1Medical condition in easily understood language
    High-grade diffuse gliomas
    Neoplasie cerebrali diffuse
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018338
    E.1.2Term Glioma
    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
    To assess safety and tolerability of continuous infusion of doxorubicin when added to standard therapy in pediatric and adult patients with newly diagnosed glioblastoma multiforme, diffuse intrisic pontine glioma, diffuse glioma of the brain stem and spinal cord, bilateral thalamic glioma, gliomatosis cerebri, anaplastic astrocytoma
    Valutare la sicurezza e la tollerabilit¿ della somministrazione prolungata di doxorubicina in combinazione con il trattamento standard nella terapia di prima linea in pazienti pediatrici e giovani adulti affetti da GBM, DIPG, gliomi diffusi del tronco encefalico, spinali e talamici bilaterali, gliomatosis cerebri e astrocitomi anaplastici.
    E.2.2Secondary objectives of the trial
    To evaluate efficacy of the treatment through assessment of event free survival (EFS) defined as tumor progression, tumor recurrence and death attributable to any cause, and overall survival (OS).
    Valutare l¿efficacia del trattamento mediante determinazione della sopravvivenza libera da eventi (EFS), quali progressione di malattia, comparsa di recidiva e mortalit¿ per qualsiasi causa, e sopravvivenza globale (OS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males and females patients, aged >3 years and < 30 years;
    Histologically confirmed newly diagnosed glioblastoma multiforme, diffuse intrisic pontine glioma, diffuse glioma of the brain stem and spinal cord, bilateral thalamic glioma, gliomatosis cerebri, anaplastic astrocytoma;
    Patients undergone either surgery or biopsy only;
    No prior chemotherapy and/or radiotherapy;
    Life expectancy = 4 weeks;
    Karnofsky/Lansky = 40 %;
    Written informed consent obtained from the patient/parents or legal representative;
    Adequate hematological function (leucocyte = 2.0 x 10^9/l - Hemoglobin = 10 g/dl - platelet = 50 x 10^9 /l);
    Adequate liver function (total bilirubin = 2.5 x ULN - ALT/AST = 5.0 x ULN);
    Adequate renal function (serum creatinine = 1.5 x ULN);
    Availability to trial treatment and ability to be compliant with the protocol
    Pazienti con glioblastoma multiforme, glioma intrinseco diffuso pontino, gliomi diffusi del tronco encefalico, spinali e talamici bilaterali, gliomatosis cerebri e astrocitomi anaplastici di prima diagnosi non precedentemente trattati (con chemio-radioterapia) o trattati solo chirurgicamente;
    Maschi e femmine di età compresa fra i 3 e i 30 anni;
    Aspettativa di vita = 4 settimane;
    Karnofsky/Lansky = 40 %;
    Funzione ematologica adeguata:
    - Conta assoluta dei leucociti = 2.0 x 10^9/l
    - Emoglobina = 10 g/dl
    - Conta delle piastrine = 50 x 10^9 /l
    Funzione epatica adeguata:
    - Bilirubina totale = 2.5 x ULN
    - ALT/AST = 5.0 x ULN
    Funzione renale adeguata:
    - Creatinina sierica = 1.5 x ULN
    Consenso informato scritto da parte del paziente, dei genitori o dei tutori legali;
    Disponibilità del paziente durante il trattamento e capacità di attenersi al protocollo;
    E.4Principal exclusion criteria
    Any disease or condition that contraindicates the use of the study treatment (es. serious mental retardation, brain palsy, congenital syndrome, cardiomyopathy)
    Prior anti-cancer therapy
    Pregnancy or breastfeeding
    Non adequate contraception
    Evidenza di qualsiasi altra malattia o condizione gravi che rappresentino una controindicazione alla terapia in studio (e.g. grave ritardo mentale, grave paralisi cerebrale, gravi sindromi congenite, cardiopatie)
    Esecuzione di un ciclo di chemioterapia di 1° linea contemporaneamente all’inizio dello studio;
    Concomitante partecipazione ad altri progetti di ricerca
    Stato di gravidanza o allattamento
    Utilizzo di metodi contraccettivi inadeguati sia da parte di pazienti di sesso femminile che maschile
    E.5 End points
    E.5.1Primary end point(s)
    Primary safety end points:
    -Time to early discontinuation of the experimental treatment (doxorubicin)
    -Percentage of subjects with SAE leading to withdrawal from the study
    -Percentage of SAE
    -Mortality due to adverse events
    -Rate of early suspension of experimental treatment with doxorubicin
    Endpoint primario di sicurezza è definito come:
    - Tempo alla sospensione precoce del trattamento sperimentale con Doxorubicina
    - Percentuale di soggetti con SAE che determinano il ritiro dallo studio
    - Percentuale di SAE
    - Mortalità per eventi avversi
    - Proporzione di sospensioni precoci del trattamento sperimentale con Doxorubicina
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.5.2Secondary end point(s)
    Secondary efficacy end points:
    -Event free survival (EFS) defined as time frame between the date of enrolment and the earliest occurence of anyone of the following: progression based on RECIST 1.1 criteria; tumor recurrence; death to any cause.
    -Overall survival (OS) defined as time frame between the date of the enrolment and the death to any cause
    -Progression free survival (PFS) defined as time frame between the date of the enrolment and the date tumor progression based on RECIST 1.1 criteria
    -Rate of treatment response (CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease) based on RECIST 1.1 criteria
    End point secondari di efficacia:
    -Sopravvivenza libera da eventi (EFS) calcolata come il tempo tra la data di arruolamento e la data di comparsa di uno dei seguenti eventi: progressione di malattia stabilita secondo i criteri RECIST 1.1; comparsa di recidiva; mortalit¿ per qualsiasi causa.
    -Sopravvivenza globale (OS) definita come il tempo tra la data di arruolamento e la data di decesso per qualsiasi causa.
    -Sopravvivenza libera da progressione di malattia (PFS) definita come il tempo tra la data di arruolamento e la data di progressione secondo i criteri RECIST 1.1
    -Proporzione di risposta al trattamento (CR, risposta completa; PR, risposta parziale; SD, malattia stabile; PD, progressione di malattia) secondo i criteri RECIST 1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 2 months
    Ogni 2 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 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 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.8.2.4Number 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
    Last visit of the follow-up of the last subject
    La fine dello studio ¿ definita come l'ultima visita di follow-up per l'ultimo paziente arruolato.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months56
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months56
    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 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 11
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 7
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2
    F.1.3Elderly (>=65 years) No
    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 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 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)
    During the follow-up period (1 year) each subject will be assessed for efficacy and safety every 3 months.
    Any subject withdrawn from the study partecipation prior to the planned treatment termination, will carry out the follow-up (1 year) and will continue to be followed by doctors of the unit according to clinical practice and they will receive the most appropriate therapy.
    Dopo la fine del trattamento sperimentale ¿ previsto un follow-up di 1 anno con valutazioni cliniche con cadenza trimestrale.
    I soggetti che usciranno dallo studio prima del termine previsto, effettueranno il follow-up e continueranno ad essere seguiti dai medici di reparto secondo pratica clinica e riceveranno la terapia pi¿ appropriata.
    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 Decision2015-11-19
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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